Welcome to our Stakeholders’ Dayqsb.webcast.fi/e/echa/echa_2017_0405_stakeholders_day... · 2017. 4. 5. · Welcome to our Stakeholders’ Day 5 April 2017 Ask questions and give

Welcome to our Stakeholders’ Day5 April 2017

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Geert DANCETExecutive DirectorECHA

• 2004-2007 - Head of the REACH Unit in the European Commission’s Directorate General for Enterprise and Industry

• 1986 - joined the European Commission

Opening address

12th Stakeholders’ Day

Geert Dancet

Executive Director

European Chemicals Agency

5 April 2017

Thank you for joining us

• 240 in the room – more online

• From 42 countries (Europe, Africa, Americas, Asia)

• 176 companies and 23 associations

• 35 SMEs

• 170 took part in IT tool training

• 80 one-to-one sessions

You want and we aim to provide

• More practical examples

• More interaction

• IT tool training web-streamed

• One-to-one sessions: more time and possibility to discuss in your own language

This is a crucial year

• Preparing your registration for 2018

• Pre-register by 31 May 2017

• Make sure your registration meets theREACH & CLP requirements

• Our completeness check is nowmore thorough to make sureyou get it right

You’re not alone…

• Thousands of companies have registered

• Help is there – online, helpdesks, sector bodies

• ECHA dispute resolution

• Directors’ group: ECHA, Commission and industry

• Identifies and resolves most challenging issues for REACH 2018 – for example access to finance and SIEFs after 2018

• Contact your industry association to raise issues

My last year as Executive Director

• Making REACH a success has been my mission

• Not going to stop now

• We are ready to help and receive registrations

• Things are achievable for small companies -cloud

• My successor will lead you to the deadline

• Safer chemicals by 2020 – we’ve all played ourparts!

10 years of REACH and ECHA

• Our story started 10 years ago

• Learning from the experience:

• Litigation seminar on 24 May

• Conference on 7 June

• Memory wall and video of staff

• Thank you all for ten cooperativeand productive years!

Save the dates for last minute help

REACH 2018 Spring School

15-19 May 2017

Stakeholders’ Day

30-31 January 2018

Wishing you a very successful year

Follow us!

News: echa.europa.eu/subscribe

Twitter: @EU_ECHA

Facebook: @EUECHA

LinkedIn: European Chemicals Agency

YouTube: EUchemicals

[email protected]

Christel

MUSSETDirector of RegistrationECHA

• Joined ECHA in 2007

• Responsible for all activities related to the registration process under REACH

• Before joining ECHA, worked at the European Chemicals Bureau (ECB) of the Joint Research Centre (JRC) where she coordinated the development of IT systems for REACH

Seven phases to successful registration


Christel Musset

5 April 2017, Helsinki

echa.europa.eu/reach-2018

Registration at the core of REACH

What is at stake?

Better knowledge of hazards, uses and risks

Improved communication in the supply chain

Better safety and control measures

Reduce exposures and hence negative impacts

Substitute (gradually) hazardous substances with less hazardous ones


Registration and classification: starting point for pro-active product stewardship

Registration dossier is vital

It demonstrates that:

• You know your portfolio

• All necessary information is available

• Your clients are informed adequately on how to safely use your substances


Provides confidence to authorities, your investors and clients

And are watched by the authorities!

One year to go!

2017 2018 2019

8 350 registrations

4 250 substances

SepJun

Deadline

extended completeness check

(3 months)

Mar

60 000 dossiers 20 000 substances (estimates)

normal completeness

check(21 days)

350 dossiers/week

Number of dossiers

Deadline completed

>8 000dossiers/week

Mar

Know your portfolio

Find co-registrants

Share data

Prepare your dossier

Submit your registration

Keep your registration up-to-date

Assess hazards and risks

7 phases to get prepared

Know your portfolio

• Identify if you need to register and if the substances in your portfolio need to be registered

• Unambiguous substance identification

• Essential for data sharing and joint submission

• Letter of access: helps you verify that data from lead registrant is suitable for your substance

• Sector specific guidance on ECHA’s website

• Plan your work and inform your downstream users


Substance identification

• Substance identity information is company-specific

• Detailed composition and analytical data

• More advice on specific cases: Q&As - Substance identity

• Improved format in IUCLID 6

• More transparent reporting

• Scope of joint submission in the substance identity profile (SIP)

• Specific fields for reporting information on nano forms

• May be checked manually during completeness check

• Inconsistencies e.g. between name and composition

• Manufacturing process for UVCB substances


https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/scope/reach/substanceidentification

Nanos: updated guidance

• Existing guidance updated based on:

• Developments in regulatory science

• Increased knowledge at OECD level

• Experience gained in doing evaluations

• To be available by May 2017:

• Identification of nanoforms (new how to guide)

• Read across and grouping between nanoforms of the same substance (new guidance)

• Nano specific advice for human health and environmental endpoints (guidance update)


Find your co-registrants

• Check your pre-registration

• Discuss substance sameness

• Joint submission for the same substance is mandatory - even in case of opt-out

• Opt-out

• Duly justified – this may trigger a compliance check

• Lead registrant

• You need the consent of the SIEF members

• Inform ECHA in case of difficulties and bring evidence


List of lead registrants


List of substances with lead registrants

https://echa.europa.eu/documents/10162/5039569/registration_statistics_lr_js_en.pdf/cf1c8cd9-890d-4277-bc1e-740bd6eab2bb

Newcomer to the market?

• Pre-registration still possible until 31 May 2017 for substances with registration deadline on 31 May 2018

• After that, the substance needs to be registered before it can be manufactured/imported

• First step: inquiry to ECHA

• You will be in contact with existing registrants

• R&D substance or process in development?

• You can get a 5-year registration exemption (PPORD)

• Only to listed customers


Data sharing

• Get organised and active in the SIEF

• Model data sharing agreements available with your sector organisations

• Make sure to cover future costs

• Negotiate costs in a fair, transparent and non-discriminatory manner

• But… there is a price to pay for quality dossiers

• Data sharing dispute can be submitted to ECHA


Assess hazard and risk

• Information required depends on tonnage and uses

• 1-10 tonnes: possible reduced data requirements for less hazardous substances

• Verify Annex III inventory – ECHA

• Justification needed in IUCLID 6

• Get quality right: relevant, transparent, reliable

• Animal testing is a last resort

• Consider alternatives

• Use the QSAR Toolbox


https://echa.europa.eu/information-on-chemicals/annex-iii-inventory

Guide for SME managers


• Advice tailored to business managers

• Simple-term explanations of the information required

• 1 to 10 tonnes/year registrations

• 10 to 100 tonnes/year registrations

• Reference document for future business decisions

Chemical safety report


• Step by step chemical safety assessment

• Comprehensive help text

• Synchronise with your IUCLID dossier

• Import use maps, standard phrases

• Generate automatic chemical safety report

• Prepare exposure scenarios for safety data sheets

• Facilitate updates

Needed for substances > 10 tonnes


• Prepare your IUCLID dossier

• Identify the registrant• Identify the substance• Information on the substance’s intrinsic

properties• Information on use and exposure

• Chemical safety report annexed if above 10 tonnes/year

• IUCLID is free of charge




• One-click installation

• Integrated help

• More structure for reporting substance identification, uses and hazard data and improving data quality

• Members who fully rely on lead registrant’s dossier can prepare their dossier in REACH-IT


Latest version of IUCLID always

available

Data stored and backed up by ECHA)

Data access from anywhere anytime

Better online support

No cost for managing installations and

hardware

Less need for manual exchange of data

New in 2017!

Service for SMEs:IUCLID online


• Check and update the information in REACH-IT

• Carefully assess your SME status

• Set up or join the joint submission in REACH-IT

• Submit your registration dossier: first the lead registrant, then all co-registrants

• Manual step introduced in completeness check

• Follow up on the communication in the REACH-IT message box


• More intuitive user interface

• Extensive help within the tool

• Help available in all EU languages

• Improved means to find existing joint submissions and lead registrants



Step-wise support available


• Introduction to the topic

• Three levels of information

• Collection of links to more material

• Explanatory webinar

REACH 2018 Spring School

• Intensive REACH 2018 week

• Live Q&A tied to re-runs of our webinars

• Practical examples for each of the phases

• Animated videos

• Save the date: 15-19 May


More help?

• National helpdesks central in supporting SMEs

• In your own language

• Contact ECHA if

• questions on your submission, e.g.

• your dossier is blocked or

• you don’t understand ECHA’s instructions for re-submission

• need technical support with the IT tools for registration

• Sector organisations

• For practical knowledge

• Can help harmonise information (exposure scenarios)

• Some have working groups or mentoring programmes

•37echa.europa.eu/reach-2018

Take home messages

• Registration is challenging but manageable

• Have a solid plan for managing your registrations by the 2018 deadline

• Support is available from ECHA, national authorities and industry organisations

Remember to keep your registration up-to-date!

Subscribe to our news: echa.europa.eu/subscribe

Follow us on:

[email protected]

https://twitter.com/eu_echa?lang=fi


https://www.youtube.com/user/EUchemicals


https://www.facebook.com/EUECHA/


https://www.linkedin.com/company/european-chemicals-agency


•Laurence HOFFSTADT•Evaluation, ECHA

• Contributes to the evaluation of registration dossiers and the development of supporting material for registrants

• Holds a PhD in toxicology

12th Stakeholders’ day 5 April 2017, Helsinki

Laurence Hoffstadt

Missing data? How to get it

Contents

• What information do I need?

• 1-10 tonnes per year (REACH Annex VII)

• Low risk substances

• 10-100 tonnes per year (REACH Annex VIII)

• How to fill in data gaps?

• Strategy for testing

• Animal testing as last resort

• Regulatory alternatives

• Cost and timelines

•echa.europa.eu/reach-2018


Support from ECHA

Roadmap 2018: phase 4 support material

Practical guide for SME managers and REACH coordinators: How to fulfil your information requirements


• Depends on your type of registration

• Intermediate, under strictly controlled conditions all available data (independent of tonnage)

• Standard registration depends on your tonnage band

What data do I need?

https://echa.europa.eu/support/registration/what-information-you-need

https://echa.europa.eu/support/registration/what-information-you-need


Annex VII: physico-chemical, environmental and mammalian properties

One test on an animal

Low risk substances

• If a low risk substance, reduced requirements = only physico-chemical properties

• Justification

• Criteria in Annex III

• List of substances requiring a full data set

1-10 tonnes per year


Annexes VII +VIII: physicochemical, environmental and mammalian properties

Updated requirements

• Irritation potential for skin and eye

• Sensitising potential for skin

• Accepted by ECHA

Fewer tests on animals – only as last resort

• If in vitro not allowing classification

• If no acceptable alternative

• Submit proposals for some tests

Submit a chemical safety report

10-100 tonnes per year

Tips

Main tests should be there – your right to be on the market

Good quality information – it will be reviewed by ECHA

• Alternatives to be used – recommendations in ECHA’s guide

• Reduces future work and costs

• Main aim is to use chemicals safely

Support is here – ECHA and helpdesks


Overview

• What information do I need?

• 1-10 tonnes per year (REACH Annex VII)

• Low risk substances

• 10-100 tonnes per year (REACH Annex VIII)

• How to fill in data gaps?

• Strategy for testing


• Regulatory alternatives

• Cost and timelines



Collect all available

information

Consider information

needs

Identify missing information

Data sharing within the

SIEF

Data of sufficient quality

Data from similar

substances (read-across)

Generate new information

Animal tests ‘as last resort’

‘Waivers’ scientifically

justified

Best strategy forward

Practical guide: How to use alternatives to animal testing

Practical guide: How to use and report QSARs



• Share existing and reliable data and• Use alternative information, i.e. “waivers”

• Ensure scientific and regulatory acceptance • Submit good and reliable information• Provide a robust justification for not running the test - crucial

importance 1. explain in the dossier why the prediction obtained using a

computer model is reliable for your substance2. demonstrate that two existing studies cover the same

criteria as what is required in a newly performed study

Avoid unnecessary animal testing

Regulatory alternatives


• In Annexes, Column 2: Specific rules for each endpoint

Rely e.g. on substance’s properties

When no need to perform a test if properly justified and meets all criteria e.g. C&L and/or risk assessment

• Annex XI – General rules

Rely on well-documented and science-based justification

+ other sections of Annex XI


Weight of evidence

What is it?

= combination of several independent sources of information

When to use?

If a single piece of evidence is not sufficient to fulfil the need

If individual studies give conflicting results or are not of the highest quality

Example: Fulfil the requirement for a property by combining in vitro, read-across and (Q)SAR results

Ensure you submit a justification and supporting data


(Q)SAR

What is it?= Computer models predicting property based on structures, qualitative or quantitative structure-activity relationship

When can I use it? For simpler properties (e.g. physico-chemical properties)

For more complex properties (e.g. repeated dose toxicity)

Example: Use QSAR Toolbox to predict short term toxicity to fish

Always report the reliability and prediction of the model

Check our practical guide for SMEs to see which models are accepted


In vitro tests

What is it?

= experiments performed in a controlled environment

When can I use it?

If environment compatible with substance (e.g. solubility)

If method is well described

On its own

Example: For acute toxicity and as part of weight of evidence approach, neutral red uptake test can be used (see Guidance update)

Always report correctly the information

Always justify the relevant classification


Grouping and read across

What is it?

= Predict a property of a substance (“target”) from data on

one or more substances (“source”)

When can I use it?

If data of good quality; if I can classify

If “source” substances are similar/relevant to “target”

If data on source is not (yet) available

Always submit a scientifically well-documentedjustification

Always submit a data matrix and all supporting data


Costs and timelines

https://echa.europa.eu/support/registration/strategy-for-gathering-your-data

Often contracted out as package of tests – time and cost-efficient

Outcome of certain tests/waivers impact need to perform further tests

https://echa.europa.eu/support/registration/strategy-for-gathering-your-data

Take home…

Have a clear strategy

Animal testing as last resort: share data and consider waivers before testing

Don’t hesitate to challenge your consultant: not all endpoints can be fulfilled with “easier” options

Do a good job! It takes time and scientific input to fill in data gaps


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Fabrice BROECKAERTSenior Scientific Officer, Unit of classification and prioritisation, ECHA

• In charge of coordination of CLP classification dossiers

• European Registered Toxicologist

• 12 years of experience in industrial sectors as regulatory and registration toxicologist

• PhD in industrial toxicology

Classifying your substance: dos and don’ts

12th Stakeholders’ day

Fabrice Broeckaert


Why classify and label?

• Worker and consumer health and safety

• Environmental protection

• Ensure correct storage/handling/transport

• Prevent consumer access to most dangerous substances and mixtures

• Preventing and handling accidents

• Instructions for handling and discarding waste


Classification and labelling vital for REACH


Classification and labelling

Environmental properties

Human health properties

Consequences in other legislationPossible

authorisation

Need for exposure assessment

Physical properties

Classification leads to…


• Effective communication of identified hazards in safety data sheets (SDS) and on labels• Hazard pictograms

• Signal word • Warning (Wng), Danger (Dgr)

• Hazard statement, e.g.• H200 – Unstable explosives

• H301 – Toxic if swallowed

• Precautionary statements, e.g.• P201 – Keep out of reach of children

• P372 – Explosion risk in case of fire

Classification leads to…


• Solid basis for REACH registration dossier and chemical safety report

• Downstream consequences on uses of substances:

• CMRs: prohibited in toys, cosmetics, materials in contact with food, medical devices…

• CMRs exposure reduction at work, in particular for young people

• Active substances in plant protection or biocidal products

New hazard pictograms


Dos: classification

• Apply existing harmonised classification and labelling (CLH) in Annex VI of CLP

• Verify existing harmonised classification and labelling (CLH):

• EURLEX

• Our search for chemicals

• C&L inventory

• REACH registration database


http://eur-lex.europa.eu/homepage.html

https://echa.europa.eu/home

https://echa.europa.eu/information-on-chemicals/cl-inventory

%C3%B7

Dos: classification

• Use decision scheme for revising existing (self)-classification


Dos: self-classification

• Identically to other REACH registrants and/or notifiers of same substance

• Differently from registrants and/or notifiers only if justifiable, e.g. own data, constituents, impurities


Self-classify if no harmonised classification exists


• Collect and assess available data for:

• Physico-chemical hazard properties

• Human health hazard properties

• Environmental hazard properties

• Compare data with classification and labelling criteria


https://echa.europa.eu/documents/10162/23036412/clp_en.pdf/


• Conclude on most appropriate classification and labelling. Record:

• Data lacking

• Data inconclusive

• Data conclusive but not sufficient for classification

• Fill in IUCLID using manual for preparing classification and labelling notifications

• Submit your classification and labelling as part of your REACH registration or update your notification


https://echa.europa.eu/documents/10162/22308542/manual_cl_notif_en.pdf/

Don’t…

• Use the Dangerous Substance Directive (DSD) system for classifying substances

• (Over)classify if your substance does not present hazardous properties


Don’t…

• Forget to specify categories related to specific hazard classes, e.g: Skin Sens. 1A or 1B or 1

• Classify less severely in case of minimum classification in Annex VI of CLP


Classify at least as Acute Tox. 3

Dos: after notification or registration

• Ensure registration and classification and labelling inventory notifications are up-to-date

• Submit a harmonised classification and labelling proposal to ECHA’s Risk Assessment Committee via a Member State or ECHA:• Industrial chemicals only and under certain conditions

(fees may apply)

• Possibility to classify, to update or to remove your substance from Annex VI of CLP

• Non-confidential data only, based on REACH dossier and possibly data submitted during Public Consultation

• Opinion by Risk Assessment Committee, decision by Commission


Dos: classifying your mixture

• Classify all mixtures on the market according to legal deadline: 1 June 2017

• Classify all mixtures according to tieredapproach for hazard classes where appropriate


Dos: classifying your mixtureTiered approach

Classification based on concentration of ingredients

• With formulas (acute toxicity, environmental hazards)

• With concentration limits as published in CLP

Bridging principles

• Annex I, part 1

• Sufficient data available for similar tested mixtures and individual hazardous ingredients


Dos: classifying your mixtureTiered approach

Testing: conditional as per CLP and as the latest alternative

• Test data as primary source, when available

• Existing information on whole mixture, tested with adequate, reliable and scientifically valid method

• Classify according to same criteria as for substances


Don’t…

• Use the Dangerous Preparation Directive (DPD) classification system


Conclusions

• Communicate and assess consequences of classification and labelling for your workplace control scheme and for supply chain

• Anticipate possible regulatory actions by ECHA or Member States (restriction, authorisation) and consequences under other EU or national legislation

• Check regularly if your substance is under scrutiny on our website (CoRAP, PACT, Registry of intentions for CLH, SVHC or restriction)

• Investigate possible substitution


Conclusions

• Health and safety concerns can be avoided

• Likelihood of unjustified regulatory attention reduced

• Helps you to be proactive: consider possible long-term consequences and innovation


Take-home messages

• Compulsory to classify and label substances

• Better supply chain communication

• Better understanding of customer needs and demands

• Increased predictability of regulatory action

• Helps focus on marketing and safer use

• Better domestic and international reputation

• Better public perception


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Mercedes VINASHead of unit Dossier Submission and PIC, ECHA

• Oversees ECHA’s activities on the submission and processing of dossiers

• In charge of implementation of the regulations on PIC and CLP

• Working on the implementation of the REACH Regulation since 2004 in the European Commission

• Chemical Engineer with a masters in European Legislation

How to ensure a successful submission

12th Stakeholders’ day

Mercedes Viñas


Contents

• Enhanced completeness check

• Overview

• Manual verification process

• Ensuring level playing field: retrospective checks

• Enforcing joint submission principle

• Ensuring your registration is complete: available help


Completeness check

• Dossiers have to be complete to get a registration number

• “Technical completeness check rules” in place to know what information needs to be provided

• Used by us to verify completeness

• By industry to check before submission

• Completeness check enhanced in 2016 to improve availability of data


Enhanced completeness check

• Since new IUCLID format in 2016

• Well ahead of 2018 registration deadline

• Based on our experience and stakeholder feedback

• Automatic rules reviewed

• New manual verification steps


Manual verification

• Automatic rules have free text field limitations

• Prevents from bypassing the system

• Still in the scope of completeness check (no assessment of quality)


Manual verification: areas of attention

• Unclear substance identity

• Information requirements waived by registrants

• Dossiers include testing proposals

• Chemical safety report missing


Manual verification:first results

• 33% of all incoming dossiers manually verified

• 20% of verified dossiers failed first check

• 95% of failed dossiers successfully updated

• If new submissions fail, no registration number issued


Retrospective checks

• Ensure level playing field for existing and upcoming registrations

• Pilot campaigns in 2016

• Study claimed ‘on-going’ for long time

• ‘Placeholder’ lead dossiers

• First results show registrants are able to fulfil information requirements, e.g. provide a missing study


Enforcing OSOR principle

• One Substance One Registration: joint submission and data sharing a legal obligation in REACH

• Avoid duplication of animal studies

• Reduce costs

• Increase consistency of safe advice


Enforcing OSOR principle

• Regulation in force since 2016 ECHA to

ensure joint submissions

• No submissions outside joint submission possible

• Leads acting without SIEF agreement can be demoted

• Contact us with a dispute in case of a difficult situation


Make sure your dossier is complete

• Run the validation assistant tool in IUCLID: a ‘must’ before submitting

• Consult our help: tips on manual verification

• Follow our webinar on 20 April

• Contact our helpdesk


Take-home messages

• We are taking action to increase availability of data

• Dossiers checked manually

• Actions address both existing and upcoming dossiers

• Joint submission mandatory

• Make use of available help to ensure a successful registration


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Interact with us!




them in that order

4. Give us feedback

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Mike PENMANManaging Director and founder, Penman Consulting

• 40 years experience in managing toxicology, regulatory affairs and information technology globally

• Involved in IUCLID, ECETOC TRA and REACH

• Awarded a UK civil honour for ‘Services to Environmental Safety’

Penman Consulting LtdStanford Mill, Faringdon Road,

Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474

Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698

Mike Penman

ECHA 12th Stakeholders day 5th April 2017

Case Study: Substance Identity

•5 April 2017




Why is it important?

Issues?

Case Studies

Conclusions

Outline - Substance ID

•5 April 2017

•ECHA Stakeholders Day

Page 100




REACH Information Requirement

Art 10 a ii, Annex 2 (2 – 2.3.7)

ECHA page -https://echa.europa.eu/regulations/reach/substance-identity

Explanation and Guidance

IUCLID

Section 1.2 - Composition

Section 1.4 - Analytical data

Substance Identity

•5 April 2017


Page 101

https://echa.europa.eu/regulations/reach/substance-identity




Starting point for any REACH discussion

What is the substance?

Chemical Composition / Physical form

Substance type Mono, multi, UVCB

One Substance One Registration (OSOR)

Link to intrinsic hazard data

Grouping / Read Across / Alternatives

Substance ID - Why it is important

•5 April 2017


Page 102




“Historical” positions

EC List and global Inventories

Availability of analytical data

Complexity of different UVCBs*

Relationship with salts and isomers

Some issues encountered (not exhaustive!)

•5 April 2017


Page 103

*Unknown, of Variable Composition, or of Biological Origin




Manufactures of novel fuels via co-processing with non-traditional feedstocks: vegetable and animal oils

For many fuels, existing EC names reflect feedstock

Also included process description

Addition of non traditional feedstock to the process results in the existing substance name being inaccurate

•5 April 2017


Page 104




Resolution Investment in extensive analytical work on all member

substances Pilot and production

Analytically similar substances “grouped” together Early discussion with ECHA Substance ID unit on naming Development of new names and process descriptors that

reflect emerging industry practice

•5 April 2017


Page 105




Subsequent actions Each Member company

Enquiry process to ECHA Pre discussion allowed for quick response and approval

Basis for OSOR Lead registrants agreed in RFC

Dossier development on basis of analytical data and enquiry process Allowed clear read across to existing data

Registration by Lead and Co-registrants

•5 April 2017


Page 106




Manufactures of Rosins and Rosin derivatives

UVCBs - Complex chemistry

Diterpenic monocarboxylic acids

Neutral fraction

No single constituents present at concentration > 10 %

Thousands of potential component structures

Different categories of derivative depending upon treatment

•5 April 2017


Page 107

Hydrocarbon Resins & Rosin Resins REACH Consortium




28 Substance registrations in 2010

ECHA 2011

Questions on Substance ID and read across of data

H4R

Appreciation that the Substance ID was critical to plausibility of a category approach for read across

How to approach when it is so complex?


•5 April 2017


Page 108




Resolution - H4R developed a common position on identification methodology Reviewed available technologies, made recommendations Gave detailed model spectra and structures Common reference substances for classes

Provided the basis for Individual registrant analysis Common text and interpretation for use in updating dossiers for all

registrants Substance Information Profiles (SIP)

Published on SIEF information pages Allowed development, with other biological data and discussion with ECHA,

consistent and plausible test strategy


•5 April 2017


Page 109




Good quality data and practices critical to success - not just for registration SIEF / Joint Registration communications / understanding Registration (OSOR) Test and read across strategies

Registrant / SIEF led - cooperative working is key Data led - agree on what is required All need to be able to work to the same standard – not exclusive Needs to be understood - over complexity excludes - but some complexity may be necessary! Fit for purpose

Supports confidence in the intrinsic hazard data Current data and any testing plans

Use the tools and help that is available

Observations on Substance ID

•5 April 2017


Page 110




Thank You

•5 April 2017


Page 111

Wera TEUBNERRegulatory toxicologist in the product safety department, BASF Switzerland

• EUROTOX-registered toxicologist

• Specialised in human health hazard, risk assessment of industrial chemicals and (Q)SAR modelling, as well as the application of in-vitro methods

• Diploma in biochemistry and PhD at the German Institute of Human Nutrition

CASE STUDYS:

APPLYING ALTERNATIVE APPROACHES

Dr. Wera Teubner, BASF Schweiz AG

12th Stakeholders` Day, April 5th, 2017 at ECHA, Helsinki, Finnland

Case study 1: In-vitro methods

Alternative methods have become OECD testing guidelines

– In-vitro skin irritation -> OECD 439 since 2010

– In-vitro eye irritation for non-irritants -> OECD 492

since July 2015

- in-vitro/in-chemico skin sensitization assays since

2015 /2016

Today these are standard information requirements

BASF studies were done under GLP and according to

validated protocols

No challenge by ECHA so far

Case study 2: Structural similarity with

mechanistic considerations

Strontium salt (1:1)

Literature/database search

Substance itself

structural analogues

azo reduction products

soluble strontium salts

OECD Toolbox / QSAR

protein binding alerts

genotoxicity alerts

BfR inclusion/exclusion rules for

irritation

CAS 67828-72-2

Identification of structural analogues

and the amine

Data matrix for Annex VII tox endpoints

WoE / read-across for acute oral toxicity

Consistent hazard profile for structural analogues

– covers b-naphthoic acid (BONA) and Strontium

– No mortality observed at or above limit dose in acute

oral studies

Absence of hazard for sulfonated aromatic amine (acute

and subacute oral study)

Poor solubilities in water and octanol point to low uptake

after ingestion, consistent with coloration of feces

Azo bond reduction well described in the literature

WoE / read-across for irritation

Consistent absence of hazard for structural analogues

Differing substitutents do not influence pH or surface activity

Consistent alert pattern (inclusion rules)

– Only alert is «phenols», present in all analogues

Physico-chemical parameters in support of «non irritating»

– BfR Skin and Eye exclusion rules (not corrosive:

octanol solubility of 0.2 mg/L and Tm> 200°C; not

irritating: water solubility <5mg/L)

WoE / read-across for the Ames test

Consistent hazard profile for structural analogues

– covers BONA and Strontium

Absence of hazard for differing sulfonated aromatic amine

Azo bond reduction well described in the literature

Ames tests done with Prival modification

Comparable physico-chemical properties

Approach worked because…

Physico-chemical data on all structural analogues available

prior to decision making

Letter of Access (LoA) / ownership for all data available

(category)

Data holders/registrants experienced in consortia work

Robust study summaries for analogues already written

Also of note: Sweat equity costs spread over several endpoints

Other considerations

standard information alternative strategy

Number of Robust

study summaries oneone for each

contributing study

Need for special

justificationno yes

Risk of challenge no yes

Suitability for other

legislations (eg Water

endangering class,

sensitive application

legislations, Korea-

REACH, registrations

outside EU, etc)

Accepted without

discussion

Might not be accepted, or will

require re-writing according to

new templates/guidance,

LoA for contributing studies if

REACH-only.

Analytics and physico-

chemical properties

needed for one

substance

needed for any contributing

substance

§

Case study 3:

Common dissociation products

Behavior in aqueous solution:

Dissociation into NH4+, CO3

2-, HCO3- (formation of several

equilibria)

source substances:

– ammonium chloride

– ammonium hydrogen carbonate

– sodium hydrogen carbonate

– ammonium sulfate

Ammonium carbamate

CAS 1111-78-0

Finding hints in the OECD toolbox

… or talk to your

production chemist

Human health endpoints

Alternative assessment applied for

– Acute inhalation toxicity

– Clastogenicity

– 90 day study (oral)

– Teratogenicity(oral)

Available studies on the substance itself:

– Ames, HPRT

– Acute oral and dermal toxicity (H302)

– Skin and eye irritation (H318)

– Skin sensitization

– Physico-chemical properties (high water solubility, solid that decomposes prior to melting)

Bridging study requested for proof of concept

13C{1H}-NMR in D20 solutions of ammonium carbamate

– 1% (pH 9-9,5) complete dissociation within

several minutes

10% formation of an equilibrium, no complete

dissociation

– 10%, acidified with DCl (stomach acid) complete

dissociation immediately after acidification

Approach was easy because

No relevant by-products/impurities

Data on source substances published or available at BASF

Expertise and experience available (regulatory and

experimental)

Reaction chemistry described in the literature

OECD SIDS available for source substances

Summary

Alternative approaches

– Offer an opportunity to avoid (animal) testing

– Can only be applied under certain conditions

– Require expertise in chemistry/toxicology/analytics

– Require extensive efforts in documentation, LoA and

justification

– Are a moving target

Monica LOCATELLIFounder of REACH Mastery

• Implementation of REACH regulation since 2001

• Specialises in risk assessment and toxicology

• Degree in chemistry and 10 years in chemical industry

ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017

Case study: cost and data sharing

Monica Locatelli – TEAM mastery s.r.l.


TEAM mastery

• TEAM mastery is an italian company, born in 2008 as a dedicated REACH consultant company

• It is based in COMO, near to one of the cores of manufacturing chemistry in Europe

Consortia

Lead Registration dossiers

InquiriesJoint submissions

Authorisation dossiers

Disputes


Data sharing in the REACH Regulation

Article 11 Joint submission of data by multiple registrants.....the information specified .......shall first be submitted by the one registrant acting with the agreement of the other assenting registrant(s) (hereinafter referred to as the lead registrant). .....Each registrant shall subsequently submit separately .........

Article 26 Studies involving vertebrate animals shall not be repeated.

Article 29 Substance Information Exchange Forums

Article 30 Sharing of data involving tests If they cannot reach such an agreement, the cost shall be shared equallyRegistrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements.


Implementing Regulation on joint submission and data sharing

justification of any cost a cost-sharing model, which shall

include a reimbursement mechanism

documentation shall be kept for 12 years

One substance, one registration

Itemisation of the data to be shared


Guidance on Data Sharing


Transparent

Transparency can be demonstrated :

Regular and open SIEF communications

Clear spreadsheets with costs related to the studies

Clear spreadsheets with costs related to admin an technical work

Clear communication of the number of registrants

Clear communication on the cost-sharing system, overall


Fair and not discriminatory

“NOT FOR PROFIT” PRINCIPLE

“REIMBURSEMENT”

The guidance of 2016 is clearly defining “Fair and non discriminatory” in the following two principles:


Case study: REACH Dyes Consortia

– three consortia with about 600 substances to be registered,

– mainly < 10 tons/year (deadline 2018),

– complex for analytical identification,

– huge number of existing studies to be managed (over 10.000)

– over 1700 different chemical structures to be analysed

“Technical comprehensive work:” since 2009 !!!

EPCG Paper

TextileDyes

Leather Dyes

The three Consortia operate independently, but they have common rules :

• Legal framework (contract)

• General rules on costs and cost-sharing

• Development of ad-hoc softwares

• Studies/data gathering, evaluation and data entry

• Grouping of chemical structures, read-across and QSAR

• SIEF communications and administration


REACH Dyes Consortia Overview

ONLY THE KEY STUDY is valued for compensation (notmandatory: see Guidance on data sharing)

Replacement cost, based on FLEISCHER LIST paper, 2007 (Officialreference, fair, not varying by lab/data owner…..)

Studies are valued with correcting factors increasing anddecreasing the value, as per Guidance on data sharing

Co-registrants only pay ACCESS to data FOR THEIR REQUIREDTONNAGE BAND (fair, non discriminatory)

Rules on Study Value


REACH Dyes Consortia Overview

Calculated on the HOURS OF WORK FOR EACH ACTIVITY by the LeadRegistrant and the consultant

Shared using a POINT SYSTEM, proportionate according to lowertonnage bands compared with the higher ones

Separate administrative COST FOR LOA MANAGEMENT

Separate administrative COST FOR SIEF MANAGEMENT

Technical and administrative work


Costs and mark-ups

– Other voices for mark-up:

– All charges are re-allocated every year among all the previous registrants (SIEF and Consortium Members)

Interest (itemisation, a special cases)

Inflation (to be considered when using historical costs)

Risk Premium (when present must be justified)


Data sharing disputes

What to do in case a SIEF member asks for an access and receives a cost that is not fair, not transparent or discriminatory?

1. Ask for explanations

2. Discuss a way forwards

3. As a last resort: open a dispute



• What to do: Collect all written documentationhttps://comments.echa.europa.eu/comments_cms/article303.aspx

https://comments.echa.europa.eu/comments_cms/article303.aspx




• What to do: Collect all written documentation

https://comments.echa.europa.eu/comments_cms/article303.aspx

• What can be asked for:Access to tests on vertebrate

• What a SIEF member obtainsA token to joint the Lead dossier

A code to indentify the studies with access granted in IUCLID


• Opt outFor all non-vertebrate tests the member has to

provide his own data

• The member has to – perform a number of data independently

– compile a complete IUCLID dossier

– fill up the summaries, derive PNEC and DNEL

– If applicable, make its own CSR and Risk Assessment



LEAD election

What happens if a dossier is sent without Lead Election,very poor, not compliant and the real Lead can not registerits dossier?

NOT SOLUTION YET

NO LEGAL FRAMEWORK

ECHA IS WORKING TO FIND THE BEST SOLUTION ……

The link to report a case is:https://echa.europa.eu/it/contact/reach


Read Across

• Obligation on data-sharing is applied when the substance is the same

• It is not mandatory for participants in different SIEFs to share data

• It is in line with the objectives of reduction of animal

• Every request for access to studies across different SIEFs will have to be negotiated on a case-by-case basis

• 12-year-rule applies also for read-across purposes.


Recommendations

If you are a Lead Registrant:

• Keep track of all your expenses bound to your dossier, be ready to communicated them in a clear way

• Objectively evaluate your expenses also if they are bound to internal resources

• Answer on time to the requests of data sharing

• Keep track of all the documentation you exchanged with SIEF members

• As soon as you can, communicate with the SIEF for Lead Election and open the Joint submission


Recommendations

If you are a Joint member:

• Be aware of all the related costs behind a dossier

• Ask clear questions and set reasonable deadlines for answers

• Open a dispute only as a last resort


Thank you for attention and.....

good luck for the 2018 deadline!

Rudolf StaabPartner at ChemAdvice GmbH

• Founded REACH ChemAdvice in 2007

• Vice-secretary and founding member of Only Representative Organisation

• PhD in inorganic chemistry

• 25 years of experience in chemical industry

Case Study Non-EU Manufacturers

Dr. Rudolf Staab

Vice Secretary of the Only Representative Organisation

Managing Director, REACh ChemAdvice GmbH

ECHA Stakeholder‘s Day

Helsinki, 5 April 2017

Introduction

REACH introduced globally a new area of chemicals management.

REACH applies to legal entities in the European Community only,

companies located outside but exporting into the EU customs territory

are not bound by REACH obligations. Authorities have no competence to

enforce on operators outside EU.

Responsibility for fulfilling REACH requirements is with EU-importers,

jurisdiction is limited to EU territory.

Non-EU Manufacturer (NEM) export into the EU via several importers,

each importer shall make a separate (pre-)registration.

If NEM prefers to register on behalf of his EU-importer, REACH allows

appointing an Only Representative (OR) located in EU (REACH Article 8).

OR takes over certain obligations on behalf of the exporter. This relieves

(eventually) EU importers within same supply chain from their

registration duties; hence they become downstream users.

REACH Article 8

Many Non-EU manufacturers are hesitating to finally register

their products under REACH…

Some quotes from our clients after our recent survey:

“The business in Europe is too small to justify the investment…”

“We don’t have any commitment from our clients that they will continue

buying from us…”

“More and more clients are pushing us to register…”

“The test cost for our small volumes do not justify a registration…”

“ We will discontinue our business in Europe…”

Only Representatives (ORS) have several duties under REACH

As a natural or legal person within the EU the OR is the legal representative

for a Non-EU manufacturer

An OR has to have the capabilities to handle huge amounts of substances

and must have the skills to understand the REACH legislation

OR acts as a trusty versus Importers, Non-EU manufacturer and authorities

OR has to take record of all imported substances and importers

OR has to have the latest update of the SDS on file.

The content of the SDS stays with the Non-EU manufacturer

OR manages the supply chain and authority communication as it pertains to

REACH compliance

Only Representatives have to fulfil the obligations of an

Importer but there are some differences…

Importer

Gets ownership of all imported substances and has to take record of them

Has the registration obligation according to the imported quantities and the resp.

deadline

Has to have the latest update of the SDS on file and is responsible for the content

Can develop his business according to his strategy

Only Representative

Has no ownership in the imported substances

Is not involved in business development and day-to-day business

On request of his Non-EU manufacturer the OR has registration obligations

Through the registration the Importers become Downstream Users

Appointment of an Only Representative is a strategic decision

of a Non-EU manufacturer…

A Non-EU manufacturer depend on the Importers and cannot develop the

business independently

Through an OR the Non-EU manufacturer can export to whom he wants

according to (pre-) registrations done by its OR

Aim should be a long-term relationship between Non-EU manufacturer and

OR; precondition for that is trust

Non-EU manufacturer must provide all required data to the OR (quantities,

client lists, updated SDS) otherwise OR needs to terminate the OR contract

The right choice of the OR is key for own business…

How to find my OR?

ORO is a good place to find a reliable and capable OR

Search on ECHA webpage whether the OR has successfully register

substances

Lead Registrations are a good indicator for the capabilities of an OR

Talk to companies which have experience with ORs

OR Fees should not be the main decision factor

The Registration Strategy is the key for a successful business

development…

Non-EU manufacturer and OR should work intensively together.

Prioritize the product portfolio

Define the own role for all substances

Analyze the SIEF and find potential co-registrants

Decide early to take the Lead Registrant role

Prepare the budget for the registrations and register as early as possible

Try to establish a strategic partnership with Importers for cost sharing or

volume commitment

The test cost are the biggest burden for SMEs and small volume

registrations…

Example 1 (Lead Registrant;Tonnage band 1-10 t/a; Substance; SME)

Test cost: ca. 25,000 € (Annex VII, Sameness, Literature search)

OR fees: ca. 5,000 - 10,000 € (dossier preparation and submission)

ECHA fees: 64 – 1,114 €

Example 2 (Lead Registrant;Tonnage band 10-100 t/a; Substance; SME)

Test cost: ca. 250,000 € (Annex VII and VIII, Sameness,

Literature search)

OR fees: ca. 15,000 - 30,000 € (dossier preparation and submission)

ECHA fees: 173 – 2,993 €

Joint Submissions

diminish the cost

The lower the volume and the margin the less profitable is a

registration …

Example 1 (SME; 5 t/a; Margin 2 €/kg; Lead Registrant)

Total Margin: 10,000 €/a

Registration cost: ca. 35,000 €

Loss first year: ca. - 25,000 €

Example 2 (SME; 95 t/a; Margin 4 €/kg; Lead Registrant)

Total Margin: 380,000 €/a

Registration cost: ca. 270,000 €

Profit first year: ca. 110,000 €

REACH can be a threat for many supply chains in Europe…

Conclusions

SMEs are hesitating to register their substances and will stop business in

Europe

Importers may lose their supply of chemicals

Downstream users may lose supply of chemicals and can no longer

manufacture their own products

A shift of supply chains to countries outside the EU may happen with all

consequences for the economy

Only Representative Organisation

(ORO) AISBL

Chaussée de Roodebeek 206

B-1200 Brussels, Belgium

[email protected]

www.onlyrepresentatives.org

[email protected]

www.reach-chemadvice.com

Thank you for your attention

Interact with us!




them in that order

4. Give us feedback

We are on a break and will return shortly

Jack DE BRUIJNDirector of Risk ManagementECHA


• Responsible for identifying and implementing the authorisation and restrictions processes under REACH and managing classification tasks from the CLP Regulation

• Before joining ECHA he worked at the European Chemicals Bureau (ECB) of the Joint Research Centre

Improving supply chain communication: now to 2020

Jack de Bruijn



Contents

• Why we care about improving supply chain communication

• Where we are now

• What is planned for 2017-2020

Basic pillars of chemicals legislation

Safe use

Supply chain communication

KnowledgeRegulatory

action

Communication in the supply chain

Conclusions – first REACH review (2013)

• Increased communication in the supply chain

• Suppliers more informed about customer uses and needs

• Significant implementation problems:

• Safety data sheets not of appropriate quality

• Large and complicated exposure scenarios

• Registrants not sufficiently aware of uses and use conditions, not able to properly link hazards and risk (in CSA) to appropriate exposure scenarios

Roadmap for supply chain communication

• Ensuring assessments are accurate, realistic and relevant and based on sector information on good practices

• Harmonisation of format and content

• Development of standard phrases (new ESComPackage)

• Annotated templates and examples

• Automated IT communication

• Developing methodologies to identify and communicate safe use information of mixtures

Chemical safety assessment

Exposure scenarios

Mixtures

http://www.cefic.org/Industry-support/Implementing-reach/escom/

http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/formats

http://echa.europa.eu/csr-es-roadmap


Exchange Network on Exposure Scenarios

• Joint initiative with industry associations and Member States.

• 10 meetings with around 120 participants from industry, Member States’ authorities and European Commission

• Aims to identify and share good practice on preparing and implementing exposure scenarios

• Forum to discuss output of the CSR/ES Roadmap

http://echa.europa.eu/enes


http://echa.europa.eu/enes


Downstream users

End users

Downstream users

Formulators

Registrants

UsesExisting conditions

Exposure Scenarios

= Safe conditions of use

Improved supply chain communication

• What are the existing uses (customer groups)?

• Under which conditions do they take place?

Use maps developed by downstream user associations: • What are the uses

relevant in one sector?• Under which conditions

do they take place?

ToolsRegistrationdossier

PublicECHA and Member States

Exposure scenarios: describing the conditions for safe use for individual DU

ESCom XML and phrase catalogue

Harmonised format

Safe use information for mixtures

Harmonised format

Safe use information for substances

SUMI

Library

Downstream users

End users

Downstream users

Formulators

Registrants

Key findings from evaluation

• CSR Roadmap/ENES is considered relevant by both Member States and industry

• Limited knowledge of what tools are available, how they work and how they can be used

• Frustration that the ENES tools are not being consistently adopted, worked or maintained by different industry sectors/companies/consortia

• Many downstream users consider that the translation of the roadmap products into other EU languages will enhance implementation

For details: https://echa.europa.eu/-/tenth-meeting-of-enes

https://echa.europa.eu/-/tenth-meeting-of-enes

2017-2020 programme for improving the information on uses and risk management advice

1. Maintain and adapt the key tools for supply chain communication

2. Support active sectors to set up and publish use maps for registrants’ chemical safety assessment

• Generate use maps in Chesar format

• Support active registrants to incorporate use map information in dossiers

3. Promote the use of the tools to different groups: registrants, Member States, end users based on market research

4. Include the end-user perspective

• Better understand needs and opportunities related to information on safe use of substances and mixtures

• Make more effective use of REACH information in the supply chain, e.g. in improving workplace health and safety and then broadening to the environment and consumer product safety

2017-2020 programme for improving the information on uses and risk management advice

These tools will help you

https://echa.europa.eu/communication-in-the-supply-chain-infographic

Why good communication matters

Good communication in the supply chain

• Protects human health and the environment

• Saves time

• Saves money

• Can be good for business

Registrant

Distributor

FormulatorArticle

producer

End user

Take home messages

• Supply chain communication a key pillar of REACH make sure it works

• Registrants: tools and support exist make full use

• Your safety data sheet is one of your business cards

• Downstream users: be critical to what you receive – create a demand for good quality information

• Downstream user sector organisations: develop use maps

Thank you

[email protected]

Follow us!


Twitter: @EU_ECHA

Facebook: @EUECHA



Geert DANCETExecutive DirectorECHA

• 2004-2007 - Head of the REACH unit in the European Commission’s Directorate General for Enterprise and Industry

• 1986 - Joined the European Commission

Marten KOPSManager Scientific & Regulatory Affairs at NVZ, the Dutch Detergents Association

• Responsible for several regulatory dossiers like REACH, CLP and the Occupational Health & Safety legislation

• Chairman of the REACH Implementation Working Group of A.I.S.E., the International Association for Soaps, Detergents and Maintenance Products

How use maps help improve supply chain communication

ECHA Stakeholder Day5 April 2017

M. Kops MSc

NVZ, on behalf of A.I.S.E.

The Detergents sector

Professional Cleaning & Hygiene

• Broad range of products

• Many different product uses

• Many SME end-user customers– NL: >10.000 SME cleaning

companies

REACH Supply Chain Communication

Manufacturer

Formulator

End-user

SDS

ESSDS

Use infor-

mation

Use infor-

mation

Safe Use Info

Chemical Safety

Assessment

SDSSDSSDSIdenti-fiedUses

Common issues

Manufacturer

• Differences in use information received

‒ Format & type of information

• Limited information on actual usesituations

• Time-consuming safe use assessment

Common issues

Formulator

• Several (end)uses not covered in Exposure Scenario’s

• Unrealistic safe use conditionsdescribed

Mixture SDSs often do not yetcontain ES-related safe use information

Common issues

End-user

• Limited resources‒ Many SME companies

• Often lack of sufficiently educated personnel

• Determining safe use conditions difficult

‒ Own safety assessment needed

‒ Chemical/toxicological knowledge needed

http://www.google.nl/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRxqFQoTCI_I3qew7McCFQZdGgodrF8ESw&url=http://www.ottomaaktschoon.nl/vloeronderhoud/&bvm=bv.102022582,d.d2s&psig=AFQjCNGxN6tnCmzMrpjSguXyj8rbC346cQ&ust=1441971401328337

http://www.google.nl/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRxqFQoTCI_I3qew7McCFQZdGgodrF8ESw&url=http://www.ottomaaktschoon.nl/vloeronderhoud/&bvm=bv.102022582,d.d2s&psig=AFQjCNGxN6tnCmzMrpjSguXyj8rbC346cQ&ust=1441971401328337

Sector use maps

Manufacturer

Formulator

End-user

SDS

ESSDS

Use infor-

mation

Use infor-

mation

Safe Use Info

Chemical Safety

Assessment

SDSSDSSDSIdenti-fiedUses

Sector use map

Sector association

Analysis of typical end-uses

•192

Sector use maps

• Overview of typical uses within sector

• Describes actual use situation

– Duration? Ventilation? Protective equipment?

• Standardized format used by all sector associations

Example uses

Example uses from detergents sector use maps: professional cleaning

• Diluting a product in a spray flask‒ Max. 1 hour per day, no LEV possible, …

• Spraying a product on a surface‒ Max. 1 hour per day, no LEV possible, …

• Brushing a product on a surface byhand

‒ Max. 8 hours per day, no LEV possible, …

Use maps benefits

Manufacturer

• Detailed information on actual use

– Reliable safety assessments

• Harmonized information format

– Harmonization between industrysectors

• Standardized use map format enables automation of assessments

– Saving time and resources

Use maps benefits

Formulator

• Reliable, high-quality exposure scenarios

• Realistic use conditions described

• Standardized communication to end-users possible

– Safe Use of Mixtures Information (SUMI)

Use maps benefits

End-user

• Reliable, realistic conditions of safe use

• Standardized, harmonized communication between suppliers

– SUMIs, tailored information for end-users

• Using the results of a chemical safety assessment done at manufacturer level

– Dutch OHS inspectorate: A.I.S.E. SUMIs can be used as a basis for the (OHS) chemical risk assessment (translation to practice required)

Closing remarks

• Use maps improve upstream communication…‒ More detailed information on actual uses

• …and therefore also downstream communication…‒ High quality, reliable exposure scenarios

• …which enables safer workplaces, especially at end-user level.‒ Using the assessment results from a more

knowledgeable player in supply chain• Acceptance from OHS authorities required

Thank you!

Thank you for your attentionUseful links:

• ECHA webpage on use maps

• ECHA use maps library

‒ Sectors with use maps available or in preparation:

https://echa.europa.eu/csr-es-roadmap/use-maps/concept

https://echa.europa.eu/nl/csr-es-roadmap/use-maps/use-maps-library

Mike RASENBERGHead of Computational Assessment & DisseminationECHA


• Before joining ECHA, worked in the area of international chemicals management, with the European Commission, chemical industry, industry associations and as a consultant

Chemical safety report as a company asset


Mike Rasenberg


Chemical safety assessment

• Aims to determine the conditions under which asubstance can be used safely during its entire life cycle

• Is to be documented in a chemical safety report – part of REACH registration

• Conditions for safe use should be communicated with a safety data sheet to all the commercial users of the substance (as such and in mixture)

When full safety assessment needed?

• You manufacture or import substances 10 or more tonnes per year (non-intermediates)

• Where the substance meets the criteria to be classified hazardous or PBT (based on the required test data)

• Duty of each registrant, but co-registrants can delegate to a lead registrant (joint chemical safety report)

• Safety report needs to cover all uses of the substance you are aware of

• For imported mixtures: for substances present above the concentration levels defined in Article 14(2)

How to assess?

Uses and condition of use

Substance properties: Hazard assessment

Risk controlled?

Substance properties: Distribution and fate assessment

Exposure estimates

Chemical safety report authorities own documentation

Exposure scenarios (conditions for safe use) annexed to SDS

Iterate…

NoYes

Use advised against communicated in safety data sheet

204

Manufacturer

Knows the properties of the substance

Downstream user

Knows how thesubstance is used

What is needed?

Communication in the supply chain is key

Safety assessment requires information on substance properties and conditions of use

Life cycle

M/I of substance

as such

User 1 produces a

mixture

M/I sells substance in

mixture

User 2 produces a

mixture

End-use of mixture by

user 3 – industrial siteEnd-use of mixture by

consumer

Substance in article

service life


user 3 – professional

M/I of substance

as such

User 1 produces a

mixture


mixture

User 2 produces a

mixture


consumer

User 1 produces a

mixture


mixture

M/I of substance

as such

User 2 produces a

mixture

Company asset

• On-site safety is the starting point

• True responsible care includes the full life cycle

• ‘Care’ includes

• impact on human health and the environment

• short term and long term

requires knowledge and ‘care’ about the substanceand its use

• Your chemical safety report is

• documented proof of this assessment and the positive outcome

• Starting point to tell customers how to use the substance safely

Risks for business

• Registration dossier is incompliant due to inconsistencies between IUCLID, chemical safety report and safety data sheet

• Customers complain about wrong or unhelpful safety data sheets

• Customers use wrong safety information

• Similar customers have to do the same assessments (efficiency lost)

• Maintenance and updating of documents is burdensome/costly:

• Registration dossier

• All safety data sheets for products containing the substance

• Authorities pick the substance for further regulatory action for “wrong” reasons

The risks are collective - affect everyone in the supply chain (substance, mixture, article)

Tools to help: Chesar

• Supports in preparing the chemical safety assessment and safety report and exposure scenarios for communication

• Supports electronic transfer of data: from use map to registration dossier (IUCLID), exposure scenario for safety data sheet

• Consistent and efficient

• Standardised workflow/document generated – efficiency gain for all actors

• Efficiency in single assessment

• Integrated exposure estimation tools

• Re-use of information across substances

• Automated generation of documents

• Facilitated updates

Chesar

• Increasing number of Chesar users: 40% of safety reports submitted since June 2016

• Next release in June 2017

• Improved support to use maps

• Editable chemical safety report

• Training programme for users

• Potential future developments:

• Update of embedded exposure tools

• Integration of other exposure tools

• More support for assessment of article service life

Improved chemical safety

Registrants

• Robust hazard data and good understanding of uses – basis for robust chemical safety assessment:

• to serve customers (via safety data sheets)

• to provide transparency to authorities and increase trust by the general public

• To reduce the risk of regulatory scrutiny or other liability

Downstream users

• Upwards communication (e.g. via use maps) isthe basis for useful information coming back

• can be used for own workplace assessment

• can be efficiently forwarded to own customers

Take-home messages

• Good chemical safety assessment is an asset for all companies using the substance throughout the supply chain

• Shared implementation efforts lead to increased safety at lower overall costs

Thank you!

[email protected]

Follow us!


Twitter: @EU_ECHA

Facebook: @EUECHA



Dirk SchwartzHead of Product Safety & Regulations at Bruno Bock Thiochemicals

• In charge of coordinating activities related to chemical inventories and regulations worldwide

• European-registered toxicologist

• Academic background in chemistry and molecular biology

BRUNO BOCKTHIOCHEMICALS

EVANSCHEMETICS

Session: Using Chemicals Safer in Europe

ECHA Stakeholders‘ Day 2017

Dr. Dirk Schwartz (ERT)Bruno Bock Chemische Fabrik GmbH & Co.Head of Product Safety & RegulationsTel: +49 4176 909 822Email: [email protected]

„Tips & Tools for Chemical Safety Reports (CSRs)“


EVANSCHEMETICS

Agenda

(1) The Company: at a glance

(2) REACH Deadlines and their consequences

(3) Tips and Tools

(4) Feedback and Outlook


EVANSCHEMETICS

(1) At a glance: the companyBruno Bock Thiochemicals & Evans Chemetics

Preeminent suppliers of organic sulfur specialty chemicals

2 production sites (3 locations) in Germany and the USA with>170 employees

not micro (< 10), not small (< 50), but mid-sized < 250

Worldwide network of agents and distributors to serve customersin >45 countries


EVANSCHEMETICS

(1) At a glance: Our Products

Organic sulfur specialty chemicals: Mercaptocarboxylic acids and derivatives

salts esters

Thio dicarboxylic estersDithio dicarboxylic esters

Polythiols


EVANSCHEMETICS

(1) At a glance: Applications

Personal & Home Care(Hair Cosmetics, Cleaners, Leather)

Plastics(Antioxidants, PVC stabilizers)

Coatings, Adhesives, Sealants(Hardeners, Binders, Crosslinkers)

Polymer Synthesis(Chain Transfer Agents)

Organic Sulfur Specialty Chemicals

http://www.brunobock.de/typo3temp/pics/Leder_1a82ed2d68.jpg

http://www.brunobock.de/typo3temp/pics/Leder_1a82ed2d68.jpg

http://www.brunobock.de/typo3temp/pics/Platine_31331414_M_772faf9562.png

http://www.brunobock.de/typo3temp/pics/Platine_31331414_M_772faf9562.png

http://www.brunobock.de/typo3temp/pics/Dauerwelle_2_68bebb2af4.jpg

http://www.brunobock.de/typo3temp/pics/Dauerwelle_2_68bebb2af4.jpg


EVANSCHEMETICS

(1) At a glance: The REACH TeamCoordination of Projects and Mgmt of Communication

REACHTeam Leader

SIEF costcalculations,

LoA, DSA, Consortia

IT support: installation andupdates of the

tools

Production, Salesand Use: tracking

substanceamounts/y and

customer ES

Consistencybetween

eSDS (CLP) andSDS (global)

IUCLIDChesar

REACH-IT

Externalpartners:

Consultants, Association

work (e.g. VCI) and CROs

Substance IDs, compositions, phys-chem., (eco)tox data

Production conditions, transportation,

environmental andoccupational safety


EVANSCHEMETICS

(1) At a glance: Our Role under Reach

• SME, Lead Registrant and OR• Manufacturer and importeur• Pure substances, no complex formulations• No CMRs• No PBTs


EVANSCHEMETICS


2010 Company Target: • Collect experience with REACH and be on the safe site. • only one consultant company doing the main work (communicate within the

supply chain/customers, monitor experimental studies, submit the dossiers)• 1 Co-registration• 4 as transported isolated Intermediate under SCC• 3 full registrations >1000 t/y

2013 Company Target: • Under REACH an SME should be able to submit a complete dossier• only marginal consultant work, main work by the internal REACH team

• 0 Co-registration• 2 as transported isolated Intermediate under SCC• 8 full registrations >100 t/y


EVANSCHEMETICS

SME: Summary of the Deadlines 2010 and 2013• A submission is not an easy job especially for SMEs• Specific expertise not always in-house available• The real exposure situation related to occupational health and the environment at Bruno

Bock which is historically controlled by national laws is not well reflected under REACH• The downstream use of our products are in some cases not realistic described by our

customers. Risks were therefore overestimated under REACH (conditions of use and riskmanagement measures)

• External support seems to be strongly recommended, but depends on the situation of theSME and their obligations under REACH


2018 Company Target: • Avoid animal experiments, close data gaps by using data from 2010 / 2013 registrations.• Many consultants involved: QSAR, Read-across, Weight-of-Evidence approaches

• 4 Co-registration• 2 as transported isolated Intermediate under SCC• 4 full registrations >1 t/y (no CSR)• 10 full registrations >10 t/y


EVANSCHEMETICS

(3) Use Maps

Customer-site (Use of ourproducts):

REACH–SECTOR USE MAPS: ECHA and Industry Collaboration

Sector use maps describethe uses of the chemicaland also have links to theinformation needed tocarry out exposureassessments.

On-site: Manufacture and Fillings:

Documentation of the real exposure situations for the environment and for theworkers, which can be used under REACH (via Chesar) as well as under national law.


EVANSCHEMETICS

(3) IUCLID 6: Hazard Tool


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(3) Chesar: Exposure Tool


EVANSCHEMETICS

(3) Chesar: Exposure Tool


EVANSCHEMETICS

(3) Outcome: CSR and the „e“ of the eSDS


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(4) SME Feedback 2014

Interview given forECHA Newsletter 2/2014:

Get wise – use Chesar

Main advantages:• Tool from ECHA itself• CSR- and eSDS

preparation by oneklick

• Inhouse database• Data exchange

format with partnersand consultants


EVANSCHEMETICS

(4) How can SMEs be supported?

1. Memorandum for shortlistings and compliance checks until 1 June 2018SMEs do not have the power to cope with all other REACH tasks duringregistration work and consultants are fully booked until June 2018

2. More support from national authorities for the ECHA toolChesarIn the past 3 years, Chesar was not even mentioned at national workshops and conferences.

3. Report-Generation in IUCLID of chapters 1 to 16 of the SDS• Full legal document from authorized (ECHA) software• Complete eSDS based on submitted data• Only one system no transfer work between different IT systems• No exchange formats needed• Safe of time and money• UN and OECD supported


EVANSCHEMETICS

Thank you for your attention

BRUNO BOCK Chemische Fabrik GmbH & Co. KG

Eichholzer Str. 23, D-21436 Marschacht, Tel. +49-4176-9098-0 Fax: +49-4176-1396, www.brunobock.de

Interact with us!




them in that order

4. Give us feedback

Jukka MALMDeputy Executive DirectorECHA


• Director of Regulatory Affairs

• Responsible of the overall coordination of regulatory decision making and opinion forming of the Agency

• Before joining ECHA, was Director of Expert Services at the Finnish Environment Institute

Closing remarks


Jukka Malm

Deputy Executive Director

European Chemicals Agency

5 April 2017

2

Thank you for sharing with us

• 190 of you here

• Over 170 online

• 25% from beyond EU

• Over 60 questions submitted

• 22,000 reached on Twitter

3

REACH 2018 – challenges you raised

• Substance identity takes time and effort

• Registering jointly:

• if poor quality, cost unfairness, substance sameness questions

• Substances not being registered – what to do?

• Diverging classifications

• Getting info from customers and non-EU suppliers

• Using alternatives to testing on animals

• Too busy before June 2018 – don’t ask for more!

4

Your advice to one another..

• Get going now!

• SMEs can register, but should consider help

• Get wise – use CHESAR and IUCLID

• Use the use maps – they help, and you avoid risk

• Be demanding! Of information, fairness, transparency

• Communicate:

• up – and then down – the supply chain

• in SIEFs

• Invest in data – it’s your business card

5

After 2018

• Your dossiers will be screened and evaluated

Keep it up to date, don’t wait for our letter…..

• We tackle substances of concern – theymay be yours!

Follow our news

• Information on all substances >1 tonne in the EU

Freely available

6

Upcoming

• REACH Spring school, 15-19 May

• Litigation seminar, 24 May

• Old CLP labels off the shelves, 1 June

• Nano observatory, June

• REACH review

• Endocrine disruptor guidance, Autumn

• Biocides Stakeholders’ Day, 26-27 September

• REACH Stakeholders’ Day, 30-31 January2018

We would like to hear from you

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• News readershipsurvey

• Give us yourfeedback and help us improve

Safe journey home!

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Documents

Welcome to our Stakeholders’ Dayqsb.webcast.fi/e/echa/echa_2017_0405_stakeholders_day... · 2017. 4. 5. · Welcome to our Stakeholders’ Day 5 April 2017 Ask questions and give