Regulation on the making available and use of biocidal products (BPR) and Wood Preservation WEI Meeting Brussels, Belgium 3 rd April 2014 M. Ludovic Chatelin European Commission DG Environment, Unit A.3 1
I State of implementation of the BPR II Status of Wood preservatives PT08 III Focus : treated articles (Art. 58), list of suppliers of AS (Art. 95) 2
I State of implementation 3
Application of the BPR Regulation (EU) 528/2012 (BPR) : entered into application on 1 st 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 for PT1, 3, 4, 5, 18, 19 (art. 42) 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. 54) Applications to ECHA for registration on the AS suppliers list (art. 95) Etc. 4
Application of the BPR o New principles : Exclusion / substitution of active substances (Art. 5 / 10 ) Comparative assessment of biocidal products containing AS meeting the substitution criteria (Art. 23) 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) Evolution of scope and transitional provisions (Art. 93) : Role of ECHA in the biocides framework Etc. 5
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 ) As from 1st Sept. 2015, making available on the market possible only if the source of AS is on ECHA's list (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 of BPR authorisations : 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 of BPs (art. 65) Notification for poisoning surveillance (art. 73), etc. 6
Transitional period (1/2) To achieve the objectives of the Regulation On the big picture, probably until 2024? : when the last BP on the EU market is authorised according to the harmonised EU regulation, and no more subject to the national systems of MSs "Transitional" provisions mostly on : Article 89 : To manage the review programme of existing active substance and new active substances started under the BPD To allow the making available and use of biocidal product under the national systems of MSs To manage the transition once the decision on the approval of the AS has been taken Article 90 : to manage the approval of the AS when the applications were submitted under the BPD Article 91 : to manage the authorisation of BPs when the applications were submitted under the BPD 7
Transitional period (2/2), and on : Article 93 : to manage the change of scope on BPs from the BPD to BPR (mainly on insitu generation), and allow a transition for concerned AS and BPs Article 94 : to manage the change of scope on Treated articles (TA) from the BPD to BPR, to allow the placing on the market if there is a support by 1 st September 2016 for the AS incorporated or which served for the treatment of the TA (it concern most of all imported TA) Article 95 : to manage the transition for the compliance of the source of AS, to ensure that all BPs made available on the EU market are compliant as from 1 st Sept 2015. 8
Implementation A lot of work on-going 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, mandatory/optional) Coordination COM/ECHA, involvement of MS and IND Some tasks with COM as leader, other with ECHA as leader : Overview : https://circabc.europa.eu/w/browse/7c9f6736-1cb1-451f-8ed1-d2bcfcaaa870 (see CA-Sept13-Doc.5.1.a - Preparatory actions.pdf) 9
Implementing legislation Regulation on changes to product authorisation : Reg. (EU) No 354/2013 of 18 th April 2013 Regulation authorisation of same biocidal products : Reg. (EU) No 414/2013 of 6 th May 2013 Regulation on fees to ECHA : Reg. (EU) No 564/2013 of 18 th June 2013 Regulation on the extension of duration of review programme to 2024 : Reg. (EU) No 736/2013 of 17 th May 2013 Regulation on the modification on data requirements (proof of technical equivalence in BP applications) : Reg. (EU) No 837/2013 of 25 th June 2013 Regulation on the procedures for the inclusion of active substances into Annex I of the BPR : Reg. (EU) No 88/2014 of 31 st January 2014 Regulation on the procedures for the renewal of authorisations by mutual recognition : under formal process of adoption, publication around April/May 2014 Regulation on the organisation of the review programme of active substances (to replace Reg. (EU) 1451/2007) : under discussion, for adoption by 2 nd semester of 2014 10
Commission guidance Work on guidance documents or proposals on various topics : Proposal of 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 Guidance on treated articles: https://circabc.europa.eu/w/browse/e1adf8de-0ad6-4484-84ec-80704391a038 Document on comparative assessment : https://circabc.europa.eu/w/browse/d309607f-f75b-46e7-acc4-1653cadcaf7e Other Guidance under discussion : Borderline between biocidal products and cosmetics : https://circabc.europa.eu/w/browse/6283ad7a-7416-4b83-a201-92ba58224222 etc. 11
Organisation of the biocides framework On-going review of the organisation 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 Objective : as from 2014, at least 50 decisions per year on the approval of existing active substances Progression of the authorisation phase of BPs for the harmonisation of the EU market 12
II Status of Wood preservatives PT08 13
PT08 Actives substances Most PT08 active substances have been reviewed and a decision on the approval has been taken Only a few PT08 active substances remain under assessment/peer review, and most of the BPC opinions will normally be delivered this year on these substances Review of PT08 : part of the 1 st priority, agreed with MSs in September 2013 Document "CA-Sept13-Doc.8.3 - Final - Review programme of AS.doc" https://circabc.europa.eu/w/browse/661e8fca- 9353-47da-a031-c1341d6aa335 Name of AS Duration of approval (in years) Date of approval Sulfuryl fluoride 10 01/01/2009 Dichlofluanide 10 01/03/2009 Thiacloprid 10 01/01/2010 Chlothianidine 10 01/02/2010 Etofenprox 10 01/02/2010 Propiconazole 10 01/04/2010 Tebuconazole 10 01/04/2010 Thiametoxam 10 01/07/2010 IPBC 10 01/07/2010 K-HDO 10 01/07/2010 Thiabendazole 10 01/07/2010 Fenpropimorph 10 01/07/2011 Disodium tetraborate 10 01/09/2011 Boric acid 10 01/09/2011 Disodium octaborate tetrahydrate 10 01/09/2011 Boric oxide 10 01/09/2011 Tolylfluanid 10 01/10/2011 Dazomet 10 01/08/2012 Bifenthrin 10 01/02/2013 Fenoxycarb 10 01/02/2013 Creosote 5 01/05/2013 DCOIT 10 01/07/2013 Copper hydroxide 10 01/02/2014 Copper (II) oxide 10 01/02/2014 Basic copper carbonate 10 01/02/2014 Flufenoxuron 3 01/02/2014 DDA Carbonate 10 01/02/2013 HCN 10 01/10/2014 DDA Chloride 10 01/02/2015 ADBAC 10 01/02/2015 Chlorfenapyr 10 01/05/2015 Cypermethrin 10 01/06/2015 Cu-HDO 10 01/09/2015 14
PT08 product authorisation stage Possibility for : o o o o National authorisation Mutual recognition in parallel Mutual recognition in sequence (Simplified authorisation procedure) + Changes, Same biocidal products Most applications : Mutual recognition in parallel, as existing products need to be authorised on the market of several Member States In addition, for : o o Single biocidal product Biocidal product family (same AS, similar composition, similar uses, similar risk and efficacy) Ex : family of different colours of a wood preservative formulation On BPF : On-going discussions to develop common understanding of the provisions and their implementation 15
PT08 product authorisation stage : Technical equivalence Requirement since 1 st September 2013 in application for product authorisation The technical equivalence (TE) of the source (s) of AS used in the product with the reference specifications shall be established o o o o o o When : Before submitting the application for product authorisation Reasons : If TE has not been established at the time of approval on a source (ex : if the source of the active substance comes from a different manufacturer, or sources which were not assessed at the time of approval from the same manufacturer) For What : For each source of the active substance used in a biocidal product (source= manufacturing site/process/manufacturer) By Who : logically, application made by the producers or importer of a source of an active substance To Who : Application for TE to be submitted to ECHA End result : Certificate of ECHA on TE, needed in the application for product authorisation ECHA Guidance: http://echa.europa.eu/regulations/biocidal-products-regulation/technical-equivalence 16
PT08 product authorisation stage : Comparative assessment Objective : Forbid or restrict the making available on the market of BP with AS candidate for substitution, to promote substitution and innovation Active substances in Yellow : Candidates for substitution https://circabc.europa.eu/w/browse/e379dc27-a2cc- 46c2-8fbb-46c89d84b73d Products containing candidates for substitution are subject to a comparative assessment before authorisation Prohibition or restriction if: Alternatives Present significantly lower risk Are sufficiently effective, and Present no significant economic or practical disadvantage, and Chemical diversity adequate to minimise resistance Name of AS Duration of approval (in years) Date of approval Sulfuryl fluoride 10 01/01/2009 Dichlofluanide 10 01/03/2009 Thiacloprid 10 01/01/2010 Chlothianidine 10 01/02/2010 Etofenprox 10 01/02/2010 Propiconazole 10 01/04/2010 Tebuconazole 10 01/04/2010 Thiametoxam 10 01/07/2010 IPBC 10 01/07/2010 K-HDO 10 01/07/2010 Thiabendazole 10 01/07/2010 Fenpropimorph 10 01/07/2011 Disodium tetraborate 10 01/09/2011 Boric acid 10 01/09/2011 Disodium octaborate tetrahydrate 10 01/09/2011 Boric oxide 10 01/09/2011 Tolylfluanid 10 01/10/2011 Dazomet 10 01/08/2012 Bifenthrin 10 01/02/2013 Fenoxycarb 10 01/02/2013 Creosote 5 01/05/2013 DCOIT 10 01/07/2013 Copper hydroxide 10 01/02/2014 Copper (II) oxide 10 01/02/2014 Basic copper carbonate 10 01/02/2014 Flufenoxuron 3 01/02/2014 DDA Carbonate 10 01/02/2013 HCN 10 01/10/2014 DDA Chloride 10 01/02/2015 ADBAC 10 01/02/2015 Chlorfenapyr 10 01/05/2015 Cypermethrin 10 01/06/2015 Cu-HDO 10 01/09/2015 17
PT08 product authorisation stage : Comparative assessment Possible derogation for MS to perform a comparative assessment for a maximum of 4 years in order to gain experience If the comparative assessment is : o o Conditions in Art. 23(3) are not met : products authorised for 5 years Conditions in Art. 23(3) are met : authorised for 4 years, but no renewal possible (for part or all uses) For the mutual recognition : easier to derogate to the mutual recognition principles (cf. Art. 37 of BPR) Guidance document on comparative assessment : https://circabc.europa.eu/w/browse/d309607f-f75b-46e7-acc4-1653cadcaf7e Work on-going : Coordination group : Ad-hoc working group on comparative assessment, to develop further guidance 18
Specific case : substances meeting the substitution criteria 10(1)(a) Art 10(1)(a) : substances that meet the exclusion criteria (CMR 1A/1B, PBT/vPvB, Endocrine disrupters), but which are nevertheless approved due to the derogations established under article 5(2), or which were/are approved under the principles of directive 98/8 (in particular substance for which the draft report from the MS were submitted before 1 st September 2013) For PT08 : Creosote, Disodium tetraborate, Disodium octaborate tetrahydrate, Boric acid, Boric oxide, Flufenoxuron, It shall be noted that : Products can only be authorised in the Member State(s) in which at least one of the conditions for derogation to exclusion mentioned in Article 5(2) is met : Negligible risks, no exposure of human/animal/environment (ex: closed systems) Essential for public or environmental health reasons Disproportionate negative impact on Society compared to the risks of using the substance/product Applicants are excepted to submit additional information to defend their application to allow the evaluation to be made under point 10 of Annex VI of the BPR Ex: for creosote, an analysis regarding the technical and economic feasibility of substitution considering the specific situation of each of the MS where an application is made Higher fees requested by MSs 19
Conclusion on Exclusion/ Substitution provisions Strong incentives to substitute 20
III Focus on measures : Treated articles, provisions on suppliers of AS 21
Focus : Treated articles (Chap. XIII, art. 58) Objective : Ensure protection of health and environment in EU, ensure better competition between treated article that are treated in EU and those treated outside EU, better information of customers/consumers Definition of "treated articles" : Substance, mixture or article (according to REACH definitions) Treated with or intentionally incorporating biocidal products Allowed on the market only if all the active substances contained in the BP are approved for the relevant product type, and it complies with relevant conditions of approval of the AS Guidance on Treated articles, borderline BPs/TA (version Sept. 13): https://circabc.europa.eu/w/browse/e1adf8de-0ad6-4484-84ec-80704391a038 22
Labelling of certain treated articles Required if Case 1 : Claim is made regarding biocidal properties of the article (ex: wood protected against attacks of insects etc.), or Case 2 : Conditions of substance approval so require Information to be provided in the national language 1. Statement that article incorporates biocides 2. Biocidal property of the article (ex: wood protected against attacks of insects etc.) 3. Name of all active substances and all nanomaterials (ex: treated with [name of AS], incorporate [name of nano] as a nanomaterial etc.) 4. Instructions for use to protect man and environment, where appropriate (ex: to protect the environment, the wood cannot be used for outdoor constructions etc...) Outside these 2 cases : Instructions for use to protect man and environment, where appropriate (see point 4 above) Obligation for suppliers to give some information at the request of a consumer within 45 days 23
Application Provisions applicable since 1 st September 2013, in particular concerning labelling provisions Provisions applicable to TA that are placed on the EU market as from 1 st September 2013 (i.e. 1 st supply whether in return of payment or free of charge, see cf. Art 3(1)(i)) Do not apply to TA already on the market on 1 st Sept. 13 (ex: all TA already present in the EU supply chain before 1st Sept. 13) Transitional provision to the obligation to contain only approved AS (see Art. 94) As from 1 st Sept 2016 : Obligation to be treated or incorporate only AS which are approved or under examination at that date Ex: if the AS is currently not supported, an application shall be submitted by 1 st September 2016, otherwise TA will not be allowed to be placed on the market anymore as from 1 st March 2017 This applies in particular to imported TA (ex: imported treated wood, imported table made of treated wood etc ) Still some on-going discussions 24
Focus : Provisions for alternative suppliers of AS cost sharing (art 95) Objective : Level playing field for interested persons on active substances (mostly suppliers of AS), avoid monopolistic situations and enhance free competition As from 1 st September 2015, only biocidal products containing supliers of active substances registered can be made available on the market List of suppliers made by ECHA, publicly available on its website since 1 st 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) 25
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 1 st protection of data will end on 2018 for the 1 st 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) 26
Focus on Art. 95 : What to do By WHO : Logically, person responsible for the placing on the market of an active substance on the EU market (i.e. 1 st 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) Indeed, these are the persons who take the 1 st benefit of the current support of these active substance in the review programme by participants) Participants in the review programme are automatically listed 27
Focus on Art. 95 : What to do HOW : submission via the Register for biocidal products (R4BP) http://echa.europa.eu/web/guest/support/dossier-submissiontools/r4bp/sign-up WHEN: submission possible since 1st September 2013 To be done ASAP 28
Focus on Art. 95 : Some advices For persons placing on the market AS (1 st supply = producers, importers) Check with the participants if you can integrate their task forces, or negotiate a LoA Or, prepare your own complete dossier on the AS Otherwise : the making available on the market of the product will have to stop (i.e. : a producer of a biocidal product will buy the AS from a registered supplier or a registered source) For the other persons making available on the market the AS ( post supplies = distributors ) : Check with your own supplier, the producer/importer of AS to have the guarantee that the registration will be made Or search other producer/importer who will do it Otherwise : the making available on the market of the product will have to stop (i.e. : a producer of a biocidal product will buy the AS from a registered supplier or a registered source) 29
Focus on Art. 95 : Some advices For importers of biocidal products (i.e. products coming from outside EU ) If the AS does not come from the participants or persons already listed, check with the participants if you can integrate their task forces, or negotiate a LoA Or, prepare your own complete dossier on the AS Otherwise : the making available on the market of the product will have to stop In addition : Later, your product will need an authorisation under the BPR. The LoA that you would have obtained for the AS in your product will be useful to obtain an authorisation under the BPR) 30
Focus on Art. 95 : Some advices For producers or persons placing on the market biocidal products Check with your supplier of AS if they have done or will do the registration (If not,) Search for other suppliers that have done or will do the registration Otherwise : the making available on the market of the product will have to stop In addition : Later, your product will need an authorisation under the BPR. The LoA that you would have obtained for the AS in your product will be useful to obtain an authorisation under the BPR) For other producers or persons making available on the market biocidal products Check with your suppliers that the product is compliant with the provisions Otherwise : the making available on the market of the product will have to stop 31
Obligation of Result: Focus on Art. 95 : Anyway As from 1 st 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) ECHA guidance document : http://echa.europa.eu/web/guest/guidance-documents/guidance-on-biocides-legislation To be noted : provisions of Art, 95 are part of the co-decision procedure on-going on the BPR, in order to : Clarify that mandatory data sharing applies to e-fate studies Open the possibility to other persons to make the registration (for instance, if a producer of an AS do want to do it, but a producer of a BP would like to do it instead) 32
Conclusion 33
BPR : same spirit as BPD, but new tool and new measures to better fulfil the objectives of the overall framework on biocides Wood preservatives : finalisation of AS review, beginnings of BPs authorisation Entry into application on 1 st September 2013 : A lot of work on-going at EU level for the implementation of the BPR Many challenges for both COM/ECHA/MSs and IND 34
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 35