EU Regulation on the making available and use of biocidal products (BPR)

Transcription

1 EU Regulation on the making available and use of biocidal products (BPR) Workshop on antifoulings SeaEurope 23/09/2016 M. Ludovic Chatelin European Commission 1

2 I Objectives and main provisions of the legislation II State of play for antifoulings in EU III Short term key dates with regulatory consequences 2

3 I Objectives and main provisions of the legislation 3

4 Biocidal Product Regulation (BPR) Regulation (EU) No 528/2012 of 22 th May 2012, replaces Directive 98/8/EC BPR entered into application on 1 st September 2013 Main objectives : Improve the harmonisation of the internal market while ensuring a higher level of safety for health and environment Encourage innovation and the making available on the market of products with better profiles Establish provisions to partly regulate treated articles with biocides Establish more detailed procedures for the making available on the market of biocidal products, in order to ensure a better enforcement by economic operators and authorities 22 different Biocidal Product-types : Antifouling products = PT 21 4

5 Biocidal Product Regulation (BPR) Keystones : o o Approval of active substances (AS) at EU level Authorisation of biocidal products containing these AS at national level or EU level A lot of provisions are now applicable : o Use of the various procedures for new applications AS approval procedures National authorisation / mutual recognition procedures at Member State level Possibilities of Union authorisation (not for antifouling products) Possibilities for parallel trade (art 53) Applications to European Chemicals Agency (ECHA) for technical equivalence of sources of AS (art. 53) Applications to ECHA for registration on the AS suppliers list (art. 95) Etc. 5

6 Application of the BPR New principles in force : Exclusion (Art 5 - CMR, PBT/vPvB, POP, ED) Substitution of active substances (Art 10) Comparative assessment of biocidal products (Art 23 BP contain 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. 6

7 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, BPR authorisation when needed, use compliant products 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 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. 7

8 II State of play for antifoulings in EU 8

9 Organisation of the biocides framework Objective : finish the review programme by the end of existing active substances (ie. present before 14 th May 2000 on EU market) supported for one or several product-types = around 620 dossiers 9

10 Process of AS evaluation Once the applicant has submitted its dossier : 10

11 Management of Review programme Minimum 50 opinions and decisions per year Priorities in the Review Programme Regulation (EU) No 1062/2014 depending of PTs (cf. Annex III) : Antifoulings Product-types Time limits for MS to submit the assessment report to ECHA Time limits for ECHA (BPC) to start the preparation of the opinion 8, 14, 16, 18, 19 and , 4 and and and , 9 and , 12, 15, 17, 20 and Dates = Deadlines 11

12 Specific case of antifoulings Discussions in with Member States and EU stakeholders on the management of antifoulings Endorsed approach: CA-March14-Doc.4.2- Final - Approach for antifoulings PT21.doc 45be-8f88-e1870bced8a5 12

13 Issues Concerns : from evaluation of AS, unacceptable risks sometimes shown to one or more environmental compartments (ex: harbour/marina), and sometimes risks for human health, for different one or several stage of use (application, maintenance & repair, in service), etc. Nevertheless, benefits : prevent the growth of marine life on ships and boats allowing their safe and efficient operation, contribution to prevention of spreading of invasive alien species, reduction of fuel consumption and related greenhouse gases emissions Decision making for the approval of AS : Without prejudice to exclusion / substitution criteria of the BPR, and as long as one safe use is demonstrated, it was agreed : To approve active substances for PT21 on the basis on the same generic conditions. Additional specific conditions or restrictions can be added on a case-by-case basis To establish the same expiry date of approval for existing AS, to facilitate the comparison at the renewal stage : 31/12/2025. To flag specific concerns related to each individual active substance in the assessment report and EHA opinions, to help BP authorisation and the renewal stage. 13

14 Generic conditions The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. In the event that products are subsequently authorised for use in non-professional antifouling products, persons making products available on the market for non-professional users shall ensure that the products are supplied with appropriate gloves. Authorisations are subject to the following conditions: 1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. 2) Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry. 3) Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area, on impermeable hard standing with bunding or on soil covered with an impermeable material to prevent losses and minimise emissions to the environment, and that any losses or waste shall be collected for reuse or disposal. 4) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded 14

15 Authorisation of products As far as possible, harmonisation of authorisation across EU, in particular for use on large commercial boats or superyatch >25m and risks for the environment, These vessels are expected to travel across EU Member States can also, on dully justified grounds, derogate to the mutual recognition and decide to ban or restrict the use of antifouling products at local levels, in accordance with Article 37 of the BPR. For instance, instance ban the use in sensitive areas, specific marinas, specific coastal zones, natural reserve, Natura 2000 zones etc. 15

16 Progress on active substances for PT21 Review of existing active substances (existing BP can stay on the market under transitional national rules of each Member State until their review finalised) Active substance EC No CAS No Status Reference for the decision Date of approval on approval/non-approval Zineb Approved Regulation (EU) No 92/ /01/2016 DCOIT Approved Regulation (EU) No 437/ /01/2016 Tolylfluanid Approved Regulation (EU) 2015/419 01/07/2016 Copper pyrithione Approved Regulation (EU) 2015/984 01/10/2016 Cybutryne Not Approved Decision (EU) 2016/107 x Copper flakes Approved Regulation (EU) 2016/ /01/2018 Dicopper oxide Approved Regulation (EU) 2016/ /01/2018 Copper thiocyanate Approved Regulation (EU) 2016/ /01/2018 Dichlofluanid Still under assessment x x Pyrithione zinc Still under assessment x x New active substances (BPs cannot be placed on the market until authorised) Active substance EC No CAS No Status Reference for the decision Date of approval on approval/non-approval Tralopyril NA Approved Regulation (EU) No 1091/ /01/2016 Medetomidine NA Approved Regulation (EU) 2015/ /01/2016 ( Medetomidine : substance under substitution, as being Persistent and Toxic ) 16

17 At technical level in ECHA Revision of the guidance document on the environmental exposure assessment for harbour/marina for pleasure crafts, to help to perform the risk assessment on antifouling products Involvement of the industry stakeholders (ex: CEFIC, CEPE..) Finalisation by the end of the year Guidance documents are used by prospective applicants for product authorisation 17

18 IV Short term key dates with regulatory consequences 18

19 Deadlines on products and treated articles 1 st semester 2017 : Art 89 of BPR : Ban of antifouling paints containing cybutryne Consequence on antifoulings paints : ban of supply on 27/01/2017, ban of use on 27/07/2017 Consequence on treated articles (ex: treated fishing nets with cybutryne ) : not possible to place on the EU market anymore (1 st supply; what is already in the EU supply chain can continue to be supplied); the use of treated articles is still possible Art 94 of BPR : No possibilities to place on the market treated articles with active substances not under evaluation in the EU (ex: importation of treated fishing nets etc.) on 1 st March st supply on the EU market impossible (ex: importation) ; what is already in the EU supply chain can continue to be supplied The use of those treated articles is still possible 19

20 Product authorisations On 01/01/2018 : As most BP contains copper compounds, deadline for submission for product authorisation for many antifouling paints which contains approved active substance Application for product authorisation must be submitted in Member States, possibility to request mutual recognition. If no application for product authorisation is submitted in due time, products will not be allowed to be made available on the market anymore, and not used anymore (cf. Article 89 BPR) NEED TO FOLLOW CLOSEDLY THE REVIEW PROGRAMME OF ACTIVE SUBSTANCES, ANTICIPATION BY PAINT MANUFACTURERS, COMMUNICATION IN THE SUPPLY CHAIN TO USERS 20

21 10 y* Today 01/01/2016 1/01/ /12/ st substance being formally approved : Zineb Estimated date of approval of the last AS for PT21 Expiry date of approval for all existing AS for PT21* 550d 31/06/2024 Timeline for Active substances approvals Deadline for submission for application for renewal of approval of AS* If the approval is not extended / renewed : authorisation of BPs will be cancelled (ie. AS not approved anymore) * Provided AS is not subject to exclusion/substitution 21

22 Authorisations granted for 10 y** Today 1/01/2018 Date of approval of most Copper compounds = Submission of many applications for antifouling BP authorisation (most BP contain copper compounds) 1/01/ /12/ /12/2025 Estimated date of approval of the last AS for PT21 = Date by which all applications for product authorisation or existing BPs have been submitted Timeline for Biocidal product authorisations Estimated date of authorisation of the existing BPs for PT21 Expiry date of approval for all existing AS for PT21* If the approval is not extended / renewed : authorisation of BPs will be cancelled (ie. AS not approved anymore) 3,5y 31/06/2029 Deadline for submission for application for renewal of authorisation for existing BPs 31/12/2030 Expiry date authorisation for existing BPs ** 550d * Provided AS is not subject to exclusion/substitution ** Provided BP is not subject to a comparative assessment 22

23 Conclusion 23

24 BPR : continuity with the former legislation (1998), new principles Various challenges for IND, Authorities Coming years for antifoulings : Only products containing sources of active substances listed on ECHA Article 95 list can remain on the market since 1 st September 2015 Finalisation of the review of antifouling active substances by 2017 Authorisations of antifouling products by 2020 Work on alternatives by IND? Fulfil objectives of the legislation : harmonisation of EU market, ensure better protection of human health, animal health and environment 24

25 Thank you for your attention For further information : Commission website : (Sante-Biocides@ec.europa.eu) ECHA website & Helpdesks on Biocides : 25