Impacts of REACH Authorisation - Europa

November 2017

Impacts of REACH Authorisation

Final Report

EUROPEAN COMMISSION

Directorate-General for Internal Market Industry Entrepreneurship and SMEs

Directorate D mdash Consumer Environmental and Health Technologies Unit D1 mdash REACH

Contact Valentina Bertato

E-mail ValentinaBERTATOeceuropaeu

European Commission B-1049 Brussels

Impacts of REACH

Authorisation

Final Report


Study on the Impacts of REACH Authorisation

2017 EUR 20177084 EN

LEGAL NOTICE

This document has been prepared for the European Commission however it reflects the views only of the authors and the Commission cannot be held responsible for any use which may be made of the information contained therein

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Impacts of REACH Authorisation Final Report

eftec November 2017

i

This document has been prepared for Unit GROWD1 REACH by

Economics for the Environment Consultancy Ltd (eftec)

4 City Road

London

EC1Y 2AA

wwwefteccouk

In association with Apeiron-Team NV Peter Fisk Associates Limited (PFA) and The Economics

Interface Limited

Study team

Rohit Mistry (eftec)

Hiram Moerman (Apeiron-Team NV)

Andreas Novak (Apeiron-Team NV)

Richard Dubourg (The Economics Interface Limited)

Oliver Warwick (PFA)

Sarah Krisht (eftec)

Sebastiana Hard (eftec)

Rachel London (PFA)

Elke Van Asbroeck (Apeiron-Team NV)

Reviewers

Ece Ozdemiroglu (eftec)

Acknowledgements

The study team would like to thank the project steering group made up of members from the

European Commission (EC) and the European Chemicals Agency (ECHA) for the inputs received

Disclaimer

Whilst eftec has endeavoured to provide accurate and reliable information eftec is reliant on the

accuracy of underlying data provided and those readily available in the public domain eftec will

not be responsible for any loss or damage caused by relying on the content contained in this report

Document evolution

Interim report 20042017 Reviewed by Ece Ozdemiroglu

Final interim report 14072017 Reviewed by Rohit Mistry

Draft final report 04092017 Reviewed by Ece Ozdemiroglu

Final report 31102017 Reviewed by Ece Ozdemiroglu

Final report ndash Reissued 28112017 Reviewed by Rohit Mistry

eftec offsets its carbon emissions through a biodiversity-friendly voluntary offset purchased from the World Land Trust (httpwwwcarbonbalancedorg) and only prints on 100 recycled paper


eftec November 2017

ii

EXECUTIVE SUMMARY

This document reports on a study on the impacts of REACH Authorisation The process of

Authorisation within REACH (Regulation (EC) No 19072006 of the European Parliament and of the

Council on the Registration Evaluation Authorisation and Restriction of Chemicals) has aims to

ensure the good functioning of the internal market while assuring that the risks from Substances of

Very High Concern (SVHCs) are properly controlled and that these substances are progressively

replaced by suitable alternative substances or technologies where these are economically and

technically viable (REACH Article 55) This present study considered a number of key elements in

order to understand the specific contribution of the authorisation process to achieving this aim

It has been ten years since REACH came into force on the 1st June 2007 and it is one of the most

comprehensive regulations on chemicals ever to be introduced anywhere in the world The

European Commission (EC) is required to review REACH every five years to monitor its operation

The first REACH review was carried out in 20121 and a second review is due in 2017 into which this

study feeds

Since the 2012 review several studies examining specific aspects of REACH Authorisation have been

carried out by the EC the European Chemicals Agency (ECHA) Member State Competent

Authorities (MSCAs) NGOs and industry associations The previous studies typically relied on

anecdotal evidence and lacked quantified (and monetised) information on the costs and benefits of

REACH Authorisation

The present study sought to build on available information as well as compare its findings with the

previous studies It is the first comprehensive study to attempt to obtain reliable quantitative

evidence on the overall impacts of Authorisation and particularly to focus on aspects for which

there has been limited information to date This includes the role of Authorisation in influencing

the decisions to substitute away from SVHCs The study involved a review of the existing literature

surveys with industry NGOs the EC ECHA and MSCAs in-depth follow-up interviews with industry

(see Table ES1) and both in-depth (Tier 1) and shorter (Tier 2) case studies on specific chemicals

or issues Some of the key findings from the study are consistent with previous studies which adds

credibility to both this study and existing literature it contributes to

Members of the project team presented at various REACH-related events spoke to industry sector

groups and NGOs (in person or over the phone) to raise awareness of the project and encourage

stakeholders to take part in the survey This was supported by efforts made by ECHA and the EC

Rather than contacting as many stakeholders as possible consultation was targeted at stakeholders

who may have been impacted by REACH Authorisation and who might be able to provide the

required data In particular any companies that had substituted from an SVHC (or were in the

process of doing so) were prioritised as this was a particular data gap needed to be addressed in

this study Therefore the sampling strategy was intentionally unrepresentative of industry as a

whole and this should be borne in mind when interpreting the results

1 httpeceuropaeuenvironmentchemicalsreachreview_2012_enhtm


eftec November 2017

iii

Table ES11 Approaches to collecting new information

Data collection method Statistics

No Contacted No Respondents

NGO survey 29 4 (+2 partial responses)

Industry survey 240 63 (+21 partial responses)

ECHA teleconferences and emails 3 webinars and 20-30 emails

(different types of data or contacts provided)

MS CA Questionnaire 20 16

EC Questionnaire 1 1

Industry interviews 64 49

Based on the information gathered the key findings are summarised below for the five key areas of

investigation

EU market changes for SVHCs (and their alternatives) ndash examined whether there were

any major changes in the market for SVHCs compared to overall market trends observed

in the EU chemicals market

According to CEFIC statistics the value of sales of the EU chemicals sector generally increased over

the period 1995-2012 with a significant dip in 2008 coinciding with the global financial crash Since

then the value of sales has declined slightly As a share of the global chemicals market however

EU sales declined over this period slowly until 2004 and more quickly since then Since 2008

exports have increased as a share of total sales in the EU chemicals sector but remain a minor (28)

proportion of the total

The best publicly available data on changes in substance volumes and sales values in the EU over

time was from Eurostat (PRODCOM) which showed that EU sales of SVHCs have generally followed

the same market trend as the overall EU chemicals market However limitations in the data means

it is not possible to assess as one might expect whether REACH Authorisation has led to a

reduction in EU sales of SVHCs and an increase in sales of alternative substances in line with the

goal of REACH to progressively replace SVHCs with suitable alternative substances or technologies

PRODCOM data were only available to 2015 and for some SVHCs most of the volume was used as

intermediate uses2 (which are exempt from Authorisation) For instance of Annex XIV substances

only 12-dichloroethane is in a PRODCOM category of its own but 99 of the use of this substance is

as an intermediate

There are a number of other factors why there has not been an apparent reduction in the market

for SVHCs Firstly substitution away from an SVHC can take time and it might still be too early to

observe changes in the EU market due to REACH Authorisation Secondly for some companiesuses

alternatives being tested may continue to prove to be unsuitable despite continued efforts to find

an alternative Finally for those uses where Authorisation has been granted (for a given review

period) there could be increased demandsales from the continued use of the SVHC after the

sunset date Overall this means that PRODCOM data are not suitable to observe any market

changes due to REACH Authorisation for only those uses of SVHCs that are subject to Authorisation

What is possible to note is that using REACH registration data as of November 2016 ECHA had

2 REACH Article 3(15) Intermediate means a substance that is manufactured for and consumed in or used for

chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis)


eftec November 2017

iv

identified 103 registrants who have ceased manufacturing or importing a SVHC 69 of which

occurred to substances on the Candidate List (the remainder to Annex XIV substances)

One of the aims of the online survey for this study was to collect information on whether REACH

Authorisation is having a market impact (eg changes in sales prices demand and

competitiveness) Whilst the results can only provide a partial view of the EU market the

responses provide some interesting insights on the types and scale of impacts for individual

companies (rather than for the whole EU economy)

Most respondents (57) to the online industry survey indicated that they experienced lsquosignificantrsquo

market related impacts due to Authorisation for downstream user markets that use SVHCs but that

REACH Authorisation has not had a lsquosignificantrsquo impact yet on the market for known alternative

substances for SVHCs or alternative products made without an SVHC The main impacts were (i) a

reduction in the number of suppliers of SVHCs (ii) reduced availability of the SVHC for their use

(iii) an increase in the price of the SVHC and (iv) conditions being imposed on safe handling and

use of an SVHC Whilst respondents were only asked to indicate impacts due to REACH

Authorisation some of these impacts could also be due to requirements under REACH Registration

rather than solely due to Authorisation

The online survey found limited cases of where companies have ceased production andor relocated

outside the EU This is in contrast to the existing literature which reports such risks However

given that all Authorisation applications to date have been granted (or recommended to be

granted) closures andor relocations due to REACH Authorisation are likely to be rare Just under

half of survey respondents did find that selling products made with SVHCs to EU companies was

ldquomore difficultrdquo but overall most respondents said REACH Authorisation had not had a significant

net impact on sales revenue (to date) The online survey also found evidence that REACH

Authorisation has led to an increase in RampD spending on finding an alternative to an SVHC but this

increase often diverts funds from other investment opportunities (eg in production capacity and

developing new markets) More detail on such market trends can be found in Section 4 of the main

report

Finally lsquominirsquo case studies were undertaken of diarsenic trioxide and arsenic acid and HBCDD The

market picture for the first two substances is complicated by the fact that significant proportions

of total use have been identified as intermediate by industry but not by ECHA Some disruption to

supply was reported in the arsenic acid market but the view expressed about diarsenic trioxide

was that the market was already on a downward trend due to earlier restrictions The HBCDD case

described a large-scale switch to an alternative with an authorisation to provide temporary

support to one use while supply capacity of the alternative increased It highlights the importance

of applying for a lsquobridgingrsquo Authorisation (eg 2 years) until it is possible for all users of HBCDD to

fully substitute to the identified alternative

Instances of substitution ndash investigated in terms of actual examples of substitution

covering what was substituted for what use the alternative used how long it took

and the costs and benefits of this substitution

As noted earlier a deliberate attempt was made to target stakeholders who may have been

impacted by REACH Authorisation and those that may have substituted a SVHC Whilst the AfA

process provides a good indication of companies and uses that require continued use of a SVHC

prior to this study little was known about the instances of substitution In this respect the online

survey for this study has been very successful with 43 of respondents indicating they have

substituted a use of a SVHC (and therefore avoided the need to apply for Authorisation) These

respondents (n=3783) provided 61 examples of substitution of SVHCs


eftec November 2017

v

There were also 44 respondents providing 71 examples of no substitution yet but actively seeking

to substitute and investin substitution related activities In some instances companies have been

successful at substituting the use of one SVHC but are still trying to phase out use of another

SVHC Whilst the specific targeting of respondents may have lead to a higher percentage of

respondents who have substituted (43) the survey provides evidence that substitution of SVHCs is

occurring Based on survey responses REACH Authorisation seems to be a major (but not the only)

driver for substitution

The survey data suggest that in 53 of the cases substitution took between one and four years In

27 of cases it took 5 to 10 years 12 took longer (11 to 20 years) 2 took over 20 years and 6

are finalising their substitution activities but do not know exactly when this will be fully

completed

The present study found that the Authorisation process leads to substitution where it is technically

feasible even if the cost of applying for Authorisation could have been cheaper This report sets

out several drivers for these substitutions with numerous case study examples Authorisation might

not necessarily be the only motive as some of the substances that have been through the entire

Authorisation process have previously been regulated by other parts of REACH and related

legislation (such as harmonised classification amp labelling and Evaluation) as well as being subject

to other regulation prior to REACH and therefore in some instances substitution related activities

have been ongoing for many decades

Where substitution was technically feasible drivers most commonly cited by companies include

their desire to avoid the lsquostigmarsquo of using SVHCs costs of regulation and uncertainty associated

with having to apply for Authorisation (and whether it is granted) Companiesrsquo internal policy to

avoid using a SVHC is also given as a reason Taking the initiative to substitute allowed these

companies to agree long-term contracts with customers and not delay investment plans (eg new

production capacity or new types of products) Interviews done for this study suggested that these

plans and contracts could otherwise have been postponed pending the outcome of the application

or companies could have even moved their part of production using SVHCs to outside the EU More

detail on substitution can be found in Section 5 of the main report

Costs of Authorisation ndash were assessed reflecting the different activities carried out by

different stakeholders along the Authorisation process administration application risk

management measures introduced because of authorisation and participating in public

consultations as well as costs of substitution and related activities

Administrative costs of running the entire Authorisation process incurred by ECHA MS CAs and the

EC appear to be around euro84million per year in total (euro43m for MS CAs euro3m for ECHA and euro11m

for the EC ndash based on 2013-2016 data) Application costs (excluding fees) might be estimated at a

similar ballpark figure of euro9m per year (50 uses per year at euro180k per use (see Table 631 in Section

6)) which is subject to significant variation given the variation in the annual number of

applications

The total costs of risk management measures introduced because of authorisation are difficult to

estimate but might add another euro7million per year assuming that all applicants implement them

(50 applicants at euro140k per applicant see Section 612) This figure is extremely uncertain

however given the small sample number of respondents

The total costs of compliance by companies affected by REACH Authorisation RampD activity

substitution and relocation are impossible to calculate because the total number of firms that


eftec November 2017

vi

might have engaged in these activities is unknown This also explains why extrapolation of the

costing results to the EU-level is not feasible

Section 67 of the main report suggests the costs of compliance are likely to run into thousands

(possibly tens of thousands) of euros per company which could make them significant at an

aggregate level

Substitution costs are uncertain due to the design of the survey used in the study with a large

proportion of respondents (78) reporting one-off substitution costs in the euro0-euro1m range However

for reasons discussed in Section 681 despite it being cheaper for these companies (at least in the

short term) to apply for authorisation these firms have chosen to substitute away from an SVHC

instead In addition it would take only a relatively small minority of firms to experience very high

costs of substitution to raise the average cost (eg euro15m one-off costs and euro768k operating costs

per year based on proportions reported in the survey) Only one respondent reported a substitution

which had no net costs and none reported cost savings

Authorisation requires that there are no suitable alternatives available to the applicant ndash defined

operationally by ECHA as (amongst other things) not entailing an increase in overall costs All but

one of the examples identified would entail an increase in overall costs and hence the applicant

may have been able to demonstrate they were not suitable ndash meaning that the firms in question

would in principle be eligible for authorisation Despite this they have elected to substitute

suggesting they have placed a premium on regulatory certainty and other factors associated with

avoiding the Authorisation process altogether

It is not possible to provide a reliable estimate of the total costs to third parties associated with

providing comments during the three public consultation stages in the Authorisation process ie

relating to (i) inclusion of a substance on the candidate list (ii) the recommendation of substances

to Annex XIV and (iii) an application for Authorisation The average time spent per submission

varies from up to 1 day to 40 days depending on the type of public consultation and stakeholder

For example tradesector associations can spend a lot of time preparing responses compared to

individual companies and NGOs Due to the small number of responses received to the survey on

this topic and variability in the estimates provided it is too speculative to derive a total cost

Costs of authorisation

Costs to EU public authorities ~euro84million per year

Costs to EU applicants ~euro9million per year

Costs of additional RMMs associated

with these applications

~euro7million per year

Costs of substitution Not possible to estimate the total costs without knowing how

many firms in the EU have substituted One off costs

estimated at lteuro1million per company (mean ~euro15million per

company) and euro768k annual operating costs per company

Costs of compliance Not possible to estimate the total costs without knowing how

many firms are affected The costs of compliance are likely

to run into thousands (possibly tens of thousands) of euros

per company which could make them significant at an

aggregate level

Costs to third parties Not possible to estimate a total cost due to limited

responses The average time spent per submission varies

from up to 1 day to 40 days depending on the type of public

consultation and stakeholder

More detail on the costs of authorisation can be found in Section 6 of the main report


eftec November 2017

vii

Benefits of authorisation ndash include reductions in worker exposure to and emissions of

SVHCs improved markets for safer alternatives to SVHCs and improved content and

sharing of relevant information

Several approaches were used to obtain data to assess the benefits associated with the

Authorisation process The most tangible benefits due to REACH authorisation are the reduction of

worker exposure to SVHCs and reduced emissions of SVHCs into the environment (eg air

wastewater and waste) This is either due to (i) improvements in RMMs where SVHCs are still

being used (ii) substitution away from an SVHC (eg to using an alternative substance or

technology) or (iii) avoided exposure and emissions within the EU due to closing andor relocating

EU production sites that previously used SVHCs within the EU

There is evidence from the online survey interviews and evidence presented within AfAs to date

that REACH authorisation is resulting in an improvement in RMMs at all stages in the authorisation

process For example the survey results show that most improvements in RMMs occurred at early

stages in the REACH process The reasons for this could be to build a case so that the SVHC was not

prioritised for inclusion on Annex XIV as well as strengthening companies cases for a possible future

application Many applicants that have submitted an AfA have also indicated that they have

improved RMMs andor have planned investment in place in order to demonstrate minimisation of

emissions Examples of some of the types of RMMs identified by respondents are noted in Table 72

(within Section 73)

Where RAC were not certain that minimisation of emissions was demonstrated in many

appplications conditions were imposed on the applicant as part of granting the application such

as improved monitoring It can (in some cases) also lead to a shorter review period than might

have been possible (eg a normal review period rather than a long review period) had there been

fewer uncertainties concerning minimisation of emissions Survey responses have suggested that at

least in some cases applicants have improved their RMMs further (or are putting further measures

in place) which have led to (or they hope will lead to) further improvements in reducing exposure

to workers and releases of emissions of SVHCs to the environment However most indicated that it

was too soon to be able to provide quantitative data on this benefit

The survey results indicate that the levels of exposure reductions and emissions reductions of

SVHCs achieved by both applicants and those that substituted (ie did not need to apply for

authorisation) seemed to be relatively small (see Section 73) This is not necessarily surprising

since companies should have been reducing their exposure over many yearsdecades While

qualitatively it can be shown that REACH authorisation is having a positive effect due to lack of

detailed data it is currently not possible to quantify these benefits

Despite being 10 years into the REACH process this study suggests it is still too early to be able to

quantify the benefits of REACH authorisation To quantify the benefits historical data on the

number of workers exposed and changes in exposure level over time would be required Some of

this data does exist at Member State (MS) level as some Member States have confidential databases

(for their MS) containing historical values for worker exposure which the study team were unable to

obtain In the future should applicants reapply for authorisation (ie review report) the monitoring

data which is set as a requirement in some of the authorisation decisions could provide some

additional data to assist in assessing the scale of reductions being achieved over time

The authorisation process creates opportunities for alternative substances and technologies In

some cases the alternative is provided by the same company as the Annex XIV substance in other

cases different companies or technologies emerge Granting an authorisation however takes


eftec November 2017

viii

account of the time needed to develop alternative substances and technology in order to allow the

applicant(s) both the users of the Annex XIV substance and the suppliers of the alternatives to

adjust to changes in market demand (and other factors like product requalification)

Whilst there will have been an overall increase in sales of alternatives (substances andor final

products not made with an SVHC) for those companies that have already adopted an alternative

prior to REACH these survey respondents did not attribute any increased sales they achieved to

REACH Authorisation Most respondents who substituted to an alternative due to REACH

authorisation indicated (at least in the short term) either a net loss in sales revenue or no net

change (relative to sales revenue when previously using an SVHC) Further details on these are set

out within Section 7 (eg case study examples)

Specific benefits of closure andor relocation were also investigated Data from existing AfAs with

relocation as a non-use scenario show that the benefits to Europe in terms of reduced exposure or

emissions as a result of relocation would be far less compared to the costs of the relocation

A few other less tangible (but important) benefits were also identified The two main ones are

improved communication within the supply chain and encouraging further development of existing

technologies and in some cases innovation For the authorities the authorisation process provides a

way to collect data on uses of SVHC in a structured way While as such this may not lead to a

reduction in exposure or emissions this information can be used for further policy development and

enforcement

Benefits of authorisation

Human Health benefits Clear evidence of improved RMM and reduced exposure

Benefits of substitution Mainly reduction in exposure and emissions

Benefits from closure and relocation Few case of relocation or closure identified

Benefits to alternative suppliers Authorisation process helps to create a market for

alternatives in a controlled way

Benefits of better information Improved transparency and communication with

authorities

Other benefits Communication between applicants leading to exchange

in experience Driver for innovation

Collection of structured information on the use of SVHC

More detail on the benefits can be found in Section 7 of the main report

Affordability for Small and Medium Sized Enterprises (SMEs) ndash was assessed in terms

of the impact the REACH Authorisation process through a bespoke online survey

The EU chemicals industry and manufacturing sector (ie key downstream users) are made up of

many SMEs but only 35 (18) of 195 applications between 2013 and 2016 were from SMEs The

survey and interviews indicate that the main factors for this are the resource and knowledge

challenges presented by the application process

Financial constraints are an important factor (both for SMEs ability to invest up-front in substitution

activities and costs associated with applying for Authorisation) The application fee charged by

ECHA is low compared to the financial costs of preparing an application finding and implementing

a suitable alternative and the impacts on forgone activities (eg RampD and innovation) as a result of

diverting time and budget to apply for authorisation Due to these factors SMEs have typically

relied on their upstream suppliers to apply for Authorisation (and hence they are covered by their

suppliers)


eftec November 2017

ix

The indirect impact of this is that SMEs become more reliant on these suppliers (eg limits who

they can buy the SVHC from) and many of them expect to pay for or have already had to pay for

this lsquoupstreamrsquo Authorisation through higher prices which they indicated they cannot pass through

onto their customers

The main issue with upstream Authorisation applications for downstream users (SMEs and large

firms) however has been that they tended to result in shorter review periods than those that

downstream user applications submit and that it took time for information on the application to

filter down the supply chain with upstream authorisation applications This can create further

business uncertainty as they cannot assure their customers of the long-term supply of their

products More detail on the affordability by SMEs can be found in Section 8 of the main report

Sections 10-12 reinforces these findings through three detailed case studies that cover much of

these impacts for a specific substance Some of the key observations from this study are

There is evidence of substitution of SVHCs within the EU due to REACH Authorisation

There is evidence of substitution despite applying for authorisation being a cheaper option

This seems to be linked to the perceived business continuation risksuncertainties

associated with having to rely on applying for authorisation to continue operating

The authorisation process is resulting in improvements in RMMs at every stage of the

process

It is still too early to be able to quantify the benefits of Authorisation due to a lack of

publicly available historical exposure data This should improve over time but further work

(requiring substantial effort and resources) is required to collect relevant information

required


eftec November 2017

x

CONTENTS

1 INTRODUCTION 1

11 Context and rationale of this study 1

12 Project objectives 2

13 Structure of this report 3

2 METHOD OVERVIEW 5

3 AUTHORISATION PROCESS 2007-2016 10

31 Screening of substances and Risk Management Option Assessment (RMOA) 10

32 Inclusion of substances in the Candidate List 12

33 Prioritisation and inclusion of substances in the Authorisation List 13

34 Applications for Authorisation (AfA) 14

35 Review of Authorisation following their review period 18

4 CHANGES IN THE EU MARKET FOR SVHCS (AND THEIR ALTERNATIVES) 19

41 Introduction 19

42 EU chemicals sector general trends and drivers of change 20

43 Summary of literature review 22

44 Survey responses 23

45 Tier 2 case study Diarsenic trioxide and arsenic acid 32

46 Tier 2 case study HBCDD 42

47 Findings using other statistical sources 48

48 Summary of observed market changes 62

5 INSTANCES OF SUBSTITUTION 64

51 Introduction 64



54 Tier 2 Case studies 76

55 Applicants ndash Future possibilities to substitute 85

56 Summary of instances of substitution 87

6 COSTS OF THE AUTHORISATION PROCESS 88

61 Introduction 88


63 Costs to Member State Competent Authorities (MSCAs) 90

64 Costs to the European Chemicals Agency (ECHA) 95

65 Costs to the European Commission (EC) 100

66 Costs to third parties for responding to public consultations 100

67 Compliance costs 114

68 Costs of substitution 117

69 Costs of RampD innovation and investment 120

610 Costs of closure and relocation 122

611 Costs to apply for authorisation 126

612 Costs to improve risk management 130


eftec November 2017

xi

613 Summary of costs 132

7 BENEFITS FROM THE AUTHORISATION PROCESS 134

71 Introduction 134



74 Human health benefits from improvement of risk management 142

75 Environmental benefits from improvement of risk management 146

76 Benefits of substitution 148

77 Benefits from closure and relocation 149

78 Benefits to alternative suppliers 151

79 Benefits of better information 152

710 Other benefits 153

711 Summary of benefits 153

8 AFFORDABILITY OF AUTHORISATION FOR SMES 156

81 Introduction 156


83 Applications to date from SMEs 158



86 Affordability analysis 166

87 SME summary 168

9 EVIDENCE OF THE lsquoANNOUNCEMENT EFFECTrsquo 169

91 Introduction 169


93 Analysis testing the announcement effect 171

94 Case studies 173

95 Summary of the announcement effect 175

10 TIER 1 CASE STUDY SUBSTANCE 1 CHROMIUM TRIOXIDE 177

101 Introduction 177

102 Substance profile 178

103 Case study rationale 179

104 REACH Authorisation timeline 179

105 Market prior to REACH authorisation 180

106 Changes in the market for the substance during the authorisation process 184

107 Substitution 186

108 Changes in the market for alternatives 191

109 Evidence of improved risk management 192

1010 Competition and competitiveness 198

1011 RampD innovation and investment 200

1012 Experience of SMEs 201

1013 Summary of Tier 1 case study 202

11 TIER 1 CASE STUDY SUBSTANCE 2 TRICHLOROETHYLENE 204



eftec November 2017

xii













12 TIER 1 CASE STUDY SUBSTANCE 3 DIBUTYL PHTHALATE (DBP) 222














13 SUMMARY AND CONCLUSIONS 234

REFERENCES 241

ANNEX A STEERING GROUP COMMITTEE 246

ANNEX B METHODOLOGY 247

B1 Project scope 247

B2 Assessment approach 248

ANNEX C AUTHORISATION PROCESS 2007-2016 260

C1 Overview 260

C2 Timeline of key events in the authorisation process (2006-2017) 264

C3 Screening of substances and Risk Management Option Assessment (RMOA) 266

C4 Inclusion of substances in the Candidate List 268

C5 Prioritisation and inclusion of substances in the Authorisation List 269

C6 Applications for Authorisation (AfA) 269

C7 Post authorisation decision 269

C8 Review of Authorisation following their review period 270

ANNEX D ACTIVITIES CARRIED OUT ALONG THE AUTHORISATION PROCESS 271

D1 STAGE 1 Screening of substances and RMOArsquos 272


eftec November 2017

xiii

D2 STAGE 2 Inclusion of substances in the Candidate List 283

D3 STAGE 3 Inclusion of substances in the Authorisation List 290

D4 STAGE 4 Applications for authorisation 296

D5 STAGE 5 Post authorisation decision 305

D6 STAGE 6 Review authorisations following review period 311

ANNEX E LITERATURE REVIEW 314

E1 Introduction 314

E2 EU chemicals market 314

E3 Market changes for SVHCs 323

E4 Instances of substitution 325

E5 Costs of authorisation 330

E6 Benefits of authorisation 335

E7 Impacts on SMEs 345

E8 Announcement effect 348

ANNEX F AUTHORISATION SURVEYS 354

F1 Purpose of the surveys 354

F2 Survey structure and design 354

F3 Respondent profile 357

F4 Data validation 358

F5 Industry survey ndash Statistical summary 359

ANNEX G STAKEHOLDERS CONTACTED 389

G1 Member State Competent Authorities 389

G2 NGOs 390

G3 Industry 391

ANNEX H TIER 1 SUPPORTING ANNEX (FOR SECTION 10) 403

CONFIDENTIAL ANNEX ERROR BOOKMARK NOT DEFINED

LIST OF TABLES

Table ES11 Approaches to collecting new information iii Table 21 Approaches to collecting new information 8 Table 31 Progress on hazard assessment and RMOA development (as of Dec 2016) 11 Table 32 Candidate list of substances (SVHC) by reason for inclusion (as of Jan 2017) 13 Table 33 Authorisation list substances (Annex XIV) by SVHC type (as of 13th June 2017) 14 Table 34 Number of Applications for Authorisation (AfA) (as of Dec 2016) 15 Table 35 Status of decisions of AfArsquos submitted (Dec 2016) 16 Table 36 Review periods applied for (Dec 2016) 16 Table 37 Were applicants given the review period they advocated for (Dec 2016) 17 Table 38 Number of uses applied for defined by Article 57 criteria (Dec 2016) 18 Table 41 Changes in the supply of (possible) SVHCs and alternatives (industry survey) 23 Table 42 Changes in competitiveness - (possible) SVHCs (industry survey) 26 Table 43 Changes in employment (industry survey) 28 Table 44 Changes in employment ndash Type of impact (industry survey) 28 Table 45 Changes in sales revenue (industry survey) 29 Table 46 Changes in sales revenue ndash Type of impact (industry survey) 30


eftec November 2017

xiv

Table 47 Changes in quality price availability (industry survey) 30 Table 48 Substance profiles 32 Table 49 REACH authorisation timelines 33 Table 410 Diarsenic trioxide in the EU 2008-2010 34 Table 411 Granted authorisation for uses of diarsenic trioxide 37 Table 412 Applications for authorisation for the use of arsenic acid 38 Table 413 Import and export notifications for diarsenic trioxide 2004-2017 40 Table 414 HBCDD substance profile 42 Table 415 HBCDD REACH authorisation timeline 43 Table 416 Summary of volumes of HBCDD (excludes imports in articles) ndash 2006 data 44 Table 417 Summary table of the different uses of HBCDD EU (20067) 45 Table 418 Demand for HBCDD in the EU (2007) 46 Table 419 Global demand for HBCDD (2011) 46 Table 420 Number of registrants ceasing manufacturing of SVHCs 49 Table 421 Change of registration status for substances on the Authorisation List 49 Table 422Examples of substances with removals of certain uses from registrations during Annex

XIV prioritisation rounds 51 Table 423 Classification of Candidate and Authorisation List substances based on quality of

PRODCOM match 53 Table 424 Authorisation List substances (with complete datasets) in Category 2 53 Table 425 Substances matched to ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM

code 20135125) 57 Table 426 Classification of alternative substances based on the quality of the PRODCOM match 60 Table 427 Assigned PRODCOM categories 60 Table 51 Whether respondents substituted a (possible) SVHC (industry survey) 66 Table 52 Instances of substitution ndash (Possible) SVHCs uses and alternatives (industry survey) 67 Table 53 Substitution activities - (Possible) SVHCs and uses (industry survey) 71 Table 54 Average air concentrations of arsenic at the Murano environmental monitoring station

2014-16 85 Table 55 RampD plans included in AfAs 85 Table 61 Average staff cost per day (euro) for time spent carrying out authorisation activities 90 Table 62 Time for and cost (euro) of carrying out a RMOA per substance 91 Table 63 Time for and costs (euro) of the Annex XV dossier process for SVHC identification 92 Table 64 Time for and costs (euro) of Member State Committee activities on authorisation (per

Member State) 93 Table 65 Time for and costs (euro) of REACH Committee activities on authorisation 93 Table 66 Time for and costs (euro) of ECHA Scientific Committee (RAC and SEAC) non-plenary

activities on authorisation applications per MS CA per AfA case 94 Table 67 ECHA time and cost (euro) spent on and number of substance RMOAs 2014-2016 96 Table 68 ECHA estimates of mean (min max) days and cost (euro) spent on Annex XV dossier

preparation 97 Table 69 Time and cost spent on candidate listing (days euro000 per substance) 97 Table 610 SVHC dossiers by hazard property per year 98 Table 611 Recent Annex XIV recommendations 98 Table 612 Time and cost spent on Annex XIV prioritisation days per year 98 Table 613 ECHA estimates of time and cost (euro000) spent on opinion-making per- use 2014-201699 Table 614 Total authorisation application fees received by ECHA 2013-2016 99 Table 615 Estimates of DG ENV and DG GROW time spent on authorisation activities 2016 100 Table 616 Number of submissions received during the public consultation 101 Table 617 Number of submissions received (per substance level) ndash 2008-2016 102 Table 618 10 substances that received the most public consultation submissions 102 Table 619 Estimated time taken to produce submission (candidate list consultation) 104


eftec November 2017

xv

Table 620 Number of submissions received during the public consultation (Annex XIV) 105 Table 621 Number of submissions received (per substance level) ndash 2008-2016 105 Table 622 10 substances that received the most public consultation submissions 106 Table 623 Estimated time taken to produce response (Annex XIV consultation) 107 Table 624 Estimated time taken to produce response (AfA consultation) 110 Table 625 Types of compliance related costs incurred 115 Table 626 Costs for companies to familiarise themselves with the requirements under REACH

Authorisation 115 Table 627 Change in RampD innovation or investment spending (by use) 120 Table 628 Change in innovation investment and RampD spending 121 Table 629 Scale of change in innovation investment and RampD spending 121 Table 630 Industry consultees reporting relocation or closure in response to authorisation 124 Table 631 Estimated closure and relocation costs from selected applications for authorisation 125 Table 632 Reported mean application costs per use and applicant 2013-2016 (source ECHA) 127 Table 633 Reported mean notional total application costs per use and applicant by supply chain

position 2013-2016 (source ECHA) 128 Table 634 Reported mean notional total application costs per use and applicant by company size

2013-2016 (source ECHA) 128 Table 635 Reported mean notional total application costs per use by application route 2013-2016

(source ECHA) 129 Table 636 Reported notional total costs for applicants in the opinion-making phase (source ECHA)

130 Table 71 Instances of improved risk management activities 140 Table 72 Instances of risk management activities ndash Description of activities carried out (industry

survey) 140 Table 73 Improvements reported in the AfA per substance 143 Table 74 Improvements reported in the AfA TH Non-TH 144 Table 75 Change in the average concentrations of arsenic in the air in the environmental

monitoring station in Murano 2014-16 149 Table 81 Definition of an SME 156 Table 82 Number of AfArsquos by size of firm 158 Table 83 Type of applications SME survey respondents were involved in 160 Table 91 Seven hypotheses around the lsquoannouncement effectrsquo 169 Table 92 Evidence relative to the seven hypotheses around the lsquoannouncement effectrsquo 175 Table 101 Chromium Trioxide substance profile 178 Table 102 Chromium Trioxide REACH authorisation timeline 179 Table 103 Presence of RampD plans in Chromium Trioxide AfArsquos 188 Table 104 Sources used for estimation of exposure to CrVI 194 Table 105 Excess lifetime (up to age 89) lung cancer risk estimates for workers exposed at

different 8h-TWA concentrations of Cr(VI) for 40 years 194 Table 106 Historical measurement campaigns on Cr(VI) reported from various EU countries values

for inhalation 195 Table 107 Results from the Belgian inspection campaign 196 Table 108 Overview of occupational exposures results from the submitted AfAs for Chromium

Trioxide expressed as ranges 196 Table 109 Number of applicants and their size per substance 201 Table 111 Trichloroethylene substance profile 204 Table 112 Trichloroethylene REACH authorisation timeline 205 Table 113 Existing OELs for TCE inhalation (adapted from the GESTIS database) 215 Table 114 Comparison of OEL levels for TCE for different EU countries over time values for

inhalation 216


eftec November 2017

xvi

Table 115 Historical measurement campaigns on TCE reported from various EU countries values

for inhalation 217 Table 116 Overview of occupational exposures results from the submitted AfAs for TCE expressed

as ranges 219 Table 121 Dibutyl Phthalate substance profile 222 Table 122 Dibutyl Phthalate REACH authorisation timeline 224 Table 123 Existing OELs for Dibutyl Phthalate for inhalation (adapted from the GESTIS database)

230 Table 124 Historical measurement campaign for DBP reported from EU countries inhalation 230 Table 125 Overview of occupational exposures results from the submitted AfAs for DBP expressed

as ranges 231 Table B01 REACH Authorisation intervention logic (non-exhaustive high-level list) 249 Table B02 Total number of activities excluded with justification 252 Table B03 Number of activities carried out along the authorisation process that are assessed in

this study 253 Table C01 The main stages in the authorisation process 263 Table E01 Authorisation application fees set in Commission Regulation (EC) No 3402008 332 Table E02 Authorisation application fees set in Regulation (EU) No 2542013 332 Table E03 Have any of your customers requested the removal of SVHCs from your products 350 Table E04 What has been the response of your firm to the placing of substances relevant to your

business in the Candidate List (Percentage of firms indicating) 352 Table G01 Stakeholders invited to take part in a MS CA questionnaire 389 Table G02 Stakeholders invited to take part in the NGO online survey 390 Table G03 Stakeholders invited to take part in the industry online survey 392

LIST OF FIGURES

Figure 21 Overview of method 5 Figure 41 Assessing changes in the market using different approaches 20 Figure 42 Changes in the supply of SVHCs and alternatives ndash Type of impact (industry survey) 25 Figure 43 Changes in competitiveness ndash Type of impact (industry survey) 27 Figure 44 Changes in quality price availability ndash Type of impact (industry survey) 31 Figure 45 Production value and import value of 12-dichloroethane (ethylene dichloride) 55 Figure 46 Export value of 12-dichloroethane (ethylene dichloride) 55 Figure 47 Production value and import value of methyloxirane (propylene oxide) 55 Figure 48 Export value of methyloxirane 55 Figure 49 Production value and import value of ldquoChromium manganese lead and copper oxides

and hydroxidesrdquo (PRODCOM code 20121200) 56 Figure 410 Export value of ldquoChromium manganese lead and copper oxides and hydroxidesrdquo

(PRODCOM code 20121200) 56 Figure 411 Production value and import value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic

trioxiderdquo (PRODCOM code 20111250) 57 Figure 412 Export value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo (PRODCOM

code 20111250) 57 Figure 413 Production value and import value of ldquoChromates and dichromates peroxochromatesrdquo

(PRODCOM code 20135125) 58 Figure 414 Export value of ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code

20135125) 58 Figure 415 Production value and import value of ldquoTrichloroethylene tetrachloroethylene 59 Figure 416 Export value of ldquoTrichloroethylene tetrachloroethylene (perchloroethylene)rdquo

(PRODCOM code 20141374) 59


eftec November 2017

xvii

Figure 417 Production and import values as well as export value of ldquoCyclohexanone and

methylcyclohexanonesrdquo ldquoDiazo- azo- or azoxy-compoundsrdquo and ldquoOther esters of orthophthalic

acidrdquo 61 Figure 51 Instances of substitution - Number of years to achieve substitution (Industry survey) 70 Figure 52 Stage in the REACH authorisation process that triggered substitution activity 71 Figure 53 Substitution activities ndash Types of activities undertaken (industry survey) 74 Figure 54 Drivers of substitution activities (industry survey) 75 Figure 55 Barriers to substitution (industry survey) 76 Figure 61 Number of AfA public consultations and comments received 108 Figure 62 Types of REACH actors that have commented on an AfA 109 Figure 63 Number of comments received by substance 109 Figure 64 Main reasons for industry stakeholder to provide comments 111 Figure 65 Whether the industry organisation read published response to their comments 112 Figure 66 Main reasons for not providing comments 112 Figure 67 Whether respondents organisation incurred costs associated with compliance with

REACH authorisation process 114 Figure 68 Cost to update registration dossier following granting of an authorisation 116 Figure 69 One off investment costs to implement alternative (substance or process) to an SVHC 118 Figure 610 Annual net operating costs to use the alternative (substance or process) to an SVHC 118 Figure 611 Annual spending on substitution activities 119 Figure 612 What authorisation stage triggered these risk management activities 130 Figure 613 Estimated one-off cost of risk management activities 131 Figure 81 Number of applicants (2013-16) by applicant size 159 Figure 82 Top 3 challenges faced by SMEs associated with the authorisation process 160 Figure 83 Top 3 challenges faced by SMEs associated with AfAs 161 Figure 84 Who SMEs used to support them 161 Figure 85 SMEs views on the REACH authorisation guidance and other information on the ECHA

website 162 Figure 91 Whether REACH authorisation has led to internal policy concerning managingknowing

what substances are used within respondents organisations including (possible) SVHCs 171 Figure 92 Authorisation stage that triggered decision to substitute from an SVHC 172 Figure 93 Authorisation stage that triggered substitution related activities 172 Figure 94 Authorisation stage that triggered further risk management activities 173 Figure 101 Chromium Trioxide imports to EU 2000-2016 181 Figure 102 Chromium Trioxide exports to outside EU 2000-2016 181 Figure 103 Supply chain for Chromium Trioxide 182 Figure 104 Chromium Trioxide ndash Market share by use 185 Figure 105 Evolution of the exposure to CrVI 197 Figure 111 Production export import volumes TCEPER 2003-2016 207 Figure 112 Uses of TCE sold into EU markets 1996 and 2003 208 Figure 113 Trichloroethylene ndash Production consumption exports imports in EU 2012-2016 209 Figure 114 Trichloroethylene ndash Production consumption in EU 2017-2022 210 Figure 115 Tetrachloroethylene ndash Production consumption exports imports in EU 2012-2016 213 Figure 116 Tetrachloroethylene ndash Production consumption in EU 2017-2022 214 Figure 117 Excess risk for carcinogenic effects-Working lifetime exposure 218 Figure 121 DBP production volumes 225 Figure 122 DBP use distribution (1998 2007) 226 Figure 123 Percentage of phthalate sales in EU compared to total plasticisers 229 Figure C01 The processes in authorisation and contributory processes 261 Figure C02 Timeline of key events in the authorisation process (2007-2016) 265 Figure E01 EU chemicals sales 315 Figure E02 Share of member states in EU chemical sales 316


eftec November 2017

xviii

Figure E03 EU chemicals sales by destination 316 Figure E04 Extra-EU imports amp exports and trade balance 317 Figure E05 EU export market share 318 Figure E06 EU chemicals production 319 Figure E07 EU regulatory cost 320 Figure E08 Capital spending 321 Figure E09 Research amp Development (RampD) Spending 322 Figure E010 Distribution of costs related to application for authorisation (micro companies) 331 Figure E011 Share of REACH REFIT respondents thinking that authorisation application fees are

too high 333 Figure E012 Legislation cost (as annual share of turnover 2004-2014) by size of firms 347


eftec November 2017

xix

LIST OF ABBREVIATIONS

AC Adequate Control

ACEA European Automobile Manufacturersrsquo Association

ADCA CC-azodi(formamide)

AfA Application for Authorisation

AfAs Applications for Authorisation

Al-RCF Aluminosilicate Refractory Ceramic Fibres

AoA Analysis of Alternatives

API Active Pharmaceutical Ingredient

BBP Benzylbutyl Phthalate

CAS Chemical Abstracts Service

CBA Cost Benefit Analysis

CCH Compliance Check

CEFIC The European Chemical Industry Council

CIRCABC Communication and Information Resource Centre for Administrations Businesses

and Citizens

CLH Harmonised Classification and Labelling

CLP Classification Labelling and Packaging

CMR Carcinogenic mutagenic or toxic to reproduction

CO2 Carbon Dioxide

COM European Commission

CoRAP Community rolling action plan

CrIII Trivalent chromium

CrVI Hexavalent chromium

CSR Chemical Safety Report

CVP Chemical Vapour Deposition

DBP Dibutyl Phthalate

DEFRA Department for Environment Food and Rural Affairs

DEHP Bis(2-ethylhexyl)phthalate

DIBP Diisobutyl Phthalate

DIDP Diisodecyl Phthalate

DINCH Di-(isononyl)-cyclohexan-12-dicarbooxylate

DINP Di-isononyl Phthalate

DMF NN-dimethylformamide

DNEL Derived No Effect Level

DOTE 2-ethylhexyl-10-ethyl-44-dioctyl-7-oxo-8-oxa-35-dithia-4-stannatetradecanoate

DPHP Bis(2-propylheptyl) Phthalate

DU Downstream User

DUs Downstream Users

EBFRIP European Brominated Flame Retardant Industry Panel

EC European Commission

ECMA European Federation of Catalyst Manufacturers

ECHA European Chemicals Agency

ECPI European Council for Plasticisers and Intermediates

ED Endocrine Disruption

EDC 12-Dichloroethane

EEA European Economic Area


eftec November 2017

xx

EEB European Environmental Bureau

EED Electro- electrodialysis

EEN Enterprise Europe Network

EPS Expanded Polystyrene

eSDS extended Safety Data Sheet

ESR Existing Substances Regulation

ESR RAR Existing Substances Regulation Risk Assessment Report

ESTAL European Association of Alumina Platers

ETP Tin-plated Steel

ETS Emissions Trading Scheme

EU European Union

EUMEPS Association for European Manufacturers of Expanded Polystyrene

FGK Fachverband Galvanisierte Kunststoffe eV

FR EPS Flame Retarded Expanded Polystyrene

FTE Full Time Equivalent

GOS Gross Operating Surplus

HBCDD Hexabromocyclododecane

HCFCs Hydrochlorofluorocarbons

HFCs Hydrofluorocarbons

HFEs Hydrofluoroethers

HH Human Health

HIPS High Impact Polystyrene

HMW High Molecular Weight

HSS High Speed Steel

HVOF High Velocity Thermal Process

IPA Institut fuer Praevention und Arbeitsmedizin der Deutschen Gesetzlichen

Unfallversicherung

IPCS International Programme on Chemical Safety

ITT Invitation to Tender

LAD Latest Application Date

LCD Liquid-Crystal Display

LOW Low Molecular Weight

MDA 44rsquo- Diaminodiphenylmethane

MHHPA Hexahydromethylphthalic Anhydride

MI Manufacturer Importer

MIs Manufacturers Importers

MA Maleic Anhydride

MEC Methylene Chloride

MOCA 22-dichloro-44-methylenedianiline

MOTE 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-

oxa-35-dithia-4-stannatetradecanoate

MS Member State

MS CA Member State Competent Authority

MS CAs Member State Competent Authorities

MSC Member State Committee

MSC-WG Member State Committee ndash Working Group

MSs Member States

NEAs National Enforcement Authorities

NeRSAP Network of REACH SEA and Analysis of Alternatives Practitioners


eftec November 2017

xxi

NGO Non-Governmental Organisation

NGOs Non-Governmental Organisations

NiB Nickel Boron

NiP Nickel-phosphor

NMP 1-methyl-2-pyrrolidone

Non-TH Non-threshold

OC Operational Conditions

OECD Organisation for Economic Co-operation and Development

OEL Occupational Exposure Limit

OSOR one substance one registration

PACT Public Activities Coordination Tool

PBT Persistent Bioaccumulative Toxic

PC Public Consultation

PCBs Printed Circuit Boards

pFR Polymeric flame retardant

PER Tetrachloroethylene

PNEC Predicted No Effect Concentration

POPAA Plating on Plastics for Automotive Applications

POPs Persistent organic pollutants

PPORD product and process orientated research and development

PRODCOM PRODCOM is abbreviated from the French Production Communautaire

PS Polystyrene

PSIS Pre-Submission Information Session

PVC Polyvinyl Chloride

PVD Physical Vapor Deposition

QC Quality Control

(Q)SARs (Quantitative) Structure-Activity Relationships

RAC Risk Assessment Committee

RAR Risk Assessment Report

RCFs Refractory Ceramic Fibres

RCOM Response to Comments document

RampD Research amp Development

REACH A European Union regulation concerning the Registration Evaluation Authorisation

amp Restriction of CHemicals

RER Rapid Evidence Review

RMM Risk Management Measure

RMMs Risk Management Measures

RMO Risk Management Option

RMOA Risk Management Option Analysis

RMOAs Risk Management Option Analyses

RoHS Restriction of the Use of Certain Hazardous Substances

RRS Risk Reduction Strategy

SCFs Supercritical Fluids

SCOEL Scientific Committee on Occupational Exposure Limits

SDS Safety Data Sheet

SDSC SUBSPORT Screening Criteria

SEA Socio Economic Analysis

SEAC Socio Economic Analysis Committee

SEAs Socio Economic Analyses


eftec November 2017

xxii

SEv Substance Evaluation

SHVC Substance of Very High Concern

SiC Standard Industrial Classification

SIEF Substance Information Exchange Forum

SME Small and Medium-sized Enterprise

SMEs Small and Medium-sized Enterprises

SVHC Substance of Very High Concern

SVHCs Substances of Very High Concern

TCE Trichloroethylene

TH Threshold

TiN Titanium Nitride

tpa Tonnes per annum

US EPA United States Environmental Protection Agency

UTC Unintentional Trace Contamination

vPvB very Persistent very Bioaccumulative

WC Tungsten Carbide

WCCo Cobalt-tungsten Carbide

WFD EQS Water Framework Directive Environmental Quality Standards

WHO World Health Organization

WP Working procedures

WSSD World Summit on Sustainable Development

WTO World Trade Organisation

XPS Extruded Polystyrene

Zr-RCF Zirconia Aluminosilicate Refractory Ceramic Fibres


eftec November 2017 1

1 INTRODUCTION

11 Context and rationale of this study

The REACH Regulation entered into force on the 1st June 2007 It was adopted to improve the

protection of human health and the environment from the risks that can be posed by chemicals and

the free circulation of chemicals in the internal market while enhancing the competitiveness and

innovation of the EU chemicals industry It also promotes alternative methods for the hazard

assessment of substances in order to reduce the number of tests on animals3

The REACH Regulation includes the obligation for a review every five years to monitor progress in

the achievement of its objectives The first review was carried out in 20124 and the second REACH

Review due in 2017 is being carried out in parallel with the fitness check on the most relevant

chemicals legislation excluding REACH This study will feed into the REACH 2017 review by

providing evidence on the impacts of REACH authorisation (ie one specific regulatory procedure of

REACH)

The first review of REACH concluded that ldquoREACH functions well and delivers on all objectives that

at present can be assessed Some needs for adjustments have been identified but balanced

against the interest of ensuring legislative stability and predictability the Commission will not

propose any changes to the enacting terms of REACH Within the current framework however

there is a need to reduce the impact of REACH on SMEsrdquo4 The findings also note that ldquothere are

many other opportunities for further improvement of the functioning of REACH by optimizing the

implementation at all levelsrdquo4

This project is the first comprehensive attempt to obtain evidence on the overall impacts of the

REACH authorisation procedure Some evidence exists within ECHA on the costs of applications and

evidence of risk reduction as part of applications for authorisation ECHA is also currently carrying

out a meta-analysis of the benefits and costs of authorisation applications However less is known

about the other costs and benefits associated with the authorisation process on different actors and

on instances where companies have substituted a substance of very high concern (SHVC) thereby

avoiding the need to apply for authorisation Such impacts include amongst others the

administrative burden to public authorities and third parties costs (and benefits) to industry (and

EU society) from complying with REACH authorisation and costs and benefits associated with

substitution and improved risk management

The project is seeking to fill such information gaps and substantiate and quantify the currently

available qualitative information on the costs benefits and other impacts of authorisation It

focusses on the areas where until now it has been more difficult to collect reliable information

namely the substitution objective of authorisation As stated in the Invitation to Tender (ITT) while

data on costs and burden may be easier to gather some of the benefits and other impacts may only

materialise much later and even if identified they are usually difficult to quantify Capturing and

quantifying them fully at this point in time would therefore not be possible However this study

makes a serious effort to include the information on benefits in a qualitative manner and quantify

what is possible

3 httpsechaeuropaeuregulationsreachunderstanding-reach 4 httpeceuropaeuenvironmentchemicalsreachreview_2012_enhtm



12 Project objectives

The main objective of the project is to evaluate the performance of REACH authorisation by

providing evidence on whether it is working as intended and achieving its objectives This final

report encompasses all the findings of this study and sets out results based on the five areas the

study sought particular information on (i) cost of authorisation (ii) benefits of authorisation (iii)

changes in the market structure (iv) substitution and (v) affordability of authorisation for SMEs

Through data collected to meet this main objective and through existing amp ongoing studies it

should also be possible to (i) provide evidence on the functioning of the current implementation of

the SVHC 2020 Roadmap (which commenced in February 20135) and in particular the risk

management option analysis (RMOA)6 and (ii) to evaluate the adequacy of current guidance for

stakeholders to facilitate the preparation of Applicants for Authorisations (AfAs) and where

possible evidence on ongoing initiatives to streamline and simplify the authorisation procedure

This extends the coverage of the authorisation process to collect information (since 2013) on the

RMOA process which is voluntary (ie not part of the processes as defined in the legislation)

Within the context of this study this means collecting information on for example the costs to

public authorities to develop RMOAs and the benefits of this process (eg whether it facilitates

substitution for those substances where authorisation is recommended)

ECHA together with Member States and the Commission has started to review some elements of

the SVHC Roadmap implementation and this will continue next year with the objective to report on

the overall review in the annual report of the SVHC Roadmap to be published in 2018

To date there has been a reasonable number of applications for authorisation through the entire

authorisation process (ie with final decisions made by the Commission) and a large number of

opinions A larger number of substances have been introduced in the process from the RMOA to

the registry of intentions the candidate list and the ECHA recommendation for inclusion on Annex

XIV With this experience now should be a good time to critically look back on the REACH

authorisation process to identify instances where companies have substituted substances instead of

submitting an AfA and to assess the current RMOA process In doing so this project is seeking to

address the following gaps

1 What effects authorisation has and what impacts these have on different stakeholders

(including public authorities and different size of firms using the substance of concern or an

alternative) and along the supply chain

2 Where along the authorisation process these stakeholders are more affected (eg from

Screening of substances and RMOAs inclusion of substances in the Candidate List all the

way through to reviewing AfAs following their review periods)

3 What the overall costs and benefits of authorisation have been both as the substance goes

through the authorisation process and as a result of authorisation decisions For example

5 Substance of Very High Concern 2020 Roadmap httpsechaeuropaeuaddressing-chemicals-of-

concernsubstances-of-potential-concernpact-substance-

rev1988del50colsynonymDynamicField_3413typeascpre1view 6 Roadmap for SVHC identification and implementation of REACH Risk Management measures from now to

2020 (called the SVHC Roadmap) ndash Available at

httpsechaeuropaeudocuments1016219126370svhc_roadmap_2015_enpdf



has authorisation lead to reduced overall risks Has it led to reduced competitiveness

relative to non-EU companies

4 How efficient the current process is and whether there is scope for reducing administrative

and regulatory steps whilst preserving the intended aims of REACH authorisation

13 Structure of this report

The remainder of this report is structured as follows

Section 2 Methodology

Section 3 Authorisation process 2007-2016

Section 4 Changes in the EU market for SVHCs (and their alternatives)

Section 5 Instances of substitution

Section 6 Costs of the authorisation process

Section 7 Benefits from the authorisation process

Section 8 Affordability of authorisation for SMEs

Section 9 Tier 2 case study Evidence of the lsquoannouncement effectrsquo

Section 10 Tier 1 case study substance 1 Chromium Trioxide

Section 11 Tier 1 case study substance 2 Trichloroethylene

Section 12 Tier 1 case study substance 3 Dibutyl Phthalate (DBP)

Section 13 Summary and conclusions

There are also a series of Annexes that provide supporting information like stakeholders

contacted details of the online surveys and an annex containing confidential information (which

wonrsquot be available in the public version of the final report)

131 Logic for the sequencing of impacts (Sections 4-9)

Given that many of the impacts are linked interdependent it would only be possible to assess

certain impacts after others have been identified and quantified This introduces a hierarchy of

what data needed to be collected first

The first step was to understand how the market for a particular substance has changed over time

This is done through identifying how the following have changed

The number of suppliers of the substance (Manufacturers or Importers (MIs))

The volumes manufactured in the EU imports into the EU and exports outside of the EU

The uses of the substance

The focus was on collecting information on (i) the market situation before the substance entered

the authorisation process (ii) during the authorisation process and (iii) the current situation

Changes in the market situation between these periods would help us understand the scope of

certain impacts like

1 Any possible substitution of the substance ndash eg comparing the uses before REACH

authorisation and currentknown uses of the substance and

2 Any possible instances of relocation and closure ndash eg closure of MIs within the EU

location of end-use markets (eg through changes in volumes of importsexports)



The second step was to understand the drivers for these changes (eg market forces fashion

technological development regulation and so forth) and when these changes occurred (eg

whether there was already a declining trend in the use of the substance before it was subject to

the REACH authorisation process)

The third step is to find out further information on possible alternatives and how the markets for

these alternatives have changed This would help us understand to what extent changes in the

market for SVHCs have been displaced by alternatives or simply a case of relocation of activities

outside of the EU The latter being an undesirable societal outcome

This would then help us estimate what changes can be attributed to the REACH authorisation

process and to estimate the costs and benefits of these changes

The report therefore sets out the information gathered in the order following this logic process






Section 9 Evidence of the lsquoannouncement effectrsquo

These individual chapters are used to explain the way the impacts are assessed and the Tier 1 case

studies that follow (in Sections 10-12) build on this framework by going into detail on these impacts

for three specific substances

Before the detailed findings Section 3 sets out some supporting context and data about the

authorisation process This information also helps assess the lsquoeffectivenessrsquo of the REACH

authorisation process relative to defined targets like having all known SVHCs on the candidate list

by 2020

132 Use of case studies

Case studies are used throughout this report to provide where possible more in-depth insights on

the five impact areas of the study (i) costs of authorisation (ii) benefits of authorisation (iii)

changes in the market structure (iv) substitution and (v) affordability of authorisation for SME

The case studies build upon existing studies and relevant information already in submitted

applications

The Tier 1 case studies (presented in Sections 10-12) are on three specific substances (Chromium

Trioxide Trichloroethylene and Dibutyl Phthalate) Within each Tier 1 case study the above five

main impact areas are covered

The Tier 2 case studies contribute to the study by collecting data on specific aspects (eg on

substitution risk management and evidence of the announcement effect) The analysis here is not

limited to any particular substance



2 METHOD OVERVIEW

This section sets out the project activities carried out Further details on the method can be found

in Annex B

This project follows the EC Better Regulation Guidelines7 and Toolbox8 in order to assess the

ldquoImpacts of REACH authorisationrdquo The evaluation needs to be evidence-based robust and able to

withstand public scrutiny since this study could be heavily referred to in the future by a wide range

of stakeholders (eg industry associations NGOs Member State Authorities the European

Commission and ECHA) as well as potentially informing future decision making on the REACH

authorisation process

211 Overview

As illustrated in Figure 21 the project was broken down into four main tasks Within each task

there were a number of sub-tasks reflecting activities that need to be undertaken in order to

successfully complete these tasks

Figure 21 Overview of method

212 Task 1 Structuring Phase

In Task 1 of this study a framework for carrying out the work the scope of the work as well as

deciding on the Tier 1 and Tier 2 case studies were agreed (see Annex B for further details) A

rapid evidence review (RER) was carried out examining a number of studies that have been carried

out concerning REACH (with a few studies specifically on REACH Authorisation) This enabled us to

7 httpeceuropaeusmart-regulationguidelinestoc_guide_enhtm 8 httpeceuropaeusmart-regulationguidelinestoc_tool_enhtm



prioritise quantitative and monetary data gaps for this study This RER was further built on as the

project developed with the results of the literature review set out in Annex E

213 Task 2 Data collection

The main steps carried out within Task 2 were

1 Mapping activities carried out along the authorisation process ndash We mapped out 150

activities carried out by different actors along the authorisation process and their impacts

(See Annex D) This enabled us to focus on those impacts worth considering further in this

study (and is feasible to do so) what information was needed who holds it and how best to

get access to it

2 Developing a consultation plan ndash We set out a plan for contacting stakeholders that may

have information useful for this study and what types of information we were targeting

from each type of stakeholder (eg what we expect to be able to get from consulting with

NGOs and industry respectively)

3 Initial stakeholder engagement ndash We spent a significant amount of time contacting over 200

stakeholders (NGOs industry associations and sector groups) that may have been impacted

by REACH authorisation and a number of relevant downstream users of whose interest in

taking part in an online survey we were aware

Various members of the project team also presented at various REACH related events

spoke to industry sector groups and NGOs (in person or over the phone) to raise the

awareness of the project and encourage stakeholders to take part in the forthcoming

survey Stakeholders were targeted to those that may have been impacted by REACH

authorisation and who can provide data required rather than contacting as many

stakeholders as possible ndash in particular any companies that had substituted from an SVHC

(or were in the process of doing so) where prioritised as this was a particular data gap that

needed to be addressed in this study Therefore some of the results of this study (eg

proportion of companies that have substituted away from an SVHC) may have been very

different if the survey was simply an open link (via a public consultation) with no prior

contact with stakeholders

This task was supported by ECHA who informed by email those stakeholders that had

commented to a public consultation on a submitted application and to applicants ECHA

also included a call for information on substitution as part of their newsletter The EC and

ECHA also both provided contacts of companies that have substituted from an SVHC (and

therefore avoided the need to submit an application for authorisation)9

The main goals were to (i) produce a list of stakeholders that have confirmed their interest

in taking part in the survey and (ii) to give these stakeholders advance notice of the survey

and what information is being requested so that they can plan ahead A list of

stakeholders contacted is set out in Annex G

9 Some companies have also substituted from an SVHC after the submission of an AfA (eg downstream users

who notified ECHA of their use and later ceased use of the SVHC)



4 Developing consultation toolsndash We issued four different questionnaires (the questionnaires

and key statistics can be found in Annex F)

a An industry online survey ndash This was originally intended to be designed and

administered using the EUSurvey tool which is the ECrsquos official survey management

tool10 However due to the need to try to collect very specific data and where

possible quantitative and monetary data the questionnaire was too complex for

the EUSurvey tool to handle (in terms of both the style and number of questions)

Instead the survey was issued via Survey Monkey The scripts were commented on

by some steering group members and changes made to address their comments

b A Non-Government Organisation (NGO) online survey ndash A similar but shorter survey

which focused on instances of substitution was developed for NGOs

c A questionnaire to Member State Competent Authorities (MS CAs) - A Word-based

questionnaire was developed to gather data from MS CAs which focused on

administrative costs they incur along the whole authorisation process Again this

was commented on by some steering group members and changes made to address

their comments

d A questionnaire to the European Commission (EC) ndash A Word-based questionnaire

similar to the one for MS CAs was developed to gather data from the EC which

focused on administrative costs they incur along the whole authorisation process

The EC have indicated they cannot fill in most aspects of the questionnaire but it

will be used as a template for what they can provide

Data was provided by ECHA on the costs they incur along the authorisation process as well

as costs associated with the Risk Assessment Committee (RAC) Socio Economic Analysis

Committee (SEAC) and Member State Committee (MSC) ECHA did not require a

questionnaire from the project team instead a call was held to discuss data needs

5 Launching online surveys ndash We sent personalised emails to stakeholders who had already

agreed to take part in the survey to inform them the survey was ready and to check their

inboxes for a separate email via Survey Monkey containing their personal link to the survey

They were able to save the link and return to the survey so as not to be required to

complete it in one go

Personalised links were also sent to the interested members of trade sector associations

through engagement in their supply chains Other stakeholders completed the open link

(whereby the survey needs to be completed in one go)

Those stakeholders who did not confirm whether they will take part were sent an email to

inform them that the survey is available and were asked to email back if they wanted to

take part

Further rounds of reminders were sent out to encourage further uptake of the online survey

and the survey was eventually closed at the end of June

10 httpseceuropaeueusurveyhomewelcomerunner



6 Data collection from other sources ndash We also collected production import and export data

from Eurostat for PRODCOM11 codes market reports and data from ECHA Further details

are set out in Section 47

7 Collating survey responses ndash We thanked all respondents to the survey for completing the

survey If they agreed to follow up questions a holding response was sent to mention the

possibility that we may query any unexpected answers and seek further evidence for

responses that would seem to be highly relevant

8 Data collection for the Tier 1 case studies ndash We collected data for the three Tier 1 case

study substances namely Chromium Trioxide Trichloroethylene and Dibutyl Phthalate

We contacted many companies connected with these substances (current and former MIs

of the substance downstream users and relevant sectortrade associations) We also

collected relevant data from existing studies and Eurostat We also explored what market

information was available from market report providers Further details are set out in

Sections 10-12

9 Further follow up with survey respondents ndash We respected the wish of the stakeholders for

their input to be anonymous However some respondents indicated they were willing to be

a case study whereby we could go into more detail than is possible through the survey on a

particular issue (eg about their substitution) These respondents were prioritised for

interviews following closure of the survey

10 Targeted interviews ndash We conducted ~50 interviews with stakeholders Depending on the

role of the stakeholder interviewed different topics were discussed including details of

any substitution away from SVHCs or any ongoing substitution activities and the impacts

incurred due to REACH authorisation (both costs and benefits)

11 Data validation of survey responses ndash We checked the completeness and accuracy of data

(eg identifying any outliers) provided by respondents This check was a critical step prior

to the detailed data analysis in Task 3

Table 21 summarises the number of stakeholders contacted for the different methods of obtaining

information and the number that responded

Table 21 Approaches to collecting new information





ECHA teleconferences and emails 3 webinars and 20-30 emails (different types of data or

contacts provided)


EC Questionnaire (DG GROW and DG

ENV only) 1 1


11 Prodcom provides statistics on the production of manufactured goods Further details can be found here

httpeceuropaeueurostatwebprodcom



214 Tasks 3 and 4 Data analysis and reporting

Upon completion of Task 2 the data gathered was used to assess the impacts of REACH

authorisation (both the process and resulting outcomes) The headline results were presented to

the steering group at a webinar at the end of June 2017 A draft final report was submitted and

discussed with the Steering group in September 2017 with comments received from DG GROW DG

ENV and ECHA in October 2017 The final report was finalised in November 2017



3 AUTHORISATION PROCESS 2007-2016

There is a long process preceding the inclusion of a substance into Annex XIV with several options

for stakeholders to provide information The process consists of (1) the official legislative steps as

set out described in the REACH regulation and (2) the voluntary steps that were introduced with

the goal to improve among others planning and predictability12

The official steps set out in the REACH regulation start from the Annex XV dossiers for SVHC

identification until the inclusion into Annex XIV and all the steps in between such as two public

consultations and a recommendation for inclusion into Annex XIV Once a substance is included into

Annex XIV industry has to either substitute before the sunset date or has to file an application for

authorisation to request authorisation for continued use for a well-justified amount of time

The voluntary steps that were introduced to improve the functioning of the process are described in

the SVHC Roadmap to 2020 Implementation Plan 9 December 201313 which defines priority criteria

until 2020 and describes the processes of Screening and Risk Management Option Analysis (RMOA)

In this study we analyse the impact of the authorisation process from 2007 when REACH came into

force until the end of 2016

Annex C provides an overview of the process highlighting the main stages and the aims and

objectives of the authorisation process from the perspective of the formal process (ie leading to

applications for authorisation) The aims are explained in terms of an lsquointervention logicrsquo which

links the objectives to actions and outcomes (as illustrated in Figure C01) Later sections

summarise some statistics collected on the main stages in authorisation that help to quantify the

levels of activity in these stages (for example the number of RMOAs processed and what stage they

are at the inclusion of substances on the Candidate list and Annex XIV and the number of AfAs

made)

31 Screening of substances and Risk Management Option Assessment (RMOA)

A study reviewing the operation of REACH14 reported a perceived lack of transparency in the

identification and selection of SVHCs as well as a need for understanding which substances would

be identified to give a higher level of certainty to prepare for authorisation applications or

substitution activities etc On the regulatory side the need was identified for consistency in the

approach for identification of SVHCs and connection to the most appropriate regulatory measures

for control of risks

The 2020 SVHC Roadmap built on the political commitment to have all relevant currently known

SVHCs included in the candidate list by 2020 There was a consequent need to analyse the

12 Roadmap on Substances of Very High Concern Council of the European Union do 586713 httpregisterconsiliumeuropaeudocsrvl=ENampf=ST20586720201320INIT 13

httpsechaeuropaeudocuments1016219126370svhc_roadmap_implementation_plan_enpdf66ba723a-

d2e4-4d1a-ae89-a78c4db4d621 14 Technical Assistance to Prepare the Commission Report on the Operation of REACH

0703072010584820SERD3 March 2012 - prepared for European Commission DG Environment by Risk amp

Policy Analysts Limited



information on a large number of substances not only to determine the relevance of known

potential SVHCs but also to identify new potential SVHCs from the processes of REACH registration

(phase-in stages completed in 2018) and evaluation The roadmap implementation plan describes

two distinct but related processes (1) the Screening process and (2) the RMOA process The

purpose of the Screening process is to identify and prioritise substances of potential concern for

further regulatory action Those substances of potential concern are those where the impact on

human health and the environment are expected to be the greatest Priority is given to substances

that have the highest exposure potential combined with their potentially hazardous properties for

example substances that are carcinogenic mutagenic and toxic to reproduction (CMR) persistent

bioaccumulative and toxicvery persistent very bioaccumulative (PBTvPvB) or endocrine

disruptors and therefore potential SVHCs Once the concern is confirmed the substance is normally

taken forward to RMOA by authorities The purpose of the RMOA is to help authorities decide

whether further regulatory risk management activities are required for a substance and if so to

identify the most appropriate instrument to address a concern Thus in view of the authorisation

process the roadmap sets out the RMOA process as central to the decision making on the inclusion

of SVHCs on the Candidate List The processes of Screening and RMOA as set out by ECHA are

described in Box C1 (see Annex C) In addition ECHA sets up the Public Activities Coordination

Tool (PACT) that provides information (published on the ECHA website) on substances that are or

have been subject to informal assessment (of their potential PBT vPvB or ED properties) andor

RMOA

Table 31 summarises the progress on Screening and RMOA to date (data collected from ECHA

statistics for this study) Of the 110 substances that have been assessed under Screening andor

RMOA 48 (44) have been found to have no concern of these 30 on the basis that they were not

PBTvPvB or ED and 18 on the basis that no further regulatory risk management was needed Seven

substances were found to be of concern due to endocrine disruption (ED) or PBTvPvB properties

and 55 substances (50 of the completed assessments) required further regulatory action to control

the risks Of these 16 were sensitizers 4 were PBT 12 were CMR and one was ED (lsquootherrsquo was also

reported in the scope and some substances were multiple categories eg CMR and PBT)

Table 31 Progress on hazard assessment and RMOA development (as of Dec 2016)

Stage

Outcome text

Number of substances

per outcome Per stage

In progress

Under development 130 229

Substance evaluation under development 99

On hold

On hold 14

25

Potential ED (but further assessment is

postponed) 1

Potential PBTvPvB but further

assessment is postponed 10

Complete - no

concern

According to authorityrsquos assessment not

ED 4

48 According to authorityrsquos assessment not

PBTvPvB 26

No need to initiate further regulatory risk

management action at this time 18

Complete ndash

concern

According to authorityrsquos assessment ED in

accordance with WHOIPCS definition 6

7 According to authorityrsquos assessment PBT

or vPvB 1



Stage

Outcome text



Complete - action

requested

Appropriate to initiate regulatory risk

management action 55 55

Totals 364 364

Source ECHA

32 Inclusion of substances in the Candidate List

The inclusion of a substance on the Candidate List designates that substance as a substance of very

high concern (SVHC) Therefore this is the first official list that indicates a substance fulfils at

least one of the Article 57 criteria and that it may be selected for listing on Annex XIV From the

implementation of the 2020 Roadmap for SVHC substances proposed to be included on the

Candidate list should be those for which the RMOA outcome indicated that the most appropriate

option to address the concerns from the use of that substance is Authorisation An exception to

this being SVHC identification of substances with PBTvPvB properties or Art 57(f) hazard properties

without harmonised criteria in Annex I of CLP (eg endocrine disruptors) In these cases the

Candidate List can also be used as an official recognition of these hazard properties when further

regulatory action (eg restriction) under REACH is deemed to be needed15 As set out in Annex C

(and illustrated in Figure C01) the selection of SVHC substances is done initially by Member

States or ECHA upon request of EC making an Annex XV dossier to demonstrate that the substance

meets the Article 57 criteria

The Commissions aim to have 136 substances on the Candidate List by the end of 2012 was

achieved and the 2020 Roadmap objective is to have all currently known SVHCs on the Candidate

List by 2020 As mentioned in the REACH 2012 review4 that objective has the merit of stimulating

an increased activity of Member States in relation to the submission of proposals for SVHC

identification The Candidate List currently (as of Jan 2017) contains 173 substances16

Table 32 below summarises the candidate list (as of Jan 2017) in terms of reason for inclusion It

can be seen from the table that the majority of substances (82) placed on the Candidate List are

due to concerns for human health hazard ie they are CMR (Carcinogenic Mutagenic or toxic to

Reproduction) or of equivalent concern In contrast substances for which there are only concerns

for the environment (ie PBTvPvB or equivalent concern) make up 12 of the substances with a

similar proportion for substances for which there are both environmental and health concerns The

total number of substances which are included because of health concerns (including with both

health and environmental) is 153 (=142+11) and the total number for which there are

environmental concerns (including both environmental and health) is 32 (=21+11)

15 httpregisterconsiliumeuropaeudocsrvl=ENampf=ST20586720201320INIT 16 There is a discrepancy of 1 between the candidate list as shown on the ECHA web site and the download of

the substances (this is assumed to be due to substance grouping)



Table 32 Candidate list of substances (SVHC) by reason for inclusion (as of Jan 2017)

Category EnvHH or both Reason for inclusion (Article 57) Number of substances

Environment Total 21

PBT 3

PBTvPvB 4

vPvB 8

Equivalent concern (Env) 6

Human Health Total 140

Carc 39

Carc and Equivalent concern (HH) 3

Muta 2

Carcmuta 6

Carcrepro 11

Repro 69

CMR 4

Equivalent concern (HH) 3

CMR and Equivalent concern (HH) 3

Human Health and environment Total 11

PBTRepro 4

CarcPBTvPvB 2

CarcmutaPBTvPvB 2

Equivalent concern (Env)Repro 1

CMR and PBT 1

Total 173

Note

- There is a discrepancy in the total of 1 between the candidate list as shown on the ECHA web site

and the download of the substances (this is assumed to be due to substance grouping)

In terms of progress towards the 2020 Roadmap objective it is difficult to judge because the data

for 1 to 100 tonnes per annum phase-in substances is not yet available from registration and

because the process is somewhat dependent on the activities of Member State CAs coming forward

with proposals for SVHCs in the form of Annex XV dossiers In addition whilst CMR and to some

extent equivalent concern to CMR (eg such as sensitisers) can be identified through classification

(CLP) environmental concerns in terms of meeting the specific criteria for PBTvPvB can only be

assessed against the criteria in Annex XIII of REACH

33 Prioritisation and inclusion of substances in the Authorisation List

The prioritisation of substances for Annex XIV is normally based on (1) the inherent properties of

the substance (2) the high volume and (3) the use (wide-dispersive) Before sending its

recommendation to the European Commission ECHA launches a public consultation which lasts for

3 months in particular on uses which should be exempt from the authorisation requirement17

According to REACH Art 58(3) ldquopriority shall normally be given to substances with (a) PBT or

vPvB properties or (b) wide dispersive use or (c) high volumesrdquo on which basis ECHA developed

17 REACH article 58(4)



the prioritisation approach18 The draft recommendation amongst other includes the following

information

Substance identity and its intrinsic properties of very high concern

lsquoSunset Datersquo from which the placing on the market and the use of a substance is

prohibited unless an authorisation is granted or the use is exempt from authorisation

The latest application date by which applications must be received if the applicant wishes

to have certainty on continued use of the substance after the sunset date but when a

decision has not been adopted yet

Review periods for certain uses if relevant and

Uses exempted from the authorisation requirement if any

The Member State Committee of ECHA prepares its opinion on the draft recommendation taking

into account the received comments The Committeersquos opinion and the comments received during

the public consultation are used by ECHA to finalise its recommendation The recommendation is

submitted to the EC The EC has the discretion to decide (or not) upon inclusion of the substances

in the Authorisation List ndash this is done as a Regulation amending Annex XIV of REACH

Table 33 sets out the number of substances on the Authorisation list (Annex XIV) according to their

inherent property Note that inherent property is just one aspect considered in the prioritisation

assessment which in addition to the Art 58(3) takes also further considerations into account eg

potential interchangeability among substances in (some of) their uses

Table 33 Authorisation list substances (Annex XIV) by SVHC type (as of 13th June 2017)


Environment

PBT 1

vPvB 1

Endocrine disrupting 2

Human Health

Carcinogenic 14

Carcinogenic Mutagenic 2

Carcinogenic toxic to Reproduction 3

Toxic to Reproduction 14

CMR 4

Environment and Heath Carcinogenic PBT vPvB 2

Total 43

34 Applications for Authorisation (AfA)

The AfA stage involves the compilation and submission of the AfA itself by industry The process

continues with the assessment by the authorities (ECHA RAC and SEAC) as well as inputs from third

parties (alternatives during the public consultation) In addition the Risk Assessment Committee

(RAC) may have specific activities prior to submission of the AfA (for example this includes the

18 ECHA (2014) Prioritisation of substances of very high concern (SVHCs) for inclusion in the

Authorisation List (Annex XIV)



defining of no effect levels (reference DNELs or PNECs) and the derivation of dose response curves

(eg for calculation of the risk from exposure to non-threshold substances)

Table 34 was taken from ECHArsquos website on (Nov 2016)19 It should be noted that in Table 34 the

figures in red text are not exactly as shown on the ECHA web site This is because applications for

these substances (namely chromium trioxide and sodium dichromate) had applications after

December 2016 (this study is considering applications up to and including December 2016)

By the end of December 2016 there were 111 applications for authorisation Contained within

these applications there have been 185 uses applied for (each application may have more than one

use (eg consultation numbers 0013-01 and 0013-02 denotes two uses associated with application

0013) By the end of 2016 the progress made on these applications could be broken down into the

stages presented in Table 35

Table 34 Number of Applications for Authorisation (AfA) (as of Dec 2016)

Substance Number

of received applications

Number of applicants

Number of uses

Bis(2-ethylhexyl) phthalate (DEHP) 5 7 10

Dibutyl phthalate (DBP) 2 2 4

Bis(2-ethylhexyl) phthalate (DEHP) and Dibutyl phthalate (DBP)

1 1 3

Lead sulfochromate yellow (CI Pigment Yellow 34) and Lead chromate molybdate sulphate red (CI Pigment Red 104)

1 1 12

Hexabromocyclododecane (HBCDDD) 1 13 2

Diarsenic trioxide 4 4 5

Trichloroethylene 13 15 19

Lead chromate 1 1 1

Chromium trioxide 25 57 41

Sodium dichromate 17 23 23

Chromium trioxide Sodium dichromate and Potassium dichromate

1 6 7

Sodium chromate 2 4 3

12-Dichloroethane (EDC) 15 17 19

Potassium dichromate 4 4 7

Ammonium dichromate 3 5 4

Dichromium tris(chromate) 1 2 2

Chromium trioxide Dichromium tris(chromate) 1 2 5

Strontium chromate 1 10 2

Potassium hydroxyoctaoxodizincatedichromate 1 5 2

Diglyme 8 8 9

19 httpsechaeuropaeuaddressing-chemicals-of-concernauthorisationapplications-for-

authorisationreceived-applications



Substance Number



Number of uses

Arsenic acid 1 1 1

Chromic acid 1 1 1

Formaldehyde oligomeric reaction products with aniline (technical MDA)

1 1 2

22-dichloro-44-methylenedianiline (MOCA) 1 1 1

Total 111 191 185

Source ECHA website

Table 35 Status of decisions of AfArsquos submitted (Dec 2016)

AfA status No of uses applied for (end Dec 16)

Opinion development 63

Opinions adopted 86

Commission decided 34

Application withdrawn 2

Total 185

The review period applied for by applicants is listed in Table 36 (the review periods recommended

by SEACRAC and granted by EC are also listed)

Table 36 Review periods applied for (Dec 2016)

Review period (years)

No of use applications - end Dec 2016

Applied for by applicants

Granted recommended

lt4 3 4

4 15 25

5-6 1 0

7 23 47

8-11 7 2

12 77 44

gt12 26 0

unclear or confidential 33 NA

decision not yet made NA 63

Total 185 185

A comparison of applied-for versus recommended andor granted review period is made in Table

37 for AfA upto the end of December 2016 Table 37 shows data for the total number of

applications at that time (185) A total 63 AfA were undergoing opinion development (by ECHA

Committees) The ECHA Committees have made its recommendation on applicants review periods

for a total of 81 AfAs of these 37 (46) were recommended to be granted the review period

requested and 34 (42) were not Note that for a number of applications it was not clear in the

AfA what length of review period was being requested (or this was confidential) this accounted for



10 AfA (12) As of the end December 2016 some 34 AfAs had been granted by the Commission of

these 6 (18) were granted the requested review period and 11 (32) were not There were 17

(50) in which the requested review period in the AfA was unclear or was confidential

Not shown specifically in Table 37 (but included in the data set summarised in the table) there

were 14 AfA for which it was not clear from the application what length of review period was

requested but for which the Commission decision granted a shorter review period than the ECHA

recommendation These were

two AfA for DEHP where 7 years was recommended and 4 years was granted

six AfA for lead sulfochromate yellow for which four AfA were recommended 12 years and

granted 7 years and two AfA were recommended 7 years and granted 4 years and

six AfA for lead chromate molybdate sulphate red for which four AfA were recommended

for 12 years and granted 7 years and two AfA were recommended 7 years and granted 4

years

The Table 37 does not differentiate between AfA from upstream (manufacturers) and downstream

(user) actors

Table 37 Were applicants given the review period they advocated for (Dec 2016)

Were applicants recommended or granted the review period (RP)

applied for

No of use applications

(up to end Dec 16)

No

Application is currently undergoing opinion development 63

Application is pending decision 5

Application has been withdrawn 2

Recommendation to grant the RP applied for

Yes 37 46

No 34 42

unclear or confidential 10 12

Total 81 100

Granted RP applied for

Yes 6 18

No 11 32


Total 34 100

Total 185

The number of applications for substances by Article 57 criteria is presented in Table 38



Table 38 Number of uses applied for defined by Article 57 criteria (Dec 2016)

SVHC identification criteria No of uses applied for

(end Dec 2016)

Toxic for reproduction (Article 57c) 26

Carcinogenic (Article 57a) 55

Carcinogenic (Article 57a) Toxic for reproduction (Article 57c)

13

Carcinogenic (Article 57a) Mutagenic (Article 57b)

48

Carcinogenic (Article 57a) Mutagenic (Article 57b) Toxic for reproduction (Article 57c)

41

PBT (Article 57 d) 2

Total 185

35 Review of Authorisation following their review period

In order that the authorisation holder benefits from continued use after the review period the

authorisation holder must submit a review report at least 18 months before the end of the review

period Should the authorisation holder not do this the authorisation for his uses would cease at

the end of the review period and further use would not be permitted unless and until a new

authorisation is granted for that use The review report must update the elements of the original

application including any aspects on which the authorisation decision requires further information

such as monitoring arrangements to reduce limitations and uncertainties in the risk assessment The

review report must also include an update of the AoA including information about any relevant

research and development activity possible new alternatives and progress made towards

substitution with safer alternatives

No authorisation holder has yet been through the review process However ECHA has received the

first review reports and for some authorisations the expiry of the review period is approaching If

the use of the SVHCs is still necessary then this should be documented in the review report



4 CHANGES IN THE EU MARKET FOR SVHCs (AND THEIR

ALTERNATIVES)

41 Introduction

Collating evidence on how the EU markets for SVHCs and potential (or proven) alternatives have

changed since the introduction of REACH authorisation is one of the five focus areas for this study

The indicators of change are (i) the number of companies manufacturing importing and using a

substance (concentration effects) (ii) number of uses of a substance and (iii) the size of the

market (volumes) The analysis is not limited to substances that have been through the whole

authorisation process For example possible market changes for substances currently on the

Candidate List are also assessed

Evidence on the drivers of such changes is also needed so that we can determine which changes can

be attributed to the REACH authorisation process To do this overall trends in the EU chemical

sector and any noticeable differences in trends for SVHCs and their (potential) alternatives need to

be identified It would then be possible to infer if authorisation leads to a concentration effect

(eg reduction of competition) development of markets for alternatives and macroeconomic

impacts (like changes in employment)

It is important to note that one of the goals of REACH (authorisation) is to promote the progressive

replacement of SVHCs where feasible Therefore over time one might expect to see a decline in

the volumes of SVHCs used in the EU over time as some companies substitute away from the use of

an SVHC as well as an increase in sales of alternatives There are of course a number of factors

why this might not necessarily be the case yet as (i) some uses are not subject to (affected by)

authorisation (eg exempted uses and intermediates) (ii) substitution away from an SVHC can take

time and it might still be too early to observe changes in the EU market due to REACH authorisation

(iii) for some companiesuses alternatives being tested may continue to prove to be unsuitable

despite continued efforts to find an alternative andor (iv) increased demandsales from the

continued use of the SVHC after the sunset date for those uses where authorisation has been

granted (for a given review period)

The section is split into seven sub-sections

Section 42 - EU Chemicals sector summarises changes in the EU chemicals sector since

2000 to understand the overall trend in the sector Supporting details are set out in Annex

E

Section 43 ndash Literature review summaries what existing studies indicate about changes in

the market for SVHCs and (possible) alternatives due to REACH authorisation Supporting

details are set out in Annex E

Section 44 ndash Survey responses summarises information provided by respondents to the

industry survey on any observed changes in their respective markets due to REACH

authorisation This does not focus on any particular substance on or off the authorisation

list and hence offers a different perspective to the Tier 2 case studies

Sections 45 ndash 46 Tier 2 case studies present changes in the market for a selection of

substances as ldquomini case studiesrdquo They make use of existing information and further



consultation with affected companiessector groups to investigate any links between the

changes in the market for these substances (and their uses) and REACH authorisation These

case studies start to build up a picture of changes in the market for specific SVHCs where

there is better data available (which may not be as readily available for all SVHCs)

Section 47 ndash Findings using other statistic sources summarises market changes that can be

observed using available statistical datasets including data held by ECHA and Eurostat

The data collection process to assess changes in the market makes use of several different types of

information The literature review presents an overview of what is known already The Tier 2 case

studies focus on individual substances The survey responses provide a glimpse of stakeholder

views The statistical analysis from Eurostat provides an overview of those SVHCs where there is a

good match between the substance and the product classification coding used Collectively these

different approaches start to build up a bigger picture of the changes in the EU market as depicted

in Figure 41

Figure 41 Assessing changes in the market using different approaches

42 EU chemicals sector general trends and drivers of change

This section presents the main findings of a literature review on the overall trends in the EU

chemicals sector20 in terms of (i) sales value (ii) imports (iii) exports (iv) the number of

companies and (v) spending on RampD and investment Data on the overall chemicals sector includes

both Substances of Very High Concern (SVHCs) and those not identified as SVHCs By comparing

changes in the market of the SVHC (eg sales volume) to the overall trend in the market for all

chemicals this allows for inferences to be made on whether the overall change in the EU market

for SVHCs might be due to REACH authorisation or follows the same trends observed in the overall

20 It is acknowledged that the manufacturing sector is also be affected by the REACH authorisation process as

it also uses SVHCs An analysis of the effects of the REACH authorisation process on this wider sector was not

possible for this study due to a lack of comprehensive EU level data over time



EU chemicals market There are of course a number of other factors (other than REACH

authorisation) that could influence market changes in SVHCs (eg price consumer preferences and

availability of alternatives) This requires a more detailed assessment of the market which is only

possible on a substance by substance This is done through the two Tier 2 studies carried out (see

Section 45 and 46)

The insights in this section are mainly based on the information provided by The European Chemical

Industry Council (see CEFIC 2014 CEFIC 2016a CEFIC 2016b) While other sources were examined

as part of the literature review the review revealed that the analysis in these other sources also

relied on the same data provided by CEFIC Therefore the CEFIC data was used as the main source

for this section

The complete literature review can be found in Annex E2 For the aforementioned purpose the

following findings of the literature review are of particular relevance

The EU share of the global chemical market has declined significantly from 323 in 1995 to

147 in 2015

While the change in annual EU chemical sales revenue has largely mirrored changes in the

global market between 1995 and 2002 the trends are divergent since 2012 According to

CEFIC data (See Annex E2) EU chemicals sales values have declined while global chemical

sales values (outside the EU) have increased since 2012 Whether this trend continued for

2016 ndash 2017 remains to be seen as there is no CEFIC data available yet

The majority of EU production (764 on average between 2005 and 2015) is sold and used

within its 28 Member States The export market therefore plays only a limited role in

determining the overall performance of the EU chemicals market

The slight decline in EU chemical sales values observed since 2012 is mainly caused by a

decline in domestic (home) sales in the Member States producing the chemicals and

specifically sales within Germany France Italy the United Kingdom the Netherlands

Spain and Belgium which together account for 84 of EU chemicals sales

The trade balance of the EU chemicals industry is positive between 2005 and 2015 which

indicates that in terms of sales value the EU exports more chemicals than it imports In

2013 imports started to increase (according to sales values) which may partly explain the

decline in home sales mentioned above

Several sources point to a decline of EU competitiveness based on export data in the short

(ie since 2013) and long term (ie since 2003)

The EU chemicals sector has experienced an unusual period of stagnation between 2012 and

2015 following a period of continuous long-term growth between 2003 and the beginning of

the global financial crisis in 2008

In addition to the exchange rate RampD intensity and energy prices ndash which are identified as

the three main drivers of competitiveness by an Oxford Economics study conducted for

CEFIC (ie CEFIC 2014) - regulatory costs can be a relevant driver of competitiveness if

businesses recover increased regulatory costs through higher prices for customers



43 Summary of literature review

To create a basis for the assessment of new results produced by this study previous literature has

been reviewed to identify and consolidate existing knowledge about the effect of REACH

authorisation on the market of SHVCs Existing literature consulted as part of this review provides

mainly anecdotal information on how key factors influencing the performance of the SVHC market

such as changes in investment and RampD decisions ndash factors closely related to innovation ndash as well as

the EUrsquos competitiveness are affected by REACH

This sub-section summarises the key findings of the aforementioned literature review and will

thereby constitute the basis for an assessment of whether the results from the present study are

aligned with findings from earlier studies as well as an assessment of the reasons behind potential

differences

The complete literature review can be found in Annex E3 The main findings of this literature

review are as follows

With respect to innovation according to a stakeholder consultation conducted as part of

the EC (2015) report21 authorisation does have an impact on innovation as investors require

regulatory certainty about the use of substances that are essential to their investment and

innovation plans Other sources point to the potential of the REACH authorisation process

to drive innovation by encouraging and pushing companies to engage in substitution

activities Overall the existing literature provides no clear assessment of whether the

REACH authorisation process affects the market for SVHC positively or negatively Both

effects are therefore possible

With respect to long-term investment in the EU the reviewed literature provides some

anecdotal examples that the REACH authorisation process could delay or divert investment

to areas outside of the EU due to a lack of predictability surrounding REACH Examples

(noted in Annex E3) concerning the nanomaterial and pharmaceutical sectors illustrate the

potential of REACH to create an environment inducing companies to implement new

projects involving large investments in countries outside of the EU and are not subject to

REACH

In terms of competitiveness a minor negative impact is possible due to EU manufacturers

being at a competitive disadvantage compared to manufacturers producing outside the EU

as the requirements of authorisation do not apply to non-EU producers of imported articles

This argument is supported in some respect by quantitative evidence on the effect of

REACH on imports and exports ndash the comparison of which is a good indicator of

competitiveness The EC (2015) industry survey revealed that the majority of respondents

experienced no changes in imports and exports as a result of REACH while the impact on

MIrsquos has tended to be negative

The literature review also points to the potential of the authorisation process to influence

the SVHC market negatively through internal demand factors In fact a business survey

conducted as part of the EC (2015) reveals that 39 of all survey respondents answering the

question whether their customers requested the removal of SVHCs from their products

21 European Commission (EC) (2015) Monitoring the Impacts of REACH on Innovation Competitiveness and

SMEs Luxembourg Publications Office of the European Union



(n=242) and even 70 of article suppliers received such requests This indicates that the

authorisation process might harm the market of SVHCs by decreasing the acceptance of

products containing SVHC among customers

In addition the EC (2015) report points to the potential for REACH authorisation to cause a

downsizing (ie reduction of the number of active companies) of the market for SVHCs due

to increasing the probability of market withdrawals and relocation The extent of this

downsizing effect is not clear as it is questionable if relocation of a use is an economically

feasible option for SMEs that make up the majority (95) of the chemical industry

44 Survey responses

This section presents survey findings regarding changes in the EU markets for (possible) SVHCs and

the respective alternative substancestechnologies caused by the authorisation process It is based

on online survey responses given by industry stakeholders The analysis relies on data provided by

46 respondents

441 Changes in the supply of SVHCs and alternatives

Fifty-seven percent of respondents (26 out of 46) to the industry survey stated that the REACH

authorisation process had led to an impact on their organisationsrsquo production or supply of (possible)

SVHCs andor their alternatives These respondents provided 30 examples of such impacts For

each example respondents provided

The (possible) SVHC or alternative that was impacted

The usefunction of the substance

The marketproduct that was affected

The type and direction of changesimpacts and

Whether any of these changes can be attributed to factors other than the REACH authorisation

process

Table 41 lists the substances (and specific uses) for which respondents reported a change in

production or supply The table also shows the number of examples given for each substance

Chromium trioxide is the substance with the highest number of reported examples of changes in

production or supply (ie 13 examples) This is followed by lead chromate with three examples In

terms of uses plating is the use with the highest number of examples Three of 30 examples refer

to this use

Table 41 Changes in the supply of (possible) SVHCs and alternatives (industry survey)

No Substance CAS number

Number of

examples

provided

Affected use(s)

1 12-dichloroethane 107-06-2 2 Pharmaceuticals

Solvent

2 2-[4-(244-trimethylpentan-2-

yl)phenoxy]ethanol 9002-93-1 2

Biotechnology

Cell lysis during

manufacturing of

vaccines and

cleaning of




Number of

examples

provided

Affected use(s)

manufacturing

equipment

3 4-(1133-Tetramethylbutyl)phenol

ethoxylated 923-960-0 1 Surfactant

4 44-methylenebis[2-chloroaniline] 101-14-4 1 Curing agent

5 Bis(2-ethylhexyl) phthalate (DEHP) 117-81-7 1 Plasticiser

6 Chromium trioxide 1333-82-0 13

Anti-corrosive

Catalyst

Decorative function

Electroplating

Etching and plating

Metalacid reaction

inhibitor

Passivation

Plating

Production of hard

chromium

Surface coating

7 Formaldehyde oligomeric reaction

products with aniline 25214-70-4 1

Polymerisation

agent

8 Lead chromate 7758-97-6 3

Pigments

Pyrotechnic

mixtures

9 Lead monoxide 1317-36-8

7439-92-1 1 Glass production

10

NN-dimethylacetamide NN-

dimethylformamide 1-methyl-2-

pyrrolidone

127-19-5 68-

12-2 872-50-4 1

Solvent

11 Sodium dichromate 7789-12-0

10588-01-9 2

Passivation

Sensitiser

12 Not stated Not stated 2 Surface treatment

Not stated

Total 30

Notes The 30 examples were provided by 26 respondents

For 80 of the examples respondents indicated that the downstream user market of the SVHCs

were the markets affected most by the authorisation process The market of SVHCs themselves

were reported lsquoaffectedrsquo in 10 of examples This is not surprising since most survey respondents

were downstream users of an SVHC rather than MIs of the SVHC

To get an idea of the type of change that their organisation had experienced respondents were

asked to indicate whether they had experienced any of the following changes

Decrease in price of (possible) SVHC

Increase in price of (possible) SVHC

Conditions imposed on safe handling of the substance

Increase in number of suppliers of alternatives to the substance



Decline in number of suppliers of the substance

Figure 42 reports the number of cases (out of 30) in which respondents stated that their

organisation experienced the changes

Figure 42 Changes in the supply of SVHCs and alternatives ndash Type of impact (industry survey)

Notes This figure is based on 30 examples provided by 26 respondents

For nearly 70 of the examples respondents attributed the reported changes to the REACH

authorisation process rather than any other possible factor For those examples in which changes

were partially attributed to other factors the most common factor was an internal

strategydecision by the organisation to progressively substitute SVHCs especially when this can be

done cost-effectively

442 Closure and relocation of organisations

Despite seeking to find companies that may have closed production and or relocated outside of the

EU only three respondents provided information about the closure andor relocation of their

organisations in the industry survey This might indicate (although difficult to conclude with

certainty) that such instances of closure andor relocation to outside of the EU due to REACH

authorisation are rare despite the reported risks of such responses within existing literature

However given this small sample it is not possible to carry out a detailed or representative

analysis of the impacts of authorisation on closure or relocation of organisations using the survey

responses as a basis The costs of closure and relocation are discussed in Section 610 using a

different data source than the online survey

443 Changes in competitiveness

Forty-one percent of respondents (19 out of 46) to the industry survey stated that the REACH

authorisation process had led to an impact on their organisationsrsquo competitiveness (ie ability to

sell products) relative to their competitors in the EU and outside For each example respondents

provided examples providing information on

The (possible) SVHC that was impacted






Whether any of these changes are attributable to factors other than the REACH authorisation

process

Table 42 lists the substances (and a broad description of the use) for which respondents reported a

change in competitiveness The table also shows the number of examples given for each substance


competitiveness (ie 10 examples) In terms of uses plating is the use with the highest number of

examples Five of 21 examples refer to this use

Table 42 Changes in competitiveness - (possible) SVHCs (industry survey)


Number of

examples

provided

Affected use(s)


2 Chromium III 16065-83-1 1 Decorative function


Catalyst

Cold rolling for steel aluminium copper

Etching and plating

Passivation

Plating Surface coating Surface treatment

4 Chromium VI Chromium ion (Cr6+)

Hexavalent chromium 18540-29-9 2 Plating

5 Lead chromate 7758-97-6 1 Pigments


7439-92-1 1

Additive to increase

refractive index

7

Orange lead Lead chromate CC-

azodi(formamide) (ADCA) Lead

246-trinitro-m-phenylene dioxide

1314-41-6

7758-97-6

123-77-3

15245-44-0

1 Pyrotechnic

mixtures


7789-12-0 2

Passivation

Sensitiser

9 Not stated Not stated 2 Not stated

Total 21

Notes The examples were provided by 19 respondents

For 86 of the examples respondents indicated that the downstream user markets for the uses of

SVHCs were most affected by the authorisation process (as opposed to markets for the sales of the

SVHCs themselves or their alternative substancestechnologies) This is not surprising since most

survey respondents were downstream users of an SVHC rather than MIrsquos of the SVHC





More difficult to sell to their non-EU customers

Easier to sell to their non-EU customers

More difficult to sell to their EU customers

Easier to sell to their EU customers

The results (n=21) are presented in Figure 43 For over 75 of the examples respondents

attributed the reported changes to the REACH authorisation process rather than any other possible

factor

Figure 43 Changes in competitiveness ndash Type of impact (industry survey)


444 Changes in spending on innovationinvestment opportunities andor RampD

Seventy-six percent of respondents (35 out of 46) reported that the authorisation process had

impacted their organisationsrsquo spending on innovationinvestment opportunities andor RampD The

analysis of these responses is presented later in the assessment of the innovationinvestment and

RampD costs reported in Section 69

445 Changes in employment

Only fifteen percent of respondents (7 out of 46) to the industry survey stated that the REACH

authorisation process had led to an impact on the number of people that their organisation

employs Given the limited number of responses indicating a change in employment the results

presented in this sub-section should be interpreted with caution and that overall REACH may not

have had a significant impact on employment (to date)

Respondents provided eight examples of this impact For each example respondents provided

details on




The direction and magnitude of changesimpacts and



Whether any of these changes are attributable to other factors than the REACH authorisation

process

Table 43 lists the substances (and related uses) for which respondents reported a change in

employment The table also shows the number of examples given for each substance

Table 43 Changes in employment (industry survey)

no Substance CAS

number

Number of

examples

provided

Affected use(s)


2 Chromium trioxide 1333-82-0 2 Plating

Not stated

3

Chromium trioxide Sodium

dichromate Potassium dichromate

Dichromium tris(chromate)

1333-82-0

7789-12-0

10588-01-9

7778-50-9

24613-89-6

1 Anti-corrosive and

surface treatment


Hexavalent chromium 18540-29-9 2

Decorative function

Plastic etching


Total 8


For all the examples provided respondents indicated that the downstream user markets for the

uses of SVHCs were the ones most affected by the authorisation process (as opposed to markets for

the SVHCs themselves or their alternative substancestechnologies)

Respondents were asked to indicate the changes that their organisations experienced in relation to

the number of people they employ (Table 44) Most of the affected respondents (63) reported an

increase in employment by 1-9 workers in their organisations For five out of eight examples

respondents attributed the reported changes in employment to the REACH authorisation process

The finding should be used with caution As set out earlier most respondents indicated no impact

of REACH authorisation on the number of people they are employing

Table 44 Changes in employment ndash Type of impact (industry survey)

(based on 8 examples)

Decrease

gt1000 workers -

100 - 1001 workers -

10 - 99 workers 25

1 - 9 workers -

Increase

1 - 9 workers 63

10 - 99 workers 13

100 - 1001 workers -

gt1000 workers -

Total 100

Notes This table is based on 8 examples provided by 7 respondents



446 Changes in sales revenue

Only twenty-two percent of respondents (10 out of 46) to the industry survey stated that the REACH

authorisation process had led to an impact on their organisationsrsquo sales revenue Overall this would

suggest that REACH may not have had a significant impact on sales revenue (at least to date) The

results presented in this sub-section should therefore be interpreted with caution since they only

refer to a minority of respondents

Respondents provided 10 examples of this impact For each example respondents provided

The product sold

The market application of the product



process

Table 45 lists the sold products for which respondents reported a change in sales revenue in

conjunction with the reported market applications of these products The table also shows the

number of examples given for each product

Table 45 Changes in sales revenue (industry survey)

No Product sold

Number of

examples

provided

Market application(s)

1 Ammunition 1 Military sector

2 Chrome plated metal components 1 Automotive sector

3 Chrome plated parts 1 Automotive sector

4 Chrome plating of customer rolls 1 Cold rolling industry

5 Chromium trioxide (CAS no 1333-82-0) 2

Dehydrogenation

catalyst

Not stated

6 Lead monoxide (CAS no 1317-36-8 7439-92-1) 1 Glass production

7 Metal liner 1 PVD-chrome

8 Not stated 2 Aerospace sector

Printers

Total 10



their sales revenue (

Table 46) Most respondents (90) reported a decrease in their sales revenue by 11 to 19 For all

examples respondents attributed the reported changes in sales revenue entirely to the REACH

authorisation process The finding should be used with caution As set out earlier most

respondents indicated no impact of REACH authorisation on sales revenue



Table 46 Changes in sales revenue ndash Type of impact (industry survey)

( based on 10 examples)

Decrease

gt20 -

11 - 19 90

1 - 10 10

Increase

1 - 10 -

11 - 19 -

gt20 -

Dont know

-

Total 100


447 Changes in quality price or availability of organisationsrsquo products

Only twenty-four percent of respondents (11 out of 46) to the industry survey stated that the

REACH authorisation process had led to an impact on the quality price or availability of their

organisationsrsquo products Overall this would suggest that REACH authorisation may not have had a

significant impact on product quality price or availability (at least to date) The results presented

in this sub-section should therefore be interpreted with caution since they only refer to a minority

of respondents

These respondents provided 13 examples of these impacts For each example respondents

provided






process

Table 47 lists the substances (and uses of that substance) for which respondents reported a change

in quality price or availability The table also shows the number of examples given for each

substance With 5 examples chromium trioxide is the substance with the highest number of

reported examples In terms of uses plating is the use with the highest number of examples

Three of 13 examples refer to this use

Table 47 Changes in quality price availability (industry survey)


Number of

examples

provided

Affected use(s)

1 Chromates Not stated 2 Anti-corrosive

Surface treatment


Decorative function

Metalacid reaction inhibitor

Passivation




Number of

examples

provided

Affected use(s)

Plating




Pyrotechnic mixtures

5 Sodium dichromate 10588-01-9 2 Passivation

Sealant

6 Strontium chromate 7789-06-2 1 Primers and

coating

Total 13




the SVHCs themselves or their alternative substancestechnologies) This is not surprising since

most survey respondents were downstream users of an SVHC rather than MIrsquos of the SVHC

To get more specific information on the type of change that their organisation had experienced

respondents were asked to indicate whether they had experienced any of the following changes

Change in availability of final (end-use) product

Change in price of final (end-use) product

Change in quality of final (end-use) product


organisation experienced the respective change Respondents were asked about both positive and

negative changes but no respondent reported a positive improvement in the above listed areas

Most respondents stated that the increase in price was a result of increased production or

compliance costs (for complying with the authorisation process) The reduction in product quality

was said to be due to the substituting to alternatives that did not adequately replace the functions

provided by using the SVHC in the final products



Figure 44 Changes in quality price availability ndash Type of impact (industry survey)


For eighty-five percent of the examples respondents attributed the reported changes to the REACH


45 Tier 2 case study Diarsenic trioxide and arsenic acid

451 Rationale for considering these substances

Arsenic acid and diarsenic trioxide were identified as case study substances due to the very small

number of applications for authorisation submitted for them (four applications for diarsenic

trioxide one application for arsenic acid) This raises the question of whether the use of these

substances has always been this limited historically or whether use has fallen over time (or some

other scenario) If use is seen to have fallen over time the questions then are first how the

markets for these substances (and their substitutes) have changed over the course of this fall and

second to what extent the authorisation requirement for these substances might have contributed

to the falls and the associated market changes

A principal use for both substances is in the manufacture of speciality glass The MSC opinion on the

prioritisation of arsenic acid stated that the substance could act as a substitute for diarsenic

trioxide and presented this as a justification for prioritisation For these reasons the substances

have been grouped together for this case study

Note that diarsenic pentaoxide was prioritised for inclusion in Annex XIV at the same time as

diarsenic trioxide because of its potential to act as a substitute for the latter substance in glass

manufacture However at the time of prioritisation there was no registration dossier for diarsenic

pentaoxide and comments from industry indicated that there was no manufacture in or import into

the EU There were also no applications for authorisation to use this substance after its sunset

date Therefore diarsenic pentaoxide is not considered further in this case study

452 Substance profiles



A profile of the substances are summarised below in Table 48

Table 48 Substance profiles

Diarsenic trioxide Arsenic acid

EC nos 215-481-4 231-901-9

CAS nos 1327-53-3 7778-39-4

SVHC Classification Carcinogenic (Article 57a) Carcinogenic (Article 57a)

Exempted uses - -

Existing restrictions REACH Annex XVII entries 19 and 28 REACH Annex XVII entries 19 and

28

Entry 19 of Annex XVII of REACH is a restriction on arsenic compounds It restricts the use of arsenic

compounds in industrial water treatment marine anti-fouling paints and for the preservation of

wood (although derogations are made for certain wood preservation uses) Entry 28 relates to

carcinogens more generally and restricts the use of such substances in substances and preparations

placed on the market for sale to the general public

453 REACH Authorisation timeline

The REACH authorisation timelines for the two substances are given in Table 49 A date for the

inclusion of diarsenic trioxide in the Registry of Intentions has not been found The time frames for

the two substances are similar with around seven years between the Annex XV dossier for diarsenic

trioxide being submitted and its subsequent Sunset Date and six years for the same process for

arsenic acid The one-year difference between the two is due to the faster time it took for arsenic

acid to be prioritised onto Annex XIV following its entry onto the Candidate List

Table 49 REACH authorisation timelines


Registry of Intentions Not known 30042008

Annex XV dossier 26062008 29082011

MSC opinion on SVHC identification 01102008 24112011

Candidate List 28102008 19122011

Annex XIV recommendation 17102010 13122012

Annex XIV 21052012 22082014

Latest Application Date 21112013 22022016

Sunset Date 21052015 22082017

454 Market prior to REACH authorisation

Diarsenic trioxide

The initial Annex XIV background document produced by ECHA in 2010 presented information on

uses and volumes collected for ECHA by the consultancy RPA in 2009 However much of this



information was judged inaccurate by the Arsenic Consortium in their response to the associated

public consultation The background document was subsequently updated and drew heavily on the

Consortiumrsquos contribution Unfortunately the Diarsenic Trioxide Consortium declined to contribute

new information to this study This section is therefore based primarily on the final ECHA Annex XIV

background document

Table 410 presents information provided to ECHA by the Arsenic Consortium on the production and

use of diarsenic trioxide in the EU over the period 2008-2010 Figures might not balance due to

inaccuracies and uncertainties

Table 410 Diarsenic trioxide in the EU 2008-2010

tonnes pa Uses tonnes pa

Manufacture 1500 Production of ultra-pure arsenic metal 30-40

Manufacture of impure form 320 Chemicals 60

Import 500-600 Zinc production 500-600

Glass 100-150

CCA wood preservative (export) 70-100

Diarsenic trioxide export 1100-1200

Waste 200

Net placed on the market 2320-2420 Total use 2060-2250

Most diarsenic trioxide is produced as a by-product of copper (and to a lesser extent lead) smelting

and refining Therefore manufacture of diarsenic trioxide depends largely on the production

volume of these metals and the arsenic impurity levels in the ores The volume placed on the

market further depends on consumer demand ndash when demand is low a higher proportion of

diarsenic trioxide is disposed of as hazardous waste whereas when demand is higher (particularly

in eg the zinc sector) both manufacture and imports can increase Only two producers of

diarsenic trioxide were identified for the 2011 background document

The primary use (around 550 tonnes per annum) of diarsenic trioxide in the EU can be seen to be in

the manufacture of zinc metal by electrolysis This use was claimed as intermediate by the Arsenic

Consortium and is identified as an intermediate use in the registration dossier However this claim

was contested by ECHA in the background document on the grounds that diarsenic trioxide used in

zinc manufacture acts as a purificationprecipitation agent This case has since been reviewed by

the ECHA Board of Appeal that concluded that the case needs to be remitted to the Agency for re-

evaluation (although the Board of Appeal has not found ECHArsquos conclusion as to the substancersquos

intermediate status in zinc manufacture to be necessarily incorrect) According to the Nordenhamer

Zinkhuumltte GmbHrsquos application for authorisation diarsenic trioxide has a dual role in zinc

manufacture in the purification of zinc sulphate solution but also in so doing producing a copper

concentrate which is then sold on to a chemicals producer



The second major use of diarsenic trioxide (c125 tonnes per year) was in glass manufacture as a

decolouring agent for glass and enamels and as a refining and oxidising agent in the manufacture

of special glass and lead crystal According to the JRC (2009)22 special glass products cover a wide

range including lighting glass (tubes and bulbs) optical glass laboratory and technical glassware

borosilicate and ceramic glasses (cookware and high temperature domestic applications) and glass

for the electronics industry (LCD panels) The Arsenic Consortium comment also identified artisanal

glass manufacture (eg in Murano Italy) where diarsenic trioxide might be used for particular

reasons This was said to account for around 8 tonnes per year As with zinc manufacture the

Consortium claimed the use in glass to be intermediate a claim which was similarly contested by

ECHA on the grounds that the substance was judged not to be used in the synthesis of glass itself

but as a processing agent for modifying the properties of the glass and specifically as a

decolourising opacifying and fining agent However it is understood that since the publication of

the ECHA background document industry has clarified that certain special glass applications as in

the manufacture of ceramic glass used for cooker hobs and stove door windows involve the use of

arsenic compounds as a lsquonetwork formerrsquo which does class as an intermediate use the use as a

fining agent in the manufacture of artistic glass is still considered non-intermediate however

The use of diarsenic trioxide in copper-chromium-arsenic wood preservatives was in 2011 said to be

much reduced in the EU compared with previously due to the introduction of the restriction

described in Section 452 and only for export It was expected that manufacture would cease

before the first ECHA registration deadline of 2010 In any case this use falls under the Biocides

Directive and hence is exempt from the REACH authorisation requirement The other uses identified

in Table 410 are not discussed in the ECHA background document Use in pharmaceuticals

identified in the Annex XV dossier had reportedly ceased in the EU by 2010 although internet

searches in July 2017 reveal suppliers of arsenic trioxide as a treatment for leukaemia and other

cancers23 Other uses referred to in the same dossier related according to the Arsenic Consortium

to uses of arsenic metal not diarsenic trioxide

A use of diarsenic trioxide not identified (separately) in the ECHA background document was the

use as a processing aid to activate the absorption and desorption of carbon dioxide by potassium

carbonate from synthesis gas which was used for the production of ammonia by Yara France

Additionally the arsenic serves as a corrosion inhibitor in this process In Yararsquos application for

authorisation (see below) the carbon dioxide removal unit was described as containing 40 tonnes

of diarsenic trioxide and potassium carbonate requiring the addition of approximately five tonnes

of diarsenic trioxide per year to compensate for the conversion of diarsenic trioxide to diarsenic

pentaoxide which is regularly extracted from the system by filtration

A further use of diarsenic trioxide which has been the subject of an application for authorisation

but not identified (separately) in the ECHA background document is in the production of etched

circuits These are used in smartcards in a range of applications such as SIMs payment cards ID

cards medical sensors RFID chips data storage cartridges and so on This is a very minor use in

volume terms (15-30kg per year) and might well not have been current at the time the document

was compiled (2010)

From Table 410 it can also be seen that imports exports and waste also accounted for significant

volumes over the 2008-2010 period As already mentioned volumes going to waste can depend on

production volumes and demand particularly from the zinc sector and from export markets

22 Joint Research Centre (2009) Best Available Techniques (BAT) Reference Document for the Manufacture of

Glass 23 httpwwwtevaukcomhcptrisenox



According to the ECHA database import notifications were received only from Switzerland over the

period 2006-2017 primarily to Germany and France but also to Sweden Belgium and the

Netherlands 24 import notifications in total are listed in the ECHA database over this period

Notifications of exports over the period 2004-2017 number 83 over the 2004-2010 period

exclusively from Spain and Germany (25 entries with two from Bulgaria and one from France) to a

variety of countries including the United States Brazil Switzerland and India Volumes are not

reported in these notifications However the greater number of export notifications compared with

import notifications (11 over 2006-2010) could be consistent with the higher export volume

reported in Table 410 compared with the import volume

Arsenic acid

Information on the use of arsenic acid prior to authorisation is provided in the Annex XV dossier

which Norway prepared to establish the substance as a SVHC and in the background document (and

associated public consultation comments) prepared by ECHA in support of the substancersquos

prioritisation for inclusion in Annex XIV Unfortunately the Arsenic Acid Consortium declined to

contribute new information for this project so these documents are the source of information on

pre-authorisation uses of arsenic acid

According to the Annex XV dossier arsenic acid can be manufactured using a variety of different

processes a typical one involving the reaction of arsenic trioxide with nitric acid in the presence of

a catalyst The Annex XV dossier reported that there had been manufacture of arsenic acid in the

EU in 2010 but that this had stopped by 2011 According to the Annex XIV background document

the registration dossier was updated to indicate manufacture below 100 tonnes in 2012 Total

volume was in the 100-1000 tonnes band

The Annex XV dossier cites the US Minerals Yearbook in stating that 89 tonnes of arsenic acid were

reported to have been imported into the US from France in 2008 with a figure of zero in 2009 In

2007 five tonnes were reported as being imported from Germany and six tonnes from France in

2006 No imports from the EU are reported in the Yearbook after 2008 None of these exports is

listed in the ECHA export notifications database

The Annex XV dossier concluded based on data reported in registration dossiers that a decreasing

trend in the total manufactured and imported volume could be assumed although information on

the trend over a more extended time period was deemed to be unavailable

Three uses of arsenic acid were considered current at the time the dossier was compiled

Ceramic glass manufacture

Copper foil production for use in printed circuit boards (PCBs) and

In a preparation as an analytical standard for test and measuring instruments

The use of arsenic acid in glass manufacture was described in the ECHA dossiers as a fining agent in

the manufacture of speciality glass for removing bubbles from the glass melt The addition of

arsenic acid releases oxygen late in the fining process which makes the bubbles more easily

absorbed by the melt This use was said to account for 97 of the total volume of use of arsenic

acid Comments to the public consultation on the prioritisation of arsenic acid indicated that the

volume used in copper foil production (the only other significant use ndash see below) was around 10

tonnes per year which might put the volume used in ceramic glass manufacturer at around 300

tonnes The definition as a process agent lead ECHA to conclude at the time that this use was not

intermediate as was claimed by industry However the function of arsenic as a lsquonetwork formerrsquo

was described by Glass Alliance Europe (2012) as follows



ldquoArsenic acid [hellip] used in the production (synthesis) of glass [hellip] reacts with other raw materials

(substances) at high temperature to produce the new substance glass During this process the

oxides from the raw materials form a new random network where different elements are linked

together by oxygen bridges Arsenic acid is completely consumed during this chemical reaction and

no longer contained as such in the final substance glass [hellip] The physico-chemical properties of the

new substance glass (chemical resistance mechanical resistance transmittance colour inertness

etc) are a function of the composition and the network formed A different composition leads to a

different glass (chemicalmolecular) structure and consequently different physico-chemical

properties of the final product [hellip] The presence of arsenic ions in the network structure confers

unique properties to the glass such as a specific redox state clarity colour transmittance absence

of bubbles lack of inclusion etchellip which are critical to the function of glassrdquo24

As discussed in the previous section the use of arsenic compounds as a network or matrix former in

the ceramic glass sector is now accepted as an intermediate use Therefore no applications for

authorisation for this use would be expected

The use of arsenic acid in copper foil production for PCBs is described in the ECHA dossiers only in

confidential annexes In the public consultation a copper foil producer indicated that two

companies used arsenic acid in the EU for this use amounting to around 10 tonnes The application

for authorisation submitted by Copper Foil Luxembourg describes their use as being to encourage

the deposition of copper and to prevent the release of hydrogen when the surface area of the

copper foil is being increased by the deposition of additional copper onto the surface of the foil

Thus increasing the surface area involves deposition (lsquogerminationrsquo) and growth (lsquonodularisationrsquo)

of copper crystals onto the surface of the copper foil This process involves using the electrolysis

bath below the current diffusion limit by reducing the bath temperature the copper concentration

and the level of agitation However doing this risks the process giving off hydrogen instead of

depositing copper Arsenic acid helps to prevent this by increasing the cathodic overpotential of the

hydrogen

Finally comments to the public consultation revealed the use of arsenic acid in a preparation as an

analytical standard for test and measuring instruments for laboratory use This use was reported to

account for minute amounts (grammes) of consumption per year and ECHA indicated in its

response to public consultation comments that this use could be regarded as exempt from

authorisation under the scientific research and development provisions of REACH Article 56(3)

455 Applications for authorisation

Diarsenic trioxide

The applications for authorisation which were submitted for the use of diarsenic trioxide are

presented in Table 411 There were four applicants for five uses Two of these applications relate

to use in zinc for a total volume of around 840 tonnes per year ndash higher than the volume reported

by the Consortium for the ECHA background document There were two further applications for

use in gold electroplating and in the production of ammonia All authorisations have been granted

The authorisation was granted to Linxens with a review period of seven years The review period

argumentation for this application is not available from the public non-confidential version The EC

decision on this application states that lsquowork towards potential implementation of an alternative

in a period of not less than 3 to 5 years is ongoingrsquo suggesting that the applicant is working

24 Glass Alliance Europe (2012) Position Paper of the European Glass Industries on the Proposed Inclusion of

Arsenic Acid on Annex XIV



towards substitution of diarsenic trioxide with an alternative for this use Authorisation was also

granted to Yara with a (requested) review period of 22 months which was designed to allow the

applicant to continue use during the implementation of a substitute process Note that there were

no applications for use in the glass industry

Table 411 Granted authorisation for uses of diarsenic trioxide

Applicant Use Use description Volume

(tpa) Status

Review

period Substitution

Boliden 1 Purification of metal impurities in

zinc electrowinning process 700

COM

decided 12 N

Nordenhamer 1 Production of copper concentrate

in zinc electrowinning process 140

COM

decided 12 N

Linxens

1 Formulation into a mixture COM

decided 7

2 Processing aid in gold

electroplating 0005

COM

decided 7

Yara France 1 Processing aid in the production

of ammonia 5

COM

decided 22 mths Y

Arsenic acid

As shown in Table 412 there has only been a single application submitted for the use of around

three tonnes per annum in the treatment of copper foil for the manufacture of printed circuit

boards (PCBs) The Committee opinions have been adopted but the decision has not yet been made

by the Commission The opinions recommend a review period of seven years with the condition

that use volumes decline over time to reflect the outline substitution plan of the applicant

However the applicant had stated that it expected to need to use arsenic acid until 2030 as this

was how long it would take users with stricter requirements to accept circuits made with an arsenic

alternative Note again that as with diarsenic trioxide there were no applications from users in

the glass sector

Table 412 Applications for authorisation for the use of arsenic acid


(tpa) Status

Review

period Substitution

Circuit Foil

Luxembourg 1

Treatment of copper foil for

the manufacture of printed

circuit boards (PCBs)

3 Opinions

adopted 7 Y

456 Changes in the market for the substance and alternatives during the authorisation process

Diarsenic trioxide

At the time of the compilation of the Annex XIV background document around 2400 tonnes of

diarsenic trioxide were estimated to be produced in or imported into the EU with around 200

tonnes going to waste Zinc production was the biggest industrial use of this volume (550 tonnes)

with glass production chemicals and arsenic production estimated to constitute around 250 tonnes

Around 1300 tonnes were estimated to be exported (leaving a discrepancy of between 70 and 360

tonnes) Thus it can be seen (in Table 410) that although zinc production represented the biggest



industrial use of diarsenic trioxide in the EU the import-export volumes were even more

significant Two producers were identified in the EU in the 2011 ECHA background document It is

not known how many suppliers of imported material there were at this time

According to information provided by Eurometaux for this study there are currently four large

copper manufacturers in the EU (in Germany Poland Spain and Sweden) each of which is a

potential or actual supplier of diarsenic trioxide As indicated in Table 411 the use of a little

under 850 tonnes of diarsenic trioxide has been authorised almost all in zinc manufacture Use of

five tonnes per year was authorised to Yara France in the production of ammonia with a review

period of 22 months only This was designed as a bridging application to facilitate the substitution

to a process based on an alternative substance (See Section 54 for more information) This review

period has now expired and Yara did not submit a review report Yara has confirmed in

communications for this project that its ammonia operations were shut down in March 2017 (before

the end of its review period) and the modified vanadium-based plant started up in August 2017

The only other granted authorisation is for less than 1 tonne per year with a review period of seven

years

Use in the production of artistic glass was not authorised and hence might be assumed to have

largely ceased As reported by ECHA (2017)25 use of arsenic trioxide in the artistic glass sector of

Murano Italy has been widely substituted following efforts by local authorities to advise users of

the authorisation requirement (See Section 54 for more information) During enforcement action

after the sunset date nine site inspections found that all but one firm had substituted to other

substances and local air pollution monitoring found that arsenic concentration had fallen by 98

between 2014 and 2016 indicating widespread substitution ECHA (2017) reports information from

the local chamber of commerce and the Italian workersrsquo insurance institute (INAIL) which indicated

that 300 companies were operating in the field of glass manufacturing in the Venice area where

Murano is located This information was combined with data obtained from the major local

distributor of diarsenic trioxide which showed that in 2013 around 24 companies in that area were

using around 5 tonnes of the substance (compared with 8 tonnes given by the Arsenic Consortium in

the public consultation submission Although this suggests that use in the Murano area has largely

(and possibly entirely) ceased it is not clear whether unauthorised use might be continuing in the

artistic glass sectors in other countries or what has happened to the 92-142 tonnes of use

identified by the Arsenic Consortium as occurring in the special glass sector Use in glass production

is still (as of September 2017) listed in the registration dossier as an intermediate use (and does not

distinguish between use for network formation and use for other reasons)

Volumes associated with imports and exports of diarsenic trioxide are not available but the ECHA

PIC database lists the number of exports and imports and the countries involved as shown in Table

413 Thus the number of imports has remained approximately the same over the 2006-2017

period with a slight peak in 2015 (No data are provided for 2004 or 2005) All of these imports

have come from Switzerland Export notifications were approximately stable over the period 2004-

2013 but since then have appeared to increase quite markedly This would be consistent with a

reduction in domestic use around the time of the latest application date (end 2013) even though

overall use volumes might not necessarily appear to have fallen particularly when Table 410 and

Table 411 are compared Eurometaux have also communicated intelligence for this study to the

effect that disposal of diarsenic trioxide to waste might also have increased since authorisation

ostensibly due to a reduction in EU demand for the substance EU copper producers were contacted

for this study in an attempt to explore these issues although only one responded The view

25 ECHA (2017) Artistic glass manufacturers in Murano Italy substituted arsenic trioxide to safer alternatives

air concentrations of arsenic reduced by 98 in two years Helsinki ECHA



expressed was that the market for diarsenic trioxide had been declining for some years already

which was largely ascribed to restrictions on the use of arsenic in wood preservation products

authorisation had not according to this producer strengthened these existing trends significantly

However it should be noted that historically use volumes of diarsenic trioxide have been

dominated by a relatively small number of uses so significant impacts of authorisation on individual

use types (eg in artistic glass manufacture) could still occur without causing significant

supplydemand impacts at the market level

Table 413 Import and export notifications for diarsenic trioxide 2004-2017

Year Exports Imports

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

1

2

4

2

5

5

6

2

1

4

20

6

12

13

nd

nd

2

2

3

2

2

2

2

0

1

6

1

1

Regarding the possible impact of authorisation on the market for alternatives the principle uses of

diarsenic trioxide are in zinc manufacture and the production of special glass The former is subject

to long-term authorisation The latter has not been authorised but it is not clear to what extent

this reflects substitution or (claimed) intermediate use Certainly the artistic glass sub-sector has

seen significant substitution activity at least in the Murano area of Italy with switches suggested

to a range of alternative substances The ECHA case study document on Murano reported that out

of 104 companies operating in the field of artistic glass in a 2015 survey 18 indicated that they

used diarsenic trioxide until 2014 but had substituted to antimony trioxide cerium dioxide lithium

oxide andor blast furnace slag The ECHA estimate of the total volume of diarsenic trioxide used in

Murano before this substitution was around 5 tonnes which is small compared with the

manufacturedimported volumes of these substances listed on the ECHA website26 Other uses of

diarsenic trioxide are even more minor in volume Therefore significant authorisation-related

changes in the market for alternatives to diarsenic trioxide are not to be expected However

specific information on changes in markets for alternatives to diarsenic trioxide has not been found

in this study

Arsenic acid

26 The Substance Information section of the ECHA website gives the following manufactureimport volumes

10000+ tonnes (antimony trioxide) 1000+ tonnes (cerium dioxide) No registration is listed for dilithium

oxide Blast furnace slag is exempt from registration as a UVCB substance (httpwwweuroslagcomstatus-

of-slagreach) The industry association Euroslag gives volumes for blast furnace slag of more than 20 million

tonnes per annum



The Annex XV dossier and Annex XIV prioritisation background document identified speciality

ceramic glass for use in high-temperature applications as by far the biggest (97) user of arsenic

acid at that time Use in copper foil manufacture was the only other material use described and

had been identified in public consultation comments as accounting for around 10 tonnes per year If

this represents around 3 of total consumption this would put ceramic glass use at around 300

tonnes per year at this time

The documents also indicated that manufacture in the EU had ceased around 2010-11 but

lsquoreappearedrsquo around 2012 when the registration dossier was updated Discussions with Circuit Foil

Luxembourg for this project support cessation around this time when it was claimed that

manufacture had ceased at this point because the manufacturer deemed the costs of registration

andor authorisation too high to be justified by the value of the market This had obliged Circuit

Foil Luxembourg to submit its own registration dossier (at considerable cost) to enable it to import

arsenic acid into the EU

The public consultation on the proposal to prioritise arsenic acid for inclusion in Annex XIV had

identified two firms using arsenic acid in the production of copper foil for PCBs Circuit Foil

Luxembourg have reported to this study that the second firm closed its facility in Europe in 2014

although it was not clear whether this was for REACH-related reasons Google searches reveal at

least one additional manufacturer of PCB copper foil in Europe27 but it has not been possible to

contact this manufacturer to ascertain the nature of its production process

As described above the vast majority (97) of the arsenic acid used in the EU in 2011 was in the

manufacture of ceramic glass which is classed as an intermediate use It is reasonable to expect

therefore that pressures to substitute this use have not been significant although no evidence is

available to support this

Moreover Copper Foil Luxembourg in discussions for this study stated that the availability of

arsenic acid in Europe has reduced around the time of the first REACH registration when

manufacture in Europe had ceased This would provide an encouragement to users to substitute or

find alternative supplies However as already discussed the ECHA prioritisation background

document states that the registration dossier had been updated in 2012 and manufacture below 100

tonnes indicated Manufacture is listed in the current registration dossier Contact was made with

this manufacturer (listed in the registration) but unfortunately they did not provide information

for this study

As also already mentioned the Circuit Foil Luxembourg application for authorisation indicated that

a (confidential) alternative to arsenic acid had been identified and introduced gradually for five

years already by the time the application was submitted Gradual introduction was envisaged to

continue with the final most stringent applications finally being substituted by 2030 at the latest

This substitution process might be expected to be expedited if the RACSEAC recommendation of a

seven-year review period (instead of the 12 requested by the applicant) is accepted in the final

authorisation decision Given the confidential status of this application it is not possible to assess

how Circuit Foil Luxembourgrsquos substitution activities might affect the markets for the substances it

intends to substitute towards

27 httpwwwgoettledeenproducted-folie-von-5-400C2B5m-mit-und-ohne-treatment-

batteriefolien_2015-08-13_10-38-12_2016-07-15_09-10-06



As with diarsenic trioxide by far the biggest use of arsenic acid (in the production of ceramic glass

for high-temperature applications) is an intermediate use and hence outside of the scope of

authorisation The remaining uses are extremely minor Hence significant authorisation-related

changes in the market for alternatives to arsenic acid are not expected

457 Summary conclusions on the impact of authorisation on these and related markets

The markets for arsenic acid and diarsenic trioxide are complex and inter-related In fact one of

the justifications for prioritising arsenic acid given in the Member State Committee opinion on the

fourth Annex XIV prioritisation was so as to prevent substitution of uses of diarsenic trioxide

straight to arsenic acid Assessing changes in these markets is complicated by the fact that major

uses have been claimed intermediate by industry and disputed by ECHA Unfortunately both the

Diarsenic Trioxide Consortium and the Arsenic Acid Consortium declined to contribute information

to this study and it has proved difficult to identify individual companies willing to provide

comment

What seems apparent from the information which has been collected is that authorisation has had

impacts on the markets for both diarsenic trioxide and arsenic acid In the former case

authorisation has incentivised substitution in the artistic glass sector as well as by two

authorisation holders in the ammonia and electronics sectors Use in zinc manufacture does not

appear to have been affected but there is evidence that overall use in the EU might have fallen

relative to production given the increase in export notifications and the reported increase in

disposal to waste

Regarding arsenic acid there does appear to have been some disruption to the supply of the

substance with the registration dossier being updated to reflect cessation and recommencement of

manufacturing in the EU One user reported having to submit its own registration dossier to be able

to import because its previous EU supplier had decided to exit the market It is possible also that

some disruption has been caused by the disputed status of arsenic acid use in ceramic glass

manufacture as intermediate No authorisations for this use were received

46 Tier 2 case study HBCDD

The substance hexabromocyclododecane was selected for a second-tier case study for a number of

reasons

The substance had a relatively high number of applicants (13 the fourth highest of all

applications made to date covering many of the downstream users for the EPS use)

although a low number of applications (one) and uses (two)

A technically and economically feasible alternative was found but it was not available in

sufficient quantity to all applicants The sufficient supply of the alternative was secured by

other companies for their uses (that did not apply for authorisation)

HBCDD is to date the only PBTvPvB substance having gone through the application for

authorisation step of the process

461 Substance profile

A profile of the substance is summarised below in Table 414



Table 414 HBCDD substance profile

HBCDD

Substance name Hexachlorocyclododecane (and all major

diastereoisomers identified)

EC nos 221-695-9

247-148-4

CAS nos

25637-99-4

3194-55-6

134237-50-6

134237-51-7

134237-52-8

Stage in authorisation process On Authorisation List

Sunset date past Yes

SVHC Classification - Intrinsic

property(ies) referred to in Article 57

PBT (Article 57 d)

Exempted (categories of) uses None

Existing restrictions No


The REACH authorisation timelines for the substance is given in Table 415

Table 415 HBCDD REACH authorisation timeline

Date

Annex XV dossier 30062008

Date of inclusion (Candidate list) 28102008

Annex XIV recommendation 01062009

Annex XIV 17022011

Latest application date 21022014

Sunset Date 21082015


HBCDD was assessed under the pre-REACH Existing Substances Regulation (ESR) programme and a

Risk Assessment Report (RAR) was finalised in 2008 The rapporteur was Sweden (done by the

chemicals regulator KemI) A risk reduction strategy (RRS) was prepared in 2007 (prior to the

official finalisation of the RAR) Based on the risks identified in the RAR the RRS recommended

limitations on uses (ie in textiles high impact polystyrene (HIPS) expanded polystyrene (EPS) and

extruded polystyrene (XPS) with exemptions for certain uses of HBCDD in EPS and XPS) In

addition the RRS recommended

The compulsory marking of exempted uses of HBCDD in EPS and XPS products and

classification of used material and products containing HBCDD as hazardous waste under

the Hazardous Waste Directive



Inclusion of HBCDD as a priority hazardous substance in Annex X of the Water Framework

Directive and

Development of a proposal for the inclusion of HBCDD in the Stockholm Convention on

POPs

Sweden prepared an Annex XV dossier proposing the substance as SVHC the Member State

Committee adopted a support document identifying the substance as SVHC (PBT) in 2008) The

substance was recommended by ECHA for inclusion in Annex XIV (ECHA prioritisation report January

2009) and was afterwards included in Annex XIV by the Commission (2011)

According to the ECHA background document (200928) HBCDD was manufactured at only one site in

the EU with an annual production volume assumed to be 6000 tonnesyear in 2005 Between 2000

and 2004 about 1000 tonnesyear of HBCDD were micronised in a grinding process occurring at a

very limited number of sites mainly for use in the textile industry It was considered likely that the

production of micronised HBCDD had reduced and was estimated to be about 210 tonnesyear

Again according to the ECHA 2009 background document at that time (pre-REACH) the total

volume of HBCDD used in the EU had been increasing over the years and was estimated to be about

11580 tonnesyear in 2006 It was believed that net imports of HBCDD had increased from less

than 4000 tonnes per year to close to 6000 tonnesyear between 2003 and 2007 The quantities of

HBCDD exported as such or in preparations as well as import in preparations were unclear No

reliable quantities of importexport of HBCDD in articles were available However it was

considered that HBCDD was likely to be imported in considerable amounts particularly in packaging

materials textiles and electricalelectronic equipment The volumes are summarised in Table 416

below

Table 416 Summary of volumes of HBCDD (excludes imports in articles) ndash 2006 data

Use Volume tonnes per year

Manufacture asymp 6000

Micronising1 1000

Net import (substance and preparations) asymp 6000

Net import (in articles) No data

Total use volume (2006) asymp 12000

1 The tonnage of HBCDD used in micronising is already included in the tonnage of the substance manufactured

Source ECHA 2009

HBCDD was reported solely as an additive flame retardant in the following main product types (data

for 2007 IOM 200829)

Expanded Polystyrene (EPS)

Extruded Polystyrene (XPS)

28 ECHA (2009) Prioritisation and Annex XIV Background Information 14 January 2009 29 IOM (2008) Data on Manufacture Import Export Uses and Releases of HBCDDD as well as Information on

Potential Alternatives to its Use Framework contract ECHA20082 (specific contract

ECHA200802SR4ECA226)



High Impact Polystyrene (HIPS)

Polymer dispersion for textiles

In all products HBCDD is uniformly incorporated as an integral encapsulated component within the

polymer matrix However it is not bound to the matrix or transformed (IOM 2008)

The main uses for EPS are insulation panelsboards in the construction sector and automobile

cushions for children Minor uses are packaging material and props for exhibitions films or similar

(IOM 2008) The use of EPS was reported as increasing from 3452 tonnesyear (2002) to 5301

tonnes per year in 2006 (IOM 2008)

XPS is mainly used in lsquocold bridgersquo insulation sandwich panels and different other uses in

construction materials (cavity insulation floors walls roofs etc) As with EPS XPS use had also

increased in the years 2002 to 2006 (3954 tonesyear to 5859 tonnes year from 2002 to 2006

respectively IOM 2008)

Although the use of EPS and XPS was expected to reduce slightly in the second decade of the

millennium because of the downturn in house-building affecting much of Europe in the longer

term industry predicted an increased use of insulation products as a response to increasing cost of

energy and awareness of climate change (IOM 2008)

The use of HBCDD into HIPS was mainly for video and stereo equipment distribution boxes for

electrical lines in the construction sector and refrigerator lining (IOM 2008) Different sources

estimate the HBCDD content of flame-retardant HIPS between 1-7 (ww) and the EU Risk

Assessment Report (cited in IOM 2008) assumed as a realistic worst case that HIPS contains 7

HBCDD The use volume has not changed in the last few years in Europe and is estimated as 210

tonnesyear (IOM 2008)

Micronised HBCDD is used in textile applications must comply with British and German DIN flame

retardant standards (IOM 2008) mainly for upholstered furniture and seating in transportation

draperies bed mattress ticking interior and automobile textiles A likely HBCDD concentration in

the final product was estimated to be 10-15 (IOM 2008) After a substantial reduction of this use

during the last few years it was estimated that only about 210 tonnes year were used in textile

coating (IOM 2008)

Table 417 provides an overview of the different uses of HBCDD The overall volume used (years

20062007) estimated on the statements of IOM (2008) was 11580 tonnesyear

Table 417 Summary table of the different uses of HBCDD EU (20067)

Use Volume tonnesyear No of sites

Expanded Polystyrene (EPS) 5301 21

Extruded Polystyrene (XPS) 5859 28

High Impact Polystyrene (HIPS) 210 3

Textile coating 210 16

Total 11580 47




There was a single application for two uses in EPS (compounding and conversion (ie making

articles)ndash in the same application with the same applicants) Companies producing XPS have

substituted before the sunset date and did not have to apply because enough of the polymeric

flame retardant (a brominated polymer) was available to them after the sunset date No application

for authorisation was submitted for the other uses Based on 20067 data EPS and XPS represented

96 of the volume use for HBCDD

465 Changes in the market for the substance during the authorisation process

The changes in market structure for HBCDD were dominated by the availability of the alternative to

HBCDD for both EPS and XPS The alternative which is for both (EPS and XPS) a brominated

polymer referred to as pFR was manufactured by the same firms that supplied HBCDD to the EU

market

The pFR alternative was known to be a higher cost product (ie it costs more for unit volume than

HBCDDD and more mass of pFR per mass of EPS is required to achieve the same function) ndash as

evidenced in the HBCDD authorisation application The AfA SEA indicated that an important

consideration was the effectiveness of the pFR alternative when compared to HBCDD on a weight

basis To meet fire safety requirements for EPS and XPS it was estimated that compared to

HBCDDD 13 times the amount of pFR was required for EPS and 11 times the amount is required for

XPS

Data presented in the AfA for HBCDD (SEA) indicate the demand for HBCDD in terms of the EU split

between ESP and XPS uses in 2007 (Table 418) and the global demand in 2011 (Table 419)

Table 418 Demand for HBCDD in the EU (2007)30

Volume produced

in 2007 (kilo

tonnes)

Amount used in

construction

applications ()

Amount

that is FR

()

Average

HBCDD

content ()

Total HBCDD

consumed (t)

EPS 1461 78 77 07 6138

XPS 313 94 98 225 6488

Total - - - - 12625

Table 419 Global demand for HBCDD (2011)

Region Total HBCDD (tonnes) Relative share of demand ()

Japan 2480 7

Americas 2480 7

Europe 14483 44

China 12090 37

Korea 1550 5

Total 33595 100

Notes

30 Table from non-confidential version of SEA from AfA for HBCDDD (EPS use)



1 Source Chemtura (2013) presentation for non-EU demand for HBCDD

2 EU estimate based on CMAI (2009) study data and growth rate of 4pa for EPS and 3pa

for XPS

The ECHA (2009) data show that EU demand for HBCDD had increased on average by 10 per year

over the period 2002 to 2007 In the AfA the applicants used confidential data (provided by the

application consortium members) which showed an increased demand for HBCDD for use in EPS

continued by ~12 per year over the period 2007-2011 Furthermore they estimated that the

demand for both final products (XPS and EPS) would increase even post-2020 due to the need to

meet energy policy (eg European Energy Performance of Buildings Directive that mandates energy

performance certification for new existing and renovated buildings to make buildings more energy

efficient)

At least one EPS producer that did not submit an AfA31 expressed a strong view that the AfA for EPS

use of HBCDD was not needed because there waswould be sufficient pFR available for all EU

users The adoption of the pFR in light of the successful AfA (granted to a consortium of EPS

manufacturers) placed these companies (that had already completely switched to the pFR) at a

competitive disadvantage because of the greater mass of pFR required to fire proof EPS (weight for

weight) the pFR is more expensive and there were significant costs to introduction of the pFR (eg

different dosing equipment (pFR is pellet HBCDD typically a powder)) trails and product

qualifications with customers The successful applicants however in theory could carry on using

HBCDD for two years (granted review period)

Substitution with the polymeric alternative for HBCDD

The Dow Chemical Company owns the patent to a block copolymer of polystyrene and brominated

polybutadiene known as the polymeric flame retardant or lsquopFRrsquo and granted licences to three

producers of HBCDD (namely Chemtura Albemarle and ICL IP) The pFR was initially designed as a

replacement for HBCDD in XPS use but can also be used for making EPS (albeit more pFR is needed

relative to HBCDD to achieve the fire-retardant requirements) At the time of the AfA

manufacturers were committed to making the polymeric alternative but there were uncertainties

about the number of production sites that would be fully operational by the sunset date if global

demand for EPS and XPS use was to be met For any pFR supply available XPS manufacturers and

some FR EPS producers that were not part of the consortium are understood to have secured

contracts for the initial supplies of the pFR that were available

As mentioned on the EUMEPS website32 the authorisation (granted on 8 January 2016 to a

consortium of companies) allowed the consortium member companies to use HBCDD in the

production of flame retarded EPS (FR EPS) and their customers to use FR EPS articles for building

applications up to 21 August 2017

According to a representative of the EPS consortium the authorisation was meant to serve as an

lsquoinsurancersquo in case of insufficient availability of alternatives However well in advance of the

original sunset date of 21 August 2015 the consortium started producing flame retarded EPS with

HBCDD-free formulations From end November 2016 the European EPS market was largely supplied

with HBCDD free EPS The companies that were granted the Authorisation started subsequently

announcing their withdrawal from the authorisation for use of HBCDD at the end of November 2016

31 Apparent from the public consultation on the AfA and from consultation done for this present project 32 httpseumepsorgnewssupply-of-eps-in-europe-is-now-HBCDD-free



Overall on the market the lsquopFRrsquo is not the only possible flame retardant alternative as indicated

in the AfA for HBCDD use for EPS There were also possible monomeric alternatives However those

alternatives had not been tested and trialled by the consortium members companies Therefore it

was not known if they could be viable alternatives either technically or long-term environmentally

It is possible however that some companies in the EU have used and are using flame retardants

other than the pFR or HBCDD for EPS Although the pFR is more expensive both because a greater

weight per weight of EPS is required and because the price per unit volume of pFR is higher (than

HBCDD) a more major factor in the profitability for EPS is the ability to pass on downstream

variations in the price of styrene monomer on a monthly basis (styrene base price)

Recycling

The authorisation process (in complementarity with the parallel activities under the Stockholm

Convention on POPs dealing also with waste containing POPs) affected the market for recycled

plastics since it changed the status of the products (for which authorisation for use of HBCDD in

their manufactureproduction was being sought) with regard to waste and recycling This impact

of recycling is considered by the Commission to be not related to Authorisation under REACH and is

therefore not assessed further in this report

466 Benefits from use of the substitute (pFR)

Consultation for this project with one major supplier of EPS indicated that no changes in worker

exposure were noted (HBCDD is a Cat 2 reproductive toxin) in the switch from HBCDD to pFR This is

because the same controls are essentially in place workers were as protected from dust exposure

then as they are now

There are environmental benefits from use of pFR The costs for environment controls are reduced

since the very low concentration of the WFD EQS for HBCDD leads to the need for very stringent

controls on releases to the environment (via waste water and sewage treatment works) However

the benefits to the environment from the switch to the pFR from HBCDD have not been quantified


Based on the available information the main market impact of the switch to the alternative for EPS

has been the higher price of the alternative for use in EPS It appears (from limited information)

that benefits in terms of a greater level of safety (lower exposure andor less need for risk

management measures) in the work place has not be realised since similar controls were in place

for dust protection However environmental benefits are envisaged since use of the pFR removes

the need for very stringent controls on waste water and reduce concentration in the (aquatic)

environment that were needed for HBCDD These benefits have not been quantified

47 Findings using other statistical sources

This section uses publicly available EU statistics to identify changes in the EU chemicals market

thereby allowing for inferences about the effect of REACH authorisation on the market



471 Data sources used

The information within this sub-section is based on (i) PRODCOM33 data about production imports

and exports provided by Eurostat and (ii) REACH registration data and data about ceased

manufacturing and importing of substances provided by ECHA

472 Manufacture import export and use of SVHCs

Ceased manufacturing and importing of SVHCs

As of November 2016 ECHA identified 103 registrants who have ceased manufacturing or importing

a substance which has been identified as SVHC Table 420 classifies these 103 cases by type of

registrant and whether the respective SVHC is on the Candidate or Authorisation List

Table 420 Number of registrants ceasing manufacturing of SVHCs

Registrant type On Candidate List On Authorisation List Total

Lead dossiers 6 4 10

Member dossiers 59 25 84

Not specified 4 5 9

Total number of dossiers ldquoceased

manufacturing or importingrdquo 69 34 103

Source ECHA - Data status 02112016

Table 421 shows the change in registration status for substances included on the authorisation list

The data shows that even after a substance is placed on the Authorisation List a significant number

of registrations remains In part this is due to the continued use of the substance for intermediate

uses which are not subject to authorisation Some of the ceased manufacturing is also potentially

related to joining two lead dossiers and in some cases due to a revocation decision by ECHA

Table 421 Change of registration status for substances on the Authorisation List

Substance on Authorisation List Remaining active

registrations Ceased manufacturing

Trichloroethylene 5 1

Diisobutyl phthalate (DIBP) 7 3

Dibutyl phthalate (DBP) 8 3

22-dichloro-44-methylenedianiline (MOCA) 5 1

44rsquo- Diaminodiphenylmethane (MDA) 10 3

12-dichloroethane (EDC) 36 6

Bis(2-ethylhexyl) phthalate (DEHP) 17 7

Diarsenic trioxide 6 1

33 PRODCOM provides statistics on the production of manufactured goods The term comes from the French

PRODuction COMmunautaire (Community Production) for mining quarrying and manufacturing sections B

and C of the Statistical Classification of Economy Activity in the European Union (NACE 2) Further details can

be found here httpeceuropaeueurostatwebprodcom





Chromium trioxide 26 2

Lead sulfochromate yellow 7 1

Ammonium dichromate 1 1

Sodium dichromate 17 2

Lead chromate molybdate sulfate red 7 1

Hexabromocyclododecane 6 2

TOTAL 158 34

Source ECHA Data status 02112016

The information in Table 421 reflects the status at the time of carrying out the analysis The

status of registrants changes over time and there is further evidence provided by ECHA that shows

more active registrants ceasing manufactureimport of an SVHC following the sunset date For

instance for the substance TCEP there is currently no active registrant whereas there had been 2

before the sunset date The document from ECHA focused on registered SVHCs for which the sunset

date had past The conclusion was that for 8 out of 11 SVHCs there was a reduction in the number

of active (not ceased) registrants between the latest application date and April 2017 The average

decline amongst those 8 was 32

Removal of certain uses from registrations during Annex XIV prioritisation rounds

REACH registrations are the main source of information for ECHAs priority assessment for

recommending substances from the Candidate List for inclusion in Annex XIV In this context ECHA

reminds registrants to update their registration dossiers with any new relevant information in

particular on uses and volumes

Table 422 below provides examples of substances for which registrants had removed from their

dossiers certain identified uses during a round of ECHArsquos prioritisation This may have happened in

the time during which the public consultation on a draft Annex XIV recommendation is held as a

reaction to the use overview information published by ECHA for a substance included in the draft

recommendation It may also have happened in the time until the next prioritisation round as a

reaction to the use overview summary published by ECHA in its prioritisation table for a substance

which had not been included in the current draft recommendation Typically the updates are

focused on professional or consumer uses the incentive being to decrease the priority of the

substance for inclusion in Annex XIV (occurrence of wide-dispersive uses in the EU increases the

priority score of a substance)

The examples were identified by checking published prioritisation documents for the past rounds of

Annex XIV recommendations Depending on the case for a given substance either all or the

majority or several registrants have removed the respective uses

Removal of a use previously identified in the dossiers of registrants means that their customers

cannot any more perform this use unless they submit have submitted a Downstream User report

(Art 38 of REACH) to ECHA In the absence of Downstream reports for the respective use and



provided that industry actors respect their REACH obligations34 removal from registrations may be

interpreted either as cease of use or as further assurance about not occurrence of use in the EU

The latter corresponds to the case where a use had been originally included in registration dossiers

only due to uncertainties about whether it still takes place downstream or not or due to a mistake

by the registrant in terms of the reported life cycle stage accuracy of use description

It should be kept in mind that the analysis performed in this report is limited to lsquousersquo data

Potential changes in the tonnage manufacturedimported or allocated to specific uses may of

course have occurred but they are out of the scope of this report

Table 422Examples of substances with removals of certain uses from registrations during Annex XIV prioritisation rounds

Substance (EC) Statements from published ECHA documentation

regarding AXIV priority assessment

Hydrazine (206-114-9) ldquoThe substance is reported as only used at industrial

site (Indication that the substance can be used by

professional workers has been removed in the updated

versions of the registration dossiers)rdquo

N-methylacetamide (201-182-6) ldquoAll other uses except the use as intermediate have

been removedrdquo

Cadmium (231-152-8) ldquoThe lead registrant and most of the members have

updated their dossier in 20142015 They have removed

the professional uses from their dossier and indicated

that professional (and consumer) uses are advised

against There is a

small minority of registrants (representing a low total

tonnage) who updated their dossier but did not remove

the professional uses and still report

professional use in cadmium based brazing products

cadmium-based soldering products and PVDcoating)

However these members refer to the lead registrants

CSR which no longer supports these usesrdquo

ldquoDossier updates were received in 2015-2016

Professional uses of cadmium based brazing

products and cadmium-based soldering products have

been removed from the majority of

the registrations The lead registrants CSR no longer

supports these uses The professional

use of brazing products if still happening in the EU is

expected to be limited to applications

derogated from the existing restriction under Annex

XVII (derogations apply to brazing

fillers used in defence and aerospace applications and

to brazing fillers used for safety reasons) No restriction

appears to apply to the use of cadmium based soldering

products and PVDcoating Considering the above it is

assumed that there is no professional use of

34 Information in eSDS supplied by registrants is kept consistent with registration Downstream Users

check and comply with eSDS received etc





cadmium in the EU (ie PROF not considered for

WDU)rdquo

Cadmium oxide (215-146-2) ldquoThe lead registrant and most of the member

registrants have recently updated their registrations

They have inter alia removed professional and

consumer uses from their registrations There are some

members who have not yet updated their registrations

and the professional and consumer uses remain in

their dossiers (eg use of CdO-containing polymers for

tube amp sheet articles) However these members refer

to the lead registrantrsquos CSR which no longer supports

these usesrdquo

Cadmium chloride (233-296-7) ldquoAccording to recently updated registration

information cadmium chloride is no longer

manufactured andor imported into the EU

However the registration status of the substance is still

active and uses in the scope of authorisation are still

registered

Therefore some uses of the substance may remain in

the EUrdquo

Lead monoxide (lead oxide) (215-267-

0)

ldquoThe lead registrant and most of the member

registrants have updated their registrations during the

spring of 2014 and they have removed the consumer

use of artistsrsquo paints containing orange lead from their

dossiers and CSR

Furthermore the International Lead Association has

informed that the use in artistsrsquo paints is an obsolete

use and the lead registrant has asked the member

registrants to update their dossiers There are some


and the use remains in their dossiers However these

members refer to the lead registrantrsquos CSR which no

longer supports the userdquo

Orange lead (lead tetroxide) (215-

235-6)





dossiers and CSR









Source ECHA (Aug 2017)

Production import and export of SVHCs



To identify changes in the EU chemicals market and a potential role of REACH authorisation

therein PRODCOM data was used to analyse trends in the production value as well as import and

export values of SVHCs Whilst PRODCOM data can be used as an indicator of market changes it is

important to be aware of the caveat that PRODCOM data is not broken down by uses of the

substance The total volumes used imported and exported therefore include uses (eg

intermediate use) that are exempt from authorisation and can continue to be used even after the

sunset date (if the SVHC is placed on Annex XIV)

The analysis was conducted by matching the 39 substances on the Authorisation List as well as 154

substances on the Candidate List with a PRODCOM code The substances were then classified into

five categories (ie 1 to 5) based on the quality of the match between the Candidate or

Authorisation List substance and the best-matching PRODCOM code The criteria used for the

classification are detailed in Table 423 in conjunction with an example for each category

Category 1 is the ideal category for the analysis of changes in production import and export of

SVHCs and the role of REACH authorisation in causing these changes Information about substances

in this category enables the most meaningful analysis of how changes in production import and

export coincide with key dates of the REACH authorisation process (ie date of placing the

substance on the candidate list and last application date) As there are only two SVHCs (12-

dichloroethane and methyloxirane) in Category 1 the nine PRODCOM codes in Category 2 relating

to 20 substances (ie 16 substances on the Authorisation and four on the Candidate List) have also

been considered for the analysis However since the PRODCOM data for some of the substances on

the Candidate List was incomplete the subsequent analysis is based solely on substances on the

Authorisation List for which complete datasets were available A list of these substances and the

relevant PRODCOM codes is provided in Table 424

Table 423 Classification of Candidate and Authorisation List substances based on quality of PRODCOM match

Cate

gory

Cri

teri

on

Example

Num

ber

of

PR

OD

CO

M c

odes

Num

ber

of

SV

HC

s

Subst

ance

PR

OD

CO

M

code

PR

OD

CO

M

desc

ripti

on

1 Exact match Single

substance in category

12-dichloroethane

(EDC) 20141353

12-Dichloroethane (ethylene dichloride)

2 2

2

Substance fits within category ldquoNarrowrdquo range of substances

within category

Hydrazine 20132580 Hydrazine and

hydroxylamine and their inorganic salts

9 20

3

Substance fits within category Larger

range of substances within category (Meaningful data

may be extracted)

Lead titanium trioxide

20121150 Titanium oxides 17 44



Cate

gory

Cri

teri

on

Example

Num

ber

of

PR

OD

CO

M c

odes

Num

ber

of

SV

HC

s

Subst

ance

PR

OD

CO

M

code

PR

OD

CO

M

desc

ripti

on

4

Substance fits within category However

the range of substances within

this category is too broad for meaningful

data to be extracted

Arsenic acid 20132460

Oxides of boron boric acids

inorganic acids (excluding hydrogen

fluoride)

35 83

5 Poor or no fit to a

category

24-dinitrotoluene

(24-DNT) 20141470

Derivatives of hydrocarbons

containing only nitro or only nitroso

groups

18 44

Table 424 Authorisation List substances (with complete datasets) in Category 2

Substance PRODCOM code

Name CAS No Description Code

Chromium trioxide

1333-82-0

Chromium manganese lead and copper oxides and hydroxides

20121200

Diarsenic trioxide

1327-53-3

Sulphur trioxide (sulphuric anhydride) diarsenic trioxide

20111250


24613-89-6

Chromates and dichromates peroxochromates

20135125

Lead chromate

7758-97-6

Lead sulfochromate yellow

1344-37-2

Pentazinc chromate octahydroxide

49663-84-5

Potassium chromate 7789-00-6

Potassium dichromate

7778-50-9

Potassium hydroxyoctaoxodizincatedichromate

11103-86-9

Sodium chromate

7775-11-3

Sodium dichromate

10588-01-9 7789-12-0





Strontium chromate

7789-06-2

Trichloroethylene

79-01-6

Trichloroethylene tetrachloroethylene (perchloroethylene)

20141374

12-dichloroethane is one of the SVHCs included in Category 1 Its date of inclusion on the

Candidate List and final application date are 19 December 2011 and 22 May 2016 respectively As

shown in Figure 45 the production value of this SVHC has mainly been in the range of euro250 to euro325

million between 2006 and 2015 The import value is very small compared to the production value

while the export value shown in Figure 46 is a reasonable share of the total production value This

indicates that the EU market relies on internal production and that the majority of production is

used in Europe

Figure 45 Production value and import value of 12-dichloroethane (ethylene dichloride)

Figure 46 Export value of 12-dichloroethane (ethylene dichloride)

Note LAD stands for last application date

In general the trend in production values of 12-dichloroethane is in line with the overall trend in

the EU chemicals market which has seen a continued increase of sales between 2005 and 2008 that

was interrupted in 2009 when sales values decreased significantly as a result of the global financial

crisis After a period of recovery and reaching pre-recession levels in 2011 the EU chemicals

industry has seen a small decline of sales since 2012 which is broadly in line with what can be

observed for the production value of 12-dichloroethane

Therefore data does not provide any indication of an effect of placing 12-dichloroethane on the

Candidate List This is not unsurprising as according to the background document35 published by

ECHA in November 2012 99 of the total volume of 12-dichloroethane is used as in intermediate

for the manufacturing of vinyl chloride monomers (VCM) and therefore exempt from authorisation

The second SVHC for which an exactly matching PRODCOM code could be found is methyloxirane

(propylene oxide) This substance has been placed on the Candidate List on 19 December 2012

Production values for methyloxirane (propylene oxide) range between euro1000 and euro2000 million

while import and export values are very small in comparison as shown in Figure 47 and Figure 48

The vast majority of methyloxirane produced in the EU is thus used internally

35 Available here httpsechaeuropaeudocuments1016238c352db-d89e-472f-9539-4fec08c6ca34



Figure 47 Production value and import value of methyloxirane (propylene oxide)

Figure 48 Export value of methyloxirane (propylene oxide)

The changes in the production value are generally in line with the trend observed in the EU

chemicals market This is also the case for the decline of the production value between 2012 and

2015 While the starting point of this decline coincides with the year in which methyloxirane was

placed on the Candidate List the inclusion in the Candidate List most likely plays a negligible role

in causing this decrease in production values The reason for this is that only a small proportion of

the total volume of methyloxirane seems to be affected by the authorisation requirement

According to the table presenting the results of ECHArsquos most recent priority assessment of

Candidate List substances only 1-10 tonnesyear out of a total volume of gt1000000 tonnesyear

are subject to authorisation36 There is consequently little indication for an effect of the

authorisation process on the market of methyloxirane

The next SVHC that has been analysed is chromium trioxide (CAS No 1333-82-0) This substance

was matched to the PRODCOM category titled ldquoChromium manganese lead and copper oxides and

hydroxidesrdquo and classified as belonging to Category 2

As shown in Figure 49 the production value for this category has ranged between euro200 and euro700

million between 2006 and 2015while import and export values were relatively stable over this time

period (as depicted in Figure 410) the share of imports relative to the total amount of chromium

trioxide available in the EU has increased since 2010

36 More information on the results of the priority assessment of Candidate List substances can be found here

(httpsechaeuropaeudocuments1016213640prioritisation_results_CL_substances_march_2017_enpdf3

91ae908-23f4-550d-94c9-090b922e50ec)



Figure 49 Production value and import value of ldquoChromium manganese lead and copper oxides and hydroxidesrdquo (PRODCOM code 20121200)

Figure 410 Export value of ldquoChromium manganese lead and copper oxides and hydroxidesrdquo (PRODCOM code 20121200)


The changes in production value are generally in line with those observed in the overall EU

chemicals market except for the fact that production values have to date not reached pre-

recession levels and that they do not follow an upward trend until 2012 but only 2010 There might

thus be a noticeable effect on the market resulting from placing chromium trioxide on the

Candidate List on 15 December 2010 This is investigated further in Section 10 which assesses

chromium trioxide in detail The effect of the final application date (ie 21 March 2016) cannot be

analysed currently due to no data being available for the period after 2015

The PRODCOM category titled ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo was used

to analyse the potential effects of subjecting diarsenic trioxide (CAS No 1327-53-3) to the REACH

authorisation process The process started on 28 October 2008 when diarsenic trioxide was placed

on the Candidate List The final date for application was 21 November 2013

The production value of diarsenic trioxide is very small (ranging from euro3 to euro55 million considered

together with sulphur trioxide) compared to that of the other analysed substances As depicted in

Figure 411 and Figure 412 imports and exports show very little fluctuations in terms of nominal

value and the majority of diarsenic trioxide produced in the EU is also used there Despite import

and export values being stable the production value has varied over time

Figure 411 Production value and import value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo (PRODCOM code 20111250)

Figure 412 Export value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo (PRODCOM code 20111250)


The changes observed after 2008 (when diarsenic trioxide was placed on the Candidate List) are not

in line with the trends observed for the EU chemicals market for the period from 2012 to 2015 The



production value of Sulphur trioxide (sulphuric anhydride) diarsenic trioxide increased from 2013

onwards while EU chemicals sales declined Thus data does not provide any indication of a

noticeable market effect of including diarsenic trioxide in the Candidate List Similarly the final

authorisation date has had no discernible effect on the market

The PRODCOM category ldquoChromates and dichromates peroxochromatesrdquo has been matched to

10 SVHCs The dates on which theses substances have been included in the Candidate List and the

final application dates are shown in Table 425 Apart from sodium dichromate which was put on

the Candidate List in 2008 all substances were included in the cCandidate List in 2010 or 2011

Lead chromate and lead sulfochromate yellow are the only substances for which the final

application data lies prior to 2016

Table 425 Substances matched to ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code 20135125)

Substance Date of inclusion (Candidate list)

Final application date Name CAS No


24613-89-6

19122011

22072017

Lead chromate

7758-97-6

13012010 21112013


1344-37-2 13012010 21112013


49663-84-5

19122011

22072017

Potassium chromate

7789-00-6

18062010

21032016


7778-50-9

18062010

21032016

Potassium hydroxyoctaoxodizincatedichr

omate

11103-86-9

19122011

22072017

Sodium chromate

7775-11-3

18062010

21032016

Sodium dichromate

10588-01-9 7789-12-0

28102008

21032016

Strontium chromate

7789-06-2

20062011

22072017

As shown in Figure 413 the EU has been reliant on imports with respect to chromates dichromates

and peroxochromates since 2006 In general the production value of chromates dichromates and

peroxochromates has declined significantly since 2011 while the import and export values have

seen little variation between 2006 and 2015



Figure 413 Production value and import value of ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code 20135125)

Figure 414 Export value of ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code 20135125)


Changes in the sum of production and import values for chromates dichromates and

peroxochromates (ie the amount available in the EU) are mostly in line with developments in the

overall EU chemicals market The only significant difference is that the EU chemicals market has

experienced growing sales values between 2009 and 2012 before starting a decline while the sum

of production and import values has started to decline in 2011 The significant drop observable in

2011 which is mainly accounted for by a significantly lower production value provides an

indication for a potential effect of placing several SVHCs on the candidate list in 2010 and 2011

The final application dates of lead chromate and lead sulfochromate yellow have no noticeable

effect on the market

Trichloroethylene (CAS No 79-01-6) was put on the Candidate List on 18 June 2010 and

companies were asked to apply for authorisation by 21 October 2014 According to the background

document37 for trichloroethylene developed by ECHA in the context of the third recommendation

for the inclusion of substances in Annex XIV the volume of trichloroethylene that is subject to

authorisation is above 10000 tonnesyear while the total volume lies between 50000 and 100000

tonnesyear The data provided for the PRODCOM category called ldquoTrichloroethylene

tetrachloroethylene (perchloroethylene)rdquo indicates that the production value declined significantly

from around euro110 million in 2006 to less than euro40 million in 2015 as shown in Figure 415

Figure 415 Production value and import value of ldquoTrichloroethylene tetrachloroethylene (perchloroethylene)rdquo (PRODCOM code 20141374)

Figure 416 Export value of ldquoTrichloroethylene tetrachloroethylene (perchloroethylene)rdquo (PRODCOM code 20141374)


37 Available here httpsechaeuropaeudocuments101629cedf499-8e10-4aef-b51d-82199a37dce5



The data presented in Figure 415 and Figure 416 also suggests that since 2010 the majority of

trichloroethylene and tetrachloroethylene produced in the EU is being exported rather than used in

the EU This is an indication for a potential effect of placing trichloroethylene (CAS No 79-01-6)

on the Candidate List However no conclusions can be drawn using this PRODCOM data as

tetrachloroethylene (perchloroethylene) is an alternative to the use of trichloroethylene

Therefore it is better to use different market data as can be seen later in a more detailed

assessment within Section 11

Conclusion

Based on the data analysis possible with publicly available PRODCOM data it is not possible to infer

what the effects of the authorisation process are This is because PRODCOM in most cases

(concerning SVHCs) merges SVHCs with other substances (similar in chemistry terms) together for

confidentiality reasons so substances cannot be assessed in isolation Where it has been possible to

assess a single substance using PRODCOM data these substances (volume wise) are mostly used as

intermediates and as it is not possible to isolate PRODCOM data to uses that are only subject to

authorisation Data is also only available until 2015 so overall PRODCOM has not been useful for

this project Further work could be done in the future using the confidential version of the

PRODCOM but this was not made available to the project team for this project

473 Manufacture import export and use of alternative substances

PRODCOM data was also used to analyse the potential effects of REACH authorisation on the

production import and export value of substances which were named as an alternative to an SVHC

by online industry survey respondents

Similar to the PRODCOM analysis of SVHCs (in Section 472) the analysis was based on matching

the mentioned alternative substances to a PRODCOM code where possible and classifying them

into one of five categories based on the quality of the match Table 426 presents the criteria used

for classification as well as the number of substances placed in each category and the number of

unique PRODCOM codes these refer to

Table 426 Classification of alternative substances based on the quality of the PRODCOM match

Category Criteria Number of

PRODCOM codes Number of substances

1 Exact match

Single substance in category 0 0

2 Substance fits within category ldquoNarrowrdquo range

of substances within category 2 2

3 Substance fits within category Larger range of substances within category (Meaningful data

may be extracted) 2 2

4 Substance fits within category However the range of substances within this category is too

broad for meaningful data to be extracted 5 6

5 Poor or no fit to a category 2 3



Only the four substances classified into Category 2 or 3 are deemed suitable for inclusion in the

analysis of changes in production import and export values as they can provide meaningful data for

this purpose For these categories the alternative substances and the PRODCOM categories they

have been matched to are listed in Table 427

Table 427 Assigned PRODCOM categories

It was necessary to exclude PRODCOM code 20141374 from the analysis as this code is identified as

being a match for an SVHC and included in the analysis of trends in production import and export

values of SVHCs in Section 472 Because of the simultaneous relevance of this PRODCOM category

for both SVHCs and alternatives a potential effect of REACH authorisation on the production

export and import value of the relevant alternative substance would not be discernible from the

data even if it existed

Figure 417 shows the trends in production and import values for Cyclohexanone and

methylcyclohexanones (PRODCOM code 20146233) Diazo- azo- or azoxy-compounds (PRODCOM

code 20144420) and Other esters of orthophthalic acid (PRODCOM code 20143420) in the left

column and the corresponding export values in the right column

Category

Alternative substance

Best-matching PRODCOM category

PRODCOM code

PRODCOM description

2 2-methylcyclohexanone 20146233

Cyclohexanone and methylcyclohexanones

Tetrachloroethylene (perchloroethylene)

20141374 Trichloroethylene tetrachloroethylene

(perchloroethylene)

3

4-(phenylamino)benzenediazonium hydrogen sulfate formaldehyde

(11) (Diazo)

20144420 Diazo- azo- or azoxy-compounds

Di-isononyl phthalate (DINP) 20143420 Other esters of orthophthalic acid



Figure 417 Production and import values as well as export value of ldquoCyclohexanone and methylcyclohexanonesrdquo ldquoDiazo- azo- or azoxy-compoundsrdquo and ldquoOther esters of orthophthalic acidrdquo

As Figure 417 shows PRODCOM data for these substances indicates no marked increase in the use

of alternatives (that were noted as a substitution for an SVHC) in the EU in the analysed time

period Based on the data analysis possible with publicly available PRODCOM data it is not possible

to infer what the effects of the authorisation process are on markets for identified alternative

substances to a previous use of an SVHC This is because PRODCOM in most cases combines

substances (similar in chemistry terms) together for confidentiality reasons so substances cannot be

assessed in isolation Data is also only available until 2015 so overall PRODCOM has not been

useful for this project Further work could be done in the future using the confidential version of

the PRODCOM but this was not made available to the project team for this project



48 Summary of observed market changes
















as an intermediate








































report












5 INSTANCES OF SUBSTITUTION

51 Introduction

Substitution ie the progressive replacement of SVHCs with suitable alternative substances and

techniques is a key objective of Title VII of REACH In this context substitution does not simply

mean replacing one substance for another but in-line with the objective of Title VII it is to replace

the SVHC whether that is with another substance or a technique Whilst information about

substitution is revealed through applicants for authorisation (AfAs) where applicants request

continued use of an SVHC the authorisation process does not require companies to inform ECHA (or

any other regulatory authority) that they have substituted and no longer use an SVHC

A number of substances that have been identified as SVHCs within REACH also have had other

regulatory and policy pressures on them which will have influenced the activities of users of these

substances to identify and implement alternatives For example CMR are substances that are

classified under the CLP Regulation as carcinogens mutagens and reproductive toxins (CMR) and

are prohibited for use by consumers in mixtures via a restriction in Annex XVII Directive

200437EC (lsquocarcinogens or mutagens at workrsquo) sets out an obligation to replace carcinogenic and

mutagenic substances in the workplace and prevent exposure (if replacement is not possible the

employer shall use closed technological systems) Other more substance-specific legislation has

also brought pressure to replace specific substances for example under the POPs legislation (eg

HBCDD) by banning or severely restricting use and other use-specific legislation such as restricting

the use of hazardous substances in electrical and electronic equipment lsquoRoHSrsquo - Directive

200295EC (eg hexavalent chromium and polybrominated biphenyls)

As is apparent from AfAs submitted to date the replacement of a SVHC substance is a complex

process and is highly dependent on the technical requirements of the process in which the

substance is being used Nevertheless there has been a considerable amount of research on the

general principles of substitution from methodologies for assessing alternatives to analysis of

specific substance types and identification of substances with similar functional properties but less

hazardous profiles (eg solvents that have the desired solvation properties but that do not meet

the Article 57 criteria for SVHC)

In this context a number of research programmes that promote substitution by for example

provision of databases case studies and shared experiences have been reviewed The detail of this

review is in Annex E4 which is summarised in Section 52

Key sources of information are the Tier 1 and 2 case studies which look in more depth at the

impacts of authorisation for specific substances In addition the results from the stakeholder

questionnaires and follow-up interviews have yielded insights into substitution Where substitution

has occurred the data gathered has allowed an attempted assessment of the effects of substitution

including assessing whether substitution has led to an overall reduction in risk (or hazard profile)

and what impacts (both positive and negative) the use of the alternative has had on demand

production costs their competitiveness product prices worker satisfactionconditions ability to

invest in RampD and profitability of the company Further detail is set out in Sections 54 and 55

below The Tier 1 case studies are set out in Sections 10 11 and 12




A number of publicly available tools are available (via the internet) to support in substitution

activities The bullet points below indicate the tools and information sources that were reviewed

and a concise summary given more detailed explanations are given in literature review Annex E

(E4) While case studies resources and methodologies are very useful and allow a systematic

process to be followed the substitution of a SVHC will normally be a complex process In all but the

simplest cases it appears that considerable product testing is required as is the adaptation of

production equipment and processes

SUBSPORT (EU based) - httpwwwsubsporteu a free-of-charge multilingual platform

for information exchange on alternative substances and technologies as well as tools and

guidance for substance evaluation and substitution management

Lowell Center for Sustainable Production (USA based) -

httpswwwumleduResearchLowell-CenterChemicals-Materials-ProductsAlternatives-

AssessmentAlternativesAssessmentaspx - process for identifying comparing and selecting

safer alternatives to chemicals of concern (including those in materials processes or

technologies) on the basis of their hazards performance and economic viability It is

intended to support decision making for scientific market or regulatory reasons

National Academy of Sciences (USA based) - A Framework to Guide Selection of Chemical

Alternatives httpswwwnapeduread18872chapter1 - on line book covering and

reviewing a wide aspect of replacement of chemicals

OECD (international) summarises a number of guide and programme on the assessment of

chemical alternatives httpwwwoecdsaatoolboxorgHomeAAGuides - Includes reports

and programmes (including the Lowell Center and SUBSPORT)

Royal Society of Chemistry (UK) ldquoChemical Alternatives Assessmentsrdquo ndash Book (not free

access)

US EPA (US-based) - Design for the Environment Alternatives Assessments -

httpswwwepagovsaferchoicedesign-environment-alternatives-assessments - Web-

based tool with key steps to conducting an alternatives assessment and case studies

BizNGO (US-based) The Commons Principles for Alternatives Assessment -

httpswwwbizngoorgalternatives-assessmentcommons-principles-alt-assessment -

Web based principles and tools for alternatives assessment

In some cases tools were developed to select alternatives for specific products and uses An

example of such a tool is ldquoCleantoolrdquo CLEANTOOL (httpwwwcleantoolorghome-3das-

projektlang=en) started in 2001 as a European Innovation Project with the goal to create a

database of best practice for the cleaning of metal surfaces The tools support the selection of the

best cleaning alternative based on very specific properties of the use such as the parts to clean and

the dirt to be removed This tool illustrates that substitution is often a matter of details about

specific use in order to be successful

The more detailed documentation of the literature review that can be found in Annex E4 indicates

in more detail some of the resources that are publicly available to assist with substitution

However although the methodologies cited are detailed and present frameworks for planning



substitution programmes these do not make the technical process of substitution substantially

easier or remove the specific barriers to substitution (which are technical and economic and linked

to specific uses) Specific uses require further considerations and the apparent technical feasibility

of an alternative does not guarantee that it is economically feasible leads to an overall reduction

in risks and is available in sufficient supply

53 Survey responses

This section summarises survey findings regarding instances of substitution due to the REACH

authorisation process The analysis relies on data provided by 83 respondents

531 Evidence of substitution from SVHCs

Forty-three percent of respondents reported that their organisation had substituted (possible)

SVHCs (Table 51) Most of them (approximately 77) substituted due to the REACH authorisation

process while approximately 23 say they substituted as a result of other drivers A further 29 of

survey respondents reported that they had undertaken activities to investigate the possibility of

substitution

Table 51 Whether respondents substituted a (possible) SVHC (industry survey)

(n = 83)

Yes partly due to the REACH authorisation process 33

Yes but not due to the REACH authorisation process 10

No but we are aware of substitution in our supply chain 2

No but we are investigating possibilities to substitute 29

No 27

Total 100

Those respondents that reported that they had substituted a (possible) SVHC (ie 37 respondents)

provided 61 examples of substitution For each example respondents provided

The (possible) SVHC that was substituted


The alternatives that the substance was replaced by and

The number of years required to substitute illustrated in

Figure 51

Table 52 lists the (possible) SVHCs for which respondents provided examples of substitution in

conjunction with the related uses and alternatives mentioned by the respondents The table also

shows the number of examples given for each substance Chromium trioxide is the substance with

the highest number of reported examples of substitution (ie 7 examples) This is followed by 12-

dichloroethane and the category lsquoChromium VI Chromium ion (Cr6+) Hexavalent chromiumrsquo for

which five and four examples were provided respectively In terms of uses the use as solvent and

plating applications are the uses with the highest number of reported examples (ie seven and four

examples of substitution respectively) In most cases substitution took place in the form of

switching to alternative substances In fact only eight out of 61 examples reported a switch to an

alternative technology



Table 52 Instances of substitution ndash (Possible) SVHCs uses and alternatives (industry survey)


Number of

examples

provided

Use of (possible) SVHC Alternative

1 12-dichloroethane 107-06-2 5 Softener for PVC

Solvent

Swelling agent

2-methylcyclohexanone

4-methylpentan-2-one

Alternative technology

Not stated

2 1-methyl-2-pyrrolidone 872-50-4 1 Solvent Not stated

3 2-(2H-benzotriazol-2-yl)-46-

ditertpentylphenol (UV-328) 25973-55-1 1 Stabiliser Bumetrizole

4

2-ethylhexyl 10-ethyl-44-

dioctyl-7-oxo-8-oxa-35-dithia-4-

stannatetradecanoate (DOTE)

15571-58-1 1 Stabiliser

2-ethylhexyl 10-ethyl-4-[[2-[(2-

ethylhexyl)oxy]-2-oxoethyl]thio]-4-

octyl-7-oxo-8-oxa-35-dithia-4-

stannatetradecanoate

5

4-(1133-

Tetramethylbutyl)phenol

ethoxylated

923-960-0 1 Surfactant Not stated

6 4-Nonylphenol branched and

linear na 1

Costabilizer for

plasticized PVC Triisotridecyl phosphite

7 Aluminosilicate Refractory

Ceramic Fibres (RCF) na 2

Insulation material

Protective heat insulating layer

Glass oxide chemicals

Not stated

8 Bis(2-ethylhexyl) phthalate

(DEHP) 117-81-7 2 Plasticiser

Di-isononyl phthalate (DINP)

Not stated

9 Bis(2-methoxyethyl) ether

(Diglyme) 111-96-6 1 Solvent Dimethyl sulfoxide

10 Bis(pentabromophenyl) ether 1163-19-5 1 Flame retardant Phosphinic acid PP-diethyl-

aluminium salt (31)

11 Boric acid 11113-50-1 2 Buffer substance

Plating Not stated

12 CC-azodi(formamide) (ADCA) 123-77-3 1 Smoke ammunition and

illuminating ammunition Alternative technology




Number of

examples

provided


13 Cadmium 7440-43-9 3

Manufacture of solder

Plating

Protection of aerospace hardware


Not stated

14 Chromic acid 7738-94-5

13530-68-2 1 Etching of copper

Disodium peroxodisulphate (Sodium

persulfate)


Anodising process

Anti-corrosive

Catalyst

Chrome plating

Electro-plating

Pre-treatment at colour-coating line

Not stated

2-ethylhexanoic acid chromium salt


Sulphuric acid

Titanium

Not stated

16 Chromium VI Chromium ion

(Cr6+) Hexavalent chromium 18540-29-9 4

Chromate conversion coating

Decorative function

Plating

Chromium III

Not stated

17 Dibutyl phthalate (DBP) 84-74-2 1 Plasticiser Not stated

18 Hexabromocyclododecane

(HBCD) 25637-99-4 3

Flame retardant

Not stated

13 Butadienestyrene copolymers

Polymeric flame retardant

Not stated

19 Lead 7439-92-1 1 Manufacture of solder Alternative technology

20 Lead chromate 7758-97-6 2 Pigments Polymeric flame retardant

Not stated

21 Lead sulfochromate yellow 1344-37-2 1 Pigments Various lead-free pigments

22 Perboric acid sodium salt

10332-33-9

11138-47-9

12040-72-1

37244-98-7

1

Bleachbleach precursor

in consumer laundry

tablets and powder

Disodium carbonate compound with

hydrogen peroxide (23) (Sodium

percarbonate)




Number of

examples

provided


23 Potassium dichromate 7778-50-9 1 Plating Not stated

24 Sodium chromate 7775-11-3 3

Descaling

Passivation of metals

Sensitiser in light-sensitive lacquer

4-(phenylamino)benzenediazonium hydrogen sulfate formaldehyde (11) (Diazo)


Chromium oxide


7789-12-0 3

Passivation

Softener

Nitric acid

Not stated

26 Trichloroethylene 79-01-6 2 Degreasing parts in

manufacture

Solvent



27 Trilead Dioxide Phosphonate 12141-20-7 1 Acid scavenger as part of stabilizer

Triisotridecyl phosphite

28 Not stated - 8

Passivation

Plastisiser

Solvent

Not stated

2-methoxy-1-methylethyl acetate

Not stated

Total 61




Figure 51 presents the survey results with respect to the time that it took to substitute the

(possible) SVHC The quantitative results presented in the pie chart have been derived by excluding

the answer categories lsquoUnknownrsquo and lsquoNot statedrsquo (which together contain 12 examples) from the

analysis The figure is therefore based on 49 examples Most respondents stated that it took their

organisations between 1 and 4 years (53) or 5 and 10 years (27) to achieve substitution

Figure 51 Instances of substitution - Number of years to achieve substitution (Industry survey)

Notes The figure is based on 49 of 61 examples (excluding the cases for which respondents said lsquounknownrsquo or

did not provide an answer

Respondents who substituted possible (SVHCs) due to the REACH authorisation process (the first row

in Table 51) were asked about the stage of the authorisation process which triggeredconfirmed

the decision to substitute (see Q19 in Annex F5) The quantitative results presented below have

been derived by excluding the answer categories lsquoNot surersquo and lsquoNot applicablersquo from the analysis

(which account for 67 of all answers given to question Q19) As shown by Figure 52 most

respondents reported that their organisations had substituted after the screening and RMOA stage

and before the AfA stage whereby

29 of respondents stated that their organisations substituted when substances were

included in the Candidate List

23 when substances were recommended for inclusion in the Authorisation List and

25 when substances were included in the Authorisation List



Figure 52 Stage in the REACH authorisation process that triggered substitution activity

532 Evidence of activities to investigate substitution

Fifty-three percent of respondents (44 out of 83) reported that their organisation had undertaken

activities to investigate the possibility of substituting (possible) SVHCs These respondents provided

71 examples of such activities For each example respondents provided

The (possible) SVHC for which the possibility of substitution is investigated

The usefunction of this substance and

The substitution activities being carried out

Table 53 lists the substances for which respondents reported that they are investigating the

possibility to substitute in conjunction with the related uses reported by the respondents The table

also shows the number of examples provided for each substance Note that some of the

respondents that indicated they have substituted a use of an SVHC (previous section) may also still

be using the SVHC (ie for different uses) or are still using a different SVHC that they are also

seeking to substitute away from Therefore the total number of respondents that have substituted

(n=37) andor those actively seeking to substitute (n=44) should not be added together

As with examples of full substitution in the preceding section chromium trioxide is the substance

with the highest number of reported examples of investigations of substitution (ie 17 examples)

This is followed by the category lsquoChromium VI Chromium ion (Cr6+) Hexavalent chromiumrsquo with

five examples and boric acid and 1-methyl-2-pyrrolidone (NMP) with four examples each In terms

of uses the use as solvent (nine examples) anti-corrosive agent (eight examples) and plating

applications (five examples) are the uses with the highest numbers of reported examples

Table 53 Substitution activities - (Possible) SVHCs and uses (industry survey)

No Substance CAS

number

Number of

examples

provided

Use of (possible) SVHC

1 12-dichloroethane 107-06-2 1 Solvent

2 1-methyl-2-pyrrolidone

(NMP) 872-50-4 4 Solvent

3

2-(2-[4-(1133-

Tetramethylbutyl)phenoxy]

ethoxy)ethanol

9036-19-5 1 Emulsifier



No Substance CAS

number

Number of

examples

provided


4

2-[4-(244-

trimethylpentan-2-

yl)phenoxy]ethanol

9002-93-1 1

Cell lysis during manufacturing

of vaccines and cleaning of

manufacturing equipment

5 44-isopropylidenediphenol

(bisphenol A) 80-05-7 2

Used in epoxy resins

Not stated

6 44-methylenebis[2-

chloroaniline] 101-14-4 1 Curing agent


Ceramic Fibres (RCF) na 1 Insulation

8 Aprotic polar solvents on

the Candidate List na 1 Solvent


(DEHP) 117-81-7 1 Component in glue

10 Boric acid 11113-50-1 4 Buffering agent

Micronutrient in biological fermentation processes

11 Cadmium 7440-43-9 1 Protection of aerospace hardware

12 Chromates na 1 Anti-corrosive


13530-68-2 1 Decorative function


Anti-corrosive

Catalyst

Conditioning and electroplating

Decorative function

Passivation

Plating

Reaction inhibitor

Surface treatment

Wear resistance

Not stated

15

Chromium VI Chromium

ion (Cr6+) Hexavalent

chromium

18540-29-9 5

Anti-corrosive

Decorative function

Plastic etching

Plating

Not stated

16 Cobalt dichloride 7646-79-9

7791-13-1 1


17 Cobalt salts - 1 Anti-corrosive

18 Disodium tetraborate

anhydrous

1303-96-4

1330-43-4

12179-04-3

2

Brazing flux

Used in smelting to increase fluidity


(HBCD) 25637-99-4 1 Flame retardant

20 Hexahydromethylphthalic

anhydride 25550-51-0 2 Hardener

21 Hydrazine 302-01-2

7803-57-8 2 Reduction agent



No Substance CAS

number

Number of

examples

provided


22 Lead 246-trinitro-m-

phenylene dioxide 15245-44-0 1 Used in pyrotechnic mixtures

23 Lead chromate 7758-97-6 1 Used in pyrotechnic mixtures


7439-92-1 1 Additive to increase refractive

index

25 Lead oxide 1335-25-7 2 Component of a glass paste

Solvent

26 Lead titanium zirconium

oxide 12626-81-2 1 Manufacture of electronic

components

27 NN-dimethylacetamide 127-19-5 1 Solvent

28 NN-dimethylformamide 68-12-2 1 Solvent

29 Nickel sulphate 7786-81-4 2 Anti-corrosive

30 Nonylphenol 25154-52-3 1 Component in glue

31 Nonylphenol ethoxylates 9016-45-9 2 Emulsifier


32 Orange lead 1314-41-6 1 Used in pyrotechnic mixtures


10588-01-9 3

Additive for suppressing parasitic reactions and oxygen evolution pH buffering and cathode corrosion protection

Passivation

Process chemical

34 Not stated Not stated 3 Coatings

Not stated

Total 71


Figure 53 shows that for most examples of substitution activities respondents reported that their

organisation had undertaken RampD activities to investigate substitution (55 of all examples)

Among those engaging in RampD activities a few reported that they are testing alternative

technologies or using alternative substances to continue to make the same product In 11 of

reported cases the organisations are currently in the process of product testing and requalification

of the products that will be made with alternative substance andor technology In a further 20 of

cases respondents were in the final stages of substituting a (possible) SVHC but had not completed

the process yet



Figure 53 Substitution activities ndash Types of activities undertaken (industry survey)

Notes This figure refers to 71 examples

Respondents who indicated that they were investigating the possibilities to substitute SVHCs were

asked about the stage of the REACH authorisation process which triggeredconfirmed these

activities (see Q60 in Annex F5) The quantitative results presented below have been derived by

excluding the answer categories lsquoNot surersquo and lsquoNot applicablersquo from the analysis (which account

for approximately 75 of all answers given to question Q60)

43 of respondents stated that the decision to investigate substitution originated when the

substances were included in the Candidate List39

27 when substances were recommended for inclusion on the Authorisation List and

11 when substances were subject to applications for authorisation

533 Drivers for substitution

This section presents information about the drivers for substitution based on the results of two

questions from the online industry survey

Respondents who indicated that they had substituted SVHCs or had been investigating substitution

through preparatory activities were asked to choose the three main reasons motivating them to

substitute a (possible) SVHC andor engage in activities investigating the possibility of substitution

out of a given list (Q62 in Annex F5) Figure 54 reports the number of respondents (out of 61) that

chose the respective reason as one of their top three reasons The figure shows that the top two

reasons for substitution activities selected by respondents are both related to the REACH

authorisation process (one option was the REACH authorisation process the other related to the

need to assess the suitability of possible alternatives as part of an AfA) The third most selected

factor for respondents whose organisations substituted was the REACH regulation in general (ie

not limited to the authorisation process) For respondents who did not (necessarily) substitute due

39 This is consistent with anecdotal evidence from the REACH 2012 report reported in Section 432 that ldquothe

placing on the Candidate List can lead in some cases to the launch of initiatives to develop new substances

or to the reformulation of existing substancesrdquo



to the authorisation process the fourth most selected factor was due to new opportunities in the

market using an alternative

Overall 33 of respondents indicated lsquoother reasonsrsquo as one of their top three reasons to substitute

or investigate substitution Some of the reasons mentioned were (i) business continuity (as the

company would then not have to worry about applying for authorisation) (ii) company internal

policies to phase out SVHCs (iii) internal company policies regarding the safety of workers and (iv)

requests by customers to transition to safer alternatives

Figure 54 Drivers of substitution activities (industry survey)

Note This figure shows the number of respondents (out of 61) that chose the respective reason as one of their top three

reasons for substituting or engaging in activities investigating the possibility to substitute

The respondents that did not engage in any substitution activities were asked to choose their three

main reasons for not carrying out any substitution activities out of a given list (Q64 in Annex F5)

Figure 55 reports the number of respondents (out of 21) that chose the respective reason as one of

their top three reasons The figure shows that the top reason that prevented respondents from

substituting SVHCs was the lack of technically feasible alternatives to deliver similar end-user

requirements This was followed by the lack of lsquonewrsquo alternatives worth investigating and financial

constraints and losing a competitive position in the market compared to those who continue to use

the SVHC

Approximately 24 of respondents chose lsquoother reasonsrsquo as one of their top reasons The reasons

they provided are (amongst others) that the substitution process was covered by the RampD program

of their partner (not them) and another noted that the identified alternative substance was

deemed equally hazardous for human health andor the environment A further reason mentioned

by one respondent is that the organisation applied for authorisation as a precautionary measure as

the organisation considers its use as an intermediate while ECHA did not



Figure 55 Barriers to substitution (industry survey)


reasons for not carrying out any substitution activities

54 Tier 2 Case studies

The tier 2 case studies provide further insights to the process of substitution as well as indicate the

drivers for those substitutions happening outside of the AfA process

During this study in addition to the online survey 49 interviews were conducted with various

stakeholders One of the focal points of these interviews was the lsquosubstitution strategyrsquo of the

stakeholders Twenty-seven of the companies interviewed were downstream users andor

applicants (both those that submitted an AfA or were covered by an AfA made by their supplier)

Three interviewees were suppliers of alternative substances or technologies NGOs were also

interviewed and provided their view on the barriers to substitution Nine industry associations were

interviewed who provided a wider view on the substitution issues of their members

NGOs expressed their concern that the authorisation process by itself could be a barrier to

substitution for companies that are granted authorisation their incentive to use alternative

technology will be low which slows down the introduction of new technologies Although this could

be correct in some cases (assuming that the timelines for introduction of alternatives in the AfA

AoA are exaggerated) interviews with other stakeholders showed that in several cases substitution

took place despite there being a case for applying for authorisation instead (see case studies 1 and

3 in this section)

Substitution can occur in the context of an application for authorisation or in absence of an

application for authorisation The first type of substitution (ie within the AfA process) can be

found within the substitution plans where the adequate control route is possible or within the

development plans (or something referred to as RampD plans) mentioned in the context of an applied

for use scenario under the SEA route These plans are discussed in the next section As such these

plans do not automatically lead to substitution as in most cases the feasibility needs to be

demonstrated (ie both lab testing and then pilot testing as well as end-usercustomer

testingapproval) but they provide some insight into how companies are considering substitution

The latter type of substitutions (ie in the absence of an AfA) are actual cases where SVHCs have

been substituted so no AfA was necessary These instances are difficult to find (ie in the public



domain) as they remain largely undocumented and are sometimes confidential Examples of both

types of substitutions are provided in this section

From the interviews it is clear that while the decision to substitute is case-specific it is driven by

some common considerations Overall the number of well documented cases of early substitutions

(that could be found) is limited Several companies indicated that a lot of substitution had been

done in the past but they were not able to provide much detail in the limited time context of the

interviews (for example because people change in the company and it is difficult to find details of

historical cases of substitution ndash However given many of these instances are prior to REACH

authorisation they are not relevant to document as part of this study)

Overall concerns that suggest that authorisation itself is a disincentive to substitution (because it

allows time-limited continued use rather than imposing blanket bans and forcing substitution)

would seem to be not well founded since the AoA forces the justification of continued use inter

alia on the basis of having done an assessment of possible alternatives and justifying why they are

not suitable

Further details of nine examples (cases) of substitution are presented below

Case 1 Use of a hexavalent chromium (CrVI) containing catalyst in a catalytic waste gas

treatment installation

This case relates to a production site of a large company active in life sciences The company

operates a large specialty chemicals manufacturing site Waste gases from the various production

installations were collected and used to be treated by a waste gas installation using a CrVI based

catalyst to destroy the hazardous substances present in the waste gas The installation was

essentially a closed-process installation with no operational exposure of workers during the use of

the substance Very limited exposure was only possible during loading and unloading of the catalyst

(an activity that did not happen every day)

When the CrVI based substance present in the catalyst was listed on Annex XIV the supplier of the

catalyst announced that the catalyst would no longer be supplied after the sunset date As a result

of this the company (a downstream user) using the catalyst started a programme to find a solution

for the problem that future supply of the catalyst would no longer be available from their supplier

Alternative catalysts were evaluated but failed technically because of the complex nature of the

waste gas stream A solution was found in an alternative technology called lsquoregenerative thermal

oxidizerrsquo Using this technology waste gases are burned with energy recovery (heat) This

technology provides the same level of emissions reduction of the hazardous substances in the waste

gas as the previous technology that used the CrVI based catalyst The investment cost for this new

installation was about euro11 million The new installation has a marginally lower operating cost of

euro100k per year The company did not consider or realise the option to import the catalyst directly

and to apply for authorisation themselves even though this solution would probably have been

cheaper

Because of the criticality of the waste gas treatment in the operation of a key production

installation relocation of the waste gas treatment or to stop processing the waste gas treatment

were both not a viable option As a result the high net cost of the replacement of the existing

installation was deemed necessary

In this example the main drivers for the substitution were

The identification and availability of a technically feasible alternative technology



Avoidance of using an Annex XIV substance and

Absence of another solution given their supplier ceasing supply of the catalyst (based on an

SVHC)

Case 2 Use of hexavalent chromium (CrVI) based acids for the plating of aluminium profiles

The authorisation requirement for CrVI containing substances such as chromium trioxide has proven

to be complex Several AfAs were made including large consortium driven applications small group

applications and individual downstream user applications However during several interviews it

was clear that several companies had substituted the use of substances such as chromium trioxide

prior to the sunset date and did not needhave to rely on an authorisation

An interesting case is the use of CrVI based substances as anti-corrosion coating for aluminium

profiles in the construction sector This industry is represented in the EU by ESTAL ESTAL

communicated to its members that authorisation for their use of CrVI would be difficult because of

the existence of alternatives The existing alternatives were known to be technically inferior to the

CrVI based solutions but it was presumed that this would not be sufficient to prove that an

authorisation should be granted

Based on this information a manufacturer of window frames assessed their specific situation and

decided not to apply for authorisation and decided to search and develop alternative technologies

for the anti-corrosion treatment of the aluminium profiles This decision was made knowing that an

upstream application was being prepared which could cover their use and would be a cheaper

option Because there has been no final decision yet on this upstream application and the

application was not made by this company it cannot be concluded if this is an instance of a

lsquoregrettable substitutionrsquo or not

In general this industry tends to be conservative regarding the replacement of anti-corrosion

technology Because without a proper anti-corrosion treatment parts of a window frame can

corrode causing blistering of the final lacquer coating Premature corrosion of window frames can

lead to significant customer complaints including consequential damage

A first type of alternative technology consisted of a Cr-free application of a very thin coating The

exact composition of the coating is confidential including to the aluminium plater This technology

was implemented based on a known technology but significantly improved by in-house

development The technology provides only a very thin and mechanically not very resistant anti-

corrosion layer Storage of the parts between the application of the anti corrosion layer and the

application of the final coating potentially can damage the thin anti corrosion layer Any damage of

this layer leads to a premature failure of the final product As a consequence the coated parts

cannot be stored between the anti-corrosion layer and the final coating Changes to the production

facilities and production procedures were required to accommodate this A second disadvantage of

this technology is its dependence on the quality of the base material as it is known that impurities

in the base material (specifically traces of iron) strongly affect the end result Because of the high

level of recycling of aluminium the possibility for iron contamination is high As a result the

company had to issue more stringent specifications for its raw material resulting in a slight price

increase (lt5) However this specification excluded sourcing the aluminium from the recycling

stream The processing cost for the alternative process is roughly the same as for the original CrVI

based process

To implement the alternative significant investments were required including for the on-line

process control Compared to the CrVI based process this alternative process is less robust and is

more sensitive to small variations in process conditions



A second alternative implemented by this company is a totally different process called lsquopre-

anodisationrsquo or lsquoanodicrsquo oxidation This technology allows an even higher corrosion protection

compared to the CrVI coating but has doubled the operating cost This technology is very robust

and tolerates iron impurities in the raw material The total investment made by this company to

implement both alternatives was euro3-4 million

Having implemented the two types of technology the manufacturer has mixed feelings On the one

hand substitution was more or less standard for this kind of application (aluminium coating in

construction sector) but there is still an AfA pending which would allow certain competitors to

avoid the investment It would be worth investigating in the future customer experiences with the


In this case the drivers for the substitution were

Based on a ESTAL communication that authorisation would not be possible

Availability of a known alternative technology with short development time

Control over raw material specifications and

Business model which allows absorption of the additional cost

Case 3 Use of an SVHC in the high-tech life science sector

This case concerns two companies considering relocation of their business to outside of the EU as a

direct consequence of the authorisation process The two companies use different SVHCs that were

at the time of the interviews in different phases of the authorisation process40 namely 12 DCE

(12-dichloroethane) and octyl phenol ethoxylate

Octyl phenol ethoxylate is a frequently used substance in the life science sector For instance in

this case it is used in the manufacturing of in vitro diagnostics kits Several manufacturers have

asked for clarification whether this use of octyl phenol ethoxylate would be exempt for

authorisation on the basis of the SRampD use of these kits This has been requested from the

authorities but they were unable to provide clear responses immediately As a result this company

immediately started to evaluate alternatives The volume of this substance required in this use is

small (less than 500 kg per year) The amount of octyl phenol ethoxylate present in the diagnostic

kits the end product is even smaller Nevertheless the exemption does not apply for their

particular case this company would have to look for an alternative or be required to apply for

authorisation The search for an alternative to the use of octyl phenol ethoxylate would in this case

require extensive scientific and development work (meaning there is no suitable alternative

available yet)

The 12 DCE is used in a high tech genetic engineering related technology The manufactured

product uses 12 DCE as solvent in volumes even smaller than the previous example (ie lt20 kg

year) The company with headquarters outside of the EU sees the authorisation process as a

complex process with no assured outcome The use conditions of the 12 DCE are cleanroom and lab

type of conditions with a very limited number of people involved and highly controlled conditions of

use Also in this case a search for alternatives would require extensive scientific and development

work (meaning there is no suitable alternative available yet)

40 More recently Otylphenol ethoxylate has been listed in Annex XIV



For both cases there are two common elements a lack of alternatives and regulatory certainty In

general these types of industry have a small physical size and can relatively easily (at least

compared to a large chemical site) be relocated

In one of the two cases it was decided not to apply for authorisation and to relocate this part of

the production (to outside the EU) In the other case the relocation option was being evaluated but

a decision was still pending at the time of interview In any case a project for a ldquocomplex and

costlyrdquo application for authorisation was not considered although for both cases the case for

authorisation would seem to be strong

For these two cases the main drivers for relocation are

Legal uncertainty

Lack of a technical alternative and

Realistic to relocate whole production outside of the EU

From consultation for this project it is known that the application and granting of patents in the

pharmaceutical industry for innovator based companies (ie companies that produce new products

under patent) is a critical factor The granting of a 25-year patent allows innovator companies to

make profit on products that no-one else can produce Therefore the optimisation of the patent

relies on applying for patent as late as possible in the product development process The

manufacturing process is included in the patent and changes to the process would require a new

patent to be applied for In the cycle of product development the closer the product gets to the

market the more investment is made (clinical trials are very expensive) Therefore unless SVHC

replacement can be made at an early stage in product development or review periods can be long

enough to cover the patent period an option will be to push production out of the EU to other

facilities (however if production facilities outside the EU do not already exist but they do in the

EU then the cost of development of those facilities can be prohibitively expensive)

Case 4 Regulatory burden as decision element

To illustrate that substitution of a substance is a result of many factors a case of a company

active in life sciences using an octyl phenol ethoxylate for two different purposes (uses) is

summarised here For both uses the required volume of the substance is low the use conditions are

very highly controlled and no suitable alternative is available at present However for one use

the substance is in direct contact with the final product and in the other use of octyl phenol

ethoxylate it is not The regulatory burden linked to substitution is different for the two different

uses because in one case there is a need to re-apply for marketing authorisation in the other case

not This was crucial in the decision-making process of the company to attempt to find a substitute

for one use (ie the one with the lowest regulatory burden) and to apply for authorisation for the

other use In fact even if a technically suitable alternative would be available it would be

impossible to obtain the regulatory approval before the sunset date required as a result of the

process change to continue to put the product on the market

Although as far as emissions are concerned the cost of the substitution most probably outweighs

the benefits of the non-use scenario in both cases only in one case the company decided to apply

for authorisation In the other case substitution was preferred even at a cost significantly higher

than the cost for an application for authorisation The reason for this mentioned by the company

was to avoid the perceived administrative and resource burden of the authorisation process and

the high likelihood to find an alternative before the sunset date



In this case the drivers for substitution were

Their ability to find and implement a suitable alternative prior to the sunset date and

Avoiding the authorisation process

Case 5 GreenCoat using an alternative technology for CrVI surface coating

The company GreenCoat uses an alternative technology to surface treat articles which does not

use Cr(VI) The technique is based on PVD (Powder Vapour Deposition) The company did not

develop the technology but has purchased it As such the company has the same role as a contract

plater using CrVI has today in the supply chain So far the company has invested about euro10 million

in this technology The company focuses on developing projects within the automotive industry for

the surface treatment of parts as this sector represents for them by far the biggest potential

market Developing this market opportunity takes about 9-12 months including process optimisation

and testing as the process needs to be repeated for each automotive part and for each car

manufacturer

An important step for further development of this market was the development of a specification

for PVD coated parts for the automotive industry This specification replaces a previous

specification for CrVI based surface treatment which was used to evaluate PVD coating Experience

has shown that in certain cases PVD coating has a clear advantage over CrVI based coatings This

advantage is related to a wider variety of base materials which can be used for PVD coating This

can for instance result in a cost saving - if cheaper base materials are used - or design

improvements - if high performance materials are used - allowing more complex designs

According to GreenCoat their technology could also be implemented in the sanitary industry

Although GreenCoat supplies their products to this market since 2013 the collaboration with the

sanitary industry seems today more difficult GreenCoat recognises that PVD coating is not a full

alternative for all CrVI based coatings but claims that for certain applications it is a real

alternative

Because of the lengthily process of introducing new PVD coated parts (for instance in the

automotive sector) the required build-up of capacity and the current price difference GreenCoat

expects that both technologies ndash CrVI based and PVD coatings - will coexist for the next 12 to 15

years This is an example where the authorisation process in principle can create new market

opportunity for new technologies in well established markets (where substitution may not have

happened without regulatory scrutiny on CrVI) However for comparison the companyrsquos turnover

is euro10 million whilst the total business volume for the automotive sector for surface coating is euro 1

billion (meaning they can only provide for a small part of the current market) However because of

the technical advantages and the expected cost reductions the company sees the replacement of

CrVI coating with PVD coating as a typical case of competing technologies The fact that

authorisation was applied for chromium VI coating does not affect the development of the business

significantly

In this case the drivers for the emergence of a CrVI alternative technology are

REACH authorisation

Technical feasibility of the alternative resulting in specific technical Specifications and

Certain technical advantages from using this alternative technology



Case 6 Yara

Yara France used diarsenic trioxide as a processing aid to activate the absorption and desorption of

carbon dioxide by potassium carbonate from synthesis gas which is used for the production of

ammonia at its site in Le Havre France The diarsenic trioxide additionally served as a corrosion

inhibitor in the process Diarsenic trioxide was previously used as it was effective in the process of

carbon dioxide stripping energy efficient clean and compatible with the comparatively low

pressures at which the Yara Le Havre site operates The Le Havre Yara operation is a 247 continual

process which held 40 tonnes of diarsenic trioxide circulating in a closed system Per year around

five tonnes were added to the system as the process is in principle catalytic but as with all such

reactions not 100 efficient

In response to diarsenic trioxide being made subject to authorisation Yara France explored

alternative physical and chemical solvents A water-based process was said to have the advantage

of being a simple process using a solvent which is not reactive with other trace constituents and

which does not introduce nitrogenous vapours into the gas stream However the carbon dioxide

partial pressure at the Le Havre installation is sufficiently low that the amount of solution required

to absorb the same amount of carbon dioxide is twice that required with chemical solvents making

the physical solvent solution incompatible with the Yara Le Havre process Using water would also

increase hydrogen contamination while other physical solvents would require the introduction of

an additional drying unit

Yara also considered switching to a process based on an amine chemical solvent This was

considered technically and economically challenging since it would require significant changes to

the existing installation costing euro20m over seven years or longer However using the existing

process but two alternative substances as activators and vanadium pentaoxide as a corrosion

inhibitor was found to have several advantages over the current diarsenic trioxide-based process

and other alternatives These included lower energy requirements lower corrosion inhibitor use

cleaner and smoother production and lower health and safety requirements

However switching to the vanadium pentaoxide-based alternative was estimated to take until the

end of March 2017 22 months after the sunset date for diarsenic trioxide The only viable solution

to this transition in case the company were not submitting an application would be complete

closure of the plant by the sunset date Yara therefore submitted an application for authorisation

to continue their use of diarsenic trioxide for 22 months after the sunset date including planning

necessary for substitution to a vanadium pentaoxide alternative

The discussion within their application concerning the time required to substitute makes it clear

that the substitution of diarsenic trioxide had already been considered early in the REACH process

(and possibly before) as part of an overall evaluation of the future of the plant A switch to an

amine-based process had originally been considered most cost-effective but further analysis in

2013 revealed that such a switch would be far costlier and technically complicated than originally

thought It was then that the vanadium pentaoxide option was evaluated and ultimately approved

The costs of implementing the switch were implied to be around euro4m (one fifth of the costs of

implementing the amine alternative) but a full net present value including energy efficiency and

other savings was not provided in the authorisation application

Contacts were made with Yara but it was not possible to discuss this substitution further with them



Case 7 Fine Chemicals company

The company in this case has a large portfolio of products that they manufacture in different

countries The regulatory constraints are managed and the use of very hazardous substances in

manufactured substances or used raw materials is tracked proactively Because of this proactive

process this company was in the past able to substitute several chemicals in a timely manner

Three examples were provided

In the first example the RampD to replace the substance started when the substance appeared on the

Candidate List The main reason for going ahead with the substitution rather than applying for

authorisation was that the AfA process was considered as an uncontrollable risk as there was no

guarantee of continued use for the foreseeable future This was because the substance is a PBT and

it was unclear to this company how a justification for continued used could be developed (given

there is no widely accepted way of valuing the risks associated with the use of a PBT substance)

Although the substance is still not on Annex XIV the use of the substance has been discontinued

and substituted by a structurally similar substance which does not meet the PBT criteria

The second example concerned a substance not on the Candidate List but recognised as a PBT and

on the CoRAP list for several other properties such as being an ED The substance was used as

additive to polymers The replacement of this substance only took six months A key driver here

was the fact that a technical alternative was available and the outcome of a possible authorisation

application was uncertain

The last example related to the use of Nonyl phenol in an imported mixture The total use volume

was fairly low (2 tpa) Although an alternative was known their customer did not want to pay for

the additional cost for the use of the alternative However the company did not want to be

associated with the sale of this SVHC and as a result authorisation was not considered and the

marketing of the substance was stopped

The common driver for substitution in these cases are mainly the proactive management of the

Chemical substance inventory in order to identify in a timely manner the possible options for

substitution and start-up research for alternatives at an early stage

Case 8 replacement of TCE by PER

In this case a company active in the aviation sector was using TCE as a metal degreasing solvent

Because of the low level of technology used for exposure control it was clear that authorisation

would not have been possible for the use An alternative provided by a solvent supplier proved to

be very expensive and a cheaper solution was sought

The alternative found was tetrachloroethylene (PER)41 This choice was made after the conclusion

of substance evaluation for PER stating that there was no need for further regulatory follow-up

Because of the low boiling point of PER new equipment was developed in collaboration with a

supplier The investment cost for the new equipment is estimated to euro1 million However because

of the lower emissions the solvent use is lower hence a lower operational cost was achieved (from

41 It is worth noting that several TCE AfA applicants viewed PER as not being a suitable alternative given it has

health and environment concerns (albeit less toxic than TCE) which could mean PER being subjected to further

regulatory scrutiny in the future However that is not to say other previous uses of TCE that did not apply for

authorisation may also have switched to PER (see Chapter 11)



euro60kyear to euro2kyear) This solution was evaluated positively to the extent that other degreasing

solvents used (kerosene) will also be replaced by the use of PER

The key drivers for this substitution are

availability of a technically suitable alternative and

Reduction of operational costs

Case 9 Substitution of diarsenic trioxide in artistic glass-making in Murano Italy

As reported in Section 45 the use of diarsenic trioxide in the production of artistic glass was

claimed intermediate by industry but assessed as a processing agent (ie non-intermediate) by

ECHA No application for authorisation was received for this use from the artistic glass sector ECHA

(2017) subsequently produced a report on the use and substitution of diarsenic trioxide in the

artistic glass sector of the Murano area of Italy and this section cites this report42

Raw materials used in glass manufacture include silica sands sodium and potassium carbonate and

others Other substances may be added to glass during manufacturing as matrix builders melting

agents stabilisers refining agents and colourants Diarsenic trioxide is used in glass manufacturing

as refining agent added mostly to remove bubbles The substance was included in Annex XIV of

REACH with latest application date 21 November 2013 and the sunset date 21 May 2015

In early 2015 local authorities began checking how authorisation obligations for diarsenic trioxide

were being handled by Murano glassmakers The glassmakersrsquo position was that their use of

diarsenic trioxide was exempt from authorisation on the grounds of being an intermediate Local

authorities supported by the Ministry of Health (Italian Competent Authority for REACH and CLP)

and ECHA concluded that the use of diarsenic trioxide as a refining agent in the manufacture of

Murano glass could not be considered intermediate and enforcement inspectors advised

glassmakers that their use of the substance after the sunset date should cease because neither EU

manufacturers nor glassmakers (downstream users of the substance) had applied before the latest

application date for authorisation to continue In September 2015 the REACH authority of the

Veneto region (having jurisdiction over Murano) decided to create a working group to monitor the

use of diarsenic trioxide in Murano glass manufacture The group was made up of members of the

Italian CA the regional environmental agency and the local control authority on REACH The action

plan of the working group included

An information campaign for local glassmakers about the ban to use of diarsenic trioxide in

glass production and

A control and inspection plan aimed to check if diarsenic trioxide was still being used after

the sunset date and to monitor levels of diarsenic trioxide in the environment

The working group began by gathering information on companies involved in glass manufacture in

the area Information from the chamber of commerce and the worker insurance institute indicated

that there were about 300 companies operating in the sector in the Veneto region This information

was integrated with data obtained from the major local distributor of diarsenic trioxide showing

that in 2013 about 24 companies in that area were using in total around 5 tonnes of diarsenic

trioxide per year





An information sheet on the regulatory status of diarsenic trioxide and a questionnaire were

prepared and sent to all these companies by the working group Responses to the questionnaire

showed that 104 companies operate in the field of artistic glass 18 of which indicated that they

had used diarsenic trioxide until 2014 but had since switched to antimony trioxide cerium oxide

lithium oxide andor blast furnace slag Use of these substances implied a change in the process

conditions and substances were used individually or in combination

Nine workplace inspections were undertaken by local enforcement authority between December

2015 and May 2016 One artistic glass manufacturer was found to be using diarsenic trioxide in

breach of REACH ie without an authorisation for its use Other inspected companies had replaced

diarsenic trioxide with other substances instead of applying for authorisation

The Veneto environmental protection agency monitored the level of arsenic in air in the Murano

area over the periods June-November 2014 SeptemberndashNovember 2015 and JulyndashDecember 2016

The data from the environmental monitoring stations (located in the neighbourhood of the primary

school of Murano) showed a significant decrease in arsenic levels (see Table 54) Concentrations

were found to have dropped from over 200 ngm3 to 4 ngm3 being in 2016 below the annual limit

of 6 ngm3 for arsenic which is the target value of the EU as agreed in Directive 2004107EC on

arsenic cadmium mercury nickel and polycyclic aromatic hydrocarbons in ambient air and

implemented by Italian Legislative Decree 155201043

Table 54 Average air concentrations of arsenic at the Murano environmental monitoring station 2014-16

Reference period Average arsenic concentration (ngm3)

June-November 2014

September-November 2015

JulyndashSeptember 2016

OctoberndashDecember 2016

2347

110

5

39

No information on the costs of switching to these alternative substances is available

55 Applicants ndash Future possibilities to substitute

In this section some cases are documented where applicants indicate future substitutions in the

public versions of their application for authorisation These developments are documented in the

AfA as RampD plans Table 55 shows to what extent these plans are included in AfAs

Table 55 RampD plans included in AfAs

Plan to substitute away from the SVHC No of Uses (AoAs) (All

substances)

Plan included 62

Plan referred to 34

No clear plan 71

Formulation uses (no plan expectednecessary) 19

Total 186

Table 55 shows for all AfAs considered (total of 111 up to end December 2016) whether the AoA

indicated a plan for how to make the non-suitable alternative suitable (ie an lsquoRampD planrsquo since a

43 Legislative Decree No 155 of 13082010 ndash conversion into Italian legislative system of Directive 200850EC

concerning air quality in Europe httpwwwcameraitparlamleggideleghe10155dlhtm



lsquosubstitution planrsquo is only relevant for AfA for SVHC in the adequate control route) Where a plan

was lsquoincludedrsquo that was where there was a clear indication and time line showing how a possible

alternatives would be identified and the steps that would be needed to introduce that including

time and actions for product acceptance by customers Where a plan was lsquoreferred torsquo this was a

less definite plan but that there was an indication of time and steps (actions) needed to justify the

review period applied for For lsquono clear planningrsquo this was where the public version of the AfA did

not indicate a plan and action and timings were not at all clear in the AfA

The quality of information within AfAs presented to date is variable (although no opinions

recommended not to grant authorisation) and as noted in Table 55 it is reported that 34 of AfA

presented a clear RampD plan 18 referred to a plan and 38 presented no clear plan at all Some of

this information may have been provided by the applicant confidentially as part of the AfA or

submitted post submission of the AfA (eg in responses to a RACSEAC question) but based on

publicly available data this suggests that even in an AfA (where there is an obvious need to

specifically consider the adoption of alternatives) overall there is not enough clear documentation

of how alternatives could be made suitable and available

In the following examples some of these plans are summarised and the key success factors or

drivers to develop such plans are indicated

Case 1 Use of TCE in a cloth dye process

The company uses trichloroethylene (TCE) in the manufacturing of a dyed textile The specific dye

process requires a wax which has to be removed from the cloth during the process For this

purpose a solvent with specific properties is required Several solvents were tested but except

PER which was considered at that point in time nearly as hazardous (the decision of the CoRAP was

not available at the time of submission of the dossier) none provided a technical solution The

company however identified a different solvent technology as a potential alternative for the use

of TCE This technology using so called switchable solvents has as only alternative the potential to

provide cost savings by eliminating the solvent evaporation step which is required by other

solvents However the technology of switchable solvents is a relatively new technology For the

development of the alternative the company has set up a joint development plan with a Canadian

research institute familiar with this technology

Although the alternative is not technically ready because of the authorisation the company has the

opportunity to develop a new technology to substitute the use of TCE while avoiding the use of

another hazardous substance (PER) with the potential outlook of a cost saving in the production

process


Cost saving potential of the new technology and

Ambition to produce SVHC free

Case 2 Grohe

The application for continued use of chromium trioxide by Grohe consisted of two uses chrome

plating and etching of plastic material prior to chrome plating Grohe elected to differentiate both

uses and filed two different uses Apparently the main driver for this decision is the difference in

substitution potential for both uses While for the etching a possible alternative seemed to have

been identified for the surface coating an alternative seemed to be further away This difference

in possible substitution was also the main argument for a difference in review period



56 Summary of instances of substitution

A deliberate attempt was made to target stakeholders who may have been impacted by REACH

Authorisation and those that may have substituted a SVHC Whilst the AfA process provides a good

indication of companies and uses that require continued use of a SVHC priority to this study little

was known about the instances of substitution In this respect the online survey for this study has

been very successful with 43 of respondents indicating they have substituted a use of a SVHC (and

therefore avoided the need to apply for Authorisation) These respondents (n=83) provided 61

examples of substitution of SVHCs


to substitute and investment in substitution related activities In some instances some companies

have been successful at substituting the use of one SVHC but are still trying to phase out use of

another SVHC Whilst the specific targeting of respondents may have led to a higher percentage of

respondents who have substituted (43) the survey at least provides evidence that substitution of

SVHCs is occurring Based on survey responses REACH Authorisation seems to be a major (but not

the only) driver for substitution




completed


feasible even if in some cases the cost of applying for Authorisation could have been cheaper

This report sets out several drivers for these substitutions with numerous case study examples

Authorisation might not necessarily be the only motive as some of the substances that have been

through the entire Authorisation process have previously been regulated by other parts of REACH

and related legislation (such as harmonised classification amp labelling and evaluation) as well as

being subject to other regulation prior to REACH and therefore in some instances substitution

related activities have been ongoing for many decades








or companies could have even moved their part of production using SVHCs to outside the EU



6 COSTS OF THE AUTHORISATION PROCESS

61 Introduction

The cost of the authorisation process is the third of the five focus areas assessed The cost analysis

seeks to set out (i) at what stage in the authorisation process are these costs incurred (building on

from the analysis in Section 3) (ii) who incurs these costs (and if they differ along the supply chain

ndash eg upstream application vs downstream user applications) (iii) how they compare with what was

anticipated (eg if there are any unintended costs) and (iv) to understand how costs are changing

over time (eg whether the total cost of drafting RMOAs is increasing due to the numbers carried

out but the time required per RMOA is falling)

The section contains the following sub-sections covering the costs included in this analysis

Section 62 Literature review ndash summaries what the key findings were from existing

studies

Section 63 Costs to Member State Competent Authorities (MS CAs) ndash sets out the costs

incurred by MS CAs along the authorisation process

Section 64 Costs to the European Chemicals Agency (ECHA) ndash sets out the costs incurred by

ECHA along the authorisation process

Section 65 Costs to the European Commission (EC) ndash sets out the costs incurred by the EC

along the authorisation process

Section 66 Costs to third parties ndash sets out the costs incurred by third parties (like NGOs)


Section 67 Compliance costs - sets out the compliance costs incurred by

manufacturersimporters (MIs) and downstream users (DUs) from continued use of an SVHC


Section 68 Costs of substitution - sets out details on the costs of substitution from an

SVHC due to the authorisation process

Section 69 Costs of RampD innovation and investment ndash sets outs details on the costs of

RampD innovation and investment encouraged by the authorisation process

Section 610 Costs of closure and relocation - sets out details on the costs of closing sites

in the EU and relocation of production outside of the EU due to the authorisation process

Section 611 Costs to apply for authorisation ndash sets out details of the costs to applicants

who requested continued use of an SVHC beyond the sunset date of the substance

Section 612 Costs to improve risk management - sets out details of the costs to improve

risk management from continued use of an SVHC due to the REACH authorisation process amp

Section 613 Summary of costs ndash sets out a summary of all the costs assessed




To create a basis for the assessment of new results produced by this study existing literature was

reviewed to identify and consolidate existing knowledge about the costs related to the

authorisation process The consulted literature includes regulation documents EC study reports a

Finnish study commissioned by ECHA as well as reports and position papers submitted during the

public consultation of the 2017 REACH Evaluation

This sub-section summarises the key findings of the literature review The complete literature

review (with supporting evidence) can be found in Annex E5 The following findings of the

literature review are of particular relevance

Based on a survey among authorisation applicants in 2013 and 2014 ECHA estimated the

average cost per applicantuse to be approximately euro230000 (EC 2015) As the average

cost per applicantuse was lower for applicants submitting AfAs in the last quarter of this

period it is expected that average costs will decline in the long run due to increasing

experience with the process

Several studies indicate that the application fees paid to ECHA make up a small share of the

total authorisation cost (at most 15) to the applicant Costs incurred to fulfilthe

information obligations set by public authorities and the preparations of application

dossiers are more significant The analysis of alternatives and the preparation of the socio-

economic analysis are shown to be the parts of the authorisation application that are the

biggest cost drivers

Despite the low share of application fees in terms of total costs the need to minimise the

regulatory cost burden for SMEs has been recognised by the EU through further lowering the

reduced application fees for such companies with the implementation of Regulation (EU) No

2542013

The public consultation to inform the 2017 REACH Evaluation reveals that almost 90 of

respondents think that the authorisation fees are too high As expected this percentage is

especially high (ie gt 90) for industry associations and businesses A considerable share of

stakeholders from the public and research sector (42 and 50 respectively) shares this

view

Submissions to the public consultation that informs the REACH REFIT indicate that costs

incurred as part of substitution activities ndash the alternative way of fulfilling the Annex XIV

requirement ndash amount to significant sums that might even be higher than direct REACH

authorisation application costs

Substitution can be linked to significant follow-up costs for the company itself authorities

or end-users of the products in certain industries Examples were provided by position

papers from stakeholders in the medical technology industry and defence sector In the

defence sector for example military authorities need to requalify products affected by

substitution and related products (eg tanks and aircrafts) that may need to be adapted to

the product directly affected by the substitution activities (eg ammunition) to ensure

compatibility

Besides industry actors EU- and Member State level institutions also incur considerable

costs during the authorisation process due to their administrative and management duties



Even state-level institutions not directly involved in these tasks such as Ministries of

Defence might face higher costs due to the need to finance more RampD activities

The public consultation conducted to inform the REACH Evaluation 2017 revealed that the

general opinion about the proportionality of costs and benefits of authorisation is the most

negative out of all analysed REACH chapters (ie registration information in the supply

chain such as extended Safety Data Sheets evaluation of dossier evaluation of substance

authorisations restriction and requirements for substances in articles)

63 Costs to Member State Competent Authorities (MSCAs)

The costs to MSCAs are largely driven by the time spent on the following activities

The screening and risk management option analysis (RMOA) stage

Inclusion of substances on the Candidate List

The Member State Committee (MSC) ECHA Scientific Committees (RAC and SEAC) and

REACH Committee

Compliance and enforcement of REACH authorisation and

Policy costs

A questionnaire was sent out to MS CAs44 requesting information on most of these activities and

responses were received from 16 CAs The findings are summarised in this section Some of these

costs have also been estimated as part of ECHArsquos time recording system (see Section 64 for more

information) This system in addition covers the activities of the RAC and SEAC whose costs are

largely paid for by MS CAs so these ECHA-estimated costs are also covered in this section ECHA

pays for the time of Committee members who undertake lsquorapporteurrsquo duties on authorisation

opinions although this might only partially cover the full cost of the membersrsquo time These costs

are included under ECHA costs

Table 61 presents responses to the question on average cost of staff employed on authorisation

activities (For this question what constitutes lsquoauthorisation activitiesrsquo was not specified) The

mean lsquoaverage costrsquo value was euro401 per day with mean upper and lower bounds of euro306 and euro412

These values appear reasonably close but they disguise significant variation across CAs ndash the lowest

lsquolow valuersquo reported was euro20 per day whereas the highest lsquohigh valuersquo was over euro1000 per day

Table 61 Average staff cost per day (euro) for time spent carrying out authorisation activities

Low Average High

Mean 306 401 412

n 10 14 9

Table 62 presents the results of the question asking CAs how much staff time they spend on

undertaking RMOAs Screening and RMOA activities were described in the questionnaire as follows

ldquoThe term lsquoscreeningrsquo covers the identification and investigation of substance (and dossier)

specific information to make a preliminary assessment on whether that substance (or

dossier) should be handled via a particular REACH or CLP process The first stage is the IT

mass screening phase which is predominately carried out by ECHA The second stage is the

httpsechaeuropaeuinformation-on-chemicalscl-inventory-database-disclidetails103892 44 The EC contacted MS CAs and those willing to take part were sent the survey



manual screening phase which is a targeted substance or dossier specific assessment of the

information provided in the registration dossier(s) in relation to the search criteria applied

As the vast majority of substances that are screened (either in mass screening or manual

screening) do not go down the authorisation route the screening phase is not being

assessed in this questionnaire

An RMOA is a voluntary step where an analysis is carried out (by ECHA upon request by the

Commission or a Member State Competent Authority (MSCA)) on a substance-by-substance

level to conclude if additional regulatory risk management should be proposed to manage

the risks to human health or the environment as well as which risk management option to

use Although there are several Risk Management Options that could be proposed (other

than Authorisation) we are interested in understanding the time taken (on average) to carry

out an RMOArdquo

The mean of the estimates of the lsquoaveragersquo was 41 days with a mean lsquolow estimatersquo of 20 days and

a mean lsquohigh estimatersquo of 70 days Again these figures mask individual extremes ndash for instance a

lsquolowrsquo of two days and a lsquohighrsquo of 175 days (the latter figure representing over six months of full-

time employment) The first set of estimates in Table 62 of the cost of undertaking a RMOA are

the means of responses from CAs who answered questions on both the staff cost and the days per

RMOA questions since not all respondents answered both questions This is why the number of

respondents (n) is different for the lsquoaverage daysrsquo responses and the lsquoown costsrsquo responses in Table

62 The second set is obtained by taking the simple means in Table 61 and Table 62 recognising

that the sample of CAs responding to each question is different Average costs obtained are around

euro13k-164k ranging from euro35k to almost euro29k Respondents generally reported that the time spent

on RMOAs is increasing over time due to greater average complexity of case substances (eg PBTs

compared with CMRs)

Table 62 Time for and cost (euro) of carrying out a RMOA per substance

Average days

Total cost per RMOA

Based on own costs Based on sample costs Low Average High Low Average High Low Average High

Mean 20 41 70 3484 12988 25112 6120 16441 28840

n 10 13 9 7 11 6 na na na

ECHA publishes data from the Public Activities Coordination Tool (PACT) which lists the substances

for which a RMOA or an informal hazard assessment for PBTvPvB (persistent bioaccumulative and

toxicvery persistent and very bioaccumulative) properties or endocrine disruptor properties is

either under development or has been completed since the implementation of the SVHC Roadmap

commenced in February 2013 The PACT currently (August 2017) lists 374 activities - 178 are

described as RMOAs of which 168 were or are being undertaken by MS CAs The assignment of

these activities to REACH authorisation is not clear-cut since some RMOAs conclude that a

restriction (or another instrument) is appropriate some have been put on hold some are still

ongoing and some are listed as having a finalisation date which precedes their inclusion on the

PACT list Seventeen RMOAs have been included in the PACT list since September 2014 which have

already concluded (four of them in 2017) that a substance should receive a SVHC follow-up This

might suggest RMOA numbers in single figures per year ultimately associated with authorisation

although clearly this will tend to be an underestimate Based on the sample-based average cost in

Table 62 this might suggest a rough cost of around euro100k per year45

45 17 RMOAs over the period September 2014-2017 or just over five per year at euro16400 each gives euro92000

per year



Table 63 presents information on the time spent on and costs of the Annex XV process for

identifying SVHCs The activities covered include dossier preparation responding to public

consultation comments (lsquoRCOMrsquo) revision of the dossier and commenting on dossiers prepared by

other CAs and by ECHA As might be expected dossier preparation itself is the most time-

consuming activity taking a mean average of 36 days per dossier (average low estimate 22 days

average high estimate 57 days) The total cost of the Annex XV dossier process for SVHC

identification is estimated at around euro19k-euro20k (own costs or sample costs) with a mean low of euro7k

(own costs) and a mean high of euro34k (sample costs) In commentary most CAs did not feel that the

Annex XV process is becoming more burdensome over time even though several did state that they

had little direct experience of dossier preparation

Table 63 Time for and costs (euro) of the Annex XV dossier process for SVHC identification

Average days Total cost per dossier

Based on own costs Based on sample costs

Low Average High Low Average High Low Average High

Preparation 22 36 57 6435 13869 20967 6757 14537 23336

RCOM 3 6 11 408 2134 3204 985 2347 4671

Revision 2 5 11 253 2094 1745 747 2060 4415

Commenting 1 2 5 259 665 2277 313 890 2061

Total 28 49 84 7354 18762 28193 8802 19835 34482

ECHA publishes data on the Registry of Intentions to submit SVHC Annex XV dossiers CAs submitted

nine such dossiers in mid-2015 or early 2016 and eight in mid-2016 or early 2017 Assuming that

these all took approximately one year to compile and an average total cost of around euro20k gives a

total annual cost of around euro160k This does not include dossiers for which an intention was lodged

but withdrawn

Table 64 presents information on the time spent on and the costs of authorisation-related Member

State Committee activities In the questionnaire this was defined as average time spent by MSC

member (and advisors) on preparing and attending for a single Member State Committee meeting

specifically for authorisation activities Time in this case is measured in hours per meeting The

responses covered MSC meetings on SVHC identification Annex XIV activities (ie prioritisation)

and other authorisation activities (not specified in the questionnaire) Substance-related activities

seem to take longer on average than other authorisation-related activities with the former

requiring about 20 hours of time (range 8-45) and the latter 13 (range 7-20) This puts the

authorisation component of MSC meetings at costing from around euro600 to over euro5k with an average

of around euro25k-euro3k This is per CA so each actual meeting will cost around 30-times that

(depending on attendance) or around euro50k-euro100k With six meetings per year the total annual

cost for CAs is around euro300k-euro600k46 This does not include the costs of attendance by ECHA the EC

or stakeholders In comments most CAs stated that MSC activities can vary significantly depending

on the number and complexity of the cases being considered as well as the role the CA is taking in

the meeting

46 An alternative approach to costing MS CA time spent on candidate listing and prioritisation based on ECHArsquos

time-recording system gives a cost of around euro330k (see the discussion at Tables 69-12)



Table 64 Time for and costs (euro) of Member State Committee activities on authorisation (per Member State)

Average hours Total cost



SVHC ID 10 21 37 202 1189 1580 412 1125 2047

Annex XIV 8 18 45 222 800 1335 323 987 2451

Authorisation 7 13 20 232 558 800 272 684 1071

Total 25 52 102 656 2546 3715 1007 2795 5569

Table 65 covers the time spent on an authorisation-related meetings of the REACH Committee

both preparation and attendance Total hours per meeting are estimated at 34 on average with a

range of 17-61 This results in mean costs of less than euro2k with a range of euro05k (own costs) up to

euro33k (sample costs) With approximately 10 meetings per year this puts average annual costs at

around euro20k for each CA or around euro600k in total per year In commentary respondents were of

the general opinion that average REACH Committee costs were increasing due to an increase in the

number and complexity of authorisation application cases which were being considered

Table 65 Time for and costs (euro) of REACH Committee activities on authorisation




Preparation 14 28 50 442 1201 2153 589 1521 2720

Meetings 3 6 11 110 270 445 111 323 586

Total 17 34 61 552 1471 2198 700 1844 3306

Table 66 covers time spent by ECHA Scientific Committee members on reviewing and commenting

on authorisation applications for which they are not acting as rapporteurs outside of plenary

meetings Responses were given in terms of hours per application On average CAs report spending

longer on SEAC opinions than RAC opinions giving a mean average cost of euro600-900 for SEAC

compared with around euro375 for RAC However one explanation for this could be that RAC members

have a heavier workload and therefore are more constrained in terms of how much time they can

spend on each case ndash this is supported by comments made by CAs in their questionnaires

Alternatively it could mean that more RAC activity is undertaken in plenary rather than outside

compared with SEAC Around 28 applications (50 uses) per year have been submitted to ECHA since

2013 implying a total non-plenary cost of around euro28-euro50k per MS CA per year depending on

whether AfA case is interpreted as an application or use applied for With 28 MS CAs in the EU and

three in the EEA this gives a total cost to MS CAs of around euro870k-euro15m



Table 66 Time for and costs (euro) of ECHA Scientific Committee (RAC and SEAC) non-plenary activities on authorisation applications per MS CA per AfA case




RAC 4 7 15 216 389 761 160 361 849

SEAC 5 12 21 272 854 814 197 623 1129

Total 9 19 36 488 1243 1375 357 984 1978

RAC and SEAC time spent in plenary was not covered in the MS CA questionnaire but was instead

estimated via the ECHA time-recording system (see Section 64) Preliminary results indicate that

the Committees spend approximately 18 days on opinion-making per use giving a cost of around

euro7200 With around 50 uses per year this gives a total annual cost of euro360000 Costs of RAC and

SEAC rapporteurs are treated as costs to ECHA and are covered in Section 64

On the subject of monitoring and enforcement CAs gave a variety of responses which are not easily

presented in tabular form Some CAs reported having no data Some responded that they did not

undertake any enforcement relating to REACH authorisation Interestingly some of these explained

this by saying that no company had yet been granted an authorisation in their country so there was

no need for enforcement even though it is the use of an Annex XIV substance without an

authorisation which is the key enforcement issue not compliance with a granted authorisation

(although this is still an issue clearly) Others estimated their time spent at around 10-20 days

Two reported spending around 70 days and over 100 days on enforcement in relation to around 25-

35 investigations Although patchy these responses do indicate that CAs are not expending very

significant effort on enforcing Annex XIV and granted authorisations

Finally CAs were asked questions designed to estimate how much time they spend on REACH

authorisation policy issues When asked to estimate the percentage of REACH staff time spent on

REACH authorisation policy issues responses ranged between zero and 20 with an average of just

under 10 CAs reported an average of just under 6 FTEs employed on REACH authorisation This

implies that policy aspects account for around 55 of one FTE At an average daily cost of euro401

this implies a cost of staff time spent on policy issues of around euro50k per year per CA

In summary questionnaire responses suggest that MS CAs might spend around

euro100k per year on undertaking RMOAs

euro160k per year on compiling Annex XV dossiers

euro300k-euro600k per year on MSC meetings

euro600k per year on REACH Committee meetings

euro870k- euro15m per year on RACSEAC non-plenary activities

euro360k per year on RACSEAC plenary activities and

euro15m per year (euro50k per CA) on lsquopolicy issuesrsquo broadly defined

This gives a total of around euro373m-euro486m per year (~euro43million per year on average) This figure

excludes enforcement activities for which insufficient data were supplied to permit costing



64 Costs to the European Chemicals Agency (ECHA)

ECHA has established a time management information system to record the time that staff spent on

different activities Using information from this system and expert judgement where necessary

ECHA has estimated time spent on the following authorisation-related activities

Risk Management Options Analysis (RMOA)

o Time spent preparing an RMOA

Annex XV dossier preparation and SVHC identification (candidate-listing)

o Time spent on Annex XV dossier preparation responding to comments from the

public consultation and preparing support documents

o Management of the Annex XV dossier evaluation process

o Member State and stakeholder analysis and commenting during the public

consultation

o Any additional time spent on Annex XV dossiers by the Member State Committee

(MSC) secretariat and members

Annex XIV recommendation

o Time spent on Annex XIV recommendation separately for ECHA and for MSC

members total (including rapporteurs and working groups)

Applications for authorisation

o Time spent on managing the applications process within ECHA

o Time spent by RAC and SEAC rapporteurs on evaluating applications

o Time spent on discussions related to applications for authorisation in RAC and SEAC

plenaries

Costs reported by ECHA were expressed in terms of days A representative cost per day for ECHA

staff time of around euro750 (including a 25 overhead)47 Time recorded by ECHA but paid for by

other agencies is not counted here

ECHA also spends time on additional activities such as providing guidance and training to applicants

(and others) developing policy in relation to aspects of the application process and

communicating to stakeholders through conferences webpages and so on ECHA also commissions

research and consultancy as part of for instance establishing Risk Assessment Committee (RAC)

dose-response functions for non-threshold substances It is assumed that these costs have not been

accounted for directly and hence appear (partly) in the 25 overhead charge

641 SVHC identification and prioritisation

ECHA has provided a description of its efforts to estimate the costs of its activities associated with

SVHC identification and prioritisation for authorisation This covers screening RMOA SVHC

identification and SVHC prioritisation

Screening

Common screening aims to make use of the full REACHCLP database and available external data to

support efficient implementation of all REACHCLP processes48 Hence the vast majority of

substances that are screened (either in mass screening or manual screening) do not go down the

47 John Wickham ECHA pers corr 11 April 2017 48 httpsechaeuropaeuaddressing-chemicals-of-concernsubstances-of-potential-concernscreening



authorisation route Therefore ECHA does not consider it meaningful to relate time and cost spent

on screening to the authorisation process

RMOA

Similarly only approximately one third of substances for which an RMOA is carried out go directly

to the authorisation route In addition most of the ECHA time spent on RMOA relates to more

generic tasks including co-ordination of Member States activities in RMOA developing approaches

supporting MSCAs and ensuring transparency and is not substance specific

Time spent on preparation of a RMOA ranges between 2-12 weeks full time equivalent (rough

estimate) with the average time spent by MSECHA being closer to the lower end of this range

This includes equivalent level of concern analysis for potential Article 57f substances where

relevant

Table 67 sets out the number of days spent by ECHA on RMOA activities and the cumulative

number of substances for which RMOA work is ongoing or concluded by ECHA or MSs in the last

three years These days are translated into cost estimates by applying the euro750 per day figure If

(as stated above) around one third of these costs are directly authorisation-related this puts

annual costs to ECHA at around euro40k-euro65k

Table 67 ECHA time and cost (euro) spent on and number of substance RMOAs 2014-2016

2014 2015 2016

Time spent (days) 236 171 264

Total cost (euro000s) 177 128 198

Cumulative number of substance RMOAs at end of year

Under development 74 89 92

Concluded 24 50 67

Total 98 139 159

The PACT started in September 2014 hence all RMOA PACT inclusions dated 2014 include all RMOA

intentions received between the start of the SVHC Roadmap (Feb 2013) and that date

At euro750 per day

Annex XV dossier preparation and SVHC Identification

Hazard identification is the primary purpose of the SVHC Annex XV dossier and in that sense

identification of substance properties (CMREDPBT etc) is an integral part of the process

However COM has advised that CLH (Harmonised Classification and Labelling) processes (which

relate primarily to identification of CMR hazards) are not in scope when calculating administrative

costs which would suggest that hazard identification activities for non-CMR properties should also

be out of scope ECHA has therefore considered two scenarios for a typical dossier

Time spent on CMR dossiers (not including CLH activities) and

Time spent on dossiers which relate to identification of other non-CLH hazards eg

PBTvPvBArt 57f dossiers

For the second category of substances time spent on dossiersubstance evaluation activities is not

included as this relates to a different regulatory process In addition time spent on the work of the

EDPBT Expert Groups is not included as these groups primarily support substance evaluation

activities



It should be noted that the time spent on Annex XV dossier preparation particularly for PBTvPvB

amp Art 57(f) dossiers is here only very roughly estimated by ECHA These estimates with associated

costs are presented in Table 68 It can be seen that the estimated time taken for PBTvPvBArt

57(f) dossier activities is significantly higher than for CMR dossiers as therefore are the costs Total

costs for a CMR dossier come to around euro20k whereas for a PBTvPvBArt 57(f) dossier costs are

more like euro100k ECHA also estimates that it spends an average of 80 days on court cases related to

PBTvPvB amp Art 57(f) dossiers

Table 68 ECHA estimates of mean (min max) days and cost (euro) spent on Annex XV dossier preparation

Task CMR PBTvPvB amp Art 57(f)

Days Cost (euro000) Days Cost (euro000)

Annex XV dossier preparation RCOM

Updating Annex XV dossier and preparing

Support Document (MSECHA)

11 825 70

(30 125)

525

(225 9375)

ECHA dossier management (including

substance ID and accordance check PC

activities)

11 825 35

(25 45)

2625

(1875 3375)

MS and stakeholder analysis and commenting

during PC (typically 20 commenters per

dossier 2 hours each)

5

(3 15)

375

(225 1125)

30

(15 45)

225

(1125 3375)

At euro750 per day

Table 69 reports estimates of additional time and cost spent by the MSC secretariat and the MSC

members on candidate listing activities MSC costs are valued at the euro401 per day figure used in the

previous section It can be seen that costs increase depending on whether the substance can go

straight to the Candidate List or needs to be referred to the MSC The upper estimates for

PBTvPvB amp Art 57(f) substances include opinion formation where MSC agreement is not reached

Table 69 Time and cost spent on candidate listing (days euro000 per substance)

CMR PBTvPvB and Art 57f

Secretariat MSC Cost

(euro000) Secretariat MSC

Cost

(euro000)

Direct to Candidate List 1-2 2-3 155-270 1-2 2-3 155-27

Referred to MSC and

addressed in WP 2-4 3-4 27-46 10-20 10-20 115-23

Referred to MSC and

addressed in plenary 4-6 4-5 46-65 20-50 20-50 23-575

In order to put some context on these figures Error Not a valid bookmark self-reference sets

out the number of SVHC dossiers dealt with per year broken down according to proposed hazard

property49 Assuming CMR dossiers cost around euro20k to administer and go straight to the Candidate

List the cost over the last three years is approximately euro200k Assuming other dossiers cost

approximately euro100k to administer go to the MSC and are 5050 addressed in plenary or working

procedures (WP) gives a cost over the last three years of euro309m The total annual cost is therefore

approximately euro11m but this is very much a ball-park figure About euro101m of this figure is cost to

ECHA with the remainder (euro83k) a cost to MS CAs

49 Note that where a substance has been proposed for SVHC identification due to both CMR and PBTvPvBArt

57(f) properties to avoid double-counting it has not been counted in the table as CMR



Table 610 SVHC dossiers by hazard property per year

2014 2015 2016

CMR 5 3 1

PBT vPvB 2 4 2

Art 57(f) 7 2 7

Total 14 9 10

Annex XIV Recommendation

Estimations of time spent on this activity are only very roughly possible in particular for MSC

members and the MSC Working Groups In addition recommendation cycles are not running per

calendar year whereas time spent is estimated per year The number of substances assessed for

priority and the number of substances in a recommendation are given as a rough indicator of

workload (see Table 611) However it needs to be remembered that there is no 11 relationship

between the number of substances and the workload eg having 11 substances in the 7th draft

recommendation compared to 22 in the 6th draft recommendation does not mean the workload in

the 7th recommendation was only half of that in the 6th recommendation

Table 611 Recent Annex XIV recommendations

5th Recommendation 6th Recommendation 7th Recommendation

Date draft June 2013 September 2014 November 2015

Date final February 2014 July 2015 November 2016

No of Substances

assessed 20 101 97

No of Substances in

draft 6 22 11

No of Substances in

final 5 15 9

Previous priority assessment approach used

Table 612 presents ECHArsquos estimates of ECHA and MSC time and cost spent on prioritisation

exercises based on the ECHA time recording system and qualitative judgement Time costs for MSC

members is based on the euro401 per day figure presented in Table 61 This suggests a total cost in

2016 of around euro05m euro0425m of which is ECHA costs

Table 612 Time and cost spent on Annex XIV prioritisation days per year

2014 2015 2016

Days Cost (euro000) Days Cost (euro000) Days Cost (euro000)

ECHA 621 46575 702 5265 566 4245

MSC members No data No data No data No data 173 694

642 Authorisation application opinion-making

ECHA has provided the first outputs of their time-recording system relating to opinion-making and

these are presented in Table 613 This indicates that on average ECHA spent just under 67 days

on opinion-making per use The estimate of time spent by the Committees is given by the average



time the Committees spend in plenary meetings to discuss each use multiplied by the average

number of Committee members in each meeting The time of rapporteurs and Committee members

is valued according to the average value in Table 61 This suggests a total direct cost (excluding

membersrsquo non-plenary time) of around euro37k per use over the period 2014-2016 of which just under

euro22k is ECHA time directly Rapporteursrsquo time is compensated for (although not necessarily to 100

of the cost) via payments made for each opinion The cost related to Committeesrsquo plenary time

listed in Table 613 have already been covered in section 63 For the purposes of this report it will

be assumed that costs to ECHA for each opinion are equal to around euro30k Assuming a rough

average of 50 opinions per year gives a figure for costs to ECHA of around euro15m annually

Table 613 ECHA estimates of time and cost (euro000) spent on opinion-making per- use 2014-2016

2014 2015 2016 2014-2016

days uses AfAs days uses AfAs days uses AfAs days cost

Secretariat 23 33 10 42 23 16 28 63 41 29 2175

Rapporteurs 14 33 10 26 23 16 24 39 26 20 8

Committees

(covered in

Section 63)

18 72

Mean total 676 37

Based on timesheets received by 31032017

643 Authorisation application fees received

ECHA receives fees from applicants for authorisation according to factors such as the number of

uses applied for the number of exposure scenarios and the size of the applicant firm or

organisation These fees are designed to cover at least part of the costs of ECHArsquos activities

relating to authorisation Authorisation fee income received by ECHA is published in the ECHA

financial accounts and is presented in Table 614 The yearly fee totals relate to the year in which

invoices were issued whereas the opinion-making stage of the application process commences only

after the invoice has been paid Thus there is no simple link between the fees received in Table

614 and the opinions and costs generated in Table 613

Table 614 Total authorisation application fees received by ECHA 2013-2016

Year Fees received (euro)

2013 587633

2014 1682281

2015 728239

2016 6074483

Total 9072636

Over the period 2013-2016 applications were received for 178 uses This implies a mean

application fee per use of just under euro51000



644 Summary

The proceeding discussion suggests that ECHA incurs costs of around euro50k per year on authorisation-

related RMOAs around euro1m on Annex XV and candidate listing and around euro0425m on Annex XIV

prioritisation Costs of opinion-making are difficult to estimate given the significant variation in the

number of cases considered per year but a figure of around euro15m per year on opinion-making

might be reasonable This suggests costs to ECHA of around euro3m per year This is quite close to the

average application fees per year received over the 2013-2016 period (around euro225m)

65 Costs to the European Commission (EC)

This section sets out the main costs incurred by the EC to manage the authorisation process Based

on initial communications with the EC as noted from the literature review the administrative costs

to the EC are expected to be much smaller compared to those incurred by ECHA and Member State

Competent Authorities

A questionnaire was sent to the EC requesting information about the time spent on activities

concerning

RMOA stage

Inclusion of substances on the candidate list

The REACH committee

Decision on applications for authorisation (AfA)

Post decisions on an AfA and

Policy costs

The responses are summarised in Table 615 for the year 2016 The average annual cost per full-

time equivalent (FTE) is set equal to euro138k the value used in EC impact assessments to value EC

staff time The breakdown of total resource across different activities is considered valid for the

last two years as this is when process of authorisation application opinions commenced Policy

development includes interpretation of for instance court case judgements

Table 615 Estimates of DG ENV and DG GROW time spent on authorisation activities 2016

DG ENV DG GROW Total

Total FTEs

22

6

82

Total cost (euro000)

3036

828

11316

RMOA and SVHC Roadmap 10 3036 20 1656 17 19596

ECHA recommendations and Annex XIV amendments 10 3036 10 828 10 11316

Authorisation decisions 50 1518 50 414 50 5658

Policy development 30 9108 20 1656 23 25668

Thus it can be seen that just over euro11m in staff costs was spent on authorisation about three

quarters of this by DG GROW (DG ENV has recently expanded its authorisation staff to three FTEs)

Both DGs spend around half of their time on authorisation decisions

66 Costs to third parties for responding to public consultations

As set out in Section 3 third parties have three formal opportunities to comment at specific times

during public consultations as a substance moves through the authorisation process



1 Inclusion on the Candidate List

2 Inclusion on the authorisation list (Annex XIV) and

3 Submission of applications for authorisation

Details on each of these public consultations are discussed below in terms of available information

on the number of responses received by ECHA from third parties and the estimated time spent they

spent producing these responses

661 Public consultation on the inclusion of a substance to the Candidate List

During the public consultation for the inclusion of a substance to the Candidate List ECHA is

seeking information concerning the ldquoidentity of the substance and intrinsic properties relevant for

the identification (unless identification is based on harmonised classification and labelling and

cannot be challenged in this context) Additionally information on uses exposure potential and

alternativesrdquo50 These public consultations occur twice a year (for 45 days in March-April and

September-October)

As set out in Table 616 from 2008 until 2016 ECHA has received 3591 submissions during public

consultation in relation to 194 substances being proposed for inclusion on the candidate list Once

on the Candidate List these substances will be Substances of Very High Concern (SVHCs) and could

be subject to authorisation in the future if included on Annex XIV (authorisation list)

Table 616 Number of submissions received during the public consultation

Type of respondent

2008 2009 2010 2011 2012 2013 2014 2015 2016 Total

Academic institution

4 7 4 3

7 25 1

Company 35 45 210 130 239 47 30 20 23 779 22

EU or National or Local governmental Organisation

27 76 64 50 10 4

231 6

Individual 27 34 136 16 66 4 6 1 2 292 8

Industry or trade association

27 46 164 128 141 33 27 11 111 688 19

Member State CA

33 44 77 146 230 75 66 40 44 755 21

NGO 52 70 55 88 256 42 62 27 36 688 19

Other 6 3 10 4 4 7

1 35 1

Trade union

18 28 35 9 2 6

98 3

Total 211 325 738 593 981 221 193 105 224 3591 -

Notes

1 Underlying data provided by ECHA on 25052017

2 The type of respondent has been simplified so the number of submissions presented in the table may

not match the underlying raw data

The main actors that responded to public consultation were (i) companies (ii) Member State

Competent Authorities (MS CAs) (iii) Non-Governmental Organisation (NGOs) and (iv) industry or

50 httpsechaeuropaeuaddressing-chemicals-of-concernauthorisationpublic-consultation-in-the-

authorisation-process



trade associations Since the costs to MS CAs were already covered in the Section 63 the

remainder of this section focuses on the costs to industry stakeholders (companies + tradeindustry

associations) and NGOs to provide comments during the public consultation for substances for

inclusion on the candidate list

As shown in Table 617 the number of submissions received by ECHA between 2008 and 2016 varied

significantly at substance level On average the number of responses received is around 13-18

responses

Table 617 Number of submissions received (per substance level) ndash 2008-2016

Candidate List Minimum Average

Maximum Median mean

Number of public consultation

submissions received per substance 1 13 18 245

The ten substances that received the most submissions are shown in Table 618 These ten

substances account for 24 of the total number of submissions A further 33 substances would have

to be added to the list to make 50 of total submissions

Table 618 10 substances that received the most public consultation submissions

Substance name Number of public

consultation submissions

Proportion of total submissions (2008-2016)

Boric acid 245 7

44rsquo-isopropylidenediphenol (bisphenol A) 123 3


Disodium tetraborate anhydrous 79 2

Diazene-12-dicarboxamide (CC-azodi(formamide)) 72 2

NN-dimethylformamide dimethyl formamide 65 2

Lead oxide (lead monoxide) 58 2

Lead tetroxide (orange lead) 46 1

Lead styphnate 41 1

Tetraboron disodium heptaoxide hydrate 41 1

TOTAL 863 24

In the NGO and industry surveys questions were asked around the average time spent providing

comments to the three public consultations covering REACH authorisation The overall numbers of

industry survey respondents were reasonably good (22) to derive indicative ranges for time spent

There were however a limited number of NGO responses (4) Based on NGO interviews most NGOs

rely on either CHEMSEC EEB or Client Earth to comment on REACH authorisation as they do not

have the resources available These respondents indicated they spend between 1-8 hours providing

a response at candidate listing stage but this does vary depending on the substance

Respondents to the industry survey were asked to describe the activities carried out as well as their

estimates for average cost and time spent The types of activities reported by respondents are

listed below (some similar responses were omitted)



ldquoTaking part in meetings within the sector getting informed about the REACH process

preparing comments organizing internal meetings with different parts of the business

talking to customers to encourage them also to commentrdquo

ldquoGathering evidence and time required to prepare responserdquo

ldquoCompiling of data from member companies preparing and validating comments with

experts from member companiesrdquo

ldquoPreparing comments sometimes achieving consensus with other industry participants

(when answering via industry association)rdquo

ldquoCollecting evidences from suppliers quantity purchased emission quantification in air

and water and waste worker exposure data collection consolidation of relevant products

sold consolidation of quality checks and time spent for new product qualification after

SVHC substitutionrdquo

ldquoCollect data and arguments to feed into industry association commentsrdquo

ldquoWorking together with associations so we can divide this in cost for associations and

company costsrdquo

ldquoAssessment of the prioritisation arguments and evidence given by official documents

evaluation of base studies (if available) gathering information comparing different facts

available interviewing experts of different knowledge sectors gathering market details

gathering risk data (if available) evaluation of datas representatively and timelinessrdquo

ldquoPerforming an impact assessment of the proposed substance on our business operations

We have thousands of specifications covering processes for millions of parts Once we

know what specifications are affected we determine whether we have relevant exposure

information (we typically do not) If there is an opportunity to provide socioeconomic

data we may do so Although SEA data is not typically sought at this stage we believe

this can be relevant information that should be taken into account when ECHA makes risk

management decisionsrdquo

Table 619 categorises the screened responses into bands for time taken to respond What can be

observed from looking at their description of activities carried out and time estimates the data

suggests that the low estimate of time often relates to responses from a single company often for

collecting information and forming a response The upper estimate of time often relates to when

industry or trade association level responses requires collating responses from individual members

or when companies and or industry (consortiatrade association) provide more detailed information

such on the intrinsic properties hazard exposure data on the substance



Table 619 Estimated time taken to produce submission (candidate list consultation)

Time taken to produce response Frequency

1 day (or less) 0

1-5 days 5

6-10 days 3

11-40 days 4

40+ days 0 Notes

Source screened online survey data (ie some only provided cost estimates but not days)

Some responses were deliberately excluded as it was clear they included costs beyond those related

to producing a submission to the public consultation

Whilst it is possible to produce indicative estimates of the total costs over the period 2008-2016

using the low and high estimates of the costs of time spent by third parties (via survey responses)

with the total number of responses which results in a too wide estimate (euro2 million to euro73 million

over the period 2008-2016) which was not deemed to be credible given the survey sample size and

that individual low and high costs represent very different types of activities carried out In reality

ECHA will have received a variety of responses some of which would have taken a long time to

prepare and others only a short quick response As some submissions prepared at sectortrade

association levels are also re-sent by individual members (with some further details in some cases)

these companies donrsquot incur the same cost to prepare their submission (or reflected within the

costs to prepare the sector response)

662 Public consultation on the inclusion of an SVHC on to Annex XIV (authorisation list)

During the public consultation for the inclusion of an SVHC into the authorisation list ECHA is

seeking ldquoconfirmation on uses and volumes used Views on the transitional arrangements and

possible exemptionsrdquo51 The public consultation normally occurs once a year and lasts for 90 days

As set out in Table 620 between 2009 and 2016 ECHA has received 3088 responses during the

public consultation in relation to 87 substances being proposed for inclusion on the authorisation

list Once on the authorisation list these substances would be subject to authorisation with a

sunset date by which time uses subject to authorisation must cease in the EU unless an

authorisation has been granted or the applicant is pending a final decision of their AfA (which was

submitted prior to the latest application date)





Table 620 Number of submissions received during the public consultation (Annex XIV)

Type of respondent 2009 2010 2011 2012 2013 2014 2015 2016 Total

Academic institution 2 4 2 8 0

Company 91 8 1040 98 218 230 42 4 1731 56


56 11 2 27 96 3

Individual 20 60 8 29 32 2 151 5


57 5 184 38 113 177 70 644 21

Member State CA 105 29 44 28 15 40 13 2 276 9

NGO 36 16 31 20 6 5 6 120 4

Other 4 1 16 2 3 8 5 39 1

Trade union 1 4 10 7 1 23 1

Total 371 60 1394 204 395 520 136 8 3088 -

Notes


2 The type of respondent has been simplified so the number of responses presented in the table may

not match underlying raw data

3 The PC for the 8th recommendation was from 2 March 2017 until 2 June 2017 so these 8 comments

were submitted in May 2017 whilst the PC for the 8th rec is still running At the close of the publc

consultation a total of 82 comments were received 3 individuals 55 company 23 Industry

association 1 MS)

The main actors that responded to public consultation were (i) companies and (ii) industry or trade

associations The remainder of this section focuses on the costs to industry stakeholders (companies

+ tradeindustry associations) to provide comments during the public consultation for substances

for inclusion on the authorisation list


significantly at substance level On average the number of responses received per substance is

around 16-35



Maximum Median mean




substances account for 53 of the total number of submissions By adding a further eight substances

to that list would account for 80 of total submissions








Chromic acid Oligomers of chromic acid and

dichromic acid dichromic acid 263 9

Boric acid 159 5


Aluminosilicate Refractory Ceramic Fibres (Al-RCF) 115 4

Potassium dichromate 108 4

Zirconia Aluminosilicate Refractory Ceramic Fibres

(Zr-RCF) 99 3

NN-dimethylformamide (DMF) 94 3

Cobalt dichloride 87 3

Cobalt(II) sulphate 87 3

TOTAL 1621 53


comments to the three public consultations covering REACH authorisation Based on NGO

interviews most NGOs rely on either CHEMSEC EEB or Client Earth to comment on REACH

authorisation as they do not have the resources available Available data from the NGO survey

suggests on the whole these NGOs do not devote as much time (~2 hours per submission) on the

Annex XIV public consultation as compared to candidate listing or on AfAs (see next sub-section)

The overall numbers of industry survey respondents were reasonably good (23) to derive indicative

ranges for time spent

Respondents to the industry survey were asked to describe the activities carried out alongside their

average cost and time spent estimate The types of activities reported by respondents are listed

below (some similar responses were omitted)

ldquoEvidence gathering and comment preparationrdquo

ldquoGathering information on the REACH process talking to customers in order to encourage

them to comment prepare commentsrdquo

ldquoData gathering coordination and approvalrdquo

ldquoGathering general data on [sector] exposure of workers and consumers use of

[substance] for [sector] short review of alternativesrdquo

ldquoReview of ECHA documents Assessment of SVHC used internally and by suppliers drafting

comments reviewing comments etcrdquo

ldquoWe have responded on our own as well as part of an industry group Activities are similar

to those of an SVHC listing proposal We perform an impact assessment and determine if

we have any relevant data that can be providedrdquo



ldquoPreparing comments joining efforts with other industry participantsrdquo


ldquoPreparing comments discussion in associations gathering information from customersrdquo

ldquo[substance] several meetings with associations exchange of information develop a huge

amount of documentsrdquo


gathering information comparing different facts available interviewing experts of

different knowledge sectors gathering market details gathering risk data (if available)

evaluation of datas representatively and timeliness gathering detailed information on all

different uses including state of the art of facilities comparing practical experiences of

uses assigning data to different uses reading and interpreting authorisations dossiersrdquo

Table 623 categorises the screened responses into bands for time taken to response Data on the

description of activities carried out and time estimates suggests that the low estimate of time

often relates to responses from a single company often for collecting information and forming a

response The upper estimate of time often relates to when industry or trade association level

responses require collating responses from individual members or when companies and or industry

(consortiatrade association) provide more detailed information such as volume and uses

information and justifications for exemptions

Table 623 Estimated time taken to produce response (Annex XIV consultation)


1 day (or less) 1

1-5 days 7

6-10 days 2

11-40 days 5

40+ days 1 Notes



to producing a response to the public consultation

The number of submissions andor time spent by industry preparing a proposal for exemptions

might be reduced by clarifications concerning when an exemption might be granted and what

supporting evidence is required for better informed decisions Further supporting information has

been made available by ECHA in March (2017) which may reduce this going forward (see

footnote52) This kind of supporting information was available in 2014 and is updated with every

recommendation round

52 ECHA(2017) - ECHArsquos general responses on issues commonly raised in public consultations on draft

recommendations - Available at

httpsechaeuropaeudocuments1016213640recom_general_responses_doc_enpdf44e192e5-ac72-4458-

b4f5-c016754a1d4c



Whilst it as possible to produce indicative estimates of the total costs over the period 2009-2016

(eg using low and high estimates or average time spent) with the total number of responses the

resulting estimates (euro02million to euro100million over the period 2009-2016) were not deemed to be

credible given the small sample and given individual low and high costs represent very different

types of activities carried out In reality ECHA will have received a variety of responses some of

which would have taken a long time to prepare and others not As some submissions prepared at

sectortrade association levels are also re-sent by individual members (with some further details in

some cases) these companies donrsquot incur the same cost to prepare their submission (or are

reflected within the costs to prepare the sector response) According to ECHA in the last years a

lot of effort has been made by industry and their associations (in close cooperation with ECHA) to

prepare and submit consolidated comments This has reduced the total number of comments but

at the same time has generally improved their quality ie ECHA get fewer submissions compared

to previous years but a higher number of those submissions are well prepared and raise important

issues with respective justifications (such comments are likely to taker longer time to prepare)

663 Public consultation on the applications for authorisations

An application for authorisation will be subject to a public consultation that fits within a public

consultation window that occurs quarterly for eight weeks (starting in mid-February mid-May mid-

August and mid-November) The number of substances included in a public consultation will vary

with some windows being busier than others As shown in Figure 61 since the first application in

2013 to the end of 2016 ECHA has conducted 180 such public consultations and received 1128

responses from various stakeholders For each AfA ECHA is seeking information on ldquoAlternative

substances or technologies to the use(s) applied for risks technical feasibility and costs of

alternativesrdquo53

Figure 61 Number of AfA public consultations and comments received

Source ECHA (10082017)



0

50

100

150

200

250

300

350

400

450

0

5

10

15

20

25

30

35

40

45

50

Co

mm

en

ts

Co

nsu

ltat

ion

s

No of consultations No of comments



As set out in Figure 62 the majority of comments have been from industry Downstream Users

(DUs) Manufacturers Importers (MIs) and industrytrade associations A large number of

comments have also been received from NGOs

Figure 62 Types of REACH actors that have commented on an AfA


As shown in Figure 63 the substance that received the most comments was Chromium trioxide

This would suggest that despite the formal intention of the public consultation to seek to gather

information about alternatives a number of responses especially in relation to upstream

applications seem to have come from their downstream supply chains providing further

information they deem relevant for RAC and SEAC and the EC in order for them to make their

opinions and decisions respectively on the outcome of the authorisation application(s)

Figure 63 Number of comments received by substance


Downstream User33

Importer8Industry or

trade association

17

Manufacturer14

MSCA2

NGO14

Individual3

Trade unionlt1

Other 8

2

11

41

6

152

232

12

115

19

9

31

6

9

449

5

2

1

1

11

13

4

0 50 100 150 200 250 300 350 400 450 500

Lead chromate

Trichloroethylene

HBCDD

Diarsenic trioxide

Lead chromate molybdate sulphate red


Dibutyl phthalate (DBP)

Bis(2-ethylhexyl) phthalate (DEHP)


Potassium hydroxyoctaoxodizincatedichromate

Sodium dichromate

Sodium chromate

Strontium chromate

Chromium trioxide

Chromic acid

Ammonium dichromate

EDC

Arsenic acid


22-dichloro-44-methylenedianiline (MOCA)

Bis(2-methoxyethyl) ether






authorisation as they do not have the resources to comment on each AfA Responses from these

NGOs suggest that they can spend between a few hours to 3 days commenting on the AfA depending

on the specific use quality of the application itself and availability of information on alternatives

The overall numbers of industry survey respondents were at a first glance reasonably good (16) to

derive indicative ranges for time spent Respondents to the industry survey were firstly asked to

describe the activities carried out alongside their average cost and time spent estimate Based on

these it was clear that some respondents had misinterpreted this as time taken to gather

information during lsquoinformalrsquo consultations that applicantsconsortia may have done to preparing

for authorisation The data from these responses were therefore excluded

The types of activities reported by the screened listed on respondents (7) are listed below (some

similar responses were omitted)

ldquoRespond to a response provided by an NGO during the public consultationrdquo

ldquoPrepare comments based on the AfA documents based on supporting evidence gatheredrdquo

ldquoData mining and then commenting timerdquo

ldquoResponse as part of an industry group We gathered information and fed it to the industry

group for aggregation along with input from other industry group members Our

comments have typically been high level and supportive of information within upstream

applicationsrdquo

ldquoIn the public consultation process alternatives had been suggested ndash Time was required to

provide information to explain why those suggested were not technically feasiblerdquo



often relates to responses from a single company for collecting information and forming a response

The upper estimate of time often relates to when industry or trade association level responses

requires collating responses from individual members or when applicants and or industry

(consortiatrade association) provide specific information on the unsuitability of an alternative

Table 624 Estimated time taken to produce response (AfA consultation)


1 day (or less) 1

1-5 days 2

6-10 days 1

11-40 days 3

40+ days 1 Notes








resulting estimates were not deemed to be credible given the small sample and that individual low

and high costs represent very different types of activities carried out This reflects reality in that


prepare and others not

664 Why stakeholders may or may not have provided a response during the public consultation

As part of the industry and NGO surveys respondents were asked for their motives for why they

responded or did not respond during the public consultation As noted earlier most NGOs do not

respond to public consultation as they rely on CHEMSEC EEB or Client Earth to comment on REACH

authorisation as they do not have the resources available The NGOs that do provide submissions

during the public consultations indicated in their responses the most common reasons for

commenting (from a list given to them) being their disagreement with the resultsfindings

presented followed by highlighting that there was critical information missing that needed to be

taken into consideration

As set out in Figure 64 the reasons why an industry stakeholder submitted a response were very

varied with some supporting and others disagreeing with the findings being shared This is because

the response is dependent on the actual public consultation Most industry stakeholders commented

because of disagreement with submissions made by regulators noting that critical information was

missing in their submissions for a substance to be included on the Candidate List and Annex XIV

respectively Comments submitted concerning AfAs on the other hand were mostly supportive as

they often came from downstream users who were being covered by an lsquoupstreamrsquo application

There were however some comments during the public consultation where some respondents

disagreed with applicants providing their information on the suitability of possible alternatives

from their perspective

Figure 64 Main reasons for industry stakeholder to provide comments

15

13

14

11

12

10

0 2 4 6 8 10 12 14 16

There was critical information missing

There were inaccuracies in informationpresented

We disagreed with the resultsfindingspresented

We agreedsupported the resultsfindingspresented

We were seeking an exemption for a specificusesector

Other (please specify)



There was more consistency in responses when respondents were asked about if they had read the

response to their submission Over 80 of respondents indicated they had read the response to

their comments with around half unsatisfied with the response given The main reason for this

was that they felt the public consultation was somewhat of a lsquoformalityrsquo and despite time and

effort to provide information or argumentation it was demotivating to get the answer such as

Thank you for your comment andor only reference to paragraphs or articles in the regulation at

the inclusion of substances onto the candidate list

Figure 65 Whether the industry organisation read published response to their comments

Whilst there is again a varied response for why stakeholders did not respond during public

consultations as set out in Figure 66 some of the key reasons were due to a lack of resources

expertise or that the information already available was sufficient or that they did not have

additional information to add

Figure 66 Main reasons for not providing comments

26

44

12

6

12Yes and I was satisfiedwith the response

Yes but I was not satisfiedwith the response

Yes but I canrsquot remember donrsquot have a particular opinion on the response

No

8

11

4

2

9

3

4

1

1

5

2

8

0 2 4 6 8 10 12

We believed the information provided was sufficient

We do not have enough staff to be able to respond

Substances and alternatives to date have not been relevantfor our organisation

We were not aware of opportunities to comment

We did not have further informationevidence to provide

We did not think commenting would influence the decision

The consultation process was too complex

The information requested was too limited (eg informationon alternatives for consultation on AfAs)

There is not enough time available to prepare comments

We did not have the technical expertise required to evaluatethe information provided

We did not know that for most of the public consultations responses to comments are later published at ECHArsquos website




Industry stakeholders who did not respond during public consultations were asked what could be

done to encourage further participation Some of the responses are shown below

ldquoWe as a medium-sized company are not in a position to participate in a public

consultation The associations that represent us complain about the complexity of the

process and the unfavourable chronological sequence In particular the association is of

the opinion that the consideration of the alternatives only happens too late during the

public consultationrdquo

ldquoIt must be possible to read answers in our mother tongue Acceptance and cooperation

would have been significantly higher if these prerequisites had been created The

navigation is too complex and you have to be a freak to work through itrdquo

ldquoIt is not clear enough communicated what the aim of the process isrdquo Some information is

not taken into consideration and this then leads to resentment and perceptions that ECHA

ldquodoes not carerdquo

ldquoMore time would be helpful for trade associations to assemble responses especially over

the summer monthsrdquo

ldquoResponses given by ECHA via RCOMs are not conclusive and provide vague (as opposed to

specific) reasons why exemptions were rejected the COM did not even bother to respond

directly to those of us who made a response during the better regulation public

consultation in SeptOct 2016 in summary specific and conclusive responses from

ECHACOM during public consultations can help during any future public consultationsrdquo

ldquoAlthough we understand the rationale behind the format proposed for input to the public

consultation we would like to highlight the importance of input from users along the

chain which may not be specifically technical about other alternatives but is nevertheless

important to support or question the content of the documents submitted in the AfA This

should be taken into account by enabling other formats of input to be submittedrdquo

ldquoAs such the consultation processes are quite transparent However the timelines can be

challengingrdquo

ldquoThe public consultation is the first public step to gather information about other

technologies that may have potential to become an alternative in the REACh context

(economically and technically feasible for the applicant) This is far too late This

collection should be performed before putting a substance on Annex XIV (eg by RMOA) In

some cases this would make the authorisation process obsolete at all in some cases this

would open the way to focus all efforts (by applicant authorities associations and public)

to the main questions and issues Instead the applicant has to deal with all possible

topics may they be serious or may they be out-of-date already and all third-parties as

well ECHA and potential applicants (possibly represented by their specific associations)

should identify the main approaches to risk reduction and alternatives available in

advance They should identify together the main issues that may be of concern The

current brute-force approach of discussing any possible use and any proposed parallel

technology without prioritising end in a lack of overview comparability assessment of

outcome and side-effects (eg risk-risk-trade-offs) EU-Commission and ECHA together

with case-specific stakeholder authorities should identify in advance the major issues that

may have a real measurable impact Only then should be part of a possible authorisation



procedure Actually too many issues are discussed late in the process giving no opportunity

of rational adjustmentrdquo

ldquoMany AfAs on chromium trioxide are concerning basically the same issue Why ask for all

these individual AfAs per applicationrdquo

Some of these issues are not new and were the basis for introducing the RMOA process The clear

message of requesting and using information on alternatives as early as possible (ie the RMOA

stage) is worth reiterating though However according to communications with ECHA (4th October

2017) from their experience sometimes companies can be hesitant to provide information on

alternatives during public consultations as this may have an impact on their relationships with

other companies along the supply chain

Some of the issues could at least be addressed by giving stakeholders more time (especially when

consultations occur in the summer holidays or during Christmas) and more justification given for

actions taken by regulators in light of all the information submitted

Based on an interview with an NGO they stated that ldquoalthough they have knowledge that

production of certain products can be done without the SVHC lack the technical details required

during the public consultation As a result the input of the NGOs is ignored by SEAC Same goes for

downstream users who use an alternative but not produce this alternative They also have the

knowledge and experience that alternatives are available (and commercial) but do not have the

technical details of the alternative (and do not want to ldquospeak for their supplierrdquo to that extentrdquo

67 Compliance costs

As illustrated in Figure 67 the majority of respondents (71) to the online survey indicated they

incurred some costs associated with compliance with REACH authorisation The type of compliance

incurred depends on the position in the supply chain (eg MIs have different requirements

compared to DUs)

Figure 67 Whether respondents organisation incurred costs associated with compliance with REACH authorisation process

Sample size 63

71

14

8

6

Yes

No

Dont know

Not applicable



Respondents were asked to select the types of compliance related costs they incurred due to

REACH authorisation As set out in Table 625 most respondents indicated they incurred some

costs to familiarise themselves with what they needed to do The remainder of the costs are

dependent on what type of actor they are (eg it would be the responsibility of a MI to produce

and maintain an extended safety data sheet)

Table 625 Types of compliance related costs incurred

Types of compliance costs

No respondents who incurred

costs

Proportion () of respondents that

indicated this specific compliance

related cost

Updating and maintaining an eSDS 23 51

Providing information to allow safe use of an article 10 22

Updating a registration dossier following AfAs 8 18

Notifying DUs of an authorised use 8 18

Complying with reporting obligations in authorisation decision and preparing review report

9 20

Familiarisation with REACH authorisation requirements 40 89

TOTAL 45 -

671 Familiarisation with REACH authorisation

Familiarisation with REACH authorisation requirement was the most commonly incurred cost All

the respondents who provided estimates for the number of days and costs incurred were collated

Whilst the estimates were within the same orders of magnitude rather than present a single

estimate the costs shown in Table 626 are differentiated between those that are SMEs and non-

SMEs as well as those involved in submitting an AfA vs those companies that have not been involved

in submitting an AfA as this helps to explain the variation in time spent

Table 626 Costs for companies to familiarise themselves with the requirements under REACH Authorisation

Familiarisation costs SME Non-SME Involved in

AfA

Not involved in

AfA

Average time (days spent per company) 46 74 76 53

Average cost (euro per company) euro 18300 euro 32700 euro 32900 euro 22000

Table notes

Sample size = 40 of which 34 respondents provided quantitative data

Two quantitative responses were excluded as they included time spent on preparing AfA

Costs were rounded to the nearest hundred euros

The results unsurprisingly show that SMEs do not spend the same amount of time familiarising

themselves with REACH authorisation as larger companies and that those companies submitting an

AfA invest more time familiarising themselves with the requirements under REACH authorisation

The averages are shown but the estimates at company level do vary as some companies have more

staff involved in regulatory compliance than others different staff costs and many respondents

noted that they may incur further costs due to keeping on top of any policy changes



672 Costs associated with information on safe use of SVHCs

It is not surprising that only a sub-set of respondents (14) indicated that they incurred some costs

associated with producing an extended Safety Data Sheet (eSDS) The majority (~90) indicated

the cost at up to euro50000 with an even spread between those indicating the cost at euro500-1000

1001-10000 and euro10000-euro50000 Only one respondent indicated a cost above euro50000 (in fact

gteuro200000 which related to biotechnology)

A smaller subset of respondents (9) noted that they incurred a cost to update an eSDS for example

reflecting on further information received from downstream users on their use of the SVHC Two

thirds of respondents indicated the costs of updating an eSDS at between euro500-50000 with the

most common estimate being euro1000-euro10000 A third of respondents indicated the cost at

gteuro100000 (these related to biotechnology aerospace and laundry detergent applications)

Once a substance is on the Candidate List it triggers obligations for article producers and importers

to notify to ECHA and for suppliers of articles to inform recipients on the presence of SVHCs in the

articles following the provisions of Articles 7(2) and 33 of REACH These requirements might not be

easy to meet especially for complex articles (see [Title 4 of REACH] for more details) A subset of

respondents (10) provided costs associated with providing information to allow safe use of an

article Half the respondents indicated the cost to be between euro100000 and euro200000 One

respondent suggested the cost was gteuro200k whilst four respondents indicated the cost at between

euro1-10000

673 Costs following the granting of an authorisation

If an authorisation is granted it requires the registration dossier to be updated (eg if there is

better information on exposure and safe use) Only a subset of respondents (8) estimated the costs

of this update As shown in Figure 68 nearly two-thirds reported costs between euro1000 and

euro50000 A further 25 of respondents reported costs between euro50000 and euro200000 while 13 of

respondents reported costs of more than euro200000

Figure 68 Cost to update registration dossier following granting of an authorisation

Sample size 8



If a downstream user uses a substance that is on the Authorisation List (Annex XIV) based on an

authorisation granted to an applicant high up in their supply chain they have to notify (for free)

their use to ECHA54

Based on just (screened) responses received from downstream users who have to submit a

notification the estimated cost was euro1001 and euro10000 For a single DU to notify ECHA believe it

should only take a few minutes DUs need to follow the link provided eg by the authorisation

holder or at ECHAs website create an account in REACH-IT select your useauthorisation number

from the pick-list and if they wish provide voluntary info on quantity and number of staff for the

use However what may be costly is the obligation in some cases due to the authorisation

decision to report on exposure andor alternatives For practical reasons ECHA have added a

functionality for attaching a file for this purpose at the notification tool The costs could therefore

in part relate to collecting new exposure data costs

The final cost of compliance estimated was the cost incurred by applicants who had reporting

obligations as part of their authorisation decision and for preparing the review report The

majority (gt75) of respondents (9) indicated the cost at between euro1000 and euro50000 (a broadly

even spread between euro1001-euro10000 and euro10001-euro50000) A minority of respondents (lt25)

however reported costs of gteuro200000 These were from applicants related to the pharmaceutical or

aerospace sector The high costs may relate to the costs of preparing a review report where a

short review period was granted costs costs of RMMs stated to be implemented in the post

submission of the AfA andor costs of any monitoring requirements

68 Costs of substitution

This sub-section focuses on the costs associated with substituting SVHCs with alternative substances

andor technologies It is based on the findings presented in Section 5 regarding instances of

substitution and efforts to substitute

681 Costs to switch from an SVHC to an alternative

Most respondents have indicated one-off substitution cost at less than euro1 million (see Figure 69)

and that the net change in operating costs at lteuro100000 per year Unfortunately the cost ranges

included in the survey were too broad to be able to derive precise point estimates of average costs

across the whole sample but if it is assumed that companiesrsquo costs were equal to the lower limit of

their cost range the mean cost per company would be euro15m for one-off costs and euro738k per year

for operating costs even though the majority of companies would be assigned zero additional costs

following this approach This is because of the very high one-off and operating cost increases

incurred by a relatively small number of companiesrespondents

This could mean that where substitution has been financially possible it has been the preferred

strategy compared with applying for authorisation This would then imply that the (intentionally)

material costs of the authorisation process ((i) fees (ii) administrative burden (complexity) and

(iii) costs to prepare for authorisation (iv) costs related to the uncertainty of the outcome of the

authorisation process (v) compliance costs after granting the authorisation (eg improved RMM and

monitoring costs)) are driving substitution because it is a cheaper option compared with a company

applying for authorisation

54 See httpsechaeuropaeusupportdossier-submission-toolsreach-itdownstream-user-authorised-use



Even though the range of substitution costs for most respondents overlaps with the average

estimated cost of submitting an authorisation application (around euro220k Section 611) it should be

remembered that the authorisation cost covers an extended period of time and assuming a

lsquostandardrsquo review period of seven years means the annual cost of authorisation is below euro40k on

average This is low enough that if firms reporting choosing substitution rather than authorisation

were doing so for financial reasons (rather than lsquoriskrsquo or other non-financial ones) it would be

reasonable to expect more respondents to report substitutions having zero net cost or even

beneficial impacts on profitability overall However as described only a single respondent

reported a substitution of zero net cost and none reported a beneficial one substitution case

studies considered in Chapter 5 also suggested substitutions have generally been cost-increasing

rather than cost-saving This suggests that other non-financial factors are indeed also contributing

to the decision to substitute However for reasons discussed firm conclusions on this topic are not

possible

Figure 69 One off investment costs to implement alternative (substance or process) to an SVHC

Figure 610 Annual net operating costs to use the alternative (substance or process) to an SVHC

The possibility is confirmed however by observing overall survey responses one reason for citing

substitution is due to an internal policydesire to not use an SVHC Another reason is the avoided

time required (and to a lesser extent the cost) for preparing for an application The limited

78

9

13

0 0

lteuro1million

euro1-euro10 million


euro51-100 million

gteuro100 million

61

28

56

0 0

lteuro100 000 per year

euro100 000 - euro1 million per year

euro1-euro10 million per year



gteuro100 million per year



possibility of getting a normallong review period if there were alternatives on the market was also

noted An alternative could be preferred even if its cost is much higher than the cost of applying

for authorisation since using an alternative avoids uncertainty and does not limit the businessesrsquo

ability to commit to long term contracts with customers

One of the survey respondents noted that the applicant (their supplier) was not applying for

authorisation for their specific use given the small volume This meant the user was lsquoforcedrsquo to

substitute to an alternative on the market even though the use of this alternative would result in an

inferior product The switch to the alternative was nevertheless a less risky option as the user

believed they would not get a favourable authorisation decision

682 Cost to undertake substitution activities

As mentioned in Section 5 around one in three respondents to the industry survey said they had not

substituted SVHCs but were investigating opportunities to substitute In total 43 respondents were

able to estimate the annual costs spent on substitution related activities (that were set out in

Section 5) As shown in Figure 611 the amount spent per year by respondents is varied but

around half the respondents noted costs between euro10-100k per year

Figure 611 Annual spending on substitution activities

Examining the data further the following observations can be made

The respondents who were also SMEs noted they spent on substitution between euro1kyear

and euro100kyear There were no SME respondents who noted annual investment in

substitution above euro100kyear

Whether the respondent was involved in an AfA or not had no significant relationship to

how much was spent on finding an alternative This would imply the average amount spent

on looking for an alternative is not linked to how far the substance is along the

authorisation process (but that it could be subject to authorisation at some point in the

future) This is supported by the analysis shown in Section 5 whereby 43 of substitution

activities were triggered by placing the substance on the Candidate List in comparison to 7

of substitution activities being driving by applications for authorisation

5

16

28

23

18

55

0


euro1 001 - euro10 000 per year





euro10 - euro100 million per year




The type of use of the SVHC or sector the respondent is from did not seem to have a

relationship with how much was spent on finding an alternative

The findings from the survey regarding the benefits of substitution are covered in Section 76

69 Costs of RampD innovation and investment

According the industry online survey more 80 of respondents (3546) indicated that authorisation

has had an impact on their annual RampD innovation investment spending These relate to the

following substances (in alphabetical order)

12-dichloroethane (EDC)

44-Methylene bis(2-chloroaniline)

Boric acid

Chromium trioxide

DEHP

Hydrazine

Lead chromate

Lead chromate lead styphnate orange lead

methylhexahydrophthalic anhydride

NMP

Not stated

octylphenol ethoxylates

Perboric acid sodium salt

Refractory Ceramic Fibres (RCFs)

sodium chromate

Sodium dichromate

Further details on the specific uses of these substances are listed in Table 627 The list above and

in the Table are organised in alphabetical order to preserve the confidentiality of individual

responses

Table 627 Change in RampD innovation or investment spending (by use)

List of uses (alphabetical order)



Buffer substance

Cell lysis during manufacturing of vaccines

Coatings and sealants

Conditioning of the plastics in the pre-treatment and for the final plating

Curing agent of polyurethane

Decorative plating

Electroplating of injected plastic parts

Etching and plating plastic parts

Galvanic surface coating

Hardener for epoxy resin

Ingredient used in surface treatment processes to deliver a barrier film

Insulation material




Manufacturing of pharma active ingredient

Metal Acid reaction inhibitor

Passivation of tin plating

Pigment

PLASTIC ETCHING (POP)

Plasticizers in tape

Plating of steel bars

Precursor for ClO2 generation

Pre-treatment of plastics

Solvent

Solvent used in the manufacture of APIs

Use as a reduction agent

Used as a Viral inactivation in API manufacturing processes

Various pyrotechnic mixtures

Respondents were asked for each use whether there was an increase or decrease in spending as

well as the option to not state a response As set out in Table 628 most respondents indicated

both an increase in innovation and investment and RampD spending as a result of the REACH


Table 628 Change in innovation investment and RampD spending

Change in annual spending

Number of respondents

Increase Decrease Didnrsquot state

Innovation and investment spending 26 (67) 7 (18) 6 (15)

RampD spending 28 (72) 5 (13) 6 (15)

Those respondents that indicated a change in spending were then asked to estimate (from a given

list) the scale of the change in annual spending (see Table 629) The results give more insight into

the scale of these changes reported increases in spending are generally lower than reported

decreases Therefore it is possible that the net impact of authorisation could be a decrease in

spending but it is not possible to say either way given the sample size

Table 629 Scale of change in innovation investment and RampD spending

Annual spending change

No respondent reporting a change in innovation investment spending

No respondent reporting a change in RampD spending

Increase Decrease Increase Decrease

lteuro1k 1 - 1 -

euro1k-10k 2 - 2 -

euro10k-euro50k 4 1 5 1

euro50k-100k 2 - 3 -

euro100k-1 million 3 4 7 1

euro1million-10million 3 - - -

euro10million-100million - 1 - 1

gteuro100million - - - 1

TOTAL 15 6 18 4

71 29 82 18



When asked if there were other factors that may have been responsible for these changes in

spending most respondents said there was not (59) whilst some said yes (23) and others did not

know (18) The main other driver for changes in spending was existing internal policies to try to

substitute away from the substance

Some of the qualitative justification respondents provided for their monetary estimates also reveal

some interesting insights

Several respondents noted that they would accelerate spending on RampD and investment to

substitute away from the SVHC However this would be funded by a decrease in spending

on developing new markets and products Some money needs to be spent doing intensive

testing of possible alternatives including laboratory testing pilot testing and spending on

raw materials and staff

Several respondents noted that many investments are based on long term planning that

pre-dates when the authorisation process starts Authorisation may not stop these plans

but would put into question if the production occurs in the EU if the continued use of the

substance is essential for the new productsmarket

One respondent noted that as ldquoeasyrdquo (eg drop in replacements) solutions have not been

identified the efforts have turned into long term projects that have required steady

funding The priority focus has been on ldquobig hitterrdquo processes where they believe they can

get the most reduction in the use of the substance and employee exposure for the budget

available With the onset of REACH the overall budget for RampD must now include REACH

compliance This has necessitated the redirection of some researchers to non-RampD activities

in support of REACH This includes supporting development and review of AoA documents

and attention spent on smallspecialty use cases

One respondent noted a diversion of investment from their EU sites to their sites outside

the EU They nevertheless expected to increase spending within the EU to find an

alternative in order to continue operations at their existing EU sites

Several respondents noted a halt in investment until the outcome of the authorisation is

known One respondent noted invest was being diverted to Switzerland where the

continued use of chromium trioxide is secured for the next 20 years

610 Costs of closure and relocation

Costs covered in this section are those incurred by firms which have no suitable alternatives to an

Annex XIV substance but which do not apply for authorisation to continue their use Instead they

choose to comply with the requirement to cease their use in the EEA by the sunset date by closing

their operations entirely or relocating them to another country outside of the EEA

Closurerelocation has been the lsquonon-usersquo scenario in the majority of applications for authorisation

submitted and publicly available end of 2016 It is reasonable to expect firms which choose to close

or relocate to face the same types of costs as those which have them only as non-use scenarios in

their applications for authorisation ndash even though it is not reasonable to assume the same

magnitude of costs faced by these two groups as explained below This means that descriptions of

non-use scenarios contained in applications for authorisation are useful for characterising the costs

of closure and relocation as a response to authorisation Examples of these costs can be

summarised as follows



Demolition site closure and remediation ndash Some costs might be offset by revenues from

plant and land sales

Redundancy costs and temporary unemployment ndash Note that redundancy payments

themselves are transfers from employers to employees so do not count as social costs

Unemployment insurance payments are excluded for similar reasons Temporary

unemployment can have costs in terms of lost output job search and deskilling (scarring)

which can be (partly) offset by increases in leisure time availability

Site acquisition buildings plant project management and recruitment and training at the

new site ndash Some costs might be offset if the company already owns suitable spare capacity

andor can transfer assets and employees (at a cost) from the old site to the new site

Temporary profit losses as a result of reductions in output during relocation or until the end

of the natural life of the assets In principle such profit losses (and other costs) can be

experienced both up and down the firmrsquos supply chain and

Outsourcing transport and inventory costs ndash Firms might need to outsource production to

maintain output during relocation projects as well as face additional transportation and

inventory costs in shipping output back to EU markets Some of these costs might be offset

by reduced costs elsewhere (eg production cost savings from closure and lower transport

costs for markets nearer the new site)

Note that impacts on the competitors of firms which close andor relocate are generally not

included explicitly in the cost assessment This is because they are captured implicitly by the

assumption of a finite length of time of impacts ndash and hence costs ndash of the closurerelocation after

which it is assumed that the level of output and profit returns to pre-closure-relocation levels If

competitors increase their output in response to an increase in demand following the closure of the

firm in question this can usually only happen with an increase in spending on capacity and

production which tends to take time What is important with closure and relocation is that they

will generally involve the premature obsolescence (and hence loss) of valuable productive capital

and the incurrence of additional investment in productive capital which would not have been

necessary otherwise Whether these are incurred by the lsquoauthorisation firmrsquo or its competitors is a

distributional question There might be some temporary increase in profit for competitors if they

are able to increase their prices in response to the increase in demand from customers of the firm

which closes but any such benefit is in reality a transfer away from customers and will be

associated with a loss in consumer surplus ie a net loss from the societal perspective Only if

competitors have excess capacity available and can supply a product of equivalent quality and price

can we assume that there will be no net societal loss ndash and in general we will not be able to

assume that is the case

The non-use scenarios included in applications for authorisation are hypothetical since they are

only proposed to apply in the event that the authorisation application is rejected and no

application has been rejected yet In addition the estimated costs of these hypothetical

closurerelocation non-use scenarios can be expected to differ from the costs of

closuresrelocations which actually do occur because clearly firms which apply for authorisation

consider the expected costs of authorisation to be lower than the expected costs of

closurerelocation Firms which choose to closerelocate on the other hand clearly expect the

opposite situation ndash that the costs of authorisation (including an assessment of the probability that

authorisation will be granted) will be greater than the costs of closurerelocation The costs of

compiling and submitting the application itself are relatively predictable (see Section 611) even



though there could be (potentially significant) additional costs in any specific case where a firm

must reduce its exposures and otherwise improve its risk management measures The costs of

closurerelocation estimated for non-use scenarios are generally relatively high (eg euromillions) but

could in principle be lower in specific cases for instance where the relevant operations are a small

part of a larger site (so the site itself will not need closure) employ few workers and there is

already a suitable alternative site operational Finally discussions with industry suggest that firms

often seem to place a significant risk premium on the authorisation route associated with the

(perceived) uncertainty over the initial authorisation decision and with the continued cost and

(perceived) uncertainty from the need to reapply for authorisation at the end of the review period

This premium could be the explanation if a firm chooses to close andor relocate its operations

even when the (financial) costs of authorisation would appear to be lower

Nevertheless in general it is reasonable to expect firms which apply for authorisation to be facing

different cost magnitudes from those which choose to close andor relocate This is why the

estimated costs of closurerelocation non-use scenarios presented in applications for authorisation

are not expected to be good indicators of the costs of closures and relocations actually

implemented by firms as a means of complying with the need to cease use of a substance by its

sunset date This in turn means that estimates of these costs can only be obtained from firms which

actually have closed or relocated which first requires these firms to be identified

In the consultation with industry only three respondents reported that their companies had

undertaken closures or relocations as a means of complying with the requirement to cease the use

of a SVHC by its sunset date and none of these respondents was willing to provide comprehensive

information on these activities including on costs One respondent who reported a closure was

actually predicting what they thought would happen in the event they were unable to continue

their use of their SVHC Anonymised details of these three respondents and responses are provided

in Table 630

Table 630 Industry consultees reporting relocation or closure in response to authorisation

No Substance Use and sector Relocationclosure Notes

1 Sodium

dichromate

Sensitiser used in

engraving of printing

screens

Relocation No reported impact on

employment

2 Chromium

trioxide

Corrosion inhibitor used in

aerospace

Diverted

investment

3 Confidential Surface treatment of

aluminium and steel Relocation Impact on employment

4 octyl phenol

ethoxylates Life sciences Relocation Case 3 chapter 53

5 Nonyl phenol Fine chemicals Closure Case 7 chapter 53

Respondent 1 reported using sodium dichromate as a sensitiser in the engraving of printing screens

This use had been relocated out of the EU No impact on employment was reported suggesting that

this could be a relatively minor use A further use of sodium dichromate as a sensitiser was

reported to have been substituted with a diazo compound No explanation was given as to why the

engraving use had been relocated instead of authorisation being sought However if it were a

minor use this could imply a relatively low cost of relocation compared with authorisation REACH

authorisation was seen as the only reason why this relocation had occurred

Respondent 2 reported using chromium trioxide for its corrosion resistance in the aerospace sector

This respondentrsquos use of chromium trioxide was continuing in the EU under a granted authorisation



However the company had recently switched an investment in chromium trioxide-based plating

which was planned for an EU country to a country outside of the EU The reason given for this was

the length of the review period of the authorisation which it was said was too short for the

investment planning required for this new project

Respondent 3 reported that the use of a confidential SVHC in the surface treatment of aluminium

and steel had ceased in the EU with impacts on jobs but no further details were provided (It is

not clear whether this relates to the respondentrsquos own use or anotherrsquos) It also reported having

relocated two production plants outside of the EU but no further details were provided

The case of respondent 4 is described in case 3 in Chapter 54

Because of the lack of information provided by these respondents a brief review was undertaken of

a small number of public applications for authorisation which had closure or relocation as their non-

use scenario Table 631 summarises these applications It reports the name of the applicant the

substance and use applied for the nature of the non-use scenario an assessment of cost and the

time over which it was estimated and any pertinent notes Because many applications do not

include financial figures in their public versions the cost figures given in Table 631 are those

reported in the associated SEAC opinion and are therefore subject to confidentiality ranges

Table 631 Estimated closure and relocation costs from selected applications for authorisation

Applicant SVHC Use NUS SEAC cost Time Notes

Parker Hannifin

TCE Process solvent for the manufacturing of modules containing hollow fibre gas separation membranes

R euro75-150m NPV

18 95 profit

Laboratoires Expanscience

EDC Process and extracting solvent in the manufacture of plant-derived pharmaceutical bioactive ingredients

C gteuro100m 12 Lost profit

Rimex Metals (UK)

Chromium trioxide

Oxidising and hardening agent in the manufacture of coloured stainless steel

C lteuro100m pa 10 Lost profit (99 customers)

Circuit Foil Luxembourg

Arsenic acid

Treatment of copper foil used in the manufacture of Printed Circuit Board

R euro300-400m 7-12 Lost profit

Topocrom Chromium trioxide

Functional chrome plating for the establishment of adjustable hemispherical surface structures

C euro5m 15 Lost profit unemployment

Veco

Ammonium dichromate

Photosensitive component in a photolithographic lacquer system

R euro10-17m 7 Lost profit unemployment relocation costs

Eli Lilly EDC Reaction medium and a solvating agent in the manufacture of an API

R euro6-20m 14 Decommissioning outsourcing (profit loss excluded)

Notes Substances ndash TCE trichloroethylene EDC ethylene dichloride Non-use scenario ndash C closure R relocation

This selection is in no way representative and is provided just to give a sense of possible

magnitudes of costs included in authorisation applications It can be seen that a few applications

have relatively low (euro5m-euro20m) costs whereas others have costs estimated to run into several

hundred million euros Closure and relocation costs themselves tend to represent a relatively small

proportion of these totals which tend to be dominated by losses in profit (from the destruction of

the capital stock or relocation of the capital stock outside of the EU) These costs are orders of

magnitude higher than the costs of applying for authorisation (Section 611) which would explain

(partly) why these companies choose to apply for authorisation rather than to relocate or close As



already discussed we expect the costs of closure and relocation to be significantly different

(higher) for applicants for authorisation than for companies which actually close or relocate

However if the costs in Table 631 are representative of the costs companies face from closure or

relocation it would go some way to explaining why so few examples of closurerelocation have

been reported in the consultation

611 Costs to apply for authorisation

Costs covered in this section are those incurred by applicants in compiling and submitting

applications for authorisation and then engaging with the application process post-submission

Costs to other parties engaged in this process are covered in other sections

Since the authorisation application process started in 2013 ECHA has used an applicant survey to

collect information on the costs to applicants of preparing and submitting an application This

survey collects information on the lsquodirect costsrsquo of the application and the amount of lsquointernal

staff timersquo expended lsquoDirect costsrsquo are defined as follows

Preparation of assessment reports

Handling of the application process (overhead project management legal advice etc)

Consortium fees

Expenses (travel hotel and meeting rooms etc) and

Application fees (payable to ECHA)

ECHA has provided these figures in terms of the mean per applicant per use applied for These have

been calculated by taking the simple average of each respondentrsquos estimated mean cost per use

That is for each respondent the total reported cost of their application is divided by the number

of uses they applied for to give a cost per use for each respondent and then the average of these

figures across all respondents is calculated Thus the simple averages reported do not take account

of the characteristics of the respondent or the application Although it is not clear what weighting

if any should be given to the figures from different respondents the fact that those reported here

are unweighted should be born in mind

A breakdown of these figures by size of applicant position in the supply chain and authorisation

route was also provided by ECHA To aid comparison the estimates of direct costs and internal

staff time expended have been converted into a total mean application cost per use using a

notional euro75000 per year total (including overhead) wage cost for internal staff

Application fees paid to ECHA are included in the application cost figures in the survey but reflect

costs incurred by ECHA in processing the application and hence have been included in the section

on costs to ECHA It has not been possible to identify the actual fees paid by individual respondents

to the ECHA survey so fees have been estimated in terms of the average per use for each class of

applicant covered in Tables 69 to 612

Table 632 presents application cost information reported by all survey respondents over the period

2013-2016 Direct costs and fees are reported in euros and internal staff time in person-months

Means reported in the final row of the table are averages of each yearrsquos figures weighted by the

number of respondents in that year It can be seen that on the basis of responses from 57

applicants covering 101 uses over four years the mean direct costs per use were just over

euro100000 and the mean number of internal staff months expended per use was just under 10 The

average fee paid was just under euro40000 per use (This compares with the figure derived in Section

643 of euro51000) Reported costs were clearly highest in the first year of applications (when the



survey response rate was also highest) but since then there has been no clear trend Given the

variation in application types substances etc and the low response rate in some years it is not

possible from these data to say whether application costs have changed over this period

Table 632 Reported mean application costs per use and applicant 2013-2016 (source ECHA)

Direct costs

exc fees

(eurok)

Fees

(eurok)

Internal

staff time

(months)

Notional

total cost Respondents Uses

Total

applicants

Response

rate

2013 19693 3656 1621 33480 8 25 14 57

2014 8043 4033 47 15014 14 23 30 47

2015 7916 3702 1051 18187 14 23 70 20

2016 9617 3929 1072 20246 21 30 82 26

10227 3860 996 20312 57 101 196 29

including co-applicants

ECHA has provided a breakdown of these figures by size of applicant position in the supply chain

and authorisation route To aid comparison the estimates of direct costs and internal staff time

expended have been converted into a total mean application cost per use using a notional euro75000

per year total (including overhead) wage cost for internal staff Thus the total mean application

cost per use across all respondents to the ECHA survey is just over euro200000 (Table 632) This can

be compared against the broken-down figures in the following tables Tables showing a greater

level of disaggregation are provided in the confidential annex

Table 633 presents reported mean notional total application costs per use broken down by the

position in the supply chain of the applicant It can be seen that over 2013-2016 the majority of

applicants (146 out of 196) have been downstream users with a survey response rate of around 13

for this group The next largest category is importers but only 3 out of 20 importers have

responded to the ECHA survey

It does appear generally that applications submitted by manufacturers (euro273000) and importers

(euro262000) have tended to be more expensive per use than those submitted by downstream users

(euro159000) with those submitted by only representatives (euro88000) being cheapest of all Fees

appear comparable across groups except for only representatives who have paid lower fees per

use perhaps reflecting economies in application costs However as can be seen from the more

detailed annual figures presented in the confidential annex there is sufficient variation in these

figures to make firm conclusions impossible In addition numbers in different categories are small

enough by year that as with the overall figures reliable time trends cannot be drawn on the basis

of these data



Table 633 Reported mean notional total application costs per use and applicant by supply chain position 2013-2016 (source ECHA)

M I OR DU MI IDU

IC F TC n(N) IC F TC n(N) IC F TC n(N) IC F TC n(N) IC F TC n(N) N IC F TC n(N)

273 37 310 3(10) 262 40 302 3(20) 88 17 105 3(10) 159 41 196 46(146) 145 34 179 2 2 - - - 0(7)

Key

M = manufacturers I = importers OR = only representatives DU = downstream users MI = manufacturer-importers IDU = importer-downstream users

IC = internal notional cost F = application fee TC = total notional cost

n = number of survey respondents in category

N = total number of applicants in category

Table 634 Reported mean notional total application costs per use and applicant by company size 2013-2016 (source ECHA)

Large Medium Small Micro

IC F TC n N IC F TC n N IC F TC n N IC F TC n N

179 42 221 48 151 119 38 156 3 18 95 16 112 4 17 32 5 37 2 10

Key





eftec 130 November 2017

However one aspect which is worth drawing attention to is the fact that the costs per user rather

than per use are likely to vary significantly across applications by supply chain position

Downstream user applications seem to be cheaper than manufacturersrsquoimportersrsquo but only cover

the bottom of the supply chain ndash essentially a single user Manufacturersrsquo and importersrsquo

applications cover the whole supply chain and hence potentially at least all users (for a given

use) The cost per user therefore is likely to be significantly lower for upstream than for

downstream applications

Table 634 presents reported mean notional total application costs per use by company size The

first thing to note is that the vast majority of applications have been from large companies (151

applicants out of 196) Large companies make up an even bigger proportion of survey respondents

(48 out of 57) Due to the very low number of respondents from non-large companies it is not

considered possible to draw conclusions about application costs for different-sized companies

Table 635 Reported mean notional total application costs per use by application route 2013-2016 (source ECHA)

Adequate control Socio-economic Analysis

Notional

internal cost Fee

Notional

total cost n(N)

Notional

internal cost Fee

Notional

total cost n(N)

272 40 311 8(18) 147 38 185 49(178)



Table 635 presents reported mean notional application costs per use by the route of application

ie lsquoadequate controlrsquo or lsquosocio-economic analysisrsquo The vast majority of applications (178 out of

196) and respondents (49 out of 57) followed the SEA route and hence drawing conclusions on the

relative costs between application routes is difficult It should also be remembered that although a

SEA is not required for applications under adequate control ECHA does advise all applicants to

compile one as a fall-back if adequate control is not demonstrated and to provide support for

other aspects of the application (eg the requested review period) However one aspect which is

worth drawing attention to is the fact that the costs per user rather than per use are likely to

vary significantly across applications by supply chain position Downstream user applications seem

to be cheaper than manufacturersrsquoimportersrsquo but only cover the bottom of the supply chain ndash

essentially a single user Manufacturersrsquo and importersrsquo applications cover the whole supply chain

and hence potentially at least all users (for a given use) The cost per user therefore is likely to

be significantly lower for upstream than for downstream applications

Table 635 suggests that applications under adequate control have not generally been cheaper

than those under the SEA route However the sample size is small and these applications might

also have included a SEA anyway so drawing conclusions is difficult

As already noted these cost estimates apply to pre-submission activities only ECHA has recently

started undertaking a survey of applicantsrsquo post-submission activities These are specified in the

survey to include

Responding to requests for additional information by RAC and SEAC

Responding to public consultation comments

Participating in the trialogue meeting with RAC and SEAC rapporteurs (if one is held) and

Providing comments on the draft opinions



The first results of this survey have been provided by ECHA and are presented in Table 636 Direct

costs are reported in euros and internal staff time in person-days Using the same notional euro75000

figure for a full-cost FTE these figures are translated into a notional total cost for applicants

during the opinion-making phase The mean notional total cost reported by applicants was just

under euro17000

Table 636 Reported notional total costs for applicants in the opinion-making phase (source ECHA)

Direct costs

(consultants fees) euro

Internal staff

time

(person days)

Notional total cost Number of

respondents Number of uses

euro13670 8 euro16526 29 49

This implies that the total (notional) cost of applying for authorisation has averaged around

euro180000 per use over the period 2013-2016 with an additional euro40000 paid to ECHA in application

fees Application fees have not apparently changed significantly over time although the number of

applications has increased markedly

612 Costs to improve risk management

This sub-section focuses on the costs associated with improving risk management of SVHCs Further

details of the uses where improved risk management took place as well as details of the measures

are set out later in Section 73 (benefits of improved risk management)

In total (n=57) 40 of industry survey respondents indicated that they had improved risk

management of SVHCs as a result of the authorisation process As set out in Figure 612 most

stages in the authorisation may trigger improved risk management This suggests that companies do

not wait until the substance is placed on the authorisation list before carrying out further risk

management

Figure 612 What authorisation stage triggered these risk management activities

However it is not surprisingly that most respondents noted the applications for authorisation stage

as a key driver for improving risk management as it is legal requirement (art 6010) for applicants

to show minimisation of emissions as part of their application Whilst there is pressure to make sure

exposure and emissions are as low as possible there are examples with TCE (as publicised in AfA

opinions) where the RAC have recommended to SEAC to grant shorter review periods when there

15

27

815

35

0Screening of substance and Risk ManagementOption Analysis (RMOA)

Inclusion of substance in Candidate List

Recommendation for inclusion of substance inAuthorisation List (Annex XIV)

Inclusion of substances in Annex XIV

Applications for authorisation (AfA)

Post-authorisation decisions (eg after sunsetdate of Annex XIV substance)



was not sufficient evidence of minimisation of emissions as well as imposing additional conditions

to improve RMMs andor monitoring requirements This is despite the evidence that a longer review

period was justified from an SEA perspective

Respondents were asked to indicate the one-off cost incurred by their organisation in implementing

these risk management activities of which a subset (n=22) were able to quantify these one-off

costs As shown in Figure 613 around half of respondents indicated the costs to around (euro10k-

100k) even though a third of respondents spent over euro100k Assuming that each company spent a

figure equal to the bottom limit of its cost range this would put the average spend per company at

just under euro140k With 200 applicants for authorisation over four years this might suggest an

annual one-off cost of around euro7m This figure is extremely uncertain however given the small

sample number of respondents

Figure 613 Estimated one-off cost of risk management activities

Examining the data further the following observations were found in the data

The respondents who were also SMEs noted they spent between euro1k and euro100k There

were no SME respondents who noted risk management investment above euro100k The risk

management investments above euro100k have therefore been carried out by non-SMEs

Whether the respondent was involved in an AfA55 or not had no significant relationship to

the average spend on improving risk management

However what could be observed (but cannot be generalised given the smaller sample size)

from the data was that the higher risk management investment seemed to be linked to the

earlier stages in the authorisation process This could be explained because

o There is more time for companies to plan for such improvements at RMOA and

candidate listing stage as well as fewer constraints on resources (financial and

human) whereby companies do not need to also prepare for an application for

authorisation There is also an incentive for companies to improve their RMMs as it

may affect their prioritisation to Annex XIV and reduce uncertainties concerning the

outcome of evaluations made by authorities on the applications for authorisation

55 This includes both applicants and downstream users covered by the application

9

14

41

27

9

0

euro0-euro10 000

euro10 001 - euro50 000

euro50 001 - euro100 000

euro100 001 - euro1 million


gt euro10 million



o There could be pressure at sectorconsortia level to drive down exposure in the

supply chain once a substance is on the candidate list so that regulators prioritise

other SVHCs for authorisation

o Applicants have already invested to reduce exposureemissions earlier in the

process so there are fewer options available at AfA stage

The effectiveness of these measures are set out later in Section 73 which sets out survey results on

the benefits of improved risk management on human health and the environment

613 Summary of costs

This chapter has covered a wide variety of different types of cost associated with the authorisation

process including administrative costs of running and engaging with the process costs of improving

risk management measures costs of substitution and costs of closure and relocation

Administrative costs of running the authorisation process incurred by ECHA MS CAs and the EC

appear to amount to around euro84million per year (euro43m for MS CAs euro3m for ECHA and euro11m for

the EC) Application costs (excluding fees) might be estimated at a similar ballpark figure of

euro9million per year (50 uses per year at euro180k per use (Table 631)) although subject to significant

variation given the variation in the annual number of applications Costs of additional risk

management measures associated with these applications are difficult to estimate given the nature

of responses to the survey but might add another euro7million per year (50 applicants at euro140k per

applicant Section 612) This figure is extremely uncertain however given the small sample size

of respondents Costs to stakeholders associated with providing comments and so on are not

estimated here due to the very small number of survey responses received








costing results to the EU-level is not feasible Section 67 of the main report suggests the costs of

compliance are likely to run into thousands (possibly tens of thousands) of euros per company

which could make them significant at an aggregate level








































aggregate level







7 BENEFITS FROM THE AUTHORISATION PROCESS

71 Introduction

Assessing the benefits from the REACH authorisation process is the fourth of the five focus areas

assessed The key benefits are expected to be the reduction in risks to human health and

environment as a result of the reduced use of a substance and through the improvement of

operational conditions (OCs) andor risk reduction measures (RMMs)

In theory reduced use (due to substitution) is associated with elimination or reduction of exposures

and releases which were occurring during the use but also of exposures and releases due to

preceding and subsequent stages (eg manufacture unless export will replace the ceased use in

the EEA article service life waste stage) In practice the applications so far have seen very few

cases where the substance is still present in the article The impact on the manufacturing stage was

also limited as in several cases the majority of the manufacturing was for intermediate use

Furthermore substitution does not only eliminate the risks from scenarios of reasonably

foreseeable use but also from occasional accidents or micro-accidents involving the use (or even

eg road transfer) of the substituted SVHC To what extent the substitues consist of an actual

reduction of risks is mostly untested For example the impact on risk of the use of a solvent with

SVHC properties with a high ignition temperature (non-ATEX regulated) versus the use of a non-

SVHC solvent with a lower ignition point is difficult to make

lsquoInternalisationrsquo of SVHC risks into firmsrsquo decision making could benefit them in several ways First

substitution of an SVHC could reduce production costs due to the reduced need for control

measures There could also be a lsquohousekeepingrsquo effect whereby actions the firms adopt to reduce

their SVHC use and emissions could increase overall production efficiency and hence reduce costs

Better risk and exposure management processes could also be implemented even if continued use is

allowed andor substitution is not possible

There are two approaches to estimating these benefits and linking them or a proportion of them

to the requirements of the REACH authorisation The first is to use the lsquono REACH authorisationrsquo

baseline This involves estimating what would have happened to use of SVHCs exposures and the

populations at risk of these exposures (eg workers local residents etc) without REACH

authorisation and compared them to what happened with it The difference is the net benefit (or

indeed cost) of the authorisation The challenge here is that the lsquono REACH authorisationrsquo baseline

is usually not known The second approach is to compare use exposure and population before and

after the REACH authorisation (at a firm or market level) The challenge here is that there are

usually many factors that lead to changes in the same period making it at best very difficult to

apportion the benefits to REACH authorisation (or indeed any other single factor)

This is not a challenge faced by this study alone Indeed there is a developing literature on what

the benefits could be and what indicators could be used to measure them For example Okopol

undertook a review of many early studies56 However as with costs studies have generally not

focused on authorisation specifically and have been undertaken prior to the authorisation process

achieving full implementation The Okopol review also states that studies have not generally

distinguished clearly between the true benefits related to improved societal outcomes and those

that relate to intermediate outcomes or distributional changes For instance lsquobetter conditions for

56 httpeceuropaeuenvironmentchemicalsreachpdfbackgroundreach_benefit_studiespdf



innovationrsquo which is mentioned as a benefit of REACH authorisation simply reflects a change in

the relative cost of using SVHCs versus using non-SVHCs and it can come about due to any ensuing

innovation not only REACH authorisation

A total different approach on evaluating the benefits of authorisation would be by comparing the

benefits if different risk management options were adopted This approach has not been followed

in this report This is evaluated in a Risk Management Option Analysis In such an analysis the

properties and the effects of each option are evaluated in a specific case to select the best RMO

which best manages the concern related to the use of a SVHC For instance what in one case is a

benefit of authorisation could consist of a disadvantage in another RMO A detailed analysis of

these choices is outside the scope of this report which focus on the actual impact of the

authorisation process not on the relative impact compared with other RMOs In that sense a

benefit for the authorities of Authorisation is that there is an additional regulatory tool available to

manage the risks associated with the use of a substance

EC (2016) reported the development of a system of indicators for the calculation of the benefits of

chemicals legislation57 and differentiates between Output Result and Impact indicators

Output indicators relate to the activities of regulators to implement the legislation (eg

number of substances with harmonised classifications) This type of indicator is of less

relevance for this project because the number of classifications that are harmonised (CLH)

does not in itself lead to any benefit to health or the environment ndash it just means that the

classifications are now agreed upon However CLH hazard warnings and labels can lead to

differences in the way the substances are handled and used that could bring about a

benefit (this would be a lsquoresults basedrsquo indicator)

Result based indicators for the benefit of authorisation are reduced use of a substance

exposure of workers and emissions to environment However even these indicators are

difficult to populate with data to assess what proportion of these reductions are due to the

authorisation process per se

Impact based indicators relate to the net effect on humans or environment such as the

occurrence of occupational diseases or the diversity of fauna and flora Because of the

multiple factors that influence the effects like the occurrence of diseases it is deemed not

possible to use this kind of impact indicators to estimate the benefit of authorisation

Therefore other albeit proxy indicators are needed to measure the benefits of authorisation For

example one indicator could be the comparison of the change in the market share of all chemicals

versus SVHCs (see Section 4) However some substances such as TCE are also marketed for uses

which are not subject to authorisation which makes it more difficult to interpret that data

Therefore such proxy indicators are also not conclusive and difficult to apportion to authorisation

with certainty

Several Member States maintain databases to collect worker exposure data for carcinogens These

databases should allow a detailed assessment of the evolution of the workers exposure over time

Within the context of this report access was requested to the databases of the Belgian German

French and Italian authorities None was able to provide detailed data The Belgian authorities

shared a recent dataset on exposure data for CrVI but no historical values Extensive discussions

57 Study on the Calculation of the Benefits of Chemicals Legislation on Human Health and the Environment

Development of a System of Indicators April 2016 prepared by RPA DHI for DG Env



were held with the responsible authorities of the German MEGA database which contains historical

data for more than 10 years However it was not possible to share more than what is already

available in public literature which comprises reports issued on a regular basis by these

authorities In the absence of large historical datasets on worker exposure the benefits from the

authorisation process on worker exposure can only be inferred from the reported (measured) data

in AfA and through the interviews and online surveys done for this present project

This section presents the information on the benefits of authorisation that was possible to compile

from literature review the responses to the on-line survey and some specific case studies both for

worker exposure and for environmental emissions Where possible the following aspects are

covered (i) at what stage in the authorisation process benefits occur (building on the analysis in

Section 3) (ii) what changes along the supply chain result in benefits (iii) who benefits (iv) how

the benefits realised compare to what was expected (eg if there are any unexpected benefits)

and (v) how benefits are changing over time

The section contains the following sub-sections covering the benefits included in this analysis

Section 72 Literature review ndash summaries the key findings from existing studies

Section 73 Survey responses ndash overviews the responses from the survey

Section 74 Human health benefits from improvement risk management

Section 75 Environmental benefits from improvement risk management

Section 76 Benefits of substitution

Section 77 Benefits to alternative suppliers

Section 78 Benefits of better information

Section 79 Other benefits and

Section 710 Summary of benefits


The review of existing literature focused on the major and influential sources in this area A more

detailed review can be found in Annex E6 The summary here pulls together key messages in terms

of the impacts of authorisation

The majority of the reports reviewed analysed the impacts of REACH and other associated

legislation rather than the process of REACH authorisation In fact only one of the reports

specifically targeted authorisation

In common with this study a number of the studies had made use of consultation with stakeholders

to compile information In general there is little reporting of quantitative benefits however there

were indications that substitution had improved worker safety as well as lsquosofterrsquo benefits such as

improved brand reputation and worker satisfaction (eg Tickner J and M Jacobs 2016) Positive

reports are made of the authorisation process triggering activity on searching for alternatives to

SVHC even though such reports are anecdotal and at a single Member State level (eg Backes D

2017) The encouragement of substitution and widening of the market for alternatives is also

reported (Lietzman et al 2017) Another study specific to a Member State (Finland) and

authorisation indicated that energy consumption labour productivity and chemical portfolio as

examples of benefits Only one benefit described as lsquoclearrsquo by the authors was identified in the

form of micro-sized companies improving their communication networks with each other (Harrikari

and Montonen 2017)



Other reports focused on case studies with specific substances ndash the case of substitution of arsenic

oxide in Murano glass was documented by ECHA and shared with us Clear decreases in exposure

levels were documented as a result of substitution which suggests benefits to health exposure

However the size of this benefit was not reported in terms of the number of workers or specific

health benefits Occupational health campaigns such as that documented in Belgium on hexavalent

chromium compounds provided no specific commentary on the benefits of control measures or

impacts of the authorisation even though that study was reported to illustrate that the REACH

authorisation process is a significant lsquoleverrsquo when it comes to the substitution process

Studies associated with the review of REACH and REFIT gave some indications of environmental

benefits ndash for example the EC (2016) Study on the Calculation of the Benefits of Chemicals

Legislation on Human Health and the Environment cited reduction in environmental contamination

of HBCDD PFOSPFOA and DEHP even though the benefits were not quantified

More general commentary of reduction in risk and business benefits is reported in Reihlen and

Luumlskow (2007) whilst other studies such as Hennig (2016) pulled together data on overall health

impacts from AfAs done on carcinogenic substances (cumulative monetised risks (cancer burden on

workers and the general population were estimated to have an upper bound of euro74 million per

year)

The DG Environment (2013)58 indicated boarder benefits of REACH authorisation in the context of

the development of the EU progress under a system of indicator in this case indicator

6 lsquoSubstitution and Phase Outrsquo

73 Survey responses

This section sets out the findings regarding the benefits of the authorisation process based on the

online survey responses by industry stakeholders The analysis of the benefits of substitution and

the benefits of risk management activities relies on 83 respondents and 68 respondents

respectively and include also partially completed surveys The exact number of relevant answers

can be different depending if the respondent provided information on that specific sub topic

731 Benefits of substitution

The benefits of substitution presented in this section reflect the views of those respondents who

provided examples of substitution carried out due to the REACH authorisation process The benefits

to organisations who substituted due to other reasons are not attributable to REACH authorisation

and therefore not reported here

Increased sales due to substitution

Although 68 respondents were involved in substitution activities only twenty-nine respondents

reported that their organisations had substituted SVHCs due to REACH authorisation or that they

knew of examples of substitution in their supply chain because of REACH Of these organisations

31 stated they did not know whether substitution to alternative substances andor technologies

had an effect on the volume or revenue from the sale of their products (see Q34 in Annex F5)

58 DG Environment (2013) Goal and an Assessment of the EU Efforts to meet the World Summit of Sustainable

Development (WSSD) Commitment



Only six respondents (21) stated that volumes and revenue had changed as follows

All six reported a decrease in the volume of products with alternative substances andor

technologies with an equal proportion of respondents indicating a reduction in volume by

1 - 10 11 - 20 and more than 20 (see Q36 in Annex F5)

Most reported a decrease in the revenue from products with alternative substances andor

technologies (see Q37 in Annex C5) following from the reduction in volume mentioned

above Most indicated that the decrease was between 1 and 10 (a third of respondents)

or more than 20 (another third of respondents) Seventeen percent of respondents

indicated that they had not seen a change in revenue from products manufactured with

alternative substances andor technologies

It is to be noted that in total 11 respondents (including the six mentioned above) replied to Q34

that the substitutions had led to changes in the sales or revenue volume Of these 11 two clearly

indicated an increase in sales and revenue as result of the substitution However the appreciation

of these respondents is that these substitutions were made outside of the REACH context The one

respondent was a supplier of a CrVI alternative and the other respondent had an alternative flame

retardant Based on this result it seems that the substitutions that have a positive business case are

implemented earlier than the other cases

Increased employment due to substitution

Most respondents (72) whose organisations substituted SVHCs due to REACH authorisation or who

provided examples of substitution in their supply chain stated that this had not lead to changes in

the number of people employed in their organisations Only 14 (4 respondents) stated that

substitution had led to changes in the number of people employed (see Q38 in Annex F5) Most of

these reported an increase by 1 - 10 workers (see Q39 in Annex F5)

Reduction in worker exposure to SVHCs due to substitution

Around half of the respondents (14 respondents) stated that substitution in the context of REACH

had led to a reduction in the number of workers exposed to SVHC (see Q40 in Annex F5) Most

stated that substitution had led to 21 ndash 50 workers with less or no exposure to SVHCs (see Q41 in

Annex F5) This was followed by nearly 20 of respondents who stated that less than 5 workers or 6

- 10 workers had less or no exposure to SVHCs as a result of substitution

On top of these 14 6 respondents reported to have reduced workers exposure to an SVHC through a

substitution not related to REACH

Reduction in emissions of SVHCs due to substitution

Around 45 of the respondents (n=13) stated that a substitution as a result of REACH had led to a

reduction in emissions of SVHCs to the environment (see Q42 in Annex F5)

Wastewater (see Q43 in Annex F5) Most respondents (75) indicated a decrease in emissions

to wastewater by up to 01 tonnes per year as a result of substituting SVHCs with alternatives

substances andor technologies

Air (see Q44) Most respondents (71) indicated a decrease in emissions to the atmosphere by

up to 01 tonnes per year as a result of substitution



Waste (see Q45) Most respondents (60) indicated that substitution had led to a reduction in

waste generated from SVHCs sent for appropriate disposaltreatment of up to 01 tonnes per

year Some 27 indicated a decrease between 02 ndash 1 tonne per year

On top of the 13 respondents 5 respondents reported that a substitution of an SVHC but not

related to REACH had resulted in a reduction of the emissions

Respondents were also asked whether substitution had led to a reduction in the volume of SVHCs in

the finished products (see Q46 in Annex F5) Over half of the 17 respondents (59) stated that the

volume of SVHCs in finished products had decreased When asked for clarification most of these

respondents indicated that they had either substituted or reduced the volume of SVHCs in their

finished products Note that these responses relate to cases of substitution which occurred before

the application stage of the authorisation process (eg inclusion on the Candidate List or the

Authorisation List)

732 Evidence of improved risk management activities

Sixty-three respondents indicated (Q68) that their organisations use (possible) SVHCs Of these

respondents 23 respondents (ie 37) indicated that their organisations had improved the handling

and operational conditions of the (possible) SVHCs as a result of the REACH authorisation process

(Q69) They provided 25 examples in terms of

The (possible) SVHCs that these risk management activities relate to

The usesfunctions of these (possible) SVHCs and

The risk management activities carried out in relation to the uses of these substances

Additionally 34 respondents replied that they did not improve the use conditions as a result of the

REACH authorisation process It is not clear which part of this group did not improve the conditions

at all and which part improved conditions outside the context of the REACH authorisation From the

targeted interviews with one of the respondents it is clear that at least some of them did improve

the use conditions outside the context of the REACH authorisation process

Table 71 lists the substances for which respondents reported improved handling and operational

conditions through the implementation of risk management activities as a result of the REACH

authorisation process The table also shows the number of examples given for each substance as

well as the reported uses With nine examples chromium trioxide is the (possible) SVHC with the

highest number of reported examples Table 72 lists the risk management activities reported by

survey respondents in conjunction with the number of examples referring to each risk management

activity



Table 71 Instances of improved risk management activities

No (Possible) SVHC CAS

number

Number of

examples

provided

Use(s)


Solvent in manufacture of active pharmaceutical ingredient

2 Acetone 67-64-1 1 Not stated

3 Bis(2-ethylhexyl)

phthalate (DEHP) 117-81-7 2

Bonding ingredient

Rocket propulsion


Decorative function

5 Cadmium 7440-43-9 1 Corrosion inhibitor and anti-scaling

6 Chloroplatinates Not stated 1 Refining and producing catalysts




Corrosion inhibitor and wear resistance

Decorative function

Plastic plating

Plating

Printing

Reaction inhibitor

Surface treatment

9 Chromium VI 18540-29-9 1 Steel plating

10 Dibutyl phthalate

(DBP) 84-74-2 1 Rocket propulsion

11 Methylenedianiline

oligomers 25214-70-4 1 Polymerization agent


7789-12-0 1 Process chemical

13 Not stated - 1 Hardener

Total 25


Table 72 Instances of risk management activities ndash Description of activities carried out (industry survey)

No Substance Number of examples

provided

1 Automating production process(es) to minimise worker exposure 1

2 Confinement of production process(es) to minimise exposure

reduced use of SVHC to limit their prevalence in final products 1

3 Employee training and examination 1

4 Exposure controls and new procedures 1

5 Improved information to workers continuous monitoring of

exposure 1

6 Improved ventilation and closed production systems 1

7 Improvements to containment and monitoring measures 1




provided

8 Personal protective equipment 1

9 Personal protective equipment improved monitoring 1

10 Protection against inhalation training workers development of

safety documents 1

11 Use of alternative substances to modify the production process 1

12 Not stated 14

Total 25


Respondents who provided examples of risk management activities were asked about the stage of

the authorisation process which triggered these activities (see Q80 in Annex F5) Most stated that

the decision to implement further risk management activities originated at the application for

authorisation stage followed by the inclusion of substances in the Candidate List (35 and 27

respectively) The recommendation for including substances on the Authorisation List (which is

distinct from their actual subsequent inclusion) triggered the smallest number of risk management

activities (8) It is important to note that the percentage values presented in this paragraph have

been derived by excluding the lsquoNot surersquo and lsquoNot applicablersquo responses from the analysis These

categories account for approximately 78 of all answers given to question Q80

733 Benefits of risk management activities

Reduction in worker exposure to SVHCs due to risk management activities

Eighty-three percent of the respondents who provided examples of risk management activities

stated that these activities had led to a reduction in worker exposure to (possible) SVHCs Most

stated that the activities had led to 6-10 or 11ndash20 workers with less exposure (33 and 30

respectively) This was followed by nearly 20 of respondents stating that 21 ndash 50 workers had less

exposure to SVHCs as a result of risk management activities

Reduction in emissions of SVHCs to the environment due to risk management activities

When asked whether risk management activities had led to a reduction in emissions of SVHCs to the

environment

22 of respondents indicated a decrease in emissions to wastewater with all respondents

stating that emissions fell by up to 01 tonnes per year

39 of respondents indicated a decrease in emissions to air with most stating that emissions

fell by up to 01 tonnes per year and

30 of respondents indicated a decrease in waste generated from SVHCs sent for appropriate

disposaltreatment Most stated the decrease was by of 6 ndash 20 tonnes per year

Only three respondents (13) stated that implementing risk management activities had led to a

reduction in the volume of SVHCs required in the production process Further respondents stated

that activities had led to a reduction in the volume of SVHCs in finished products Given the small



sample sizes quantitative results for this decrease are not representative and therefore not

presented here

Risk management activities post-submission of applications for authorisation

Sixty-five percent of the respondents (41 out of 63) stated they had submitted an application for

authorisation (AfA) or had been covered by an application by an upstream actor Of these 32 (13

respondents) stated that their AfA included specific risk management activities to be implemented

post-submission or that they had carried out further activities following submission Around 1 in 4

respondents (27) stated that these activities had led to reductions in workplace exposure and

emissions to the environment

Twelve respondents indicated that RAC had included conditions within their opinions in relation to

risk management measures and five of these respondents stated that complying with these

conditions had led to a reduction in workplace exposure andor emissions to the environment

74 Human health benefits from improvement of risk management

The results of the online survey showed (section 731) that the most pronounced benefit of

substitution is the reduction in worker exposure and emissions of SVHCs to the environment

Estimate the human health benefits of this requires knowing the exposure levels and the number of

workers exposed before and after substitution The benefits should also be estimated as net of the

health risks of the alternative substance For instance the use of TCE as a solvent has been

reduced through substitution However according to a distributer of solvents the alternative

solvent frequently used is tetrachloroethylene (PER) which is classified as Carcinogen 2 and aquatic

chronic 2 More details on the substitution of TCE is provided in Section 11

Several cases were identified where the authorisation process resulted in improvements in risk

management measures that lead to reductions in worker exposure According to the online survey

(see Q80 annex F5) these improvements are either prior to an application for authorisation or

realised in the course of an application or improvement plans announced in the AfA Some of the

improvements were made as early as during the RMOA phase which could explain why some

respondents see these improvements as not related to the authorisation process (Q69) There are

also the improvements imposed by the authorisation decision itself (eg based on a RAC opinion)

Overall in about 35 of the public versions of the applications for authorisation improvements in

exposure andor emissions were either recently implemented or were planned for the future Table

73 reported the improvements are listed per substance for the chrome related dossiers which are

the majority of the AfA in the scope of the evaluation 32 of the AfAs mentioned recent

improvements or improvement plans For the organic substances in about 40 of the AfAs an

improvement was either announced or recently done These findings are in line with the results

obtained via the online survey Based on the responses received 23 out of 63 respondents (37)

have provided information on risk management improvements due to REACH authorisation (See

Section 732) This indicates that the fact that a substance is subject to authorisation invites

companies to revisit their exposure values but only in a minority of the cases leads to improved

RMM reported in the applications for authorisation The data in the AfA does not enable estimation

of to what extent the emissions and exposure were reduced



Table 73 Improvements reported in the AfA per substance

Substance No evidence of improvement

plan in AfA ( of applications)

Evidence of improvement plan

in AfA ( of applications)

Acids from Cr trioxide 100 0


Arsenic acid 0 100

Chromic acids 50 50


DBP 67 33

DEHP 100 0


Diglyme 44 56

EDC 42 58

HBCDD 0 100

Lead chromate 0 100

Mixture of Cr VI 100 0

Pigment yellow 100 0

Pigment Yellow 34 100 0


Sodium chromate 0 100


Strontium chromate 100 0

Technical MDA 0 100


Grand Total 65 35

ECHA reported that the numbers in Table 73 could be an underestimate Based on their

experiences the majority of applications already show improved OC and RMM as a result of

monitoring and reassessment in the preparation of the application (either through improvement in

specific RMMs during the preparation of the application or through the implementation of plans to

reduce overall exposure to SVHC) Also nearly all downstream applications indicate new (2013-

2015) campaigns to measure exposure or intensification of existing monitoring programmes This

information is not publicly available but ECHA may know of this through the Committeesrsquo QampAs and

trialogues

The meta-analysis by ECHA on the applications for authorisation shows that in 72 of the cases

improvements and or additional RMMOC are requested Thus in the majority of the cases an

application for authorisation can be expected to lead spontaneously or via the opinion of RAC to

improvements in RMM and OCs However in the survey only in 27 of the cases the applicant

expected that complying with these conditions would lead to a reduction in workplace exposure

andor emissions to the environmentA possible follow-up could be to check the effects of such

improvements on exposure after the implementation of the RMMOC for example through

enforcement campaigns and data presented in the review reports (for companies that decide to re-

apply)

During the interviews very little detailed information could be collected on exposure improvement

plans even though several companies indicated that they improved the conditions as a direct result



of the authorisation process Also most companies stated in general terms that they pursue

continuous improvement in these matters

More than 80 of the companies interviewed who were involved in a AfA of a Cr(VI) based

substance indicated that they saw no possibility to further reduction in the exposures because a

lot of improvements were already implemented in the past The driver of these improvements was

not REACH authorisation but compliance with the national exposure limits (OELsWELs etc) There

is not enough information available to judge if this result from the interviews is in line with the

result represented in Table 71 where 9 of the 25 instances of improved RMM were attributed to

Chromium trioxide use In any case from the interviews it was clear that the users of Chromium

trioxide had a history of improvements To what extent these improvements are sufficient or these

are related to REACH authorisation is difficult to tell

This is in clear contrast with the observation of ECHA that in the majority of the cases the OCs and

RMMs were improved as a result of an AfA The difference may be related to the fact that ECHA in

their communication mostly speak with the applicants while most of the interviews on Cr(VI) uses

were with DUs

A recent report (2017) on benefits from authorisation was published in Finland59 In this report 14

Finnish companies (mostly in electroplating business using Cr(VI) compounds) involved in the

authorisation process were interviewed The overall conclusion of the report is that there is no

consistent improvement of worker safety for all involved companies Only in one case a change in

RMMs were reported as a direct result of the AfA

One company interviewed was not yet applying for authorisation but worked with substances

(metals) which could end up on Annex XIV They indicated that they have recently agreed on a euro5

million improvement plan for emission and exposure reduction The main driver for them was the

current legislation (local OELs) Although exposure values on average were below the limits peak

values did exist and should be addressed by the new investments

The difference in threshold (TH) non-threshold (Non-TH) has a direct impact on the analysis of

the use conditions as reported in the CSR For threshold substances there are significantly fewer

improvement plans in the AfAs (28) while for non-threshold substances more than 41 of the AfAs

contain some form of improvement plan

Table 74 Improvements reported in the AfA TH Non-TH

No evidence of improvement




All 65 35

Threshold (TH) 73 28

Non- Threshold (Non-TH) 59 41

For the cases where AfAs were filed the improvement in human health can be estimated by

comparing the historical exposure levels with the exposure documented in the CSR of the AfA Key

in this analysis is the availability of historical exposure data Several Member States have such data

but it was not possible to obtain it for this project In the case studies on chromium trioxide and

TCE an attempt is made to estimate the improvement based on the publicly available information

59 How the REACH authorisation process affects and benefits companies A Harrikari amp R Montonen 2017



In the next section examples of improvements directly related to the applications for authorisation

are documented In all of the cases the improvements during the application phase were an

extension of on-going improvement plans This confirms the results from interviews where almost

all respondents confirmed that over the years significant investments have been made to reduce

the emissions of and exposure to SVHCs

In theory human health benefits can be due to closure or relocation of the economic activity

involving an SVHC or substitution of an SVHC or through implementation of improved RMM and OCs

In practice it was not possible to estimate the benefits to human health due to closure or

relocation The few cases of relocations that are documented in this report have a very low

exposure and are probably not representative

Case 1 Use of TCE in the manufacturing of dyed cloth

In this process TCE is used by Vlisco to remove a wax from cloth and to remove the wax from the

waste water For the continued use of the substance the company filed an AfA The AfA reported

significant improvements over the past years in the enclosure of the installations where TCE is

used These improvements reduced both the workersrsquo exposure and the emissions to the

environment The application provides an extensive overview of the technical and procedural

improvements over the years and the resulting significant reduction of the emission of TCE Due to

local legislation the applicant reported that it was not possible to use the historical worker bio

monitoring data due to protection of personal data This campaign revealed that the emission of

TCE could lead to exposure of workers in the same area even though they are not directly involved

in the TCE using activity New engineering measures were defined Some of these measures could

not be implemented before the latest application date but would be implemented before the

sunset date

Case 2 Use of TCE in the manufacturing of high performance polymer membranes

Parker is a company located in the Netherlands and uses TCE in the manufacturing of polymer

membranes The company applied for authorisation for the continued use of TCE The company

already had an extensive program in place for the minimisation of the emissions and worker

exposure However in the context of the application for authorisation the company had a new

campaign of worker exposure monitoring This monitoring program was based on analysis of

activities of the workers as would be reported in the AfA (contributing scenarios) The campaign

confirmed the low exposure of workers except for one location where the exposure was still low

but could be further minimized This would improve the far field exposure of several workers in the

surroundings An engineering measure was defined and budgeted but could not be installed prior to

the latest application date hence the assessment was made on the current installation This

assessment showed a very low exposure but in this case the monitoring programme and

engineering creativity will allow a further reduction in the exposure

Case 3 Use of chromium trioxide in electroplating by a large company at several locations

A large company operating several electroplating installations applied for authorisation for the

continued use of Chromium Trioxide Monitoring programmes already existed but the methodology

and the sample locations were not aligned between the different sites which made comparing the

results difficult In the context of the AfA a new monitoring program was designed to align

measurement methods However even in a controlled setup it was not possible to achieve exactly

the same detection limit for the different sites The methods of available local suppliers could not

be aligned Within the context of the AfA working with local suppliers instead of a central

analytical lab was chosen as a more sustainable solution for the future



Despite the differences in detection limits it was possible to compare the performance of the

different sites Although the risk reduction measures were different in different sites the exposure

and emissions were comparable In this case the AfA did not lead to reductions in the exposure or

emissions but created a relationship between the sites to continue to exchange best practices

Case 4 Use of EDC as solvent in polymer production

A polymer producing company uses EDC as solvent in the manufacturing of the polymer The

process is a closed system and the solvent is separated from the manufactured polymer and is

recycled Over time the company had reduced the solvent losses significantly by monitoring the

inventory of the solvent carefully However this methodology has its limits to detect small losses

In the context of the application for authorisation a worker exposure monitoring program was set

up and a survey of the process was done by an external expert to evaluate the minimisation of

emissions as required for an AfA As a result of both measures hot spots for worker exposure were

identified and additional engineering measures were installed to reduce the emissions In the

future the company will implement a leak detection and repair (LDAR) programme to minimise the

fugitive emissions The production site is fairly small and use of external experts allowed the

company to achieve a significantly lower level of worker exposure and emissions

Case 5 Use of EDC in the manufacturing of an active pharmaceutical ingredient

A producer of Active Pharmaceutical Ingredients (APIs) used EDC as a solvent in the manufacturing

of two APIs As can be expected in a pharmaceutical environment the exposure to any substance

during the manufacturing of the API is very low Very high levels of confinement are achieved to

prevent exposure of workers to the APIs In the context of an AfA a monitoring program was set up

and a survey was conducted to evaluate the minimisation of the emissions The monitoring

programme confirmed the low level of exposure during the API manufacturing but both the

monitoring programme and the survey indicated that the unloading of the EDC from barrels resulted

in the highest exposure level New engineering measures were defined and implemented before the

filing of the application

The cases summarised above show that the application for authorisation has proven to be a driver

for the review of exposure and emissions situation of the SVHC The contribution of external

experts has proven in several cases to be crucial in the review and renewal of existing loss and

exposure reduction programs Exact magnitudes of reductions are very difficult to obtain Often the

reductions are small because most companies already have reduction programmes in place

eliminating the largest losses A longer evaluation period is required to quantify the effect of these

additional measures and to accurately measure the reduction

More cases on benefits by the authorisation process on the exposure to Annex XIV substances are

provided in the TIER 1 case studies (Chapters 1011 and12)

75 Environmental benefits from improvement of risk management

As noted in Chapter 3 (and elsewhere in this report) the only SVHC to have gone through the

authorisation process for environmental hazards (ie subject to and AfA for which a final decision

has been made) is hexabromocyclododecane (HBCDD) According to REACH Title VII (Article 60 (2))

the AfA should consider the risks for which the SVHC has been placed on the Authorisation List (ie

under which parts of Article 57) In this section we consider the benefits to the environment only

the benefit to the general public is not considered For HBCDD the PBT risk was considered in the



AfA But the applicants argued that no further assessment of risks to human health (ie workers

and professionals) was required since adequate controls on category 2 reproductive toxicant

substances were already demonstrated in the CSR The RAC commented that human health risks

should be considered but did not require the applicants to reassess In the end the argumentation

in the AfA for HBCDD was focussed very much on the non-availability of the alternative to the

applicants rather than a comparison of the risks The RAC stated that they could not conclude on

environmental risk Therefore a real test of whether environmental risk can be quantified in order

to compare to overall benefits has not been made It remains for other PBT and vPvB AfA to show

this

It should be noted that it is the obligation of all registrants to make a PBT assessment of their

substances against the criteria in Annex XIII of REACH If they conclude that the substance is PBT or

vPvB then since adequate control cannot be demonstrated for the environment release to the

environment must be controlled to levels that are as low as possible (ldquomeasures which minimise

exposures and emissions to humans and the environmentrdquo60) regardless of whether the substance is

actually listed on the Candidate List

Quantified benefits for the environment from additional controls (ie risk management measures)

are difficult to identify however as reported in the literature (see Section 72) there is qualitative

and anecdotal evidence that additional environmental controls promoted by the authorisation

process have led to environmental benefits AfA that have focused on risk to human health for

workers but that also have environmental releases shows evidence that controls have been at

least optimised to reduce exposure to the environment In the AfAs for trichloroethylene (TCE) for

example the applicants considered the exposure of the general public (sometimes referred to as

lsquoman via the environmentrsquo in risk assessment terminology) such that the impacts on both workers

directly exposed to the SVHC in the workplace and general public (exposed thought the

environment) were considered In addition to hazard to human health (for which the substance was

placed on the candidate list) TCE has an environmental hazard classification (H412 Harmful to

aquatic life with long lasting effects) and was one of the very few substances for which a Predicted

No Effect Concentration (PNEC) was derived for air in the (pre-REACH) substances regulation (EC

Council Regulation (EEC) No 79393) Therefore in the AfA assessments the applicants assessed

concentrations against the PNECair and determined adequate control based on this It is noted that

during the ESR process a risk reduction strategy for environmental risk of TCE concluded that risk to

the environment should be controlled through measures that control releases to atmosphere (such

as the lsquoSolvents Emissions Directiversquo 199913EC) and legalisation controlling emissions from

certain processes (formerly IPPC (Directive 20081EC) now IED (Directive 201075EU))

The actual effect on the environment of the authorisation process was investigated through the on-

line survey For instance it was shown (Q42) that in 45 of the substitution cases the emissions to

environment were reduced Also in 39 of the cases (Q84) additional risk management measures

have resulted in reduced emissions to the environment This shows that although the large

majority of the substances present on the authorisation list are selected for human hazard there is

still a benefit of the environment in terms of reduded emissions To what extent this reduction also

resulted in a reduced risk for the environment is untested In case the emissions prior to the

authorisation process were adequately controlled the reductions of the emissions due to

authorisation would not have contributed to a reduction of risk 60 REACH Annex 1 Paragraph 65 ldquoFor substances satisfying the PBT and vPvB criteria the manufacturer or

importer shall use the information as obtained in Section 5 Step 2 when implementing on its site and

recommending for downstream users risk management measures which minimise exposures and emissions to

humans and the environment throughout the lifecycle of the substance that results from manufacture or

identified usesrdquo




Evidence of benefits due to substitution triggered by the authorisation process was collected via

the on-line survey targeted interviews and via leads provided by the European Commission and

ECHA The following potential benefits due to substitution were investigated through the online

survey which received twenty-nine responses on this topic (as shown in Section 731)

Increased sales

Increased employment

Reduction in worker exposure to SVHCs and

Reduction in emissions of SVHCs

It seems that there were no net benefits in terms of volume of sales or revenue There were some

very small indications of net changes (increase) in employment

The main benefits from substitution appear to come from reductions in exposure emissions or

waste In addition respondents reported better handling operations for SVHCs as well as risk

management measures leading to reductions in worker exposure to SVHCs Whilst the survey

sought responses on who had taken action to control risks and indicated the range of volumes to

which such actions apply no specific evidence was gathered that allowed a quantification of the

benefits of substitution The evidence gathered is qualitative but suggests improvements in

exposure control for workers and decreases in releases to the environment This is substantiated by

a review of the literature (Section 72) and the example shown below

Case 1 Substitution of As2O3 in the production of Murano Glass

Artistic glass makers in Murano have used arsenic trioxide (As2O3) widely as a refining agent for

centuries The Commissionrsquos decision to include it to the Authorisation List (Annex XIV of REACH)

in 2011 forced local glass manufacturers to decide on whether to apply for authorisation or

substitute to other substances or techniques After getting the clarity that the use of As2O3 was not

an intermediate Murano glass manufacturers decided to opt for substitution based on research

carried out by the Stazione Sperimentale del Vetro in 2010

The substitution of As2O3 by Antimony Trioxide Cerium Oxide Lithium Oxide and blast furnace slag

resulted in a significant reduction in the concentration of arsenic in air from over 200 ngm3 in 2014

to about 4 ngm3 in 2016 This is below the annual limit of 6 ngm3 of arsenic which is the target

value of the EU as agreed in Directive 2004107EC on arsenic cadmium mercury nickel and

polycyclic aromatic hydrocarbons in ambient air and implemented by the Legislative Decree

155201061 in Italy (see Table 75)





Table 75 Change in the average concentrations of arsenic in the air in the environmental monitoring station in Murano 2014-16

Source Reports of Veneto environmental authority of 2014-15

Information from the Chamber of Commerce and the worker insurance institute (INAIL) indicated

that there were about 300 companies operating in glass manufacturing in the area of Venice (where

Murano is located) This information has been integrated with data obtained from the major local

distributor of As2O3 showing that in 2013 about 24 companies in that area were using As2O3 in

quantities between 5 kg and 5 tonnes per year Site inspections made in 2016 corroborated that

As2O3 was no longer used by any of the inspected companies apart from one

77 Benefits from closure and relocation

The benefits towards reduced worker exposure and emissions to the environment in the EEA are

obvious in the case of closure or relocation of the use of the substance But these have to be seen

in light of the emissions and exposure in the receiving location and in comparison to the cost of

relocation changes to profitability and loss of knowhow from the EEA

Closure and relocation of a use and related activities mean that exposure to and emissions of the

affected Annex XIV substances cease in the EEA The net benefits for the society would require

taking into account the loss of revenue employment etc In the context of this report lsquoclosurersquo

refers to the case when the use activity andor the complete business of which use is a part is

stopped For instance a company could decide to discontinue the manufacturing of a certain

product which specifically uses the Annex XIV substance if their other products cannot be

substitute In case of relocation the use is discontinued in the EEA but is moved to outside of the

EEA In the case of a relocation of a use a company can split a manufacturing process and relocate

a specific use This comes typically at an additional logistics cost and increased complexity of the

manufacturing When this burden is too high a full relocation of all production process can be

decided This study has not identified any cases of such full relocation

An analysis of 158 authorisation files publicly available at the end of 2016 found that 58 of them

(37) indicated relocation as an option for the non-use scenario It was not analysed if this reported

relocation would mean only a relocation of a specific use or if this would result in relocation of

additional processes or in the extreme would lead to the relocation of the complete company

During the interviews and the online survey two cases were reported where the use of the

substance had ceased as a direct result of the authorisation process (see Table 622 in Section 610

and case 3 in Section 54) In both cases the volume of the Annex XIV substance was very small and

it was used in well controlled conditions As such the benefit for the EEA from this relocation would

be as far as exposure is concerned small Again in both cases the companies had the intention to

relocate a part of the business and import the final products In one case the final product did not

contain the Annex XIV substance and in the other case contained the Annex XIV substance but at a

concentration less than 01 This means that in the latter case the relocation only resulted in the

reduction of exposure and emissions during the manufacturing phase

Reference period Average content of arsenic (ngm3)

June-November 2014 2347

September-November 2015 110

JulyndashSeptember 2016 5

OctoberndashDecember 2016 39



Another downstream user of a SVHC on the Annex XIV active in the aviation industry indicated in

an interview that an investment in an expansion of a production site using that SVHC had stopped

because of the authorisation process According to this downstream user the authorisation process

made things more complex to operate in the EEA Although he expected that a closure or relocation

decision would seldom be made solely on the basis of regulation the REACH authorisation process

was seen as a factor which supported such a decision In the same line the AmCham position

paper62 reports two cases where investments (life science and aerospace) were not made in the EEA

as a direct result of the uncertainty created by the authorisation process While these cases are

strictly not cases of relocation they indicate the impact of the authorisation process on business

decisions

From this we can conclude that relocation is considered by industry as an option in response to

authorisation requirements The costs associated with this were discussed in Section 610 which

also explained that respondents interviewees were very reluctant to provide much detail on the

relocation cases Therefore this report cannot be conclusive about to what extend the relocation

or closure actually occurs and results in reduced the worker exposure and emissions

As mentioned above the net benefits to the EEA from a closure or relocation can be assessed by

comparing the benefits due to a reduction of worker exposure or environmental emission to other

impacts such as the one-time relocation costs loss of employment loss of profit increased logistic

costs etc Such a comparison is done during the evaluation of an authorisation dossier So far no

authorisation has been refused Therefore without a detailed analysis of the individual cases it

can be concluded that in the cases where an application was filed with a relocation as non-use

scenario the benefits of reduced exposure or emission were deemed to be less than the costs to

society

However Section 610 already indicated that the costs for closure or relocation as reported in the

AfA are probably not a good indication of the costs related to actual cases of closure and

relocation In the same way the direct benefits from relocation or closure as reported in the non-

use scenarios are also not a good indicator of the benefits in the actual cases of closure or

relocation

The interviews and the online survey show that companies often take decisions on alternatives

(including in a limited number of cases closure and relocation) without filing for authorisation

Those decisions are taken on the basis of criteria set by the companies themselves Individual

companies will not consider larger societal impacts in case of a decision to relocate For instance

it might be a justifiable decision for a company to relocate a high-tech manufacturing process to

avoid the hassle of the authorisation process while relocation could cost the wider society loss of

knowhow

In addition other interviews showed that in some cases companies take decisions on authorisation

which are not economically justified from their own perspective (see case 3 in Section 53) In that

case the company decided to relocate the business outside the EEA when (objectively assessed)

reduction in emissions and exposure will be negligible but loss of profit and technology will be

measurable The driver for the relocation was the perceived uncertainty of the outcome of the


62 AmCham EU (2016) A private sector view on REACH and competitiveness - 2017 REFIT evaluation key to

addressing outstanding obstacles Position Paper for REACH REFIT Evaluation November 2016



In terms of the worker exposure or emissions beyond the EEA relocation could lead to benefits in

exposure and emission reduction only if the RMM at the new locations are better than those in the

EEA In the context of this report this aspect was not studied But in general one could assume

that the RMM in place in the EEA are better than the average RMM in the rest of the world meaning

that on average a relocation outside the EEA can be expected to result in an increase in exposure

or emissions Counter examples exist For instance in the DBP application of Huntsman it was

reported that the RMM in the European site was improved after comparing it with the US site At

the same time this example indicates that when a company has an alternative site outside of the

EEA with better RMM it could still be cheaper to upgrade the EEA site than relocate During an

interview with a plater using chromium trioxide the company mentioned that if they were to

relocate to China they would still operate in line with the technology they currently use in Europe

In conclusion while at the EEA level a closure or relocation results in an obvious and direct benefit

in terms of reducing exposure andor emissions in the EEA on a global scale it is unlikely that

relocation would result in any benefits Few examples of relocation were identified in the course of

the project but the reason why these companies considered relocation was generic not specific to

their case and could be applicable for others However insufficient details were available to have a

quantitative assessment of the total benefits of closure or relocation on the EEA

78 Benefits to alternative suppliers

It has been shown that the authorisation process leads in many cases to the use of alternative

substances or technologies

The DUs responding to the online survey confirmed this and indicated that the REACH authorisation

process has in the majority (59) of the cases been a driver for substitution This means that

REACH authorisation is indirectly a driver for the development of the business for the suppliers of

alternatives This is further confirmed in interviews with suppliers of alternatives such as

GreenCoat and another supplier of a similar technology

In Section 5 more details are provided how the markets as a result of authorisation change Two

additional examples are provided here

An interview with a distributor of solvents indicated that for Trichloroethylene the market was

largely taken over by perchloroethylene (see for instance case 8 in Section 54) Details of this are

reported in Section 11

A totally different type of benefit for the supplier of alternatives is found in the HBCDD case

HBCDD has been regulated by REACH but also by the POPs regulation For the use of HBCDD as

flame retardant in EPS an alternative has been developed called pFR (polymeric flame retardant)

and taken into production However it was clear that at the sunset date there would be

insufficient amount of pFR available on the market Without authorisation several EEA based EPS

manufacturers were at risk to have to stop production because of lack of flame retardant In the

AfA the applicants showed that this interruption of business could lead to a permanent loss of EPS

capacity in the EEA By granting the authorisation not only they were able to introduce the

alternative as it became sufficiently available on the market but also protected the market for the

suppliers of the alternative by safeguarding the demand for the flame retardant Thus by taking

the availability of the alternative over time into account the authorisation supported the

introduction of the alternative

Both for trichloroethylene and HBCDD the supplier of the alternative substances was also the

supplier for the Annex XIV substance Nevertheless the position of the supplier was totally



different in the two cases In the case of TCE the manufacturer of TCE took the initiative to apply

for authorisation for a large part of its market The manufacturer of HBCDD did not apply for

authorisation but left this initiative to the DU of the substance

In the case of Chromium trioxide the situation is again quite different For this substance the

alternative is either a totally different technology not using chrome or adapting an existing

technology using CrIII which is not on Annex XIV However the majority of the CrIII supply into the

EEA is by the company that imports the CrVI containing compounds In the case of CrVI the

initiative for an AfA was also taken up the supply chain by the importers of the CrVI compounds

Also in this case the authorisation allows the supplier of the alternative substance CrIII to delay

the introduction of alternatives until the technology is available without disruption of the market as

could be the case without authorisation

The suppliers of alternatives clearly benefit from the authorisation process The authorisation

process not only creates a market for alternatives but also allows time for the introduction of

alternatives so that it can align with the availability of alternatives Otherwise if the authorisation

is pushed or if the manufacturers or users decide to close or relocate outside the EEA this would

destroy the market opportunities for the alternative substances and technologies

79 Benefits of better information

The study found no evidence through its surveys and literature review that would allow

quantification of benefits from better information It is clear however that the authorisation

process has prompted a number of sources of information on SVHCs themselves and methods for

and instances (eg case studies) of substitution (see Section 52) Indeed the transparency of the

authorisation process is welcomed by some stakeholders (particularly NGOs) such that increased

knowledge of hazards regulatory action (such as authorisation and restrictions) are more widely

understood

Information on the specific control of risks is less widely available because it is rather specific to

the uses for which SVHC are being used Although AfA are publicly available specific parts dealing

with exposure control may be considered confidential by the applicants so may not necessarily be

in the public domain

It is the obligation of suppliers to communicate control of substances in the supply chain (in the

form of extended safety data sheets) for SVHC subject to authorisation These will include details

of control measures to be applied that were considered by RAC in their assessment of the AfA

However this is not specifically prompted by the authorisation process

For the authorities a benefit from authorisation is the availability of structured information on

remaining uses of SVHCs and via the Art 66 notifications of the sites were the substances are

used While this information does not lead directly to reduced exposure or emission this

information can be used for targeted actions to further support substitution and control of exposure

and emissions and for enforcement The monitoring requests will help to develop a database of

exposure and emissions that could be used to check improvements The extent of such benefits

cannot be assessed now and they will become more evident when more authorisations have been

granted



710 Other benefits

A Finnish study on the benefits from the authorisation process could not identify many structural

benefits for 14 Finnish companies involved in applications for authorisation One benefit however

was clear the authorisation process has led to better networking among companies This has

resulted at least in one case of sharing best practices on exposure reduction measures

One of the expected side effects of authorisation at the outset was improved innovation to find

substitutes to the use of SVHCs During the various interviews several cases were reported Two

cases are reported here where the innovation was clearly related to the authorisation process

Case 1 Dyed cloth manufacturer

The application for authorisation by Vlisco for the continued use of trichloroethylene contains an

ambitious research plan for the development of a new technology using switchable solvents to

remove a resin during the manufacturing of dyed cloth This novel technology was developed in

Canada In this sense the authorisation process was the direct cause for an innovation and a

transfer of knowledge into the EEA

Case 2 Chemicals management as starting point for innovation

The authorisation process has resulted in several companies setting-up new or additional chemicals

management programs to track the use of hazardous chemicals in their processes or supply chain

The ELV Directive had already led to the development of extensive chemicals tracking programs in

the automotive industry This tracking system focuses on certain chemicals present in car

components The REACH authorisation process requires the companies to go further and track the

use of chemicals in manufacturing processes if these chemicals are present in the end product A

world scale fine chemicals manufacturing company reported during an interview that they have an

extensive chemicals management system in place which flags if any substance they use appear in

the Candidate List It was reported that in several cases this has led to an early replacement of the

substance In all of these cases this was only possible after an RampD phase In this sense the

authorisation process has resulted in several companies having a better view on the use of

hazardous substances and having initiated RampD activities

711 Summary of benefits




wastewater and waste) This is either due to (i) improvements in RMMs where SVHCs are still be

used (ii) substitution away from an SVHC (eg to using an alternative substance or technology) or

(iii) avoided exposure and emissions within the EU due to closing andor relocating EU production

sites that previously used in SVHCs within the EU




stages in the REACH process perhaps so that the SVHC was not prioritised for inclusion on Annex

XIV as well as strengthening companiesrsquo cases for a possible future application Many applicants

that have submitted an AfA have also indicated that they have improved RMMs andor have planned



investment in place in order to demonstrate minimisation of emissions Examples of some of the

types of RMMs identified by respondents are noted in Table 72 (within Section 73)

Where RAC were not certain that minimisation of emissions was demonstrated in some cases

conditions were imposed on the applicant as part of granting the application (as well as potentially

recommending a shorter review period than might have been possible had there been fewer

uncertainties concerning minimisation of emissions) Survey responses have suggested that at least

some cases that they have improved their RMMs further (or are putting further measures in place)

which have led to (or they hope it will lead to) further improvements in reducing exposure to

workers and releases of emissions of SVHCs to the environment However most indicated that it










number of workers exposed and the exposure level over time would be required Some of this data

does exist as at Member State (MS) level as some Member States have confidential databases (for

their MS) containing historical values for worker exposure which the study team were unable to




The authorisation process creates opportunities for alternative products In some cases the

alternative is provided by the same company as the Annex XIV substance in other cases different

companies or technologies emerge Granting an authorisation however takes account of the time

needed to develop alternative substances and technological in order to allow the applicant(s) both

the users of the Annex XIV substance and the suppliers of the alternatives to adjust to in market

demand (and other factors like product requalification)








Specific benefits of closure andor relocation were also investigated Data from existing AfAs show

that the benefits in terms of reduced exposure or emissions as a result of relocation are far less

compared to the costs of the relocation Case studies on the other hand have shown that companies

have decided to relocate at a cost higher than the cost for an AfA and most probably higher than

the monetized benefit of reduced exposure Uncertainty about the authorisation process is

mentioned as a driver for this



Few other less tangible benefits were also identified The two main ones are improved

communication within the supply chain and encouraging further development of existing

technologies and in some cases innovation








authorities






8 AFFORDABILITY OF AUTHORISATION FOR SMEs

81 Introduction

The affordability of the authorisation process to Small and Medium Sized Enterprises (SMEs) is the

fifth and final focus area assessed It made sense to assess this area following the analysis of

changes in the market the level of substitution away from SVHCs and the costs associated with the


SMEs are defined in the EU recommendation 2003361 Following that definition and as set out

Table 81 the main factors determining whether an enterprise is an SME are (i) staff headcount and

either (ii) turnover or (iii) balance sheet total

Table 81 Definition of an SME

Company category Staff headcount Turnover Balance sheet total

Medium-sized lt 250 le euro 50 m le euro 43 m

Small lt 50 le euro 10 m le euro 10 m

Micro lt 10 le euro 2 m le euro 2 m

Source What is an SME (EC 2017)

According to the EC (DG GROW)63 SMEs represent 99 of all businesses in the EU The EC CCA study

(EC 2015) states the proportion of SMEs is stable among all subsectors of the EU chemical industry

between 96 and 98 of chemical companies are SMEs

The Chapter is split into six sub-sections

Section 82 Summary of literature review ndash sets out what the key findings were from

existing studies ndash The detailed review is set out in Annex E7

Section 83 Applicants from SMEs ndash summarises how many applications have so far been

received from SMEs compared to large firms

Section 84 Survey responses - summarises information provided by SME respondents to the

industry survey This does not focus on any particular substance(s) on the authorisation list

Section 85 Tier 2 Case studies - presents impacts on SMEs using specific companies as

ldquomini case studiesrdquo using survey responses existing information and further consultation

with affected companiessector groups to try to explain role REACH authorisation has had

on them These case studies build up a picture of challenges faced by SMEs

Section 86 Affordability ndash concludes on the affordability of the authorisation process for

SMEs taking into account the experience of SMEs that submitted applications on their own

or as members of existing authorisation consortia It also sets out to what extent the

63 What is an SME (EC 2017)- Available at httpeceuropaeugrowthsmesbusiness-friendly-

environmentsme-definition_en



recommendations from the REACH 2012 review have been implemented and their

effectiveness

Section 87 ndash concludes the Chapter with a summary


Existing literature has been reviewed to put the new results about the impacts on SMEs produced by

this study in the context of research to date This literature includes regulation documents EC

study reports studies commissioned by ECHA (ie Harrikari and Montonen 2017 Tickner and

Jacobs 2016) a journal paper written by Philipp Hennig from the German Federal Institute for

Occupational Safety and Health as well as reports and position papers submitted during the public

consultation of the REACH REFIT Evaluation 2017

The complete literature review can be found in Annex E7 The key findings of the literature

review are

Studies commissioned by the EU and ECHA as well as position papers submitted during the

REACH REFIT Evaluation 2017 suggest that affordability of applying for authorisation or

substitution to avoid an application is a bigger problem for SMEs than larger firms

The above finding is in line with the results of a cumulative cost assessment for the EU

chemical industry (EC 2016) revealing that the financial impact of chemicals legislation in

general differs based on company size While total chemical legislation costs as a

percentage of annual turnover is low (lt1) for SMEs it is more than twice as high for SMEs

as for large firms

The regulatory burden that REACH authorisation places on SMEs is recognised by the EU

which tries to minimise it by lowering the existing reduced application fees through

Regulation (EC) No 3402208

With respect to affordability the authorisation application fees seem to be less significant

than administrative costs of preparing an application dossier The dossier preparation is

particularly costly when external expertise is required which is more likely for SMEs

according to several sources

Affordability of authorisation is further worsened for SMEs by the difficulty to finance some

of the additional costs through an increase in product prices In fact studies on the

experience of Austrian and Finnish companies reveal that companies find it difficult to

recover additional costs through price increases due to low acceptance of such increases

among customers and the expectation that doing so would lead to a loss of customers

For SMEs the affordability of internal REACH-related activities is a bigger issue than the

availability of qualified persons to deal with these activities

REACH authorisation is expected to affect SMEs more strongly economically by drawing

away resources from other potentially revenue-raising activities such as innovation and

RampD



Differences with respect to the impact of REACH on business performance ndash a factor

influencing the evaluation of the affordability of authorisation in the long term - were

revealed by the EC (2015) study titled Monitoring the Impacts of REACH on Innovation

Competitiveness and SMEs According to that study the loss of international

competitiveness is a less significant issue for SMEs than large firms A higher percentage of

SMEs than large firms (47 compared to 32) even reported a positive effect on their

competitiveness Regarding trade inside the EU the effect on SMEsrsquo business performance

seems to be more negative as a higher percentage of small and micro firms (17 and 50

respectively) compared to large firms (63) reports a decrease of intra-EU exports

83 Applications to date from SMEs

Table 82 provides a high-level summary of data provided by ECHA on the number of applicants

received by size of firm during the period 2013-2016

Table 82 Number of AfArsquos by size of firm

Size of firm Total (2013-2016) Share (nearest )

Micro 9 5

Small 15 8

Medium 11 6

Large 160 82

Total 195 100

Source ECHA (updated data 10082017) In total for the period 2013-2016 around 18 of applications64 have been from SMEs As shown in

Figure 81 the highest number of SME applicants was in 2016 related to one of the several

Chromium compounds that were subject to authorisation The highest proportion of SMEs relative

to the total number of applicants was in 2015 where 35 of applicants were SMEs

64 An application is received in terms of Article 64(1) of REACH when ECHA has received the application fee

SMEs pay a reduced fee to ECHA compared to large firms



Figure 81 Number of applicants (2013-16) by applicant size

Data source ECHA (updated data 10082017)

Despite the EU chemicals sector being dominated by SMEs the majority of SMEs have relied on the

upstream supply chain (eg MIs of the substance) to submit applications for authorisation that

cover their use of the substance This is not surprising as it was envisaged during the time of

developing the authorisation guidance documents that most applications would be made by MIs of

the substance rather than downstream users in the supply chain However there are unintended

(and somewhat unforeseen) consequences associated with upstream applications whereby uses are

defined too broad suffer from less precise data on exposure and information on the suitability of

alternatives which tend to result in shorter review periods This adversely affects all actors

involved in the supply chain ndash both large firms and SMEs which are set out in more detail in the

remainder of this section Whilst the analysis below better reflects the consequences and impacts

associated with upstream applicants it is relevant to cover in the SME section given that SMEs rely

on upstream actors covering their use within their application

84 Survey responses

In total 20 SMEs responded to our survey accounting for 32 of all survey respondents Most SMEs

were involved in an lsquoupstreamrsquo application by their supplier or someone even higher up the supply

chain (eg MI of the SVHC) meaning that SMEs did not submit the application themselves It is

reasonable to assume that those that answered lsquodonrsquot knowrsquo are SMEs that did not submit an

application themselves but supported an applicant (eg financially andor with data) higher up in

the supply chain

10

33

20

132

0

20

40

60

80

100

120

140

2013 2014 2015 2016

Number of applicants (2013-16) by applicant size

Micro

Small

Medium

Large



Table 83 Type of applications SME survey respondents were involved in

Type of application that SME survey respondents were involved in Number

Joint or individual upstream application (or application by an actor up in my supply chain covering my use)

7

Joint application (group of actors came together) 4

Individual application (I applied for my own use only) 3

Donrsquot know 8

Total 22

Note There are 20 respondents but 22 responses because an SME was involved in more than one type of application

Respondents were asked to identify their main challenges associated with the authorisation process

(they could select up to three) As shown in Figure 82 the most common responses were

Understanding what was required how they were affected

Internal staff time required for preparing an AfA and

Finding a possible alternative to the SVHC in question

The data would suggest the main challenges faced by SMEs were knowledge based followed by

resource constraints and finally financial constraints Further details to support these responses

were gathered as part of follow up interviews with the results set out in Section 85

Figure 82 Top 3 challenges faced by SMEs associated with the authorisation process

Note ldquoOtherrdquo was excluded as respondents who selected this option did not clarify what this challenge was

SME respondents were also asked to identify their main challenges associated with the applying for

authorisation (again they could select up to three) As shown in Figure 83 the most common

responses were

Resources required for preparing applicationmy organisationrsquos inputs

Understanding what data is required and

Collecting the necessary data



Figure 83 Top 3 challenges faced by SMEs associated with AfAs

Note ldquoOtherrdquo was excluded as the respondent indicated they were responding on behalf of several SMEs

The data would suggest the main challenges faced by SMEs were again concerning knowledge and

resources rather than financial constraints Further details to support these responses were

gathered as part of the follow up interviews with the results set out in Section 85

SMEs were asked about where they got support from during the AfA process As set out in Figure

84 SMEs relied mostly on consultants who knew about REACH authorisation from their MI or

tradesector association

Figure 84 Who SMEs used to support them

Respondents were specifically asked to comment on how helpful REACH authorisation guidance and

other information on the ECHA website were There was quite a mixed response with nearly a third

of respondents indicating they did not use any of the information nearly a third indicating it was

either very helpful or helpful (combined total) and a fifth of respondents finding it not helpful and

a fifth with no opinion either way Further details to support these responses were gathered as part

of follow up interviews with the results set out in Section 85



Figure 85 SMEs views on the REACH authorisation guidance and other information on the ECHA website


In total five survey respondents who were SMEs and involved in an application for authorisation

indicated they were willing to be contacted further In the follow up four companies remained

engaged and two telephone interviews were carried out and two written responses were received

To use their limited time in the most efficient way the questions focused on areas of particular

interest as identified by the project steering group

What were the consequences on their business as a result of the main challenges they faced

applying for authorisation and with the authorisation process

If there was any supportguidanceinformation that ECHA could provide that they would

have found helpful and might have saved them some time costs and

Their views on the ECHA website and authorisation related guidance

There were two types of responses between the four respondents all of whom were involved in an

upstream application ie they did not submit the application themselves which was submitted by

their supplier or someone even higher up the supply chain (eg MI of the SVHC) Those that were

more active65 or knowledgeable about REACH authorisation were able to give more feedback whilst

those less active knowledgeable were able to give limited feedback beyond what they had

already set out in the online survey It is important to present both sets of responses rather than

aggregating all their responses as they also reflect well on the differences in responses from micro

sized firms compared to small and medium sized firms

Those SMEs less familiaractive with REACH authorisation

65 By active we refer to attendance to meetings with sectortrade association concerning REACH attendance

at Authorisation application REACHAfA Consortia meetings or any ECHAEC webinars conferences meetings

concerning REACH authorisation

0

1

2

3

4

5

6

7

Very helpful Helpful No opinion eitherway

Not helpful Very unhelpful I did not use any ofthis information

Fre

quency



They opted to rely on their suppliers (further up in the supply chain) to submit the

authorisation application as they felt carrying out their own application was too

complicated and expensive As small companies applying for authorisation themselves

would have meant forgoing too many activities and this would have had a detrimental

impact on profits They gave support to the applicant by assisting the collection of

necessary information This alone was costly and time consuming from their perspective

and was paid from profits rather than through charging higher prices Due to the

international competition in the market it was not possible to raise prices for their

customers so they had to forgo some profits

Because they did not apply for authorisation themselves they did not make any use of the

guidance or material on the ECHA website

One respondent described the authorisation process as a ldquojourneyrdquo with a certain amount

of ldquolearning by doingrdquo with questions like should we do an authorisation on our own or

should we join a consortium and what are the advantage disadvantage of such a choice

One respondents felt that the main way the EC and ECHA could help would be to reduce the

time taken to examine applications and make final decisions quicker They often ldquofelt in

the darkrdquo when customers ask about REACH authorisation and if they can continue to

provide them with their products

Another respondent noted that reducing the complexity of the process would help They

suggested that perhaps an exact listing of requirements step by step and in detail how to

fulfil the need for documentation and a dedicated tool to fill up all these steps would help

For environmental purposes in the Netherlands they noted something similar called

ldquoeMJV66rdquo might be a good example for how this could work

Those SMEs more familiaractive with REACH authorisation

As SMEs applying for authorisation themselves would have meant forgoing too many

activities and this would have had a detrimental impact on profits They gave support to

the applicant by assisting in the collection of necessary information

One respondent was involved at consortium level meetings and noted it took a lot of time

and effort to get the lsquoinfrastructurersquo right to talk and share and develop the AfA within a

joint consortium application ndash Most SMEs donrsquot have this time This alone was costly and

time consuming from their perspective and was paid through profits rather than charging

higher prices Neither gave an exact estimate on how much they spent but said it was a 5-

digit number (so between euro10-99k)

One respondent noted that understanding what is required and the resources to provide it

can be complicated because many documents are in English That and the technical nature

of what data is required makes it impossible for their company to answer questions quickly

The process of answering the questions is very time-consuming as they first needed to

translate the documents from English to German before preparing an answer in German

which is subsequently translated in English

66 eMJV electronic environmental reporting httpwwwe-mjvnl



One respondent noted it would be useful to know what similar firms have provided in terms

of information so that the same things are not mentioned repeatedly He said that this

would also help in terms of knowing what information is relevant However they

recognised that with consortium level questionnaires the applicants are trying to gather as

much information from as many companies as possible so this level of data sharing is not

feasible (also from a confidentiality perspective)

The main problem with authorisation is that they donrsquot have enough capacity in terms of

staff availability to deal with it Both respondents noted that they donrsquot have a specific

resource (staff member) dedicated to REACH and therefore it is hard to coordinate

responses to data requests or understand what is required Collecting data requires

communicating with a number of people and cannot be assigned to one person

Nevertheless the work needed to be done if they wanted to continue to compete in the

market

One respondent noted that for an SME the provision of socio-economic information can be

challenging and at times they felt overwhelmed by the task This is because they donrsquot

have the ability to do it and donrsquot even lsquohave a cluersquo about where to start

One respondent noted they are involved in their third AfA (as they use several SVHCs) for

two of which they have been part of a consortium and for the last one they are the single

applicant They noted the additional time required to do their own application but felt this

was the best way forward from their experience to date as they felt they were punished

being part of a consortium application due to the short review periods granted and as such

it felt like a never-ending application process From their experience the bigger the

consortium the harder the AfA ndash the smaller the consortia the tighter the exposure

scenarios and the fewer uncertainties

They noted it is a very stressful process and despite going through the process for a third

time there are lsquoa lot of sleepless nightsrsquo worrying about what would happen if they donrsquot

get authorisation They also noted that deadlines set by RAC and SEAC for answering their

questions post submission are particularly unfair on SMEs given the limitations on resources

and partially because data requests often come during holiday periods They cannot stop

people going on holiday as they donrsquot know sufficiently in advance when comments will

come and therefore this can compromise what information can be provided to respond to

RAC and SEAC questions It would also help to know which questions were essential to

respond to which ones were nice to know and if they could signpost to the AfA itself

where they felt they had already answered this point

Both respondents noted a sense of perceived unfairness that big companies who have the

financial capacity and necessary staff to work on their own AfAs got long review periods

(eg 12 years) while upstream applications only got an authorisation for four years For

them that means that those with the fewest resources have to provide the highest input as

they need to deal with an AfA repeatedly (with shorter intervals) They acknowledged that

one reason for this situation is certainly that bigger companies can produce more

convincing dossiers with stronger arguments as they can allocate more time and resources

to it One respondent mentioned that his company just does not have the ability and

capacity to produce a dossier that is as convincing

ECHA in their communications do explain the advantages and disadvantages of individual

applications vs upstream applications keeping in mind that there is not one solution that

works best for every usecompany However one respondent was also unhappy because



they perceived that they received contradicting information They said industry actors were

first advised to apply in big groups if possible The information they got was that the bigger

the group the better (as it would avoid multiple applicants for the same use) They pointed

out that in contrast to this advice they are now being told that it might be better to apply

in smaller groups as this increases the chances for a longer authorisation period

Both respondents noted that the authorisation process is problematic as it creates lots of

business uncertainty as they are unable to predict how long they will be permitted to use

the substance This is an issue when it results in not being able to give contractual

commitments to their customers

o One respondent said that for Chromium Trioxide the sunset date has passed but

they have not received their confirmation about an authorisation yet They get

many phone calls and emails from worried clients asking them what will happen

and they are unable to give them any information about the future as no one knows

what will happen The only thing they can tell them is that they assume that they

will get an authorisation for four years (based on the RACSEAC opinion) but that

this is far from certain Thus the situation makes them and their clients feel very

insecure and worried and creates fears about the continued existence of their

companies

o The other respondent noted that SMEs further down the supply chain donrsquot get

access to information coming from ECHA committees so they feel they are lsquoleft in

the darkrsquo for months and months whilst they have customers asking if they can

continue to supply them with products This is despite the fact that ECHA inform

stakeholders of new published material through the ECHA Weekly which anyone

can sign up to67

With regards to the ECHA website and related documentation one respondent noted that

they found it difficult to know where to go on the site for the information and often had to

use search engine providers to find information on the ECHA website instead They also

mentioned that a problem is that they dont get notified when new information has been

published This means that they need to check the website manually to keep track of

changes or new information which is not practically feasible

The other respondent indicated that guidance documents are far too long citing the

downstream user guidance at 132 pages They said it is difficult to say what kind of

guidance they would find useful as there is no substitute for experience gained from going

through the process It might therefore be useful to collect information from those who

have been through the process and to see what can be learned from their experiences

rather than more guidance This has already been addressed by ECHA in their 2016 lsquohow to

apply for authorisationrsquo guide68

67 ECHA Weekly httpsechaeuropaeusubscribe 68 This issue has been looked at by ECHA as part of their lsquoHow to apply for authorisationrsquo guide which was

based on the experiences gained by applicants ECHA the Commission and other stakeholders over the first

couple of years of the AfA process The purpose of this guide was to be practical rather than theoretical and

ECHA undertook a lot of consultations with various stakeholders (both before and during the drafting stage) to

ensure that they covered the most important experiences gained It includes short explanations practical

examples and links to where further information can be found if needed See

httpsechaeuropaeudocuments1016213637apply_for_authorisation_enpdfbd1c2842-4c90-7a1a-3e48-

f5eaf3954676



The biggest challenge they faced was the supply chain complexity ndash How can guidance help

here For very long and complex supply chains products can get used six times (by

different downstream users) before they end up with the final end-user The respondents

often donrsquot know more than one company down along the supply chain end user so it is

hard to get data further downstream They noted that end-users might not have a good

understanding of REACH and its hard to get data from customers stress the importance of

having this information to give to ECHA

One respondent noted that a clear and easy document highlighting the main steps would be

helpful They are very active within their association and therefore relatively well

informed but has experienced that many competitors act based on what they hear along

the supply chain

We made other attempts to get feedback from SME applicants but we encountered similar

problems as noted by other EC studies that it has been difficult to obtain information directly from

SMEs

86 Affordability analysis

The assessment builds on the affordability of the authorisation process for SMEs taking into

account the experience noted above from SMEs that submitted applications on their own or as

members of existing authorisation consortia

This sub-section examines the extent to which the recommendations from the REACH 2012 review

have been implemented and their effectiveness The REACH 2012 recommended revising the Fee

Regulation to lower the costs for SMEs This has been implemented and whilst affected SMEs will

have welcomed the change survey responses (and existing literature) do not highlight the fee paid

to ECHA associated with an AfA as being the main affordability issue for SMEs

The interviews with SMEs and SME survey responses show that resource and knowledge constraints

are bigger challenges than the fees paid to ECHA for applications A reduction in fees does not

change the requirements in terms of what SMEs need to submit as part of their AfA SME applicants

are expected to submit the same types of document and level of detail required (to make their

case) as a large firm who have more financial and human resources available They are also given

the same amount of time to respond to RAC and SEAC comments and planning for lsquotrialoguesrsquo

As shown in Chapter 6 the authorisation process does present financial challenges that are not

necessarily linked to the fee for submitting an application Chapter 6 shows that SMEs do not have

the same financial capacity to invest in RampD innovation investigating alternativessubstitution

activities and improved risk management SMEs who decide to submit their own application

therefore have to sacrifice new investments andor divert both staff and budgets away from RampD

and innovation or new marketproduct development in order to prepare their applicant

Due to the resource commitment and financial implications on the business many SMEs have relied

on actors higher up in the supply chain to apply for authorisation instead They weigh up the

reduced resource commitment and financial implications of an upstream application against the

higher costs and resources required to submit their own application which may be more successful

in getting a longer review period They have noted upstream applications to be a lsquonecessary evilrsquo as

from their experiences consortia applications have generally been granted shorter review periods

compared to single applicant company applications They do recognise this is because single



applicants can provide much more information specific to their company and operations which are

not possible with a jointconsortia level application

The interviews with SMEs specifically highlighted that responding both to RAC and SEAC questions

are particularly challenging given the short time period available to respond For example the

companies cannot stop staff going on holiday as these requests (in their cases) came during times

when people are away (eg summer vacations and the Christmas period in December)

Interviewees felt they were unfairly punished as they didnrsquot have sufficient time or the right person

to respond and this jeopardises the quality of the response they could give (eg directly to ECHA or

through their upstream applicant)

It would have been helpful if the Committees were to give more time for SMEs or at least separate

questions that are lsquoessentialrsquo for the Committee decision making and those that are lsquonice to know

more aboutrsquo so that limited resources could be focused on providing responses to the former

group

Part of the issue may be the difficulties for the upstream applicants to filter information provided

by ECHA further down the supply chain to those affected ECHA does try to facilitate applicantsrsquo

planning by sending them the indicative timelines for RACSEAC questions trialogue etc after

submission (See Annex 1 in the How to apply for authorisation guide) For every application there

is an lsquoAuthorisation team managerrsquo running the process within ECHA After submission the

applicant is sent the team managerrsquos contact details (and the team manager also tends to contact

the applicants directly) For any questions the applicant has about the process eg in terms of

the timing of the key steps or regarding the reasons for specific questions they can contact the

team manager directly as this person is also the contact person for the rapporteurs of the case and

therefore is usually well informed about why the rapporteurs ask the questions they ask

There was a perception that the numbers of questions asked (especially by RAC) on the CSR

(specifically the exposure scenario) were not proportionate to the scale of the problem They felt

they were not in line with what they expected based on the ECHA guidance and templates and

therefore if the lsquogoal postsrsquo had moved this should be reflected in available guidance templates

and information on the ECHA website This is important since it is better (from both a financial and

resource perspective) to provide the necessary information in the application

The REACH 2012 review also recommended ldquoECHA and industry should develop more user-focused

guidance with special attention to SMEs The review identified a specific problem in relation to

the vast amount of guidance developed to support the implementation of REACHrdquo This was further

confirmed through survey responses and industry interviews that guidance documents are too long

and shorter documents (available in all EU languages) would better assist SMEs Whilst ECHA have

recently updated some of the support documents associated with authorisation this is not support

specifically designed for SMEs69

ECHA industry Member States and NGOs have come together noticeably through the Network of

REACH SEA and Analysis of Alternatives practitioners (NeRSAP)70 to advance and review concepts

methods and experiences for Socio-economic Analysis (SEA) and Analysis of Alternatives (AoA) on

EU-wide or national chemicals management implementation Whilst there still remains insufficient

representation from industry in NeRSAP it could be a forum through which further practical

That said keeping SMEs specifically in mind ECHA made an effort to present the advice in a clear and

concise way with plenty of examples from real applications 70 httpsechaeuropaeusupportsocio-economic-analysis-in-reachnetwork-of-reach-sea-and-analysis-of-

alternatives-practitioners



information guidance is generated on how the authorisation process could be made more

affordable for SMEs

87 SME summary

The EU chemicals industry is mainly made up of SMEs (see Section 42) However only 35 (18) of

195 applicants between 2013 and 2017 were from SMEs The surveys identified (and the interviews

provide supporting details) that the main factors for this were the resource and knowledge

challenges presented by the authorisation process

SMEs have typically relied on their MIs trade associations or their consultants for support on the

AfA process There were mixed views on available information on the ECHA website and relevant

guidance Whilst it is not disputed that relevant information is there respondents often referred

to difficulties with finding the information they need and the length and complexity of the

guidance documents especially since the SMEs donrsquot have dedicated personnel who deal with

REACH

Financial constraints are an important factor for SMEs both due to their limited ability to invest up-

front in substitution activities and to meet the costs associated with applying for authorisation The

fee charged by ECHA is a cost item but it is insignificant compared to the financial costs of

preparing an application finding and implementing a suitable alternative and the impacts on the

forgone activities (eg RampD and innovation) as a result of diverting time and budget to apply for

authorisation Due to these factors SMEs have typically relied on their upstream suppliers to apply

for authorisation (and therefore they are covered by their suppliers)

As noted in the survey findings in Section 4 the indirect impact of this is that SMEs become reliant

on these suppliers (eg limits who they can buy the SVHC from) and many of them expect or have

already had to pay for this lsquoupstreamrsquo authorisation through higher prices which they cannot pass

through onto their customers

The main issue with lsquoupstreamrsquo authorisation applications for SMEs however has been that they

tended to result in shorter review periods and that it took time for information on the application

to filter down the supply chain This creates further business uncertainty both for the SMEs and

their customers with regards to the long-term supply of their products



9 EVIDENCE OF THE lsquoANNOUNCEMENT EFFECTrsquo

91 Introduction

Evidence of the lsquoannouncement effectrsquo represents the last of the Tier 2 study areas A study by

Oumlkopol GmbH (2007) for the European Commission developed seven hypotheses around the

lsquoannouncement effectrsquo ie once a substance was added to the Candidate List As set out in Table

91 the report suggests there was some supporting results for some of the hypotheses one was

disproved and the rest had mixed results

Table 91 Seven hypotheses around the lsquoannouncement effectrsquo

No Hypothesis Results

1 Increasing awareness of risks and further risk management Supporting

2 Companies will look at the candidate list and consider it in their product

development Supporting

3 Industry will try to demonstrate adequate control of identified threshold

SVHC during registration Disproved

4 Importers producers and professional recipients of articles will prefer

articles without SVHC Supporting

5 Innovative alternatives not using identified SVHC will be promoted Mixed

6 The candidate list provides a harmonised tool for prioritisation of substances Mixed

7 With the candidate list the actors in the supply chains get time to identify

optimum solutions Mixed

Source Oumlkopol GmbH (2007) Case study on ldquoAnnouncement effectrdquo in the market related to the Candidate List of

substances subject to authorisation

This section sets out further information on the lsquoannouncement effectrsquo using the results of the

online survey case studies and further literature review carried out since the Oumlkopol study In

particular it seeks to identify if effects like early substitution improvement of exposure conditions

and market disturbance were lsquotriggeredrsquo by key announcements like candidate listing authorisation

listing and the sunset date

The section is split into four sub-sections

Section 92 Literature review ndash sets out what the key findings are from existing studies

Section 93 Analysis testing the announcement effect - uses available statistics to see if

there is an observable effect that can be explained by key REACH authorisation

announcements (eg sunset dates)

Section 94 Case studies - presents evidence around the lsquoannouncement effectrsquo for specific

companies as ldquomini case studiesrdquo They make use of survey responses existing information



and further consultation with affected companiessector groups to try to explain the role of

REACH authorisation



In order to create a basis for the assessment of new results produced by this study a literature

review has been conducted to identify and consolidate existing knowledge about the announcement

effect The consulted literature includes regulation documents the report prepared by Heitmann

and Reihlen (2007) as part of the Oumlkopol study several EC study reports a Finnish study

commissioned by ECHA (ie Harrikari and Montonen 2017) as well as reports and position papers

submitted during the public consultation of the REACH REFIT Evaluation 2017



Heitmann and Reihlenrsquos analysis of past reaction patterns of industry actors to comparable

legal approaches reveals that the extent of the announcement effect of the Candidate List

is likely to depend on market pressure exerted by downstream users article producers and

retailers as well as the ldquoimaginary pressurerdquo of the Candidate List

o According to Heitmann and Reihlen (2007) the market pressure exerted by

downstream users tends to be higher for companies producing or selling consumer

products (eg household articles and cosmetics) and companies with brand names as

they are more susceptible to NGO campaigns calling for the disuse of hazardous

substances

o With respect to ldquoimaginary pressurerdquo Heitmann and Reihlen (2007) point out that the

expert consultation revealed that this is likely to depend on the number of the

substances placed on the Candidate List as it will influence the perception about

whether the authorisation requirement is perceived as an imminent situation

EC (2015) report titled Monitoring the Impacts of REACH on Innovation Competitiveness

and SMEs provides numerical evidence for market pressure in the authorisation context It

indicates that an open-ended business survey with companies from all 28 EU Member States

as well as EEA and non-EU countries revealed that 388 of all respondents answering the

question (n=242) received requests from their customers to remove SVHCs from the

products as a reaction to the candidate listing

EC (2015) also provides anecdotal and numerical evidence for an announcement effect

o In terms of anecdotal evidence it stresses that according to the interviews conducted

as part of the EC (2015) study substitution attempts are often only based on the legal

status of the substance (ie that it is listed on the Candidate List) Information about

potentially negative implications of this announcement effect can be found in Annex

E8

o In terms of numerical evidence the open-ended on-line business survey reveals that

i 246 of SMEs and 419 of large firms launched reformulation initiatives in

response to the Candidate List



ii 189 of SMEs and 368 of large firms requested substitution of substances as

a result of the substance being placed on the Candidate List

iii Out of the respondents (n=278) providing an answer to the question what their

response to the placing of substances relevant to the firm on the Candidate

List was only 187 indicated that they took no special action

According to the numerical evidence provided by the EC (2015) study the announcement

effect thus seems to be stronger in the case of large firms than SMEs Further anecdotal

evidence for the existence of an announcement effect comes from reports and position

papers submitted during the public consultation of the REACH REFIT Evaluation 2017 The

position paper by the European Environmental Bureau71 even provides evidence for an

announcement effect on companies that are located in countries that are not subject to

REACH by referring to the Swiss company Hoffmann-La Roche This company committed to

phase out SVHCs wherever possible within a decade of their addition to the Candidate

List The main reason for this is the risk of supply chain discontinuity in the future

93 Analysis testing the announcement effect

The online survey generated data on the announcement effect that could act as supporting

evidence to validate much of the key findings from existing literature The survey results (see

Figure 91) show that REACH authorisation is triggering internal policies to learn more about and

better manage the use of SVHCs

Figure 91 Whether REACH authorisation has led to internal policy concerning managingknowing what substances are used within respondents organisations including (possible) SVHCs

Source Online survey Q5 (n=83)

71 European Environmental Bureau (na) EEB Comments to the REACH REFIT public consultation Position

Paper for REACH REFIT Evaluation

Yes47

Yes but not due to REACH

authorisation

36

No13

No but we are considering

having a policy

4



As set out in Figure 92 the early stages of the authorisation process do trigger substitution away

from the use of SVHCs About 66 of survey respondents indicated they had already begun

substitution away from an SVHC before it was placed on the Authorisation List

Figure 92 Authorisation stage that triggered decision to substitute from an SVHC


This would suggest that where substitution is possible the REACH authorisation process (in

particular the inclusion on the Candidate List) triggers substitution The results reported in Section

6 show that substitution costs can be higher than the costs of applying for authorisation which may

support the view that companies are switching away from SHVCs for other reasons such as avoided

stigma associated with SVHCs as well as avoiding future regulatory costs and being able to give

customers certainty of supply (as they are not faced with the perspective of a sunset date on use or

that their continued use is reliant on the outcome of an AfA decision)

Where available alternatives are not evident the survey responses (see Figure 93) also give a good

indication that the announcing the inclusion of an SVHC in the Candidate List triggers further

substitution related activities (See Section 53 for more details)

Figure 93 Authorisation stage that triggered substitution related activities


As set out in Figure 94 most stages in the authorisation may trigger improved risk management

This suggests that companies do not wait until the substance is placed on the Authorisation List

before carrying out further risk management However it is not surprising that most respondents

noted the application for authorisation stage as a key driver for improving risk management as it is

14

29

23

25

9

0Screening of substance and Risk Management OptionAnalysis (RMOA)





Post-authorisation decisions (eg after sunset date ofAnnex XIV substance)

9

43

27

7

11









a legal requirement (Article 6010) for applicants to show minimisation of emissions as part of their

application There is therefore pressure to make sure exposure and emissions are as low as possible

even though there are numerous examples from RAC comments of AfAs to suggest that applicants

are not presenting sufficient evidence of minimisation of emissions

Figure 94 Authorisation stage that triggered further risk management activities


The PRODCOM data shown in Section 47 also provides mixed results on observed changes in the

market although there is potentially an indication that candidate listing may have resulted in a

decline in the production and use of these SVHCs This is however difficult to be conclusive about

given limitations with the data and difficulties of getting reliable market data to confirm the

observed trends

94 Case studies

A large number of stakeholders (both companies and trade associations) were contacted to improve

the understanding of which activities are triggered by various announcements such as candidate

listing and recommendations for inclusion on Annex XIV Whilst initial contacts seemed promising

and stakeholders understood the overall value of providing information not all stakeholders wanted

to share their specific information given the risk that it would raise awareness of their substances

to regulators and this in turn may lead to further regulatory scrutiny

Only in a few cases were some stakeholders willing to provide information that was already in the

public domain given the information is not necessarily widely read (eg public consultation

response to ECHA) These are briefly discussed below

Case 1 - Space sector

The European space sector is likely to be affected by authorisation as more and more substances

they use fall within the authorisation process The sector has been affected and contributed to the

Cr(VI) applications for several uses (eg corrosion protection and inhibitors) However the focus is

15

27

815

35









on activities being carried out for substances on the Candidate List A position paper72 was prepared

and sent to ECHA and the EC proposing an exemption73 for propellant-related use of hydrazine

from REACH authorisation The substance was included on the Candidate List on 20 June 2011 and

could be prioritised for Inclusion in Annex XIV of REACH in the future The paper sets out details

for an exemption providing information on the importance of continued use of hydrazine for the

space sector

Reference is made to a hydrazine REACH Authorisation Task Force of the European Space Industry

The task force work has triggered a number of activities (eg in relation to looking at substitution)

and generated availableknown information about alternatives that may otherwise not have been

produced if hydrazine was not placed on the Candidate List

This example highlights that candidate listing can stimulate action on RampD substitution where

possible information on alternatives and information on the importance of these uses of such

substances Based on the initial engagement with a number of other stakeholders and the public

consultation submission statistics shown in Section 66 coordinated efforts to gather information

(and to apply for exemptions) is very common especially for sectors and trade associations that are

already well engaged with the REACH authorisation process74

Case 2 ndash Automotive sector

A Tier 2 supplier of the automotive sector expects that a SVHC listing of his substance would have a

detrimental effect on the competitive position of the product The downstream user of the

substance produces articles which still contain the substance and are built directly into the cars

The automotive sector has a comprehensive system to track the use of hazardous substances in

their supply chain

The expectation of the supplier of the substance reflects the attitude the automotive sector has

regarding the use of substances The supplier of the substance expects that even well before the

substance is listed but based on the hazard properties the pressure on substitution by the article

manufacture will be very high

While the listing or announcement effect in the automotive sector is supported by uniform data

collection tools other companies also map their supply chain and try to identify when hazardous

substances are used However this is mostly company specific and only seldom has a scope beyond

the direct supply (Tier one)

Case 3 ndash Company level ndash Evaluation on the use of hazardous substances

One company reports on its website the use of a management system which evaluates the use of

hazardous substances and does this in advance of possible legislation

72 httpwwweurospaceorgposition-paper-on-reach-and-hydrazine-in-the-space-sectoraspx 73 Stakeholders have an opportunity to comment during the public consultation within three months of

publication under Article 58(4) when a substance is being proposed for inclusion on Annex XIV lsquoInterested

partiesrsquo are invited in particular to comment on ldquouses which should be exempt from the authorisation

requirementrdquo 74 For example (and there are many others) the International Lead Association (ILA) provided evidence for

proposed use specific exemptions for four lead compounds currently on the 7th draft recommendation on

priority substances for inclusion in REACH Annex XIV httpsila-reachorgwp-

contentuploads201605Briefing-Note-REACH-Article-582-v2pdf



ldquoOur company-wide priority substance process takes a systematic approach to the identification

review and management of hazardous substances that we use in our products and chemical

processes Taking this proactive approach promotes the use of safer and sustainable products and

means we often take action to manage harmful substances in advance of legislation future-

proofing our products against changes in regulations

The process identifies hazardous substances for review by scoring them on the basis of their

human and environmental hazards and where societal concern exists over their use Substances

with higher scores are designated as priority substances and are subject to review by our experts

Where a safer and effective alternative exists (which is economically feasible) priority substances

are substituted with less hazardous materials In cases where substitution is not possible a full

risk assessment is carried out on the substance using state-of-the-art techniques from the EU

REACH regulations

Only when use of a priority substance can be managed safely can it be used in [name omitted]

products and processesrdquo

Other companies have similar systems which they announce on their websites For instance a

different company has an open ldquobanned substancesrdquo list which they set up using an in-house

developed tool

ldquoOur Product Stewardship group monitors developments in both regulation and public perception

for all relevant hazardous chemicals that either fulfil or are suspected to fulfil SVHC criteria

The substances are ranked by their risk using a tailor-made toolrdquo

Despite these policies in certain cases these companies still find it impossible to substitute the

use of the substance and have either initiated an authorisation or are using substances for which

and authorisation has been applied for

95 Summary of the announcement effect

Table 92 summarises the findings from this study using the seven hypotheses around the

lsquoannouncement effectrsquo presented earlier in Table 91 Overall the findings from this study align

well to existing literature concerning the announcement effect (but some hypotheses are outside of

the scope of this study and therefore were not assessed)

Table 92 Evidence relative to the seven hypotheses around the lsquoannouncement effectrsquo

No Hypothesis

Results

Oumlkopol GmbH

(2007) This study

1 Increasing awareness of risks and further risk

management Supporting

2 Companies will look at the candidate list and consider it

in their product development Supporting

3 Industry will try to demonstrate adequate control of

identified threshold SVHC during registration Disproved

Not assessed

in this study

4 Importers producers and professional recipients of

articles will prefer articles without SVHC Supporting

Not assessed

in this study



No Hypothesis

Results

Oumlkopol GmbH

(2007) This study

5 Innovative alternatives not using identified SVHC will be

promoted Mixed

6 The candidate list provides a harmonised tool for

prioritisation of substances Mixed

Not assessed

in this study

7 With the candidate list the actors in the supply chains

get time to identify optimum solutions Mixed

The survey results interviews and Tier 1 amp 2 case studies both show that companies have sought

to improve risk management as a result of announcement made along the whole authorisation

process All stages in the authorisation process lead to further RMM investment ndash most occurred at

candidate listing (43 followed by 27 at recommendation to authorisation list) For example

companies may have improved RMM at earlier stages within the authorisation process so as to delay

being prioritised for inclusion on Annex XIV and even once on Annex XIV applicants have sought in

their applications to demonstrate that further RMMs have been introduced or are being planned so

as to demonstrate minimisation of emissions within their AfA

The survey data shows that authorisation process lead many companies (~46) to set up an

internal policy to managingknowing about use of SVHCs (~36 already had one) The case

studies above also examples where a lot of effort is spent on seeking exemptions and there

is a stigmadesire to switch once a substance becomes an SVHC Around 66 of respondents

had also already substituted a use of an SVHC before the substance was on the

authorisation list showing that classifying a substance as an SVHC and placing on the

substance on the candidate list does trigger and drive substitution It also shows in many

cases that substitution was possible prior the sunset date and therefore these companies

avoided the need for authorisation



10 TIER 1 CASE STUDY SUBSTANCE 1 CHROMIUM TRIOXIDE

101 Introduction

Tier 1 case studies are an attempt to assess the impacts associated with REACH authorisation

through detailed analysis on a few specific substances This chapter sets out the evidence found

for the substance of Chromium Trioxide

As noted earlier in Table 622 Chromium Trioxide received the most responses (493) during the

public consultation compared to any other substance to date when it was proposed to be included

on the authorisation list75 A more detailed breakdown of the reasons for commenting is described

in Section 104 Chromium Trioxide also received the most comments (compared to other

substances) during the public consultation for applicants for authorisation with 449 (~40 of total

number of comments received to date) The large number of comments also means that a large

number of businesses are affected and the use of the substance in industry is extensive These were

the reasons for choosing Chromium Trioxide as a case study Further reasons for this choice are set

out in Section 103

A study on the impact of authorisation for chrome VI by the Dutch consultancy Panteia (2016)76

estimates that close to 730000 employees in around 42200 businesses in the EU are directly or

indirectly affected by the application for authorisation of Chromium Trioxide

Information for this Tier 1 case study has been gathered on market volumes as well as the online

survey results and follow-up interviews Of the 66 online survey responses about 50 originated

from applicants downstream users providers of alternatives NGOs or associations dealing with

Chromium Trioxide (34 survey participants) 29 of the 34 respondents were applicants or

downstream users

In addition to the survey data follow up interviews with stakeholders for Chromium Trioxide were

held (12 in total)

NGOs (1)

Associations (1)

Applicants (3)

Suppliers of alternatives (1)

Previous Downstream Users who did not apply for authorisation (6)

The objective was to collect as much information as possible for a more in-depth review of the

main impacts experienced by the businesses applying for authorisation and other stakeholders like

providers of alternatives and NGOs

75 Due to the grouping of the comments in different categories some of the comments could be counted double

as they would fit several categories 76 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo




Table 101 Chromium Trioxide substance profile

Name Chromium Trioxide

EC no 215-607-8

CAS no 1333-82-0

Stage in Authorisation Process On Authorisation List


property(ies) referred to

in Article 57

Carcinogenic (Art 57a)

Mutagenic (Art 57b)

Exempted (categories of) uses none

Existing restrictions No Annex XVII restrictions

Restricted by RoHS

Stage in Authorisation Process On Authorisation list

The production of Chromium Trioxide starts with chromium ore (FeCr2O4) which has historically

been mined in Russia Philippines Southern Africa and Finland In 2016 29 million tonnes of ore

were mined77 The majority of the ore (95) is metallurgical grade and used for stainless steel

alloyed steels and non-ferrous steel78 This use is outside the scope of the authorisation of

hexavalent chromium compounds

Only 078 million tons or 27 of the globally produced chrome ore is chemical grade79 The first

step to transform the chromite ore to Chromium Trioxide is the extraction of the chromium as

sodium chromate (Na2CrO4) The vast majority of the sodium chromate is converted to sodium

dichromate (Na2Cr2O7) In 2010 the global production of sodium dichromate was estimated at

700000 tonnes which is split into the following downstream products ndash basic chrome sulphates

(33) chromic acids (33) chrome trioxides (29) and other products (5)80 Chromium Trioxide is

made by the reaction of sodium dichromate with sulfuric acid The reaction can be carried out with

solid sodium dichromate or with solutions or suspensions Both methods are in use industrially

Chromium can exist either as elemental chromium alone or combined with other metals or

chemically bound to other substances In the latter case the chromium can be either trivalent

Cr(III) or hexavalent (Cr(VI) The toxicological hazard of chrome predominantly exists for the

substances containing Cr(VI) as Cr(III) does not have a classification which complies with Art 57

criteria for SVHC Also the requirement for authorisation is only for Cr(VI) containing substances

such as Chromium Trioxide

Based on studies that show its genotoxic potential the Risk Assessment Committee (RAC) concluded

that Chromium Trioxide (EC no 215-607-8 CAS no 1333-82-0) should be considered as a non-

threshold substance with respect to risk characterisation for carcinogenic effect of hexavalent

chromium81

77 httpwwwicdacrcomindexphpoption=com_contentampview=articleampid=1026ampItemid=1069amplang=en 78 No exact data is available what volumes are used within EEA however 70 of the global chromite

production is consumed domestically in ferro-chrome production in the country of origin 79 httpwwwicdacrcomindexphpoption=com_contentampview=articleampid=1026ampItemid=1069amplang=en 80 httpwwwicdacrcomindexphpoption=com_contentampview=articleampid=1026ampItemid=1069amplang=en 81 Reference to the studies examined are included in the RAC document RAC27201306 Rev 1 Final



103 Case study rationale

Chromium Trioxide fulfils all the key criteria set for the selection of a Tier 1 case study substance

Latest application date has passed so that the impacts of the whole authorisation process

should be possible to assess ndash for Chromium Trioxide this was 21 March 2016

There are a large number of applications and applicants which increases the opportunities

for getting data ndash for Chromium Trioxide there were 20 applications for 54 applicants

There are a large number of uses applied for ndash 37 different uses

There are diverse and complementary impact aspects ndash widespread use in the EU by

numerous SMEs with widespread applications82

There is little accurate data available on the number of companies impacted by the authorisation

of Chromium Trioxide A study on the impact of authorisation for chrome VI by the Dutch

consultancy Panteia (2016) estimates that close to 730000 employees in around 42200 businesses

in the EU are directly or indirectly affected by this application for authorisation83

The available data from ECHA shows that for the continued use of Chromium Trioxide most of the

applications for authorisation were from SMEs This is supported by a number of consortia applying

for authorisation (nine applications out of submitted 20 were by consortia) Although this criterion

was not used explicitly this selection meant that this aspect (affordability for SME) could be

explored within this Tier 1 case study



Table 102 Chromium Trioxide REACH authorisation timeline

Key REACH authorisation timeline Date

Inclusion to Candidate list 15122010

Inclusion to Annex XIV 20122011

Latest Application Date (LAD) 21032016

Sunset date 21092017

In accordance with Article 57(a) and (b) Chromium Trioxide was identified as a Substance of Very

High Concern (SVHC) It is classified as carcinogen category 1A and mutagen category 1B The

reasoning behind the decision to prioritise and include Chromium Trioxide on Annex XIV was that it

is supplied for uses in high volumes and for many sites Therefore significant workplace exposure

may occur in a number of sites

Chromium Trioxide was included on the Candidate List on 15 December 2010 for possible

authorisation in the future During the period for commenting 173 comments were submitted by

82 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo 83 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo



industry (123) associationstrade unionsMember State authorities (42) and NGOs (8)84 Half the

submitted statements related to general comments (85) and the other half to the use exposure

alternatives and risks (74) A large majority of the comments (almost 75) were submitted from

France Prior to this inclusion no RMOA was carried out (as the RMOA process had not been

established at this stage) In 2012 Eurometaux indicated in an article in Chemical Watch that

ldquoWorker exposure would have been best covered he says by developing and implementing

other more focused risk management tools like an EU-wide occupational exposure limit

(OEL) for chromium VI and chromium III and updated pollution prevention guidance on

best available techniques (BAT) for sites producing or using itrdquo85

On 20 December 2011 the substance was included to Annex XIV This meant that the use of

Chromium Trioxide would require authorisation after the sunset date of 21 September 2017 with a

latest application date on 21 March 2016

During the period for commenting for the inclusion of Chromium Trioxide to Annex XIV 1229

comments were submitted by industry (1084) industry associations Member States trade unions

academic institutions (139) and NGOs (6) The majority of the comments related to general

comments on the recommendation to include the substance in Annex XIV (489) followed by the uses

that should be exempted from authorisation (389) and transitional arrangements (218)

By end of 2016 28 applications by 52 applicants for the uses of Chromium Trioxide after sunset

date were submitted In addition one application was made jointly with sodium dichromate and

one application was made jointly with dichromium tris(chromate)


The risk assessment report86 for Chromium Trioxide was finalised in 2005 The rapporteur was the

United Kingdom The same report mentions three producers of hexavalent chromium compounds

even though it is not stated where these are located In 2006 the last manufacturer of Chromium

Trioxide ceased production of the substance in the EU (Elementis Chromium in the UK) Since 2006

all of Chromium Trioxide used in the EU is imported (see Figure 101)

The EU is a net importer of Chromium Trioxide Less than 10 of the volume imported is exported

outside the EU from formulators within EU The export volume comes from formulators that sell

their products to customers outside the EU (see Figure 102)

For the last five years the import volume has been relatively stable at around 12000 tons per year

In principle this is also the volume covered by the scope of the submitted AfAs for Chromium

Trioxide The import market is split between 7-10 key players The number of formulators using

Chromium Trioxide in the EU is estimated to be about 20 companies87

84 Due to the grouping of the comments in different categories some of the comments could be counted more

than once as they would fit several categories 85 httpschemicalwatchcom12927chrome-platers-put-their-case-for-chromium-trioxide-authorisations 86 European Chemicals Bureau ndash Risk Assessment Report Chromium Trioxide Sodium Chromate Sodium

Dichromate Ammoniul Dichromate and Potassium Dichromate 2005 87 (ref LANXESS presentation 20121001 ECHA Helsinki)



Figure 101 Chromium Trioxide imports to EU 2000-2016

Figure 102 Chromium Trioxide exports to outside EU 2000-2016



1051 Supply chain structure

In the context of the authorisation of Chromium Trioxide it is important to elaborate briefly on the

structure of the supply chain for the surface treatment industry in the EU All six interviewed

applicants and downstream users stated their frustration that in their experience their own

particular position in the supply chain was not taken into consideration sufficiently during the

authorisation process This refers mainly to their ability to alter the process to use alternative

substances without explicit approval from their customers (which means the products still matching

the customerrsquo specifications)

As mentioned above there is no manufacturer of Chromium Trioxide left in the EU Imports are

entering the EU mostly through importers with manufacturing facilities outside the EU LANXESS

estimates that there are approximately 10 key importers for the substance88 Most of the Chromium

Trioxide is then supplied to formulators that use it in specific formulations to be used by their end

users (Figure 103)

Figure 103 Supply chain for Chromium Trioxide89

The supply chain differs here from that of other industries A substantial number of companies can

be identified amongst the downstream users which are contract manufacturers (contract platers)

using Chromium Trioxide containing substances or mixtures Contract manufacturers tend to be

SMEs and manufacture products to the specifications of their customers in a variety of industries

(eg aerospace automotive construction furniture machinery sanitary ware consumer products

and packaging) As a consequence the contract manufacturers cannot change the process unless

approved by their customers and unless the different process still ensures that the same

specifications defined by their customers are met

88Lanxess Deutschland GmbH Dr Martin Kleban 10012012 Presentation ldquoChromium Trioxide Authorisation

Consortium CTACrdquo 89Lanxess Deutschland GmbH Dr Martin Kleban 10012012 Presentation ldquoChromium Trioxide Authorisation

Consortium CTAC



The contract manufacturers are in fact dependent on their customers being able to change to an

alternative process If the customers do not see any advantage to do so ndash main reason often being

to reduce costs ndash the contract manufacturers cannot change the process A key feature of the

contract manufacturers is also that they have no or limited capacities for research and

development for example for a new process

Manufacturers that develop produce (surface treat) and sell their own products are different to

contract manufacturer They define their own specifications and have therefore the advantage to

make their own decisions about which process to use for their products

Although there is no detailed information on the structure of the plating industry across the EU and

hence the supply chain available it can be estimated based on the report published by the Dutch

consultancy Panteia that many companies in the EU are affected by the authorisation of Chromium

Trioxide90 The majority of these are estimated to be SMEs

Some contract manufacturers also use the opportunity to organise themselves into networks and

join efforts to carry out RampD into alternatives One particular example is the Fachverband

Galvanisierte Kunststoffe eV (FGK) in Germany which was established by 13 that also submitted

two applications for the authorisation for Chromium Trioxide

In total at the end of the supply chain the surface plating downstream users are covering millions of

articles that use chrome plated or passivated parts Also for the customers it is almost impossible

to identify which components are treated with Chromium Trioxide in the production process as it

is not part of the component or end product Therefore customers complain about the complexity

to identify relevant components that would need to undergo a different process to phase out

Chromium Trioxide ldquoThe search has to be carried out by responsible component

developersbuyerssuppliers within a complex supply chain with 1500 to 4500 suppliers per

OEMrdquo91

1052 Uses

Chromium Trioxide is used in various applications where metal finishing (surface treatment) is by

far the biggest use The Annex XV report from 201092 estimates the quantitative apportionment of

Chromium Trioxide in industrial chemical substances and mixtures is 75 in metal treatment

formulations 15 in wood protection formulations and 10 in other uses This means that the risk

associated with a significant part of the uses can be managed via authorisation

The same report mentions the following main uses for Chromium Trioxide

Metal finishing (for electroplating eg hard chrome plating decorative or bright-chrome

plating conversion coatings eg passivation of zinc aluminum cadmium and brass

pickling [CrO3 solution]) and

Manufacture of wood preservation products (biocidal agent (not relevant for REACH93)

90 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo 91 Verband der Automobilindustrie Dr Wolfgang Marquardt 11122014 Zulassung unter REACH und die

Herausforderungen aus Sicht desVerbands der Automobilindustrie eV (VDA) 92 ANNEX XV report ldquoProposal for identification of a substance as a CMR Cat 1 or 2 PBT vPvB or a substance of

an equivalent level of concernrdquo August 2010 93 At the 21th Competent Authorities meeting in 2006 it was decided that biocidal products containing

chromium had to be removed from the market by 1 September 2006



fixing agent in waterborne wood preservatives)

The report refers also to ancillaryother uses like

Catalyst manufacture

Chromium dioxide manufacture

Pigment manufacture

Manufacture of paints varnishes and inks putty (anticorrosive dye)

Oxidant in organic chemistry

Electronic component manufacturing (characterization of silicon wafers)

Production of polyethylene and other plastics (catalyst)

Metallurgy of nonferrous metals (elaboration of chromium metal)

Manufacture of soap detergents and cleaning agents

Manufacture of other organic basic chemicals

Inorganic hardening agent layer of photosensitive galantine

Manufacture of jewelry (production of synthetic sapphire)

Additionally there are some uses in research and development for the hardening of microscopic

preparation or as oxidizers (Jones reagent Sarret reagent)

There are currently 23 active registrations Two registrations are inactive The total use based on

the tonnage band is according to the ECHA website in the range of 10000-100000 tonnes per

year The actual import of the substance is in the range of 12000 to 16000 tonnes per year (see

Figure 101)

The uses identified in the registration dossier and falling under authorisation are

Formulation of preparations used eg in metal finishing or as catalysts

Manufacture of other chromium substances

Manufacture of Chromium Trioxide (as substance and in catalysts)

Manufacture of preparations used in metal finishing and non-metal surface treatment

Catalyst production

Manufacture of Chromium Trioxide as a catalyst precursor

Catalyst use

Metal treatmentfinishing

The use of Chromium Trioxide as fixing agent for the manufacture of wood preservation products is

not specifically registered According to the lead registrant for Chromium Trioxide during the

preparation for registration dossier this use was no longer in demand as alternatives were available

on the market Therefore the lead registrant decided not to register the use in the registration

dossier for Chromium Trioxide


The available information shows that during the authorisation process (since inclusion of the

substance on Annex XIV) no substantial changes in market volumes could be identified relating to

the authorisation of Chromium Trioxide Since 2011 the import volume for Chromium Trioxide

remained stable around a yearly import volume of approximately 12000 tonnes

The split of the various applications in 2016 was similar to the one in 2010 (see Figure 104)



Figure 104 Chromium Trioxide ndash Market share by use

At the end of 2011 Chromium Trioxide was included in Annex XIV One of the key players (an

importer with manufacturing capacities outside EU) took the lead to form a consortium for a joint

upstream application This approach was supported by ECHA who feared otherwise a very high

number of applications for authorisation The key player was also the lead registrant for the

substance

To facilitate a systematic and efficient dossier preparation this consortium concluded to include

the following uses in the application for authorisation

Formulation of mixtures

Functional chrome plating

Functional chrome plating with decorative character

Surface treatment (except passivation of tin-plated steel (ETP)) for applications in various

industry sectors namely architectural automotive metal manufacturing and finishing and

general engineering (unrelated to functional chrome plating or functional chrome plating

with decorative character)

Surface treatment for applications in the aeronautics and aerospace industries unrelated

to functional chrome plating or functional chrome plating with decorative character

Passivation of tin-plated steel (ETP)

Of all submitted applications for authorisation for Chromium Trioxide more than 80 could be

allocated to the above listed use categories Besides the joint application lead several other

applications were made by individual or groups of downstream users

An analysis of changes in registration data through the authorisation milestones concluded for

Chromium Trioxide that some of the registered uses do not seem to be covered by any applications

for authorisation so far (eg impregnating agent for carbon filter media or catalyst manufacturing)

For the latter example this discrepancy could be explained by an early position taken by ECMA

(European Federation of Catalyst Manufacturers) that catalysts are in some cases transported



isolated intermediates94 and hence exempt from authorisation or because these catalysts are not

manufactured in the EU

The online survey results indicate that nearly half of the businesses participating in the survey and

using Chromium Trioxide experienced changes in the market structure in some form (13 of 29) The

biggest impact that the majority of the companies (seven) stated was that it led to an increase in

prices for Chromium Trioxide while the number of suppliers of products containing Chromium

Trioxide decreased Three out of 34 survey participants stated that their organisation was impacted

by a closure within the EU or a relocation to outside EU as a result of REACH authorisation process

A follow up interview with these three asked for the reason of the relocation that and one stated

ldquosome of our customers do not want to source certain components from the EU because of concerns

about the uncertainties caused by REACH authorisationrdquo

During the follow-up interviews the decline in the amount of possible suppliers was seen as

especially critical by four respondents The next critical issue was the fear that the upstream

application would make them dependant on their supplier Companies also expected that

consolidation of suppliers would eventually lead to higher prices One downstream user working in

the hard chrome plating sector said

ldquoA lot of money has been invested into the authorisations Only suppliers with

authorisation remain and they will push their cost into the supply chainrdquo

Only one out of 29 survey respondents felt that the authorisation has led to an increase in the

number of alternatives suppliers

107 Substitution

One objective of REACH is to eliminate the use of SVHC over time which can only be achieved if

alternative substances processes or products are developed The search for alternatives to replace

Chromium Trioxide has been on-going for decades with substantial amounts of money and

resources already invested (both by industry and via projects sponsored by various authorities) to

find alternatives to avoid using hexavalent chromium in their various applications

A detailed overview of the best available techniques for the surface treatment of metals and

plastics has been published by European Commission in 200695 This document comprehensively

describes the various alternatives that were available and the state of the art in technology in the

surface treatment at the time

Some alternative substances and processes are available today an important question is whether

these alternatives are also technically and economically suitable The question whether there are

suitable alternatives has been the basis for intensive discussions during the authorisation process

Applicants insist that there is no suitable alternative currently available for chrome trioxide

especially for the functional metal plating use Providers of alternatives and NGOs claim the

opposite

94 REACH and Catalysts (Fresh and Spent) A position paper by the European Catalyst Manufacturers Association

(ECMA) September 2008 Annex 1 added November 2008 Amended (Annex 1 amp consideration of intermediates

without SCC) November 2009 Amended (Waste Framework Directive amp Annex 1 EINECSCAS for MoS2 added)

May 2012 95 European Commission 2006 ldquoReference Document on Best Available Techniques for the Surface Treatment

for Metals and Plasticsrdquo (under the Council Directive 9661EC on Integrated Pollution Prevention and Control)



To allow a more neutral assessment of the different positions the feasibility of substitution of

Chromium Trioxide is assessed from different perspectives

Applicants

Non-applicants

Non-industrial stakeholders

Providers of alternatives

1071 Applicantsrsquo perspective

The particularity of the supply chain of the users of Chromium Trioxide has been described in

Section 105 The fact that Chromium Trioxide has a key function in a high number of very different

manufacturing processes ranging from car parts sanitary equipment military equipment space

and aviation building materials and others adds a level of complexity to looking for alternatives

Each of these sectors has its own dynamics and specific technical requirements

The challenge to develop alternatives arises from the numerous varying specifications that must be

met for the millions of articles that use chrome plated or passivated parts Therefore it is not

sufficient to develop an alternative process but the alternative process must be sufficiently

technically mature and economically feasible to cover a wide range of the required specifications

of the final articles While currently one process seems to be capable to cover a wide range of

specifications there are indications that several alternatives are required to cover the wide range

of applications of the chrome plated parts (eg see case on alternatives for alumina plating in the

window frame industry) Moreover several of these parts are used in a safety context andor in a

highly regulated industry such as aviation and hence require specific product qualification testing

For example it is estimated that more than 10000 chrome plated parts with different

specifications are in use per car manufacturer96 (eg for interior exterior specific parts injector

valve piston rod safety belt lock and so forth) Each of these parts is introduced only after

testing Any significant process change in the plating of these parts would require a specific re-

qualification

In addition some alternatives like Boric Acid or Cobalt compounds are expected to face in future

the same authorisation requirement as Chromium Trioxide therefore adding to uncertainty about

whether investments for the development of the alternatives should be carried out A presentation

for the German automotive industry in 2014 stated that the industry has to face the possibility that

approximately 100 potential alternatives will have to be further researched and tested97

As part of the application for authorisation applicants may have submitted an RampD plan to setting

out details of efforts to substitute away from Chromium Trioxide A screening of the public versions

of the applications for authorisation for available RampD plans shows that compared to the average

percentage of applications containing RampD for other substances the share of applications for

Chromium Trioxide is higher at 43 (Table 103) The actual percentage of improvement plans may

be higher as further information could also be provided as part of the committees (RAC and SEAC)

QampA and the trialogues

96 European Automobile Manufacturers Association Presentation by Dr Wolfgang Marquardt (BMW)

27032014 Authorisation for Chromium Trioxide ndash Automotive Industry Challenges 97 Verband der Automobilindustrie Presentation by Dr Wolfgang Marquardt 11122014 Zulassung unter

REACH und die Herausforderungen aus Sicht desVerbands der Automobilindustrie eV (VDA)



Table 103 Presence of RampD plans in Chromium Trioxide AfArsquos

All Subst of AfAs

Chromium Trioxide AfAs

No

RampD plan included 62 (34) 16 43

RampD plan referred to 34 (18) 7 19

No clear RampD plan 89 (48) 14 38

Total 184 37 100

Applicants also indicated that in some cases the use of an alternative solution would face

competition from imported articles from outside of the EEA still using the Chromium Trioxide (cfr

Grohe AfA)

Looking at the results from the online survey from the applicants andor downstream users three

out of a 29 (Chromium Trioxide only) reported a successful substitution yet two of those three

companies still applied for authorisation Seventeen out of 29 companies indicated that they were

busy with substitution activities The remaining nine respondents stated that they were not

investigating any substitution alternatives

Although not representative further interviews with stakeholders showed additional cases in which

companies also decided to take a parallel route and apply for authorisation while at the same time

carrying out substitution (see Section 54)

A leading high-tech company stated that the drive for substitution was due to safety reasons ndash they

did not want to expose their workers to Chromium Trioxide any longer After reviewing and testing

possible alternatives they switched to a more effective tin-based passivation As process owners

the high-tech company could make the decision to shift to an alternative more easily than a

contract manufacturer ndash as mentioned above

A leading company in the field of pharmaceuticals used Chromium Trioxide as a catalyst in waste

gas burner As their supplier decided to discontinue the supply the company was effectively

ldquoforcedrdquo to invest in an alternative Tests with alternative catalysts failed leading to the

development of a different technology While the new technology operates with slightly lower costs

(close to euro01 million) it required an overall investment of about euro10 million

The interviews with stakeholders clearly showed that there is a link between substitution and

competitiveness In those cases where the products made were in markets under severe price

competition customers (further down the supply chain) would only support substitution effort if it

led to a reduction in the cost of the product providing them a tangible benefit

1072 Non-applicantsrsquo perspective

Non-applicants are companies that previously used Chromium Trioxide but have since discontinued

their use (for that specific use) by either implementing an alternative substance or a different

process before the sunset date Therefore these companies did not have to apply for authorisation

The cases of early substitution are limited and less well documented

During the interviews companies which used to use Chromium Trioxide but have discontinued this

use without applying for authorisation were also identified



A manufacturer of alumina window and door frames stated in one of the interviews that after

receiving input from their sector organisation ESTAL98 they decided not to apply for authorisation

due to the estimated low chance of obtaining an authorisation As a result in 2014 the company

started to develop two alternative technologies that would enable them to produce and coat

alumina frames without chrome VI After investing between euro3 to 4 million in new equipment they

managed to switch to chrome VI free production but with considerable limitations One of the new

alternative technologies doubled operating costs the other technology is less robust and requires

tighter process control with better quality base material A key driver for successful substitution in

this case was the fact that this manufacturer controlled the full manufacturing process including

the choice of the raw materials

Another route to identifying early substitution cases is the analysis of the registered uses compared

to the filed applications for authorisation It is expected that a registered use will after the

inclusion of Chromium Trioxide to Annex XIV lead also to an application for authorisation The

examples of uses registered but without an application for authorisation have already been

described in Section 106

1073 Non-industrial stakeholdersrsquo perspective

Non-industrial stakeholders such as NGOs are indicating that there are several possibilities for

substitution of Chromium Trioxide They believe that the authorisation process itself could act as

an obstacle to substitution From their perspective they claim that companies that are granted

authorisation will have less incentive to look for an alternative to Chromium Trioxide Additionally

NGOs claim that the authorisation process does not provide sufficient clarity about why applicants

are not using the alternatives that are available on the market and what efforts the applicants are

undertaking to phase out the substance Client Earth a NGO stated that

ldquoIn relation to applications for authorisation participation can be increased by setting

criteria that need to be fulfilled for an alternative to be considered suitable At the

moment the SEAC has no such criteria and there is no evidence the SEAC would be able to

positively assess the suitability of an alternativerdquo

In the online survey the participating NGOs mentioned several tools that businesses looking for a

substitution of Chromium Trioxide could use

An example of a useful tool is the substitution support portal (SUBSPORT) developed by the

Koordinationsstelle Hamburg IFE An overview paper available on the SUBSPORT website99

describes a range of alternatives for the use of Chromium Trioxide In addition the report

also lists potential alternatives which should be rejected as they would pose a high risk to

the environment or human health (ldquoregrettable substitutesrdquo) For that SUBSPORT uses its

own database containing substances that are not accepted for substitution due to their

hazards (SDSC) Alternatives for Chromium Trioxide that would pass the screening test can

also be found on their website

98 ESTAL ndash European Association of Alumina Platers (Italy excluded) with around 400 member mainly SMEs 99

httpwwwsubsporteucasestoriessearch=chromium+trioxideampsektor=0ampFunction=0ampprozess=0ampcslimit=15amp

methodology_check=onamptype=case_studiesx413-en



Another NGO ChemSec is offering a web-based platform ldquoChemSec marketplacerdquo100 via

which buyers and sellers of alternatives to hazardous chemicals can interact It offers

producers of safer alternatives a window to display their ldquogreenrdquo alternatives to

downstream user companies looking to substitute hazardous chemicals in their products or

processes

ChemSec also stated that the OECD Substitution and Alternatives Assessment Toolbox

(SAAT)101 could prove very helpful the tool is an approach for evaluating a chemical

material process product andor technology for attribute analysis within a chemical

substitutionalternatives assessment

In their application for authorisation the leading consortium CTAC provides a detailed and long

(possibly not exhaustive) list of the possible alternatives for substitution of Chromium Trioxide eg

for the use of hard chrome plating such as

Electroless plating

Nickel and Nickel alloy electroplating

Case hardening Carburizing carbonitriding cyaniding nitriding borodizing

Chemical vapour deposition (CVP)

Nanocristalling Cobalt Phosphorus alloy coating

High velocity thermal process (HVOF)

Trivalent chrome plating

Physical vapour deposition 5PVD)

Plasma spraying

General laser and weld coating technology

Stainless steel and high-speed steel (HSS)

Thermal spray coating

During the follow up interviews one NGO stated with reference to substitution that during the AfA

process SEAC does not seem to take the comments from providers of alternatives into

consideration This would lead to reluctance on the alternative providersrsquo part to participate in the

trialogue due to ldquobad experiencerdquo The NGO however also recognised that the setup of providing

alternatives during the public consultation was not ideal for collaboration between providers of

alternatives and applicants Both the consequence of a possible alternative (refused application)

and the limited time for the applicant to reply (14 days) were regarded as a reason why this process

was not as successful as it could be

1074 Providers of alternativesrsquo perspective

Authorisation applicants have to assess what alternatives for their use of Chromium Trioxide exist

in the context of the analysis of alternatives (AoA) and argue their feasibility against four criteria

(technical and economic feasibility availability and overall reduction of risk) In the AoA

applicants therefore should describe alternatives known to them

Additional providers of alternatives were identified during the public consultation rounds for

Chromium Trioxide In the context of this project interviews were held with some providers of

alternatives who clearly indicated that there is an increased interest in their product For instance

100 httpsmarketplacechemsecorg 101 httpwwwoecdsaatoolboxorg



a supplier of PVD coating technology reported that several projects were on-going with car

manufactures to introduce PVD coated parts The same provider reported that a major obstacle for

the introduction of this new technology was the existing specifications based on chrome plating

For some car manufacturers he was able to develop bespoke specifications for PVD coated

particles The supplier expects now that this specification is developed the introduction of more

parts will be easier The supplier confirmed that an authorisation for chrome VI based plating is

required as there is at present insufficient capacity for PVD plating available Significant capacity

building is still required and he expects that the two technologies will co-exist for a while even

though he is confident that in the end a switch to the alternative process will be possible

In some cases clear collaboration between suppliers of alternatives and applicants is reported in

the AfA For instance in the Grohe application for the use of Chromium Trioxide for the etching of

plastic parts prior to chrome plating Grohe reports details of an on-going development program

with a supplier of alternative technologies In these cases the provider obviously did not come

forward during the public consultation phase

An interviewed provider of alternatives that had developed a patented new alternative cylinder

technology stated that he encountered quite some resistance from potential customers when he

introduced and promoted his new technology for the printing and flexible packing industry Due to

the fact that companies assumed they would be successful with their application for authorisation

for Chromium Trioxide it appeared that the trigger for an alternative based on purely health

improvements would not be strong enough Only when he was able to provide (after more testing)

additional value in the form of lower operating costs and longer durability of the cylinders he

experienced substantially more interest from industry

The Belgian authorities carried out an inspection campaign in 2015 on chemical agents in the sector

of surface treatment and coating of metals with focus on hexavalent chromium listed under REACH

Annex XIV In this campaign 83 companies were visited and inspected In the course of the

inspection companies were also questioned about specific impacts of REACH and the authorisation

obligation The report on this campaign comes to the conclusion that ldquothe authorisation procedure

under REACH drives substitution much more efficientlythan OSHrdquo ndash ldquotrigger to substituterdquo102

108 Changes in the market for alternatives

No publicly (or commercially) available information was identified that could help to evaluate

relevant changes in the markets for alternatives While providers of alternatives stated that they

experienced an increasing interest in their products and processes there is little or no hard data to

assess the impact for the market of alternatives So far the volume of alternatives supplied is still

minimal NGOs which were interviewed for this project expressed their concern regarding the

impact of granting authorisation on the development of the market for alternatives They fear that

granting of authorisation will prevent alternatives to enter the market It appears however that

despite authorisation providers of alternatives are confident that they will be able to penetrate

the market over time

102 The Federal Public Service Employment Labour and Social Dialogue and the Belgian REACH Competent

Authority 2016 Results of Inspection Campaign for Chemical Agents in the metal surface treatment sector



109 Evidence of improved risk management

The reduction of the occupational and environmental exposure to the SVHC is one of the key

objectives of REACH To what extend this has happened or will happen for the Chromium Trioxide

applications is investigated in this section using two approaches Firstly the number additional risk

management measures that were implemented or announced as a result of the authorisation

process is investigated Secondly historical exposure data is compared with exposure data from the

AfA The information for both approaches was collected from literature the on-line survey the

public available AfA files and targeted interviews with stakeholders involved in the authorisation

process for chromium trioxide

Additional risk management measures

In 24 of the public versions of the AfAs dossiers for Chromium Trioxide improvements in RMM

were mentioned This is similar to all AfA (35 mentioning improved RMM in the context of the

public dossier) Four out of 37 Chromium Trioxide dossiers reviewed had clear indications of

improvements of RMM In seven other applications general statements regarding improvements of

RMM were identified

Several of the AfA for chromium trioxide are upstream applications In these applications there is

no mention of improved RMM as a result of the authorisation process This can be the direct result

of the fact that these are upstream applications which typically contain less detail on specific use

conditions

The availability of new measured exposure data as a result of the AfA was mentioned as an

example of improvement

ldquodue to authorisation businesses have been generating new data on exposure levels

(occupational or environmental) which helped them identify areas for further

improvementsrdquo

In a survey carried out in the context of a workshop on chromates authorisation application103 one

third of the respondents stated that the authorisation process led to improvements in risk

management which is in line with the findings based on the AfAs The workshop participants

claimed that the authorisation process would lead to improvements by focussing activities but most

of the improvements in exposure and emission were achieved prior to the REACH authorisation

process

The data from the analysis of the applications for authorisation on improvements is also supported

by the survey results The survey results indicate that (nine out of 29 31) were able to improve

their risk management activities as a consequence of the authorisation For all these companies

the measures have led to a reduction or elimination of the occupational exposure to their workers

For seven of these companies less than 20 employees were affected by the measures Five

companies stated a reduction of emissions to air and wastewater though without providing

detailed information about how much In four of the companies the improved risk measures also

led to a reduction either in the waste or in the consumption of the SVHC

103 ldquoChromates Authorisation Application workshoprdquo 2829062017 organised by Eurometaux



Asked for the key trigger to improve the handling and operational conditions for using Chromium

Trioxide the companies stated equally the inclusion to the Candidate List the inclusion to Annex

XIV and the application for authorisation as the starting points for their measures

Although In the interviews stakeholders did not provide additional input on possible improvement

for risk management measures other than generic statements some qualitative comments were

collected

One interviewed downstream user mentioned that there was not much expectation that the

authorisation would lead to benefits in reducing exposure as most of the work (on exposure

reduction) had already been done

This is in contrast with three other interviewed stakeholders stating that despite continuous

improvements over the last 10 years the event of the application of authorisation led to a renewed

view on the processes to identify possible improvements But since they believed that the levels of

exposure were already under control the willingness to invest in additional improvements was

limited

All evidence shows that improvements in risk management measures were implemented in the

context of the authorisation process Although the level of improvements is probably different for

the different users of chromium trioxide This could be the direct result of the fact that some up

stream applications refer to local OEL with which companies have to comply but do not argue

minimisation based on the technology which is employed

Exposure measurements

Several Member States manage databases which contain measured exposure data For Chromium

Trioxide substantial information is available because hexavalent chromium has been under the

close attention of authorities for at least two decades due to the known substance hazards

Unfortunately of the relevant bodies few were able to supply any information (Belgium Germany)

France and Italy did not respond to the request to supply data but published data could be used

Publicly available studies on the development of occupational exposure levels have been analysed

to extract trends in the improvement efforts covering almost the past two decades (Belgium

France Italy Germany)

Historically several measurement campaigns have been carried out by different Member States

authorities to assess the level of occupational exposure (see Table 107) Unfortunately the setup

and the reporting of these data vary across Member States This makes it difficult to compare the

values and to compare them with the values mentioned in the AfAs Nevertheless these values can

be used as reference points to highlight the trend in the reduction of occupational exposure levels

over the years when compared to the values in the Afas

The sources listed in Table 104 were used and cover several CrVI compounds in addition to

chromium trioxide



Table 104 Sources used for estimation of exposure to CrVI

Country Publication Period

Italy Hexavalent Chromium Compounds in the Workplace

Assessing the Extent and Magnitude of

Occupational Exposure in Italy

1996-2009

Germany MEGA-auswertungen zur Erstellung von REACH-Expositionsszenarien

fuumlr Chrom(VI)-Verbindungen (2000-2009) in Deutschland

2000-2009

Galvanotechnik und Eloxieren

Empfehlungen Gefaumlhrdungsermittlung der Unfallversicherungstraumlger

(EGU) nach der Gefahrstoffverordnung (DGUVI 213-716)

2001-2011

France Occupational Exposure to Chrome VI Compounds in French Companies

Results of a National Campaign to Measure Exposure (2010ndash2013)

2010-2013

Belgium Resultaten Inspectiecampagne Chemische Agentia in de sector van de

oppervlaktebehandeling van metalen

2015

For the interpretation of the exposure levels it is useful to use the reference dose response curve

published by ECHA104 In Table 105 the values are provided for workers exposure

Table 105 Excess lifetime (up to age 89) lung cancer risk estimates for workers exposed at different 8h-TWA concentrations of Cr(VI) for 40 years

Ambient Cr(VI) exposure concentration (μgm3)

Excess lung cancer risk in the general population (x10-3)

25 100

125 50

10 40

5 20

25 10

1 4

05 2

025 1

01 04

001 004 Background cumulative lifetime risk of dying from lung cancer between ages 0 and 74 in EU males is 481000 (Globocan

2008)

Additionally a new proposal by the EU Commission on carcinogens and mutagens at work105

foresees a proposed limit for Chromium Trioxide of 10 microgm3 for the first five years after the date

of transposition of the Directive and a limit of 5 microgm3 after then will apply

In Table 106 values are provided from German and French measurement campaigns From this it

can be noticed that the French and more recent results provide a lower value compared to the

German values (eg Chrome plating max = 171 microgm3 while P90 value for Germany 13 microgm3)

104 Application for Authorisation Establishing a Reference Dose Response Relationship for Carcinogenicity of

Hexavalent Chromium (RAC27201306 Rev1) 105 Proposal for a Directive of the European Parliament and of the Council amending Directive 200437EC on

the protection of workers from the risks related to exposure to carcinogens or mutagens at work



Table 106 Historical measurement campaigns on Cr(VI) reported from various EU countries values for inhalation

EU-

country Trade sector Application Samples Sites

Values

microgm3

Referenc

e

Range (1)

France

Metal fabrication

Hard chrome plating

Chrome plating

Aeronautics painting

Hot metal spraying (HVOFarc

plasma spray)

99

97

90

77

8

99

lt002 - 97

lt003 ndash 23

lt002 ndash 171

lt002 ndash 896

182 ndash 15

90 value (2)

Germany

Metal construction

Equipment manufacturing

Manufacturing transport

equipment

Electroplating

Engine and vehicle

construction in generall

Machine building

Metal working in general

Surface treatment and

hardening

Application of liquid coatings

160

123

99

1174

83

272

774

100

71

79

55

31

379

33

120

398

40

15

28

50

132

13

326

208

11

14

283

Note

(1) Measurement campaign carried out by seven CARSAT chemistry laboratories CRAMIF laboratory and

INRS over the 2010 ndash 2013 period106 incl 99 companies involved in various activity sectors

(2) Measurements carried out in Germany in the period 2000 to 2009 measurements taken from

companies in the machine building and metal working sector (measurements from 1218 companies)

107

The slightly more recent data from the DGUVI 213-716 nuances by providing more detail on the

Galvanik use mentioned in the Table 106 Depending on the process step the Cr exposure value

(P95) varies between 25 microgm3 (hardchrome) to 67 microgm3 The value for the loading and unloading

positions is the same as in Table 106 13 microgm3

Belgian authorities that audited 83 companies that used Chromium Trioxide at the end of 2015

supply the most recent data

106 Vincent Gillet Goutet Guichard and others 2014 Occupational Exposure to Chrome VI Compounds in

French Companies Results of a National Campaign to Measure Exposure (2010-2013) 107 IFA Institut fuer Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung February 2012 MEGA-

Auswertungen zur Erstellung von REACH-Expositionsszenarien fuer Chrom(VI)-Verbindungen (2000 bis 2009) in

Deutschland



Table 107 Results from the Belgian inspection campaign108

Type of sample lt 1 microgm3 1 - 10 microgm3 gt 10 microgm3

Personal sample 45 50 5

Stationary Sample 43 52 5

Total 44 51 5

(1) Results of inspection campaign for chemical agents in the metal surface treatment sector inspection

in 83 companies in 2015

This Belgian data does not allow a like for like comparison as it neither differentiates the uses

accurately nor it takes the available technology into consideration However the campaign

provides a high-level view on the exposure to CrVI

Recently ECHA estimated the impact of the authorisation on the exposure to CrVI in a meta-

analysis109 This analysis started from the data of the French publication and compared these

results with the exposure values reported in the AfAs on chrome compounds According to ECHA in

the AfAs used in that analysis a maximum exposure level of 2 microgm3 was imposed Assuming that

the French data is representative for the EU and an estimated number of workers in sectors using

CrVI the number of avoided cancer case was calculated In case of an exposure level of 2 microgm3

post authorisation the number of avoided lung cancer cases amounts 82 per year in case 15 of

the CrVI workers were actually exposed to CrVI The value of 15 of the workforce exposed is a

rough estimate but for instance for the AfA for Grohe about 11 of the total workforce was

potentially exposed to Cr(VI)

This value could be even optimistic in the sense that the French data estimates more than 60 of

the exposure below 1 microgm3 while the data collected by the Belgian authorities indicates that in

2015 only 45 of the samples were below 1 microgm3

Additionally the value of 2 microgm3 is in several cases an overestimate In practice several

applicants estimate the exposure value lower An overview generated from the publicly available

AfAs documents (for Chromium Trioxide) delivered the following exposure results (see Table 108)

Table 108 Overview of occupational exposures results from the submitted AfAs for Chromium Trioxide expressed as ranges

Inhalation

Measured data Modelled data

Range in microgm3 Range in microgm3

lt1 1-10 10-50 lt1 1-10 10-50

15 7 1 15 17 1

This means that the number of avoided cancer cases as a result of the authorisation CrVI as

estimated by ECHA could be underestimated For instance if the real exposure level after

authorisation would be closer to 1 microgm3 the number of avoided cancer cases would be closer to

11 per year (same assumption of 15 of the CrVI workers exposed)


Authority 2016 Results of Inspection Campaign for Chemical Agents in the metal surface treatment sector 109 Socio-economic impacts of REACH authorisations mdashA meta-analysis of the first 100 applications for

authorisation (September 2017)



These values can be compared with the values reported by the Italian authorities indicating that

over the period 1996-2009 the average exposure level to CrVI was still more than 30 microgm3

However this report differentiates between the CrVI compounds For chromium trioxide the

reported P95 exposure level is below 2 microgm3 In the publication the authors show that over the

period 1997-2008 there is a statistically non-relevant decreasing trend in the exposure values (see

Figure 105)

In any case different publications show that some caution needs to be taken when using overall

data The difference between the exposure depending on the task or the substance used can be

very significant In that sense the estimation of the number of avoided cancer cases can only be a

rough estimate A better estimate would for instance require a more exact number of people

exposed at a certain level

Figure 105 Evolution of the exposure to CrVI110

There seems at first sight a discrepancy between the improvement in exposure as a result of the

authorisation process based on the measured values and the results of the interviews While the

interviewed stakeholders were generally sceptical and claimed that the majority of the

improvements were done independent of authorisation comparing the recent actual exposure data

110 Alberto Scarselli Alessandra Binazzi Davide Di Marzio Alessandro Marinaccio amp Sergio Iavicoli (2012) Hexavalent Chromium Compounds in the Workplace Assessing the Extent and Magnitude of Occupational Exposure in Italy Journal of Occupational and Environmental Hygiene 96 398-407 DOI 101080154596242012682216



shows that still a reduction of the number of cancer cases can be expected after the

implementation of authorisations

Despite the frustration about the burden of the application process one SME owner we interviewed

expressed the hope that ldquoone of the visible benefits due to authorisation will be the consolidation

amongst the small contract platers The lsquoblack sheeprsquo of the trade will eventually be forced either

to improve their working conditions or they will disappearrdquo

1010 Competition and competitiveness

It is difficult to assess the impact of the authorisation process on competition and competitiveness

due to limited research available The time to the sunset date (2192017) is too short to

experience any visible effects in market volumes It is expected that in time the impact will be

better supported by data

A Finnish study looking at impact and benefits of the REACH authorisation covering 14 Finnish

companies working with hexavalent chromium came to the conclusion that ldquouncertainty about the

scope of the process itself (authorisation process) caused confusion for all enterprisesrdquo111 A

similar statement did also recur in almost three quarters of the interviewed applicants and

downstream users for Chromium Trioxide Uncertainty and unpredictability about the outcome of

the authorisation process would substantially weaken the competitive position of their businesses

During a breakfast briefing in the European Parliament on the topic of EU 2020 and Industrial

Competitiveness SMEs in the Surface Engineering Sector in 2014 Mr Dave Elliott President of the

Committee for Surface Treatment which represents around 20000 SMEs in total stated in

reference to REACH that

ldquoThe surface engineering industries are suffering from mounting environmental legislation

that always assumes the worst-case scenario This threatens the very survival of many

surface engineering companies reduces their global competitiveness and poses the risk

that industrial value chains relocate part of the productions processes outside the EUrdquo

Later in this briefing it was also concluded that SMEs require stability predictability confidence

and better regulation ndash where better regulation means reducing the administrative burden and

simplifying REACH112

The responses to the online survey indicate that 11 out of 29 businesses experienced a negative

impact of the authorisation on their competitiveness Except for one business all respondents

stated authorisation made it more difficult to sell products to EU customers The uncertainty about

the success of the applications for authorisation led to customers shifting their orders to Non-EU

competitors For measure of balance it has to be noted that a shift to Non-EU customers would

face a different set of challenges such as ensuring the required quality standards flow of knowhow

and the unknown future development of regulatory process in Non-EU countries (like China and

Turkey) Customers would pick up information that Chromium Trioxide would be banned after

sunset date via medianews or associations ndash this required some businesses to invest efforts into

111 ldquoHow the REACH authorisation process affects and benefits companiesrdquo 2017 Atte Harrikari amp Riku

Montonen Aalto UniversityECHA 112 Paul Ruebig MEP Austria EU 2020 and Industrial Competitiveness SMEs in the Surface Engineering

Sector13th November 2014



informing customers about REACH Another negative impact on the competitiveness was the

increase in cost due to the applications for authorisation The additional cost burden would provide

an advantage to competitors outside EU

A particular case was mentioned in the defence industry As a consequence of REACH authorisation

applicants experienced that their customers would ask for products free of substances from the

Candidate List stating that they would not want to continue the uses of these hazardous

substances While this may represent an ultimate goal it would be difficult if not impossible to

implement in the short term

The follow up interviews with stakeholders confirmed the statement that businesses felt their

competitive position weaken due to the authorisation process More detailed impacts on the

competitive position was possible to clarify during the interviews The typical impacts mentioned in

the interviews were

Weakening of competitiveness due to reallocation of RampD to support substitution efforts

(and away from other innovative development work)

The fear of losing or the actual loss of orders as customers would shift to non-EU

competitors

The additional cost burden associated with the authorisation in a market operating with

tight profit margins and thus allowing no or only exceptional price increases

Almost all of the interviewed companiesdownstream users stated that the uncertainty about the

outcome of the application for authorisation and the possible threat of a short review period would

lead to discussions with customers who would demand (long term) planning security As that

security could not be provided customers started shifting the orders to suppliers outside EU One

interviewed company stated an estimated loss of turnover of around euro30 million for the last three

years due to orders being shifted to outside EU Another interviewee stated that their production

facilities in Germany lost new development projects and the subsequent orders went to a Swiss

production facility due to the fact that the local legislative framework there provided longer term

clarity for the use of Chromium Trioxide (20 years) which determined the customerrsquos decision to

shift to Switzerland In Switzerland chrome plating companies will have to comply with a new

threshold limit value of 1 microgm3 (from previously 5 microgm3)113

A typical small contract plating business stated that they had lost orders from customers outside

the EU but for now were able to compensate these orders with orders from other customers In the

past however customers would develop new products in cooperation with them that would allow

the business future orders for five to seven years and therefore represent the business base At the

time of the interview the downstream user expressed the concern that no development order was

in the pipeline due to the uncertainty of the authorisation and the short review period that had

been proposed by RAC and SEAC Admittedly this statement was only by one contract plater

However the way in which it is losing customers could be applicable for more small businesses

This is in contrast to the optimism expressed by the Dutch association of coating shops that stated

at the end of 2016 that all of its member companies had the best year of their history and that

demand for its services was soaring

While one of the objectives of REACH is to improve competitiveness it appears that in the case of

Chromium Trioxide many businesses experienced the opposite As discussed under the topic of

substitution mainly smaller companies felt that authorities (especially the assessment committees)

113 ldquoSchweizer Galvano-Briefrdquo Ausgabe Mai 2017 p52



do not understand their industrial environment114 Especially the so-called contract platers ndash

traditionally SMEs with limited or no influence on the product specifications set by their customers

- experienced that their particular situation was not appreciated

While the key message on the impact of the authorisation on the competitiveness is clearly that

companies from the survey and the interviews feel disadvantaged some stakeholders particularly in

the interviews also stated positive effects Consolidation of the plating business was stated as one

advantage that some interviewed stakeholder identified Those companies that would (or could)

not adopt either by switching to alternative technologies or by improving their exposure conditions

would inevitably disappear over time One small contract plater mentioned that ldquoI think that we

will especially in the running up to the re-application of authorisation see some companies simply

disappearingrdquo

Providers of alternatives also judged a positive effect of the authorisation on their competitiveness

As a result of the uncertainty the authorisation process generated amongst the customersrsquo

research would be accelerated and more resources allocated However they also indicated that

their role in the process of authorisation proved to be difficult To comment as a supplier of

alternative technologies during public consultation was considered by one interviewee ldquocommercial

suiciderdquo meaning that supplier of alternative technologies would not want to confront applicants

and therefore potential future customers during the public consultation

1011 RampD innovation and investment

Due to its hazardous characteristics the replacement of hexavalent chromium received substantial

attention even before the introduction of REACH Several EU-funded projects were commissioned

about replacement of Cr(VI) or reduction of the use of Cr(VI) such as CRAFT (1999) ndash See Annex H

In addition in several Member States research programmes have been carried out with the

objective of developing suitable alternatives for the use of Chromium Trioxide eg in France The

impact of this funded research has been to enable new technologies to be supported during their

development to help them reach the market

From the survey results of the 27 respondents referring to Chromium Trioxide two thirds (17)

responded that the authorisation did have an impact on their organisationsrsquo spending on innovation

or investment opportunities andor RampD The large majority (13 out of 17) indicated that they

increased their spending on RampD efforts while three stated a reduction in RampD spending

In contrast the majority of the interviewed stakeholders (six) referred to not having increased the

RampD budgets but to have it deprioritised In the process of the preparation of an application for

authorisation the available RampD resources would be shifted away from innovation projects to

support authorisation and the search for an alternative substance or process

A leading supplier to the defence industry stated that due to the authorisation process overall RampD

budget could not be increased but was in fact redirected from required new technology

development to finding an alternative for Chromium Trioxide The required military qualification

for products produced with an alternative would be costly and time consuming ndash on top of that the

supplier had to expect that their products would not list high on the priority list for the military

114 Harrikari A and R Montonen (2017) How the REACH authorisation process affects and benefits

companies Aalto Aalto University



qualification for their customers As a consequence the supplier felt that resources were wasted

and instead of developing innovative new products their non-EU competitors would benefit from

not having to apply for authorisation

Another discrepancy in the result from the online survey and the interviews was the attitude

towards investments andor innovations In the online survey 13 of the 17 respondents stated that

due to authorisation they had increased the volume for innovation and investment opportunities

During the interviews the opposite was stated In five of the interviews the stakeholder confirmed

investment freezes in the EU locations as a consequence of authorisation Due to the uncertainty

about the outcome of the authorisation process new investment projects in the EU have been put

on hold or directly shifted to suppliers outside the EU In two instances even replacement

investments were limited to the minimum pending the outcome of the application for

authorisation

1012 Experience of SMEs

For Chromium Trioxide applications for authorisation have been filed for different sized companies

(Table 109) For some small and medium enterprises the fact that continued use of Chromium

Trioxide would need authorisation came as a surprise

Table 109 Number of applicants and their size per substance

Substance Large Medium Small Micro

Chromium trioxide 42 2 9 8

Chromium trioxide Dichromium tris(chromate) 2 2

Chromium trioxide Potassium

dichromate Sodium dichromate 5 1

Total 49 3 9 10

Data provided by ECHA (03112016)

However this provides only a limited view on the impact of the inclusion of Chromium Trioxide on

Annex XIV on SMEs Ninety eight percent of the surface plating industry of more than 1000 chrome

plating shops in the EU are thought to be SMEs

As expected the majority of the SMEs sought the umbrella of a consortium to apply for

authorisation In total of the 27 applications for authorisation for Chromium Trioxide submitted

nine have been prepared by consortia The big consortia were able to join large numbers of

businesses CTAC mentions approximately 150 members and HAPOCVecco indicates more than 170

members Key reasons for SMEs joining consortia were (i) the reduction in cost for an application

and (ii) the avoided time and expertise required to prepare for an application

The case of German HAPOCVecco is of interest To cope with the application challenges seven

SMEs established an association (Vecco) to support the authorisation activities The intention of this

association is also to cooperate beyond the authorisation by joining forces on RampD providing

consulting work sharing best practices and enforcing standards amongst member companies in the

form of audits and reporting As an association could not submit an application for authorisation a

company (HAPOC) was founded that would act as importerformulatordistributor for the member

companies of the Vecco association According to the Vecco website the association had more than

170 members in 2015



In a recent study in Finland on the benefits of authorisation115 14 Finnish applicants for

authorisation have been interviewed Half of these companies were SMEs or micro companies

Several of these companies applied for authorisation for Chromium Trioxide Although the main

purpose of the study was related to benefits also the SME aspect was investigated

Eleven of the 14 Finnish companies interviewed by the study used Chromium Trioxide and stated

that the first issue the businesses associate the authorisation with is the additional cost burden

This was also confirmed by the statistics that except for one company all were organised in some

form of consortia to address the application for authorisation This joining of forces led over time

also to improved networking As a result one company ldquoadopted the idea of using a foaming agent

in their process baths from better performing companies and improved their process safetyrdquo116 The

report also states that a majority of the micro-sized companies got into contact with partner

companies in other EU countries like Sweden UK or Germany

The OY Kromatec application for the use of Chromium Trioxide for functional plating is the result of

collaboration between seven Nordic plating companies (CRAN) According to the SEA of the AfA

these companies are all small or micro sized companies Although the total profit of turnover for

the companies is not provided in the AfA it is mentioned that the discontinuation of the use of

Cr(VI) would result in a cost of euro79 million over the total applied for review period of 12 years

based on 46 jobs lost Based on the details of the volume of Cr(VI) used it seems that the group

consists of six companies fairly similar in size and one larger company (annual volume of Cr(VI) used

is 10 tons per year for one site and between 1-5 tons per year for the 6 others)

This application is next to other applications which include the use ldquofunctional platingrdquo For

instance the application ndeg 32 with LANXESS as the lead applicant Provided that the applicants in

the OY Kromatec application can be supplied by one of these applicants the Kromatec application

can be seen as redundant An own application however would also provide the independence to

choose suppliers themselves rather than depending on the supply via suppliers from the consortium

(CTAC) Nevertheless and probably with the knowledge of the existing other application the

Nordic SMEs still elected to submit their own application Both the LANXESS application and the

Kromatec application applied for a review period of 12 years and for both applications the

recommended review period is seven years (no final decision yet) For the other applications there

was no recommendation yet available In any case the application of Kromatec showed that groups

of even micro companies can apply for authorisation

1013 Summary of Tier 1 case study

Looking at all influencing factors for the case of Chromium Trioxide three main consequences could

be identified

Benefits in the form of exposure reduction

The substitution challenge

Impacts on the competitiveness of applicants


companies Aalto Aalto University 116 Harrikari A and R Montonen (2017) How the REACH authorisation process affects and benefits




At the time of writing of the report the sunset date was not passed and hence it was not possible

to have actual exposure and emission data post authorisation It was only possible to a very limited

extent to estimate the benefit with regards to exposure and emissions prior to the sunset data

Measured and reported exposure data in the AfAs and announced additional RMM lead to the

expectation that a further reduction of exposure will be possible after the sunset date The exact

value of this improvement is hard to estimate but based on the interviews the interviewed

stakeholders stated that the majority of their exposure reduction was done before authorisation for

Chromium Trioxide was considered It is a common statement by industry that a lot has been done

before authorisation was considered nevertheless if one compares the exposure level

recommended by RAC (r2 ugmsup3) improvements could still be achieved by authorisation It is

expected that after the authorisation decisions have been fully implemented and enforced the

benefits of reduced exposure will be recognised

From a hazard perspective hexavalent chromium poses a severe hazard to humans For the

majority of the uses the authorisation process can be used to manage the risks However the

widespread use of Chromium Trioxide particularly in surface plating means that the authorisation of

this substance affects a large number of businesses of which a number have reported a

considerable negative economic impact for the business in this sector

The online survey responses and the interviews carried out within this study support the position

that especially contract manufacturers are facing difficulties This is because they are not the

owners of the process and hence cannot independently change to an alternative as customers shift

their orders to non-EU suppliers rather than support the development of an alternative technology

or move directly to platers that have invested into alternative technology This means that as a

consequence of the authorisation a consolidation in the surface treatment industry can be

expected over the next few years This will result in companies that will adopt and perhaps be even

strengthened by authorisation and others that will likely cease in the process There is no hard data

currently available to support this conclusion as sunset date is still in the future and the final

decision by the EU commission is still pending but there is a general consensus in the industry that

this will be the future

While not originally in the scope of the case study it is worth mentioning that Chromium Trioxide

shows clearly the challenge for upstream applications As upstream applications cover potentially a

broad range of uses they also face uncertainties on for example exposure levels The advantage

of an upstream application is a commercial one ndash the cost spread over large number of companies is

lower but this comes at the price of a shorter review period While industry regards this as a

ldquopunishmentrdquo one could argue that the cost per review year might be fairly acceptable The lesson

learned from Chromium Trioxide is that data specific applications with a clear use tend to receive

recommendations for longer review periods This may come at the price of an increase in the

number of applications and most probably also higher application costs for smaller businesses that

decide to apply by their own rather than being covered by an upstream application However

longer review periods deliver security for investments and customers Without the planning for

stability customers are shifting orders to outside EU according to the interviewed stakeholders

mainly to China but also to Turkey



11 TIER 1 CASE STUDY SUBSTANCE 2 TRICHLOROETHYLENE

111 Introduction

Due to concerns about its toxicity the use of trichloroethylene (TCE) has been banned in the food

and pharmaceutical industries in much of the world since the 1970s At the end of the 1990s and

the beginning of 2000 companies made substantial efforts in reducing the consumption of the

substance as a solvent also driven by the Volatile Emissions Directive which forced companies to

reduce emissions considerably to comply with the legislation

One of the key reasons for the recommendation of this substance registered in volumes up to 1

million tonnes for inclusion in Annex XIV was that ECHA concluded that the volumes allocated to

the uses in the scope of authorisation were very high and at least some of the described uses would

potentially create significant exposure of industrial workers and professionals and hence could be

considered wide-dispersive However with the biggest use allocated as intermediate the volumes

for which authorisation is sought are considerably lower at a range of close to 20000 tonnes for all

the uses except for ldquopackagingrdquo which is in the range of 10000 to 100000 tonnes

There were six responses to the online survey from applicants downstream users or NGOs dealing

with TCE and only four of these responded to questions with reference to TCE Of the four

respondents three were downstream users and one an NGO This is much less than those for

Chromium Trioxide

For the follow up interviews four stakeholders for TCE were contacted

NGO (1)

Associations (0)

Applicants (1)

Downstream users (0)

Users non-applicants (2)


Table 111 Trichloroethylene substance profile

Name Trichloroethylene

EC no 201-167-4

CAS no 79-01-6




Carcinogenic (Article 57a)



Trichloroethylene is a chlorinated hydrocarbon Most TCE is produced from ethylene Ethylene is

chlorinated over a ferric chloride catalyst to produce 12-dichloroethane (ClCH2CH2Cl) When

heated to around 400degC with additional chlorine 12-dichloroethane is converted to

trichloroethylene (C2HCl3)



This reaction can be catalyzed by a variety of substances (a most commonly used catalyst is a

mixture of potassium chloride and aluminum chloride) This reaction produces tetrachloroethylene

as a byproduct Depending on the amount of chlorine fed to the reaction tetrachloroethylene (or

perchloroethylene in the following referred to as PER) can even be the major product Typically

TCE and PER are collected together and then separated by distillation In Europe an alternative

process is in place which starts from PER and uses catalytic hydrogenation117

Based on studies that show its carcinogenic potential it was concluded that TCE (EC no 201-167-4

CAS no 79-01-6) should be considered as a non-threshold substance


TCE fulfils most of the key criteria set for the selection of a Tier 1 case study substance

Latest application date has passed so that we should be able to assess the impacts of the

whole authorisation process ndash for TCE this was 21 April 2014

There is a high number of applications and applicants which increases the opportunities for

getting data ndash for TCE there were 13 applications for 14 applicants

There is a high number of uses applied for ndash 19 uses and

The impacts are diverse and complementary ndash high volumes allocated to the uses and

widespread use in EU in numerous businesses (especially for the metal degreasing and

surface cleaning use) with widespread applications

There is little information available to quantify accurately the number of companies potentially

affected A report from 2011 estimated that up to 141000 companies engaged in the lsquotreatment

and coating of metalsrsquo employing around 11 million employees could be affected EU wide118 While

the Eurostat data cannot differentiate whether all these companies are using TCE this number can

still be ndash as a worst case - assumed as TCE has been regarded as an effective and widely used

solvent for the cleaning of metals



Table 112 Trichloroethylene REACH authorisation timeline


Date of inclusion to Candidate list 18062010

Date of inclusion to Annex XIV 20122011



117 European Chlorinated Solvent Association ndash Trichloroethylen Legislation Markets Use 2010 118 Institute of Occupational Medicine Research Project P9373 (2011) - Health socio-economic and

environmental aspects of possible amendments to the EU Directive on the protection of workers from the risks

related to exposure to carcinogens and mutagens at work ndash Trichloroethylene Data from Eurostat 2006



According to Article 57(a) TCE was identified as a substance of very high concern It is classified as

carcinogen category 1A ECHA concluded that the volumes of TCE allocated to the uses in the scope

of authorisations were very high and at least some of the described uses would bear the potential

for significant exposures of industrial workers and professional and could hence be considered wide

dispersive

TCE was included on the Candidate List for authorisation on 18 June 2010 During the period for

commenting 38 comments were submitted by industry (6) and industry associationstrade

unionsMember States authorities (32) The majority related to general comments (17) followed by

specific comments on use exposure alternatives and risks (12)119

On 20 December 2011 the substance was included in Annex XIV This meant that the use of TCE

would require authorisation after the sunset date of 21 April 2016 with a latest application date of

21 April 2014

During the period for commenting for the inclusion of TCE to Annex XIV 95 comments were

submitted by industry (65) industry associationstrade unionsMember States authorities (23) and

NGOs (7) The majority related to comments on uses that should be exempted from authorisation

(36) and general comments on the recommendation to include the substance in Annex XIV (34)

By end of 2016 13 applications by 14 applicants for 19 uses of TCE after sunset date were

submitted


Trichloroethylene was assessed in the context of a risk assessment report finalised in 2004 with the

UK as the rapporteur120 The report refers to four producers of TCE in the EU and in the Defra risk

reduction strategy report from 2005 three producers of TCE in the EU are mentioned One French

producer ceased the production of trichloroethylene in 2006

Since 1996 the sales volumes of TCE in the EU have steadily declined from levels of 100000 tons

per year to around 38000 in 2003 The key reasons for the decrease were related to the continuous

substitution of TCE by alternative substances or technologies

Use of closed systems The introduction of closed loop safety containers (ldquosafetainersrdquo)

led to an elimination of emissions during filling and

The process improvements by converting to closed systems in surface cleaning led to a

minimisation of solvent emissions and a reduction of solvent consumption by improved

recycling and re-use

The main driver for industry to make efforts to improve emissions respectively substitute

trichloroethylene as a process solvent were to comply with the Solvent Emissions Directive

(introduced in its first version in 1999121) and in anticipation of REACH sometimes even in the form

119 Due to the grouping of the comments in different categories some of the comments could be counted

double as they would fit several categories 120 European Union Risk Assessment Report Trichloroethylene European Chemicals Bureau 2004 121 The purpose of the Solvent Emissions Directive is to prevent or reduce the direct and indirect effects of

emissions of volatile organic compounds into the environment mainly into air and the potential risks to

human health by providing measures and procedures to be implemented for certain activities (description by

Department for Environment Food and Rural Affairs)



of voluntary industry commitments The risk assessment report of 2004 stated that the Directive

caused a significant reduction in use and emissions of TCE in metal cleaning due to requirements to

phase out the substance where feasible and to impose limits upon emissions to atmosphere by the

use of closed systems The Defra report of 2005 expected that ldquodue to the use of closed systems

respectively substitution to other solvents the trichloroethylene consumption into solvent

applications would drop by an additional 60 compared to the 2006 consumptionrdquo122 The same

report states that in 2007 the TCE use as a solvent accounted for in the EU was 25 of the EU

production The rest would be used as intermediates ndash this is a substantial change as in 1996 TCE

was used up approximately 63 as solvent and intermediate use was 37 of the EU TCE production

(see Figure 111 and 112)

Figure 111 Production export import volumes TCEPER 2003-2016

Note The numbers in this figure represent the combined figures for TCE and PER

122 Defra - Risk Reduction Strategy and Analysis of Advantages and Drawbacks for Trichloroethylene Entec UK

2005



Figure 112 Uses of TCE sold into EU markets 1996 and 2003

According to the Annex XV report of 2010123 the majority of the TCE volume produced today is used

as a chemical intermediate (estimated at 80) which is out of scope of the authorisation under

REACH The same report mentions that the remaining volume is allocated to the following main

uses

Industrial solvent for metal cleaning and degreasing and

Solvent used in certain adhesives

The Annex XV report refers also to miscellaneous uses as solvent like

In the metal processing

For asphalt testing

For wool scouring

For high-tech ceramic goods production

As process solvent

As heat transfer fluid

TRI has long been replaced in dry cleaning machines with tetrachloroethylene (PER) due to the

milder solver action Additionally it is mentioned that some consumer products could still contain

trichloroethylene such as corrective liquids (for typing machines) paint removers adhesives stain

removers and liquids for carpet cleaning but only at concentrations of 01

There are currently five registrations active The total use is in the range of 100000 to 1 million

tons per year based on the tonnage bands presented on the ECHA website The actual import of the

substance is as shown in the Table 115 has been on average for the past five years in the range of

just below 6000 tons per year

123 ANNEX XV report ndash Proposal for identification of a substance as a CMR cat 1 or 2 PBT vPvB or a substance

of an equivalent level of concern submitted by France 2010




Industrial use as heat transfer fluid

Industrial use as process chemical

Industrial use as process chemical (closed systems)

Industrial use as process chemical (semi-closed systems)

Industrial use as process chemical (enclosed systems)

Industrial use in surface cleaning (enclosed systems)

Industrial use in surface cleaning (closed systems)

Industrial use as intermediate

Distribution and (re)packing

Industrial use of adhesive

Industrial use in adhesives

Industrial use in textile scouring


The Annex XV report states that due to rationalisation and consolidation the number of European

producers of TCE declined from more than 10 in 1984 to two producers in 2009124 After one of the

manufacturer ceased production of TCE in 2016 after a merger with a competitor only one

manufacturer remains today (in Romania) The available information shows that the decline of the

production and consumption of TCE has further declined after 2006 Figure 113 shows the trend

between 2012 and 2016

Figure 113 Trichloroethylene ndash Production consumption exports imports in EU 2012-2016





At the end of 2011 TCE was included in Annex XIV One of the key players Dow Chemicals

(manufacturer of the substance) took the lead to submit an upstream application for authorisation

for five uses Of all submitted applications for authorisation for trichloroethylene (15 in total) more

than 90 could be allocated to the use as solvent either for surface cleaning metal degreasing or

as processextraction solvent

An analysis of changes in the registration data through the authorisation milestones125 concluded for

TCE that at least one of the registered uses (use as heat transfer fluid reported by four registrants)

does not seem to be covered by any applications for authorisation When checking whether any of

the uses which were applied for regarded uses not registered before (or not reported according on

Article 38 of REACH) the same report concludes that ldquoall uses applied for appear to fall under the

generic scope of the registered uses the names of which were however not specified further after

sunset date The comparison relies solely on the use names and therefore is not conclusiverdquo In

total for TCE there is one registrant less today compared to pre-authorisation period

Based on market research information (Figure 114) the production and consumption of TCE in the

EU will further decrease to an estimated level of 23500 tonnes per year by 2022

Figure 114 Trichloroethylene ndash Production consumption in EU 2017-2022

At the time of generation of the market research report there were still two producers of TCE in

the EU The data forecast for the production of TCE in the EU as described in Figure 114 is

therefore considerably lower as the maximum capacity of the remaining producer is around 12000

tonnes per year However the consumption levels in the graph are still regarded as accurate as

the difference in production volume will likely be compensated by an increase in imports of TCE

In one of the interviews held for this study a stakeholder expressed his concern that the market for

TCE was ldquorapidly decreasingrdquo His expectation was that TCE consumption would be ldquostable for the

125 ECHA Changes in the registration data through authorisation milestones TCE DBP CrO3 Status as of 10th

April 2017 p12



market as intermediate but the availability of alternatives would further reduce the demand for

TCE as a solvent for the metal degreasing industryrdquo A forecast for the metal cleaning equipment

industry in the EU126 however predicts a steady growth for the metal cleaning industry with an

estimated annual growth of 62 between 2016 and 2024

117 Substitution

The substantial decline in the production and consumption of TCE over the last two decades means

that alternatives have been available for a long time and companies have been actively seeking to

substitute or change the process even before REACH One of the main legal drivers for this was the

Solvent Emission Directive Despite the substitution efforts for more than 10 years and the

availability of quite a number of alternatives especially in the area of metal cleaning and surface

degreasing some critical applications still remain where the use of TCE is essential for the process

andor the quality of the goods produced127

There are numerous alternatives to TCE in its use as a solvent for metal cleaning and degreasing

Those substances closest to be as drop-in substances are chlorinated solvents ndash tetrachloroethylene

(PER) and methylene chloride (MEC) Dow Chemicals refers to additional alternatives and processes

such as128

Aqueous cleaning The process uses detergent-water or an alkaline chemical solution which

is a very popular alternative but not always as effective at removing grease and oils

Aqueous cleaning is quite successful with steel parts less efficient with aluminium parts

and even less so for mixed metals

Semi-aqueous or emulsion cleaning Parts are exposed to a non-chlorinated solvent that

incorporates a surfactant The surfactant ensures that remove residual solvents and

residual oils from the parts carrying them into aqueous phase

Non-chlorinated solvents Acetone n-methylpyrrolidone (NMP) or terpenes can often

provide good cleaning However these are mainly limited to cold cleaning applications due

to their characteristics as flammable or combustible substances In addition new

engineered solvents have been developed such as volatile methyl siloxanes oxygenated

solvents (glycol ethers and dibasic esters) the hydrochlorofluorocarbons (HCFCs)

hydrofluorocarbons (HFCs) hydrofluoroethers (HFEs) and n-propyl bromide The

disadvantages of the alternatives are the usual lower performance and considerably higher

cost (12 to 15 times the cost of a traditional chlorinated solvent)

Supercritical fluids (SCFs) Particularly supercritical carbon dioxide (CO2) does have good

cleaning properties with little environmental impact Since the substances reach their

supercritical phase only when compressed and heated beyond their critical pressure and

temperature the process requires costly equipment with safety features

Other options There are additional cleaning processes available as plasma cleaning laser

cleaning thermal vacuum cleaning and mechanical cleaning

126 Transparency Market Research ndash Metal Cleaning Equipment Market Analysis 2016 127 ECSA European Chlorinated Solvents Association ndash Trichloroethylene Legislation Markets and Use 2010 128 Dox Clorinated Solvents ndash Newsletter Volume 3 Alternatives to chlorinated solvents



An online research delivered several available tools that businesses looking for alternatives for a

substitution of TCE could use

The substitution portal SUBSPORT (as described under Section 1073) The portal also

describes 14 case studies in which TCE has been successfully substituted for different

applications

Cleantool is an online best practice database dedicated to alternatives for best options for

cleaning of metal surfaces129 The database has been developed between 2001 and 2004 by

five partners with the Kooperationsstelle Hamburg IFE in the lead supported by funds from

EU research programme

A similar database has been developed for users by the Technical University of Dortmund

called ldquoBauteilereinigungrdquo130 available in German The database was mainly developed for

users from automotive industry and allows selection of both alternative substances and

alternative processes depending on the size and type of parts that need to be cleaned

An analysis of the submitted applications shows that in eight cases the alternative mentioned in the

analysis of alternatives refers to PER as an at least technically feasible alternative This confirms

the view of Defra (2005)131 that ldquoperchloroethylene is reported to be the most technically feasible

substitute for trichloroethylene in the majority of the cases even though this will depend upon the

particular applicationrdquo

Looking at the results from the online survey from the applicants andor downstream users two out

of six companies had substituted TCE successfully Half of the respondents (three) mentioned that

they were not investigating any substitution two indicated successful substitution with one

company confirming to carry out substitution activities

An example of early substitution was followed up during the interviews A supplier to the defence

industry stated that substitution of TCE started as early as in the 1990s with switching to

alternative processes (aqueous cleaning) for applications where the qualitative result would allow

it Even before TCE was identified as a substance of very high concern (SVHC) in 2010 the company

decided to substitute the substance and not follow the route of an application for authorisation

Main reason for this was the doubt that an application would be successful due to relatively old

technology used in the processes cleaning with the substance PER was considered as a suitable

alternative but first rejected on the grounds of its hazard profile in addition PER was under

substance evaluation from a Member State authority (Latvia in 2014) As the evaluation concluded

that PER was not a SVHC and no further measures were required it was reconsidered as an

alternative As a consequence a new installation for vapour degreasing has been developed and

implemented based on PER that consumes and emits considerably less solvent This installation was

implemented just before sunset date for trichloroethylene

129 wwwcleantoolorg 130 ldquoBauteilreinigungrdquo means ldquocomponent parts cleaning - wwwbauteilereinigungde 131 Defra ndash ldquoRisk Reduction Strategy and Analysis of Advantages and Drawbacks for Tryichloroethylenerdquo 2005

Entec UK Ltd




Depending on the application and use there are alternatives for TCE Very little publicly (or

commercially) available information was identified that could help to evaluate relevant changes in

the markets for alternatives

Tetrachloroethylene (PER) has been regarded by the supplier of TCE as a technically suitable

alternative to TCE From its hazard characteristics (suspected for causing cancer) it was expected

that PER would follow a similar route as TCE and require authorisation is some years But as

mentioned above the result of the Latvian substance evaluation in 2014 ensured suppliers of PERrsquos

long term stability

The available information shows (see Figure 115) that the EU is a net exporter of PER with

negligible import volumes On average in the last five years 150000 tons of PER were produced in

the EU per year compared to an average import volume of less than 300 tons

After the decision of the substance evaluation in 2014 the consumption of PER peaked towards the

sunset date in 2016 This is in line with a peak in the production volumes in 2016 compared to the

last five years

Figure 115 Tetrachloroethylene ndash Production consumption exports imports in EU 2012-2016

In a market report for tetrachloroethylene132 (Figure 116) the forecast for the next five years

indicates that the production level for PER will continue to decrease while consumption will remain

around a level similar to the average of the last five years This could mean that despite PER being

a technically feasible alternative for the substitution of TCE it is either disregarded due to its

132 BAC reports Trichloroethylene Tetrachloroethylene (Perchloroethylene) ndash European Union Market Outlook

2017 and or Forest till 2022 2017



hazard profile or only substituted in cases where exposure is well-controlled and minimised (eg

closed systems)

Figure 116 Tetrachloroethylene ndash Production consumption in EU 2017-2022


Also for TCE the improvements in risk management are documented in this case study by means of

the evolution of the exposure values and the implemented RMM


As part of the public versions of the AfAs for TCE 27 of the dossiers mention improvements in

RMM This is slightly lower in comparison to all AfA submitted (35 mentioning improved RMM in the

context of the dossier) However as mentioned above according to ECHA most applicants refer to

improved RMM during the application process (PSIS RAC questions) even though data is not

available Furthermore again as mentioned above it seems to be more difficult for upstream

applications to document the improvements in RMM in detail

Nevertheless for two TCE applications applicants clearly mention additional RMMs which were

implemented as a result of the authorisation process (eg Vlisco Parker) In the Vlisco application

more than 20 emissions reduction was announced as a result of process modifications that were

planned to be implemented before the sunset date These improvements were identified on the

basis of mass balances exposure measurements and field audits Another key element in that

dossier was that it also described and documented previous (historical) efforts in minimising

exposure In the Parker case it was also possible to reduce the emissions in the workplace

significantly by process modifications Because of this Parker will be able to double its capacity

without increasing the use of solvent exposure or emission In practice even after such capacity

expansion the exposure will be 20 lower compared to today



Akzo identified in their application for authorisation for the continued use of TCE several

opportunities for improvements using close follow up of the solvent consumption in combination

with field audits and exposure measurements These findings resulted in the change of certain parts

of the installation and the introduction of new maintenance programs

None of the survey respondents replied to the questions on improved risk management activities In

the interviews with stakeholders no reference or comments were made with regards to

improvements in exposure reductions implemented or planned

Exposure values

A basic approach to assess the exposure to TCE at the workplace is by evaluation of the imposed

limit values While the limit values are not indicators of the actual exposure values it can be

assumed that lowering the limit value will lower the average exposure value

TCE is considered as a non-threshold carcinogen without any DNEL value There are however still

local occupational exposure limits with which companies have to comply The existing OEL values

across Europe show a considerable variance between a minimum level of 33 mgm3 for workers

inhalation in Austria and a maximum level of 550 mgm3 in the UK (Table 113)

In 2009 SCOEL proposed new occupational exposure limit for TCE of 10 ppm 547 mgm3 (8-hour

TWA) and 30 ppm 164 mgm3 (short-term exposure limit 15 min)133

Table 113 Existing OELs for TCE inhalation (adapted from the GESTIS database134)

EU-country

Limit value ndash

Eight hours TWA

Limit value ndash

Short term

mgm3 mgm3

Austria 33 132

Belgium 55 137

Bulgaria 135

Croatia 550 820

Cyprus 535

Czech Republic 250 750

Denmark 55 110

Finland 50

France 405 1080

Germany 60

Hungary 540

Ireland 1375

Italy 54 140

Latvia 10

Lithuania 50 134

Malta 55 1375

Poland 50 100

133 Recommendation from the Scientific Committee on Occupational Exposure Limitsfor Trichloroethylene

2009 SCOELSUM142 134 Commission staff working document Impact Assessment - Accompanying the document Proposal for a

Directive of the European Parliament and of the Council amending Directive 200437EC on the protection of

workers from the risks related to exposure to carcinogens or mutagens at work (2017)



EU-country

Limit value ndash

Eight hours TWA

Limit value ndash

Short term

mgm3 mgm3

Romania 100 150

Spain 55

Sweden 50 140

Slovakia 275

Slovenia 270 1080

United Kingdom 550 820

A comparison of the development of the occupational exposure limits over time shows that

considerable improvements can be expected to have been achieved by adjusting the OELs over time

to lower levels (Table 114)

Table 114 Comparison of OEL levels for TCE for different EU countries over time values for inhalation

EU-country

2010135 2017136

Limit value ndash Eight hours Limit value ndash Eight hours

ppm mgm3 ppm mgm3

Austria 50 270 06 33

Belgium 50 269 10 55

Denmark 30 160 10 55

Finland 30 160 10 50

France 75 405 75 405

Ireland 100 535 10

Sweden 10 50 10 50

United Kingdom 100 550 100 550


authorities to assess the level of occupational exposure (see Table 115) While these results are

not representative and should not be compared like-for-like they serve as reference point and can

be compared with the values as reported in the AfA The following sources were used

Country Reference Period

France INRS Raymond VINCENT (2009) Donneacutees COLCHIC dexposition professionnelle agrave divers agents chimiques pour la peacuteriode 2002-2008 Butylglycol et aceacutetate de butylglycol Toluegravene Dichloromeacutethane Perchloroeacutethylegravene Trichloroeacutethylegravene Styregravene Acrylamide As reported in the Annex XV report for trichloro ethylene France 2010

2002-2008

Germany BGAA Report 199 Altstoffe ndash Expositionen am Arbeitsplatz Hauptverband der gewerblichen Berufsgenossenschaften

1990-1994

135 Annex XV Report Proposal for Identification of a Substance as CMR cat 1 or 2 PBT vPvB or a substance of

an equivalent level of concern France 2010 136 GESTIS 2017 httplimitvalueifadguvde



Table 115 Historical measurement campaigns on TCE reported from various EU countries values for inhalation

EU-

country Trade sector Application values companies

90 value

(mgm3)

Refere

nce

France

Manufacture metal products

except machinery and

equipment

215

152 sites

236

(1)

Printing and reproduction 91 194

Manufacture of rubber

products and plastics 85 191

Manufacture computer

electronic and optical

components

38 89

Manufacture of electrical

equipment 23 1

Chemical industry 14 859

Other sectors 274 215

Germany

Loading and distillation in

chemicals industry

- without LEV

- with LEV

31

10

19

16

8

9

71

32

82

(2)

Surface coating Adhesive

bonding laminating lining

stopping

- with LEV

-without LEV

144

74

66

78

44

41

215

185

232

Surface cleaning manually 14 7 304

Surface cleaning

installations

- without LEV

- with LEV

188

23

159

90

18

74

241

282

239

Notes (1) Colchic study 2002-2008137 and (2) BGAA Report 199 Altstoffe ndash Expositionen am Arbeitsplatz

Hauptverband der gewerblichen Berufsgenossenschaften

For the applications for authorisation RAC has published a reference dose response curve138


an equivalent level of concern France 2010 138 Application for Authorisation Establishing a Reference Dose Response Relationship for Carcinogenicity of Trichloroethylene (RAC28201407 rev 2)



Figure 117 Excess risk for carcinogenic effects-Working lifetime exposure139

It is to be noted that in BEkGS910140 the risk level of 4x10-4 6 ppm (32 mgm3) is considered an

ldquoacceptable riskrdquo until 2013 2018 latest even though it is not considered to be a formal reference

value for an AfA After that date 4x10-5 is considered as an acceptable risk level which corresponds

to 06 ppm (32 mgm3)

An analysis of the submitted AfAs shows that in 11 of the 13 applications actual measurements

were available with some supported by modelled data The ranges shown in Table 116 refer to the

highest exposure value found per application in different scenarios for workers which means the

data represents the worst-case exposure information both because the highest value is reported

and there is no correction for duration of the contributing scenario

139 Application for Authorisation Establishing a Reference Dose Response Relationship for Carcinogenicity of Trichloroethylene (RAC28201407 rev 2) 140

httpswwwgooglebeurlsa=tamprct=jampq=ampesrc=sampsource=webampcd=4ampved=0ahUKEwjkvtOuy4TXAhWOaFAKHe

wdBr4QFgg7MAMampurl=https3A2F2Fwwwbauade2FDE2FAngebote2FRechtstexte-und-Technische-

Regeln2FRegelwerk2FTRGS2Fpdf2F9102F910-

trichlorethenpdf3F__blob3DpublicationFileampusg=AOvVaw1QS_qPaFsmMdl7_lRgcVB1



Table 116 Overview of occupational exposures results from the submitted AfAs for TCE expressed as ranges

Inhalation Dermal

Measured data Modelled data Measured data(1) Modelled data

Range in mgm3 Range in mgm3 Range in mgkgday Range in mgkgday

lt1 1-10 10-50 lt1 1-10 10-50 lt01 01 - 1 1 - 5 lt01 01 - 1 1 - 5

2 6 3 1 7 8 1 12 5

Note (1) No measured data for dermal exposure was identified in the submitted AfAs

Although the historical numbers cannot be compared directly with the numbers in the AfA it is

clear that after the implementation of the exposure scenarios of the AfA the exposure level will be

significantly reduced compared to the historical exposure While historically only 4 sectors had an

exposure level below 50 mgm3 (8 hrs average) (Table 115) as a result of the authorisation

process all sectors will have a maximal exposure level below 50 mgm3 (Table 116) meaning that

the actual 8 hrs average exposure level will be even lower

The COLCHIC data reported in the Annex XV background document shows that 25 of the measured

data (8 hrs average) is above 50 mgm3 (10 ppm) The average exposure level is 749 mgm3 (139

ppm) and a 90 percentile of 168 mgm3 (311 ppm) The raw data is missing to estimate the number

of avoided cancer cases However if the average exposure to TCE would be historically about 749

mgm3 the reduction to an exposure of 34 mgm3 (6 ppm risk = 4 10-4) represents for an estimated

population exposed to TCE in the EU of 200000141 workers 1137 avoided cancer cases

In conclusion both when looking at historical exposure data and when interpreting the AfA it is

clear that during the authorisation process the exposure level of TCE has decreased Although it is

difficult to prove that these reductions are a direct result of the authorisation in at least three AfA

and based on the observations of ECHA this seems to be the case


The impact of the authorisation process on competition and competitiveness for TCE is difficult due

to limited research available on that topic As in the case of Chromium Trioxide it is expected that

a large number of the surface cleaning companies in the EU are SMEs and are providing surface

cleaning as contract manufacturers even though no statistical data is available

Of the four online survey respondents referring to TCE none referred to any impacts authorisation

had on their competitive position

In one of the follow up interviews one stakeholder mentioned that the impact of authorisation on

their companyrsquos competitive position was not ldquoon their horizonrdquo He stated that ldquoin the metal

degreasing industry the main consolidation already happened 10 years ago We have been in the

business of looking at alternatives for TCE for 20 years so this has become part of our business

and authorisation did not impact that in any wayrdquo

In another interview the stakeholder referred to the problem of uncertainty about the process

The uncertainty about the outcome of the application for authorisation led to a decision to

141 Extrapolation based on Risk of Cancer Among Workers Exposed to Trichloroethylene Analysis of Three

Nordic Cohort Studies



substitute TCE prior to the sunset date ldquoWe would rather accept the cost of an alternative process

than face the risk of possibly not being granted authorisationrdquo


Due to its hazardous characteristics the replacement of TCE was already in the focus before the

introduction of REACH even though a search on the internet deliver only a few specifically TCE-

related projects funded by EU Most of the funded projects have been targeted at the

bioremediation of soil contaminated with TCE (andor other chlorinated solvents)

From the survey results of the four respondents referring to TCE none responded to the question

whether the authorisation did have an impact on their organisationrsquos spending on innovation or

investment opportunities andor RampD

The interviews with stakeholders did not provided any additional information on this topic In the

one case where the company substituted TCE with PER prior to the sunset date the stakeholder

mentioned that the pay back for investments would be compensated by the reduction in

operational costs (less maintenance better recycling and re-use of the solvent less consumption of

the solvent)


It is estimated that the market for metal degreasing is dominated by SMEs who would provide the

service of degreasing as contract manufacturers However no data could be found to indicate the

structure of SMEs in the surface cleaning industry

Further information on the experience of SMEs in the authorisation process for TCE could not be

obtained from the online survey or the interviews with stakeholders

In one of the interviews a stakeholder mentioned that as a consequence of the authorisation for

TCE the company even considered to insource the service of metal degreasingsurface cleaning

He stated ldquoit is strange to think that 20 years ago we outsourced this activity and were thinking

now about integrating it again to have direct control of the operating conditions and the exposure

situation but the question was whether these small companies would be able to do what was

required to get an authorisation And there we were doubtfulrdquo


Looking at all influencing factors for the case of TCE two main consequences could be identified

Benefits in the form of exposure reduction and Impacts on the competitiveness of applicants

TCE is a SVHC and the risk profile has been known for decades Therefore a lot of work prior to

REACH has gone into improving occupational exposure also driven by other legislation (eg Solvents

Emission Directive) Closed systems and better re-cycling loops recommended by the European

Commission in 2008 have led to fewer emissions and consequently also lower consumption of TCE

For instance Dow Chemicals had already their Safetainer packaging system for TCE introduced



years before the authorisation process In a JRC report142 a 25 reduction of solvent use was

reported in 2006 as a result of the introduction of the Safetainer

There are various substitutes for TCE and substitution has been taking place since the 1990s The

authorisation is today covering basically uses for which no alternative is yet available The

authorisation dossiers also show that in the case of TCE at least one third is continuing to invest

into research to find a suitable alternative in the coming years

At the time of writing of this report it was not possible to have actual exposure and emission data

post authorisation Measured and reported exposure data in the AfAs and announced additional

RMM lead to the expectation that a further reduction of exposure will be possible following the

sunset date The exact value of this improvement is hard to estimate The survey responses and the

interviews confirmed the statement that the majority of the benefits in the form of exposure

reduction were achieved before REACH

As in the case of Chromium Trioxide it seems evident that uncertainty from the legislative position

is a key driver for the companiesrsquo decisions with regards to authorisation The fact that even

today 15 months after the sunset date there is no final decision on some TCE AfA is creating a

huge delay increasing the uncertainty for the applicants In one way or the other this is influencing

decisions

A surprising element is that despite expected similarities in the market structure (supply chain)

between the surface cleaning and the surface plating industries there were less intensive

discussions on the role of the contract manufacturers using TCE It appears that in the case of TCE

downstream users have long been exposed to the question of alternatives and substitution despite

the estimated small size of the businesses Also the question of relocation as a form of substitution

of TCE was not mentioned at all This could also support the statement that most of the impacts

have happened prior to REACH and businesses have long adapted to the framework

142 Chemical product services in the European Union (January 2006)

(httpswwwgooglebeurlsa=tamprct=jampq=ampesrc=sampsource=webampcd=8ampved=0ahUKEwimpfm73oTXAhWCaFAKH

RPjDX8QFghfMAcampurl=ftp3A2F2Fftpjrces2Fpub2FEURdoc2Feur22213enpdfampusg=AOvVaw20-

2NiGi1nXDl9H7uYB6aH



12 TIER 1 CASE STUDY SUBSTANCE 3 DIBUTYL PHTHALATE

(DBP)

121 Introduction

Phthalates like Dibutyl Phthalate (in the following referred to as DBP) are the most commonly used

plasticizers in the world accounting for more than 80 of worldwide plasticizer production143 The

different phthalates provide flexibility to PVC as well as to other products and can be found in

almost anything including toys automobiles food packaging cleaning materials cosmetics

building materials medical devices clothing and household furnishings

One of the key reasons for the recommendation for inclusion for Annex XIV was that ECHA

concluded from the available information that DBP is supplied for uses and applications that must

be considered as wide dispersive in high volumes The registration dossier refers to the registered

volume tonnage for DBP in the range of 1000 to 10000 tons per year

As DBP only covers a narrow market there were only few responses in the online survey with

regards to that substance ndash of the 66 online survey responses five originated from applicants

downstream users or NGOs dealing with the substance (two were applicants or downstream users

two were usersnon-applicants one was an NGO) For the follow up interviews four stakeholders

for DBP were contacted

NGO (1)

Associations (0)

Applicantsdownstream users (3)



Table 121 Dibutyl Phthalate substance profile

Name Dibutyl Phthalate

EC no 201-557-4

CAS no 84-74-2

93952-11-5




Toxic for reproduction (Article 57c)

Exempted (categories of) uses

Uses in the immediate packaging of medicinal

products covered under Regulation (EC) No 7262004

Directive 200182EC andor Directive 20183EC


In 2016 another proposal was submitted to restrict four phthalates (DEHP BBP DBP DIBP) on articles containing the four phthalates for (i) indoor use and (ii) outdoor use if in contact with

143 wwwplasticizerorg



human skin or mucous membrane144 This proposal is still waiting for the final decision by the EU Commission Dibutyl Phthalate (DBP) does not occur naturally in the environment145 It is produced by the

reaction of phthalic anhydride with n-butanol in the presence of concentrated sulphuric acid as a

catalyst Excess alcohol is recovered and recycled and the di-n-butyl phthalate is purified by

vacuum distillation andor activated charcoal146

In the decision for the inclusion in Annex XIV it was concluded that due to available information it

seems possible to determine a toxicological threshold in accordance with Section 64 of Annex I

Therefore applicants intending to apply for authorisation for DBP would be able to demonstrate

adequate control of the exposure to this substance


DBP fulfils only two of the key criteria set for the selection of a Tier 1 case study substance


whole authorisation process ndash for DBP this was 21 August 2013


getting data ndash for DBP there were three applications for three applicants

There is a high number of used applied for ndash for DBP there were six uses and

There is diversity and complementarity of impact aspects ndash high volumes allocated to the

uses and widespread use in EU in numerous businesses with widespread applications

There is little information available to quantify the number of companies potentially affected A

background document for the recommendation for the inclusion of DBP in Annex XIV estimated that

50 to 100 companies EU wide could be affected147 It is also assumed that a large number of

companies (gt1000) is involved in further processing and formulation of DBP in the supply chain ldquoas

downstream users and users of preparations and articles containing DBP represent several different

industry sectorsrdquo148

144 ECHA Danish Environmental Protection Agency Annex XV Proposal for a Restriction for four Phthalates

5DEHP BBP DBP DIBP) 2016 145 EU Commission Scientific Committee on Occupational Exposure Limits SCOELREC143 Di-n-butyl phthalate

Recommendation from the SCOEL 2016 146 Chemical Substance Bureau The Netherlands 2003 Dibutyl Phthalate Risk Assessment 147 ECHA 2009 Background document for dibutyl phthalate (DBP) - Document developed in the context of

ECHArsquos first Recommendation for the inclusion of substances in Annex XIV 148 ECHA 2009 Dibutyl Phthalate - Prioritisation and Annex XIV background information




The REACH authorisation timeline for the substance is given in Table 122

Table 122 Dibutyl Phthalate REACH authorisation timeline


Date of inclusion to Candidate List 28102008




According to Article 57(c) DBP was identified as a substance of very high concern It is classified as

toxic for reproduction category 2 ECHA concluded that the volumes of DBP allocated to the uses

in the scope of authorisations were very high and could be considered wide dispersive

In 2014 Denmark submitted a proposal for DBP to be identified as a substance of very high concern

in accordance with Article 57(f) of Regulation (EC) 19072006 (REACH) as an endocrine disruptor

This means it has endocrine disrupting properties for which there is scientific evidence of probable

serious effects to human health and to the environment and this gives rise to an equivalent level

of concern to those of other substances listed in points (a) to (e) of Article 57 REACH Should this

proposal be accepted DBP would once again be included in Annex XIV on the basis of being an

endocrine disruptor


DBP was assessed under the pre-REACH Existing Substances Regulation (ESR) the risk assessment

report (RAR) was finalised in 2003 with The Netherlands as the rapporteur149 The report states a

clear decreasing trend in the production of DBP coming from 49000 in 1994 to 37000 in 1997 to

26000 tons per year in 1998 The RAR refers to three production sites in the EU that produced DBP

in quantities of more than 1000 tons per year in 1998 (two in Germany one in Italy) (Figure 121)

149 Chemical Substance Bureau The Netherlands 2003 Dibutyl Phthalate Risk Assessment



Figure 121 DBP production volumes

The background document to the Annex XIV report150 concludes that in 2007 of the approximately

10000 tons produced in the EU an estimated 2000 tons was exported the distribution of the

different uses is shown in Figure 122 Formulation and processing of DBP into preparations and into

polymer products by major users was estimated to take place at 50 to 100 sites in the EU

150150 ECHA 2009 Background document for dibutyl phthalate (DBP) - Document developed in the context of

ECHArsquos first Recommendation for the inclusion of substances in Annex XIV



Figure 122 DBP use distribution (1998 2007)

According to the report by COWI IOM and Entec151 the largest use of DBP in general is as a

plasticizer in resins and polymers such as polyvinyl chloride Plasticizers are materials incorporated

into a plastic in order to increase its workability and distendability In addition DBP is used in

printing inks adhesives sealantsgrouting agents nitrocellulose paints film coatings and glass

fibres

The Annex XV report of 2003 refers also to the following uses

Use as plasticizer (softener) in polymers industry

Use as softener in adhesives for paper and packaging wood building and automobile

industry

Use as softener in the printing inks for the pulp paper and board industry and

Other uses as softenersolvent (eg sealants nitrocellulose paints film coatings glass

fibres and cosmetics)

In addition it is mentioned that human population can be exposed to DBP not only at the

workplace but also from the use of consumer products and indirectly via the environment The

exposure via end products is not within the scope of the authorisation and therefore of no

relevance to this study

There are currently six registrations active with four inactive The total based on the tonnage band

is according to the ECHA website in the range of 1000 to 10000 tons per year DBP is included in

the actual trade statistics as part of the group ldquoDibutyl and dioctyl orthophthalatesrdquo (Prodcomm

20143410) which also includes di-isobutyl phthalate (DIBP) which is used in some applications as

151 COWI AS Entec UK Ltd 2009 ndash Data on Manufacture Import Export Uses and Releases of Dibutyl

Phthalate (DBP) as well as Information on Potential Alternatives to its Use



an alternative to DBP As stated in COWI and Entec (2009)152 no statistical data is available on the

distribution of the substances within this group


Formulation of DBP in compounds

Formulation in propellants


Industrial use of DBP for production of PVC articles

Industrial use as laboratory reagent analytics QC

Formulation and industrial use of DBP as a plasticizer

Laboratory use

Formulation and use in polymers

Use as a solvent

Use as an absorption solvent in a closed system in the manufacturer of maleic anhydride

(MA)

Use in ceramics


There is no statistical data available to identify changes in the market volumes of DBP According to

an industry source the production and sale of DBP remained stable during the period of 2009 to

2015 at a level of around 1000 tonnes per year Comparing this information with the last publicly

available data on the production level of DBP in the EU one can conclude that between 2007 and

20092010 a substantial decrease in the production of DBP occurred (from just below 10000 tonnes

to around 1000 tonnes per year) This leads to the conclusion that in the run-up to the inclusion of

DBP to the Candidate List in 2008 and the inclusion to Annex XIV in 2009 companies using DBP

either substituted DBP discontinued the use or relocated the relevant production capacities to

outside EU In none of the responses to the online survey or the interviews with stakeholders a

relocation of production facilities outside EU was mentioned

The ECPI mentions in their report153 that the total sales of LEW phthalates in the EU were slightly

lower than 200000 tons per year COWI IOM and Entec (2009) estimated that DBP represents less

than 1 of the EU manufacturing of phthalates Assuming this would provide an estimation for the

volume of DBP in the EU of below 2000 tonnes which is in line with the industry source mentioned

The volume applied for in the authorisation applications is around 700 tonnes which is considerably

less than the pre-authorisation volume Several uses of DBP have not been applied for and it is

estimated that either DBP was substituted prior to sunset date or the use was discontinued

An analysis of changes in the registration data through the authorisation milestones154 concluded

that for DBP at least one of the registered uses (use in polymers production of PVC article

reported by two registrants) does not seem to be covered by any application for authorisation The


Phthalate (DBP) as well as Information on Potential Alternatives to its Use 153 European Council for Plasticisers and Intermediates 2011

httpwwwplasticseuropeorgdocumentsdocument20110422155920-vinyl2010__progress_report_2011pdf 154 ECHA Changes in the registration data through authorisation milestones TCE DBP CrO3 Status as of 10

April 2017 p20



same applies to the professional use as a metal working fluid reported by one registrant When

checking whether any of the uses which were applied for included any uses previously not

registered (or not reported as per Article 38 of REACH) the same report concluded the following

ldquoall uses applied for appear to fall under the generic scope of the registered uses the names of

which were however not specified further after sunset date The comparison relies solely on the

use names and therefore is not conclusiverdquo In total for DBP there are two registrants less today

compared to the pre-authorisation period

127 Substitution

The substantial decline in the production and consumption of DBP over the last two decades means

that there have been alternatives available for the substitution of DBP The EU Phthalates Directive

200584EC1 from 16 January 2007 which bans DEHP DBP and BBP for use in PVC and other

plasticised materials in all toys and childcare articles could be regarded as an accelerator for the

shift to substitute DBP

The alternatives to the use of DBP in various technical applications have been well documented in

several reports The 2009 report of COWI IOM and Entec155 covers a wide range of alternative

substances for the various technical applications of DBP such as

DINCH (Di-(isononyl)-cyclohexan-12-dicarbooxylate) DINCH has been designed as an

alternative to phthalate plasticisers As an alternative for DBP DINCH could be applied in

thermoplastics polar rubbers coatings and printing inks

Other alternative substances for non-PVC applications 21 alternatives to phthalates (not only

DBP) were identified by COWI in a report in 2000 which provided results in the form of a

substitution matrix with references to different applications

Alternative techniques For some polymer application the polymer with DBP may be replaced

by a totally different material this might be relevant for DBP especially for the use in flooring

A report commissioned by ECHA in 2011 on the costs of abatement for a range of hazardous

substances also covers four phthalates including DBP156 The study was intended to improve the

capability in assessing the costs of reducing the use emissions or exposure of hazardous

substances While the study also documents experience in the substitution of DBP by main

alternatives and product group the report concludes that ldquoalternatives are available for all

applications and it has not been possible to identify applications for which the substitution is

particularly difficultrdquo

An online research delivered two tools that businesses looking for alternatives for a substitution of

DBP could use

The substitution portal SUBSPORT (as described under Section 1073) The portal also describes

nine case studies in which DBP has been successfully substituted for different applications and

The Lowell Centre for Sustainable Production in Massachusetts published a brochure (technical

briefing) with the title

For two uses in the applications for authorisation two substitution plans have been submitted

Looking at the results from the online survey only one applicant andor downstream user had

155 COWI AS IOM Entec UK Ltd 2009 ndash Data on Manufacture Import Export Uses and Releases of Dibutyl

Phthalate (DBP) as well as Information on Potential Alternatives to its Use 156 ECHA 2011 Estimating the abatement costs of hazardous chemicals p 61



substituted DBP successfully or intended to substitute The other respondents did not respond to

this question

In one of the follow up interviews a stakeholder mentioned that sufficient alternatives would allow

users to switch to an alternative However some uses for which no suitable alternative is yet

available would remain and hence DBP continues to be the best suitable substance


There is little publicly available information to assess in detail for which alternatives DBP has been

substituted The European Council for Plasticisers and Intermediates (ECPI) stated in their 2011

annual report that ldquoAs a result of the EU risk assessments and the REACH regulation and thanks to

the constant efforts of the plasticiser industry to adapt to both regulatory and market demand

the use of plasticisers in Europe has evolved in a progressive shift from Low (DEHP BBP DBP

DIBP) to High (DINP DIDP DPHP) Molecular Weight phthalates and ndash to a smaller extent ndash to some

other plasticisersrdquo157 They state that the sales of phthalates like DBP in the EU has decreased

sharply in the period between 2001 and 2009 compensated by an increase in other (HMW)

phthalates

The ECPI also mentions in their report that the total sales of LEW phthalates in the EU were slightly

lower than 200000 tonnes per year (Figure 123) COWI IOM and Entec (2009) estimated that DBP

represents less than 1 of the EU manufacturing of phthalates This provides an estimation for the

volume of DBP in the EU of below 2000 tonnes which is in line with the industry source

mentioned

Figure 123 Percentage of phthalate sales in EU compared to total plasticisers

157 European Council for Plasticisers and Intermediates 2011

httpwwwplasticseuropeorgdocumentsdocument20110422155920-vinyl2010__progress_report_2011pdf

p 25




DBP is considered a threshold substance in 2013 RAC established a reference DNEL for DBP for

inhalation of workers at 013 mgm3 and for dermal exposure at 019 mgkgday158 The existing

OEL values across Europe show a considerable variance between a minimum level of 058 mgm3 for

workers inhalation in Germany and a maximum level of 5 mgm3 in several countries (Austria

Belgium France Ireland Poland Spain and the UK) (Table 123) In 2016 SCOEL made another

proposal for an OEL for DBP for inhalation 058 mgm3

Table 123 Existing OELs for Dibutyl Phthalate for inhalation (adapted from the GESTIS database159)

EU-country Limit value ndash Eight hours Limit value ndash Short term

ppm mgm3 ppm mgm3

Austria 5

Belgium 5

Denmark 3 6

France 5

Germany (AGS) 005(1) 058(1) 01(1)(2) 116(1)(2)

Germany (DFG) 005(1) 058(2) 01(1)(2) 116(1)(2)

Ireland 5 10(2)

Latvia 05

Poland 5 10

Spain 5

Sweden 3 5(3)

United Kingdom 5 10

Notes (1) Inhalable aerosol and vapour (2) 15 minutes reference period and (3) 15 minutes average value

Only one example could be identified where a Member State Authority carried out a measurement

campaign to assess the level of occupational exposure (Table 124) While these results are not

representative and should not be compared like-for-like they serve as indicators to highlight the

trend in the reduction of occupational exposure levels over the years

Table 124 Historical measurement campaign for DBP reported from EU countries inhalation

EU-

country Trade sector Application Values companies

90

value

mgm3

Refere

nce

Germany

Extrusion injection moulding

reaction foam moulding

22

14

(2)

(1)

Plastic welding hot air

welding

13

6

003

Surface coating (spray

coating bonding venting dip

coating)

21

11

057

Notes (1) BGAA Report 199 Altstoffe ndash Expositionen am Arbeitsplatz Hauptverband der gewerblichen

Berufsgenossenschaften (2) Values are below detection limit

158 ECHA 2013 RAC24201309_rev 2 ndash Authorisation ndash establishing reference DNELs for DBP 159 GESTIS 2017 httplimitvalueifadguvde



Improvements in RMM were mentioned in 33 of the public versions of the AfAs for DBP This is

comparable to all AfA submitted (36 mentioning improved RMM in the context of the dossier) In

the case of DBP in two applications the applicants clearly mention additional RMMs that were

implemented as a result of the authorisation process and led to an improvement in exposure (Deza

Sasol-Huntsman) The same comment as made before is also valid here Based on the observations

of ECHA the actual number of cases where RMM were improved in the course of the AfA could be

significantly higher

An analysis of the submitted AfAs shows that in all applications the exposure data was modelled

The ranges shown in Table 124 refer to the highest exposure value found per application in the

different workers contributing scenarios which means the data represents the worst-case exposure

information In one application the value of the dermal exposure of one worker contributing

scenario was outside the maximum range of the table

Looking at the threshold for inhalation for DBP of 013 mgm3 all applications could demonstrate

adequate control for dermal exposure with a threshold for DBP of 019 mgkgday in some

applications the maximum exposure values bordered at the threshold (Table 125)

Table 125 Overview of occupational exposures results from the submitted AfAs for DBP expressed as ranges

Inhalation Dermal

Measured data Modelled data (1) Measured data(1) Modelled data


lt001 001 ndash

005

005-

01 lt001

001 ndash

005

005-

01 lt001

001 ndash

005

005-

02 lt001

001 ndash

005 005-02

2 4 3 2

Note (1) No measured data for inhalation or dermal exposure was identified in the submitted AfAs

One survey participant stated in the online survey that due to implemented RMM less workers were

exposed to the DBP but also less DBP was consumed The follow up interviews did not deliver any

additional information on the topic of improvement by RMMs

The case of the application of Sasol-Huntsman demonstrates the positive effects that can be

achieved due to the authorisation In 2011 the applicant contracted a third party (IPA160) to carry

out a screening study on the workplace exposures This not only confirmed that the exposure levels

were safe but also identified further improvement opportunities In addition a benchmarking

exercise was carried out in the course of the preparation of the AfA amongst German and US plants

This revealed several ldquobest practicesrdquo procedural and capital improvement opportunities such as

PPE specifications and replacement protocols

Maintenance of DBP containing equipment

Sampling frequency

Closed loop sampling systems

Closed back-flushing filters

Additional biomonitoring in 2012 showed that compared to 2011 worker exposure was more than

half According to Sasol-Huntsman the investment into the improvement measures was still more

160 IPA Institut fuer Praevention und Arbeitsmedizin der Deutschen Gesetzlichen Unfallversicherung



cost effective than a conversion of the whole installation to an alternative to DBP In that sense

REACH could claim some credit for the improvements

Based on limited data it could be concluded that in the case of DBP the authorisation was the

direct cause of improvements in RMM with a reduction of the exposure as a result


Two applicants Deza and Sasol-Huntsman closely cooperated during the preparation of their AfAs

This is particularly of interest as Deza is the supplier of DBP to Sasol-Huntsman Sasol-Huntsman as

a downstream user would be covered by Dezarsquos successful application but still decided to submit

its own application This was partly done to be more independent of its supplier but also as a

contingency in case Deza decided to cease production of DBP

None of the survey respondents using DBP referred to any impacts on their competitive position due

to the authorisation process Also in the interviews no further insight could be obtained During

the follow up interviews a stakeholder only mentioned generic impacts eg the re-allocation of

RampD resources away from innovation research to find alternatives would expectedly have a

negative effect in the medium term


A search on the internet on projects and new patents to substitute DBP did not deliver any results

There are patents pending using DBP but all of the patent applications are outside EU

During the online survey of the four participants using DBP none responded that the authorisation

had an impact on their organisationsrsquo spending on innovationinvestment opportunities andor

RampD


No further information could be obtained with regards to the experience of SMEs in the

authorisation process for DBP through the online survey or the stakeholder interviews


Looking at all influencing factors for the case of DBP two main impacts could be identified

Availability of alternatives for substitution and Benefits in the form of exposure reduction

As with the two other substances that are assessed as Tier 1 case studies a lot of work has also

been done for DBP in the pre-REACH period This is clearly visible in the substantial reduction of

the EU market volumes for DBP from around 50000 tons per year in 1994 to around 1000 tons per

year in 2015

The main driver for this reduction was regulatory measures The ban of DBP in PVC and other

plasticized materials in all toys and childcare articles led to a decrease of the use of DBP Where

possible businesses have substituted DBP and consequently the authorisations cover only uses for

which no alternative is (yet) available Where alternatives are available and the changeover does



not lead to a substantial increase in costs it is logical to decide not to follow the authorisation

route

Comparing the available measurement results from 1999 with the SCOEL proposal for an OEL in

2016 shows that some companies had low exposure levels already at the end of the last century

even though this is of course not representative The application from Sasol-Huntsman however

also proves that if authorisation is accepted as an opportunity to change for the better (meaning

to improve working conditions and reduce occupational exposure) substantial improvement still can

be achieved The question remains whether improvements and optimised exposure results could not

have been achieved by setting the ldquorightrdquo exposure limits



13 SUMMARY AND CONCLUSIONS


investigation



















as an intermediate








































report
































completed


























applications











aggregate level








































aggregate level

























(within Section 73)















































enforcement








authorities
















suppliers)










products










process




required



REFERENCES

Note na stands for ldquonot availablerdquo and is used in this reference list in cases in which no date of

publication is available

Airbus Airlines for Europe Boeing and GE Aviation (2017) The Aerospace Industry Support Paper

on REACH REFIT 2017 Position Paper for REACH REFIT Evaluation January 2017

Available here httpseceuropaeugrowthsectorschemicalsreachreview_en

AmCham EU (2016) A private sector view on REACH and competitiveness - 2017 REFIT evaluation

key to addressing outstanding obstacles Position Paper for REACH REFIT Evaluation November

2016 Available here httpseceuropaeugrowthsectorschemicalsreachreview_en

American Chemistry Council (2017) ACC Input for EU REACH REFIT Position Paper for REACH

REFIT Evaluation January 2017


ASD-Eurospace (2017) Space sector contribution to the EC REACH Review 2017 ndash Position paper

Position paper for REACH REFIT Evaluation January 2017


Austrian Federal Economic Chamber ndash WKO (2016) REACH REFIT Review 2016 Position Paper for

REACH REFIT Evaluation December 2016


Austrian Federal Ministry of Agriculture Forestry Environment and Water Management (2015)

REACH - Evaluation of the impact on the affected industries and the whole economy in Austria

Final Report of the study March 2015 Vienna Denkstatt Institute for Industrial Research amp Vienna

University of Technology ndash Center of Public Finance and Infrastructure Policy

Backes D (2017) Monitoring of the authorisation process under the REACH regulation Test of a

proposed methodology Final Report May 2017 Vienna Austrian Federal Ministry of Agriculture

Forestry Environment and Water Management

BDSV (2017) BDSV input to public consultation on REACH Review 2017 Position Paper for REACH



BusinessEurope (2017) REACH Review Better implementation is needed not a revision Position

Paper for REACH REFIT Evaluation January 2017


CEFIC-The European Chemical Industry Council (2014) Evolution of competitiveness in the

European chemical industry Historical trends ands and future prospects Brussels Oxford

Economics Available here httpwwwceficorgDocumentsRESOURCESReports-and-

BrochureOxford-Study-2014pdf

CEFIC-The European Chemical Industry Council (2016a) Facts amp Figures 2016 of the European

chemical industry (xls format) Brussels cefic Available here httpwwwceficorgFacts-and-

Figures



CEFIC-The European Chemical Industry Council (2016b) Facts amp Figures 2016 of the European

chemical industry Brussels cefic Available here httpwwwceficorgFacts-and-Figures

Chemical Industries Association (2017) REACH REFIT Evaluation (REACH Review 2017) stakeholder

consultation ndash CIA Response Position Paper for REACH REFIT Evaluation January 2017


Chemical Industry Federation of Finland ndash CIFF (2017) CIFF submission ndash REACH REVIEW 2017

Position Paper for REACH REFIT Evaluation


Cii ndash Cross-Industry Initiative for better regulation in chemicals management (2016) Synergies

between REACH and workplace legislation Improved analysis of alternatives and substitution

Position Paper for REACH REFIT Evaluation November 2016


Comiteacute Franceacuteclat (2017) Contribution agrave la consultation publique relative

agrave leacutevaluation du regraveglement REACH Position Paper for REACH REFIT Evaluation January 2017


ECSIP (2016) Impacts of REACH and corresponding legislation governing the conditions for

marketing and use of chemicals in different countriesregions on international competitiveness of

EU industry Draft Final Report (1st draft) February 2016

Available at httpscircabceuropaeuwebdavCircaBCenvcaracalLibrary0120-

20CARACALCARACAL-2020(0820-200920March202016)2520-20CA_14_201620-

20Draft20final20report20REACH20studypdf

EFPIA Vaccines Europe IFAH Europe PPTA IPFA and EBE (na) Statement for Part IV Public

Consultation in relation to the REACH REFIT evaluation Position Paper for REACH Refit Evaluation


EuropaBio (2017) EuropaBio Statement for Part IV of the Public Consultation in relation to the

REACH REFIT (2017) evaluation Position Paper for REACH REFIT Evaluation January 2017


European Commission (EC) (2003) Commission Staff Working Paper Regulation of the European

Parliament and of the Council concerning the Registration Evaluation Authorisation and

Restrictions of Chemicals (REACH) establishing a European Chemicals Agency and amending

Directive 199945EC and Regulation (EC) on Persistent Organic Pollutants Extended Impact

Assessment Brussels European Commission

European Commission (EC) (2006) REGULATION (EC) No 19072006 OF THE EUROPEAN PARLIAMENT

AND OF THE COUNCIL of 18 December 2006 concerning the Registration Evaluation Authorisation

and Restriction of Chemicals (REACH) establishing a European Chemicals Agency amending

Directive 199945EC and repealing Council Regulation (EEC) No 79393 and Commission

Regulation (EC) No 148894 as well as Council Directive 76769EEC and Commission Directives

91155EEC 9367EEC 93105EC and 200021EC Available here httpeur-

lexeuropaeulegal-contentENTXTPDFuri=CELEX32006R1907ampfrom=EN

European Commission (EC) (2008) COMMISSION REGULATION (EC) No 3402008 of April 2008 on

the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No

19072006 of the European Parliament and of the Council on the Registration Evaluation



Authorisation and Restriction of Chemicals (REACH) Available here httpeur-

lexeuropaeuLexUriServLexUriServdouri=OJL200810700060025enPDF

European Commission (EC) (2013a) COMMISSION IMPLEMENTING REGULATION (EU) No 2542013 of

March 2013 amending Regulation (EC) No 3402008 on the fees and charges payable to the

European Chemicals Agency pursuant to Regulation (EC) No 19072006 of the European Parliament

and of the Council on the Registration Evaluation Authorisation and Restriction of Chemicals

(REACH) Available here

httpeur-lexeuropaeuLexUriServLexUriServdouri=OJL201307900070018ENPDF

European Commission (EC) (2013b) COMMISSION STAFF WORKING DOCUMENT - General Report on

REACH accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN

PARLIAMENT THE COUNCIL THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE

COMMITTEE OF THE REGIONS in accordance with Article 117(4) REACH and Article 46(2) CLP and a

review of certain elements of REACH in line with Articles 75(2) 138(3) and 138(6) of REACH

Available here

httpeur-lexeuropaeulegal-contentENTXTPDFuri=CELEX52013SC0025ampfrom=EN

European Commission (2013c) Interpretation of the WSSD 2020 Chemicals Goal and an Assessment

of EU Efforts to meet the WSSD Commitment Final Report June 2013 Luxembourg Office for

Official Publications of the European Communities Available here

httpspublicationseuropaeuenpublication-detail-publicatione636b772-1164-4a91-b024-

069000bf5626

European Commission (EC) (2015) Monitoring the Impacts of REACH on Innovation

Competitiveness and SMEs Luxembourg Publications Office of the European Union Available here

httpeceuropaeuDocsRoomdocuments14581attachments1translationsenrenditionsnati

ve

European Commission (EC) (2016a) Cumulative Cost Assessment for the EU Chemical Industry

Brussels European Commission

European Commission (EC) (2016b) Study on the Calculation of the Benefits of Chemicals

Legislation on Human Health and the Environment Development of a System of Indicators Final

Report Luxembourg Publications Office of the European Union Available here

httpspublicationseuropaeuenpublication-detail-publication3dcb5c7a-1029-11e6-ba9a-

01aa75ed71a1

European Defence Agency (EDA) (2016) Study on the impact of RAECH and CLP European chemical

regulations on the defence sector Final report 16 December 2016 Brussels Espoo REACHLaw

Ltd Available here httpswwwedaeuropaeudocsdefault-sourcedocumentseda-reach-

study-final-report-2016-december-16-ppdf

European Environmental Bureau (na) EEB Comments to the REACH REFIT public consultation



Eurostat (2017) Industry by employment size class (NACE Rev 2 B-E) Available here

httpappssoeurostateceuropaeunuishowdodataset=sbs_sc_ind_r2amplang=en



French Federation of Mechanical Engineering Industries (2017) FIM Position paper Public

consultation of the European Commission ndash REACH REFIT Evaluation Position Paper for REACH



Harrikari A and R Montonen (2017) How the REACH authorisation process affects and benefits


Heitmann K and A Reihlen (2007) Case study on ldquoAnnouncement effectrdquo in the market related

to the candidate list of substances subject to authorisation Final Report January 2007 Hamburg

Oumlkopol GmbH

Hennig P (2016) Socio-economic benefits and risks of the use of carcinogenic substances subject

to authorisation under REACH Zeitschrift fuumlr Umweltpolitik amp Umweltrecht 02-03 149-168

Lietzmann J Oulegraves L Pelsy F Fries-Tersch E And T Tugran (2017) Analysis of the results of

the open public and SME consultation of the REACH REFIT evaluation Draft final report on the

OPEN Public consultation March 2017 Brussels Milieu Ltd

MedTech Europe (2017) Public Consultation in relation to the REACH REFIT evaluation Position



Netherlands (na) REACH evaluation attention points from the Netherlands Position Paper for

REACH REFIT Evaluation


ORGALIME ndash the European Engineering Industries Association (2017) ORGALIME response and

position paper ndash Public consultation REACH REFIT evaluation Position Paper for REACH REFIT

Evaluation January 2017


Reihlen A and H Luumlskow (2007) Analysis of studies discussing benefits of REACH Report for the

European Commission February 2007 Available here

httpeceuropaeuenvironmentchemicalsreachpdfbackgroundreach_benefit_studiespdf

RPA (2016) Industry and Consultancy Representatives Survey Results ndash Extract from ongoing work

for the DG Environmentrsquos study into ldquothe strategy for a non-toxic environment of the 7th

Environment Action Programme (EAP)rdquo

Swedish Chemicals Agency (2017) Additional comments relevant to the public consultation on the

REACH refit evaluation Position Paper for REACH REFIT Evaluation January 2017 Available here

httpseceuropaeugrowthsectorschemicalsreachreview_en

Technology Industries of Finland (2017) Technology Industries of Finland Position paper on Public

Consultation REACH REFIT Position Paper for REACH REFIT Evaluation January 2017


The Association of German Chambers of Commerce and Industry - DIHK (2017) Stellungnahme zur

oumlffentlichen Konsultation zu REACH REFIT 2017 Position Paper for REACH REFIT Evaluation

January 2017




Tickner J and M Jacobs (2016) Improving the Identification Evaluation Adoption and

Development of Safer Alternatives Needs and Opportunities to Enhance Substitution Efforts

within the Context of REACH Report for the European Chemicals Agency (ECHA) Available here

httpsechaeuropaeudocuments1016213630substitution_capacity_lcsp_enpdf2b7489e1-

6d96-4f65-8467-72974b032d7b

UEAPME - The European Association of Craft Small and Medium-Sized Enterprises (2017)

UEAPMErsquos main views on the REACH REFIT Review 2016 Position Paper for REACH REFIT Evaluation

January 2017




ANNEX A STEERING GROUP COMMITTEE

Steering Group Member Organisation

Valentina Bertato European Commission

Anna Borras European Commission

Sanna Henrichson ECHA

Patricia Hualde European Commission

Mark Pirrung European Commission

Katarina Pirselova European Commission

Pavel Prokes European Commission

Annette Schaefer European Commission



ANNEX B METHODOLOGY

This section supports Section 2 of the main report This Annex is broken down into two

subsections setting out

Section B1 The scope and boundaries of the project and

Section B2 The approach to assessing impacts

B1 Project scope

Some important aspects concerning the scope of the project were agreed with the Commission

during and following the kick off meeting

Coverage ndash The study will only cover the impacts of REACH authorisation The impacts of

other aspects of REACH such as registration and restrictions are considered outside the

scope of this study This study would cover all the authorisation decisions and ECHA

Committee (RACSEAC) opinions to date (and their respective review periods) since REACH

came into force in 2007 until the end of 2016 as well as some of those currently along the

REACH authorisation process (eg from candidate listing to those recently submitted in

the May submission window)

Forecasting the potential costs and benefits of REACH authorisation for SVHC substances

that may appear on the candidate list between 2017 and 2020 (ie as part of goal of the

2020 roadmap) are outside the scope of this work given the scale of uncertainty

associated with such an assessment

Time period for impacts ndash Costs and benefits will be presented in annual terms where

possible

Geographical boundary ndash The focus is on the impacts of REACH within the European

Economic Area (EEA) with impacts outside of the EEA noted Any potential relocation

outside of the EEA as a result of REACH Authorisation is captured within this study through

changes in risks employment and value added (eg profits from sales of products) within

the EEA

Targeted consultation ndash The online surveys are to be sent to pre-identified stakeholders

rather than an open invitation which would be used if this was a formal public

consultation A rationale for this is that there a number of REACH related surveys being

carried out and the EC is keen to minimise survey fatigue amongst stakeholders It is also

believed that a more targeted consultation of stakeholders is required to get more

quantitative information

Tiered approach to case studies agreed ndash Following clarification there was general

agreement on the idea of three Tier 1 substance specific case studies assessing all

relevant aspects of this study in depth for the selected substances and five Tier 2 case

studies covering specific issues in more detail (ie not focusing on a particular

substance) Further details on these case studies can be found in Section 0



Make use of existing information where possible ndash It is important that this study utilises

information already obtained Relevant information gathered from these existing studies

are summarised within later chapters under the heading lsquoliterature reviewrsquo

Report focus ndash The final report will encompass all the findings of this study and will set

out results based on the five areas the study is seeking particular information on (i) cost

of authorisation (ii) benefits of authorisation (iii) changes in the market structure (iv)

substitution and (v) affordability of authorisation for SMEs

B2 Assessment approach

This subsection sets out further details on how impacts due to REACH authorisation process were

(i) identified (ii) screened and (iii) will be assessed (as part of Task 3) as well as details on the

(iv) Tier 1 and 2 case studies

Section B21 ndash Identification of impacts

Section B22 ndash Screening of impacts

Section B23 ndash Assessing impacts

Section B24 ndash Tier 1 and 2 case studies

B21 Identification of impacts

In order to help identify a variety of possible impacts associated with the authorisation process

there was a need to identify activities carried out along the authorisation process by different

actors To help do this we started off with a simple lsquointervention logicrsquo setting out

The need for authorisation

The objectives of authorisation

A list of actions carried out along the authorisation process

The outputs of these actions

Their impacts and the outcomes

The types of actor considered were either those that carry out the activity identified or those

actors most affected by it and included

Consumers - Consumers are referred to as people who buy end-use products currently made

with an SVHC They can be impacted in terms of price quality and availability of the

products made with an SVHC

General population - The general population refers to those that might be affected by

releases of the SVHC into the environment (eg fugitive emissions) and not necessary

related to consumer exposure of the end-product

Industry - Annex XIV substance supply chain ndash These are companies who may be affected

due to the use of an SVHC at some stage along the supply chain

Industry - alternatives supply chain - These are companies who make similar end-user

products with the use of an SVHC (currently) subject to an authorisation who may

indirectly benefit depending on the outcome of the authorisation process



NGO ndash These are non-governmental organisations that may have an interest in commenting

at various public consultations for SVHCs as they move along the authorisation process as

well as on individual applications for authorisation (AfAs)

Regulatory authorities ndash Member States incur administrative regulatory and enforcement

costs (and savings) as SVHCs move along the authorisation process

Workers ndash These refers to workers from companies that use an SVHC or with alternatives

The simple (high level and non-exhaustive) lsquointervention logicrsquo is shown in Table B01 The needs

and objectives listed are those most applicable to authorisation and exclude other REACH

objectives and needs identified for the REACH evaluation (like avoiding unnecessary testing on

animals) which deviate from the focus of this study

Table B01 REACH Authorisation intervention logic (non-exhaustive high-level list)

Intervention

stage Details

Needs Speed up the risk management of chemicals prioritise regulation of SVHCs (eg through their inclusion on Annex XIV) in light of limited public-sector resources available

Objectives Identify what known substances are deemed relevant for authorisation (eg meet the criteria set out in Article 57(a)-(f))

Promote the progressive replacement of SVHCs to safer alternatives where those are technically and economically available

Provide a forum (ie public consultations) for the identification and sharing of information on the suitability of alternatives for SVHCs

Ensure risks are minimised or impose further Risk Management Measures (RMM) conditions on the continued use of a substance after the sunset date where authorisation has been granted

Ensure the good functioning of the internal market

Actions

(inputs)

The authorisation process enables a shift in the burden of proof (in line with the polluter pays principle) for the continued use of SVHCs from public authorities to industry that also have a better understanding and access of data on the risks and benefits of continued use

Screen substances and RMOAs o Screen REACHCLP databases (using also external data sources) to identify

substance of potential concern (MS CA and ECHA) o Carry out a RMOA to identify substances that are appropriate for

authorisation (MS CA or ECHA) o Declare intention to prepare an Annex XV dossier (Registry of Intention) o Prepare an Annex XV dossier for SVHCs (MS or ECHA)

Inclusion of substances in the Candidate List o Propose substances for inclusion on the candidate list (MS CA or ECHA +

interested party consultation)

Inclusion of substances in the Authorisation List o Prioritise those for inclusion on Annex XIV with sunset dates uses of the

substance which would be exempt from authorisation and latest application date (LAD) (Recommendations by ECHA + interested party consultation)

Compliance strategy (at each stage in the authorisation process) o Compliance with authorisation (MI and DUs of the SVHC) o Compliance with the sunset date (by DUs) switch to an alternative

relocate production outside the EEA cease production or apply for authorisation



Intervention

stage Details

Substitution of SVHC by a downstream user o Carry out research and engage with supply chain on identify possible

alternatives to the SVHC(s) being used o Assess alternatives to determine if any are feasible (ie technically

economically lead to a reduction in overall risks and is available in sufficient supply)

o Develop plan to switch to a feasible or potentially feasible alternative in the future (if applicable)

Applications for authorisation o Identify if it is possible to derive a no effect level (DNEL) for the substance

(ie threshold level) listed on the authorisation list (RAC) o Derive a dose response relationship for non-threshold substances (RAC) o Pre-Submission Information Session (PSIS) - (ECHA + applicants) o Submission of AfAs (applicants) o Publication (ECHA) o Information on alternatives (third parties) o Trialogue (if relevant ndash ECHA third party + Applicant) o Conformity check (ECHA) o Draft opinion of the Risk Assessment Committee (RAC) and Socio-Economic

Analysis Committee (SEAC) o Final opinion of RAC and SEAC o Final decision by the EC (+ REACH Committee)

Post authorisation decision o Obligation to update registration dossier in light of authorisation outcome

(eg registrants CSR) o Downstream User notification o Enforcement by National Enforcement Authorities

Non-compliance ceasing use of a substance post sunset date Compliance with conditions of use set out in the AfA as well as

any conditions or monitoring arrangements specified in the authorisation

Post Review period o Reapply for authorisation (ie submit a review report) or substitutecease

productionrelocation (applicant) If the applicant reapplies then Pre-Submission Information Session (PSIS) - (ECHA + applicants) Publication (ECHA) Information on alternatives (third parties) Trialogue (if relevant ndash ECHA third party + Applicant) Conformity check Draft opinion of RAC and SEAC Final opinion of RAC and SEAC Final opinion of EC (+ REACH Committee)

Outputs Number of RMOAs where authorisation is deemed the most appropriate RMO

Number of Annex XV dossiers submitted

Number of substances on the candidate list

Number of uses exempt that would have required authorisation

Number of substances on the authorisation list

Number of uses for which substitution of SVHC has been successfully achieved (and therefore AfA avoided)

Number of cases where authorisation lead to an improvement in RMMs

Number of substances with an up to date extended safety data sheet (eSDS)

Number of AfAs

Granting or refusal of an authorisation (may include conditions attached if granted)

Number of substances where registration dossiers are up to date following



Intervention

stage Details

submission of AfAs (eg updated exposure scenarios)

Number of draft and final opinions from RAC and SEAC

Number of final authorisation decisions from the EC (based on a draft decision to REACH committee to make final decision)

Enforcement controls of sunset date for non-authorised uses of the substance

Enforcement controls of RMMs set out in AfA exposure scenarios

Enforcement controls of any conditions attached to authorisations

Review reports (and no further applications) following review period

Outcomes Improved knowledge of known uses of the substance

Improved knowledge on the suitability of alternatives for specific uses

Improved supply chain communications

Substitution from the SVHC where ldquosuitablerdquo alternatives exist

Minimisation of emissions (where use is authorised) or conditions within the AfAauthorisation for further risk reduction

Improved knowledge on the societal benefits of continued use of SVHCS for specific uses

RampD plans where no suitable alternative currently exist

Time limited authorisations with review periods

Increased demand for safer alternatives

Possible uncertainty in legal status of some substances

Impacts (in

the context

of this

study)

Costs to EU based MI of the Annex XIV substance ndash AfA sharing information lost profit employment

Costs to Downstream Users (DUs) of the Annex XIV substances ndash transition to alternatives relocation ceasing production AfA cost

Benefits to EU based Manufacturer Importer (MI) of alternative substances ndash increased profit employment

Benefits to EU DUs of an alternative who competes with products made with Annex XIV substance

Costs to Member States such as from enforcement submission of RMOAs Annex XV dossiers and meetings concerning submitted AfAs and policy discussions on possible changes to the process

Costs to Member State Committee (MSC) involved in Candidate List inclusion and in Annex XIV recommendation processes

Costs to ECHA Secretariat such as to process and publish information on substances throughout the process submission of RMOAs Annex XV dossiers Annex XIV recommendation PSIS meetings processing AfAs

Costs to the RAC and SEAC ndash Derived No Effect Level (DNEL) dose response documentation opinion-development meetings and supporting guidance

Costs to EC ndash Decision on Annex XIV inclusion authorisation decisions requests to ECHA observing on applications (eg trialogues) changes to authorisation process and authorisation reviews

Costs to third parties to submit information during public consultations related to any part of the authorisation process

Changes in the market structure ndash Number of companies level of competition competitiveness employment trade balance RampD spending innovation and resilience of companies

Impact on business decisions like investment production RampD innovation and spending on risk management

Impacts to workers (eg reduction in risks from improvements through RMMs substitution and change in risks associated with use of alternative)

Impacts to consumers (eg reduction in exposure of SVHCs in products change in the price quality and availability of products)



Intervention

stage Details

Impacts to general population (eg reduction in releases from exposure of chemicals around production sites due to substitution or improvements in RMMs and change in risks associated with production and use of alternatives)

Impact to the environment (eg changes in releases of SVHCs to air wastewater waste and releases to the environment from use of alternatives)

Note - Impacts noted in this study are consistent with the lsquotypes of impactsrsquo to be assessed within this study It is

however noted that this is not consistent with the Better Regulation guidelines where costs would have been mentioned in

the inputs part of the table

The next step was to expand this list to identify a more precise list of activities This resulted in

150 activities carried out along the authorisation process This is set out in Annex D which also

shows

At what stage in the authorisation process each activity occurs

Which actor carries out each activity (eg EC ECHA MS CA Applicant NGO MI third

party and MI or DU of an alternative product)

The associated impact (eg administrative cost reduction in risks change in competition)

The data needed to assess that impact

Who is likely to have that data and

Which consultation tool is best to gather the information needed

B22 Screening of impacts

The total number of activities was then screened down from 150 to 96 The justification for

excluding some activities is listed below in Table B02 Annex D shows which exact activities were

screened out

Table B02 Total number of activities excluded with justification

Exclusion criteria Justification for excluding activities

Number of

activities

excluded

No refused

authorisation

applications yet

Some activities have not occurred yet as there are no rejected

AfAs 5

Only possible to

generate

anecdotal

responses that

already exist

Some activities and associated impacts are unlikely to be

accurately quantified beyond anecdotal evidence so we have

proposed to rule these out (eg improvements in supply chain

communication) Note that these aspects may be indirectly

assessed later using ldquonewrdquo information gathered or through

aspects that can be monitored (eg instances where industry

wide voluntary agreementsactions were noted and then

carried out)

5

This aspect is

deemed out of the

scope of the

project

(RMOA stage only)

A few activities carried out at RMOA are not being considered

for this project as they are deemed not significant especially

because assessing the functioning of the RMOA process is not

the main objective of this study

3




Number of

activities

excluded

Too early to assess

this aspect of

authorisation

Some activities have not occurred yet such as there are no

reapplications following the review period 17

Unlikely to be able

to obtain sufficient

quantitative data

required to assess

this

This relates to aspects such as changes in prices and quality of

consumer products from switching to alternatives and certain

impacts to the general population associated with use of

alternatives ndash It is deemed better therefore to focus on aspects

we can get quantitative data for Note the study may still

obtain information indirectly on these issues which will be

reported

19

Voluntary activity

that should not be

included within

the assessment

These include spending on lobbying (both by industry and

NGOs) should not be included within the assessment (however

time spent on public consultations is valid and included in the

assessment)

5

Grand Total 54

As a result of the screening it was justified for this study to exclude

1 Impacts associated with stage 6 Review AfAs following review period and

2 Impacts associated with consumers of the final products

However there is still good coverage of the whole authorisation process as shown in Table B03 Table B03 Number of activities carried out along the authorisation process that are assessed in this study

Type of actor

Stages along the authorisation process

1

Scre

enin

g o

f

subst

ances

and R

MO

As

2

Inclu

sion o

f

subst

ances

in t

he

Candid

ate

Lis

t

3

Inclu

sion o

f

subst

ances

in t

he

Auth

ori

sati

on L

ist

4

Applicati

ons

for

auth

ori

sati

on

5

Post

auth

ori

sati

on

decis

ion

6

Revie

w A

fAs

follow

ing r

evie

w p

eri

od

Gra

nd

To

tal

Consumers Excluded

Exclu

ded

-

General population - - - 1 1 2

Industry - alternatives supply chain

6 4 2 8 - 20

Industry - Annex XIV substance supply chain

6 7 6 12 5 36

NGO 1 1 2 1 2 7

Workers 3 3 3 3 1 13

Regulatory authorities 5 3 3 4 3 18

Grand Total 21 18 16 29 12 - 96



This systemic approach enabled us to identify the types of activities and associated impacts that we

needed to collect data for It also helped us identify the main types of information required from

different stakeholders

Regulatory authorities for their administrative costs along the authorisation process -

However ECHA will also be asked for data related to impacts not incurred by them but for

which they will have some relevant data (eg costs of AFAs)

NGOs for their administrative costs from responding to public consultations but also for

evidence of substitution and changes in the market structure

Impacts on workers focus on risk reduction (un)employment and improvements as a result

of new RMMs at various stages in the AfA process

Impacts on general population (and the environment) focus on (but not limited to)

improvements as a result of new RMMs introduced as a result of submissions of AfA or due

to substitution or ceasingrelocation production outside of the EU

Impacts on industry focus on the costs and market implications for the supply chain that

use the Annex XIV substance (including any business uncertainty or impacts on decision

making like on RampD and investment due to the authorisation process) and from relevant

competing supply chains that use an alternative Therefore the data collection is not

limited to applicants and MIs of the Annex XIV substance but also competitors using an

alternative (substance process or different product) This will mean we need to speak to

different stakeholders to identify relevant companies (eg trade associations registrants

suppliers MIs distributors and DUs)

B23 Assessing impacts

The two main evaluation criteria that this study will contribute towards for the REACH review are

The effectiveness of REACH authorisation and

The efficiency of REACH authorisation

Effectiveness

As set out in the Toolkit 42 of the better regulation toolbox effectiveness analysis considers how

successful EU action (in this instance authorisation) has been in achieving or progressing towards its

objectives

This study will provide supporting evidence that should allow the EC to form an opinion on the

progress made to date and the role of the authorisation process in delivering the observed changes

If the REACH authorisation objectives have not been achieved supporting evidence will be provided

to indicate the extent to which progress has fallen short of the target and what factors have

influenced why something hasnt been successful or why it has not yet been achieved

Consideration will also be given to whether the objectives can still be achieved on time or with

what delay (eg progress with targets set out in the 2020 Roadmap) Critically the analysis will also

seek to identify if any unexpected or unintended effects have occurred which were not

envisagedintended when REACH authorisation was designed



The starting point for the assessment will be to collect available information on targets for

authorisation (eg within the SHVC 2020 Roadmap) statistics tracking the progress of substances

along the authorisation process and the speed of decision making Much of the data required to

assess the effectiveness of REACH has been collected and is presented in Section 3

Efficiency

The assessment of the ldquoImpacts of REACH authorisationrdquo and in particular the evaluation questions

on ldquoefficiencyrdquo is being unpicked using a Cost Benefit Analysis (CBA) framework ndash the key question

being lsquoare the costs of REACH authorisation greater or lesser than the benefits of REACH

authorisationrsquo This sub-section follows the structure of a standard CBA It will be revised

throughout the project as further evidence becomes available

Objectives

Baseline

Baseline and counterfactual scenarios

Identify and estimate costs and benefits

Compare costs and benefits

Sensitivity analysis

Objective

The ultimate objective of adapting a CBA framework here is to help the EC answer some of the

questions related to the efficiency of the REACH authorisation process

What are the costs and benefits associated with the implementation of REACH

authorisation

To what extent are the costs proportionate to the benefits achieved

Was the distribution of costs proportionate between the different stakeholders (eg larger

companies vs SMEs or among different industrial sectors)

To what extent are there unnecessary burdens on stakeholders (related to the

proportionality question)

How are costs distributed among public authorities at EU and national levels

What aspects of REACH authorisation (including procedural aspects) are the most efficient

and what are the least efficient (including the development of scientific opinions work of

scientific committees urgency procedures etc)

A key aspect of the overall evaluation and hence the CBA component is the costs and benefits

occurring within the EU But where REACH authorisation has an effect beyond the EU these will be

noted

Baseline scenario

The baseline scenario for an ex-post study like this (ie looking back on an existing

regulationpolicy) is the current situation in this instance it is a world where REACH Authorisation

exists

Specifically for this study the assessment scope begins when RMOAs have been prepared for

substances where authorisation has been recommended as the most appropriate RMO or prior to

the introduction of an RMOA when an Annex XV dossier has been prepared Whilst there is no set

timeframe from which an Annex XV dossier has been submitted to when that substance appears on

the authorisation list the ldquoannouncing effectrdquo that a substance could be subject to authorisation in



the near future may already trigger action (activities) to both MIs and DUs of the substance in

relation to RampD investment plans the searchimplementation of a possible alternative andor

improvements in risk management of the substance

It may also trigger action (activities) to MIs and DUs that do not use the substance but use an

alternative (substance or process) or make an alternative end-product that could be used for

similar end-use applications These activities could range from providing more information about

the suitability of their products and increased marketing to changes in production

capacityproduct modifications where there is for example scope for increasing their market share

in existing and new end-use applications (which may otherwise have not been possible eg due to

higher costs associated with the alternative)

These activities or at least the incentivesurgency for them should in theory increase as the

substance moves through the authorisation process Once on the authorisation list downstream

users must decide if they

i Apply for REACH authorisation (themselves collectively or via an upstream application)

and incur the cost of preparing the dossier the fees for applying for authorisation any

costs to minimise emissions and potentially the costs to make a currently lsquounsuitablersquo

alternative suitable in the future

ii Donrsquot apply for REACH authorisation ndash This will save companies the cost of applying for

authorisation but they must stop using the substance by the sunset date (for the uses

subject to authorisation only) Society as a whole could benefit in terms of a net reduced

risk to worker and public health and a net reduction in emissions to the environment

However there may be costs associated with ceasing use of the Annex XIV substance such

as the costs (and risks) of substituting to an alternative relocating production out of the

EEA or ceasing production altogether As noted above the decision to not apply for

authorisation may occur much earlier in the authorisation process

iii Do nothing - ie donrsquot apply for REACH authorisation and donrsquot change the volume and use

of the Annex XIV substance This effectively is non-compliance of the REACH regulation

which is considered beyond the scope of this study It is assumed that firms comply with

the REACH regulation and therefore this option is not considered further

Under the baseline scenario there is good information on the number of companies that apply for

authorisation (response i) but there is significant uncertainty over the number of companies that

do not apply for authorisation (response ii) and this is a fundamental data collection task for this

study Both responses (i+ii) are assessed as they both are possible in the baseline scenario

Counterfactual scenario

A CBA is generally used ex ante ndash ie before a decision is made to assess the relative costs and

benefits of different options for helping make the decisions and its implementation As this is an

ex-post analysis we are trying to assess the past and ongoing costs and benefits of effectively a

world without REACH authorisation through what is called a lsquocounterfactualrsquo scenario what would

have happened or ldquopre-REACH and other factors independent of REACH like market trends and the

economic crisisrdquo as well as other known regulation in place at the time (eg OSH) as referred to in

the tender

What we are seeking to do is to determine the ldquonetrdquo impacts of the whole REACH authorisation

process taking into consideration what would have happened under the counterfactual for



example would a company have substituted to an alternative [substanceprocess] anyway or was

REACH authorisation a major reason for the substitution

A very complicated counterfactual often leads to criticism of false accuracy The key is being

transparent on what the assumptions are for determining the counterfactual scenario and setting

these out clearly and openly


REACH authorisation has an impact on the way the substances are used through two responses and

the costs and benefits of both routes need to be assessed

Through the application process ndash companies prepare and submit for REACH authorisations

and as a result are either granted permission for continued use or denied permission (and

have to switch to a less risky alternative relocate or cease production) and

Through the preventative power of the regulation ndash companies pre-empt (at an earlier

stage in the authorisation process) a future requirement for REACH authorisation and

substitute away from a substance relocate or cease production without informing ECHA or

any other organisation

All impacts will be considered but not all enter the cost benefit analysis (eg changes to the

market structure are not a matter for such analysis) As noted earlier there is more evidence on

the application route as the SEAs submitted contain most of the necessary information ndash even

though not all may be quantitative or monetary or some may not be (at least immediately public)

due to confidentiality issues

Even less is known about the second route as there are no reporting recording requirements for

such decisions Whilst there is some qualitative information in some existing REACH studies much

of it is confidential ndash eg company names and uses substituted Therefore new information would

need to be derived as part of this study162 in part through the case studies (Task 24) and also the

online survey (Task 23) There is a general limitationscaling issue that case studies and survey

respondents even collectively will not account for all the marketsocietyaffected parties and

therefore estimating the total impacts of REACH authorisation will not be possible

It is also difficult to attribute the company decision (to substituterelocationcease production)

solely to REACH authorisation as there are other regulations (chemical and non-chemicals) and

market forces (eg cheaper production costs outside of the EEA) that could influence the decision

made The only way to get more information about such incentives for substitution is through direct

consultation with those that have substituted through surveys in-depth interviews and as case

study participants


One of the efficiency questions in the REACH evaluation is lsquoto what extent are the costs

proportionate to the benefits achievedrsquo This will require financial health and environmental costs

and benefits to be measured and compared in the same unit ideally but not exclusively monetary

terms Comparison could be made in terms of Net Present Value (benefits minus costs discounted

162 ECHA were able to provide examples of substances for which some uses were removed from registrations at

the AXIV Recommendation phase (the motivation was to decrease the priority of the substance for inclusion in

AXIV)



over time) or Cost Benefit Ration (benefits divided by costs discounted over time) depending on

the quality of information available As agreed in the kick off meeting with the EC we would seek

to present costs and benefits in annual terms to enable such a comparison

Assessing the proportionality of REACH authorisation requires one of three conditions to be met

1 Costs are less than benefits

2 Costs are more than benefits but the lsquooverspendrsquo is deemed proportional especially given that

it is not possible to quantify and monetise all benefits (or indeed all costs) and

3 Regardless of whether costs are more or less than the benefits they are distributed

proportionally amongst the relevant stakeholders eg by companies in different points on the

supply chain and large companies vs SMEs The distribution should be in accordance with their

contribution to the problem and their ability to afford ndash two criteria that could at times

conflict with each other


In an ex-ante analysis we could undertake sensitivity analysis by changing our assumptions about

key factors that estimate costs and benefits and see what the effect of such changes is on the

comparisons In this case we could compare evidence from different sources and see what they

indicate (ie how they affect the main findings)

This step is particularly important in applications like this where the scope is wide and evidence is

sparse Sensitivity analysis would help us make the most of the evidence available to draw lessons

for the future

B24 Tier 1 and 2 case studies

Case studies will be conducted to gain more in-depth insights on the five impact areas of the study

(i) costs of authorisation (ii) benefits of authorisation (iii) changes in the market structure (iv)

substitution and (v) affordability of authorisation for SME The case studies will build upon existing

studies and relevant information already in submitted applications

Within this study two types of case studies are presented

The Tier 1 case studies deal with the various authorisation related aspects for one

substance Both cases where an AfA was filed but also (non-applicant) cases with

substitutionrelocation or cease use will be discussed in this case study In order to be able

to deal with all aspects it is necessary that these substances have advanced far enough in

the authorisation process For this reason only substances for which applications have been

filed and which passed the Latest Application Date (LAD) were considered for the Tier 1

case studies

Within each Tier 1 case study the five main impact areas will be covered The goal is to

provide a comprehensive view on the authorisation process for these substances and its

effects Where possible and available quantitative data will be provided however for

illustrative purposes more narrative sections will also be used

The Tier 2 case studies contribute to the study by collecting data on specific aspects For

instance for substitution it could be relevant to conduct a case study on evidence of



substitution of substances and thereby avoiding having to apply for authorisation

Information at impact level will be collected for various substances and collated It is

expected that for some aspects it will be difficult to collect comprehensive quantitative

data However we expect to derive trends and mechanisms from the information collected

over various substances

While for the Tier 1 case studies only data on one substance is used for each respective

case study for each Tier 2 case study data over several substances are used There is also

no need for the Tier 2 case studies to limit the choice of substances to those that passed

the LAD or for which applications have been filled

The Tier 2 case studies are especially efficient to address issues for which it will be difficult

to obtain a significant amount of data for one substance In this way Tier 2 case studies

complement the Tier 1 case studies in aspects where there is opportunity to combine data

from multiple substances



ANNEX C AUTHORISATION PROCESS 2007-2016

C1 Overview

The authorisation process is initiated by the identification of a substance as SVHC done by the

submission and acceptance of an Annex XV dossier For human health hazard concerns (CMR) this

depends upon the classification of the substance as Category 1a1b Carcinogen Mutagen or

Reproductive toxicity For environmental hazard concerns (PBTvPvB) this means that the

substance is demonstrated to meet the criteria set out in Annex XIII of REACH (a substance can also

be SVHC on the basis of equivalent concern to a CMR or PBTvPvB ndash Article 57f) The process of

identification of a substance as fulfilling the criteria for SVHC therefore depends upon other

processes in REACH and the Classification Labelling and Packaging Regulation (CLP) requirements

Compliance checks (dossier evaluation) examine any registration dossier to verify if the information

submitted by registrants is compliant with the legal requirements Compliance checks evaluate the

substance identity description the study data and the safety information in the dossier including

the chemical safety report or specific parts of the dossier This can lead to additional information

being requested The process of substance evaluation in which all REACH registration dossiers of

one substance are assessed for risks can identify the need for further information such as

information to confirm if a substance could be CMR or PBTvPvB (or of equivalent concern) If the

additional information indicates that the substance has SVHC potential then this can lead to the

substance being placed on the candidate list (ie identified as SVHC) The evaluation process

being it dossier or substance evaluation is therefore a key influence on possible later needs for

authorisation It is often the start of a process in which further information is generated to identify

or confirm hazardous properties of a substance that could lead it to be identified as SVHC and

also importantly the possible exposure of humans andor the environment to that substance

The EC has committed to have ldquoall relevant currently known Substances of Very High Concern

(SVHCs) included in the candidate list by 2020163 The so called lsquo2020 Roadmaprsquo sets how that will

be achieved and emphasises the application of a screening process followed by a risk management

options analysis (RMOA) process

Figure C01 below illustrates the main processes within authorisation (blue boxes) and also

associated processes in REACH and CLP (green boxes) as well as processes that are not formally

within REACH but influence the decision-making on the identification and assessment for

substances that are relevant to the authorisation process (amber boxes) The main actors or

information sources are indicated in each case

163 European Commission (2013) Roadmap on Substances of Very High Concern Page 4



Figure C01 The processes in authorisation and contributory processes

As set out in the legal text the aim of authorisation is ldquoto ensure the good functioning of the

internal market while assuring that the risks from substances of very high concern are properly

controlled and that these substances are progressively replaced by suitable alternative substances

or technologies where these are economically and technically viable To this end all manufacturers

importers and downstream users applying for authorisations shall analyse the availability of

alternatives and consider their risks and the technical and economic feasibility of substitutionrdquo164

The whole authorisation process (as illustrated in Figure C01) has the objectives to

Ensure that the risks from SVHCs are properly controlled

Progressively replace SVHCs with suitable alternative substances or technologies where

these are economically and technically viable and


Using the following tools

Identify substances that meet the criteria of Article 57 (SVHC ndash candidate list)

164 REACH legal text Article 55

2020 roadmap -RMOMSCAsECHA

Compliance checkSubstance EvaluationMSCAs ECHA

CLP harmonisationMSCAsECHA

Annex XV dossierfor SVHCMSCAsECHA

Prioritisation - ECHA

Candidate list of SVHCs - ECHA

RegistrationIndustry

Existing informationeg ESR RAR

Formal authorisation process

Contributory processes

Review ECHAEC

Inclusion in Annex XIV - EC (ECHA recommend)



Prioritise SVHCs based on use volume and inherent property that require Authorisation

(Annex XIV)

Place the burden of proof on industry to make the case for continued use (ie to analyse

the availability of alternatives and consider their risks and the technical and economic

feasibility of substitution)

In REACH as a whole the burden for information provision (ie to assess the hazards exposure and

risks) is on the importers manufacturers and to a lesser extent downstream users REACH

indicates (in Recital 30) that the aim is To achieve fair burden sharing with their customers

manufacturers and importers should in their chemical safety assessment address not only their own

uses and the uses for which they place their substances on the market but also all uses which their

customers ask them to address As indicated in Recital 30 the onus is on manufacturers and

importers to produce safety assessments to address their uses and those of their customers (ie

downstream users) Authorisation applications have a chemical safety assessment as part of the

AfA however a large number of AfAs (and therefore safety assessments) have been done by DUs

ie the applied for uses hashave not been supported by the manufacturerimporter (ECHA data

from 196 applications indicates that almost 70 of the applications were made by DUs165)

Whilst it was envisaged that the manufacturers and importers placing substances on the market

would take the burden to show safe use for their customers (as stated in Recital 30) the DU

customers are not only paying for substances themselves but also paying to keep those substances

on the market for the product including the increase in control measures in order to drive down

exposure and the cost of applying for authorisation (including possible costs for the use of

information in registration dossiers)

Intervention logic actors and actions

An lsquointervention logicrsquo is a tool that links the design of an intervention (policy legislation) and the

operational actions with the outputs obtained and effects (outcomes and impacts) observed It

shows the link between the inputs and outputs and from its results to its impacts

As part of the preparation for the consultation plan (see Chapter 2 of this report) the intervention

logic was checked so that the main stages in the authorisation process could be linked to specific

actions which in turn can be linked to the achievement of the objectives of authorisation and the

impacts on specific actors

As indicated in Figure C01 there are several discrete stages in the authorisation process through

which a substance can pass The process may stop at particular stages if criteria are not fulfilled or

actions not taken Actions may not however be immediately visible within the authorisation process

since they may be actions which are not reportable to the regulatory authorities (for example not

making an application for a specific use or identification of an alternative to an SVHC) and thus

specific data are not necessarily gathered by the authorities on these actions and activities It is

these less visible actions that the Commission has a particular interest in since they indicate the

responses of the market to the Authorisation process that are not otherwise quantified Table C01

below very briefly summarises the main stages in the authorisation process and the possible actions

for actors in the process with comments on how data is being gathered)

165 Data provided by ECHA for the purposes of this study (status as of 20102016)



Table C01 The main stages in the authorisation process

Stage Explanation Comment

1 Screening of substances and RMOAs

Screening of substances by MS CA

andor ECHA that meet Article 57

criteria and have non-exempt uses

Proposal for a substance to go onto

Annex XIV means it must meet the

Article 57 criteria for SVHC

The Screening and RMOA are not a part

of the process that is set out in the

legal text (RMOA was developed in

2009 and formally introduced

together with the Screening process

in the EC lsquoRoadmap on Substances of

Very High Concernrsquo in 2013) but the

submission of Annex XV dossier by MS

CAs and ECHA is an official part of the

process


Substances demonstrated (in an

Annex XV dossier) to meet the

Article 57 criteria can be placed

onto the Candidate list

Inclusion on the Candidate list brings

obligations eg under Article 33 and

Article 7(2)

3 ECHA recommendation for Annex XIV

Recommendations for SVHC to be

placed in the Authorisation list

(Annex XIV) are made by ECHA

(including latest application and

sunset date review period and

exemptions)

-

4Inclusion of substances on Annex XIV

The EC amends REACH (Annex XIV)

The EC has the discretion not to follow

the recommendations by ECHA when

deciding on which and when to add

substances to the Annex XIV


Applications are made by industry

for continued use of SVHCs

Applications have to be made 18

months before the sunset date to

benefit from the transitional

arrangements under Article 58(c)(ii)

(the so-called latest application date)

meaning that the use can continue

even after the sunset date until the

Commission has issued its decision

ie if the decision has not yet been

adopted by the sunset date

Applications made after the latest

application date would have to stop

the use after the sunset date and

await granting of the authorisation

before use can be continued (or

initiated if it is a new use)

6 Post authorisation decision

Opinions (including review period

and conditions) are made by

scientific committees RAC and SEAC

for each use applied for

The decision on whether or not to

grant the authorisation is done by

EC

MS NEA are responsible for

enforcement




7 Review reports following review period

This is a re-application

Re-application is to be done 18 months

before the end of the review period if

the use of the substance is still

necessary A review report is to be

submitted (to ECHA) by the applicant

C2 Timeline of key events in the authorisation process (2006-2017)

The main stages of the authorisation process (as illustrated in Figure C01) are specifically referred to in Title VII of REACH

Article 57 substances to be included in Annex XIV

Article 58 ndash inclusion of substances in Annex XIV

Article 59 identification of substances referred to in Article 57

Article 60 granting of authorisations

Article 61 review of authorisations

Article 62 Applications for Authorisation

Article 63 subsequent applications for authorisation and

Article 64 Procedure for authorisation decisions

However the selection of substances in Articles 57 and 58 does not refer to the RMOA process

PACT list or the 2020 Roadmap These parts of the process have been added to aid the decision

making efficiency and transparency of the authorisation process A timeline for the development

of the process and the additions to the process are set out in this section In addition summary-

statistics have been collated in order to give an indication of the volume of substances passing

through the process and where substances are in a snapshot of the process as it is (as of December

2016) The presentation of these statistics is not intended as a detailed overview of the process

but rather to put into context the analysis that is possible



Figure C02 Timeline of key events in the authorisation process (2007-2016)



C3 Screening of substances and Risk Management Option Assessment (RMOA)

The 2020 SVHC Roadmap committed to have all relevant currently known SVHCs included in the

candidate list by 2020 There was a consequent need to analyse the information on a large number

of substances not only to determine the relevance of known potential SVHCs but also to identify

new potential SVHCs from the processes of REACH registration (phase-in stages completed in 2018)

and evaluation The roadmap implementation plan describes two distinct but related processes (1)

the Screening process and (2) the RMOA process The purpose of the Screening process is to identify

and prioritise substances of potential concern for further regulatory action Those substances of

potential concern are those where the impact on human health and the environment are expected

to be the greatest Priority is given to substances that have the highest exposure potential

combined with their potentially hazardous properties for example substances that are

carcinogenic mutagenic and toxic to reproduction (CMR) persistent bioaccumulative and

toxicvery persistent very bioaccumulative (PBTvPvB) or endocrine disruptors and therefore

potential SVHCs Once the concern is confirmed the substance is normally taken forward to RMOA

by authorities The purpose of the RMOA is to help authorities decide whether further regulatory

risk management activities are required for substances and if so to identify the most appropriate

instrument to address a concern Thus in view of the authorisation process the roadmap sets out

the RMOA process as central to the decision making on the inclusion of SVHCs on the Candidate List

The processes of Screening and RMOA as set out by ECHA is described in Box 31 below In addition

ECHA set up the Public Activities Coordination Tool (PACT) that provides information (published on

the ECHA website) on substances that are or have been subject to informal assessment (of their

potential PBT vPvB or ED properties) andor RMOA

Box C1 Risk Management Option Analysis

The purpose of the risk management option analysis (RMOA) is to help decide whether further

regulatory risk management activities are required for a substance and to identify the most

appropriate instrument to address a concern A Member State or ECHA (at the request of the

Commission) can carry out this case-by-case analysis

The RMOA is an important step agreed in the SVHC Roadmap but it is voluntary (ie not part of

the processes defined in the legislation) For authorities documenting the RMOA allows

information to be shared This promotes early discussion which helps create a common

understanding on the appropriate action to be taken

An RMOA can conclude that regulatory risk management is required for a substance (for example

harmonised classification and labelling inclusion on the Candidate List restriction other EU

legislation) or that no regulatory action is required Subsequent regulatory processes include

consulting interested parties and appropriate decision making involving the MSCAs and

Commission as defined in REACH

Communicating information on substances undergoing RMOA through the Public Activities

Coordination Tool (PACT) allows stakeholders and the general public to better predict which

substances may be addressed by which formal risk management routes in the future This gives

registrants the opportunity to update their registration data consider the best business strategy

to address substances of potential concern and to prepare for public consultation during any

subsequent regulatory processes



The responsibility for the content of an RMOA rests with the authority that developed it RMOAs

and their conclusions are compiled on the basis of available information and may change in the

light of new information or further assessment

Source ECHA web page on RMOA

httpsechaeuropaeuaddressing-chemicals-of-concernsubstances-of-potential-concernrmoa

Box C2 Public Activities Coordination Tool

The Public Activities Coordination Tool (PACT) gives advance notice of the substances that are on

an authoritys radar for exploring the potential need for regulatory risk management

PACT lists the substances for which an RMOA or an informal hazard assessment for PBTvPvB

(persistent bioaccumulative and toxic very persistent and very bioaccumulative) properties or

endocrine disruptor properties is either under development or has been completed since the

implementation of the SVHC Roadmap commenced in February 2013 Substances for which a

hazard assessment is performed are also discussed informally by the PBT Expert Group or the

Endocrine Disruptor Expert Group as appropriate

Inclusion in the PACT means that a Member State or ECHA is examining the substance It does not

mean that a substance has the suspected properties or that there is a need for regulatory risk

management actions The purpose of the hazard assessment is to explore a potential PBTvPvB

or endocrine disruptor concern

Frequently the outcome of such an informal assessment is that the substance is considered to

not have the hazard properties investigated based on the available information Similarly an

RMOA aims to clarify whether regulatory risk management is necessary and if yes which

measures would be the most appropriate to initiate

Even if the outcome of the RMOA is that it would be appropriate to initiate regulatory risk

management action or of a hazard assessment is that a substance is considered to have PBT or

endocrine disrupting properties such outcomes do not have direct legal implications and

regulatory relevance as the outcomes presented in PACT are just those of the evaluating

authority

To gain legal and regulatory relevance the substance assessed needs to successfully pass one or

more of the formal risk management and decision-making processes under REACH or CLP such as

harmonised classification and labelling (CLH) SVHC identificationauthorisation or restriction

The intentions to submit a dossier to the mentioned formal processes are notified in the Registry

of Intentions

Early information through PACT gives registrants more time to make sure that their registration

data is up to date Stakeholders will have more time to prepare their contributions to a formal

regulatory management process which potentially will follow the preparatory steps and outcomes

indicated in PACT Anyone else with data on the substance information on safer alternatives or

other material will also have more time to prepare to make their case in the public consultation

phase of a potential formal process

Source ECHA web pages on PACT

httpsechaeuropaeuaddressing-chemicals-of-concernsubstances-of-potential-

concernpactstatus-and-purpose



The processes of screening substances and selecting the most relevant ones for the RMOA is in the

hands of regulatory authorities with the main actors being ECHA and the MS CAs

Within this study the assessment focuses on substances that have been identified as SVHC This of

course is difficult to judge precisely without re-conducting an RMOA on the substances although it

may be possible to compare the outcomes of the RMOAs done with the main objectives of the 2020

Roadmap

1 The substance shows some evidence of being produced andor used in Europe in relevant

quantities (fulfilled by already registered substances or substances that will be registered

by 2020)166

2 The substance has not only been registered for intermediate uses

3 The available information does not prima facie demonstrate that there is a risk that is not

adequately controlled and needs to be addressed at EU level167

4 The known uses of the substance

a are not exempted from the authorisation requirement on the basis of Article 2(5) or

Article 56(3) (4) or (5) or Article 60(2)

b are not already regulated by specific EU legislation that provides a pressure for

substitution leading to the conclusion that no further regulatory action is needed

under REACH

The latest SVHC Roadmap annual report can be referred to for more information

httpsechaeuropaeudocuments1016219126370svhc_roadmap_2017_enpdfa8430302-c03c-

d55a-b7d1-822451dfc34e

The roadmap implementation web page can be found at

httpsechaeuropaeuaddressing-chemicals-of-concernsubstances-of-potential-concernsvhc-

roadmap-to-2020-implementation

C4 Inclusion of substances in the Candidate List










regulatory action (eg restriction) under REACH is deemed to be needed168 As set out earlier in

this section and illustrated in Figure C1 the selection of SVHC substances is done initially by

166 There might be cases in which non-registered substances can still be considered relevant for identification

One example might be a substance that is currently not produced or used in Europe but might be used as an

alternative to another relevant SVHC This exemption is particularly relevant when the most appropriate

approach is the category approach (ie analogous substances) 167 For those uses that have a demonstrated risk according to Articles 69(1) and 69(4) a restriction process

should be started 168 httpregisterconsiliumeuropaeudocsrvl=ENampf=ST20586720201320INIT



Member States or ECHA upon request of EC making an Annex XV dossier to demonstrate that the

substance meets the Article 57 criteria

C5 Prioritisation and inclusion of substances in the Authorisation List


the substance (2) the high volume and (3) the use (wide- dispersive) Before sending its






information














C6 Applications for Authorisation (AfA)



parties (alternatives during the public consultation) In addition the risk assessment committee




C7 Post authorisation decision

Once an Authorisation is granted or refused ndash done by the Commission and published with relevant

conditions in the Official Journal the relevant actors must act on this Upstream authorisation

holders that is manufacturers importers or only representatives must include the authorisation

169 REACH article 58(4) 170 ECHA (2014) Prioritisation of substances of very high concern (SVHCs) for inclusion in the




number on the label before they place the substance or the mixture containing the substance on

the market Upstream authorisation holders must also update the safety data sheet (SDS)

Downstream users of an Annex XIV substance covered by the authorisation of an upstream actor

must comply with the conditions of the decision and notify to ECHA their use of the substance

within three months of the first supply of the substance Downstream authorisation holders must

comply with the conditions of the decision

C8 Review of Authorisation following their review period
















ANNEX D ACTIVITIES CARRIED OUT ALONG THE

AUTHORISATION PROCESS



actors This Annex sets out the 150 activities identified

The authorisation process was divided into 6 stages171

1 Screening of substances and Risk Management Option Analysis (RMOA)


3 Inclusion of substances in the Authorisation List



6 Review AfAs following review period

The information is further split by type of actor (either those that carry out the activity identified

or those actors most affected by this activity)

Consumers

General population



NGO

Regulatory authorities

Workers

171 This aligns with the list in the overall REACH intervention logic



D1 STAGE 1 Screening of substances and RMOArsquos

Actor Regulatory authorities

ACTIVITY Impacts Shortlisted

impact

Justification

for

exclusion

Information needed From

whom

Proposed

tool

MSCA - Screening - selection of substances of concern

based available information from registration andor

other sources to defineconclude on hazardous

properties (CMR PBTvPvB or equivalent concern)

Core Activities - focus on specific substances

NB Screening may lead to a number of outcomes to

SEv and or CCH to CLH which may lead to RMOA (or

to no further action)

Supplementary Activities - to identify further

(potential) SVHC substances similar to the SVHCs with

registrations for non-intermediate uses (and therefore

may be

taken forward together with these latter substances

during RMOA development)

Coordination and organisation of agreed plans and

tasks and to avoid duplication of work

Working in groupscommittees

bull A substance specific coordination group (CMR

sensitisers) or

bull An Expert group (PBT Expert Group ED Expert

Group)

National strategy on specific compounds or types of

compound

Other

bullData collection and national monitoring and research

Administrat

ive costs

Yes - Resources required for

substance screening

Cost of resources

Motivation for screening

activities

National policy drivers

Substances that have been

screened and why

MSCAs Data

request

to MS CA




impact

Justification

for

exclusion


whom

Proposed

tool

programmes

bullPolicy development at national level

ECHA - Screening - selection of substances of concern

based on available information from registration

andor other sources to defineconclude on hazardous









may be taken forward together with these latter

substances during RMOA development)

Coordination and organisation of tasks to adhere to

agreed plans and tasks and to

avoid duplication of work

Coordination of groupscommittees


sensitisers) or


Group)

Other

bull resource use and distribution (request from EC to

look at particular substance types)

bull policy development on substances of high concern

bull prioritisation and coordination of work on substance

of concern

improvement of screening methodology and guidance

Administrat

ive costs


substance screening

Cost of resources


activities

Policy drivers


screened and why

ECHA Data

request

to ECHA




impact

Justification

for

exclusion


whom

Proposed

tool

ECHA - RMOA

bull Progress monitoring

bull Communication - web etc

bull PACT annual report

bull Assessment of substance - SVHC properties

bull Assessment of and conclusion on measures

bull Reporting and responding

bull Coordination of activities

COM - Screening

bull Production of policy on screening (2020 Roadmap)

review and update of policy

bull Potential endocrine disruptors list - develop and

maintain

Coordination and organisation of tasks in order to

adhere to agreed plans and tasks and to avoid

duplication of work

Developing criteria for the identification of such ED-

substances that require regulatory action

Other

bull resource use and distribution (request to ECHA to



bull improvement of screening methodology

bull review and update of policy and procedure for

substance selection


of concern

Administrat

ive costs Yes -

Resources required for

substance screening

Cost of resources


activities

Policy drivers

COM

Data

request

to EC

MSCA - RMOA


bull Communication - web site etc

Administrat

ive costs

Yes - Cost of resources MSCAs Data

request

to MS CA




impact

Justification

for

exclusion


whom

Proposed

tool




bull Providing experts to committees - eg PBT Expert

Group (PBT-EG) Endocrine Disruptor Expert Group

(ED-EG)

COM ndash RMOA



Administrat

ive costs

Yes - Cost of resources COM Data

request

to EC

Actor Industry ndash Annex XIV substance supply chain


impact

Justification

for exclusion Information needed From whom

Proposed

tool

Informally provide

information requested on

a substance RMOA

Administrat

ive costs

No This RMOA

aspect deemed

out of the scope

of the project

The number of substances where industry

have been asked to comment on an RMOA

The estimated time (days) taken by

industry

This is based on literatureexpert

judgementinformal consultation) - to

minimise number of questions formally

asked from industry

Need to ask

ECHA for list of

industry

contacted about

RMOA

Data request

to ECHA

Trigger internal

discussions following

regulatory scrutiny and

spending decisions on

options for substitution

RampD costs No This RMOA

aspect deemed

out of the scope

of the project

Estimated cost (euro)

Indicate over what time period or if itrsquos

an annual cost

Identify substance and use

Would need a

general informal

question to be

asked to

companies

identified via

Further

research

targeted

data request




impact

Justification


Proposed

tool

ECHA to

estimate admin

+ RampD costs

Substitution from

substance on RMOA

selected for authorisation

Substitutio

n

Yes - Instances of substitution - Substance and

Use

Costs of substitution

Impacts - eg changes in sales profit

risk management

Trade

association or

REACH

consortia

Industry using

an RMOA

substance

Industry

online survey

Communication with MI

and trade association or

relevant REACH consortia

Improved

supply

chain

communica

tion

No Only possible to

generate

anecdotal

responses that

already exist

Communication to MS CA

ECHA that industry will

be doing voluntary action

to substitutereduce risks

Improved

supply

chain

communica

tion

Yes - Instances where industry wide voluntary

agreementsactions were noted and

then carried out

Ask ECHA for list

of companies

who indicated

they are

introducing

voluntary

action RMMs

substitution

Data request

to ECHA

Substitution from

substance following

Annex XV dossier

Substitutio

n


Use


Trade

association or

REACH

Industry

online survey




impact

Justification


Proposed

tool


risk management

consortia

MI that have

ceased

production

(list from

ECHA)

Industry using

substance with

an Annex XV

dossier

Decide whether to shut

down operations or

relocate outside of the

EU following RMOA or

Annex XV dossier

Closure

relocation

Yes - Instances of ceasing operations -

Substance and Use

Instances of relocating - Substance and

Use

Trade

association or

REACH

consortia

MI that have

ceased

production

(list from

ECHA) to

identify

industry that

have

substituted

from

substance at

Annex XV

dossier stage

Industry

online survey




impact

Justification


Proposed

tool

Decide whether to

postpone delay

increase investment

following RMOA or Annex

XV dossier

Investment

decision

Yes - Instances of postponed or delaying

investment - Substance and Use

Instances of increased investment -

Substance and Use

Trade

association or

REACH

consortia

Industry using

an RMOA

Substance

Industry

online survey

Improvements in working

conditions and RMMs

Reduction

in risk

(human

health

andor

environ-

mental)

Yes - For each substance and use

How working conditions have improved

What RMMs were introduced and their

effectiveness

If that resulted in change in skills

required or number of staff required

Estimated cost

Trade

association or

REACH

consortia

Industry using

an RMOA

Substance

Industry

online survey

Actor Industry - alternatives supply chain


impact

Justificatio

n for

exclusion

Information needed From whom Proposed

tool

Promote the use of

their alternative

(substance technology

or product) in order for

companies to switch

from using substance(s)

on the RMOA

recommended for

authorisation

Substitution Yes - Find suppliers of alternatives

Find specific cases of substitution

priorwithout AfA

Company size of supplier of alternative

Company size of the user of the alter-

native

Details on the annex XIV to be

substituted the use and alternative

Suppliers of

alternatives via

distributers of the

annex XIV substance

via direct leads via

consultation of

industry experts via

industry associations

Industry

online survey




impact

Justificatio

n for

exclusion


tool

Reduction in risks from

use of an alternative

Reduction in

risk (human

health andor

environ-

mental)

Yes - Risk from use of Annex XIV substance

Risk of the use of the alternative

DUs of the

alternative

Tier 1 and 2

case study

Promote the use of

their alternative



companies to switch


on the RMOA

recommended for

authorisation

Increase in

sales

market share

Yes - Sales volume of alternative in

replacement of the annex XIV

substance compared to the total

market volume of the annex XIV

substance in this use

Suppliers of

alternatives

Tier 1 and 2

case study

Switch to alternative -

resulting in change in

production costs

Production

costs

Yes - Location of manufacturing of

alternative substance

Cost impact of the alternative (one-

time costs running costs)

Suppliers of

alternatives

users of the

alternative

Tier 1 and 2

case study

Development and supply

of alternative substance

or technology

Innovation Yes - How did REACHauthorisation process

affect the development of the

alternative (Eg As of when was the

alternative available on the market)

Specific suppliers of

alternatives

Tier 1 and 2

case study

Change in volume

supplied of alternative

Changes in

market

structure

Yes - Evolution of import of finished goods

produced with annex XIV substance and

produced outside of the EEA

How does the supply chain of the

annex XIV substance compare with the

supply chain of the alternative (eg

number of suppliers)

DUs of the

alternative

Specific suppliers

of alternatives

Tier 1 and 2

case study



Actor NGO

ACTIVITY Impacts Shortliste

d impact

Justification for

exclusion Information needed

From

whom

Proposed

tool

Informally provide

information on a

substance RMOA

Administrative

costs

No This RMOA aspect

deemed out of the

scope of the project

Number of hours spent preparing and

submitting information

RMOA substances for which information was

provided

NGOs NGO survey

Informally provide

information on

substitution possibilities

Substitution Yes - NGOs opinion about whether the RMOA

process is working

Information about cases where substitution

has taken place before a substance has

appeared on the authorisation list

Information about whether this stage of the

authorisation process is driving innovation

and a transition to safer alternatives

NGOs NGO survey

Active lobbying including

producing research

papers position

statements press

releases liaising with

other NGOs industry

etc

Administrative

costs

No Voluntary action

that should not be

included within the

assessment

Number of hours spent on these activities

Which stages of the authorisation process the

activities relate to

Number of AfAssubstancesuses that these


NGOs NGO survey



Actor Workers


impact

Justification

for exclusion Information needed

From

whom

Proposed

tool

Exposure in firms

substituting away from

substance on RMOA selected

for authorisation or

relocating use

Reduction in

risk (human

health andor

environmental)

Yes - Use of substance by industry prior to

RMOA

Average exposure of workers in industry

using substance

Number of workers

Dose-response etc

function for substance

Value of health impacts

Industry

ECHA

website

Tier 1 and 2

case study

Employment in firms



for authorisation via

relocation

Unemployment Yes - Number of firms substituting via

relocation

Average number of workers in firms

substituting via relocation

Average wage of workers in firms


Industry Tier 1 and 2

case study

Exposure in firms improving

RMMs related to use of


for authorisation

Reduction in

risk (human

health andor

environmental)


RMOA


using substance pre-RMOA


using substance post-RMOA

Number of workers

Dose-response etc function for

substance


Industry

ECHA

website

Tier 1 and 2

case study

Actor Consumers




impact

Justification for

exclusion

Information

needed

From

whom

Proposed

tool

Consumption of products produced by firms who have

substituted away from substance or relocated use of

substance on RMOA selected for authorisation

Changes in

product price

andor quality

No Only possible to generate

anecdotal responses that

already exist

Actor General population


impact

Justification for

exclusion

Information

needed

From

whom

Proposed

tool

Exposure via environment to substances used by firms

substituting away from substance on RMOA selected for

authorisation

Reduction in

risk (human

health andor

environmental)

No Unlikely to be able to

obtain sufficient

quantitative data

required to assess this


improving RMMs related to use of substance on RMOA


Reduction in

risk (human

health andor

environmental)


obtain sufficient

quantitative data


Use (and non-use) of environmental services affected by

use of substances by firms substituting away from

substance or relocating use of substance on RMOA


Reduction in

risk (human

health andor

environmental)


obtain sufficient

quantitative data



use of substances by firms improving RMMs related to use

of substance on RMOA selected for authorisation

Reduction in

risk (human

health andor

environmental)


obtain sufficient

quantitative data




D2 STAGE 2 Inclusion of substances in the Candidate List



impact

Justification

for exclusion

Information

needed

From

whom

Proposed

tool

MSCA - Annex XV dossier for SVHC

The Annex XV SVHC report - attached to the technical dossier

in IUCLID

A technical dossier (in IUCLID format) This should include

information on substance

composition and can include robust study summaries imported

from registration dossiers

collect the relevant information

assess the information

compare info to the relevant criteria

draw conclusions as to whether the criteria are met

document the information assessment and conclusions in the

Annex XV SVHC report

Administrative

costs

Yes - Cost of

resources

(days spent)

MSCAs Data

request to

MS CA

ECHA - Annex XV dossier for SVHC

The Annex XV SVHC report and IUCLID ECHA- Annex XV dossier

for SVHC collect the relevant information







Administrative

costs

Yes - Cost of

resources

(days spent)

ECHA Data

request to

ECHA

COM - Annex XV dossier for SVHC

Art 59(9) - if no unanimous agreement by MSC - COM prepares

draft proposal and decision taken by Committee procedure

(Art 133)

Administrative

costs

Yes - Cost of

resources

(days spent)

COM Data

request to

EC





impact

Justification


Proposed

tool

Provide information during public

consultation on the inclusion the

substance in the Candidate list

Administrative

costs

Yes - Estimated cost (euro) and

for what substance

Trade association

REACH consortia

Industry using a

substance on

candidate list

Industry

online

survey

Trigger internal discussions

following regulatory scrutiny and

spending decisions on options for

substitution

RampD costs Yes - Instances of RampD

spending - Substance

and Use

Estimated euro spending

(one-off or annual)

Trade association

REACH consortia

Industry using a

substance on

candidate list

Industry

online

survey

Substitution from substance on

candidate list

Substitution Yes - Instances of

substitution -

Substance and Use


Impacts - eg changes

in sales profit risk

management

Trade association

REACH consortia

Industry using a

substance on

candidate list

Online

industry

survey amp

case

study

Communication with MI and trade

association or relevant REACH

consortia

Improved supply

chain

communication

No Only possible to

generate

anecdotal

responses that

already exist

Communication to MS CA ECHA

that industry will be doing

voluntary action to

substitutereduce risks

Improved supply

chain

communication

Yes - Instances where

industry wide

voluntary

agreementsactions

were noted and then

carried out

Ask ECHA for list of

companies who

indicated they are

introducing

voluntary action

RMMs substitution

Data

request

to ECHA




impact

Justification


Proposed

tool

Decide whether to shut down

operations or relocate outside of

the EU following candidate listing

Closure

relocation

Yes - Instances of ceasing

operations -Substance

and Use

Instances of relocating

-Substance and Use

Trade association

REACH consortia

Industry using

substance on

candidate list

Online

industry

survey amp

case

study

Decide whether to

postponedelay

increase investment following

candidate listing

Investment

decision

Yes - Instances of

postponed or delaying

investment -

Substance and Use

Instances of increased

investment -

Substance and Use

Trade association

REACH consortia

Industry using an

RMOA Substance

Online

industry

survey amp

case

study


conditions and RMMs

Reduction in risk

(human health

andor

environmental)

Yes - For each substance and

use

How working

conditions have

improved

What RMMs were

introduced and their

effectiveness

If that resulted in

change in skills

required or number of

staff required

Estimated cost

Trade association

REACH consortia

Industry using an

RMOA Substance

Industry

online

survey





impact

Justification


Proposed

tool

Contribution during

public consultation

Administrative

costs

Yes - Cost of the participation

to the public consultation

References received from

ECHA (see other question)

Industry

online survey

Promote the use of

their alternative



companies to switch


on the RMOA

recommended for

authorisation

Increase in

salesmarket

share

Yes - Sales volume of

alternative in replacement

of the annex XIV substance

Suppliers of alternatives Tier 1 and 2

case study

Change in volume


Changes in

market

structure

Yes - Evolution of import of

finished goods produced

with annex XIV substance

and produced outside of

the EEA

How does the supply chain


compare with the supply

chain of the alternative

(eg number of suppliers)

DUs of the alternative


alternatives

Tier 1 and 2

case study

Contribution during

public consultation

Administrative

costs

Yes - A list of existing AfAs that

would have been applicable

for the lsquolow volumersquo

simplification authorisation

route

ECHA Data request

to ECHA



Actor NGO


impact

Justification


From

whom

Proposed

tool

Provide comments during public

consultation on inclusion of substances

on the Candidate List (as per Article

58(4))

Administrativ

e costs

Yes - Number of hours spent preparing

and submitting information

Candidate List substances for

which information was provided

NGOs NGO

survey

Active lobbying including producing

research papers position statements

press releases liaising with other

NGOs industry etc

Administrativ

e costs

No Voluntary action

that should not

be included

within the

assessment

Number of hours spent on these

activities

Which stages of the authorisation

process the activities relate to

Number of AfAssubstancesuses

that these activities relate to

NGOs NGO

survey

Actor Workers


impact

Justification

for

exclusion


whom

Proposed

tool

Exposure in firms


substance included on

Candidate List for

authorisation or relocating

use

Reduction in

risk (human

health andor

environmental)

Yes - Use of substance by industry prior


using substance

Number of workers

Dose-response etc

Function for substance


Industry

ECHA

website

Tier 1 and

2 case

study

Employment in firms



Candidate List for

Unemployment Yes - Number of firms substituting via relocation




Industry Tier 1 and

2 case

study




impact

Justification

for

exclusion


whom

Proposed

tool

authorisation via relocation substituting via relocation




Candidate List for

authorisation

Reduction in

risk (human

health andor

environmental)



using substance

Pre-Average exposure of workers in industry

using substance

Post-Number of workers

Dose-response etc



Industry

ECHA

website

Tier 1 and

2 case

study

Actor Consumers


impact

Justification for

exclusion

Information

needed

From

whom

Proposed

tool

Consumptions of products produced by firms who have


substance included on Candidate List for authorisation

Changes in

product price

andor quality

No Unlikely to be able


quantitative data

required to assess

this





impact

Justification

for exclusion

Information

needed

From

whom

Proposed

tool


substituting away from substance included on Candidate

List for authorisation

Reduction in

risk (human

health andor

environmental)



quantitative data

required to assess

this


improving RMMs related to use of substance included on

Candidate List for authorisation

Reduction in

risk (human

health andor

environmental)



quantitative data

required to assess

this



substance or relocating use of substance included on


Reduction in

risk (human

health andor

environmental)



quantitative data

required to assess

this


use of substances by firms improving RMMS related to use

of substance included on Candidate List for authorisation

Reduction in

risk (human

health andor

environmental)



quantitative data

required to assess

this



D3 STAGE 3 Inclusion of substances in the Authorisation List



impact

Justification


From

whom Proposed tool

MSCA- Comment on Recommendations

MSC - Comment on recommendations

(experts supplied by MSCA)

Administrative

costs

Yes - Cost of resources

(days spent)

MSCAs Data request

to MS CA

ECHA- Recommendations for Annex XIV

Select substances from Candidate list

based on Art 58(3) also accounting for

outcome of RMOA

Make Recommendation (including

specification set out in Art 58 (1) a-e

(identity properties latest application

and sunset date review periods use

category exemptions)

Organise and carry out and take into

account public consultation on

Recommendation

Administrative

costs


(days spent)

ECHA Data request

to ECHA

COM - Recommendations for Annex XIV

Decision in accordance with Art133 (4) -

Committee procedure (1999468EC)

Administrative

costs


(days spent)

COM Data request

to EC





impact

Justification


Proposed

tool

Provide information

during public

consultation to seek

exemption on use

from substance

being included on

authorisation list and

on uses and volumes

and views on

LADSSD

Administrative

costs

Yes - Estimated cost (euro)


an annual cost



industry This is based on

literatureexpert judgementinformal

consultation) - to minimise number of

questions formally asked from industry


uses and associated

companies that

argued for an

exemption to

authorisation for

their use

Data

request

to ECHA

Trigger internal


regulatory scrutiny

and spending

decisions on options

for substitution

RampD costs Yes - Instances of RampD spending - Substance

and Use

Estimated euro spending (one-off or annual)

Trade

association

REACH consortia

Industry using

substance on

authorisation list

Industry

online

survey

Substitution of

substance

Substitution Yes - Instances of substitution - Substance and

Use



risk management

Trade association

REACH

consortia

Industry using

substance on

authorisation list

Online

industry

survey amp

case

study

Communication with

MI and trade

association or

relevant REACH

consortia

Improved supply

chain

communication

No Only possible

to generate

anecdotal

responses that

already exist

Decide whether to Closure Yes - Instances of ceasing operations - Trade Online




impact

Justification


Proposed

tool

shut down

operations or

relocate outside of

the EU

relocation Substance and Use


Use

association

REACH consortia

Industry using an

RMOA substance

industry

survey amp

case

study

Decide whether to

postponedelay

increase investment

Investment

decision




Substance and Use

Trade

association

REACH consortia

Industry using

substance on

authorisation list

Online

industry

survey amp

case

study

Improvements in

working conditions

and RMMs

Reduction in

risk (human

health andor

environmental)

Yes - For each substance and Use



effectiveness



Estimated cost

Trade association

REACH

consortia

Industry using

substance on

authorisation list

Online

industry

survey amp

case

study



impact

Justification for

exclusion Information needed From whom

Proposed

tool

Promote the use of their

alternative (substance technology

or product) in order for companies

to switch from using substance(s)

on the RMOA recommended for

authorisation

Increase in

salesmarket

share



substance

Suppliers of

alternatives

Tier 1 and 2

case study

Change in volume supplied of

alternative

Changes in

market



DUs of the

alternative

Tier 1 and 2

case study




impact

Justification for


Proposed

tool

structure with annex XIV substance

and produced outside of the

EEA






Specific

suppliers of

alternatives

Actor NGO


d impact

Justification for


From

whom

Proposed

tool


producing research papers

position statements press

releases liaising with other

NGOs industry etc

Administrative

costs

No Voluntary action

that should not

be included

within the

assessment


activities



Number of AfAssubstancesuses that

these activities relate to

NGOs NGO survey

Informally provide information on


Substitution Yes - Information about cases where

substitution has taken place after a

substance has appeared on the

authorisation list

Information about whether this stage

of the authorisation process is driving

innovation and a transition to safer

alternatives

NGOs NGO survey


consultation on possible

exemptions for uses (of a

Administrative

costs

Yes - Number of hours spent on these

activities


NGOs NGO survey




d impact

Justification for


From

whom

Proposed

tool

substance proposed for

Authorisation list)


Actor Workers


impact

Justification


From

whom

Proposed

tool

Exposure in firms


substance included in

Annex XIV or relocating

use

Reduction in

risk (human

health andor

environmental)



using substance

Number of workers

Dose-response etc



Industry

ECHA

website

Tier 1 and

2 case

study

Employment in firms



Annex XIV via relocation






Industry Tier 1 and

2 case

study

Exposure in firms

improving RMMs related

to use of substance

included in Annex XIV

Reduction in

risk (human

health andor

environmental)



using substance


using substance


Dose-response etc



Industry

ECHA

website

Tier 1 and

2 case

study



Actor Consumers


impact

Justification

for exclusion

Information

needed

From

whom

Proposed

tool


substituted away from substance or relocated use of substance


Changes in

product price

andor quality

No Unlikely to be

able to obtain

sufficient

quantitative

data required to

assess this



impact Justification for exclusion

Information

needed

From

whom

Proposed

tool

Exposure via environment to substances

used by firms substituting away from

substance included in Annex XIV

Reduction in risk

(human health andor

environmental)

No Unlikely to be able to obtain

sufficient quantitative data



used by firms improving RMMs related to

use of substance included in Annex XIV

Reduction in risk

(human health andor

environmental)




Use (and non-use) of environmental

services affected by use of substances by

firms substituting away from substance

or relocating use of substance included in

Annex XIV

Reduction in risk

(human health andor

environmental)






firms improving RMMS related to use of


Reduction in risk

(human health andor

environmental)






D4 STAGE 4 Applications for authorisation



impact

Justification


From

whom

Proposed

tool

ECHA - Provide IUCLID platform pages for submitting

AfAs application templates guidance ECHA procedure

and policy etc

ECHA - Administer and support Committees in

application-related activities (not opinion-related - eg

establishing D-R functions)

ECHA - Provide PSISs

ECHA - Undertake business rules etc checks following

submission

ECHA - Issue invoices and receive fee payments

ECHA - Support rapporteurs and Committees during

opinion-making

ECHA - Administer public consultation on alternatives

Administrative

costs

Yes - Information

provided by ECHA

(Level of detail

will be determined

by ECHA record

keeping)

Data on

Committee

funding

payments

ECHA Data

request

to ECHA

RAC and SEAC activities

bull Meeting attendance

bull Admin

bull Assessment of AFA

bull Rapporteur activities

Administrative

costs


(days spent) per type

of activity

ECHA Data

request

to ECHA

CAs - Provision and funding of Committee members

CAs - REACH Committee etc involved in evaluating

approving COM decisions

Administrative

costs

Yes - Number of FTEs

associated with CA

Committee

membership

representation

Cost per FTE

CAs

ECHA

Data

request

to MS CA




impact

Justification


From

whom

Proposed

tool

Fee receipts

COM - General administration of and policy

development for authorisation application process

COM - formulate AfA decisions

COM - Administer REACH-related committees

Administrative

costs

Yes - Information

provided by COM

(Level of detail

will be determined

by COM record

keeping)

COM Data

request

to EC



impact

Justificat

ion for

exclusion


whom

Proposed

tool

Trigger internal discussions following listing

and spending decisions on options for

substitution

RampD costs Yes - Instances of RampD spending

- Substance and Use

Estimated euro spending (one-

off or annual)

Applicants Online

industry

survey amp

case study

Substitution from substance Substitution Yes - Instances of substitution -

Substance and Use


Impacts - eg changes in

sales profit risk

management

Applicants Online

industry

survey amp

case study

Communication with MI and trade association

or relevant REACH consortia

Improved

supply chain

communicatio

n

No Only

possible

to

generate

anecdotal

responses

that




impact

Justificat

ion for

exclusion


whom

Proposed

tool

already

exist

Costs to prepare AfA Cost of AfA Yes - Estimated cost (euro)

Identify substance and

use

ECHA

Applicants

Data

request to

ECHA

Decide whether to postponedelayincrease

investment

Investment

decision

Yes - Instances of postponed or

delaying investment -

Substance and Use


investment - Substance

and Use

Applicants Online

industry

survey amp

case study

Improvements in working conditions and RMMs Reduction in

risk (human

health andor

environ-

mental)


How working conditions

have improved

What RMMs were


effectiveness

If that resulted in change

in skills required or

number of staff required

Estimated cost

Applicants Industry

online

survey

Did any publicly available information

provided by ECHA save time in terms of how

to prepare for authorisation

Administrative

costs

Yes - One off time saved

(number)

How useful any

information waswasnrsquot

(scale)

How often did they use

them (frequency)

Areas for improvements

Applicants Industry

online

survey




impact

Justificat

ion for

exclusion


whom

Proposed

tool

(free text)

Did the PSIS with ECHA save time in terms of

knowing what to do to be compliant andor

how to prepare for authorisation

Cost of AfA Yes - One off time saved

How useful any


(scale)

There are

the PSIS

questionnai

re which

ECHA

collects

after each

session

Data

request to

ECHA

Availability of a DNEL and dose response

curves

Cost of AfA Yes - Here we need info from ECHA

for which substances was the

DNEL dose response curve

available and when came this

officially available

ECHA Data

request to

ECHA

Option to use of low volume dossier route Cost of AfA Yes - Would they have benefited

could they benefit in the

future

Would it save a significant

amount of costs (fees and

requirements)

Would it make it easier for

SMEs to apply

How could the low volume

dossier route be improved

Question

for ECHA is

for whom it

would have

made a

difference

in applying

for

authorisati

on

Data

request to

ECHA

Option to use of legacy spare parts route Cost of AfA Yes - Would they have benefited


future


amount of costs


Question

for ECHA is

for whom it

would have

made a

difference

Data

request to

ECHA




impact

Justificat

ion for

exclusion


whom

Proposed

tool

SMEs to apply



in applying

for

authorisati

on

SME - costs Cost of AfA Yes - Authorisation process - key

challenges for SMEs

Applicants

(SMES only)

Tier 1 and

2 case

study

SME - challenges Barriers to

applying

Yes - What are the main barriers for

applying for authorisation for

an SME (are they the same as

a non-SME)

Applicants

(SMES only)

Tier 1 and

2 case

study



impact

Justification


Proposed

tool

Contribution during public

consultation and trialogue

Administrative

costs

Yes - A list of existing AfAs that would have

been applicable for the lsquolegacy spare

parts routersquo simplification authorisation

route

ECHA Data

request to

ECHA


alternative (substance

technology or product) in

order for companies to

switch from using

substance(s) on the RMOA

recommended for

authorisation

Increase in

salesmarket

share



substance

Suppliers of

alternatives

Tier 1 and

2 case

study

Change in volume supplied Changes in Yes - Evolution of import of finished goods DUs of the Tier 1 and




impact

Justification


Proposed

tool

of alternative market

structure

produced with annex XIV substance

and produced outside of the EEA


annex XIV substance compare with

the supply chain of the alternative


alternative

Specific

suppliers of

alternatives

2 case

study

Supply of alternative

substance or technology

Substitution Yes - Applications with a supplier of an

alternative present in trialogue

ECHA Data

request to

ECHA



Administrative

costs

Yes - Man hour cost (days spent) of suppliers

of alternatives to comment and

participate to trialogue

References

received from

ECHA (see other

question)

Industry

online

survey



Substitution Yes - In which cases were there any changes

in the application or the intentions of

the applicant regarding substitution as

a result of the public consultation or

trialogue

ECHA Data

request to

ECHA





switch from using

substance(s) on

authorisation list

Reduction in

risk (human

health andor

environmental

)

Yes - Are the risks of the alternatives

known as well as for the annex XIV

substance

How much Is the risk of the

alternative substance mentioned in a

substitution plan lower

application

dossiers

Further

research

targeted

data

request

Change in volume supplied

of alternative

Changes in

market

structure

Yes - Impact of granting authorisation on the

business of the alternative

Specific

suppliers of

alternatives

mentioned in

application files

Tier 1 and

2 case

study



Actor NGO


impact

Justification


Proposed

tool

Provide comments as part

of public consultation eg

about possible alternative

substances and

technologies

Administrative

costs

Yes - Number of hours spent preparing and


Number of AfAs (and substancesuses)

for which information was provided

NGOs NGO survey





other NGOs industry etc

Administrative

costs

No Voluntary action

that should not

be included

within the

assessment


activities





NGOs NGO survey

Actor Workers


impact

Justification


From

whom

Proposed

tool

Exposure in firms substituting

away from substance during

application process or

relocating use

Reduction in

risk (human

health andor

environmental)


Average exposure of workers in

industry using substance

Number of workers


substance



case study

Employment in firms


substance during application

process via relocation


relocation

Average number of workers in

firms substituting via relocation


case study




impact

Justification


From

whom

Proposed

tool






process

Reduction in

risk (human

health andor

environmental)




pre-Average exposure of workers

in industry using substance


Dose-response etc



AfAs Tier 1 and 2

case study

Actor Consumers


impact

Justification

for exclusion

Information

needed From whom Proposed tool Comments

Consumptions of products

produced by firms who have

substituted away from

substance or relocated use of


process

Changes in

product price

andor quality

No Unlikely to be

able to obtain

sufficient

quantitative

data required to

assess this

There might be

some anecdotal

evidence of

changes in price

availability etc





impact

Justification

for exclusion

Information

needed

From

whom

Proposed

tool Comments

Exposure via environment to

substances used by firms



process

Reduction in

risk (human

health andor

environmental)

No Unlikely to be

able to obtain

sufficient

quantitative

data required to

assess this

Some indication

could be obtained

from information

on use and

emissions of

substances



improving RMMs related to use

of substance during

application process

Reduction in

risk (human

health andor

environmental)

Yes - Pre- and post-

RMM exposures

Population at

risk

Dose-response

etc function

Values of

health impacts

AfAs

Opinions

Applicants

Tier 1 and

2 case

study

Use (and non-use) of

environmental services

affected by use of substances

by firms substituting away

from substance or relocating

use of substance during

application process

Reduction in

risk (human

health andor

environmental)

No Unlikely to be

able to obtain

sufficient

quantitative

data required to

assess this

Some indication

could be obtained

from information

on use and

emissions of

substances




by firms improving RMMS

related to use of substance

during application process

Reduction in

risk (human

health andor

environmental)

No Unlikely to be

able to obtain

sufficient

quantitative

data required to

assess this

Some indication

could be obtained

from information

on use and

emissions of

substances



D5 STAGE 5 Post authorisation decision



impact

Justification


From

whom

Proposed

tool

ECHA - Maintain register of

applications and DUs

Administrative

costs

Yes - Information provided by ECHA Level of

detail will be determined by ECHA record

keeping

ECHA Data request

to ECHA

CAs and NEAs - Monitoring and

enforcement of authorisations

and rejected applications

Administrative

costs

Yes - CA spend on REACH authorisation

enforcement and monitoring activities

CAs Data request

to MS CA

COM - post-decision activities Administrative

costs

Yes - Activities carried out and time taken Data request

to EC



impact

Justification


Proposed

tool

Update registration dossiers Administrative

costs

Yes Estimated cost (euro)


Registrants Tier 1 and

2 case

study

Update eSDS in all languages

and communication with the

supply chain

Administrative

costs

No Too early to

assess this

aspect of

authorisation


Identify substance

Applicants Industry

online

survey

Downstream user notifications Administrative

costs



Applicants Industry

online

survey




impact

Justification


Proposed

tool

Compliance with conditions

set out in authorisation

Administrative

costs

Yes - Estimated cost (euro) - one off or annual


Applicants Online

industry

survey amp

case study



Reduction in

risk (human

health andor

environ-

mental)


How working conditions have

improved


effectiveness



Estimated cost

Applicants Industry

online

survey

Registered number of DUs and

manufacturers of the

substance

Changes in

market

structure

Yes - Changes in the number of companies

level of competition competing

products

Changes in prices of supply product

prices quality

Applicants Tier 1 and

2 case

study

Decide whether to substitute

submit review report shut

down operations or relocate

outside of the EU following

review period granted

Closure

relocation

No Too early to

assess this

aspect of

authorisation

Instances of ceasing operations -

Substance and Use

Instances of relocating - Substance

and Use

Applicants Online

industry

survey amp

case study

Decide whether to

postponedelayincrease

investment following review

period granted

Investment

decision

No Too early to

assess this

aspect of

authorisation

Instances of postponed or delaying



Substance and Use

Applicants Online

industry

survey amp

case study





impact Justification for exclusion Information needed From whom

Proposed

tool



Changes in market

structure

No Too early to assess this

aspect of authorisation

Actor NGO


impact

Justification

for

exclusion


whom

Proposed

tool





NGOs industry etc

Administrative

costs

No Voluntary

action that

should not

be included

within the

assessment


Which stages of the authorisation process

the activities relate to



NGOs NGO survey

Identification of examples of

changes in market structure

Changes in

market

structure

Yes - NGOs perceptions about the impact of

authorisation on market structure (for

SVHCs and alternatives) including impacts

on number of companies level of

competition employment trade balance

Information about whether this stage of

the authorisation process is creating

opportunities for companies that produce

safer alternative to gain market share

NGOs NGO survey

Examples of substitution by

companies despite granted

authorisation for the same use

Substitution Yes - - Information about cases where substitution

has taken place after authorisation has been

granted past last LAD

- Information (quantitative where possible)

NGOs NGO survey




impact

Justification

for

exclusion


whom

Proposed

tool

about whether granted authorisation is

leading to a delayed transition to

alternative substances

Actor Workers


impact

Justification


From

whom

Proposed

tool


away from substance following

failed application

Reduction in

risk (human

health andor

environmental)

No -

Employment in firms


substance via relocation

following failed application

Unemployment No -



substance as a result of

conditions in granted

authorisation

Reduction in

risk (human

health andor

environmental)



using substance pre


using substance post

Number of workers

Dose-response etc



AfAs

Opinions

Applicants

Tier 1 and

2 case

study



Actor Consumers


impact

Justification

for exclusion

Information

needed

From

whom

Proposed

tool



substance following failed application

Changes in

product price

andor quality

No -



impact

Justification


From

whom

Proposed

tool

Exposure via environment to substances used by

firms substituting away from substance following

failed application

Reduction in

risk (human

health andor

environmental)

No -


firms improving RMMs related to use of substance

as a result of conditions in granted authorisation

Reduction in

risk (human

health andor

environmental)

Yes - Use of substance by

industry prior

Average exposure of

workers in industry

using substance pre

Average exposure of

workers in industry


Number of workers

Dose-response etc

function for

substance

Value of health

impacts

AfAs

Opinions

Applicants

Tier 1 and

2 case

study

Use (and non-use) of environmental services Reduction in No -




impact

Justification


From

whom

Proposed

tool

affected by use of substances by firms

substituting away from substance or relocating

use of substance following failed application

risk (human

health andor

environmental)

Use (and non-use) of environmental services

affected by use of substances by firms improving

RMMS related to use of substance as a result of

conditions in granted authorisation

Reduction in

risk (human

health andor

environmental)

No Unlikely to be

able to obtain

sufficient

quantitative

data required

to assess this



D6 STAGE 6 Review authorisations following review period




Information

needed

From

whom

Proposed

tool

As per Applications for

authorisation

Administrative

costs

No Too early to assess this aspect of

authorisation




Information

needed

From

whom

Proposed

tool

Reapply for authorisation

following review period

Cost of review

report


authorisation




Information

needed

From

whom

Proposed

tool

Submit comments during public

consultation on use and

availability of suitable

alternatives

Administrative

costs


authorisation

Actor NGO



Information

needed

From

whom

Proposed

tool





Information

needed

From

whom

Proposed

tool

Provide comments on review

reports following the review

period

Administrative

costs


authorisation





NGOs industry etc

Administrative

costs


authorisation

Actor Workers



Information

needed

From

whom

Proposed

tool



application process relocating

use

Reduction in

risk (human

health andor

environmental)


authorisation

Employment in firms




Unemployment No Too early to assess this aspect of

authorisation




process

Reduction in

risk (human

health andor

environmental)


authorisation



Actor Consumers



Information

needed

From

whom

Proposed

tool






process

Changes in

product price

andor quality


authorisation




Information

needed

From

whom

Proposed

tool



substance during application process

Reduction in risk

(human health

andor

environmental)

No Too early to assess this aspect

of authorisation


used by firms improving RMMs related

to use of substance on RMOA selected

for authorisation

Reduction in risk

(human health

andor

environmental)


of authorisation


services affected by use of substances

by firms substituting away from

substance or relocating use of


Reduction in risk

(human health

andor

environmental)


of authorisation



by firms improving RMMS related to use

of substance on RMOA selected for

authorisation

Reduction in risk

(human health

andor

environmental)


of authorisation



ANNEX E LITERATURE REVIEW

E1 Introduction

It was important that this project made use of existing information already in the public domain

Therefore as part of this work a literature review was carried out on each of the focus areas of

this study

Changes in the market SHVCs ndash This is covered in Section E3 In order to understand if

any changes in the market for SVHCs are due to authorisation there is a need to understand

the overall EU chemicals market which is covered first in Section E2

Instances of substitution of SVHCs ndash This is covered in Section E4 setting out instances of

substitution of SHVCs due to REACH authorisation

Costs of REACH authorisation ndash This is covered in Section E5

Benefits of REACH authorisation ndash This is covered in Section E6

Affordability on SMEs ndash This is covered in Section E7

Announcement effect - This is covered in Section E8

A summary of the literature review can be found within the main chapters for each focus area

E2 EU chemicals market

In this section the overall trends in the EU chemicals sector are identified in terms of (i) sales

value (ii) imports (iii) exports (iv) number of companies and (v) spending on RampD and investment

This information provides a point of comparison for the trends in the market for SVHCs and possible

alternative substances identified as part of this study It helps to understand whether the observed

changes in the market for SVHCs closely follow the trends of the overall EU chemicals market or

whether there are significant differences An analysis of the drivers for sector-specific market

changes will assist in determining the SVHC market changes that can be attributed to the REACH


The insights in this section are mainly based on information provided by The European Chemical

Industry Council (CEFIC) Other sources were reviewed but the analysis in these sources also rely on

the data provided by CEFIC

This section is split into four sub-sections

Section E21 - EU chemical industry sales - Overall trend presents an overview of the

fluctuation in sales values experienced by the EU chemicals sector and how this compares

to the global chemicals market

Section E22 - EU internal chemicals market provides an insight into EU chemical sales

broken down by Member State and trade amongst Member States



Section E23 - Extra-EU trade summarises information about trends in imports and exports

from and to countries outside the EU and the resulting trade balance

Section E24 ndash Growth competitiveness and drivers of change presents some of the

potential drivers for the decline in the EUrsquos global market share including market related

drivers like capital and RampD spending labour costs exchange rate fluctuations and

legislative drivers

Section E25 ndash Capital and RampD spending presents trends in capital and Research amp

Development (RampD) spending

E21 EU chemical industry sales - Overall trend

The EU chemicals industry172 sales value increased between 1995 and 2012 with the exception of

2009 which saw a decline Despite this the share of the EU market in the global market declined

significantly from 323 in 1995 to 147 in 2015 as shown in Figure E01 (CEFIC 2016a)

Figure E01 EU chemicals sales

Sales value of the EU chemicals market and share of the global market

Based on underlying data from CEFIC (2016a)

The change in annual EU chemicals sales revenue has largely mirrored those of world chemicals

sales values between 1995 and 2012 However global chemical sales values have been increasing

continuously from euro3050 billion in 2012 to euro3534 billion in 2015 while EU chemical sales values

have declined (CEFIC 2016a) This recovery in global chemical sales is mainly driven by growth in

China (CEFIC 2016b)

172 ldquoChemical industryrdquo excluding pharmaceuticals in the 28 EU countries as defined by CEFIC



E22 EU internal chemicals market

The EU chemicals market has been dominated by seven Member States in 2015 As shown in Figure

E02 Germany France Italy the United Kingdom the Netherlands Spain and Belgium together

account for 84 of total EU chemical sales (CEFIC 2016b)

Figure E02 Share of member states in EU chemical sales

(Source CEFIC 2016a)

As indicated by Figure E03 the majority of EU production (764 on average between 2005 and

2015) is sold and used within its 28 Member States A significant but decreasing proportion (about

28 on average) is used in the Member State producing the chemicals (referred to as ldquohome salesrdquo

in Figure E03) The share of home sales has declined from approximately 37 in 2005 to 17 in

2015 Whilst the export market seems to be recovering since 2010 (potentially due to increased

growth outside the EU) the amount of intra-EU exports has remained fairly constant Given the

slightly declining overall sales values this suggests that the overall performance of the EU chemical

industry is significantly influenced by home sales within the seven Member States shown in Figure

E02

Figure E03 EU chemicals sales by destination




E23 Extra-EU trade

As shown in Figure E04 the EU exports more than it imports As indicated by the orange line

imports have increased since 2013 which may partly explain the decline in home sales observed in

Figure E03

Figure E04 Extra-EU imports amp exports and trade balance


Figure E04 also shows that imports have grown at a faster pace than exports since 2013 The

resulting decline in the EU trade balance (ie difference between imports and exports) combined

with a growing global chemical market implies a possible decline of EU competitiveness Further

evidence for a decline in competitiveness is provided by Figure E05 showing a marked decline of

the export market share of the EU since 2003

This trend in competitiveness as measured by export share differs across the Member States The

largest EU countries (ie Germany France UK and Italy) generally experienced a decline of

competitiveness since the 1990s (CEFIC 2014) The ldquostrengthening trade links of Eastern European

countries both inside and outside the EUrdquo (CEFIC 2014 p11) after the end of the Cold War are the

most likely driver behind this trend Countries such as Poland and the Czech Republic profited from

these improving trade links due to their lower production costs which allowed them to take export

market share from the higher-production cost countries such as Germany (CEFIC 2014) In the long-

term Poland has become the main outlier with respect to export market share by markedly

increasing its export market share since the 1990s In comparison with the largest EU countries

mentioned above the change in competitiveness was not as large in most small EU countries such

as the Netherlands and Belgium Spain is the sole Western European country maintaining an export

market share level above the one it had in 1991 (CEFIC 2014)



Figure E05 EU export market share

(Source CEFIC 2014)

E24 Growth competitiveness and drivers of change

After recovering from a sharp decline in production in 2009 as a consequence of the economic and

financial crisis EU chemicals production has stayed relatively constant since 2012 as depicted by

the orange line in Figure E06 (CEFIC 2016b) This long period of stagnant growth is unusual for

the sector which has enjoyed a period of continuous long-term growth between 2003 and the

beginning of the global financial crisis in 2008 Despite this the number of enterprises

manufacturing chemicals and chemical products has increased from 28208 in 2011 to 28560 in

2014 as indicated by Eurostat (2017) data



Figure E06 EU chemicals production


Given the EUrsquos declining share of the global market Oxford Economics investigated the drivers of

EU competitiveness more closely by applying a ldquoconstant-market share methodology to chemical

exportsrdquo (CEFIC 2014 p1) The results of this analysis are also useful as a potential explanation

for the period of stagnant growth The report identifies three main drivers for the change in

competitiveness

Exchange rate

Research amp Development (RampD) intensity and

Energy prices

The effect of changes in the currency value are shown to be ldquostronger than most of the other core

drivers with every 10 change in the exchange rate [being] associated with a 4 change in

competitivenessrdquo (CEFIC 2014p19) Another factor being identified as a relevant driver of

competitiveness in the case of the EU is capital investment which is shown to have a nearly

immediate positive effect on competitiveness But this effect is smaller than that of RampD

investment (CEFIC 2014) Besides these three main drivers of competitiveness the Oxford

Economics report also concludes that labour costs have an effect on competitiveness but that this

effect is quantitatively smaller (CEFIC 2014)

CEFIC (2016b) supports the relevance of energy prices as an important driver of competitiveness it

states that the higher energy price is one of the main weaknesses of the European chemical

industry especially compared to the Middle East and the United States experiencing a shale gas

boom (CEFIC 2016b)

Regulatory costs are an additional factor potentially influencing EU competitiveness As shown in

Figure E07 chemicals legislation energy legislation and emissions and processes legislation (eg

Phase 3 of the Emissions Trading System) are the main contributors to the increase of regulatory



costs The major milestones causing the increase in regulatory costs related to chemicals legislation

are the introduction of REACH and the Classification Labelling and Packaging (CLP) Regulation in

2007 and 2008 (CEFIC 2016b EC 2016)

Using Gross Operating Surplus (GOS)173 the EC (2016) study titled Cumulative Cost Assessment for

the EU Chemical Industry found that legislation costs represent 30 of the GOS thereby

ldquoindicating that legislation costs is among the important factors shaping the profitability of the EU

chemical industryrdquo (EC 2016a p8) If businesses recover increased costs through higher prices for

customers regulatory costs can thus affect competitiveness

Figure E07 EU regulatory cost

(Source EC 2016)

While providing a good insight to the role of regulatory costs as a determinant of competitiveness

the evolution of the legislation burden depicted in Figure E07 ldquohas to be interpreted with

caution as [it] is an estimate of the trend based on the extrapolation of data from a limited

number of [key] companies and their recollections of past costsrdquo (EC 2016a p11) Comparison

with Eurostat data for capital and operating expenditures for environmental protection revealed

that the accurateness of the data underlying this estimate is higher in the period after 2008 than

before

173 GOS differs from profits shown in company accounts for several reasons Only a subset of total costs are

subtracted from gross output to calculate the GOS Essentially GOS is gross output less the cost of

intermediate goods and services to give gross value added and less compensation of employees and taxes and

subsidies on production and imports It is gross because it makes no allowance for consumption of fixed capital

(CFC) By deducting CFC from GOS one calculates net operating surplus (NOS)

httpeceuropaeueurostatstatistics-explainedindexphpGlossaryGross_operating_surplus_(GOS)_-_NA



E25 Capital and RampD spending

The Oxford Economics study (CEFIC 2014) suggests ndash as mentioned above - that capital and RampD

spending are important drivers of competitiveness Figure E08 which illustrates fluctuations in

capital spending between 1998 and 2015 indicates that 2004 is a turning point in terms of capital

spending (both in absolute terms and intensity) Following a decline since 1999 capital spending

increases steadily between 2004 and 2008 reaching a level to the one in 1999 This upward trend

was interrupted in 2009 and 2010 as a likely result of the global financial crisis Capital spending

started to recover in 2011 resuming an upward trend

Figure E08 Capital spending


The upcoming implementation of REACH in 2007 is a possible explanation for the upward trend

after 2004 as companies may have increased capital spending in anticipation of REACH to invest in

improved risk management measures and to prepare for substitution to alternatives Similarly the

upward trend since 2010 might have been at least partially due to EU legislation As mentioned by

the EC (2016) study companies may have made additional investments ldquoafter 2009 in anticipation

of the enforcement of Seveso III174 in 2012 and ETS Phase 3 in 2013rdquo (EC 2016 p11)

174 Seveso III refers to legislation aimed at preventing accidents involving hazardous substances and limiting

the consequences for human health and the environment in case of the occurrence of an accident To do so

the legislation specifies several obligatory measure to be taken by operators such as the production of internal

emergency plans Further details can be found at httpeceuropaeuenvironmentsevesolegislationhtm



Despite the upward trend since 2011 capital spending has not reached pre-recession levels One

reason might be that the shift of investment from the EU to countries outside the EU between 2008

and 2013 as revealed by a CEFIC survey among major chemical companies (CEFIC 2016b) The

responses to that survey showed that the share of domestic investment (ie investment in chemical

production facilities based in the EU) to total investment decreased by 10 percentage points in the

aforementioned period According to CEFIC (2016b) this is an indication of a decline in

attractiveness of the EU business and economic environment

As regards the reason behind this decline CEFIC (2016b p45) mentions that a key factor affecting

competitiveness ldquois the growing cumulative cost of implementing European legislationrdquo which

ldquotakes both personnel and capital resources away from innovation and production and into

regulatory compliancerdquo Thus CEFIC (2016b) seems to see European legislation as a key reason for

the loss of attractiveness of the EU business environment for chemical companies from the

European Union CEFIC (2016b) also predicts that ldquolimited investment will be dedicated to Europe

as opposed to other more competitive regionsrdquo without a supportive business environment which

CEFIC defines as an environment with a globally comparable regulatory burden and ldquocompetitive

access to energy and feedstocksrdquo (CEFIC 2016b 45) Resource prices are thus the second reason

behind the loss of attractiveness of the EU for the chemical sector

RampD spending (shown in Figure E09) in turn was relatively stable between 1993 and 2005 with

the main exception being the year 2000 when RampD spending increased by euro05 billion Similar

exceptional increases can be observed from 2005 to 2006 (ie increase by euro07 billion) as well as in

2012 and 2014 Despite relatively stable levels of RampD spending the intensity of RampD spending (ie

its size compared to sales values) has declined overall between 1993 and 2015 as shown in Figure

E09 The increase in RampD spending intensity between 2008 and 2009 can be explained by falling

sales values due to the recession but relatively constant levels of RampD spending

Figure E09 Research amp Development (RampD) Spending




E3 Market changes for SVHCs

This sub-section summarises previous findings concerning changes in the market for SVHCs over

time It considers information available prior to the launch of REACH findings from the REACH 2012

review and subsequent studies This allows for an assessment of whether the results from the

present study are aligned with findings from earlier studies as well as an assessment of the reasons

behind potential differences

An extended impact assessment on the adoption of REACH (in 2007) was published in 2003 (EC

2003) on the basis that ldquoexisting legislation was not capable of responding adequately to public

concern in Europe about the potential impact of chemicals on health and the environment and

would be increasingly unable to meet expectations in the futurerdquo (EC 2003 p 4) The assessment

of impacts of REACH on the EU chemicals market conducted as a part thereof relates to REACH as a

whole and provides no analysis specific to REACH authorisation

Studies carried out subsequently provide some information on key factors influencing the

performance of the SVHC market such as changes in investment and RampD decisions (factors closely

related to innovation) as well as the EUrsquos competitiveness in the global market and how they are

affected by the REACH process However the information provided in these reports is mostly

anecdotal and lack quantitative and monetary information

The EC (2015) report mentions that the associated stakeholder consultation revealed that ldquoindustry

representatives and companies [generally] agree that authorisation does have an impact on

competitiveness innovation and investment decisionsrdquo (EC 2015 p157) as investors require

regulatory certainty about the use of substances that are substantial to their investment and

innovation plans

In addition the REACH 2012 report suggests in relation to innovation that the Candidate List is ldquoone

of the instruments of REACH that could drive innovation thanks to substitution of SVHCs with

safer substancesrdquo (EC 2013b p68) Anecdotal evidence was provided that ldquothe placing on the

Candidate List can lead in some cases to the launch of initiatives to develop new substances or to

the reformulation of existing substancesrdquo (EC 2013b p68)

This viewpoint is supported by AmCham EU (2016) which concluded in its position paper submitted

for the REACH REFIT Evaluation that ldquoREACH has had one positive impact on innovation

management it has pushed companies to systematically identify and prioritise which substances

they are not interested in producing or using in the futurerdquo (AmCham EU 2016 p4)

A report published by the European Competitiveness and Sustainable Industrial Policy Consortium

(ECSIP 2016) emphasises that the interviews with the European Automobile Manufacturers

Association (ACEA) the European Tire and Rubber Manufacturers Association (ETRMA) the

European Apparel and Textile Confederation (EURATEX) and the European Consumer Organisation

(BEUC) revealed agreement that REACH has at most had a minimal impact on innovation This

report notes that ldquo[i]nnovation is driven by other parametersrdquo (ECSIP 2016 p36) and that

ldquoinnovation processes have been in place for a very long timerdquo (ECSIP 2016 p36-37) before

REACH This is exemplified by the SAFERUBBER project from the rubber amp plastics sector175 The

SAFERUBBER project comprised RampD activities conducted to replace a specific hazardous chemical

(ETU) that were not caused by REACH but the result of an industry initiative The report indicates

nevertheless that interviewees agreed that REACH could ldquohelp increase the momentum for certain

175 httpwwwsaferubbereu (See also Section E7)



innovation and RampD projectsrdquo (ECSIP 2016 p37) by helping to prioritise the proactive substitution

of certain chemical substances for example

With respect to long-term investment AmCham EU (2016) points out that REACH acts as a

deterrent of long-term investment as the lack of predictability surrounding REACH means

companies producing in Europe cannot be certain that a substance which is allowed now will be

available for use in three five or ten years ndash when a new product range is ready to go to the

market It is pointed out that the uncertainty over the outcome and duration of a RMOA the

outcome of the CoRAP listing and the probability of a transfer of a substance from the Candidate

List to Annex XIV makes the planning of new product lines or technology extremely challenging It

may even stop some new productstechnologies from coming to market An example for this

deterring effect mentioned by AmCham EU (2016) are nanomaterials The report stated that the

fear that they will be regulated under REACH pushed RampD and market deployment efforts to

outside of Europe A second example given in AmCham EU (2016) refers to two pharmaceutical

companies that made the decision not to move the manufacturing of two new pharmaceuticals to

the EU due to the reliance of the process on the use of aprotic solvents that are on the Candidate

List and may soon be prioritised and added to Annex XIV

With respect to competitiveness the ECSIP (2016) report states that based on case studies and the

results of quantitative modelling REACH (not specifically the authorisation process) has a minor

negative impact on the competitiveness of the EU industry in relation to their third-country

competitors The study refers to three distinct market situations (i) production within the EU for

sale within the EU (ii) production in the EU for sale in third countries and (iii) production in third

countries for the EU (and other third country) markets) The first market situation (ie production

within the EU for sale within the EU) is the most relevant for REACH authorisation It is pointed out

that REACH creates a level playing field for EU chemicals producers and third country producers of

chemicals competing in the EU market since third-country producers will also have to meet REACH

requirements when operating in the EU However the authorisation requirement has the potential

to harm competitiveness EU article manufacturers may be at a competitive disadvantage since the

requirement for authorisation of SVHCs does not apply to imported articles The competitors

producing outside the EU for export to the EU market thus do not have this cost element

In relation to imports and exports ndash one indicator for the performance of the SVCH market - the EC

(2015)176 report mentions that the majority of respondents to an industry survey report no changes

to imports and exports as a result of the implementation of REACH Nevertheless the impact on

manufacturer and importers (MIs) has tended to be negative due to increased prices related to

costs of REACH compliance and increased transaction costs with non-EU suppliers that cannot be

recovered through higher prices Article suppliers are said to have experienced more positive

impacts on this front

The EC (2015)176 report also provides insight on the effects of including substances in the Candidate

List and Annex XIV on the costumers of the SVHC market The results of a business survey show that

39 of survey respondents answering the question whether their customers requested the removal

of SVHCs from their products (n=242) received such requests Among companies self-declaring as

suppliers of articles around 70 received such requests





The EC (2015) report also stresses that the extent of downsizing in the SVHC market in terms of the

reduction of the number of active companies ldquodepends on the criticality of the substance going

through Authorisation and on the feasibility of substitutionrdquo (EC 2015 p157) as it influences the

propensity to withdraw from the market or to relocate to countries outside the European Union

Two scenarios through which authorisation can impact on the size of the market are mentioned

The first one focuses on companies with manufacturing facilities in a country that is not part of the

EU These companies might see relocating as the straight-forward solution allowing them to avoid

the authorisation procedure as a whole The second scenario refers to companies facing the

necessity to submit a costly (and time-limited) application for an authorisation which can push

them to contemplate solutions outside the EU The authors note that ndash despite the undeniable

potential for a downsizing effect ndash it is not certain that the market will shrink significantly as the

share of SMEs among chemical companies and its downstream users is about 95 and as it is

questionable whether relocation to a non-EU country is economically feasible for many of them

E4 Instances of substitution

This subsection considers incidences of substitution that have been found in literature As per the

interim report a list of key databases is listed below with some commentary on each

SUBSPORT (EU based) - httpwwwsubsporteu

This web-based resource is a free-of-charge multilingual platform for information

exchange on alternative substances and technologies It also provides tools and guidance

for substance evaluation and substitution management

The SUBSPORT indicates that it provides information to support efforts in substituting

hazardous substances The web site sets out pages on specific areas of substitution

Substitution Steps

An outline methodology is described to organise a substitution programme with a short

narrative on each step providing lsquouseful linksrsquo to other external web-based information as

each stage The stages are 1 Define the Problem 2 Set substitution criteria 3 Search

for alternatives 4 Assess and compare alternatives 5 Experiment on pilot and 6

Implement and improve

Substitution in Legislation

This provides summaries of legislation and international agreements that are relevant to

substitution whether they refer to it directly or are closely related Links to the original

documents as well as archived copies of the relevant legislationagreements are also

provided EU US and Chinese legislation and International agreements are listed

Identifying Substances of Concern

This page of the web site presents an overview of the criteria and their definitions that are

most used by different sources to identify substances of concern More detailed

descriptions are also available with links to the original documents The summary data are

presented in a series of tables namely

o health hazards sub divided to acute toxicity (highly toxic corrosionirritation of

skineyes) and chronic toxicity (highly toxic carcinogenicity mutagenicity

genotoxicity reprotoxicity (including developmental toxicology) endocrine

disruptors sensitization of the skin or respiratory system neurotoxicity immune



system effects and systemic toxicityorgan effects (via single or repeated

exposure)

o environmental effects subdivided to persistence andor bioaccumulation and

toxicity ozone depletion environmental toxicity and aquatic toxicity and

o fire and explosion hazards subdivided to explosion flammability oxidising and

other properties

The tables set out definitions that are listed in European and non-European systems that

are both regulatory and non-regulatory The following sources are referred to directly in

the tables (not all are relevant to all hazard categories)

o Column Model IFA (Germany)

o Quick Scan VROM (Netherlands)

o PRIO KEMI (Sweden)

o SIN LIST ChemSec (Sweden)

o ISTAS Black list ISTAS (Spain)

o Trade Union List European Trade Union Confederation (ETUC)

o NTP 712 INSHT National Institute for Health and Safety at Work (Spain)

o COSHH Essentials Health and Safety Executive (UK)

o MAL code system

o National Plan to implement Stockholm Convention and Regulation 8502004 on

Persistent Organic Pollutants Ministry of Environment (Spain)

o REACH Regulation European Union

o Cradle to Cradle Design Protocol MBDC (USA Germany)

o Five Chemicals Alternatives Assessment Study TURI (USA)

o Design for the Environment Formulator Program EPA (USA)

o Green Screen for Safer Chemicals Clean Production Action (Canada US)

o SC Johnson Greenlist

Restricted and Priority Substances Database

The on-line searchable database contains 34 lists of substances that are legally or

voluntarily restricted or are recommended for restriction because of their hazards Lists are

grouped in five categories international agreements EU regulatory lists governmental

lists NGO and trade union lists as well as company lists The database is suggested as a tool

to check whether a substance is listed and therefore indicating the need to substitute it or

not to accept it as an alternative Descriptions of the lists and links to the original sources

are indicated in the database

Case Story Database

This part provides substitution examples information on alternative substances and

technologies from enterprises published reports and other sources The case stories are

intended to serve as lsquoinspirationrsquo and to offer help to companies or organisations searching

for substitutes to hazardous chemicals The case study chemicals listed are

o chloroalkanes

o chromium VI and compounds

o bisphenol A

o lead and its inorganic compounds

o nonylphenol and ethoxylates

o tetrachloroethylene



o formaldehyde

o brominated flame retardant hexabromocyclododecane (HBCDDD)

o parabens (methylparaben ethylparaben propylparaben butylparaben)

Substitution Tools

Although it was last updated over six years ago (last updated on 22122010) these pages

include summaries of lsquotoolsrsquo that may be used in the substitution process The pages

include links to the information sources (detailed description of the tools can be accessed)

Whenever the original document is available in other languages besides English information

on how to access those versions is included in the summaries

Tools and guidance to support substitution are provided either by authorities industry

associations by scientific bodies or NGOs Guidance is general and does not go beyond

basic principles of substitution Tools supporting substitution are mostly focussed on taking

a step-wise approach (eg decision criteria assessment of alternatives implementation

planning) Some tools are focused on substitution (eg Green Screen for Safer Chemicals)

others are more focused on the implementation of safety regimes in the workplace (eg

COSHH Essentials) or prioritisation for risk management (eg PRIO) and one of the listed

tools is a workplace exposure and exposure control model (Stoffenmanager)

List of tools described

o Column Model for Chemical Substitutes Assessment

o COSHH Essentials

o Technical Rules for Hazardous Substances (TRGS) 600

o Green Screen for Safer Chemicals

o Determination and work with code numbered products (MAL Code)

o Pollution Prevention Options Analysis System (P2OASys)

o Priority-Setting Guide (PRIO)

o Quick Scan

o Stockholm Convention Alternatives Guidance

o Stoffenmanager



AssessmentAlternativesAssessmentaspx

Lowell Centre is an academic institution that is part of the University of Massachusetts

(USA) Web pages are dedicated to setting out a process for identifying comparing and

selecting safer alternatives to chemicals of concern (including those in materials processes

or technologies) on the basis of their hazards performance and economic viability It is

intended to support decision making for scientific market or regulatory reasons The

process is based on two decades of research in the area it is influenced more by USA

regulations and concerns than by European issues or legalisation (such as REACH) The web

pages provide links to resources and publications ndash a significant one is TURI (Toxics Use

Reduction Institute) which also provides links to resources and information intended to

support and guide and also research programmes and sources of funding for relevant

projects Specific detailed methodologies or databases of alternative substances do not

appear to be provided






This US publication is based on the work of an expert committee and the development of

that committeersquos framework which built upon the work of US regulatory agencies

academic institutions and others who have developed alternatives assessment frameworks

This report provides a description of the committeersquos 13-step framework which is

structured to support decision-making about alternatives to chemicals of concern The

framework is flexible enough for an assessor to use a hybrid approach in which certain

steps are completed sequentially in parallel or iteratively providing an opportunity for

fit-for-purpose decision making

The alternatives assessment framework has the following main activities (optional activities

asterisked)

Step 1 Identify Chemical of Concern

Step 2 Scoping and Problem Formulation

Step 3 Identify Potential Alternatives

Step 4 Initial Screening of Identified Alternatives

Step 5 Assess Physicochemical Properties

Step 6-1 Assess Human Health Hazards

Step 6-2 Assess Ecotoxicity

Step 6-3 Conduct Comparative Exposure Assessment

Step 7 Integration of Information to Identify Safer Alternatives

Step 8 Life Cycle Thinking

Step 9-1 Additional Life Cycle Assessment

Step 9-2 Performance Assessment

Step 9-3 Economic Assessment

Step 10 Integrate Data and Identify Acceptable Alternatives

Step 11 Compare Alternatives

Step 12 Implement Alternatives

Step 13 Research and Innovation

The publication is influenced by the US and global agenda on chemicals and alternatives

and does not appear to be aimed or influenced specifically by REACH



and programmes (including the Lowell Center and SUBSPORT) This is a compilation of web-

based resources relevant to chemical substitution and alternatives assessments There are

four resource areas namely

o Alternatives Assessment Tool Selector A filterable inventory of chemical hazard

assessment tools and data sources to help you identify tools most relevant to your

substitution and alternatives assessment goals A listing of non-hazard assessment tools

is also available

o Alternatives Assessment Frameworks A summary of the current frameworks that can be

used to assess alternatives Guides and other resources for conducting a chemical

substitution or alternatives assessment are included



o Case Studies and Other Resources Links to case studies toolkits and product rating

systems that provide examples insights and lessons learned on substitution and

alternatives assessment approaches

o Regulations and Restrictions A list of regulations and restrictions throughout OECD

member countries that are driving the increased need for chemical substitution and


Since the OECD includes the EU Member States REACH is referred to through the ECHA guidance

and EC reports cited The website is largely a collection of information resources and

methodologies set up by others


access)

This publication is an in-depth academic analysis of different alternatives assessment

methods and their application It provides critical evaluation of methods in theory and

practise as well as specific chapters on certain chemical types (eg flame retardants)

The RSC is a UK-based institution but the publication takes a global perspective and does

not appear to be focused on any specific legislative regime and not driven by REACH

US Environment Protection Agency (US) - Design for the Environment Alternatives

Assessments - httpswwwepagovsaferchoicedesign-environment-alternatives-

assessments - Web-based tool with key steps to conducting an alternatives assessment and

case studies

The EPA uses alternatives assessments to identify safer chemicals Design for the

Environment (DfE) alternatives assessments are conducted as risk management actions

when warranted for TSCA (Toxic Substances Control Act) Work Plan Chemicals DfE have

also been conducted under Chemical Action Plans By identifying and evaluating the safety

of alternative chemicals this approach can

o encourage industry to move to safer alternatives

o complement regulatory action by showing that safer and higher functioning

alternatives are available or

o point out the limitations to chemical substitution for a particular use

Specific example projects are listed on the USEPA web site include Alternatives to Certain

Phthalates

o BPA in Thermal Paper

o Flame Retardant Alternatives to DecaBDE

o Flame Retardant Alternatives to HBCD

o Flame retardants in flexible polyurethane foam logo

o Flame Retardants in Flexible Polyurethane Foam

o Flame Retardants in Printed Circuit Boards

o Nonylphenol Ethoxylates

The EPArsquos work is focused solely on US law and US regulatory drivers and programmes






In October 2012 a group of 26 environmental health scientists advocates funders and

policy makers met in Boston Massachusetts for two days of meetings entitled Building a

Chemical Commons Data Sharing Alternatives Assessment and Communities of Practice

One of the key outcomes of this meeting was an agreement regarding the need for a

common definition and set of principles for chemicals alternatives assessment Following

this meeting a subcommittee met over four months in 2013 to refine a consensus set of

principles These principles were based on earlier foundational work by the Lowell Center

for Sustainable Production the Massachusetts Toxics Use Reduction Institute the

Environmental Defense Fund and the BizNGO Working Group These principles are shared

and used in framing discussions about alternatives assessment and to guide decision making

about safer chemical use

Alternatives Assessment is described as a process for identifying comparing and selecting


technologies) on the basis of their hazards performance and economic viability A primary

goal of Alternatives Assessment is to reduce risk to humans and the environment by

identifying safer choices

BizNGO Chemical Alternatives Assessment Protocol is a decision framework for

substituting chemicals of concern to human health or the environment with safer

alternatives It describes a process for identifying alternatives to a chemical of concern

screening out equally hazardous alternatives and selecting an alternative that is

technically and economically viable and does not have the potential for causing significant

environmental or human health impacts Many other schemes such as the ones already

listed and described above are referred to The initiative is US focused but refers to other

schemes globally REACH is not a specific driver for this initiative

E5 Costs of authorisation

The EC (2015) report titled Monitoring the Impacts of REACH on Innovation Competitiveness and

SMEs notes that ECHA estimates the average cost per applicantuse to be approximately euro230000

based on a survey conducted among authorisation applicants in 2013 and 2014 This survey which

received 24 responses indicates a decline of the average cost in the long run as ldquoapplicants that

submitted AfAs in the second half of 2014 had average costs of less than euro200000 per

applicantuserdquo (EC 2015 p144) The authors of the EC (2015) study highlight that these figures

were confirmed by interviews conducted as part of their study and mention the increasing

experience with the process as the reason for this decline in average cost

In addition the EC (2015) study uses ECHA data to analyse the shares of cost components related to

an application for authorisation It finds that the biggest share of the total cost are expenses and

internal staff time (25) followed by consulting fees for the analysis of alternatives (20) and the

preparation of the socio-economic analysis (18) Application fees only account for 15 of the total

cost Their share of the total cost is therefore only slightly bigger than that of consulting fees paid

for the preparation of the Chemical Safety Report (13) The aforementioned internal staff time

includes - among others - the time spent on fulfilling information obligations set by public

authorities according to the EC (2016) study This study mentions that in the case of authorisation

this involves providing responses to Candidate List consultations preparing inputs to chemical

safety assessments and justifications for authorisation as well as providing responses to Committee

opinions on applications



Further evidence for the limited role of application fees in terms of total cost is provided by

Harrikari and Montonen (2017) Their survey among 14 Finnish companies revealed that for micro

companiesrsquo regulatory charges accounted only for 12 of total costs as shown in Figure E010 The

category named Working hours in the pie chart includes time used for gathering information from

the company database and putting it in the correct format attending meetings and conducting

additional measurements and implementing changes in practises The work interruption costs (5 of

the total) refer to costs caused by attending meetings and therefore being absent from the factory

operations and processes Harrikari and Montonen also point out that for large companies ldquo[t]he

distribution of costs [hellip] for applying for authorisation was nearly identical to that of the micro

companies but on a different scalerdquo (Harrikari and Montonen 2017 p 13)

Figure E010 Distribution of costs related to application for authorisation (micro companies)

Source (Harrikari and Montonen 2017)

In terms of total AfA costs the Finnish study reveals that for micro companies ldquothe costs of AfA

were between euro36000 and euro45000 for each companyrdquo (Harrikari and Montonen 2017 p12) applying

as part of a consortium These figures exclude the cost of working hours which are estimated to

add between 16 and 30 to the cost figure above Despite the surveys revealing that the costs of

the AfA were bigger than 10 of annual turnover ndash and therefore considered significant - only for

two of six micro companies the interviews showed that ldquo[a]pplying alone would have increased the

costs to an impossible level for micro companiesrdquo (Harrikarri and Montonen 2017 p11)

In the case of large companies those applying alone faced lower AfA costs in terms of the

percentage of turnover than those that applied as part of a consortium Nevertheless Harrikari and

Montonenrsquos interviews revealed that the companies applying alone found that the process was very

expensive

As demonstrated above application fees payable to the ECHA are only one of several types of costs

related to authorisation Commission Regulation (EC) No 3402008 (see EC 2008) sets these fees

Article 8 therein states that the fee consists of a base fee covering one substance one use and one

applicant and an additional fee for any further substance use or applicant covered in the AfA

These fees - set out in Annex VI of the regulation - are shown in Table E01 Article 9 of the

regulation states that a fee must also be paid upon submission of an authorisation review report



and these fees which are set out in Annex VII are exactly the same as for an initial application for

authorisation

Table E01 Authorisation application fees set in Commission Regulation (EC) No 3402008

Standard fees

(in EUR)

Reduced fees (in EUR) forhellip

Medium

enterprises

Small

enterprises

Micro

enterprises

Base fee 50000 40000 25000 7500

Additional fee per substance 10000 8000 5000 1500

Additional fee per use 10000 8000 5000 1500

Addit

ional fe

e p

er

applicant

Additional applicant is

not an SME 37500

Additional applicant is a

medium enterprise 30000 30000


small enterprise 18750 18750 18750


micro enterprise 5625 5625 5625 5625

Based on underlying information from Annex VI in Commission Regulation (EC) No 3402008

Regulation (EU) No 2542013 fulfils the requirement set out in Commission Regulation (EC) No

3402008 to adapt the authorisation application fees and charges to account for inflation by

increasing the fees to the currently applicable values (shown in Table E02) thereby accounting for

ldquothe applicable average annual inflation rate of 31 for April 2012rdquo (EC 2013a p1) In addition

to fulfilling the duty to adapt fees to account for inflation these values are in line with the

decision to further reduce the ldquoexisting reduced fees and charges applicable to micro small and

medium-sized enterprises (SMEs) [hellip] in order to minimise the regulatory burden and the numerous

practical challenges faced by SMEs in complying with REACH obligationrdquo (EC 2013a p1) The

decrease of fees for SMEs is rebalanced by an increase of 35 of standard authorisation application

fees

Table E02 Authorisation application fees set in Regulation (EU) No 2542013

Standard fees

(in EUR)


Medium

enterprises

Small

enterprises

Micro

enterprises

Base fee 53300 39975 23985 5330



Addit

ional fe

e p

er

applicant


not an SME

39 975


medium enterprise

29981 29981


small enterprise

17989 17989 17989


micro enterprise

3998 3998 3998 3998

Based on underlying information from Annex VI in Regulation (EU) No 2542013

Lietzmann et al (2017) analysed the 453 responses to the REACH REFIT open public consultation

survey (October 2016 - January 2017) and the 146 (position) papers submitted by the respondents

They find that almost 90 of respondents to the public consultation think that the aforementioned



authorisation fees are too high The share of respondents thinking that the authorisation fees are

too high differs significantly across different types of stakeholders as illustrated in Figure E011

Figure E011 Share of REACH REFIT respondents thinking that authorisation application fees are too high

Adapted from Figure 16 in Lietzmann et al (2017)

Costs incurred as part of substitution activities (a way of fulfilling the Annex XIV requirements

without making use of an authorisation) are also an essential part of the costs of authorisation

The European Defence Agency (2016) study177 on the impact of REACH and CLP regulations on the

defence sector even notes that the costs related to SVHC substitution and RampD are some of the

largest REACH compliance costs Similarly ASD-Eurospace notes in its REACH REFIT position paper

that it is clear that substitution costs for the space industry ldquoare far higher that the direct REACH

authorisation application costsrdquo (ASD-Eurospace 2017 p5)

The costs related to substitution can be huge An interview with the European Automobile

Manufacturersrsquo Association (ACEA) conducted as part of the ECSIP (2016) report reveals for example

that complex tests (eg retesting of airbags) must be performed when attempting substitution in

this industry which easily leads to costs of millions of euros for substance substitution

Similarly MedTech Europe (2017) mentions in its REACH REFIT position paper that substitution

would be very complex in the medical technology industry due to its highly regulated environment

that would ldquonecessitate a complete re-design including re-validation verification and stability

testingrdquo (MedTech Europe 2017 p2) as well as new conformity assessments The estimated

substitution cost is over euro100 million per substance - which is described as a conservative estimate

MedTech Europe concludes that the ldquoentire process of substitution poses a significant cost when

seen against the total IVD178 European market revenues of euro10635 billion (2014 figures)rdquo (MedTech

Europe 2017 p2) especially since the sector 95 of companies are micro small or medium

enterprises

177 European Defence Agency (EDA) (2016) Study on the impact of RAECH and CLP European chemical

regulations on the defence sector Final report 16 December 2016 Brussels Espoo REACHLaw Ltd 178 IVD refers to in vitro diagnostic

0

10

20

30

40

50

60

70

80

90

100

NGO Citizen Research Public IndustryAssociation

Business TradeUnion

Other Total



Beside the aforementioned costs substitution is linked to additional follow-up costs in some

industries increasing the costs of the authorisation process further MedTech Europe (2017) for

example points out that technology changes related to substitution lead not only to costs for the

medical technology industry sector itself but also the end-users of their products (ie clinical

laboratories)

Another example is the defence industry where suitable substitutes have to be requalified by

military authorities as noted by the Federation of the German Security and Defence Industries

(BDSV eV) in its position paper179 It is noted that this is a process with high costs due to the

necessity of conducting various tests BDSV (2017 p4) points out that these ldquocosts apply in

addition to the costs necessary for substitutionrdquo which makes REACH substitution overall more

disproportionate for this industry In addition substitution leads to additional costs due to the

necessity to make changes to related products BDSV (2017) mentions that the interplay between

defence products is very complex and products need to be well adapted to each other

Substitutions in the production of ammunition for example will necessitate changes to the design of

tanks and aircrafts

In addition to the costs faced during the preparation of an application or as part of activities

necessary to fulfil the Annex XIV requirements in another way (eg substitution and withdrawal)

there are potential long-term costs related to the authorisation requirement The European

Defence Agency (2016) points to the possibility that maintenance costs of defence equipment might

increase as a consequence of replacing SVHCs by less well performing alternatives Cr(VI)

replacements for tank barrels airplanes and ships are given as an example in which increased

maintenance costs are expected

Costs of the authorisation process affect not only companies but also the EU and Member State

level authorities involved Commission Regulation (EC) No 3402008 highlights that the ldquostructure

and amount of the fees should take account of the work [hellip] to be carried out by the Agency and

the competent authorities and should be fixed at such a level as to ensure that the revenue

derived from them when combined with other sources of the Agencyrsquos revenue [hellip] is sufficient to

cover the cost of the services deliveredrdquo (EC 2008 p1)

The European Defence Agency (2016) study illustrates that Member State level institutions that are

not directly related in REACH authorisation also incur costs by pointing to expenses of defence

ministries It mentions a survey which revealed that ~46 of Ministries of Defence experienced an

increase of their RampD costs whilst the other ministries were unable to provide an indication of any

changes in costs to RampD spending (in part because funding is paid for by another government

department)

In light of the various costs related to the authorisation process the open public consultation of the

REACH REFIT Evaluation asked stakeholders for their opinion about the extent to which costs (for

society companies public authorities etc) linked to different REACH chapters are proportionate

to the benefits Lietzmann et al (2017)rsquos analysis of the answers reveals that the opinion about the

proportionality of costs of authorisation is one of the most negative of all analysed REACH chapters

(ie registration information in the supply chain such as extended Safety Data Sheets evaluation

of dossier evaluation of substance authorisations restriction and requirements for substances in

articles) In fact ldquonegative views prevail to a large extent for costs related to authorisation [hellip]

179 BDSV (2017) BDSV input to public consultation on REACH Review 2017 Position Paper for REACH REFIT




for which large share (30-40) think that costs are not at all proportionaterdquo (Lietzmann et al

2017 p38) The other aspect where respondents had similar negative comments about the

disproportionality of costs relates to the requirements for substances in articles

The analysis conducted by Lietzmann et al (2017) also shows that businesses are more critical

about the proportionality of the cost of authorisation than trade unions consumer associations

public authorities NGOs Among businesses SME views are more negative than those of micro and

large businesses Further evidence for the prevalence of this critical view is provided by the

European Defence Agency (2016 p16) report which notes that ldquo[c]ompliance cost for REACH (eg

Article 33 and authorisation applications) are often considered as disproportionately high by

industry when compared to the benefitrdquo

E6 Benefits of authorisation

The word literature is used in the wider sense in this section of the review meaning information and

thus includes web-based information The objective is to report on studies and information that has

attempted to describe and quantify the benefits of authorisation using the following sources

1 Tickner J and M Jacobs (2016) Improving the Identification Evaluation Adoption and


within the Context of REACH

This report is the output of a project commissioned by the ECHA to assess uptake of

alternatives and how that could be promoted in the context of REACH The main focus of

the report appears to be on current practice and recommendations to improve the uptake

of alternatives for SVHCs The research done for the report included a survey of

stakeholders within which specific questions were asked on the benefits of substitution

Summaries of this information is presented in the report

ldquoThe most commonly identified benefits of substitution outlined by companies that have

implemented substitutes include improved worker safety (72 of responses) improved

brand reputation (51) improved worker satisfaction (40) decreased regulatory costs

(32) and decreased chemicals management costs (28) However companies noted a

number of common challenges most notably increased production costs (67) customer

concerns with productprocess changes (46) reduced performanceproduct quality (41)

supply chain availability of the alternative (40) and that the substitute turns out to also

be a substance of concern and subject to regulatory and non-regulatory actions (37)rdquo

Benefits were not quantified further than this and did not appear to be monetised

2 Backes D (2017) Monitoring of the authorisation process under the REACH regulation Test

of a proposed methodology Final Report May 2017 Vienna Austrian Federal Ministry of

Agriculture Forestry Environment and Water Management

The aim of the project was to test a methodology proposed by the Monitoring Task Force of

RiME to measure if and how the objectives of the authorisation under REACH have been

achieved The indicators together with other information were considered in support of

answering the main policy questions concerning the achievement of the goals of

authorisation under REACH



1 Has the objective of substitution worked

2 Are there less articles containing substances of very high concern (SVHCs) on the market

or has production and uses of SVHCs just been shifted outside Europe

3 What are the major substitutes for SVHCs and are these alternates safer

4 Have authorisation decisions led to better control of risks

5 Is the authorisation as such or parts thereof a cost-effective policy for protecting man

and environment

6 Does authorisation work better for certain types of substances than for others and would

this help to make more appropriate choices on SVHC candidates

Using information on 34 selected SVHCs the proposed indicators were assessed from the

IUCLID database numbers of registrations annual tonnages use descriptors and

supplemented by other types of information including

Information of uses from applications for authorisations and public consultations at

the ECHA website on the authorisation process

Tonnage information from the ldquoSubstances in Preparations in Nordic Countries

databaserdquo (SPIN)

Tonnage information from EUROSTAT (provided by the European Commission)

Aggregation of ambient monitoring data based on European initiatives such as the

Water Framework Directive the Rhine and Danube conventions the European

Pollutant Release and Transfer Register (E-PRTR)

A survey of experiences of companies with the authorisation process and

Market analysis of regional and worldwide uses of phthalates in the period 2007 ndash

2015 from Ceresana

The conclusions (lsquorather anecdotal responsesrsquo) were considered useful for further

discussions on different possibly more successful approaches

a REACH and more particularly the authorisation process has triggered the search

for alternatives by the affected companies

b According to the survey the inclusion of substances in the Candidate List

(identification of SVHCs) has led companies to consider the possibility of

alternatives There are a number of obstacles and barriers for implementing

alternatives

c All companies which implemented alternatives faced negative cost implications It

remained unclear if improvements as a net result of substitution would have finally

outweighed the additional costs

d An important obstacle for substitution is that most of the alternatives are

toxicologically not well known and companies hesitate to make efforts to introduce

these substitutes which may at a later stage become also stigmatised

e Although authorisation seems to provide some pressure towards substitution most

companies do not seem to feel that investments will actually pay and that the

major implication will be a disadvantage against competitors outside the EU This is

particularly the case for the use of SVHCs in articles while EU users are bound by

the authorisation the importers of articles containing SVHCs are not

f The discussion on SVHCs applied for in authorisation procedures seems to have

triggered a scrutiny of the existing risk management measures in companies

potentially resulting in improvements for workerrsquos health and risk reduction

measures for downstream users (consumers and professionals)



g Only few companies indicated that they have ongoing relocation plans to place

production outside of the EU because of the costs for authorisation andor the lack

of an alternative

3 Lietzman J Oulegraves L Pelsy F Fries-Tersch E and T Tugran (2017) Analysis of the

results of the open public and SME consultation of the REACH REFIT evaluation Draft final

report on the Open Public consultation Brussels Milieu Ltd

This report provides an analysis of 453 responses to a twelve-week open public

consultation It also included the results of a specific survey dedicated to SMEs (lsquoSME

panelrsquo) also conducted as part of the REACH REFIT consultation strategy

This study does not specifically report on benefits of REACH authorisation but reports of

REACH as a whole However there are some indications of responses from the surveys that

are relevant to the benefits of authorisation as follows (at page 68 of the report)

35 respondents mentioned benefits of REACH in their responses

Statements Number

REACH has increased knowledge on chemicals increased transparency 35

REACH has achieved better communication in the supply chain 22

REACH encouraged substitution larger market share for alternatives 19

The last statement indicates some reporting of the benefit of authorisation from the

perspective of substitution

4 Harrikari A and R Montonen (2017) How the REACH authorisation process affects and

benefits companies Aalto Aalto University

This report is the output from a project that was a lsquocustomized student business projectrsquo -

a concept by Aalto University School of Business The work was done for ECHA The project

was supervised by both Aalto University and the European Chemicals Agency The

supervisors were Sami Tuomi and Tommi Vihervaara from Aalto University and Matti Vainio

Spyridon Merkourakis Christoph Rheinberger and Kalle Kivelauml from ECHA

The objective of the study was to identify benefits that are not directly associated with

impacts on human health and environment since these are already covered in AfAs In total

14 Finland based firms were interviewed for the project (seven large companies and seven

micro companies) The authors name energy consumption labour productivity and chemical

portfolio as examples of other areas where benefits may be gained The authors found only

one lsquoclearrsquo benefit which was that micro-sized companies improved their communication

networks with each other Nevertheless the authors also mention that authorisation

prompted search for alternatives and imposition of improved safety measures (it is not

clear if measurable benefit was indicated by either of these)

5 Substitution of As2O3 in Murano Glass This is a lsquocase studyrsquo provided by ECHA the

information is not dated but was provided to the authors of this present study in May 2017

Murano have used arsenic trioxide (As2O3) widely as a refining agent by for centuries The

Commissionrsquos decision to include it in the Authorisation List (Annex XIV of REACH) in 2011

forced local glass manufacturers to decide on whether to apply for authorisation or

substitute to other substances or techniques After getting the clarity that the use of As2O3



was not an intermediate Murano glass manufacturers decided to opt for substitution based

on research carried out by the Stazione Sperimentale del Vetro in 2010

The substitution of As2O3 by antimony trioxide cerium oxide lithium oxide and blast

furnace slag resulted in a significant reduction in the concentration of arsenic in air from

over 200 ngm3 in 2014 to about 4 ngm3 in 2016 Site inspections made in 2016

corroborated that As2O3 was no longer used by all inspected companies apart from one

ECHA reports that

o The authorisation requirement resulted in over 100 small and medium sized

companies substituting As2O3 less hazardous substances In inspections only one

company has thus far not found to be in compliance

o Air concentrations of arsenic in the vicinity of Murano dropped from 2014 by 98 to

about 4 ngm3 which is now within the legal limit of about 6 ngm3 Not only has

this substitution considerably reduced the health risks of workers but also of the

population living in and nearby Murano

In the information provided ECHA does not report how many people were affected and thus

benefited from the increased quality of the air No attempt was made to quantify benefit in

terms of people affected or monetisation of benefit due to improved health or decrease in

the need for RMMs

6 Occupational safety and health (OSH) Belgium Results of inspection campaign for chemical

agents in the metal surface treatment sector

This report is a summary of an inspection campaign by the Belgian authorities with regard

to hexavalent chromium exposure Summary data are reported on exposure and risk control

measures however no specific commentary on the benefits of control measures or impacts

of the authorisation process is given

Eighty-three companies were visited in the context of the campaign in the period between

October 2015 and January 2016 Over 70 of the companies visited were businesses with

fewer than 50 employees One in two of the companies visited had fewer than 20

employees

61 of the companies visited had never conducted measurements into exposure to chemical

agents Findings from the campaign show that the majority of companies visited were made

aware by the supplier or sector organisation (Agoria andor VOM) of the inclusion of

hexavalent chromium compounds on the authorisation list and the consequences thereof on

the use of this substance

The results also showed that for a large percentage of the applications for which hexavalent

chromium compounds are used (pre-treatments such as chromate conversion) there were

suitable alternatives available or there is ongoing research into possible alternatives For a

specific application such as hard chrome plating there are currently no suitable

alternatives and the companies concerned are hoping for a possible authorisation with

regard to the use of hexavalent chromium compounds The visits illustrated that the REACH

authorisation process is a significant lever when it comes to the substitution process in the

context of the Royal Decree of 2 December 1993 on the protection of employees against the

risks of exposure to carcinogenic and mutagenic agents at work



7 EC (2016b) Study on the Calculation of the Benefits of Chemicals Legislation on Human

Health and the Environment Final Report

The project was commissioned by the European Commission DG Environment in the

framework of the Regulatory Fitness Programme (REFIT) for the chemicals policy area It

has a focus on the REACH and CLP Regulations Together with the findings of other studies

its results will inform the general report on the operation of the REACH Regulation and

more in general of the chemical legislative framework expected in 2017 The objective of

the study was to develop a system of indicators which can establish and measure the links

between chemical substances and their impacts on human health and the environment and

measure the role that chemicals legislation has had in reducing such impacts

The focus of this study was to investigate possible indicators of benefits of chemicals policy

and legalisation that could be usual to apply Some data specific chemicals in terms of

(downward) trends of concentrations in human tissues and body fluid and the environment

are set out but due to the multiple actions of various legalisation on these substances it

does not seem clear if specific benefits are attributed to the contribution of authorisation

Example are The occurrence of HBCDDD in wild birdsrsquo eggs (gulls) and PFOS and PFOA in

blood plasma

8 European Defence Agency (2016) Study on the impact of REACH and CLP European

Chemical Regulations on the defence sector Final Report Brussels Espoo REACHLaw Ltd

The objectives of this study were to provide

o Impact analysis of REACH and CLP on EU defence sector both industry and

governments

o Practical proposals on improvements for REACH and CLP and their current

implementation regime to serve as a basis for EDA and its participating Member

Statesrsquo (pMS) input to the EC for the next REACH review and as suggestions for

REACH evolutions beyond 2018 and

o Synthesis of information on impacts of other chemical regulations on EU Member

States MoDs and the defence sector (especially BPR ODS POP) their interaction

with REACH and CLP and a strategy (draft as a minimum) with proposals for

improvements

This report focused on the costs and negative impacts on the defence industries rather than

indicating benefits The following observations were made with respect to authorisation

REACH authorisation timelines are strongly mismatched to the defence sector

There is a strong mismatch between the timelines of REACH authorisation (sunset dates of

typically 3 years after Annex XIV inclusion and review periods for granted authorisations

ranging from 4 7 to 12 years) for Substances of Very High Concern (SVHCs) and the very

long equipment lifecycles in the defence sector which often requires the use of particular

SVHC substances (up to several decades) for production and maintenance This has

sometimes lead defence companies to implement quick substitutes of mostly lower

technical performance (short term substitution) to avoid the double resource-intensive

effort of authorisation and replacement dependence on a shrinking number of suppliers

and uncertainties associated with the possible need for several authorisation renewals even

if prospects to obtain authorisation may be good if the argumentation is robust This

negatively affects the defence companiesrsquo competitiveness and innovation potential



Insufficient Research and Development (RampD) funding for SVHC substitution

ldquoThere is insufficient RampD funding for substitution at all levels industry Member States and

EU RampD policy makers at national (Member State defence industry) or EU level often

consider REACH related substitution as a regulatory cost issue and not as innovative RampD At

the same time there is a strong willingness both within industry and MoDs to perform

substitution RampD in a collaborative approach at least at low Technology Readiness Levels

(TRL) A large majority of defence industry stakeholders (786) have confirmed that

substitution RampD activities have increased in their organisation or supply chain as a result of

REACH About half of MoDs (455) are performing financing or promoting RampD activities

for SVHC substitution including through the EDA and NATO However the budgets of both

defence industry and MoDs have not increased and the RampD for substitution is performed to

the detriment of other RampD activities Diminished innovative RampD could therefore

potentially lead to a loss of future competitiveness A large majority of the defence

industry (70) foresee a specific threat in this regard while only 13 consider that REACH

has already led to a gain on the companyrsquos global competitivenessrdquo

Unpredictability of REACH SVHC regulation

ldquoThe unpredictability surrounding the regulatory fate of SVHCs (ie whether when and in

which process(es) it will be further regulated under REACH) creates substantial

uncertainties and risks for the defence industry and ndash as a consequence ndash the MoDs as the

customer The visibility of the authorisation listing process is not in line with the defence

industriesrsquo development cycle difficulties arise in anticipating what action will be taken

against a substance and when Substance-level tracking is consequently difficult There is

the further risk that one SVHC is substituted with an alternative substance which could

transpire to be equally as harmful and subsequently be targeted by REACH during the long

product service life (regrettable substitution)rdquo

Possible EU policy conflicts with regard to SVHC regulation

ldquoREACH impacts the military uses of many inorganic substances including those linked to

Critical Raw Materials which according to the ECrsquos related policy are very hard to

substitute (eg beryllium borates cobalt salts) New Occupational Exposure Limits (OELs)

under the EU workplace legislation (eg beryllium hydrazine refractory ceramic fibres)

and Circular Economy are emerging as additional requirements on top of existing ones (eg

for lead and its compounds) The link between these EU laws and policies and REACH risk

management options such as authorisation is not very clear today leading to possible EU

policy inconsistency The case of chromates raises questions about the appropriateness of

authorisation as a blanket risk management instrument for certain substances (like the

above illustrative examples) which cannot be easily replaced are broadly used in various

sectors including high tech domains such as defence and are also addressed by other EU

policiesrdquo

Military Application for Authorisation (AfA) not fully fit for purpose

ldquoBased on the defence industry survey and a dedicated analysis of applications for

authorisation (AfAs) by the Contractor the defence sector has already been strongly

affected by the AfA process eg phthalates lead sulfochromate yellow lead chromate and

severely for Cr(VI) compounds While the allowance of defence exemptions under REACH

Article 2(3) is reserved for specific cases and does not cover civil applications of dual use

substances the AfA for military uses is often seen by defence industry stakeholders but

also some MoDs as customers and supporting the AfA as disproportionate and not fully fit

for purpose



Evidence of the large socio-economic benefit to European society and the control of the

risks in using SVHC substances within the defence sector can be seen from past AfAs Of the

AfAs that supplied Socio-Economic Analysis information that were analysed as part of this

study in which military uses are identified a simple average cost benefit analysis ratio for

military specific or dual use downstream user applications is approximately 177 million

This raises questions of proportionality when having to go through such a burdensome

process while the business case is generally clear given the limited scope for substitution

in defence equipment There is currently no dedicated defence sector-approach to

authorisation Non-air domains tend to be overlooked and a number of issues relating to

military AfAs are unclear such as the sufficiency of qualitative arguments (eg non-

quantifiable impacts on the operational capabilities of the military and the ability to

comply with international obligations as partner nations at EU level and wider field eg

with NATO) in lieu of economic quantification

Authorisation costs and through life maintenance activities using chemicals are a

particular concern with the likely need for repeated renewals in high reliability sectors

such as defence Chemical supplier interest in supporting continued authorisation is also

likely to diminish

Decision uncertainty (review periodconditions) is a general concern especially for

upstream AfAs However generally at the level of downstream user AfAs ECHA considered

that the applicants have been able to make their caserdquo

9 Reihlen Aand H Luumlskow (2007) Analysis of studies discussing benefits of REACH For the

European Commission February 2007

The aim of this study was to identify which types of benefits have been qualitatively

described in studies on REACH and how the described benefits have been linked to actual

REACH mechanisms or policy outcomes of REACH and to extract how the benefits have been

assessed and quantified It was not the aim of this report to provide an in-depth critique of

each of the analysed studies or to develop a method for benefit analysis However the

approaches and methods applied questionable assumptions and procedures are described

in the detailed analyses

Summaries of studies are divided into different types of benefits and what part of REACH

the various studies attribute those benefits to Examples of this are listed below

Business benefits Benefit to formulators as they can (on the basis of SVHC listing) clearly

see the criteria for substances potentially falling under the authorisation regime are

communicated very early the candidate list for authorisation will add to that information

and make long-term planning is possible

Human health and environmental benefits Reduction of risk (expressed as decreasing

exposure to CMRs or EDCs)

Identification of CMRs and endocrine disruptors in registration Currently there are health

risks due to exposures to CMRs and endocrine disruptors

Restrictions of use andor strict conditions of use imposed in the granting of authorisations

reduce exposure

Reduction of risk expressed in decreasing emissions exposures of PBTsvPvBs or EDCs ndash

Currently there are environmental risks due to exposures to PBTsvPvBs and EDC

PBTsvPvBs and EDCs or substances of similar concern are insufficiently regulated to

prevent environmental damage at present



Identification of PBTsvPvBs and EDCs in registration Restrictions of use andor strict

conditions of use imposed in the granting of authorisations reduce exposure

Other benefits include community wide measures more targeted The information base

for community wide risk management measures of substances is poor Priority setting

for risk management is mainly based on hazard information

10 EC (2015) Monitoring the Impacts of REACH on Innovation Competitiveness and SMEs

Final Report

This study done by RPA and others for the Commission DG Internal Market Industry

Entrepreneurship and SMEs had the objectives to

o Identify test and apply methodologies for evaluating the coherence efficiency

effectiveness sustainability and impacts of REACH in relation to the chemical

industry and major downstream user sectors

o Identify the strengths and weaknesses of REACH implementation with respect to the

conditions and structure of the market consumer choice compliance costs and

administrative procedures and any other relevant indicators identified during the

course of the study

o Provide recommendations to remedy any weaknesses identified in REACH

implementation so as to minimise the possible adverse effects of REACH

implementation and to maximise the impacts of specific REACH mechanisms that

improve business conditions for economic operators

The study comprised extensive information gathering from stakeholders using a number of

survey tools It did not include assessment of the impacts of REACH related to human

safety health and the environment

With SVHC and authorisation the report concluded that more information on uses (and

exposure scenarios) of SVHCs for which authorisation has been granted is now publicly

available additional substances have been identified as SVHCs and added to the candidate

list and 31 substances are currently in Annex XIV for about half of which no applications

for authorisation have been received The first authorisations have been processed and

granted and more are in the pipeline Costs of Authorisation have been estimated by ECHA

to be in the region of euro230k and declining as experience with the process is gained The

ability of SMEs to carry out authorisations remains to be tested Inclusion of substances on

the PACT CORAP the Candidate List and ultimately Annex XIV has led to significant levels

of activity as regards substitution withdrawal and replacement Areas within Authorisation

that the Commission is currently looking into are low volume uses legacy spare parts

substances subject to type-approval and biological essential ingredients

In general REACH terms under efficiency is reported that ldquohellipthere is a strong view in

industry that the costs incurred for implementation have for the present delivered little in

terms of enhanced competitiveness and innovation and that benefits of implementation in

as much as they exist need to be sought in the wider health safety and environmental

benefits of the legislationrdquo

11 Hennig P (2016) Socio-economic benefits and risks of the use of carcinogenic substances

subject to authorisation under REACH

This article addresses the benefits and risks of industrial uses of hazardous chemical

substances (carcinogens) for which applications for authorisation have been submitted



under the REACH Regulation It is based on a review of information submitted by industry as

part of application dossiers and made publicly available by the European Chemicals Agency

(ECHA) This type of detailed information has only recently become available thanks to the

relatively new application for authorisation process for substances of very high concern

Building on the results of the analysis some preliminary reflections on the functioning of

the authorisation process are made in light of the long-term goal of REACH that these

substances should be substituted when possible and authorised only when the use can be

justified for socio-economic reasons and no suitable alternatives are available

Based on the applications submitted by industry and the opinions published by the European

Chemicals Agency the aggregated impacts of the 32 uses of 9 carcinogenic substances can

be estimated The cumulative socio-economic benefits (direct and indirect compliance

costs related to non-use which would be avoided if the use is allowed to continue) amount

to at least euro368 million per year The total quantity of the substances in use is up to 84

thousand tons per year The cumulative monetised risks (cancer burden on workers and the

general population) are estimated to have an upper bound of euro74 million per year It

should be noted that this value does not reflect actual cancer cases but rather the

statistical cancer burden modelled via the dose-response function for carcinogenicity of

each substance

As data on the benefits and risks of specific uses of chemicals is usually scarce the detailed

information now publicly available as a result of the authorisation process under REACH is

instrumental in being able to systematically analyse the socio-economic impacts of

substances of very high concern One key observation is the substantial variation in the

benefits and risks of the individual uses not only between different substances but also

between different uses of the same substance This underlines the importance of a

transparent case-by-case evaluation to support authoritiesrsquo decisions to authorise or

restrict the use of hazardous chemicals

12 European Commission (2013c) Interpretation of the WSSD 2020 Chemicals Goal and an

Assessment of EU Efforts to meet the WSSD Commitment

This study is concerned with evaluation of the EUrsquos commitment to the WSSD (World

Summit of Sustainable Development) 2020 Goal The report proposes a set of 20 indicators

against which EU progress towards achieving that goal from a baseline year of 2002 up until

the end of 2012 can be evaluated The report identifies gaps in progress to date and

develops recommendations to address specific gaps The recommendations are organised in

a lsquoRoadmap of actionsrsquo for the EU from 2013 to 2020 aiming to lsquoensure that the EU meets

the WSSD 2020 Goalrsquo In this wide remit some benefits of REACH Authorisation are

discussed

The EU Progress under Indicator 6 lsquoSubstitution and Phase Outrsquo is relevant case studies of

substance DEHP DBP (both phthalates) and HBCDD (brominated flame retardant) are given

to illustrate declines in use and release (and increasing control) of these substances The

benefit to the environment is inferred due to the decrease in release and contamination

This study points to other studies that have made recommendation on the optimisation of

benefits from the REACH processes that control the riskiest substances The RPA study

(RPA 2012 Assessment of health and environmental benefits of REACH

ENVD3SER20110027r) recommended actions for improving benefits to human health

and the environment from REACH authorisations and restrictions are set out



In order to protect against substitution with similarly hazardous substances the following

actions should be taken

o Consideration of listing substance groups where substitution with a substance

within the same group is likely (ECHA and MS)

o Development of guidance and training on alternatives assessment (Industry)

o Compilation of information on possible alternatives to the use of the SVHC from

commenting and other information sources (Industry Member States ECHA) as

well as ldquoexclusionrdquo of substances known to be preferred alternatives but also

having problematic properties

o Research to determine whether or not substitution takes place with less hazardous

substances and the impact that candidate listing is having in this respect

13 ECSIP (2016) Impacts of REACH and corresponding legislation governing the conditions for

marketing and use of chemicals in different countries regions on international

competitiveness of the EU industry

This study was conducted for the DG Enterprise (now GROW) and considers the impacts of

REACH and corresponding legislation governing the conditions for marketing and use of

chemicals in different countriesregions on international competitiveness of the EU

industry

The study looked at comparative legislation outside the EU and the impacts of EU

legalisation looking at specific sectors including rubber and plastics textiles and motor

vehicles production industries In terms of benefits no evidence could be provided by the

interviewed companies and stakeholders on chemicals regulation yet having achieved

benefits in terms of improved working environment health or environmental benefits

although some benefits are expected over time Other benefits in terms of the availability

of information on chemicals and increased transparency and awareness within the

industries and their supplier industries were however identified The motor vehicles

industry stated that so far the effort spent on REACH is not in proportion to the results that

the industry has seen and pointed to a lack of proportionality in banning certain substances

which may be used in production processes but cannot be traced in the final product This

was reported to be supported by previous studies surveying firms on the impacts of REACH

which generally concluded that it is still too early to see concrete evidence of the benefits

that REACH is expected to bring about in terms of environment health and working

environment

14 Austrian Federal Ministry of Agriculture Forestry Environment and Water Management

(2015) REACH - Evaluation of the impact on the affected industries and the whole

economy in Austria Final Report of the study March 2015 Vienna Denkstatt Institute for

Industrial Research amp Vienna University of Technology ndash Center of Public Finance and

Infrastructure Policy

This study had the objective of to analyse and quantify the impact of REACH on the

Austrian economy after a six-year period of implementation It included direct stakeholder

survey through interviews and a workshop was conducted The authorisation process is not

a particular focus of the assessment but a more general assessment of the costs and

benefits of REACH on the Austrian economy is made

The public and occupational health environmental and business benefits were analysed

The authors reported that in general quantifying these benefits is a difficult task For

example quantification and monetisation of business benefits (eg competitive advantages



and disadvantages) was not feasible The business benefits were only considered in a

qualitative way for the in-depth analysis Results from another Austrian survey which asked

relevant organisations how and to what extent REACH has brought benefits for human and

environmental health the respondents stated that quantifying REACH related effects would

not be possible

A lsquomain scenariorsquo considered the most reasonably estimated mean values for all benefits

and costs considered in the model used in the study Based on these analyses the relevant

influences and thresholds for a benefits surplus for Austria were discussed The main

scenario showed that the adoption of REACH results in a considerable economic resource

gain (eg benefits of private households public budgets and companies present value of

net benefits) that amounts to about euro25 billion The high efficiency of REACH is also

indicated by the internal rate of return (about 35) and the benefit-cost ratio of about 9

The results crucially depend on several variables Sensitivity analyses were conducted to

control for the influence of the discount rate the positive health benefits assumed and the

underlying economic estimates as well as the projected costs (introduction and full

implementation) The authors report that given that the calculations of the main scenario

and sensitivity analyses rely on assumptions a cautious interpretation appears to be

warranted the estimates of benefits and costs are based on the best available data but

fundamental uncertainties remain However the implementation of REACH results in

positive net benefits even if worst case assumptions are applied to the single cost and

benefits measures

A fourfold increase of the discount rate (4 instead of 1 in the main scenario) results

in a halving of the economic net benefits (euro12 billion instead of euro25 billion in the main

scenario)

If REACH only leads to a reduction of adverse health effects by 1 (instead of 5 in the

main scenario) the net benefits amount to euro300 million

A doubling of direct costs results in a decrease of net benefits at the level of euro2 billion

and

An increase of indirect net costs corresponding to ten times the direct costs (in-stead of

three times in the main scenario) results in a marginal reduction of the economic net

benefits (euro2 billion instead of euro25 billion in the main scenario)

E7 Impacts on SMEs

Evidence suggests that the affordability of applying for authorisation or substitution to avoid

applying is a barrier for SMEs (EC 2013 EC 2015 Tickner and Jacobs 2016) The EC (2015) study

titled Monitoring the Impacts of REACH on Innovation Competitiveness and SMEs points out that

ldquoSMEs have been more acutely affected than large enterprises by the compliance costsrdquo (EC 2015

p200) linked to REACH thereby showing that affordability seems to be related to company size

This is supported by several position papers submitted to the online public consultation (October

2016 ndash January 2017) carried out as part of the REACH REFIT Evaluation For example

BusinessEurope stresses that due to ldquoSMEs simply hav[ing] less capacity and fewer resources than

other actors the process of registering and authorising adds a significant burden both in terms of



time and costs on themrdquo (Business Europe 2017 p2) Similar comments pointing towards a bigger

problem of affordability for SMEs have been made in the position papers submitted by180

The Chemical Industry Federation of Finland (2017)

Comiteacute Franceacuteclat (2017)

Airbus Airlines for Europe Boeing and GE Aviation (2017)

EuropaBio (2017)

The French Federation of Mechanical Engineering Industries (2017)

AmCham EU (2016)

ORGALIME (2017)

Technology Industries of Finland (2017)

UEAPME (2017)

The Association of German Chambers of Commerce and Industry (2017)

The Austrian Federal Economic Chamber (2016) and

The Dutch authorities (see Netherlands na)

Some insight on the range of factors affecting the affordability of authorisation for SMEs (eg ECHA

fees administrative costs and substitution) is provided by available literature

Preparation costs and fee payable to ECHA make up the substantial proportion of the costs linked to

REACH authorisation as shown by the detailed review of the literature on the costs of REACH

authorisation in Section E5 With respect to the fees the Commission Regulation (EC) No

3402008 states that ldquo[r]educed fees and charges should also apply to micro small and medium-

sized enterprises (SMEs)rdquo (EC 2008 p1) Furthermore Regulation (EU) No 2542013 which

amends Regulation (EC) No 3402208 recognises that ldquoexisting reduced fees and charges applicable

to micro small and medium-sized enterprises (SMEs) should be further reduced in order to

minimise the regulatory burden and the numerous practical challenges faced by SMEs in complying

with REACH obligationsrdquo (EC 2013a p1) thereby indirectly recognising that the affordability of

authorisation is a potential problem for SMEs

Hennig (2016) points out however that the authorisation application fees are less significant with

respect to the affordability of authorisation than the administrative costs linked to the preparation

of the application dossier The comprehensive AfA consisting of several assessment reports may be

ldquocost intensive to prepare particularly when external expertise is required for scientific or

technical issuesrdquo (Hennig 2016 p 157-58) which is more likely for SMEs as mentioned by Tickner

and Jacobs (2016) In combination with costs arising for submission and potential defence of the

dossier the administrative costs amount to significant values for SMEs (Hennig 2016)

With respect to substitution which has been covered in detail in Section E4 Tickner and Jacobs

(2016) point out that the actual adoption of identified alternative substances in the industrial

process could pose higher challenges to SMEs in terms of affordability than bigger companies The

authors state that SMEs are less likely to have the resources for implementing the necessary

processproduct design modifications The position paper181 submitted to the REACH REFIT public

consultation by Cii ndash the Cross-Industry Initiative for better regulation in chemicals management -

provides further evidence for affordability problems related to the substitution process through the

SAFERUBBER substitution project which was financed by the 7th Framework Programme This

180 The exact titles of the position papers can be found in the reference list 181 Cii ndash Cross-Industry Initiative for better regulation in chemicals management (2016) Synergies between

REACH and workplace legislation Improved analysis of alternatives and substitution Position Paper for REACH

REFIT Evaluation November 2016



project had the objective to find an alternative to thiourea-based accelerators ndash a substance mainly

used by SMEs The search for an alternative for this substance used in the vulcanisation process

proved successful Cii (2016) stresses however that finding an alternative would not have been

possible for SMEs without EU funds thereby highlighting that affordability is a barrier for SMEs in the


Similarly the EC (2016) study conducting a cumulative cost assessment for the EU chemical

industry indicates that affordability is a bigger issue for SMEs than larger firms in terms of the

general financial impact of chemicals legislation It finds that ldquocompany size seems to [a]ffect the

impact of legislation on costrdquo (EC 2016 p112) as the share of the costs in annual turnover is

higher for SMEs for all legislation sectors shown in Figure E012 except lsquocustoms and tradersquordquo As

shown in the figure below chemicals legislation cost as a percentage of annual turnover is below

1 but more than twice as much for SMEs as for large firms More specifically Harrikari and

Montonen (2017) compare AfA costs to micro companiesrsquo annual turnover when analysing the effect

of REACH authorisation on Finnish companies They find that AfA costs were significant (ie bigger

than 10 of annual turnover) for two out of six micro companies interviewed as part of a survey of

14 Finnish companies The study further mentions that micro companies applied as part of a

consortium as ldquoapplying alone would have increased the costs to an impossible level for micro

companiesrdquo (Harrikari and Montonen 2017 p11)

Figure E012 Legislation cost (as annual share of turnover 2004-2014) by size of firms182

(Source EC 2016)

The EC (2016) study notes that ldquoSMEs in general incur higher costs compared to large structures

because the costs to comply with legislation are not linear and cannot be amortised on large

volumes of chemicalsrdquo (EC 2016 p140) An additional reason for the higher cost is that ldquoSMEs

tend to outsource expertise and service to external providersrdquo (EC 2016 p140) In fact the EC

(2015) study results indicate that 64 of SMEs fully outsource their compliance activities as

compared to only 24 of large companies The proportion of outsorucing varies significantly across

the types of SMEs 27 65 and 18 for medium small and micro firms respectively

In addition to the scale of additional costs their financing is a further challenge making

affordability more problematic for SMEs A survey conducted among Austrain companies as part of

the study titled REACH - Evaluation of the impact on the affected industries and the whole

182 This excludes specialty chemicals due to available data being insufficient for estimation



economy in Austria commissioned by the Austrian Federal Ministry of Agriculture Forestry

Environment and Water Management revealed that ldquoadditional costs for companies caused by

REACH can only be partially passed on to the customers since they do not accept a higher price

and do not see REACH compliance as an argument for a price increaserdquo (Austrian Federal Ministry

of Agriculture Forestry Environment and Water Management 2015 p5) Similarly Harrikarri and

Montonen (2017) find that only one of seven micro-sized companies interviewed in Finland passed

on some of the costs by increasing prices The main reason for not increasing prices was the

companiesrsquo expectations that an increase in price would push costumers to do business with

companies in other countries

Notwithstanding the higher propensity to outsource among SMEs the EC (2015) study reveals that

ldquothere are [no] significant differences between SMEs and large firms as regards availability of

qualified persons to deal with REACH-related activitiesrdquo (EC 2015 p109) This conclusion is

reached despite fewer SMEs reporting the existence of a dedicated REACH unit (174 compared to

327 in larger companies) and a REACH manager (286 compared to 483) In fact targeted

company interviews showed that ldquothe key issue for SMEs is affordability rather than availabilityrdquo

(EC 2015 p109)

REACH authorisation is also more likely to affect SMEs than large companies in terms of drawing

resources away from other potentially revenue-raising activities The EC (2015) study mentions that

ldquocompliance activities can be particularly high in terms of opportunity costs for other firm

activities such as innovation as often one person is responsible for RampD and compliancerdquo (EC 2015

p139) in small and micro-firms

SMEs are also differently affected by the outcomes of REACH in terms of competitiveness and

profitability compared to larger firms The EC (2015) study reveals that loss of international

competitiveness was a lower concern for SMEs (21 as compared to 27 for large firms) This is

linked to a higher share of SMEs (47) reporting that their competitive position had strengthened as

compared to large firms (32) Nevertheless profitability is shown to be an issue related to REACH

(including authorisation) for several SMEs ldquoIn-depth interviews suggest that the actual impact [for

affected SMEs] may be more severe as survival or independent survival may be at stake for themrdquo

(EC 2015 p106) The in-depth interviews also reveal that several SMEs affected by authorisation

are considering to transfer their production to outside the EU ldquowhile many micro and small firms

and family businesses are confronted with survival issuesrdquo (EC 2015 p 31) including the prospect

of acquisition by larger firms with more funds The effect on business performance also varies

significantly between SMEs and larger companies with respect to trade inside the EU The EC (2015)

study reveals that approximately 17 of small firms and nearly 50 of micro firms had seen their

intra-EU exports decreasing as compared to only 63 of large companies

In conclusion SMEs seem to face more problems in terms of affordability than larger firms In

addition there is also some indication for a bigger economic impact of REACH on SMEs compared to

large firms as exemplified through the higher opportunity cost for other firm activities and the

higher occurrence of declining intra-EU exports

E8 Announcement effect

Article 55 of EC Regulation No 19072006 highlights that one of the aims of REACH authorisation is

that substances of very high concern ldquoare progressively replaced by suitable alternative substances

or technologies where these are economically and technically viablerdquo (EC 2006 p138) Heitmann

and Reihlen (2007 p6) point out that announcing the substances that are potentially subject to



authorisation in advance through the Candidate List ldquomight be an incentive for producers and users

of these substances to strive for the substitution goal pro-activelyrdquo The Candidate List could thus

potentially have an announcement effect In their report titled Case study on ldquoAnnouncement

effectrdquo in the market related to the candidate list of substances subject to authorisation

Heitmann and Reihlen (2007) use information about how industry actors reacted to comparable

legal approaches in the past (eg Danish list of undesirable substances (LOUS) Swedish observation

list (OBS) and the OSPAR list of substance for priority action) to make inferences about the

potential announcement effect of the Candidate List Information on stakeholdersrsquo reactions to

these legal approaches was gathered through expert interviews and document analysis

This analysis showed that the extent of the announcement effect of the Candidate List is likely to

depend on market pressure exerted by downstream users article producers and retailers who tend

to ldquouse substance lists to exclude specific substances from their products and thus exert pressure

on the supply chainrdquo (Heitmann and Reihlen 2007 p13) The reaction of these actors is essential

in determining the extent of the announcement effect as manufacturers and importers of SVHCs

tend to argue for continued use of their product on the basis of the use benefits of the substance

and the better possibility to control risks for known substances than alternatives These actors tend

to show little reaction to non-legally binding lists in terms of investment in the development of

alternatives unless there is an expectation ndash induced through the reaction of downstream users and

retailers - that ldquothe business risks from introducing an alternative [are] compensated by extra

(net) revenuesrdquo (Heitmann and Reihlen 2007 p9) Similarly the reaction of chemical formulators

is dependent on the reaction of these actors as they take future regulations and customer demand

into consideration when developing their products in order to prevent repeated reformulation

The market pressure exerted by downstream users is however not uniform Proactive behaviour ndash

increasing the probability for a strong announcement effect ndash is especially observed in companies

producing or selling consumer products (eg household articles and cosmetics) and companies with

a brand name according to Heitmann and Reihlenrsquos analysis The reason behind this is that such

companies are more vulnerable to NGO-campaigns calling for the disuse of hazardous substances

Such campaigns are a possible consequence of the inclusion of substances in the Candidate List By

proactively engaging in substitution activities these stakeholders attempt to improve their

reputation and avoid negative publicity

With respect to market pressure the EC (2015) report titled Monitoring the Impacts of REACH on

Innovation Competitiveness and SMEs provides useful information through an open-ended on-line

business survey (OBS) answered by 566 respondents from 28 Member States EEA and non-EU

countries The survey reveals that 388 of all respondents answering the question whether they

received requests from their customers to remove SVHCs from their products as a reaction to the

candidate listing reported that they received such requests The percentage of companies facing

these requests differs however significantly based on the type of company as shown in Table

E03 The EC (2015) report highlights that the main reaction to placing a substance on the

Candidate List is not withdrawal of the substance but finding alternatives through the procurement

of existing alternatives or the initiation of a research programme



Table E03 Have any of your customers requested the removal of SVHCs from your products

(Source EC 2015)

Similarly the European Defence Agency (2016) reports that customers (ie European Ministries of

Defence) exert pressure on prime contractors to implement substitutes by imposing contractual

constrains beyond REACH requirements Seventy-nine percent of respondents to their consultation

indicated that such constraints in the form of bans on certain substances exist The report also

highlights that some Ministries of Defence use the Candidate List as the basis for such constraints

Thus the Candidate List exerts pressure on industry actors to substitute SVHCs and according to the

interviews conducted as part of the EC (2015) study substitution attempts are often only based on

the legal status of the substance (ie that it is listed on the Candidate List) This shows that the

Candidate List has had a considerable announcement effect However this effect is not necessarily

beneficial to achieve the REACH objectives according to the EC (2015) as only in a few cases has it

led ldquoto the development of new less hazardous alternative substances or implementation of new

processes at the level of the substance manufacturerrdquo (EC 2015 p119) In many cases the SVHC

was substituted for another substance available in the supplier portfolio allowing the downstream

user to further use their existing technology Downstream users have reported that this has in some

cases led to lowering the quality of their products The American Chemistry Council (2017)183 and

Cii (2016) position papers submitted as part of the REACH REFIT evaluation support the view that

the announcement effect is not entirely positive as substitution induced by the Candidate List has

in many cases resulted in regrettable substitutions lsquoRegrettable substitutionrsquo thereby refers to

substitution by an alternative posing at least similar if not more risks and alternatives that are

unsustainable with respect to energy consumption or resource efficiency (Cii 2017)

The EC (2015) study also notes that research activities to find substitutes are more likely to be

executed by the formulator or article producer than substance manufacturer and that these

ldquo[i]nnovations are frequently realised because the elimination of a SVHC in products has been on

the agenda in the firms anyway and is [then] treated with higher priorityrdquo (EC 2015 p119) ndash

thereby relativizing the positive role of the Candidate List in terms of promoting substitution

A further factor determining the extent of the announcement effect mentioned by Heitmann and

Reihlen (2007) is the ldquoimaginary pressurerdquo which is dependent on how companies perceive the

probability that a substance on the Candidate List will be subjected to authorisation The expert

consultation revealed that imaginary pressure felt by companies is likely to depend on the number

of the substances placed on the Candidate List as it will influence the perception about whether

the authorisation requirement is perceived as an imminent situation The authors highlight however

that a promotion of substitution through the Candidate List ndash and therefore an announcement

effect ndash is possible even if the probability of a transfer to Annex XIV is perceived as low as ldquoa high

183 American Chemistry Council (2017) ACC Input for EU REACH REFIT Position Paper for REACH REFIT




level of uncertainty may trigger long-term planning companies to apply for substitutionrdquo

(Heitmann and Reihlen 2007 p16)

In addition Heitmann and Reihlenrsquos analysis showed that substance lists naming legally restricted

and declarable substances as well as lists of substances subject to voluntary agreements are used as

black lists by companies The lists thereby promote a phase-out of listed substances Heitmann and

Reihlen (2007 p13) note however that industry feedback shows that industry actors find it

ldquodifficult to consider all the different national lists on the European market and that one

harmonised EU-List would be appreciatedrdquo This is a potential explanation for the existence of an

announcement effect as the Candidate List serves as such an EU-wide agreed list All experts

consulted by Heitmann and Reihlen (2007) expected the Candidate List to be used in a similar way

as the analysed indicative lists (ie a black list) thereby promoting phase-outs

The use of the Candidate List seems indeed to follow the predicted pattern according to the REACH

REFIT position paper submitted by the American Chemistry Council which mentions that ldquohazard

based selection of SVHCs has triggered behaviours from downstream uses de-selecting substances

that go beyond regulatory requirementsrdquo (American Chemistry Council 2017 p4) thereby

suggesting that the Candidate List is viewed as a black list

Surveys conducted as part of EC (2015) study on the impacts of REACH on innovation

competitiveness and SMEs provide additional evidence for the existence of an announcement

effect It was revealed that 246 of SMEs and 419 of large firms launched reformulation

initiatives in response to the Candidate List The survey results also indicate that 189 of SMEs and

368 of large firms requested substitution of substances as a result of the substance being placed

on the Candidate List As the effect of the list was similar in all other aspects for these two

categories according to the EC (2015) study it can be concluded that the announcement effect was

stronger in the case of large firms than SMEs

The EC (2015) study also provides information on the strength of the announcement effect in terms

of the type of industry stakeholder The computer aided telephone interview (CATI) survey which

led to 1076 responses indicated that 30 of respondents reported that one or more of the

substances used or produced by them was placed on the candidate list Out of those respondents

94 started research programmes to develop an alternative substance and 301 started a search

for alternative formulations of existing substances The announcement effect of the Candidate List

was thereby strongest among formulators The EC (2015) Online Business Survey (OBS) survey shows

that when asked about their reaction to the placing of substances relevant to the firm on the

Candidate List only 187 indicated that they took no special action This indicates that there has

been a strong announcement effect as it implies that 76 of the respondents that saw a substance

relevant to their business being placed on the Candidate List took some action More detailed

information on the actions taken by industry stakeholders as result of the Candidate List can be

found in Table E04



Table E04 What has been the response of your firm to the placing of substances relevant to your business in the Candidate List (Percentage of firms indicating)

(Source EC 2015)

An online survey conducted by RPA (see RPA 2016) among industry and consultancy representatives

between March and May 2016 provides further evidence for an announcement effect It indicates

that in the responses of 100 industry representatives to a question about the relative importance of

drivers of substitution inclusion in the Candidate List was particularly named as the mechanism

triggering substitution considerations Similarly the textile industry mentions the Candidate List as

the main reason for substitution and phase-outs in the sector according to the ECISP (2016) report

Additional evidence for the existence of an announcement effect is provided in several REACH

REFIT 2017 position papers

The Chemical Industries Association (2017 p2) reports that they received ldquoinformal

reports from companies that substances have been eliminated from product portfolios in

some situations on the basis of registration costs andor SVHC listingrdquo

The joint position paper of the European Federation of Pharmaceutical Industries and

Associations Vaccines Europe the International Federation of Animal Health Europe the

Plasma Protein Therapeutics Association the International Plasma Fraction Association and

European Biopharmaceutical Enterprises highlights that ldquothe presence of a substance in the



Candidate List has in many cases proven to be sufficient to reduce the use of certain

substancesrdquo (EFPIA et al na p5)

The European Environmental Bureau (na) position paper provides a concrete example for

announcement effect by referring to the Swiss company Hoffmann-La Roche It thereby

highlights that the Candidate List even has an announcement effect in countries that are

not part of the EU and therefore are not subject to compliance Hoffmann-La Roche

committed to phase out SVHCs wherever possible within a decade of their addition to the

Candidate List One reason provided for this by the company is the risk of supply chain

discontinuity in the future

The position paper submitted by the Swedish Chemicals Agency (2017 p4) also mentions

that it has already been ldquoshown that the Candidate List itself seems to have had a positive

effect on substitution partly caused by expectation from producers on future measuresrdquo

The Swedish Chemical Agency also critically remarks in this respect that this positive

announcement effect can only be maintained if these expectations do not disappear due to

generous authorisations for broad uses Authorisations being perceived to be granted too

generously is a problem according to them as experiences has shown that ldquoall authorisation

applications (regardless of their quality) have been found compliant and lead to approvalrdquo

(Swedish Chemicals Agency 2017 p4)



ANNEX F AUTHORISATION SURVEYS

F1 Purpose of the surveys

The purpose of the online surveys for industry stakeholders and NGOs was to target a large number

of stakeholders and collect data and information from them in a consistent way The surveys also

allowed for the identification of additional companies suitable for case studies and targeted follow-

up interviews

The industry survey was designed to cover all impact areas of interest in this study namely

Substitution of substances


Changes in market structure

Costs of authorisation and

Specific impacts on Small and Medium-Sized Enterprises (SMEs)

It targeted stakeholders (ie MIs and DUs) active in the manufacturing import and use of both

SVHCs and alternatives

The NGO survey covered the same impacts as the industry survey and was targeted to those

stakeholders known to be active in REACH

Having separate surveys for industry stakeholders and NGOs had the benefit of the surveys being

shorter than a single all-inclusive survey and being more relevant to each type of stakeholder

As part of this study questionnaires were also sent to the European Commission and Member State

Competent Authorities (MS CAs) to assess the administrative burden of REACH authorisation on

these public authorities

F2 Survey structure and design

F21 Industry survey

The online survey software SurveyMonkey was used for the industry survey This allowed for the

provision of a streamlined survey to each respondent depending on hisher specific answers as it

allowed for the use of dependent questions This ensured that the survey automatically limited the

number of questions to those that are most relevant to the respondent

The survey used single and multiple choice and open-ended questions It also provided the option to

attach supporting documents Single and multiple-choice questions were used to standardise

responses and facilitate the data analysis The open-ended questions had the purpose to capture

respondentsrsquo specific experiences in the REACH authorisation process

The industry survey consisted of a total of nine sections including an introduction section informing

respondents about the functionality and content of the survey Section II to Section IX included

survey questions The eight sections containing survey questions are listed below in conjunction

with the question range of the specific section



II About your organisation Q1 ndash Q4

III Substitution Q5 ndash Q67

IV Benefits of authorisation ndash Improved risk management of SVHCs Q68 - Q102

V Changes in market structure Q103 - Q338

VI Costs incurred during the authorisation process Q339 - Q369

VII Small and medium-sized enterprises (SMEs) Q370 - Q376

VIII Other questions Q377 - Q387

IX Confidentiality Q368

The section titled II About your organisation asked respondents to provide some information

about their organisation in order to facilitate the aggregation of responses (eg by type of actor)

and improve the understanding of responses

The third section (III Substitution) focused on gathering evidence of the objective of the REACH

Regulation to progressively replace SVHCs by suitable alternative substances andor technologies

The section was designed to collect evidence enabling the assessment of the extent to which the

entire REACH authorisation process is leading to substitution or triggering activities that may lead

to substitution in the future In particular it examined whether any substitution occurs before a

substance is placed on the Authorisation List Where substitution had happened it also attempted

to collect evidence for its impacts on the business of the respondent and the overall market

The fourth section (IV Benefits of authorisation ndash Improved risk management of SVHCs) looked at

the aim of the REACH authorisation process to generate benefits to the environment and to human

health through improved risk management of SVHCs along the supply chain (even in cases where an

authorisation for the continued use of an SVHC has been granted) This section sought evidence of

whether the entire REACH authorisation process has led to environmental and human health

benefits

The fifth section (V Changes in market structure) sought to understand whether the REACH

authorisation process has led to changes in the structure of the EU market for products made by

using SVHCs as well as their alternative substances andor technologies

The sixth section (VI Cost incurred during the authorisation process) sought information on the

costs incurred by EU companies at each stage in the REACH authorisation process It thereby

focused on the costs of providing evidence during the RMOA process and ECHA public consultations

and the costs of complying with any requirements resulting from the REACH authorisation process

F22 NGO survey

The online survey software SurveyMonkey was used for the NGO survey This allowed for the

provision of a streamlined survey to each respondent depending on its specific answers by using

dependent questions This ensured that the survey automatically limited the number of questions

to those that are most relevant to the respondent

Similar to the industry survey the survey included a mix of single and multiple choice and open-

ended questions It also provided the option to attach supporting documents

The NGO survey consisted of a total of seven sections including an introduction section informing

respondents about the functionality and content of the survey and asking for the provision of

contact details Section II to Section VII included survey questions These sections are listed below

in conjunction with question range of the specific section



II Substitution Q2 ndash Q35

III Benefits of authorisation ndash Improved risk management of SVHCs Q36 - Q38

IV Changes in market structure Q39 - Q42

V Administrative costs Q43 - Q53

VI Other questions Q54 ndash Q64

VII Confidentiality Q65

The sections titled II Substitution III Benefits of authorisation ndash Improved risk management of

SVHCs and IV Changes in market structure thereby followed the intention and design of the

sections of the same names in the industry survey

The fifth section (V Administrative costs) attempted to collect information on the administrative

costs that NGO respondents had incurred in providing comments as part of public consultations and

providing input to policy developments at different stages of the REACH authorisation process

Questions focused on the three stages of the authorisation process where public consultations are

held (ie inclusion of substances of the Candidate List inclusion of substances in the Authorisation

List and applications for authorisation)

F23 Surveys for public authorities

For the assessment of the administrative burden of REACH authorisation on public authorities a

separate questionnaire in the Word document format was sent to the European Commission and

Member State Competent Authorities (MS CAs) The questions within this questionnaire reflected

the activities these actors partake across the various stages of the authorisation process

The questionnaire for the European Commission contained the following sections

I Staff costs Q1

II Screening and RMOA stage Q2 ndash Q4

III Inclusion of substances in the Candidate List Q5

IV REACH Committee Q6 ndash Q7

V Decision on applications for authorisation (AfA) Q8 ndash Q10

VI Post decision on an AfA Q11 ndash Q13

VII Policy costs Q14 ndash Q15

VIII Other Q16 ndash Q17

The questionnaire for the Member State Competent Authorities contained the following sections

I Staff costs Q1

II RMOA stage Q2 ndash Q4

III Inclusion of substances in the Candidate List Q5 ndash Q7

IV Member State Committee (MSC) Q8 ndash Q9

V REACH Committee Q10 ndash Q11

VI Compliance and enforcement of REACH Authorisation Q12 ndash Q16

VII Policy costs Q17 - 18

VIII Other Q19 - 20



F3 Respondent profile

F31 Industry and NGO surveys

An e-mail invitation with a link to the industry online survey was sent to 240 individuals In some

cases several individuals from the same company were invited In the case of the NGO survey an

invitation was sent to 30 individuals

At the beginning of May a reminder was sent to all stakeholders which had started to fill out the

survey but had not fully completed their response at that point as well as those individuals that had

not started to fill out the survey at all Different e-mail versions adapted to the state of the

individualrsquos survey response (ie incomplete survey not started) were used for this purpose

For the NGO survey 4 complete responses and 2 partial responses were received

The industry survey resulted in 63 complete responses and 21 partial responses The partial

responses were included whenever respondents had fully completed certain sub-sections of the

survey Information about whether the respondentrsquos organisation is an SME is only available for the

63 complete responses Twenty (32) of those respondents indicated that their organisation is an

SME

A list with the actor types used to classify survey respondents (in Question 2 of the survey) is

provided below in conjunction with the number of respondents indicating that they belonged to

that category It is important to note in this respect that a single respondent can be part of several

categories

On-going manufacturerimporter of a substance of very high concern (SVHC) 17 (12)

Ceased manufacturerimporter of an SVHC 5 (4)

Manufacturerimporter of an alternative substance andor technology to an SVHC

7 (5)

Downstream user of an SVHC 59 (42)

Downstream user of alternative substance andor technology to an SVHC 22 (16)

Distributor of an SVHC 6 (4)

Distributor of an alternative substance andor technology to an SVHC 5 (4)

Tradesector association 9 (6)

Other 11 (8)

In Question 3 of the survey respondents were also asked to indicate the perspective from which

they were completing the survey The subsequent list shows possible answers as well as the number

and percentage of respondents answering the survey from this perspective

For entire organisation 55 (65)

For a specific useproductmarketsector in organisation 11 (13)

For a specific substance or group of substances 11 (13)

On behalf of members within association 5 (6)

Other 2 (2)



F32 MS CA survey

The questionnaire was sent to 22 individuals from 20 countries via e-mail at the beginning of May

2017 A list of the countries that were contacted for this survey can be found in Annex G1 A

reminder was sent out to those MS CAs that had not yet submitted their completed questionnaire

on 6 June 2017 Sixteen completed questionnaires have been received which equals a response rate

of 80

F4 Data validation


The industry survey data was analysed in two rounds For the interim report submitted at the end

of April 2017 only complete responses received before this date were taken into consideration For

the current report all complete responses received by the closure of the survey on 20 June 2017 as

well as fully completed sections from partial survey responses have been analysed

The information from complete survey responses was compiled in a spreadsheet which allowed for

a check of data quality in terms of the comprehensiveness of the responses It was also used for

identifying cases for which clarifying information was required for the given answers

After closure of the survey the spreadsheet was used to identify the stakeholders for which follow-

up telephone interviews were deemed useful for the preparation of case studies The spreadsheet

was also used to determine the specific section or sections (eg substitution market impacts SME)

on which the stakeholder should be interviewed Besides providing input to the case studies the

interviews conducted in the aftermath of the online survey also enabled the project team to

validate the data received during the survey

F42 MS CA survey

The survey data was validated by collating the survey responses in a spreadsheet and screening this

spreadsheet for outliers The purpose of this approach was to identify respondents with whom

further contact needed to be initiated to gather information about potential reasons for the

outliers



F5 Industry survey ndash Statistical summary

The remainder of this section summarises a number of responses (but not all ndash eg Q1 provides contact details of the respondents) to the online industry

survey for each question Some questions include options for ldquoDonrsquot knowrdquo ldquoNot statedrdquo or equivalent options These options are reported in this annex

for completeness However the main report excludes such responses in order to accurately reflect the sample size that the results are based on Open-

ended questions are summarised qualitatively in the main report

II About your organisation

Q2 Type of actor in the REACH authorisation process

n

Yes No Total Yes No Total

On-going manufacturerimporter of a substance of very high concern (SVHC) 17 67 84 20 80 100

Ceased manufacturerimporter of an SVHC 5 79 84 6 94 100

Manufacturerimporter of an alternative substance andor technology to an SVHC 7 77 84 8 92 100

Downstream user of an SVHC 59 25 84 70 30 100

Downstream user of alternative substance andor technology to an SVHC 22 62 84 26 74 100

Distributor of an SVHC 6 78 84 7 93 100

Distributor of an alternative substance andor technology to an SVHC 5 79 84 6 94 100

Tradesector association 9 75 84 11 89 100

Other 11 73 84 13 87 100

Q3 Perspective in completing survey n

For entire organisation 55 65

For a specific useproductmarketsector in organisation 11 13

For a specific substance or group of substances 11 13

On behalf of members within association 5 6

Other 2 2

Total 84 100



III Substitution Q5 Whether REACH authorisation had led to internal policy concerning managingknowing what substances are used within respondents organisation including (possible) SVHCs

n

Yes 39 47

Yes but not due to REACH authorisation 30 36

No 11 13

No but we are considering having a policy 3 4

Total 83 100

Q8 Whether respondent has substituted a (possible) SVHC with an alternative substance andor technology

n

Yes partly due to the REACH authorisation process 27 33

Yes but not due to the REACH authorisation process 8 10

No but we are aware of substitution in our supply chain 2 2

No but we are investigating possibilities to substitute 24 29

No 22 27

Total 83 100

Q9 - Q17 Number of examples of substitution due to REACH authorisation

n

Number of respondents with 1 example 27

Of these number of respondents with 2 examples 10






Q19 Stage(s) of authorisation process that triggered confirmed decision to substitute (total number of examples provided)

n

Scre

enin

g o

f su

bst

ance a

nd R

isk

Managem

ent

Opti

on A

naly

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion

of

subst

ance in A

uth

ori

sati

on

Lis

t (A

nnex X

IV)

Inclu

sion o

f su

bst

ances

in A

nnex

XIV

Applicati

ons

for

auth

ori

sati

on

(AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex

XIV

subst

ance)

Not

sure

Not

applicable

Tota

l

Scre

enin

g o

f su

bst

ance a

nd R

isk

Managem

ent

Opti

on A

naly

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion

of

subst

ance in A

uth

ori

sati

on

Lis

t (A

nnex X

IV)

Inclu

sion o

f su

bst

ances

in A

nnex

XIV

Applicati

ons

for

auth

ori

sati

on

(AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex

XIV

subst

ance)

Not

sure

Not

applicable

Tota

l

6 13 10 11 4 0 6 85 135 4 10 7 8 3 0 4 63 100

Q20 - Q28 Number of examples of substitution not due to REACH authorisation or in respondents supply chain

n






Q30 Whether instances of substitution led to any one-off costs

n

Yes 24 83

No 1 3

Dont know 4 14

Total 29 100



Q31 Estimated one-off costs of substitution (total number of examples provided)

n lteuro1m

illion

euro1-euro

10 m

illion

euro11-euro

50 m

illion

euro51-euro

100 m

illion

gteuro100 m

illion

Not

applicable

Donrsquot

know

Tota

l

lteuro1m

illion

euro1-euro

10 m

illion

euro11-euro

50 m

illion

euro51-1

00 m

illion

gteuro100 m

illion

Not

applicable

Donrsquot

know

Tota

l

25 3 4 0 0 63 25 120 21 3 3 0 0 53 21 100

Q32 Whether instances of substitution led to an increase or savings in annual operating cost

n

Net increase in operating costs 14 48

Net saving in operating costs 0 0

No change in operating costs 6 21

Dont know 9 31

Total 29 100

Q33 Estimated change in annual operating costs from implementing alternative substances andor technologies (total number of examples provided)

n

lteuro100 0

00 p

er

year

euro100 0

00 -

euro1

million p

er

year

euro1-euro

10 m

illion

per

year

euro11-euro

50 m

illion

per

year

euro50-euro

100 m

illion

per

year

gteuro100 m

illion

per

year

Not

applicable

Donrsquot

know

Tota

l

lteuro100 0

00 p

er

year

euro100 0

00 -

euro1

million p

er

year

euro1-euro

10 m

illion

per

year

euro11-euro

50 m

illion

per

year

euro50-euro

100 m

illion

per

year

gteuro100 m

illion

per

year

Not

applicable

Donrsquot

know

Tota

l

11 5 1 1 0 0 37 15 70 16 7 1 1 0 0 53 21 100

This question asks respondents for the change in their organisationsrsquo annual operating cost which can be a decrease or increase The results in this table reflect an increase in operating costs because all respondents indicated increases rather than decreases in annual operating costs



Q34 Whether instances of substitution led to changes in volume sold or revenue achieve for the product made

n

Yes 6 21

No 14 48

Dont know 9 31

Total 29 100

Q36 Estimated annual average change (to date) in sales volume of products made using alternative substances andor technologies (total number of examples provided)

n

Reducti

on

gt20

Reducti

on

11

-20

Reducti

on 1

-

10

No c

hange

Incre

ase

1

-

10

Incre

ase

11

-

20

Incre

ase

gt20

Not

applicable

Donrsquot

know

Tota

l

Reducti

on

gt20

Reducti

on

11

-20

Reducti

on 1

-

10

No c

hange

Incre

ase

1

-

10

Incre

ase

11

-

20

Incre

ase

gt20

Not

applicable

Donrsquot

know

Tota

l

2 2 2 0 0 0 0 23 1 30 7 7 7 0 0 0 0 77 3 100

Q37 Estimated annual average change (to date) in revenue from products made using alternative substances andor technologies (total number of examples provided)

n

Reducti

on

gt20

Reducti

on

11

-20

Reducti

on 1

-

10

No c

hange

Incre

ase

1

-

10

Incre

ase

11

-

20

Incre

ase

gt20

Not

applicable

Donrsquot

know

Tota

l

Reducti

on

gt20

Reducti

on

11

-20

Reducti

on 1

-

10

No c

hange

Incre

ase

1

-

10

Incre

ase

11

-

20

Incre

ase

gt20

Not

applicable

Donrsquot

know

Tota

l

2 1 2 1 0 0 0 23 1 30 7 3 7 3 0 0 0 77 3 100



Q38 Whether instances of substitution led to change in the number of people employed

n

Yes 4 14

No 21 72

Dont know 4 14

Total 29 100

Q39 Estimated change in employment (to date) from implementing alternative substances andor technologies (total number of examples provided)

n

Reducti

on gt

250 w

ork

ers

Reducti

on 1

00-2

50 w

ork

ers

Reducti

on 5

0-9

9 w

ork

ers

Reducti

on 1

1-5

1 w

ork

ers

Reducti

on 1

-9 w

ork

ers

No c

hange

Incre

ase

1-1

0 w

ork

ers

Incre

ase

11-5

0 w

ork

ers

Incre

ase

51-9

9 w

ork

ers

Incre

ase

100-2

50 w

ork

ers

Incre

ase

gt250 w

ork

ers

Not

applicable

Dont

know

Tota

l

Reducti

on gt

250 w

ork

ers

Reducti

on 1

00-2

50 w

ork

ers

Reducti

on 5

0-9

9 w

ork

ers

Reducti

on 1

1-5

1 w

ork

ers

Reducti

on 1

-9 w

ork

ers

No c

hange

Incre

ase

1-1

0 w

ork

ers

Incre

ase

11-5

0 w

ork

ers

Incre

ase

51-9

9 w

ork

ers

Incre

ase

100-2

50 w

ork

ers

Incre

ase

gt250 w

ork

ers

Not

applicable

Dont

know

Tota

l

0 0 0 1 0 0 4 0 0 0 0 15 0 20 0 0 0 5 0 0 20 0 0 0 0 75 0 100

Q40 Whether instances of substitution led to reduction in worker exposure levels to (possible) SVHCs

n

Yes 14 48

No 11 38

Dont know 4 14

Total 29 100



Q41 Estimated number of workers with reducedno exposure to (possible) SVHCs due to implementing alternative substances andor technologies (total number of examples provided)

n

lt5 w

ork

ers

6-1

0 w

ork

ers

11-2

0 w

ork

ers

21-5

0 w

ork

ers

51-1

00 w

ork

ers

101-2

00 w

ork

ers

gt200 w

ork

ers

Not

applicable

Donrsquot

know

Tota

l

lt5 w

ork

ers

6-1

0 w

ork

ers

11-2

0 w

ork

ers

21-5

0 w

ork

ers

51-1

00 w

ork

ers

101-2

00 w

ork

ers

gt200 w

ork

ers

Not

applicable

Donrsquot

know

Tota

l

4 4 7 3 1 0 2 41 8 70 6 6 10 4 1 0 3 59 11 100

Q42 Whether instances of substitution led to reduction in emissions of (possible) SVHCs to the environment

n

Yes 13 45

No 10 34

Dont know 6 21

Total 29 100

Q43 Estimated annual reduction in emissions of (possible) SVHCs to wastewater after implementing alternative substances andor technologies (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

12 1 2 1 0 0 0 40 9 65 18 2 3 2 0 0 0 62 14 100



Q44 Estimated annual reduction in emissions of (possible) SVHCs to air (the atmosphere) after implementing alternative substances andor technologies (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

10 2 1 1 0 0 0 45 6 65 15 3 2 2 0 0 0 69 9 100

Q45 Estimated annual reduction in waste generated from (possible) SVHCs sent for appropriate disposaltreatment after implementing alternative substances andor technologies (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

9 4 0 0 0 2 0 43 7 65 14 6 0 0 0 3 0 66 11 100

Q46 Whether instances of substitution led to reduction in volume of SVHCs in finished products

n

Yes 17 59

No 10 34

Dont know 2 7

Total 29 100



Q49 Whether respondent uses any (possible) SVHCs for any other uses

n

Yes and we are investigating the possibility to substitute 20 54

Yes but we have not investigated the possibility to substitute yet 5 14

No Donrsquot know 12 32

Total 37 100

Q50 - Q58 Number of examples of substitution activities

n






Q60 Stage(s) of authorisation process that triggered substitution activities (total number of examples provided)

n

Scre

enin

g o

f su

bst

ance a

nd R

isk

Managem

ent

Opti

on A

naly

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion

of

subst

ance in A

uth

ori

sati

on

Lis

t (A

nnex X

IV)

Inclu

sion o

f su

bst

ances

in A

nnex

XIV

Applicati

ons

for

auth

ori

sati

on

(AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex

XIV

subst

ance)

Not

sure

Not

applicable

Tota

l

Scre

enin

g o

f su

bst

ance a

nd R

isk

Managem

ent

Opti

on A

naly

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion

of

subst

ance in A

uth

ori

sati

on

Lis

t (A

nnex X

IV)

Inclu

sion o

f su

bst

ances

in A

nnex

XIV

Applicati

ons

for

auth

ori

sati

on

(AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex

XIV

subst

ance)

Not

sure

Not

applicable

Tota

l

5 24 15 4 6 2 9 155 220 2 11 7 2 3 1 4 70 100



Q61 Estimated annual cost of substitution activities (total number of examples provided)

n

lteuro1 0

00 p

er

year

euro1 0

01 -

euro10

000 p

er

year

euro10 0

01 -

euro50

000 p

er

year

euro50 0

01 -

euro100

000 p

er

year

euro100 0

01 -

euro1

million p

er

year

euro1-euro

10 m

illion

per

year

euro10 -

euro100

million p

er

year

gteuro100 m

illion

per

year

Not

applicable

Donrsquot

know

Tota

l

lteuro1 0

00 p

er

year

euro1 0

01 -

euro10

000 p

er

year

euro10 0

01 -

euro50

000 p

er

year

euro50 0

01 -

euro100

000 p

er

year

euro100 0

01 -

euro1

million p

er

year

euro1-euro

10 m

illion

per

year

euro10 -

euro100

million p

er

year

gteuro100 m

illion

per

year

Not

applicable

Donrsquot

know

Tota

l

2 7 12 10 8 2 2 0 137 40 220 1 3 5 5 4 1 1 0 62 18 100

Q62 Top three reasons for carrying out substitution activities

n


REACH authorisation process 36 25 61 59 41 100

REACH but not the authorisation process 11 50 61 18 82 100

Other EU regulation 4 57 61 7 93 100

Non-EU regulation 3 58 61 5 95 100

Financial savings from switching 5 56 61 8 92 100

New opportunities in the market 14 47 61 23 77 100

To assess the suitability of possible alternatives as part of an AfA 32 29 61 52 48 100

To implement a known alternative on the market 4 57 61 7 93 100

Other 20 41 61 33 67 100



Q64 Top three reasons for not carrying out substitution activities

n


Financial constraints to carry out investigations 6 16 22 27 73 100

Constraints on internal RampD staff to carry out investigations 4 18 22 18 82 100

Lack of lsquonewrsquo alternatives worth investigating 10 12 22 45 55 100

No technically feasible alternative to deliver similar end-user requirements 16 6 22 73 27 100

Concerns about market approval if we substitute 5 17 22 23 77 100

Concerns of the economic costs associated with any switch to an alternative 5 17 22 23 77 100

Unable to pass on recover the costs to switch to an alternative 4 18 22 18 82 100

Non-competitive in the market against those that continue to use the SVHC 6 16 22 27 73 100

Other 10 12 22 45 55 100

IV Benefits of authorisation ndash Improved risk management of SVHCs

Q68 Whether organisation currently uses a (possible) SVHC

n

Yes 63 93

No 5 7

Total 68 100

Q69 Whether organisation has improved handling and use (operational) conditions of (possible) SVHCs as a result of REACH authorisation

n

Yes 23 37

No 34 54

Dont know 6 10

Total 63 100



Q70 -78 Number of examples of risk management-related activities

n






Q80 Stage(s) of authorisation process that triggered risk management activities (total number of examples provided)

n

Scre

enin

g o

f su

bst

ance a

nd

Ris

k M

anagem

ent

Opti

on

Analy

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion o

f su

bst

ance in

Auth

ori

sati

on L

ist

(Annex

XIV

)

Inclu

sion o

f su

bst

ances

in

Annex X

IV

Applicati

ons

for

auth

ori

sati

on (

AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex X

IV s

ubst

ance)

Not

sure

Not

applicable

Tota

l

Scre

enin

g o

f su

bst

ance a

nd

Ris

k M

anagem

ent

Opti

on

Analy

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion o

f su

bst

ance in

Auth

ori

sati

on L

ist

(Annex

XIV

)

Inclu

sion o

f su

bst

ances

in

Annex X

IV

Applicati

ons

for

auth

ori

sati

on (

AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex X

IV s

ubst

ance)

Not

sure

Not

applicable

Tota

l

4 7 2 4 9 0 9 80 115 3 6 2 3 8 0 8 70 100

Q81 Estimated one-off costs of risk management activities (total number of examples provided)

n

euro0-euro

10 0

00

euro10 0

01 -

euro50 0

00

euro50 0

01 -

euro100 0

00

euro100 0

01 -

euro1 m

illion

euro1-euro

10

million

gt euro

10

million

Not

applicable

Dont

know

Tota

l

euro0-euro

10 0

00

euro10 0

01 -

euro50 0

00

euro50 0

01 -

euro100 0

00

euro100 0

01 -

euro1 m

illion

euro1-euro

10

million

gt euro

10

million

Not

applicable

Dont

know

Tota

l

2 3 9 6 2 0 68 25 115 2 3 8 5 2 0 59 22 100



Q82 Whether risk management activities led to reduction in worker exposure levels to (possible) SVHCs

n

Yes 19 83

No 1 4

Dont know 3 13

Total 23 100

Q83 Estimated number of workers with reducedno exposure to (possible) SVHCs due to risk management activities (total number of examples provided)

n

lt5 w

ork

ers

6-1

0 w

ork

ers

11-2

0 w

ork

ers

21-5

0 w

ork

ers

51-1

00 w

ork

ers

101-2

00 w

ork

ers

gt200 w

ork

ers

Not

applicable

Donrsquot

know

Tota

l

lt5 w

ork

ers

6-1

0 w

ork

ers

11-2

0 w

ork

ers

21-5

0 w

ork

ers

51-1

00 w

ork

ers

101-2

00 w

ork

ers

gt200 w

ork

ers

Not

applicable

Donrsquot

know

Tota

l

2 9 8 5 2 0 1 68 0 95 2 9 8 5 2 0 1 72 0 100

Q84 Whether risk management activities led to reduction in emissions of (possible) SVHCs to the atmosphere

n

Yes 9 39

No 8 35

Dont know 6 26

Total 23 100



Q85 Estimated annual reduction in emissions of (possible) SVHCs to air (the atmosphere) after implementing risk management activities (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

6 1 0 0 0 0 0 25 13 45 13 2 0 0 0 0 0 56 29 100

Q86 Whether risk management activities led to reduction in emissions of (possible) SVHCs to wastewater

n

Yes 5 22

No 12 52

Dont know 6 26

Total 23 100

Q87 Estimated annual reduction in emissions of (possible) SVHCs to wastewater after implementing risk management activities (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

7 0 0 0 0 0 0 8 10 25 28 0 0 0 0 0 0 32 40 100



Q88 Whether risk management activities led to reduction in waste sent for appropriate disposaltreatment

n

Yes 7 30

No 11 48

Dont know 5 22

Total 23 100

Q89 Estimated annual reduction in waste generated from (possible) SVHCs sent for appropriate disposaltreatment after implementing risk management activities (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

2 1 1 5 0 0 0 21 5 35 6 3 3 14 0 0 0 60 14 100

Q90 Whether risk management activities led to reduction in volume of (possible) SVHCs required

n

Yes 3 13

No 16 70

Dont know 4 17

Total 23 100



Q91 Estimated annual reduction in volume of (possible) SVHCs required after implementing risk management activities (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

1 1 1 0 0 0 0 12 0 15 7 7 7 0 0 0 0 80 0 100

Q92 Whether risk management activities led to reduction in volume of (possible) SVHCs in finished products

n

Yes 2 9

No 18 78

Dont know 3 13

Total 23 100

Q93 Estimated annual reduction in volume of (possible) SVHCs in finished products after implementing risk management activities (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

2 0 0 0 0 0 0 7 1 10 20 0 0 0 0 0 0 70 10 100



Q94 Whether organisation submitted an application for authorisation (AfA) or was covered by an upstream AfA

n

Yes 41 65

No 22 35

Total 63 100

Q95 Whether organisations AfA included specific risk management activities to be implemented after AfA submission

n

Yes 13 32

No but we have carried out further management activities following submission 9 22

No 19 46

Total 41 100

Q96 Whether risk management activities led to reduction in workplace exposure andor emissions to the environment

n

Yes 6 27

No 8 36

Too early to say 8 36

Total 22 100

Q97 Whether final opinion has been made by the ECHA Committees on organisations AfA

n

Yes 16 73

No 6 27

Total 22 100



Q98 Whether Risk Assessment Committee recommended andor imposed conditions as part of the AfA decision in relation to risk management measures

n

Yes 12 75

No 2 13


Total 16 100

Q99 Whether complying with conditions as part of the AfA decision has led to a reduction in workplace exposure andor emissions to the environment

n

Yes 5 42

No 4 33


Total 12 100

Q100 Whether respondent has supporting data that they are willing to share regarding these reductions in workplace exposure andor emissions to the environment

n

Yes 1 8

No 5 42

Not applicable (no data available yet) 6 50

Total 12 100



V Changes in market structure

Q103 Whether REACH authorisation has led to market impacts on respondents organisation

n

Yes 46 73

No 8 13

Dont know 3 5

Not applicable 6 10

Total 63 100

Q104 Whether REACH authorisation has led to an impact on organisations production or supply of (possible) SVHCs or alternatives

n

Yes 26 57

No 12 26

Dont know 5 11

Not applicable 3 7

Total 46 100

Q134 Whether REACH authorisation has led to organisation closing or relocating any of its EU production

n

Yes 3 7

No 34 74

Not applicable 9 20

Total 46 100



Q159 Whether REACH authorisation has impacted organisations competitiveness

n

Yes 19 41

No 21 46

Not applicable 6 13

Total 46 100

Q189 Whether REACH authorisation has impacted organisations spending on innovationinvestment opportunities andor RampD

n

Yes 35 76

No 8 17

Not applicable 3 7

Total 46 100

Q244 Whether REACH authorisation has impacted organisations employment

n

Yes 7 15

No 34 74

Not applicable 5 11

Total 46 100

Q274 Whether REACH authorisation has impacted organisations sales revenue

n

Yes 10 22

No 29 63

Not applicable 7 15

Total 46 100



Q304 Whether REACH authorisation has impacted quality price and availability of organisations product

n

Yes 11 24

No 27 59

Not applicable 8 17

Total 46 100

VI Costs incurred during the authorisation process

Q339 Whether organisation provided comments during ECHAs public consultation process

n

Yes 34 54

No 29 46

Total 63 100

Q340 Whether organisation provided comments during ECHAs public consultation process for substances on the Candidate List or their alternatives

n

Yes 22 65

No 12 35

Total 34 100

Q342 Whether organisation provided comments during ECHAs public consultation process for substances on the Authorisation List or their alternatives

n

Yes 23 68

No 11 32

Total 34 100



Q344 Whether organisation provided comments during consultations for AfAs

n

Yes 16 47

No 18 53

Total 34 100

Q346 Main reasons for providing comments throughout authorisation process

n


There was critical information missing 15 19 34 44 56 100

There were inaccuracies in information presented 13 21 34 38 62 100

We disagreed with the resultsfindings presented 14 20 34 41 59 100

We agreedsupported the resultsfindings presented 11 23 34 32 68 100

We were seeking an exemption for a specific usesector 12 22 34 35 65 100

Other (please specify) 10 24 34 29 71 100

Q348 Whether organisation read published response to their comments

n

Yes and I was satisfied with the response 9 26

Yes but I was not satisfied with the response 15 44

Yes but I canrsquot remember donrsquot have a particular opinion on the response 4 12

No 2 6

I canrsquot remember I donrsquot know 4 12

Total 34 100



Q349 Main reasons for not providing comments throughout authorisation process

n


We believed the information provided was sufficient 8 21 29 28 72 100

We do not have enough staff to be able to respond 11 18 29 38 62 100

Substances and alternatives to date have not been relevant for our organisation 4 25 29 14 86 100

We were not aware of opportunities to comment 2 27 29 7 93 100

We did not have further informationevidence to provide 9 20 29 31 69 100

We did not think commenting would influence the decision 3 26 29 10 90 100

The consultation process was too complex 4 25 29 14 86 100

The information requested was too limited (eg information on alternatives for consultation on AfAs) 1 28 29 3 97 100

There is not enough time available to prepare comments 1 28 29 3 97 100

We did not have the technical expertise required to evaluate the information provided 5 24 29 17 83 100


2 27 29 7 93 100


Q353 Whether respondents organisation incurred costs associated with compliance with REACH authorisation process

n

Yes 45 71

No 9 14

Dont know 5 8

Not applicable 4 6

Total 63 100



Q354 Whether respondents organisation incurred costs by producing and maintaining an (extended) safety data sheet (SDS)

n

Yes 14 31

No 31 69

Total 45 100

Q355 Cost of producing and maintaining an extended SDS

n

euro0 - euro500 1 7

euro501 - euro1 000 2 14

euro1 001 - euro10 000 3 21

euro10 001 - euro50 000 2 14

euro50 001 - euro100 000 0 0

euro100 001 - euro200 000 0 0

gt euro200 000 1 7

Dont know 5 36

Total 14 100

Q356 Whether respondents organisation incurred costs by producing information to enable an (extended) safety data sheet (SDS) to be appropriately updated

n

Yes 9 20

No 36 80

Total 45 100



Q357 Cost of updating an extended SDS n

euro0 - euro500 0 0

euro501 - euro1 000 2 22

euro1 001 - euro10 000 3 33

euro10 001 - euro50 000 1 11

euro50 001 - euro100 000 0 0

euro100 001 - euro200 000 1 11

gt euro200 000 2 22

Dont know 0 0

Total 9 100

Q358 Whether respondents organisation incurred costs by providing information to allow safe use of an article

n

Yes 10 22

No 35 78

Total 45 100

Q359 Cost of providing information to allow safe use of an article

n

euro0 - euro500 1 10

euro501 - euro1 000 1 10

euro1 001 - euro10 000 2 20

euro10 001 - euro50 000 0 0

euro50 001 - euro100 000 0 0

euro100 001 - euro200 000 5 50

gt euro200 000 1 10

Dont know 0 0

Total 10 100



Q360 Whether respondents organisation incurred costs by updating a registration dossier following AfAs

n

Yes 8 18

No 37 82

Total 45 100

Q361 Cost of updating registration dossier following AfAs

n

euro0 - euro500 0 0

euro501 - euro1 000 0 0

euro1 001 - euro10 000 2 25

euro10 001 - euro50 000 3 38

euro50 001 - euro100 000 1 13

euro100 001 - euro200 000 1 13

gt euro200 000 1 13

Dont know 0 0

Total 8 100

Q362 Whether respondents organisation incurred costs by notifying DUs of authorised uses

n

Yes 8 18

No 37 82

Total 45 100



Q363 Estimated costs of notifying DUs of authorised uses

n


euro501 - euro1 000 0 0

euro1 001 - euro10 000 3 38

euro10 001 - euro50 000 0 0

euro50 001 - euro100 000 1 13

euro100 001 - euro200 000 0 0

gt euro200 000 3 38

Dont know 0 0

Total 8 100

Q364 Whether respondents organisation incurred costs by complying with reporting obligations in their authorisation decision and preparing the review report

n

Yes 9 20

No 36 80

Total 45 100



Q365 Cost of complying with reporting obligation in authorisation decision and preparing the review report

n

euro0 - euro500 0 0

euro501 - euro1 000 0 0

euro1 001 - euro10 000 3 33

euro10 001 - euro50 000 4 44

euro50 001 - euro100 000 0 0

euro100 001 - euro200 000 0 0

gt euro200 000 2 22

Dont know 0 0

Total 9 100

Q366 Whether respondents organisation incurred costs by familiarising themselves with REACH authorisation requirements

n

Yes 40 89

No 5 11

Total 45 100

VII Small and medium-sized enterprises (SMEs)

Q370 Whether respondents organisation is an SME n

Yes 20 32

No 43 68

Total 63 100



Q371 Type of AfA respondent has been involved in

n



7 13 20 35 65 100

Joint application (group of actors came together) 4 16 20 20 80 100

Individual application (I applied for my own use only) 3 17 20 15 85 100

Donrsquot know 8 12 20 40 60 100

Q372 Top 3 challenges with AfAs

n


Understanding what data is required 11 9 20 55 45 100

Resources required for preparing applicationmy organisationrsquos inputs 15 5 20 75 25 100

Collecting the necessary data 10 10 20 50 50 100

Timescales for providing further information post-submission 2 18 20 10 90 100

Costs of preparing an AfA 9 11 20 45 55 100

Costs and effort of meeting requests for further information post-submission 1 19 20 5 95 100

Costs associated with business uncertainty 3 17 20 15 85 100


Q373 How helpful REACH authorisation guidance and other information on ECHA website is

n

Very helpful 1 5

Helpful 5 25

No opinion either way 4 20

Not helpful 4 20

Very unhelpful 0 0

I did not use any of this information 6 30

Total 20 100



Q374 Sources of support used

n


Manufacturerimporter of the SVHC 9 11 20 45 55 100

Other applicants who have been through the process 4 16 20 20 80 100

Relevant tradesector association 5 15 20 25 75 100

Consultants who know about REACH authorisation 11 9 20 55 45 100

Member State Competent Authority(ies) including national helpdesks 1 19 20 5 95 100

ECHA helpdesk 2 18 20 10 90 100

Review other applications and opinionsdecisions that are publicly available 3 17 20 15 85 100

None of the above 3 17 20 15 85 100

Q375 Top 3 challenges with REACH authorisation process

n


Understanding what is required how am I affected 13 7 20 65 35 100

Cost of preparing an AfA (or providing data to the applicant) 8 12 20 40 60 100

Internal staff time required for preparing an AfA 11 9 20 55 45 100

Finding possible alternatives to the SVHC in question 11 9 20 55 45 100

Assessing the ldquosuitabilityrdquo of alternatives 9 11 20 45 55 100





ANNEX G STAKEHOLDERS CONTACTED

This annex sets out a list of stakeholders contacted as part of this study

G1 Member State Competent Authorities

Table G01 sets out Member State Competent Authorities (MS CAs) that were invited to complete the questionnaire about the administrative burden of

the REACH authorisation process These stakeholders were first contacted by the EC

Table G01 Stakeholders invited to take part in a MS CA questionnaire

Member State Competent Authority

Austria

Belgium

Bulgaria

Denmark

Finland

France

Germany

Hungary

Ireland

Italy

Lithuania

Luxembourg

Netherlands

Norway

Poland



Portugal

Slovakia

Spain

Sweden

UK

G2 NGOs

Table G02 sets out stakeholders that were invited to take part in the NGO online survey These stakeholders were contacted by phone or sent an email

when it was not possible to speak to them over the phone

Table G02 Stakeholders invited to take part in the NGO online survey

Organisation

BEUC - The European Consumer Organisation

Center for International Environmental Law (CIEL)

Chemicals Health and Environment Monitoring (CHEM) Trust

ChemSec (International Chemical Secretariat)

Clean Production Action

ClientEarth

Cruelty Free International

Darmstadt University of Applied Sciences

Department of Environmental Science and Analytical Chemistry ndash Stockholm University

European Association for Chemical and Molecular Sciences (EuCheMS)

European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC)

European Coalition to End Animal Experiments (ECEAE)



European Consensus Platform for Alternatives (ECOPA)

European Environmental Bureau (EEB)

Federation of Small Businesses

Friends of the Earth Europe

Green Chemistry Centre of Excellence - University of York

Green Chemistry Network

Greenpeace

Health amp Environment Alliance (HEAL)

Health Care without Harm (HCWH) Europe

Italia Nostra ONLUS

Knowledge Transfer Network

National Federation of Womenrsquos Institute

RISK Consultancy

Royal Society of Chemistry

Society of Chemical Industry

Trades Union Congress

Wemos Foundation

Wildfowl amp Wetlands Trust (WWT)

G3 Industry

Table G03 sets out stakeholders that were invited to take part in the industry online survey These stakeholders were directly contacted by phone or

sent an email when it was not possible to speak to them over the phone Some additional stakeholders were also contacted indirectly by their

sectortrade associations or via ECHA (eg applicants) These stakeholders are not included in this list



Table G03 Stakeholders invited to take part in the industry online survey

Organisation

ALPA SpA

ADS Group

Agas

Agnico-Eagle Finland Kittilauml Mine

Agosi Allgemeine Gold- und Silberscheideanstalt AG

AISE - International Association for Soaps Detergents and Maintenance Products

AkzoNobel

Alcantara SpA

AmCham EU (American Chamber of Commerce to the European Union)

Ames Goldsmith

Andritz Hydro

Anglo Platinum Management Services (Pty) Ltd

Apple

ArcelorMittal Europe

Association of European Automotive and Industrial Battery Manufacturers (EUROBAT)

Atotech Deutschland GmbH

Aurubis AG

Baaske Oberflaumlchenveredlung GmbH

Banner Batterien GmbH

Banner Chemicals

BASF Catalysts

BASF SE

Bayer AG

Belinka doo



Biacchessi GmbH amp Co KG

BIAL

Boeing

Boliden Harjavalta Oy

Bolta Werke GmbH

Boncrom SL

Borealis

Brenntag Nederland BV

British Association for Chemical Specialities

British Coatings Federation

British Plastics Federation

British Retail Consortium

Brominated Compounds Consortium

Burello Srl

Business Council for Sustainable Development (UK)

BusinessEurope

C Hafner GmbH amp Co KG

CEFIC

Cendres amp Metaux Holding SA

CEPE - European Council of the Paint Printing Ink and Artists Colours Industry

Cepsa

Chamber of Commerce Austria

Chemical Business Association

Chemical Industries Association

Chemtura Corporation



CHIMET SpA

Chrom ndash Muumlller Metallveredelung GmbH

Chromates Consortia lead (CTAC and CCST)

Chrom-Schmitt GmbH

Circa Group


Clariant Produkte (Deutschland) GmbH

Cobalt Reach Consortia (CoRCCDI)

Collini GmbH

COMMERZBANK AG Luxembourg

Concawe

COOP

Cosmetics Europe

Coventya Ltd

Cromados Estevez SL - Autocromes

Dell

DETIC

DEZA as

DLAC Dienstleistungsagentur Chemie GmbH

Doduco GmbH

DOURECA - Produtos Plaacutesticos Lda

DOW

Dr Hesse GmbH amp CIE KG

DSM

DuPont (UK) Ltd



Ecobat Technologies

EEF - The Manufacturers Organisation

Electroquimica De Hernani SA

Eli Lilly and Company

ELIN Motoren GmbH

EMCEF

ENTEK

Environmental Services Association

Ercros SA

Essenscia

Estalki

Etienne Lacroix

ETRMA

EurEau

Eurohueco SAU

Eurometaux

European Association of Environmental and Resource Economists (EAERE)

European Committee for Surface Treatment (CETS)

European Committee of Domestic Equipment Manufacturers (CECED)

European Crop Protection (ECPA)

European Federation of Pharmaceutical Industries and Associations (EFPIA)

European Plastics Converters (EuPC)

European Precious Metals Federation (EPMF)

European Semiconductor Industry Association (EECA-ESIA)

European Space Research and Technology Centre



European Trade Union Institute (ETUI ETUC)

Europeacuteenne de Lyophilisation SA

Exide Technologies SA Polang

FHoffmann-La Roche Ltd

Fachvereinigung Edelmetalle eV

FCIO - Fachverband der Chemischen Industrie Oumlsterreichs


FEFCO

FERRO GmbH

Fertilizers Europe

Festo AG amp Co KG

Fipra

Galvacon

Galvano Roumlhrig GmbH

Gamarti SL

Gammacolor srl

GE Healthcare Bio-Sciences AB

Glass Service as

Glencore Xstrata Nikkelverk AS

Goodyear

Green Coat SRL

Grohe AG

HampR Oumllwerke Schindler

Handy amp Harmann

Heimerle amp Meule GmbH



Heraeus Group

Herbert Bauer GmbH amp Co KG

HM

Honeywell

HP

Hunstman

Huta Cynku Miasteczko Slaskie

ICL

IDT

IHI Hauzer Techno Coating BV

IKEA

ILZRO

IMA-Europe

Indestructible Paint Ltd

Ineos

INOVYN Chlorvinyls Limited

International Antimony Association

International Zinc Association

INTERTEK France (Columbia Chemical)

Janssen - Pharmaceutical Companies of Johnson amp Johnson

Jobatec

Johnson Matthey Plc

Karl Simon GmbH amp Co KG

KCM 2000 SA

KCM AD



Kemira Oy

Kesseboumlhmer Beschlagsysteme GmbH amp Co KG

Keyser amp Mackay

KGHM Polska Miedz SA

K-I Chemical Europe SANV

KIESOW DRBRINKMANN GmbH amp Co KG

Kingfisher

Kludi GmbH amp Co KG

Koppers

Kunststofftechnik Bernt GmbH


Lanxess Deutschland GmbH

Lead REACH Consortium

LKS Kronenberger

Lyondell Basel

MacDermid

Maier Group

Menage amp Confort Centro de Produccioacuten

Metallo-Chimique

Metalor Technologies France SA

Microporous GmbH

Montanwerke Brixlegg AG

MTV Metallveredlung GmbH amp Co KG

MVA Metallveredelung Helmut Ansorge

Nickel Institute



Non-Ferrous Alliance

Nord Chrome

Nordenhamer Zinkhuumltte GmbH

Norilsk Nickel Harjavalta Oy

Oberflaumlchenchemie Dr Klupsch GmbH amp Co KG

OcheseSCL

Oerlikon

Olin Corporation

Olon SpA

Omnichem

Organoclick

Ovako Twente BV

PAMP SA

Parker Hanifin

Partec Partner der Technologie GmbH

Paxymer

Pfizer

Plating Brap SA

Polynt Composites France

PPG Aerospace

PPTA

Praumlzisionsgalvanik GmbH Wolfen

Profel

Profin Protective Finishing Ltd

PX Services SA



R A Chilton Ltd

RAG

Ravago Monotez SA

REACH Centrum

REACHLaw Ltd

Reco SL

Reconsile

REHAU AG + Co

Rheinmetall Waffe Munition GmbH

Rolls-Royce plc

ROQUETTE-Lestrem

Rosenberger Hochfrequenztechnik GmbH amp Co KG

Roxel (UK Rocket Motors) Limited

Safimet SpA

SAFT Batteries

Sasol Wax GmbH

Saudi Arabian Industries Corporation (SABIC)

Savroc

SAXONIA Edelmetalle GmbH

Schloetter

Sempsa Joyeria Plateria SA

Shell

SK USS

Skanska

Socieacuteteacute des Fonderies de Plomb de Zellidja (Maroc)



Solutia

Solvay SA

Sopo International Ltd

Southwest Metal Finishing Ltd

SPGPrints BV

ST Microelectronics

STI Deutschland

Sunpor Kunststoff GmbH

Surface Design Srl

Surface Engineering Association (SEA)

Sveriges Byggindustrier (The Swedish Construction Federation)

Talleres Acro SA

Tanaka Kikinzoku Kogyo KK

Tata Steel

TCO Development

Technocorp Holding SA

TechUK

The Association of European Producers of Steel for Packaging (APEAL)

Thoma Metallveredelung GmbH

Thyssen Krupp

Traxys

TUPAI SA

U S Steel Kosice sro

UEAPME (European Association of Craft Small and Medium-Sized Enterprises)

UK Cleaning Products Industry Association



UMICORE AG amp CoKG

UMICORE Olen

UMICORE Precious Metals Refining

Unifrax

Unilever

United Technologies Corp

Valcambi SA

VALE Europe Ltd

VECCO

Versalis SpA

Vilaelectroquimica SA

Vlisco

VNCI

VWR

Wafa Spain SA

Walzen Service Center GmbH

West and Senior Ltd

Wilhelm Bauer GmbH amp Co KG

Wilhelm Grillo Handelsgesellschaft mbH



ANNEX H TIER 1 SUPPORTING ANNEX (FOR SECTION 10)

REACH registrants

Number of active

registrants (132017) 23

List of active

registrants (132017)

BASF Nederland BV Groningensingel 1 Postbus 1019 6801 MC Arnhem Netherlands

BONDEX TRADING LTD in its legal capacity as Only Representative of Aktyubinsk Chromium Chemicals Plant Kazakhstan 125 Wood Street EC2V 7AN London United Kingdom

CHEMICAL INSPECTION amp REGULATION SERVICE LIMITED Unit 1 Ardee Business Park Hale Street Co Louth Ardee Ireland

CHEMICAL INSPECTION amp REGULATION SERVICE LIMITED Singleton House Laurence Street Co Louth Drogheda Ireland

Chemservice SA (H5P7) 5 an de Laengten 6776 Grevenmacher Luxembourg

Clariant Produkte (Deutschland) GmbH Am Unisys-Park 1 65843 Sulzbach am Taunus Germany

Clariant Produkte (Deutschland) GmbH - US01 Am Unisys-Park 1 65843 Sulzbach am Taunus Germany

CROMITAL SPA in its legal capacity as Only Representative of Soda Sanayii AS Strada Quattro Pal A7 - 20090 Assago (MI) Italia 20090 AssagoMilano Italy

EGIS Pharmaceuticals PLC Keresztuacuteri uacutet 30-38 H-1106 Budapest Hungary

Elementis Chromium LLP in its legal capacity as Only Representative of Elementis Chromium Inc Elementis Chromium Eaglescliffe TS16 0QG Stockton on Tees United Kingdom

Evonik Degussa GmbH Rellinghauser Strasse 1 - 11 C-ES 45128 Essen Germany

Gentrochema BV Esdoornlaan 19a 4254 AT Sleeuwijk Netherlands

Grupa Azoty SA ul Kwiatkowskiego 8 33-101 Tarnow Poland

Haldor Topsoe AS Nymoslashllevej 50 DK28000 Lyngby Denmark

LANXESS Deutschland GmbH in its legal capacity as Only



Representative of LANXESS CISA (Pty) Ltd Kennedyplatz 1 50569 Koumlln NRW Germany

momaja sro Karolinskaacute 6501 186-00 Prague 8 Czech Republic

REACHLaw Ltd Vaumlnrikinkuja 3 JK 21 02600 Espoo Finland

REPSOL QUIacuteMICA Calle Mendez Alvaro 44 28045 Madrid Spain

RusChrome GmbH Industriestrasse 4 70565 Stuttgart Germany

SABIC Petrochemicals BV Europaboulevard 1 6135 LD Sittard Netherlands

Sustainability Support Services (Europe) AB Markaskaumllsvaumlgen 6 22647 Lund Sweden

Total Petrochemicals Antwerpen NV Scheldelaan 4 2030 Antwerpen Belgium

[Confidential] [Confidential]

Number of inactive


2

List of inactive


Johnson Matthey PLC 5th Floor 25 Farringdon Street EC4A 4AB

London United Kingdom

RS Bruce (Metals amp Machinery) Ltd March Street Darnall S9 5DQ Sheffield United Kingdom

Tonnage band

registration

10000 ndash 100000 tpa

Alternatives according to SUBSPORT



In the same document reference is made to a screening of alternatives for the use of hexavalent chromium compounds against SUBSPORT Screening

Criteria (SDSC)

The alternatives that pass the screening against the SDSC are for anti-corrosive and decorative coating



Physical Vapor Deposition (PVD)Chemical Vapor Deposition vacuum process with titanium nitride (CAS 25583-20-4) or chromic nitride (CAS 24094-

93-7) or tungsten carbide (CAS 12070-12-1)

Heat treatment gas nitriding with ammonia (CAS 7664-41-7) plasma nitriding with nitrogen

for plastic pigments

chrome antimony titanium buff rutile (CAS 68186-90-3)

niobium sulfur tin zinc oxide (CAS 1374645-21-2)

for leather tanning

chromium (III) sulphate (CAS 10101-53-8)

aluminium chloride basic (CAS 1327-41-9)

zirconium sulphate (CAS 14644-61-2)

iron (II) sulphate (CAS 7720-78-7)

wattle bark myrobolan nuts chestnut

for textile deying mordants

potassium aluminum sulphate (CAS 10043-67-1)

stannous chloride (CAS 7772-99-8)

copper sulphate (CAS 7758-98-7) iron (II) sulphate (CAS 7720-78-7)

sulfated castor oil (CAS 8002-33-3) disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2- sulphonatophenyl]azo]-45-dihydro-3-methyl-5-oxo-1H-

pyrazol-1-yl]-25- dichlorobenzenesulphonate (CAS 70247-70-0 )

tetrasodium 4-amino-5-hydroxy-36-bis[[4-[[2- (sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-27-disulphonate (CAS 17095- 24-8)

for wood treatment

copper oxide (CAS 1317-38-0) didecyldimethylammonium chloride (CAS 7173-51-5)

copper oxide (CAS 1317-38-0)and alkyldimethylbenzylammonium chloride (CAS 8001-54- 5)

EU supported projects and RampD to eliminate hexavalent chromium

Project Description

CRAFT Prevention of chromium(VI) formation by improving the tannery processes (1999)



Project Description

Recy-Chrom 90 of chromium-plating facilities in Europe are SMEs with all resources allocated to the daily work The social and environmental concern related to the toxicity of the chromic acid used in the baths is leading the sector to a difficult decision the investment in very complex and expensive systems to control and reduce the emissions could lead them to a non-competitive position The basic objective of RECY-CHORM is to develop and validate a new system to recover chromium from the rinsing bath using a clean technology such as electro-electrodialisis (EED) with 3 compartments which does not need either water or chemical products to work This system will be modular portable and cheap to be affordable and valuable for SMEs For this to be achieved the consortium has been formed with partners skilled in different technologies involved (membranes electrodialisis raw material recovery and surface treatments) as well as planting industries to validate the results

Ecochrom Electrolytic hard chrome-plating is the most used wear resistant process for engineering industries aeronautic steel-or paper-makers The major drawback is that it uses CrVI classified as carcinogenic by the International Agency of Search on Cancer The likely banning of CR VI in the years to come and need of successful coatings opened the way to interesting expensive and difficult replacement techniques often impossible on big parts That is why electrolytic chrome-plating will remain the process of choice with two conditions provide guarantees to employees and environment compete with techniques of replacement in terms of performance The object of the proposal is to study and develop processes allowing to obtain thick chromium coatings more successful than the traditional ones from a new and non toxic electrolytic solution Developed processes will be applicable to chromium platers without major modifications of installations

Hardalt The aim of this project is to eliminate the use of hard chromium plating across the European electroplating industry by delivering a suitable substitute which will be based on nano structured Ni-P and Ni-P composite coatings (with for example SiC or BC as reinforcing nanoparticles)

The successful outcome of the HardAlt project will lead to the reduction or even elimination of the use of hexavalent chromium in the electrodeposition industry thereby circumventing EU legislation As HardAlt coatings will exhibit equivalent or even enhanced functional properties compared to hard chrome they will be adopted by the metal working industry in applications where wear and corrosion resistance is of critical importance The three most common



Project Description

applications of Hard Chrome that will be targeted have been identified as

Hydraulicpneumatic pistons and cylinders

Specialized oil and gas exploration equipment

Moulds and press tools

Significant benefit will be the customization of the HardAlt coatings to the need of each application whilst using the same bath thereby leading to savings in raw materials and the minimizing of waste from the electroplating industry

SAMDOKAN The main goal of SAMDOKAN project is to industrialize a novel hexavalent chrome Cr(VI) free environmentally friendly high performance electroplating pre-treatment for plastic surfaces using molecular self assembly nanotechnology (SAM) Sectors such as automotive white goods electric-appliances and sanitary are the main consumers of this type of plastic parts In Europe about 1350 companies have chrome plating installations of which over 98 are SMEs SAM technology has been already demonstrated in ECOSAM FP 6 project to be a successful alternative to the traditional electroplating technology SAMDOKAN project objectives are aligned with Eco-innovation programme since an eco-innovative production methodology will be industrial scale-up which aims to prevent and reduce environmental impacts such as the generation of potentially hazardous waste going to landfill andor incineration transport associated to this waste etc The specific objectives of the project are the following To scale up the SAM pre-treatment process in three electroplater companies and plastic types 100 elimination of carcinogenic chromic acid (Cr (VI)) and toxic PdSn colloids in the pre-treatment process at industrial scale This means a reduction of 5 steps in the pre-treatment process a 30 in total reactive consume and a reduction of 35 of clean water consume An overall 20 cost reduction of the pre-treatment can be achieved Increase the production capacity of current plants in at least 25 and a reduction in 50 of total energy consumption To expand the electroplating market on a broader range of plastics and to provide end-users a greater scope for design (filled polypropylene (PP) and filled polyamide (PA)



Project Description

No health concerns (water based treatments and low toxicity chemicals for electroplating pre-treatment process and for waste water treatment) Reduction of 3 plastics consumption due to a reduction of rejected parts and thickness of plastic parts

httpwwwsamdokanprojecteu



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(httpeeaseuropaeudelegationsindex_enhtm)

by contacting the Europe Direct service

(httpeuropaeueuropedirectindex_enhtm) or calling 00 800 6 7 8 9 10 11

(freephone number from anywhere in the EU) ()

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doi 102873769886

ET-0

7-1

7-0

28-E

N-N

EUROPEAN COMMISSION


Directorate D mdash Consumer Environmental and Health Technologies Unit D1 mdash REACH

Contact Valentina Bertato

E-mail ValentinaBERTATOeceuropaeu

European Commission B-1049 Brussels

Impacts of REACH

Authorisation

Final Report


Study on the Impacts of REACH Authorisation

2017 EUR 20177084 EN

LEGAL NOTICE

This document has been prepared for the European Commission however it reflects the views only of the authors and the Commission cannot be held responsible for any use which may be made of the information contained therein

More information on the European Union is available on the Internet (httpwwweuropaeu)

Luxembourg Publications Office of the European Union 2014

ISBN 978-92-79-75758-7 doi 102873769886

copy European Union 2014

Printed in Belgium

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to your questions about the European Union

Freephone number ()

00 800 6 7 8 9 10 11

() The information given is free as are most calls (though some operators phone boxes or hotels may charge you)


eftec November 2017

i

This document has been prepared for Unit GROWD1 REACH by

Economics for the Environment Consultancy Ltd (eftec)

4 City Road

London

EC1Y 2AA

wwwefteccouk

In association with Apeiron-Team NV Peter Fisk Associates Limited (PFA) and The Economics

Interface Limited

Study team

Rohit Mistry (eftec)

Hiram Moerman (Apeiron-Team NV)

Andreas Novak (Apeiron-Team NV)

Richard Dubourg (The Economics Interface Limited)

Oliver Warwick (PFA)

Sarah Krisht (eftec)

Sebastiana Hard (eftec)

Rachel London (PFA)

Elke Van Asbroeck (Apeiron-Team NV)

Reviewers

Ece Ozdemiroglu (eftec)

Acknowledgements

The study team would like to thank the project steering group made up of members from the

European Commission (EC) and the European Chemicals Agency (ECHA) for the inputs received

Disclaimer

Whilst eftec has endeavoured to provide accurate and reliable information eftec is reliant on the

accuracy of underlying data provided and those readily available in the public domain eftec will

not be responsible for any loss or damage caused by relying on the content contained in this report

Document evolution

Interim report 20042017 Reviewed by Ece Ozdemiroglu

Final interim report 14072017 Reviewed by Rohit Mistry

Draft final report 04092017 Reviewed by Ece Ozdemiroglu

Final report 31102017 Reviewed by Ece Ozdemiroglu

Final report ndash Reissued 28112017 Reviewed by Rohit Mistry

eftec offsets its carbon emissions through a biodiversity-friendly voluntary offset purchased from the World Land Trust (httpwwwcarbonbalancedorg) and only prints on 100 recycled paper


eftec November 2017

ii

EXECUTIVE SUMMARY

This document reports on a study on the impacts of REACH Authorisation The process of

Authorisation within REACH (Regulation (EC) No 19072006 of the European Parliament and of the

Council on the Registration Evaluation Authorisation and Restriction of Chemicals) has aims to

ensure the good functioning of the internal market while assuring that the risks from Substances of

Very High Concern (SVHCs) are properly controlled and that these substances are progressively

replaced by suitable alternative substances or technologies where these are economically and

technically viable (REACH Article 55) This present study considered a number of key elements in

order to understand the specific contribution of the authorisation process to achieving this aim

It has been ten years since REACH came into force on the 1st June 2007 and it is one of the most

comprehensive regulations on chemicals ever to be introduced anywhere in the world The

European Commission (EC) is required to review REACH every five years to monitor its operation

The first REACH review was carried out in 20121 and a second review is due in 2017 into which this

study feeds

Since the 2012 review several studies examining specific aspects of REACH Authorisation have been

carried out by the EC the European Chemicals Agency (ECHA) Member State Competent

Authorities (MSCAs) NGOs and industry associations The previous studies typically relied on

anecdotal evidence and lacked quantified (and monetised) information on the costs and benefits of

REACH Authorisation

The present study sought to build on available information as well as compare its findings with the

previous studies It is the first comprehensive study to attempt to obtain reliable quantitative

evidence on the overall impacts of Authorisation and particularly to focus on aspects for which

there has been limited information to date This includes the role of Authorisation in influencing

the decisions to substitute away from SVHCs The study involved a review of the existing literature

surveys with industry NGOs the EC ECHA and MSCAs in-depth follow-up interviews with industry

(see Table ES1) and both in-depth (Tier 1) and shorter (Tier 2) case studies on specific chemicals

or issues Some of the key findings from the study are consistent with previous studies which adds

credibility to both this study and existing literature it contributes to

Members of the project team presented at various REACH-related events spoke to industry sector

groups and NGOs (in person or over the phone) to raise awareness of the project and encourage

stakeholders to take part in the survey This was supported by efforts made by ECHA and the EC

Rather than contacting as many stakeholders as possible consultation was targeted at stakeholders

who may have been impacted by REACH Authorisation and who might be able to provide the

required data In particular any companies that had substituted from an SVHC (or were in the

process of doing so) were prioritised as this was a particular data gap needed to be addressed in

this study Therefore the sampling strategy was intentionally unrepresentative of industry as a

whole and this should be borne in mind when interpreting the results

1 httpeceuropaeuenvironmentchemicalsreachreview_2012_enhtm


eftec November 2017

iii

Table ES11 Approaches to collecting new information





ECHA teleconferences and emails 3 webinars and 20-30 emails

(different types of data or contacts provided)


EC Questionnaire 1 1



investigation



















as an intermediate













eftec November 2017

iv



























report





















eftec November 2017

v











completed
















or companies could have even moved their part of production using SVHCs to outside the EU More

detail on substitution can be found in Section 5 of the main report










applications








eftec November 2017

vi





aggregate level






































aggregate level





More detail on the costs of authorisation can be found in Section 6 of the main report


eftec November 2017

vii



















(within Section 73)




























eftec November 2017

viii



















enforcement








authorities




More detail on the benefits can be found in Section 7 of the main report













suppliers)


eftec November 2017

ix










products More detail on the affordability by SMEs can be found in Section 8 of the main report








process




required


eftec November 2017

x

CONTENTS

1 INTRODUCTION 1

11 Context and rationale of this study 1

12 Project objectives 2

13 Structure of this report 3

2 METHOD OVERVIEW 5

3 AUTHORISATION PROCESS 2007-2016 10

31 Screening of substances and Risk Management Option Assessment (RMOA) 10

32 Inclusion of substances in the Candidate List 12

33 Prioritisation and inclusion of substances in the Authorisation List 13

34 Applications for Authorisation (AfA) 14

35 Review of Authorisation following their review period 18

4 CHANGES IN THE EU MARKET FOR SVHCS (AND THEIR ALTERNATIVES) 19

41 Introduction 19

42 EU chemicals sector general trends and drivers of change 20



45 Tier 2 case study Diarsenic trioxide and arsenic acid 32

46 Tier 2 case study HBCDD 42

47 Findings using other statistical sources 48

48 Summary of observed market changes 62

5 INSTANCES OF SUBSTITUTION 64

51 Introduction 64




55 Applicants ndash Future possibilities to substitute 85

56 Summary of instances of substitution 87

6 COSTS OF THE AUTHORISATION PROCESS 88

61 Introduction 88


63 Costs to Member State Competent Authorities (MSCAs) 90

64 Costs to the European Chemicals Agency (ECHA) 95

65 Costs to the European Commission (EC) 100

66 Costs to third parties for responding to public consultations 100

67 Compliance costs 114

68 Costs of substitution 117

69 Costs of RampD innovation and investment 120

610 Costs of closure and relocation 122

611 Costs to apply for authorisation 126

612 Costs to improve risk management 130


eftec November 2017

xi

613 Summary of costs 132

7 BENEFITS FROM THE AUTHORISATION PROCESS 134

71 Introduction 134



74 Human health benefits from improvement of risk management 142

75 Environmental benefits from improvement of risk management 146

76 Benefits of substitution 148

77 Benefits from closure and relocation 149

78 Benefits to alternative suppliers 151

79 Benefits of better information 152

710 Other benefits 153

711 Summary of benefits 153

8 AFFORDABILITY OF AUTHORISATION FOR SMES 156

81 Introduction 156


83 Applications to date from SMEs 158



86 Affordability analysis 166

87 SME summary 168

9 EVIDENCE OF THE lsquoANNOUNCEMENT EFFECTrsquo 169

91 Introduction 169


93 Analysis testing the announcement effect 171

94 Case studies 173

95 Summary of the announcement effect 175

10 TIER 1 CASE STUDY SUBSTANCE 1 CHROMIUM TRIOXIDE 177














11 TIER 1 CASE STUDY SUBSTANCE 2 TRICHLOROETHYLENE 204



eftec November 2017

xii













12 TIER 1 CASE STUDY SUBSTANCE 3 DIBUTYL PHTHALATE (DBP) 222














13 SUMMARY AND CONCLUSIONS 234

REFERENCES 241

ANNEX A STEERING GROUP COMMITTEE 246

ANNEX B METHODOLOGY 247

B1 Project scope 247

B2 Assessment approach 248

ANNEX C AUTHORISATION PROCESS 2007-2016 260

C1 Overview 260

C2 Timeline of key events in the authorisation process (2006-2017) 264

C3 Screening of substances and Risk Management Option Assessment (RMOA) 266

C4 Inclusion of substances in the Candidate List 268

C5 Prioritisation and inclusion of substances in the Authorisation List 269

C6 Applications for Authorisation (AfA) 269

C7 Post authorisation decision 269

C8 Review of Authorisation following their review period 270

ANNEX D ACTIVITIES CARRIED OUT ALONG THE AUTHORISATION PROCESS 271

D1 STAGE 1 Screening of substances and RMOArsquos 272


eftec November 2017

xiii

D2 STAGE 2 Inclusion of substances in the Candidate List 283

D3 STAGE 3 Inclusion of substances in the Authorisation List 290

D4 STAGE 4 Applications for authorisation 296

D5 STAGE 5 Post authorisation decision 305

D6 STAGE 6 Review authorisations following review period 311

ANNEX E LITERATURE REVIEW 314

E1 Introduction 314

E2 EU chemicals market 314

E3 Market changes for SVHCs 323

E4 Instances of substitution 325

E5 Costs of authorisation 330

E6 Benefits of authorisation 335

E7 Impacts on SMEs 345

E8 Announcement effect 348

ANNEX F AUTHORISATION SURVEYS 354

F1 Purpose of the surveys 354

F2 Survey structure and design 354

F3 Respondent profile 357

F4 Data validation 358

F5 Industry survey ndash Statistical summary 359

ANNEX G STAKEHOLDERS CONTACTED 389

G1 Member State Competent Authorities 389

G2 NGOs 390

G3 Industry 391

ANNEX H TIER 1 SUPPORTING ANNEX (FOR SECTION 10) 403

CONFIDENTIAL ANNEX ERROR BOOKMARK NOT DEFINED

LIST OF TABLES

Table ES11 Approaches to collecting new information iii Table 21 Approaches to collecting new information 8 Table 31 Progress on hazard assessment and RMOA development (as of Dec 2016) 11 Table 32 Candidate list of substances (SVHC) by reason for inclusion (as of Jan 2017) 13 Table 33 Authorisation list substances (Annex XIV) by SVHC type (as of 13th June 2017) 14 Table 34 Number of Applications for Authorisation (AfA) (as of Dec 2016) 15 Table 35 Status of decisions of AfArsquos submitted (Dec 2016) 16 Table 36 Review periods applied for (Dec 2016) 16 Table 37 Were applicants given the review period they advocated for (Dec 2016) 17 Table 38 Number of uses applied for defined by Article 57 criteria (Dec 2016) 18 Table 41 Changes in the supply of (possible) SVHCs and alternatives (industry survey) 23 Table 42 Changes in competitiveness - (possible) SVHCs (industry survey) 26 Table 43 Changes in employment (industry survey) 28 Table 44 Changes in employment ndash Type of impact (industry survey) 28 Table 45 Changes in sales revenue (industry survey) 29 Table 46 Changes in sales revenue ndash Type of impact (industry survey) 30


eftec November 2017

xiv

Table 47 Changes in quality price availability (industry survey) 30 Table 48 Substance profiles 32 Table 49 REACH authorisation timelines 33 Table 410 Diarsenic trioxide in the EU 2008-2010 34 Table 411 Granted authorisation for uses of diarsenic trioxide 37 Table 412 Applications for authorisation for the use of arsenic acid 38 Table 413 Import and export notifications for diarsenic trioxide 2004-2017 40 Table 414 HBCDD substance profile 42 Table 415 HBCDD REACH authorisation timeline 43 Table 416 Summary of volumes of HBCDD (excludes imports in articles) ndash 2006 data 44 Table 417 Summary table of the different uses of HBCDD EU (20067) 45 Table 418 Demand for HBCDD in the EU (2007) 46 Table 419 Global demand for HBCDD (2011) 46 Table 420 Number of registrants ceasing manufacturing of SVHCs 49 Table 421 Change of registration status for substances on the Authorisation List 49 Table 422Examples of substances with removals of certain uses from registrations during Annex

XIV prioritisation rounds 51 Table 423 Classification of Candidate and Authorisation List substances based on quality of

PRODCOM match 53 Table 424 Authorisation List substances (with complete datasets) in Category 2 53 Table 425 Substances matched to ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM

code 20135125) 57 Table 426 Classification of alternative substances based on the quality of the PRODCOM match 60 Table 427 Assigned PRODCOM categories 60 Table 51 Whether respondents substituted a (possible) SVHC (industry survey) 66 Table 52 Instances of substitution ndash (Possible) SVHCs uses and alternatives (industry survey) 67 Table 53 Substitution activities - (Possible) SVHCs and uses (industry survey) 71 Table 54 Average air concentrations of arsenic at the Murano environmental monitoring station

2014-16 85 Table 55 RampD plans included in AfAs 85 Table 61 Average staff cost per day (euro) for time spent carrying out authorisation activities 90 Table 62 Time for and cost (euro) of carrying out a RMOA per substance 91 Table 63 Time for and costs (euro) of the Annex XV dossier process for SVHC identification 92 Table 64 Time for and costs (euro) of Member State Committee activities on authorisation (per

Member State) 93 Table 65 Time for and costs (euro) of REACH Committee activities on authorisation 93 Table 66 Time for and costs (euro) of ECHA Scientific Committee (RAC and SEAC) non-plenary

activities on authorisation applications per MS CA per AfA case 94 Table 67 ECHA time and cost (euro) spent on and number of substance RMOAs 2014-2016 96 Table 68 ECHA estimates of mean (min max) days and cost (euro) spent on Annex XV dossier

preparation 97 Table 69 Time and cost spent on candidate listing (days euro000 per substance) 97 Table 610 SVHC dossiers by hazard property per year 98 Table 611 Recent Annex XIV recommendations 98 Table 612 Time and cost spent on Annex XIV prioritisation days per year 98 Table 613 ECHA estimates of time and cost (euro000) spent on opinion-making per- use 2014-201699 Table 614 Total authorisation application fees received by ECHA 2013-2016 99 Table 615 Estimates of DG ENV and DG GROW time spent on authorisation activities 2016 100 Table 616 Number of submissions received during the public consultation 101 Table 617 Number of submissions received (per substance level) ndash 2008-2016 102 Table 618 10 substances that received the most public consultation submissions 102 Table 619 Estimated time taken to produce submission (candidate list consultation) 104


eftec November 2017

xv

Table 620 Number of submissions received during the public consultation (Annex XIV) 105 Table 621 Number of submissions received (per substance level) ndash 2008-2016 105 Table 622 10 substances that received the most public consultation submissions 106 Table 623 Estimated time taken to produce response (Annex XIV consultation) 107 Table 624 Estimated time taken to produce response (AfA consultation) 110 Table 625 Types of compliance related costs incurred 115 Table 626 Costs for companies to familiarise themselves with the requirements under REACH

Authorisation 115 Table 627 Change in RampD innovation or investment spending (by use) 120 Table 628 Change in innovation investment and RampD spending 121 Table 629 Scale of change in innovation investment and RampD spending 121 Table 630 Industry consultees reporting relocation or closure in response to authorisation 124 Table 631 Estimated closure and relocation costs from selected applications for authorisation 125 Table 632 Reported mean application costs per use and applicant 2013-2016 (source ECHA) 127 Table 633 Reported mean notional total application costs per use and applicant by supply chain

position 2013-2016 (source ECHA) 128 Table 634 Reported mean notional total application costs per use and applicant by company size

2013-2016 (source ECHA) 128 Table 635 Reported mean notional total application costs per use by application route 2013-2016

(source ECHA) 129 Table 636 Reported notional total costs for applicants in the opinion-making phase (source ECHA)

130 Table 71 Instances of improved risk management activities 140 Table 72 Instances of risk management activities ndash Description of activities carried out (industry

survey) 140 Table 73 Improvements reported in the AfA per substance 143 Table 74 Improvements reported in the AfA TH Non-TH 144 Table 75 Change in the average concentrations of arsenic in the air in the environmental

monitoring station in Murano 2014-16 149 Table 81 Definition of an SME 156 Table 82 Number of AfArsquos by size of firm 158 Table 83 Type of applications SME survey respondents were involved in 160 Table 91 Seven hypotheses around the lsquoannouncement effectrsquo 169 Table 92 Evidence relative to the seven hypotheses around the lsquoannouncement effectrsquo 175 Table 101 Chromium Trioxide substance profile 178 Table 102 Chromium Trioxide REACH authorisation timeline 179 Table 103 Presence of RampD plans in Chromium Trioxide AfArsquos 188 Table 104 Sources used for estimation of exposure to CrVI 194 Table 105 Excess lifetime (up to age 89) lung cancer risk estimates for workers exposed at

different 8h-TWA concentrations of Cr(VI) for 40 years 194 Table 106 Historical measurement campaigns on Cr(VI) reported from various EU countries values

for inhalation 195 Table 107 Results from the Belgian inspection campaign 196 Table 108 Overview of occupational exposures results from the submitted AfAs for Chromium

Trioxide expressed as ranges 196 Table 109 Number of applicants and their size per substance 201 Table 111 Trichloroethylene substance profile 204 Table 112 Trichloroethylene REACH authorisation timeline 205 Table 113 Existing OELs for TCE inhalation (adapted from the GESTIS database) 215 Table 114 Comparison of OEL levels for TCE for different EU countries over time values for

inhalation 216


eftec November 2017

xvi

Table 115 Historical measurement campaigns on TCE reported from various EU countries values

for inhalation 217 Table 116 Overview of occupational exposures results from the submitted AfAs for TCE expressed

as ranges 219 Table 121 Dibutyl Phthalate substance profile 222 Table 122 Dibutyl Phthalate REACH authorisation timeline 224 Table 123 Existing OELs for Dibutyl Phthalate for inhalation (adapted from the GESTIS database)

230 Table 124 Historical measurement campaign for DBP reported from EU countries inhalation 230 Table 125 Overview of occupational exposures results from the submitted AfAs for DBP expressed

as ranges 231 Table B01 REACH Authorisation intervention logic (non-exhaustive high-level list) 249 Table B02 Total number of activities excluded with justification 252 Table B03 Number of activities carried out along the authorisation process that are assessed in

this study 253 Table C01 The main stages in the authorisation process 263 Table E01 Authorisation application fees set in Commission Regulation (EC) No 3402008 332 Table E02 Authorisation application fees set in Regulation (EU) No 2542013 332 Table E03 Have any of your customers requested the removal of SVHCs from your products 350 Table E04 What has been the response of your firm to the placing of substances relevant to your

business in the Candidate List (Percentage of firms indicating) 352 Table G01 Stakeholders invited to take part in a MS CA questionnaire 389 Table G02 Stakeholders invited to take part in the NGO online survey 390 Table G03 Stakeholders invited to take part in the industry online survey 392

LIST OF FIGURES

Figure 21 Overview of method 5 Figure 41 Assessing changes in the market using different approaches 20 Figure 42 Changes in the supply of SVHCs and alternatives ndash Type of impact (industry survey) 25 Figure 43 Changes in competitiveness ndash Type of impact (industry survey) 27 Figure 44 Changes in quality price availability ndash Type of impact (industry survey) 31 Figure 45 Production value and import value of 12-dichloroethane (ethylene dichloride) 55 Figure 46 Export value of 12-dichloroethane (ethylene dichloride) 55 Figure 47 Production value and import value of methyloxirane (propylene oxide) 55 Figure 48 Export value of methyloxirane 55 Figure 49 Production value and import value of ldquoChromium manganese lead and copper oxides

and hydroxidesrdquo (PRODCOM code 20121200) 56 Figure 410 Export value of ldquoChromium manganese lead and copper oxides and hydroxidesrdquo

(PRODCOM code 20121200) 56 Figure 411 Production value and import value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic

trioxiderdquo (PRODCOM code 20111250) 57 Figure 412 Export value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo (PRODCOM

code 20111250) 57 Figure 413 Production value and import value of ldquoChromates and dichromates peroxochromatesrdquo

(PRODCOM code 20135125) 58 Figure 414 Export value of ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code

20135125) 58 Figure 415 Production value and import value of ldquoTrichloroethylene tetrachloroethylene 59 Figure 416 Export value of ldquoTrichloroethylene tetrachloroethylene (perchloroethylene)rdquo

(PRODCOM code 20141374) 59


eftec November 2017

xvii

Figure 417 Production and import values as well as export value of ldquoCyclohexanone and

methylcyclohexanonesrdquo ldquoDiazo- azo- or azoxy-compoundsrdquo and ldquoOther esters of orthophthalic

acidrdquo 61 Figure 51 Instances of substitution - Number of years to achieve substitution (Industry survey) 70 Figure 52 Stage in the REACH authorisation process that triggered substitution activity 71 Figure 53 Substitution activities ndash Types of activities undertaken (industry survey) 74 Figure 54 Drivers of substitution activities (industry survey) 75 Figure 55 Barriers to substitution (industry survey) 76 Figure 61 Number of AfA public consultations and comments received 108 Figure 62 Types of REACH actors that have commented on an AfA 109 Figure 63 Number of comments received by substance 109 Figure 64 Main reasons for industry stakeholder to provide comments 111 Figure 65 Whether the industry organisation read published response to their comments 112 Figure 66 Main reasons for not providing comments 112 Figure 67 Whether respondents organisation incurred costs associated with compliance with

REACH authorisation process 114 Figure 68 Cost to update registration dossier following granting of an authorisation 116 Figure 69 One off investment costs to implement alternative (substance or process) to an SVHC 118 Figure 610 Annual net operating costs to use the alternative (substance or process) to an SVHC 118 Figure 611 Annual spending on substitution activities 119 Figure 612 What authorisation stage triggered these risk management activities 130 Figure 613 Estimated one-off cost of risk management activities 131 Figure 81 Number of applicants (2013-16) by applicant size 159 Figure 82 Top 3 challenges faced by SMEs associated with the authorisation process 160 Figure 83 Top 3 challenges faced by SMEs associated with AfAs 161 Figure 84 Who SMEs used to support them 161 Figure 85 SMEs views on the REACH authorisation guidance and other information on the ECHA

website 162 Figure 91 Whether REACH authorisation has led to internal policy concerning managingknowing

what substances are used within respondents organisations including (possible) SVHCs 171 Figure 92 Authorisation stage that triggered decision to substitute from an SVHC 172 Figure 93 Authorisation stage that triggered substitution related activities 172 Figure 94 Authorisation stage that triggered further risk management activities 173 Figure 101 Chromium Trioxide imports to EU 2000-2016 181 Figure 102 Chromium Trioxide exports to outside EU 2000-2016 181 Figure 103 Supply chain for Chromium Trioxide 182 Figure 104 Chromium Trioxide ndash Market share by use 185 Figure 105 Evolution of the exposure to CrVI 197 Figure 111 Production export import volumes TCEPER 2003-2016 207 Figure 112 Uses of TCE sold into EU markets 1996 and 2003 208 Figure 113 Trichloroethylene ndash Production consumption exports imports in EU 2012-2016 209 Figure 114 Trichloroethylene ndash Production consumption in EU 2017-2022 210 Figure 115 Tetrachloroethylene ndash Production consumption exports imports in EU 2012-2016 213 Figure 116 Tetrachloroethylene ndash Production consumption in EU 2017-2022 214 Figure 117 Excess risk for carcinogenic effects-Working lifetime exposure 218 Figure 121 DBP production volumes 225 Figure 122 DBP use distribution (1998 2007) 226 Figure 123 Percentage of phthalate sales in EU compared to total plasticisers 229 Figure C01 The processes in authorisation and contributory processes 261 Figure C02 Timeline of key events in the authorisation process (2007-2016) 265 Figure E01 EU chemicals sales 315 Figure E02 Share of member states in EU chemical sales 316


eftec November 2017

xviii

Figure E03 EU chemicals sales by destination 316 Figure E04 Extra-EU imports amp exports and trade balance 317 Figure E05 EU export market share 318 Figure E06 EU chemicals production 319 Figure E07 EU regulatory cost 320 Figure E08 Capital spending 321 Figure E09 Research amp Development (RampD) Spending 322 Figure E010 Distribution of costs related to application for authorisation (micro companies) 331 Figure E011 Share of REACH REFIT respondents thinking that authorisation application fees are

too high 333 Figure E012 Legislation cost (as annual share of turnover 2004-2014) by size of firms 347


eftec November 2017

xix

LIST OF ABBREVIATIONS

AC Adequate Control

ACEA European Automobile Manufacturersrsquo Association

ADCA CC-azodi(formamide)

AfA Application for Authorisation

AfAs Applications for Authorisation

Al-RCF Aluminosilicate Refractory Ceramic Fibres

AoA Analysis of Alternatives

API Active Pharmaceutical Ingredient

BBP Benzylbutyl Phthalate

CAS Chemical Abstracts Service

CBA Cost Benefit Analysis

CCH Compliance Check

CEFIC The European Chemical Industry Council

CIRCABC Communication and Information Resource Centre for Administrations Businesses

and Citizens

CLH Harmonised Classification and Labelling

CLP Classification Labelling and Packaging

CMR Carcinogenic mutagenic or toxic to reproduction

CO2 Carbon Dioxide

COM European Commission

CoRAP Community rolling action plan

CrIII Trivalent chromium

CrVI Hexavalent chromium

CSR Chemical Safety Report

CVP Chemical Vapour Deposition

DBP Dibutyl Phthalate

DEFRA Department for Environment Food and Rural Affairs

DEHP Bis(2-ethylhexyl)phthalate

DIBP Diisobutyl Phthalate

DIDP Diisodecyl Phthalate

DINCH Di-(isononyl)-cyclohexan-12-dicarbooxylate

DINP Di-isononyl Phthalate

DMF NN-dimethylformamide

DNEL Derived No Effect Level

DOTE 2-ethylhexyl-10-ethyl-44-dioctyl-7-oxo-8-oxa-35-dithia-4-stannatetradecanoate

DPHP Bis(2-propylheptyl) Phthalate

DU Downstream User

DUs Downstream Users

EBFRIP European Brominated Flame Retardant Industry Panel

EC European Commission

ECMA European Federation of Catalyst Manufacturers

ECHA European Chemicals Agency

ECPI European Council for Plasticisers and Intermediates

ED Endocrine Disruption

EDC 12-Dichloroethane

EEA European Economic Area


eftec November 2017

xx

EEB European Environmental Bureau

EED Electro- electrodialysis

EEN Enterprise Europe Network

EPS Expanded Polystyrene

eSDS extended Safety Data Sheet

ESR Existing Substances Regulation

ESR RAR Existing Substances Regulation Risk Assessment Report

ESTAL European Association of Alumina Platers

ETP Tin-plated Steel

ETS Emissions Trading Scheme

EU European Union

EUMEPS Association for European Manufacturers of Expanded Polystyrene

FGK Fachverband Galvanisierte Kunststoffe eV

FR EPS Flame Retarded Expanded Polystyrene

FTE Full Time Equivalent

GOS Gross Operating Surplus

HBCDD Hexabromocyclododecane

HCFCs Hydrochlorofluorocarbons

HFCs Hydrofluorocarbons

HFEs Hydrofluoroethers

HH Human Health

HIPS High Impact Polystyrene

HMW High Molecular Weight

HSS High Speed Steel

HVOF High Velocity Thermal Process

IPA Institut fuer Praevention und Arbeitsmedizin der Deutschen Gesetzlichen

Unfallversicherung

IPCS International Programme on Chemical Safety

ITT Invitation to Tender

LAD Latest Application Date

LCD Liquid-Crystal Display

LOW Low Molecular Weight

MDA 44rsquo- Diaminodiphenylmethane

MHHPA Hexahydromethylphthalic Anhydride

MI Manufacturer Importer

MIs Manufacturers Importers

MA Maleic Anhydride

MEC Methylene Chloride

MOCA 22-dichloro-44-methylenedianiline

MOTE 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-

oxa-35-dithia-4-stannatetradecanoate

MS Member State

MS CA Member State Competent Authority

MS CAs Member State Competent Authorities

MSC Member State Committee

MSC-WG Member State Committee ndash Working Group

MSs Member States

NEAs National Enforcement Authorities

NeRSAP Network of REACH SEA and Analysis of Alternatives Practitioners


eftec November 2017

xxi

NGO Non-Governmental Organisation

NGOs Non-Governmental Organisations

NiB Nickel Boron

NiP Nickel-phosphor

NMP 1-methyl-2-pyrrolidone

Non-TH Non-threshold

OC Operational Conditions

OECD Organisation for Economic Co-operation and Development

OEL Occupational Exposure Limit

OSOR one substance one registration

PACT Public Activities Coordination Tool

PBT Persistent Bioaccumulative Toxic

PC Public Consultation

PCBs Printed Circuit Boards

pFR Polymeric flame retardant

PER Tetrachloroethylene

PNEC Predicted No Effect Concentration

POPAA Plating on Plastics for Automotive Applications

POPs Persistent organic pollutants

PPORD product and process orientated research and development

PRODCOM PRODCOM is abbreviated from the French Production Communautaire

PS Polystyrene

PSIS Pre-Submission Information Session

PVC Polyvinyl Chloride

PVD Physical Vapor Deposition

QC Quality Control

(Q)SARs (Quantitative) Structure-Activity Relationships

RAC Risk Assessment Committee

RAR Risk Assessment Report

RCFs Refractory Ceramic Fibres

RCOM Response to Comments document

RampD Research amp Development

REACH A European Union regulation concerning the Registration Evaluation Authorisation

amp Restriction of CHemicals

RER Rapid Evidence Review

RMM Risk Management Measure

RMMs Risk Management Measures

RMO Risk Management Option

RMOA Risk Management Option Analysis

RMOAs Risk Management Option Analyses

RoHS Restriction of the Use of Certain Hazardous Substances

RRS Risk Reduction Strategy

SCFs Supercritical Fluids

SCOEL Scientific Committee on Occupational Exposure Limits

SDS Safety Data Sheet

SDSC SUBSPORT Screening Criteria

SEA Socio Economic Analysis

SEAC Socio Economic Analysis Committee

SEAs Socio Economic Analyses


eftec November 2017

xxii

SEv Substance Evaluation

SHVC Substance of Very High Concern

SiC Standard Industrial Classification

SIEF Substance Information Exchange Forum

SME Small and Medium-sized Enterprise

SMEs Small and Medium-sized Enterprises

SVHC Substance of Very High Concern

SVHCs Substances of Very High Concern

TCE Trichloroethylene

TH Threshold

TiN Titanium Nitride

tpa Tonnes per annum

US EPA United States Environmental Protection Agency

UTC Unintentional Trace Contamination

vPvB very Persistent very Bioaccumulative

WC Tungsten Carbide

WCCo Cobalt-tungsten Carbide

WFD EQS Water Framework Directive Environmental Quality Standards

WHO World Health Organization

WP Working procedures

WSSD World Summit on Sustainable Development

WTO World Trade Organisation

XPS Extruded Polystyrene

Zr-RCF Zirconia Aluminosilicate Refractory Ceramic Fibres



1 INTRODUCTION

11 Context and rationale of this study

The REACH Regulation entered into force on the 1st June 2007 It was adopted to improve the

protection of human health and the environment from the risks that can be posed by chemicals and

the free circulation of chemicals in the internal market while enhancing the competitiveness and

innovation of the EU chemicals industry It also promotes alternative methods for the hazard

assessment of substances in order to reduce the number of tests on animals3

The REACH Regulation includes the obligation for a review every five years to monitor progress in

the achievement of its objectives The first review was carried out in 20124 and the second REACH

Review due in 2017 is being carried out in parallel with the fitness check on the most relevant

chemicals legislation excluding REACH This study will feed into the REACH 2017 review by

providing evidence on the impacts of REACH authorisation (ie one specific regulatory procedure of

REACH)

The first review of REACH concluded that ldquoREACH functions well and delivers on all objectives that

at present can be assessed Some needs for adjustments have been identified but balanced

against the interest of ensuring legislative stability and predictability the Commission will not

propose any changes to the enacting terms of REACH Within the current framework however

there is a need to reduce the impact of REACH on SMEsrdquo4 The findings also note that ldquothere are

many other opportunities for further improvement of the functioning of REACH by optimizing the

implementation at all levelsrdquo4

This project is the first comprehensive attempt to obtain evidence on the overall impacts of the

REACH authorisation procedure Some evidence exists within ECHA on the costs of applications and

evidence of risk reduction as part of applications for authorisation ECHA is also currently carrying

out a meta-analysis of the benefits and costs of authorisation applications However less is known

about the other costs and benefits associated with the authorisation process on different actors and

on instances where companies have substituted a substance of very high concern (SHVC) thereby

avoiding the need to apply for authorisation Such impacts include amongst others the

administrative burden to public authorities and third parties costs (and benefits) to industry (and

EU society) from complying with REACH authorisation and costs and benefits associated with

substitution and improved risk management

The project is seeking to fill such information gaps and substantiate and quantify the currently

available qualitative information on the costs benefits and other impacts of authorisation It

focusses on the areas where until now it has been more difficult to collect reliable information

namely the substitution objective of authorisation As stated in the Invitation to Tender (ITT) while

data on costs and burden may be easier to gather some of the benefits and other impacts may only

materialise much later and even if identified they are usually difficult to quantify Capturing and

quantifying them fully at this point in time would therefore not be possible However this study

makes a serious effort to include the information on benefits in a qualitative manner and quantify

what is possible

3 httpsechaeuropaeuregulationsreachunderstanding-reach 4 httpeceuropaeuenvironmentchemicalsreachreview_2012_enhtm



12 Project objectives

The main objective of the project is to evaluate the performance of REACH authorisation by

providing evidence on whether it is working as intended and achieving its objectives This final

report encompasses all the findings of this study and sets out results based on the five areas the

study sought particular information on (i) cost of authorisation (ii) benefits of authorisation (iii)

changes in the market structure (iv) substitution and (v) affordability of authorisation for SMEs

Through data collected to meet this main objective and through existing amp ongoing studies it

should also be possible to (i) provide evidence on the functioning of the current implementation of

the SVHC 2020 Roadmap (which commenced in February 20135) and in particular the risk

management option analysis (RMOA)6 and (ii) to evaluate the adequacy of current guidance for

stakeholders to facilitate the preparation of Applicants for Authorisations (AfAs) and where

possible evidence on ongoing initiatives to streamline and simplify the authorisation procedure

This extends the coverage of the authorisation process to collect information (since 2013) on the

RMOA process which is voluntary (ie not part of the processes as defined in the legislation)

Within the context of this study this means collecting information on for example the costs to

public authorities to develop RMOAs and the benefits of this process (eg whether it facilitates

substitution for those substances where authorisation is recommended)

ECHA together with Member States and the Commission has started to review some elements of

the SVHC Roadmap implementation and this will continue next year with the objective to report on

the overall review in the annual report of the SVHC Roadmap to be published in 2018

To date there has been a reasonable number of applications for authorisation through the entire

authorisation process (ie with final decisions made by the Commission) and a large number of

opinions A larger number of substances have been introduced in the process from the RMOA to

the registry of intentions the candidate list and the ECHA recommendation for inclusion on Annex

XIV With this experience now should be a good time to critically look back on the REACH

authorisation process to identify instances where companies have substituted substances instead of

submitting an AfA and to assess the current RMOA process In doing so this project is seeking to

address the following gaps

1 What effects authorisation has and what impacts these have on different stakeholders

(including public authorities and different size of firms using the substance of concern or an

alternative) and along the supply chain

2 Where along the authorisation process these stakeholders are more affected (eg from

Screening of substances and RMOAs inclusion of substances in the Candidate List all the

way through to reviewing AfAs following their review periods)

3 What the overall costs and benefits of authorisation have been both as the substance goes

through the authorisation process and as a result of authorisation decisions For example

5 Substance of Very High Concern 2020 Roadmap httpsechaeuropaeuaddressing-chemicals-of-

concernsubstances-of-potential-concernpact-substance-

rev1988del50colsynonymDynamicField_3413typeascpre1view 6 Roadmap for SVHC identification and implementation of REACH Risk Management measures from now to

2020 (called the SVHC Roadmap) ndash Available at

httpsechaeuropaeudocuments1016219126370svhc_roadmap_2015_enpdf



has authorisation lead to reduced overall risks Has it led to reduced competitiveness

relative to non-EU companies

4 How efficient the current process is and whether there is scope for reducing administrative

and regulatory steps whilst preserving the intended aims of REACH authorisation

13 Structure of this report

The remainder of this report is structured as follows

Section 2 Methodology

Section 3 Authorisation process 2007-2016






Section 9 Tier 2 case study Evidence of the lsquoannouncement effectrsquo

Section 10 Tier 1 case study substance 1 Chromium Trioxide

Section 11 Tier 1 case study substance 2 Trichloroethylene

Section 12 Tier 1 case study substance 3 Dibutyl Phthalate (DBP)

Section 13 Summary and conclusions

There are also a series of Annexes that provide supporting information like stakeholders

contacted details of the online surveys and an annex containing confidential information (which

wonrsquot be available in the public version of the final report)

131 Logic for the sequencing of impacts (Sections 4-9)

Given that many of the impacts are linked interdependent it would only be possible to assess

certain impacts after others have been identified and quantified This introduces a hierarchy of

what data needed to be collected first

The first step was to understand how the market for a particular substance has changed over time

This is done through identifying how the following have changed

The number of suppliers of the substance (Manufacturers or Importers (MIs))

The volumes manufactured in the EU imports into the EU and exports outside of the EU

The uses of the substance

The focus was on collecting information on (i) the market situation before the substance entered

the authorisation process (ii) during the authorisation process and (iii) the current situation

Changes in the market situation between these periods would help us understand the scope of

certain impacts like

1 Any possible substitution of the substance ndash eg comparing the uses before REACH

authorisation and currentknown uses of the substance and

2 Any possible instances of relocation and closure ndash eg closure of MIs within the EU

location of end-use markets (eg through changes in volumes of importsexports)



The second step was to understand the drivers for these changes (eg market forces fashion

technological development regulation and so forth) and when these changes occurred (eg

whether there was already a declining trend in the use of the substance before it was subject to

the REACH authorisation process)

The third step is to find out further information on possible alternatives and how the markets for

these alternatives have changed This would help us understand to what extent changes in the

market for SVHCs have been displaced by alternatives or simply a case of relocation of activities

outside of the EU The latter being an undesirable societal outcome

This would then help us estimate what changes can be attributed to the REACH authorisation

process and to estimate the costs and benefits of these changes

The report therefore sets out the information gathered in the order following this logic process






Section 9 Evidence of the lsquoannouncement effectrsquo

These individual chapters are used to explain the way the impacts are assessed and the Tier 1 case

studies that follow (in Sections 10-12) build on this framework by going into detail on these impacts

for three specific substances

Before the detailed findings Section 3 sets out some supporting context and data about the

authorisation process This information also helps assess the lsquoeffectivenessrsquo of the REACH

authorisation process relative to defined targets like having all known SVHCs on the candidate list

by 2020

132 Use of case studies

Case studies are used throughout this report to provide where possible more in-depth insights on

the five impact areas of the study (i) costs of authorisation (ii) benefits of authorisation (iii)

changes in the market structure (iv) substitution and (v) affordability of authorisation for SME

The case studies build upon existing studies and relevant information already in submitted

applications

The Tier 1 case studies (presented in Sections 10-12) are on three specific substances (Chromium

Trioxide Trichloroethylene and Dibutyl Phthalate) Within each Tier 1 case study the above five

main impact areas are covered

The Tier 2 case studies contribute to the study by collecting data on specific aspects (eg on

substitution risk management and evidence of the announcement effect) The analysis here is not

limited to any particular substance



2 METHOD OVERVIEW

This section sets out the project activities carried out Further details on the method can be found

in Annex B

This project follows the EC Better Regulation Guidelines7 and Toolbox8 in order to assess the

ldquoImpacts of REACH authorisationrdquo The evaluation needs to be evidence-based robust and able to

withstand public scrutiny since this study could be heavily referred to in the future by a wide range

of stakeholders (eg industry associations NGOs Member State Authorities the European

Commission and ECHA) as well as potentially informing future decision making on the REACH


211 Overview

As illustrated in Figure 21 the project was broken down into four main tasks Within each task

there were a number of sub-tasks reflecting activities that need to be undertaken in order to

successfully complete these tasks

Figure 21 Overview of method

212 Task 1 Structuring Phase

In Task 1 of this study a framework for carrying out the work the scope of the work as well as

deciding on the Tier 1 and Tier 2 case studies were agreed (see Annex B for further details) A

rapid evidence review (RER) was carried out examining a number of studies that have been carried

out concerning REACH (with a few studies specifically on REACH Authorisation) This enabled us to

7 httpeceuropaeusmart-regulationguidelinestoc_guide_enhtm 8 httpeceuropaeusmart-regulationguidelinestoc_tool_enhtm



prioritise quantitative and monetary data gaps for this study This RER was further built on as the

project developed with the results of the literature review set out in Annex E

213 Task 2 Data collection

The main steps carried out within Task 2 were

1 Mapping activities carried out along the authorisation process ndash We mapped out 150

activities carried out by different actors along the authorisation process and their impacts

(See Annex D) This enabled us to focus on those impacts worth considering further in this

study (and is feasible to do so) what information was needed who holds it and how best to

get access to it

2 Developing a consultation plan ndash We set out a plan for contacting stakeholders that may

have information useful for this study and what types of information we were targeting

from each type of stakeholder (eg what we expect to be able to get from consulting with

NGOs and industry respectively)

3 Initial stakeholder engagement ndash We spent a significant amount of time contacting over 200

stakeholders (NGOs industry associations and sector groups) that may have been impacted

by REACH authorisation and a number of relevant downstream users of whose interest in

taking part in an online survey we were aware

Various members of the project team also presented at various REACH related events

spoke to industry sector groups and NGOs (in person or over the phone) to raise the

awareness of the project and encourage stakeholders to take part in the forthcoming

survey Stakeholders were targeted to those that may have been impacted by REACH

authorisation and who can provide data required rather than contacting as many

stakeholders as possible ndash in particular any companies that had substituted from an SVHC

(or were in the process of doing so) where prioritised as this was a particular data gap that

needed to be addressed in this study Therefore some of the results of this study (eg

proportion of companies that have substituted away from an SVHC) may have been very

different if the survey was simply an open link (via a public consultation) with no prior

contact with stakeholders

This task was supported by ECHA who informed by email those stakeholders that had

commented to a public consultation on a submitted application and to applicants ECHA

also included a call for information on substitution as part of their newsletter The EC and

ECHA also both provided contacts of companies that have substituted from an SVHC (and

therefore avoided the need to submit an application for authorisation)9

The main goals were to (i) produce a list of stakeholders that have confirmed their interest

in taking part in the survey and (ii) to give these stakeholders advance notice of the survey

and what information is being requested so that they can plan ahead A list of

stakeholders contacted is set out in Annex G

9 Some companies have also substituted from an SVHC after the submission of an AfA (eg downstream users

who notified ECHA of their use and later ceased use of the SVHC)



4 Developing consultation toolsndash We issued four different questionnaires (the questionnaires

and key statistics can be found in Annex F)

a An industry online survey ndash This was originally intended to be designed and

administered using the EUSurvey tool which is the ECrsquos official survey management

tool10 However due to the need to try to collect very specific data and where

possible quantitative and monetary data the questionnaire was too complex for

the EUSurvey tool to handle (in terms of both the style and number of questions)

Instead the survey was issued via Survey Monkey The scripts were commented on

by some steering group members and changes made to address their comments

b A Non-Government Organisation (NGO) online survey ndash A similar but shorter survey

which focused on instances of substitution was developed for NGOs

c A questionnaire to Member State Competent Authorities (MS CAs) - A Word-based

questionnaire was developed to gather data from MS CAs which focused on

administrative costs they incur along the whole authorisation process Again this

was commented on by some steering group members and changes made to address

their comments

d A questionnaire to the European Commission (EC) ndash A Word-based questionnaire

similar to the one for MS CAs was developed to gather data from the EC which

focused on administrative costs they incur along the whole authorisation process

The EC have indicated they cannot fill in most aspects of the questionnaire but it

will be used as a template for what they can provide

Data was provided by ECHA on the costs they incur along the authorisation process as well

as costs associated with the Risk Assessment Committee (RAC) Socio Economic Analysis

Committee (SEAC) and Member State Committee (MSC) ECHA did not require a

questionnaire from the project team instead a call was held to discuss data needs

5 Launching online surveys ndash We sent personalised emails to stakeholders who had already

agreed to take part in the survey to inform them the survey was ready and to check their

inboxes for a separate email via Survey Monkey containing their personal link to the survey

They were able to save the link and return to the survey so as not to be required to

complete it in one go

Personalised links were also sent to the interested members of trade sector associations

through engagement in their supply chains Other stakeholders completed the open link

(whereby the survey needs to be completed in one go)

Those stakeholders who did not confirm whether they will take part were sent an email to

inform them that the survey is available and were asked to email back if they wanted to

take part

Further rounds of reminders were sent out to encourage further uptake of the online survey

and the survey was eventually closed at the end of June

10 httpseceuropaeueusurveyhomewelcomerunner



6 Data collection from other sources ndash We also collected production import and export data

from Eurostat for PRODCOM11 codes market reports and data from ECHA Further details

are set out in Section 47

7 Collating survey responses ndash We thanked all respondents to the survey for completing the

survey If they agreed to follow up questions a holding response was sent to mention the

possibility that we may query any unexpected answers and seek further evidence for

responses that would seem to be highly relevant

8 Data collection for the Tier 1 case studies ndash We collected data for the three Tier 1 case

study substances namely Chromium Trioxide Trichloroethylene and Dibutyl Phthalate

We contacted many companies connected with these substances (current and former MIs

of the substance downstream users and relevant sectortrade associations) We also

collected relevant data from existing studies and Eurostat We also explored what market

information was available from market report providers Further details are set out in

Sections 10-12

9 Further follow up with survey respondents ndash We respected the wish of the stakeholders for

their input to be anonymous However some respondents indicated they were willing to be

a case study whereby we could go into more detail than is possible through the survey on a

particular issue (eg about their substitution) These respondents were prioritised for

interviews following closure of the survey

10 Targeted interviews ndash We conducted ~50 interviews with stakeholders Depending on the

role of the stakeholder interviewed different topics were discussed including details of

any substitution away from SVHCs or any ongoing substitution activities and the impacts

incurred due to REACH authorisation (both costs and benefits)

11 Data validation of survey responses ndash We checked the completeness and accuracy of data

(eg identifying any outliers) provided by respondents This check was a critical step prior

to the detailed data analysis in Task 3

Table 21 summarises the number of stakeholders contacted for the different methods of obtaining

information and the number that responded

Table 21 Approaches to collecting new information





ECHA teleconferences and emails 3 webinars and 20-30 emails (different types of data or

contacts provided)


EC Questionnaire (DG GROW and DG

ENV only) 1 1


11 Prodcom provides statistics on the production of manufactured goods Further details can be found here

httpeceuropaeueurostatwebprodcom



214 Tasks 3 and 4 Data analysis and reporting

Upon completion of Task 2 the data gathered was used to assess the impacts of REACH

authorisation (both the process and resulting outcomes) The headline results were presented to

the steering group at a webinar at the end of June 2017 A draft final report was submitted and

discussed with the Steering group in September 2017 with comments received from DG GROW DG

ENV and ECHA in October 2017 The final report was finalised in November 2017



3 AUTHORISATION PROCESS 2007-2016

There is a long process preceding the inclusion of a substance into Annex XIV with several options

for stakeholders to provide information The process consists of (1) the official legislative steps as

set out described in the REACH regulation and (2) the voluntary steps that were introduced with

the goal to improve among others planning and predictability12

The official steps set out in the REACH regulation start from the Annex XV dossiers for SVHC

identification until the inclusion into Annex XIV and all the steps in between such as two public

consultations and a recommendation for inclusion into Annex XIV Once a substance is included into

Annex XIV industry has to either substitute before the sunset date or has to file an application for

authorisation to request authorisation for continued use for a well-justified amount of time

The voluntary steps that were introduced to improve the functioning of the process are described in

the SVHC Roadmap to 2020 Implementation Plan 9 December 201313 which defines priority criteria

until 2020 and describes the processes of Screening and Risk Management Option Analysis (RMOA)

In this study we analyse the impact of the authorisation process from 2007 when REACH came into

force until the end of 2016

Annex C provides an overview of the process highlighting the main stages and the aims and

objectives of the authorisation process from the perspective of the formal process (ie leading to

applications for authorisation) The aims are explained in terms of an lsquointervention logicrsquo which

links the objectives to actions and outcomes (as illustrated in Figure C01) Later sections

summarise some statistics collected on the main stages in authorisation that help to quantify the

levels of activity in these stages (for example the number of RMOAs processed and what stage they

are at the inclusion of substances on the Candidate list and Annex XIV and the number of AfAs

made)

31 Screening of substances and Risk Management Option Assessment (RMOA)

A study reviewing the operation of REACH14 reported a perceived lack of transparency in the

identification and selection of SVHCs as well as a need for understanding which substances would

be identified to give a higher level of certainty to prepare for authorisation applications or

substitution activities etc On the regulatory side the need was identified for consistency in the

approach for identification of SVHCs and connection to the most appropriate regulatory measures

for control of risks

The 2020 SVHC Roadmap built on the political commitment to have all relevant currently known

SVHCs included in the candidate list by 2020 There was a consequent need to analyse the

12 Roadmap on Substances of Very High Concern Council of the European Union do 586713 httpregisterconsiliumeuropaeudocsrvl=ENampf=ST20586720201320INIT 13

httpsechaeuropaeudocuments1016219126370svhc_roadmap_implementation_plan_enpdf66ba723a-

d2e4-4d1a-ae89-a78c4db4d621 14 Technical Assistance to Prepare the Commission Report on the Operation of REACH

0703072010584820SERD3 March 2012 - prepared for European Commission DG Environment by Risk amp

Policy Analysts Limited



information on a large number of substances not only to determine the relevance of known

potential SVHCs but also to identify new potential SVHCs from the processes of REACH registration

(phase-in stages completed in 2018) and evaluation The roadmap implementation plan describes

two distinct but related processes (1) the Screening process and (2) the RMOA process The

purpose of the Screening process is to identify and prioritise substances of potential concern for

further regulatory action Those substances of potential concern are those where the impact on

human health and the environment are expected to be the greatest Priority is given to substances

that have the highest exposure potential combined with their potentially hazardous properties for

example substances that are carcinogenic mutagenic and toxic to reproduction (CMR) persistent

bioaccumulative and toxicvery persistent very bioaccumulative (PBTvPvB) or endocrine

disruptors and therefore potential SVHCs Once the concern is confirmed the substance is normally

taken forward to RMOA by authorities The purpose of the RMOA is to help authorities decide

whether further regulatory risk management activities are required for a substance and if so to

identify the most appropriate instrument to address a concern Thus in view of the authorisation

process the roadmap sets out the RMOA process as central to the decision making on the inclusion

of SVHCs on the Candidate List The processes of Screening and RMOA as set out by ECHA are

described in Box C1 (see Annex C) In addition ECHA sets up the Public Activities Coordination

Tool (PACT) that provides information (published on the ECHA website) on substances that are or

have been subject to informal assessment (of their potential PBT vPvB or ED properties) andor

RMOA

Table 31 summarises the progress on Screening and RMOA to date (data collected from ECHA

statistics for this study) Of the 110 substances that have been assessed under Screening andor

RMOA 48 (44) have been found to have no concern of these 30 on the basis that they were not

PBTvPvB or ED and 18 on the basis that no further regulatory risk management was needed Seven

substances were found to be of concern due to endocrine disruption (ED) or PBTvPvB properties

and 55 substances (50 of the completed assessments) required further regulatory action to control

the risks Of these 16 were sensitizers 4 were PBT 12 were CMR and one was ED (lsquootherrsquo was also

reported in the scope and some substances were multiple categories eg CMR and PBT)

Table 31 Progress on hazard assessment and RMOA development (as of Dec 2016)

Stage

Outcome text



In progress

Under development 130 229

Substance evaluation under development 99

On hold

On hold 14

25

Potential ED (but further assessment is

postponed) 1

Potential PBTvPvB but further

assessment is postponed 10

Complete - no

concern

According to authorityrsquos assessment not

ED 4

48 According to authorityrsquos assessment not

PBTvPvB 26

No need to initiate further regulatory risk

management action at this time 18

Complete ndash

concern

According to authorityrsquos assessment ED in

accordance with WHOIPCS definition 6

7 According to authorityrsquos assessment PBT

or vPvB 1



Stage

Outcome text



Complete - action

requested

Appropriate to initiate regulatory risk

management action 55 55

Totals 364 364

Source ECHA











regulatory action (eg restriction) under REACH is deemed to be needed15 As set out in Annex C

(and illustrated in Figure C01) the selection of SVHC substances is done initially by Member

States or ECHA upon request of EC making an Annex XV dossier to demonstrate that the substance

meets the Article 57 criteria

The Commissions aim to have 136 substances on the Candidate List by the end of 2012 was

achieved and the 2020 Roadmap objective is to have all currently known SVHCs on the Candidate

List by 2020 As mentioned in the REACH 2012 review4 that objective has the merit of stimulating

an increased activity of Member States in relation to the submission of proposals for SVHC

identification The Candidate List currently (as of Jan 2017) contains 173 substances16

Table 32 below summarises the candidate list (as of Jan 2017) in terms of reason for inclusion It

can be seen from the table that the majority of substances (82) placed on the Candidate List are

due to concerns for human health hazard ie they are CMR (Carcinogenic Mutagenic or toxic to

Reproduction) or of equivalent concern In contrast substances for which there are only concerns

for the environment (ie PBTvPvB or equivalent concern) make up 12 of the substances with a

similar proportion for substances for which there are both environmental and health concerns The

total number of substances which are included because of health concerns (including with both

health and environmental) is 153 (=142+11) and the total number for which there are

environmental concerns (including both environmental and health) is 32 (=21+11)

15 httpregisterconsiliumeuropaeudocsrvl=ENampf=ST20586720201320INIT 16 There is a discrepancy of 1 between the candidate list as shown on the ECHA web site and the download of

the substances (this is assumed to be due to substance grouping)



Table 32 Candidate list of substances (SVHC) by reason for inclusion (as of Jan 2017)


Environment Total 21

PBT 3

PBTvPvB 4

vPvB 8

Equivalent concern (Env) 6

Human Health Total 140

Carc 39

Carc and Equivalent concern (HH) 3

Muta 2

Carcmuta 6

Carcrepro 11

Repro 69

CMR 4

Equivalent concern (HH) 3

CMR and Equivalent concern (HH) 3

Human Health and environment Total 11

PBTRepro 4

CarcPBTvPvB 2

CarcmutaPBTvPvB 2

Equivalent concern (Env)Repro 1

CMR and PBT 1

Total 173

Note

- There is a discrepancy in the total of 1 between the candidate list as shown on the ECHA web site

and the download of the substances (this is assumed to be due to substance grouping)

In terms of progress towards the 2020 Roadmap objective it is difficult to judge because the data

for 1 to 100 tonnes per annum phase-in substances is not yet available from registration and

because the process is somewhat dependent on the activities of Member State CAs coming forward

with proposals for SVHCs in the form of Annex XV dossiers In addition whilst CMR and to some

extent equivalent concern to CMR (eg such as sensitisers) can be identified through classification

(CLP) environmental concerns in terms of meeting the specific criteria for PBTvPvB can only be

assessed against the criteria in Annex XIII of REACH

33 Prioritisation and inclusion of substances in the Authorisation List


the substance (2) the high volume and (3) the use (wide-dispersive) Before sending its





17 REACH article 58(4)




information














Table 33 sets out the number of substances on the Authorisation list (Annex XIV) according to their

inherent property Note that inherent property is just one aspect considered in the prioritisation

assessment which in addition to the Art 58(3) takes also further considerations into account eg

potential interchangeability among substances in (some of) their uses

Table 33 Authorisation list substances (Annex XIV) by SVHC type (as of 13th June 2017)


Environment

PBT 1

vPvB 1

Endocrine disrupting 2

Human Health

Carcinogenic 14

Carcinogenic Mutagenic 2

Carcinogenic toxic to Reproduction 3

Toxic to Reproduction 14

CMR 4

Environment and Heath Carcinogenic PBT vPvB 2

Total 43




parties (alternatives during the public consultation) In addition the Risk Assessment Committee


18 ECHA (2014) Prioritisation of substances of very high concern (SVHCs) for inclusion in the






Table 34 was taken from ECHArsquos website on (Nov 2016)19 It should be noted that in Table 34 the

figures in red text are not exactly as shown on the ECHA web site This is because applications for

these substances (namely chromium trioxide and sodium dichromate) had applications after

December 2016 (this study is considering applications up to and including December 2016)

By the end of December 2016 there were 111 applications for authorisation Contained within

these applications there have been 185 uses applied for (each application may have more than one

use (eg consultation numbers 0013-01 and 0013-02 denotes two uses associated with application

0013) By the end of 2016 the progress made on these applications could be broken down into the

stages presented in Table 35

Table 34 Number of Applications for Authorisation (AfA) (as of Dec 2016)

Substance Number



Number of uses

Bis(2-ethylhexyl) phthalate (DEHP) 5 7 10

Dibutyl phthalate (DBP) 2 2 4

Bis(2-ethylhexyl) phthalate (DEHP) and Dibutyl phthalate (DBP)

1 1 3

Lead sulfochromate yellow (CI Pigment Yellow 34) and Lead chromate molybdate sulphate red (CI Pigment Red 104)

1 1 12

Hexabromocyclododecane (HBCDDD) 1 13 2

Diarsenic trioxide 4 4 5

Trichloroethylene 13 15 19

Lead chromate 1 1 1

Chromium trioxide 25 57 41

Sodium dichromate 17 23 23

Chromium trioxide Sodium dichromate and Potassium dichromate

1 6 7

Sodium chromate 2 4 3

12-Dichloroethane (EDC) 15 17 19

Potassium dichromate 4 4 7

Ammonium dichromate 3 5 4

Dichromium tris(chromate) 1 2 2

Chromium trioxide Dichromium tris(chromate) 1 2 5

Strontium chromate 1 10 2

Potassium hydroxyoctaoxodizincatedichromate 1 5 2

Diglyme 8 8 9

19 httpsechaeuropaeuaddressing-chemicals-of-concernauthorisationapplications-for-

authorisationreceived-applications



Substance Number



Number of uses

Arsenic acid 1 1 1

Chromic acid 1 1 1

Formaldehyde oligomeric reaction products with aniline (technical MDA)

1 1 2

22-dichloro-44-methylenedianiline (MOCA) 1 1 1

Total 111 191 185

Source ECHA website

Table 35 Status of decisions of AfArsquos submitted (Dec 2016)

AfA status No of uses applied for (end Dec 16)

Opinion development 63

Opinions adopted 86

Commission decided 34

Application withdrawn 2

Total 185

The review period applied for by applicants is listed in Table 36 (the review periods recommended

by SEACRAC and granted by EC are also listed)

Table 36 Review periods applied for (Dec 2016)

Review period (years)

No of use applications - end Dec 2016

Applied for by applicants

Granted recommended

lt4 3 4

4 15 25

5-6 1 0

7 23 47

8-11 7 2

12 77 44

gt12 26 0

unclear or confidential 33 NA

decision not yet made NA 63

Total 185 185

A comparison of applied-for versus recommended andor granted review period is made in Table

37 for AfA upto the end of December 2016 Table 37 shows data for the total number of

applications at that time (185) A total 63 AfA were undergoing opinion development (by ECHA

Committees) The ECHA Committees have made its recommendation on applicants review periods

for a total of 81 AfAs of these 37 (46) were recommended to be granted the review period

requested and 34 (42) were not Note that for a number of applications it was not clear in the

AfA what length of review period was being requested (or this was confidential) this accounted for



10 AfA (12) As of the end December 2016 some 34 AfAs had been granted by the Commission of

these 6 (18) were granted the requested review period and 11 (32) were not There were 17

(50) in which the requested review period in the AfA was unclear or was confidential

Not shown specifically in Table 37 (but included in the data set summarised in the table) there

were 14 AfA for which it was not clear from the application what length of review period was

requested but for which the Commission decision granted a shorter review period than the ECHA

recommendation These were

two AfA for DEHP where 7 years was recommended and 4 years was granted

six AfA for lead sulfochromate yellow for which four AfA were recommended 12 years and

granted 7 years and two AfA were recommended 7 years and granted 4 years and

six AfA for lead chromate molybdate sulphate red for which four AfA were recommended

for 12 years and granted 7 years and two AfA were recommended 7 years and granted 4

years

The Table 37 does not differentiate between AfA from upstream (manufacturers) and downstream

(user) actors

Table 37 Were applicants given the review period they advocated for (Dec 2016)

Were applicants recommended or granted the review period (RP)

applied for

No of use applications

(up to end Dec 16)

No

Application is currently undergoing opinion development 63

Application is pending decision 5

Application has been withdrawn 2

Recommendation to grant the RP applied for

Yes 37 46

No 34 42


Total 81 100

Granted RP applied for

Yes 6 18

No 11 32


Total 34 100

Total 185

The number of applications for substances by Article 57 criteria is presented in Table 38



Table 38 Number of uses applied for defined by Article 57 criteria (Dec 2016)

SVHC identification criteria No of uses applied for

(end Dec 2016)

Toxic for reproduction (Article 57c) 26

Carcinogenic (Article 57a) 55

Carcinogenic (Article 57a) Toxic for reproduction (Article 57c)

13

Carcinogenic (Article 57a) Mutagenic (Article 57b)

48

Carcinogenic (Article 57a) Mutagenic (Article 57b) Toxic for reproduction (Article 57c)

41

PBT (Article 57 d) 2

Total 185

35 Review of Authorisation following their review period
















4 CHANGES IN THE EU MARKET FOR SVHCs (AND THEIR

ALTERNATIVES)

41 Introduction

Collating evidence on how the EU markets for SVHCs and potential (or proven) alternatives have

changed since the introduction of REACH authorisation is one of the five focus areas for this study

The indicators of change are (i) the number of companies manufacturing importing and using a

substance (concentration effects) (ii) number of uses of a substance and (iii) the size of the

market (volumes) The analysis is not limited to substances that have been through the whole

authorisation process For example possible market changes for substances currently on the

Candidate List are also assessed

Evidence on the drivers of such changes is also needed so that we can determine which changes can

be attributed to the REACH authorisation process To do this overall trends in the EU chemical

sector and any noticeable differences in trends for SVHCs and their (potential) alternatives need to

be identified It would then be possible to infer if authorisation leads to a concentration effect

(eg reduction of competition) development of markets for alternatives and macroeconomic

impacts (like changes in employment)

It is important to note that one of the goals of REACH (authorisation) is to promote the progressive

replacement of SVHCs where feasible Therefore over time one might expect to see a decline in

the volumes of SVHCs used in the EU over time as some companies substitute away from the use of

an SVHC as well as an increase in sales of alternatives There are of course a number of factors

why this might not necessarily be the case yet as (i) some uses are not subject to (affected by)

authorisation (eg exempted uses and intermediates) (ii) substitution away from an SVHC can take

time and it might still be too early to observe changes in the EU market due to REACH authorisation

(iii) for some companiesuses alternatives being tested may continue to prove to be unsuitable

despite continued efforts to find an alternative andor (iv) increased demandsales from the

continued use of the SVHC after the sunset date for those uses where authorisation has been

granted (for a given review period)

The section is split into seven sub-sections

Section 42 - EU Chemicals sector summarises changes in the EU chemicals sector since

2000 to understand the overall trend in the sector Supporting details are set out in Annex

E

Section 43 ndash Literature review summaries what existing studies indicate about changes in

the market for SVHCs and (possible) alternatives due to REACH authorisation Supporting

details are set out in Annex E

Section 44 ndash Survey responses summarises information provided by respondents to the

industry survey on any observed changes in their respective markets due to REACH

authorisation This does not focus on any particular substance on or off the authorisation

list and hence offers a different perspective to the Tier 2 case studies

Sections 45 ndash 46 Tier 2 case studies present changes in the market for a selection of

substances as ldquomini case studiesrdquo They make use of existing information and further



consultation with affected companiessector groups to investigate any links between the

changes in the market for these substances (and their uses) and REACH authorisation These

case studies start to build up a picture of changes in the market for specific SVHCs where

there is better data available (which may not be as readily available for all SVHCs)

Section 47 ndash Findings using other statistic sources summarises market changes that can be

observed using available statistical datasets including data held by ECHA and Eurostat

The data collection process to assess changes in the market makes use of several different types of

information The literature review presents an overview of what is known already The Tier 2 case

studies focus on individual substances The survey responses provide a glimpse of stakeholder

views The statistical analysis from Eurostat provides an overview of those SVHCs where there is a

good match between the substance and the product classification coding used Collectively these

different approaches start to build up a bigger picture of the changes in the EU market as depicted

in Figure 41

Figure 41 Assessing changes in the market using different approaches

42 EU chemicals sector general trends and drivers of change

This section presents the main findings of a literature review on the overall trends in the EU

chemicals sector20 in terms of (i) sales value (ii) imports (iii) exports (iv) the number of

companies and (v) spending on RampD and investment Data on the overall chemicals sector includes

both Substances of Very High Concern (SVHCs) and those not identified as SVHCs By comparing

changes in the market of the SVHC (eg sales volume) to the overall trend in the market for all

chemicals this allows for inferences to be made on whether the overall change in the EU market

for SVHCs might be due to REACH authorisation or follows the same trends observed in the overall

20 It is acknowledged that the manufacturing sector is also be affected by the REACH authorisation process as

it also uses SVHCs An analysis of the effects of the REACH authorisation process on this wider sector was not

possible for this study due to a lack of comprehensive EU level data over time



EU chemicals market There are of course a number of other factors (other than REACH

authorisation) that could influence market changes in SVHCs (eg price consumer preferences and

availability of alternatives) This requires a more detailed assessment of the market which is only

possible on a substance by substance This is done through the two Tier 2 studies carried out (see

Section 45 and 46)

The insights in this section are mainly based on the information provided by The European Chemical

Industry Council (see CEFIC 2014 CEFIC 2016a CEFIC 2016b) While other sources were examined

as part of the literature review the review revealed that the analysis in these other sources also

relied on the same data provided by CEFIC Therefore the CEFIC data was used as the main source

for this section

The complete literature review can be found in Annex E2 For the aforementioned purpose the

following findings of the literature review are of particular relevance

The EU share of the global chemical market has declined significantly from 323 in 1995 to

147 in 2015

While the change in annual EU chemical sales revenue has largely mirrored changes in the

global market between 1995 and 2002 the trends are divergent since 2012 According to

CEFIC data (See Annex E2) EU chemicals sales values have declined while global chemical

sales values (outside the EU) have increased since 2012 Whether this trend continued for

2016 ndash 2017 remains to be seen as there is no CEFIC data available yet

The majority of EU production (764 on average between 2005 and 2015) is sold and used

within its 28 Member States The export market therefore plays only a limited role in

determining the overall performance of the EU chemicals market

The slight decline in EU chemical sales values observed since 2012 is mainly caused by a

decline in domestic (home) sales in the Member States producing the chemicals and

specifically sales within Germany France Italy the United Kingdom the Netherlands

Spain and Belgium which together account for 84 of EU chemicals sales

The trade balance of the EU chemicals industry is positive between 2005 and 2015 which

indicates that in terms of sales value the EU exports more chemicals than it imports In

2013 imports started to increase (according to sales values) which may partly explain the

decline in home sales mentioned above

Several sources point to a decline of EU competitiveness based on export data in the short

(ie since 2013) and long term (ie since 2003)

The EU chemicals sector has experienced an unusual period of stagnation between 2012 and

2015 following a period of continuous long-term growth between 2003 and the beginning of

the global financial crisis in 2008

In addition to the exchange rate RampD intensity and energy prices ndash which are identified as

the three main drivers of competitiveness by an Oxford Economics study conducted for

CEFIC (ie CEFIC 2014) - regulatory costs can be a relevant driver of competitiveness if

businesses recover increased regulatory costs through higher prices for customers




To create a basis for the assessment of new results produced by this study previous literature has

been reviewed to identify and consolidate existing knowledge about the effect of REACH

authorisation on the market of SHVCs Existing literature consulted as part of this review provides

mainly anecdotal information on how key factors influencing the performance of the SVHC market

such as changes in investment and RampD decisions ndash factors closely related to innovation ndash as well as

the EUrsquos competitiveness are affected by REACH

This sub-section summarises the key findings of the aforementioned literature review and will

thereby constitute the basis for an assessment of whether the results from the present study are

aligned with findings from earlier studies as well as an assessment of the reasons behind potential

differences

The complete literature review can be found in Annex E3 The main findings of this literature


With respect to innovation according to a stakeholder consultation conducted as part of

the EC (2015) report21 authorisation does have an impact on innovation as investors require

regulatory certainty about the use of substances that are essential to their investment and

innovation plans Other sources point to the potential of the REACH authorisation process

to drive innovation by encouraging and pushing companies to engage in substitution

activities Overall the existing literature provides no clear assessment of whether the

REACH authorisation process affects the market for SVHC positively or negatively Both

effects are therefore possible

With respect to long-term investment in the EU the reviewed literature provides some

anecdotal examples that the REACH authorisation process could delay or divert investment

to areas outside of the EU due to a lack of predictability surrounding REACH Examples

(noted in Annex E3) concerning the nanomaterial and pharmaceutical sectors illustrate the

potential of REACH to create an environment inducing companies to implement new

projects involving large investments in countries outside of the EU and are not subject to

REACH

In terms of competitiveness a minor negative impact is possible due to EU manufacturers

being at a competitive disadvantage compared to manufacturers producing outside the EU

as the requirements of authorisation do not apply to non-EU producers of imported articles

This argument is supported in some respect by quantitative evidence on the effect of

REACH on imports and exports ndash the comparison of which is a good indicator of

competitiveness The EC (2015) industry survey revealed that the majority of respondents

experienced no changes in imports and exports as a result of REACH while the impact on

MIrsquos has tended to be negative

The literature review also points to the potential of the authorisation process to influence

the SVHC market negatively through internal demand factors In fact a business survey

conducted as part of the EC (2015) reveals that 39 of all survey respondents answering the

question whether their customers requested the removal of SVHCs from their products





(n=242) and even 70 of article suppliers received such requests This indicates that the

authorisation process might harm the market of SVHCs by decreasing the acceptance of

products containing SVHC among customers

In addition the EC (2015) report points to the potential for REACH authorisation to cause a

downsizing (ie reduction of the number of active companies) of the market for SVHCs due

to increasing the probability of market withdrawals and relocation The extent of this

downsizing effect is not clear as it is questionable if relocation of a use is an economically

feasible option for SMEs that make up the majority (95) of the chemical industry

44 Survey responses

This section presents survey findings regarding changes in the EU markets for (possible) SVHCs and

the respective alternative substancestechnologies caused by the authorisation process It is based

on online survey responses given by industry stakeholders The analysis relies on data provided by

46 respondents

441 Changes in the supply of SVHCs and alternatives

Fifty-seven percent of respondents (26 out of 46) to the industry survey stated that the REACH

authorisation process had led to an impact on their organisationsrsquo production or supply of (possible)

SVHCs andor their alternatives These respondents provided 30 examples of such impacts For

each example respondents provided

The (possible) SVHC or alternative that was impacted




Whether any of these changes can be attributed to factors other than the REACH authorisation

process

Table 41 lists the substances (and specific uses) for which respondents reported a change in

production or supply The table also shows the number of examples given for each substance


production or supply (ie 13 examples) This is followed by lead chromate with three examples In

terms of uses plating is the use with the highest number of examples Three of 30 examples refer

to this use

Table 41 Changes in the supply of (possible) SVHCs and alternatives (industry survey)


Number of

examples

provided

Affected use(s)


Solvent

2 2-[4-(244-trimethylpentan-2-

yl)phenoxy]ethanol 9002-93-1 2

Biotechnology

Cell lysis during

manufacturing of

vaccines and

cleaning of




Number of

examples

provided

Affected use(s)

manufacturing

equipment

3 4-(1133-Tetramethylbutyl)phenol

ethoxylated 923-960-0 1 Surfactant


5 Bis(2-ethylhexyl) phthalate (DEHP) 117-81-7 1 Plasticiser


Anti-corrosive

Catalyst

Decorative function

Electroplating

Etching and plating

Metalacid reaction

inhibitor

Passivation

Plating

Production of hard

chromium

Surface coating

7 Formaldehyde oligomeric reaction

products with aniline 25214-70-4 1

Polymerisation

agent

8 Lead chromate 7758-97-6 3

Pigments

Pyrotechnic

mixtures


7439-92-1 1 Glass production

10

NN-dimethylacetamide NN-

dimethylformamide 1-methyl-2-

pyrrolidone

127-19-5 68-

12-2 872-50-4 1

Solvent


10588-01-9 2

Passivation

Sensitiser

12 Not stated Not stated 2 Surface treatment

Not stated

Total 30

Notes The 30 examples were provided by 26 respondents

For 80 of the examples respondents indicated that the downstream user market of the SVHCs

were the markets affected most by the authorisation process The market of SVHCs themselves

were reported lsquoaffectedrsquo in 10 of examples This is not surprising since most survey respondents

were downstream users of an SVHC rather than MIs of the SVHC



Decrease in price of (possible) SVHC

Increase in price of (possible) SVHC

Conditions imposed on safe handling of the substance

Increase in number of suppliers of alternatives to the substance



Decline in number of suppliers of the substance


organisation experienced the changes

Figure 42 Changes in the supply of SVHCs and alternatives ndash Type of impact (industry survey)


For nearly 70 of the examples respondents attributed the reported changes to the REACH

authorisation process rather than any other possible factor For those examples in which changes

were partially attributed to other factors the most common factor was an internal

strategydecision by the organisation to progressively substitute SVHCs especially when this can be

done cost-effectively

442 Closure and relocation of organisations

Despite seeking to find companies that may have closed production and or relocated outside of the

EU only three respondents provided information about the closure andor relocation of their

organisations in the industry survey This might indicate (although difficult to conclude with

certainty) that such instances of closure andor relocation to outside of the EU due to REACH

authorisation are rare despite the reported risks of such responses within existing literature

However given this small sample it is not possible to carry out a detailed or representative

analysis of the impacts of authorisation on closure or relocation of organisations using the survey

responses as a basis The costs of closure and relocation are discussed in Section 610 using a

different data source than the online survey

443 Changes in competitiveness

Forty-one percent of respondents (19 out of 46) to the industry survey stated that the REACH

authorisation process had led to an impact on their organisationsrsquo competitiveness (ie ability to

sell products) relative to their competitors in the EU and outside For each example respondents

provided examples providing information on







Whether any of these changes are attributable to factors other than the REACH authorisation

process

Table 42 lists the substances (and a broad description of the use) for which respondents reported a

change in competitiveness The table also shows the number of examples given for each substance


competitiveness (ie 10 examples) In terms of uses plating is the use with the highest number of

examples Five of 21 examples refer to this use

Table 42 Changes in competitiveness - (possible) SVHCs (industry survey)


Number of

examples

provided

Affected use(s)


2 Chromium III 16065-83-1 1 Decorative function


Catalyst

Cold rolling for steel aluminium copper

Etching and plating

Passivation

Plating Surface coating Surface treatment





7439-92-1 1

Additive to increase

refractive index

7

Orange lead Lead chromate CC-

azodi(formamide) (ADCA) Lead

246-trinitro-m-phenylene dioxide

1314-41-6

7758-97-6

123-77-3

15245-44-0

1 Pyrotechnic

mixtures


7789-12-0 2

Passivation

Sensitiser


Total 21


For 86 of the examples respondents indicated that the downstream user markets for the uses of

SVHCs were most affected by the authorisation process (as opposed to markets for the sales of the

SVHCs themselves or their alternative substancestechnologies) This is not surprising since most

survey respondents were downstream users of an SVHC rather than MIrsquos of the SVHC





More difficult to sell to their non-EU customers

Easier to sell to their non-EU customers

More difficult to sell to their EU customers

Easier to sell to their EU customers

The results (n=21) are presented in Figure 43 For over 75 of the examples respondents

attributed the reported changes to the REACH authorisation process rather than any other possible

factor

Figure 43 Changes in competitiveness ndash Type of impact (industry survey)


444 Changes in spending on innovationinvestment opportunities andor RampD

Seventy-six percent of respondents (35 out of 46) reported that the authorisation process had

impacted their organisationsrsquo spending on innovationinvestment opportunities andor RampD The

analysis of these responses is presented later in the assessment of the innovationinvestment and

RampD costs reported in Section 69

445 Changes in employment

Only fifteen percent of respondents (7 out of 46) to the industry survey stated that the REACH

authorisation process had led to an impact on the number of people that their organisation

employs Given the limited number of responses indicating a change in employment the results

presented in this sub-section should be interpreted with caution and that overall REACH may not

have had a significant impact on employment (to date)

Respondents provided eight examples of this impact For each example respondents provided

details on








process

Table 43 lists the substances (and related uses) for which respondents reported a change in

employment The table also shows the number of examples given for each substance

Table 43 Changes in employment (industry survey)

no Substance CAS

number

Number of

examples

provided

Affected use(s)


2 Chromium trioxide 1333-82-0 2 Plating

Not stated

3

Chromium trioxide Sodium

dichromate Potassium dichromate


1333-82-0

7789-12-0

10588-01-9

7778-50-9

24613-89-6

1 Anti-corrosive and

surface treatment


Hexavalent chromium 18540-29-9 2

Decorative function

Plastic etching


Total 8




the SVHCs themselves or their alternative substancestechnologies)


the number of people they employ (Table 44) Most of the affected respondents (63) reported an

increase in employment by 1-9 workers in their organisations For five out of eight examples

respondents attributed the reported changes in employment to the REACH authorisation process

The finding should be used with caution As set out earlier most respondents indicated no impact

of REACH authorisation on the number of people they are employing

Table 44 Changes in employment ndash Type of impact (industry survey)

(based on 8 examples)

Decrease

gt1000 workers -

100 - 1001 workers -

10 - 99 workers 25

1 - 9 workers -

Increase

1 - 9 workers 63

10 - 99 workers 13

100 - 1001 workers -

gt1000 workers -

Total 100




446 Changes in sales revenue

Only twenty-two percent of respondents (10 out of 46) to the industry survey stated that the REACH

authorisation process had led to an impact on their organisationsrsquo sales revenue Overall this would

suggest that REACH may not have had a significant impact on sales revenue (at least to date) The

results presented in this sub-section should therefore be interpreted with caution since they only

refer to a minority of respondents

Respondents provided 10 examples of this impact For each example respondents provided

The product sold

The market application of the product



process

Table 45 lists the sold products for which respondents reported a change in sales revenue in

conjunction with the reported market applications of these products The table also shows the

number of examples given for each product

Table 45 Changes in sales revenue (industry survey)

No Product sold

Number of

examples

provided

Market application(s)

1 Ammunition 1 Military sector

2 Chrome plated metal components 1 Automotive sector

3 Chrome plated parts 1 Automotive sector

4 Chrome plating of customer rolls 1 Cold rolling industry

5 Chromium trioxide (CAS no 1333-82-0) 2

Dehydrogenation

catalyst

Not stated

6 Lead monoxide (CAS no 1317-36-8 7439-92-1) 1 Glass production

7 Metal liner 1 PVD-chrome

8 Not stated 2 Aerospace sector

Printers

Total 10



their sales revenue (

Table 46) Most respondents (90) reported a decrease in their sales revenue by 11 to 19 For all

examples respondents attributed the reported changes in sales revenue entirely to the REACH

authorisation process The finding should be used with caution As set out earlier most

respondents indicated no impact of REACH authorisation on sales revenue



Table 46 Changes in sales revenue ndash Type of impact (industry survey)

( based on 10 examples)

Decrease

gt20 -

11 - 19 90

1 - 10 10

Increase

1 - 10 -

11 - 19 -

gt20 -

Dont know

-

Total 100


447 Changes in quality price or availability of organisationsrsquo products

Only twenty-four percent of respondents (11 out of 46) to the industry survey stated that the

REACH authorisation process had led to an impact on the quality price or availability of their

organisationsrsquo products Overall this would suggest that REACH authorisation may not have had a

significant impact on product quality price or availability (at least to date) The results presented

in this sub-section should therefore be interpreted with caution since they only refer to a minority

of respondents

These respondents provided 13 examples of these impacts For each example respondents

provided






process

Table 47 lists the substances (and uses of that substance) for which respondents reported a change

in quality price or availability The table also shows the number of examples given for each

substance With 5 examples chromium trioxide is the substance with the highest number of

reported examples In terms of uses plating is the use with the highest number of examples

Three of 13 examples refer to this use

Table 47 Changes in quality price availability (industry survey)


Number of

examples

provided

Affected use(s)

1 Chromates Not stated 2 Anti-corrosive

Surface treatment


Decorative function

Metalacid reaction inhibitor

Passivation




Number of

examples

provided

Affected use(s)

Plating




Pyrotechnic mixtures

5 Sodium dichromate 10588-01-9 2 Passivation

Sealant

6 Strontium chromate 7789-06-2 1 Primers and

coating

Total 13




the SVHCs themselves or their alternative substancestechnologies) This is not surprising since

most survey respondents were downstream users of an SVHC rather than MIrsquos of the SVHC

To get more specific information on the type of change that their organisation had experienced

respondents were asked to indicate whether they had experienced any of the following changes

Change in availability of final (end-use) product

Change in price of final (end-use) product

Change in quality of final (end-use) product


organisation experienced the respective change Respondents were asked about both positive and

negative changes but no respondent reported a positive improvement in the above listed areas

Most respondents stated that the increase in price was a result of increased production or

compliance costs (for complying with the authorisation process) The reduction in product quality

was said to be due to the substituting to alternatives that did not adequately replace the functions

provided by using the SVHC in the final products



Figure 44 Changes in quality price availability ndash Type of impact (industry survey)


For eighty-five percent of the examples respondents attributed the reported changes to the REACH


45 Tier 2 case study Diarsenic trioxide and arsenic acid

451 Rationale for considering these substances

Arsenic acid and diarsenic trioxide were identified as case study substances due to the very small

number of applications for authorisation submitted for them (four applications for diarsenic

trioxide one application for arsenic acid) This raises the question of whether the use of these

substances has always been this limited historically or whether use has fallen over time (or some

other scenario) If use is seen to have fallen over time the questions then are first how the

markets for these substances (and their substitutes) have changed over the course of this fall and

second to what extent the authorisation requirement for these substances might have contributed

to the falls and the associated market changes

A principal use for both substances is in the manufacture of speciality glass The MSC opinion on the

prioritisation of arsenic acid stated that the substance could act as a substitute for diarsenic

trioxide and presented this as a justification for prioritisation For these reasons the substances

have been grouped together for this case study

Note that diarsenic pentaoxide was prioritised for inclusion in Annex XIV at the same time as

diarsenic trioxide because of its potential to act as a substitute for the latter substance in glass

manufacture However at the time of prioritisation there was no registration dossier for diarsenic

pentaoxide and comments from industry indicated that there was no manufacture in or import into

the EU There were also no applications for authorisation to use this substance after its sunset

date Therefore diarsenic pentaoxide is not considered further in this case study

452 Substance profiles



A profile of the substances are summarised below in Table 48

Table 48 Substance profiles


EC nos 215-481-4 231-901-9

CAS nos 1327-53-3 7778-39-4

SVHC Classification Carcinogenic (Article 57a) Carcinogenic (Article 57a)

Exempted uses - -

Existing restrictions REACH Annex XVII entries 19 and 28 REACH Annex XVII entries 19 and

28

Entry 19 of Annex XVII of REACH is a restriction on arsenic compounds It restricts the use of arsenic

compounds in industrial water treatment marine anti-fouling paints and for the preservation of

wood (although derogations are made for certain wood preservation uses) Entry 28 relates to

carcinogens more generally and restricts the use of such substances in substances and preparations

placed on the market for sale to the general public


The REACH authorisation timelines for the two substances are given in Table 49 A date for the

inclusion of diarsenic trioxide in the Registry of Intentions has not been found The time frames for

the two substances are similar with around seven years between the Annex XV dossier for diarsenic

trioxide being submitted and its subsequent Sunset Date and six years for the same process for

arsenic acid The one-year difference between the two is due to the faster time it took for arsenic

acid to be prioritised onto Annex XIV following its entry onto the Candidate List

Table 49 REACH authorisation timelines


Registry of Intentions Not known 30042008

Annex XV dossier 26062008 29082011

MSC opinion on SVHC identification 01102008 24112011

Candidate List 28102008 19122011

Annex XIV recommendation 17102010 13122012

Annex XIV 21052012 22082014

Latest Application Date 21112013 22022016

Sunset Date 21052015 22082017


Diarsenic trioxide

The initial Annex XIV background document produced by ECHA in 2010 presented information on

uses and volumes collected for ECHA by the consultancy RPA in 2009 However much of this



information was judged inaccurate by the Arsenic Consortium in their response to the associated

public consultation The background document was subsequently updated and drew heavily on the

Consortiumrsquos contribution Unfortunately the Diarsenic Trioxide Consortium declined to contribute

new information to this study This section is therefore based primarily on the final ECHA Annex XIV

background document

Table 410 presents information provided to ECHA by the Arsenic Consortium on the production and

use of diarsenic trioxide in the EU over the period 2008-2010 Figures might not balance due to

inaccuracies and uncertainties

Table 410 Diarsenic trioxide in the EU 2008-2010

tonnes pa Uses tonnes pa

Manufacture 1500 Production of ultra-pure arsenic metal 30-40

Manufacture of impure form 320 Chemicals 60

Import 500-600 Zinc production 500-600

Glass 100-150

CCA wood preservative (export) 70-100

Diarsenic trioxide export 1100-1200

Waste 200

Net placed on the market 2320-2420 Total use 2060-2250

Most diarsenic trioxide is produced as a by-product of copper (and to a lesser extent lead) smelting

and refining Therefore manufacture of diarsenic trioxide depends largely on the production

volume of these metals and the arsenic impurity levels in the ores The volume placed on the

market further depends on consumer demand ndash when demand is low a higher proportion of

diarsenic trioxide is disposed of as hazardous waste whereas when demand is higher (particularly

in eg the zinc sector) both manufacture and imports can increase Only two producers of

diarsenic trioxide were identified for the 2011 background document

The primary use (around 550 tonnes per annum) of diarsenic trioxide in the EU can be seen to be in

the manufacture of zinc metal by electrolysis This use was claimed as intermediate by the Arsenic

Consortium and is identified as an intermediate use in the registration dossier However this claim

was contested by ECHA in the background document on the grounds that diarsenic trioxide used in

zinc manufacture acts as a purificationprecipitation agent This case has since been reviewed by

the ECHA Board of Appeal that concluded that the case needs to be remitted to the Agency for re-

evaluation (although the Board of Appeal has not found ECHArsquos conclusion as to the substancersquos

intermediate status in zinc manufacture to be necessarily incorrect) According to the Nordenhamer

Zinkhuumltte GmbHrsquos application for authorisation diarsenic trioxide has a dual role in zinc

manufacture in the purification of zinc sulphate solution but also in so doing producing a copper

concentrate which is then sold on to a chemicals producer



The second major use of diarsenic trioxide (c125 tonnes per year) was in glass manufacture as a

decolouring agent for glass and enamels and as a refining and oxidising agent in the manufacture

of special glass and lead crystal According to the JRC (2009)22 special glass products cover a wide

range including lighting glass (tubes and bulbs) optical glass laboratory and technical glassware

borosilicate and ceramic glasses (cookware and high temperature domestic applications) and glass

for the electronics industry (LCD panels) The Arsenic Consortium comment also identified artisanal

glass manufacture (eg in Murano Italy) where diarsenic trioxide might be used for particular

reasons This was said to account for around 8 tonnes per year As with zinc manufacture the

Consortium claimed the use in glass to be intermediate a claim which was similarly contested by

ECHA on the grounds that the substance was judged not to be used in the synthesis of glass itself

but as a processing agent for modifying the properties of the glass and specifically as a

decolourising opacifying and fining agent However it is understood that since the publication of

the ECHA background document industry has clarified that certain special glass applications as in

the manufacture of ceramic glass used for cooker hobs and stove door windows involve the use of

arsenic compounds as a lsquonetwork formerrsquo which does class as an intermediate use the use as a

fining agent in the manufacture of artistic glass is still considered non-intermediate however

The use of diarsenic trioxide in copper-chromium-arsenic wood preservatives was in 2011 said to be

much reduced in the EU compared with previously due to the introduction of the restriction

described in Section 452 and only for export It was expected that manufacture would cease

before the first ECHA registration deadline of 2010 In any case this use falls under the Biocides

Directive and hence is exempt from the REACH authorisation requirement The other uses identified

in Table 410 are not discussed in the ECHA background document Use in pharmaceuticals

identified in the Annex XV dossier had reportedly ceased in the EU by 2010 although internet

searches in July 2017 reveal suppliers of arsenic trioxide as a treatment for leukaemia and other

cancers23 Other uses referred to in the same dossier related according to the Arsenic Consortium

to uses of arsenic metal not diarsenic trioxide

A use of diarsenic trioxide not identified (separately) in the ECHA background document was the

use as a processing aid to activate the absorption and desorption of carbon dioxide by potassium

carbonate from synthesis gas which was used for the production of ammonia by Yara France

Additionally the arsenic serves as a corrosion inhibitor in this process In Yararsquos application for

authorisation (see below) the carbon dioxide removal unit was described as containing 40 tonnes

of diarsenic trioxide and potassium carbonate requiring the addition of approximately five tonnes

of diarsenic trioxide per year to compensate for the conversion of diarsenic trioxide to diarsenic

pentaoxide which is regularly extracted from the system by filtration

A further use of diarsenic trioxide which has been the subject of an application for authorisation

but not identified (separately) in the ECHA background document is in the production of etched

circuits These are used in smartcards in a range of applications such as SIMs payment cards ID

cards medical sensors RFID chips data storage cartridges and so on This is a very minor use in

volume terms (15-30kg per year) and might well not have been current at the time the document

was compiled (2010)

From Table 410 it can also be seen that imports exports and waste also accounted for significant

volumes over the 2008-2010 period As already mentioned volumes going to waste can depend on

production volumes and demand particularly from the zinc sector and from export markets

22 Joint Research Centre (2009) Best Available Techniques (BAT) Reference Document for the Manufacture of

Glass 23 httpwwwtevaukcomhcptrisenox



According to the ECHA database import notifications were received only from Switzerland over the

period 2006-2017 primarily to Germany and France but also to Sweden Belgium and the

Netherlands 24 import notifications in total are listed in the ECHA database over this period

Notifications of exports over the period 2004-2017 number 83 over the 2004-2010 period

exclusively from Spain and Germany (25 entries with two from Bulgaria and one from France) to a

variety of countries including the United States Brazil Switzerland and India Volumes are not

reported in these notifications However the greater number of export notifications compared with

import notifications (11 over 2006-2010) could be consistent with the higher export volume

reported in Table 410 compared with the import volume

Arsenic acid

Information on the use of arsenic acid prior to authorisation is provided in the Annex XV dossier

which Norway prepared to establish the substance as a SVHC and in the background document (and

associated public consultation comments) prepared by ECHA in support of the substancersquos

prioritisation for inclusion in Annex XIV Unfortunately the Arsenic Acid Consortium declined to

contribute new information for this project so these documents are the source of information on

pre-authorisation uses of arsenic acid

According to the Annex XV dossier arsenic acid can be manufactured using a variety of different

processes a typical one involving the reaction of arsenic trioxide with nitric acid in the presence of

a catalyst The Annex XV dossier reported that there had been manufacture of arsenic acid in the

EU in 2010 but that this had stopped by 2011 According to the Annex XIV background document

the registration dossier was updated to indicate manufacture below 100 tonnes in 2012 Total

volume was in the 100-1000 tonnes band

The Annex XV dossier cites the US Minerals Yearbook in stating that 89 tonnes of arsenic acid were

reported to have been imported into the US from France in 2008 with a figure of zero in 2009 In

2007 five tonnes were reported as being imported from Germany and six tonnes from France in

2006 No imports from the EU are reported in the Yearbook after 2008 None of these exports is

listed in the ECHA export notifications database

The Annex XV dossier concluded based on data reported in registration dossiers that a decreasing

trend in the total manufactured and imported volume could be assumed although information on

the trend over a more extended time period was deemed to be unavailable

Three uses of arsenic acid were considered current at the time the dossier was compiled

Ceramic glass manufacture

Copper foil production for use in printed circuit boards (PCBs) and

In a preparation as an analytical standard for test and measuring instruments

The use of arsenic acid in glass manufacture was described in the ECHA dossiers as a fining agent in

the manufacture of speciality glass for removing bubbles from the glass melt The addition of

arsenic acid releases oxygen late in the fining process which makes the bubbles more easily

absorbed by the melt This use was said to account for 97 of the total volume of use of arsenic

acid Comments to the public consultation on the prioritisation of arsenic acid indicated that the

volume used in copper foil production (the only other significant use ndash see below) was around 10

tonnes per year which might put the volume used in ceramic glass manufacturer at around 300

tonnes The definition as a process agent lead ECHA to conclude at the time that this use was not

intermediate as was claimed by industry However the function of arsenic as a lsquonetwork formerrsquo

was described by Glass Alliance Europe (2012) as follows



ldquoArsenic acid [hellip] used in the production (synthesis) of glass [hellip] reacts with other raw materials

(substances) at high temperature to produce the new substance glass During this process the

oxides from the raw materials form a new random network where different elements are linked

together by oxygen bridges Arsenic acid is completely consumed during this chemical reaction and

no longer contained as such in the final substance glass [hellip] The physico-chemical properties of the

new substance glass (chemical resistance mechanical resistance transmittance colour inertness

etc) are a function of the composition and the network formed A different composition leads to a

different glass (chemicalmolecular) structure and consequently different physico-chemical

properties of the final product [hellip] The presence of arsenic ions in the network structure confers

unique properties to the glass such as a specific redox state clarity colour transmittance absence

of bubbles lack of inclusion etchellip which are critical to the function of glassrdquo24

As discussed in the previous section the use of arsenic compounds as a network or matrix former in

the ceramic glass sector is now accepted as an intermediate use Therefore no applications for

authorisation for this use would be expected

The use of arsenic acid in copper foil production for PCBs is described in the ECHA dossiers only in

confidential annexes In the public consultation a copper foil producer indicated that two

companies used arsenic acid in the EU for this use amounting to around 10 tonnes The application

for authorisation submitted by Copper Foil Luxembourg describes their use as being to encourage

the deposition of copper and to prevent the release of hydrogen when the surface area of the

copper foil is being increased by the deposition of additional copper onto the surface of the foil

Thus increasing the surface area involves deposition (lsquogerminationrsquo) and growth (lsquonodularisationrsquo)

of copper crystals onto the surface of the copper foil This process involves using the electrolysis

bath below the current diffusion limit by reducing the bath temperature the copper concentration

and the level of agitation However doing this risks the process giving off hydrogen instead of

depositing copper Arsenic acid helps to prevent this by increasing the cathodic overpotential of the

hydrogen

Finally comments to the public consultation revealed the use of arsenic acid in a preparation as an

analytical standard for test and measuring instruments for laboratory use This use was reported to

account for minute amounts (grammes) of consumption per year and ECHA indicated in its

response to public consultation comments that this use could be regarded as exempt from

authorisation under the scientific research and development provisions of REACH Article 56(3)


Diarsenic trioxide

The applications for authorisation which were submitted for the use of diarsenic trioxide are

presented in Table 411 There were four applicants for five uses Two of these applications relate

to use in zinc for a total volume of around 840 tonnes per year ndash higher than the volume reported

by the Consortium for the ECHA background document There were two further applications for

use in gold electroplating and in the production of ammonia All authorisations have been granted

The authorisation was granted to Linxens with a review period of seven years The review period

argumentation for this application is not available from the public non-confidential version The EC

decision on this application states that lsquowork towards potential implementation of an alternative

in a period of not less than 3 to 5 years is ongoingrsquo suggesting that the applicant is working

24 Glass Alliance Europe (2012) Position Paper of the European Glass Industries on the Proposed Inclusion of

Arsenic Acid on Annex XIV



towards substitution of diarsenic trioxide with an alternative for this use Authorisation was also

granted to Yara with a (requested) review period of 22 months which was designed to allow the

applicant to continue use during the implementation of a substitute process Note that there were

no applications for use in the glass industry

Table 411 Granted authorisation for uses of diarsenic trioxide


(tpa) Status

Review

period Substitution

Boliden 1 Purification of metal impurities in

zinc electrowinning process 700

COM

decided 12 N

Nordenhamer 1 Production of copper concentrate

in zinc electrowinning process 140

COM

decided 12 N

Linxens

1 Formulation into a mixture COM

decided 7

2 Processing aid in gold

electroplating 0005

COM

decided 7

Yara France 1 Processing aid in the production

of ammonia 5

COM

decided 22 mths Y

Arsenic acid

As shown in Table 412 there has only been a single application submitted for the use of around

three tonnes per annum in the treatment of copper foil for the manufacture of printed circuit

boards (PCBs) The Committee opinions have been adopted but the decision has not yet been made

by the Commission The opinions recommend a review period of seven years with the condition

that use volumes decline over time to reflect the outline substitution plan of the applicant

However the applicant had stated that it expected to need to use arsenic acid until 2030 as this

was how long it would take users with stricter requirements to accept circuits made with an arsenic

alternative Note again that as with diarsenic trioxide there were no applications from users in

the glass sector

Table 412 Applications for authorisation for the use of arsenic acid


(tpa) Status

Review

period Substitution

Circuit Foil

Luxembourg 1

Treatment of copper foil for

the manufacture of printed

circuit boards (PCBs)

3 Opinions

adopted 7 Y

456 Changes in the market for the substance and alternatives during the authorisation process

Diarsenic trioxide

At the time of the compilation of the Annex XIV background document around 2400 tonnes of

diarsenic trioxide were estimated to be produced in or imported into the EU with around 200

tonnes going to waste Zinc production was the biggest industrial use of this volume (550 tonnes)

with glass production chemicals and arsenic production estimated to constitute around 250 tonnes

Around 1300 tonnes were estimated to be exported (leaving a discrepancy of between 70 and 360

tonnes) Thus it can be seen (in Table 410) that although zinc production represented the biggest



industrial use of diarsenic trioxide in the EU the import-export volumes were even more

significant Two producers were identified in the EU in the 2011 ECHA background document It is

not known how many suppliers of imported material there were at this time

According to information provided by Eurometaux for this study there are currently four large

copper manufacturers in the EU (in Germany Poland Spain and Sweden) each of which is a

potential or actual supplier of diarsenic trioxide As indicated in Table 411 the use of a little

under 850 tonnes of diarsenic trioxide has been authorised almost all in zinc manufacture Use of

five tonnes per year was authorised to Yara France in the production of ammonia with a review

period of 22 months only This was designed as a bridging application to facilitate the substitution

to a process based on an alternative substance (See Section 54 for more information) This review

period has now expired and Yara did not submit a review report Yara has confirmed in

communications for this project that its ammonia operations were shut down in March 2017 (before

the end of its review period) and the modified vanadium-based plant started up in August 2017

The only other granted authorisation is for less than 1 tonne per year with a review period of seven

years

Use in the production of artistic glass was not authorised and hence might be assumed to have

largely ceased As reported by ECHA (2017)25 use of arsenic trioxide in the artistic glass sector of

Murano Italy has been widely substituted following efforts by local authorities to advise users of

the authorisation requirement (See Section 54 for more information) During enforcement action

after the sunset date nine site inspections found that all but one firm had substituted to other

substances and local air pollution monitoring found that arsenic concentration had fallen by 98

between 2014 and 2016 indicating widespread substitution ECHA (2017) reports information from

the local chamber of commerce and the Italian workersrsquo insurance institute (INAIL) which indicated

that 300 companies were operating in the field of glass manufacturing in the Venice area where

Murano is located This information was combined with data obtained from the major local

distributor of diarsenic trioxide which showed that in 2013 around 24 companies in that area were

using around 5 tonnes of the substance (compared with 8 tonnes given by the Arsenic Consortium in

the public consultation submission Although this suggests that use in the Murano area has largely

(and possibly entirely) ceased it is not clear whether unauthorised use might be continuing in the

artistic glass sectors in other countries or what has happened to the 92-142 tonnes of use

identified by the Arsenic Consortium as occurring in the special glass sector Use in glass production

is still (as of September 2017) listed in the registration dossier as an intermediate use (and does not

distinguish between use for network formation and use for other reasons)

Volumes associated with imports and exports of diarsenic trioxide are not available but the ECHA

PIC database lists the number of exports and imports and the countries involved as shown in Table

413 Thus the number of imports has remained approximately the same over the 2006-2017

period with a slight peak in 2015 (No data are provided for 2004 or 2005) All of these imports

have come from Switzerland Export notifications were approximately stable over the period 2004-

2013 but since then have appeared to increase quite markedly This would be consistent with a

reduction in domestic use around the time of the latest application date (end 2013) even though

overall use volumes might not necessarily appear to have fallen particularly when Table 410 and

Table 411 are compared Eurometaux have also communicated intelligence for this study to the

effect that disposal of diarsenic trioxide to waste might also have increased since authorisation

ostensibly due to a reduction in EU demand for the substance EU copper producers were contacted

for this study in an attempt to explore these issues although only one responded The view





expressed was that the market for diarsenic trioxide had been declining for some years already

which was largely ascribed to restrictions on the use of arsenic in wood preservation products

authorisation had not according to this producer strengthened these existing trends significantly

However it should be noted that historically use volumes of diarsenic trioxide have been

dominated by a relatively small number of uses so significant impacts of authorisation on individual

use types (eg in artistic glass manufacture) could still occur without causing significant

supplydemand impacts at the market level

Table 413 Import and export notifications for diarsenic trioxide 2004-2017

Year Exports Imports

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

1

2

4

2

5

5

6

2

1

4

20

6

12

13

nd

nd

2

2

3

2

2

2

2

0

1

6

1

1

Regarding the possible impact of authorisation on the market for alternatives the principle uses of

diarsenic trioxide are in zinc manufacture and the production of special glass The former is subject

to long-term authorisation The latter has not been authorised but it is not clear to what extent

this reflects substitution or (claimed) intermediate use Certainly the artistic glass sub-sector has

seen significant substitution activity at least in the Murano area of Italy with switches suggested

to a range of alternative substances The ECHA case study document on Murano reported that out

of 104 companies operating in the field of artistic glass in a 2015 survey 18 indicated that they

used diarsenic trioxide until 2014 but had substituted to antimony trioxide cerium dioxide lithium

oxide andor blast furnace slag The ECHA estimate of the total volume of diarsenic trioxide used in

Murano before this substitution was around 5 tonnes which is small compared with the

manufacturedimported volumes of these substances listed on the ECHA website26 Other uses of

diarsenic trioxide are even more minor in volume Therefore significant authorisation-related

changes in the market for alternatives to diarsenic trioxide are not to be expected However

specific information on changes in markets for alternatives to diarsenic trioxide has not been found

in this study

Arsenic acid

26 The Substance Information section of the ECHA website gives the following manufactureimport volumes

10000+ tonnes (antimony trioxide) 1000+ tonnes (cerium dioxide) No registration is listed for dilithium

oxide Blast furnace slag is exempt from registration as a UVCB substance (httpwwweuroslagcomstatus-

of-slagreach) The industry association Euroslag gives volumes for blast furnace slag of more than 20 million

tonnes per annum



The Annex XV dossier and Annex XIV prioritisation background document identified speciality

ceramic glass for use in high-temperature applications as by far the biggest (97) user of arsenic

acid at that time Use in copper foil manufacture was the only other material use described and

had been identified in public consultation comments as accounting for around 10 tonnes per year If

this represents around 3 of total consumption this would put ceramic glass use at around 300

tonnes per year at this time

The documents also indicated that manufacture in the EU had ceased around 2010-11 but

lsquoreappearedrsquo around 2012 when the registration dossier was updated Discussions with Circuit Foil

Luxembourg for this project support cessation around this time when it was claimed that

manufacture had ceased at this point because the manufacturer deemed the costs of registration

andor authorisation too high to be justified by the value of the market This had obliged Circuit

Foil Luxembourg to submit its own registration dossier (at considerable cost) to enable it to import

arsenic acid into the EU

The public consultation on the proposal to prioritise arsenic acid for inclusion in Annex XIV had

identified two firms using arsenic acid in the production of copper foil for PCBs Circuit Foil

Luxembourg have reported to this study that the second firm closed its facility in Europe in 2014

although it was not clear whether this was for REACH-related reasons Google searches reveal at

least one additional manufacturer of PCB copper foil in Europe27 but it has not been possible to

contact this manufacturer to ascertain the nature of its production process

As described above the vast majority (97) of the arsenic acid used in the EU in 2011 was in the

manufacture of ceramic glass which is classed as an intermediate use It is reasonable to expect

therefore that pressures to substitute this use have not been significant although no evidence is

available to support this

Moreover Copper Foil Luxembourg in discussions for this study stated that the availability of

arsenic acid in Europe has reduced around the time of the first REACH registration when

manufacture in Europe had ceased This would provide an encouragement to users to substitute or

find alternative supplies However as already discussed the ECHA prioritisation background

document states that the registration dossier had been updated in 2012 and manufacture below 100

tonnes indicated Manufacture is listed in the current registration dossier Contact was made with

this manufacturer (listed in the registration) but unfortunately they did not provide information

for this study

As also already mentioned the Circuit Foil Luxembourg application for authorisation indicated that

a (confidential) alternative to arsenic acid had been identified and introduced gradually for five

years already by the time the application was submitted Gradual introduction was envisaged to

continue with the final most stringent applications finally being substituted by 2030 at the latest

This substitution process might be expected to be expedited if the RACSEAC recommendation of a

seven-year review period (instead of the 12 requested by the applicant) is accepted in the final

authorisation decision Given the confidential status of this application it is not possible to assess

how Circuit Foil Luxembourgrsquos substitution activities might affect the markets for the substances it

intends to substitute towards

27 httpwwwgoettledeenproducted-folie-von-5-400C2B5m-mit-und-ohne-treatment-

batteriefolien_2015-08-13_10-38-12_2016-07-15_09-10-06



As with diarsenic trioxide by far the biggest use of arsenic acid (in the production of ceramic glass

for high-temperature applications) is an intermediate use and hence outside of the scope of

authorisation The remaining uses are extremely minor Hence significant authorisation-related

changes in the market for alternatives to arsenic acid are not expected


The markets for arsenic acid and diarsenic trioxide are complex and inter-related In fact one of

the justifications for prioritising arsenic acid given in the Member State Committee opinion on the

fourth Annex XIV prioritisation was so as to prevent substitution of uses of diarsenic trioxide

straight to arsenic acid Assessing changes in these markets is complicated by the fact that major

uses have been claimed intermediate by industry and disputed by ECHA Unfortunately both the

Diarsenic Trioxide Consortium and the Arsenic Acid Consortium declined to contribute information

to this study and it has proved difficult to identify individual companies willing to provide

comment

What seems apparent from the information which has been collected is that authorisation has had

impacts on the markets for both diarsenic trioxide and arsenic acid In the former case

authorisation has incentivised substitution in the artistic glass sector as well as by two

authorisation holders in the ammonia and electronics sectors Use in zinc manufacture does not

appear to have been affected but there is evidence that overall use in the EU might have fallen

relative to production given the increase in export notifications and the reported increase in

disposal to waste

Regarding arsenic acid there does appear to have been some disruption to the supply of the

substance with the registration dossier being updated to reflect cessation and recommencement of

manufacturing in the EU One user reported having to submit its own registration dossier to be able

to import because its previous EU supplier had decided to exit the market It is possible also that

some disruption has been caused by the disputed status of arsenic acid use in ceramic glass

manufacture as intermediate No authorisations for this use were received

46 Tier 2 case study HBCDD

The substance hexabromocyclododecane was selected for a second-tier case study for a number of

reasons

The substance had a relatively high number of applicants (13 the fourth highest of all

applications made to date covering many of the downstream users for the EPS use)

although a low number of applications (one) and uses (two)

A technically and economically feasible alternative was found but it was not available in

sufficient quantity to all applicants The sufficient supply of the alternative was secured by

other companies for their uses (that did not apply for authorisation)

HBCDD is to date the only PBTvPvB substance having gone through the application for

authorisation step of the process


A profile of the substance is summarised below in Table 414



Table 414 HBCDD substance profile

HBCDD

Substance name Hexachlorocyclododecane (and all major

diastereoisomers identified)

EC nos 221-695-9

247-148-4

CAS nos

25637-99-4

3194-55-6

134237-50-6

134237-51-7

134237-52-8

Stage in authorisation process On Authorisation List

Sunset date past Yes



PBT (Article 57 d)


Existing restrictions No



Table 415 HBCDD REACH authorisation timeline

Date

Annex XV dossier 30062008

Date of inclusion (Candidate list) 28102008

Annex XIV recommendation 01062009

Annex XIV 17022011


Sunset Date 21082015


HBCDD was assessed under the pre-REACH Existing Substances Regulation (ESR) programme and a

Risk Assessment Report (RAR) was finalised in 2008 The rapporteur was Sweden (done by the

chemicals regulator KemI) A risk reduction strategy (RRS) was prepared in 2007 (prior to the

official finalisation of the RAR) Based on the risks identified in the RAR the RRS recommended

limitations on uses (ie in textiles high impact polystyrene (HIPS) expanded polystyrene (EPS) and

extruded polystyrene (XPS) with exemptions for certain uses of HBCDD in EPS and XPS) In

addition the RRS recommended

The compulsory marking of exempted uses of HBCDD in EPS and XPS products and

classification of used material and products containing HBCDD as hazardous waste under

the Hazardous Waste Directive



Inclusion of HBCDD as a priority hazardous substance in Annex X of the Water Framework

Directive and

Development of a proposal for the inclusion of HBCDD in the Stockholm Convention on

POPs

Sweden prepared an Annex XV dossier proposing the substance as SVHC the Member State

Committee adopted a support document identifying the substance as SVHC (PBT) in 2008) The

substance was recommended by ECHA for inclusion in Annex XIV (ECHA prioritisation report January

2009) and was afterwards included in Annex XIV by the Commission (2011)

According to the ECHA background document (200928) HBCDD was manufactured at only one site in

the EU with an annual production volume assumed to be 6000 tonnesyear in 2005 Between 2000

and 2004 about 1000 tonnesyear of HBCDD were micronised in a grinding process occurring at a

very limited number of sites mainly for use in the textile industry It was considered likely that the

production of micronised HBCDD had reduced and was estimated to be about 210 tonnesyear

Again according to the ECHA 2009 background document at that time (pre-REACH) the total

volume of HBCDD used in the EU had been increasing over the years and was estimated to be about

11580 tonnesyear in 2006 It was believed that net imports of HBCDD had increased from less

than 4000 tonnes per year to close to 6000 tonnesyear between 2003 and 2007 The quantities of

HBCDD exported as such or in preparations as well as import in preparations were unclear No

reliable quantities of importexport of HBCDD in articles were available However it was

considered that HBCDD was likely to be imported in considerable amounts particularly in packaging

materials textiles and electricalelectronic equipment The volumes are summarised in Table 416

below

Table 416 Summary of volumes of HBCDD (excludes imports in articles) ndash 2006 data

Use Volume tonnes per year

Manufacture asymp 6000

Micronising1 1000

Net import (substance and preparations) asymp 6000

Net import (in articles) No data

Total use volume (2006) asymp 12000

1 The tonnage of HBCDD used in micronising is already included in the tonnage of the substance manufactured

Source ECHA 2009

HBCDD was reported solely as an additive flame retardant in the following main product types (data

for 2007 IOM 200829)

Expanded Polystyrene (EPS)

Extruded Polystyrene (XPS)

28 ECHA (2009) Prioritisation and Annex XIV Background Information 14 January 2009 29 IOM (2008) Data on Manufacture Import Export Uses and Releases of HBCDDD as well as Information on

Potential Alternatives to its Use Framework contract ECHA20082 (specific contract

ECHA200802SR4ECA226)



High Impact Polystyrene (HIPS)

Polymer dispersion for textiles

In all products HBCDD is uniformly incorporated as an integral encapsulated component within the

polymer matrix However it is not bound to the matrix or transformed (IOM 2008)

The main uses for EPS are insulation panelsboards in the construction sector and automobile

cushions for children Minor uses are packaging material and props for exhibitions films or similar

(IOM 2008) The use of EPS was reported as increasing from 3452 tonnesyear (2002) to 5301

tonnes per year in 2006 (IOM 2008)

XPS is mainly used in lsquocold bridgersquo insulation sandwich panels and different other uses in

construction materials (cavity insulation floors walls roofs etc) As with EPS XPS use had also

increased in the years 2002 to 2006 (3954 tonesyear to 5859 tonnes year from 2002 to 2006

respectively IOM 2008)

Although the use of EPS and XPS was expected to reduce slightly in the second decade of the

millennium because of the downturn in house-building affecting much of Europe in the longer

term industry predicted an increased use of insulation products as a response to increasing cost of

energy and awareness of climate change (IOM 2008)

The use of HBCDD into HIPS was mainly for video and stereo equipment distribution boxes for

electrical lines in the construction sector and refrigerator lining (IOM 2008) Different sources

estimate the HBCDD content of flame-retardant HIPS between 1-7 (ww) and the EU Risk

Assessment Report (cited in IOM 2008) assumed as a realistic worst case that HIPS contains 7

HBCDD The use volume has not changed in the last few years in Europe and is estimated as 210

tonnesyear (IOM 2008)

Micronised HBCDD is used in textile applications must comply with British and German DIN flame

retardant standards (IOM 2008) mainly for upholstered furniture and seating in transportation

draperies bed mattress ticking interior and automobile textiles A likely HBCDD concentration in

the final product was estimated to be 10-15 (IOM 2008) After a substantial reduction of this use

during the last few years it was estimated that only about 210 tonnes year were used in textile

coating (IOM 2008)

Table 417 provides an overview of the different uses of HBCDD The overall volume used (years

20062007) estimated on the statements of IOM (2008) was 11580 tonnesyear

Table 417 Summary table of the different uses of HBCDD EU (20067)

Use Volume tonnesyear No of sites

Expanded Polystyrene (EPS) 5301 21

Extruded Polystyrene (XPS) 5859 28

High Impact Polystyrene (HIPS) 210 3

Textile coating 210 16

Total 11580 47




There was a single application for two uses in EPS (compounding and conversion (ie making

articles)ndash in the same application with the same applicants) Companies producing XPS have

substituted before the sunset date and did not have to apply because enough of the polymeric

flame retardant (a brominated polymer) was available to them after the sunset date No application

for authorisation was submitted for the other uses Based on 20067 data EPS and XPS represented

96 of the volume use for HBCDD


The changes in market structure for HBCDD were dominated by the availability of the alternative to

HBCDD for both EPS and XPS The alternative which is for both (EPS and XPS) a brominated

polymer referred to as pFR was manufactured by the same firms that supplied HBCDD to the EU

market

The pFR alternative was known to be a higher cost product (ie it costs more for unit volume than

HBCDDD and more mass of pFR per mass of EPS is required to achieve the same function) ndash as

evidenced in the HBCDD authorisation application The AfA SEA indicated that an important

consideration was the effectiveness of the pFR alternative when compared to HBCDD on a weight

basis To meet fire safety requirements for EPS and XPS it was estimated that compared to

HBCDDD 13 times the amount of pFR was required for EPS and 11 times the amount is required for

XPS

Data presented in the AfA for HBCDD (SEA) indicate the demand for HBCDD in terms of the EU split

between ESP and XPS uses in 2007 (Table 418) and the global demand in 2011 (Table 419)

Table 418 Demand for HBCDD in the EU (2007)30

Volume produced

in 2007 (kilo

tonnes)

Amount used in

construction

applications ()

Amount

that is FR

()

Average

HBCDD

content ()

Total HBCDD

consumed (t)

EPS 1461 78 77 07 6138

XPS 313 94 98 225 6488

Total - - - - 12625

Table 419 Global demand for HBCDD (2011)

Region Total HBCDD (tonnes) Relative share of demand ()

Japan 2480 7

Americas 2480 7

Europe 14483 44

China 12090 37

Korea 1550 5

Total 33595 100

Notes

30 Table from non-confidential version of SEA from AfA for HBCDDD (EPS use)



1 Source Chemtura (2013) presentation for non-EU demand for HBCDD

2 EU estimate based on CMAI (2009) study data and growth rate of 4pa for EPS and 3pa

for XPS

The ECHA (2009) data show that EU demand for HBCDD had increased on average by 10 per year

over the period 2002 to 2007 In the AfA the applicants used confidential data (provided by the

application consortium members) which showed an increased demand for HBCDD for use in EPS

continued by ~12 per year over the period 2007-2011 Furthermore they estimated that the

demand for both final products (XPS and EPS) would increase even post-2020 due to the need to

meet energy policy (eg European Energy Performance of Buildings Directive that mandates energy

performance certification for new existing and renovated buildings to make buildings more energy

efficient)

At least one EPS producer that did not submit an AfA31 expressed a strong view that the AfA for EPS

use of HBCDD was not needed because there waswould be sufficient pFR available for all EU

users The adoption of the pFR in light of the successful AfA (granted to a consortium of EPS

manufacturers) placed these companies (that had already completely switched to the pFR) at a

competitive disadvantage because of the greater mass of pFR required to fire proof EPS (weight for

weight) the pFR is more expensive and there were significant costs to introduction of the pFR (eg

different dosing equipment (pFR is pellet HBCDD typically a powder)) trails and product

qualifications with customers The successful applicants however in theory could carry on using

HBCDD for two years (granted review period)

Substitution with the polymeric alternative for HBCDD

The Dow Chemical Company owns the patent to a block copolymer of polystyrene and brominated

polybutadiene known as the polymeric flame retardant or lsquopFRrsquo and granted licences to three

producers of HBCDD (namely Chemtura Albemarle and ICL IP) The pFR was initially designed as a

replacement for HBCDD in XPS use but can also be used for making EPS (albeit more pFR is needed

relative to HBCDD to achieve the fire-retardant requirements) At the time of the AfA

manufacturers were committed to making the polymeric alternative but there were uncertainties

about the number of production sites that would be fully operational by the sunset date if global

demand for EPS and XPS use was to be met For any pFR supply available XPS manufacturers and

some FR EPS producers that were not part of the consortium are understood to have secured

contracts for the initial supplies of the pFR that were available

As mentioned on the EUMEPS website32 the authorisation (granted on 8 January 2016 to a

consortium of companies) allowed the consortium member companies to use HBCDD in the

production of flame retarded EPS (FR EPS) and their customers to use FR EPS articles for building

applications up to 21 August 2017

According to a representative of the EPS consortium the authorisation was meant to serve as an

lsquoinsurancersquo in case of insufficient availability of alternatives However well in advance of the

original sunset date of 21 August 2015 the consortium started producing flame retarded EPS with

HBCDD-free formulations From end November 2016 the European EPS market was largely supplied

with HBCDD free EPS The companies that were granted the Authorisation started subsequently

announcing their withdrawal from the authorisation for use of HBCDD at the end of November 2016

31 Apparent from the public consultation on the AfA and from consultation done for this present project 32 httpseumepsorgnewssupply-of-eps-in-europe-is-now-HBCDD-free



Overall on the market the lsquopFRrsquo is not the only possible flame retardant alternative as indicated

in the AfA for HBCDD use for EPS There were also possible monomeric alternatives However those

alternatives had not been tested and trialled by the consortium members companies Therefore it

was not known if they could be viable alternatives either technically or long-term environmentally

It is possible however that some companies in the EU have used and are using flame retardants

other than the pFR or HBCDD for EPS Although the pFR is more expensive both because a greater

weight per weight of EPS is required and because the price per unit volume of pFR is higher (than

HBCDD) a more major factor in the profitability for EPS is the ability to pass on downstream

variations in the price of styrene monomer on a monthly basis (styrene base price)

Recycling

The authorisation process (in complementarity with the parallel activities under the Stockholm

Convention on POPs dealing also with waste containing POPs) affected the market for recycled

plastics since it changed the status of the products (for which authorisation for use of HBCDD in

their manufactureproduction was being sought) with regard to waste and recycling This impact

of recycling is considered by the Commission to be not related to Authorisation under REACH and is

therefore not assessed further in this report

466 Benefits from use of the substitute (pFR)

Consultation for this project with one major supplier of EPS indicated that no changes in worker

exposure were noted (HBCDD is a Cat 2 reproductive toxin) in the switch from HBCDD to pFR This is

because the same controls are essentially in place workers were as protected from dust exposure

then as they are now

There are environmental benefits from use of pFR The costs for environment controls are reduced

since the very low concentration of the WFD EQS for HBCDD leads to the need for very stringent

controls on releases to the environment (via waste water and sewage treatment works) However

the benefits to the environment from the switch to the pFR from HBCDD have not been quantified


Based on the available information the main market impact of the switch to the alternative for EPS

has been the higher price of the alternative for use in EPS It appears (from limited information)

that benefits in terms of a greater level of safety (lower exposure andor less need for risk

management measures) in the work place has not be realised since similar controls were in place

for dust protection However environmental benefits are envisaged since use of the pFR removes

the need for very stringent controls on waste water and reduce concentration in the (aquatic)

environment that were needed for HBCDD These benefits have not been quantified

47 Findings using other statistical sources

This section uses publicly available EU statistics to identify changes in the EU chemicals market

thereby allowing for inferences about the effect of REACH authorisation on the market



471 Data sources used

The information within this sub-section is based on (i) PRODCOM33 data about production imports

and exports provided by Eurostat and (ii) REACH registration data and data about ceased

manufacturing and importing of substances provided by ECHA

472 Manufacture import export and use of SVHCs

Ceased manufacturing and importing of SVHCs

As of November 2016 ECHA identified 103 registrants who have ceased manufacturing or importing

a substance which has been identified as SVHC Table 420 classifies these 103 cases by type of

registrant and whether the respective SVHC is on the Candidate or Authorisation List

Table 420 Number of registrants ceasing manufacturing of SVHCs

Registrant type On Candidate List On Authorisation List Total

Lead dossiers 6 4 10

Member dossiers 59 25 84

Not specified 4 5 9

Total number of dossiers ldquoceased

manufacturing or importingrdquo 69 34 103

Source ECHA - Data status 02112016

Table 421 shows the change in registration status for substances included on the authorisation list

The data shows that even after a substance is placed on the Authorisation List a significant number

of registrations remains In part this is due to the continued use of the substance for intermediate

uses which are not subject to authorisation Some of the ceased manufacturing is also potentially

related to joining two lead dossiers and in some cases due to a revocation decision by ECHA

Table 421 Change of registration status for substances on the Authorisation List




Diisobutyl phthalate (DIBP) 7 3

Dibutyl phthalate (DBP) 8 3

22-dichloro-44-methylenedianiline (MOCA) 5 1

44rsquo- Diaminodiphenylmethane (MDA) 10 3

12-dichloroethane (EDC) 36 6

Bis(2-ethylhexyl) phthalate (DEHP) 17 7


33 PRODCOM provides statistics on the production of manufactured goods The term comes from the French

PRODuction COMmunautaire (Community Production) for mining quarrying and manufacturing sections B

and C of the Statistical Classification of Economy Activity in the European Union (NACE 2) Further details can

be found here httpeceuropaeueurostatwebprodcom






Lead sulfochromate yellow 7 1



Lead chromate molybdate sulfate red 7 1

Hexabromocyclododecane 6 2

TOTAL 158 34

Source ECHA Data status 02112016

The information in Table 421 reflects the status at the time of carrying out the analysis The

status of registrants changes over time and there is further evidence provided by ECHA that shows

more active registrants ceasing manufactureimport of an SVHC following the sunset date For

instance for the substance TCEP there is currently no active registrant whereas there had been 2

before the sunset date The document from ECHA focused on registered SVHCs for which the sunset

date had past The conclusion was that for 8 out of 11 SVHCs there was a reduction in the number

of active (not ceased) registrants between the latest application date and April 2017 The average

decline amongst those 8 was 32

Removal of certain uses from registrations during Annex XIV prioritisation rounds

REACH registrations are the main source of information for ECHAs priority assessment for

recommending substances from the Candidate List for inclusion in Annex XIV In this context ECHA

reminds registrants to update their registration dossiers with any new relevant information in

particular on uses and volumes

Table 422 below provides examples of substances for which registrants had removed from their

dossiers certain identified uses during a round of ECHArsquos prioritisation This may have happened in

the time during which the public consultation on a draft Annex XIV recommendation is held as a

reaction to the use overview information published by ECHA for a substance included in the draft

recommendation It may also have happened in the time until the next prioritisation round as a

reaction to the use overview summary published by ECHA in its prioritisation table for a substance

which had not been included in the current draft recommendation Typically the updates are

focused on professional or consumer uses the incentive being to decrease the priority of the

substance for inclusion in Annex XIV (occurrence of wide-dispersive uses in the EU increases the

priority score of a substance)

The examples were identified by checking published prioritisation documents for the past rounds of

Annex XIV recommendations Depending on the case for a given substance either all or the

majority or several registrants have removed the respective uses

Removal of a use previously identified in the dossiers of registrants means that their customers

cannot any more perform this use unless they submit have submitted a Downstream User report

(Art 38 of REACH) to ECHA In the absence of Downstream reports for the respective use and



provided that industry actors respect their REACH obligations34 removal from registrations may be

interpreted either as cease of use or as further assurance about not occurrence of use in the EU

The latter corresponds to the case where a use had been originally included in registration dossiers

only due to uncertainties about whether it still takes place downstream or not or due to a mistake

by the registrant in terms of the reported life cycle stage accuracy of use description

It should be kept in mind that the analysis performed in this report is limited to lsquousersquo data

Potential changes in the tonnage manufacturedimported or allocated to specific uses may of

course have occurred but they are out of the scope of this report

Table 422Examples of substances with removals of certain uses from registrations during Annex XIV prioritisation rounds



Hydrazine (206-114-9) ldquoThe substance is reported as only used at industrial

site (Indication that the substance can be used by

professional workers has been removed in the updated

versions of the registration dossiers)rdquo

N-methylacetamide (201-182-6) ldquoAll other uses except the use as intermediate have

been removedrdquo

Cadmium (231-152-8) ldquoThe lead registrant and most of the members have

updated their dossier in 20142015 They have removed

the professional uses from their dossier and indicated

that professional (and consumer) uses are advised

against There is a

small minority of registrants (representing a low total

tonnage) who updated their dossier but did not remove

the professional uses and still report

professional use in cadmium based brazing products

cadmium-based soldering products and PVDcoating)

However these members refer to the lead registrants

CSR which no longer supports these usesrdquo

ldquoDossier updates were received in 2015-2016

Professional uses of cadmium based brazing

products and cadmium-based soldering products have

been removed from the majority of

the registrations The lead registrants CSR no longer

supports these uses The professional

use of brazing products if still happening in the EU is

expected to be limited to applications

derogated from the existing restriction under Annex

XVII (derogations apply to brazing

fillers used in defence and aerospace applications and

to brazing fillers used for safety reasons) No restriction

appears to apply to the use of cadmium based soldering

products and PVDcoating Considering the above it is

assumed that there is no professional use of

34 Information in eSDS supplied by registrants is kept consistent with registration Downstream Users

check and comply with eSDS received etc





cadmium in the EU (ie PROF not considered for

WDU)rdquo

Cadmium oxide (215-146-2) ldquoThe lead registrant and most of the member

registrants have recently updated their registrations

They have inter alia removed professional and

consumer uses from their registrations There are some


and the professional and consumer uses remain in

their dossiers (eg use of CdO-containing polymers for

tube amp sheet articles) However these members refer

to the lead registrantrsquos CSR which no longer supports

these usesrdquo

Cadmium chloride (233-296-7) ldquoAccording to recently updated registration

information cadmium chloride is no longer

manufactured andor imported into the EU

However the registration status of the substance is still

active and uses in the scope of authorisation are still

registered

Therefore some uses of the substance may remain in

the EUrdquo

Lead monoxide (lead oxide) (215-267-

0)





dossiers and CSR









Orange lead (lead tetroxide) (215-

235-6)





dossiers and CSR









Source ECHA (Aug 2017)

Production import and export of SVHCs



To identify changes in the EU chemicals market and a potential role of REACH authorisation

therein PRODCOM data was used to analyse trends in the production value as well as import and

export values of SVHCs Whilst PRODCOM data can be used as an indicator of market changes it is

important to be aware of the caveat that PRODCOM data is not broken down by uses of the

substance The total volumes used imported and exported therefore include uses (eg

intermediate use) that are exempt from authorisation and can continue to be used even after the

sunset date (if the SVHC is placed on Annex XIV)

The analysis was conducted by matching the 39 substances on the Authorisation List as well as 154

substances on the Candidate List with a PRODCOM code The substances were then classified into

five categories (ie 1 to 5) based on the quality of the match between the Candidate or

Authorisation List substance and the best-matching PRODCOM code The criteria used for the

classification are detailed in Table 423 in conjunction with an example for each category

Category 1 is the ideal category for the analysis of changes in production import and export of

SVHCs and the role of REACH authorisation in causing these changes Information about substances

in this category enables the most meaningful analysis of how changes in production import and

export coincide with key dates of the REACH authorisation process (ie date of placing the

substance on the candidate list and last application date) As there are only two SVHCs (12-

dichloroethane and methyloxirane) in Category 1 the nine PRODCOM codes in Category 2 relating

to 20 substances (ie 16 substances on the Authorisation and four on the Candidate List) have also

been considered for the analysis However since the PRODCOM data for some of the substances on

the Candidate List was incomplete the subsequent analysis is based solely on substances on the

Authorisation List for which complete datasets were available A list of these substances and the

relevant PRODCOM codes is provided in Table 424

Table 423 Classification of Candidate and Authorisation List substances based on quality of PRODCOM match

Cate

gory

Cri

teri

on

Example

Num

ber

of

PR

OD

CO

M c

odes

Num

ber

of

SV

HC

s

Subst

ance

PR

OD

CO

M

code

PR

OD

CO

M

desc

ripti

on

1 Exact match Single

substance in category

12-dichloroethane

(EDC) 20141353

12-Dichloroethane (ethylene dichloride)

2 2

2

Substance fits within category ldquoNarrowrdquo range of substances

within category

Hydrazine 20132580 Hydrazine and

hydroxylamine and their inorganic salts

9 20

3

Substance fits within category Larger

range of substances within category (Meaningful data

may be extracted)

Lead titanium trioxide

20121150 Titanium oxides 17 44



Cate

gory

Cri

teri

on

Example

Num

ber

of

PR

OD

CO

M c

odes

Num

ber

of

SV

HC

s

Subst

ance

PR

OD

CO

M

code

PR

OD

CO

M

desc

ripti

on

4

Substance fits within category However

the range of substances within

this category is too broad for meaningful

data to be extracted

Arsenic acid 20132460

Oxides of boron boric acids

inorganic acids (excluding hydrogen

fluoride)

35 83

5 Poor or no fit to a

category

24-dinitrotoluene

(24-DNT) 20141470

Derivatives of hydrocarbons

containing only nitro or only nitroso

groups

18 44

Table 424 Authorisation List substances (with complete datasets) in Category 2



Chromium trioxide

1333-82-0

Chromium manganese lead and copper oxides and hydroxides

20121200

Diarsenic trioxide

1327-53-3

Sulphur trioxide (sulphuric anhydride) diarsenic trioxide

20111250


24613-89-6

Chromates and dichromates peroxochromates

20135125

Lead chromate

7758-97-6


1344-37-2


49663-84-5

Potassium chromate 7789-00-6


7778-50-9

Potassium hydroxyoctaoxodizincatedichromate

11103-86-9

Sodium chromate

7775-11-3

Sodium dichromate

10588-01-9 7789-12-0





Strontium chromate

7789-06-2

Trichloroethylene

79-01-6

Trichloroethylene tetrachloroethylene (perchloroethylene)

20141374

12-dichloroethane is one of the SVHCs included in Category 1 Its date of inclusion on the

Candidate List and final application date are 19 December 2011 and 22 May 2016 respectively As

shown in Figure 45 the production value of this SVHC has mainly been in the range of euro250 to euro325

million between 2006 and 2015 The import value is very small compared to the production value

while the export value shown in Figure 46 is a reasonable share of the total production value This

indicates that the EU market relies on internal production and that the majority of production is

used in Europe

Figure 45 Production value and import value of 12-dichloroethane (ethylene dichloride)

Figure 46 Export value of 12-dichloroethane (ethylene dichloride)


In general the trend in production values of 12-dichloroethane is in line with the overall trend in

the EU chemicals market which has seen a continued increase of sales between 2005 and 2008 that

was interrupted in 2009 when sales values decreased significantly as a result of the global financial

crisis After a period of recovery and reaching pre-recession levels in 2011 the EU chemicals

industry has seen a small decline of sales since 2012 which is broadly in line with what can be

observed for the production value of 12-dichloroethane

Therefore data does not provide any indication of an effect of placing 12-dichloroethane on the

Candidate List This is not unsurprising as according to the background document35 published by

ECHA in November 2012 99 of the total volume of 12-dichloroethane is used as in intermediate

for the manufacturing of vinyl chloride monomers (VCM) and therefore exempt from authorisation

The second SVHC for which an exactly matching PRODCOM code could be found is methyloxirane

(propylene oxide) This substance has been placed on the Candidate List on 19 December 2012

Production values for methyloxirane (propylene oxide) range between euro1000 and euro2000 million

while import and export values are very small in comparison as shown in Figure 47 and Figure 48

The vast majority of methyloxirane produced in the EU is thus used internally

35 Available here httpsechaeuropaeudocuments1016238c352db-d89e-472f-9539-4fec08c6ca34



Figure 47 Production value and import value of methyloxirane (propylene oxide)

Figure 48 Export value of methyloxirane (propylene oxide)

The changes in the production value are generally in line with the trend observed in the EU

chemicals market This is also the case for the decline of the production value between 2012 and

2015 While the starting point of this decline coincides with the year in which methyloxirane was

placed on the Candidate List the inclusion in the Candidate List most likely plays a negligible role

in causing this decrease in production values The reason for this is that only a small proportion of

the total volume of methyloxirane seems to be affected by the authorisation requirement

According to the table presenting the results of ECHArsquos most recent priority assessment of

Candidate List substances only 1-10 tonnesyear out of a total volume of gt1000000 tonnesyear

are subject to authorisation36 There is consequently little indication for an effect of the

authorisation process on the market of methyloxirane

The next SVHC that has been analysed is chromium trioxide (CAS No 1333-82-0) This substance

was matched to the PRODCOM category titled ldquoChromium manganese lead and copper oxides and

hydroxidesrdquo and classified as belonging to Category 2

As shown in Figure 49 the production value for this category has ranged between euro200 and euro700

million between 2006 and 2015while import and export values were relatively stable over this time

period (as depicted in Figure 410) the share of imports relative to the total amount of chromium

trioxide available in the EU has increased since 2010

36 More information on the results of the priority assessment of Candidate List substances can be found here

(httpsechaeuropaeudocuments1016213640prioritisation_results_CL_substances_march_2017_enpdf3

91ae908-23f4-550d-94c9-090b922e50ec)



Figure 49 Production value and import value of ldquoChromium manganese lead and copper oxides and hydroxidesrdquo (PRODCOM code 20121200)

Figure 410 Export value of ldquoChromium manganese lead and copper oxides and hydroxidesrdquo (PRODCOM code 20121200)


The changes in production value are generally in line with those observed in the overall EU

chemicals market except for the fact that production values have to date not reached pre-

recession levels and that they do not follow an upward trend until 2012 but only 2010 There might

thus be a noticeable effect on the market resulting from placing chromium trioxide on the

Candidate List on 15 December 2010 This is investigated further in Section 10 which assesses

chromium trioxide in detail The effect of the final application date (ie 21 March 2016) cannot be

analysed currently due to no data being available for the period after 2015

The PRODCOM category titled ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo was used

to analyse the potential effects of subjecting diarsenic trioxide (CAS No 1327-53-3) to the REACH

authorisation process The process started on 28 October 2008 when diarsenic trioxide was placed

on the Candidate List The final date for application was 21 November 2013

The production value of diarsenic trioxide is very small (ranging from euro3 to euro55 million considered

together with sulphur trioxide) compared to that of the other analysed substances As depicted in

Figure 411 and Figure 412 imports and exports show very little fluctuations in terms of nominal

value and the majority of diarsenic trioxide produced in the EU is also used there Despite import

and export values being stable the production value has varied over time

Figure 411 Production value and import value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo (PRODCOM code 20111250)

Figure 412 Export value of ldquoSulphur trioxide (sulphuric anhydride) diarsenic trioxiderdquo (PRODCOM code 20111250)


The changes observed after 2008 (when diarsenic trioxide was placed on the Candidate List) are not

in line with the trends observed for the EU chemicals market for the period from 2012 to 2015 The



production value of Sulphur trioxide (sulphuric anhydride) diarsenic trioxide increased from 2013

onwards while EU chemicals sales declined Thus data does not provide any indication of a

noticeable market effect of including diarsenic trioxide in the Candidate List Similarly the final

authorisation date has had no discernible effect on the market

The PRODCOM category ldquoChromates and dichromates peroxochromatesrdquo has been matched to

10 SVHCs The dates on which theses substances have been included in the Candidate List and the

final application dates are shown in Table 425 Apart from sodium dichromate which was put on

the Candidate List in 2008 all substances were included in the cCandidate List in 2010 or 2011

Lead chromate and lead sulfochromate yellow are the only substances for which the final

application data lies prior to 2016

Table 425 Substances matched to ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code 20135125)

Substance Date of inclusion (Candidate list)

Final application date Name CAS No


24613-89-6

19122011

22072017

Lead chromate

7758-97-6

13012010 21112013


1344-37-2 13012010 21112013


49663-84-5

19122011

22072017

Potassium chromate

7789-00-6

18062010

21032016


7778-50-9

18062010

21032016

Potassium hydroxyoctaoxodizincatedichr

omate

11103-86-9

19122011

22072017

Sodium chromate

7775-11-3

18062010

21032016

Sodium dichromate

10588-01-9 7789-12-0

28102008

21032016

Strontium chromate

7789-06-2

20062011

22072017

As shown in Figure 413 the EU has been reliant on imports with respect to chromates dichromates

and peroxochromates since 2006 In general the production value of chromates dichromates and

peroxochromates has declined significantly since 2011 while the import and export values have

seen little variation between 2006 and 2015



Figure 413 Production value and import value of ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code 20135125)

Figure 414 Export value of ldquoChromates and dichromates peroxochromatesrdquo (PRODCOM code 20135125)


Changes in the sum of production and import values for chromates dichromates and

peroxochromates (ie the amount available in the EU) are mostly in line with developments in the

overall EU chemicals market The only significant difference is that the EU chemicals market has

experienced growing sales values between 2009 and 2012 before starting a decline while the sum

of production and import values has started to decline in 2011 The significant drop observable in

2011 which is mainly accounted for by a significantly lower production value provides an

indication for a potential effect of placing several SVHCs on the candidate list in 2010 and 2011

The final application dates of lead chromate and lead sulfochromate yellow have no noticeable

effect on the market

Trichloroethylene (CAS No 79-01-6) was put on the Candidate List on 18 June 2010 and

companies were asked to apply for authorisation by 21 October 2014 According to the background

document37 for trichloroethylene developed by ECHA in the context of the third recommendation

for the inclusion of substances in Annex XIV the volume of trichloroethylene that is subject to

authorisation is above 10000 tonnesyear while the total volume lies between 50000 and 100000

tonnesyear The data provided for the PRODCOM category called ldquoTrichloroethylene

tetrachloroethylene (perchloroethylene)rdquo indicates that the production value declined significantly

from around euro110 million in 2006 to less than euro40 million in 2015 as shown in Figure 415

Figure 415 Production value and import value of ldquoTrichloroethylene tetrachloroethylene (perchloroethylene)rdquo (PRODCOM code 20141374)

Figure 416 Export value of ldquoTrichloroethylene tetrachloroethylene (perchloroethylene)rdquo (PRODCOM code 20141374)


37 Available here httpsechaeuropaeudocuments101629cedf499-8e10-4aef-b51d-82199a37dce5



The data presented in Figure 415 and Figure 416 also suggests that since 2010 the majority of

trichloroethylene and tetrachloroethylene produced in the EU is being exported rather than used in

the EU This is an indication for a potential effect of placing trichloroethylene (CAS No 79-01-6)

on the Candidate List However no conclusions can be drawn using this PRODCOM data as

tetrachloroethylene (perchloroethylene) is an alternative to the use of trichloroethylene

Therefore it is better to use different market data as can be seen later in a more detailed

assessment within Section 11

Conclusion

Based on the data analysis possible with publicly available PRODCOM data it is not possible to infer

what the effects of the authorisation process are This is because PRODCOM in most cases

(concerning SVHCs) merges SVHCs with other substances (similar in chemistry terms) together for

confidentiality reasons so substances cannot be assessed in isolation Where it has been possible to

assess a single substance using PRODCOM data these substances (volume wise) are mostly used as

intermediates and as it is not possible to isolate PRODCOM data to uses that are only subject to

authorisation Data is also only available until 2015 so overall PRODCOM has not been useful for

this project Further work could be done in the future using the confidential version of the

PRODCOM but this was not made available to the project team for this project

473 Manufacture import export and use of alternative substances

PRODCOM data was also used to analyse the potential effects of REACH authorisation on the

production import and export value of substances which were named as an alternative to an SVHC

by online industry survey respondents

Similar to the PRODCOM analysis of SVHCs (in Section 472) the analysis was based on matching

the mentioned alternative substances to a PRODCOM code where possible and classifying them

into one of five categories based on the quality of the match Table 426 presents the criteria used

for classification as well as the number of substances placed in each category and the number of

unique PRODCOM codes these refer to

Table 426 Classification of alternative substances based on the quality of the PRODCOM match

Category Criteria Number of

PRODCOM codes Number of substances

1 Exact match

Single substance in category 0 0

2 Substance fits within category ldquoNarrowrdquo range

of substances within category 2 2

3 Substance fits within category Larger range of substances within category (Meaningful data

may be extracted) 2 2

4 Substance fits within category However the range of substances within this category is too

broad for meaningful data to be extracted 5 6

5 Poor or no fit to a category 2 3



Only the four substances classified into Category 2 or 3 are deemed suitable for inclusion in the

analysis of changes in production import and export values as they can provide meaningful data for

this purpose For these categories the alternative substances and the PRODCOM categories they

have been matched to are listed in Table 427

Table 427 Assigned PRODCOM categories

It was necessary to exclude PRODCOM code 20141374 from the analysis as this code is identified as

being a match for an SVHC and included in the analysis of trends in production import and export

values of SVHCs in Section 472 Because of the simultaneous relevance of this PRODCOM category

for both SVHCs and alternatives a potential effect of REACH authorisation on the production

export and import value of the relevant alternative substance would not be discernible from the

data even if it existed

Figure 417 shows the trends in production and import values for Cyclohexanone and

methylcyclohexanones (PRODCOM code 20146233) Diazo- azo- or azoxy-compounds (PRODCOM

code 20144420) and Other esters of orthophthalic acid (PRODCOM code 20143420) in the left

column and the corresponding export values in the right column

Category

Alternative substance

Best-matching PRODCOM category

PRODCOM code

PRODCOM description

2 2-methylcyclohexanone 20146233

Cyclohexanone and methylcyclohexanones


20141374 Trichloroethylene tetrachloroethylene

(perchloroethylene)

3

4-(phenylamino)benzenediazonium hydrogen sulfate formaldehyde

(11) (Diazo)

20144420 Diazo- azo- or azoxy-compounds

Di-isononyl phthalate (DINP) 20143420 Other esters of orthophthalic acid



Figure 417 Production and import values as well as export value of ldquoCyclohexanone and methylcyclohexanonesrdquo ldquoDiazo- azo- or azoxy-compoundsrdquo and ldquoOther esters of orthophthalic acidrdquo

As Figure 417 shows PRODCOM data for these substances indicates no marked increase in the use

of alternatives (that were noted as a substitution for an SVHC) in the EU in the analysed time

period Based on the data analysis possible with publicly available PRODCOM data it is not possible

to infer what the effects of the authorisation process are on markets for identified alternative

substances to a previous use of an SVHC This is because PRODCOM in most cases combines

substances (similar in chemistry terms) together for confidentiality reasons so substances cannot be

assessed in isolation Data is also only available until 2015 so overall PRODCOM has not been

useful for this project Further work could be done in the future using the confidential version of

the PRODCOM but this was not made available to the project team for this project



48 Summary of observed market changes
















as an intermediate








































report












5 INSTANCES OF SUBSTITUTION

51 Introduction

Substitution ie the progressive replacement of SVHCs with suitable alternative substances and

techniques is a key objective of Title VII of REACH In this context substitution does not simply

mean replacing one substance for another but in-line with the objective of Title VII it is to replace

the SVHC whether that is with another substance or a technique Whilst information about

substitution is revealed through applicants for authorisation (AfAs) where applicants request

continued use of an SVHC the authorisation process does not require companies to inform ECHA (or

any other regulatory authority) that they have substituted and no longer use an SVHC

A number of substances that have been identified as SVHCs within REACH also have had other

regulatory and policy pressures on them which will have influenced the activities of users of these

substances to identify and implement alternatives For example CMR are substances that are

classified under the CLP Regulation as carcinogens mutagens and reproductive toxins (CMR) and

are prohibited for use by consumers in mixtures via a restriction in Annex XVII Directive

200437EC (lsquocarcinogens or mutagens at workrsquo) sets out an obligation to replace carcinogenic and

mutagenic substances in the workplace and prevent exposure (if replacement is not possible the

employer shall use closed technological systems) Other more substance-specific legislation has

also brought pressure to replace specific substances for example under the POPs legislation (eg

HBCDD) by banning or severely restricting use and other use-specific legislation such as restricting

the use of hazardous substances in electrical and electronic equipment lsquoRoHSrsquo - Directive

200295EC (eg hexavalent chromium and polybrominated biphenyls)

As is apparent from AfAs submitted to date the replacement of a SVHC substance is a complex

process and is highly dependent on the technical requirements of the process in which the

substance is being used Nevertheless there has been a considerable amount of research on the

general principles of substitution from methodologies for assessing alternatives to analysis of

specific substance types and identification of substances with similar functional properties but less

hazardous profiles (eg solvents that have the desired solvation properties but that do not meet

the Article 57 criteria for SVHC)

In this context a number of research programmes that promote substitution by for example

provision of databases case studies and shared experiences have been reviewed The detail of this

review is in Annex E4 which is summarised in Section 52

Key sources of information are the Tier 1 and 2 case studies which look in more depth at the

impacts of authorisation for specific substances In addition the results from the stakeholder

questionnaires and follow-up interviews have yielded insights into substitution Where substitution

has occurred the data gathered has allowed an attempted assessment of the effects of substitution

including assessing whether substitution has led to an overall reduction in risk (or hazard profile)

and what impacts (both positive and negative) the use of the alternative has had on demand

production costs their competitiveness product prices worker satisfactionconditions ability to

invest in RampD and profitability of the company Further detail is set out in Sections 54 and 55

below The Tier 1 case studies are set out in Sections 10 11 and 12




A number of publicly available tools are available (via the internet) to support in substitution

activities The bullet points below indicate the tools and information sources that were reviewed

and a concise summary given more detailed explanations are given in literature review Annex E

(E4) While case studies resources and methodologies are very useful and allow a systematic

process to be followed the substitution of a SVHC will normally be a complex process In all but the

simplest cases it appears that considerable product testing is required as is the adaptation of

production equipment and processes

SUBSPORT (EU based) - httpwwwsubsporteu a free-of-charge multilingual platform

for information exchange on alternative substances and technologies as well as tools and

guidance for substance evaluation and substitution management



AssessmentAlternativesAssessmentaspx - process for identifying comparing and selecting


technologies) on the basis of their hazards performance and economic viability It is

intended to support decision making for scientific market or regulatory reasons






and programmes (including the Lowell Center and SUBSPORT)


access)

US EPA (US-based) - Design for the Environment Alternatives Assessments -

httpswwwepagovsaferchoicedesign-environment-alternatives-assessments - Web-

based tool with key steps to conducting an alternatives assessment and case studies




In some cases tools were developed to select alternatives for specific products and uses An

example of such a tool is ldquoCleantoolrdquo CLEANTOOL (httpwwwcleantoolorghome-3das-

projektlang=en) started in 2001 as a European Innovation Project with the goal to create a

database of best practice for the cleaning of metal surfaces The tools support the selection of the

best cleaning alternative based on very specific properties of the use such as the parts to clean and

the dirt to be removed This tool illustrates that substitution is often a matter of details about

specific use in order to be successful

The more detailed documentation of the literature review that can be found in Annex E4 indicates

in more detail some of the resources that are publicly available to assist with substitution

However although the methodologies cited are detailed and present frameworks for planning



substitution programmes these do not make the technical process of substitution substantially

easier or remove the specific barriers to substitution (which are technical and economic and linked

to specific uses) Specific uses require further considerations and the apparent technical feasibility

of an alternative does not guarantee that it is economically feasible leads to an overall reduction

in risks and is available in sufficient supply

53 Survey responses

This section summarises survey findings regarding instances of substitution due to the REACH

authorisation process The analysis relies on data provided by 83 respondents

531 Evidence of substitution from SVHCs

Forty-three percent of respondents reported that their organisation had substituted (possible)

SVHCs (Table 51) Most of them (approximately 77) substituted due to the REACH authorisation

process while approximately 23 say they substituted as a result of other drivers A further 29 of

survey respondents reported that they had undertaken activities to investigate the possibility of

substitution

Table 51 Whether respondents substituted a (possible) SVHC (industry survey)

(n = 83)

Yes partly due to the REACH authorisation process 33

Yes but not due to the REACH authorisation process 10

No but we are aware of substitution in our supply chain 2

No but we are investigating possibilities to substitute 29

No 27

Total 100

Those respondents that reported that they had substituted a (possible) SVHC (ie 37 respondents)

provided 61 examples of substitution For each example respondents provided

The (possible) SVHC that was substituted


The alternatives that the substance was replaced by and

The number of years required to substitute illustrated in

Figure 51

Table 52 lists the (possible) SVHCs for which respondents provided examples of substitution in

conjunction with the related uses and alternatives mentioned by the respondents The table also

shows the number of examples given for each substance Chromium trioxide is the substance with

the highest number of reported examples of substitution (ie 7 examples) This is followed by 12-

dichloroethane and the category lsquoChromium VI Chromium ion (Cr6+) Hexavalent chromiumrsquo for

which five and four examples were provided respectively In terms of uses the use as solvent and

plating applications are the uses with the highest number of reported examples (ie seven and four

examples of substitution respectively) In most cases substitution took place in the form of

switching to alternative substances In fact only eight out of 61 examples reported a switch to an




Table 52 Instances of substitution ndash (Possible) SVHCs uses and alternatives (industry survey)


Number of

examples

provided


1 12-dichloroethane 107-06-2 5 Softener for PVC

Solvent

Swelling agent

2-methylcyclohexanone

4-methylpentan-2-one


Not stated

2 1-methyl-2-pyrrolidone 872-50-4 1 Solvent Not stated

3 2-(2H-benzotriazol-2-yl)-46-

ditertpentylphenol (UV-328) 25973-55-1 1 Stabiliser Bumetrizole

4

2-ethylhexyl 10-ethyl-44-

dioctyl-7-oxo-8-oxa-35-dithia-4-

stannatetradecanoate (DOTE)

15571-58-1 1 Stabiliser

2-ethylhexyl 10-ethyl-4-[[2-[(2-

ethylhexyl)oxy]-2-oxoethyl]thio]-4-

octyl-7-oxo-8-oxa-35-dithia-4-

stannatetradecanoate

5

4-(1133-

Tetramethylbutyl)phenol

ethoxylated

923-960-0 1 Surfactant Not stated

6 4-Nonylphenol branched and

linear na 1

Costabilizer for

plasticized PVC Triisotridecyl phosphite


Ceramic Fibres (RCF) na 2

Insulation material

Protective heat insulating layer

Glass oxide chemicals

Not stated


(DEHP) 117-81-7 2 Plasticiser

Di-isononyl phthalate (DINP)

Not stated

9 Bis(2-methoxyethyl) ether

(Diglyme) 111-96-6 1 Solvent Dimethyl sulfoxide

10 Bis(pentabromophenyl) ether 1163-19-5 1 Flame retardant Phosphinic acid PP-diethyl-

aluminium salt (31)


Plating Not stated

12 CC-azodi(formamide) (ADCA) 123-77-3 1 Smoke ammunition and

illuminating ammunition Alternative technology




Number of

examples

provided


13 Cadmium 7440-43-9 3

Manufacture of solder

Plating

Protection of aerospace hardware


Not stated


13530-68-2 1 Etching of copper

Disodium peroxodisulphate (Sodium

persulfate)


Anodising process

Anti-corrosive

Catalyst

Chrome plating

Electro-plating

Pre-treatment at colour-coating line

Not stated

2-ethylhexanoic acid chromium salt


Sulphuric acid

Titanium

Not stated

16 Chromium VI Chromium ion

(Cr6+) Hexavalent chromium 18540-29-9 4

Chromate conversion coating

Decorative function

Plating

Chromium III

Not stated

17 Dibutyl phthalate (DBP) 84-74-2 1 Plasticiser Not stated


(HBCD) 25637-99-4 3

Flame retardant

Not stated

13 Butadienestyrene copolymers

Polymeric flame retardant

Not stated

19 Lead 7439-92-1 1 Manufacture of solder Alternative technology

20 Lead chromate 7758-97-6 2 Pigments Polymeric flame retardant

Not stated

21 Lead sulfochromate yellow 1344-37-2 1 Pigments Various lead-free pigments

22 Perboric acid sodium salt

10332-33-9

11138-47-9

12040-72-1

37244-98-7

1


in consumer laundry

tablets and powder

Disodium carbonate compound with

hydrogen peroxide (23) (Sodium

percarbonate)




Number of

examples

provided


23 Potassium dichromate 7778-50-9 1 Plating Not stated

24 Sodium chromate 7775-11-3 3

Descaling

Passivation of metals

Sensitiser in light-sensitive lacquer

4-(phenylamino)benzenediazonium hydrogen sulfate formaldehyde (11) (Diazo)


Chromium oxide


7789-12-0 3

Passivation

Softener

Nitric acid

Not stated

26 Trichloroethylene 79-01-6 2 Degreasing parts in

manufacture

Solvent



27 Trilead Dioxide Phosphonate 12141-20-7 1 Acid scavenger as part of stabilizer

Triisotridecyl phosphite

28 Not stated - 8

Passivation

Plastisiser

Solvent

Not stated

2-methoxy-1-methylethyl acetate

Not stated

Total 61




Figure 51 presents the survey results with respect to the time that it took to substitute the

(possible) SVHC The quantitative results presented in the pie chart have been derived by excluding

the answer categories lsquoUnknownrsquo and lsquoNot statedrsquo (which together contain 12 examples) from the

analysis The figure is therefore based on 49 examples Most respondents stated that it took their

organisations between 1 and 4 years (53) or 5 and 10 years (27) to achieve substitution

Figure 51 Instances of substitution - Number of years to achieve substitution (Industry survey)

Notes The figure is based on 49 of 61 examples (excluding the cases for which respondents said lsquounknownrsquo or

did not provide an answer

Respondents who substituted possible (SVHCs) due to the REACH authorisation process (the first row

in Table 51) were asked about the stage of the authorisation process which triggeredconfirmed

the decision to substitute (see Q19 in Annex F5) The quantitative results presented below have

been derived by excluding the answer categories lsquoNot surersquo and lsquoNot applicablersquo from the analysis

(which account for 67 of all answers given to question Q19) As shown by Figure 52 most

respondents reported that their organisations had substituted after the screening and RMOA stage

and before the AfA stage whereby

29 of respondents stated that their organisations substituted when substances were

included in the Candidate List

23 when substances were recommended for inclusion in the Authorisation List and

25 when substances were included in the Authorisation List



Figure 52 Stage in the REACH authorisation process that triggered substitution activity

532 Evidence of activities to investigate substitution

Fifty-three percent of respondents (44 out of 83) reported that their organisation had undertaken

activities to investigate the possibility of substituting (possible) SVHCs These respondents provided

71 examples of such activities For each example respondents provided

The (possible) SVHC for which the possibility of substitution is investigated

The usefunction of this substance and

The substitution activities being carried out

Table 53 lists the substances for which respondents reported that they are investigating the

possibility to substitute in conjunction with the related uses reported by the respondents The table

also shows the number of examples provided for each substance Note that some of the

respondents that indicated they have substituted a use of an SVHC (previous section) may also still

be using the SVHC (ie for different uses) or are still using a different SVHC that they are also

seeking to substitute away from Therefore the total number of respondents that have substituted

(n=37) andor those actively seeking to substitute (n=44) should not be added together

As with examples of full substitution in the preceding section chromium trioxide is the substance

with the highest number of reported examples of investigations of substitution (ie 17 examples)

This is followed by the category lsquoChromium VI Chromium ion (Cr6+) Hexavalent chromiumrsquo with

five examples and boric acid and 1-methyl-2-pyrrolidone (NMP) with four examples each In terms

of uses the use as solvent (nine examples) anti-corrosive agent (eight examples) and plating

applications (five examples) are the uses with the highest numbers of reported examples

Table 53 Substitution activities - (Possible) SVHCs and uses (industry survey)

No Substance CAS

number

Number of

examples

provided



2 1-methyl-2-pyrrolidone

(NMP) 872-50-4 4 Solvent

3

2-(2-[4-(1133-

Tetramethylbutyl)phenoxy]

ethoxy)ethanol

9036-19-5 1 Emulsifier



No Substance CAS

number

Number of

examples

provided


4

2-[4-(244-

trimethylpentan-2-

yl)phenoxy]ethanol

9002-93-1 1

Cell lysis during manufacturing

of vaccines and cleaning of

manufacturing equipment

5 44-isopropylidenediphenol

(bisphenol A) 80-05-7 2


Not stated

6 44-methylenebis[2-

chloroaniline] 101-14-4 1 Curing agent


Ceramic Fibres (RCF) na 1 Insulation

8 Aprotic polar solvents on

the Candidate List na 1 Solvent


(DEHP) 117-81-7 1 Component in glue

10 Boric acid 11113-50-1 4 Buffering agent


11 Cadmium 7440-43-9 1 Protection of aerospace hardware

12 Chromates na 1 Anti-corrosive




Anti-corrosive

Catalyst

Conditioning and electroplating

Decorative function

Passivation

Plating

Reaction inhibitor

Surface treatment

Wear resistance

Not stated

15

Chromium VI Chromium

ion (Cr6+) Hexavalent

chromium

18540-29-9 5

Anti-corrosive

Decorative function

Plastic etching

Plating

Not stated

16 Cobalt dichloride 7646-79-9

7791-13-1 1


17 Cobalt salts - 1 Anti-corrosive

18 Disodium tetraborate

anhydrous

1303-96-4

1330-43-4

12179-04-3

2

Brazing flux

Used in smelting to increase fluidity


(HBCD) 25637-99-4 1 Flame retardant

20 Hexahydromethylphthalic

anhydride 25550-51-0 2 Hardener

21 Hydrazine 302-01-2

7803-57-8 2 Reduction agent



No Substance CAS

number

Number of

examples

provided


22 Lead 246-trinitro-m-

phenylene dioxide 15245-44-0 1 Used in pyrotechnic mixtures

23 Lead chromate 7758-97-6 1 Used in pyrotechnic mixtures


7439-92-1 1 Additive to increase refractive

index

25 Lead oxide 1335-25-7 2 Component of a glass paste

Solvent

26 Lead titanium zirconium

oxide 12626-81-2 1 Manufacture of electronic

components

27 NN-dimethylacetamide 127-19-5 1 Solvent

28 NN-dimethylformamide 68-12-2 1 Solvent

29 Nickel sulphate 7786-81-4 2 Anti-corrosive

30 Nonylphenol 25154-52-3 1 Component in glue

31 Nonylphenol ethoxylates 9016-45-9 2 Emulsifier


32 Orange lead 1314-41-6 1 Used in pyrotechnic mixtures


10588-01-9 3


Passivation

Process chemical

34 Not stated Not stated 3 Coatings

Not stated

Total 71


Figure 53 shows that for most examples of substitution activities respondents reported that their

organisation had undertaken RampD activities to investigate substitution (55 of all examples)

Among those engaging in RampD activities a few reported that they are testing alternative

technologies or using alternative substances to continue to make the same product In 11 of

reported cases the organisations are currently in the process of product testing and requalification

of the products that will be made with alternative substance andor technology In a further 20 of

cases respondents were in the final stages of substituting a (possible) SVHC but had not completed

the process yet



Figure 53 Substitution activities ndash Types of activities undertaken (industry survey)

Notes This figure refers to 71 examples

Respondents who indicated that they were investigating the possibilities to substitute SVHCs were

asked about the stage of the REACH authorisation process which triggeredconfirmed these

activities (see Q60 in Annex F5) The quantitative results presented below have been derived by

excluding the answer categories lsquoNot surersquo and lsquoNot applicablersquo from the analysis (which account

for approximately 75 of all answers given to question Q60)

43 of respondents stated that the decision to investigate substitution originated when the

substances were included in the Candidate List39

27 when substances were recommended for inclusion on the Authorisation List and

11 when substances were subject to applications for authorisation

533 Drivers for substitution

This section presents information about the drivers for substitution based on the results of two

questions from the online industry survey

Respondents who indicated that they had substituted SVHCs or had been investigating substitution

through preparatory activities were asked to choose the three main reasons motivating them to

substitute a (possible) SVHC andor engage in activities investigating the possibility of substitution

out of a given list (Q62 in Annex F5) Figure 54 reports the number of respondents (out of 61) that

chose the respective reason as one of their top three reasons The figure shows that the top two

reasons for substitution activities selected by respondents are both related to the REACH

authorisation process (one option was the REACH authorisation process the other related to the

need to assess the suitability of possible alternatives as part of an AfA) The third most selected

factor for respondents whose organisations substituted was the REACH regulation in general (ie

not limited to the authorisation process) For respondents who did not (necessarily) substitute due

39 This is consistent with anecdotal evidence from the REACH 2012 report reported in Section 432 that ldquothe

placing on the Candidate List can lead in some cases to the launch of initiatives to develop new substances

or to the reformulation of existing substancesrdquo



to the authorisation process the fourth most selected factor was due to new opportunities in the

market using an alternative

Overall 33 of respondents indicated lsquoother reasonsrsquo as one of their top three reasons to substitute

or investigate substitution Some of the reasons mentioned were (i) business continuity (as the

company would then not have to worry about applying for authorisation) (ii) company internal

policies to phase out SVHCs (iii) internal company policies regarding the safety of workers and (iv)

requests by customers to transition to safer alternatives

Figure 54 Drivers of substitution activities (industry survey)


reasons for substituting or engaging in activities investigating the possibility to substitute

The respondents that did not engage in any substitution activities were asked to choose their three

main reasons for not carrying out any substitution activities out of a given list (Q64 in Annex F5)

Figure 55 reports the number of respondents (out of 21) that chose the respective reason as one of

their top three reasons The figure shows that the top reason that prevented respondents from

substituting SVHCs was the lack of technically feasible alternatives to deliver similar end-user

requirements This was followed by the lack of lsquonewrsquo alternatives worth investigating and financial

constraints and losing a competitive position in the market compared to those who continue to use

the SVHC

Approximately 24 of respondents chose lsquoother reasonsrsquo as one of their top reasons The reasons

they provided are (amongst others) that the substitution process was covered by the RampD program

of their partner (not them) and another noted that the identified alternative substance was

deemed equally hazardous for human health andor the environment A further reason mentioned

by one respondent is that the organisation applied for authorisation as a precautionary measure as

the organisation considers its use as an intermediate while ECHA did not



Figure 55 Barriers to substitution (industry survey)


reasons for not carrying out any substitution activities


The tier 2 case studies provide further insights to the process of substitution as well as indicate the

drivers for those substitutions happening outside of the AfA process

During this study in addition to the online survey 49 interviews were conducted with various

stakeholders One of the focal points of these interviews was the lsquosubstitution strategyrsquo of the

stakeholders Twenty-seven of the companies interviewed were downstream users andor

applicants (both those that submitted an AfA or were covered by an AfA made by their supplier)

Three interviewees were suppliers of alternative substances or technologies NGOs were also

interviewed and provided their view on the barriers to substitution Nine industry associations were

interviewed who provided a wider view on the substitution issues of their members

NGOs expressed their concern that the authorisation process by itself could be a barrier to

substitution for companies that are granted authorisation their incentive to use alternative

technology will be low which slows down the introduction of new technologies Although this could

be correct in some cases (assuming that the timelines for introduction of alternatives in the AfA

AoA are exaggerated) interviews with other stakeholders showed that in several cases substitution

took place despite there being a case for applying for authorisation instead (see case studies 1 and

3 in this section)

Substitution can occur in the context of an application for authorisation or in absence of an

application for authorisation The first type of substitution (ie within the AfA process) can be

found within the substitution plans where the adequate control route is possible or within the

development plans (or something referred to as RampD plans) mentioned in the context of an applied

for use scenario under the SEA route These plans are discussed in the next section As such these

plans do not automatically lead to substitution as in most cases the feasibility needs to be

demonstrated (ie both lab testing and then pilot testing as well as end-usercustomer

testingapproval) but they provide some insight into how companies are considering substitution

The latter type of substitutions (ie in the absence of an AfA) are actual cases where SVHCs have

been substituted so no AfA was necessary These instances are difficult to find (ie in the public



domain) as they remain largely undocumented and are sometimes confidential Examples of both

types of substitutions are provided in this section

From the interviews it is clear that while the decision to substitute is case-specific it is driven by

some common considerations Overall the number of well documented cases of early substitutions

(that could be found) is limited Several companies indicated that a lot of substitution had been

done in the past but they were not able to provide much detail in the limited time context of the

interviews (for example because people change in the company and it is difficult to find details of

historical cases of substitution ndash However given many of these instances are prior to REACH

authorisation they are not relevant to document as part of this study)

Overall concerns that suggest that authorisation itself is a disincentive to substitution (because it

allows time-limited continued use rather than imposing blanket bans and forcing substitution)

would seem to be not well founded since the AoA forces the justification of continued use inter

alia on the basis of having done an assessment of possible alternatives and justifying why they are

not suitable

Further details of nine examples (cases) of substitution are presented below

Case 1 Use of a hexavalent chromium (CrVI) containing catalyst in a catalytic waste gas

treatment installation

This case relates to a production site of a large company active in life sciences The company

operates a large specialty chemicals manufacturing site Waste gases from the various production

installations were collected and used to be treated by a waste gas installation using a CrVI based

catalyst to destroy the hazardous substances present in the waste gas The installation was

essentially a closed-process installation with no operational exposure of workers during the use of

the substance Very limited exposure was only possible during loading and unloading of the catalyst

(an activity that did not happen every day)

When the CrVI based substance present in the catalyst was listed on Annex XIV the supplier of the

catalyst announced that the catalyst would no longer be supplied after the sunset date As a result

of this the company (a downstream user) using the catalyst started a programme to find a solution

for the problem that future supply of the catalyst would no longer be available from their supplier

Alternative catalysts were evaluated but failed technically because of the complex nature of the

waste gas stream A solution was found in an alternative technology called lsquoregenerative thermal

oxidizerrsquo Using this technology waste gases are burned with energy recovery (heat) This

technology provides the same level of emissions reduction of the hazardous substances in the waste

gas as the previous technology that used the CrVI based catalyst The investment cost for this new

installation was about euro11 million The new installation has a marginally lower operating cost of

euro100k per year The company did not consider or realise the option to import the catalyst directly

and to apply for authorisation themselves even though this solution would probably have been

cheaper

Because of the criticality of the waste gas treatment in the operation of a key production

installation relocation of the waste gas treatment or to stop processing the waste gas treatment

were both not a viable option As a result the high net cost of the replacement of the existing

installation was deemed necessary

In this example the main drivers for the substitution were

The identification and availability of a technically feasible alternative technology



Avoidance of using an Annex XIV substance and

Absence of another solution given their supplier ceasing supply of the catalyst (based on an

SVHC)

Case 2 Use of hexavalent chromium (CrVI) based acids for the plating of aluminium profiles

The authorisation requirement for CrVI containing substances such as chromium trioxide has proven

to be complex Several AfAs were made including large consortium driven applications small group

applications and individual downstream user applications However during several interviews it

was clear that several companies had substituted the use of substances such as chromium trioxide

prior to the sunset date and did not needhave to rely on an authorisation

An interesting case is the use of CrVI based substances as anti-corrosion coating for aluminium

profiles in the construction sector This industry is represented in the EU by ESTAL ESTAL

communicated to its members that authorisation for their use of CrVI would be difficult because of

the existence of alternatives The existing alternatives were known to be technically inferior to the

CrVI based solutions but it was presumed that this would not be sufficient to prove that an

authorisation should be granted

Based on this information a manufacturer of window frames assessed their specific situation and

decided not to apply for authorisation and decided to search and develop alternative technologies

for the anti-corrosion treatment of the aluminium profiles This decision was made knowing that an

upstream application was being prepared which could cover their use and would be a cheaper

option Because there has been no final decision yet on this upstream application and the

application was not made by this company it cannot be concluded if this is an instance of a

lsquoregrettable substitutionrsquo or not

In general this industry tends to be conservative regarding the replacement of anti-corrosion

technology Because without a proper anti-corrosion treatment parts of a window frame can

corrode causing blistering of the final lacquer coating Premature corrosion of window frames can

lead to significant customer complaints including consequential damage

A first type of alternative technology consisted of a Cr-free application of a very thin coating The

exact composition of the coating is confidential including to the aluminium plater This technology

was implemented based on a known technology but significantly improved by in-house

development The technology provides only a very thin and mechanically not very resistant anti-

corrosion layer Storage of the parts between the application of the anti corrosion layer and the

application of the final coating potentially can damage the thin anti corrosion layer Any damage of

this layer leads to a premature failure of the final product As a consequence the coated parts

cannot be stored between the anti-corrosion layer and the final coating Changes to the production

facilities and production procedures were required to accommodate this A second disadvantage of

this technology is its dependence on the quality of the base material as it is known that impurities

in the base material (specifically traces of iron) strongly affect the end result Because of the high

level of recycling of aluminium the possibility for iron contamination is high As a result the

company had to issue more stringent specifications for its raw material resulting in a slight price

increase (lt5) However this specification excluded sourcing the aluminium from the recycling

stream The processing cost for the alternative process is roughly the same as for the original CrVI

based process

To implement the alternative significant investments were required including for the on-line

process control Compared to the CrVI based process this alternative process is less robust and is

more sensitive to small variations in process conditions



A second alternative implemented by this company is a totally different process called lsquopre-

anodisationrsquo or lsquoanodicrsquo oxidation This technology allows an even higher corrosion protection

compared to the CrVI coating but has doubled the operating cost This technology is very robust

and tolerates iron impurities in the raw material The total investment made by this company to

implement both alternatives was euro3-4 million

Having implemented the two types of technology the manufacturer has mixed feelings On the one

hand substitution was more or less standard for this kind of application (aluminium coating in

construction sector) but there is still an AfA pending which would allow certain competitors to

avoid the investment It would be worth investigating in the future customer experiences with the



Based on a ESTAL communication that authorisation would not be possible

Availability of a known alternative technology with short development time

Control over raw material specifications and

Business model which allows absorption of the additional cost

Case 3 Use of an SVHC in the high-tech life science sector

This case concerns two companies considering relocation of their business to outside of the EU as a

direct consequence of the authorisation process The two companies use different SVHCs that were

at the time of the interviews in different phases of the authorisation process40 namely 12 DCE

(12-dichloroethane) and octyl phenol ethoxylate

Octyl phenol ethoxylate is a frequently used substance in the life science sector For instance in

this case it is used in the manufacturing of in vitro diagnostics kits Several manufacturers have

asked for clarification whether this use of octyl phenol ethoxylate would be exempt for

authorisation on the basis of the SRampD use of these kits This has been requested from the

authorities but they were unable to provide clear responses immediately As a result this company

immediately started to evaluate alternatives The volume of this substance required in this use is

small (less than 500 kg per year) The amount of octyl phenol ethoxylate present in the diagnostic

kits the end product is even smaller Nevertheless the exemption does not apply for their

particular case this company would have to look for an alternative or be required to apply for

authorisation The search for an alternative to the use of octyl phenol ethoxylate would in this case

require extensive scientific and development work (meaning there is no suitable alternative

available yet)

The 12 DCE is used in a high tech genetic engineering related technology The manufactured

product uses 12 DCE as solvent in volumes even smaller than the previous example (ie lt20 kg

year) The company with headquarters outside of the EU sees the authorisation process as a

complex process with no assured outcome The use conditions of the 12 DCE are cleanroom and lab

type of conditions with a very limited number of people involved and highly controlled conditions of

use Also in this case a search for alternatives would require extensive scientific and development

work (meaning there is no suitable alternative available yet)

40 More recently Otylphenol ethoxylate has been listed in Annex XIV



For both cases there are two common elements a lack of alternatives and regulatory certainty In

general these types of industry have a small physical size and can relatively easily (at least

compared to a large chemical site) be relocated

In one of the two cases it was decided not to apply for authorisation and to relocate this part of

the production (to outside the EU) In the other case the relocation option was being evaluated but

a decision was still pending at the time of interview In any case a project for a ldquocomplex and

costlyrdquo application for authorisation was not considered although for both cases the case for

authorisation would seem to be strong

For these two cases the main drivers for relocation are

Legal uncertainty

Lack of a technical alternative and

Realistic to relocate whole production outside of the EU

From consultation for this project it is known that the application and granting of patents in the

pharmaceutical industry for innovator based companies (ie companies that produce new products

under patent) is a critical factor The granting of a 25-year patent allows innovator companies to

make profit on products that no-one else can produce Therefore the optimisation of the patent

relies on applying for patent as late as possible in the product development process The

manufacturing process is included in the patent and changes to the process would require a new

patent to be applied for In the cycle of product development the closer the product gets to the

market the more investment is made (clinical trials are very expensive) Therefore unless SVHC

replacement can be made at an early stage in product development or review periods can be long

enough to cover the patent period an option will be to push production out of the EU to other

facilities (however if production facilities outside the EU do not already exist but they do in the

EU then the cost of development of those facilities can be prohibitively expensive)

Case 4 Regulatory burden as decision element

To illustrate that substitution of a substance is a result of many factors a case of a company

active in life sciences using an octyl phenol ethoxylate for two different purposes (uses) is

summarised here For both uses the required volume of the substance is low the use conditions are

very highly controlled and no suitable alternative is available at present However for one use

the substance is in direct contact with the final product and in the other use of octyl phenol

ethoxylate it is not The regulatory burden linked to substitution is different for the two different

uses because in one case there is a need to re-apply for marketing authorisation in the other case

not This was crucial in the decision-making process of the company to attempt to find a substitute

for one use (ie the one with the lowest regulatory burden) and to apply for authorisation for the

other use In fact even if a technically suitable alternative would be available it would be

impossible to obtain the regulatory approval before the sunset date required as a result of the

process change to continue to put the product on the market

Although as far as emissions are concerned the cost of the substitution most probably outweighs

the benefits of the non-use scenario in both cases only in one case the company decided to apply

for authorisation In the other case substitution was preferred even at a cost significantly higher

than the cost for an application for authorisation The reason for this mentioned by the company

was to avoid the perceived administrative and resource burden of the authorisation process and

the high likelihood to find an alternative before the sunset date



In this case the drivers for substitution were

Their ability to find and implement a suitable alternative prior to the sunset date and

Avoiding the authorisation process

Case 5 GreenCoat using an alternative technology for CrVI surface coating

The company GreenCoat uses an alternative technology to surface treat articles which does not

use Cr(VI) The technique is based on PVD (Powder Vapour Deposition) The company did not

develop the technology but has purchased it As such the company has the same role as a contract

plater using CrVI has today in the supply chain So far the company has invested about euro10 million

in this technology The company focuses on developing projects within the automotive industry for

the surface treatment of parts as this sector represents for them by far the biggest potential

market Developing this market opportunity takes about 9-12 months including process optimisation

and testing as the process needs to be repeated for each automotive part and for each car

manufacturer

An important step for further development of this market was the development of a specification

for PVD coated parts for the automotive industry This specification replaces a previous

specification for CrVI based surface treatment which was used to evaluate PVD coating Experience

has shown that in certain cases PVD coating has a clear advantage over CrVI based coatings This

advantage is related to a wider variety of base materials which can be used for PVD coating This

can for instance result in a cost saving - if cheaper base materials are used - or design

improvements - if high performance materials are used - allowing more complex designs

According to GreenCoat their technology could also be implemented in the sanitary industry

Although GreenCoat supplies their products to this market since 2013 the collaboration with the

sanitary industry seems today more difficult GreenCoat recognises that PVD coating is not a full

alternative for all CrVI based coatings but claims that for certain applications it is a real

alternative

Because of the lengthily process of introducing new PVD coated parts (for instance in the

automotive sector) the required build-up of capacity and the current price difference GreenCoat

expects that both technologies ndash CrVI based and PVD coatings - will coexist for the next 12 to 15

years This is an example where the authorisation process in principle can create new market

opportunity for new technologies in well established markets (where substitution may not have

happened without regulatory scrutiny on CrVI) However for comparison the companyrsquos turnover

is euro10 million whilst the total business volume for the automotive sector for surface coating is euro 1

billion (meaning they can only provide for a small part of the current market) However because of

the technical advantages and the expected cost reductions the company sees the replacement of

CrVI coating with PVD coating as a typical case of competing technologies The fact that

authorisation was applied for chromium VI coating does not affect the development of the business

significantly

In this case the drivers for the emergence of a CrVI alternative technology are

REACH authorisation

Technical feasibility of the alternative resulting in specific technical Specifications and

Certain technical advantages from using this alternative technology



Case 6 Yara

Yara France used diarsenic trioxide as a processing aid to activate the absorption and desorption of

carbon dioxide by potassium carbonate from synthesis gas which is used for the production of

ammonia at its site in Le Havre France The diarsenic trioxide additionally served as a corrosion

inhibitor in the process Diarsenic trioxide was previously used as it was effective in the process of

carbon dioxide stripping energy efficient clean and compatible with the comparatively low

pressures at which the Yara Le Havre site operates The Le Havre Yara operation is a 247 continual

process which held 40 tonnes of diarsenic trioxide circulating in a closed system Per year around

five tonnes were added to the system as the process is in principle catalytic but as with all such

reactions not 100 efficient

In response to diarsenic trioxide being made subject to authorisation Yara France explored

alternative physical and chemical solvents A water-based process was said to have the advantage

of being a simple process using a solvent which is not reactive with other trace constituents and

which does not introduce nitrogenous vapours into the gas stream However the carbon dioxide

partial pressure at the Le Havre installation is sufficiently low that the amount of solution required

to absorb the same amount of carbon dioxide is twice that required with chemical solvents making

the physical solvent solution incompatible with the Yara Le Havre process Using water would also

increase hydrogen contamination while other physical solvents would require the introduction of

an additional drying unit

Yara also considered switching to a process based on an amine chemical solvent This was

considered technically and economically challenging since it would require significant changes to

the existing installation costing euro20m over seven years or longer However using the existing

process but two alternative substances as activators and vanadium pentaoxide as a corrosion

inhibitor was found to have several advantages over the current diarsenic trioxide-based process

and other alternatives These included lower energy requirements lower corrosion inhibitor use

cleaner and smoother production and lower health and safety requirements

However switching to the vanadium pentaoxide-based alternative was estimated to take until the

end of March 2017 22 months after the sunset date for diarsenic trioxide The only viable solution

to this transition in case the company were not submitting an application would be complete

closure of the plant by the sunset date Yara therefore submitted an application for authorisation

to continue their use of diarsenic trioxide for 22 months after the sunset date including planning

necessary for substitution to a vanadium pentaoxide alternative

The discussion within their application concerning the time required to substitute makes it clear

that the substitution of diarsenic trioxide had already been considered early in the REACH process

(and possibly before) as part of an overall evaluation of the future of the plant A switch to an

amine-based process had originally been considered most cost-effective but further analysis in

2013 revealed that such a switch would be far costlier and technically complicated than originally

thought It was then that the vanadium pentaoxide option was evaluated and ultimately approved

The costs of implementing the switch were implied to be around euro4m (one fifth of the costs of

implementing the amine alternative) but a full net present value including energy efficiency and

other savings was not provided in the authorisation application

Contacts were made with Yara but it was not possible to discuss this substitution further with them



Case 7 Fine Chemicals company

The company in this case has a large portfolio of products that they manufacture in different

countries The regulatory constraints are managed and the use of very hazardous substances in

manufactured substances or used raw materials is tracked proactively Because of this proactive

process this company was in the past able to substitute several chemicals in a timely manner

Three examples were provided

In the first example the RampD to replace the substance started when the substance appeared on the

Candidate List The main reason for going ahead with the substitution rather than applying for

authorisation was that the AfA process was considered as an uncontrollable risk as there was no

guarantee of continued use for the foreseeable future This was because the substance is a PBT and

it was unclear to this company how a justification for continued used could be developed (given

there is no widely accepted way of valuing the risks associated with the use of a PBT substance)

Although the substance is still not on Annex XIV the use of the substance has been discontinued

and substituted by a structurally similar substance which does not meet the PBT criteria

The second example concerned a substance not on the Candidate List but recognised as a PBT and

on the CoRAP list for several other properties such as being an ED The substance was used as

additive to polymers The replacement of this substance only took six months A key driver here

was the fact that a technical alternative was available and the outcome of a possible authorisation

application was uncertain

The last example related to the use of Nonyl phenol in an imported mixture The total use volume

was fairly low (2 tpa) Although an alternative was known their customer did not want to pay for

the additional cost for the use of the alternative However the company did not want to be

associated with the sale of this SVHC and as a result authorisation was not considered and the

marketing of the substance was stopped

The common driver for substitution in these cases are mainly the proactive management of the

Chemical substance inventory in order to identify in a timely manner the possible options for

substitution and start-up research for alternatives at an early stage

Case 8 replacement of TCE by PER

In this case a company active in the aviation sector was using TCE as a metal degreasing solvent

Because of the low level of technology used for exposure control it was clear that authorisation

would not have been possible for the use An alternative provided by a solvent supplier proved to

be very expensive and a cheaper solution was sought

The alternative found was tetrachloroethylene (PER)41 This choice was made after the conclusion

of substance evaluation for PER stating that there was no need for further regulatory follow-up

Because of the low boiling point of PER new equipment was developed in collaboration with a

supplier The investment cost for the new equipment is estimated to euro1 million However because

of the lower emissions the solvent use is lower hence a lower operational cost was achieved (from

41 It is worth noting that several TCE AfA applicants viewed PER as not being a suitable alternative given it has

health and environment concerns (albeit less toxic than TCE) which could mean PER being subjected to further

regulatory scrutiny in the future However that is not to say other previous uses of TCE that did not apply for

authorisation may also have switched to PER (see Chapter 11)



euro60kyear to euro2kyear) This solution was evaluated positively to the extent that other degreasing

solvents used (kerosene) will also be replaced by the use of PER

The key drivers for this substitution are

availability of a technically suitable alternative and

Reduction of operational costs

Case 9 Substitution of diarsenic trioxide in artistic glass-making in Murano Italy

As reported in Section 45 the use of diarsenic trioxide in the production of artistic glass was

claimed intermediate by industry but assessed as a processing agent (ie non-intermediate) by

ECHA No application for authorisation was received for this use from the artistic glass sector ECHA

(2017) subsequently produced a report on the use and substitution of diarsenic trioxide in the

artistic glass sector of the Murano area of Italy and this section cites this report42

Raw materials used in glass manufacture include silica sands sodium and potassium carbonate and

others Other substances may be added to glass during manufacturing as matrix builders melting

agents stabilisers refining agents and colourants Diarsenic trioxide is used in glass manufacturing

as refining agent added mostly to remove bubbles The substance was included in Annex XIV of

REACH with latest application date 21 November 2013 and the sunset date 21 May 2015

In early 2015 local authorities began checking how authorisation obligations for diarsenic trioxide

were being handled by Murano glassmakers The glassmakersrsquo position was that their use of

diarsenic trioxide was exempt from authorisation on the grounds of being an intermediate Local

authorities supported by the Ministry of Health (Italian Competent Authority for REACH and CLP)

and ECHA concluded that the use of diarsenic trioxide as a refining agent in the manufacture of

Murano glass could not be considered intermediate and enforcement inspectors advised

glassmakers that their use of the substance after the sunset date should cease because neither EU

manufacturers nor glassmakers (downstream users of the substance) had applied before the latest

application date for authorisation to continue In September 2015 the REACH authority of the

Veneto region (having jurisdiction over Murano) decided to create a working group to monitor the

use of diarsenic trioxide in Murano glass manufacture The group was made up of members of the

Italian CA the regional environmental agency and the local control authority on REACH The action

plan of the working group included

An information campaign for local glassmakers about the ban to use of diarsenic trioxide in

glass production and

A control and inspection plan aimed to check if diarsenic trioxide was still being used after

the sunset date and to monitor levels of diarsenic trioxide in the environment

The working group began by gathering information on companies involved in glass manufacture in

the area Information from the chamber of commerce and the worker insurance institute indicated

that there were about 300 companies operating in the sector in the Veneto region This information

was integrated with data obtained from the major local distributor of diarsenic trioxide showing

that in 2013 about 24 companies in that area were using in total around 5 tonnes of diarsenic

trioxide per year





An information sheet on the regulatory status of diarsenic trioxide and a questionnaire were

prepared and sent to all these companies by the working group Responses to the questionnaire

showed that 104 companies operate in the field of artistic glass 18 of which indicated that they

had used diarsenic trioxide until 2014 but had since switched to antimony trioxide cerium oxide

lithium oxide andor blast furnace slag Use of these substances implied a change in the process

conditions and substances were used individually or in combination

Nine workplace inspections were undertaken by local enforcement authority between December

2015 and May 2016 One artistic glass manufacturer was found to be using diarsenic trioxide in

breach of REACH ie without an authorisation for its use Other inspected companies had replaced

diarsenic trioxide with other substances instead of applying for authorisation

The Veneto environmental protection agency monitored the level of arsenic in air in the Murano

area over the periods June-November 2014 SeptemberndashNovember 2015 and JulyndashDecember 2016

The data from the environmental monitoring stations (located in the neighbourhood of the primary

school of Murano) showed a significant decrease in arsenic levels (see Table 54) Concentrations

were found to have dropped from over 200 ngm3 to 4 ngm3 being in 2016 below the annual limit

of 6 ngm3 for arsenic which is the target value of the EU as agreed in Directive 2004107EC on

arsenic cadmium mercury nickel and polycyclic aromatic hydrocarbons in ambient air and

implemented by Italian Legislative Decree 155201043

Table 54 Average air concentrations of arsenic at the Murano environmental monitoring station 2014-16

Reference period Average arsenic concentration (ngm3)

June-November 2014

September-November 2015

JulyndashSeptember 2016

OctoberndashDecember 2016

2347

110

5

39

No information on the costs of switching to these alternative substances is available

55 Applicants ndash Future possibilities to substitute

In this section some cases are documented where applicants indicate future substitutions in the

public versions of their application for authorisation These developments are documented in the

AfA as RampD plans Table 55 shows to what extent these plans are included in AfAs

Table 55 RampD plans included in AfAs

Plan to substitute away from the SVHC No of Uses (AoAs) (All

substances)

Plan included 62

Plan referred to 34

No clear plan 71

Formulation uses (no plan expectednecessary) 19

Total 186

Table 55 shows for all AfAs considered (total of 111 up to end December 2016) whether the AoA

indicated a plan for how to make the non-suitable alternative suitable (ie an lsquoRampD planrsquo since a





lsquosubstitution planrsquo is only relevant for AfA for SVHC in the adequate control route) Where a plan

was lsquoincludedrsquo that was where there was a clear indication and time line showing how a possible

alternatives would be identified and the steps that would be needed to introduce that including

time and actions for product acceptance by customers Where a plan was lsquoreferred torsquo this was a

less definite plan but that there was an indication of time and steps (actions) needed to justify the

review period applied for For lsquono clear planningrsquo this was where the public version of the AfA did

not indicate a plan and action and timings were not at all clear in the AfA

The quality of information within AfAs presented to date is variable (although no opinions

recommended not to grant authorisation) and as noted in Table 55 it is reported that 34 of AfA

presented a clear RampD plan 18 referred to a plan and 38 presented no clear plan at all Some of

this information may have been provided by the applicant confidentially as part of the AfA or

submitted post submission of the AfA (eg in responses to a RACSEAC question) but based on

publicly available data this suggests that even in an AfA (where there is an obvious need to

specifically consider the adoption of alternatives) overall there is not enough clear documentation

of how alternatives could be made suitable and available

In the following examples some of these plans are summarised and the key success factors or

drivers to develop such plans are indicated

Case 1 Use of TCE in a cloth dye process

The company uses trichloroethylene (TCE) in the manufacturing of a dyed textile The specific dye

process requires a wax which has to be removed from the cloth during the process For this

purpose a solvent with specific properties is required Several solvents were tested but except

PER which was considered at that point in time nearly as hazardous (the decision of the CoRAP was

not available at the time of submission of the dossier) none provided a technical solution The

company however identified a different solvent technology as a potential alternative for the use

of TCE This technology using so called switchable solvents has as only alternative the potential to

provide cost savings by eliminating the solvent evaporation step which is required by other

solvents However the technology of switchable solvents is a relatively new technology For the

development of the alternative the company has set up a joint development plan with a Canadian

research institute familiar with this technology

Although the alternative is not technically ready because of the authorisation the company has the

opportunity to develop a new technology to substitute the use of TCE while avoiding the use of

another hazardous substance (PER) with the potential outlook of a cost saving in the production

process


Cost saving potential of the new technology and

Ambition to produce SVHC free

Case 2 Grohe

The application for continued use of chromium trioxide by Grohe consisted of two uses chrome

plating and etching of plastic material prior to chrome plating Grohe elected to differentiate both

uses and filed two different uses Apparently the main driver for this decision is the difference in

substitution potential for both uses While for the etching a possible alternative seemed to have

been identified for the surface coating an alternative seemed to be further away This difference

in possible substitution was also the main argument for a difference in review period



56 Summary of instances of substitution

A deliberate attempt was made to target stakeholders who may have been impacted by REACH

Authorisation and those that may have substituted a SVHC Whilst the AfA process provides a good

indication of companies and uses that require continued use of a SVHC priority to this study little

was known about the instances of substitution In this respect the online survey for this study has

been very successful with 43 of respondents indicating they have substituted a use of a SVHC (and

therefore avoided the need to apply for Authorisation) These respondents (n=83) provided 61

examples of substitution of SVHCs


to substitute and investment in substitution related activities In some instances some companies

have been successful at substituting the use of one SVHC but are still trying to phase out use of

another SVHC Whilst the specific targeting of respondents may have led to a higher percentage of

respondents who have substituted (43) the survey at least provides evidence that substitution of

SVHCs is occurring Based on survey responses REACH Authorisation seems to be a major (but not

the only) driver for substitution




completed


feasible even if in some cases the cost of applying for Authorisation could have been cheaper

This report sets out several drivers for these substitutions with numerous case study examples

Authorisation might not necessarily be the only motive as some of the substances that have been

through the entire Authorisation process have previously been regulated by other parts of REACH

and related legislation (such as harmonised classification amp labelling and evaluation) as well as

being subject to other regulation prior to REACH and therefore in some instances substitution

related activities have been ongoing for many decades











6 COSTS OF THE AUTHORISATION PROCESS

61 Introduction

The cost of the authorisation process is the third of the five focus areas assessed The cost analysis

seeks to set out (i) at what stage in the authorisation process are these costs incurred (building on

from the analysis in Section 3) (ii) who incurs these costs (and if they differ along the supply chain

ndash eg upstream application vs downstream user applications) (iii) how they compare with what was

anticipated (eg if there are any unintended costs) and (iv) to understand how costs are changing

over time (eg whether the total cost of drafting RMOAs is increasing due to the numbers carried

out but the time required per RMOA is falling)

The section contains the following sub-sections covering the costs included in this analysis

Section 62 Literature review ndash summaries what the key findings were from existing

studies

Section 63 Costs to Member State Competent Authorities (MS CAs) ndash sets out the costs

incurred by MS CAs along the authorisation process

Section 64 Costs to the European Chemicals Agency (ECHA) ndash sets out the costs incurred by

ECHA along the authorisation process

Section 65 Costs to the European Commission (EC) ndash sets out the costs incurred by the EC


Section 66 Costs to third parties ndash sets out the costs incurred by third parties (like NGOs)


Section 67 Compliance costs - sets out the compliance costs incurred by

manufacturersimporters (MIs) and downstream users (DUs) from continued use of an SVHC


Section 68 Costs of substitution - sets out details on the costs of substitution from an

SVHC due to the authorisation process

Section 69 Costs of RampD innovation and investment ndash sets outs details on the costs of

RampD innovation and investment encouraged by the authorisation process

Section 610 Costs of closure and relocation - sets out details on the costs of closing sites

in the EU and relocation of production outside of the EU due to the authorisation process

Section 611 Costs to apply for authorisation ndash sets out details of the costs to applicants

who requested continued use of an SVHC beyond the sunset date of the substance

Section 612 Costs to improve risk management - sets out details of the costs to improve

risk management from continued use of an SVHC due to the REACH authorisation process amp

Section 613 Summary of costs ndash sets out a summary of all the costs assessed




To create a basis for the assessment of new results produced by this study existing literature was

reviewed to identify and consolidate existing knowledge about the costs related to the

authorisation process The consulted literature includes regulation documents EC study reports a

Finnish study commissioned by ECHA as well as reports and position papers submitted during the

public consultation of the 2017 REACH Evaluation

This sub-section summarises the key findings of the literature review The complete literature

review (with supporting evidence) can be found in Annex E5 The following findings of the

literature review are of particular relevance

Based on a survey among authorisation applicants in 2013 and 2014 ECHA estimated the

average cost per applicantuse to be approximately euro230000 (EC 2015) As the average

cost per applicantuse was lower for applicants submitting AfAs in the last quarter of this

period it is expected that average costs will decline in the long run due to increasing

experience with the process

Several studies indicate that the application fees paid to ECHA make up a small share of the

total authorisation cost (at most 15) to the applicant Costs incurred to fulfilthe

information obligations set by public authorities and the preparations of application

dossiers are more significant The analysis of alternatives and the preparation of the socio-

economic analysis are shown to be the parts of the authorisation application that are the

biggest cost drivers

Despite the low share of application fees in terms of total costs the need to minimise the

regulatory cost burden for SMEs has been recognised by the EU through further lowering the

reduced application fees for such companies with the implementation of Regulation (EU) No

2542013

The public consultation to inform the 2017 REACH Evaluation reveals that almost 90 of

respondents think that the authorisation fees are too high As expected this percentage is

especially high (ie gt 90) for industry associations and businesses A considerable share of

stakeholders from the public and research sector (42 and 50 respectively) shares this

view

Submissions to the public consultation that informs the REACH REFIT indicate that costs

incurred as part of substitution activities ndash the alternative way of fulfilling the Annex XIV

requirement ndash amount to significant sums that might even be higher than direct REACH

authorisation application costs

Substitution can be linked to significant follow-up costs for the company itself authorities

or end-users of the products in certain industries Examples were provided by position

papers from stakeholders in the medical technology industry and defence sector In the

defence sector for example military authorities need to requalify products affected by

substitution and related products (eg tanks and aircrafts) that may need to be adapted to

the product directly affected by the substitution activities (eg ammunition) to ensure

compatibility

Besides industry actors EU- and Member State level institutions also incur considerable

costs during the authorisation process due to their administrative and management duties



Even state-level institutions not directly involved in these tasks such as Ministries of

Defence might face higher costs due to the need to finance more RampD activities

The public consultation conducted to inform the REACH Evaluation 2017 revealed that the

general opinion about the proportionality of costs and benefits of authorisation is the most

negative out of all analysed REACH chapters (ie registration information in the supply

chain such as extended Safety Data Sheets evaluation of dossier evaluation of substance

authorisations restriction and requirements for substances in articles)

63 Costs to Member State Competent Authorities (MSCAs)

The costs to MSCAs are largely driven by the time spent on the following activities

The screening and risk management option analysis (RMOA) stage

Inclusion of substances on the Candidate List

The Member State Committee (MSC) ECHA Scientific Committees (RAC and SEAC) and

REACH Committee

Compliance and enforcement of REACH authorisation and

Policy costs

A questionnaire was sent out to MS CAs44 requesting information on most of these activities and

responses were received from 16 CAs The findings are summarised in this section Some of these

costs have also been estimated as part of ECHArsquos time recording system (see Section 64 for more

information) This system in addition covers the activities of the RAC and SEAC whose costs are

largely paid for by MS CAs so these ECHA-estimated costs are also covered in this section ECHA

pays for the time of Committee members who undertake lsquorapporteurrsquo duties on authorisation

opinions although this might only partially cover the full cost of the membersrsquo time These costs

are included under ECHA costs

Table 61 presents responses to the question on average cost of staff employed on authorisation

activities (For this question what constitutes lsquoauthorisation activitiesrsquo was not specified) The

mean lsquoaverage costrsquo value was euro401 per day with mean upper and lower bounds of euro306 and euro412

These values appear reasonably close but they disguise significant variation across CAs ndash the lowest

lsquolow valuersquo reported was euro20 per day whereas the highest lsquohigh valuersquo was over euro1000 per day

Table 61 Average staff cost per day (euro) for time spent carrying out authorisation activities

Low Average High

Mean 306 401 412

n 10 14 9

Table 62 presents the results of the question asking CAs how much staff time they spend on

undertaking RMOAs Screening and RMOA activities were described in the questionnaire as follows

ldquoThe term lsquoscreeningrsquo covers the identification and investigation of substance (and dossier)

specific information to make a preliminary assessment on whether that substance (or

dossier) should be handled via a particular REACH or CLP process The first stage is the IT

mass screening phase which is predominately carried out by ECHA The second stage is the

httpsechaeuropaeuinformation-on-chemicalscl-inventory-database-disclidetails103892 44 The EC contacted MS CAs and those willing to take part were sent the survey



manual screening phase which is a targeted substance or dossier specific assessment of the

information provided in the registration dossier(s) in relation to the search criteria applied

As the vast majority of substances that are screened (either in mass screening or manual

screening) do not go down the authorisation route the screening phase is not being

assessed in this questionnaire

An RMOA is a voluntary step where an analysis is carried out (by ECHA upon request by the

Commission or a Member State Competent Authority (MSCA)) on a substance-by-substance

level to conclude if additional regulatory risk management should be proposed to manage

the risks to human health or the environment as well as which risk management option to

use Although there are several Risk Management Options that could be proposed (other

than Authorisation) we are interested in understanding the time taken (on average) to carry

out an RMOArdquo

The mean of the estimates of the lsquoaveragersquo was 41 days with a mean lsquolow estimatersquo of 20 days and

a mean lsquohigh estimatersquo of 70 days Again these figures mask individual extremes ndash for instance a

lsquolowrsquo of two days and a lsquohighrsquo of 175 days (the latter figure representing over six months of full-

time employment) The first set of estimates in Table 62 of the cost of undertaking a RMOA are

the means of responses from CAs who answered questions on both the staff cost and the days per

RMOA questions since not all respondents answered both questions This is why the number of

respondents (n) is different for the lsquoaverage daysrsquo responses and the lsquoown costsrsquo responses in Table

62 The second set is obtained by taking the simple means in Table 61 and Table 62 recognising

that the sample of CAs responding to each question is different Average costs obtained are around

euro13k-164k ranging from euro35k to almost euro29k Respondents generally reported that the time spent

on RMOAs is increasing over time due to greater average complexity of case substances (eg PBTs

compared with CMRs)

Table 62 Time for and cost (euro) of carrying out a RMOA per substance

Average days

Total cost per RMOA

Based on own costs Based on sample costs Low Average High Low Average High Low Average High

Mean 20 41 70 3484 12988 25112 6120 16441 28840

n 10 13 9 7 11 6 na na na

ECHA publishes data from the Public Activities Coordination Tool (PACT) which lists the substances

for which a RMOA or an informal hazard assessment for PBTvPvB (persistent bioaccumulative and

toxicvery persistent and very bioaccumulative) properties or endocrine disruptor properties is

either under development or has been completed since the implementation of the SVHC Roadmap

commenced in February 2013 The PACT currently (August 2017) lists 374 activities - 178 are

described as RMOAs of which 168 were or are being undertaken by MS CAs The assignment of

these activities to REACH authorisation is not clear-cut since some RMOAs conclude that a

restriction (or another instrument) is appropriate some have been put on hold some are still

ongoing and some are listed as having a finalisation date which precedes their inclusion on the

PACT list Seventeen RMOAs have been included in the PACT list since September 2014 which have

already concluded (four of them in 2017) that a substance should receive a SVHC follow-up This

might suggest RMOA numbers in single figures per year ultimately associated with authorisation

although clearly this will tend to be an underestimate Based on the sample-based average cost in

Table 62 this might suggest a rough cost of around euro100k per year45

45 17 RMOAs over the period September 2014-2017 or just over five per year at euro16400 each gives euro92000

per year



Table 63 presents information on the time spent on and costs of the Annex XV process for

identifying SVHCs The activities covered include dossier preparation responding to public

consultation comments (lsquoRCOMrsquo) revision of the dossier and commenting on dossiers prepared by

other CAs and by ECHA As might be expected dossier preparation itself is the most time-

consuming activity taking a mean average of 36 days per dossier (average low estimate 22 days

average high estimate 57 days) The total cost of the Annex XV dossier process for SVHC

identification is estimated at around euro19k-euro20k (own costs or sample costs) with a mean low of euro7k

(own costs) and a mean high of euro34k (sample costs) In commentary most CAs did not feel that the

Annex XV process is becoming more burdensome over time even though several did state that they

had little direct experience of dossier preparation

Table 63 Time for and costs (euro) of the Annex XV dossier process for SVHC identification

Average days Total cost per dossier



Preparation 22 36 57 6435 13869 20967 6757 14537 23336

RCOM 3 6 11 408 2134 3204 985 2347 4671

Revision 2 5 11 253 2094 1745 747 2060 4415

Commenting 1 2 5 259 665 2277 313 890 2061

Total 28 49 84 7354 18762 28193 8802 19835 34482

ECHA publishes data on the Registry of Intentions to submit SVHC Annex XV dossiers CAs submitted

nine such dossiers in mid-2015 or early 2016 and eight in mid-2016 or early 2017 Assuming that

these all took approximately one year to compile and an average total cost of around euro20k gives a

total annual cost of around euro160k This does not include dossiers for which an intention was lodged

but withdrawn

Table 64 presents information on the time spent on and the costs of authorisation-related Member

State Committee activities In the questionnaire this was defined as average time spent by MSC

member (and advisors) on preparing and attending for a single Member State Committee meeting

specifically for authorisation activities Time in this case is measured in hours per meeting The

responses covered MSC meetings on SVHC identification Annex XIV activities (ie prioritisation)

and other authorisation activities (not specified in the questionnaire) Substance-related activities

seem to take longer on average than other authorisation-related activities with the former

requiring about 20 hours of time (range 8-45) and the latter 13 (range 7-20) This puts the

authorisation component of MSC meetings at costing from around euro600 to over euro5k with an average

of around euro25k-euro3k This is per CA so each actual meeting will cost around 30-times that

(depending on attendance) or around euro50k-euro100k With six meetings per year the total annual

cost for CAs is around euro300k-euro600k46 This does not include the costs of attendance by ECHA the EC

or stakeholders In comments most CAs stated that MSC activities can vary significantly depending

on the number and complexity of the cases being considered as well as the role the CA is taking in

the meeting

46 An alternative approach to costing MS CA time spent on candidate listing and prioritisation based on ECHArsquos

time-recording system gives a cost of around euro330k (see the discussion at Tables 69-12)



Table 64 Time for and costs (euro) of Member State Committee activities on authorisation (per Member State)




SVHC ID 10 21 37 202 1189 1580 412 1125 2047

Annex XIV 8 18 45 222 800 1335 323 987 2451

Authorisation 7 13 20 232 558 800 272 684 1071

Total 25 52 102 656 2546 3715 1007 2795 5569

Table 65 covers the time spent on an authorisation-related meetings of the REACH Committee

both preparation and attendance Total hours per meeting are estimated at 34 on average with a

range of 17-61 This results in mean costs of less than euro2k with a range of euro05k (own costs) up to

euro33k (sample costs) With approximately 10 meetings per year this puts average annual costs at

around euro20k for each CA or around euro600k in total per year In commentary respondents were of

the general opinion that average REACH Committee costs were increasing due to an increase in the

number and complexity of authorisation application cases which were being considered

Table 65 Time for and costs (euro) of REACH Committee activities on authorisation




Preparation 14 28 50 442 1201 2153 589 1521 2720

Meetings 3 6 11 110 270 445 111 323 586

Total 17 34 61 552 1471 2198 700 1844 3306

Table 66 covers time spent by ECHA Scientific Committee members on reviewing and commenting

on authorisation applications for which they are not acting as rapporteurs outside of plenary

meetings Responses were given in terms of hours per application On average CAs report spending

longer on SEAC opinions than RAC opinions giving a mean average cost of euro600-900 for SEAC

compared with around euro375 for RAC However one explanation for this could be that RAC members

have a heavier workload and therefore are more constrained in terms of how much time they can

spend on each case ndash this is supported by comments made by CAs in their questionnaires

Alternatively it could mean that more RAC activity is undertaken in plenary rather than outside

compared with SEAC Around 28 applications (50 uses) per year have been submitted to ECHA since

2013 implying a total non-plenary cost of around euro28-euro50k per MS CA per year depending on

whether AfA case is interpreted as an application or use applied for With 28 MS CAs in the EU and

three in the EEA this gives a total cost to MS CAs of around euro870k-euro15m



Table 66 Time for and costs (euro) of ECHA Scientific Committee (RAC and SEAC) non-plenary activities on authorisation applications per MS CA per AfA case




RAC 4 7 15 216 389 761 160 361 849

SEAC 5 12 21 272 854 814 197 623 1129

Total 9 19 36 488 1243 1375 357 984 1978

RAC and SEAC time spent in plenary was not covered in the MS CA questionnaire but was instead

estimated via the ECHA time-recording system (see Section 64) Preliminary results indicate that

the Committees spend approximately 18 days on opinion-making per use giving a cost of around

euro7200 With around 50 uses per year this gives a total annual cost of euro360000 Costs of RAC and

SEAC rapporteurs are treated as costs to ECHA and are covered in Section 64

On the subject of monitoring and enforcement CAs gave a variety of responses which are not easily

presented in tabular form Some CAs reported having no data Some responded that they did not

undertake any enforcement relating to REACH authorisation Interestingly some of these explained

this by saying that no company had yet been granted an authorisation in their country so there was

no need for enforcement even though it is the use of an Annex XIV substance without an

authorisation which is the key enforcement issue not compliance with a granted authorisation

(although this is still an issue clearly) Others estimated their time spent at around 10-20 days

Two reported spending around 70 days and over 100 days on enforcement in relation to around 25-

35 investigations Although patchy these responses do indicate that CAs are not expending very

significant effort on enforcing Annex XIV and granted authorisations

Finally CAs were asked questions designed to estimate how much time they spend on REACH

authorisation policy issues When asked to estimate the percentage of REACH staff time spent on

REACH authorisation policy issues responses ranged between zero and 20 with an average of just

under 10 CAs reported an average of just under 6 FTEs employed on REACH authorisation This

implies that policy aspects account for around 55 of one FTE At an average daily cost of euro401

this implies a cost of staff time spent on policy issues of around euro50k per year per CA

In summary questionnaire responses suggest that MS CAs might spend around

euro100k per year on undertaking RMOAs

euro160k per year on compiling Annex XV dossiers

euro300k-euro600k per year on MSC meetings

euro600k per year on REACH Committee meetings

euro870k- euro15m per year on RACSEAC non-plenary activities

euro360k per year on RACSEAC plenary activities and

euro15m per year (euro50k per CA) on lsquopolicy issuesrsquo broadly defined

This gives a total of around euro373m-euro486m per year (~euro43million per year on average) This figure

excludes enforcement activities for which insufficient data were supplied to permit costing



64 Costs to the European Chemicals Agency (ECHA)

ECHA has established a time management information system to record the time that staff spent on

different activities Using information from this system and expert judgement where necessary

ECHA has estimated time spent on the following authorisation-related activities

Risk Management Options Analysis (RMOA)

o Time spent preparing an RMOA

Annex XV dossier preparation and SVHC identification (candidate-listing)

o Time spent on Annex XV dossier preparation responding to comments from the

public consultation and preparing support documents

o Management of the Annex XV dossier evaluation process

o Member State and stakeholder analysis and commenting during the public

consultation

o Any additional time spent on Annex XV dossiers by the Member State Committee

(MSC) secretariat and members

Annex XIV recommendation

o Time spent on Annex XIV recommendation separately for ECHA and for MSC

members total (including rapporteurs and working groups)

Applications for authorisation

o Time spent on managing the applications process within ECHA

o Time spent by RAC and SEAC rapporteurs on evaluating applications

o Time spent on discussions related to applications for authorisation in RAC and SEAC

plenaries

Costs reported by ECHA were expressed in terms of days A representative cost per day for ECHA

staff time of around euro750 (including a 25 overhead)47 Time recorded by ECHA but paid for by

other agencies is not counted here

ECHA also spends time on additional activities such as providing guidance and training to applicants

(and others) developing policy in relation to aspects of the application process and

communicating to stakeholders through conferences webpages and so on ECHA also commissions

research and consultancy as part of for instance establishing Risk Assessment Committee (RAC)

dose-response functions for non-threshold substances It is assumed that these costs have not been

accounted for directly and hence appear (partly) in the 25 overhead charge

641 SVHC identification and prioritisation

ECHA has provided a description of its efforts to estimate the costs of its activities associated with

SVHC identification and prioritisation for authorisation This covers screening RMOA SVHC

identification and SVHC prioritisation

Screening

Common screening aims to make use of the full REACHCLP database and available external data to

support efficient implementation of all REACHCLP processes48 Hence the vast majority of

substances that are screened (either in mass screening or manual screening) do not go down the

47 John Wickham ECHA pers corr 11 April 2017 48 httpsechaeuropaeuaddressing-chemicals-of-concernsubstances-of-potential-concernscreening



authorisation route Therefore ECHA does not consider it meaningful to relate time and cost spent

on screening to the authorisation process

RMOA

Similarly only approximately one third of substances for which an RMOA is carried out go directly

to the authorisation route In addition most of the ECHA time spent on RMOA relates to more

generic tasks including co-ordination of Member States activities in RMOA developing approaches

supporting MSCAs and ensuring transparency and is not substance specific

Time spent on preparation of a RMOA ranges between 2-12 weeks full time equivalent (rough

estimate) with the average time spent by MSECHA being closer to the lower end of this range

This includes equivalent level of concern analysis for potential Article 57f substances where

relevant

Table 67 sets out the number of days spent by ECHA on RMOA activities and the cumulative

number of substances for which RMOA work is ongoing or concluded by ECHA or MSs in the last

three years These days are translated into cost estimates by applying the euro750 per day figure If

(as stated above) around one third of these costs are directly authorisation-related this puts

annual costs to ECHA at around euro40k-euro65k

Table 67 ECHA time and cost (euro) spent on and number of substance RMOAs 2014-2016

2014 2015 2016

Time spent (days) 236 171 264

Total cost (euro000s) 177 128 198

Cumulative number of substance RMOAs at end of year

Under development 74 89 92

Concluded 24 50 67

Total 98 139 159

The PACT started in September 2014 hence all RMOA PACT inclusions dated 2014 include all RMOA

intentions received between the start of the SVHC Roadmap (Feb 2013) and that date

At euro750 per day

Annex XV dossier preparation and SVHC Identification

Hazard identification is the primary purpose of the SVHC Annex XV dossier and in that sense

identification of substance properties (CMREDPBT etc) is an integral part of the process

However COM has advised that CLH (Harmonised Classification and Labelling) processes (which

relate primarily to identification of CMR hazards) are not in scope when calculating administrative

costs which would suggest that hazard identification activities for non-CMR properties should also

be out of scope ECHA has therefore considered two scenarios for a typical dossier

Time spent on CMR dossiers (not including CLH activities) and

Time spent on dossiers which relate to identification of other non-CLH hazards eg

PBTvPvBArt 57f dossiers

For the second category of substances time spent on dossiersubstance evaluation activities is not

included as this relates to a different regulatory process In addition time spent on the work of the

EDPBT Expert Groups is not included as these groups primarily support substance evaluation

activities



It should be noted that the time spent on Annex XV dossier preparation particularly for PBTvPvB

amp Art 57(f) dossiers is here only very roughly estimated by ECHA These estimates with associated

costs are presented in Table 68 It can be seen that the estimated time taken for PBTvPvBArt

57(f) dossier activities is significantly higher than for CMR dossiers as therefore are the costs Total

costs for a CMR dossier come to around euro20k whereas for a PBTvPvBArt 57(f) dossier costs are

more like euro100k ECHA also estimates that it spends an average of 80 days on court cases related to

PBTvPvB amp Art 57(f) dossiers

Table 68 ECHA estimates of mean (min max) days and cost (euro) spent on Annex XV dossier preparation

Task CMR PBTvPvB amp Art 57(f)

Days Cost (euro000) Days Cost (euro000)

Annex XV dossier preparation RCOM

Updating Annex XV dossier and preparing

Support Document (MSECHA)

11 825 70

(30 125)

525

(225 9375)

ECHA dossier management (including

substance ID and accordance check PC

activities)

11 825 35

(25 45)

2625

(1875 3375)

MS and stakeholder analysis and commenting

during PC (typically 20 commenters per

dossier 2 hours each)

5

(3 15)

375

(225 1125)

30

(15 45)

225

(1125 3375)

At euro750 per day

Table 69 reports estimates of additional time and cost spent by the MSC secretariat and the MSC

members on candidate listing activities MSC costs are valued at the euro401 per day figure used in the

previous section It can be seen that costs increase depending on whether the substance can go

straight to the Candidate List or needs to be referred to the MSC The upper estimates for

PBTvPvB amp Art 57(f) substances include opinion formation where MSC agreement is not reached

Table 69 Time and cost spent on candidate listing (days euro000 per substance)

CMR PBTvPvB and Art 57f

Secretariat MSC Cost

(euro000) Secretariat MSC

Cost

(euro000)

Direct to Candidate List 1-2 2-3 155-270 1-2 2-3 155-27

Referred to MSC and

addressed in WP 2-4 3-4 27-46 10-20 10-20 115-23

Referred to MSC and

addressed in plenary 4-6 4-5 46-65 20-50 20-50 23-575

In order to put some context on these figures Error Not a valid bookmark self-reference sets

out the number of SVHC dossiers dealt with per year broken down according to proposed hazard

property49 Assuming CMR dossiers cost around euro20k to administer and go straight to the Candidate

List the cost over the last three years is approximately euro200k Assuming other dossiers cost

approximately euro100k to administer go to the MSC and are 5050 addressed in plenary or working

procedures (WP) gives a cost over the last three years of euro309m The total annual cost is therefore

approximately euro11m but this is very much a ball-park figure About euro101m of this figure is cost to

ECHA with the remainder (euro83k) a cost to MS CAs

49 Note that where a substance has been proposed for SVHC identification due to both CMR and PBTvPvBArt

57(f) properties to avoid double-counting it has not been counted in the table as CMR



Table 610 SVHC dossiers by hazard property per year

2014 2015 2016

CMR 5 3 1

PBT vPvB 2 4 2

Art 57(f) 7 2 7

Total 14 9 10

Annex XIV Recommendation

Estimations of time spent on this activity are only very roughly possible in particular for MSC

members and the MSC Working Groups In addition recommendation cycles are not running per

calendar year whereas time spent is estimated per year The number of substances assessed for

priority and the number of substances in a recommendation are given as a rough indicator of

workload (see Table 611) However it needs to be remembered that there is no 11 relationship

between the number of substances and the workload eg having 11 substances in the 7th draft

recommendation compared to 22 in the 6th draft recommendation does not mean the workload in

the 7th recommendation was only half of that in the 6th recommendation

Table 611 Recent Annex XIV recommendations

5th Recommendation 6th Recommendation 7th Recommendation

Date draft June 2013 September 2014 November 2015

Date final February 2014 July 2015 November 2016

No of Substances

assessed 20 101 97

No of Substances in

draft 6 22 11

No of Substances in

final 5 15 9

Previous priority assessment approach used

Table 612 presents ECHArsquos estimates of ECHA and MSC time and cost spent on prioritisation

exercises based on the ECHA time recording system and qualitative judgement Time costs for MSC

members is based on the euro401 per day figure presented in Table 61 This suggests a total cost in

2016 of around euro05m euro0425m of which is ECHA costs

Table 612 Time and cost spent on Annex XIV prioritisation days per year

2014 2015 2016

Days Cost (euro000) Days Cost (euro000) Days Cost (euro000)

ECHA 621 46575 702 5265 566 4245

MSC members No data No data No data No data 173 694

642 Authorisation application opinion-making

ECHA has provided the first outputs of their time-recording system relating to opinion-making and

these are presented in Table 613 This indicates that on average ECHA spent just under 67 days

on opinion-making per use The estimate of time spent by the Committees is given by the average



time the Committees spend in plenary meetings to discuss each use multiplied by the average

number of Committee members in each meeting The time of rapporteurs and Committee members

is valued according to the average value in Table 61 This suggests a total direct cost (excluding

membersrsquo non-plenary time) of around euro37k per use over the period 2014-2016 of which just under

euro22k is ECHA time directly Rapporteursrsquo time is compensated for (although not necessarily to 100

of the cost) via payments made for each opinion The cost related to Committeesrsquo plenary time

listed in Table 613 have already been covered in section 63 For the purposes of this report it will

be assumed that costs to ECHA for each opinion are equal to around euro30k Assuming a rough

average of 50 opinions per year gives a figure for costs to ECHA of around euro15m annually

Table 613 ECHA estimates of time and cost (euro000) spent on opinion-making per- use 2014-2016

2014 2015 2016 2014-2016

days uses AfAs days uses AfAs days uses AfAs days cost

Secretariat 23 33 10 42 23 16 28 63 41 29 2175

Rapporteurs 14 33 10 26 23 16 24 39 26 20 8

Committees

(covered in

Section 63)

18 72

Mean total 676 37

Based on timesheets received by 31032017

643 Authorisation application fees received

ECHA receives fees from applicants for authorisation according to factors such as the number of

uses applied for the number of exposure scenarios and the size of the applicant firm or

organisation These fees are designed to cover at least part of the costs of ECHArsquos activities

relating to authorisation Authorisation fee income received by ECHA is published in the ECHA

financial accounts and is presented in Table 614 The yearly fee totals relate to the year in which

invoices were issued whereas the opinion-making stage of the application process commences only

after the invoice has been paid Thus there is no simple link between the fees received in Table

614 and the opinions and costs generated in Table 613

Table 614 Total authorisation application fees received by ECHA 2013-2016

Year Fees received (euro)

2013 587633

2014 1682281

2015 728239

2016 6074483

Total 9072636

Over the period 2013-2016 applications were received for 178 uses This implies a mean

application fee per use of just under euro51000



644 Summary

The proceeding discussion suggests that ECHA incurs costs of around euro50k per year on authorisation-

related RMOAs around euro1m on Annex XV and candidate listing and around euro0425m on Annex XIV

prioritisation Costs of opinion-making are difficult to estimate given the significant variation in the

number of cases considered per year but a figure of around euro15m per year on opinion-making

might be reasonable This suggests costs to ECHA of around euro3m per year This is quite close to the

average application fees per year received over the 2013-2016 period (around euro225m)

65 Costs to the European Commission (EC)

This section sets out the main costs incurred by the EC to manage the authorisation process Based

on initial communications with the EC as noted from the literature review the administrative costs

to the EC are expected to be much smaller compared to those incurred by ECHA and Member State

Competent Authorities

A questionnaire was sent to the EC requesting information about the time spent on activities

concerning

RMOA stage

Inclusion of substances on the candidate list

The REACH committee

Decision on applications for authorisation (AfA)

Post decisions on an AfA and

Policy costs

The responses are summarised in Table 615 for the year 2016 The average annual cost per full-

time equivalent (FTE) is set equal to euro138k the value used in EC impact assessments to value EC

staff time The breakdown of total resource across different activities is considered valid for the

last two years as this is when process of authorisation application opinions commenced Policy

development includes interpretation of for instance court case judgements

Table 615 Estimates of DG ENV and DG GROW time spent on authorisation activities 2016

DG ENV DG GROW Total

Total FTEs

22

6

82

Total cost (euro000)

3036

828

11316

RMOA and SVHC Roadmap 10 3036 20 1656 17 19596

ECHA recommendations and Annex XIV amendments 10 3036 10 828 10 11316

Authorisation decisions 50 1518 50 414 50 5658

Policy development 30 9108 20 1656 23 25668

Thus it can be seen that just over euro11m in staff costs was spent on authorisation about three

quarters of this by DG GROW (DG ENV has recently expanded its authorisation staff to three FTEs)

Both DGs spend around half of their time on authorisation decisions

66 Costs to third parties for responding to public consultations

As set out in Section 3 third parties have three formal opportunities to comment at specific times

during public consultations as a substance moves through the authorisation process



1 Inclusion on the Candidate List

2 Inclusion on the authorisation list (Annex XIV) and

3 Submission of applications for authorisation

Details on each of these public consultations are discussed below in terms of available information

on the number of responses received by ECHA from third parties and the estimated time spent they

spent producing these responses

661 Public consultation on the inclusion of a substance to the Candidate List

During the public consultation for the inclusion of a substance to the Candidate List ECHA is

seeking information concerning the ldquoidentity of the substance and intrinsic properties relevant for

the identification (unless identification is based on harmonised classification and labelling and

cannot be challenged in this context) Additionally information on uses exposure potential and

alternativesrdquo50 These public consultations occur twice a year (for 45 days in March-April and

September-October)

As set out in Table 616 from 2008 until 2016 ECHA has received 3591 submissions during public

consultation in relation to 194 substances being proposed for inclusion on the candidate list Once

on the Candidate List these substances will be Substances of Very High Concern (SVHCs) and could

be subject to authorisation in the future if included on Annex XIV (authorisation list)

Table 616 Number of submissions received during the public consultation

Type of respondent

2008 2009 2010 2011 2012 2013 2014 2015 2016 Total

Academic institution

4 7 4 3

7 25 1

Company 35 45 210 130 239 47 30 20 23 779 22


27 76 64 50 10 4

231 6

Individual 27 34 136 16 66 4 6 1 2 292 8


27 46 164 128 141 33 27 11 111 688 19

Member State CA

33 44 77 146 230 75 66 40 44 755 21

NGO 52 70 55 88 256 42 62 27 36 688 19

Other 6 3 10 4 4 7

1 35 1

Trade union

18 28 35 9 2 6

98 3

Total 211 325 738 593 981 221 193 105 224 3591 -

Notes


2 The type of respondent has been simplified so the number of submissions presented in the table may

not match the underlying raw data

The main actors that responded to public consultation were (i) companies (ii) Member State

Competent Authorities (MS CAs) (iii) Non-Governmental Organisation (NGOs) and (iv) industry or





trade associations Since the costs to MS CAs were already covered in the Section 63 the

remainder of this section focuses on the costs to industry stakeholders (companies + tradeindustry

associations) and NGOs to provide comments during the public consultation for substances for

inclusion on the candidate list


significantly at substance level On average the number of responses received is around 13-18

responses



Maximum Median mean




substances account for 24 of the total number of submissions A further 33 substances would have

to be added to the list to make 50 of total submissions





Boric acid 245 7

44rsquo-isopropylidenediphenol (bisphenol A) 123 3


Disodium tetraborate anhydrous 79 2

Diazene-12-dicarboxamide (CC-azodi(formamide)) 72 2

NN-dimethylformamide dimethyl formamide 65 2

Lead oxide (lead monoxide) 58 2

Lead tetroxide (orange lead) 46 1

Lead styphnate 41 1

Tetraboron disodium heptaoxide hydrate 41 1

TOTAL 863 24


comments to the three public consultations covering REACH authorisation The overall numbers of

industry survey respondents were reasonably good (22) to derive indicative ranges for time spent

There were however a limited number of NGO responses (4) Based on NGO interviews most NGOs

rely on either CHEMSEC EEB or Client Earth to comment on REACH authorisation as they do not

have the resources available These respondents indicated they spend between 1-8 hours providing

a response at candidate listing stage but this does vary depending on the substance

Respondents to the industry survey were asked to describe the activities carried out as well as their

estimates for average cost and time spent The types of activities reported by respondents are

listed below (some similar responses were omitted)



ldquoTaking part in meetings within the sector getting informed about the REACH process

preparing comments organizing internal meetings with different parts of the business

talking to customers to encourage them also to commentrdquo

ldquoGathering evidence and time required to prepare responserdquo

ldquoCompiling of data from member companies preparing and validating comments with

experts from member companiesrdquo

ldquoPreparing comments sometimes achieving consensus with other industry participants

(when answering via industry association)rdquo

ldquoCollecting evidences from suppliers quantity purchased emission quantification in air

and water and waste worker exposure data collection consolidation of relevant products

sold consolidation of quality checks and time spent for new product qualification after

SVHC substitutionrdquo


ldquoWorking together with associations so we can divide this in cost for associations and

company costsrdquo


evaluation of base studies (if available) gathering information comparing different facts

available interviewing experts of different knowledge sectors gathering market details

gathering risk data (if available) evaluation of datas representatively and timelinessrdquo

ldquoPerforming an impact assessment of the proposed substance on our business operations

We have thousands of specifications covering processes for millions of parts Once we

know what specifications are affected we determine whether we have relevant exposure

information (we typically do not) If there is an opportunity to provide socioeconomic

data we may do so Although SEA data is not typically sought at this stage we believe

this can be relevant information that should be taken into account when ECHA makes risk

management decisionsrdquo

Table 619 categorises the screened responses into bands for time taken to respond What can be

observed from looking at their description of activities carried out and time estimates the data

suggests that the low estimate of time often relates to responses from a single company often for

collecting information and forming a response The upper estimate of time often relates to when

industry or trade association level responses requires collating responses from individual members

or when companies and or industry (consortiatrade association) provide more detailed information

such on the intrinsic properties hazard exposure data on the substance



Table 619 Estimated time taken to produce submission (candidate list consultation)


1 day (or less) 0

1-5 days 5

6-10 days 3

11-40 days 4

40+ days 0 Notes



to producing a submission to the public consultation


using the low and high estimates of the costs of time spent by third parties (via survey responses)

with the total number of responses which results in a too wide estimate (euro2 million to euro73 million

over the period 2008-2016) which was not deemed to be credible given the survey sample size and

that individual low and high costs represent very different types of activities carried out In reality


prepare and others only a short quick response As some submissions prepared at sectortrade

association levels are also re-sent by individual members (with some further details in some cases)

these companies donrsquot incur the same cost to prepare their submission (or reflected within the

costs to prepare the sector response)

662 Public consultation on the inclusion of an SVHC on to Annex XIV (authorisation list)

During the public consultation for the inclusion of an SVHC into the authorisation list ECHA is

seeking ldquoconfirmation on uses and volumes used Views on the transitional arrangements and

possible exemptionsrdquo51 The public consultation normally occurs once a year and lasts for 90 days

As set out in Table 620 between 2009 and 2016 ECHA has received 3088 responses during the

public consultation in relation to 87 substances being proposed for inclusion on the authorisation

list Once on the authorisation list these substances would be subject to authorisation with a

sunset date by which time uses subject to authorisation must cease in the EU unless an

authorisation has been granted or the applicant is pending a final decision of their AfA (which was

submitted prior to the latest application date)





Table 620 Number of submissions received during the public consultation (Annex XIV)

Type of respondent 2009 2010 2011 2012 2013 2014 2015 2016 Total

Academic institution 2 4 2 8 0

Company 91 8 1040 98 218 230 42 4 1731 56


56 11 2 27 96 3

Individual 20 60 8 29 32 2 151 5


57 5 184 38 113 177 70 644 21

Member State CA 105 29 44 28 15 40 13 2 276 9

NGO 36 16 31 20 6 5 6 120 4

Other 4 1 16 2 3 8 5 39 1

Trade union 1 4 10 7 1 23 1

Total 371 60 1394 204 395 520 136 8 3088 -

Notes


2 The type of respondent has been simplified so the number of responses presented in the table may

not match underlying raw data

3 The PC for the 8th recommendation was from 2 March 2017 until 2 June 2017 so these 8 comments

were submitted in May 2017 whilst the PC for the 8th rec is still running At the close of the publc

consultation a total of 82 comments were received 3 individuals 55 company 23 Industry

association 1 MS)

The main actors that responded to public consultation were (i) companies and (ii) industry or trade

associations The remainder of this section focuses on the costs to industry stakeholders (companies

+ tradeindustry associations) to provide comments during the public consultation for substances

for inclusion on the authorisation list


significantly at substance level On average the number of responses received per substance is

around 16-35



Maximum Median mean




substances account for 53 of the total number of submissions By adding a further eight substances

to that list would account for 80 of total submissions








Chromic acid Oligomers of chromic acid and

dichromic acid dichromic acid 263 9

Boric acid 159 5


Aluminosilicate Refractory Ceramic Fibres (Al-RCF) 115 4


Zirconia Aluminosilicate Refractory Ceramic Fibres

(Zr-RCF) 99 3

NN-dimethylformamide (DMF) 94 3

Cobalt dichloride 87 3

Cobalt(II) sulphate 87 3

TOTAL 1621 53




authorisation as they do not have the resources available Available data from the NGO survey

suggests on the whole these NGOs do not devote as much time (~2 hours per submission) on the

Annex XIV public consultation as compared to candidate listing or on AfAs (see next sub-section)

The overall numbers of industry survey respondents were reasonably good (23) to derive indicative

ranges for time spent

Respondents to the industry survey were asked to describe the activities carried out alongside their

average cost and time spent estimate The types of activities reported by respondents are listed

below (some similar responses were omitted)

ldquoEvidence gathering and comment preparationrdquo

ldquoGathering information on the REACH process talking to customers in order to encourage

them to comment prepare commentsrdquo

ldquoData gathering coordination and approvalrdquo

ldquoGathering general data on [sector] exposure of workers and consumers use of

[substance] for [sector] short review of alternativesrdquo

ldquoReview of ECHA documents Assessment of SVHC used internally and by suppliers drafting

comments reviewing comments etcrdquo

ldquoWe have responded on our own as well as part of an industry group Activities are similar

to those of an SVHC listing proposal We perform an impact assessment and determine if

we have any relevant data that can be providedrdquo



ldquoPreparing comments joining efforts with other industry participantsrdquo


ldquoPreparing comments discussion in associations gathering information from customersrdquo

ldquo[substance] several meetings with associations exchange of information develop a huge

amount of documentsrdquo


gathering information comparing different facts available interviewing experts of

different knowledge sectors gathering market details gathering risk data (if available)

evaluation of datas representatively and timeliness gathering detailed information on all

different uses including state of the art of facilities comparing practical experiences of

uses assigning data to different uses reading and interpreting authorisations dossiersrdquo



often relates to responses from a single company often for collecting information and forming a

response The upper estimate of time often relates to when industry or trade association level

responses require collating responses from individual members or when companies and or industry

(consortiatrade association) provide more detailed information such as volume and uses

information and justifications for exemptions

Table 623 Estimated time taken to produce response (Annex XIV consultation)


1 day (or less) 1

1-5 days 7

6-10 days 2

11-40 days 5

40+ days 1 Notes




The number of submissions andor time spent by industry preparing a proposal for exemptions

might be reduced by clarifications concerning when an exemption might be granted and what

supporting evidence is required for better informed decisions Further supporting information has

been made available by ECHA in March (2017) which may reduce this going forward (see

footnote52) This kind of supporting information was available in 2014 and is updated with every

recommendation round

52 ECHA(2017) - ECHArsquos general responses on issues commonly raised in public consultations on draft

recommendations - Available at

httpsechaeuropaeudocuments1016213640recom_general_responses_doc_enpdf44e192e5-ac72-4458-

b4f5-c016754a1d4c



Whilst it as possible to produce indicative estimates of the total costs over the period 2009-2016


resulting estimates (euro02million to euro100million over the period 2009-2016) were not deemed to be

credible given the small sample and given individual low and high costs represent very different

types of activities carried out In reality ECHA will have received a variety of responses some of

which would have taken a long time to prepare and others not As some submissions prepared at

sectortrade association levels are also re-sent by individual members (with some further details in

some cases) these companies donrsquot incur the same cost to prepare their submission (or are

reflected within the costs to prepare the sector response) According to ECHA in the last years a

lot of effort has been made by industry and their associations (in close cooperation with ECHA) to

prepare and submit consolidated comments This has reduced the total number of comments but

at the same time has generally improved their quality ie ECHA get fewer submissions compared

to previous years but a higher number of those submissions are well prepared and raise important

issues with respective justifications (such comments are likely to taker longer time to prepare)

663 Public consultation on the applications for authorisations

An application for authorisation will be subject to a public consultation that fits within a public

consultation window that occurs quarterly for eight weeks (starting in mid-February mid-May mid-

August and mid-November) The number of substances included in a public consultation will vary

with some windows being busier than others As shown in Figure 61 since the first application in

2013 to the end of 2016 ECHA has conducted 180 such public consultations and received 1128

responses from various stakeholders For each AfA ECHA is seeking information on ldquoAlternative

substances or technologies to the use(s) applied for risks technical feasibility and costs of

alternativesrdquo53

Figure 61 Number of AfA public consultations and comments received




0

50

100

150

200

250

300

350

400

450

0

5

10

15

20

25

30

35

40

45

50

Co

mm

en

ts

Co

nsu

ltat

ion

s

No of consultations No of comments



As set out in Figure 62 the majority of comments have been from industry Downstream Users

(DUs) Manufacturers Importers (MIs) and industrytrade associations A large number of

comments have also been received from NGOs

Figure 62 Types of REACH actors that have commented on an AfA


As shown in Figure 63 the substance that received the most comments was Chromium trioxide

This would suggest that despite the formal intention of the public consultation to seek to gather

information about alternatives a number of responses especially in relation to upstream

applications seem to have come from their downstream supply chains providing further

information they deem relevant for RAC and SEAC and the EC in order for them to make their

opinions and decisions respectively on the outcome of the authorisation application(s)

Figure 63 Number of comments received by substance


Downstream User33

Importer8Industry or

trade association

17

Manufacturer14

MSCA2

NGO14

Individual3

Trade unionlt1

Other 8

2

11

41

6

152

232

12

115

19

9

31

6

9

449

5

2

1

1

11

13

4

0 50 100 150 200 250 300 350 400 450 500

Lead chromate

Trichloroethylene

HBCDD

Diarsenic trioxide

Lead chromate molybdate sulphate red


Dibutyl phthalate (DBP)

Bis(2-ethylhexyl) phthalate (DEHP)


Potassium hydroxyoctaoxodizincatedichromate

Sodium dichromate

Sodium chromate

Strontium chromate

Chromium trioxide

Chromic acid

Ammonium dichromate

EDC

Arsenic acid


22-dichloro-44-methylenedianiline (MOCA)

Bis(2-methoxyethyl) ether






authorisation as they do not have the resources to comment on each AfA Responses from these

NGOs suggest that they can spend between a few hours to 3 days commenting on the AfA depending

on the specific use quality of the application itself and availability of information on alternatives

The overall numbers of industry survey respondents were at a first glance reasonably good (16) to

derive indicative ranges for time spent Respondents to the industry survey were firstly asked to

describe the activities carried out alongside their average cost and time spent estimate Based on

these it was clear that some respondents had misinterpreted this as time taken to gather

information during lsquoinformalrsquo consultations that applicantsconsortia may have done to preparing

for authorisation The data from these responses were therefore excluded

The types of activities reported by the screened listed on respondents (7) are listed below (some

similar responses were omitted)

ldquoRespond to a response provided by an NGO during the public consultationrdquo

ldquoPrepare comments based on the AfA documents based on supporting evidence gatheredrdquo

ldquoData mining and then commenting timerdquo

ldquoResponse as part of an industry group We gathered information and fed it to the industry

group for aggregation along with input from other industry group members Our

comments have typically been high level and supportive of information within upstream

applicationsrdquo

ldquoIn the public consultation process alternatives had been suggested ndash Time was required to

provide information to explain why those suggested were not technically feasiblerdquo



often relates to responses from a single company for collecting information and forming a response

The upper estimate of time often relates to when industry or trade association level responses

requires collating responses from individual members or when applicants and or industry

(consortiatrade association) provide specific information on the unsuitability of an alternative

Table 624 Estimated time taken to produce response (AfA consultation)


1 day (or less) 1

1-5 days 2

6-10 days 1

11-40 days 3

40+ days 1 Notes








resulting estimates were not deemed to be credible given the small sample and that individual low

and high costs represent very different types of activities carried out This reflects reality in that


prepare and others not

664 Why stakeholders may or may not have provided a response during the public consultation

As part of the industry and NGO surveys respondents were asked for their motives for why they

responded or did not respond during the public consultation As noted earlier most NGOs do not

respond to public consultation as they rely on CHEMSEC EEB or Client Earth to comment on REACH

authorisation as they do not have the resources available The NGOs that do provide submissions

during the public consultations indicated in their responses the most common reasons for

commenting (from a list given to them) being their disagreement with the resultsfindings

presented followed by highlighting that there was critical information missing that needed to be

taken into consideration

As set out in Figure 64 the reasons why an industry stakeholder submitted a response were very

varied with some supporting and others disagreeing with the findings being shared This is because

the response is dependent on the actual public consultation Most industry stakeholders commented

because of disagreement with submissions made by regulators noting that critical information was

missing in their submissions for a substance to be included on the Candidate List and Annex XIV

respectively Comments submitted concerning AfAs on the other hand were mostly supportive as

they often came from downstream users who were being covered by an lsquoupstreamrsquo application

There were however some comments during the public consultation where some respondents

disagreed with applicants providing their information on the suitability of possible alternatives

from their perspective

Figure 64 Main reasons for industry stakeholder to provide comments

15

13

14

11

12

10

0 2 4 6 8 10 12 14 16

There was critical information missing

There were inaccuracies in informationpresented

We disagreed with the resultsfindingspresented

We agreedsupported the resultsfindingspresented

We were seeking an exemption for a specificusesector




There was more consistency in responses when respondents were asked about if they had read the

response to their submission Over 80 of respondents indicated they had read the response to

their comments with around half unsatisfied with the response given The main reason for this

was that they felt the public consultation was somewhat of a lsquoformalityrsquo and despite time and

effort to provide information or argumentation it was demotivating to get the answer such as

Thank you for your comment andor only reference to paragraphs or articles in the regulation at

the inclusion of substances onto the candidate list

Figure 65 Whether the industry organisation read published response to their comments

Whilst there is again a varied response for why stakeholders did not respond during public

consultations as set out in Figure 66 some of the key reasons were due to a lack of resources

expertise or that the information already available was sufficient or that they did not have

additional information to add

Figure 66 Main reasons for not providing comments

26

44

12

6

12Yes and I was satisfiedwith the response

Yes but I was not satisfiedwith the response

Yes but I canrsquot remember donrsquot have a particular opinion on the response

No

8

11

4

2

9

3

4

1

1

5

2

8

0 2 4 6 8 10 12

We believed the information provided was sufficient

We do not have enough staff to be able to respond

Substances and alternatives to date have not been relevantfor our organisation

We were not aware of opportunities to comment

We did not have further informationevidence to provide

We did not think commenting would influence the decision

The consultation process was too complex

The information requested was too limited (eg informationon alternatives for consultation on AfAs)

There is not enough time available to prepare comments

We did not have the technical expertise required to evaluatethe information provided





Industry stakeholders who did not respond during public consultations were asked what could be

done to encourage further participation Some of the responses are shown below

ldquoWe as a medium-sized company are not in a position to participate in a public

consultation The associations that represent us complain about the complexity of the

process and the unfavourable chronological sequence In particular the association is of

the opinion that the consideration of the alternatives only happens too late during the

public consultationrdquo

ldquoIt must be possible to read answers in our mother tongue Acceptance and cooperation

would have been significantly higher if these prerequisites had been created The

navigation is too complex and you have to be a freak to work through itrdquo

ldquoIt is not clear enough communicated what the aim of the process isrdquo Some information is

not taken into consideration and this then leads to resentment and perceptions that ECHA

ldquodoes not carerdquo

ldquoMore time would be helpful for trade associations to assemble responses especially over

the summer monthsrdquo

ldquoResponses given by ECHA via RCOMs are not conclusive and provide vague (as opposed to

specific) reasons why exemptions were rejected the COM did not even bother to respond

directly to those of us who made a response during the better regulation public

consultation in SeptOct 2016 in summary specific and conclusive responses from

ECHACOM during public consultations can help during any future public consultationsrdquo

ldquoAlthough we understand the rationale behind the format proposed for input to the public

consultation we would like to highlight the importance of input from users along the

chain which may not be specifically technical about other alternatives but is nevertheless

important to support or question the content of the documents submitted in the AfA This

should be taken into account by enabling other formats of input to be submittedrdquo

ldquoAs such the consultation processes are quite transparent However the timelines can be

challengingrdquo

ldquoThe public consultation is the first public step to gather information about other

technologies that may have potential to become an alternative in the REACh context

(economically and technically feasible for the applicant) This is far too late This

collection should be performed before putting a substance on Annex XIV (eg by RMOA) In

some cases this would make the authorisation process obsolete at all in some cases this

would open the way to focus all efforts (by applicant authorities associations and public)

to the main questions and issues Instead the applicant has to deal with all possible

topics may they be serious or may they be out-of-date already and all third-parties as

well ECHA and potential applicants (possibly represented by their specific associations)

should identify the main approaches to risk reduction and alternatives available in

advance They should identify together the main issues that may be of concern The

current brute-force approach of discussing any possible use and any proposed parallel

technology without prioritising end in a lack of overview comparability assessment of

outcome and side-effects (eg risk-risk-trade-offs) EU-Commission and ECHA together

with case-specific stakeholder authorities should identify in advance the major issues that

may have a real measurable impact Only then should be part of a possible authorisation



procedure Actually too many issues are discussed late in the process giving no opportunity

of rational adjustmentrdquo

ldquoMany AfAs on chromium trioxide are concerning basically the same issue Why ask for all

these individual AfAs per applicationrdquo

Some of these issues are not new and were the basis for introducing the RMOA process The clear

message of requesting and using information on alternatives as early as possible (ie the RMOA

stage) is worth reiterating though However according to communications with ECHA (4th October

2017) from their experience sometimes companies can be hesitant to provide information on

alternatives during public consultations as this may have an impact on their relationships with

other companies along the supply chain

Some of the issues could at least be addressed by giving stakeholders more time (especially when

consultations occur in the summer holidays or during Christmas) and more justification given for

actions taken by regulators in light of all the information submitted

Based on an interview with an NGO they stated that ldquoalthough they have knowledge that

production of certain products can be done without the SVHC lack the technical details required

during the public consultation As a result the input of the NGOs is ignored by SEAC Same goes for

downstream users who use an alternative but not produce this alternative They also have the

knowledge and experience that alternatives are available (and commercial) but do not have the

technical details of the alternative (and do not want to ldquospeak for their supplierrdquo to that extentrdquo

67 Compliance costs

As illustrated in Figure 67 the majority of respondents (71) to the online survey indicated they

incurred some costs associated with compliance with REACH authorisation The type of compliance

incurred depends on the position in the supply chain (eg MIs have different requirements

compared to DUs)

Figure 67 Whether respondents organisation incurred costs associated with compliance with REACH authorisation process

Sample size 63

71

14

8

6

Yes

No

Dont know

Not applicable



Respondents were asked to select the types of compliance related costs they incurred due to

REACH authorisation As set out in Table 625 most respondents indicated they incurred some

costs to familiarise themselves with what they needed to do The remainder of the costs are

dependent on what type of actor they are (eg it would be the responsibility of a MI to produce

and maintain an extended safety data sheet)

Table 625 Types of compliance related costs incurred

Types of compliance costs

No respondents who incurred

costs

Proportion () of respondents that

indicated this specific compliance

related cost

Updating and maintaining an eSDS 23 51

Providing information to allow safe use of an article 10 22

Updating a registration dossier following AfAs 8 18

Notifying DUs of an authorised use 8 18

Complying with reporting obligations in authorisation decision and preparing review report

9 20

Familiarisation with REACH authorisation requirements 40 89

TOTAL 45 -

671 Familiarisation with REACH authorisation

Familiarisation with REACH authorisation requirement was the most commonly incurred cost All

the respondents who provided estimates for the number of days and costs incurred were collated

Whilst the estimates were within the same orders of magnitude rather than present a single

estimate the costs shown in Table 626 are differentiated between those that are SMEs and non-

SMEs as well as those involved in submitting an AfA vs those companies that have not been involved

in submitting an AfA as this helps to explain the variation in time spent

Table 626 Costs for companies to familiarise themselves with the requirements under REACH Authorisation

Familiarisation costs SME Non-SME Involved in

AfA

Not involved in

AfA

Average time (days spent per company) 46 74 76 53

Average cost (euro per company) euro 18300 euro 32700 euro 32900 euro 22000

Table notes

Sample size = 40 of which 34 respondents provided quantitative data

Two quantitative responses were excluded as they included time spent on preparing AfA

Costs were rounded to the nearest hundred euros

The results unsurprisingly show that SMEs do not spend the same amount of time familiarising

themselves with REACH authorisation as larger companies and that those companies submitting an

AfA invest more time familiarising themselves with the requirements under REACH authorisation

The averages are shown but the estimates at company level do vary as some companies have more

staff involved in regulatory compliance than others different staff costs and many respondents

noted that they may incur further costs due to keeping on top of any policy changes



672 Costs associated with information on safe use of SVHCs

It is not surprising that only a sub-set of respondents (14) indicated that they incurred some costs

associated with producing an extended Safety Data Sheet (eSDS) The majority (~90) indicated

the cost at up to euro50000 with an even spread between those indicating the cost at euro500-1000

1001-10000 and euro10000-euro50000 Only one respondent indicated a cost above euro50000 (in fact

gteuro200000 which related to biotechnology)

A smaller subset of respondents (9) noted that they incurred a cost to update an eSDS for example

reflecting on further information received from downstream users on their use of the SVHC Two

thirds of respondents indicated the costs of updating an eSDS at between euro500-50000 with the

most common estimate being euro1000-euro10000 A third of respondents indicated the cost at

gteuro100000 (these related to biotechnology aerospace and laundry detergent applications)

Once a substance is on the Candidate List it triggers obligations for article producers and importers

to notify to ECHA and for suppliers of articles to inform recipients on the presence of SVHCs in the

articles following the provisions of Articles 7(2) and 33 of REACH These requirements might not be

easy to meet especially for complex articles (see [Title 4 of REACH] for more details) A subset of

respondents (10) provided costs associated with providing information to allow safe use of an

article Half the respondents indicated the cost to be between euro100000 and euro200000 One

respondent suggested the cost was gteuro200k whilst four respondents indicated the cost at between

euro1-10000

673 Costs following the granting of an authorisation

If an authorisation is granted it requires the registration dossier to be updated (eg if there is

better information on exposure and safe use) Only a subset of respondents (8) estimated the costs

of this update As shown in Figure 68 nearly two-thirds reported costs between euro1000 and

euro50000 A further 25 of respondents reported costs between euro50000 and euro200000 while 13 of

respondents reported costs of more than euro200000

Figure 68 Cost to update registration dossier following granting of an authorisation

Sample size 8



If a downstream user uses a substance that is on the Authorisation List (Annex XIV) based on an

authorisation granted to an applicant high up in their supply chain they have to notify (for free)

their use to ECHA54

Based on just (screened) responses received from downstream users who have to submit a

notification the estimated cost was euro1001 and euro10000 For a single DU to notify ECHA believe it

should only take a few minutes DUs need to follow the link provided eg by the authorisation

holder or at ECHAs website create an account in REACH-IT select your useauthorisation number

from the pick-list and if they wish provide voluntary info on quantity and number of staff for the

use However what may be costly is the obligation in some cases due to the authorisation

decision to report on exposure andor alternatives For practical reasons ECHA have added a

functionality for attaching a file for this purpose at the notification tool The costs could therefore

in part relate to collecting new exposure data costs

The final cost of compliance estimated was the cost incurred by applicants who had reporting

obligations as part of their authorisation decision and for preparing the review report The

majority (gt75) of respondents (9) indicated the cost at between euro1000 and euro50000 (a broadly

even spread between euro1001-euro10000 and euro10001-euro50000) A minority of respondents (lt25)

however reported costs of gteuro200000 These were from applicants related to the pharmaceutical or

aerospace sector The high costs may relate to the costs of preparing a review report where a

short review period was granted costs costs of RMMs stated to be implemented in the post

submission of the AfA andor costs of any monitoring requirements

68 Costs of substitution

This sub-section focuses on the costs associated with substituting SVHCs with alternative substances

andor technologies It is based on the findings presented in Section 5 regarding instances of

substitution and efforts to substitute

681 Costs to switch from an SVHC to an alternative

Most respondents have indicated one-off substitution cost at less than euro1 million (see Figure 69)

and that the net change in operating costs at lteuro100000 per year Unfortunately the cost ranges

included in the survey were too broad to be able to derive precise point estimates of average costs

across the whole sample but if it is assumed that companiesrsquo costs were equal to the lower limit of

their cost range the mean cost per company would be euro15m for one-off costs and euro738k per year

for operating costs even though the majority of companies would be assigned zero additional costs

following this approach This is because of the very high one-off and operating cost increases

incurred by a relatively small number of companiesrespondents

This could mean that where substitution has been financially possible it has been the preferred

strategy compared with applying for authorisation This would then imply that the (intentionally)

material costs of the authorisation process ((i) fees (ii) administrative burden (complexity) and

(iii) costs to prepare for authorisation (iv) costs related to the uncertainty of the outcome of the

authorisation process (v) compliance costs after granting the authorisation (eg improved RMM and

monitoring costs)) are driving substitution because it is a cheaper option compared with a company

applying for authorisation

54 See httpsechaeuropaeusupportdossier-submission-toolsreach-itdownstream-user-authorised-use



Even though the range of substitution costs for most respondents overlaps with the average

estimated cost of submitting an authorisation application (around euro220k Section 611) it should be

remembered that the authorisation cost covers an extended period of time and assuming a

lsquostandardrsquo review period of seven years means the annual cost of authorisation is below euro40k on

average This is low enough that if firms reporting choosing substitution rather than authorisation

were doing so for financial reasons (rather than lsquoriskrsquo or other non-financial ones) it would be

reasonable to expect more respondents to report substitutions having zero net cost or even

beneficial impacts on profitability overall However as described only a single respondent

reported a substitution of zero net cost and none reported a beneficial one substitution case

studies considered in Chapter 5 also suggested substitutions have generally been cost-increasing

rather than cost-saving This suggests that other non-financial factors are indeed also contributing

to the decision to substitute However for reasons discussed firm conclusions on this topic are not

possible

Figure 69 One off investment costs to implement alternative (substance or process) to an SVHC

Figure 610 Annual net operating costs to use the alternative (substance or process) to an SVHC

The possibility is confirmed however by observing overall survey responses one reason for citing

substitution is due to an internal policydesire to not use an SVHC Another reason is the avoided

time required (and to a lesser extent the cost) for preparing for an application The limited

78

9

13

0 0

lteuro1million



euro51-100 million

gteuro100 million

61

28

56

0 0









possibility of getting a normallong review period if there were alternatives on the market was also

noted An alternative could be preferred even if its cost is much higher than the cost of applying

for authorisation since using an alternative avoids uncertainty and does not limit the businessesrsquo

ability to commit to long term contracts with customers

One of the survey respondents noted that the applicant (their supplier) was not applying for

authorisation for their specific use given the small volume This meant the user was lsquoforcedrsquo to

substitute to an alternative on the market even though the use of this alternative would result in an

inferior product The switch to the alternative was nevertheless a less risky option as the user

believed they would not get a favourable authorisation decision

682 Cost to undertake substitution activities

As mentioned in Section 5 around one in three respondents to the industry survey said they had not

substituted SVHCs but were investigating opportunities to substitute In total 43 respondents were

able to estimate the annual costs spent on substitution related activities (that were set out in

Section 5) As shown in Figure 611 the amount spent per year by respondents is varied but

around half the respondents noted costs between euro10-100k per year

Figure 611 Annual spending on substitution activities

Examining the data further the following observations can be made

The respondents who were also SMEs noted they spent on substitution between euro1kyear

and euro100kyear There were no SME respondents who noted annual investment in

substitution above euro100kyear

Whether the respondent was involved in an AfA or not had no significant relationship to

how much was spent on finding an alternative This would imply the average amount spent

on looking for an alternative is not linked to how far the substance is along the

authorisation process (but that it could be subject to authorisation at some point in the

future) This is supported by the analysis shown in Section 5 whereby 43 of substitution

activities were triggered by placing the substance on the Candidate List in comparison to 7

of substitution activities being driving by applications for authorisation

5

16

28

23

18

55

0







euro10 - euro100 million per year




The type of use of the SVHC or sector the respondent is from did not seem to have a

relationship with how much was spent on finding an alternative

The findings from the survey regarding the benefits of substitution are covered in Section 76

69 Costs of RampD innovation and investment

According the industry online survey more 80 of respondents (3546) indicated that authorisation

has had an impact on their annual RampD innovation investment spending These relate to the

following substances (in alphabetical order)

12-dichloroethane (EDC)

44-Methylene bis(2-chloroaniline)

Boric acid

Chromium trioxide

DEHP

Hydrazine

Lead chromate

Lead chromate lead styphnate orange lead

methylhexahydrophthalic anhydride

NMP

Not stated

octylphenol ethoxylates

Perboric acid sodium salt

Refractory Ceramic Fibres (RCFs)

sodium chromate

Sodium dichromate

Further details on the specific uses of these substances are listed in Table 627 The list above and

in the Table are organised in alphabetical order to preserve the confidentiality of individual

responses

Table 627 Change in RampD innovation or investment spending (by use)




Buffer substance

Cell lysis during manufacturing of vaccines

Coatings and sealants

Conditioning of the plastics in the pre-treatment and for the final plating

Curing agent of polyurethane

Decorative plating

Electroplating of injected plastic parts

Etching and plating plastic parts

Galvanic surface coating

Hardener for epoxy resin

Ingredient used in surface treatment processes to deliver a barrier film

Insulation material




Manufacturing of pharma active ingredient

Metal Acid reaction inhibitor

Passivation of tin plating

Pigment

PLASTIC ETCHING (POP)

Plasticizers in tape

Plating of steel bars

Precursor for ClO2 generation

Pre-treatment of plastics

Solvent

Solvent used in the manufacture of APIs

Use as a reduction agent

Used as a Viral inactivation in API manufacturing processes

Various pyrotechnic mixtures

Respondents were asked for each use whether there was an increase or decrease in spending as

well as the option to not state a response As set out in Table 628 most respondents indicated

both an increase in innovation and investment and RampD spending as a result of the REACH


Table 628 Change in innovation investment and RampD spending

Change in annual spending

Number of respondents

Increase Decrease Didnrsquot state

Innovation and investment spending 26 (67) 7 (18) 6 (15)

RampD spending 28 (72) 5 (13) 6 (15)

Those respondents that indicated a change in spending were then asked to estimate (from a given

list) the scale of the change in annual spending (see Table 629) The results give more insight into

the scale of these changes reported increases in spending are generally lower than reported

decreases Therefore it is possible that the net impact of authorisation could be a decrease in

spending but it is not possible to say either way given the sample size

Table 629 Scale of change in innovation investment and RampD spending

Annual spending change

No respondent reporting a change in innovation investment spending

No respondent reporting a change in RampD spending

Increase Decrease Increase Decrease

lteuro1k 1 - 1 -

euro1k-10k 2 - 2 -

euro10k-euro50k 4 1 5 1

euro50k-100k 2 - 3 -

euro100k-1 million 3 4 7 1

euro1million-10million 3 - - -

euro10million-100million - 1 - 1

gteuro100million - - - 1

TOTAL 15 6 18 4

71 29 82 18



When asked if there were other factors that may have been responsible for these changes in

spending most respondents said there was not (59) whilst some said yes (23) and others did not

know (18) The main other driver for changes in spending was existing internal policies to try to

substitute away from the substance

Some of the qualitative justification respondents provided for their monetary estimates also reveal

some interesting insights

Several respondents noted that they would accelerate spending on RampD and investment to

substitute away from the SVHC However this would be funded by a decrease in spending

on developing new markets and products Some money needs to be spent doing intensive

testing of possible alternatives including laboratory testing pilot testing and spending on

raw materials and staff

Several respondents noted that many investments are based on long term planning that

pre-dates when the authorisation process starts Authorisation may not stop these plans

but would put into question if the production occurs in the EU if the continued use of the

substance is essential for the new productsmarket

One respondent noted that as ldquoeasyrdquo (eg drop in replacements) solutions have not been

identified the efforts have turned into long term projects that have required steady

funding The priority focus has been on ldquobig hitterrdquo processes where they believe they can

get the most reduction in the use of the substance and employee exposure for the budget

available With the onset of REACH the overall budget for RampD must now include REACH

compliance This has necessitated the redirection of some researchers to non-RampD activities

in support of REACH This includes supporting development and review of AoA documents

and attention spent on smallspecialty use cases

One respondent noted a diversion of investment from their EU sites to their sites outside

the EU They nevertheless expected to increase spending within the EU to find an

alternative in order to continue operations at their existing EU sites

Several respondents noted a halt in investment until the outcome of the authorisation is

known One respondent noted invest was being diverted to Switzerland where the

continued use of chromium trioxide is secured for the next 20 years

610 Costs of closure and relocation

Costs covered in this section are those incurred by firms which have no suitable alternatives to an

Annex XIV substance but which do not apply for authorisation to continue their use Instead they

choose to comply with the requirement to cease their use in the EEA by the sunset date by closing

their operations entirely or relocating them to another country outside of the EEA

Closurerelocation has been the lsquonon-usersquo scenario in the majority of applications for authorisation

submitted and publicly available end of 2016 It is reasonable to expect firms which choose to close

or relocate to face the same types of costs as those which have them only as non-use scenarios in

their applications for authorisation ndash even though it is not reasonable to assume the same

magnitude of costs faced by these two groups as explained below This means that descriptions of

non-use scenarios contained in applications for authorisation are useful for characterising the costs

of closure and relocation as a response to authorisation Examples of these costs can be

summarised as follows



Demolition site closure and remediation ndash Some costs might be offset by revenues from

plant and land sales

Redundancy costs and temporary unemployment ndash Note that redundancy payments

themselves are transfers from employers to employees so do not count as social costs

Unemployment insurance payments are excluded for similar reasons Temporary

unemployment can have costs in terms of lost output job search and deskilling (scarring)

which can be (partly) offset by increases in leisure time availability

Site acquisition buildings plant project management and recruitment and training at the

new site ndash Some costs might be offset if the company already owns suitable spare capacity

andor can transfer assets and employees (at a cost) from the old site to the new site

Temporary profit losses as a result of reductions in output during relocation or until the end

of the natural life of the assets In principle such profit losses (and other costs) can be

experienced both up and down the firmrsquos supply chain and

Outsourcing transport and inventory costs ndash Firms might need to outsource production to

maintain output during relocation projects as well as face additional transportation and

inventory costs in shipping output back to EU markets Some of these costs might be offset

by reduced costs elsewhere (eg production cost savings from closure and lower transport

costs for markets nearer the new site)

Note that impacts on the competitors of firms which close andor relocate are generally not

included explicitly in the cost assessment This is because they are captured implicitly by the

assumption of a finite length of time of impacts ndash and hence costs ndash of the closurerelocation after

which it is assumed that the level of output and profit returns to pre-closure-relocation levels If

competitors increase their output in response to an increase in demand following the closure of the

firm in question this can usually only happen with an increase in spending on capacity and

production which tends to take time What is important with closure and relocation is that they

will generally involve the premature obsolescence (and hence loss) of valuable productive capital

and the incurrence of additional investment in productive capital which would not have been

necessary otherwise Whether these are incurred by the lsquoauthorisation firmrsquo or its competitors is a

distributional question There might be some temporary increase in profit for competitors if they

are able to increase their prices in response to the increase in demand from customers of the firm

which closes but any such benefit is in reality a transfer away from customers and will be

associated with a loss in consumer surplus ie a net loss from the societal perspective Only if

competitors have excess capacity available and can supply a product of equivalent quality and price

can we assume that there will be no net societal loss ndash and in general we will not be able to

assume that is the case

The non-use scenarios included in applications for authorisation are hypothetical since they are

only proposed to apply in the event that the authorisation application is rejected and no

application has been rejected yet In addition the estimated costs of these hypothetical

closurerelocation non-use scenarios can be expected to differ from the costs of

closuresrelocations which actually do occur because clearly firms which apply for authorisation

consider the expected costs of authorisation to be lower than the expected costs of

closurerelocation Firms which choose to closerelocate on the other hand clearly expect the

opposite situation ndash that the costs of authorisation (including an assessment of the probability that

authorisation will be granted) will be greater than the costs of closurerelocation The costs of

compiling and submitting the application itself are relatively predictable (see Section 611) even



though there could be (potentially significant) additional costs in any specific case where a firm

must reduce its exposures and otherwise improve its risk management measures The costs of

closurerelocation estimated for non-use scenarios are generally relatively high (eg euromillions) but

could in principle be lower in specific cases for instance where the relevant operations are a small

part of a larger site (so the site itself will not need closure) employ few workers and there is

already a suitable alternative site operational Finally discussions with industry suggest that firms

often seem to place a significant risk premium on the authorisation route associated with the

(perceived) uncertainty over the initial authorisation decision and with the continued cost and

(perceived) uncertainty from the need to reapply for authorisation at the end of the review period

This premium could be the explanation if a firm chooses to close andor relocate its operations

even when the (financial) costs of authorisation would appear to be lower

Nevertheless in general it is reasonable to expect firms which apply for authorisation to be facing

different cost magnitudes from those which choose to close andor relocate This is why the

estimated costs of closurerelocation non-use scenarios presented in applications for authorisation

are not expected to be good indicators of the costs of closures and relocations actually

implemented by firms as a means of complying with the need to cease use of a substance by its

sunset date This in turn means that estimates of these costs can only be obtained from firms which

actually have closed or relocated which first requires these firms to be identified

In the consultation with industry only three respondents reported that their companies had

undertaken closures or relocations as a means of complying with the requirement to cease the use

of a SVHC by its sunset date and none of these respondents was willing to provide comprehensive

information on these activities including on costs One respondent who reported a closure was

actually predicting what they thought would happen in the event they were unable to continue

their use of their SVHC Anonymised details of these three respondents and responses are provided

in Table 630

Table 630 Industry consultees reporting relocation or closure in response to authorisation

No Substance Use and sector Relocationclosure Notes

1 Sodium

dichromate

Sensitiser used in

engraving of printing

screens

Relocation No reported impact on

employment

2 Chromium

trioxide

Corrosion inhibitor used in

aerospace

Diverted

investment

3 Confidential Surface treatment of

aluminium and steel Relocation Impact on employment

4 octyl phenol

ethoxylates Life sciences Relocation Case 3 chapter 53

5 Nonyl phenol Fine chemicals Closure Case 7 chapter 53

Respondent 1 reported using sodium dichromate as a sensitiser in the engraving of printing screens

This use had been relocated out of the EU No impact on employment was reported suggesting that

this could be a relatively minor use A further use of sodium dichromate as a sensitiser was

reported to have been substituted with a diazo compound No explanation was given as to why the

engraving use had been relocated instead of authorisation being sought However if it were a

minor use this could imply a relatively low cost of relocation compared with authorisation REACH

authorisation was seen as the only reason why this relocation had occurred

Respondent 2 reported using chromium trioxide for its corrosion resistance in the aerospace sector

This respondentrsquos use of chromium trioxide was continuing in the EU under a granted authorisation



However the company had recently switched an investment in chromium trioxide-based plating

which was planned for an EU country to a country outside of the EU The reason given for this was

the length of the review period of the authorisation which it was said was too short for the

investment planning required for this new project

Respondent 3 reported that the use of a confidential SVHC in the surface treatment of aluminium

and steel had ceased in the EU with impacts on jobs but no further details were provided (It is

not clear whether this relates to the respondentrsquos own use or anotherrsquos) It also reported having

relocated two production plants outside of the EU but no further details were provided

The case of respondent 4 is described in case 3 in Chapter 54

Because of the lack of information provided by these respondents a brief review was undertaken of

a small number of public applications for authorisation which had closure or relocation as their non-

use scenario Table 631 summarises these applications It reports the name of the applicant the

substance and use applied for the nature of the non-use scenario an assessment of cost and the

time over which it was estimated and any pertinent notes Because many applications do not

include financial figures in their public versions the cost figures given in Table 631 are those

reported in the associated SEAC opinion and are therefore subject to confidentiality ranges

Table 631 Estimated closure and relocation costs from selected applications for authorisation

Applicant SVHC Use NUS SEAC cost Time Notes

Parker Hannifin

TCE Process solvent for the manufacturing of modules containing hollow fibre gas separation membranes

R euro75-150m NPV

18 95 profit


EDC Process and extracting solvent in the manufacture of plant-derived pharmaceutical bioactive ingredients

C gteuro100m 12 Lost profit

Rimex Metals (UK)

Chromium trioxide

Oxidising and hardening agent in the manufacture of coloured stainless steel

C lteuro100m pa 10 Lost profit (99 customers)


Arsenic acid

Treatment of copper foil used in the manufacture of Printed Circuit Board

R euro300-400m 7-12 Lost profit

Topocrom Chromium trioxide

Functional chrome plating for the establishment of adjustable hemispherical surface structures

C euro5m 15 Lost profit unemployment

Veco

Ammonium dichromate

Photosensitive component in a photolithographic lacquer system

R euro10-17m 7 Lost profit unemployment relocation costs

Eli Lilly EDC Reaction medium and a solvating agent in the manufacture of an API

R euro6-20m 14 Decommissioning outsourcing (profit loss excluded)

Notes Substances ndash TCE trichloroethylene EDC ethylene dichloride Non-use scenario ndash C closure R relocation

This selection is in no way representative and is provided just to give a sense of possible

magnitudes of costs included in authorisation applications It can be seen that a few applications

have relatively low (euro5m-euro20m) costs whereas others have costs estimated to run into several

hundred million euros Closure and relocation costs themselves tend to represent a relatively small

proportion of these totals which tend to be dominated by losses in profit (from the destruction of

the capital stock or relocation of the capital stock outside of the EU) These costs are orders of

magnitude higher than the costs of applying for authorisation (Section 611) which would explain

(partly) why these companies choose to apply for authorisation rather than to relocate or close As



already discussed we expect the costs of closure and relocation to be significantly different

(higher) for applicants for authorisation than for companies which actually close or relocate

However if the costs in Table 631 are representative of the costs companies face from closure or

relocation it would go some way to explaining why so few examples of closurerelocation have

been reported in the consultation

611 Costs to apply for authorisation

Costs covered in this section are those incurred by applicants in compiling and submitting

applications for authorisation and then engaging with the application process post-submission

Costs to other parties engaged in this process are covered in other sections

Since the authorisation application process started in 2013 ECHA has used an applicant survey to

collect information on the costs to applicants of preparing and submitting an application This

survey collects information on the lsquodirect costsrsquo of the application and the amount of lsquointernal

staff timersquo expended lsquoDirect costsrsquo are defined as follows

Preparation of assessment reports

Handling of the application process (overhead project management legal advice etc)

Consortium fees

Expenses (travel hotel and meeting rooms etc) and

Application fees (payable to ECHA)

ECHA has provided these figures in terms of the mean per applicant per use applied for These have

been calculated by taking the simple average of each respondentrsquos estimated mean cost per use

That is for each respondent the total reported cost of their application is divided by the number

of uses they applied for to give a cost per use for each respondent and then the average of these

figures across all respondents is calculated Thus the simple averages reported do not take account

of the characteristics of the respondent or the application Although it is not clear what weighting

if any should be given to the figures from different respondents the fact that those reported here

are unweighted should be born in mind

A breakdown of these figures by size of applicant position in the supply chain and authorisation

route was also provided by ECHA To aid comparison the estimates of direct costs and internal

staff time expended have been converted into a total mean application cost per use using a

notional euro75000 per year total (including overhead) wage cost for internal staff

Application fees paid to ECHA are included in the application cost figures in the survey but reflect

costs incurred by ECHA in processing the application and hence have been included in the section

on costs to ECHA It has not been possible to identify the actual fees paid by individual respondents

to the ECHA survey so fees have been estimated in terms of the average per use for each class of

applicant covered in Tables 69 to 612

Table 632 presents application cost information reported by all survey respondents over the period

2013-2016 Direct costs and fees are reported in euros and internal staff time in person-months

Means reported in the final row of the table are averages of each yearrsquos figures weighted by the

number of respondents in that year It can be seen that on the basis of responses from 57

applicants covering 101 uses over four years the mean direct costs per use were just over

euro100000 and the mean number of internal staff months expended per use was just under 10 The

average fee paid was just under euro40000 per use (This compares with the figure derived in Section

643 of euro51000) Reported costs were clearly highest in the first year of applications (when the



survey response rate was also highest) but since then there has been no clear trend Given the

variation in application types substances etc and the low response rate in some years it is not

possible from these data to say whether application costs have changed over this period

Table 632 Reported mean application costs per use and applicant 2013-2016 (source ECHA)

Direct costs

exc fees

(eurok)

Fees

(eurok)

Internal

staff time

(months)

Notional

total cost Respondents Uses

Total

applicants

Response

rate

2013 19693 3656 1621 33480 8 25 14 57

2014 8043 4033 47 15014 14 23 30 47

2015 7916 3702 1051 18187 14 23 70 20

2016 9617 3929 1072 20246 21 30 82 26

10227 3860 996 20312 57 101 196 29

including co-applicants

ECHA has provided a breakdown of these figures by size of applicant position in the supply chain

and authorisation route To aid comparison the estimates of direct costs and internal staff time

expended have been converted into a total mean application cost per use using a notional euro75000

per year total (including overhead) wage cost for internal staff Thus the total mean application

cost per use across all respondents to the ECHA survey is just over euro200000 (Table 632) This can

be compared against the broken-down figures in the following tables Tables showing a greater

level of disaggregation are provided in the confidential annex

Table 633 presents reported mean notional total application costs per use broken down by the

position in the supply chain of the applicant It can be seen that over 2013-2016 the majority of

applicants (146 out of 196) have been downstream users with a survey response rate of around 13

for this group The next largest category is importers but only 3 out of 20 importers have

responded to the ECHA survey

It does appear generally that applications submitted by manufacturers (euro273000) and importers

(euro262000) have tended to be more expensive per use than those submitted by downstream users

(euro159000) with those submitted by only representatives (euro88000) being cheapest of all Fees

appear comparable across groups except for only representatives who have paid lower fees per

use perhaps reflecting economies in application costs However as can be seen from the more

detailed annual figures presented in the confidential annex there is sufficient variation in these

figures to make firm conclusions impossible In addition numbers in different categories are small

enough by year that as with the overall figures reliable time trends cannot be drawn on the basis

of these data



Table 633 Reported mean notional total application costs per use and applicant by supply chain position 2013-2016 (source ECHA)

M I OR DU MI IDU

IC F TC n(N) IC F TC n(N) IC F TC n(N) IC F TC n(N) IC F TC n(N) N IC F TC n(N)

273 37 310 3(10) 262 40 302 3(20) 88 17 105 3(10) 159 41 196 46(146) 145 34 179 2 2 - - - 0(7)

Key

M = manufacturers I = importers OR = only representatives DU = downstream users MI = manufacturer-importers IDU = importer-downstream users




Table 634 Reported mean notional total application costs per use and applicant by company size 2013-2016 (source ECHA)

Large Medium Small Micro

IC F TC n N IC F TC n N IC F TC n N IC F TC n N

179 42 221 48 151 119 38 156 3 18 95 16 112 4 17 32 5 37 2 10

Key






However one aspect which is worth drawing attention to is the fact that the costs per user rather

than per use are likely to vary significantly across applications by supply chain position

Downstream user applications seem to be cheaper than manufacturersrsquoimportersrsquo but only cover

the bottom of the supply chain ndash essentially a single user Manufacturersrsquo and importersrsquo

applications cover the whole supply chain and hence potentially at least all users (for a given

use) The cost per user therefore is likely to be significantly lower for upstream than for

downstream applications

Table 634 presents reported mean notional total application costs per use by company size The

first thing to note is that the vast majority of applications have been from large companies (151

applicants out of 196) Large companies make up an even bigger proportion of survey respondents

(48 out of 57) Due to the very low number of respondents from non-large companies it is not

considered possible to draw conclusions about application costs for different-sized companies

Table 635 Reported mean notional total application costs per use by application route 2013-2016 (source ECHA)

Adequate control Socio-economic Analysis

Notional

internal cost Fee

Notional

total cost n(N)

Notional

internal cost Fee

Notional

total cost n(N)

272 40 311 8(18) 147 38 185 49(178)



Table 635 presents reported mean notional application costs per use by the route of application

ie lsquoadequate controlrsquo or lsquosocio-economic analysisrsquo The vast majority of applications (178 out of

196) and respondents (49 out of 57) followed the SEA route and hence drawing conclusions on the

relative costs between application routes is difficult It should also be remembered that although a

SEA is not required for applications under adequate control ECHA does advise all applicants to

compile one as a fall-back if adequate control is not demonstrated and to provide support for

other aspects of the application (eg the requested review period) However one aspect which is

worth drawing attention to is the fact that the costs per user rather than per use are likely to

vary significantly across applications by supply chain position Downstream user applications seem

to be cheaper than manufacturersrsquoimportersrsquo but only cover the bottom of the supply chain ndash

essentially a single user Manufacturersrsquo and importersrsquo applications cover the whole supply chain

and hence potentially at least all users (for a given use) The cost per user therefore is likely to

be significantly lower for upstream than for downstream applications

Table 635 suggests that applications under adequate control have not generally been cheaper

than those under the SEA route However the sample size is small and these applications might

also have included a SEA anyway so drawing conclusions is difficult

As already noted these cost estimates apply to pre-submission activities only ECHA has recently

started undertaking a survey of applicantsrsquo post-submission activities These are specified in the

survey to include

Responding to requests for additional information by RAC and SEAC

Responding to public consultation comments

Participating in the trialogue meeting with RAC and SEAC rapporteurs (if one is held) and

Providing comments on the draft opinions



The first results of this survey have been provided by ECHA and are presented in Table 636 Direct

costs are reported in euros and internal staff time in person-days Using the same notional euro75000

figure for a full-cost FTE these figures are translated into a notional total cost for applicants

during the opinion-making phase The mean notional total cost reported by applicants was just

under euro17000

Table 636 Reported notional total costs for applicants in the opinion-making phase (source ECHA)

Direct costs

(consultants fees) euro

Internal staff

time

(person days)

Notional total cost Number of

respondents Number of uses

euro13670 8 euro16526 29 49

This implies that the total (notional) cost of applying for authorisation has averaged around

euro180000 per use over the period 2013-2016 with an additional euro40000 paid to ECHA in application

fees Application fees have not apparently changed significantly over time although the number of

applications has increased markedly

612 Costs to improve risk management

This sub-section focuses on the costs associated with improving risk management of SVHCs Further

details of the uses where improved risk management took place as well as details of the measures

are set out later in Section 73 (benefits of improved risk management)

In total (n=57) 40 of industry survey respondents indicated that they had improved risk

management of SVHCs as a result of the authorisation process As set out in Figure 612 most

stages in the authorisation may trigger improved risk management This suggests that companies do

not wait until the substance is placed on the authorisation list before carrying out further risk

management

Figure 612 What authorisation stage triggered these risk management activities

However it is not surprisingly that most respondents noted the applications for authorisation stage

as a key driver for improving risk management as it is legal requirement (art 6010) for applicants

to show minimisation of emissions as part of their application Whilst there is pressure to make sure

exposure and emissions are as low as possible there are examples with TCE (as publicised in AfA

opinions) where the RAC have recommended to SEAC to grant shorter review periods when there

15

27

815

35









was not sufficient evidence of minimisation of emissions as well as imposing additional conditions

to improve RMMs andor monitoring requirements This is despite the evidence that a longer review

period was justified from an SEA perspective

Respondents were asked to indicate the one-off cost incurred by their organisation in implementing

these risk management activities of which a subset (n=22) were able to quantify these one-off

costs As shown in Figure 613 around half of respondents indicated the costs to around (euro10k-

100k) even though a third of respondents spent over euro100k Assuming that each company spent a

figure equal to the bottom limit of its cost range this would put the average spend per company at

just under euro140k With 200 applicants for authorisation over four years this might suggest an

annual one-off cost of around euro7m This figure is extremely uncertain however given the small

sample number of respondents

Figure 613 Estimated one-off cost of risk management activities

Examining the data further the following observations were found in the data

The respondents who were also SMEs noted they spent between euro1k and euro100k There

were no SME respondents who noted risk management investment above euro100k The risk

management investments above euro100k have therefore been carried out by non-SMEs

Whether the respondent was involved in an AfA55 or not had no significant relationship to

the average spend on improving risk management

However what could be observed (but cannot be generalised given the smaller sample size)

from the data was that the higher risk management investment seemed to be linked to the

earlier stages in the authorisation process This could be explained because

o There is more time for companies to plan for such improvements at RMOA and

candidate listing stage as well as fewer constraints on resources (financial and

human) whereby companies do not need to also prepare for an application for

authorisation There is also an incentive for companies to improve their RMMs as it

may affect their prioritisation to Annex XIV and reduce uncertainties concerning the

outcome of evaluations made by authorities on the applications for authorisation

55 This includes both applicants and downstream users covered by the application

9

14

41

27

9

0

euro0-euro10 000

euro10 001 - euro50 000

euro50 001 - euro100 000

euro100 001 - euro1 million


gt euro10 million



o There could be pressure at sectorconsortia level to drive down exposure in the

supply chain once a substance is on the candidate list so that regulators prioritise

other SVHCs for authorisation

o Applicants have already invested to reduce exposureemissions earlier in the

process so there are fewer options available at AfA stage

The effectiveness of these measures are set out later in Section 73 which sets out survey results on

the benefits of improved risk management on human health and the environment

613 Summary of costs

This chapter has covered a wide variety of different types of cost associated with the authorisation

process including administrative costs of running and engaging with the process costs of improving

risk management measures costs of substitution and costs of closure and relocation

Administrative costs of running the authorisation process incurred by ECHA MS CAs and the EC

appear to amount to around euro84million per year (euro43m for MS CAs euro3m for ECHA and euro11m for

the EC) Application costs (excluding fees) might be estimated at a similar ballpark figure of

euro9million per year (50 uses per year at euro180k per use (Table 631)) although subject to significant

variation given the variation in the annual number of applications Costs of additional risk

management measures associated with these applications are difficult to estimate given the nature

of responses to the survey but might add another euro7million per year (50 applicants at euro140k per

applicant Section 612) This figure is extremely uncertain however given the small sample size

of respondents Costs to stakeholders associated with providing comments and so on are not

estimated here due to the very small number of survey responses received








costing results to the EU-level is not feasible Section 67 of the main report suggests the costs of

compliance are likely to run into thousands (possibly tens of thousands) of euros per company

which could make them significant at an aggregate level








































aggregate level







7 BENEFITS FROM THE AUTHORISATION PROCESS

71 Introduction

Assessing the benefits from the REACH authorisation process is the fourth of the five focus areas

assessed The key benefits are expected to be the reduction in risks to human health and

environment as a result of the reduced use of a substance and through the improvement of

operational conditions (OCs) andor risk reduction measures (RMMs)

In theory reduced use (due to substitution) is associated with elimination or reduction of exposures

and releases which were occurring during the use but also of exposures and releases due to

preceding and subsequent stages (eg manufacture unless export will replace the ceased use in

the EEA article service life waste stage) In practice the applications so far have seen very few

cases where the substance is still present in the article The impact on the manufacturing stage was

also limited as in several cases the majority of the manufacturing was for intermediate use

Furthermore substitution does not only eliminate the risks from scenarios of reasonably

foreseeable use but also from occasional accidents or micro-accidents involving the use (or even

eg road transfer) of the substituted SVHC To what extent the substitues consist of an actual

reduction of risks is mostly untested For example the impact on risk of the use of a solvent with

SVHC properties with a high ignition temperature (non-ATEX regulated) versus the use of a non-

SVHC solvent with a lower ignition point is difficult to make

lsquoInternalisationrsquo of SVHC risks into firmsrsquo decision making could benefit them in several ways First

substitution of an SVHC could reduce production costs due to the reduced need for control

measures There could also be a lsquohousekeepingrsquo effect whereby actions the firms adopt to reduce

their SVHC use and emissions could increase overall production efficiency and hence reduce costs

Better risk and exposure management processes could also be implemented even if continued use is

allowed andor substitution is not possible

There are two approaches to estimating these benefits and linking them or a proportion of them

to the requirements of the REACH authorisation The first is to use the lsquono REACH authorisationrsquo

baseline This involves estimating what would have happened to use of SVHCs exposures and the

populations at risk of these exposures (eg workers local residents etc) without REACH

authorisation and compared them to what happened with it The difference is the net benefit (or

indeed cost) of the authorisation The challenge here is that the lsquono REACH authorisationrsquo baseline

is usually not known The second approach is to compare use exposure and population before and

after the REACH authorisation (at a firm or market level) The challenge here is that there are

usually many factors that lead to changes in the same period making it at best very difficult to

apportion the benefits to REACH authorisation (or indeed any other single factor)

This is not a challenge faced by this study alone Indeed there is a developing literature on what

the benefits could be and what indicators could be used to measure them For example Okopol

undertook a review of many early studies56 However as with costs studies have generally not

focused on authorisation specifically and have been undertaken prior to the authorisation process

achieving full implementation The Okopol review also states that studies have not generally

distinguished clearly between the true benefits related to improved societal outcomes and those

that relate to intermediate outcomes or distributional changes For instance lsquobetter conditions for

56 httpeceuropaeuenvironmentchemicalsreachpdfbackgroundreach_benefit_studiespdf



innovationrsquo which is mentioned as a benefit of REACH authorisation simply reflects a change in

the relative cost of using SVHCs versus using non-SVHCs and it can come about due to any ensuing

innovation not only REACH authorisation

A total different approach on evaluating the benefits of authorisation would be by comparing the

benefits if different risk management options were adopted This approach has not been followed

in this report This is evaluated in a Risk Management Option Analysis In such an analysis the

properties and the effects of each option are evaluated in a specific case to select the best RMO

which best manages the concern related to the use of a SVHC For instance what in one case is a

benefit of authorisation could consist of a disadvantage in another RMO A detailed analysis of

these choices is outside the scope of this report which focus on the actual impact of the

authorisation process not on the relative impact compared with other RMOs In that sense a

benefit for the authorities of Authorisation is that there is an additional regulatory tool available to

manage the risks associated with the use of a substance

EC (2016) reported the development of a system of indicators for the calculation of the benefits of

chemicals legislation57 and differentiates between Output Result and Impact indicators

Output indicators relate to the activities of regulators to implement the legislation (eg

number of substances with harmonised classifications) This type of indicator is of less

relevance for this project because the number of classifications that are harmonised (CLH)

does not in itself lead to any benefit to health or the environment ndash it just means that the

classifications are now agreed upon However CLH hazard warnings and labels can lead to

differences in the way the substances are handled and used that could bring about a

benefit (this would be a lsquoresults basedrsquo indicator)

Result based indicators for the benefit of authorisation are reduced use of a substance

exposure of workers and emissions to environment However even these indicators are

difficult to populate with data to assess what proportion of these reductions are due to the

authorisation process per se

Impact based indicators relate to the net effect on humans or environment such as the

occurrence of occupational diseases or the diversity of fauna and flora Because of the

multiple factors that influence the effects like the occurrence of diseases it is deemed not

possible to use this kind of impact indicators to estimate the benefit of authorisation

Therefore other albeit proxy indicators are needed to measure the benefits of authorisation For

example one indicator could be the comparison of the change in the market share of all chemicals

versus SVHCs (see Section 4) However some substances such as TCE are also marketed for uses

which are not subject to authorisation which makes it more difficult to interpret that data

Therefore such proxy indicators are also not conclusive and difficult to apportion to authorisation

with certainty

Several Member States maintain databases to collect worker exposure data for carcinogens These

databases should allow a detailed assessment of the evolution of the workers exposure over time

Within the context of this report access was requested to the databases of the Belgian German

French and Italian authorities None was able to provide detailed data The Belgian authorities

shared a recent dataset on exposure data for CrVI but no historical values Extensive discussions

57 Study on the Calculation of the Benefits of Chemicals Legislation on Human Health and the Environment

Development of a System of Indicators April 2016 prepared by RPA DHI for DG Env



were held with the responsible authorities of the German MEGA database which contains historical

data for more than 10 years However it was not possible to share more than what is already

available in public literature which comprises reports issued on a regular basis by these

authorities In the absence of large historical datasets on worker exposure the benefits from the

authorisation process on worker exposure can only be inferred from the reported (measured) data

in AfA and through the interviews and online surveys done for this present project

This section presents the information on the benefits of authorisation that was possible to compile

from literature review the responses to the on-line survey and some specific case studies both for

worker exposure and for environmental emissions Where possible the following aspects are

covered (i) at what stage in the authorisation process benefits occur (building on the analysis in

Section 3) (ii) what changes along the supply chain result in benefits (iii) who benefits (iv) how

the benefits realised compare to what was expected (eg if there are any unexpected benefits)

and (v) how benefits are changing over time

The section contains the following sub-sections covering the benefits included in this analysis

Section 72 Literature review ndash summaries the key findings from existing studies

Section 73 Survey responses ndash overviews the responses from the survey

Section 74 Human health benefits from improvement risk management

Section 75 Environmental benefits from improvement risk management

Section 76 Benefits of substitution

Section 77 Benefits to alternative suppliers

Section 78 Benefits of better information

Section 79 Other benefits and

Section 710 Summary of benefits


The review of existing literature focused on the major and influential sources in this area A more

detailed review can be found in Annex E6 The summary here pulls together key messages in terms

of the impacts of authorisation

The majority of the reports reviewed analysed the impacts of REACH and other associated

legislation rather than the process of REACH authorisation In fact only one of the reports

specifically targeted authorisation

In common with this study a number of the studies had made use of consultation with stakeholders

to compile information In general there is little reporting of quantitative benefits however there

were indications that substitution had improved worker safety as well as lsquosofterrsquo benefits such as

improved brand reputation and worker satisfaction (eg Tickner J and M Jacobs 2016) Positive

reports are made of the authorisation process triggering activity on searching for alternatives to

SVHC even though such reports are anecdotal and at a single Member State level (eg Backes D

2017) The encouragement of substitution and widening of the market for alternatives is also

reported (Lietzman et al 2017) Another study specific to a Member State (Finland) and

authorisation indicated that energy consumption labour productivity and chemical portfolio as

examples of benefits Only one benefit described as lsquoclearrsquo by the authors was identified in the

form of micro-sized companies improving their communication networks with each other (Harrikari

and Montonen 2017)



Other reports focused on case studies with specific substances ndash the case of substitution of arsenic

oxide in Murano glass was documented by ECHA and shared with us Clear decreases in exposure

levels were documented as a result of substitution which suggests benefits to health exposure

However the size of this benefit was not reported in terms of the number of workers or specific

health benefits Occupational health campaigns such as that documented in Belgium on hexavalent

chromium compounds provided no specific commentary on the benefits of control measures or

impacts of the authorisation even though that study was reported to illustrate that the REACH

authorisation process is a significant lsquoleverrsquo when it comes to the substitution process

Studies associated with the review of REACH and REFIT gave some indications of environmental

benefits ndash for example the EC (2016) Study on the Calculation of the Benefits of Chemicals

Legislation on Human Health and the Environment cited reduction in environmental contamination

of HBCDD PFOSPFOA and DEHP even though the benefits were not quantified

More general commentary of reduction in risk and business benefits is reported in Reihlen and

Luumlskow (2007) whilst other studies such as Hennig (2016) pulled together data on overall health

impacts from AfAs done on carcinogenic substances (cumulative monetised risks (cancer burden on

workers and the general population were estimated to have an upper bound of euro74 million per

year)

The DG Environment (2013)58 indicated boarder benefits of REACH authorisation in the context of

the development of the EU progress under a system of indicator in this case indicator

6 lsquoSubstitution and Phase Outrsquo

73 Survey responses

This section sets out the findings regarding the benefits of the authorisation process based on the

online survey responses by industry stakeholders The analysis of the benefits of substitution and

the benefits of risk management activities relies on 83 respondents and 68 respondents

respectively and include also partially completed surveys The exact number of relevant answers

can be different depending if the respondent provided information on that specific sub topic


The benefits of substitution presented in this section reflect the views of those respondents who

provided examples of substitution carried out due to the REACH authorisation process The benefits

to organisations who substituted due to other reasons are not attributable to REACH authorisation

and therefore not reported here

Increased sales due to substitution

Although 68 respondents were involved in substitution activities only twenty-nine respondents

reported that their organisations had substituted SVHCs due to REACH authorisation or that they

knew of examples of substitution in their supply chain because of REACH Of these organisations

31 stated they did not know whether substitution to alternative substances andor technologies

had an effect on the volume or revenue from the sale of their products (see Q34 in Annex F5)

58 DG Environment (2013) Goal and an Assessment of the EU Efforts to meet the World Summit of Sustainable

Development (WSSD) Commitment



Only six respondents (21) stated that volumes and revenue had changed as follows

All six reported a decrease in the volume of products with alternative substances andor

technologies with an equal proportion of respondents indicating a reduction in volume by

1 - 10 11 - 20 and more than 20 (see Q36 in Annex F5)

Most reported a decrease in the revenue from products with alternative substances andor

technologies (see Q37 in Annex C5) following from the reduction in volume mentioned

above Most indicated that the decrease was between 1 and 10 (a third of respondents)

or more than 20 (another third of respondents) Seventeen percent of respondents

indicated that they had not seen a change in revenue from products manufactured with

alternative substances andor technologies

It is to be noted that in total 11 respondents (including the six mentioned above) replied to Q34

that the substitutions had led to changes in the sales or revenue volume Of these 11 two clearly

indicated an increase in sales and revenue as result of the substitution However the appreciation

of these respondents is that these substitutions were made outside of the REACH context The one

respondent was a supplier of a CrVI alternative and the other respondent had an alternative flame

retardant Based on this result it seems that the substitutions that have a positive business case are

implemented earlier than the other cases

Increased employment due to substitution

Most respondents (72) whose organisations substituted SVHCs due to REACH authorisation or who

provided examples of substitution in their supply chain stated that this had not lead to changes in

the number of people employed in their organisations Only 14 (4 respondents) stated that

substitution had led to changes in the number of people employed (see Q38 in Annex F5) Most of

these reported an increase by 1 - 10 workers (see Q39 in Annex F5)

Reduction in worker exposure to SVHCs due to substitution

Around half of the respondents (14 respondents) stated that substitution in the context of REACH

had led to a reduction in the number of workers exposed to SVHC (see Q40 in Annex F5) Most

stated that substitution had led to 21 ndash 50 workers with less or no exposure to SVHCs (see Q41 in

Annex F5) This was followed by nearly 20 of respondents who stated that less than 5 workers or 6

- 10 workers had less or no exposure to SVHCs as a result of substitution

On top of these 14 6 respondents reported to have reduced workers exposure to an SVHC through a

substitution not related to REACH

Reduction in emissions of SVHCs due to substitution

Around 45 of the respondents (n=13) stated that a substitution as a result of REACH had led to a

reduction in emissions of SVHCs to the environment (see Q42 in Annex F5)

Wastewater (see Q43 in Annex F5) Most respondents (75) indicated a decrease in emissions

to wastewater by up to 01 tonnes per year as a result of substituting SVHCs with alternatives

substances andor technologies

Air (see Q44) Most respondents (71) indicated a decrease in emissions to the atmosphere by

up to 01 tonnes per year as a result of substitution



Waste (see Q45) Most respondents (60) indicated that substitution had led to a reduction in

waste generated from SVHCs sent for appropriate disposaltreatment of up to 01 tonnes per

year Some 27 indicated a decrease between 02 ndash 1 tonne per year

On top of the 13 respondents 5 respondents reported that a substitution of an SVHC but not

related to REACH had resulted in a reduction of the emissions

Respondents were also asked whether substitution had led to a reduction in the volume of SVHCs in

the finished products (see Q46 in Annex F5) Over half of the 17 respondents (59) stated that the

volume of SVHCs in finished products had decreased When asked for clarification most of these

respondents indicated that they had either substituted or reduced the volume of SVHCs in their

finished products Note that these responses relate to cases of substitution which occurred before

the application stage of the authorisation process (eg inclusion on the Candidate List or the

Authorisation List)

732 Evidence of improved risk management activities

Sixty-three respondents indicated (Q68) that their organisations use (possible) SVHCs Of these

respondents 23 respondents (ie 37) indicated that their organisations had improved the handling

and operational conditions of the (possible) SVHCs as a result of the REACH authorisation process

(Q69) They provided 25 examples in terms of

The (possible) SVHCs that these risk management activities relate to

The usesfunctions of these (possible) SVHCs and

The risk management activities carried out in relation to the uses of these substances

Additionally 34 respondents replied that they did not improve the use conditions as a result of the

REACH authorisation process It is not clear which part of this group did not improve the conditions

at all and which part improved conditions outside the context of the REACH authorisation From the

targeted interviews with one of the respondents it is clear that at least some of them did improve

the use conditions outside the context of the REACH authorisation process

Table 71 lists the substances for which respondents reported improved handling and operational

conditions through the implementation of risk management activities as a result of the REACH

authorisation process The table also shows the number of examples given for each substance as

well as the reported uses With nine examples chromium trioxide is the (possible) SVHC with the

highest number of reported examples Table 72 lists the risk management activities reported by

survey respondents in conjunction with the number of examples referring to each risk management

activity



Table 71 Instances of improved risk management activities

No (Possible) SVHC CAS

number

Number of

examples

provided

Use(s)


Solvent in manufacture of active pharmaceutical ingredient

2 Acetone 67-64-1 1 Not stated

3 Bis(2-ethylhexyl)

phthalate (DEHP) 117-81-7 2

Bonding ingredient

Rocket propulsion


Decorative function

5 Cadmium 7440-43-9 1 Corrosion inhibitor and anti-scaling

6 Chloroplatinates Not stated 1 Refining and producing catalysts




Corrosion inhibitor and wear resistance

Decorative function

Plastic plating

Plating

Printing

Reaction inhibitor

Surface treatment

9 Chromium VI 18540-29-9 1 Steel plating

10 Dibutyl phthalate

(DBP) 84-74-2 1 Rocket propulsion

11 Methylenedianiline

oligomers 25214-70-4 1 Polymerization agent


7789-12-0 1 Process chemical

13 Not stated - 1 Hardener

Total 25


Table 72 Instances of risk management activities ndash Description of activities carried out (industry survey)


provided

1 Automating production process(es) to minimise worker exposure 1

2 Confinement of production process(es) to minimise exposure

reduced use of SVHC to limit their prevalence in final products 1

3 Employee training and examination 1

4 Exposure controls and new procedures 1

5 Improved information to workers continuous monitoring of

exposure 1

6 Improved ventilation and closed production systems 1

7 Improvements to containment and monitoring measures 1




provided

8 Personal protective equipment 1

9 Personal protective equipment improved monitoring 1

10 Protection against inhalation training workers development of

safety documents 1

11 Use of alternative substances to modify the production process 1

12 Not stated 14

Total 25


Respondents who provided examples of risk management activities were asked about the stage of

the authorisation process which triggered these activities (see Q80 in Annex F5) Most stated that

the decision to implement further risk management activities originated at the application for

authorisation stage followed by the inclusion of substances in the Candidate List (35 and 27

respectively) The recommendation for including substances on the Authorisation List (which is

distinct from their actual subsequent inclusion) triggered the smallest number of risk management

activities (8) It is important to note that the percentage values presented in this paragraph have

been derived by excluding the lsquoNot surersquo and lsquoNot applicablersquo responses from the analysis These

categories account for approximately 78 of all answers given to question Q80

733 Benefits of risk management activities

Reduction in worker exposure to SVHCs due to risk management activities

Eighty-three percent of the respondents who provided examples of risk management activities

stated that these activities had led to a reduction in worker exposure to (possible) SVHCs Most

stated that the activities had led to 6-10 or 11ndash20 workers with less exposure (33 and 30

respectively) This was followed by nearly 20 of respondents stating that 21 ndash 50 workers had less

exposure to SVHCs as a result of risk management activities

Reduction in emissions of SVHCs to the environment due to risk management activities

When asked whether risk management activities had led to a reduction in emissions of SVHCs to the

environment

22 of respondents indicated a decrease in emissions to wastewater with all respondents

stating that emissions fell by up to 01 tonnes per year

39 of respondents indicated a decrease in emissions to air with most stating that emissions

fell by up to 01 tonnes per year and

30 of respondents indicated a decrease in waste generated from SVHCs sent for appropriate

disposaltreatment Most stated the decrease was by of 6 ndash 20 tonnes per year

Only three respondents (13) stated that implementing risk management activities had led to a

reduction in the volume of SVHCs required in the production process Further respondents stated

that activities had led to a reduction in the volume of SVHCs in finished products Given the small



sample sizes quantitative results for this decrease are not representative and therefore not

presented here

Risk management activities post-submission of applications for authorisation

Sixty-five percent of the respondents (41 out of 63) stated they had submitted an application for

authorisation (AfA) or had been covered by an application by an upstream actor Of these 32 (13

respondents) stated that their AfA included specific risk management activities to be implemented

post-submission or that they had carried out further activities following submission Around 1 in 4

respondents (27) stated that these activities had led to reductions in workplace exposure and

emissions to the environment

Twelve respondents indicated that RAC had included conditions within their opinions in relation to

risk management measures and five of these respondents stated that complying with these

conditions had led to a reduction in workplace exposure andor emissions to the environment

74 Human health benefits from improvement of risk management

The results of the online survey showed (section 731) that the most pronounced benefit of

substitution is the reduction in worker exposure and emissions of SVHCs to the environment

Estimate the human health benefits of this requires knowing the exposure levels and the number of

workers exposed before and after substitution The benefits should also be estimated as net of the

health risks of the alternative substance For instance the use of TCE as a solvent has been

reduced through substitution However according to a distributer of solvents the alternative

solvent frequently used is tetrachloroethylene (PER) which is classified as Carcinogen 2 and aquatic

chronic 2 More details on the substitution of TCE is provided in Section 11

Several cases were identified where the authorisation process resulted in improvements in risk

management measures that lead to reductions in worker exposure According to the online survey

(see Q80 annex F5) these improvements are either prior to an application for authorisation or

realised in the course of an application or improvement plans announced in the AfA Some of the

improvements were made as early as during the RMOA phase which could explain why some

respondents see these improvements as not related to the authorisation process (Q69) There are

also the improvements imposed by the authorisation decision itself (eg based on a RAC opinion)

Overall in about 35 of the public versions of the applications for authorisation improvements in

exposure andor emissions were either recently implemented or were planned for the future Table

73 reported the improvements are listed per substance for the chrome related dossiers which are

the majority of the AfA in the scope of the evaluation 32 of the AfAs mentioned recent

improvements or improvement plans For the organic substances in about 40 of the AfAs an

improvement was either announced or recently done These findings are in line with the results

obtained via the online survey Based on the responses received 23 out of 63 respondents (37)

have provided information on risk management improvements due to REACH authorisation (See

Section 732) This indicates that the fact that a substance is subject to authorisation invites

companies to revisit their exposure values but only in a minority of the cases leads to improved

RMM reported in the applications for authorisation The data in the AfA does not enable estimation

of to what extent the emissions and exposure were reduced



Table 73 Improvements reported in the AfA per substance

Substance No evidence of improvement




Acids from Cr trioxide 100 0


Arsenic acid 0 100

Chromic acids 50 50


DBP 67 33

DEHP 100 0


Diglyme 44 56

EDC 42 58

HBCDD 0 100

Lead chromate 0 100

Mixture of Cr VI 100 0

Pigment yellow 100 0

Pigment Yellow 34 100 0


Sodium chromate 0 100


Strontium chromate 100 0

Technical MDA 0 100


Grand Total 65 35

ECHA reported that the numbers in Table 73 could be an underestimate Based on their

experiences the majority of applications already show improved OC and RMM as a result of

monitoring and reassessment in the preparation of the application (either through improvement in

specific RMMs during the preparation of the application or through the implementation of plans to

reduce overall exposure to SVHC) Also nearly all downstream applications indicate new (2013-

2015) campaigns to measure exposure or intensification of existing monitoring programmes This

information is not publicly available but ECHA may know of this through the Committeesrsquo QampAs and

trialogues

The meta-analysis by ECHA on the applications for authorisation shows that in 72 of the cases

improvements and or additional RMMOC are requested Thus in the majority of the cases an

application for authorisation can be expected to lead spontaneously or via the opinion of RAC to

improvements in RMM and OCs However in the survey only in 27 of the cases the applicant

expected that complying with these conditions would lead to a reduction in workplace exposure

andor emissions to the environmentA possible follow-up could be to check the effects of such

improvements on exposure after the implementation of the RMMOC for example through

enforcement campaigns and data presented in the review reports (for companies that decide to re-

apply)

During the interviews very little detailed information could be collected on exposure improvement

plans even though several companies indicated that they improved the conditions as a direct result



of the authorisation process Also most companies stated in general terms that they pursue

continuous improvement in these matters

More than 80 of the companies interviewed who were involved in a AfA of a Cr(VI) based

substance indicated that they saw no possibility to further reduction in the exposures because a

lot of improvements were already implemented in the past The driver of these improvements was

not REACH authorisation but compliance with the national exposure limits (OELsWELs etc) There

is not enough information available to judge if this result from the interviews is in line with the

result represented in Table 71 where 9 of the 25 instances of improved RMM were attributed to

Chromium trioxide use In any case from the interviews it was clear that the users of Chromium

trioxide had a history of improvements To what extent these improvements are sufficient or these

are related to REACH authorisation is difficult to tell

This is in clear contrast with the observation of ECHA that in the majority of the cases the OCs and

RMMs were improved as a result of an AfA The difference may be related to the fact that ECHA in

their communication mostly speak with the applicants while most of the interviews on Cr(VI) uses

were with DUs

A recent report (2017) on benefits from authorisation was published in Finland59 In this report 14

Finnish companies (mostly in electroplating business using Cr(VI) compounds) involved in the

authorisation process were interviewed The overall conclusion of the report is that there is no

consistent improvement of worker safety for all involved companies Only in one case a change in

RMMs were reported as a direct result of the AfA

One company interviewed was not yet applying for authorisation but worked with substances

(metals) which could end up on Annex XIV They indicated that they have recently agreed on a euro5

million improvement plan for emission and exposure reduction The main driver for them was the

current legislation (local OELs) Although exposure values on average were below the limits peak

values did exist and should be addressed by the new investments

The difference in threshold (TH) non-threshold (Non-TH) has a direct impact on the analysis of

the use conditions as reported in the CSR For threshold substances there are significantly fewer

improvement plans in the AfAs (28) while for non-threshold substances more than 41 of the AfAs

contain some form of improvement plan

Table 74 Improvements reported in the AfA TH Non-TH

No evidence of improvement




All 65 35

Threshold (TH) 73 28

Non- Threshold (Non-TH) 59 41

For the cases where AfAs were filed the improvement in human health can be estimated by

comparing the historical exposure levels with the exposure documented in the CSR of the AfA Key

in this analysis is the availability of historical exposure data Several Member States have such data

but it was not possible to obtain it for this project In the case studies on chromium trioxide and

TCE an attempt is made to estimate the improvement based on the publicly available information

59 How the REACH authorisation process affects and benefits companies A Harrikari amp R Montonen 2017



In the next section examples of improvements directly related to the applications for authorisation

are documented In all of the cases the improvements during the application phase were an

extension of on-going improvement plans This confirms the results from interviews where almost

all respondents confirmed that over the years significant investments have been made to reduce

the emissions of and exposure to SVHCs

In theory human health benefits can be due to closure or relocation of the economic activity

involving an SVHC or substitution of an SVHC or through implementation of improved RMM and OCs

In practice it was not possible to estimate the benefits to human health due to closure or

relocation The few cases of relocations that are documented in this report have a very low

exposure and are probably not representative

Case 1 Use of TCE in the manufacturing of dyed cloth

In this process TCE is used by Vlisco to remove a wax from cloth and to remove the wax from the

waste water For the continued use of the substance the company filed an AfA The AfA reported

significant improvements over the past years in the enclosure of the installations where TCE is

used These improvements reduced both the workersrsquo exposure and the emissions to the

environment The application provides an extensive overview of the technical and procedural

improvements over the years and the resulting significant reduction of the emission of TCE Due to

local legislation the applicant reported that it was not possible to use the historical worker bio

monitoring data due to protection of personal data This campaign revealed that the emission of

TCE could lead to exposure of workers in the same area even though they are not directly involved

in the TCE using activity New engineering measures were defined Some of these measures could

not be implemented before the latest application date but would be implemented before the

sunset date

Case 2 Use of TCE in the manufacturing of high performance polymer membranes

Parker is a company located in the Netherlands and uses TCE in the manufacturing of polymer

membranes The company applied for authorisation for the continued use of TCE The company

already had an extensive program in place for the minimisation of the emissions and worker

exposure However in the context of the application for authorisation the company had a new

campaign of worker exposure monitoring This monitoring program was based on analysis of

activities of the workers as would be reported in the AfA (contributing scenarios) The campaign

confirmed the low exposure of workers except for one location where the exposure was still low

but could be further minimized This would improve the far field exposure of several workers in the

surroundings An engineering measure was defined and budgeted but could not be installed prior to

the latest application date hence the assessment was made on the current installation This

assessment showed a very low exposure but in this case the monitoring programme and

engineering creativity will allow a further reduction in the exposure

Case 3 Use of chromium trioxide in electroplating by a large company at several locations

A large company operating several electroplating installations applied for authorisation for the

continued use of Chromium Trioxide Monitoring programmes already existed but the methodology

and the sample locations were not aligned between the different sites which made comparing the

results difficult In the context of the AfA a new monitoring program was designed to align

measurement methods However even in a controlled setup it was not possible to achieve exactly

the same detection limit for the different sites The methods of available local suppliers could not

be aligned Within the context of the AfA working with local suppliers instead of a central

analytical lab was chosen as a more sustainable solution for the future



Despite the differences in detection limits it was possible to compare the performance of the

different sites Although the risk reduction measures were different in different sites the exposure

and emissions were comparable In this case the AfA did not lead to reductions in the exposure or

emissions but created a relationship between the sites to continue to exchange best practices

Case 4 Use of EDC as solvent in polymer production

A polymer producing company uses EDC as solvent in the manufacturing of the polymer The

process is a closed system and the solvent is separated from the manufactured polymer and is

recycled Over time the company had reduced the solvent losses significantly by monitoring the

inventory of the solvent carefully However this methodology has its limits to detect small losses

In the context of the application for authorisation a worker exposure monitoring program was set

up and a survey of the process was done by an external expert to evaluate the minimisation of

emissions as required for an AfA As a result of both measures hot spots for worker exposure were

identified and additional engineering measures were installed to reduce the emissions In the

future the company will implement a leak detection and repair (LDAR) programme to minimise the

fugitive emissions The production site is fairly small and use of external experts allowed the

company to achieve a significantly lower level of worker exposure and emissions

Case 5 Use of EDC in the manufacturing of an active pharmaceutical ingredient

A producer of Active Pharmaceutical Ingredients (APIs) used EDC as a solvent in the manufacturing

of two APIs As can be expected in a pharmaceutical environment the exposure to any substance

during the manufacturing of the API is very low Very high levels of confinement are achieved to

prevent exposure of workers to the APIs In the context of an AfA a monitoring program was set up

and a survey was conducted to evaluate the minimisation of the emissions The monitoring

programme confirmed the low level of exposure during the API manufacturing but both the

monitoring programme and the survey indicated that the unloading of the EDC from barrels resulted

in the highest exposure level New engineering measures were defined and implemented before the

filing of the application

The cases summarised above show that the application for authorisation has proven to be a driver

for the review of exposure and emissions situation of the SVHC The contribution of external

experts has proven in several cases to be crucial in the review and renewal of existing loss and

exposure reduction programs Exact magnitudes of reductions are very difficult to obtain Often the

reductions are small because most companies already have reduction programmes in place

eliminating the largest losses A longer evaluation period is required to quantify the effect of these

additional measures and to accurately measure the reduction

More cases on benefits by the authorisation process on the exposure to Annex XIV substances are

provided in the TIER 1 case studies (Chapters 1011 and12)

75 Environmental benefits from improvement of risk management

As noted in Chapter 3 (and elsewhere in this report) the only SVHC to have gone through the

authorisation process for environmental hazards (ie subject to and AfA for which a final decision

has been made) is hexabromocyclododecane (HBCDD) According to REACH Title VII (Article 60 (2))

the AfA should consider the risks for which the SVHC has been placed on the Authorisation List (ie

under which parts of Article 57) In this section we consider the benefits to the environment only

the benefit to the general public is not considered For HBCDD the PBT risk was considered in the



AfA But the applicants argued that no further assessment of risks to human health (ie workers

and professionals) was required since adequate controls on category 2 reproductive toxicant

substances were already demonstrated in the CSR The RAC commented that human health risks

should be considered but did not require the applicants to reassess In the end the argumentation

in the AfA for HBCDD was focussed very much on the non-availability of the alternative to the

applicants rather than a comparison of the risks The RAC stated that they could not conclude on

environmental risk Therefore a real test of whether environmental risk can be quantified in order

to compare to overall benefits has not been made It remains for other PBT and vPvB AfA to show

this

It should be noted that it is the obligation of all registrants to make a PBT assessment of their

substances against the criteria in Annex XIII of REACH If they conclude that the substance is PBT or

vPvB then since adequate control cannot be demonstrated for the environment release to the

environment must be controlled to levels that are as low as possible (ldquomeasures which minimise

exposures and emissions to humans and the environmentrdquo60) regardless of whether the substance is

actually listed on the Candidate List

Quantified benefits for the environment from additional controls (ie risk management measures)

are difficult to identify however as reported in the literature (see Section 72) there is qualitative

and anecdotal evidence that additional environmental controls promoted by the authorisation

process have led to environmental benefits AfA that have focused on risk to human health for

workers but that also have environmental releases shows evidence that controls have been at

least optimised to reduce exposure to the environment In the AfAs for trichloroethylene (TCE) for

example the applicants considered the exposure of the general public (sometimes referred to as

lsquoman via the environmentrsquo in risk assessment terminology) such that the impacts on both workers

directly exposed to the SVHC in the workplace and general public (exposed thought the

environment) were considered In addition to hazard to human health (for which the substance was

placed on the candidate list) TCE has an environmental hazard classification (H412 Harmful to

aquatic life with long lasting effects) and was one of the very few substances for which a Predicted

No Effect Concentration (PNEC) was derived for air in the (pre-REACH) substances regulation (EC

Council Regulation (EEC) No 79393) Therefore in the AfA assessments the applicants assessed

concentrations against the PNECair and determined adequate control based on this It is noted that

during the ESR process a risk reduction strategy for environmental risk of TCE concluded that risk to

the environment should be controlled through measures that control releases to atmosphere (such

as the lsquoSolvents Emissions Directiversquo 199913EC) and legalisation controlling emissions from

certain processes (formerly IPPC (Directive 20081EC) now IED (Directive 201075EU))

The actual effect on the environment of the authorisation process was investigated through the on-

line survey For instance it was shown (Q42) that in 45 of the substitution cases the emissions to

environment were reduced Also in 39 of the cases (Q84) additional risk management measures

have resulted in reduced emissions to the environment This shows that although the large

majority of the substances present on the authorisation list are selected for human hazard there is

still a benefit of the environment in terms of reduded emissions To what extent this reduction also

resulted in a reduced risk for the environment is untested In case the emissions prior to the

authorisation process were adequately controlled the reductions of the emissions due to

authorisation would not have contributed to a reduction of risk 60 REACH Annex 1 Paragraph 65 ldquoFor substances satisfying the PBT and vPvB criteria the manufacturer or

importer shall use the information as obtained in Section 5 Step 2 when implementing on its site and

recommending for downstream users risk management measures which minimise exposures and emissions to

humans and the environment throughout the lifecycle of the substance that results from manufacture or

identified usesrdquo




Evidence of benefits due to substitution triggered by the authorisation process was collected via

the on-line survey targeted interviews and via leads provided by the European Commission and

ECHA The following potential benefits due to substitution were investigated through the online

survey which received twenty-nine responses on this topic (as shown in Section 731)

Increased sales

Increased employment

Reduction in worker exposure to SVHCs and

Reduction in emissions of SVHCs

It seems that there were no net benefits in terms of volume of sales or revenue There were some

very small indications of net changes (increase) in employment

The main benefits from substitution appear to come from reductions in exposure emissions or

waste In addition respondents reported better handling operations for SVHCs as well as risk

management measures leading to reductions in worker exposure to SVHCs Whilst the survey

sought responses on who had taken action to control risks and indicated the range of volumes to

which such actions apply no specific evidence was gathered that allowed a quantification of the

benefits of substitution The evidence gathered is qualitative but suggests improvements in

exposure control for workers and decreases in releases to the environment This is substantiated by

a review of the literature (Section 72) and the example shown below

Case 1 Substitution of As2O3 in the production of Murano Glass

Artistic glass makers in Murano have used arsenic trioxide (As2O3) widely as a refining agent for

centuries The Commissionrsquos decision to include it to the Authorisation List (Annex XIV of REACH)

in 2011 forced local glass manufacturers to decide on whether to apply for authorisation or

substitute to other substances or techniques After getting the clarity that the use of As2O3 was not

an intermediate Murano glass manufacturers decided to opt for substitution based on research

carried out by the Stazione Sperimentale del Vetro in 2010

The substitution of As2O3 by Antimony Trioxide Cerium Oxide Lithium Oxide and blast furnace slag

resulted in a significant reduction in the concentration of arsenic in air from over 200 ngm3 in 2014

to about 4 ngm3 in 2016 This is below the annual limit of 6 ngm3 of arsenic which is the target

value of the EU as agreed in Directive 2004107EC on arsenic cadmium mercury nickel and

polycyclic aromatic hydrocarbons in ambient air and implemented by the Legislative Decree

155201061 in Italy (see Table 75)





Table 75 Change in the average concentrations of arsenic in the air in the environmental monitoring station in Murano 2014-16

Source Reports of Veneto environmental authority of 2014-15

Information from the Chamber of Commerce and the worker insurance institute (INAIL) indicated

that there were about 300 companies operating in glass manufacturing in the area of Venice (where

Murano is located) This information has been integrated with data obtained from the major local

distributor of As2O3 showing that in 2013 about 24 companies in that area were using As2O3 in

quantities between 5 kg and 5 tonnes per year Site inspections made in 2016 corroborated that

As2O3 was no longer used by any of the inspected companies apart from one

77 Benefits from closure and relocation

The benefits towards reduced worker exposure and emissions to the environment in the EEA are

obvious in the case of closure or relocation of the use of the substance But these have to be seen

in light of the emissions and exposure in the receiving location and in comparison to the cost of

relocation changes to profitability and loss of knowhow from the EEA

Closure and relocation of a use and related activities mean that exposure to and emissions of the

affected Annex XIV substances cease in the EEA The net benefits for the society would require

taking into account the loss of revenue employment etc In the context of this report lsquoclosurersquo

refers to the case when the use activity andor the complete business of which use is a part is

stopped For instance a company could decide to discontinue the manufacturing of a certain

product which specifically uses the Annex XIV substance if their other products cannot be

substitute In case of relocation the use is discontinued in the EEA but is moved to outside of the

EEA In the case of a relocation of a use a company can split a manufacturing process and relocate

a specific use This comes typically at an additional logistics cost and increased complexity of the

manufacturing When this burden is too high a full relocation of all production process can be

decided This study has not identified any cases of such full relocation

An analysis of 158 authorisation files publicly available at the end of 2016 found that 58 of them

(37) indicated relocation as an option for the non-use scenario It was not analysed if this reported

relocation would mean only a relocation of a specific use or if this would result in relocation of

additional processes or in the extreme would lead to the relocation of the complete company

During the interviews and the online survey two cases were reported where the use of the

substance had ceased as a direct result of the authorisation process (see Table 622 in Section 610

and case 3 in Section 54) In both cases the volume of the Annex XIV substance was very small and

it was used in well controlled conditions As such the benefit for the EEA from this relocation would

be as far as exposure is concerned small Again in both cases the companies had the intention to

relocate a part of the business and import the final products In one case the final product did not

contain the Annex XIV substance and in the other case contained the Annex XIV substance but at a

concentration less than 01 This means that in the latter case the relocation only resulted in the

reduction of exposure and emissions during the manufacturing phase

Reference period Average content of arsenic (ngm3)

June-November 2014 2347

September-November 2015 110

JulyndashSeptember 2016 5

OctoberndashDecember 2016 39



Another downstream user of a SVHC on the Annex XIV active in the aviation industry indicated in

an interview that an investment in an expansion of a production site using that SVHC had stopped

because of the authorisation process According to this downstream user the authorisation process

made things more complex to operate in the EEA Although he expected that a closure or relocation

decision would seldom be made solely on the basis of regulation the REACH authorisation process

was seen as a factor which supported such a decision In the same line the AmCham position

paper62 reports two cases where investments (life science and aerospace) were not made in the EEA

as a direct result of the uncertainty created by the authorisation process While these cases are

strictly not cases of relocation they indicate the impact of the authorisation process on business

decisions

From this we can conclude that relocation is considered by industry as an option in response to

authorisation requirements The costs associated with this were discussed in Section 610 which

also explained that respondents interviewees were very reluctant to provide much detail on the

relocation cases Therefore this report cannot be conclusive about to what extend the relocation

or closure actually occurs and results in reduced the worker exposure and emissions

As mentioned above the net benefits to the EEA from a closure or relocation can be assessed by

comparing the benefits due to a reduction of worker exposure or environmental emission to other

impacts such as the one-time relocation costs loss of employment loss of profit increased logistic

costs etc Such a comparison is done during the evaluation of an authorisation dossier So far no

authorisation has been refused Therefore without a detailed analysis of the individual cases it

can be concluded that in the cases where an application was filed with a relocation as non-use

scenario the benefits of reduced exposure or emission were deemed to be less than the costs to

society

However Section 610 already indicated that the costs for closure or relocation as reported in the

AfA are probably not a good indication of the costs related to actual cases of closure and

relocation In the same way the direct benefits from relocation or closure as reported in the non-

use scenarios are also not a good indicator of the benefits in the actual cases of closure or

relocation

The interviews and the online survey show that companies often take decisions on alternatives

(including in a limited number of cases closure and relocation) without filing for authorisation

Those decisions are taken on the basis of criteria set by the companies themselves Individual

companies will not consider larger societal impacts in case of a decision to relocate For instance

it might be a justifiable decision for a company to relocate a high-tech manufacturing process to

avoid the hassle of the authorisation process while relocation could cost the wider society loss of

knowhow

In addition other interviews showed that in some cases companies take decisions on authorisation

which are not economically justified from their own perspective (see case 3 in Section 53) In that

case the company decided to relocate the business outside the EEA when (objectively assessed)

reduction in emissions and exposure will be negligible but loss of profit and technology will be

measurable The driver for the relocation was the perceived uncertainty of the outcome of the


62 AmCham EU (2016) A private sector view on REACH and competitiveness - 2017 REFIT evaluation key to

addressing outstanding obstacles Position Paper for REACH REFIT Evaluation November 2016



In terms of the worker exposure or emissions beyond the EEA relocation could lead to benefits in

exposure and emission reduction only if the RMM at the new locations are better than those in the

EEA In the context of this report this aspect was not studied But in general one could assume

that the RMM in place in the EEA are better than the average RMM in the rest of the world meaning

that on average a relocation outside the EEA can be expected to result in an increase in exposure

or emissions Counter examples exist For instance in the DBP application of Huntsman it was

reported that the RMM in the European site was improved after comparing it with the US site At

the same time this example indicates that when a company has an alternative site outside of the

EEA with better RMM it could still be cheaper to upgrade the EEA site than relocate During an

interview with a plater using chromium trioxide the company mentioned that if they were to

relocate to China they would still operate in line with the technology they currently use in Europe

In conclusion while at the EEA level a closure or relocation results in an obvious and direct benefit

in terms of reducing exposure andor emissions in the EEA on a global scale it is unlikely that

relocation would result in any benefits Few examples of relocation were identified in the course of

the project but the reason why these companies considered relocation was generic not specific to

their case and could be applicable for others However insufficient details were available to have a

quantitative assessment of the total benefits of closure or relocation on the EEA

78 Benefits to alternative suppliers

It has been shown that the authorisation process leads in many cases to the use of alternative

substances or technologies

The DUs responding to the online survey confirmed this and indicated that the REACH authorisation

process has in the majority (59) of the cases been a driver for substitution This means that

REACH authorisation is indirectly a driver for the development of the business for the suppliers of

alternatives This is further confirmed in interviews with suppliers of alternatives such as

GreenCoat and another supplier of a similar technology

In Section 5 more details are provided how the markets as a result of authorisation change Two

additional examples are provided here

An interview with a distributor of solvents indicated that for Trichloroethylene the market was

largely taken over by perchloroethylene (see for instance case 8 in Section 54) Details of this are

reported in Section 11

A totally different type of benefit for the supplier of alternatives is found in the HBCDD case

HBCDD has been regulated by REACH but also by the POPs regulation For the use of HBCDD as

flame retardant in EPS an alternative has been developed called pFR (polymeric flame retardant)

and taken into production However it was clear that at the sunset date there would be

insufficient amount of pFR available on the market Without authorisation several EEA based EPS

manufacturers were at risk to have to stop production because of lack of flame retardant In the

AfA the applicants showed that this interruption of business could lead to a permanent loss of EPS

capacity in the EEA By granting the authorisation not only they were able to introduce the

alternative as it became sufficiently available on the market but also protected the market for the

suppliers of the alternative by safeguarding the demand for the flame retardant Thus by taking

the availability of the alternative over time into account the authorisation supported the

introduction of the alternative

Both for trichloroethylene and HBCDD the supplier of the alternative substances was also the

supplier for the Annex XIV substance Nevertheless the position of the supplier was totally



different in the two cases In the case of TCE the manufacturer of TCE took the initiative to apply

for authorisation for a large part of its market The manufacturer of HBCDD did not apply for

authorisation but left this initiative to the DU of the substance

In the case of Chromium trioxide the situation is again quite different For this substance the

alternative is either a totally different technology not using chrome or adapting an existing

technology using CrIII which is not on Annex XIV However the majority of the CrIII supply into the

EEA is by the company that imports the CrVI containing compounds In the case of CrVI the

initiative for an AfA was also taken up the supply chain by the importers of the CrVI compounds

Also in this case the authorisation allows the supplier of the alternative substance CrIII to delay

the introduction of alternatives until the technology is available without disruption of the market as

could be the case without authorisation

The suppliers of alternatives clearly benefit from the authorisation process The authorisation

process not only creates a market for alternatives but also allows time for the introduction of

alternatives so that it can align with the availability of alternatives Otherwise if the authorisation

is pushed or if the manufacturers or users decide to close or relocate outside the EEA this would

destroy the market opportunities for the alternative substances and technologies

79 Benefits of better information

The study found no evidence through its surveys and literature review that would allow

quantification of benefits from better information It is clear however that the authorisation

process has prompted a number of sources of information on SVHCs themselves and methods for

and instances (eg case studies) of substitution (see Section 52) Indeed the transparency of the

authorisation process is welcomed by some stakeholders (particularly NGOs) such that increased

knowledge of hazards regulatory action (such as authorisation and restrictions) are more widely

understood

Information on the specific control of risks is less widely available because it is rather specific to

the uses for which SVHC are being used Although AfA are publicly available specific parts dealing

with exposure control may be considered confidential by the applicants so may not necessarily be

in the public domain

It is the obligation of suppliers to communicate control of substances in the supply chain (in the

form of extended safety data sheets) for SVHC subject to authorisation These will include details

of control measures to be applied that were considered by RAC in their assessment of the AfA

However this is not specifically prompted by the authorisation process

For the authorities a benefit from authorisation is the availability of structured information on

remaining uses of SVHCs and via the Art 66 notifications of the sites were the substances are

used While this information does not lead directly to reduced exposure or emission this

information can be used for targeted actions to further support substitution and control of exposure

and emissions and for enforcement The monitoring requests will help to develop a database of

exposure and emissions that could be used to check improvements The extent of such benefits

cannot be assessed now and they will become more evident when more authorisations have been

granted



710 Other benefits

A Finnish study on the benefits from the authorisation process could not identify many structural

benefits for 14 Finnish companies involved in applications for authorisation One benefit however

was clear the authorisation process has led to better networking among companies This has

resulted at least in one case of sharing best practices on exposure reduction measures

One of the expected side effects of authorisation at the outset was improved innovation to find

substitutes to the use of SVHCs During the various interviews several cases were reported Two

cases are reported here where the innovation was clearly related to the authorisation process

Case 1 Dyed cloth manufacturer

The application for authorisation by Vlisco for the continued use of trichloroethylene contains an

ambitious research plan for the development of a new technology using switchable solvents to

remove a resin during the manufacturing of dyed cloth This novel technology was developed in

Canada In this sense the authorisation process was the direct cause for an innovation and a

transfer of knowledge into the EEA

Case 2 Chemicals management as starting point for innovation

The authorisation process has resulted in several companies setting-up new or additional chemicals

management programs to track the use of hazardous chemicals in their processes or supply chain

The ELV Directive had already led to the development of extensive chemicals tracking programs in

the automotive industry This tracking system focuses on certain chemicals present in car

components The REACH authorisation process requires the companies to go further and track the

use of chemicals in manufacturing processes if these chemicals are present in the end product A

world scale fine chemicals manufacturing company reported during an interview that they have an

extensive chemicals management system in place which flags if any substance they use appear in

the Candidate List It was reported that in several cases this has led to an early replacement of the

substance In all of these cases this was only possible after an RampD phase In this sense the

authorisation process has resulted in several companies having a better view on the use of

hazardous substances and having initiated RampD activities

711 Summary of benefits




wastewater and waste) This is either due to (i) improvements in RMMs where SVHCs are still be

used (ii) substitution away from an SVHC (eg to using an alternative substance or technology) or

(iii) avoided exposure and emissions within the EU due to closing andor relocating EU production

sites that previously used in SVHCs within the EU




stages in the REACH process perhaps so that the SVHC was not prioritised for inclusion on Annex

XIV as well as strengthening companiesrsquo cases for a possible future application Many applicants

that have submitted an AfA have also indicated that they have improved RMMs andor have planned



investment in place in order to demonstrate minimisation of emissions Examples of some of the

types of RMMs identified by respondents are noted in Table 72 (within Section 73)

Where RAC were not certain that minimisation of emissions was demonstrated in some cases

conditions were imposed on the applicant as part of granting the application (as well as potentially

recommending a shorter review period than might have been possible had there been fewer

uncertainties concerning minimisation of emissions) Survey responses have suggested that at least

some cases that they have improved their RMMs further (or are putting further measures in place)

which have led to (or they hope it will lead to) further improvements in reducing exposure to

workers and releases of emissions of SVHCs to the environment However most indicated that it










number of workers exposed and the exposure level over time would be required Some of this data

does exist as at Member State (MS) level as some Member States have confidential databases (for

their MS) containing historical values for worker exposure which the study team were unable to




The authorisation process creates opportunities for alternative products In some cases the

alternative is provided by the same company as the Annex XIV substance in other cases different

companies or technologies emerge Granting an authorisation however takes account of the time

needed to develop alternative substances and technological in order to allow the applicant(s) both

the users of the Annex XIV substance and the suppliers of the alternatives to adjust to in market

demand (and other factors like product requalification)








Specific benefits of closure andor relocation were also investigated Data from existing AfAs show

that the benefits in terms of reduced exposure or emissions as a result of relocation are far less

compared to the costs of the relocation Case studies on the other hand have shown that companies

have decided to relocate at a cost higher than the cost for an AfA and most probably higher than

the monetized benefit of reduced exposure Uncertainty about the authorisation process is

mentioned as a driver for this



Few other less tangible benefits were also identified The two main ones are improved

communication within the supply chain and encouraging further development of existing

technologies and in some cases innovation








authorities






8 AFFORDABILITY OF AUTHORISATION FOR SMEs

81 Introduction

The affordability of the authorisation process to Small and Medium Sized Enterprises (SMEs) is the

fifth and final focus area assessed It made sense to assess this area following the analysis of

changes in the market the level of substitution away from SVHCs and the costs associated with the


SMEs are defined in the EU recommendation 2003361 Following that definition and as set out

Table 81 the main factors determining whether an enterprise is an SME are (i) staff headcount and

either (ii) turnover or (iii) balance sheet total

Table 81 Definition of an SME

Company category Staff headcount Turnover Balance sheet total

Medium-sized lt 250 le euro 50 m le euro 43 m

Small lt 50 le euro 10 m le euro 10 m

Micro lt 10 le euro 2 m le euro 2 m

Source What is an SME (EC 2017)

According to the EC (DG GROW)63 SMEs represent 99 of all businesses in the EU The EC CCA study

(EC 2015) states the proportion of SMEs is stable among all subsectors of the EU chemical industry

between 96 and 98 of chemical companies are SMEs

The Chapter is split into six sub-sections

Section 82 Summary of literature review ndash sets out what the key findings were from

existing studies ndash The detailed review is set out in Annex E7

Section 83 Applicants from SMEs ndash summarises how many applications have so far been

received from SMEs compared to large firms

Section 84 Survey responses - summarises information provided by SME respondents to the

industry survey This does not focus on any particular substance(s) on the authorisation list

Section 85 Tier 2 Case studies - presents impacts on SMEs using specific companies as

ldquomini case studiesrdquo using survey responses existing information and further consultation

with affected companiessector groups to try to explain role REACH authorisation has had

on them These case studies build up a picture of challenges faced by SMEs

Section 86 Affordability ndash concludes on the affordability of the authorisation process for

SMEs taking into account the experience of SMEs that submitted applications on their own

or as members of existing authorisation consortia It also sets out to what extent the

63 What is an SME (EC 2017)- Available at httpeceuropaeugrowthsmesbusiness-friendly-

environmentsme-definition_en



recommendations from the REACH 2012 review have been implemented and their

effectiveness



Existing literature has been reviewed to put the new results about the impacts on SMEs produced by

this study in the context of research to date This literature includes regulation documents EC

study reports studies commissioned by ECHA (ie Harrikari and Montonen 2017 Tickner and

Jacobs 2016) a journal paper written by Philipp Hennig from the German Federal Institute for

Occupational Safety and Health as well as reports and position papers submitted during the public

consultation of the REACH REFIT Evaluation 2017


review are

Studies commissioned by the EU and ECHA as well as position papers submitted during the

REACH REFIT Evaluation 2017 suggest that affordability of applying for authorisation or

substitution to avoid an application is a bigger problem for SMEs than larger firms

The above finding is in line with the results of a cumulative cost assessment for the EU

chemical industry (EC 2016) revealing that the financial impact of chemicals legislation in

general differs based on company size While total chemical legislation costs as a

percentage of annual turnover is low (lt1) for SMEs it is more than twice as high for SMEs

as for large firms

The regulatory burden that REACH authorisation places on SMEs is recognised by the EU

which tries to minimise it by lowering the existing reduced application fees through

Regulation (EC) No 3402208

With respect to affordability the authorisation application fees seem to be less significant

than administrative costs of preparing an application dossier The dossier preparation is

particularly costly when external expertise is required which is more likely for SMEs

according to several sources

Affordability of authorisation is further worsened for SMEs by the difficulty to finance some

of the additional costs through an increase in product prices In fact studies on the

experience of Austrian and Finnish companies reveal that companies find it difficult to

recover additional costs through price increases due to low acceptance of such increases

among customers and the expectation that doing so would lead to a loss of customers

For SMEs the affordability of internal REACH-related activities is a bigger issue than the

availability of qualified persons to deal with these activities

REACH authorisation is expected to affect SMEs more strongly economically by drawing

away resources from other potentially revenue-raising activities such as innovation and

RampD



Differences with respect to the impact of REACH on business performance ndash a factor

influencing the evaluation of the affordability of authorisation in the long term - were

revealed by the EC (2015) study titled Monitoring the Impacts of REACH on Innovation

Competitiveness and SMEs According to that study the loss of international

competitiveness is a less significant issue for SMEs than large firms A higher percentage of

SMEs than large firms (47 compared to 32) even reported a positive effect on their

competitiveness Regarding trade inside the EU the effect on SMEsrsquo business performance

seems to be more negative as a higher percentage of small and micro firms (17 and 50

respectively) compared to large firms (63) reports a decrease of intra-EU exports

83 Applications to date from SMEs

Table 82 provides a high-level summary of data provided by ECHA on the number of applicants

received by size of firm during the period 2013-2016

Table 82 Number of AfArsquos by size of firm

Size of firm Total (2013-2016) Share (nearest )

Micro 9 5

Small 15 8

Medium 11 6

Large 160 82

Total 195 100

Source ECHA (updated data 10082017) In total for the period 2013-2016 around 18 of applications64 have been from SMEs As shown in

Figure 81 the highest number of SME applicants was in 2016 related to one of the several

Chromium compounds that were subject to authorisation The highest proportion of SMEs relative

to the total number of applicants was in 2015 where 35 of applicants were SMEs

64 An application is received in terms of Article 64(1) of REACH when ECHA has received the application fee

SMEs pay a reduced fee to ECHA compared to large firms



Figure 81 Number of applicants (2013-16) by applicant size

Data source ECHA (updated data 10082017)

Despite the EU chemicals sector being dominated by SMEs the majority of SMEs have relied on the

upstream supply chain (eg MIs of the substance) to submit applications for authorisation that

cover their use of the substance This is not surprising as it was envisaged during the time of

developing the authorisation guidance documents that most applications would be made by MIs of

the substance rather than downstream users in the supply chain However there are unintended

(and somewhat unforeseen) consequences associated with upstream applications whereby uses are

defined too broad suffer from less precise data on exposure and information on the suitability of

alternatives which tend to result in shorter review periods This adversely affects all actors

involved in the supply chain ndash both large firms and SMEs which are set out in more detail in the

remainder of this section Whilst the analysis below better reflects the consequences and impacts

associated with upstream applicants it is relevant to cover in the SME section given that SMEs rely

on upstream actors covering their use within their application

84 Survey responses

In total 20 SMEs responded to our survey accounting for 32 of all survey respondents Most SMEs

were involved in an lsquoupstreamrsquo application by their supplier or someone even higher up the supply

chain (eg MI of the SVHC) meaning that SMEs did not submit the application themselves It is

reasonable to assume that those that answered lsquodonrsquot knowrsquo are SMEs that did not submit an

application themselves but supported an applicant (eg financially andor with data) higher up in

the supply chain

10

33

20

132

0

20

40

60

80

100

120

140

2013 2014 2015 2016

Number of applicants (2013-16) by applicant size

Micro

Small

Medium

Large



Table 83 Type of applications SME survey respondents were involved in

Type of application that SME survey respondents were involved in Number


7

Joint application (group of actors came together) 4

Individual application (I applied for my own use only) 3

Donrsquot know 8

Total 22

Note There are 20 respondents but 22 responses because an SME was involved in more than one type of application

Respondents were asked to identify their main challenges associated with the authorisation process

(they could select up to three) As shown in Figure 82 the most common responses were

Understanding what was required how they were affected

Internal staff time required for preparing an AfA and

Finding a possible alternative to the SVHC in question

The data would suggest the main challenges faced by SMEs were knowledge based followed by

resource constraints and finally financial constraints Further details to support these responses

were gathered as part of follow up interviews with the results set out in Section 85

Figure 82 Top 3 challenges faced by SMEs associated with the authorisation process

Note ldquoOtherrdquo was excluded as respondents who selected this option did not clarify what this challenge was

SME respondents were also asked to identify their main challenges associated with the applying for

authorisation (again they could select up to three) As shown in Figure 83 the most common

responses were

Resources required for preparing applicationmy organisationrsquos inputs

Understanding what data is required and

Collecting the necessary data



Figure 83 Top 3 challenges faced by SMEs associated with AfAs

Note ldquoOtherrdquo was excluded as the respondent indicated they were responding on behalf of several SMEs

The data would suggest the main challenges faced by SMEs were again concerning knowledge and

resources rather than financial constraints Further details to support these responses were

gathered as part of the follow up interviews with the results set out in Section 85

SMEs were asked about where they got support from during the AfA process As set out in Figure

84 SMEs relied mostly on consultants who knew about REACH authorisation from their MI or

tradesector association

Figure 84 Who SMEs used to support them

Respondents were specifically asked to comment on how helpful REACH authorisation guidance and

other information on the ECHA website were There was quite a mixed response with nearly a third

of respondents indicating they did not use any of the information nearly a third indicating it was

either very helpful or helpful (combined total) and a fifth of respondents finding it not helpful and

a fifth with no opinion either way Further details to support these responses were gathered as part

of follow up interviews with the results set out in Section 85



Figure 85 SMEs views on the REACH authorisation guidance and other information on the ECHA website


In total five survey respondents who were SMEs and involved in an application for authorisation

indicated they were willing to be contacted further In the follow up four companies remained

engaged and two telephone interviews were carried out and two written responses were received

To use their limited time in the most efficient way the questions focused on areas of particular

interest as identified by the project steering group

What were the consequences on their business as a result of the main challenges they faced

applying for authorisation and with the authorisation process

If there was any supportguidanceinformation that ECHA could provide that they would

have found helpful and might have saved them some time costs and

Their views on the ECHA website and authorisation related guidance

There were two types of responses between the four respondents all of whom were involved in an

upstream application ie they did not submit the application themselves which was submitted by

their supplier or someone even higher up the supply chain (eg MI of the SVHC) Those that were

more active65 or knowledgeable about REACH authorisation were able to give more feedback whilst

those less active knowledgeable were able to give limited feedback beyond what they had

already set out in the online survey It is important to present both sets of responses rather than

aggregating all their responses as they also reflect well on the differences in responses from micro

sized firms compared to small and medium sized firms

Those SMEs less familiaractive with REACH authorisation

65 By active we refer to attendance to meetings with sectortrade association concerning REACH attendance

at Authorisation application REACHAfA Consortia meetings or any ECHAEC webinars conferences meetings

concerning REACH authorisation

0

1

2

3

4

5

6

7

Very helpful Helpful No opinion eitherway

Not helpful Very unhelpful I did not use any ofthis information

Fre

quency



They opted to rely on their suppliers (further up in the supply chain) to submit the

authorisation application as they felt carrying out their own application was too

complicated and expensive As small companies applying for authorisation themselves

would have meant forgoing too many activities and this would have had a detrimental

impact on profits They gave support to the applicant by assisting the collection of

necessary information This alone was costly and time consuming from their perspective

and was paid from profits rather than through charging higher prices Due to the

international competition in the market it was not possible to raise prices for their

customers so they had to forgo some profits

Because they did not apply for authorisation themselves they did not make any use of the

guidance or material on the ECHA website

One respondent described the authorisation process as a ldquojourneyrdquo with a certain amount

of ldquolearning by doingrdquo with questions like should we do an authorisation on our own or

should we join a consortium and what are the advantage disadvantage of such a choice

One respondents felt that the main way the EC and ECHA could help would be to reduce the

time taken to examine applications and make final decisions quicker They often ldquofelt in

the darkrdquo when customers ask about REACH authorisation and if they can continue to

provide them with their products

Another respondent noted that reducing the complexity of the process would help They

suggested that perhaps an exact listing of requirements step by step and in detail how to

fulfil the need for documentation and a dedicated tool to fill up all these steps would help

For environmental purposes in the Netherlands they noted something similar called

ldquoeMJV66rdquo might be a good example for how this could work

Those SMEs more familiaractive with REACH authorisation

As SMEs applying for authorisation themselves would have meant forgoing too many

activities and this would have had a detrimental impact on profits They gave support to

the applicant by assisting in the collection of necessary information

One respondent was involved at consortium level meetings and noted it took a lot of time

and effort to get the lsquoinfrastructurersquo right to talk and share and develop the AfA within a

joint consortium application ndash Most SMEs donrsquot have this time This alone was costly and

time consuming from their perspective and was paid through profits rather than charging

higher prices Neither gave an exact estimate on how much they spent but said it was a 5-

digit number (so between euro10-99k)

One respondent noted that understanding what is required and the resources to provide it

can be complicated because many documents are in English That and the technical nature

of what data is required makes it impossible for their company to answer questions quickly

The process of answering the questions is very time-consuming as they first needed to

translate the documents from English to German before preparing an answer in German

which is subsequently translated in English

66 eMJV electronic environmental reporting httpwwwe-mjvnl



One respondent noted it would be useful to know what similar firms have provided in terms

of information so that the same things are not mentioned repeatedly He said that this

would also help in terms of knowing what information is relevant However they

recognised that with consortium level questionnaires the applicants are trying to gather as

much information from as many companies as possible so this level of data sharing is not

feasible (also from a confidentiality perspective)

The main problem with authorisation is that they donrsquot have enough capacity in terms of

staff availability to deal with it Both respondents noted that they donrsquot have a specific

resource (staff member) dedicated to REACH and therefore it is hard to coordinate

responses to data requests or understand what is required Collecting data requires

communicating with a number of people and cannot be assigned to one person

Nevertheless the work needed to be done if they wanted to continue to compete in the

market

One respondent noted that for an SME the provision of socio-economic information can be

challenging and at times they felt overwhelmed by the task This is because they donrsquot

have the ability to do it and donrsquot even lsquohave a cluersquo about where to start

One respondent noted they are involved in their third AfA (as they use several SVHCs) for

two of which they have been part of a consortium and for the last one they are the single

applicant They noted the additional time required to do their own application but felt this

was the best way forward from their experience to date as they felt they were punished

being part of a consortium application due to the short review periods granted and as such

it felt like a never-ending application process From their experience the bigger the

consortium the harder the AfA ndash the smaller the consortia the tighter the exposure

scenarios and the fewer uncertainties

They noted it is a very stressful process and despite going through the process for a third

time there are lsquoa lot of sleepless nightsrsquo worrying about what would happen if they donrsquot

get authorisation They also noted that deadlines set by RAC and SEAC for answering their

questions post submission are particularly unfair on SMEs given the limitations on resources

and partially because data requests often come during holiday periods They cannot stop

people going on holiday as they donrsquot know sufficiently in advance when comments will

come and therefore this can compromise what information can be provided to respond to

RAC and SEAC questions It would also help to know which questions were essential to

respond to which ones were nice to know and if they could signpost to the AfA itself

where they felt they had already answered this point

Both respondents noted a sense of perceived unfairness that big companies who have the

financial capacity and necessary staff to work on their own AfAs got long review periods

(eg 12 years) while upstream applications only got an authorisation for four years For

them that means that those with the fewest resources have to provide the highest input as

they need to deal with an AfA repeatedly (with shorter intervals) They acknowledged that

one reason for this situation is certainly that bigger companies can produce more

convincing dossiers with stronger arguments as they can allocate more time and resources

to it One respondent mentioned that his company just does not have the ability and

capacity to produce a dossier that is as convincing

ECHA in their communications do explain the advantages and disadvantages of individual

applications vs upstream applications keeping in mind that there is not one solution that

works best for every usecompany However one respondent was also unhappy because



they perceived that they received contradicting information They said industry actors were

first advised to apply in big groups if possible The information they got was that the bigger

the group the better (as it would avoid multiple applicants for the same use) They pointed

out that in contrast to this advice they are now being told that it might be better to apply

in smaller groups as this increases the chances for a longer authorisation period

Both respondents noted that the authorisation process is problematic as it creates lots of

business uncertainty as they are unable to predict how long they will be permitted to use

the substance This is an issue when it results in not being able to give contractual

commitments to their customers

o One respondent said that for Chromium Trioxide the sunset date has passed but

they have not received their confirmation about an authorisation yet They get

many phone calls and emails from worried clients asking them what will happen

and they are unable to give them any information about the future as no one knows

what will happen The only thing they can tell them is that they assume that they

will get an authorisation for four years (based on the RACSEAC opinion) but that

this is far from certain Thus the situation makes them and their clients feel very

insecure and worried and creates fears about the continued existence of their

companies

o The other respondent noted that SMEs further down the supply chain donrsquot get

access to information coming from ECHA committees so they feel they are lsquoleft in

the darkrsquo for months and months whilst they have customers asking if they can

continue to supply them with products This is despite the fact that ECHA inform

stakeholders of new published material through the ECHA Weekly which anyone

can sign up to67

With regards to the ECHA website and related documentation one respondent noted that

they found it difficult to know where to go on the site for the information and often had to

use search engine providers to find information on the ECHA website instead They also

mentioned that a problem is that they dont get notified when new information has been

published This means that they need to check the website manually to keep track of

changes or new information which is not practically feasible

The other respondent indicated that guidance documents are far too long citing the

downstream user guidance at 132 pages They said it is difficult to say what kind of

guidance they would find useful as there is no substitute for experience gained from going

through the process It might therefore be useful to collect information from those who

have been through the process and to see what can be learned from their experiences

rather than more guidance This has already been addressed by ECHA in their 2016 lsquohow to

apply for authorisationrsquo guide68

67 ECHA Weekly httpsechaeuropaeusubscribe 68 This issue has been looked at by ECHA as part of their lsquoHow to apply for authorisationrsquo guide which was

based on the experiences gained by applicants ECHA the Commission and other stakeholders over the first

couple of years of the AfA process The purpose of this guide was to be practical rather than theoretical and

ECHA undertook a lot of consultations with various stakeholders (both before and during the drafting stage) to

ensure that they covered the most important experiences gained It includes short explanations practical

examples and links to where further information can be found if needed See

httpsechaeuropaeudocuments1016213637apply_for_authorisation_enpdfbd1c2842-4c90-7a1a-3e48-

f5eaf3954676



The biggest challenge they faced was the supply chain complexity ndash How can guidance help

here For very long and complex supply chains products can get used six times (by

different downstream users) before they end up with the final end-user The respondents

often donrsquot know more than one company down along the supply chain end user so it is

hard to get data further downstream They noted that end-users might not have a good

understanding of REACH and its hard to get data from customers stress the importance of

having this information to give to ECHA

One respondent noted that a clear and easy document highlighting the main steps would be

helpful They are very active within their association and therefore relatively well

informed but has experienced that many competitors act based on what they hear along

the supply chain

We made other attempts to get feedback from SME applicants but we encountered similar

problems as noted by other EC studies that it has been difficult to obtain information directly from

SMEs

86 Affordability analysis

The assessment builds on the affordability of the authorisation process for SMEs taking into

account the experience noted above from SMEs that submitted applications on their own or as

members of existing authorisation consortia

This sub-section examines the extent to which the recommendations from the REACH 2012 review

have been implemented and their effectiveness The REACH 2012 recommended revising the Fee

Regulation to lower the costs for SMEs This has been implemented and whilst affected SMEs will

have welcomed the change survey responses (and existing literature) do not highlight the fee paid

to ECHA associated with an AfA as being the main affordability issue for SMEs

The interviews with SMEs and SME survey responses show that resource and knowledge constraints

are bigger challenges than the fees paid to ECHA for applications A reduction in fees does not

change the requirements in terms of what SMEs need to submit as part of their AfA SME applicants

are expected to submit the same types of document and level of detail required (to make their

case) as a large firm who have more financial and human resources available They are also given

the same amount of time to respond to RAC and SEAC comments and planning for lsquotrialoguesrsquo

As shown in Chapter 6 the authorisation process does present financial challenges that are not

necessarily linked to the fee for submitting an application Chapter 6 shows that SMEs do not have

the same financial capacity to invest in RampD innovation investigating alternativessubstitution

activities and improved risk management SMEs who decide to submit their own application

therefore have to sacrifice new investments andor divert both staff and budgets away from RampD

and innovation or new marketproduct development in order to prepare their applicant

Due to the resource commitment and financial implications on the business many SMEs have relied

on actors higher up in the supply chain to apply for authorisation instead They weigh up the

reduced resource commitment and financial implications of an upstream application against the

higher costs and resources required to submit their own application which may be more successful

in getting a longer review period They have noted upstream applications to be a lsquonecessary evilrsquo as

from their experiences consortia applications have generally been granted shorter review periods

compared to single applicant company applications They do recognise this is because single



applicants can provide much more information specific to their company and operations which are

not possible with a jointconsortia level application

The interviews with SMEs specifically highlighted that responding both to RAC and SEAC questions

are particularly challenging given the short time period available to respond For example the

companies cannot stop staff going on holiday as these requests (in their cases) came during times

when people are away (eg summer vacations and the Christmas period in December)

Interviewees felt they were unfairly punished as they didnrsquot have sufficient time or the right person

to respond and this jeopardises the quality of the response they could give (eg directly to ECHA or

through their upstream applicant)

It would have been helpful if the Committees were to give more time for SMEs or at least separate

questions that are lsquoessentialrsquo for the Committee decision making and those that are lsquonice to know

more aboutrsquo so that limited resources could be focused on providing responses to the former

group

Part of the issue may be the difficulties for the upstream applicants to filter information provided

by ECHA further down the supply chain to those affected ECHA does try to facilitate applicantsrsquo

planning by sending them the indicative timelines for RACSEAC questions trialogue etc after

submission (See Annex 1 in the How to apply for authorisation guide) For every application there

is an lsquoAuthorisation team managerrsquo running the process within ECHA After submission the

applicant is sent the team managerrsquos contact details (and the team manager also tends to contact

the applicants directly) For any questions the applicant has about the process eg in terms of

the timing of the key steps or regarding the reasons for specific questions they can contact the

team manager directly as this person is also the contact person for the rapporteurs of the case and

therefore is usually well informed about why the rapporteurs ask the questions they ask

There was a perception that the numbers of questions asked (especially by RAC) on the CSR

(specifically the exposure scenario) were not proportionate to the scale of the problem They felt

they were not in line with what they expected based on the ECHA guidance and templates and

therefore if the lsquogoal postsrsquo had moved this should be reflected in available guidance templates

and information on the ECHA website This is important since it is better (from both a financial and

resource perspective) to provide the necessary information in the application

The REACH 2012 review also recommended ldquoECHA and industry should develop more user-focused

guidance with special attention to SMEs The review identified a specific problem in relation to

the vast amount of guidance developed to support the implementation of REACHrdquo This was further

confirmed through survey responses and industry interviews that guidance documents are too long

and shorter documents (available in all EU languages) would better assist SMEs Whilst ECHA have

recently updated some of the support documents associated with authorisation this is not support

specifically designed for SMEs69

ECHA industry Member States and NGOs have come together noticeably through the Network of

REACH SEA and Analysis of Alternatives practitioners (NeRSAP)70 to advance and review concepts

methods and experiences for Socio-economic Analysis (SEA) and Analysis of Alternatives (AoA) on

EU-wide or national chemicals management implementation Whilst there still remains insufficient

representation from industry in NeRSAP it could be a forum through which further practical

That said keeping SMEs specifically in mind ECHA made an effort to present the advice in a clear and

concise way with plenty of examples from real applications 70 httpsechaeuropaeusupportsocio-economic-analysis-in-reachnetwork-of-reach-sea-and-analysis-of-

alternatives-practitioners



information guidance is generated on how the authorisation process could be made more

affordable for SMEs

87 SME summary

The EU chemicals industry is mainly made up of SMEs (see Section 42) However only 35 (18) of

195 applicants between 2013 and 2017 were from SMEs The surveys identified (and the interviews

provide supporting details) that the main factors for this were the resource and knowledge

challenges presented by the authorisation process

SMEs have typically relied on their MIs trade associations or their consultants for support on the

AfA process There were mixed views on available information on the ECHA website and relevant

guidance Whilst it is not disputed that relevant information is there respondents often referred

to difficulties with finding the information they need and the length and complexity of the

guidance documents especially since the SMEs donrsquot have dedicated personnel who deal with

REACH

Financial constraints are an important factor for SMEs both due to their limited ability to invest up-

front in substitution activities and to meet the costs associated with applying for authorisation The

fee charged by ECHA is a cost item but it is insignificant compared to the financial costs of

preparing an application finding and implementing a suitable alternative and the impacts on the

forgone activities (eg RampD and innovation) as a result of diverting time and budget to apply for

authorisation Due to these factors SMEs have typically relied on their upstream suppliers to apply

for authorisation (and therefore they are covered by their suppliers)

As noted in the survey findings in Section 4 the indirect impact of this is that SMEs become reliant

on these suppliers (eg limits who they can buy the SVHC from) and many of them expect or have

already had to pay for this lsquoupstreamrsquo authorisation through higher prices which they cannot pass

through onto their customers

The main issue with lsquoupstreamrsquo authorisation applications for SMEs however has been that they

tended to result in shorter review periods and that it took time for information on the application

to filter down the supply chain This creates further business uncertainty both for the SMEs and

their customers with regards to the long-term supply of their products



9 EVIDENCE OF THE lsquoANNOUNCEMENT EFFECTrsquo

91 Introduction

Evidence of the lsquoannouncement effectrsquo represents the last of the Tier 2 study areas A study by

Oumlkopol GmbH (2007) for the European Commission developed seven hypotheses around the

lsquoannouncement effectrsquo ie once a substance was added to the Candidate List As set out in Table

91 the report suggests there was some supporting results for some of the hypotheses one was

disproved and the rest had mixed results

Table 91 Seven hypotheses around the lsquoannouncement effectrsquo

No Hypothesis Results

1 Increasing awareness of risks and further risk management Supporting

2 Companies will look at the candidate list and consider it in their product

development Supporting

3 Industry will try to demonstrate adequate control of identified threshold

SVHC during registration Disproved

4 Importers producers and professional recipients of articles will prefer

articles without SVHC Supporting

5 Innovative alternatives not using identified SVHC will be promoted Mixed

6 The candidate list provides a harmonised tool for prioritisation of substances Mixed

7 With the candidate list the actors in the supply chains get time to identify

optimum solutions Mixed

Source Oumlkopol GmbH (2007) Case study on ldquoAnnouncement effectrdquo in the market related to the Candidate List of

substances subject to authorisation

This section sets out further information on the lsquoannouncement effectrsquo using the results of the

online survey case studies and further literature review carried out since the Oumlkopol study In

particular it seeks to identify if effects like early substitution improvement of exposure conditions

and market disturbance were lsquotriggeredrsquo by key announcements like candidate listing authorisation

listing and the sunset date

The section is split into four sub-sections

Section 92 Literature review ndash sets out what the key findings are from existing studies

Section 93 Analysis testing the announcement effect - uses available statistics to see if

there is an observable effect that can be explained by key REACH authorisation

announcements (eg sunset dates)

Section 94 Case studies - presents evidence around the lsquoannouncement effectrsquo for specific

companies as ldquomini case studiesrdquo They make use of survey responses existing information



and further consultation with affected companiessector groups to try to explain the role of

REACH authorisation



In order to create a basis for the assessment of new results produced by this study a literature

review has been conducted to identify and consolidate existing knowledge about the announcement

effect The consulted literature includes regulation documents the report prepared by Heitmann

and Reihlen (2007) as part of the Oumlkopol study several EC study reports a Finnish study

commissioned by ECHA (ie Harrikari and Montonen 2017) as well as reports and position papers

submitted during the public consultation of the REACH REFIT Evaluation 2017



Heitmann and Reihlenrsquos analysis of past reaction patterns of industry actors to comparable

legal approaches reveals that the extent of the announcement effect of the Candidate List

is likely to depend on market pressure exerted by downstream users article producers and

retailers as well as the ldquoimaginary pressurerdquo of the Candidate List

o According to Heitmann and Reihlen (2007) the market pressure exerted by

downstream users tends to be higher for companies producing or selling consumer

products (eg household articles and cosmetics) and companies with brand names as

they are more susceptible to NGO campaigns calling for the disuse of hazardous

substances

o With respect to ldquoimaginary pressurerdquo Heitmann and Reihlen (2007) point out that the

expert consultation revealed that this is likely to depend on the number of the

substances placed on the Candidate List as it will influence the perception about

whether the authorisation requirement is perceived as an imminent situation

EC (2015) report titled Monitoring the Impacts of REACH on Innovation Competitiveness

and SMEs provides numerical evidence for market pressure in the authorisation context It

indicates that an open-ended business survey with companies from all 28 EU Member States

as well as EEA and non-EU countries revealed that 388 of all respondents answering the

question (n=242) received requests from their customers to remove SVHCs from the

products as a reaction to the candidate listing

EC (2015) also provides anecdotal and numerical evidence for an announcement effect

o In terms of anecdotal evidence it stresses that according to the interviews conducted

as part of the EC (2015) study substitution attempts are often only based on the legal

status of the substance (ie that it is listed on the Candidate List) Information about

potentially negative implications of this announcement effect can be found in Annex

E8

o In terms of numerical evidence the open-ended on-line business survey reveals that

i 246 of SMEs and 419 of large firms launched reformulation initiatives in

response to the Candidate List



ii 189 of SMEs and 368 of large firms requested substitution of substances as

a result of the substance being placed on the Candidate List

iii Out of the respondents (n=278) providing an answer to the question what their

response to the placing of substances relevant to the firm on the Candidate

List was only 187 indicated that they took no special action

According to the numerical evidence provided by the EC (2015) study the announcement

effect thus seems to be stronger in the case of large firms than SMEs Further anecdotal

evidence for the existence of an announcement effect comes from reports and position

papers submitted during the public consultation of the REACH REFIT Evaluation 2017 The

position paper by the European Environmental Bureau71 even provides evidence for an

announcement effect on companies that are located in countries that are not subject to

REACH by referring to the Swiss company Hoffmann-La Roche This company committed to

phase out SVHCs wherever possible within a decade of their addition to the Candidate

List The main reason for this is the risk of supply chain discontinuity in the future

93 Analysis testing the announcement effect

The online survey generated data on the announcement effect that could act as supporting

evidence to validate much of the key findings from existing literature The survey results (see

Figure 91) show that REACH authorisation is triggering internal policies to learn more about and

better manage the use of SVHCs

Figure 91 Whether REACH authorisation has led to internal policy concerning managingknowing what substances are used within respondents organisations including (possible) SVHCs


71 European Environmental Bureau (na) EEB Comments to the REACH REFIT public consultation Position

Paper for REACH REFIT Evaluation

Yes47

Yes but not due to REACH

authorisation

36

No13

No but we are considering

having a policy

4



As set out in Figure 92 the early stages of the authorisation process do trigger substitution away

from the use of SVHCs About 66 of survey respondents indicated they had already begun

substitution away from an SVHC before it was placed on the Authorisation List

Figure 92 Authorisation stage that triggered decision to substitute from an SVHC


This would suggest that where substitution is possible the REACH authorisation process (in

particular the inclusion on the Candidate List) triggers substitution The results reported in Section

6 show that substitution costs can be higher than the costs of applying for authorisation which may

support the view that companies are switching away from SHVCs for other reasons such as avoided

stigma associated with SVHCs as well as avoiding future regulatory costs and being able to give

customers certainty of supply (as they are not faced with the perspective of a sunset date on use or

that their continued use is reliant on the outcome of an AfA decision)

Where available alternatives are not evident the survey responses (see Figure 93) also give a good

indication that the announcing the inclusion of an SVHC in the Candidate List triggers further

substitution related activities (See Section 53 for more details)

Figure 93 Authorisation stage that triggered substitution related activities


As set out in Figure 94 most stages in the authorisation may trigger improved risk management

This suggests that companies do not wait until the substance is placed on the Authorisation List

before carrying out further risk management However it is not surprising that most respondents

noted the application for authorisation stage as a key driver for improving risk management as it is

14

29

23

25

9







9

43

27

7

11









a legal requirement (Article 6010) for applicants to show minimisation of emissions as part of their

application There is therefore pressure to make sure exposure and emissions are as low as possible

even though there are numerous examples from RAC comments of AfAs to suggest that applicants

are not presenting sufficient evidence of minimisation of emissions

Figure 94 Authorisation stage that triggered further risk management activities


The PRODCOM data shown in Section 47 also provides mixed results on observed changes in the

market although there is potentially an indication that candidate listing may have resulted in a

decline in the production and use of these SVHCs This is however difficult to be conclusive about

given limitations with the data and difficulties of getting reliable market data to confirm the

observed trends

94 Case studies

A large number of stakeholders (both companies and trade associations) were contacted to improve

the understanding of which activities are triggered by various announcements such as candidate

listing and recommendations for inclusion on Annex XIV Whilst initial contacts seemed promising

and stakeholders understood the overall value of providing information not all stakeholders wanted

to share their specific information given the risk that it would raise awareness of their substances

to regulators and this in turn may lead to further regulatory scrutiny

Only in a few cases were some stakeholders willing to provide information that was already in the

public domain given the information is not necessarily widely read (eg public consultation

response to ECHA) These are briefly discussed below

Case 1 - Space sector

The European space sector is likely to be affected by authorisation as more and more substances

they use fall within the authorisation process The sector has been affected and contributed to the

Cr(VI) applications for several uses (eg corrosion protection and inhibitors) However the focus is

15

27

815

35









on activities being carried out for substances on the Candidate List A position paper72 was prepared

and sent to ECHA and the EC proposing an exemption73 for propellant-related use of hydrazine

from REACH authorisation The substance was included on the Candidate List on 20 June 2011 and

could be prioritised for Inclusion in Annex XIV of REACH in the future The paper sets out details

for an exemption providing information on the importance of continued use of hydrazine for the

space sector

Reference is made to a hydrazine REACH Authorisation Task Force of the European Space Industry

The task force work has triggered a number of activities (eg in relation to looking at substitution)

and generated availableknown information about alternatives that may otherwise not have been

produced if hydrazine was not placed on the Candidate List

This example highlights that candidate listing can stimulate action on RampD substitution where

possible information on alternatives and information on the importance of these uses of such

substances Based on the initial engagement with a number of other stakeholders and the public

consultation submission statistics shown in Section 66 coordinated efforts to gather information

(and to apply for exemptions) is very common especially for sectors and trade associations that are

already well engaged with the REACH authorisation process74

Case 2 ndash Automotive sector

A Tier 2 supplier of the automotive sector expects that a SVHC listing of his substance would have a

detrimental effect on the competitive position of the product The downstream user of the

substance produces articles which still contain the substance and are built directly into the cars

The automotive sector has a comprehensive system to track the use of hazardous substances in

their supply chain

The expectation of the supplier of the substance reflects the attitude the automotive sector has

regarding the use of substances The supplier of the substance expects that even well before the

substance is listed but based on the hazard properties the pressure on substitution by the article

manufacture will be very high

While the listing or announcement effect in the automotive sector is supported by uniform data

collection tools other companies also map their supply chain and try to identify when hazardous

substances are used However this is mostly company specific and only seldom has a scope beyond

the direct supply (Tier one)

Case 3 ndash Company level ndash Evaluation on the use of hazardous substances

One company reports on its website the use of a management system which evaluates the use of

hazardous substances and does this in advance of possible legislation

72 httpwwweurospaceorgposition-paper-on-reach-and-hydrazine-in-the-space-sectoraspx 73 Stakeholders have an opportunity to comment during the public consultation within three months of

publication under Article 58(4) when a substance is being proposed for inclusion on Annex XIV lsquoInterested

partiesrsquo are invited in particular to comment on ldquouses which should be exempt from the authorisation

requirementrdquo 74 For example (and there are many others) the International Lead Association (ILA) provided evidence for

proposed use specific exemptions for four lead compounds currently on the 7th draft recommendation on

priority substances for inclusion in REACH Annex XIV httpsila-reachorgwp-

contentuploads201605Briefing-Note-REACH-Article-582-v2pdf



ldquoOur company-wide priority substance process takes a systematic approach to the identification

review and management of hazardous substances that we use in our products and chemical

processes Taking this proactive approach promotes the use of safer and sustainable products and

means we often take action to manage harmful substances in advance of legislation future-

proofing our products against changes in regulations

The process identifies hazardous substances for review by scoring them on the basis of their

human and environmental hazards and where societal concern exists over their use Substances

with higher scores are designated as priority substances and are subject to review by our experts

Where a safer and effective alternative exists (which is economically feasible) priority substances

are substituted with less hazardous materials In cases where substitution is not possible a full

risk assessment is carried out on the substance using state-of-the-art techniques from the EU

REACH regulations

Only when use of a priority substance can be managed safely can it be used in [name omitted]

products and processesrdquo

Other companies have similar systems which they announce on their websites For instance a

different company has an open ldquobanned substancesrdquo list which they set up using an in-house

developed tool

ldquoOur Product Stewardship group monitors developments in both regulation and public perception

for all relevant hazardous chemicals that either fulfil or are suspected to fulfil SVHC criteria

The substances are ranked by their risk using a tailor-made toolrdquo

Despite these policies in certain cases these companies still find it impossible to substitute the

use of the substance and have either initiated an authorisation or are using substances for which

and authorisation has been applied for

95 Summary of the announcement effect

Table 92 summarises the findings from this study using the seven hypotheses around the

lsquoannouncement effectrsquo presented earlier in Table 91 Overall the findings from this study align

well to existing literature concerning the announcement effect (but some hypotheses are outside of

the scope of this study and therefore were not assessed)

Table 92 Evidence relative to the seven hypotheses around the lsquoannouncement effectrsquo

No Hypothesis

Results

Oumlkopol GmbH

(2007) This study

1 Increasing awareness of risks and further risk

management Supporting

2 Companies will look at the candidate list and consider it

in their product development Supporting

3 Industry will try to demonstrate adequate control of

identified threshold SVHC during registration Disproved

Not assessed

in this study

4 Importers producers and professional recipients of

articles will prefer articles without SVHC Supporting

Not assessed

in this study



No Hypothesis

Results

Oumlkopol GmbH

(2007) This study

5 Innovative alternatives not using identified SVHC will be

promoted Mixed

6 The candidate list provides a harmonised tool for

prioritisation of substances Mixed

Not assessed

in this study

7 With the candidate list the actors in the supply chains

get time to identify optimum solutions Mixed

The survey results interviews and Tier 1 amp 2 case studies both show that companies have sought

to improve risk management as a result of announcement made along the whole authorisation

process All stages in the authorisation process lead to further RMM investment ndash most occurred at

candidate listing (43 followed by 27 at recommendation to authorisation list) For example

companies may have improved RMM at earlier stages within the authorisation process so as to delay

being prioritised for inclusion on Annex XIV and even once on Annex XIV applicants have sought in

their applications to demonstrate that further RMMs have been introduced or are being planned so

as to demonstrate minimisation of emissions within their AfA

The survey data shows that authorisation process lead many companies (~46) to set up an

internal policy to managingknowing about use of SVHCs (~36 already had one) The case

studies above also examples where a lot of effort is spent on seeking exemptions and there

is a stigmadesire to switch once a substance becomes an SVHC Around 66 of respondents

had also already substituted a use of an SVHC before the substance was on the

authorisation list showing that classifying a substance as an SVHC and placing on the

substance on the candidate list does trigger and drive substitution It also shows in many

cases that substitution was possible prior the sunset date and therefore these companies

avoided the need for authorisation



10 TIER 1 CASE STUDY SUBSTANCE 1 CHROMIUM TRIOXIDE

101 Introduction

Tier 1 case studies are an attempt to assess the impacts associated with REACH authorisation

through detailed analysis on a few specific substances This chapter sets out the evidence found

for the substance of Chromium Trioxide

As noted earlier in Table 622 Chromium Trioxide received the most responses (493) during the

public consultation compared to any other substance to date when it was proposed to be included

on the authorisation list75 A more detailed breakdown of the reasons for commenting is described

in Section 104 Chromium Trioxide also received the most comments (compared to other

substances) during the public consultation for applicants for authorisation with 449 (~40 of total

number of comments received to date) The large number of comments also means that a large

number of businesses are affected and the use of the substance in industry is extensive These were

the reasons for choosing Chromium Trioxide as a case study Further reasons for this choice are set

out in Section 103

A study on the impact of authorisation for chrome VI by the Dutch consultancy Panteia (2016)76

estimates that close to 730000 employees in around 42200 businesses in the EU are directly or

indirectly affected by the application for authorisation of Chromium Trioxide

Information for this Tier 1 case study has been gathered on market volumes as well as the online

survey results and follow-up interviews Of the 66 online survey responses about 50 originated

from applicants downstream users providers of alternatives NGOs or associations dealing with

Chromium Trioxide (34 survey participants) 29 of the 34 respondents were applicants or

downstream users

In addition to the survey data follow up interviews with stakeholders for Chromium Trioxide were

held (12 in total)

NGOs (1)

Associations (1)

Applicants (3)

Suppliers of alternatives (1)

Previous Downstream Users who did not apply for authorisation (6)

The objective was to collect as much information as possible for a more in-depth review of the

main impacts experienced by the businesses applying for authorisation and other stakeholders like

providers of alternatives and NGOs

75 Due to the grouping of the comments in different categories some of the comments could be counted double

as they would fit several categories 76 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo




Table 101 Chromium Trioxide substance profile

Name Chromium Trioxide

EC no 215-607-8

CAS no 1333-82-0



property(ies) referred to

in Article 57

Carcinogenic (Art 57a)

Mutagenic (Art 57b)

Exempted (categories of) uses none


Restricted by RoHS

Stage in Authorisation Process On Authorisation list

The production of Chromium Trioxide starts with chromium ore (FeCr2O4) which has historically

been mined in Russia Philippines Southern Africa and Finland In 2016 29 million tonnes of ore

were mined77 The majority of the ore (95) is metallurgical grade and used for stainless steel

alloyed steels and non-ferrous steel78 This use is outside the scope of the authorisation of

hexavalent chromium compounds

Only 078 million tons or 27 of the globally produced chrome ore is chemical grade79 The first

step to transform the chromite ore to Chromium Trioxide is the extraction of the chromium as

sodium chromate (Na2CrO4) The vast majority of the sodium chromate is converted to sodium

dichromate (Na2Cr2O7) In 2010 the global production of sodium dichromate was estimated at

700000 tonnes which is split into the following downstream products ndash basic chrome sulphates

(33) chromic acids (33) chrome trioxides (29) and other products (5)80 Chromium Trioxide is

made by the reaction of sodium dichromate with sulfuric acid The reaction can be carried out with

solid sodium dichromate or with solutions or suspensions Both methods are in use industrially

Chromium can exist either as elemental chromium alone or combined with other metals or

chemically bound to other substances In the latter case the chromium can be either trivalent

Cr(III) or hexavalent (Cr(VI) The toxicological hazard of chrome predominantly exists for the

substances containing Cr(VI) as Cr(III) does not have a classification which complies with Art 57

criteria for SVHC Also the requirement for authorisation is only for Cr(VI) containing substances

such as Chromium Trioxide

Based on studies that show its genotoxic potential the Risk Assessment Committee (RAC) concluded

that Chromium Trioxide (EC no 215-607-8 CAS no 1333-82-0) should be considered as a non-

threshold substance with respect to risk characterisation for carcinogenic effect of hexavalent

chromium81

77 httpwwwicdacrcomindexphpoption=com_contentampview=articleampid=1026ampItemid=1069amplang=en 78 No exact data is available what volumes are used within EEA however 70 of the global chromite

production is consumed domestically in ferro-chrome production in the country of origin 79 httpwwwicdacrcomindexphpoption=com_contentampview=articleampid=1026ampItemid=1069amplang=en 80 httpwwwicdacrcomindexphpoption=com_contentampview=articleampid=1026ampItemid=1069amplang=en 81 Reference to the studies examined are included in the RAC document RAC27201306 Rev 1 Final




Chromium Trioxide fulfils all the key criteria set for the selection of a Tier 1 case study substance

Latest application date has passed so that the impacts of the whole authorisation process

should be possible to assess ndash for Chromium Trioxide this was 21 March 2016

There are a large number of applications and applicants which increases the opportunities

for getting data ndash for Chromium Trioxide there were 20 applications for 54 applicants

There are a large number of uses applied for ndash 37 different uses

There are diverse and complementary impact aspects ndash widespread use in the EU by

numerous SMEs with widespread applications82

There is little accurate data available on the number of companies impacted by the authorisation

of Chromium Trioxide A study on the impact of authorisation for chrome VI by the Dutch

consultancy Panteia (2016) estimates that close to 730000 employees in around 42200 businesses

in the EU are directly or indirectly affected by this application for authorisation83

The available data from ECHA shows that for the continued use of Chromium Trioxide most of the

applications for authorisation were from SMEs This is supported by a number of consortia applying

for authorisation (nine applications out of submitted 20 were by consortia) Although this criterion

was not used explicitly this selection meant that this aspect (affordability for SME) could be

explored within this Tier 1 case study



Table 102 Chromium Trioxide REACH authorisation timeline


Inclusion to Candidate list 15122010

Inclusion to Annex XIV 20122011

Latest Application Date (LAD) 21032016


In accordance with Article 57(a) and (b) Chromium Trioxide was identified as a Substance of Very

High Concern (SVHC) It is classified as carcinogen category 1A and mutagen category 1B The

reasoning behind the decision to prioritise and include Chromium Trioxide on Annex XIV was that it

is supplied for uses in high volumes and for many sites Therefore significant workplace exposure

may occur in a number of sites

Chromium Trioxide was included on the Candidate List on 15 December 2010 for possible

authorisation in the future During the period for commenting 173 comments were submitted by

82 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo 83 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo



industry (123) associationstrade unionsMember State authorities (42) and NGOs (8)84 Half the

submitted statements related to general comments (85) and the other half to the use exposure

alternatives and risks (74) A large majority of the comments (almost 75) were submitted from

France Prior to this inclusion no RMOA was carried out (as the RMOA process had not been

established at this stage) In 2012 Eurometaux indicated in an article in Chemical Watch that

ldquoWorker exposure would have been best covered he says by developing and implementing

other more focused risk management tools like an EU-wide occupational exposure limit

(OEL) for chromium VI and chromium III and updated pollution prevention guidance on

best available techniques (BAT) for sites producing or using itrdquo85

On 20 December 2011 the substance was included to Annex XIV This meant that the use of

Chromium Trioxide would require authorisation after the sunset date of 21 September 2017 with a

latest application date on 21 March 2016

During the period for commenting for the inclusion of Chromium Trioxide to Annex XIV 1229

comments were submitted by industry (1084) industry associations Member States trade unions

academic institutions (139) and NGOs (6) The majority of the comments related to general

comments on the recommendation to include the substance in Annex XIV (489) followed by the uses

that should be exempted from authorisation (389) and transitional arrangements (218)

By end of 2016 28 applications by 52 applicants for the uses of Chromium Trioxide after sunset

date were submitted In addition one application was made jointly with sodium dichromate and

one application was made jointly with dichromium tris(chromate)


The risk assessment report86 for Chromium Trioxide was finalised in 2005 The rapporteur was the

United Kingdom The same report mentions three producers of hexavalent chromium compounds

even though it is not stated where these are located In 2006 the last manufacturer of Chromium

Trioxide ceased production of the substance in the EU (Elementis Chromium in the UK) Since 2006

all of Chromium Trioxide used in the EU is imported (see Figure 101)

The EU is a net importer of Chromium Trioxide Less than 10 of the volume imported is exported

outside the EU from formulators within EU The export volume comes from formulators that sell

their products to customers outside the EU (see Figure 102)

For the last five years the import volume has been relatively stable at around 12000 tons per year

In principle this is also the volume covered by the scope of the submitted AfAs for Chromium

Trioxide The import market is split between 7-10 key players The number of formulators using

Chromium Trioxide in the EU is estimated to be about 20 companies87

84 Due to the grouping of the comments in different categories some of the comments could be counted more

than once as they would fit several categories 85 httpschemicalwatchcom12927chrome-platers-put-their-case-for-chromium-trioxide-authorisations 86 European Chemicals Bureau ndash Risk Assessment Report Chromium Trioxide Sodium Chromate Sodium

Dichromate Ammoniul Dichromate and Potassium Dichromate 2005 87 (ref LANXESS presentation 20121001 ECHA Helsinki)



Figure 101 Chromium Trioxide imports to EU 2000-2016

Figure 102 Chromium Trioxide exports to outside EU 2000-2016



1051 Supply chain structure

In the context of the authorisation of Chromium Trioxide it is important to elaborate briefly on the

structure of the supply chain for the surface treatment industry in the EU All six interviewed

applicants and downstream users stated their frustration that in their experience their own

particular position in the supply chain was not taken into consideration sufficiently during the

authorisation process This refers mainly to their ability to alter the process to use alternative

substances without explicit approval from their customers (which means the products still matching

the customerrsquo specifications)

As mentioned above there is no manufacturer of Chromium Trioxide left in the EU Imports are

entering the EU mostly through importers with manufacturing facilities outside the EU LANXESS

estimates that there are approximately 10 key importers for the substance88 Most of the Chromium

Trioxide is then supplied to formulators that use it in specific formulations to be used by their end

users (Figure 103)

Figure 103 Supply chain for Chromium Trioxide89

The supply chain differs here from that of other industries A substantial number of companies can

be identified amongst the downstream users which are contract manufacturers (contract platers)

using Chromium Trioxide containing substances or mixtures Contract manufacturers tend to be

SMEs and manufacture products to the specifications of their customers in a variety of industries

(eg aerospace automotive construction furniture machinery sanitary ware consumer products

and packaging) As a consequence the contract manufacturers cannot change the process unless

approved by their customers and unless the different process still ensures that the same

specifications defined by their customers are met

88Lanxess Deutschland GmbH Dr Martin Kleban 10012012 Presentation ldquoChromium Trioxide Authorisation

Consortium CTACrdquo 89Lanxess Deutschland GmbH Dr Martin Kleban 10012012 Presentation ldquoChromium Trioxide Authorisation

Consortium CTAC



The contract manufacturers are in fact dependent on their customers being able to change to an

alternative process If the customers do not see any advantage to do so ndash main reason often being

to reduce costs ndash the contract manufacturers cannot change the process A key feature of the

contract manufacturers is also that they have no or limited capacities for research and

development for example for a new process

Manufacturers that develop produce (surface treat) and sell their own products are different to

contract manufacturer They define their own specifications and have therefore the advantage to

make their own decisions about which process to use for their products

Although there is no detailed information on the structure of the plating industry across the EU and

hence the supply chain available it can be estimated based on the report published by the Dutch

consultancy Panteia that many companies in the EU are affected by the authorisation of Chromium

Trioxide90 The majority of these are estimated to be SMEs

Some contract manufacturers also use the opportunity to organise themselves into networks and

join efforts to carry out RampD into alternatives One particular example is the Fachverband

Galvanisierte Kunststoffe eV (FGK) in Germany which was established by 13 that also submitted

two applications for the authorisation for Chromium Trioxide

In total at the end of the supply chain the surface plating downstream users are covering millions of

articles that use chrome plated or passivated parts Also for the customers it is almost impossible

to identify which components are treated with Chromium Trioxide in the production process as it

is not part of the component or end product Therefore customers complain about the complexity

to identify relevant components that would need to undergo a different process to phase out

Chromium Trioxide ldquoThe search has to be carried out by responsible component

developersbuyerssuppliers within a complex supply chain with 1500 to 4500 suppliers per

OEMrdquo91

1052 Uses

Chromium Trioxide is used in various applications where metal finishing (surface treatment) is by

far the biggest use The Annex XV report from 201092 estimates the quantitative apportionment of

Chromium Trioxide in industrial chemical substances and mixtures is 75 in metal treatment

formulations 15 in wood protection formulations and 10 in other uses This means that the risk

associated with a significant part of the uses can be managed via authorisation

The same report mentions the following main uses for Chromium Trioxide

Metal finishing (for electroplating eg hard chrome plating decorative or bright-chrome

plating conversion coatings eg passivation of zinc aluminum cadmium and brass

pickling [CrO3 solution]) and

Manufacture of wood preservation products (biocidal agent (not relevant for REACH93)

90 Panteia 2016 - ldquoEconomic impact authorisation Chrome VIrdquo 91 Verband der Automobilindustrie Dr Wolfgang Marquardt 11122014 Zulassung unter REACH und die

Herausforderungen aus Sicht desVerbands der Automobilindustrie eV (VDA) 92 ANNEX XV report ldquoProposal for identification of a substance as a CMR Cat 1 or 2 PBT vPvB or a substance of

an equivalent level of concernrdquo August 2010 93 At the 21th Competent Authorities meeting in 2006 it was decided that biocidal products containing

chromium had to be removed from the market by 1 September 2006



fixing agent in waterborne wood preservatives)

The report refers also to ancillaryother uses like

Catalyst manufacture

Chromium dioxide manufacture

Pigment manufacture

Manufacture of paints varnishes and inks putty (anticorrosive dye)

Oxidant in organic chemistry

Electronic component manufacturing (characterization of silicon wafers)

Production of polyethylene and other plastics (catalyst)

Metallurgy of nonferrous metals (elaboration of chromium metal)

Manufacture of soap detergents and cleaning agents

Manufacture of other organic basic chemicals

Inorganic hardening agent layer of photosensitive galantine

Manufacture of jewelry (production of synthetic sapphire)

Additionally there are some uses in research and development for the hardening of microscopic

preparation or as oxidizers (Jones reagent Sarret reagent)

There are currently 23 active registrations Two registrations are inactive The total use based on

the tonnage band is according to the ECHA website in the range of 10000-100000 tonnes per

year The actual import of the substance is in the range of 12000 to 16000 tonnes per year (see

Figure 101)


Formulation of preparations used eg in metal finishing or as catalysts

Manufacture of other chromium substances

Manufacture of Chromium Trioxide (as substance and in catalysts)

Manufacture of preparations used in metal finishing and non-metal surface treatment

Catalyst production

Manufacture of Chromium Trioxide as a catalyst precursor

Catalyst use

Metal treatmentfinishing

The use of Chromium Trioxide as fixing agent for the manufacture of wood preservation products is

not specifically registered According to the lead registrant for Chromium Trioxide during the

preparation for registration dossier this use was no longer in demand as alternatives were available

on the market Therefore the lead registrant decided not to register the use in the registration

dossier for Chromium Trioxide


The available information shows that during the authorisation process (since inclusion of the

substance on Annex XIV) no substantial changes in market volumes could be identified relating to

the authorisation of Chromium Trioxide Since 2011 the import volume for Chromium Trioxide

remained stable around a yearly import volume of approximately 12000 tonnes

The split of the various applications in 2016 was similar to the one in 2010 (see Figure 104)



Figure 104 Chromium Trioxide ndash Market share by use

At the end of 2011 Chromium Trioxide was included in Annex XIV One of the key players (an

importer with manufacturing capacities outside EU) took the lead to form a consortium for a joint

upstream application This approach was supported by ECHA who feared otherwise a very high

number of applications for authorisation The key player was also the lead registrant for the

substance

To facilitate a systematic and efficient dossier preparation this consortium concluded to include

the following uses in the application for authorisation

Formulation of mixtures

Functional chrome plating

Functional chrome plating with decorative character

Surface treatment (except passivation of tin-plated steel (ETP)) for applications in various

industry sectors namely architectural automotive metal manufacturing and finishing and

general engineering (unrelated to functional chrome plating or functional chrome plating

with decorative character)

Surface treatment for applications in the aeronautics and aerospace industries unrelated

to functional chrome plating or functional chrome plating with decorative character

Passivation of tin-plated steel (ETP)

Of all submitted applications for authorisation for Chromium Trioxide more than 80 could be

allocated to the above listed use categories Besides the joint application lead several other

applications were made by individual or groups of downstream users

An analysis of changes in registration data through the authorisation milestones concluded for

Chromium Trioxide that some of the registered uses do not seem to be covered by any applications

for authorisation so far (eg impregnating agent for carbon filter media or catalyst manufacturing)

For the latter example this discrepancy could be explained by an early position taken by ECMA

(European Federation of Catalyst Manufacturers) that catalysts are in some cases transported



isolated intermediates94 and hence exempt from authorisation or because these catalysts are not

manufactured in the EU

The online survey results indicate that nearly half of the businesses participating in the survey and

using Chromium Trioxide experienced changes in the market structure in some form (13 of 29) The

biggest impact that the majority of the companies (seven) stated was that it led to an increase in

prices for Chromium Trioxide while the number of suppliers of products containing Chromium

Trioxide decreased Three out of 34 survey participants stated that their organisation was impacted

by a closure within the EU or a relocation to outside EU as a result of REACH authorisation process

A follow up interview with these three asked for the reason of the relocation that and one stated

ldquosome of our customers do not want to source certain components from the EU because of concerns

about the uncertainties caused by REACH authorisationrdquo

During the follow-up interviews the decline in the amount of possible suppliers was seen as

especially critical by four respondents The next critical issue was the fear that the upstream

application would make them dependant on their supplier Companies also expected that

consolidation of suppliers would eventually lead to higher prices One downstream user working in

the hard chrome plating sector said

ldquoA lot of money has been invested into the authorisations Only suppliers with

authorisation remain and they will push their cost into the supply chainrdquo

Only one out of 29 survey respondents felt that the authorisation has led to an increase in the

number of alternatives suppliers

107 Substitution

One objective of REACH is to eliminate the use of SVHC over time which can only be achieved if

alternative substances processes or products are developed The search for alternatives to replace

Chromium Trioxide has been on-going for decades with substantial amounts of money and

resources already invested (both by industry and via projects sponsored by various authorities) to

find alternatives to avoid using hexavalent chromium in their various applications

A detailed overview of the best available techniques for the surface treatment of metals and

plastics has been published by European Commission in 200695 This document comprehensively

describes the various alternatives that were available and the state of the art in technology in the

surface treatment at the time

Some alternative substances and processes are available today an important question is whether

these alternatives are also technically and economically suitable The question whether there are

suitable alternatives has been the basis for intensive discussions during the authorisation process

Applicants insist that there is no suitable alternative currently available for chrome trioxide

especially for the functional metal plating use Providers of alternatives and NGOs claim the

opposite

94 REACH and Catalysts (Fresh and Spent) A position paper by the European Catalyst Manufacturers Association

(ECMA) September 2008 Annex 1 added November 2008 Amended (Annex 1 amp consideration of intermediates

without SCC) November 2009 Amended (Waste Framework Directive amp Annex 1 EINECSCAS for MoS2 added)

May 2012 95 European Commission 2006 ldquoReference Document on Best Available Techniques for the Surface Treatment

for Metals and Plasticsrdquo (under the Council Directive 9661EC on Integrated Pollution Prevention and Control)



To allow a more neutral assessment of the different positions the feasibility of substitution of

Chromium Trioxide is assessed from different perspectives

Applicants

Non-applicants

Non-industrial stakeholders

Providers of alternatives

1071 Applicantsrsquo perspective

The particularity of the supply chain of the users of Chromium Trioxide has been described in

Section 105 The fact that Chromium Trioxide has a key function in a high number of very different

manufacturing processes ranging from car parts sanitary equipment military equipment space

and aviation building materials and others adds a level of complexity to looking for alternatives

Each of these sectors has its own dynamics and specific technical requirements

The challenge to develop alternatives arises from the numerous varying specifications that must be

met for the millions of articles that use chrome plated or passivated parts Therefore it is not

sufficient to develop an alternative process but the alternative process must be sufficiently

technically mature and economically feasible to cover a wide range of the required specifications

of the final articles While currently one process seems to be capable to cover a wide range of

specifications there are indications that several alternatives are required to cover the wide range

of applications of the chrome plated parts (eg see case on alternatives for alumina plating in the

window frame industry) Moreover several of these parts are used in a safety context andor in a

highly regulated industry such as aviation and hence require specific product qualification testing

For example it is estimated that more than 10000 chrome plated parts with different

specifications are in use per car manufacturer96 (eg for interior exterior specific parts injector

valve piston rod safety belt lock and so forth) Each of these parts is introduced only after

testing Any significant process change in the plating of these parts would require a specific re-

qualification

In addition some alternatives like Boric Acid or Cobalt compounds are expected to face in future

the same authorisation requirement as Chromium Trioxide therefore adding to uncertainty about

whether investments for the development of the alternatives should be carried out A presentation

for the German automotive industry in 2014 stated that the industry has to face the possibility that

approximately 100 potential alternatives will have to be further researched and tested97

As part of the application for authorisation applicants may have submitted an RampD plan to setting

out details of efforts to substitute away from Chromium Trioxide A screening of the public versions

of the applications for authorisation for available RampD plans shows that compared to the average

percentage of applications containing RampD for other substances the share of applications for

Chromium Trioxide is higher at 43 (Table 103) The actual percentage of improvement plans may

be higher as further information could also be provided as part of the committees (RAC and SEAC)

QampA and the trialogues

96 European Automobile Manufacturers Association Presentation by Dr Wolfgang Marquardt (BMW)

27032014 Authorisation for Chromium Trioxide ndash Automotive Industry Challenges 97 Verband der Automobilindustrie Presentation by Dr Wolfgang Marquardt 11122014 Zulassung unter

REACH und die Herausforderungen aus Sicht desVerbands der Automobilindustrie eV (VDA)



Table 103 Presence of RampD plans in Chromium Trioxide AfArsquos

All Subst of AfAs

Chromium Trioxide AfAs

No

RampD plan included 62 (34) 16 43

RampD plan referred to 34 (18) 7 19

No clear RampD plan 89 (48) 14 38

Total 184 37 100

Applicants also indicated that in some cases the use of an alternative solution would face

competition from imported articles from outside of the EEA still using the Chromium Trioxide (cfr

Grohe AfA)

Looking at the results from the online survey from the applicants andor downstream users three

out of a 29 (Chromium Trioxide only) reported a successful substitution yet two of those three

companies still applied for authorisation Seventeen out of 29 companies indicated that they were

busy with substitution activities The remaining nine respondents stated that they were not

investigating any substitution alternatives

Although not representative further interviews with stakeholders showed additional cases in which

companies also decided to take a parallel route and apply for authorisation while at the same time

carrying out substitution (see Section 54)

A leading high-tech company stated that the drive for substitution was due to safety reasons ndash they

did not want to expose their workers to Chromium Trioxide any longer After reviewing and testing

possible alternatives they switched to a more effective tin-based passivation As process owners

the high-tech company could make the decision to shift to an alternative more easily than a

contract manufacturer ndash as mentioned above

A leading company in the field of pharmaceuticals used Chromium Trioxide as a catalyst in waste

gas burner As their supplier decided to discontinue the supply the company was effectively

ldquoforcedrdquo to invest in an alternative Tests with alternative catalysts failed leading to the

development of a different technology While the new technology operates with slightly lower costs

(close to euro01 million) it required an overall investment of about euro10 million

The interviews with stakeholders clearly showed that there is a link between substitution and

competitiveness In those cases where the products made were in markets under severe price

competition customers (further down the supply chain) would only support substitution effort if it

led to a reduction in the cost of the product providing them a tangible benefit

1072 Non-applicantsrsquo perspective

Non-applicants are companies that previously used Chromium Trioxide but have since discontinued

their use (for that specific use) by either implementing an alternative substance or a different

process before the sunset date Therefore these companies did not have to apply for authorisation

The cases of early substitution are limited and less well documented

During the interviews companies which used to use Chromium Trioxide but have discontinued this

use without applying for authorisation were also identified



A manufacturer of alumina window and door frames stated in one of the interviews that after

receiving input from their sector organisation ESTAL98 they decided not to apply for authorisation

due to the estimated low chance of obtaining an authorisation As a result in 2014 the company

started to develop two alternative technologies that would enable them to produce and coat

alumina frames without chrome VI After investing between euro3 to 4 million in new equipment they

managed to switch to chrome VI free production but with considerable limitations One of the new

alternative technologies doubled operating costs the other technology is less robust and requires

tighter process control with better quality base material A key driver for successful substitution in

this case was the fact that this manufacturer controlled the full manufacturing process including

the choice of the raw materials

Another route to identifying early substitution cases is the analysis of the registered uses compared

to the filed applications for authorisation It is expected that a registered use will after the

inclusion of Chromium Trioxide to Annex XIV lead also to an application for authorisation The

examples of uses registered but without an application for authorisation have already been

described in Section 106

1073 Non-industrial stakeholdersrsquo perspective

Non-industrial stakeholders such as NGOs are indicating that there are several possibilities for

substitution of Chromium Trioxide They believe that the authorisation process itself could act as

an obstacle to substitution From their perspective they claim that companies that are granted

authorisation will have less incentive to look for an alternative to Chromium Trioxide Additionally

NGOs claim that the authorisation process does not provide sufficient clarity about why applicants

are not using the alternatives that are available on the market and what efforts the applicants are

undertaking to phase out the substance Client Earth a NGO stated that

ldquoIn relation to applications for authorisation participation can be increased by setting

criteria that need to be fulfilled for an alternative to be considered suitable At the

moment the SEAC has no such criteria and there is no evidence the SEAC would be able to

positively assess the suitability of an alternativerdquo

In the online survey the participating NGOs mentioned several tools that businesses looking for a

substitution of Chromium Trioxide could use

An example of a useful tool is the substitution support portal (SUBSPORT) developed by the

Koordinationsstelle Hamburg IFE An overview paper available on the SUBSPORT website99

describes a range of alternatives for the use of Chromium Trioxide In addition the report

also lists potential alternatives which should be rejected as they would pose a high risk to

the environment or human health (ldquoregrettable substitutesrdquo) For that SUBSPORT uses its

own database containing substances that are not accepted for substitution due to their

hazards (SDSC) Alternatives for Chromium Trioxide that would pass the screening test can

also be found on their website

98 ESTAL ndash European Association of Alumina Platers (Italy excluded) with around 400 member mainly SMEs 99

httpwwwsubsporteucasestoriessearch=chromium+trioxideampsektor=0ampFunction=0ampprozess=0ampcslimit=15amp

methodology_check=onamptype=case_studiesx413-en



Another NGO ChemSec is offering a web-based platform ldquoChemSec marketplacerdquo100 via

which buyers and sellers of alternatives to hazardous chemicals can interact It offers

producers of safer alternatives a window to display their ldquogreenrdquo alternatives to

downstream user companies looking to substitute hazardous chemicals in their products or

processes

ChemSec also stated that the OECD Substitution and Alternatives Assessment Toolbox

(SAAT)101 could prove very helpful the tool is an approach for evaluating a chemical

material process product andor technology for attribute analysis within a chemical

substitutionalternatives assessment

In their application for authorisation the leading consortium CTAC provides a detailed and long

(possibly not exhaustive) list of the possible alternatives for substitution of Chromium Trioxide eg

for the use of hard chrome plating such as

Electroless plating

Nickel and Nickel alloy electroplating

Case hardening Carburizing carbonitriding cyaniding nitriding borodizing

Chemical vapour deposition (CVP)

Nanocristalling Cobalt Phosphorus alloy coating

High velocity thermal process (HVOF)

Trivalent chrome plating

Physical vapour deposition 5PVD)

Plasma spraying

General laser and weld coating technology

Stainless steel and high-speed steel (HSS)

Thermal spray coating

During the follow up interviews one NGO stated with reference to substitution that during the AfA

process SEAC does not seem to take the comments from providers of alternatives into

consideration This would lead to reluctance on the alternative providersrsquo part to participate in the

trialogue due to ldquobad experiencerdquo The NGO however also recognised that the setup of providing

alternatives during the public consultation was not ideal for collaboration between providers of

alternatives and applicants Both the consequence of a possible alternative (refused application)

and the limited time for the applicant to reply (14 days) were regarded as a reason why this process

was not as successful as it could be

1074 Providers of alternativesrsquo perspective

Authorisation applicants have to assess what alternatives for their use of Chromium Trioxide exist

in the context of the analysis of alternatives (AoA) and argue their feasibility against four criteria

(technical and economic feasibility availability and overall reduction of risk) In the AoA

applicants therefore should describe alternatives known to them

Additional providers of alternatives were identified during the public consultation rounds for

Chromium Trioxide In the context of this project interviews were held with some providers of

alternatives who clearly indicated that there is an increased interest in their product For instance

100 httpsmarketplacechemsecorg 101 httpwwwoecdsaatoolboxorg



a supplier of PVD coating technology reported that several projects were on-going with car

manufactures to introduce PVD coated parts The same provider reported that a major obstacle for

the introduction of this new technology was the existing specifications based on chrome plating

For some car manufacturers he was able to develop bespoke specifications for PVD coated

particles The supplier expects now that this specification is developed the introduction of more

parts will be easier The supplier confirmed that an authorisation for chrome VI based plating is

required as there is at present insufficient capacity for PVD plating available Significant capacity

building is still required and he expects that the two technologies will co-exist for a while even

though he is confident that in the end a switch to the alternative process will be possible

In some cases clear collaboration between suppliers of alternatives and applicants is reported in

the AfA For instance in the Grohe application for the use of Chromium Trioxide for the etching of

plastic parts prior to chrome plating Grohe reports details of an on-going development program

with a supplier of alternative technologies In these cases the provider obviously did not come

forward during the public consultation phase

An interviewed provider of alternatives that had developed a patented new alternative cylinder

technology stated that he encountered quite some resistance from potential customers when he

introduced and promoted his new technology for the printing and flexible packing industry Due to

the fact that companies assumed they would be successful with their application for authorisation

for Chromium Trioxide it appeared that the trigger for an alternative based on purely health

improvements would not be strong enough Only when he was able to provide (after more testing)

additional value in the form of lower operating costs and longer durability of the cylinders he

experienced substantially more interest from industry

The Belgian authorities carried out an inspection campaign in 2015 on chemical agents in the sector

of surface treatment and coating of metals with focus on hexavalent chromium listed under REACH

Annex XIV In this campaign 83 companies were visited and inspected In the course of the

inspection companies were also questioned about specific impacts of REACH and the authorisation

obligation The report on this campaign comes to the conclusion that ldquothe authorisation procedure

under REACH drives substitution much more efficientlythan OSHrdquo ndash ldquotrigger to substituterdquo102


No publicly (or commercially) available information was identified that could help to evaluate

relevant changes in the markets for alternatives While providers of alternatives stated that they

experienced an increasing interest in their products and processes there is little or no hard data to

assess the impact for the market of alternatives So far the volume of alternatives supplied is still

minimal NGOs which were interviewed for this project expressed their concern regarding the

impact of granting authorisation on the development of the market for alternatives They fear that

granting of authorisation will prevent alternatives to enter the market It appears however that

despite authorisation providers of alternatives are confident that they will be able to penetrate

the market over time


Authority 2016 Results of Inspection Campaign for Chemical Agents in the metal surface treatment sector




The reduction of the occupational and environmental exposure to the SVHC is one of the key

objectives of REACH To what extend this has happened or will happen for the Chromium Trioxide

applications is investigated in this section using two approaches Firstly the number additional risk

management measures that were implemented or announced as a result of the authorisation

process is investigated Secondly historical exposure data is compared with exposure data from the

AfA The information for both approaches was collected from literature the on-line survey the

public available AfA files and targeted interviews with stakeholders involved in the authorisation

process for chromium trioxide


In 24 of the public versions of the AfAs dossiers for Chromium Trioxide improvements in RMM

were mentioned This is similar to all AfA (35 mentioning improved RMM in the context of the

public dossier) Four out of 37 Chromium Trioxide dossiers reviewed had clear indications of

improvements of RMM In seven other applications general statements regarding improvements of

RMM were identified

Several of the AfA for chromium trioxide are upstream applications In these applications there is

no mention of improved RMM as a result of the authorisation process This can be the direct result

of the fact that these are upstream applications which typically contain less detail on specific use

conditions

The availability of new measured exposure data as a result of the AfA was mentioned as an

example of improvement

ldquodue to authorisation businesses have been generating new data on exposure levels

(occupational or environmental) which helped them identify areas for further

improvementsrdquo

In a survey carried out in the context of a workshop on chromates authorisation application103 one

third of the respondents stated that the authorisation process led to improvements in risk

management which is in line with the findings based on the AfAs The workshop participants

claimed that the authorisation process would lead to improvements by focussing activities but most

of the improvements in exposure and emission were achieved prior to the REACH authorisation

process

The data from the analysis of the applications for authorisation on improvements is also supported

by the survey results The survey results indicate that (nine out of 29 31) were able to improve

their risk management activities as a consequence of the authorisation For all these companies

the measures have led to a reduction or elimination of the occupational exposure to their workers

For seven of these companies less than 20 employees were affected by the measures Five

companies stated a reduction of emissions to air and wastewater though without providing

detailed information about how much In four of the companies the improved risk measures also

led to a reduction either in the waste or in the consumption of the SVHC

103 ldquoChromates Authorisation Application workshoprdquo 2829062017 organised by Eurometaux



Asked for the key trigger to improve the handling and operational conditions for using Chromium

Trioxide the companies stated equally the inclusion to the Candidate List the inclusion to Annex

XIV and the application for authorisation as the starting points for their measures

Although In the interviews stakeholders did not provide additional input on possible improvement

for risk management measures other than generic statements some qualitative comments were

collected

One interviewed downstream user mentioned that there was not much expectation that the

authorisation would lead to benefits in reducing exposure as most of the work (on exposure

reduction) had already been done

This is in contrast with three other interviewed stakeholders stating that despite continuous

improvements over the last 10 years the event of the application of authorisation led to a renewed

view on the processes to identify possible improvements But since they believed that the levels of

exposure were already under control the willingness to invest in additional improvements was

limited

All evidence shows that improvements in risk management measures were implemented in the

context of the authorisation process Although the level of improvements is probably different for

the different users of chromium trioxide This could be the direct result of the fact that some up

stream applications refer to local OEL with which companies have to comply but do not argue

minimisation based on the technology which is employed

Exposure measurements

Several Member States manage databases which contain measured exposure data For Chromium

Trioxide substantial information is available because hexavalent chromium has been under the

close attention of authorities for at least two decades due to the known substance hazards

Unfortunately of the relevant bodies few were able to supply any information (Belgium Germany)

France and Italy did not respond to the request to supply data but published data could be used

Publicly available studies on the development of occupational exposure levels have been analysed

to extract trends in the improvement efforts covering almost the past two decades (Belgium

France Italy Germany)


authorities to assess the level of occupational exposure (see Table 107) Unfortunately the setup

and the reporting of these data vary across Member States This makes it difficult to compare the

values and to compare them with the values mentioned in the AfAs Nevertheless these values can

be used as reference points to highlight the trend in the reduction of occupational exposure levels

over the years when compared to the values in the Afas

The sources listed in Table 104 were used and cover several CrVI compounds in addition to

chromium trioxide



Table 104 Sources used for estimation of exposure to CrVI

Country Publication Period

Italy Hexavalent Chromium Compounds in the Workplace

Assessing the Extent and Magnitude of

Occupational Exposure in Italy

1996-2009

Germany MEGA-auswertungen zur Erstellung von REACH-Expositionsszenarien

fuumlr Chrom(VI)-Verbindungen (2000-2009) in Deutschland

2000-2009

Galvanotechnik und Eloxieren

Empfehlungen Gefaumlhrdungsermittlung der Unfallversicherungstraumlger

(EGU) nach der Gefahrstoffverordnung (DGUVI 213-716)

2001-2011

France Occupational Exposure to Chrome VI Compounds in French Companies

Results of a National Campaign to Measure Exposure (2010ndash2013)

2010-2013

Belgium Resultaten Inspectiecampagne Chemische Agentia in de sector van de

oppervlaktebehandeling van metalen

2015

For the interpretation of the exposure levels it is useful to use the reference dose response curve

published by ECHA104 In Table 105 the values are provided for workers exposure

Table 105 Excess lifetime (up to age 89) lung cancer risk estimates for workers exposed at different 8h-TWA concentrations of Cr(VI) for 40 years

Ambient Cr(VI) exposure concentration (μgm3)

Excess lung cancer risk in the general population (x10-3)

25 100

125 50

10 40

5 20

25 10

1 4

05 2

025 1

01 04

001 004 Background cumulative lifetime risk of dying from lung cancer between ages 0 and 74 in EU males is 481000 (Globocan

2008)

Additionally a new proposal by the EU Commission on carcinogens and mutagens at work105

foresees a proposed limit for Chromium Trioxide of 10 microgm3 for the first five years after the date

of transposition of the Directive and a limit of 5 microgm3 after then will apply

In Table 106 values are provided from German and French measurement campaigns From this it

can be noticed that the French and more recent results provide a lower value compared to the

German values (eg Chrome plating max = 171 microgm3 while P90 value for Germany 13 microgm3)

104 Application for Authorisation Establishing a Reference Dose Response Relationship for Carcinogenicity of

Hexavalent Chromium (RAC27201306 Rev1) 105 Proposal for a Directive of the European Parliament and of the Council amending Directive 200437EC on

the protection of workers from the risks related to exposure to carcinogens or mutagens at work



Table 106 Historical measurement campaigns on Cr(VI) reported from various EU countries values for inhalation

EU-

country Trade sector Application Samples Sites

Values

microgm3

Referenc

e

Range (1)

France

Metal fabrication

Hard chrome plating

Chrome plating

Aeronautics painting

Hot metal spraying (HVOFarc

plasma spray)

99

97

90

77

8

99

lt002 - 97

lt003 ndash 23

lt002 ndash 171

lt002 ndash 896

182 ndash 15

90 value (2)

Germany

Metal construction

Equipment manufacturing

Manufacturing transport

equipment

Electroplating

Engine and vehicle

construction in generall

Machine building

Metal working in general

Surface treatment and

hardening

Application of liquid coatings

160

123

99

1174

83

272

774

100

71

79

55

31

379

33

120

398

40

15

28

50

132

13

326

208

11

14

283

Note

(1) Measurement campaign carried out by seven CARSAT chemistry laboratories CRAMIF laboratory and

INRS over the 2010 ndash 2013 period106 incl 99 companies involved in various activity sectors

(2) Measurements carried out in Germany in the period 2000 to 2009 measurements taken from

companies in the machine building and metal working sector (measurements from 1218 companies)

107

The slightly more recent data from the DGUVI 213-716 nuances by providing more detail on the

Galvanik use mentioned in the Table 106 Depending on the process step the Cr exposure value

(P95) varies between 25 microgm3 (hardchrome) to 67 microgm3 The value for the loading and unloading

positions is the same as in Table 106 13 microgm3

Belgian authorities that audited 83 companies that used Chromium Trioxide at the end of 2015

supply the most recent data

106 Vincent Gillet Goutet Guichard and others 2014 Occupational Exposure to Chrome VI Compounds in

French Companies Results of a National Campaign to Measure Exposure (2010-2013) 107 IFA Institut fuer Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung February 2012 MEGA-

Auswertungen zur Erstellung von REACH-Expositionsszenarien fuer Chrom(VI)-Verbindungen (2000 bis 2009) in

Deutschland



Table 107 Results from the Belgian inspection campaign108

Type of sample lt 1 microgm3 1 - 10 microgm3 gt 10 microgm3

Personal sample 45 50 5

Stationary Sample 43 52 5

Total 44 51 5

(1) Results of inspection campaign for chemical agents in the metal surface treatment sector inspection

in 83 companies in 2015

This Belgian data does not allow a like for like comparison as it neither differentiates the uses

accurately nor it takes the available technology into consideration However the campaign

provides a high-level view on the exposure to CrVI

Recently ECHA estimated the impact of the authorisation on the exposure to CrVI in a meta-

analysis109 This analysis started from the data of the French publication and compared these

results with the exposure values reported in the AfAs on chrome compounds According to ECHA in

the AfAs used in that analysis a maximum exposure level of 2 microgm3 was imposed Assuming that

the French data is representative for the EU and an estimated number of workers in sectors using

CrVI the number of avoided cancer case was calculated In case of an exposure level of 2 microgm3

post authorisation the number of avoided lung cancer cases amounts 82 per year in case 15 of

the CrVI workers were actually exposed to CrVI The value of 15 of the workforce exposed is a

rough estimate but for instance for the AfA for Grohe about 11 of the total workforce was

potentially exposed to Cr(VI)

This value could be even optimistic in the sense that the French data estimates more than 60 of

the exposure below 1 microgm3 while the data collected by the Belgian authorities indicates that in

2015 only 45 of the samples were below 1 microgm3

Additionally the value of 2 microgm3 is in several cases an overestimate In practice several

applicants estimate the exposure value lower An overview generated from the publicly available

AfAs documents (for Chromium Trioxide) delivered the following exposure results (see Table 108)

Table 108 Overview of occupational exposures results from the submitted AfAs for Chromium Trioxide expressed as ranges

Inhalation

Measured data Modelled data

Range in microgm3 Range in microgm3

lt1 1-10 10-50 lt1 1-10 10-50

15 7 1 15 17 1

This means that the number of avoided cancer cases as a result of the authorisation CrVI as

estimated by ECHA could be underestimated For instance if the real exposure level after

authorisation would be closer to 1 microgm3 the number of avoided cancer cases would be closer to

11 per year (same assumption of 15 of the CrVI workers exposed)


Authority 2016 Results of Inspection Campaign for Chemical Agents in the metal surface treatment sector 109 Socio-economic impacts of REACH authorisations mdashA meta-analysis of the first 100 applications for

authorisation (September 2017)



These values can be compared with the values reported by the Italian authorities indicating that

over the period 1996-2009 the average exposure level to CrVI was still more than 30 microgm3

However this report differentiates between the CrVI compounds For chromium trioxide the

reported P95 exposure level is below 2 microgm3 In the publication the authors show that over the

period 1997-2008 there is a statistically non-relevant decreasing trend in the exposure values (see

Figure 105)

In any case different publications show that some caution needs to be taken when using overall

data The difference between the exposure depending on the task or the substance used can be

very significant In that sense the estimation of the number of avoided cancer cases can only be a

rough estimate A better estimate would for instance require a more exact number of people

exposed at a certain level

Figure 105 Evolution of the exposure to CrVI110

There seems at first sight a discrepancy between the improvement in exposure as a result of the

authorisation process based on the measured values and the results of the interviews While the

interviewed stakeholders were generally sceptical and claimed that the majority of the

improvements were done independent of authorisation comparing the recent actual exposure data

110 Alberto Scarselli Alessandra Binazzi Davide Di Marzio Alessandro Marinaccio amp Sergio Iavicoli (2012) Hexavalent Chromium Compounds in the Workplace Assessing the Extent and Magnitude of Occupational Exposure in Italy Journal of Occupational and Environmental Hygiene 96 398-407 DOI 101080154596242012682216



shows that still a reduction of the number of cancer cases can be expected after the

implementation of authorisations

Despite the frustration about the burden of the application process one SME owner we interviewed

expressed the hope that ldquoone of the visible benefits due to authorisation will be the consolidation

amongst the small contract platers The lsquoblack sheeprsquo of the trade will eventually be forced either

to improve their working conditions or they will disappearrdquo


It is difficult to assess the impact of the authorisation process on competition and competitiveness

due to limited research available The time to the sunset date (2192017) is too short to

experience any visible effects in market volumes It is expected that in time the impact will be

better supported by data

A Finnish study looking at impact and benefits of the REACH authorisation covering 14 Finnish

companies working with hexavalent chromium came to the conclusion that ldquouncertainty about the

scope of the process itself (authorisation process) caused confusion for all enterprisesrdquo111 A

similar statement did also recur in almost three quarters of the interviewed applicants and

downstream users for Chromium Trioxide Uncertainty and unpredictability about the outcome of

the authorisation process would substantially weaken the competitive position of their businesses

During a breakfast briefing in the European Parliament on the topic of EU 2020 and Industrial

Competitiveness SMEs in the Surface Engineering Sector in 2014 Mr Dave Elliott President of the

Committee for Surface Treatment which represents around 20000 SMEs in total stated in

reference to REACH that

ldquoThe surface engineering industries are suffering from mounting environmental legislation

that always assumes the worst-case scenario This threatens the very survival of many

surface engineering companies reduces their global competitiveness and poses the risk

that industrial value chains relocate part of the productions processes outside the EUrdquo

Later in this briefing it was also concluded that SMEs require stability predictability confidence

and better regulation ndash where better regulation means reducing the administrative burden and

simplifying REACH112

The responses to the online survey indicate that 11 out of 29 businesses experienced a negative

impact of the authorisation on their competitiveness Except for one business all respondents

stated authorisation made it more difficult to sell products to EU customers The uncertainty about

the success of the applications for authorisation led to customers shifting their orders to Non-EU

competitors For measure of balance it has to be noted that a shift to Non-EU customers would

face a different set of challenges such as ensuring the required quality standards flow of knowhow

and the unknown future development of regulatory process in Non-EU countries (like China and

Turkey) Customers would pick up information that Chromium Trioxide would be banned after

sunset date via medianews or associations ndash this required some businesses to invest efforts into

111 ldquoHow the REACH authorisation process affects and benefits companiesrdquo 2017 Atte Harrikari amp Riku

Montonen Aalto UniversityECHA 112 Paul Ruebig MEP Austria EU 2020 and Industrial Competitiveness SMEs in the Surface Engineering

Sector13th November 2014



informing customers about REACH Another negative impact on the competitiveness was the

increase in cost due to the applications for authorisation The additional cost burden would provide

an advantage to competitors outside EU

A particular case was mentioned in the defence industry As a consequence of REACH authorisation

applicants experienced that their customers would ask for products free of substances from the

Candidate List stating that they would not want to continue the uses of these hazardous

substances While this may represent an ultimate goal it would be difficult if not impossible to

implement in the short term

The follow up interviews with stakeholders confirmed the statement that businesses felt their

competitive position weaken due to the authorisation process More detailed impacts on the

competitive position was possible to clarify during the interviews The typical impacts mentioned in

the interviews were

Weakening of competitiveness due to reallocation of RampD to support substitution efforts

(and away from other innovative development work)

The fear of losing or the actual loss of orders as customers would shift to non-EU

competitors

The additional cost burden associated with the authorisation in a market operating with

tight profit margins and thus allowing no or only exceptional price increases

Almost all of the interviewed companiesdownstream users stated that the uncertainty about the

outcome of the application for authorisation and the possible threat of a short review period would

lead to discussions with customers who would demand (long term) planning security As that

security could not be provided customers started shifting the orders to suppliers outside EU One

interviewed company stated an estimated loss of turnover of around euro30 million for the last three

years due to orders being shifted to outside EU Another interviewee stated that their production

facilities in Germany lost new development projects and the subsequent orders went to a Swiss

production facility due to the fact that the local legislative framework there provided longer term

clarity for the use of Chromium Trioxide (20 years) which determined the customerrsquos decision to

shift to Switzerland In Switzerland chrome plating companies will have to comply with a new

threshold limit value of 1 microgm3 (from previously 5 microgm3)113

A typical small contract plating business stated that they had lost orders from customers outside

the EU but for now were able to compensate these orders with orders from other customers In the

past however customers would develop new products in cooperation with them that would allow

the business future orders for five to seven years and therefore represent the business base At the

time of the interview the downstream user expressed the concern that no development order was

in the pipeline due to the uncertainty of the authorisation and the short review period that had

been proposed by RAC and SEAC Admittedly this statement was only by one contract plater

However the way in which it is losing customers could be applicable for more small businesses

This is in contrast to the optimism expressed by the Dutch association of coating shops that stated

at the end of 2016 that all of its member companies had the best year of their history and that

demand for its services was soaring

While one of the objectives of REACH is to improve competitiveness it appears that in the case of

Chromium Trioxide many businesses experienced the opposite As discussed under the topic of

substitution mainly smaller companies felt that authorities (especially the assessment committees)

113 ldquoSchweizer Galvano-Briefrdquo Ausgabe Mai 2017 p52



do not understand their industrial environment114 Especially the so-called contract platers ndash

traditionally SMEs with limited or no influence on the product specifications set by their customers

- experienced that their particular situation was not appreciated

While the key message on the impact of the authorisation on the competitiveness is clearly that

companies from the survey and the interviews feel disadvantaged some stakeholders particularly in

the interviews also stated positive effects Consolidation of the plating business was stated as one

advantage that some interviewed stakeholder identified Those companies that would (or could)

not adopt either by switching to alternative technologies or by improving their exposure conditions

would inevitably disappear over time One small contract plater mentioned that ldquoI think that we

will especially in the running up to the re-application of authorisation see some companies simply

disappearingrdquo

Providers of alternatives also judged a positive effect of the authorisation on their competitiveness

As a result of the uncertainty the authorisation process generated amongst the customersrsquo

research would be accelerated and more resources allocated However they also indicated that

their role in the process of authorisation proved to be difficult To comment as a supplier of

alternative technologies during public consultation was considered by one interviewee ldquocommercial

suiciderdquo meaning that supplier of alternative technologies would not want to confront applicants

and therefore potential future customers during the public consultation


Due to its hazardous characteristics the replacement of hexavalent chromium received substantial

attention even before the introduction of REACH Several EU-funded projects were commissioned

about replacement of Cr(VI) or reduction of the use of Cr(VI) such as CRAFT (1999) ndash See Annex H

In addition in several Member States research programmes have been carried out with the

objective of developing suitable alternatives for the use of Chromium Trioxide eg in France The

impact of this funded research has been to enable new technologies to be supported during their

development to help them reach the market

From the survey results of the 27 respondents referring to Chromium Trioxide two thirds (17)

responded that the authorisation did have an impact on their organisationsrsquo spending on innovation

or investment opportunities andor RampD The large majority (13 out of 17) indicated that they

increased their spending on RampD efforts while three stated a reduction in RampD spending

In contrast the majority of the interviewed stakeholders (six) referred to not having increased the

RampD budgets but to have it deprioritised In the process of the preparation of an application for

authorisation the available RampD resources would be shifted away from innovation projects to

support authorisation and the search for an alternative substance or process

A leading supplier to the defence industry stated that due to the authorisation process overall RampD

budget could not be increased but was in fact redirected from required new technology

development to finding an alternative for Chromium Trioxide The required military qualification

for products produced with an alternative would be costly and time consuming ndash on top of that the

supplier had to expect that their products would not list high on the priority list for the military





qualification for their customers As a consequence the supplier felt that resources were wasted

and instead of developing innovative new products their non-EU competitors would benefit from

not having to apply for authorisation

Another discrepancy in the result from the online survey and the interviews was the attitude

towards investments andor innovations In the online survey 13 of the 17 respondents stated that

due to authorisation they had increased the volume for innovation and investment opportunities

During the interviews the opposite was stated In five of the interviews the stakeholder confirmed

investment freezes in the EU locations as a consequence of authorisation Due to the uncertainty

about the outcome of the authorisation process new investment projects in the EU have been put

on hold or directly shifted to suppliers outside the EU In two instances even replacement

investments were limited to the minimum pending the outcome of the application for

authorisation


For Chromium Trioxide applications for authorisation have been filed for different sized companies

(Table 109) For some small and medium enterprises the fact that continued use of Chromium

Trioxide would need authorisation came as a surprise

Table 109 Number of applicants and their size per substance

Substance Large Medium Small Micro

Chromium trioxide 42 2 9 8

Chromium trioxide Dichromium tris(chromate) 2 2

Chromium trioxide Potassium

dichromate Sodium dichromate 5 1

Total 49 3 9 10

Data provided by ECHA (03112016)

However this provides only a limited view on the impact of the inclusion of Chromium Trioxide on

Annex XIV on SMEs Ninety eight percent of the surface plating industry of more than 1000 chrome

plating shops in the EU are thought to be SMEs

As expected the majority of the SMEs sought the umbrella of a consortium to apply for

authorisation In total of the 27 applications for authorisation for Chromium Trioxide submitted

nine have been prepared by consortia The big consortia were able to join large numbers of

businesses CTAC mentions approximately 150 members and HAPOCVecco indicates more than 170

members Key reasons for SMEs joining consortia were (i) the reduction in cost for an application

and (ii) the avoided time and expertise required to prepare for an application

The case of German HAPOCVecco is of interest To cope with the application challenges seven

SMEs established an association (Vecco) to support the authorisation activities The intention of this

association is also to cooperate beyond the authorisation by joining forces on RampD providing

consulting work sharing best practices and enforcing standards amongst member companies in the

form of audits and reporting As an association could not submit an application for authorisation a

company (HAPOC) was founded that would act as importerformulatordistributor for the member

companies of the Vecco association According to the Vecco website the association had more than

170 members in 2015



In a recent study in Finland on the benefits of authorisation115 14 Finnish applicants for

authorisation have been interviewed Half of these companies were SMEs or micro companies

Several of these companies applied for authorisation for Chromium Trioxide Although the main

purpose of the study was related to benefits also the SME aspect was investigated

Eleven of the 14 Finnish companies interviewed by the study used Chromium Trioxide and stated

that the first issue the businesses associate the authorisation with is the additional cost burden

This was also confirmed by the statistics that except for one company all were organised in some

form of consortia to address the application for authorisation This joining of forces led over time

also to improved networking As a result one company ldquoadopted the idea of using a foaming agent

in their process baths from better performing companies and improved their process safetyrdquo116 The

report also states that a majority of the micro-sized companies got into contact with partner

companies in other EU countries like Sweden UK or Germany

The OY Kromatec application for the use of Chromium Trioxide for functional plating is the result of

collaboration between seven Nordic plating companies (CRAN) According to the SEA of the AfA

these companies are all small or micro sized companies Although the total profit of turnover for

the companies is not provided in the AfA it is mentioned that the discontinuation of the use of

Cr(VI) would result in a cost of euro79 million over the total applied for review period of 12 years

based on 46 jobs lost Based on the details of the volume of Cr(VI) used it seems that the group

consists of six companies fairly similar in size and one larger company (annual volume of Cr(VI) used

is 10 tons per year for one site and between 1-5 tons per year for the 6 others)

This application is next to other applications which include the use ldquofunctional platingrdquo For

instance the application ndeg 32 with LANXESS as the lead applicant Provided that the applicants in

the OY Kromatec application can be supplied by one of these applicants the Kromatec application

can be seen as redundant An own application however would also provide the independence to

choose suppliers themselves rather than depending on the supply via suppliers from the consortium

(CTAC) Nevertheless and probably with the knowledge of the existing other application the

Nordic SMEs still elected to submit their own application Both the LANXESS application and the

Kromatec application applied for a review period of 12 years and for both applications the

recommended review period is seven years (no final decision yet) For the other applications there

was no recommendation yet available In any case the application of Kromatec showed that groups

of even micro companies can apply for authorisation


Looking at all influencing factors for the case of Chromium Trioxide three main consequences could

be identified

Benefits in the form of exposure reduction

The substitution challenge

Impacts on the competitiveness of applicants


companies Aalto Aalto University 116 Harrikari A and R Montonen (2017) How the REACH authorisation process affects and benefits




At the time of writing of the report the sunset date was not passed and hence it was not possible

to have actual exposure and emission data post authorisation It was only possible to a very limited

extent to estimate the benefit with regards to exposure and emissions prior to the sunset data

Measured and reported exposure data in the AfAs and announced additional RMM lead to the

expectation that a further reduction of exposure will be possible after the sunset date The exact

value of this improvement is hard to estimate but based on the interviews the interviewed

stakeholders stated that the majority of their exposure reduction was done before authorisation for

Chromium Trioxide was considered It is a common statement by industry that a lot has been done

before authorisation was considered nevertheless if one compares the exposure level

recommended by RAC (r2 ugmsup3) improvements could still be achieved by authorisation It is

expected that after the authorisation decisions have been fully implemented and enforced the

benefits of reduced exposure will be recognised

From a hazard perspective hexavalent chromium poses a severe hazard to humans For the

majority of the uses the authorisation process can be used to manage the risks However the

widespread use of Chromium Trioxide particularly in surface plating means that the authorisation of

this substance affects a large number of businesses of which a number have reported a

considerable negative economic impact for the business in this sector

The online survey responses and the interviews carried out within this study support the position

that especially contract manufacturers are facing difficulties This is because they are not the

owners of the process and hence cannot independently change to an alternative as customers shift

their orders to non-EU suppliers rather than support the development of an alternative technology

or move directly to platers that have invested into alternative technology This means that as a

consequence of the authorisation a consolidation in the surface treatment industry can be

expected over the next few years This will result in companies that will adopt and perhaps be even

strengthened by authorisation and others that will likely cease in the process There is no hard data

currently available to support this conclusion as sunset date is still in the future and the final

decision by the EU commission is still pending but there is a general consensus in the industry that

this will be the future

While not originally in the scope of the case study it is worth mentioning that Chromium Trioxide

shows clearly the challenge for upstream applications As upstream applications cover potentially a

broad range of uses they also face uncertainties on for example exposure levels The advantage

of an upstream application is a commercial one ndash the cost spread over large number of companies is

lower but this comes at the price of a shorter review period While industry regards this as a

ldquopunishmentrdquo one could argue that the cost per review year might be fairly acceptable The lesson

learned from Chromium Trioxide is that data specific applications with a clear use tend to receive

recommendations for longer review periods This may come at the price of an increase in the

number of applications and most probably also higher application costs for smaller businesses that

decide to apply by their own rather than being covered by an upstream application However

longer review periods deliver security for investments and customers Without the planning for

stability customers are shifting orders to outside EU according to the interviewed stakeholders

mainly to China but also to Turkey



11 TIER 1 CASE STUDY SUBSTANCE 2 TRICHLOROETHYLENE

111 Introduction

Due to concerns about its toxicity the use of trichloroethylene (TCE) has been banned in the food

and pharmaceutical industries in much of the world since the 1970s At the end of the 1990s and

the beginning of 2000 companies made substantial efforts in reducing the consumption of the

substance as a solvent also driven by the Volatile Emissions Directive which forced companies to

reduce emissions considerably to comply with the legislation

One of the key reasons for the recommendation of this substance registered in volumes up to 1

million tonnes for inclusion in Annex XIV was that ECHA concluded that the volumes allocated to

the uses in the scope of authorisation were very high and at least some of the described uses would

potentially create significant exposure of industrial workers and professionals and hence could be

considered wide-dispersive However with the biggest use allocated as intermediate the volumes

for which authorisation is sought are considerably lower at a range of close to 20000 tonnes for all

the uses except for ldquopackagingrdquo which is in the range of 10000 to 100000 tonnes

There were six responses to the online survey from applicants downstream users or NGOs dealing

with TCE and only four of these responded to questions with reference to TCE Of the four

respondents three were downstream users and one an NGO This is much less than those for

Chromium Trioxide

For the follow up interviews four stakeholders for TCE were contacted

NGO (1)

Associations (0)

Applicants (1)

Downstream users (0)



Table 111 Trichloroethylene substance profile

Name Trichloroethylene

EC no 201-167-4

CAS no 79-01-6




Carcinogenic (Article 57a)



Trichloroethylene is a chlorinated hydrocarbon Most TCE is produced from ethylene Ethylene is

chlorinated over a ferric chloride catalyst to produce 12-dichloroethane (ClCH2CH2Cl) When

heated to around 400degC with additional chlorine 12-dichloroethane is converted to

trichloroethylene (C2HCl3)



This reaction can be catalyzed by a variety of substances (a most commonly used catalyst is a

mixture of potassium chloride and aluminum chloride) This reaction produces tetrachloroethylene

as a byproduct Depending on the amount of chlorine fed to the reaction tetrachloroethylene (or

perchloroethylene in the following referred to as PER) can even be the major product Typically

TCE and PER are collected together and then separated by distillation In Europe an alternative

process is in place which starts from PER and uses catalytic hydrogenation117

Based on studies that show its carcinogenic potential it was concluded that TCE (EC no 201-167-4

CAS no 79-01-6) should be considered as a non-threshold substance


TCE fulfils most of the key criteria set for the selection of a Tier 1 case study substance


whole authorisation process ndash for TCE this was 21 April 2014


getting data ndash for TCE there were 13 applications for 14 applicants

There is a high number of uses applied for ndash 19 uses and

The impacts are diverse and complementary ndash high volumes allocated to the uses and

widespread use in EU in numerous businesses (especially for the metal degreasing and

surface cleaning use) with widespread applications

There is little information available to quantify accurately the number of companies potentially

affected A report from 2011 estimated that up to 141000 companies engaged in the lsquotreatment

and coating of metalsrsquo employing around 11 million employees could be affected EU wide118 While

the Eurostat data cannot differentiate whether all these companies are using TCE this number can

still be ndash as a worst case - assumed as TCE has been regarded as an effective and widely used

solvent for the cleaning of metals



Table 112 Trichloroethylene REACH authorisation timeline


Date of inclusion to Candidate list 18062010




117 European Chlorinated Solvent Association ndash Trichloroethylen Legislation Markets Use 2010 118 Institute of Occupational Medicine Research Project P9373 (2011) - Health socio-economic and

environmental aspects of possible amendments to the EU Directive on the protection of workers from the risks

related to exposure to carcinogens and mutagens at work ndash Trichloroethylene Data from Eurostat 2006



According to Article 57(a) TCE was identified as a substance of very high concern It is classified as

carcinogen category 1A ECHA concluded that the volumes of TCE allocated to the uses in the scope

of authorisations were very high and at least some of the described uses would bear the potential

for significant exposures of industrial workers and professional and could hence be considered wide

dispersive

TCE was included on the Candidate List for authorisation on 18 June 2010 During the period for

commenting 38 comments were submitted by industry (6) and industry associationstrade

unionsMember States authorities (32) The majority related to general comments (17) followed by

specific comments on use exposure alternatives and risks (12)119

On 20 December 2011 the substance was included in Annex XIV This meant that the use of TCE

would require authorisation after the sunset date of 21 April 2016 with a latest application date of

21 April 2014

During the period for commenting for the inclusion of TCE to Annex XIV 95 comments were

submitted by industry (65) industry associationstrade unionsMember States authorities (23) and

NGOs (7) The majority related to comments on uses that should be exempted from authorisation

(36) and general comments on the recommendation to include the substance in Annex XIV (34)

By end of 2016 13 applications by 14 applicants for 19 uses of TCE after sunset date were

submitted


Trichloroethylene was assessed in the context of a risk assessment report finalised in 2004 with the

UK as the rapporteur120 The report refers to four producers of TCE in the EU and in the Defra risk

reduction strategy report from 2005 three producers of TCE in the EU are mentioned One French

producer ceased the production of trichloroethylene in 2006

Since 1996 the sales volumes of TCE in the EU have steadily declined from levels of 100000 tons

per year to around 38000 in 2003 The key reasons for the decrease were related to the continuous

substitution of TCE by alternative substances or technologies

Use of closed systems The introduction of closed loop safety containers (ldquosafetainersrdquo)

led to an elimination of emissions during filling and

The process improvements by converting to closed systems in surface cleaning led to a

minimisation of solvent emissions and a reduction of solvent consumption by improved

recycling and re-use

The main driver for industry to make efforts to improve emissions respectively substitute

trichloroethylene as a process solvent were to comply with the Solvent Emissions Directive

(introduced in its first version in 1999121) and in anticipation of REACH sometimes even in the form

119 Due to the grouping of the comments in different categories some of the comments could be counted

double as they would fit several categories 120 European Union Risk Assessment Report Trichloroethylene European Chemicals Bureau 2004 121 The purpose of the Solvent Emissions Directive is to prevent or reduce the direct and indirect effects of

emissions of volatile organic compounds into the environment mainly into air and the potential risks to

human health by providing measures and procedures to be implemented for certain activities (description by

Department for Environment Food and Rural Affairs)



of voluntary industry commitments The risk assessment report of 2004 stated that the Directive

caused a significant reduction in use and emissions of TCE in metal cleaning due to requirements to

phase out the substance where feasible and to impose limits upon emissions to atmosphere by the

use of closed systems The Defra report of 2005 expected that ldquodue to the use of closed systems

respectively substitution to other solvents the trichloroethylene consumption into solvent

applications would drop by an additional 60 compared to the 2006 consumptionrdquo122 The same

report states that in 2007 the TCE use as a solvent accounted for in the EU was 25 of the EU

production The rest would be used as intermediates ndash this is a substantial change as in 1996 TCE

was used up approximately 63 as solvent and intermediate use was 37 of the EU TCE production

(see Figure 111 and 112)

Figure 111 Production export import volumes TCEPER 2003-2016

Note The numbers in this figure represent the combined figures for TCE and PER

122 Defra - Risk Reduction Strategy and Analysis of Advantages and Drawbacks for Trichloroethylene Entec UK

2005



Figure 112 Uses of TCE sold into EU markets 1996 and 2003

According to the Annex XV report of 2010123 the majority of the TCE volume produced today is used

as a chemical intermediate (estimated at 80) which is out of scope of the authorisation under

REACH The same report mentions that the remaining volume is allocated to the following main

uses

Industrial solvent for metal cleaning and degreasing and

Solvent used in certain adhesives

The Annex XV report refers also to miscellaneous uses as solvent like

In the metal processing

For asphalt testing

For wool scouring

For high-tech ceramic goods production

As process solvent

As heat transfer fluid

TRI has long been replaced in dry cleaning machines with tetrachloroethylene (PER) due to the

milder solver action Additionally it is mentioned that some consumer products could still contain

trichloroethylene such as corrective liquids (for typing machines) paint removers adhesives stain

removers and liquids for carpet cleaning but only at concentrations of 01

There are currently five registrations active The total use is in the range of 100000 to 1 million

tons per year based on the tonnage bands presented on the ECHA website The actual import of the

substance is as shown in the Table 115 has been on average for the past five years in the range of

just below 6000 tons per year






Industrial use as heat transfer fluid

Industrial use as process chemical

Industrial use as process chemical (closed systems)

Industrial use as process chemical (semi-closed systems)

Industrial use as process chemical (enclosed systems)

Industrial use in surface cleaning (enclosed systems)

Industrial use in surface cleaning (closed systems)


Distribution and (re)packing

Industrial use of adhesive

Industrial use in adhesives

Industrial use in textile scouring


The Annex XV report states that due to rationalisation and consolidation the number of European

producers of TCE declined from more than 10 in 1984 to two producers in 2009124 After one of the

manufacturer ceased production of TCE in 2016 after a merger with a competitor only one

manufacturer remains today (in Romania) The available information shows that the decline of the

production and consumption of TCE has further declined after 2006 Figure 113 shows the trend

between 2012 and 2016

Figure 113 Trichloroethylene ndash Production consumption exports imports in EU 2012-2016





At the end of 2011 TCE was included in Annex XIV One of the key players Dow Chemicals

(manufacturer of the substance) took the lead to submit an upstream application for authorisation

for five uses Of all submitted applications for authorisation for trichloroethylene (15 in total) more

than 90 could be allocated to the use as solvent either for surface cleaning metal degreasing or

as processextraction solvent

An analysis of changes in the registration data through the authorisation milestones125 concluded for

TCE that at least one of the registered uses (use as heat transfer fluid reported by four registrants)

does not seem to be covered by any applications for authorisation When checking whether any of

the uses which were applied for regarded uses not registered before (or not reported according on

Article 38 of REACH) the same report concludes that ldquoall uses applied for appear to fall under the

generic scope of the registered uses the names of which were however not specified further after

sunset date The comparison relies solely on the use names and therefore is not conclusiverdquo In

total for TCE there is one registrant less today compared to pre-authorisation period

Based on market research information (Figure 114) the production and consumption of TCE in the

EU will further decrease to an estimated level of 23500 tonnes per year by 2022

Figure 114 Trichloroethylene ndash Production consumption in EU 2017-2022

At the time of generation of the market research report there were still two producers of TCE in

the EU The data forecast for the production of TCE in the EU as described in Figure 114 is

therefore considerably lower as the maximum capacity of the remaining producer is around 12000

tonnes per year However the consumption levels in the graph are still regarded as accurate as

the difference in production volume will likely be compensated by an increase in imports of TCE

In one of the interviews held for this study a stakeholder expressed his concern that the market for

TCE was ldquorapidly decreasingrdquo His expectation was that TCE consumption would be ldquostable for the

125 ECHA Changes in the registration data through authorisation milestones TCE DBP CrO3 Status as of 10th

April 2017 p12



market as intermediate but the availability of alternatives would further reduce the demand for

TCE as a solvent for the metal degreasing industryrdquo A forecast for the metal cleaning equipment

industry in the EU126 however predicts a steady growth for the metal cleaning industry with an

estimated annual growth of 62 between 2016 and 2024

117 Substitution

The substantial decline in the production and consumption of TCE over the last two decades means

that alternatives have been available for a long time and companies have been actively seeking to

substitute or change the process even before REACH One of the main legal drivers for this was the

Solvent Emission Directive Despite the substitution efforts for more than 10 years and the

availability of quite a number of alternatives especially in the area of metal cleaning and surface

degreasing some critical applications still remain where the use of TCE is essential for the process

andor the quality of the goods produced127

There are numerous alternatives to TCE in its use as a solvent for metal cleaning and degreasing

Those substances closest to be as drop-in substances are chlorinated solvents ndash tetrachloroethylene

(PER) and methylene chloride (MEC) Dow Chemicals refers to additional alternatives and processes

such as128

Aqueous cleaning The process uses detergent-water or an alkaline chemical solution which

is a very popular alternative but not always as effective at removing grease and oils

Aqueous cleaning is quite successful with steel parts less efficient with aluminium parts

and even less so for mixed metals

Semi-aqueous or emulsion cleaning Parts are exposed to a non-chlorinated solvent that

incorporates a surfactant The surfactant ensures that remove residual solvents and

residual oils from the parts carrying them into aqueous phase

Non-chlorinated solvents Acetone n-methylpyrrolidone (NMP) or terpenes can often

provide good cleaning However these are mainly limited to cold cleaning applications due

to their characteristics as flammable or combustible substances In addition new

engineered solvents have been developed such as volatile methyl siloxanes oxygenated

solvents (glycol ethers and dibasic esters) the hydrochlorofluorocarbons (HCFCs)

hydrofluorocarbons (HFCs) hydrofluoroethers (HFEs) and n-propyl bromide The

disadvantages of the alternatives are the usual lower performance and considerably higher

cost (12 to 15 times the cost of a traditional chlorinated solvent)

Supercritical fluids (SCFs) Particularly supercritical carbon dioxide (CO2) does have good

cleaning properties with little environmental impact Since the substances reach their

supercritical phase only when compressed and heated beyond their critical pressure and

temperature the process requires costly equipment with safety features

Other options There are additional cleaning processes available as plasma cleaning laser

cleaning thermal vacuum cleaning and mechanical cleaning

126 Transparency Market Research ndash Metal Cleaning Equipment Market Analysis 2016 127 ECSA European Chlorinated Solvents Association ndash Trichloroethylene Legislation Markets and Use 2010 128 Dox Clorinated Solvents ndash Newsletter Volume 3 Alternatives to chlorinated solvents



An online research delivered several available tools that businesses looking for alternatives for a

substitution of TCE could use

The substitution portal SUBSPORT (as described under Section 1073) The portal also

describes 14 case studies in which TCE has been successfully substituted for different

applications

Cleantool is an online best practice database dedicated to alternatives for best options for

cleaning of metal surfaces129 The database has been developed between 2001 and 2004 by

five partners with the Kooperationsstelle Hamburg IFE in the lead supported by funds from

EU research programme

A similar database has been developed for users by the Technical University of Dortmund

called ldquoBauteilereinigungrdquo130 available in German The database was mainly developed for

users from automotive industry and allows selection of both alternative substances and

alternative processes depending on the size and type of parts that need to be cleaned

An analysis of the submitted applications shows that in eight cases the alternative mentioned in the

analysis of alternatives refers to PER as an at least technically feasible alternative This confirms

the view of Defra (2005)131 that ldquoperchloroethylene is reported to be the most technically feasible

substitute for trichloroethylene in the majority of the cases even though this will depend upon the

particular applicationrdquo

Looking at the results from the online survey from the applicants andor downstream users two out

of six companies had substituted TCE successfully Half of the respondents (three) mentioned that

they were not investigating any substitution two indicated successful substitution with one

company confirming to carry out substitution activities

An example of early substitution was followed up during the interviews A supplier to the defence

industry stated that substitution of TCE started as early as in the 1990s with switching to

alternative processes (aqueous cleaning) for applications where the qualitative result would allow

it Even before TCE was identified as a substance of very high concern (SVHC) in 2010 the company

decided to substitute the substance and not follow the route of an application for authorisation

Main reason for this was the doubt that an application would be successful due to relatively old

technology used in the processes cleaning with the substance PER was considered as a suitable

alternative but first rejected on the grounds of its hazard profile in addition PER was under

substance evaluation from a Member State authority (Latvia in 2014) As the evaluation concluded

that PER was not a SVHC and no further measures were required it was reconsidered as an

alternative As a consequence a new installation for vapour degreasing has been developed and

implemented based on PER that consumes and emits considerably less solvent This installation was

implemented just before sunset date for trichloroethylene

129 wwwcleantoolorg 130 ldquoBauteilreinigungrdquo means ldquocomponent parts cleaning - wwwbauteilereinigungde 131 Defra ndash ldquoRisk Reduction Strategy and Analysis of Advantages and Drawbacks for Tryichloroethylenerdquo 2005

Entec UK Ltd




Depending on the application and use there are alternatives for TCE Very little publicly (or

commercially) available information was identified that could help to evaluate relevant changes in

the markets for alternatives

Tetrachloroethylene (PER) has been regarded by the supplier of TCE as a technically suitable

alternative to TCE From its hazard characteristics (suspected for causing cancer) it was expected

that PER would follow a similar route as TCE and require authorisation is some years But as

mentioned above the result of the Latvian substance evaluation in 2014 ensured suppliers of PERrsquos

long term stability

The available information shows (see Figure 115) that the EU is a net exporter of PER with

negligible import volumes On average in the last five years 150000 tons of PER were produced in

the EU per year compared to an average import volume of less than 300 tons

After the decision of the substance evaluation in 2014 the consumption of PER peaked towards the

sunset date in 2016 This is in line with a peak in the production volumes in 2016 compared to the

last five years

Figure 115 Tetrachloroethylene ndash Production consumption exports imports in EU 2012-2016

In a market report for tetrachloroethylene132 (Figure 116) the forecast for the next five years

indicates that the production level for PER will continue to decrease while consumption will remain

around a level similar to the average of the last five years This could mean that despite PER being

a technically feasible alternative for the substitution of TCE it is either disregarded due to its

132 BAC reports Trichloroethylene Tetrachloroethylene (Perchloroethylene) ndash European Union Market Outlook

2017 and or Forest till 2022 2017



hazard profile or only substituted in cases where exposure is well-controlled and minimised (eg

closed systems)

Figure 116 Tetrachloroethylene ndash Production consumption in EU 2017-2022


Also for TCE the improvements in risk management are documented in this case study by means of

the evolution of the exposure values and the implemented RMM


As part of the public versions of the AfAs for TCE 27 of the dossiers mention improvements in

RMM This is slightly lower in comparison to all AfA submitted (35 mentioning improved RMM in the

context of the dossier) However as mentioned above according to ECHA most applicants refer to

improved RMM during the application process (PSIS RAC questions) even though data is not

available Furthermore again as mentioned above it seems to be more difficult for upstream

applications to document the improvements in RMM in detail

Nevertheless for two TCE applications applicants clearly mention additional RMMs which were

implemented as a result of the authorisation process (eg Vlisco Parker) In the Vlisco application

more than 20 emissions reduction was announced as a result of process modifications that were

planned to be implemented before the sunset date These improvements were identified on the

basis of mass balances exposure measurements and field audits Another key element in that

dossier was that it also described and documented previous (historical) efforts in minimising

exposure In the Parker case it was also possible to reduce the emissions in the workplace

significantly by process modifications Because of this Parker will be able to double its capacity

without increasing the use of solvent exposure or emission In practice even after such capacity

expansion the exposure will be 20 lower compared to today



Akzo identified in their application for authorisation for the continued use of TCE several

opportunities for improvements using close follow up of the solvent consumption in combination

with field audits and exposure measurements These findings resulted in the change of certain parts

of the installation and the introduction of new maintenance programs

None of the survey respondents replied to the questions on improved risk management activities In

the interviews with stakeholders no reference or comments were made with regards to

improvements in exposure reductions implemented or planned

Exposure values

A basic approach to assess the exposure to TCE at the workplace is by evaluation of the imposed

limit values While the limit values are not indicators of the actual exposure values it can be

assumed that lowering the limit value will lower the average exposure value

TCE is considered as a non-threshold carcinogen without any DNEL value There are however still

local occupational exposure limits with which companies have to comply The existing OEL values

across Europe show a considerable variance between a minimum level of 33 mgm3 for workers

inhalation in Austria and a maximum level of 550 mgm3 in the UK (Table 113)

In 2009 SCOEL proposed new occupational exposure limit for TCE of 10 ppm 547 mgm3 (8-hour

TWA) and 30 ppm 164 mgm3 (short-term exposure limit 15 min)133

Table 113 Existing OELs for TCE inhalation (adapted from the GESTIS database134)

EU-country

Limit value ndash

Eight hours TWA

Limit value ndash

Short term

mgm3 mgm3

Austria 33 132

Belgium 55 137

Bulgaria 135

Croatia 550 820

Cyprus 535

Czech Republic 250 750

Denmark 55 110

Finland 50

France 405 1080

Germany 60

Hungary 540

Ireland 1375

Italy 54 140

Latvia 10

Lithuania 50 134

Malta 55 1375

Poland 50 100

133 Recommendation from the Scientific Committee on Occupational Exposure Limitsfor Trichloroethylene

2009 SCOELSUM142 134 Commission staff working document Impact Assessment - Accompanying the document Proposal for a

Directive of the European Parliament and of the Council amending Directive 200437EC on the protection of

workers from the risks related to exposure to carcinogens or mutagens at work (2017)



EU-country

Limit value ndash

Eight hours TWA

Limit value ndash

Short term

mgm3 mgm3

Romania 100 150

Spain 55

Sweden 50 140

Slovakia 275

Slovenia 270 1080

United Kingdom 550 820

A comparison of the development of the occupational exposure limits over time shows that

considerable improvements can be expected to have been achieved by adjusting the OELs over time

to lower levels (Table 114)

Table 114 Comparison of OEL levels for TCE for different EU countries over time values for inhalation

EU-country

2010135 2017136

Limit value ndash Eight hours Limit value ndash Eight hours

ppm mgm3 ppm mgm3

Austria 50 270 06 33

Belgium 50 269 10 55

Denmark 30 160 10 55

Finland 30 160 10 50

France 75 405 75 405

Ireland 100 535 10

Sweden 10 50 10 50

United Kingdom 100 550 100 550


authorities to assess the level of occupational exposure (see Table 115) While these results are

not representative and should not be compared like-for-like they serve as reference point and can

be compared with the values as reported in the AfA The following sources were used

Country Reference Period

France INRS Raymond VINCENT (2009) Donneacutees COLCHIC dexposition professionnelle agrave divers agents chimiques pour la peacuteriode 2002-2008 Butylglycol et aceacutetate de butylglycol Toluegravene Dichloromeacutethane Perchloroeacutethylegravene Trichloroeacutethylegravene Styregravene Acrylamide As reported in the Annex XV report for trichloro ethylene France 2010

2002-2008

Germany BGAA Report 199 Altstoffe ndash Expositionen am Arbeitsplatz Hauptverband der gewerblichen Berufsgenossenschaften

1990-1994


an equivalent level of concern France 2010 136 GESTIS 2017 httplimitvalueifadguvde



Table 115 Historical measurement campaigns on TCE reported from various EU countries values for inhalation

EU-

country Trade sector Application values companies

90 value

(mgm3)

Refere

nce

France

Manufacture metal products

except machinery and

equipment

215

152 sites

236

(1)

Printing and reproduction 91 194

Manufacture of rubber

products and plastics 85 191

Manufacture computer

electronic and optical

components

38 89

Manufacture of electrical

equipment 23 1

Chemical industry 14 859

Other sectors 274 215

Germany

Loading and distillation in

chemicals industry

- without LEV

- with LEV

31

10

19

16

8

9

71

32

82

(2)

Surface coating Adhesive

bonding laminating lining

stopping

- with LEV

-without LEV

144

74

66

78

44

41

215

185

232

Surface cleaning manually 14 7 304

Surface cleaning

installations

- without LEV

- with LEV

188

23

159

90

18

74

241

282

239

Notes (1) Colchic study 2002-2008137 and (2) BGAA Report 199 Altstoffe ndash Expositionen am Arbeitsplatz

Hauptverband der gewerblichen Berufsgenossenschaften

For the applications for authorisation RAC has published a reference dose response curve138


an equivalent level of concern France 2010 138 Application for Authorisation Establishing a Reference Dose Response Relationship for Carcinogenicity of Trichloroethylene (RAC28201407 rev 2)



Figure 117 Excess risk for carcinogenic effects-Working lifetime exposure139

It is to be noted that in BEkGS910140 the risk level of 4x10-4 6 ppm (32 mgm3) is considered an

ldquoacceptable riskrdquo until 2013 2018 latest even though it is not considered to be a formal reference

value for an AfA After that date 4x10-5 is considered as an acceptable risk level which corresponds

to 06 ppm (32 mgm3)

An analysis of the submitted AfAs shows that in 11 of the 13 applications actual measurements

were available with some supported by modelled data The ranges shown in Table 116 refer to the

highest exposure value found per application in different scenarios for workers which means the

data represents the worst-case exposure information both because the highest value is reported

and there is no correction for duration of the contributing scenario

139 Application for Authorisation Establishing a Reference Dose Response Relationship for Carcinogenicity of Trichloroethylene (RAC28201407 rev 2) 140

httpswwwgooglebeurlsa=tamprct=jampq=ampesrc=sampsource=webampcd=4ampved=0ahUKEwjkvtOuy4TXAhWOaFAKHe

wdBr4QFgg7MAMampurl=https3A2F2Fwwwbauade2FDE2FAngebote2FRechtstexte-und-Technische-

Regeln2FRegelwerk2FTRGS2Fpdf2F9102F910-

trichlorethenpdf3F__blob3DpublicationFileampusg=AOvVaw1QS_qPaFsmMdl7_lRgcVB1



Table 116 Overview of occupational exposures results from the submitted AfAs for TCE expressed as ranges

Inhalation Dermal

Measured data Modelled data Measured data(1) Modelled data


lt1 1-10 10-50 lt1 1-10 10-50 lt01 01 - 1 1 - 5 lt01 01 - 1 1 - 5

2 6 3 1 7 8 1 12 5

Note (1) No measured data for dermal exposure was identified in the submitted AfAs

Although the historical numbers cannot be compared directly with the numbers in the AfA it is

clear that after the implementation of the exposure scenarios of the AfA the exposure level will be

significantly reduced compared to the historical exposure While historically only 4 sectors had an

exposure level below 50 mgm3 (8 hrs average) (Table 115) as a result of the authorisation

process all sectors will have a maximal exposure level below 50 mgm3 (Table 116) meaning that

the actual 8 hrs average exposure level will be even lower

The COLCHIC data reported in the Annex XV background document shows that 25 of the measured

data (8 hrs average) is above 50 mgm3 (10 ppm) The average exposure level is 749 mgm3 (139

ppm) and a 90 percentile of 168 mgm3 (311 ppm) The raw data is missing to estimate the number

of avoided cancer cases However if the average exposure to TCE would be historically about 749

mgm3 the reduction to an exposure of 34 mgm3 (6 ppm risk = 4 10-4) represents for an estimated

population exposed to TCE in the EU of 200000141 workers 1137 avoided cancer cases

In conclusion both when looking at historical exposure data and when interpreting the AfA it is

clear that during the authorisation process the exposure level of TCE has decreased Although it is

difficult to prove that these reductions are a direct result of the authorisation in at least three AfA

and based on the observations of ECHA this seems to be the case


The impact of the authorisation process on competition and competitiveness for TCE is difficult due

to limited research available on that topic As in the case of Chromium Trioxide it is expected that

a large number of the surface cleaning companies in the EU are SMEs and are providing surface

cleaning as contract manufacturers even though no statistical data is available

Of the four online survey respondents referring to TCE none referred to any impacts authorisation

had on their competitive position

In one of the follow up interviews one stakeholder mentioned that the impact of authorisation on

their companyrsquos competitive position was not ldquoon their horizonrdquo He stated that ldquoin the metal

degreasing industry the main consolidation already happened 10 years ago We have been in the

business of looking at alternatives for TCE for 20 years so this has become part of our business

and authorisation did not impact that in any wayrdquo

In another interview the stakeholder referred to the problem of uncertainty about the process

The uncertainty about the outcome of the application for authorisation led to a decision to

141 Extrapolation based on Risk of Cancer Among Workers Exposed to Trichloroethylene Analysis of Three

Nordic Cohort Studies



substitute TCE prior to the sunset date ldquoWe would rather accept the cost of an alternative process

than face the risk of possibly not being granted authorisationrdquo


Due to its hazardous characteristics the replacement of TCE was already in the focus before the

introduction of REACH even though a search on the internet deliver only a few specifically TCE-

related projects funded by EU Most of the funded projects have been targeted at the

bioremediation of soil contaminated with TCE (andor other chlorinated solvents)

From the survey results of the four respondents referring to TCE none responded to the question

whether the authorisation did have an impact on their organisationrsquos spending on innovation or

investment opportunities andor RampD

The interviews with stakeholders did not provided any additional information on this topic In the

one case where the company substituted TCE with PER prior to the sunset date the stakeholder

mentioned that the pay back for investments would be compensated by the reduction in

operational costs (less maintenance better recycling and re-use of the solvent less consumption of

the solvent)


It is estimated that the market for metal degreasing is dominated by SMEs who would provide the

service of degreasing as contract manufacturers However no data could be found to indicate the

structure of SMEs in the surface cleaning industry

Further information on the experience of SMEs in the authorisation process for TCE could not be

obtained from the online survey or the interviews with stakeholders

In one of the interviews a stakeholder mentioned that as a consequence of the authorisation for

TCE the company even considered to insource the service of metal degreasingsurface cleaning

He stated ldquoit is strange to think that 20 years ago we outsourced this activity and were thinking

now about integrating it again to have direct control of the operating conditions and the exposure

situation but the question was whether these small companies would be able to do what was

required to get an authorisation And there we were doubtfulrdquo


Looking at all influencing factors for the case of TCE two main consequences could be identified

Benefits in the form of exposure reduction and Impacts on the competitiveness of applicants

TCE is a SVHC and the risk profile has been known for decades Therefore a lot of work prior to

REACH has gone into improving occupational exposure also driven by other legislation (eg Solvents

Emission Directive) Closed systems and better re-cycling loops recommended by the European

Commission in 2008 have led to fewer emissions and consequently also lower consumption of TCE

For instance Dow Chemicals had already their Safetainer packaging system for TCE introduced



years before the authorisation process In a JRC report142 a 25 reduction of solvent use was

reported in 2006 as a result of the introduction of the Safetainer

There are various substitutes for TCE and substitution has been taking place since the 1990s The

authorisation is today covering basically uses for which no alternative is yet available The

authorisation dossiers also show that in the case of TCE at least one third is continuing to invest

into research to find a suitable alternative in the coming years

At the time of writing of this report it was not possible to have actual exposure and emission data

post authorisation Measured and reported exposure data in the AfAs and announced additional

RMM lead to the expectation that a further reduction of exposure will be possible following the

sunset date The exact value of this improvement is hard to estimate The survey responses and the

interviews confirmed the statement that the majority of the benefits in the form of exposure

reduction were achieved before REACH

As in the case of Chromium Trioxide it seems evident that uncertainty from the legislative position

is a key driver for the companiesrsquo decisions with regards to authorisation The fact that even

today 15 months after the sunset date there is no final decision on some TCE AfA is creating a

huge delay increasing the uncertainty for the applicants In one way or the other this is influencing

decisions

A surprising element is that despite expected similarities in the market structure (supply chain)

between the surface cleaning and the surface plating industries there were less intensive

discussions on the role of the contract manufacturers using TCE It appears that in the case of TCE

downstream users have long been exposed to the question of alternatives and substitution despite

the estimated small size of the businesses Also the question of relocation as a form of substitution

of TCE was not mentioned at all This could also support the statement that most of the impacts

have happened prior to REACH and businesses have long adapted to the framework

142 Chemical product services in the European Union (January 2006)

(httpswwwgooglebeurlsa=tamprct=jampq=ampesrc=sampsource=webampcd=8ampved=0ahUKEwimpfm73oTXAhWCaFAKH

RPjDX8QFghfMAcampurl=ftp3A2F2Fftpjrces2Fpub2FEURdoc2Feur22213enpdfampusg=AOvVaw20-

2NiGi1nXDl9H7uYB6aH



12 TIER 1 CASE STUDY SUBSTANCE 3 DIBUTYL PHTHALATE

(DBP)

121 Introduction

Phthalates like Dibutyl Phthalate (in the following referred to as DBP) are the most commonly used

plasticizers in the world accounting for more than 80 of worldwide plasticizer production143 The

different phthalates provide flexibility to PVC as well as to other products and can be found in

almost anything including toys automobiles food packaging cleaning materials cosmetics

building materials medical devices clothing and household furnishings

One of the key reasons for the recommendation for inclusion for Annex XIV was that ECHA

concluded from the available information that DBP is supplied for uses and applications that must

be considered as wide dispersive in high volumes The registration dossier refers to the registered

volume tonnage for DBP in the range of 1000 to 10000 tons per year

As DBP only covers a narrow market there were only few responses in the online survey with

regards to that substance ndash of the 66 online survey responses five originated from applicants

downstream users or NGOs dealing with the substance (two were applicants or downstream users

two were usersnon-applicants one was an NGO) For the follow up interviews four stakeholders

for DBP were contacted

NGO (1)

Associations (0)

Applicantsdownstream users (3)



Table 121 Dibutyl Phthalate substance profile

Name Dibutyl Phthalate

EC no 201-557-4

CAS no 84-74-2

93952-11-5




Toxic for reproduction (Article 57c)

Exempted (categories of) uses

Uses in the immediate packaging of medicinal

products covered under Regulation (EC) No 7262004

Directive 200182EC andor Directive 20183EC


In 2016 another proposal was submitted to restrict four phthalates (DEHP BBP DBP DIBP) on articles containing the four phthalates for (i) indoor use and (ii) outdoor use if in contact with

143 wwwplasticizerorg



human skin or mucous membrane144 This proposal is still waiting for the final decision by the EU Commission Dibutyl Phthalate (DBP) does not occur naturally in the environment145 It is produced by the

reaction of phthalic anhydride with n-butanol in the presence of concentrated sulphuric acid as a

catalyst Excess alcohol is recovered and recycled and the di-n-butyl phthalate is purified by

vacuum distillation andor activated charcoal146

In the decision for the inclusion in Annex XIV it was concluded that due to available information it

seems possible to determine a toxicological threshold in accordance with Section 64 of Annex I

Therefore applicants intending to apply for authorisation for DBP would be able to demonstrate

adequate control of the exposure to this substance


DBP fulfils only two of the key criteria set for the selection of a Tier 1 case study substance


whole authorisation process ndash for DBP this was 21 August 2013


getting data ndash for DBP there were three applications for three applicants

There is a high number of used applied for ndash for DBP there were six uses and

There is diversity and complementarity of impact aspects ndash high volumes allocated to the

uses and widespread use in EU in numerous businesses with widespread applications

There is little information available to quantify the number of companies potentially affected A

background document for the recommendation for the inclusion of DBP in Annex XIV estimated that

50 to 100 companies EU wide could be affected147 It is also assumed that a large number of

companies (gt1000) is involved in further processing and formulation of DBP in the supply chain ldquoas

downstream users and users of preparations and articles containing DBP represent several different

industry sectorsrdquo148

144 ECHA Danish Environmental Protection Agency Annex XV Proposal for a Restriction for four Phthalates

5DEHP BBP DBP DIBP) 2016 145 EU Commission Scientific Committee on Occupational Exposure Limits SCOELREC143 Di-n-butyl phthalate

Recommendation from the SCOEL 2016 146 Chemical Substance Bureau The Netherlands 2003 Dibutyl Phthalate Risk Assessment 147 ECHA 2009 Background document for dibutyl phthalate (DBP) - Document developed in the context of

ECHArsquos first Recommendation for the inclusion of substances in Annex XIV 148 ECHA 2009 Dibutyl Phthalate - Prioritisation and Annex XIV background information




The REACH authorisation timeline for the substance is given in Table 122

Table 122 Dibutyl Phthalate REACH authorisation timeline


Date of inclusion to Candidate List 28102008




According to Article 57(c) DBP was identified as a substance of very high concern It is classified as

toxic for reproduction category 2 ECHA concluded that the volumes of DBP allocated to the uses

in the scope of authorisations were very high and could be considered wide dispersive

In 2014 Denmark submitted a proposal for DBP to be identified as a substance of very high concern

in accordance with Article 57(f) of Regulation (EC) 19072006 (REACH) as an endocrine disruptor

This means it has endocrine disrupting properties for which there is scientific evidence of probable

serious effects to human health and to the environment and this gives rise to an equivalent level

of concern to those of other substances listed in points (a) to (e) of Article 57 REACH Should this

proposal be accepted DBP would once again be included in Annex XIV on the basis of being an

endocrine disruptor


DBP was assessed under the pre-REACH Existing Substances Regulation (ESR) the risk assessment

report (RAR) was finalised in 2003 with The Netherlands as the rapporteur149 The report states a

clear decreasing trend in the production of DBP coming from 49000 in 1994 to 37000 in 1997 to

26000 tons per year in 1998 The RAR refers to three production sites in the EU that produced DBP

in quantities of more than 1000 tons per year in 1998 (two in Germany one in Italy) (Figure 121)

149 Chemical Substance Bureau The Netherlands 2003 Dibutyl Phthalate Risk Assessment



Figure 121 DBP production volumes

The background document to the Annex XIV report150 concludes that in 2007 of the approximately

10000 tons produced in the EU an estimated 2000 tons was exported the distribution of the

different uses is shown in Figure 122 Formulation and processing of DBP into preparations and into

polymer products by major users was estimated to take place at 50 to 100 sites in the EU

150150 ECHA 2009 Background document for dibutyl phthalate (DBP) - Document developed in the context of

ECHArsquos first Recommendation for the inclusion of substances in Annex XIV



Figure 122 DBP use distribution (1998 2007)

According to the report by COWI IOM and Entec151 the largest use of DBP in general is as a

plasticizer in resins and polymers such as polyvinyl chloride Plasticizers are materials incorporated

into a plastic in order to increase its workability and distendability In addition DBP is used in

printing inks adhesives sealantsgrouting agents nitrocellulose paints film coatings and glass

fibres

The Annex XV report of 2003 refers also to the following uses

Use as plasticizer (softener) in polymers industry

Use as softener in adhesives for paper and packaging wood building and automobile

industry

Use as softener in the printing inks for the pulp paper and board industry and

Other uses as softenersolvent (eg sealants nitrocellulose paints film coatings glass

fibres and cosmetics)

In addition it is mentioned that human population can be exposed to DBP not only at the

workplace but also from the use of consumer products and indirectly via the environment The

exposure via end products is not within the scope of the authorisation and therefore of no

relevance to this study

There are currently six registrations active with four inactive The total based on the tonnage band

is according to the ECHA website in the range of 1000 to 10000 tons per year DBP is included in

the actual trade statistics as part of the group ldquoDibutyl and dioctyl orthophthalatesrdquo (Prodcomm

20143410) which also includes di-isobutyl phthalate (DIBP) which is used in some applications as


Phthalate (DBP) as well as Information on Potential Alternatives to its Use



an alternative to DBP As stated in COWI and Entec (2009)152 no statistical data is available on the

distribution of the substances within this group


Formulation of DBP in compounds

Formulation in propellants


Industrial use of DBP for production of PVC articles

Industrial use as laboratory reagent analytics QC

Formulation and industrial use of DBP as a plasticizer

Laboratory use

Formulation and use in polymers

Use as a solvent

Use as an absorption solvent in a closed system in the manufacturer of maleic anhydride

(MA)

Use in ceramics


There is no statistical data available to identify changes in the market volumes of DBP According to

an industry source the production and sale of DBP remained stable during the period of 2009 to

2015 at a level of around 1000 tonnes per year Comparing this information with the last publicly

available data on the production level of DBP in the EU one can conclude that between 2007 and

20092010 a substantial decrease in the production of DBP occurred (from just below 10000 tonnes

to around 1000 tonnes per year) This leads to the conclusion that in the run-up to the inclusion of

DBP to the Candidate List in 2008 and the inclusion to Annex XIV in 2009 companies using DBP

either substituted DBP discontinued the use or relocated the relevant production capacities to

outside EU In none of the responses to the online survey or the interviews with stakeholders a

relocation of production facilities outside EU was mentioned

The ECPI mentions in their report153 that the total sales of LEW phthalates in the EU were slightly

lower than 200000 tons per year COWI IOM and Entec (2009) estimated that DBP represents less

than 1 of the EU manufacturing of phthalates Assuming this would provide an estimation for the

volume of DBP in the EU of below 2000 tonnes which is in line with the industry source mentioned

The volume applied for in the authorisation applications is around 700 tonnes which is considerably

less than the pre-authorisation volume Several uses of DBP have not been applied for and it is

estimated that either DBP was substituted prior to sunset date or the use was discontinued

An analysis of changes in the registration data through the authorisation milestones154 concluded

that for DBP at least one of the registered uses (use in polymers production of PVC article

reported by two registrants) does not seem to be covered by any application for authorisation The


Phthalate (DBP) as well as Information on Potential Alternatives to its Use 153 European Council for Plasticisers and Intermediates 2011

httpwwwplasticseuropeorgdocumentsdocument20110422155920-vinyl2010__progress_report_2011pdf 154 ECHA Changes in the registration data through authorisation milestones TCE DBP CrO3 Status as of 10

April 2017 p20



same applies to the professional use as a metal working fluid reported by one registrant When

checking whether any of the uses which were applied for included any uses previously not

registered (or not reported as per Article 38 of REACH) the same report concluded the following

ldquoall uses applied for appear to fall under the generic scope of the registered uses the names of

which were however not specified further after sunset date The comparison relies solely on the

use names and therefore is not conclusiverdquo In total for DBP there are two registrants less today

compared to the pre-authorisation period

127 Substitution

The substantial decline in the production and consumption of DBP over the last two decades means

that there have been alternatives available for the substitution of DBP The EU Phthalates Directive

200584EC1 from 16 January 2007 which bans DEHP DBP and BBP for use in PVC and other

plasticised materials in all toys and childcare articles could be regarded as an accelerator for the

shift to substitute DBP

The alternatives to the use of DBP in various technical applications have been well documented in

several reports The 2009 report of COWI IOM and Entec155 covers a wide range of alternative

substances for the various technical applications of DBP such as

DINCH (Di-(isononyl)-cyclohexan-12-dicarbooxylate) DINCH has been designed as an

alternative to phthalate plasticisers As an alternative for DBP DINCH could be applied in

thermoplastics polar rubbers coatings and printing inks

Other alternative substances for non-PVC applications 21 alternatives to phthalates (not only

DBP) were identified by COWI in a report in 2000 which provided results in the form of a

substitution matrix with references to different applications

Alternative techniques For some polymer application the polymer with DBP may be replaced

by a totally different material this might be relevant for DBP especially for the use in flooring

A report commissioned by ECHA in 2011 on the costs of abatement for a range of hazardous

substances also covers four phthalates including DBP156 The study was intended to improve the

capability in assessing the costs of reducing the use emissions or exposure of hazardous

substances While the study also documents experience in the substitution of DBP by main

alternatives and product group the report concludes that ldquoalternatives are available for all

applications and it has not been possible to identify applications for which the substitution is

particularly difficultrdquo

An online research delivered two tools that businesses looking for alternatives for a substitution of

DBP could use

The substitution portal SUBSPORT (as described under Section 1073) The portal also describes

nine case studies in which DBP has been successfully substituted for different applications and

The Lowell Centre for Sustainable Production in Massachusetts published a brochure (technical

briefing) with the title

For two uses in the applications for authorisation two substitution plans have been submitted

Looking at the results from the online survey only one applicant andor downstream user had

155 COWI AS IOM Entec UK Ltd 2009 ndash Data on Manufacture Import Export Uses and Releases of Dibutyl

Phthalate (DBP) as well as Information on Potential Alternatives to its Use 156 ECHA 2011 Estimating the abatement costs of hazardous chemicals p 61



substituted DBP successfully or intended to substitute The other respondents did not respond to

this question

In one of the follow up interviews a stakeholder mentioned that sufficient alternatives would allow

users to switch to an alternative However some uses for which no suitable alternative is yet

available would remain and hence DBP continues to be the best suitable substance


There is little publicly available information to assess in detail for which alternatives DBP has been

substituted The European Council for Plasticisers and Intermediates (ECPI) stated in their 2011

annual report that ldquoAs a result of the EU risk assessments and the REACH regulation and thanks to

the constant efforts of the plasticiser industry to adapt to both regulatory and market demand

the use of plasticisers in Europe has evolved in a progressive shift from Low (DEHP BBP DBP

DIBP) to High (DINP DIDP DPHP) Molecular Weight phthalates and ndash to a smaller extent ndash to some

other plasticisersrdquo157 They state that the sales of phthalates like DBP in the EU has decreased

sharply in the period between 2001 and 2009 compensated by an increase in other (HMW)

phthalates

The ECPI also mentions in their report that the total sales of LEW phthalates in the EU were slightly

lower than 200000 tonnes per year (Figure 123) COWI IOM and Entec (2009) estimated that DBP

represents less than 1 of the EU manufacturing of phthalates This provides an estimation for the

volume of DBP in the EU of below 2000 tonnes which is in line with the industry source

mentioned

Figure 123 Percentage of phthalate sales in EU compared to total plasticisers

157 European Council for Plasticisers and Intermediates 2011

httpwwwplasticseuropeorgdocumentsdocument20110422155920-vinyl2010__progress_report_2011pdf

p 25




DBP is considered a threshold substance in 2013 RAC established a reference DNEL for DBP for

inhalation of workers at 013 mgm3 and for dermal exposure at 019 mgkgday158 The existing

OEL values across Europe show a considerable variance between a minimum level of 058 mgm3 for

workers inhalation in Germany and a maximum level of 5 mgm3 in several countries (Austria

Belgium France Ireland Poland Spain and the UK) (Table 123) In 2016 SCOEL made another

proposal for an OEL for DBP for inhalation 058 mgm3

Table 123 Existing OELs for Dibutyl Phthalate for inhalation (adapted from the GESTIS database159)

EU-country Limit value ndash Eight hours Limit value ndash Short term

ppm mgm3 ppm mgm3

Austria 5

Belgium 5

Denmark 3 6

France 5

Germany (AGS) 005(1) 058(1) 01(1)(2) 116(1)(2)

Germany (DFG) 005(1) 058(2) 01(1)(2) 116(1)(2)

Ireland 5 10(2)

Latvia 05

Poland 5 10

Spain 5

Sweden 3 5(3)

United Kingdom 5 10

Notes (1) Inhalable aerosol and vapour (2) 15 minutes reference period and (3) 15 minutes average value

Only one example could be identified where a Member State Authority carried out a measurement

campaign to assess the level of occupational exposure (Table 124) While these results are not

representative and should not be compared like-for-like they serve as indicators to highlight the

trend in the reduction of occupational exposure levels over the years

Table 124 Historical measurement campaign for DBP reported from EU countries inhalation

EU-

country Trade sector Application Values companies

90

value

mgm3

Refere

nce

Germany

Extrusion injection moulding

reaction foam moulding

22

14

(2)

(1)

Plastic welding hot air

welding

13

6

003

Surface coating (spray

coating bonding venting dip

coating)

21

11

057

Notes (1) BGAA Report 199 Altstoffe ndash Expositionen am Arbeitsplatz Hauptverband der gewerblichen

Berufsgenossenschaften (2) Values are below detection limit

158 ECHA 2013 RAC24201309_rev 2 ndash Authorisation ndash establishing reference DNELs for DBP 159 GESTIS 2017 httplimitvalueifadguvde



Improvements in RMM were mentioned in 33 of the public versions of the AfAs for DBP This is

comparable to all AfA submitted (36 mentioning improved RMM in the context of the dossier) In

the case of DBP in two applications the applicants clearly mention additional RMMs that were

implemented as a result of the authorisation process and led to an improvement in exposure (Deza

Sasol-Huntsman) The same comment as made before is also valid here Based on the observations

of ECHA the actual number of cases where RMM were improved in the course of the AfA could be

significantly higher

An analysis of the submitted AfAs shows that in all applications the exposure data was modelled

The ranges shown in Table 124 refer to the highest exposure value found per application in the

different workers contributing scenarios which means the data represents the worst-case exposure

information In one application the value of the dermal exposure of one worker contributing

scenario was outside the maximum range of the table

Looking at the threshold for inhalation for DBP of 013 mgm3 all applications could demonstrate

adequate control for dermal exposure with a threshold for DBP of 019 mgkgday in some

applications the maximum exposure values bordered at the threshold (Table 125)

Table 125 Overview of occupational exposures results from the submitted AfAs for DBP expressed as ranges

Inhalation Dermal

Measured data Modelled data (1) Measured data(1) Modelled data


lt001 001 ndash

005

005-

01 lt001

001 ndash

005

005-

01 lt001

001 ndash

005

005-

02 lt001

001 ndash

005 005-02

2 4 3 2

Note (1) No measured data for inhalation or dermal exposure was identified in the submitted AfAs

One survey participant stated in the online survey that due to implemented RMM less workers were

exposed to the DBP but also less DBP was consumed The follow up interviews did not deliver any

additional information on the topic of improvement by RMMs

The case of the application of Sasol-Huntsman demonstrates the positive effects that can be

achieved due to the authorisation In 2011 the applicant contracted a third party (IPA160) to carry

out a screening study on the workplace exposures This not only confirmed that the exposure levels

were safe but also identified further improvement opportunities In addition a benchmarking

exercise was carried out in the course of the preparation of the AfA amongst German and US plants

This revealed several ldquobest practicesrdquo procedural and capital improvement opportunities such as

PPE specifications and replacement protocols

Maintenance of DBP containing equipment

Sampling frequency

Closed loop sampling systems

Closed back-flushing filters

Additional biomonitoring in 2012 showed that compared to 2011 worker exposure was more than

half According to Sasol-Huntsman the investment into the improvement measures was still more

160 IPA Institut fuer Praevention und Arbeitsmedizin der Deutschen Gesetzlichen Unfallversicherung



cost effective than a conversion of the whole installation to an alternative to DBP In that sense

REACH could claim some credit for the improvements

Based on limited data it could be concluded that in the case of DBP the authorisation was the

direct cause of improvements in RMM with a reduction of the exposure as a result


Two applicants Deza and Sasol-Huntsman closely cooperated during the preparation of their AfAs

This is particularly of interest as Deza is the supplier of DBP to Sasol-Huntsman Sasol-Huntsman as

a downstream user would be covered by Dezarsquos successful application but still decided to submit

its own application This was partly done to be more independent of its supplier but also as a

contingency in case Deza decided to cease production of DBP

None of the survey respondents using DBP referred to any impacts on their competitive position due

to the authorisation process Also in the interviews no further insight could be obtained During

the follow up interviews a stakeholder only mentioned generic impacts eg the re-allocation of

RampD resources away from innovation research to find alternatives would expectedly have a

negative effect in the medium term


A search on the internet on projects and new patents to substitute DBP did not deliver any results

There are patents pending using DBP but all of the patent applications are outside EU

During the online survey of the four participants using DBP none responded that the authorisation

had an impact on their organisationsrsquo spending on innovationinvestment opportunities andor

RampD


No further information could be obtained with regards to the experience of SMEs in the

authorisation process for DBP through the online survey or the stakeholder interviews


Looking at all influencing factors for the case of DBP two main impacts could be identified

Availability of alternatives for substitution and Benefits in the form of exposure reduction

As with the two other substances that are assessed as Tier 1 case studies a lot of work has also

been done for DBP in the pre-REACH period This is clearly visible in the substantial reduction of

the EU market volumes for DBP from around 50000 tons per year in 1994 to around 1000 tons per

year in 2015

The main driver for this reduction was regulatory measures The ban of DBP in PVC and other

plasticized materials in all toys and childcare articles led to a decrease of the use of DBP Where

possible businesses have substituted DBP and consequently the authorisations cover only uses for

which no alternative is (yet) available Where alternatives are available and the changeover does



not lead to a substantial increase in costs it is logical to decide not to follow the authorisation

route

Comparing the available measurement results from 1999 with the SCOEL proposal for an OEL in

2016 shows that some companies had low exposure levels already at the end of the last century

even though this is of course not representative The application from Sasol-Huntsman however

also proves that if authorisation is accepted as an opportunity to change for the better (meaning

to improve working conditions and reduce occupational exposure) substantial improvement still can

be achieved The question remains whether improvements and optimised exposure results could not

have been achieved by setting the ldquorightrdquo exposure limits



13 SUMMARY AND CONCLUSIONS


investigation



















as an intermediate








































report
































completed


























applications











aggregate level








































aggregate level

























(within Section 73)















































enforcement








authorities
















suppliers)










products










process




required



REFERENCES

Note na stands for ldquonot availablerdquo and is used in this reference list in cases in which no date of

publication is available

Airbus Airlines for Europe Boeing and GE Aviation (2017) The Aerospace Industry Support Paper

on REACH REFIT 2017 Position Paper for REACH REFIT Evaluation January 2017


AmCham EU (2016) A private sector view on REACH and competitiveness - 2017 REFIT evaluation

key to addressing outstanding obstacles Position Paper for REACH REFIT Evaluation November

2016 Available here httpseceuropaeugrowthsectorschemicalsreachreview_en

American Chemistry Council (2017) ACC Input for EU REACH REFIT Position Paper for REACH



ASD-Eurospace (2017) Space sector contribution to the EC REACH Review 2017 ndash Position paper

Position paper for REACH REFIT Evaluation January 2017


Austrian Federal Economic Chamber ndash WKO (2016) REACH REFIT Review 2016 Position Paper for

REACH REFIT Evaluation December 2016


Austrian Federal Ministry of Agriculture Forestry Environment and Water Management (2015)

REACH - Evaluation of the impact on the affected industries and the whole economy in Austria

Final Report of the study March 2015 Vienna Denkstatt Institute for Industrial Research amp Vienna

University of Technology ndash Center of Public Finance and Infrastructure Policy

Backes D (2017) Monitoring of the authorisation process under the REACH regulation Test of a

proposed methodology Final Report May 2017 Vienna Austrian Federal Ministry of Agriculture

Forestry Environment and Water Management

BDSV (2017) BDSV input to public consultation on REACH Review 2017 Position Paper for REACH



BusinessEurope (2017) REACH Review Better implementation is needed not a revision Position



CEFIC-The European Chemical Industry Council (2014) Evolution of competitiveness in the

European chemical industry Historical trends ands and future prospects Brussels Oxford

Economics Available here httpwwwceficorgDocumentsRESOURCESReports-and-

BrochureOxford-Study-2014pdf

CEFIC-The European Chemical Industry Council (2016a) Facts amp Figures 2016 of the European

chemical industry (xls format) Brussels cefic Available here httpwwwceficorgFacts-and-

Figures



CEFIC-The European Chemical Industry Council (2016b) Facts amp Figures 2016 of the European

chemical industry Brussels cefic Available here httpwwwceficorgFacts-and-Figures

Chemical Industries Association (2017) REACH REFIT Evaluation (REACH Review 2017) stakeholder

consultation ndash CIA Response Position Paper for REACH REFIT Evaluation January 2017


Chemical Industry Federation of Finland ndash CIFF (2017) CIFF submission ndash REACH REVIEW 2017



Cii ndash Cross-Industry Initiative for better regulation in chemicals management (2016) Synergies

between REACH and workplace legislation Improved analysis of alternatives and substitution

Position Paper for REACH REFIT Evaluation November 2016


Comiteacute Franceacuteclat (2017) Contribution agrave la consultation publique relative

agrave leacutevaluation du regraveglement REACH Position Paper for REACH REFIT Evaluation January 2017


ECSIP (2016) Impacts of REACH and corresponding legislation governing the conditions for

marketing and use of chemicals in different countriesregions on international competitiveness of

EU industry Draft Final Report (1st draft) February 2016

Available at httpscircabceuropaeuwebdavCircaBCenvcaracalLibrary0120-

20CARACALCARACAL-2020(0820-200920March202016)2520-20CA_14_201620-

20Draft20final20report20REACH20studypdf

EFPIA Vaccines Europe IFAH Europe PPTA IPFA and EBE (na) Statement for Part IV Public

Consultation in relation to the REACH REFIT evaluation Position Paper for REACH Refit Evaluation


EuropaBio (2017) EuropaBio Statement for Part IV of the Public Consultation in relation to the

REACH REFIT (2017) evaluation Position Paper for REACH REFIT Evaluation January 2017


European Commission (EC) (2003) Commission Staff Working Paper Regulation of the European

Parliament and of the Council concerning the Registration Evaluation Authorisation and

Restrictions of Chemicals (REACH) establishing a European Chemicals Agency and amending

Directive 199945EC and Regulation (EC) on Persistent Organic Pollutants Extended Impact

Assessment Brussels European Commission

European Commission (EC) (2006) REGULATION (EC) No 19072006 OF THE EUROPEAN PARLIAMENT

AND OF THE COUNCIL of 18 December 2006 concerning the Registration Evaluation Authorisation

and Restriction of Chemicals (REACH) establishing a European Chemicals Agency amending

Directive 199945EC and repealing Council Regulation (EEC) No 79393 and Commission

Regulation (EC) No 148894 as well as Council Directive 76769EEC and Commission Directives

91155EEC 9367EEC 93105EC and 200021EC Available here httpeur-

lexeuropaeulegal-contentENTXTPDFuri=CELEX32006R1907ampfrom=EN

European Commission (EC) (2008) COMMISSION REGULATION (EC) No 3402008 of April 2008 on

the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No

19072006 of the European Parliament and of the Council on the Registration Evaluation



Authorisation and Restriction of Chemicals (REACH) Available here httpeur-

lexeuropaeuLexUriServLexUriServdouri=OJL200810700060025enPDF

European Commission (EC) (2013a) COMMISSION IMPLEMENTING REGULATION (EU) No 2542013 of

March 2013 amending Regulation (EC) No 3402008 on the fees and charges payable to the

European Chemicals Agency pursuant to Regulation (EC) No 19072006 of the European Parliament

and of the Council on the Registration Evaluation Authorisation and Restriction of Chemicals

(REACH) Available here

httpeur-lexeuropaeuLexUriServLexUriServdouri=OJL201307900070018ENPDF

European Commission (EC) (2013b) COMMISSION STAFF WORKING DOCUMENT - General Report on

REACH accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN

PARLIAMENT THE COUNCIL THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE

COMMITTEE OF THE REGIONS in accordance with Article 117(4) REACH and Article 46(2) CLP and a

review of certain elements of REACH in line with Articles 75(2) 138(3) and 138(6) of REACH

Available here

httpeur-lexeuropaeulegal-contentENTXTPDFuri=CELEX52013SC0025ampfrom=EN

European Commission (2013c) Interpretation of the WSSD 2020 Chemicals Goal and an Assessment

of EU Efforts to meet the WSSD Commitment Final Report June 2013 Luxembourg Office for

Official Publications of the European Communities Available here

httpspublicationseuropaeuenpublication-detail-publicatione636b772-1164-4a91-b024-

069000bf5626

European Commission (EC) (2015) Monitoring the Impacts of REACH on Innovation

Competitiveness and SMEs Luxembourg Publications Office of the European Union Available here

httpeceuropaeuDocsRoomdocuments14581attachments1translationsenrenditionsnati

ve

European Commission (EC) (2016a) Cumulative Cost Assessment for the EU Chemical Industry

Brussels European Commission

European Commission (EC) (2016b) Study on the Calculation of the Benefits of Chemicals

Legislation on Human Health and the Environment Development of a System of Indicators Final

Report Luxembourg Publications Office of the European Union Available here

httpspublicationseuropaeuenpublication-detail-publication3dcb5c7a-1029-11e6-ba9a-

01aa75ed71a1

European Defence Agency (EDA) (2016) Study on the impact of RAECH and CLP European chemical

regulations on the defence sector Final report 16 December 2016 Brussels Espoo REACHLaw

Ltd Available here httpswwwedaeuropaeudocsdefault-sourcedocumentseda-reach-

study-final-report-2016-december-16-ppdf

European Environmental Bureau (na) EEB Comments to the REACH REFIT public consultation



Eurostat (2017) Industry by employment size class (NACE Rev 2 B-E) Available here

httpappssoeurostateceuropaeunuishowdodataset=sbs_sc_ind_r2amplang=en



French Federation of Mechanical Engineering Industries (2017) FIM Position paper Public

consultation of the European Commission ndash REACH REFIT Evaluation Position Paper for REACH



Harrikari A and R Montonen (2017) How the REACH authorisation process affects and benefits


Heitmann K and A Reihlen (2007) Case study on ldquoAnnouncement effectrdquo in the market related

to the candidate list of substances subject to authorisation Final Report January 2007 Hamburg

Oumlkopol GmbH

Hennig P (2016) Socio-economic benefits and risks of the use of carcinogenic substances subject

to authorisation under REACH Zeitschrift fuumlr Umweltpolitik amp Umweltrecht 02-03 149-168

Lietzmann J Oulegraves L Pelsy F Fries-Tersch E And T Tugran (2017) Analysis of the results of

the open public and SME consultation of the REACH REFIT evaluation Draft final report on the

OPEN Public consultation March 2017 Brussels Milieu Ltd

MedTech Europe (2017) Public Consultation in relation to the REACH REFIT evaluation Position



Netherlands (na) REACH evaluation attention points from the Netherlands Position Paper for

REACH REFIT Evaluation


ORGALIME ndash the European Engineering Industries Association (2017) ORGALIME response and

position paper ndash Public consultation REACH REFIT evaluation Position Paper for REACH REFIT



Reihlen A and H Luumlskow (2007) Analysis of studies discussing benefits of REACH Report for the

European Commission February 2007 Available here

httpeceuropaeuenvironmentchemicalsreachpdfbackgroundreach_benefit_studiespdf

RPA (2016) Industry and Consultancy Representatives Survey Results ndash Extract from ongoing work

for the DG Environmentrsquos study into ldquothe strategy for a non-toxic environment of the 7th

Environment Action Programme (EAP)rdquo

Swedish Chemicals Agency (2017) Additional comments relevant to the public consultation on the

REACH refit evaluation Position Paper for REACH REFIT Evaluation January 2017 Available here

httpseceuropaeugrowthsectorschemicalsreachreview_en

Technology Industries of Finland (2017) Technology Industries of Finland Position paper on Public

Consultation REACH REFIT Position Paper for REACH REFIT Evaluation January 2017


The Association of German Chambers of Commerce and Industry - DIHK (2017) Stellungnahme zur

oumlffentlichen Konsultation zu REACH REFIT 2017 Position Paper for REACH REFIT Evaluation

January 2017




Tickner J and M Jacobs (2016) Improving the Identification Evaluation Adoption and


within the Context of REACH Report for the European Chemicals Agency (ECHA) Available here

httpsechaeuropaeudocuments1016213630substitution_capacity_lcsp_enpdf2b7489e1-

6d96-4f65-8467-72974b032d7b

UEAPME - The European Association of Craft Small and Medium-Sized Enterprises (2017)

UEAPMErsquos main views on the REACH REFIT Review 2016 Position Paper for REACH REFIT Evaluation

January 2017




ANNEX A STEERING GROUP COMMITTEE

Steering Group Member Organisation

Valentina Bertato European Commission

Anna Borras European Commission

Sanna Henrichson ECHA

Patricia Hualde European Commission

Mark Pirrung European Commission

Katarina Pirselova European Commission

Pavel Prokes European Commission

Annette Schaefer European Commission



ANNEX B METHODOLOGY

This section supports Section 2 of the main report This Annex is broken down into two

subsections setting out

Section B1 The scope and boundaries of the project and

Section B2 The approach to assessing impacts

B1 Project scope

Some important aspects concerning the scope of the project were agreed with the Commission

during and following the kick off meeting

Coverage ndash The study will only cover the impacts of REACH authorisation The impacts of

other aspects of REACH such as registration and restrictions are considered outside the

scope of this study This study would cover all the authorisation decisions and ECHA

Committee (RACSEAC) opinions to date (and their respective review periods) since REACH

came into force in 2007 until the end of 2016 as well as some of those currently along the

REACH authorisation process (eg from candidate listing to those recently submitted in

the May submission window)

Forecasting the potential costs and benefits of REACH authorisation for SVHC substances

that may appear on the candidate list between 2017 and 2020 (ie as part of goal of the

2020 roadmap) are outside the scope of this work given the scale of uncertainty

associated with such an assessment

Time period for impacts ndash Costs and benefits will be presented in annual terms where

possible

Geographical boundary ndash The focus is on the impacts of REACH within the European

Economic Area (EEA) with impacts outside of the EEA noted Any potential relocation

outside of the EEA as a result of REACH Authorisation is captured within this study through

changes in risks employment and value added (eg profits from sales of products) within

the EEA

Targeted consultation ndash The online surveys are to be sent to pre-identified stakeholders

rather than an open invitation which would be used if this was a formal public

consultation A rationale for this is that there a number of REACH related surveys being

carried out and the EC is keen to minimise survey fatigue amongst stakeholders It is also

believed that a more targeted consultation of stakeholders is required to get more

quantitative information

Tiered approach to case studies agreed ndash Following clarification there was general

agreement on the idea of three Tier 1 substance specific case studies assessing all

relevant aspects of this study in depth for the selected substances and five Tier 2 case

studies covering specific issues in more detail (ie not focusing on a particular

substance) Further details on these case studies can be found in Section 0



Make use of existing information where possible ndash It is important that this study utilises

information already obtained Relevant information gathered from these existing studies

are summarised within later chapters under the heading lsquoliterature reviewrsquo

Report focus ndash The final report will encompass all the findings of this study and will set

out results based on the five areas the study is seeking particular information on (i) cost

of authorisation (ii) benefits of authorisation (iii) changes in the market structure (iv)

substitution and (v) affordability of authorisation for SMEs

B2 Assessment approach

This subsection sets out further details on how impacts due to REACH authorisation process were

(i) identified (ii) screened and (iii) will be assessed (as part of Task 3) as well as details on the

(iv) Tier 1 and 2 case studies

Section B21 ndash Identification of impacts

Section B22 ndash Screening of impacts

Section B23 ndash Assessing impacts

Section B24 ndash Tier 1 and 2 case studies

B21 Identification of impacts



actors To help do this we started off with a simple lsquointervention logicrsquo setting out

The need for authorisation

The objectives of authorisation

A list of actions carried out along the authorisation process

The outputs of these actions

Their impacts and the outcomes

The types of actor considered were either those that carry out the activity identified or those

actors most affected by it and included

Consumers - Consumers are referred to as people who buy end-use products currently made

with an SVHC They can be impacted in terms of price quality and availability of the

products made with an SVHC

General population - The general population refers to those that might be affected by

releases of the SVHC into the environment (eg fugitive emissions) and not necessary

related to consumer exposure of the end-product

Industry - Annex XIV substance supply chain ndash These are companies who may be affected

due to the use of an SVHC at some stage along the supply chain

Industry - alternatives supply chain - These are companies who make similar end-user

products with the use of an SVHC (currently) subject to an authorisation who may

indirectly benefit depending on the outcome of the authorisation process



NGO ndash These are non-governmental organisations that may have an interest in commenting

at various public consultations for SVHCs as they move along the authorisation process as

well as on individual applications for authorisation (AfAs)

Regulatory authorities ndash Member States incur administrative regulatory and enforcement

costs (and savings) as SVHCs move along the authorisation process

Workers ndash These refers to workers from companies that use an SVHC or with alternatives

The simple (high level and non-exhaustive) lsquointervention logicrsquo is shown in Table B01 The needs

and objectives listed are those most applicable to authorisation and exclude other REACH

objectives and needs identified for the REACH evaluation (like avoiding unnecessary testing on

animals) which deviate from the focus of this study

Table B01 REACH Authorisation intervention logic (non-exhaustive high-level list)

Intervention

stage Details

Needs Speed up the risk management of chemicals prioritise regulation of SVHCs (eg through their inclusion on Annex XIV) in light of limited public-sector resources available

Objectives Identify what known substances are deemed relevant for authorisation (eg meet the criteria set out in Article 57(a)-(f))

Promote the progressive replacement of SVHCs to safer alternatives where those are technically and economically available

Provide a forum (ie public consultations) for the identification and sharing of information on the suitability of alternatives for SVHCs

Ensure risks are minimised or impose further Risk Management Measures (RMM) conditions on the continued use of a substance after the sunset date where authorisation has been granted


Actions

(inputs)

The authorisation process enables a shift in the burden of proof (in line with the polluter pays principle) for the continued use of SVHCs from public authorities to industry that also have a better understanding and access of data on the risks and benefits of continued use

Screen substances and RMOAs o Screen REACHCLP databases (using also external data sources) to identify

substance of potential concern (MS CA and ECHA) o Carry out a RMOA to identify substances that are appropriate for

authorisation (MS CA or ECHA) o Declare intention to prepare an Annex XV dossier (Registry of Intention) o Prepare an Annex XV dossier for SVHCs (MS or ECHA)

Inclusion of substances in the Candidate List o Propose substances for inclusion on the candidate list (MS CA or ECHA +

interested party consultation)

Inclusion of substances in the Authorisation List o Prioritise those for inclusion on Annex XIV with sunset dates uses of the

substance which would be exempt from authorisation and latest application date (LAD) (Recommendations by ECHA + interested party consultation)

Compliance strategy (at each stage in the authorisation process) o Compliance with authorisation (MI and DUs of the SVHC) o Compliance with the sunset date (by DUs) switch to an alternative

relocate production outside the EEA cease production or apply for authorisation



Intervention

stage Details

Substitution of SVHC by a downstream user o Carry out research and engage with supply chain on identify possible

alternatives to the SVHC(s) being used o Assess alternatives to determine if any are feasible (ie technically

economically lead to a reduction in overall risks and is available in sufficient supply)

o Develop plan to switch to a feasible or potentially feasible alternative in the future (if applicable)

Applications for authorisation o Identify if it is possible to derive a no effect level (DNEL) for the substance

(ie threshold level) listed on the authorisation list (RAC) o Derive a dose response relationship for non-threshold substances (RAC) o Pre-Submission Information Session (PSIS) - (ECHA + applicants) o Submission of AfAs (applicants) o Publication (ECHA) o Information on alternatives (third parties) o Trialogue (if relevant ndash ECHA third party + Applicant) o Conformity check (ECHA) o Draft opinion of the Risk Assessment Committee (RAC) and Socio-Economic

Analysis Committee (SEAC) o Final opinion of RAC and SEAC o Final decision by the EC (+ REACH Committee)

Post authorisation decision o Obligation to update registration dossier in light of authorisation outcome

(eg registrants CSR) o Downstream User notification o Enforcement by National Enforcement Authorities

Non-compliance ceasing use of a substance post sunset date Compliance with conditions of use set out in the AfA as well as

any conditions or monitoring arrangements specified in the authorisation

Post Review period o Reapply for authorisation (ie submit a review report) or substitutecease

productionrelocation (applicant) If the applicant reapplies then Pre-Submission Information Session (PSIS) - (ECHA + applicants) Publication (ECHA) Information on alternatives (third parties) Trialogue (if relevant ndash ECHA third party + Applicant) Conformity check Draft opinion of RAC and SEAC Final opinion of RAC and SEAC Final opinion of EC (+ REACH Committee)

Outputs Number of RMOAs where authorisation is deemed the most appropriate RMO

Number of Annex XV dossiers submitted

Number of substances on the candidate list

Number of uses exempt that would have required authorisation

Number of substances on the authorisation list

Number of uses for which substitution of SVHC has been successfully achieved (and therefore AfA avoided)

Number of cases where authorisation lead to an improvement in RMMs

Number of substances with an up to date extended safety data sheet (eSDS)

Number of AfAs

Granting or refusal of an authorisation (may include conditions attached if granted)

Number of substances where registration dossiers are up to date following



Intervention

stage Details

submission of AfAs (eg updated exposure scenarios)

Number of draft and final opinions from RAC and SEAC

Number of final authorisation decisions from the EC (based on a draft decision to REACH committee to make final decision)

Enforcement controls of sunset date for non-authorised uses of the substance

Enforcement controls of RMMs set out in AfA exposure scenarios

Enforcement controls of any conditions attached to authorisations

Review reports (and no further applications) following review period

Outcomes Improved knowledge of known uses of the substance

Improved knowledge on the suitability of alternatives for specific uses

Improved supply chain communications

Substitution from the SVHC where ldquosuitablerdquo alternatives exist

Minimisation of emissions (where use is authorised) or conditions within the AfAauthorisation for further risk reduction

Improved knowledge on the societal benefits of continued use of SVHCS for specific uses

RampD plans where no suitable alternative currently exist

Time limited authorisations with review periods

Increased demand for safer alternatives

Possible uncertainty in legal status of some substances

Impacts (in

the context

of this

study)

Costs to EU based MI of the Annex XIV substance ndash AfA sharing information lost profit employment

Costs to Downstream Users (DUs) of the Annex XIV substances ndash transition to alternatives relocation ceasing production AfA cost

Benefits to EU based Manufacturer Importer (MI) of alternative substances ndash increased profit employment

Benefits to EU DUs of an alternative who competes with products made with Annex XIV substance

Costs to Member States such as from enforcement submission of RMOAs Annex XV dossiers and meetings concerning submitted AfAs and policy discussions on possible changes to the process

Costs to Member State Committee (MSC) involved in Candidate List inclusion and in Annex XIV recommendation processes

Costs to ECHA Secretariat such as to process and publish information on substances throughout the process submission of RMOAs Annex XV dossiers Annex XIV recommendation PSIS meetings processing AfAs

Costs to the RAC and SEAC ndash Derived No Effect Level (DNEL) dose response documentation opinion-development meetings and supporting guidance

Costs to EC ndash Decision on Annex XIV inclusion authorisation decisions requests to ECHA observing on applications (eg trialogues) changes to authorisation process and authorisation reviews

Costs to third parties to submit information during public consultations related to any part of the authorisation process

Changes in the market structure ndash Number of companies level of competition competitiveness employment trade balance RampD spending innovation and resilience of companies

Impact on business decisions like investment production RampD innovation and spending on risk management

Impacts to workers (eg reduction in risks from improvements through RMMs substitution and change in risks associated with use of alternative)

Impacts to consumers (eg reduction in exposure of SVHCs in products change in the price quality and availability of products)



Intervention

stage Details

Impacts to general population (eg reduction in releases from exposure of chemicals around production sites due to substitution or improvements in RMMs and change in risks associated with production and use of alternatives)

Impact to the environment (eg changes in releases of SVHCs to air wastewater waste and releases to the environment from use of alternatives)

Note - Impacts noted in this study are consistent with the lsquotypes of impactsrsquo to be assessed within this study It is

however noted that this is not consistent with the Better Regulation guidelines where costs would have been mentioned in

the inputs part of the table

The next step was to expand this list to identify a more precise list of activities This resulted in

150 activities carried out along the authorisation process This is set out in Annex D which also

shows

At what stage in the authorisation process each activity occurs

Which actor carries out each activity (eg EC ECHA MS CA Applicant NGO MI third

party and MI or DU of an alternative product)

The associated impact (eg administrative cost reduction in risks change in competition)

The data needed to assess that impact

Who is likely to have that data and

Which consultation tool is best to gather the information needed

B22 Screening of impacts

The total number of activities was then screened down from 150 to 96 The justification for

excluding some activities is listed below in Table B02 Annex D shows which exact activities were

screened out

Table B02 Total number of activities excluded with justification


Number of

activities

excluded

No refused

authorisation

applications yet

Some activities have not occurred yet as there are no rejected

AfAs 5

Only possible to

generate

anecdotal

responses that

already exist

Some activities and associated impacts are unlikely to be

accurately quantified beyond anecdotal evidence so we have

proposed to rule these out (eg improvements in supply chain

communication) Note that these aspects may be indirectly

assessed later using ldquonewrdquo information gathered or through

aspects that can be monitored (eg instances where industry

wide voluntary agreementsactions were noted and then

carried out)

5

This aspect is

deemed out of the

scope of the

project

(RMOA stage only)

A few activities carried out at RMOA are not being considered

for this project as they are deemed not significant especially

because assessing the functioning of the RMOA process is not

the main objective of this study

3




Number of

activities

excluded

Too early to assess

this aspect of

authorisation

Some activities have not occurred yet such as there are no

reapplications following the review period 17

Unlikely to be able


quantitative data

required to assess

this

This relates to aspects such as changes in prices and quality of

consumer products from switching to alternatives and certain

impacts to the general population associated with use of

alternatives ndash It is deemed better therefore to focus on aspects

we can get quantitative data for Note the study may still

obtain information indirectly on these issues which will be

reported

19

Voluntary activity

that should not be

included within

the assessment

These include spending on lobbying (both by industry and

NGOs) should not be included within the assessment (however

time spent on public consultations is valid and included in the

assessment)

5

Grand Total 54

As a result of the screening it was justified for this study to exclude

1 Impacts associated with stage 6 Review AfAs following review period and

2 Impacts associated with consumers of the final products

However there is still good coverage of the whole authorisation process as shown in Table B03 Table B03 Number of activities carried out along the authorisation process that are assessed in this study

Type of actor

Stages along the authorisation process

1

Scre

enin

g o

f

subst

ances

and R

MO

As

2

Inclu

sion o

f

subst

ances

in t

he

Candid

ate

Lis

t

3

Inclu

sion o

f

subst

ances

in t

he

Auth

ori

sati

on L

ist

4

Applicati

ons

for

auth

ori

sati

on

5

Post

auth

ori

sati

on

decis

ion

6

Revie

w A

fAs

follow

ing r

evie

w p

eri

od

Gra

nd

To

tal

Consumers Excluded

Exclu

ded

-

General population - - - 1 1 2


6 4 2 8 - 20


6 7 6 12 5 36

NGO 1 1 2 1 2 7

Workers 3 3 3 3 1 13

Regulatory authorities 5 3 3 4 3 18

Grand Total 21 18 16 29 12 - 96



This systemic approach enabled us to identify the types of activities and associated impacts that we

needed to collect data for It also helped us identify the main types of information required from

different stakeholders

Regulatory authorities for their administrative costs along the authorisation process -

However ECHA will also be asked for data related to impacts not incurred by them but for

which they will have some relevant data (eg costs of AFAs)

NGOs for their administrative costs from responding to public consultations but also for

evidence of substitution and changes in the market structure

Impacts on workers focus on risk reduction (un)employment and improvements as a result

of new RMMs at various stages in the AfA process

Impacts on general population (and the environment) focus on (but not limited to)

improvements as a result of new RMMs introduced as a result of submissions of AfA or due

to substitution or ceasingrelocation production outside of the EU

Impacts on industry focus on the costs and market implications for the supply chain that

use the Annex XIV substance (including any business uncertainty or impacts on decision

making like on RampD and investment due to the authorisation process) and from relevant

competing supply chains that use an alternative Therefore the data collection is not

limited to applicants and MIs of the Annex XIV substance but also competitors using an

alternative (substance process or different product) This will mean we need to speak to

different stakeholders to identify relevant companies (eg trade associations registrants

suppliers MIs distributors and DUs)

B23 Assessing impacts

The two main evaluation criteria that this study will contribute towards for the REACH review are

The effectiveness of REACH authorisation and

The efficiency of REACH authorisation

Effectiveness

As set out in the Toolkit 42 of the better regulation toolbox effectiveness analysis considers how

successful EU action (in this instance authorisation) has been in achieving or progressing towards its

objectives

This study will provide supporting evidence that should allow the EC to form an opinion on the

progress made to date and the role of the authorisation process in delivering the observed changes

If the REACH authorisation objectives have not been achieved supporting evidence will be provided

to indicate the extent to which progress has fallen short of the target and what factors have

influenced why something hasnt been successful or why it has not yet been achieved

Consideration will also be given to whether the objectives can still be achieved on time or with

what delay (eg progress with targets set out in the 2020 Roadmap) Critically the analysis will also

seek to identify if any unexpected or unintended effects have occurred which were not

envisagedintended when REACH authorisation was designed



The starting point for the assessment will be to collect available information on targets for

authorisation (eg within the SHVC 2020 Roadmap) statistics tracking the progress of substances

along the authorisation process and the speed of decision making Much of the data required to

assess the effectiveness of REACH has been collected and is presented in Section 3

Efficiency

The assessment of the ldquoImpacts of REACH authorisationrdquo and in particular the evaluation questions

on ldquoefficiencyrdquo is being unpicked using a Cost Benefit Analysis (CBA) framework ndash the key question

being lsquoare the costs of REACH authorisation greater or lesser than the benefits of REACH

authorisationrsquo This sub-section follows the structure of a standard CBA It will be revised

throughout the project as further evidence becomes available

Objectives

Baseline

Baseline and counterfactual scenarios




Objective

The ultimate objective of adapting a CBA framework here is to help the EC answer some of the

questions related to the efficiency of the REACH authorisation process

What are the costs and benefits associated with the implementation of REACH

authorisation

To what extent are the costs proportionate to the benefits achieved

Was the distribution of costs proportionate between the different stakeholders (eg larger

companies vs SMEs or among different industrial sectors)

To what extent are there unnecessary burdens on stakeholders (related to the

proportionality question)

How are costs distributed among public authorities at EU and national levels

What aspects of REACH authorisation (including procedural aspects) are the most efficient

and what are the least efficient (including the development of scientific opinions work of

scientific committees urgency procedures etc)

A key aspect of the overall evaluation and hence the CBA component is the costs and benefits

occurring within the EU But where REACH authorisation has an effect beyond the EU these will be

noted

Baseline scenario

The baseline scenario for an ex-post study like this (ie looking back on an existing

regulationpolicy) is the current situation in this instance it is a world where REACH Authorisation

exists

Specifically for this study the assessment scope begins when RMOAs have been prepared for

substances where authorisation has been recommended as the most appropriate RMO or prior to

the introduction of an RMOA when an Annex XV dossier has been prepared Whilst there is no set

timeframe from which an Annex XV dossier has been submitted to when that substance appears on

the authorisation list the ldquoannouncing effectrdquo that a substance could be subject to authorisation in



the near future may already trigger action (activities) to both MIs and DUs of the substance in

relation to RampD investment plans the searchimplementation of a possible alternative andor

improvements in risk management of the substance

It may also trigger action (activities) to MIs and DUs that do not use the substance but use an

alternative (substance or process) or make an alternative end-product that could be used for

similar end-use applications These activities could range from providing more information about

the suitability of their products and increased marketing to changes in production

capacityproduct modifications where there is for example scope for increasing their market share

in existing and new end-use applications (which may otherwise have not been possible eg due to

higher costs associated with the alternative)

These activities or at least the incentivesurgency for them should in theory increase as the

substance moves through the authorisation process Once on the authorisation list downstream

users must decide if they

i Apply for REACH authorisation (themselves collectively or via an upstream application)

and incur the cost of preparing the dossier the fees for applying for authorisation any

costs to minimise emissions and potentially the costs to make a currently lsquounsuitablersquo

alternative suitable in the future

ii Donrsquot apply for REACH authorisation ndash This will save companies the cost of applying for

authorisation but they must stop using the substance by the sunset date (for the uses

subject to authorisation only) Society as a whole could benefit in terms of a net reduced

risk to worker and public health and a net reduction in emissions to the environment

However there may be costs associated with ceasing use of the Annex XIV substance such

as the costs (and risks) of substituting to an alternative relocating production out of the

EEA or ceasing production altogether As noted above the decision to not apply for

authorisation may occur much earlier in the authorisation process

iii Do nothing - ie donrsquot apply for REACH authorisation and donrsquot change the volume and use

of the Annex XIV substance This effectively is non-compliance of the REACH regulation

which is considered beyond the scope of this study It is assumed that firms comply with

the REACH regulation and therefore this option is not considered further

Under the baseline scenario there is good information on the number of companies that apply for

authorisation (response i) but there is significant uncertainty over the number of companies that

do not apply for authorisation (response ii) and this is a fundamental data collection task for this

study Both responses (i+ii) are assessed as they both are possible in the baseline scenario

Counterfactual scenario

A CBA is generally used ex ante ndash ie before a decision is made to assess the relative costs and

benefits of different options for helping make the decisions and its implementation As this is an

ex-post analysis we are trying to assess the past and ongoing costs and benefits of effectively a

world without REACH authorisation through what is called a lsquocounterfactualrsquo scenario what would

have happened or ldquopre-REACH and other factors independent of REACH like market trends and the

economic crisisrdquo as well as other known regulation in place at the time (eg OSH) as referred to in

the tender

What we are seeking to do is to determine the ldquonetrdquo impacts of the whole REACH authorisation

process taking into consideration what would have happened under the counterfactual for



example would a company have substituted to an alternative [substanceprocess] anyway or was

REACH authorisation a major reason for the substitution

A very complicated counterfactual often leads to criticism of false accuracy The key is being

transparent on what the assumptions are for determining the counterfactual scenario and setting

these out clearly and openly


REACH authorisation has an impact on the way the substances are used through two responses and

the costs and benefits of both routes need to be assessed

Through the application process ndash companies prepare and submit for REACH authorisations

and as a result are either granted permission for continued use or denied permission (and

have to switch to a less risky alternative relocate or cease production) and

Through the preventative power of the regulation ndash companies pre-empt (at an earlier

stage in the authorisation process) a future requirement for REACH authorisation and

substitute away from a substance relocate or cease production without informing ECHA or

any other organisation

All impacts will be considered but not all enter the cost benefit analysis (eg changes to the

market structure are not a matter for such analysis) As noted earlier there is more evidence on

the application route as the SEAs submitted contain most of the necessary information ndash even

though not all may be quantitative or monetary or some may not be (at least immediately public)

due to confidentiality issues

Even less is known about the second route as there are no reporting recording requirements for

such decisions Whilst there is some qualitative information in some existing REACH studies much

of it is confidential ndash eg company names and uses substituted Therefore new information would

need to be derived as part of this study162 in part through the case studies (Task 24) and also the

online survey (Task 23) There is a general limitationscaling issue that case studies and survey

respondents even collectively will not account for all the marketsocietyaffected parties and

therefore estimating the total impacts of REACH authorisation will not be possible

It is also difficult to attribute the company decision (to substituterelocationcease production)

solely to REACH authorisation as there are other regulations (chemical and non-chemicals) and

market forces (eg cheaper production costs outside of the EEA) that could influence the decision

made The only way to get more information about such incentives for substitution is through direct

consultation with those that have substituted through surveys in-depth interviews and as case

study participants


One of the efficiency questions in the REACH evaluation is lsquoto what extent are the costs

proportionate to the benefits achievedrsquo This will require financial health and environmental costs

and benefits to be measured and compared in the same unit ideally but not exclusively monetary

terms Comparison could be made in terms of Net Present Value (benefits minus costs discounted

162 ECHA were able to provide examples of substances for which some uses were removed from registrations at

the AXIV Recommendation phase (the motivation was to decrease the priority of the substance for inclusion in

AXIV)



over time) or Cost Benefit Ration (benefits divided by costs discounted over time) depending on

the quality of information available As agreed in the kick off meeting with the EC we would seek

to present costs and benefits in annual terms to enable such a comparison

Assessing the proportionality of REACH authorisation requires one of three conditions to be met

1 Costs are less than benefits

2 Costs are more than benefits but the lsquooverspendrsquo is deemed proportional especially given that

it is not possible to quantify and monetise all benefits (or indeed all costs) and

3 Regardless of whether costs are more or less than the benefits they are distributed

proportionally amongst the relevant stakeholders eg by companies in different points on the

supply chain and large companies vs SMEs The distribution should be in accordance with their

contribution to the problem and their ability to afford ndash two criteria that could at times

conflict with each other


In an ex-ante analysis we could undertake sensitivity analysis by changing our assumptions about

key factors that estimate costs and benefits and see what the effect of such changes is on the

comparisons In this case we could compare evidence from different sources and see what they

indicate (ie how they affect the main findings)

This step is particularly important in applications like this where the scope is wide and evidence is

sparse Sensitivity analysis would help us make the most of the evidence available to draw lessons

for the future

B24 Tier 1 and 2 case studies

Case studies will be conducted to gain more in-depth insights on the five impact areas of the study

(i) costs of authorisation (ii) benefits of authorisation (iii) changes in the market structure (iv)

substitution and (v) affordability of authorisation for SME The case studies will build upon existing

studies and relevant information already in submitted applications

Within this study two types of case studies are presented

The Tier 1 case studies deal with the various authorisation related aspects for one

substance Both cases where an AfA was filed but also (non-applicant) cases with

substitutionrelocation or cease use will be discussed in this case study In order to be able

to deal with all aspects it is necessary that these substances have advanced far enough in

the authorisation process For this reason only substances for which applications have been

filed and which passed the Latest Application Date (LAD) were considered for the Tier 1

case studies

Within each Tier 1 case study the five main impact areas will be covered The goal is to

provide a comprehensive view on the authorisation process for these substances and its

effects Where possible and available quantitative data will be provided however for

illustrative purposes more narrative sections will also be used

The Tier 2 case studies contribute to the study by collecting data on specific aspects For

instance for substitution it could be relevant to conduct a case study on evidence of



substitution of substances and thereby avoiding having to apply for authorisation

Information at impact level will be collected for various substances and collated It is

expected that for some aspects it will be difficult to collect comprehensive quantitative

data However we expect to derive trends and mechanisms from the information collected

over various substances

While for the Tier 1 case studies only data on one substance is used for each respective

case study for each Tier 2 case study data over several substances are used There is also

no need for the Tier 2 case studies to limit the choice of substances to those that passed

the LAD or for which applications have been filled

The Tier 2 case studies are especially efficient to address issues for which it will be difficult

to obtain a significant amount of data for one substance In this way Tier 2 case studies

complement the Tier 1 case studies in aspects where there is opportunity to combine data

from multiple substances



ANNEX C AUTHORISATION PROCESS 2007-2016

C1 Overview

The authorisation process is initiated by the identification of a substance as SVHC done by the

submission and acceptance of an Annex XV dossier For human health hazard concerns (CMR) this

depends upon the classification of the substance as Category 1a1b Carcinogen Mutagen or

Reproductive toxicity For environmental hazard concerns (PBTvPvB) this means that the

substance is demonstrated to meet the criteria set out in Annex XIII of REACH (a substance can also

be SVHC on the basis of equivalent concern to a CMR or PBTvPvB ndash Article 57f) The process of

identification of a substance as fulfilling the criteria for SVHC therefore depends upon other

processes in REACH and the Classification Labelling and Packaging Regulation (CLP) requirements

Compliance checks (dossier evaluation) examine any registration dossier to verify if the information

submitted by registrants is compliant with the legal requirements Compliance checks evaluate the

substance identity description the study data and the safety information in the dossier including

the chemical safety report or specific parts of the dossier This can lead to additional information

being requested The process of substance evaluation in which all REACH registration dossiers of

one substance are assessed for risks can identify the need for further information such as

information to confirm if a substance could be CMR or PBTvPvB (or of equivalent concern) If the

additional information indicates that the substance has SVHC potential then this can lead to the

substance being placed on the candidate list (ie identified as SVHC) The evaluation process

being it dossier or substance evaluation is therefore a key influence on possible later needs for

authorisation It is often the start of a process in which further information is generated to identify

or confirm hazardous properties of a substance that could lead it to be identified as SVHC and

also importantly the possible exposure of humans andor the environment to that substance

The EC has committed to have ldquoall relevant currently known Substances of Very High Concern

(SVHCs) included in the candidate list by 2020163 The so called lsquo2020 Roadmaprsquo sets how that will

be achieved and emphasises the application of a screening process followed by a risk management

options analysis (RMOA) process

Figure C01 below illustrates the main processes within authorisation (blue boxes) and also

associated processes in REACH and CLP (green boxes) as well as processes that are not formally

within REACH but influence the decision-making on the identification and assessment for

substances that are relevant to the authorisation process (amber boxes) The main actors or

information sources are indicated in each case

163 European Commission (2013) Roadmap on Substances of Very High Concern Page 4



Figure C01 The processes in authorisation and contributory processes

As set out in the legal text the aim of authorisation is ldquoto ensure the good functioning of the

internal market while assuring that the risks from substances of very high concern are properly

controlled and that these substances are progressively replaced by suitable alternative substances

or technologies where these are economically and technically viable To this end all manufacturers

importers and downstream users applying for authorisations shall analyse the availability of

alternatives and consider their risks and the technical and economic feasibility of substitutionrdquo164

The whole authorisation process (as illustrated in Figure C01) has the objectives to

Ensure that the risks from SVHCs are properly controlled

Progressively replace SVHCs with suitable alternative substances or technologies where

these are economically and technically viable and


Using the following tools

Identify substances that meet the criteria of Article 57 (SVHC ndash candidate list)

164 REACH legal text Article 55

2020 roadmap -RMOMSCAsECHA

Compliance checkSubstance EvaluationMSCAs ECHA

CLP harmonisationMSCAsECHA

Annex XV dossierfor SVHCMSCAsECHA

Prioritisation - ECHA

Candidate list of SVHCs - ECHA

RegistrationIndustry

Existing informationeg ESR RAR

Formal authorisation process

Contributory processes

Review ECHAEC

Inclusion in Annex XIV - EC (ECHA recommend)



Prioritise SVHCs based on use volume and inherent property that require Authorisation

(Annex XIV)

Place the burden of proof on industry to make the case for continued use (ie to analyse

the availability of alternatives and consider their risks and the technical and economic

feasibility of substitution)

In REACH as a whole the burden for information provision (ie to assess the hazards exposure and

risks) is on the importers manufacturers and to a lesser extent downstream users REACH

indicates (in Recital 30) that the aim is To achieve fair burden sharing with their customers

manufacturers and importers should in their chemical safety assessment address not only their own

uses and the uses for which they place their substances on the market but also all uses which their

customers ask them to address As indicated in Recital 30 the onus is on manufacturers and

importers to produce safety assessments to address their uses and those of their customers (ie

downstream users) Authorisation applications have a chemical safety assessment as part of the

AfA however a large number of AfAs (and therefore safety assessments) have been done by DUs

ie the applied for uses hashave not been supported by the manufacturerimporter (ECHA data

from 196 applications indicates that almost 70 of the applications were made by DUs165)

Whilst it was envisaged that the manufacturers and importers placing substances on the market

would take the burden to show safe use for their customers (as stated in Recital 30) the DU

customers are not only paying for substances themselves but also paying to keep those substances

on the market for the product including the increase in control measures in order to drive down

exposure and the cost of applying for authorisation (including possible costs for the use of

information in registration dossiers)

Intervention logic actors and actions

An lsquointervention logicrsquo is a tool that links the design of an intervention (policy legislation) and the

operational actions with the outputs obtained and effects (outcomes and impacts) observed It

shows the link between the inputs and outputs and from its results to its impacts

As part of the preparation for the consultation plan (see Chapter 2 of this report) the intervention

logic was checked so that the main stages in the authorisation process could be linked to specific

actions which in turn can be linked to the achievement of the objectives of authorisation and the

impacts on specific actors

As indicated in Figure C01 there are several discrete stages in the authorisation process through

which a substance can pass The process may stop at particular stages if criteria are not fulfilled or

actions not taken Actions may not however be immediately visible within the authorisation process

since they may be actions which are not reportable to the regulatory authorities (for example not

making an application for a specific use or identification of an alternative to an SVHC) and thus

specific data are not necessarily gathered by the authorities on these actions and activities It is

these less visible actions that the Commission has a particular interest in since they indicate the

responses of the market to the Authorisation process that are not otherwise quantified Table C01

below very briefly summarises the main stages in the authorisation process and the possible actions

for actors in the process with comments on how data is being gathered)

165 Data provided by ECHA for the purposes of this study (status as of 20102016)



Table C01 The main stages in the authorisation process


1 Screening of substances and RMOAs

Screening of substances by MS CA

andor ECHA that meet Article 57

criteria and have non-exempt uses

Proposal for a substance to go onto

Annex XIV means it must meet the

Article 57 criteria for SVHC

The Screening and RMOA are not a part

of the process that is set out in the

legal text (RMOA was developed in

2009 and formally introduced

together with the Screening process

in the EC lsquoRoadmap on Substances of

Very High Concernrsquo in 2013) but the

submission of Annex XV dossier by MS

CAs and ECHA is an official part of the

process


Substances demonstrated (in an

Annex XV dossier) to meet the

Article 57 criteria can be placed

onto the Candidate list

Inclusion on the Candidate list brings

obligations eg under Article 33 and

Article 7(2)

3 ECHA recommendation for Annex XIV

Recommendations for SVHC to be

placed in the Authorisation list

(Annex XIV) are made by ECHA

(including latest application and

sunset date review period and

exemptions)

-

4Inclusion of substances on Annex XIV

The EC amends REACH (Annex XIV)

The EC has the discretion not to follow

the recommendations by ECHA when

deciding on which and when to add

substances to the Annex XIV


Applications are made by industry

for continued use of SVHCs

Applications have to be made 18

months before the sunset date to

benefit from the transitional

arrangements under Article 58(c)(ii)

(the so-called latest application date)

meaning that the use can continue

even after the sunset date until the

Commission has issued its decision

ie if the decision has not yet been

adopted by the sunset date

Applications made after the latest

application date would have to stop

the use after the sunset date and

await granting of the authorisation

before use can be continued (or

initiated if it is a new use)


Opinions (including review period

and conditions) are made by

scientific committees RAC and SEAC

for each use applied for

The decision on whether or not to

grant the authorisation is done by

EC

MS NEA are responsible for

enforcement




7 Review reports following review period

This is a re-application

Re-application is to be done 18 months

before the end of the review period if

the use of the substance is still

necessary A review report is to be

submitted (to ECHA) by the applicant

C2 Timeline of key events in the authorisation process (2006-2017)

The main stages of the authorisation process (as illustrated in Figure C01) are specifically referred to in Title VII of REACH

Article 57 substances to be included in Annex XIV

Article 58 ndash inclusion of substances in Annex XIV

Article 59 identification of substances referred to in Article 57

Article 60 granting of authorisations

Article 61 review of authorisations

Article 62 Applications for Authorisation

Article 63 subsequent applications for authorisation and

Article 64 Procedure for authorisation decisions

However the selection of substances in Articles 57 and 58 does not refer to the RMOA process

PACT list or the 2020 Roadmap These parts of the process have been added to aid the decision

making efficiency and transparency of the authorisation process A timeline for the development

of the process and the additions to the process are set out in this section In addition summary-

statistics have been collated in order to give an indication of the volume of substances passing

through the process and where substances are in a snapshot of the process as it is (as of December

2016) The presentation of these statistics is not intended as a detailed overview of the process

but rather to put into context the analysis that is possible



Figure C02 Timeline of key events in the authorisation process (2007-2016)



C3 Screening of substances and Risk Management Option Assessment (RMOA)

The 2020 SVHC Roadmap committed to have all relevant currently known SVHCs included in the

candidate list by 2020 There was a consequent need to analyse the information on a large number

of substances not only to determine the relevance of known potential SVHCs but also to identify

new potential SVHCs from the processes of REACH registration (phase-in stages completed in 2018)

and evaluation The roadmap implementation plan describes two distinct but related processes (1)

the Screening process and (2) the RMOA process The purpose of the Screening process is to identify

and prioritise substances of potential concern for further regulatory action Those substances of

potential concern are those where the impact on human health and the environment are expected

to be the greatest Priority is given to substances that have the highest exposure potential

combined with their potentially hazardous properties for example substances that are

carcinogenic mutagenic and toxic to reproduction (CMR) persistent bioaccumulative and

toxicvery persistent very bioaccumulative (PBTvPvB) or endocrine disruptors and therefore

potential SVHCs Once the concern is confirmed the substance is normally taken forward to RMOA

by authorities The purpose of the RMOA is to help authorities decide whether further regulatory

risk management activities are required for substances and if so to identify the most appropriate

instrument to address a concern Thus in view of the authorisation process the roadmap sets out

the RMOA process as central to the decision making on the inclusion of SVHCs on the Candidate List

The processes of Screening and RMOA as set out by ECHA is described in Box 31 below In addition

ECHA set up the Public Activities Coordination Tool (PACT) that provides information (published on

the ECHA website) on substances that are or have been subject to informal assessment (of their

potential PBT vPvB or ED properties) andor RMOA

Box C1 Risk Management Option Analysis

The purpose of the risk management option analysis (RMOA) is to help decide whether further

regulatory risk management activities are required for a substance and to identify the most

appropriate instrument to address a concern A Member State or ECHA (at the request of the

Commission) can carry out this case-by-case analysis

The RMOA is an important step agreed in the SVHC Roadmap but it is voluntary (ie not part of

the processes defined in the legislation) For authorities documenting the RMOA allows

information to be shared This promotes early discussion which helps create a common

understanding on the appropriate action to be taken

An RMOA can conclude that regulatory risk management is required for a substance (for example

harmonised classification and labelling inclusion on the Candidate List restriction other EU

legislation) or that no regulatory action is required Subsequent regulatory processes include

consulting interested parties and appropriate decision making involving the MSCAs and

Commission as defined in REACH

Communicating information on substances undergoing RMOA through the Public Activities

Coordination Tool (PACT) allows stakeholders and the general public to better predict which

substances may be addressed by which formal risk management routes in the future This gives

registrants the opportunity to update their registration data consider the best business strategy

to address substances of potential concern and to prepare for public consultation during any

subsequent regulatory processes



The responsibility for the content of an RMOA rests with the authority that developed it RMOAs

and their conclusions are compiled on the basis of available information and may change in the

light of new information or further assessment

Source ECHA web page on RMOA

httpsechaeuropaeuaddressing-chemicals-of-concernsubstances-of-potential-concernrmoa

Box C2 Public Activities Coordination Tool

The Public Activities Coordination Tool (PACT) gives advance notice of the substances that are on

an authoritys radar for exploring the potential need for regulatory risk management

PACT lists the substances for which an RMOA or an informal hazard assessment for PBTvPvB

(persistent bioaccumulative and toxic very persistent and very bioaccumulative) properties or

endocrine disruptor properties is either under development or has been completed since the

implementation of the SVHC Roadmap commenced in February 2013 Substances for which a

hazard assessment is performed are also discussed informally by the PBT Expert Group or the

Endocrine Disruptor Expert Group as appropriate

Inclusion in the PACT means that a Member State or ECHA is examining the substance It does not

mean that a substance has the suspected properties or that there is a need for regulatory risk

management actions The purpose of the hazard assessment is to explore a potential PBTvPvB

or endocrine disruptor concern

Frequently the outcome of such an informal assessment is that the substance is considered to

not have the hazard properties investigated based on the available information Similarly an

RMOA aims to clarify whether regulatory risk management is necessary and if yes which

measures would be the most appropriate to initiate

Even if the outcome of the RMOA is that it would be appropriate to initiate regulatory risk

management action or of a hazard assessment is that a substance is considered to have PBT or

endocrine disrupting properties such outcomes do not have direct legal implications and

regulatory relevance as the outcomes presented in PACT are just those of the evaluating

authority

To gain legal and regulatory relevance the substance assessed needs to successfully pass one or

more of the formal risk management and decision-making processes under REACH or CLP such as

harmonised classification and labelling (CLH) SVHC identificationauthorisation or restriction

The intentions to submit a dossier to the mentioned formal processes are notified in the Registry

of Intentions

Early information through PACT gives registrants more time to make sure that their registration

data is up to date Stakeholders will have more time to prepare their contributions to a formal

regulatory management process which potentially will follow the preparatory steps and outcomes

indicated in PACT Anyone else with data on the substance information on safer alternatives or

other material will also have more time to prepare to make their case in the public consultation

phase of a potential formal process

Source ECHA web pages on PACT

httpsechaeuropaeuaddressing-chemicals-of-concernsubstances-of-potential-

concernpactstatus-and-purpose



The processes of screening substances and selecting the most relevant ones for the RMOA is in the

hands of regulatory authorities with the main actors being ECHA and the MS CAs

Within this study the assessment focuses on substances that have been identified as SVHC This of

course is difficult to judge precisely without re-conducting an RMOA on the substances although it

may be possible to compare the outcomes of the RMOAs done with the main objectives of the 2020

Roadmap

1 The substance shows some evidence of being produced andor used in Europe in relevant

quantities (fulfilled by already registered substances or substances that will be registered

by 2020)166

2 The substance has not only been registered for intermediate uses

3 The available information does not prima facie demonstrate that there is a risk that is not

adequately controlled and needs to be addressed at EU level167

4 The known uses of the substance

a are not exempted from the authorisation requirement on the basis of Article 2(5) or

Article 56(3) (4) or (5) or Article 60(2)

b are not already regulated by specific EU legislation that provides a pressure for

substitution leading to the conclusion that no further regulatory action is needed

under REACH

The latest SVHC Roadmap annual report can be referred to for more information

httpsechaeuropaeudocuments1016219126370svhc_roadmap_2017_enpdfa8430302-c03c-

d55a-b7d1-822451dfc34e

The roadmap implementation web page can be found at

httpsechaeuropaeuaddressing-chemicals-of-concernsubstances-of-potential-concernsvhc-

roadmap-to-2020-implementation

C4 Inclusion of substances in the Candidate List










regulatory action (eg restriction) under REACH is deemed to be needed168 As set out earlier in

this section and illustrated in Figure C1 the selection of SVHC substances is done initially by

166 There might be cases in which non-registered substances can still be considered relevant for identification

One example might be a substance that is currently not produced or used in Europe but might be used as an

alternative to another relevant SVHC This exemption is particularly relevant when the most appropriate

approach is the category approach (ie analogous substances) 167 For those uses that have a demonstrated risk according to Articles 69(1) and 69(4) a restriction process

should be started 168 httpregisterconsiliumeuropaeudocsrvl=ENampf=ST20586720201320INIT



Member States or ECHA upon request of EC making an Annex XV dossier to demonstrate that the

substance meets the Article 57 criteria

C5 Prioritisation and inclusion of substances in the Authorisation List


the substance (2) the high volume and (3) the use (wide- dispersive) Before sending its






information














C6 Applications for Authorisation (AfA)



parties (alternatives during the public consultation) In addition the risk assessment committee




C7 Post authorisation decision

Once an Authorisation is granted or refused ndash done by the Commission and published with relevant

conditions in the Official Journal the relevant actors must act on this Upstream authorisation

holders that is manufacturers importers or only representatives must include the authorisation

169 REACH article 58(4) 170 ECHA (2014) Prioritisation of substances of very high concern (SVHCs) for inclusion in the




number on the label before they place the substance or the mixture containing the substance on

the market Upstream authorisation holders must also update the safety data sheet (SDS)

Downstream users of an Annex XIV substance covered by the authorisation of an upstream actor

must comply with the conditions of the decision and notify to ECHA their use of the substance

within three months of the first supply of the substance Downstream authorisation holders must

comply with the conditions of the decision

C8 Review of Authorisation following their review period
















ANNEX D ACTIVITIES CARRIED OUT ALONG THE

AUTHORISATION PROCESS



actors This Annex sets out the 150 activities identified

The authorisation process was divided into 6 stages171

1 Screening of substances and Risk Management Option Analysis (RMOA)


3 Inclusion of substances in the Authorisation List



6 Review AfAs following review period

The information is further split by type of actor (either those that carry out the activity identified

or those actors most affected by this activity)

Consumers

General population



NGO

Regulatory authorities

Workers

171 This aligns with the list in the overall REACH intervention logic



D1 STAGE 1 Screening of substances and RMOArsquos



impact

Justification

for

exclusion


whom

Proposed

tool

MSCA - Screening - selection of substances of concern

based available information from registration andor

other sources to defineconclude on hazardous









may be

taken forward together with these latter substances

during RMOA development)

Coordination and organisation of agreed plans and

tasks and to avoid duplication of work

Working in groupscommittees


sensitisers) or


Group)

National strategy on specific compounds or types of

compound

Other

bullData collection and national monitoring and research

Administrat

ive costs


substance screening

Cost of resources


activities

National policy drivers


screened and why

MSCAs Data

request

to MS CA




impact

Justification

for

exclusion


whom

Proposed

tool

programmes

bullPolicy development at national level

ECHA - Screening - selection of substances of concern

based on available information from registration

andor other sources to defineconclude on hazardous









may be taken forward together with these latter

substances during RMOA development)

Coordination and organisation of tasks to adhere to

agreed plans and tasks and to

avoid duplication of work

Coordination of groupscommittees


sensitisers) or


Group)

Other

bull resource use and distribution (request from EC to




of concern

improvement of screening methodology and guidance

Administrat

ive costs


substance screening

Cost of resources


activities

Policy drivers


screened and why

ECHA Data

request

to ECHA




impact

Justification

for

exclusion


whom

Proposed

tool

ECHA - RMOA



bull PACT annual report




bull Coordination of activities

COM - Screening

bull Production of policy on screening (2020 Roadmap)

review and update of policy

bull Potential endocrine disruptors list - develop and

maintain

Coordination and organisation of tasks in order to

adhere to agreed plans and tasks and to avoid

duplication of work

Developing criteria for the identification of such ED-

substances that require regulatory action

Other

bull resource use and distribution (request to ECHA to



bull improvement of screening methodology

bull review and update of policy and procedure for

substance selection


of concern

Administrat

ive costs Yes -

Resources required for

substance screening

Cost of resources


activities

Policy drivers

COM

Data

request

to EC

MSCA - RMOA


bull Communication - web site etc

Administrat

ive costs

Yes - Cost of resources MSCAs Data

request

to MS CA




impact

Justification

for

exclusion


whom

Proposed

tool




bull Providing experts to committees - eg PBT Expert

Group (PBT-EG) Endocrine Disruptor Expert Group

(ED-EG)

COM ndash RMOA



Administrat

ive costs

Yes - Cost of resources COM Data

request

to EC



impact

Justification


Proposed

tool

Informally provide

information requested on

a substance RMOA

Administrat

ive costs

No This RMOA

aspect deemed

out of the scope

of the project

The number of substances where industry

have been asked to comment on an RMOA


industry

This is based on literatureexpert

judgementinformal consultation) - to

minimise number of questions formally

asked from industry

Need to ask

ECHA for list of

industry

contacted about

RMOA

Data request

to ECHA

Trigger internal


regulatory scrutiny and

spending decisions on

options for substitution

RampD costs No This RMOA

aspect deemed

out of the scope

of the project



an annual cost


Would need a

general informal

question to be

asked to

companies

identified via

Further

research

targeted

data request




impact

Justification


Proposed

tool

ECHA to

estimate admin

+ RampD costs

Substitution from

substance on RMOA


Substitutio

n


Use



risk management

Trade

association or

REACH

consortia

Industry using

an RMOA

substance

Industry

online survey

Communication with MI

and trade association or

relevant REACH consortia

Improved

supply

chain

communica

tion

No Only possible to

generate

anecdotal

responses that

already exist

Communication to MS CA

ECHA that industry will

be doing voluntary action

to substitutereduce risks

Improved

supply

chain

communica

tion

Yes - Instances where industry wide voluntary

agreementsactions were noted and

then carried out

Ask ECHA for list

of companies

who indicated

they are

introducing

voluntary

action RMMs

substitution

Data request

to ECHA

Substitution from

substance following

Annex XV dossier

Substitutio

n


Use


Trade

association or

REACH

Industry

online survey




impact

Justification


Proposed

tool


risk management

consortia

MI that have

ceased

production

(list from

ECHA)

Industry using

substance with

an Annex XV

dossier

Decide whether to shut

down operations or

relocate outside of the

EU following RMOA or

Annex XV dossier

Closure

relocation

Yes - Instances of ceasing operations -

Substance and Use


Use

Trade

association or

REACH

consortia

MI that have

ceased

production

(list from

ECHA) to

identify

industry that

have

substituted

from

substance at

Annex XV

dossier stage

Industry

online survey




impact

Justification


Proposed

tool

Decide whether to

postpone delay

increase investment

following RMOA or Annex

XV dossier

Investment

decision




Substance and Use

Trade

association or

REACH

consortia

Industry using

an RMOA

Substance

Industry

online survey


conditions and RMMs

Reduction

in risk

(human

health

andor

environ-

mental)

Yes - For each substance and use



effectiveness



Estimated cost

Trade

association or

REACH

consortia

Industry using

an RMOA

Substance

Industry

online survey



impact

Justificatio

n for

exclusion


tool

Promote the use of

their alternative



companies to switch


on the RMOA

recommended for

authorisation

Substitution Yes - Find suppliers of alternatives

Find specific cases of substitution

priorwithout AfA

Company size of supplier of alternative

Company size of the user of the alter-

native

Details on the annex XIV to be

substituted the use and alternative

Suppliers of

alternatives via

distributers of the

annex XIV substance

via direct leads via

consultation of

industry experts via

industry associations

Industry

online survey




impact

Justificatio

n for

exclusion


tool

Reduction in risks from

use of an alternative

Reduction in

risk (human

health andor

environ-

mental)

Yes - Risk from use of Annex XIV substance

Risk of the use of the alternative

DUs of the

alternative

Tier 1 and 2

case study

Promote the use of

their alternative



companies to switch


on the RMOA

recommended for

authorisation

Increase in

sales

market share



substance compared to the total

market volume of the annex XIV

substance in this use

Suppliers of

alternatives

Tier 1 and 2

case study

Switch to alternative -

resulting in change in

production costs

Production

costs

Yes - Location of manufacturing of

alternative substance

Cost impact of the alternative (one-

time costs running costs)

Suppliers of

alternatives

users of the

alternative

Tier 1 and 2

case study

Development and supply

of alternative substance

or technology

Innovation Yes - How did REACHauthorisation process

affect the development of the

alternative (Eg As of when was the

alternative available on the market)


alternatives

Tier 1 and 2

case study

Change in volume


Changes in

market

structure

Yes - Evolution of import of finished goods

produced with annex XIV substance and

produced outside of the EEA


annex XIV substance compare with the

supply chain of the alternative (eg

number of suppliers)

DUs of the

alternative

Specific suppliers

of alternatives

Tier 1 and 2

case study



Actor NGO


d impact

Justification for


From

whom

Proposed

tool

Informally provide

information on a

substance RMOA

Administrative

costs

No This RMOA aspect

deemed out of the

scope of the project

Number of hours spent preparing and


RMOA substances for which information was

provided

NGOs NGO survey

Informally provide

information on


Substitution Yes - NGOs opinion about whether the RMOA

process is working

Information about cases where substitution

has taken place before a substance has

appeared on the authorisation list

Information about whether this stage of the

authorisation process is driving innovation

and a transition to safer alternatives

NGOs NGO survey


producing research

papers position

statements press


other NGOs industry

etc

Administrative

costs

No Voluntary action

that should not be

included within the

assessment


Which stages of the authorisation process the


Number of AfAssubstancesuses that these


NGOs NGO survey



Actor Workers


impact

Justification


From

whom

Proposed

tool

Exposure in firms



for authorisation or

relocating use

Reduction in

risk (human

health andor

environmental)


RMOA


using substance

Number of workers

Dose-response etc



Industry

ECHA

website

Tier 1 and 2

case study

Employment in firms



for authorisation via

relocation


relocation






case study




for authorisation

Reduction in

risk (human

health andor

environmental)


RMOA


using substance pre-RMOA


using substance post-RMOA

Number of workers


substance


Industry

ECHA

website

Tier 1 and 2

case study

Actor Consumers




impact

Justification for

exclusion

Information

needed

From

whom

Proposed

tool

Consumption of products produced by firms who have


substance on RMOA selected for authorisation

Changes in

product price

andor quality

No Only possible to generate

anecdotal responses that

already exist



impact

Justification for

exclusion

Information

needed

From

whom

Proposed

tool


substituting away from substance on RMOA selected for

authorisation

Reduction in

risk (human

health andor

environmental)


obtain sufficient

quantitative data



improving RMMs related to use of substance on RMOA


Reduction in

risk (human

health andor

environmental)


obtain sufficient

quantitative data




substance or relocating use of substance on RMOA


Reduction in

risk (human

health andor

environmental)


obtain sufficient

quantitative data



use of substances by firms improving RMMs related to use

of substance on RMOA selected for authorisation

Reduction in

risk (human

health andor

environmental)


obtain sufficient

quantitative data




D2 STAGE 2 Inclusion of substances in the Candidate List



impact

Justification

for exclusion

Information

needed

From

whom

Proposed

tool

MSCA - Annex XV dossier for SVHC

The Annex XV SVHC report - attached to the technical dossier

in IUCLID

A technical dossier (in IUCLID format) This should include

information on substance

composition and can include robust study summaries imported

from registration dossiers

collect the relevant information






Administrative

costs

Yes - Cost of

resources

(days spent)

MSCAs Data

request to

MS CA


The Annex XV SVHC report and IUCLID ECHA- Annex XV dossier

for SVHC collect the relevant information







Administrative

costs

Yes - Cost of

resources

(days spent)

ECHA Data

request to

ECHA

COM - Annex XV dossier for SVHC

Art 59(9) - if no unanimous agreement by MSC - COM prepares

draft proposal and decision taken by Committee procedure

(Art 133)

Administrative

costs

Yes - Cost of

resources

(days spent)

COM Data

request to

EC





impact

Justification


Proposed

tool


consultation on the inclusion the

substance in the Candidate list

Administrative

costs

Yes - Estimated cost (euro) and

for what substance

Trade association

REACH consortia

Industry using a

substance on

candidate list

Industry

online

survey

Trigger internal discussions

following regulatory scrutiny and

spending decisions on options for

substitution

RampD costs Yes - Instances of RampD

spending - Substance

and Use

Estimated euro spending

(one-off or annual)

Trade association

REACH consortia

Industry using a

substance on

candidate list

Industry

online

survey

Substitution from substance on

candidate list

Substitution Yes - Instances of

substitution -

Substance and Use


Impacts - eg changes

in sales profit risk

management

Trade association

REACH consortia

Industry using a

substance on

candidate list

Online

industry

survey amp

case

study

Communication with MI and trade

association or relevant REACH

consortia

Improved supply

chain

communication

No Only possible to

generate

anecdotal

responses that

already exist

Communication to MS CA ECHA

that industry will be doing

voluntary action to

substitutereduce risks

Improved supply

chain

communication

Yes - Instances where

industry wide

voluntary

agreementsactions

were noted and then

carried out


companies who

indicated they are

introducing

voluntary action

RMMs substitution

Data

request

to ECHA




impact

Justification


Proposed

tool

Decide whether to shut down

operations or relocate outside of

the EU following candidate listing

Closure

relocation

Yes - Instances of ceasing

operations -Substance

and Use

Instances of relocating

-Substance and Use

Trade association

REACH consortia

Industry using

substance on

candidate list

Online

industry

survey amp

case

study

Decide whether to

postponedelay

increase investment following

candidate listing

Investment

decision

Yes - Instances of

postponed or delaying

investment -

Substance and Use


investment -

Substance and Use

Trade association

REACH consortia

Industry using an

RMOA Substance

Online

industry

survey amp

case

study


conditions and RMMs

Reduction in risk

(human health

andor

environmental)

Yes - For each substance and

use

How working

conditions have

improved

What RMMs were


effectiveness

If that resulted in

change in skills

required or number of

staff required

Estimated cost

Trade association

REACH consortia

Industry using an

RMOA Substance

Industry

online

survey





impact

Justification


Proposed

tool

Contribution during

public consultation

Administrative

costs

Yes - Cost of the participation

to the public consultation

References received from

ECHA (see other question)

Industry

online survey

Promote the use of

their alternative



companies to switch


on the RMOA

recommended for

authorisation

Increase in

salesmarket

share

Yes - Sales volume of

alternative in replacement


Suppliers of alternatives Tier 1 and 2

case study

Change in volume


Changes in

market

structure



with annex XIV substance

and produced outside of

the EEA






DUs of the alternative


alternatives

Tier 1 and 2

case study

Contribution during

public consultation

Administrative

costs

Yes - A list of existing AfAs that

would have been applicable

for the lsquolow volumersquo

simplification authorisation

route

ECHA Data request

to ECHA



Actor NGO


impact

Justification


From

whom

Proposed

tool

Provide comments during public

consultation on inclusion of substances

on the Candidate List (as per Article

58(4))

Administrativ

e costs

Yes - Number of hours spent preparing

and submitting information

Candidate List substances for

which information was provided

NGOs NGO

survey

Active lobbying including producing

research papers position statements

press releases liaising with other

NGOs industry etc

Administrativ

e costs

No Voluntary action

that should not

be included

within the

assessment


activities



Number of AfAssubstancesuses

that these activities relate to

NGOs NGO

survey

Actor Workers


impact

Justification

for

exclusion


whom

Proposed

tool

Exposure in firms



Candidate List for

authorisation or relocating

use

Reduction in

risk (human

health andor

environmental)



using substance

Number of workers

Dose-response etc

Function for substance


Industry

ECHA

website

Tier 1 and

2 case

study

Employment in firms



Candidate List for





Industry Tier 1 and

2 case

study




impact

Justification

for

exclusion


whom

Proposed

tool

authorisation via relocation substituting via relocation




Candidate List for

authorisation

Reduction in

risk (human

health andor

environmental)



using substance


using substance


Dose-response etc



Industry

ECHA

website

Tier 1 and

2 case

study

Actor Consumers


impact

Justification for

exclusion

Information

needed

From

whom

Proposed

tool



substance included on Candidate List for authorisation

Changes in

product price

andor quality



quantitative data

required to assess

this





impact

Justification

for exclusion

Information

needed

From

whom

Proposed

tool


substituting away from substance included on Candidate

List for authorisation

Reduction in

risk (human

health andor

environmental)



quantitative data

required to assess

this


improving RMMs related to use of substance included on


Reduction in

risk (human

health andor

environmental)



quantitative data

required to assess

this



substance or relocating use of substance included on


Reduction in

risk (human

health andor

environmental)



quantitative data

required to assess

this


use of substances by firms improving RMMS related to use

of substance included on Candidate List for authorisation

Reduction in

risk (human

health andor

environmental)



quantitative data

required to assess

this



D3 STAGE 3 Inclusion of substances in the Authorisation List



impact

Justification


From

whom Proposed tool

MSCA- Comment on Recommendations

MSC - Comment on recommendations

(experts supplied by MSCA)

Administrative

costs


(days spent)

MSCAs Data request

to MS CA

ECHA- Recommendations for Annex XIV

Select substances from Candidate list

based on Art 58(3) also accounting for

outcome of RMOA

Make Recommendation (including

specification set out in Art 58 (1) a-e

(identity properties latest application

and sunset date review periods use

category exemptions)

Organise and carry out and take into

account public consultation on

Recommendation

Administrative

costs


(days spent)

ECHA Data request

to ECHA

COM - Recommendations for Annex XIV

Decision in accordance with Art133 (4) -

Committee procedure (1999468EC)

Administrative

costs


(days spent)

COM Data request

to EC





impact

Justification


Proposed

tool

Provide information

during public

consultation to seek

exemption on use

from substance

being included on

authorisation list and

on uses and volumes

and views on

LADSSD

Administrative

costs



an annual cost



industry This is based on

literatureexpert judgementinformal

consultation) - to minimise number of

questions formally asked from industry


uses and associated

companies that

argued for an

exemption to

authorisation for

their use

Data

request

to ECHA

Trigger internal


regulatory scrutiny

and spending

decisions on options

for substitution

RampD costs Yes - Instances of RampD spending - Substance

and Use

Estimated euro spending (one-off or annual)

Trade

association

REACH consortia

Industry using

substance on

authorisation list

Industry

online

survey

Substitution of

substance

Substitution Yes - Instances of substitution - Substance and

Use



risk management

Trade association

REACH

consortia

Industry using

substance on

authorisation list

Online

industry

survey amp

case

study

Communication with

MI and trade

association or

relevant REACH

consortia

Improved supply

chain

communication

No Only possible

to generate

anecdotal

responses that

already exist

Decide whether to Closure Yes - Instances of ceasing operations - Trade Online




impact

Justification


Proposed

tool

shut down

operations or

relocate outside of

the EU

relocation Substance and Use


Use

association

REACH consortia

Industry using an

RMOA substance

industry

survey amp

case

study

Decide whether to

postponedelay

increase investment

Investment

decision




Substance and Use

Trade

association

REACH consortia

Industry using

substance on

authorisation list

Online

industry

survey amp

case

study

Improvements in

working conditions

and RMMs

Reduction in

risk (human

health andor

environmental)




effectiveness



Estimated cost

Trade association

REACH

consortia

Industry using

substance on

authorisation list

Online

industry

survey amp

case

study



impact

Justification for


Proposed

tool


alternative (substance technology

or product) in order for companies

to switch from using substance(s)

on the RMOA recommended for

authorisation

Increase in

salesmarket

share



substance

Suppliers of

alternatives

Tier 1 and 2

case study

Change in volume supplied of

alternative

Changes in

market



DUs of the

alternative

Tier 1 and 2

case study




impact

Justification for


Proposed

tool

structure with annex XIV substance

and produced outside of the

EEA






Specific

suppliers of

alternatives

Actor NGO


d impact

Justification for


From

whom

Proposed

tool





NGOs industry etc

Administrative

costs

No Voluntary action

that should not

be included

within the

assessment


activities





NGOs NGO survey

Informally provide information on


Substitution Yes - Information about cases where

substitution has taken place after a

substance has appeared on the

authorisation list

Information about whether this stage

of the authorisation process is driving

innovation and a transition to safer

alternatives

NGOs NGO survey


consultation on possible

exemptions for uses (of a

Administrative

costs

Yes - Number of hours spent on these

activities


NGOs NGO survey




d impact

Justification for


From

whom

Proposed

tool

substance proposed for

Authorisation list)


Actor Workers


impact

Justification


From

whom

Proposed

tool

Exposure in firms



Annex XIV or relocating

use

Reduction in

risk (human

health andor

environmental)



using substance

Number of workers

Dose-response etc



Industry

ECHA

website

Tier 1 and

2 case

study

Employment in firms



Annex XIV via relocation






Industry Tier 1 and

2 case

study

Exposure in firms

improving RMMs related

to use of substance


Reduction in

risk (human

health andor

environmental)



using substance


using substance


Dose-response etc



Industry

ECHA

website

Tier 1 and

2 case

study



Actor Consumers


impact

Justification

for exclusion

Information

needed

From

whom

Proposed

tool


substituted away from substance or relocated use of substance


Changes in

product price

andor quality

No Unlikely to be

able to obtain

sufficient

quantitative

data required to

assess this




Information

needed

From

whom

Proposed

tool




Reduction in risk

(human health andor

environmental)





used by firms improving RMMs related to

use of substance included in Annex XIV

Reduction in risk

(human health andor

environmental)






firms substituting away from substance

or relocating use of substance included in

Annex XIV

Reduction in risk

(human health andor

environmental)






firms improving RMMS related to use of


Reduction in risk

(human health andor

environmental)






D4 STAGE 4 Applications for authorisation



impact

Justification


From

whom

Proposed

tool

ECHA - Provide IUCLID platform pages for submitting

AfAs application templates guidance ECHA procedure

and policy etc

ECHA - Administer and support Committees in

application-related activities (not opinion-related - eg

establishing D-R functions)

ECHA - Provide PSISs

ECHA - Undertake business rules etc checks following

submission

ECHA - Issue invoices and receive fee payments

ECHA - Support rapporteurs and Committees during

opinion-making

ECHA - Administer public consultation on alternatives

Administrative

costs

Yes - Information

provided by ECHA

(Level of detail

will be determined

by ECHA record

keeping)

Data on

Committee

funding

payments

ECHA Data

request

to ECHA

RAC and SEAC activities

bull Meeting attendance

bull Admin

bull Assessment of AFA

bull Rapporteur activities

Administrative

costs


(days spent) per type

of activity

ECHA Data

request

to ECHA

CAs - Provision and funding of Committee members

CAs - REACH Committee etc involved in evaluating

approving COM decisions

Administrative

costs

Yes - Number of FTEs

associated with CA

Committee

membership

representation

Cost per FTE

CAs

ECHA

Data

request

to MS CA




impact

Justification


From

whom

Proposed

tool

Fee receipts

COM - General administration of and policy

development for authorisation application process

COM - formulate AfA decisions

COM - Administer REACH-related committees

Administrative

costs

Yes - Information

provided by COM

(Level of detail

will be determined

by COM record

keeping)

COM Data

request

to EC



impact

Justificat

ion for

exclusion


whom

Proposed

tool

Trigger internal discussions following listing

and spending decisions on options for

substitution

RampD costs Yes - Instances of RampD spending

- Substance and Use

Estimated euro spending (one-

off or annual)

Applicants Online

industry

survey amp

case study

Substitution from substance Substitution Yes - Instances of substitution -

Substance and Use


Impacts - eg changes in

sales profit risk

management

Applicants Online

industry

survey amp

case study

Communication with MI and trade association

or relevant REACH consortia

Improved

supply chain

communicatio

n

No Only

possible

to

generate

anecdotal

responses

that




impact

Justificat

ion for

exclusion


whom

Proposed

tool

already

exist

Costs to prepare AfA Cost of AfA Yes - Estimated cost (euro)

Identify substance and

use

ECHA

Applicants

Data

request to

ECHA

Decide whether to postponedelayincrease

investment

Investment

decision

Yes - Instances of postponed or

delaying investment -

Substance and Use


investment - Substance

and Use

Applicants Online

industry

survey amp

case study

Improvements in working conditions and RMMs Reduction in

risk (human

health andor

environ-

mental)


How working conditions

have improved

What RMMs were


effectiveness

If that resulted in change

in skills required or

number of staff required

Estimated cost

Applicants Industry

online

survey

Did any publicly available information

provided by ECHA save time in terms of how

to prepare for authorisation

Administrative

costs

Yes - One off time saved

(number)

How useful any


(scale)

How often did they use

them (frequency)

Areas for improvements

Applicants Industry

online

survey




impact

Justificat

ion for

exclusion


whom

Proposed

tool

(free text)

Did the PSIS with ECHA save time in terms of

knowing what to do to be compliant andor

how to prepare for authorisation

Cost of AfA Yes - One off time saved

How useful any


(scale)

There are

the PSIS

questionnai

re which

ECHA

collects

after each

session

Data

request to

ECHA

Availability of a DNEL and dose response

curves

Cost of AfA Yes - Here we need info from ECHA

for which substances was the

DNEL dose response curve

available and when came this

officially available

ECHA Data

request to

ECHA

Option to use of low volume dossier route Cost of AfA Yes - Would they have benefited


future


amount of costs (fees and

requirements)


SMEs to apply



Question

for ECHA is

for whom it

would have

made a

difference

in applying

for

authorisati

on

Data

request to

ECHA

Option to use of legacy spare parts route Cost of AfA Yes - Would they have benefited


future


amount of costs


Question

for ECHA is

for whom it

would have

made a

difference

Data

request to

ECHA




impact

Justificat

ion for

exclusion


whom

Proposed

tool

SMEs to apply



in applying

for

authorisati

on

SME - costs Cost of AfA Yes - Authorisation process - key

challenges for SMEs

Applicants

(SMES only)

Tier 1 and

2 case

study

SME - challenges Barriers to

applying

Yes - What are the main barriers for

applying for authorisation for

an SME (are they the same as

a non-SME)

Applicants

(SMES only)

Tier 1 and

2 case

study



impact

Justification


Proposed

tool



Administrative

costs

Yes - A list of existing AfAs that would have

been applicable for the lsquolegacy spare

parts routersquo simplification authorisation

route

ECHA Data

request to

ECHA





switch from using

substance(s) on the RMOA

recommended for

authorisation

Increase in

salesmarket

share



substance

Suppliers of

alternatives

Tier 1 and

2 case

study

Change in volume supplied Changes in Yes - Evolution of import of finished goods DUs of the Tier 1 and




impact

Justification


Proposed

tool

of alternative market

structure

produced with annex XIV substance

and produced outside of the EEA


annex XIV substance compare with

the supply chain of the alternative


alternative

Specific

suppliers of

alternatives

2 case

study



Substitution Yes - Applications with a supplier of an

alternative present in trialogue

ECHA Data

request to

ECHA



Administrative

costs

Yes - Man hour cost (days spent) of suppliers

of alternatives to comment and

participate to trialogue

References

received from

ECHA (see other

question)

Industry

online

survey



Substitution Yes - In which cases were there any changes

in the application or the intentions of

the applicant regarding substitution as

a result of the public consultation or

trialogue

ECHA Data

request to

ECHA





switch from using

substance(s) on

authorisation list

Reduction in

risk (human

health andor

environmental

)

Yes - Are the risks of the alternatives

known as well as for the annex XIV

substance

How much Is the risk of the

alternative substance mentioned in a

substitution plan lower

application

dossiers

Further

research

targeted

data

request

Change in volume supplied

of alternative

Changes in

market

structure

Yes - Impact of granting authorisation on the

business of the alternative

Specific

suppliers of

alternatives

mentioned in

application files

Tier 1 and

2 case

study



Actor NGO


impact

Justification


Proposed

tool

Provide comments as part

of public consultation eg

about possible alternative

substances and

technologies

Administrative

costs

Yes - Number of hours spent preparing and


Number of AfAs (and substancesuses)

for which information was provided

NGOs NGO survey





other NGOs industry etc

Administrative

costs

No Voluntary action

that should not

be included

within the

assessment


activities





NGOs NGO survey

Actor Workers


impact

Justification


From

whom

Proposed

tool



application process or

relocating use

Reduction in

risk (human

health andor

environmental)




Number of workers


substance



case study

Employment in firms





relocation

Average number of workers in

firms substituting via relocation


case study




impact

Justification


From

whom

Proposed

tool






process

Reduction in

risk (human

health andor

environmental)




pre-Average exposure of workers

in industry using substance


Dose-response etc



AfAs Tier 1 and 2

case study

Actor Consumers


impact

Justification

for exclusion

Information

needed From whom Proposed tool Comments






process

Changes in

product price

andor quality

No Unlikely to be

able to obtain

sufficient

quantitative

data required to

assess this

There might be

some anecdotal

evidence of

changes in price

availability etc





impact

Justification

for exclusion

Information

needed

From

whom

Proposed

tool Comments





process

Reduction in

risk (human

health andor

environmental)

No Unlikely to be

able to obtain

sufficient

quantitative

data required to

assess this

Some indication

could be obtained

from information

on use and

emissions of

substances



improving RMMs related to use

of substance during

application process

Reduction in

risk (human

health andor

environmental)

Yes - Pre- and post-

RMM exposures

Population at

risk

Dose-response

etc function

Values of

health impacts

AfAs

Opinions

Applicants

Tier 1 and

2 case

study




by firms substituting away

from substance or relocating

use of substance during

application process

Reduction in

risk (human

health andor

environmental)

No Unlikely to be

able to obtain

sufficient

quantitative

data required to

assess this

Some indication

could be obtained

from information

on use and

emissions of

substances




by firms improving RMMS

related to use of substance

during application process

Reduction in

risk (human

health andor

environmental)

No Unlikely to be

able to obtain

sufficient

quantitative

data required to

assess this

Some indication

could be obtained

from information

on use and

emissions of

substances



D5 STAGE 5 Post authorisation decision



impact

Justification


From

whom

Proposed

tool

ECHA - Maintain register of

applications and DUs

Administrative

costs

Yes - Information provided by ECHA Level of

detail will be determined by ECHA record

keeping

ECHA Data request

to ECHA

CAs and NEAs - Monitoring and

enforcement of authorisations

and rejected applications

Administrative

costs

Yes - CA spend on REACH authorisation

enforcement and monitoring activities

CAs Data request

to MS CA

COM - post-decision activities Administrative

costs

Yes - Activities carried out and time taken Data request

to EC



impact

Justification


Proposed

tool

Update registration dossiers Administrative

costs

Yes Estimated cost (euro)


Registrants Tier 1 and

2 case

study

Update eSDS in all languages

and communication with the

supply chain

Administrative

costs

No Too early to

assess this

aspect of

authorisation


Identify substance

Applicants Industry

online

survey

Downstream user notifications Administrative

costs



Applicants Industry

online

survey




impact

Justification


Proposed

tool



Administrative

costs

Yes - Estimated cost (euro) - one off or annual


Applicants Online

industry

survey amp

case study



Reduction in

risk (human

health andor

environ-

mental)


How working conditions have

improved


effectiveness



Estimated cost

Applicants Industry

online

survey

Registered number of DUs and

manufacturers of the

substance

Changes in

market

structure

Yes - Changes in the number of companies

level of competition competing

products

Changes in prices of supply product

prices quality

Applicants Tier 1 and

2 case

study

Decide whether to substitute

submit review report shut

down operations or relocate

outside of the EU following

review period granted

Closure

relocation

No Too early to

assess this

aspect of

authorisation

Instances of ceasing operations -

Substance and Use

Instances of relocating - Substance

and Use

Applicants Online

industry

survey amp

case study

Decide whether to

postponedelayincrease

investment following review

period granted

Investment

decision

No Too early to

assess this

aspect of

authorisation

Instances of postponed or delaying



Substance and Use

Applicants Online

industry

survey amp

case study





impact Justification for exclusion Information needed From whom

Proposed

tool



Changes in market

structure

No Too early to assess this

aspect of authorisation

Actor NGO


impact

Justification

for

exclusion


whom

Proposed

tool





NGOs industry etc

Administrative

costs

No Voluntary

action that

should not

be included

within the

assessment


Which stages of the authorisation process

the activities relate to



NGOs NGO survey

Identification of examples of

changes in market structure

Changes in

market

structure

Yes - NGOs perceptions about the impact of

authorisation on market structure (for

SVHCs and alternatives) including impacts

on number of companies level of

competition employment trade balance

Information about whether this stage of

the authorisation process is creating

opportunities for companies that produce

safer alternative to gain market share

NGOs NGO survey

Examples of substitution by

companies despite granted

authorisation for the same use

Substitution Yes - - Information about cases where substitution

has taken place after authorisation has been

granted past last LAD

- Information (quantitative where possible)

NGOs NGO survey




impact

Justification

for

exclusion


whom

Proposed

tool

about whether granted authorisation is

leading to a delayed transition to

alternative substances

Actor Workers


impact

Justification


From

whom

Proposed

tool


away from substance following

failed application

Reduction in

risk (human

health andor

environmental)

No -

Employment in firms


substance via relocation

following failed application

Unemployment No -



substance as a result of

conditions in granted

authorisation

Reduction in

risk (human

health andor

environmental)



using substance pre



Number of workers

Dose-response etc



AfAs

Opinions

Applicants

Tier 1 and

2 case

study



Actor Consumers


impact

Justification

for exclusion

Information

needed

From

whom

Proposed

tool



substance following failed application

Changes in

product price

andor quality

No -



impact

Justification


From

whom

Proposed

tool


firms substituting away from substance following

failed application

Reduction in

risk (human

health andor

environmental)

No -


firms improving RMMs related to use of substance

as a result of conditions in granted authorisation

Reduction in

risk (human

health andor

environmental)

Yes - Use of substance by

industry prior

Average exposure of

workers in industry

using substance pre

Average exposure of

workers in industry


Number of workers

Dose-response etc

function for

substance

Value of health

impacts

AfAs

Opinions

Applicants

Tier 1 and

2 case

study

Use (and non-use) of environmental services Reduction in No -




impact

Justification


From

whom

Proposed

tool

affected by use of substances by firms

substituting away from substance or relocating

use of substance following failed application

risk (human

health andor

environmental)

Use (and non-use) of environmental services

affected by use of substances by firms improving

RMMS related to use of substance as a result of

conditions in granted authorisation

Reduction in

risk (human

health andor

environmental)

No Unlikely to be

able to obtain

sufficient

quantitative

data required

to assess this



D6 STAGE 6 Review authorisations following review period




Information

needed

From

whom

Proposed

tool

As per Applications for

authorisation

Administrative

costs


authorisation




Information

needed

From

whom

Proposed

tool

Reapply for authorisation

following review period

Cost of review

report


authorisation




Information

needed

From

whom

Proposed

tool

Submit comments during public

consultation on use and

availability of suitable

alternatives

Administrative

costs


authorisation

Actor NGO



Information

needed

From

whom

Proposed

tool





Information

needed

From

whom

Proposed

tool

Provide comments on review

reports following the review

period

Administrative

costs


authorisation





NGOs industry etc

Administrative

costs


authorisation

Actor Workers



Information

needed

From

whom

Proposed

tool



application process relocating

use

Reduction in

risk (human

health andor

environmental)


authorisation

Employment in firms




Unemployment No Too early to assess this aspect of

authorisation




process

Reduction in

risk (human

health andor

environmental)


authorisation



Actor Consumers



Information

needed

From

whom

Proposed

tool






process

Changes in

product price

andor quality


authorisation




Information

needed

From

whom

Proposed

tool




Reduction in risk

(human health

andor

environmental)


of authorisation


used by firms improving RMMs related

to use of substance on RMOA selected

for authorisation

Reduction in risk

(human health

andor

environmental)


of authorisation



by firms substituting away from

substance or relocating use of


Reduction in risk

(human health

andor

environmental)


of authorisation



by firms improving RMMS related to use

of substance on RMOA selected for

authorisation

Reduction in risk

(human health

andor

environmental)


of authorisation



ANNEX E LITERATURE REVIEW

E1 Introduction

It was important that this project made use of existing information already in the public domain

Therefore as part of this work a literature review was carried out on each of the focus areas of

this study

Changes in the market SHVCs ndash This is covered in Section E3 In order to understand if

any changes in the market for SVHCs are due to authorisation there is a need to understand

the overall EU chemicals market which is covered first in Section E2

Instances of substitution of SVHCs ndash This is covered in Section E4 setting out instances of

substitution of SHVCs due to REACH authorisation

Costs of REACH authorisation ndash This is covered in Section E5

Benefits of REACH authorisation ndash This is covered in Section E6

Affordability on SMEs ndash This is covered in Section E7

Announcement effect - This is covered in Section E8

A summary of the literature review can be found within the main chapters for each focus area

E2 EU chemicals market

In this section the overall trends in the EU chemicals sector are identified in terms of (i) sales

value (ii) imports (iii) exports (iv) number of companies and (v) spending on RampD and investment

This information provides a point of comparison for the trends in the market for SVHCs and possible

alternative substances identified as part of this study It helps to understand whether the observed

changes in the market for SVHCs closely follow the trends of the overall EU chemicals market or

whether there are significant differences An analysis of the drivers for sector-specific market

changes will assist in determining the SVHC market changes that can be attributed to the REACH


The insights in this section are mainly based on information provided by The European Chemical

Industry Council (CEFIC) Other sources were reviewed but the analysis in these sources also rely on

the data provided by CEFIC

This section is split into four sub-sections

Section E21 - EU chemical industry sales - Overall trend presents an overview of the

fluctuation in sales values experienced by the EU chemicals sector and how this compares

to the global chemicals market

Section E22 - EU internal chemicals market provides an insight into EU chemical sales

broken down by Member State and trade amongst Member States



Section E23 - Extra-EU trade summarises information about trends in imports and exports

from and to countries outside the EU and the resulting trade balance

Section E24 ndash Growth competitiveness and drivers of change presents some of the

potential drivers for the decline in the EUrsquos global market share including market related

drivers like capital and RampD spending labour costs exchange rate fluctuations and

legislative drivers

Section E25 ndash Capital and RampD spending presents trends in capital and Research amp

Development (RampD) spending

E21 EU chemical industry sales - Overall trend

The EU chemicals industry172 sales value increased between 1995 and 2012 with the exception of

2009 which saw a decline Despite this the share of the EU market in the global market declined

significantly from 323 in 1995 to 147 in 2015 as shown in Figure E01 (CEFIC 2016a)

Figure E01 EU chemicals sales

Sales value of the EU chemicals market and share of the global market


The change in annual EU chemicals sales revenue has largely mirrored those of world chemicals

sales values between 1995 and 2012 However global chemical sales values have been increasing

continuously from euro3050 billion in 2012 to euro3534 billion in 2015 while EU chemical sales values

have declined (CEFIC 2016a) This recovery in global chemical sales is mainly driven by growth in

China (CEFIC 2016b)

172 ldquoChemical industryrdquo excluding pharmaceuticals in the 28 EU countries as defined by CEFIC



E22 EU internal chemicals market

The EU chemicals market has been dominated by seven Member States in 2015 As shown in Figure

E02 Germany France Italy the United Kingdom the Netherlands Spain and Belgium together

account for 84 of total EU chemical sales (CEFIC 2016b)

Figure E02 Share of member states in EU chemical sales


As indicated by Figure E03 the majority of EU production (764 on average between 2005 and

2015) is sold and used within its 28 Member States A significant but decreasing proportion (about

28 on average) is used in the Member State producing the chemicals (referred to as ldquohome salesrdquo

in Figure E03) The share of home sales has declined from approximately 37 in 2005 to 17 in

2015 Whilst the export market seems to be recovering since 2010 (potentially due to increased

growth outside the EU) the amount of intra-EU exports has remained fairly constant Given the

slightly declining overall sales values this suggests that the overall performance of the EU chemical

industry is significantly influenced by home sales within the seven Member States shown in Figure

E02

Figure E03 EU chemicals sales by destination




E23 Extra-EU trade

As shown in Figure E04 the EU exports more than it imports As indicated by the orange line

imports have increased since 2013 which may partly explain the decline in home sales observed in

Figure E03

Figure E04 Extra-EU imports amp exports and trade balance


Figure E04 also shows that imports have grown at a faster pace than exports since 2013 The

resulting decline in the EU trade balance (ie difference between imports and exports) combined

with a growing global chemical market implies a possible decline of EU competitiveness Further

evidence for a decline in competitiveness is provided by Figure E05 showing a marked decline of

the export market share of the EU since 2003

This trend in competitiveness as measured by export share differs across the Member States The

largest EU countries (ie Germany France UK and Italy) generally experienced a decline of

competitiveness since the 1990s (CEFIC 2014) The ldquostrengthening trade links of Eastern European

countries both inside and outside the EUrdquo (CEFIC 2014 p11) after the end of the Cold War are the

most likely driver behind this trend Countries such as Poland and the Czech Republic profited from

these improving trade links due to their lower production costs which allowed them to take export

market share from the higher-production cost countries such as Germany (CEFIC 2014) In the long-

term Poland has become the main outlier with respect to export market share by markedly

increasing its export market share since the 1990s In comparison with the largest EU countries

mentioned above the change in competitiveness was not as large in most small EU countries such

as the Netherlands and Belgium Spain is the sole Western European country maintaining an export

market share level above the one it had in 1991 (CEFIC 2014)



Figure E05 EU export market share

(Source CEFIC 2014)

E24 Growth competitiveness and drivers of change

After recovering from a sharp decline in production in 2009 as a consequence of the economic and

financial crisis EU chemicals production has stayed relatively constant since 2012 as depicted by

the orange line in Figure E06 (CEFIC 2016b) This long period of stagnant growth is unusual for

the sector which has enjoyed a period of continuous long-term growth between 2003 and the

beginning of the global financial crisis in 2008 Despite this the number of enterprises

manufacturing chemicals and chemical products has increased from 28208 in 2011 to 28560 in

2014 as indicated by Eurostat (2017) data



Figure E06 EU chemicals production


Given the EUrsquos declining share of the global market Oxford Economics investigated the drivers of

EU competitiveness more closely by applying a ldquoconstant-market share methodology to chemical

exportsrdquo (CEFIC 2014 p1) The results of this analysis are also useful as a potential explanation

for the period of stagnant growth The report identifies three main drivers for the change in

competitiveness

Exchange rate

Research amp Development (RampD) intensity and

Energy prices

The effect of changes in the currency value are shown to be ldquostronger than most of the other core

drivers with every 10 change in the exchange rate [being] associated with a 4 change in

competitivenessrdquo (CEFIC 2014p19) Another factor being identified as a relevant driver of

competitiveness in the case of the EU is capital investment which is shown to have a nearly

immediate positive effect on competitiveness But this effect is smaller than that of RampD

investment (CEFIC 2014) Besides these three main drivers of competitiveness the Oxford

Economics report also concludes that labour costs have an effect on competitiveness but that this

effect is quantitatively smaller (CEFIC 2014)

CEFIC (2016b) supports the relevance of energy prices as an important driver of competitiveness it

states that the higher energy price is one of the main weaknesses of the European chemical

industry especially compared to the Middle East and the United States experiencing a shale gas

boom (CEFIC 2016b)

Regulatory costs are an additional factor potentially influencing EU competitiveness As shown in

Figure E07 chemicals legislation energy legislation and emissions and processes legislation (eg

Phase 3 of the Emissions Trading System) are the main contributors to the increase of regulatory



costs The major milestones causing the increase in regulatory costs related to chemicals legislation

are the introduction of REACH and the Classification Labelling and Packaging (CLP) Regulation in

2007 and 2008 (CEFIC 2016b EC 2016)

Using Gross Operating Surplus (GOS)173 the EC (2016) study titled Cumulative Cost Assessment for

the EU Chemical Industry found that legislation costs represent 30 of the GOS thereby

ldquoindicating that legislation costs is among the important factors shaping the profitability of the EU

chemical industryrdquo (EC 2016a p8) If businesses recover increased costs through higher prices for

customers regulatory costs can thus affect competitiveness

Figure E07 EU regulatory cost

(Source EC 2016)

While providing a good insight to the role of regulatory costs as a determinant of competitiveness

the evolution of the legislation burden depicted in Figure E07 ldquohas to be interpreted with

caution as [it] is an estimate of the trend based on the extrapolation of data from a limited

number of [key] companies and their recollections of past costsrdquo (EC 2016a p11) Comparison

with Eurostat data for capital and operating expenditures for environmental protection revealed

that the accurateness of the data underlying this estimate is higher in the period after 2008 than

before

173 GOS differs from profits shown in company accounts for several reasons Only a subset of total costs are

subtracted from gross output to calculate the GOS Essentially GOS is gross output less the cost of

intermediate goods and services to give gross value added and less compensation of employees and taxes and

subsidies on production and imports It is gross because it makes no allowance for consumption of fixed capital

(CFC) By deducting CFC from GOS one calculates net operating surplus (NOS)

httpeceuropaeueurostatstatistics-explainedindexphpGlossaryGross_operating_surplus_(GOS)_-_NA



E25 Capital and RampD spending

The Oxford Economics study (CEFIC 2014) suggests ndash as mentioned above - that capital and RampD

spending are important drivers of competitiveness Figure E08 which illustrates fluctuations in

capital spending between 1998 and 2015 indicates that 2004 is a turning point in terms of capital

spending (both in absolute terms and intensity) Following a decline since 1999 capital spending

increases steadily between 2004 and 2008 reaching a level to the one in 1999 This upward trend

was interrupted in 2009 and 2010 as a likely result of the global financial crisis Capital spending

started to recover in 2011 resuming an upward trend

Figure E08 Capital spending


The upcoming implementation of REACH in 2007 is a possible explanation for the upward trend

after 2004 as companies may have increased capital spending in anticipation of REACH to invest in

improved risk management measures and to prepare for substitution to alternatives Similarly the

upward trend since 2010 might have been at least partially due to EU legislation As mentioned by

the EC (2016) study companies may have made additional investments ldquoafter 2009 in anticipation

of the enforcement of Seveso III174 in 2012 and ETS Phase 3 in 2013rdquo (EC 2016 p11)

174 Seveso III refers to legislation aimed at preventing accidents involving hazardous substances and limiting

the consequences for human health and the environment in case of the occurrence of an accident To do so

the legislation specifies several obligatory measure to be taken by operators such as the production of internal

emergency plans Further details can be found at httpeceuropaeuenvironmentsevesolegislationhtm



Despite the upward trend since 2011 capital spending has not reached pre-recession levels One

reason might be that the shift of investment from the EU to countries outside the EU between 2008

and 2013 as revealed by a CEFIC survey among major chemical companies (CEFIC 2016b) The

responses to that survey showed that the share of domestic investment (ie investment in chemical

production facilities based in the EU) to total investment decreased by 10 percentage points in the

aforementioned period According to CEFIC (2016b) this is an indication of a decline in

attractiveness of the EU business and economic environment

As regards the reason behind this decline CEFIC (2016b p45) mentions that a key factor affecting

competitiveness ldquois the growing cumulative cost of implementing European legislationrdquo which

ldquotakes both personnel and capital resources away from innovation and production and into

regulatory compliancerdquo Thus CEFIC (2016b) seems to see European legislation as a key reason for

the loss of attractiveness of the EU business environment for chemical companies from the

European Union CEFIC (2016b) also predicts that ldquolimited investment will be dedicated to Europe

as opposed to other more competitive regionsrdquo without a supportive business environment which

CEFIC defines as an environment with a globally comparable regulatory burden and ldquocompetitive

access to energy and feedstocksrdquo (CEFIC 2016b 45) Resource prices are thus the second reason

behind the loss of attractiveness of the EU for the chemical sector

RampD spending (shown in Figure E09) in turn was relatively stable between 1993 and 2005 with

the main exception being the year 2000 when RampD spending increased by euro05 billion Similar

exceptional increases can be observed from 2005 to 2006 (ie increase by euro07 billion) as well as in

2012 and 2014 Despite relatively stable levels of RampD spending the intensity of RampD spending (ie

its size compared to sales values) has declined overall between 1993 and 2015 as shown in Figure

E09 The increase in RampD spending intensity between 2008 and 2009 can be explained by falling

sales values due to the recession but relatively constant levels of RampD spending

Figure E09 Research amp Development (RampD) Spending




E3 Market changes for SVHCs

This sub-section summarises previous findings concerning changes in the market for SVHCs over

time It considers information available prior to the launch of REACH findings from the REACH 2012

review and subsequent studies This allows for an assessment of whether the results from the

present study are aligned with findings from earlier studies as well as an assessment of the reasons

behind potential differences

An extended impact assessment on the adoption of REACH (in 2007) was published in 2003 (EC

2003) on the basis that ldquoexisting legislation was not capable of responding adequately to public

concern in Europe about the potential impact of chemicals on health and the environment and

would be increasingly unable to meet expectations in the futurerdquo (EC 2003 p 4) The assessment

of impacts of REACH on the EU chemicals market conducted as a part thereof relates to REACH as a

whole and provides no analysis specific to REACH authorisation

Studies carried out subsequently provide some information on key factors influencing the

performance of the SVHC market such as changes in investment and RampD decisions (factors closely

related to innovation) as well as the EUrsquos competitiveness in the global market and how they are

affected by the REACH process However the information provided in these reports is mostly

anecdotal and lack quantitative and monetary information

The EC (2015) report mentions that the associated stakeholder consultation revealed that ldquoindustry

representatives and companies [generally] agree that authorisation does have an impact on

competitiveness innovation and investment decisionsrdquo (EC 2015 p157) as investors require

regulatory certainty about the use of substances that are substantial to their investment and

innovation plans

In addition the REACH 2012 report suggests in relation to innovation that the Candidate List is ldquoone

of the instruments of REACH that could drive innovation thanks to substitution of SVHCs with

safer substancesrdquo (EC 2013b p68) Anecdotal evidence was provided that ldquothe placing on the

Candidate List can lead in some cases to the launch of initiatives to develop new substances or to

the reformulation of existing substancesrdquo (EC 2013b p68)

This viewpoint is supported by AmCham EU (2016) which concluded in its position paper submitted

for the REACH REFIT Evaluation that ldquoREACH has had one positive impact on innovation

management it has pushed companies to systematically identify and prioritise which substances

they are not interested in producing or using in the futurerdquo (AmCham EU 2016 p4)

A report published by the European Competitiveness and Sustainable Industrial Policy Consortium

(ECSIP 2016) emphasises that the interviews with the European Automobile Manufacturers

Association (ACEA) the European Tire and Rubber Manufacturers Association (ETRMA) the

European Apparel and Textile Confederation (EURATEX) and the European Consumer Organisation

(BEUC) revealed agreement that REACH has at most had a minimal impact on innovation This

report notes that ldquo[i]nnovation is driven by other parametersrdquo (ECSIP 2016 p36) and that

ldquoinnovation processes have been in place for a very long timerdquo (ECSIP 2016 p36-37) before

REACH This is exemplified by the SAFERUBBER project from the rubber amp plastics sector175 The

SAFERUBBER project comprised RampD activities conducted to replace a specific hazardous chemical

(ETU) that were not caused by REACH but the result of an industry initiative The report indicates

nevertheless that interviewees agreed that REACH could ldquohelp increase the momentum for certain

175 httpwwwsaferubbereu (See also Section E7)



innovation and RampD projectsrdquo (ECSIP 2016 p37) by helping to prioritise the proactive substitution

of certain chemical substances for example

With respect to long-term investment AmCham EU (2016) points out that REACH acts as a

deterrent of long-term investment as the lack of predictability surrounding REACH means

companies producing in Europe cannot be certain that a substance which is allowed now will be

available for use in three five or ten years ndash when a new product range is ready to go to the

market It is pointed out that the uncertainty over the outcome and duration of a RMOA the

outcome of the CoRAP listing and the probability of a transfer of a substance from the Candidate

List to Annex XIV makes the planning of new product lines or technology extremely challenging It

may even stop some new productstechnologies from coming to market An example for this

deterring effect mentioned by AmCham EU (2016) are nanomaterials The report stated that the

fear that they will be regulated under REACH pushed RampD and market deployment efforts to

outside of Europe A second example given in AmCham EU (2016) refers to two pharmaceutical

companies that made the decision not to move the manufacturing of two new pharmaceuticals to

the EU due to the reliance of the process on the use of aprotic solvents that are on the Candidate

List and may soon be prioritised and added to Annex XIV

With respect to competitiveness the ECSIP (2016) report states that based on case studies and the

results of quantitative modelling REACH (not specifically the authorisation process) has a minor

negative impact on the competitiveness of the EU industry in relation to their third-country

competitors The study refers to three distinct market situations (i) production within the EU for

sale within the EU (ii) production in the EU for sale in third countries and (iii) production in third

countries for the EU (and other third country) markets) The first market situation (ie production

within the EU for sale within the EU) is the most relevant for REACH authorisation It is pointed out

that REACH creates a level playing field for EU chemicals producers and third country producers of

chemicals competing in the EU market since third-country producers will also have to meet REACH

requirements when operating in the EU However the authorisation requirement has the potential

to harm competitiveness EU article manufacturers may be at a competitive disadvantage since the

requirement for authorisation of SVHCs does not apply to imported articles The competitors

producing outside the EU for export to the EU market thus do not have this cost element

In relation to imports and exports ndash one indicator for the performance of the SVCH market - the EC

(2015)176 report mentions that the majority of respondents to an industry survey report no changes

to imports and exports as a result of the implementation of REACH Nevertheless the impact on

manufacturer and importers (MIs) has tended to be negative due to increased prices related to

costs of REACH compliance and increased transaction costs with non-EU suppliers that cannot be

recovered through higher prices Article suppliers are said to have experienced more positive

impacts on this front

The EC (2015)176 report also provides insight on the effects of including substances in the Candidate

List and Annex XIV on the costumers of the SVHC market The results of a business survey show that

39 of survey respondents answering the question whether their customers requested the removal

of SVHCs from their products (n=242) received such requests Among companies self-declaring as

suppliers of articles around 70 received such requests





The EC (2015) report also stresses that the extent of downsizing in the SVHC market in terms of the

reduction of the number of active companies ldquodepends on the criticality of the substance going

through Authorisation and on the feasibility of substitutionrdquo (EC 2015 p157) as it influences the

propensity to withdraw from the market or to relocate to countries outside the European Union

Two scenarios through which authorisation can impact on the size of the market are mentioned

The first one focuses on companies with manufacturing facilities in a country that is not part of the

EU These companies might see relocating as the straight-forward solution allowing them to avoid

the authorisation procedure as a whole The second scenario refers to companies facing the

necessity to submit a costly (and time-limited) application for an authorisation which can push

them to contemplate solutions outside the EU The authors note that ndash despite the undeniable

potential for a downsizing effect ndash it is not certain that the market will shrink significantly as the

share of SMEs among chemical companies and its downstream users is about 95 and as it is

questionable whether relocation to a non-EU country is economically feasible for many of them

E4 Instances of substitution

This subsection considers incidences of substitution that have been found in literature As per the

interim report a list of key databases is listed below with some commentary on each

SUBSPORT (EU based) - httpwwwsubsporteu

This web-based resource is a free-of-charge multilingual platform for information

exchange on alternative substances and technologies It also provides tools and guidance

for substance evaluation and substitution management

The SUBSPORT indicates that it provides information to support efforts in substituting

hazardous substances The web site sets out pages on specific areas of substitution

Substitution Steps

An outline methodology is described to organise a substitution programme with a short

narrative on each step providing lsquouseful linksrsquo to other external web-based information as

each stage The stages are 1 Define the Problem 2 Set substitution criteria 3 Search

for alternatives 4 Assess and compare alternatives 5 Experiment on pilot and 6

Implement and improve

Substitution in Legislation

This provides summaries of legislation and international agreements that are relevant to

substitution whether they refer to it directly or are closely related Links to the original

documents as well as archived copies of the relevant legislationagreements are also

provided EU US and Chinese legislation and International agreements are listed

Identifying Substances of Concern

This page of the web site presents an overview of the criteria and their definitions that are

most used by different sources to identify substances of concern More detailed

descriptions are also available with links to the original documents The summary data are

presented in a series of tables namely

o health hazards sub divided to acute toxicity (highly toxic corrosionirritation of

skineyes) and chronic toxicity (highly toxic carcinogenicity mutagenicity

genotoxicity reprotoxicity (including developmental toxicology) endocrine

disruptors sensitization of the skin or respiratory system neurotoxicity immune



system effects and systemic toxicityorgan effects (via single or repeated

exposure)

o environmental effects subdivided to persistence andor bioaccumulation and

toxicity ozone depletion environmental toxicity and aquatic toxicity and

o fire and explosion hazards subdivided to explosion flammability oxidising and

other properties

The tables set out definitions that are listed in European and non-European systems that

are both regulatory and non-regulatory The following sources are referred to directly in

the tables (not all are relevant to all hazard categories)

o Column Model IFA (Germany)

o Quick Scan VROM (Netherlands)

o PRIO KEMI (Sweden)

o SIN LIST ChemSec (Sweden)

o ISTAS Black list ISTAS (Spain)

o Trade Union List European Trade Union Confederation (ETUC)

o NTP 712 INSHT National Institute for Health and Safety at Work (Spain)

o COSHH Essentials Health and Safety Executive (UK)

o MAL code system

o National Plan to implement Stockholm Convention and Regulation 8502004 on

Persistent Organic Pollutants Ministry of Environment (Spain)

o REACH Regulation European Union

o Cradle to Cradle Design Protocol MBDC (USA Germany)

o Five Chemicals Alternatives Assessment Study TURI (USA)

o Design for the Environment Formulator Program EPA (USA)

o Green Screen for Safer Chemicals Clean Production Action (Canada US)

o SC Johnson Greenlist

Restricted and Priority Substances Database

The on-line searchable database contains 34 lists of substances that are legally or

voluntarily restricted or are recommended for restriction because of their hazards Lists are

grouped in five categories international agreements EU regulatory lists governmental

lists NGO and trade union lists as well as company lists The database is suggested as a tool

to check whether a substance is listed and therefore indicating the need to substitute it or

not to accept it as an alternative Descriptions of the lists and links to the original sources

are indicated in the database

Case Story Database

This part provides substitution examples information on alternative substances and

technologies from enterprises published reports and other sources The case stories are

intended to serve as lsquoinspirationrsquo and to offer help to companies or organisations searching

for substitutes to hazardous chemicals The case study chemicals listed are

o chloroalkanes

o chromium VI and compounds

o bisphenol A

o lead and its inorganic compounds

o nonylphenol and ethoxylates

o tetrachloroethylene



o formaldehyde

o brominated flame retardant hexabromocyclododecane (HBCDDD)

o parabens (methylparaben ethylparaben propylparaben butylparaben)

Substitution Tools

Although it was last updated over six years ago (last updated on 22122010) these pages

include summaries of lsquotoolsrsquo that may be used in the substitution process The pages

include links to the information sources (detailed description of the tools can be accessed)

Whenever the original document is available in other languages besides English information

on how to access those versions is included in the summaries

Tools and guidance to support substitution are provided either by authorities industry

associations by scientific bodies or NGOs Guidance is general and does not go beyond

basic principles of substitution Tools supporting substitution are mostly focussed on taking

a step-wise approach (eg decision criteria assessment of alternatives implementation

planning) Some tools are focused on substitution (eg Green Screen for Safer Chemicals)

others are more focused on the implementation of safety regimes in the workplace (eg

COSHH Essentials) or prioritisation for risk management (eg PRIO) and one of the listed

tools is a workplace exposure and exposure control model (Stoffenmanager)

List of tools described

o Column Model for Chemical Substitutes Assessment

o COSHH Essentials

o Technical Rules for Hazardous Substances (TRGS) 600

o Green Screen for Safer Chemicals

o Determination and work with code numbered products (MAL Code)

o Pollution Prevention Options Analysis System (P2OASys)

o Priority-Setting Guide (PRIO)

o Quick Scan

o Stockholm Convention Alternatives Guidance

o Stoffenmanager



AssessmentAlternativesAssessmentaspx

Lowell Centre is an academic institution that is part of the University of Massachusetts

(USA) Web pages are dedicated to setting out a process for identifying comparing and

selecting safer alternatives to chemicals of concern (including those in materials processes

or technologies) on the basis of their hazards performance and economic viability It is

intended to support decision making for scientific market or regulatory reasons The

process is based on two decades of research in the area it is influenced more by USA

regulations and concerns than by European issues or legalisation (such as REACH) The web

pages provide links to resources and publications ndash a significant one is TURI (Toxics Use

Reduction Institute) which also provides links to resources and information intended to

support and guide and also research programmes and sources of funding for relevant

projects Specific detailed methodologies or databases of alternative substances do not

appear to be provided






This US publication is based on the work of an expert committee and the development of

that committeersquos framework which built upon the work of US regulatory agencies

academic institutions and others who have developed alternatives assessment frameworks

This report provides a description of the committeersquos 13-step framework which is

structured to support decision-making about alternatives to chemicals of concern The

framework is flexible enough for an assessor to use a hybrid approach in which certain

steps are completed sequentially in parallel or iteratively providing an opportunity for

fit-for-purpose decision making

The alternatives assessment framework has the following main activities (optional activities

asterisked)

Step 1 Identify Chemical of Concern

Step 2 Scoping and Problem Formulation

Step 3 Identify Potential Alternatives

Step 4 Initial Screening of Identified Alternatives

Step 5 Assess Physicochemical Properties

Step 6-1 Assess Human Health Hazards

Step 6-2 Assess Ecotoxicity

Step 6-3 Conduct Comparative Exposure Assessment

Step 7 Integration of Information to Identify Safer Alternatives

Step 8 Life Cycle Thinking

Step 9-1 Additional Life Cycle Assessment

Step 9-2 Performance Assessment

Step 9-3 Economic Assessment

Step 10 Integrate Data and Identify Acceptable Alternatives

Step 11 Compare Alternatives

Step 12 Implement Alternatives

Step 13 Research and Innovation

The publication is influenced by the US and global agenda on chemicals and alternatives

and does not appear to be aimed or influenced specifically by REACH



and programmes (including the Lowell Center and SUBSPORT) This is a compilation of web-

based resources relevant to chemical substitution and alternatives assessments There are

four resource areas namely

o Alternatives Assessment Tool Selector A filterable inventory of chemical hazard

assessment tools and data sources to help you identify tools most relevant to your

substitution and alternatives assessment goals A listing of non-hazard assessment tools

is also available

o Alternatives Assessment Frameworks A summary of the current frameworks that can be

used to assess alternatives Guides and other resources for conducting a chemical

substitution or alternatives assessment are included



o Case Studies and Other Resources Links to case studies toolkits and product rating

systems that provide examples insights and lessons learned on substitution and


o Regulations and Restrictions A list of regulations and restrictions throughout OECD

member countries that are driving the increased need for chemical substitution and


Since the OECD includes the EU Member States REACH is referred to through the ECHA guidance

and EC reports cited The website is largely a collection of information resources and

methodologies set up by others


access)

This publication is an in-depth academic analysis of different alternatives assessment

methods and their application It provides critical evaluation of methods in theory and

practise as well as specific chapters on certain chemical types (eg flame retardants)

The RSC is a UK-based institution but the publication takes a global perspective and does

not appear to be focused on any specific legislative regime and not driven by REACH

US Environment Protection Agency (US) - Design for the Environment Alternatives

Assessments - httpswwwepagovsaferchoicedesign-environment-alternatives-

assessments - Web-based tool with key steps to conducting an alternatives assessment and

case studies

The EPA uses alternatives assessments to identify safer chemicals Design for the

Environment (DfE) alternatives assessments are conducted as risk management actions

when warranted for TSCA (Toxic Substances Control Act) Work Plan Chemicals DfE have

also been conducted under Chemical Action Plans By identifying and evaluating the safety

of alternative chemicals this approach can

o encourage industry to move to safer alternatives

o complement regulatory action by showing that safer and higher functioning

alternatives are available or

o point out the limitations to chemical substitution for a particular use

Specific example projects are listed on the USEPA web site include Alternatives to Certain

Phthalates

o BPA in Thermal Paper

o Flame Retardant Alternatives to DecaBDE

o Flame Retardant Alternatives to HBCD

o Flame retardants in flexible polyurethane foam logo

o Flame Retardants in Flexible Polyurethane Foam

o Flame Retardants in Printed Circuit Boards

o Nonylphenol Ethoxylates

The EPArsquos work is focused solely on US law and US regulatory drivers and programmes






In October 2012 a group of 26 environmental health scientists advocates funders and

policy makers met in Boston Massachusetts for two days of meetings entitled Building a

Chemical Commons Data Sharing Alternatives Assessment and Communities of Practice

One of the key outcomes of this meeting was an agreement regarding the need for a

common definition and set of principles for chemicals alternatives assessment Following

this meeting a subcommittee met over four months in 2013 to refine a consensus set of

principles These principles were based on earlier foundational work by the Lowell Center

for Sustainable Production the Massachusetts Toxics Use Reduction Institute the

Environmental Defense Fund and the BizNGO Working Group These principles are shared

and used in framing discussions about alternatives assessment and to guide decision making

about safer chemical use

Alternatives Assessment is described as a process for identifying comparing and selecting


technologies) on the basis of their hazards performance and economic viability A primary

goal of Alternatives Assessment is to reduce risk to humans and the environment by

identifying safer choices

BizNGO Chemical Alternatives Assessment Protocol is a decision framework for

substituting chemicals of concern to human health or the environment with safer

alternatives It describes a process for identifying alternatives to a chemical of concern

screening out equally hazardous alternatives and selecting an alternative that is

technically and economically viable and does not have the potential for causing significant

environmental or human health impacts Many other schemes such as the ones already

listed and described above are referred to The initiative is US focused but refers to other

schemes globally REACH is not a specific driver for this initiative

E5 Costs of authorisation

The EC (2015) report titled Monitoring the Impacts of REACH on Innovation Competitiveness and

SMEs notes that ECHA estimates the average cost per applicantuse to be approximately euro230000

based on a survey conducted among authorisation applicants in 2013 and 2014 This survey which

received 24 responses indicates a decline of the average cost in the long run as ldquoapplicants that

submitted AfAs in the second half of 2014 had average costs of less than euro200000 per

applicantuserdquo (EC 2015 p144) The authors of the EC (2015) study highlight that these figures

were confirmed by interviews conducted as part of their study and mention the increasing

experience with the process as the reason for this decline in average cost

In addition the EC (2015) study uses ECHA data to analyse the shares of cost components related to

an application for authorisation It finds that the biggest share of the total cost are expenses and

internal staff time (25) followed by consulting fees for the analysis of alternatives (20) and the

preparation of the socio-economic analysis (18) Application fees only account for 15 of the total

cost Their share of the total cost is therefore only slightly bigger than that of consulting fees paid

for the preparation of the Chemical Safety Report (13) The aforementioned internal staff time

includes - among others - the time spent on fulfilling information obligations set by public

authorities according to the EC (2016) study This study mentions that in the case of authorisation

this involves providing responses to Candidate List consultations preparing inputs to chemical

safety assessments and justifications for authorisation as well as providing responses to Committee

opinions on applications



Further evidence for the limited role of application fees in terms of total cost is provided by

Harrikari and Montonen (2017) Their survey among 14 Finnish companies revealed that for micro

companiesrsquo regulatory charges accounted only for 12 of total costs as shown in Figure E010 The

category named Working hours in the pie chart includes time used for gathering information from

the company database and putting it in the correct format attending meetings and conducting

additional measurements and implementing changes in practises The work interruption costs (5 of

the total) refer to costs caused by attending meetings and therefore being absent from the factory

operations and processes Harrikari and Montonen also point out that for large companies ldquo[t]he

distribution of costs [hellip] for applying for authorisation was nearly identical to that of the micro

companies but on a different scalerdquo (Harrikari and Montonen 2017 p 13)

Figure E010 Distribution of costs related to application for authorisation (micro companies)

Source (Harrikari and Montonen 2017)

In terms of total AfA costs the Finnish study reveals that for micro companies ldquothe costs of AfA

were between euro36000 and euro45000 for each companyrdquo (Harrikari and Montonen 2017 p12) applying

as part of a consortium These figures exclude the cost of working hours which are estimated to

add between 16 and 30 to the cost figure above Despite the surveys revealing that the costs of

the AfA were bigger than 10 of annual turnover ndash and therefore considered significant - only for

two of six micro companies the interviews showed that ldquo[a]pplying alone would have increased the

costs to an impossible level for micro companiesrdquo (Harrikarri and Montonen 2017 p11)

In the case of large companies those applying alone faced lower AfA costs in terms of the

percentage of turnover than those that applied as part of a consortium Nevertheless Harrikari and

Montonenrsquos interviews revealed that the companies applying alone found that the process was very

expensive

As demonstrated above application fees payable to the ECHA are only one of several types of costs

related to authorisation Commission Regulation (EC) No 3402008 (see EC 2008) sets these fees

Article 8 therein states that the fee consists of a base fee covering one substance one use and one

applicant and an additional fee for any further substance use or applicant covered in the AfA

These fees - set out in Annex VI of the regulation - are shown in Table E01 Article 9 of the

regulation states that a fee must also be paid upon submission of an authorisation review report



and these fees which are set out in Annex VII are exactly the same as for an initial application for

authorisation

Table E01 Authorisation application fees set in Commission Regulation (EC) No 3402008

Standard fees

(in EUR)


Medium

enterprises

Small

enterprises

Micro

enterprises

Base fee 50000 40000 25000 7500



Addit

ional fe

e p

er

applicant


not an SME 37500


medium enterprise 30000 30000


small enterprise 18750 18750 18750


micro enterprise 5625 5625 5625 5625

Based on underlying information from Annex VI in Commission Regulation (EC) No 3402008

Regulation (EU) No 2542013 fulfils the requirement set out in Commission Regulation (EC) No

3402008 to adapt the authorisation application fees and charges to account for inflation by

increasing the fees to the currently applicable values (shown in Table E02) thereby accounting for

ldquothe applicable average annual inflation rate of 31 for April 2012rdquo (EC 2013a p1) In addition

to fulfilling the duty to adapt fees to account for inflation these values are in line with the

decision to further reduce the ldquoexisting reduced fees and charges applicable to micro small and

medium-sized enterprises (SMEs) [hellip] in order to minimise the regulatory burden and the numerous

practical challenges faced by SMEs in complying with REACH obligationrdquo (EC 2013a p1) The

decrease of fees for SMEs is rebalanced by an increase of 35 of standard authorisation application

fees

Table E02 Authorisation application fees set in Regulation (EU) No 2542013

Standard fees

(in EUR)


Medium

enterprises

Small

enterprises

Micro

enterprises

Base fee 53300 39975 23985 5330



Addit

ional fe

e p

er

applicant


not an SME

39 975


medium enterprise

29981 29981


small enterprise

17989 17989 17989


micro enterprise

3998 3998 3998 3998

Based on underlying information from Annex VI in Regulation (EU) No 2542013

Lietzmann et al (2017) analysed the 453 responses to the REACH REFIT open public consultation

survey (October 2016 - January 2017) and the 146 (position) papers submitted by the respondents

They find that almost 90 of respondents to the public consultation think that the aforementioned



authorisation fees are too high The share of respondents thinking that the authorisation fees are

too high differs significantly across different types of stakeholders as illustrated in Figure E011

Figure E011 Share of REACH REFIT respondents thinking that authorisation application fees are too high

Adapted from Figure 16 in Lietzmann et al (2017)

Costs incurred as part of substitution activities (a way of fulfilling the Annex XIV requirements

without making use of an authorisation) are also an essential part of the costs of authorisation

The European Defence Agency (2016) study177 on the impact of REACH and CLP regulations on the

defence sector even notes that the costs related to SVHC substitution and RampD are some of the

largest REACH compliance costs Similarly ASD-Eurospace notes in its REACH REFIT position paper

that it is clear that substitution costs for the space industry ldquoare far higher that the direct REACH

authorisation application costsrdquo (ASD-Eurospace 2017 p5)

The costs related to substitution can be huge An interview with the European Automobile

Manufacturersrsquo Association (ACEA) conducted as part of the ECSIP (2016) report reveals for example

that complex tests (eg retesting of airbags) must be performed when attempting substitution in

this industry which easily leads to costs of millions of euros for substance substitution

Similarly MedTech Europe (2017) mentions in its REACH REFIT position paper that substitution

would be very complex in the medical technology industry due to its highly regulated environment

that would ldquonecessitate a complete re-design including re-validation verification and stability

testingrdquo (MedTech Europe 2017 p2) as well as new conformity assessments The estimated

substitution cost is over euro100 million per substance - which is described as a conservative estimate

MedTech Europe concludes that the ldquoentire process of substitution poses a significant cost when

seen against the total IVD178 European market revenues of euro10635 billion (2014 figures)rdquo (MedTech

Europe 2017 p2) especially since the sector 95 of companies are micro small or medium

enterprises

177 European Defence Agency (EDA) (2016) Study on the impact of RAECH and CLP European chemical

regulations on the defence sector Final report 16 December 2016 Brussels Espoo REACHLaw Ltd 178 IVD refers to in vitro diagnostic

0

10

20

30

40

50

60

70

80

90

100

NGO Citizen Research Public IndustryAssociation

Business TradeUnion

Other Total



Beside the aforementioned costs substitution is linked to additional follow-up costs in some

industries increasing the costs of the authorisation process further MedTech Europe (2017) for

example points out that technology changes related to substitution lead not only to costs for the

medical technology industry sector itself but also the end-users of their products (ie clinical

laboratories)

Another example is the defence industry where suitable substitutes have to be requalified by

military authorities as noted by the Federation of the German Security and Defence Industries

(BDSV eV) in its position paper179 It is noted that this is a process with high costs due to the

necessity of conducting various tests BDSV (2017 p4) points out that these ldquocosts apply in

addition to the costs necessary for substitutionrdquo which makes REACH substitution overall more

disproportionate for this industry In addition substitution leads to additional costs due to the

necessity to make changes to related products BDSV (2017) mentions that the interplay between

defence products is very complex and products need to be well adapted to each other

Substitutions in the production of ammunition for example will necessitate changes to the design of

tanks and aircrafts

In addition to the costs faced during the preparation of an application or as part of activities

necessary to fulfil the Annex XIV requirements in another way (eg substitution and withdrawal)

there are potential long-term costs related to the authorisation requirement The European

Defence Agency (2016) points to the possibility that maintenance costs of defence equipment might

increase as a consequence of replacing SVHCs by less well performing alternatives Cr(VI)

replacements for tank barrels airplanes and ships are given as an example in which increased

maintenance costs are expected

Costs of the authorisation process affect not only companies but also the EU and Member State

level authorities involved Commission Regulation (EC) No 3402008 highlights that the ldquostructure

and amount of the fees should take account of the work [hellip] to be carried out by the Agency and

the competent authorities and should be fixed at such a level as to ensure that the revenue

derived from them when combined with other sources of the Agencyrsquos revenue [hellip] is sufficient to

cover the cost of the services deliveredrdquo (EC 2008 p1)

The European Defence Agency (2016) study illustrates that Member State level institutions that are

not directly related in REACH authorisation also incur costs by pointing to expenses of defence

ministries It mentions a survey which revealed that ~46 of Ministries of Defence experienced an

increase of their RampD costs whilst the other ministries were unable to provide an indication of any

changes in costs to RampD spending (in part because funding is paid for by another government

department)

In light of the various costs related to the authorisation process the open public consultation of the

REACH REFIT Evaluation asked stakeholders for their opinion about the extent to which costs (for

society companies public authorities etc) linked to different REACH chapters are proportionate

to the benefits Lietzmann et al (2017)rsquos analysis of the answers reveals that the opinion about the

proportionality of costs of authorisation is one of the most negative of all analysed REACH chapters

(ie registration information in the supply chain such as extended Safety Data Sheets evaluation

of dossier evaluation of substance authorisations restriction and requirements for substances in

articles) In fact ldquonegative views prevail to a large extent for costs related to authorisation [hellip]

179 BDSV (2017) BDSV input to public consultation on REACH Review 2017 Position Paper for REACH REFIT




for which large share (30-40) think that costs are not at all proportionaterdquo (Lietzmann et al

2017 p38) The other aspect where respondents had similar negative comments about the

disproportionality of costs relates to the requirements for substances in articles

The analysis conducted by Lietzmann et al (2017) also shows that businesses are more critical

about the proportionality of the cost of authorisation than trade unions consumer associations

public authorities NGOs Among businesses SME views are more negative than those of micro and

large businesses Further evidence for the prevalence of this critical view is provided by the

European Defence Agency (2016 p16) report which notes that ldquo[c]ompliance cost for REACH (eg

Article 33 and authorisation applications) are often considered as disproportionately high by

industry when compared to the benefitrdquo

E6 Benefits of authorisation

The word literature is used in the wider sense in this section of the review meaning information and

thus includes web-based information The objective is to report on studies and information that has

attempted to describe and quantify the benefits of authorisation using the following sources

1 Tickner J and M Jacobs (2016) Improving the Identification Evaluation Adoption and


within the Context of REACH

This report is the output of a project commissioned by the ECHA to assess uptake of

alternatives and how that could be promoted in the context of REACH The main focus of

the report appears to be on current practice and recommendations to improve the uptake

of alternatives for SVHCs The research done for the report included a survey of

stakeholders within which specific questions were asked on the benefits of substitution

Summaries of this information is presented in the report

ldquoThe most commonly identified benefits of substitution outlined by companies that have

implemented substitutes include improved worker safety (72 of responses) improved

brand reputation (51) improved worker satisfaction (40) decreased regulatory costs

(32) and decreased chemicals management costs (28) However companies noted a

number of common challenges most notably increased production costs (67) customer

concerns with productprocess changes (46) reduced performanceproduct quality (41)

supply chain availability of the alternative (40) and that the substitute turns out to also

be a substance of concern and subject to regulatory and non-regulatory actions (37)rdquo

Benefits were not quantified further than this and did not appear to be monetised

2 Backes D (2017) Monitoring of the authorisation process under the REACH regulation Test

of a proposed methodology Final Report May 2017 Vienna Austrian Federal Ministry of

Agriculture Forestry Environment and Water Management

The aim of the project was to test a methodology proposed by the Monitoring Task Force of

RiME to measure if and how the objectives of the authorisation under REACH have been

achieved The indicators together with other information were considered in support of

answering the main policy questions concerning the achievement of the goals of

authorisation under REACH



1 Has the objective of substitution worked

2 Are there less articles containing substances of very high concern (SVHCs) on the market

or has production and uses of SVHCs just been shifted outside Europe

3 What are the major substitutes for SVHCs and are these alternates safer

4 Have authorisation decisions led to better control of risks

5 Is the authorisation as such or parts thereof a cost-effective policy for protecting man

and environment

6 Does authorisation work better for certain types of substances than for others and would

this help to make more appropriate choices on SVHC candidates

Using information on 34 selected SVHCs the proposed indicators were assessed from the

IUCLID database numbers of registrations annual tonnages use descriptors and

supplemented by other types of information including

Information of uses from applications for authorisations and public consultations at

the ECHA website on the authorisation process

Tonnage information from the ldquoSubstances in Preparations in Nordic Countries

databaserdquo (SPIN)

Tonnage information from EUROSTAT (provided by the European Commission)

Aggregation of ambient monitoring data based on European initiatives such as the

Water Framework Directive the Rhine and Danube conventions the European

Pollutant Release and Transfer Register (E-PRTR)

A survey of experiences of companies with the authorisation process and

Market analysis of regional and worldwide uses of phthalates in the period 2007 ndash

2015 from Ceresana

The conclusions (lsquorather anecdotal responsesrsquo) were considered useful for further

discussions on different possibly more successful approaches

a REACH and more particularly the authorisation process has triggered the search

for alternatives by the affected companies

b According to the survey the inclusion of substances in the Candidate List

(identification of SVHCs) has led companies to consider the possibility of

alternatives There are a number of obstacles and barriers for implementing

alternatives

c All companies which implemented alternatives faced negative cost implications It

remained unclear if improvements as a net result of substitution would have finally

outweighed the additional costs

d An important obstacle for substitution is that most of the alternatives are

toxicologically not well known and companies hesitate to make efforts to introduce

these substitutes which may at a later stage become also stigmatised

e Although authorisation seems to provide some pressure towards substitution most

companies do not seem to feel that investments will actually pay and that the

major implication will be a disadvantage against competitors outside the EU This is

particularly the case for the use of SVHCs in articles while EU users are bound by

the authorisation the importers of articles containing SVHCs are not

f The discussion on SVHCs applied for in authorisation procedures seems to have

triggered a scrutiny of the existing risk management measures in companies

potentially resulting in improvements for workerrsquos health and risk reduction

measures for downstream users (consumers and professionals)



g Only few companies indicated that they have ongoing relocation plans to place

production outside of the EU because of the costs for authorisation andor the lack

of an alternative

3 Lietzman J Oulegraves L Pelsy F Fries-Tersch E and T Tugran (2017) Analysis of the

results of the open public and SME consultation of the REACH REFIT evaluation Draft final

report on the Open Public consultation Brussels Milieu Ltd

This report provides an analysis of 453 responses to a twelve-week open public

consultation It also included the results of a specific survey dedicated to SMEs (lsquoSME

panelrsquo) also conducted as part of the REACH REFIT consultation strategy

This study does not specifically report on benefits of REACH authorisation but reports of

REACH as a whole However there are some indications of responses from the surveys that

are relevant to the benefits of authorisation as follows (at page 68 of the report)

35 respondents mentioned benefits of REACH in their responses

Statements Number

REACH has increased knowledge on chemicals increased transparency 35

REACH has achieved better communication in the supply chain 22

REACH encouraged substitution larger market share for alternatives 19

The last statement indicates some reporting of the benefit of authorisation from the

perspective of substitution

4 Harrikari A and R Montonen (2017) How the REACH authorisation process affects and

benefits companies Aalto Aalto University

This report is the output from a project that was a lsquocustomized student business projectrsquo -

a concept by Aalto University School of Business The work was done for ECHA The project

was supervised by both Aalto University and the European Chemicals Agency The

supervisors were Sami Tuomi and Tommi Vihervaara from Aalto University and Matti Vainio

Spyridon Merkourakis Christoph Rheinberger and Kalle Kivelauml from ECHA

The objective of the study was to identify benefits that are not directly associated with

impacts on human health and environment since these are already covered in AfAs In total

14 Finland based firms were interviewed for the project (seven large companies and seven

micro companies) The authors name energy consumption labour productivity and chemical

portfolio as examples of other areas where benefits may be gained The authors found only

one lsquoclearrsquo benefit which was that micro-sized companies improved their communication

networks with each other Nevertheless the authors also mention that authorisation

prompted search for alternatives and imposition of improved safety measures (it is not

clear if measurable benefit was indicated by either of these)

5 Substitution of As2O3 in Murano Glass This is a lsquocase studyrsquo provided by ECHA the

information is not dated but was provided to the authors of this present study in May 2017

Murano have used arsenic trioxide (As2O3) widely as a refining agent by for centuries The

Commissionrsquos decision to include it in the Authorisation List (Annex XIV of REACH) in 2011

forced local glass manufacturers to decide on whether to apply for authorisation or

substitute to other substances or techniques After getting the clarity that the use of As2O3



was not an intermediate Murano glass manufacturers decided to opt for substitution based

on research carried out by the Stazione Sperimentale del Vetro in 2010

The substitution of As2O3 by antimony trioxide cerium oxide lithium oxide and blast

furnace slag resulted in a significant reduction in the concentration of arsenic in air from

over 200 ngm3 in 2014 to about 4 ngm3 in 2016 Site inspections made in 2016

corroborated that As2O3 was no longer used by all inspected companies apart from one

ECHA reports that

o The authorisation requirement resulted in over 100 small and medium sized

companies substituting As2O3 less hazardous substances In inspections only one

company has thus far not found to be in compliance

o Air concentrations of arsenic in the vicinity of Murano dropped from 2014 by 98 to

about 4 ngm3 which is now within the legal limit of about 6 ngm3 Not only has

this substitution considerably reduced the health risks of workers but also of the

population living in and nearby Murano

In the information provided ECHA does not report how many people were affected and thus

benefited from the increased quality of the air No attempt was made to quantify benefit in

terms of people affected or monetisation of benefit due to improved health or decrease in

the need for RMMs

6 Occupational safety and health (OSH) Belgium Results of inspection campaign for chemical

agents in the metal surface treatment sector

This report is a summary of an inspection campaign by the Belgian authorities with regard

to hexavalent chromium exposure Summary data are reported on exposure and risk control

measures however no specific commentary on the benefits of control measures or impacts

of the authorisation process is given

Eighty-three companies were visited in the context of the campaign in the period between

October 2015 and January 2016 Over 70 of the companies visited were businesses with

fewer than 50 employees One in two of the companies visited had fewer than 20

employees

61 of the companies visited had never conducted measurements into exposure to chemical

agents Findings from the campaign show that the majority of companies visited were made

aware by the supplier or sector organisation (Agoria andor VOM) of the inclusion of

hexavalent chromium compounds on the authorisation list and the consequences thereof on

the use of this substance

The results also showed that for a large percentage of the applications for which hexavalent

chromium compounds are used (pre-treatments such as chromate conversion) there were

suitable alternatives available or there is ongoing research into possible alternatives For a

specific application such as hard chrome plating there are currently no suitable

alternatives and the companies concerned are hoping for a possible authorisation with

regard to the use of hexavalent chromium compounds The visits illustrated that the REACH

authorisation process is a significant lever when it comes to the substitution process in the

context of the Royal Decree of 2 December 1993 on the protection of employees against the

risks of exposure to carcinogenic and mutagenic agents at work



7 EC (2016b) Study on the Calculation of the Benefits of Chemicals Legislation on Human

Health and the Environment Final Report

The project was commissioned by the European Commission DG Environment in the

framework of the Regulatory Fitness Programme (REFIT) for the chemicals policy area It

has a focus on the REACH and CLP Regulations Together with the findings of other studies

its results will inform the general report on the operation of the REACH Regulation and

more in general of the chemical legislative framework expected in 2017 The objective of

the study was to develop a system of indicators which can establish and measure the links

between chemical substances and their impacts on human health and the environment and

measure the role that chemicals legislation has had in reducing such impacts

The focus of this study was to investigate possible indicators of benefits of chemicals policy

and legalisation that could be usual to apply Some data specific chemicals in terms of

(downward) trends of concentrations in human tissues and body fluid and the environment

are set out but due to the multiple actions of various legalisation on these substances it

does not seem clear if specific benefits are attributed to the contribution of authorisation

Example are The occurrence of HBCDDD in wild birdsrsquo eggs (gulls) and PFOS and PFOA in

blood plasma

8 European Defence Agency (2016) Study on the impact of REACH and CLP European

Chemical Regulations on the defence sector Final Report Brussels Espoo REACHLaw Ltd

The objectives of this study were to provide

o Impact analysis of REACH and CLP on EU defence sector both industry and

governments

o Practical proposals on improvements for REACH and CLP and their current

implementation regime to serve as a basis for EDA and its participating Member

Statesrsquo (pMS) input to the EC for the next REACH review and as suggestions for

REACH evolutions beyond 2018 and

o Synthesis of information on impacts of other chemical regulations on EU Member

States MoDs and the defence sector (especially BPR ODS POP) their interaction

with REACH and CLP and a strategy (draft as a minimum) with proposals for

improvements

This report focused on the costs and negative impacts on the defence industries rather than

indicating benefits The following observations were made with respect to authorisation

REACH authorisation timelines are strongly mismatched to the defence sector

There is a strong mismatch between the timelines of REACH authorisation (sunset dates of

typically 3 years after Annex XIV inclusion and review periods for granted authorisations

ranging from 4 7 to 12 years) for Substances of Very High Concern (SVHCs) and the very

long equipment lifecycles in the defence sector which often requires the use of particular

SVHC substances (up to several decades) for production and maintenance This has

sometimes lead defence companies to implement quick substitutes of mostly lower

technical performance (short term substitution) to avoid the double resource-intensive

effort of authorisation and replacement dependence on a shrinking number of suppliers

and uncertainties associated with the possible need for several authorisation renewals even

if prospects to obtain authorisation may be good if the argumentation is robust This

negatively affects the defence companiesrsquo competitiveness and innovation potential



Insufficient Research and Development (RampD) funding for SVHC substitution

ldquoThere is insufficient RampD funding for substitution at all levels industry Member States and

EU RampD policy makers at national (Member State defence industry) or EU level often

consider REACH related substitution as a regulatory cost issue and not as innovative RampD At

the same time there is a strong willingness both within industry and MoDs to perform

substitution RampD in a collaborative approach at least at low Technology Readiness Levels

(TRL) A large majority of defence industry stakeholders (786) have confirmed that

substitution RampD activities have increased in their organisation or supply chain as a result of

REACH About half of MoDs (455) are performing financing or promoting RampD activities

for SVHC substitution including through the EDA and NATO However the budgets of both

defence industry and MoDs have not increased and the RampD for substitution is performed to

the detriment of other RampD activities Diminished innovative RampD could therefore

potentially lead to a loss of future competitiveness A large majority of the defence

industry (70) foresee a specific threat in this regard while only 13 consider that REACH

has already led to a gain on the companyrsquos global competitivenessrdquo

Unpredictability of REACH SVHC regulation

ldquoThe unpredictability surrounding the regulatory fate of SVHCs (ie whether when and in

which process(es) it will be further regulated under REACH) creates substantial

uncertainties and risks for the defence industry and ndash as a consequence ndash the MoDs as the

customer The visibility of the authorisation listing process is not in line with the defence

industriesrsquo development cycle difficulties arise in anticipating what action will be taken

against a substance and when Substance-level tracking is consequently difficult There is

the further risk that one SVHC is substituted with an alternative substance which could

transpire to be equally as harmful and subsequently be targeted by REACH during the long

product service life (regrettable substitution)rdquo

Possible EU policy conflicts with regard to SVHC regulation

ldquoREACH impacts the military uses of many inorganic substances including those linked to

Critical Raw Materials which according to the ECrsquos related policy are very hard to

substitute (eg beryllium borates cobalt salts) New Occupational Exposure Limits (OELs)

under the EU workplace legislation (eg beryllium hydrazine refractory ceramic fibres)

and Circular Economy are emerging as additional requirements on top of existing ones (eg

for lead and its compounds) The link between these EU laws and policies and REACH risk

management options such as authorisation is not very clear today leading to possible EU

policy inconsistency The case of chromates raises questions about the appropriateness of

authorisation as a blanket risk management instrument for certain substances (like the

above illustrative examples) which cannot be easily replaced are broadly used in various

sectors including high tech domains such as defence and are also addressed by other EU

policiesrdquo

Military Application for Authorisation (AfA) not fully fit for purpose

ldquoBased on the defence industry survey and a dedicated analysis of applications for

authorisation (AfAs) by the Contractor the defence sector has already been strongly

affected by the AfA process eg phthalates lead sulfochromate yellow lead chromate and

severely for Cr(VI) compounds While the allowance of defence exemptions under REACH

Article 2(3) is reserved for specific cases and does not cover civil applications of dual use

substances the AfA for military uses is often seen by defence industry stakeholders but

also some MoDs as customers and supporting the AfA as disproportionate and not fully fit

for purpose



Evidence of the large socio-economic benefit to European society and the control of the

risks in using SVHC substances within the defence sector can be seen from past AfAs Of the

AfAs that supplied Socio-Economic Analysis information that were analysed as part of this

study in which military uses are identified a simple average cost benefit analysis ratio for

military specific or dual use downstream user applications is approximately 177 million

This raises questions of proportionality when having to go through such a burdensome

process while the business case is generally clear given the limited scope for substitution

in defence equipment There is currently no dedicated defence sector-approach to

authorisation Non-air domains tend to be overlooked and a number of issues relating to

military AfAs are unclear such as the sufficiency of qualitative arguments (eg non-

quantifiable impacts on the operational capabilities of the military and the ability to

comply with international obligations as partner nations at EU level and wider field eg

with NATO) in lieu of economic quantification

Authorisation costs and through life maintenance activities using chemicals are a

particular concern with the likely need for repeated renewals in high reliability sectors

such as defence Chemical supplier interest in supporting continued authorisation is also

likely to diminish

Decision uncertainty (review periodconditions) is a general concern especially for

upstream AfAs However generally at the level of downstream user AfAs ECHA considered

that the applicants have been able to make their caserdquo

9 Reihlen Aand H Luumlskow (2007) Analysis of studies discussing benefits of REACH For the

European Commission February 2007

The aim of this study was to identify which types of benefits have been qualitatively

described in studies on REACH and how the described benefits have been linked to actual

REACH mechanisms or policy outcomes of REACH and to extract how the benefits have been

assessed and quantified It was not the aim of this report to provide an in-depth critique of

each of the analysed studies or to develop a method for benefit analysis However the

approaches and methods applied questionable assumptions and procedures are described

in the detailed analyses

Summaries of studies are divided into different types of benefits and what part of REACH

the various studies attribute those benefits to Examples of this are listed below

Business benefits Benefit to formulators as they can (on the basis of SVHC listing) clearly

see the criteria for substances potentially falling under the authorisation regime are

communicated very early the candidate list for authorisation will add to that information

and make long-term planning is possible

Human health and environmental benefits Reduction of risk (expressed as decreasing

exposure to CMRs or EDCs)

Identification of CMRs and endocrine disruptors in registration Currently there are health

risks due to exposures to CMRs and endocrine disruptors

Restrictions of use andor strict conditions of use imposed in the granting of authorisations

reduce exposure

Reduction of risk expressed in decreasing emissions exposures of PBTsvPvBs or EDCs ndash

Currently there are environmental risks due to exposures to PBTsvPvBs and EDC

PBTsvPvBs and EDCs or substances of similar concern are insufficiently regulated to

prevent environmental damage at present



Identification of PBTsvPvBs and EDCs in registration Restrictions of use andor strict

conditions of use imposed in the granting of authorisations reduce exposure

Other benefits include community wide measures more targeted The information base

for community wide risk management measures of substances is poor Priority setting

for risk management is mainly based on hazard information

10 EC (2015) Monitoring the Impacts of REACH on Innovation Competitiveness and SMEs

Final Report

This study done by RPA and others for the Commission DG Internal Market Industry

Entrepreneurship and SMEs had the objectives to

o Identify test and apply methodologies for evaluating the coherence efficiency

effectiveness sustainability and impacts of REACH in relation to the chemical

industry and major downstream user sectors

o Identify the strengths and weaknesses of REACH implementation with respect to the

conditions and structure of the market consumer choice compliance costs and

administrative procedures and any other relevant indicators identified during the

course of the study

o Provide recommendations to remedy any weaknesses identified in REACH

implementation so as to minimise the possible adverse effects of REACH

implementation and to maximise the impacts of specific REACH mechanisms that

improve business conditions for economic operators

The study comprised extensive information gathering from stakeholders using a number of

survey tools It did not include assessment of the impacts of REACH related to human

safety health and the environment

With SVHC and authorisation the report concluded that more information on uses (and

exposure scenarios) of SVHCs for which authorisation has been granted is now publicly

available additional substances have been identified as SVHCs and added to the candidate

list and 31 substances are currently in Annex XIV for about half of which no applications

for authorisation have been received The first authorisations have been processed and

granted and more are in the pipeline Costs of Authorisation have been estimated by ECHA

to be in the region of euro230k and declining as experience with the process is gained The

ability of SMEs to carry out authorisations remains to be tested Inclusion of substances on

the PACT CORAP the Candidate List and ultimately Annex XIV has led to significant levels

of activity as regards substitution withdrawal and replacement Areas within Authorisation

that the Commission is currently looking into are low volume uses legacy spare parts

substances subject to type-approval and biological essential ingredients

In general REACH terms under efficiency is reported that ldquohellipthere is a strong view in

industry that the costs incurred for implementation have for the present delivered little in

terms of enhanced competitiveness and innovation and that benefits of implementation in

as much as they exist need to be sought in the wider health safety and environmental

benefits of the legislationrdquo

11 Hennig P (2016) Socio-economic benefits and risks of the use of carcinogenic substances

subject to authorisation under REACH

This article addresses the benefits and risks of industrial uses of hazardous chemical

substances (carcinogens) for which applications for authorisation have been submitted



under the REACH Regulation It is based on a review of information submitted by industry as

part of application dossiers and made publicly available by the European Chemicals Agency

(ECHA) This type of detailed information has only recently become available thanks to the

relatively new application for authorisation process for substances of very high concern

Building on the results of the analysis some preliminary reflections on the functioning of

the authorisation process are made in light of the long-term goal of REACH that these

substances should be substituted when possible and authorised only when the use can be

justified for socio-economic reasons and no suitable alternatives are available

Based on the applications submitted by industry and the opinions published by the European

Chemicals Agency the aggregated impacts of the 32 uses of 9 carcinogenic substances can

be estimated The cumulative socio-economic benefits (direct and indirect compliance

costs related to non-use which would be avoided if the use is allowed to continue) amount

to at least euro368 million per year The total quantity of the substances in use is up to 84

thousand tons per year The cumulative monetised risks (cancer burden on workers and the

general population) are estimated to have an upper bound of euro74 million per year It

should be noted that this value does not reflect actual cancer cases but rather the

statistical cancer burden modelled via the dose-response function for carcinogenicity of

each substance

As data on the benefits and risks of specific uses of chemicals is usually scarce the detailed

information now publicly available as a result of the authorisation process under REACH is

instrumental in being able to systematically analyse the socio-economic impacts of

substances of very high concern One key observation is the substantial variation in the

benefits and risks of the individual uses not only between different substances but also

between different uses of the same substance This underlines the importance of a

transparent case-by-case evaluation to support authoritiesrsquo decisions to authorise or

restrict the use of hazardous chemicals

12 European Commission (2013c) Interpretation of the WSSD 2020 Chemicals Goal and an

Assessment of EU Efforts to meet the WSSD Commitment

This study is concerned with evaluation of the EUrsquos commitment to the WSSD (World

Summit of Sustainable Development) 2020 Goal The report proposes a set of 20 indicators

against which EU progress towards achieving that goal from a baseline year of 2002 up until

the end of 2012 can be evaluated The report identifies gaps in progress to date and

develops recommendations to address specific gaps The recommendations are organised in

a lsquoRoadmap of actionsrsquo for the EU from 2013 to 2020 aiming to lsquoensure that the EU meets

the WSSD 2020 Goalrsquo In this wide remit some benefits of REACH Authorisation are

discussed

The EU Progress under Indicator 6 lsquoSubstitution and Phase Outrsquo is relevant case studies of

substance DEHP DBP (both phthalates) and HBCDD (brominated flame retardant) are given

to illustrate declines in use and release (and increasing control) of these substances The

benefit to the environment is inferred due to the decrease in release and contamination

This study points to other studies that have made recommendation on the optimisation of

benefits from the REACH processes that control the riskiest substances The RPA study

(RPA 2012 Assessment of health and environmental benefits of REACH

ENVD3SER20110027r) recommended actions for improving benefits to human health

and the environment from REACH authorisations and restrictions are set out



In order to protect against substitution with similarly hazardous substances the following

actions should be taken

o Consideration of listing substance groups where substitution with a substance

within the same group is likely (ECHA and MS)

o Development of guidance and training on alternatives assessment (Industry)

o Compilation of information on possible alternatives to the use of the SVHC from

commenting and other information sources (Industry Member States ECHA) as

well as ldquoexclusionrdquo of substances known to be preferred alternatives but also

having problematic properties

o Research to determine whether or not substitution takes place with less hazardous

substances and the impact that candidate listing is having in this respect

13 ECSIP (2016) Impacts of REACH and corresponding legislation governing the conditions for

marketing and use of chemicals in different countries regions on international

competitiveness of the EU industry

This study was conducted for the DG Enterprise (now GROW) and considers the impacts of

REACH and corresponding legislation governing the conditions for marketing and use of

chemicals in different countriesregions on international competitiveness of the EU

industry

The study looked at comparative legislation outside the EU and the impacts of EU

legalisation looking at specific sectors including rubber and plastics textiles and motor

vehicles production industries In terms of benefits no evidence could be provided by the

interviewed companies and stakeholders on chemicals regulation yet having achieved

benefits in terms of improved working environment health or environmental benefits

although some benefits are expected over time Other benefits in terms of the availability

of information on chemicals and increased transparency and awareness within the

industries and their supplier industries were however identified The motor vehicles

industry stated that so far the effort spent on REACH is not in proportion to the results that

the industry has seen and pointed to a lack of proportionality in banning certain substances

which may be used in production processes but cannot be traced in the final product This

was reported to be supported by previous studies surveying firms on the impacts of REACH

which generally concluded that it is still too early to see concrete evidence of the benefits

that REACH is expected to bring about in terms of environment health and working

environment

14 Austrian Federal Ministry of Agriculture Forestry Environment and Water Management

(2015) REACH - Evaluation of the impact on the affected industries and the whole

economy in Austria Final Report of the study March 2015 Vienna Denkstatt Institute for

Industrial Research amp Vienna University of Technology ndash Center of Public Finance and

Infrastructure Policy

This study had the objective of to analyse and quantify the impact of REACH on the

Austrian economy after a six-year period of implementation It included direct stakeholder

survey through interviews and a workshop was conducted The authorisation process is not

a particular focus of the assessment but a more general assessment of the costs and

benefits of REACH on the Austrian economy is made

The public and occupational health environmental and business benefits were analysed

The authors reported that in general quantifying these benefits is a difficult task For

example quantification and monetisation of business benefits (eg competitive advantages



and disadvantages) was not feasible The business benefits were only considered in a

qualitative way for the in-depth analysis Results from another Austrian survey which asked

relevant organisations how and to what extent REACH has brought benefits for human and

environmental health the respondents stated that quantifying REACH related effects would

not be possible

A lsquomain scenariorsquo considered the most reasonably estimated mean values for all benefits

and costs considered in the model used in the study Based on these analyses the relevant

influences and thresholds for a benefits surplus for Austria were discussed The main

scenario showed that the adoption of REACH results in a considerable economic resource

gain (eg benefits of private households public budgets and companies present value of

net benefits) that amounts to about euro25 billion The high efficiency of REACH is also

indicated by the internal rate of return (about 35) and the benefit-cost ratio of about 9

The results crucially depend on several variables Sensitivity analyses were conducted to

control for the influence of the discount rate the positive health benefits assumed and the

underlying economic estimates as well as the projected costs (introduction and full

implementation) The authors report that given that the calculations of the main scenario

and sensitivity analyses rely on assumptions a cautious interpretation appears to be

warranted the estimates of benefits and costs are based on the best available data but

fundamental uncertainties remain However the implementation of REACH results in

positive net benefits even if worst case assumptions are applied to the single cost and

benefits measures

A fourfold increase of the discount rate (4 instead of 1 in the main scenario) results

in a halving of the economic net benefits (euro12 billion instead of euro25 billion in the main

scenario)

If REACH only leads to a reduction of adverse health effects by 1 (instead of 5 in the

main scenario) the net benefits amount to euro300 million

A doubling of direct costs results in a decrease of net benefits at the level of euro2 billion

and

An increase of indirect net costs corresponding to ten times the direct costs (in-stead of

three times in the main scenario) results in a marginal reduction of the economic net

benefits (euro2 billion instead of euro25 billion in the main scenario)

E7 Impacts on SMEs

Evidence suggests that the affordability of applying for authorisation or substitution to avoid

applying is a barrier for SMEs (EC 2013 EC 2015 Tickner and Jacobs 2016) The EC (2015) study

titled Monitoring the Impacts of REACH on Innovation Competitiveness and SMEs points out that

ldquoSMEs have been more acutely affected than large enterprises by the compliance costsrdquo (EC 2015

p200) linked to REACH thereby showing that affordability seems to be related to company size

This is supported by several position papers submitted to the online public consultation (October

2016 ndash January 2017) carried out as part of the REACH REFIT Evaluation For example

BusinessEurope stresses that due to ldquoSMEs simply hav[ing] less capacity and fewer resources than

other actors the process of registering and authorising adds a significant burden both in terms of



time and costs on themrdquo (Business Europe 2017 p2) Similar comments pointing towards a bigger

problem of affordability for SMEs have been made in the position papers submitted by180

The Chemical Industry Federation of Finland (2017)

Comiteacute Franceacuteclat (2017)

Airbus Airlines for Europe Boeing and GE Aviation (2017)

EuropaBio (2017)

The French Federation of Mechanical Engineering Industries (2017)

AmCham EU (2016)

ORGALIME (2017)

Technology Industries of Finland (2017)

UEAPME (2017)

The Association of German Chambers of Commerce and Industry (2017)

The Austrian Federal Economic Chamber (2016) and

The Dutch authorities (see Netherlands na)

Some insight on the range of factors affecting the affordability of authorisation for SMEs (eg ECHA

fees administrative costs and substitution) is provided by available literature

Preparation costs and fee payable to ECHA make up the substantial proportion of the costs linked to

REACH authorisation as shown by the detailed review of the literature on the costs of REACH

authorisation in Section E5 With respect to the fees the Commission Regulation (EC) No

3402008 states that ldquo[r]educed fees and charges should also apply to micro small and medium-

sized enterprises (SMEs)rdquo (EC 2008 p1) Furthermore Regulation (EU) No 2542013 which

amends Regulation (EC) No 3402208 recognises that ldquoexisting reduced fees and charges applicable

to micro small and medium-sized enterprises (SMEs) should be further reduced in order to

minimise the regulatory burden and the numerous practical challenges faced by SMEs in complying

with REACH obligationsrdquo (EC 2013a p1) thereby indirectly recognising that the affordability of

authorisation is a potential problem for SMEs

Hennig (2016) points out however that the authorisation application fees are less significant with

respect to the affordability of authorisation than the administrative costs linked to the preparation

of the application dossier The comprehensive AfA consisting of several assessment reports may be

ldquocost intensive to prepare particularly when external expertise is required for scientific or

technical issuesrdquo (Hennig 2016 p 157-58) which is more likely for SMEs as mentioned by Tickner

and Jacobs (2016) In combination with costs arising for submission and potential defence of the

dossier the administrative costs amount to significant values for SMEs (Hennig 2016)

With respect to substitution which has been covered in detail in Section E4 Tickner and Jacobs

(2016) point out that the actual adoption of identified alternative substances in the industrial

process could pose higher challenges to SMEs in terms of affordability than bigger companies The

authors state that SMEs are less likely to have the resources for implementing the necessary

processproduct design modifications The position paper181 submitted to the REACH REFIT public

consultation by Cii ndash the Cross-Industry Initiative for better regulation in chemicals management -

provides further evidence for affordability problems related to the substitution process through the

SAFERUBBER substitution project which was financed by the 7th Framework Programme This

180 The exact titles of the position papers can be found in the reference list 181 Cii ndash Cross-Industry Initiative for better regulation in chemicals management (2016) Synergies between

REACH and workplace legislation Improved analysis of alternatives and substitution Position Paper for REACH

REFIT Evaluation November 2016



project had the objective to find an alternative to thiourea-based accelerators ndash a substance mainly

used by SMEs The search for an alternative for this substance used in the vulcanisation process

proved successful Cii (2016) stresses however that finding an alternative would not have been

possible for SMEs without EU funds thereby highlighting that affordability is a barrier for SMEs in the


Similarly the EC (2016) study conducting a cumulative cost assessment for the EU chemical

industry indicates that affordability is a bigger issue for SMEs than larger firms in terms of the

general financial impact of chemicals legislation It finds that ldquocompany size seems to [a]ffect the

impact of legislation on costrdquo (EC 2016 p112) as the share of the costs in annual turnover is

higher for SMEs for all legislation sectors shown in Figure E012 except lsquocustoms and tradersquordquo As

shown in the figure below chemicals legislation cost as a percentage of annual turnover is below

1 but more than twice as much for SMEs as for large firms More specifically Harrikari and

Montonen (2017) compare AfA costs to micro companiesrsquo annual turnover when analysing the effect

of REACH authorisation on Finnish companies They find that AfA costs were significant (ie bigger

than 10 of annual turnover) for two out of six micro companies interviewed as part of a survey of

14 Finnish companies The study further mentions that micro companies applied as part of a

consortium as ldquoapplying alone would have increased the costs to an impossible level for micro

companiesrdquo (Harrikari and Montonen 2017 p11)

Figure E012 Legislation cost (as annual share of turnover 2004-2014) by size of firms182

(Source EC 2016)

The EC (2016) study notes that ldquoSMEs in general incur higher costs compared to large structures

because the costs to comply with legislation are not linear and cannot be amortised on large

volumes of chemicalsrdquo (EC 2016 p140) An additional reason for the higher cost is that ldquoSMEs

tend to outsource expertise and service to external providersrdquo (EC 2016 p140) In fact the EC

(2015) study results indicate that 64 of SMEs fully outsource their compliance activities as

compared to only 24 of large companies The proportion of outsorucing varies significantly across

the types of SMEs 27 65 and 18 for medium small and micro firms respectively

In addition to the scale of additional costs their financing is a further challenge making

affordability more problematic for SMEs A survey conducted among Austrain companies as part of

the study titled REACH - Evaluation of the impact on the affected industries and the whole

182 This excludes specialty chemicals due to available data being insufficient for estimation



economy in Austria commissioned by the Austrian Federal Ministry of Agriculture Forestry

Environment and Water Management revealed that ldquoadditional costs for companies caused by

REACH can only be partially passed on to the customers since they do not accept a higher price

and do not see REACH compliance as an argument for a price increaserdquo (Austrian Federal Ministry

of Agriculture Forestry Environment and Water Management 2015 p5) Similarly Harrikarri and

Montonen (2017) find that only one of seven micro-sized companies interviewed in Finland passed

on some of the costs by increasing prices The main reason for not increasing prices was the

companiesrsquo expectations that an increase in price would push costumers to do business with

companies in other countries

Notwithstanding the higher propensity to outsource among SMEs the EC (2015) study reveals that

ldquothere are [no] significant differences between SMEs and large firms as regards availability of

qualified persons to deal with REACH-related activitiesrdquo (EC 2015 p109) This conclusion is

reached despite fewer SMEs reporting the existence of a dedicated REACH unit (174 compared to

327 in larger companies) and a REACH manager (286 compared to 483) In fact targeted

company interviews showed that ldquothe key issue for SMEs is affordability rather than availabilityrdquo

(EC 2015 p109)

REACH authorisation is also more likely to affect SMEs than large companies in terms of drawing

resources away from other potentially revenue-raising activities The EC (2015) study mentions that

ldquocompliance activities can be particularly high in terms of opportunity costs for other firm

activities such as innovation as often one person is responsible for RampD and compliancerdquo (EC 2015

p139) in small and micro-firms

SMEs are also differently affected by the outcomes of REACH in terms of competitiveness and

profitability compared to larger firms The EC (2015) study reveals that loss of international

competitiveness was a lower concern for SMEs (21 as compared to 27 for large firms) This is

linked to a higher share of SMEs (47) reporting that their competitive position had strengthened as

compared to large firms (32) Nevertheless profitability is shown to be an issue related to REACH

(including authorisation) for several SMEs ldquoIn-depth interviews suggest that the actual impact [for

affected SMEs] may be more severe as survival or independent survival may be at stake for themrdquo

(EC 2015 p106) The in-depth interviews also reveal that several SMEs affected by authorisation

are considering to transfer their production to outside the EU ldquowhile many micro and small firms

and family businesses are confronted with survival issuesrdquo (EC 2015 p 31) including the prospect

of acquisition by larger firms with more funds The effect on business performance also varies

significantly between SMEs and larger companies with respect to trade inside the EU The EC (2015)

study reveals that approximately 17 of small firms and nearly 50 of micro firms had seen their

intra-EU exports decreasing as compared to only 63 of large companies

In conclusion SMEs seem to face more problems in terms of affordability than larger firms In

addition there is also some indication for a bigger economic impact of REACH on SMEs compared to

large firms as exemplified through the higher opportunity cost for other firm activities and the

higher occurrence of declining intra-EU exports

E8 Announcement effect

Article 55 of EC Regulation No 19072006 highlights that one of the aims of REACH authorisation is

that substances of very high concern ldquoare progressively replaced by suitable alternative substances

or technologies where these are economically and technically viablerdquo (EC 2006 p138) Heitmann

and Reihlen (2007 p6) point out that announcing the substances that are potentially subject to



authorisation in advance through the Candidate List ldquomight be an incentive for producers and users

of these substances to strive for the substitution goal pro-activelyrdquo The Candidate List could thus

potentially have an announcement effect In their report titled Case study on ldquoAnnouncement

effectrdquo in the market related to the candidate list of substances subject to authorisation

Heitmann and Reihlen (2007) use information about how industry actors reacted to comparable

legal approaches in the past (eg Danish list of undesirable substances (LOUS) Swedish observation

list (OBS) and the OSPAR list of substance for priority action) to make inferences about the

potential announcement effect of the Candidate List Information on stakeholdersrsquo reactions to

these legal approaches was gathered through expert interviews and document analysis

This analysis showed that the extent of the announcement effect of the Candidate List is likely to

depend on market pressure exerted by downstream users article producers and retailers who tend

to ldquouse substance lists to exclude specific substances from their products and thus exert pressure

on the supply chainrdquo (Heitmann and Reihlen 2007 p13) The reaction of these actors is essential

in determining the extent of the announcement effect as manufacturers and importers of SVHCs

tend to argue for continued use of their product on the basis of the use benefits of the substance

and the better possibility to control risks for known substances than alternatives These actors tend

to show little reaction to non-legally binding lists in terms of investment in the development of

alternatives unless there is an expectation ndash induced through the reaction of downstream users and

retailers - that ldquothe business risks from introducing an alternative [are] compensated by extra

(net) revenuesrdquo (Heitmann and Reihlen 2007 p9) Similarly the reaction of chemical formulators

is dependent on the reaction of these actors as they take future regulations and customer demand

into consideration when developing their products in order to prevent repeated reformulation

The market pressure exerted by downstream users is however not uniform Proactive behaviour ndash

increasing the probability for a strong announcement effect ndash is especially observed in companies

producing or selling consumer products (eg household articles and cosmetics) and companies with

a brand name according to Heitmann and Reihlenrsquos analysis The reason behind this is that such

companies are more vulnerable to NGO-campaigns calling for the disuse of hazardous substances

Such campaigns are a possible consequence of the inclusion of substances in the Candidate List By

proactively engaging in substitution activities these stakeholders attempt to improve their

reputation and avoid negative publicity

With respect to market pressure the EC (2015) report titled Monitoring the Impacts of REACH on

Innovation Competitiveness and SMEs provides useful information through an open-ended on-line

business survey (OBS) answered by 566 respondents from 28 Member States EEA and non-EU

countries The survey reveals that 388 of all respondents answering the question whether they

received requests from their customers to remove SVHCs from their products as a reaction to the

candidate listing reported that they received such requests The percentage of companies facing

these requests differs however significantly based on the type of company as shown in Table

E03 The EC (2015) report highlights that the main reaction to placing a substance on the

Candidate List is not withdrawal of the substance but finding alternatives through the procurement

of existing alternatives or the initiation of a research programme



Table E03 Have any of your customers requested the removal of SVHCs from your products

(Source EC 2015)

Similarly the European Defence Agency (2016) reports that customers (ie European Ministries of

Defence) exert pressure on prime contractors to implement substitutes by imposing contractual

constrains beyond REACH requirements Seventy-nine percent of respondents to their consultation

indicated that such constraints in the form of bans on certain substances exist The report also

highlights that some Ministries of Defence use the Candidate List as the basis for such constraints

Thus the Candidate List exerts pressure on industry actors to substitute SVHCs and according to the

interviews conducted as part of the EC (2015) study substitution attempts are often only based on

the legal status of the substance (ie that it is listed on the Candidate List) This shows that the

Candidate List has had a considerable announcement effect However this effect is not necessarily

beneficial to achieve the REACH objectives according to the EC (2015) as only in a few cases has it

led ldquoto the development of new less hazardous alternative substances or implementation of new

processes at the level of the substance manufacturerrdquo (EC 2015 p119) In many cases the SVHC

was substituted for another substance available in the supplier portfolio allowing the downstream

user to further use their existing technology Downstream users have reported that this has in some

cases led to lowering the quality of their products The American Chemistry Council (2017)183 and

Cii (2016) position papers submitted as part of the REACH REFIT evaluation support the view that

the announcement effect is not entirely positive as substitution induced by the Candidate List has

in many cases resulted in regrettable substitutions lsquoRegrettable substitutionrsquo thereby refers to

substitution by an alternative posing at least similar if not more risks and alternatives that are

unsustainable with respect to energy consumption or resource efficiency (Cii 2017)

The EC (2015) study also notes that research activities to find substitutes are more likely to be

executed by the formulator or article producer than substance manufacturer and that these

ldquo[i]nnovations are frequently realised because the elimination of a SVHC in products has been on

the agenda in the firms anyway and is [then] treated with higher priorityrdquo (EC 2015 p119) ndash

thereby relativizing the positive role of the Candidate List in terms of promoting substitution

A further factor determining the extent of the announcement effect mentioned by Heitmann and

Reihlen (2007) is the ldquoimaginary pressurerdquo which is dependent on how companies perceive the

probability that a substance on the Candidate List will be subjected to authorisation The expert

consultation revealed that imaginary pressure felt by companies is likely to depend on the number

of the substances placed on the Candidate List as it will influence the perception about whether

the authorisation requirement is perceived as an imminent situation The authors highlight however

that a promotion of substitution through the Candidate List ndash and therefore an announcement

effect ndash is possible even if the probability of a transfer to Annex XIV is perceived as low as ldquoa high

183 American Chemistry Council (2017) ACC Input for EU REACH REFIT Position Paper for REACH REFIT




level of uncertainty may trigger long-term planning companies to apply for substitutionrdquo

(Heitmann and Reihlen 2007 p16)

In addition Heitmann and Reihlenrsquos analysis showed that substance lists naming legally restricted

and declarable substances as well as lists of substances subject to voluntary agreements are used as

black lists by companies The lists thereby promote a phase-out of listed substances Heitmann and

Reihlen (2007 p13) note however that industry feedback shows that industry actors find it

ldquodifficult to consider all the different national lists on the European market and that one

harmonised EU-List would be appreciatedrdquo This is a potential explanation for the existence of an

announcement effect as the Candidate List serves as such an EU-wide agreed list All experts

consulted by Heitmann and Reihlen (2007) expected the Candidate List to be used in a similar way

as the analysed indicative lists (ie a black list) thereby promoting phase-outs

The use of the Candidate List seems indeed to follow the predicted pattern according to the REACH

REFIT position paper submitted by the American Chemistry Council which mentions that ldquohazard

based selection of SVHCs has triggered behaviours from downstream uses de-selecting substances

that go beyond regulatory requirementsrdquo (American Chemistry Council 2017 p4) thereby

suggesting that the Candidate List is viewed as a black list

Surveys conducted as part of EC (2015) study on the impacts of REACH on innovation

competitiveness and SMEs provide additional evidence for the existence of an announcement

effect It was revealed that 246 of SMEs and 419 of large firms launched reformulation

initiatives in response to the Candidate List The survey results also indicate that 189 of SMEs and

368 of large firms requested substitution of substances as a result of the substance being placed

on the Candidate List As the effect of the list was similar in all other aspects for these two

categories according to the EC (2015) study it can be concluded that the announcement effect was

stronger in the case of large firms than SMEs

The EC (2015) study also provides information on the strength of the announcement effect in terms

of the type of industry stakeholder The computer aided telephone interview (CATI) survey which

led to 1076 responses indicated that 30 of respondents reported that one or more of the

substances used or produced by them was placed on the candidate list Out of those respondents

94 started research programmes to develop an alternative substance and 301 started a search

for alternative formulations of existing substances The announcement effect of the Candidate List

was thereby strongest among formulators The EC (2015) Online Business Survey (OBS) survey shows

that when asked about their reaction to the placing of substances relevant to the firm on the

Candidate List only 187 indicated that they took no special action This indicates that there has

been a strong announcement effect as it implies that 76 of the respondents that saw a substance

relevant to their business being placed on the Candidate List took some action More detailed

information on the actions taken by industry stakeholders as result of the Candidate List can be

found in Table E04



Table E04 What has been the response of your firm to the placing of substances relevant to your business in the Candidate List (Percentage of firms indicating)

(Source EC 2015)

An online survey conducted by RPA (see RPA 2016) among industry and consultancy representatives

between March and May 2016 provides further evidence for an announcement effect It indicates

that in the responses of 100 industry representatives to a question about the relative importance of

drivers of substitution inclusion in the Candidate List was particularly named as the mechanism

triggering substitution considerations Similarly the textile industry mentions the Candidate List as

the main reason for substitution and phase-outs in the sector according to the ECISP (2016) report

Additional evidence for the existence of an announcement effect is provided in several REACH

REFIT 2017 position papers

The Chemical Industries Association (2017 p2) reports that they received ldquoinformal

reports from companies that substances have been eliminated from product portfolios in

some situations on the basis of registration costs andor SVHC listingrdquo

The joint position paper of the European Federation of Pharmaceutical Industries and

Associations Vaccines Europe the International Federation of Animal Health Europe the

Plasma Protein Therapeutics Association the International Plasma Fraction Association and

European Biopharmaceutical Enterprises highlights that ldquothe presence of a substance in the



Candidate List has in many cases proven to be sufficient to reduce the use of certain

substancesrdquo (EFPIA et al na p5)

The European Environmental Bureau (na) position paper provides a concrete example for

announcement effect by referring to the Swiss company Hoffmann-La Roche It thereby

highlights that the Candidate List even has an announcement effect in countries that are

not part of the EU and therefore are not subject to compliance Hoffmann-La Roche

committed to phase out SVHCs wherever possible within a decade of their addition to the

Candidate List One reason provided for this by the company is the risk of supply chain

discontinuity in the future

The position paper submitted by the Swedish Chemicals Agency (2017 p4) also mentions

that it has already been ldquoshown that the Candidate List itself seems to have had a positive

effect on substitution partly caused by expectation from producers on future measuresrdquo

The Swedish Chemical Agency also critically remarks in this respect that this positive

announcement effect can only be maintained if these expectations do not disappear due to

generous authorisations for broad uses Authorisations being perceived to be granted too

generously is a problem according to them as experiences has shown that ldquoall authorisation

applications (regardless of their quality) have been found compliant and lead to approvalrdquo

(Swedish Chemicals Agency 2017 p4)



ANNEX F AUTHORISATION SURVEYS

F1 Purpose of the surveys

The purpose of the online surveys for industry stakeholders and NGOs was to target a large number

of stakeholders and collect data and information from them in a consistent way The surveys also

allowed for the identification of additional companies suitable for case studies and targeted follow-

up interviews

The industry survey was designed to cover all impact areas of interest in this study namely

Substitution of substances


Changes in market structure

Costs of authorisation and

Specific impacts on Small and Medium-Sized Enterprises (SMEs)

It targeted stakeholders (ie MIs and DUs) active in the manufacturing import and use of both

SVHCs and alternatives

The NGO survey covered the same impacts as the industry survey and was targeted to those

stakeholders known to be active in REACH

Having separate surveys for industry stakeholders and NGOs had the benefit of the surveys being

shorter than a single all-inclusive survey and being more relevant to each type of stakeholder

As part of this study questionnaires were also sent to the European Commission and Member State

Competent Authorities (MS CAs) to assess the administrative burden of REACH authorisation on

these public authorities

F2 Survey structure and design

F21 Industry survey

The online survey software SurveyMonkey was used for the industry survey This allowed for the

provision of a streamlined survey to each respondent depending on hisher specific answers as it

allowed for the use of dependent questions This ensured that the survey automatically limited the

number of questions to those that are most relevant to the respondent

The survey used single and multiple choice and open-ended questions It also provided the option to

attach supporting documents Single and multiple-choice questions were used to standardise

responses and facilitate the data analysis The open-ended questions had the purpose to capture

respondentsrsquo specific experiences in the REACH authorisation process

The industry survey consisted of a total of nine sections including an introduction section informing

respondents about the functionality and content of the survey Section II to Section IX included

survey questions The eight sections containing survey questions are listed below in conjunction

with the question range of the specific section



II About your organisation Q1 ndash Q4

III Substitution Q5 ndash Q67

IV Benefits of authorisation ndash Improved risk management of SVHCs Q68 - Q102

V Changes in market structure Q103 - Q338

VI Costs incurred during the authorisation process Q339 - Q369

VII Small and medium-sized enterprises (SMEs) Q370 - Q376

VIII Other questions Q377 - Q387

IX Confidentiality Q368

The section titled II About your organisation asked respondents to provide some information

about their organisation in order to facilitate the aggregation of responses (eg by type of actor)

and improve the understanding of responses

The third section (III Substitution) focused on gathering evidence of the objective of the REACH

Regulation to progressively replace SVHCs by suitable alternative substances andor technologies

The section was designed to collect evidence enabling the assessment of the extent to which the

entire REACH authorisation process is leading to substitution or triggering activities that may lead

to substitution in the future In particular it examined whether any substitution occurs before a

substance is placed on the Authorisation List Where substitution had happened it also attempted

to collect evidence for its impacts on the business of the respondent and the overall market

The fourth section (IV Benefits of authorisation ndash Improved risk management of SVHCs) looked at

the aim of the REACH authorisation process to generate benefits to the environment and to human

health through improved risk management of SVHCs along the supply chain (even in cases where an

authorisation for the continued use of an SVHC has been granted) This section sought evidence of

whether the entire REACH authorisation process has led to environmental and human health

benefits

The fifth section (V Changes in market structure) sought to understand whether the REACH

authorisation process has led to changes in the structure of the EU market for products made by

using SVHCs as well as their alternative substances andor technologies

The sixth section (VI Cost incurred during the authorisation process) sought information on the

costs incurred by EU companies at each stage in the REACH authorisation process It thereby

focused on the costs of providing evidence during the RMOA process and ECHA public consultations

and the costs of complying with any requirements resulting from the REACH authorisation process

F22 NGO survey

The online survey software SurveyMonkey was used for the NGO survey This allowed for the

provision of a streamlined survey to each respondent depending on its specific answers by using

dependent questions This ensured that the survey automatically limited the number of questions

to those that are most relevant to the respondent

Similar to the industry survey the survey included a mix of single and multiple choice and open-

ended questions It also provided the option to attach supporting documents

The NGO survey consisted of a total of seven sections including an introduction section informing

respondents about the functionality and content of the survey and asking for the provision of

contact details Section II to Section VII included survey questions These sections are listed below

in conjunction with question range of the specific section



II Substitution Q2 ndash Q35

III Benefits of authorisation ndash Improved risk management of SVHCs Q36 - Q38

IV Changes in market structure Q39 - Q42

V Administrative costs Q43 - Q53

VI Other questions Q54 ndash Q64

VII Confidentiality Q65

The sections titled II Substitution III Benefits of authorisation ndash Improved risk management of

SVHCs and IV Changes in market structure thereby followed the intention and design of the

sections of the same names in the industry survey

The fifth section (V Administrative costs) attempted to collect information on the administrative

costs that NGO respondents had incurred in providing comments as part of public consultations and

providing input to policy developments at different stages of the REACH authorisation process

Questions focused on the three stages of the authorisation process where public consultations are

held (ie inclusion of substances of the Candidate List inclusion of substances in the Authorisation

List and applications for authorisation)

F23 Surveys for public authorities

For the assessment of the administrative burden of REACH authorisation on public authorities a

separate questionnaire in the Word document format was sent to the European Commission and

Member State Competent Authorities (MS CAs) The questions within this questionnaire reflected

the activities these actors partake across the various stages of the authorisation process

The questionnaire for the European Commission contained the following sections

I Staff costs Q1

II Screening and RMOA stage Q2 ndash Q4

III Inclusion of substances in the Candidate List Q5

IV REACH Committee Q6 ndash Q7

V Decision on applications for authorisation (AfA) Q8 ndash Q10

VI Post decision on an AfA Q11 ndash Q13

VII Policy costs Q14 ndash Q15

VIII Other Q16 ndash Q17

The questionnaire for the Member State Competent Authorities contained the following sections

I Staff costs Q1

II RMOA stage Q2 ndash Q4

III Inclusion of substances in the Candidate List Q5 ndash Q7

IV Member State Committee (MSC) Q8 ndash Q9

V REACH Committee Q10 ndash Q11

VI Compliance and enforcement of REACH Authorisation Q12 ndash Q16

VII Policy costs Q17 - 18

VIII Other Q19 - 20



F3 Respondent profile


An e-mail invitation with a link to the industry online survey was sent to 240 individuals In some

cases several individuals from the same company were invited In the case of the NGO survey an

invitation was sent to 30 individuals

At the beginning of May a reminder was sent to all stakeholders which had started to fill out the

survey but had not fully completed their response at that point as well as those individuals that had

not started to fill out the survey at all Different e-mail versions adapted to the state of the

individualrsquos survey response (ie incomplete survey not started) were used for this purpose

For the NGO survey 4 complete responses and 2 partial responses were received

The industry survey resulted in 63 complete responses and 21 partial responses The partial

responses were included whenever respondents had fully completed certain sub-sections of the

survey Information about whether the respondentrsquos organisation is an SME is only available for the

63 complete responses Twenty (32) of those respondents indicated that their organisation is an

SME

A list with the actor types used to classify survey respondents (in Question 2 of the survey) is

provided below in conjunction with the number of respondents indicating that they belonged to

that category It is important to note in this respect that a single respondent can be part of several

categories

On-going manufacturerimporter of a substance of very high concern (SVHC) 17 (12)

Ceased manufacturerimporter of an SVHC 5 (4)

Manufacturerimporter of an alternative substance andor technology to an SVHC

7 (5)

Downstream user of an SVHC 59 (42)

Downstream user of alternative substance andor technology to an SVHC 22 (16)

Distributor of an SVHC 6 (4)

Distributor of an alternative substance andor technology to an SVHC 5 (4)

Tradesector association 9 (6)

Other 11 (8)

In Question 3 of the survey respondents were also asked to indicate the perspective from which

they were completing the survey The subsequent list shows possible answers as well as the number

and percentage of respondents answering the survey from this perspective

For entire organisation 55 (65)

For a specific useproductmarketsector in organisation 11 (13)

For a specific substance or group of substances 11 (13)

On behalf of members within association 5 (6)

Other 2 (2)



F32 MS CA survey

The questionnaire was sent to 22 individuals from 20 countries via e-mail at the beginning of May

2017 A list of the countries that were contacted for this survey can be found in Annex G1 A

reminder was sent out to those MS CAs that had not yet submitted their completed questionnaire

on 6 June 2017 Sixteen completed questionnaires have been received which equals a response rate

of 80

F4 Data validation


The industry survey data was analysed in two rounds For the interim report submitted at the end

of April 2017 only complete responses received before this date were taken into consideration For

the current report all complete responses received by the closure of the survey on 20 June 2017 as

well as fully completed sections from partial survey responses have been analysed

The information from complete survey responses was compiled in a spreadsheet which allowed for

a check of data quality in terms of the comprehensiveness of the responses It was also used for

identifying cases for which clarifying information was required for the given answers

After closure of the survey the spreadsheet was used to identify the stakeholders for which follow-

up telephone interviews were deemed useful for the preparation of case studies The spreadsheet

was also used to determine the specific section or sections (eg substitution market impacts SME)

on which the stakeholder should be interviewed Besides providing input to the case studies the

interviews conducted in the aftermath of the online survey also enabled the project team to

validate the data received during the survey

F42 MS CA survey

The survey data was validated by collating the survey responses in a spreadsheet and screening this

spreadsheet for outliers The purpose of this approach was to identify respondents with whom

further contact needed to be initiated to gather information about potential reasons for the

outliers



F5 Industry survey ndash Statistical summary

The remainder of this section summarises a number of responses (but not all ndash eg Q1 provides contact details of the respondents) to the online industry

survey for each question Some questions include options for ldquoDonrsquot knowrdquo ldquoNot statedrdquo or equivalent options These options are reported in this annex

for completeness However the main report excludes such responses in order to accurately reflect the sample size that the results are based on Open-

ended questions are summarised qualitatively in the main report

II About your organisation

Q2 Type of actor in the REACH authorisation process

n


On-going manufacturerimporter of a substance of very high concern (SVHC) 17 67 84 20 80 100

Ceased manufacturerimporter of an SVHC 5 79 84 6 94 100

Manufacturerimporter of an alternative substance andor technology to an SVHC 7 77 84 8 92 100

Downstream user of an SVHC 59 25 84 70 30 100

Downstream user of alternative substance andor technology to an SVHC 22 62 84 26 74 100

Distributor of an SVHC 6 78 84 7 93 100

Distributor of an alternative substance andor technology to an SVHC 5 79 84 6 94 100

Tradesector association 9 75 84 11 89 100

Other 11 73 84 13 87 100

Q3 Perspective in completing survey n

For entire organisation 55 65

For a specific useproductmarketsector in organisation 11 13

For a specific substance or group of substances 11 13

On behalf of members within association 5 6

Other 2 2

Total 84 100



III Substitution Q5 Whether REACH authorisation had led to internal policy concerning managingknowing what substances are used within respondents organisation including (possible) SVHCs

n

Yes 39 47

Yes but not due to REACH authorisation 30 36

No 11 13

No but we are considering having a policy 3 4

Total 83 100

Q8 Whether respondent has substituted a (possible) SVHC with an alternative substance andor technology

n

Yes partly due to the REACH authorisation process 27 33

Yes but not due to the REACH authorisation process 8 10

No but we are aware of substitution in our supply chain 2 2

No but we are investigating possibilities to substitute 24 29

No 22 27

Total 83 100

Q9 - Q17 Number of examples of substitution due to REACH authorisation

n








Q19 Stage(s) of authorisation process that triggered confirmed decision to substitute (total number of examples provided)

n

Scre

enin

g o

f su

bst

ance a

nd R

isk

Managem

ent

Opti

on A

naly

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion

of

subst

ance in A

uth

ori

sati

on

Lis

t (A

nnex X

IV)

Inclu

sion o

f su

bst

ances

in A

nnex

XIV

Applicati

ons

for

auth

ori

sati

on

(AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex

XIV

subst

ance)

Not

sure

Not

applicable

Tota

l

Scre

enin

g o

f su

bst

ance a

nd R

isk

Managem

ent

Opti

on A

naly

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion

of

subst

ance in A

uth

ori

sati

on

Lis

t (A

nnex X

IV)

Inclu

sion o

f su

bst

ances

in A

nnex

XIV

Applicati

ons

for

auth

ori

sati

on

(AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex

XIV

subst

ance)

Not

sure

Not

applicable

Tota

l

6 13 10 11 4 0 6 85 135 4 10 7 8 3 0 4 63 100

Q20 - Q28 Number of examples of substitution not due to REACH authorisation or in respondents supply chain

n






Q30 Whether instances of substitution led to any one-off costs

n

Yes 24 83

No 1 3

Dont know 4 14

Total 29 100



Q31 Estimated one-off costs of substitution (total number of examples provided)

n lteuro1m

illion

euro1-euro

10 m

illion

euro11-euro

50 m

illion

euro51-euro

100 m

illion

gteuro100 m

illion

Not

applicable

Donrsquot

know

Tota

l

lteuro1m

illion

euro1-euro

10 m

illion

euro11-euro

50 m

illion

euro51-1

00 m

illion

gteuro100 m

illion

Not

applicable

Donrsquot

know

Tota

l

25 3 4 0 0 63 25 120 21 3 3 0 0 53 21 100

Q32 Whether instances of substitution led to an increase or savings in annual operating cost

n

Net increase in operating costs 14 48

Net saving in operating costs 0 0

No change in operating costs 6 21

Dont know 9 31

Total 29 100

Q33 Estimated change in annual operating costs from implementing alternative substances andor technologies (total number of examples provided)

n

lteuro100 0

00 p

er

year

euro100 0

00 -

euro1

million p

er

year

euro1-euro

10 m

illion

per

year

euro11-euro

50 m

illion

per

year

euro50-euro

100 m

illion

per

year

gteuro100 m

illion

per

year

Not

applicable

Donrsquot

know

Tota

l

lteuro100 0

00 p

er

year

euro100 0

00 -

euro1

million p

er

year

euro1-euro

10 m

illion

per

year

euro11-euro

50 m

illion

per

year

euro50-euro

100 m

illion

per

year

gteuro100 m

illion

per

year

Not

applicable

Donrsquot

know

Tota

l

11 5 1 1 0 0 37 15 70 16 7 1 1 0 0 53 21 100

This question asks respondents for the change in their organisationsrsquo annual operating cost which can be a decrease or increase The results in this table reflect an increase in operating costs because all respondents indicated increases rather than decreases in annual operating costs



Q34 Whether instances of substitution led to changes in volume sold or revenue achieve for the product made

n

Yes 6 21

No 14 48

Dont know 9 31

Total 29 100

Q36 Estimated annual average change (to date) in sales volume of products made using alternative substances andor technologies (total number of examples provided)

n

Reducti

on

gt20

Reducti

on

11

-20

Reducti

on 1

-

10

No c

hange

Incre

ase

1

-

10

Incre

ase

11

-

20

Incre

ase

gt20

Not

applicable

Donrsquot

know

Tota

l

Reducti

on

gt20

Reducti

on

11

-20

Reducti

on 1

-

10

No c

hange

Incre

ase

1

-

10

Incre

ase

11

-

20

Incre

ase

gt20

Not

applicable

Donrsquot

know

Tota

l

2 2 2 0 0 0 0 23 1 30 7 7 7 0 0 0 0 77 3 100

Q37 Estimated annual average change (to date) in revenue from products made using alternative substances andor technologies (total number of examples provided)

n

Reducti

on

gt20

Reducti

on

11

-20

Reducti

on 1

-

10

No c

hange

Incre

ase

1

-

10

Incre

ase

11

-

20

Incre

ase

gt20

Not

applicable

Donrsquot

know

Tota

l

Reducti

on

gt20

Reducti

on

11

-20

Reducti

on 1

-

10

No c

hange

Incre

ase

1

-

10

Incre

ase

11

-

20

Incre

ase

gt20

Not

applicable

Donrsquot

know

Tota

l

2 1 2 1 0 0 0 23 1 30 7 3 7 3 0 0 0 77 3 100



Q38 Whether instances of substitution led to change in the number of people employed

n

Yes 4 14

No 21 72

Dont know 4 14

Total 29 100

Q39 Estimated change in employment (to date) from implementing alternative substances andor technologies (total number of examples provided)

n

Reducti

on gt

250 w

ork

ers

Reducti

on 1

00-2

50 w

ork

ers

Reducti

on 5

0-9

9 w

ork

ers

Reducti

on 1

1-5

1 w

ork

ers

Reducti

on 1

-9 w

ork

ers

No c

hange

Incre

ase

1-1

0 w

ork

ers

Incre

ase

11-5

0 w

ork

ers

Incre

ase

51-9

9 w

ork

ers

Incre

ase

100-2

50 w

ork

ers

Incre

ase

gt250 w

ork

ers

Not

applicable

Dont

know

Tota

l

Reducti

on gt

250 w

ork

ers

Reducti

on 1

00-2

50 w

ork

ers

Reducti

on 5

0-9

9 w

ork

ers

Reducti

on 1

1-5

1 w

ork

ers

Reducti

on 1

-9 w

ork

ers

No c

hange

Incre

ase

1-1

0 w

ork

ers

Incre

ase

11-5

0 w

ork

ers

Incre

ase

51-9

9 w

ork

ers

Incre

ase

100-2

50 w

ork

ers

Incre

ase

gt250 w

ork

ers

Not

applicable

Dont

know

Tota

l

0 0 0 1 0 0 4 0 0 0 0 15 0 20 0 0 0 5 0 0 20 0 0 0 0 75 0 100

Q40 Whether instances of substitution led to reduction in worker exposure levels to (possible) SVHCs

n

Yes 14 48

No 11 38

Dont know 4 14

Total 29 100



Q41 Estimated number of workers with reducedno exposure to (possible) SVHCs due to implementing alternative substances andor technologies (total number of examples provided)

n

lt5 w

ork

ers

6-1

0 w

ork

ers

11-2

0 w

ork

ers

21-5

0 w

ork

ers

51-1

00 w

ork

ers

101-2

00 w

ork

ers

gt200 w

ork

ers

Not

applicable

Donrsquot

know

Tota

l

lt5 w

ork

ers

6-1

0 w

ork

ers

11-2

0 w

ork

ers

21-5

0 w

ork

ers

51-1

00 w

ork

ers

101-2

00 w

ork

ers

gt200 w

ork

ers

Not

applicable

Donrsquot

know

Tota

l

4 4 7 3 1 0 2 41 8 70 6 6 10 4 1 0 3 59 11 100

Q42 Whether instances of substitution led to reduction in emissions of (possible) SVHCs to the environment

n

Yes 13 45

No 10 34

Dont know 6 21

Total 29 100

Q43 Estimated annual reduction in emissions of (possible) SVHCs to wastewater after implementing alternative substances andor technologies (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

12 1 2 1 0 0 0 40 9 65 18 2 3 2 0 0 0 62 14 100



Q44 Estimated annual reduction in emissions of (possible) SVHCs to air (the atmosphere) after implementing alternative substances andor technologies (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

10 2 1 1 0 0 0 45 6 65 15 3 2 2 0 0 0 69 9 100

Q45 Estimated annual reduction in waste generated from (possible) SVHCs sent for appropriate disposaltreatment after implementing alternative substances andor technologies (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

11

-10 t

onnes

year

11-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

9 4 0 0 0 2 0 43 7 65 14 6 0 0 0 3 0 66 11 100

Q46 Whether instances of substitution led to reduction in volume of SVHCs in finished products

n

Yes 17 59

No 10 34

Dont know 2 7

Total 29 100



Q49 Whether respondent uses any (possible) SVHCs for any other uses

n

Yes and we are investigating the possibility to substitute 20 54

Yes but we have not investigated the possibility to substitute yet 5 14

No Donrsquot know 12 32

Total 37 100

Q50 - Q58 Number of examples of substitution activities

n






Q60 Stage(s) of authorisation process that triggered substitution activities (total number of examples provided)

n

Scre

enin

g o

f su

bst

ance a

nd R

isk

Managem

ent

Opti

on A

naly

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion

of

subst

ance in A

uth

ori

sati

on

Lis

t (A

nnex X

IV)

Inclu

sion o

f su

bst

ances

in A

nnex

XIV

Applicati

ons

for

auth

ori

sati

on

(AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex

XIV

subst

ance)

Not

sure

Not

applicable

Tota

l

Scre

enin

g o

f su

bst

ance a

nd R

isk

Managem

ent

Opti

on A

naly

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion

of

subst

ance in A

uth

ori

sati

on

Lis

t (A

nnex X

IV)

Inclu

sion o

f su

bst

ances

in A

nnex

XIV

Applicati

ons

for

auth

ori

sati

on

(AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex

XIV

subst

ance)

Not

sure

Not

applicable

Tota

l

5 24 15 4 6 2 9 155 220 2 11 7 2 3 1 4 70 100



Q61 Estimated annual cost of substitution activities (total number of examples provided)

n

lteuro1 0

00 p

er

year

euro1 0

01 -

euro10

000 p

er

year

euro10 0

01 -

euro50

000 p

er

year

euro50 0

01 -

euro100

000 p

er

year

euro100 0

01 -

euro1

million p

er

year

euro1-euro

10 m

illion

per

year

euro10 -

euro100

million p

er

year

gteuro100 m

illion

per

year

Not

applicable

Donrsquot

know

Tota

l

lteuro1 0

00 p

er

year

euro1 0

01 -

euro10

000 p

er

year

euro10 0

01 -

euro50

000 p

er

year

euro50 0

01 -

euro100

000 p

er

year

euro100 0

01 -

euro1

million p

er

year

euro1-euro

10 m

illion

per

year

euro10 -

euro100

million p

er

year

gteuro100 m

illion

per

year

Not

applicable

Donrsquot

know

Tota

l

2 7 12 10 8 2 2 0 137 40 220 1 3 5 5 4 1 1 0 62 18 100

Q62 Top three reasons for carrying out substitution activities

n


REACH authorisation process 36 25 61 59 41 100

REACH but not the authorisation process 11 50 61 18 82 100

Other EU regulation 4 57 61 7 93 100

Non-EU regulation 3 58 61 5 95 100

Financial savings from switching 5 56 61 8 92 100

New opportunities in the market 14 47 61 23 77 100

To assess the suitability of possible alternatives as part of an AfA 32 29 61 52 48 100

To implement a known alternative on the market 4 57 61 7 93 100

Other 20 41 61 33 67 100



Q64 Top three reasons for not carrying out substitution activities

n


Financial constraints to carry out investigations 6 16 22 27 73 100

Constraints on internal RampD staff to carry out investigations 4 18 22 18 82 100

Lack of lsquonewrsquo alternatives worth investigating 10 12 22 45 55 100

No technically feasible alternative to deliver similar end-user requirements 16 6 22 73 27 100

Concerns about market approval if we substitute 5 17 22 23 77 100

Concerns of the economic costs associated with any switch to an alternative 5 17 22 23 77 100

Unable to pass on recover the costs to switch to an alternative 4 18 22 18 82 100

Non-competitive in the market against those that continue to use the SVHC 6 16 22 27 73 100

Other 10 12 22 45 55 100

IV Benefits of authorisation ndash Improved risk management of SVHCs

Q68 Whether organisation currently uses a (possible) SVHC

n

Yes 63 93

No 5 7

Total 68 100

Q69 Whether organisation has improved handling and use (operational) conditions of (possible) SVHCs as a result of REACH authorisation

n

Yes 23 37

No 34 54

Dont know 6 10

Total 63 100



Q70 -78 Number of examples of risk management-related activities

n






Q80 Stage(s) of authorisation process that triggered risk management activities (total number of examples provided)

n

Scre

enin

g o

f su

bst

ance a

nd

Ris

k M

anagem

ent

Opti

on

Analy

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion o

f su

bst

ance in

Auth

ori

sati

on L

ist

(Annex

XIV

)

Inclu

sion o

f su

bst

ances

in

Annex X

IV

Applicati

ons

for

auth

ori

sati

on (

AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex X

IV s

ubst

ance)

Not

sure

Not

applicable

Tota

l

Scre

enin

g o

f su

bst

ance a

nd

Ris

k M

anagem

ent

Opti

on

Analy

sis

(RM

OA

)

Inclu

sion o

f su

bst

ance in

Candid

ate

Lis

t

Recom

mendati

on f

or

inclu

sion o

f su

bst

ance in

Auth

ori

sati

on L

ist

(Annex

XIV

)

Inclu

sion o

f su

bst

ances

in

Annex X

IV

Applicati

ons

for

auth

ori

sati

on (

AfA

)

Post

-auth

ori

sati

on d

ecis

ions

(eg

aft

er

sunse

t date

of

Annex X

IV s

ubst

ance)

Not

sure

Not

applicable

Tota

l

4 7 2 4 9 0 9 80 115 3 6 2 3 8 0 8 70 100

Q81 Estimated one-off costs of risk management activities (total number of examples provided)

n

euro0-euro

10 0

00

euro10 0

01 -

euro50 0

00

euro50 0

01 -

euro100 0

00

euro100 0

01 -

euro1 m

illion

euro1-euro

10

million

gt euro

10

million

Not

applicable

Dont

know

Tota

l

euro0-euro

10 0

00

euro10 0

01 -

euro50 0

00

euro50 0

01 -

euro100 0

00

euro100 0

01 -

euro1 m

illion

euro1-euro

10

million

gt euro

10

million

Not

applicable

Dont

know

Tota

l

2 3 9 6 2 0 68 25 115 2 3 8 5 2 0 59 22 100



Q82 Whether risk management activities led to reduction in worker exposure levels to (possible) SVHCs

n

Yes 19 83

No 1 4

Dont know 3 13

Total 23 100

Q83 Estimated number of workers with reducedno exposure to (possible) SVHCs due to risk management activities (total number of examples provided)

n

lt5 w

ork

ers

6-1

0 w

ork

ers

11-2

0 w

ork

ers

21-5

0 w

ork

ers

51-1

00 w

ork

ers

101-2

00 w

ork

ers

gt200 w

ork

ers

Not

applicable

Donrsquot

know

Tota

l

lt5 w

ork

ers

6-1

0 w

ork

ers

11-2

0 w

ork

ers

21-5

0 w

ork

ers

51-1

00 w

ork

ers

101-2

00 w

ork

ers

gt200 w

ork

ers

Not

applicable

Donrsquot

know

Tota

l

2 9 8 5 2 0 1 68 0 95 2 9 8 5 2 0 1 72 0 100

Q84 Whether risk management activities led to reduction in emissions of (possible) SVHCs to the atmosphere

n

Yes 9 39

No 8 35

Dont know 6 26

Total 23 100



Q85 Estimated annual reduction in emissions of (possible) SVHCs to air (the atmosphere) after implementing risk management activities (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

6 1 0 0 0 0 0 25 13 45 13 2 0 0 0 0 0 56 29 100

Q86 Whether risk management activities led to reduction in emissions of (possible) SVHCs to wastewater

n

Yes 5 22

No 12 52

Dont know 6 26

Total 23 100

Q87 Estimated annual reduction in emissions of (possible) SVHCs to wastewater after implementing risk management activities (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

7 0 0 0 0 0 0 8 10 25 28 0 0 0 0 0 0 32 40 100



Q88 Whether risk management activities led to reduction in waste sent for appropriate disposaltreatment

n

Yes 7 30

No 11 48

Dont know 5 22

Total 23 100

Q89 Estimated annual reduction in waste generated from (possible) SVHCs sent for appropriate disposaltreatment after implementing risk management activities (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

2 1 1 5 0 0 0 21 5 35 6 3 3 14 0 0 0 60 14 100

Q90 Whether risk management activities led to reduction in volume of (possible) SVHCs required

n

Yes 3 13

No 16 70

Dont know 4 17

Total 23 100



Q91 Estimated annual reduction in volume of (possible) SVHCs required after implementing risk management activities (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

1 1 1 0 0 0 0 12 0 15 7 7 7 0 0 0 0 80 0 100

Q92 Whether risk management activities led to reduction in volume of (possible) SVHCs in finished products

n

Yes 2 9

No 18 78

Dont know 3 13

Total 23 100

Q93 Estimated annual reduction in volume of (possible) SVHCs in finished products after implementing risk management activities (total number of examples provided)

n

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

lt01

tonnes

year

02

-1 t

onnes

year

2-5

tonnes

year

6-2

0 t

onnes

year

21-5

0 t

onnes

year

51-1

00 t

onnes

year

gt100 t

onnes

year

Not

applicable

Donrsquot

know

Tota

l

2 0 0 0 0 0 0 7 1 10 20 0 0 0 0 0 0 70 10 100



Q94 Whether organisation submitted an application for authorisation (AfA) or was covered by an upstream AfA

n

Yes 41 65

No 22 35

Total 63 100

Q95 Whether organisations AfA included specific risk management activities to be implemented after AfA submission

n

Yes 13 32

No but we have carried out further management activities following submission 9 22

No 19 46

Total 41 100

Q96 Whether risk management activities led to reduction in workplace exposure andor emissions to the environment

n

Yes 6 27

No 8 36


Total 22 100

Q97 Whether final opinion has been made by the ECHA Committees on organisations AfA

n

Yes 16 73

No 6 27

Total 22 100



Q98 Whether Risk Assessment Committee recommended andor imposed conditions as part of the AfA decision in relation to risk management measures

n

Yes 12 75

No 2 13


Total 16 100

Q99 Whether complying with conditions as part of the AfA decision has led to a reduction in workplace exposure andor emissions to the environment

n

Yes 5 42

No 4 33


Total 12 100

Q100 Whether respondent has supporting data that they are willing to share regarding these reductions in workplace exposure andor emissions to the environment

n

Yes 1 8

No 5 42

Not applicable (no data available yet) 6 50

Total 12 100



V Changes in market structure

Q103 Whether REACH authorisation has led to market impacts on respondents organisation

n

Yes 46 73

No 8 13

Dont know 3 5

Not applicable 6 10

Total 63 100

Q104 Whether REACH authorisation has led to an impact on organisations production or supply of (possible) SVHCs or alternatives

n

Yes 26 57

No 12 26

Dont know 5 11

Not applicable 3 7

Total 46 100

Q134 Whether REACH authorisation has led to organisation closing or relocating any of its EU production

n

Yes 3 7

No 34 74

Not applicable 9 20

Total 46 100



Q159 Whether REACH authorisation has impacted organisations competitiveness

n

Yes 19 41

No 21 46

Not applicable 6 13

Total 46 100

Q189 Whether REACH authorisation has impacted organisations spending on innovationinvestment opportunities andor RampD

n

Yes 35 76

No 8 17

Not applicable 3 7

Total 46 100

Q244 Whether REACH authorisation has impacted organisations employment

n

Yes 7 15

No 34 74

Not applicable 5 11

Total 46 100

Q274 Whether REACH authorisation has impacted organisations sales revenue

n

Yes 10 22

No 29 63

Not applicable 7 15

Total 46 100



Q304 Whether REACH authorisation has impacted quality price and availability of organisations product

n

Yes 11 24

No 27 59

Not applicable 8 17

Total 46 100

VI Costs incurred during the authorisation process

Q339 Whether organisation provided comments during ECHAs public consultation process

n

Yes 34 54

No 29 46

Total 63 100

Q340 Whether organisation provided comments during ECHAs public consultation process for substances on the Candidate List or their alternatives

n

Yes 22 65

No 12 35

Total 34 100

Q342 Whether organisation provided comments during ECHAs public consultation process for substances on the Authorisation List or their alternatives

n

Yes 23 68

No 11 32

Total 34 100



Q344 Whether organisation provided comments during consultations for AfAs

n

Yes 16 47

No 18 53

Total 34 100

Q346 Main reasons for providing comments throughout authorisation process

n


There was critical information missing 15 19 34 44 56 100

There were inaccuracies in information presented 13 21 34 38 62 100

We disagreed with the resultsfindings presented 14 20 34 41 59 100

We agreedsupported the resultsfindings presented 11 23 34 32 68 100

We were seeking an exemption for a specific usesector 12 22 34 35 65 100


Q348 Whether organisation read published response to their comments

n

Yes and I was satisfied with the response 9 26

Yes but I was not satisfied with the response 15 44

Yes but I canrsquot remember donrsquot have a particular opinion on the response 4 12

No 2 6

I canrsquot remember I donrsquot know 4 12

Total 34 100



Q349 Main reasons for not providing comments throughout authorisation process

n


We believed the information provided was sufficient 8 21 29 28 72 100

We do not have enough staff to be able to respond 11 18 29 38 62 100

Substances and alternatives to date have not been relevant for our organisation 4 25 29 14 86 100

We were not aware of opportunities to comment 2 27 29 7 93 100

We did not have further informationevidence to provide 9 20 29 31 69 100

We did not think commenting would influence the decision 3 26 29 10 90 100

The consultation process was too complex 4 25 29 14 86 100

The information requested was too limited (eg information on alternatives for consultation on AfAs) 1 28 29 3 97 100

There is not enough time available to prepare comments 1 28 29 3 97 100

We did not have the technical expertise required to evaluate the information provided 5 24 29 17 83 100


2 27 29 7 93 100


Q353 Whether respondents organisation incurred costs associated with compliance with REACH authorisation process

n

Yes 45 71

No 9 14

Dont know 5 8

Not applicable 4 6

Total 63 100



Q354 Whether respondents organisation incurred costs by producing and maintaining an (extended) safety data sheet (SDS)

n

Yes 14 31

No 31 69

Total 45 100

Q355 Cost of producing and maintaining an extended SDS

n

euro0 - euro500 1 7

euro501 - euro1 000 2 14

euro1 001 - euro10 000 3 21

euro10 001 - euro50 000 2 14

euro50 001 - euro100 000 0 0

euro100 001 - euro200 000 0 0

gt euro200 000 1 7

Dont know 5 36

Total 14 100

Q356 Whether respondents organisation incurred costs by producing information to enable an (extended) safety data sheet (SDS) to be appropriately updated

n

Yes 9 20

No 36 80

Total 45 100



Q357 Cost of updating an extended SDS n

euro0 - euro500 0 0

euro501 - euro1 000 2 22

euro1 001 - euro10 000 3 33

euro10 001 - euro50 000 1 11

euro50 001 - euro100 000 0 0

euro100 001 - euro200 000 1 11

gt euro200 000 2 22

Dont know 0 0

Total 9 100

Q358 Whether respondents organisation incurred costs by providing information to allow safe use of an article

n

Yes 10 22

No 35 78

Total 45 100

Q359 Cost of providing information to allow safe use of an article

n


euro501 - euro1 000 1 10

euro1 001 - euro10 000 2 20

euro10 001 - euro50 000 0 0

euro50 001 - euro100 000 0 0

euro100 001 - euro200 000 5 50

gt euro200 000 1 10

Dont know 0 0

Total 10 100



Q360 Whether respondents organisation incurred costs by updating a registration dossier following AfAs

n

Yes 8 18

No 37 82

Total 45 100

Q361 Cost of updating registration dossier following AfAs

n

euro0 - euro500 0 0

euro501 - euro1 000 0 0

euro1 001 - euro10 000 2 25

euro10 001 - euro50 000 3 38

euro50 001 - euro100 000 1 13

euro100 001 - euro200 000 1 13

gt euro200 000 1 13

Dont know 0 0

Total 8 100

Q362 Whether respondents organisation incurred costs by notifying DUs of authorised uses

n

Yes 8 18

No 37 82

Total 45 100



Q363 Estimated costs of notifying DUs of authorised uses

n


euro501 - euro1 000 0 0

euro1 001 - euro10 000 3 38

euro10 001 - euro50 000 0 0

euro50 001 - euro100 000 1 13

euro100 001 - euro200 000 0 0

gt euro200 000 3 38

Dont know 0 0

Total 8 100

Q364 Whether respondents organisation incurred costs by complying with reporting obligations in their authorisation decision and preparing the review report

n

Yes 9 20

No 36 80

Total 45 100



Q365 Cost of complying with reporting obligation in authorisation decision and preparing the review report

n

euro0 - euro500 0 0

euro501 - euro1 000 0 0

euro1 001 - euro10 000 3 33

euro10 001 - euro50 000 4 44

euro50 001 - euro100 000 0 0

euro100 001 - euro200 000 0 0

gt euro200 000 2 22

Dont know 0 0

Total 9 100

Q366 Whether respondents organisation incurred costs by familiarising themselves with REACH authorisation requirements

n

Yes 40 89

No 5 11

Total 45 100

VII Small and medium-sized enterprises (SMEs)

Q370 Whether respondents organisation is an SME n

Yes 20 32

No 43 68

Total 63 100



Q371 Type of AfA respondent has been involved in

n



7 13 20 35 65 100

Joint application (group of actors came together) 4 16 20 20 80 100

Individual application (I applied for my own use only) 3 17 20 15 85 100

Donrsquot know 8 12 20 40 60 100

Q372 Top 3 challenges with AfAs

n


Understanding what data is required 11 9 20 55 45 100

Resources required for preparing applicationmy organisationrsquos inputs 15 5 20 75 25 100

Collecting the necessary data 10 10 20 50 50 100

Timescales for providing further information post-submission 2 18 20 10 90 100

Costs of preparing an AfA 9 11 20 45 55 100

Costs and effort of meeting requests for further information post-submission 1 19 20 5 95 100



Q373 How helpful REACH authorisation guidance and other information on ECHA website is

n

Very helpful 1 5

Helpful 5 25

No opinion either way 4 20

Not helpful 4 20

Very unhelpful 0 0

I did not use any of this information 6 30

Total 20 100



Q374 Sources of support used

n


Manufacturerimporter of the SVHC 9 11 20 45 55 100

Other applicants who have been through the process 4 16 20 20 80 100

Relevant tradesector association 5 15 20 25 75 100

Consultants who know about REACH authorisation 11 9 20 55 45 100

Member State Competent Authority(ies) including national helpdesks 1 19 20 5 95 100

ECHA helpdesk 2 18 20 10 90 100

Review other applications and opinionsdecisions that are publicly available 3 17 20 15 85 100

None of the above 3 17 20 15 85 100

Q375 Top 3 challenges with REACH authorisation process

n


Understanding what is required how am I affected 13 7 20 65 35 100

Cost of preparing an AfA (or providing data to the applicant) 8 12 20 40 60 100

Internal staff time required for preparing an AfA 11 9 20 55 45 100

Finding possible alternatives to the SVHC in question 11 9 20 55 45 100

Assessing the ldquosuitabilityrdquo of alternatives 9 11 20 45 55 100





ANNEX G STAKEHOLDERS CONTACTED

This annex sets out a list of stakeholders contacted as part of this study

G1 Member State Competent Authorities

Table G01 sets out Member State Competent Authorities (MS CAs) that were invited to complete the questionnaire about the administrative burden of

the REACH authorisation process These stakeholders were first contacted by the EC

Table G01 Stakeholders invited to take part in a MS CA questionnaire

Member State Competent Authority

Austria

Belgium

Bulgaria

Denmark

Finland

France

Germany

Hungary

Ireland

Italy

Lithuania

Luxembourg

Netherlands

Norway

Poland



Portugal

Slovakia

Spain

Sweden

UK

G2 NGOs

Table G02 sets out stakeholders that were invited to take part in the NGO online survey These stakeholders were contacted by phone or sent an email

when it was not possible to speak to them over the phone

Table G02 Stakeholders invited to take part in the NGO online survey

Organisation

BEUC - The European Consumer Organisation

Center for International Environmental Law (CIEL)

Chemicals Health and Environment Monitoring (CHEM) Trust

ChemSec (International Chemical Secretariat)

Clean Production Action

ClientEarth

Cruelty Free International

Darmstadt University of Applied Sciences

Department of Environmental Science and Analytical Chemistry ndash Stockholm University

European Association for Chemical and Molecular Sciences (EuCheMS)

European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC)

European Coalition to End Animal Experiments (ECEAE)



European Consensus Platform for Alternatives (ECOPA)

European Environmental Bureau (EEB)


Friends of the Earth Europe

Green Chemistry Centre of Excellence - University of York

Green Chemistry Network

Greenpeace

Health amp Environment Alliance (HEAL)

Health Care without Harm (HCWH) Europe

Italia Nostra ONLUS

Knowledge Transfer Network

National Federation of Womenrsquos Institute

RISK Consultancy

Royal Society of Chemistry

Society of Chemical Industry

Trades Union Congress

Wemos Foundation

Wildfowl amp Wetlands Trust (WWT)

G3 Industry

Table G03 sets out stakeholders that were invited to take part in the industry online survey These stakeholders were directly contacted by phone or

sent an email when it was not possible to speak to them over the phone Some additional stakeholders were also contacted indirectly by their

sectortrade associations or via ECHA (eg applicants) These stakeholders are not included in this list



Table G03 Stakeholders invited to take part in the industry online survey

Organisation

ALPA SpA

ADS Group

Agas

Agnico-Eagle Finland Kittilauml Mine

Agosi Allgemeine Gold- und Silberscheideanstalt AG

AISE - International Association for Soaps Detergents and Maintenance Products

AkzoNobel

Alcantara SpA

AmCham EU (American Chamber of Commerce to the European Union)

Ames Goldsmith

Andritz Hydro

Anglo Platinum Management Services (Pty) Ltd

Apple

ArcelorMittal Europe

Association of European Automotive and Industrial Battery Manufacturers (EUROBAT)

Atotech Deutschland GmbH

Aurubis AG

Baaske Oberflaumlchenveredlung GmbH

Banner Batterien GmbH

Banner Chemicals

BASF Catalysts

BASF SE

Bayer AG

Belinka doo



Biacchessi GmbH amp Co KG

BIAL

Boeing

Boliden Harjavalta Oy

Bolta Werke GmbH

Boncrom SL

Borealis

Brenntag Nederland BV

British Association for Chemical Specialities

British Coatings Federation

British Plastics Federation

British Retail Consortium

Brominated Compounds Consortium

Burello Srl

Business Council for Sustainable Development (UK)

BusinessEurope

C Hafner GmbH amp Co KG

CEFIC

Cendres amp Metaux Holding SA

CEPE - European Council of the Paint Printing Ink and Artists Colours Industry

Cepsa

Chamber of Commerce Austria

Chemical Business Association

Chemical Industries Association

Chemtura Corporation



CHIMET SpA

Chrom ndash Muumlller Metallveredelung GmbH

Chromates Consortia lead (CTAC and CCST)

Chrom-Schmitt GmbH

Circa Group


Clariant Produkte (Deutschland) GmbH

Cobalt Reach Consortia (CoRCCDI)

Collini GmbH

COMMERZBANK AG Luxembourg

Concawe

COOP

Cosmetics Europe

Coventya Ltd

Cromados Estevez SL - Autocromes

Dell

DETIC

DEZA as

DLAC Dienstleistungsagentur Chemie GmbH

Doduco GmbH

DOURECA - Produtos Plaacutesticos Lda

DOW

Dr Hesse GmbH amp CIE KG

DSM

DuPont (UK) Ltd



Ecobat Technologies

EEF - The Manufacturers Organisation

Electroquimica De Hernani SA

Eli Lilly and Company

ELIN Motoren GmbH

EMCEF

ENTEK

Environmental Services Association

Ercros SA

Essenscia

Estalki

Etienne Lacroix

ETRMA

EurEau

Eurohueco SAU

Eurometaux

European Association of Environmental and Resource Economists (EAERE)

European Committee for Surface Treatment (CETS)

European Committee of Domestic Equipment Manufacturers (CECED)

European Crop Protection (ECPA)

European Federation of Pharmaceutical Industries and Associations (EFPIA)

European Plastics Converters (EuPC)

European Precious Metals Federation (EPMF)

European Semiconductor Industry Association (EECA-ESIA)

European Space Research and Technology Centre



European Trade Union Institute (ETUI ETUC)

Europeacuteenne de Lyophilisation SA

Exide Technologies SA Polang

FHoffmann-La Roche Ltd

Fachvereinigung Edelmetalle eV

FCIO - Fachverband der Chemischen Industrie Oumlsterreichs


FEFCO

FERRO GmbH

Fertilizers Europe

Festo AG amp Co KG

Fipra

Galvacon

Galvano Roumlhrig GmbH

Gamarti SL

Gammacolor srl

GE Healthcare Bio-Sciences AB

Glass Service as

Glencore Xstrata Nikkelverk AS

Goodyear

Green Coat SRL

Grohe AG

HampR Oumllwerke Schindler

Handy amp Harmann

Heimerle amp Meule GmbH



Heraeus Group

Herbert Bauer GmbH amp Co KG

HM

Honeywell

HP

Hunstman

Huta Cynku Miasteczko Slaskie

ICL

IDT

IHI Hauzer Techno Coating BV

IKEA

ILZRO

IMA-Europe

Indestructible Paint Ltd

Ineos

INOVYN Chlorvinyls Limited

International Antimony Association

International Zinc Association

INTERTEK France (Columbia Chemical)

Janssen - Pharmaceutical Companies of Johnson amp Johnson

Jobatec

Johnson Matthey Plc

Karl Simon GmbH amp Co KG

KCM 2000 SA

KCM AD



Kemira Oy

Kesseboumlhmer Beschlagsysteme GmbH amp Co KG

Keyser amp Mackay

KGHM Polska Miedz SA

K-I Chemical Europe SANV

KIESOW DRBRINKMANN GmbH amp Co KG

Kingfisher

Kludi GmbH amp Co KG

Koppers

Kunststofftechnik Bernt GmbH


Lanxess Deutschland GmbH

Lead REACH Consortium

LKS Kronenberger

Lyondell Basel

MacDermid

Maier Group

Menage amp Confort Centro de Produccioacuten

Metallo-Chimique

Metalor Technologies France SA

Microporous GmbH

Montanwerke Brixlegg AG

MTV Metallveredlung GmbH amp Co KG

MVA Metallveredelung Helmut Ansorge

Nickel Institute



Non-Ferrous Alliance

Nord Chrome

Nordenhamer Zinkhuumltte GmbH

Norilsk Nickel Harjavalta Oy

Oberflaumlchenchemie Dr Klupsch GmbH amp Co KG

OcheseSCL

Oerlikon

Olin Corporation

Olon SpA

Omnichem

Organoclick

Ovako Twente BV

PAMP SA

Parker Hanifin

Partec Partner der Technologie GmbH

Paxymer

Pfizer

Plating Brap SA

Polynt Composites France

PPG Aerospace

PPTA

Praumlzisionsgalvanik GmbH Wolfen

Profel

Profin Protective Finishing Ltd

PX Services SA



R A Chilton Ltd

RAG

Ravago Monotez SA

REACH Centrum

REACHLaw Ltd

Reco SL

Reconsile

REHAU AG + Co

Rheinmetall Waffe Munition GmbH

Rolls-Royce plc

ROQUETTE-Lestrem

Rosenberger Hochfrequenztechnik GmbH amp Co KG

Roxel (UK Rocket Motors) Limited

Safimet SpA

SAFT Batteries

Sasol Wax GmbH

Saudi Arabian Industries Corporation (SABIC)

Savroc

SAXONIA Edelmetalle GmbH

Schloetter

Sempsa Joyeria Plateria SA

Shell

SK USS

Skanska

Socieacuteteacute des Fonderies de Plomb de Zellidja (Maroc)



Solutia

Solvay SA

Sopo International Ltd

Southwest Metal Finishing Ltd

SPGPrints BV

ST Microelectronics

STI Deutschland

Sunpor Kunststoff GmbH

Surface Design Srl

Surface Engineering Association (SEA)

Sveriges Byggindustrier (The Swedish Construction Federation)

Talleres Acro SA

Tanaka Kikinzoku Kogyo KK

Tata Steel

TCO Development

Technocorp Holding SA

TechUK

The Association of European Producers of Steel for Packaging (APEAL)

Thoma Metallveredelung GmbH

Thyssen Krupp

Traxys

TUPAI SA

U S Steel Kosice sro

UEAPME (European Association of Craft Small and Medium-Sized Enterprises)

UK Cleaning Products Industry Association



UMICORE AG amp CoKG

UMICORE Olen

UMICORE Precious Metals Refining

Unifrax

Unilever

United Technologies Corp

Valcambi SA

VALE Europe Ltd

VECCO

Versalis SpA

Vilaelectroquimica SA

Vlisco

VNCI

VWR

Wafa Spain SA

Walzen Service Center GmbH

West and Senior Ltd

Wilhelm Bauer GmbH amp Co KG

Wilhelm Grillo Handelsgesellschaft mbH



ANNEX H TIER 1 SUPPORTING ANNEX (FOR SECTION 10)

REACH registrants

Number of active

registrants (132017) 23

List of active


BASF Nederland BV Groningensingel 1 Postbus 1019 6801 MC Arnhem Netherlands

BONDEX TRADING LTD in its legal capacity as Only Representative of Aktyubinsk Chromium Chemicals Plant Kazakhstan 125 Wood Street EC2V 7AN London United Kingdom

CHEMICAL INSPECTION amp REGULATION SERVICE LIMITED Unit 1 Ardee Business Park Hale Street Co Louth Ardee Ireland

CHEMICAL INSPECTION amp REGULATION SERVICE LIMITED Singleton House Laurence Street Co Louth Drogheda Ireland

Chemservice SA (H5P7) 5 an de Laengten 6776 Grevenmacher Luxembourg

Clariant Produkte (Deutschland) GmbH Am Unisys-Park 1 65843 Sulzbach am Taunus Germany

Clariant Produkte (Deutschland) GmbH - US01 Am Unisys-Park 1 65843 Sulzbach am Taunus Germany

CROMITAL SPA in its legal capacity as Only Representative of Soda Sanayii AS Strada Quattro Pal A7 - 20090 Assago (MI) Italia 20090 AssagoMilano Italy

EGIS Pharmaceuticals PLC Keresztuacuteri uacutet 30-38 H-1106 Budapest Hungary

Elementis Chromium LLP in its legal capacity as Only Representative of Elementis Chromium Inc Elementis Chromium Eaglescliffe TS16 0QG Stockton on Tees United Kingdom

Evonik Degussa GmbH Rellinghauser Strasse 1 - 11 C-ES 45128 Essen Germany

Gentrochema BV Esdoornlaan 19a 4254 AT Sleeuwijk Netherlands

Grupa Azoty SA ul Kwiatkowskiego 8 33-101 Tarnow Poland

Haldor Topsoe AS Nymoslashllevej 50 DK28000 Lyngby Denmark

LANXESS Deutschland GmbH in its legal capacity as Only



Representative of LANXESS CISA (Pty) Ltd Kennedyplatz 1 50569 Koumlln NRW Germany

momaja sro Karolinskaacute 6501 186-00 Prague 8 Czech Republic

REACHLaw Ltd Vaumlnrikinkuja 3 JK 21 02600 Espoo Finland

REPSOL QUIacuteMICA Calle Mendez Alvaro 44 28045 Madrid Spain

RusChrome GmbH Industriestrasse 4 70565 Stuttgart Germany

SABIC Petrochemicals BV Europaboulevard 1 6135 LD Sittard Netherlands

Sustainability Support Services (Europe) AB Markaskaumllsvaumlgen 6 22647 Lund Sweden

Total Petrochemicals Antwerpen NV Scheldelaan 4 2030 Antwerpen Belgium

[Confidential] [Confidential]

Number of inactive


2

List of inactive


Johnson Matthey PLC 5th Floor 25 Farringdon Street EC4A 4AB

London United Kingdom

RS Bruce (Metals amp Machinery) Ltd March Street Darnall S9 5DQ Sheffield United Kingdom

Tonnage band

registration

10000 ndash 100000 tpa

Alternatives according to SUBSPORT



In the same document reference is made to a screening of alternatives for the use of hexavalent chromium compounds against SUBSPORT Screening

Criteria (SDSC)

The alternatives that pass the screening against the SDSC are for anti-corrosive and decorative coating



Physical Vapor Deposition (PVD)Chemical Vapor Deposition vacuum process with titanium nitride (CAS 25583-20-4) or chromic nitride (CAS 24094-

93-7) or tungsten carbide (CAS 12070-12-1)

Heat treatment gas nitriding with ammonia (CAS 7664-41-7) plasma nitriding with nitrogen

for plastic pigments

chrome antimony titanium buff rutile (CAS 68186-90-3)

niobium sulfur tin zinc oxide (CAS 1374645-21-2)

for leather tanning

chromium (III) sulphate (CAS 10101-53-8)

aluminium chloride basic (CAS 1327-41-9)

zirconium sulphate (CAS 14644-61-2)

iron (II) sulphate (CAS 7720-78-7)

wattle bark myrobolan nuts chestnut

for textile deying mordants

potassium aluminum sulphate (CAS 10043-67-1)

stannous chloride (CAS 7772-99-8)

copper sulphate (CAS 7758-98-7) iron (II) sulphate (CAS 7720-78-7)

sulfated castor oil (CAS 8002-33-3) disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2- sulphonatophenyl]azo]-45-dihydro-3-methyl-5-oxo-1H-

pyrazol-1-yl]-25- dichlorobenzenesulphonate (CAS 70247-70-0 )

tetrasodium 4-amino-5-hydroxy-36-bis[[4-[[2- (sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-27-disulphonate (CAS 17095- 24-8)

for wood treatment

copper oxide (CAS 1317-38-0) didecyldimethylammonium chloride (CAS 7173-51-5)

copper oxide (CAS 1317-38-0)and alkyldimethylbenzylammonium chloride (CAS 8001-54- 5)

EU supported projects and RampD to eliminate hexavalent chromium

Project Description

CRAFT Prevention of chromium(VI) formation by improving the tannery processes (1999)



Project Description

Recy-Chrom 90 of chromium-plating facilities in Europe are SMEs with all resources allocated to the daily work The social and environmental concern related to the toxicity of the chromic acid used in the baths is leading the sector to a difficult decision the investment in very complex and expensive systems to control and reduce the emissions could lead them to a non-competitive position The basic objective of RECY-CHORM is to develop and validate a new system to recover chromium from the rinsing bath using a clean technology such as electro-electrodialisis (EED) with 3 compartments which does not need either water or chemical products to work This system will be modular portable and cheap to be affordable and valuable for SMEs For this to be achieved the consortium has been formed with partners skilled in different technologies involved (membranes electrodialisis raw material recovery and surface treatments) as well as planting industries to validate the results

Ecochrom Electrolytic hard chrome-plating is the most used wear resistant process for engineering industries aeronautic steel-or paper-makers The major drawback is that it uses CrVI classified as carcinogenic by the International Agency of Search on Cancer The likely banning of CR VI in the years to come and need of successful coatings opened the way to interesting expensive and difficult replacement techniques often impossible on big parts That is why electrolytic chrome-plating will remain the process of choice with two conditions provide guarantees to employees and environment compete with techniques of replacement in terms of performance The object of the proposal is to study and develop processes allowing to obtain thick chromium coatings more successful than the traditional ones from a new and non toxic electrolytic solution Developed processes will be applicable to chromium platers without major modifications of installations

Hardalt The aim of this project is to eliminate the use of hard chromium plating across the European electroplating industry by delivering a suitable substitute which will be based on nano structured Ni-P and Ni-P composite coatings (with for example SiC or BC as reinforcing nanoparticles)

The successful outcome of the HardAlt project will lead to the reduction or even elimination of the use of hexavalent chromium in the electrodeposition industry thereby circumventing EU legislation As HardAlt coatings will exhibit equivalent or even enhanced functional properties compared to hard chrome they will be adopted by the metal working industry in applications where wear and corrosion resistance is of critical importance The three most common



Project Description

applications of Hard Chrome that will be targeted have been identified as

Hydraulicpneumatic pistons and cylinders

Specialized oil and gas exploration equipment

Moulds and press tools

Significant benefit will be the customization of the HardAlt coatings to the need of each application whilst using the same bath thereby leading to savings in raw materials and the minimizing of waste from the electroplating industry

SAMDOKAN The main goal of SAMDOKAN project is to industrialize a novel hexavalent chrome Cr(VI) free environmentally friendly high performance electroplating pre-treatment for plastic surfaces using molecular self assembly nanotechnology (SAM) Sectors such as automotive white goods electric-appliances and sanitary are the main consumers of this type of plastic parts In Europe about 1350 companies have chrome plating installations of which over 98 are SMEs SAM technology has been already demonstrated in ECOSAM FP 6 project to be a successful alternative to the traditional electroplating technology SAMDOKAN project objectives are aligned with Eco-innovation programme since an eco-innovative production methodology will be industrial scale-up which aims to prevent and reduce environmental impacts such as the generation of potentially hazardous waste going to landfill andor incineration transport associated to this waste etc The specific objectives of the project are the following To scale up the SAM pre-treatment process in three electroplater companies and plastic types 100 elimination of carcinogenic chromic acid (Cr (VI)) and toxic PdSn colloids in the pre-treatment process at industrial scale This means a reduction of 5 steps in the pre-treatment process a 30 in total reactive consume and a reduction of 35 of clean water consume An overall 20 cost reduction of the pre-treatment can be achieved Increase the production capacity of current plants in at least 25 and a reduction in 50 of total energy consumption To expand the electroplating market on a broader range of plastics and to provide end-users a greater scope for design (filled polypropylene (PP) and filled polyamide (PA)



Project Description

No health concerns (water based treatments and low toxicity chemicals for electroplating pre-treatment process and for waste water treatment) Reduction of 3 plastics consumption due to a reduction of rejected parts and thickness of plastic parts

httpwwwsamdokanprojecteu



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doi 102873769886

ET-0

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