M. Ludovic Chatelin European Commission

Regulation on the making available and use of

biocidal products (BPR) : Update on the

implementation Conference Biocides 2014

Wien, Austria 10th December 2014

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I – Application II – Implementation III – Latest development on nanomaterials and in situ generation IV – Short term key dates V – Focus on the list of suppliers of AS (Art. 95)

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I – Application

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Application of the BPR BPR entered into application on 1st September 2013 A lot of provisions are now applicable :

o Use of the various procedures for new applications AS approval procedures National authorisation / mutual recognition procedures Possibilities to apply for Union authorisation, already for BP with new AS or BP for

PT1, 3, 4, 5, 18, 19; and 2,6,13 but authorisations cannot be granted before 2017 for )

Possibilities to apply for a authorization via a simplified authorisation procedure (art. 26)

Possibilities for parallel trade (art 53) Applications to ECHA for technical equivalence (art. 53) Applications to ECHA for registration on the AS suppliers list (art. 95) Etc.

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Application of the BPR New principles in force :

Exclusion / substitution of active substances Comparative assessment of biocidal products (contains AS meeting the substitution

criteria) Nanomaterials excluded if not explicitly covered in the approvals of AS Labelling provisions of treated articles (art.58) Mandatory data sharing of data on vertebrates (art. 62) Mandatory data sharing of all toxicological and environmental data for the sake of

the listing on the AS supplier list of ECHA (art. 95) Data protection periods (Art. 60) Etc.

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Obligations For all parties involved : Industry, Member States, Commission, ECHA For Industry:

Compliance with "basic" provisions of the BPR (ex: AS in the review programme, transitional measures/systems in Member States, if no BPR authorisation when needed no making available on the market possible etc.)

Compliance with the procedures (timing for submitting application, additional data , fee payments etc…)

Compliance with the sources of active substances contained in BPs, list of suppliers of AS (art. 95)

Provisions on R&D (art. 56)

Compliance with treatment or incorporation of AS supported in EU in Treated Articles (art. 58 + transitional measures 94)

Compliance with labelling of Treated Articles when needed (art. 58, no transitional measures)

Authorisation holder :

Classification & Labelling (art. 69)

Information of any adverse effect (art. 47)

Holding a register during the validity of the authorisation + 10 years after the end of validity (art. 68)

Quality compliance for manufacturers (art. 65)

Notification for poisoning surveillance (art. 73), etc.

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II – Implementation of the BPR

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Implementation

A lot of work at EU level in order to implement the BPR and continue the construction of the biocides framework

42 tasks foreseen directly in the BPR (delegated/implementing acts, guidelines) A lot of them now finished

Coordination COM/ECHA, involvement of MS and IND Overview : https://circabc.europa.eu/w/browse/7c9f6736-1cb1-451f-8ed1-

d2bcfcaaa870 (see CA-Sept13-Doc.5.1.a - Preparatory actions.pdf)

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Implementing legislation Regulation on changes to product authorisation : Reg. (EU) No 354/2013 of 18th

April 2013

Regulation authorisation of same biocidal products : Reg. (EU) No 414/2013 of 6th May 2013

Regulation on fees to ECHA : Reg. (EU) No 564/2013 of 18th June 2013

Regulation on the extension of duration of review programme to 2024 : Reg. (EU) No 736/2013 of 17th May 2013

Regulation on the modification on data requirements (proof of technical equivalence in BP applications) : Reg. (EU) No 837/2013 of 25th June 2013

Regulation on the procedures for the inclusion of active substances into Annex I of the BPR : Reg. (EU) No 88/2014 of 31st January 2014

Regulation on the procedures for the renewal of authorisations by mutual recognition : Reg. (EU) No 492/2014 of 7th March 2014

New Regulation on the organisation of the review programme of active substances (to replace Reg. (EU) 1451/2007) : Reg. (EU) No 1062/2014 of 4th August 2014

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Commission guidance Work on guidance documents or proposals on various topics :

Management of nanomaterials: https://circabc.europa.eu/w/browse/f2d79b34-2f5a-4bb4-97e8-b982c9def765

Guidance on fees payable to Member States: https://circabc.europa.eu/w/browse/b5c900a2-ef66-4a46-996d-00d5a29aee9a Guidance on similar conditions of use, for the Union authorisation : https://circabc.europa.eu/w/browse/2ac21f0f-d790-4667-9358-1bcd0db0b35e Document on comparative assessment (March 2014 version): https://circabc.europa.eu/w/browse/d309607f-f75b-46e7-acc4-1653cadcaf7e Guidance on treated articles (November 2014 version): https://circabc.europa.eu/w/browse/d7363efd-d8fb-43e6-8036-5bcc5e87bf22 Document on biocidal product families (November 2014 version): https://circabc.europa.eu/w/browse/df02104b-d5e3-4b11-b960-13a0f08133af

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Organisation of the biocides framework Organisation of the evaluation of existing active substances, in order

to meet the objective of finishing the review programme by the end of 2024 :

https://circabc.europa.eu/w/browse/661e8fca-9353-47da-a031-c1341d6aa335

Organisation : CA-Feb13-Doc.8.3, CA-Sept13-Doc.8.3-Final Principles for approval : CA-March14-Doc.4.1-Final Adoption of decision by COM on the approval of active substances after evaluation

Objective : at least 50 decisions per year on the approval of existing

active substances

Decisions are taken on around 17% of dossiers in the review programme

Year 1 2 3 4 6 7 8 9 10 12 14 18 19 20 21 22 Total2006 1 12007 2 1 32008 8 2 102009 7 6 3 162010 1 1 3 5 1 112011 4 0 6 2 122012 2 6 1 6 2 172013 1 1 2 1 1 4 1 1 1 5 1 19

2014 (on-going) 1 1 3 3 0 6 3 3 1 21Total 1 3 2 5 1 1 36 1 1 1 14 31 8 1 3 1 110

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Work plan of BPC

Multiannual work plan, updated at each meeting of the BPC : http://echa.europa.eu/web/guest/about-us/who-we-are/biocidal-products-

committee

2014, transitional year: 35 opinions on AS adopted by BPC http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-

active-substances/bpc-opinions-on-active-substance-approval

On the receipt of the BPC opinion: preparation of a draft decision, discussions, consultation of the Standing committee on biocidal products, adoption

On average, decision taken within 6 months after the adoption of the BPC opinion, except for specific cases

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New Review programme Regulation

Regulation (EU) No 1062/2014 of 4 August 2014

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Management of Review programme

Update procedures according to BPR

Respect of deadlines by applicants : If additional data are not submitted within the required timeframe: equivalent

to a withdrawal of participation

For submission of dCARs to ECHA: Submission of CLP, PBT, ED dossiers at the latest at the same time of

submission of the dCAR When the substance would meet the criteria to be classified CMR 1A / 1B,

PBT/vPvB, ED : opinions from RAC or adhoc committee before sending the draft CAR

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Priorities in the RP depending of PTs (cf. Annex III) :

Dates = Deadlines! As long as all conditions for submission are met, dCAR can be submitted, and MS

shall not wait the deadline to submit them ECHA (BPC) starts to deliver opinions on AS/TP concerned by the last priority list

as well (ex: AS for PT11 or 12)

Management of Review programme

Product-types Time limits for MS to submit the assessment report to ECHA

Time limits for ECHA (BPC) to start the preparation of the

opinion8, 14, 16, 18, 19 and 21 31.12.2015 31.3.2016

3, 4 and 5 31.12.2016 31.3.20171 and 2 31.12.2018 31.3.20196 and 13 31.12.2019 31.3.2020

7, 9 and10 31.12.2020 31.3.202111, 12, 15, 17, 20 and 22 31.12.2022 30.9.2023

Additional information on the review programme

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Information on ECHA website:

http://echa.europa.eu/regulations/bi

ocidal-products-regulation/approval-of-active-substances/existing-active-substance

procedure, template for

declaration of intention to notify etc….

Organisation of the biocides framework …. while continuing the progression of the authorisation phase of BPs

for the harmonisation of the EU market :

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A lot of positions, procedures, approaches recently agreed in CA meetings "Finalised documents" : https://circabc.europa.eu/w/browse/386abfea-55ce-4764-8a31-f9d4f6ceaf0a

Policy definition

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On-going / Future works On-going :

ECHA : some guidance documents AS approval, BP authorisation, review of the Article 95 guidance document, continuous development of the R4PB COM : discussions on MRLs, study on sustainable use, guidance on comparative assessment, biocidal product families etc… Specific tasks on :

Nanomaterials, in situ-generation Guidance on Data sharing, Letter of Access, and Consortia RMM on rodenticide, and renewal of AS/BP Coordination Group Workshop on Biocidal product families

Main priorities : Finalise main orientations and guidance for implementation Settle the rhythm of AS/PT opinions and decisions (50 per year) Finish the review programme of active substances Authorisation of biocidal products, process of MR and Union authorisation

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III – Latest developments on nanomaterials and in situ generation

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A – Nanomaterials

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Scope BPR: 1st Regulation with a definition based on Commission Recommendation n°

2011/696/EU Art 3 (1)(z) "Nanomaterial": means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.

Nanomaterial : as such, already covered by directive 98/8/EC (not excluded,

therefore covered!) Ex : Nano-silver used in articles for antimicrobial properties Nevertheless : need for clarifications about their management under the biocides

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Nanomaterials (2/3)

Provisions : o Within the BPR : COM can decide if a substance is a nano or not (Art. 3(3)) o The approval of an AS does not cover the nanoform, unless explicitly mentioned (Art. 4(4)) o In case of use in a BP (a nano as an AS, or a nano as a coformulant), risk to human/animal

health or to the environment has to be assessed separately (Art. 19(1)(f)) o A BP containing nanomaterial is not eligible to the simplified authorisation procedure (Art.

25 (c)) o Treated articles with BP : when the TA already to needs to be labelled (ie. claim, or provision in

approval), has to indicate also if presence of nano due to the biocidal treatment (Art. 58(3)(d)) o Labelling of biocidal products : indication of specific, as well as the word "nano" after the

indication of each nanomaterial (Art. 69(2)(b)) o Data to be submitted for AS approval or BPO authorisation : justification of the scientific

relevance of tests submitted for nanos, and when relevant, of technical adaptations made to take into account the specificity of these nanos (Annexes II andIII)

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Need to clarify what was currently supported under the review programme, and what was on the market

Approach taken is described in doc "CA-May13-Doc.5.1.g - Biocides and nanomaterials.doc" (https://circabc.europa.eu/w/browse/f2d79b34-2f5a-4bb4-97e8-b982c9def765 )

Results: Clarifications of existing nanos currently under assessment (cf. Annex II

part 1 of Regulation (EU) 1062/2014) Only 2 nanomaterials used for biocidal purposes currently under review :

Silver adsorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale) Silicon dioxide (as a nanomaterial formed by aggregates and agglomerates)

Possibility given to support potential nano of existing AS which are currently not supported, cf. Annex II Part 2 of Reg 1062/2014 : notification to be submitted to ECHA by 30 October 2015 If finally not supported, will have to be withdrawn from the EU market

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Nanomaterials (3/3)

B – In situ generation

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In situ generation (1/4) "In situ generation" : case where the active substance is not "physically" present in the product

placed on the market, but generated while using one or several products (called "precursors" ")

Dir. 98/8/EC : definition of a "biocidal product" not totally adapted, as the active substance is not "physically" present in the product as placed on the market

Guidance under dir. 98/8/CE : borderline based on the claims when placing on the market the precursors : If there was a biocidal claim, the placing on the market and the use to generate the active substance was already in the scope directive 98/8/EC Otherwise, these were not in the scope of directive 98/8/EC Guidance document (version 2012) : https://circabc.europa.eu/w/browse/58e91140-2dc1-48ee-b70a-1d0a162a51f7

Case by case approach, for instance : Cu/Ag electrolysis system : electrodes of Cu/Ag were in scope of dir. 98/8/CE, as produced and placed on the market specifically for that purpose + fit into the former definition of a BP Electrolysis system with NaCl to generate chlorine in a swimming pool : in the scope of dir 98/8/EC if there was a biocidal claim etc.

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With BPR : new definition of a "biocidal product", that explicitly covers cases of in situ generation

Biocidal product definition (Art 3(1)(a)) : any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action, any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action

Concern "precursors" placed on the market to generate an active substance (ex : NaCl used in electrolysis systems to generate chlorine etc.) Concern active substances and products (mixtures containing one or more AS) generated with precursors placed on the market (ex: ozone generated via oxygen from air)

In situ generation (2/4)

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By default, as any other biocidal product : The active substances need to be approved The biocidal products will need an authorisation

Clarification work initiated end of 2013 : questionnaire from Commission sent to participant in the RP, EU federations Objective : get some information on the current situation, information on existing cases of in situ generation, clarify what is under assessment in the RP

Agreement on a proposal presented at the last CA meeting in November 2014 in document "CA-Nov14-Doc.4.1 - Substances generated in situ.doc": https://circabc.europa.eu/w/browse/97b0c64b-9534-49a4-ab13-fc1cbedf5d09

In situ generation (3/4)

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Main points of agreements :

o Mutualisation in the work, and equilibrium between the AS approval stage, and the BPN authorisation stage

o Approve AS/precursors combination, and make some grouping when possible. o Clarification of the AS supported under the RP : see Annex to the document “CA-

Nov14-Doc.4.1 - Substances generated in situ.doc" (under final review until end of December 2014)

o For situations already covered by the BPD : provide the opportunity to take over the role of participants for unsupported AS/precursors combinations (via Art.13 of the Review Regulation 1062/2014)

o For situations not covered by the scope of BPD, but now covered under the scope of BPR : submission under Art. 93 of BPR

o IMPORTANT : Article 95 is already applicable for AS/precursors combinations for which a dossier has been submitted, and must be done by the "relevant product supplier "if not already a participant (ie. suppliers of precursors on the market)

Situations can be diverse and complex : in case of interest, contact ECHA Helpdesk.

In situ generation (4/4)

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IV – Short term key dates

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Short term key dates for Industry

REMINDER, 1st September 2013 : Labelling of treated articles in accordance with Article 58 of the BPR, no transitional provisions

[July 2015 – Report on the sustainable use of Biocides of COM to be submitted to

Council and EU Parliament] 1st September 2015 : All products made available on the market must contain a

source of AS listed on ECHA list under Art. 95 No making available on the EU market possible for uncompliant products (ie. any supply on the EU market is forbidden)

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Short term key dates for Industry 30 October 2015 (ie. 12 months after the entry into force of the new Review Regulation

(EU) No 1062/2014 – new RR): (a) Deadline for submission of a notification to ECHA for AS included into part II of Annex II, to take over their support in the review programme of AS (see Art 14(3) of new RR) (b) Deadline for sending a declaration of interest to notify to ECHA for active

substance which are food/feed which benefited from the former derogation under Article 6 of Regulation (EC) No 1451/2007 (see Art 16(1)(b) of new RR)

(c) Deadline for sending a declaration of interest to notify to COM for active

substances which result not notified due to the evolution of scope of the BPR in the definition of product types (ie. modification from PT10 to PT02 of algaecides used for remedial treatments of construction materials); (see Art 16(1)(c) of new RR)

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Short term key dates for Industry 1st September 2016 :

Deadline to submit applications to support AS of BP which were not in the scope of the BPD but are now in the scope of the BPR (see Art 93 of BPR)

o If no submission, no making available on the market of BPs possible on 1st March 2017

o From the date of validation of the application (around 6 months after submission) : the AS suppliers of the dossier will be listed in Article 95's ECHA. Provisions of Article 95 directly starts to apply for that AS and only sources listed on Article 95's ECHA list is allowed

Deadline to submit applications to support existing AS used in TA if not yet supported (see Art 94 of BPR) ; (ex: AS that are used outside EU in imported TA)

o If no submission, no placing on the market of TA possible as from 1st March 2017

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Short term key dates for Industry 30 October 2016 (ie. 24 months after the entry into force of the new RR, see Art

21(1) of new RR) : No more making available on the market of BPs containing active substances of slide 32 case b and c for which no declaration of interest to notify was submitted and accepted

30 April 2017 (30 months after the entry into force of the new RR, see Art 21(1) of

new RR) : No more use of BPs containing active substances of slide 32 case b and c for which no declaration of interest to notify was submitted and accepted

[December 2017 – Report on the functioning of Union Authorisation of COM to be submitted to Council and EU Parliament]

IN GENERAL : Need to follow closely the review programme of active substances.

(In case of approval / non-approval, provisions of Art 89 applies) 34

IV – Focus on the list of suppliers of AS (Art. 95)

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Objective : Level playing field for interested persons on active substances (mostly suppliers of AS), avoid monopolistic situations and enhance free competition • As from 1st September 2015, only biocidal products containing suppliers

of active substances registered can be made available on the market

List of suppliers made by ECHA, publicly available on its website since 1st September 2013, and regularly updated : http://echa.europa.eu/information-on-chemicals/active-substance-suppliers

• This provision applies to all biocidal products (whether they are place

on the market under the transitional rules of MS, or subject to a BPR authorisation)

Provisions for alternative suppliers of AS – cost sharing (art 95)

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Focus on Art. 95 : What to do WHAT : Submit an application of registration to ECHA, which includes :

Either a letter of access to the data (LoA) currently under assessment for the AS, or the data which already led to the approval of the AS

Or, a complete dossier with all data on the AS (Annex II of BPR), similar to the

one currently under assessment for the AS, or the data which already led to the approval of the AS

Or, a reference to a complete dossier, whose data are not protected anymore

(the 1st protection of data will end on 2018 for the 1st active substance approved – sulfuryl fluoride – but in practise, the data protection will fall in 2025 for most of the existing active substances)

Encouraged way to fulfil this duty : use letter of access (LoA) To this specific end : Mandatory data sharing extended to all tox and ecotox data (including e-fate studies),

including data not made via tests on vertebrates Data sharing compensation mechanism (art. 63) Persons obtaining these LoA can use them or share them to obtain product authorisations

(ex: a supplier of AS will share them with its clients, in order that they can obtain their product authorisation) 37

By WHO :

Logically, person responsible for the placing on the market of an active substance on the EU market (i.e. 1st supply of an AS on the EU territory) : Producer of an AS, importer of an AS Importer of a biocidal product (i.e. it contains a source of AS

introduced de facto on the EU market) (these are the persons who take the 1st benefit of the current support of these

active substance in the review programme by participants)

In case of a source of AS produced from a company not established in EU, ECHA is considering to allow non-EU companies to be represented by an EU representative for the purpose of Article 95

(ie. to avoid that all importers of that source to make a submission, and allow that only one person makes the submission instead)

Participants in the review programme are automatically listed

Focus on Art. 95 : What to do

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HOW : submission via the Register for biocidal products (R4BP)

http://echa.europa.eu/web/guest/support/dossier-submission-tools/r4bp/sign-up

WHEN: submission possible since 1st September 2013

To be done ASAP

Focus on Art. 95 : What to do

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Focus on Art. 95 : Anyway…

… Obligation of Result: As from 1st September 2015, only biocidal products containing sources of active substances registered and listed by ECHA can be made available

on the market (i.e. all supply banned for other biocidal products, throughout the supply

chain)

ECHA Guidance document :

http://echa.europa.eu/web/guest/guidance-documents/guidance-on-biocides-legislation?panel=guidance_active_substance_suppliers

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Conclusion

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Many progresses since its adoption in 2012 Many principles, guidance agreed at CA level with Member States Coming year :

For AS : Finalisation of the clarification of the review programme Standard operation of the BPC and decisions of AS

For BP : Work on renewal of anticoagulant rodenticides Work on the sustainable use of biocide Union authorisation Biocidal product families

On track for 2025 objective : end of review programme,

harmonisation of EU market with authorised BPs 42

Thank you for your attention

For further information :

Commission website : http://ec.europa.eu/environment/biocides/

https://circabc.europa.eu/w/browse/e947a950-8032-4df9-a3f0-f61eefd3d81b (ENV-Biocides@ec.europa.eu)

ECHA website & Helpdesk on Biocides :

http://echa.europa.eu/regulations/biocidal-products-regulation

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