1. The Biocidal Products Directive. ECB INFODAYS, Zagreb 11-12 th December, 2006 Sharon Munn European Commission DG JRC Institute for Health and Consumer Protection, European Chemicals Bureau

2. This presentation Overview of the Legal frame Dossier preparation and submission Evaluation of dossiers Discussions at TM and CA levels Next step: Authorisation of products Web pages

3. Overview of the Legal frame The relevant directive is Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market. The Directive regulates the placing of Biocidal products on the market in a two step procedure. The first step is evaluation of the active substances at EU level (Annex I entry) and the second step is product authorisation at member state level.

4. Legal frame - Definitions A biocidal product is defined as (art. 2(1)(a)): (a) Biocidal products Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means. An exhaustive list of 23 product types with an indicative set of descriptions within each type is given in Annex V.

5. Legal frame - definitions The substance definition is the same as in Directive 67/548/EEC, as amended by 92/32/EEC. Substances are divided into new and existing active substances, defined by the date of implementation (14 May 2000). New substances have to be evaluated before they can be placed on the market. Existing substances go through a review programme and can stay on the market.

6. Legal frame – data requirements An Annex I entry is based on data. Requirements are given in the annexes of 98/8/EC and address both the substance and a product. Requirements are the same for new and existing substances. Chemicals Annexes IIA and IIB Annexes IIIA and IIIB Details in TNsG on Data Requirements Micro-organisms incl. viruses and fungi Directive 50/2006/EC amending Annexes IVA & IVB

7. Legal frame – review of Existing substances Following the adoption of this Directive, the Commission shall commence a 10-year programme of work for the systematic examination of all active substances already on the market on (14 th May 2000, existing active substances) …. A Regulation … will provide for all provisions necessary for the establishment and implementation of the programme including the setting of priorities for the evaluation …and a timetable. Article 16 (2) of Directive 98/8/EC The 10 years review programme

8. Legal frame – Review Regulations Implementation of Art. 16 (2) of the BPD: 1.First Review Regulation ( 1896/2000 of 7 September 2000 ) - Identification of existing active substances - Notification (supported by basic information) - Selection of two Product Types, PT 08 and 14 1a. Regulation EC No 1687/2002 of 25 th September 2002 on an additional notification period for certain active substances 2. Second Review Regulation (2032/2003 of 4 Nov. 2003) - Allocation of Rapporteurs for 1 st and 2 nd list

9. Legal frame – Review Regulations Implementation of Art. 16 (2) of the BPD: 3. Third Review Regulation (1048/2005 of 13 June 2005) - Allocation of Rapporteurs for 3 rd and 4 th list 4. Additional Regulations to phase out the active substances for which no dossier was submitted, and list substances for which essential use has been claimed. Identified substances phased out by 1 Sep. 2006, unless Art. 4b dossier submitted or essential use is claimed.

10. Art 1: Subject matter This Regulation lays down detailed rules for the implementation of the second phase of the programme of work for the systematic examination of all active substances already on the market on 14 May 2000 as active substances of biocidal products, hereinafter “the review programme”, referred to in Article 16(2) of Directive 98/8/EC. Legal frame – Second Review Regulation (2032/2003)

11. Main objectives: Lists of identified (Annex III) and notified (Annex II) substances (all substances: Annex I) Phase-out period for substances neither identified nor notified Time schedule for dossier submission for notified substances according to PTs (Annex V) Details on dossier submission and the evaluation process

12. Legal frame – Second Review Regulation (2032/2003) Active substances listed in Annex II to 2 nd RR: shall not be included in Annex I, IA or IB to Directive 98/8/EC within the framework of the review programme in relation to any PT not specified in Annex II. Active substances listed in Annex III to 2 nd RR: to be phased out by 1 Sep. 2006 Amended according to 1048/2005 : an identification can be upgraded to a notification by submission of a complete dossier by 1 March 2006.

13. Legal frame – Second Review Regulation (2032/2003) Member States shall cancel all existing authorisations/registrations for biocidal products, except for those containing the substances listed in Annex II for the notified PTs by 1 Sep. 2006. may apply the derogation referred to in Article 16(1) of Directive 98/8/EC (i.e. applying the former national system) only to substances listed in Annex II / PT

14. Legal frame – Second Review Regulation (2032/2003) Part A. 28.03.200408 Wood preservatives 14 Rodenticides Part B. 30.04.200616 Molluscicides 18 Insecticides, acaricides and products to control other arthropods 19 Repellents and attractants 21 Antifouling products Part C. 31.07.2007 PTs 1, 2, 3, 4, 5, 6, and 13 (Disinfectants and start of preservatives) Part D. 31.10.2008 PTs 7, 9, 10, 12, 15, 17, 20, 22 and 23 (Preservatives and other biocidal products)

15. The Rapporteur Member states have been allocated for substances on Parts A and B in Reg. 2032/2003, and for Parts C and D in Reg. 1048/2005. Substances will continue with the same RMS throughout the review programme The 10 new member states will participate as RMS for Parts C and D Legal frame – Allocation of Rapporteur Member States

16. Legal frame Possibilities for withdrawn actives. RRII, Art 8. 8(1)To replace participant  producer, formulator or association (P F A) inform COM and RMS. 8(2)To discontinue participation  producer, formulator or association inform COM and RMS stating the reasons. 8(3)If withdrawal of all participants  COM inform MS & 8(4) 3 months  another P F A or MS take over 8(5)COM decision non inclusion in Annex I for PTs A substance can always be submitted according to Art. 11of the BPD (e.g. withdrawn or ‘only identified’ subst.)

17. Dossier Preparation and Submission Information requested a dossier for a biocidal product ( Art. 11(1)(a)(ii) BPD covering the use in the PT (Exposure to man and environment)) a summary dossier for all studies and end-points (toxicology, ecotoxicology and general issues) in case of joint application: (a) names of all participants (b) a person responsible If no joint dossier was prepared: explanation why not Breakdown of costs (dossier, animal testing,…)

18. Dossier preparation and submission A complete dossier has 4 levels: –Level I: overall summary and assessment –Level II: risk assessment –Level III: ‘robust’ study summaries of the test reports –Level IV: test reports The Rapporteur has all 4 levels – the other member states have levels 1, 2 and 3

19. Doc. IV-B: Test and Study Reports b.p.(s) Doc. IV-A: Test and Study Reports a.s. Doc II-A Effects and Exposure 3) Assess. Active Substance 2) Doc II-B Effects and Exposure Assess. Biocidal Prod.(s) 2) Doc. II-C Risk Characterisation for Use of A.S. in B.P.(s) Doc. II Risk Assessment Doc. I Overall Summary and Assessment 1) Document III-B Study Summaries Biocidal Product(s) 2) Document III-A Study Summaries Active Substance 2) 1) To append: List of end points 2) To append: Reference lists List of abbreviations Check for completeness Summary Dossier Complete Dossier Overview of the composition of a biocides dossier

20. Evaluation: Guidance documents Technical Notes for Guidance (TNsG) on data requirements TNsG on Annex I inclusion TNsG on dossier preparation and study evaluation TNsG on product evaluation TNsGs on environmental emission scenarios TNsGs on Human Exposure TGD on Risk Assessment http://ecb.jrc.it/ http://ecb.jrc.it/ To ensure transparancy and harmonise the implementation

21. Evaluation: Completeness check of dossier by RMS The Rapporteur MS shall verify the dossier concerning the acceptability within 3 month. In difficult cases the period shall be prolonged up to a maximum of 3 month. If a participant fails to submit the data within the deadline (also fees), he will be excluded form the programme. A new deadline may be established only under exceptional circumstances. Within 1 month after the acceptance of the dossier the participant forwards the summary dossier to COM and to the other MSs.

22. Evaluation of dossiers by the RMS The CA of the RMS shall carry out the evaluation and prepare an evaluation report Additional information from the participant (or third parties) shall only be taken into account, if 1. the participant informed the RMS at dossier submission 2. the data is submitted at latest 3 month before the end of evaluation 3. the data is more reliable 4. the result changes the outcome of the recommendation 12 months

23. Evaluation by the RMS The RMS shall submit the “competent authority report” to COM, MSs and the applicant which includes a recommendation either: to include the existing active substance in Annex I, IA or IB to Directive 98/8/EC stating the conditions for inclusion, or not to include the substance in Annex I, IA or IB, mentioning the reasons for the non-inclusion, or in the case RMS request additional information deadline is established by RMS  participants may submit updated summary dossiers to COM and MSs

24. Evaluation: Commission procedures COM gives 90 days to the other Member States and the applicant to comment the “competent authority report”. COM shall organise, when necessary, meetings with experts. COM may consult the appropriate Scientific Committee(s). After the commenting period  COM prepares  a draft for decision to include the substances in Annex I, IA or IB to Dir. 98/8/EC, setting out the conditions, or  a draft for decision addressed to the MS not to include the substance in Annex I, IA or IB, mentioning the reasons for non-inclusion, requesting MS to cancel existing authorisations/registrations for biocidal products containing the substance

25. 30.04.200628.03.200431.07.200731.10.2008 Completeness check Evaluation Comment phase Decision phase Timescale for the review programme

26. Results of Completeness check and beyond PT 08 Wood preservatives No. of substances in 2032/2003:81 No. of substances for which a dossier was submitted: 37 No. of substances with multiple dossiers:4 No. of substances withdrawn during completeness:0 Prolonged completeness:2 Art. 4b substances, still awaiting dossier:2 Finalised CA reports: 19 Discussed CA reports at TM: 8 Substances in Annex I 1 Delayed reports (add. data needed or other): 18

27. Results of Completeness check and beyond PT 14 Rodenticides No. of substances in 2032/2003:17 No. of substances for which a dossier was submitted: 14 No. of substances with multiple dossiers:3 No. of substances withdrawn during completeness:1 Prolonged completeness0 Finalised CA reports:11 Discussed CA reports: 6 Delayed reports (add. data needed or other): 2

28. Results of Completeness check and beyond PT 16 Moulluscicides : No dossiers were submitted PT 18 Insecticides: No. of substances in 2032/2003:81 No. of substances for which a dossier was submitted: 64 No. of substances with multiple dossiers:8 No. of substances withdrawn during completeness: 0 Prolonged completeness 7 Complete dossiers50 Incomplete dossiers 2+5

29. Results of Completeness check and beyond PT 19 Attractants and repellents No. of substances in 2032/2003:42 No. of substances for which a dossier was submitted: 16 No. of substances with multiple dossiers: 1 No. of substances withdrawn during completeness: 1 Prolonged completeness 2 Complete dossiers11 Incomplete dossiers 2

30. Results of Completeness check and beyond PT 21 Antifoulants No. of substances in 2032/2003:46 No. of substances for which a dossier was submitted: 10 No. of substances with multiple dossiers:2 No. of substances withdrawn during completeness:0 Prolonged completeness:4 Complete dossiers:6

31. Doc. IV-B: Test and Study Reports b.p.(s) Doc. IV-A: Test and Study Reports a.s. Doc II-A Effects and Exposure 3) Assess. Active Substance 2) Doc II-B Effects and Exposure Assess. Biocidal Prod.(s) 2) Doc. II-C Risk Characterisation for Use of A.S. in B.P.(s) Doc. II Risk Assessment Doc. I Overall Summary and Assessment 1) Document III-B Study Summaries Biocidal Product(s) 2) Document III-A Study Summaries Active Substance 2) 1) To append: List of end points 2) To append: Reference lists List of abbreviations Check for completeness Summary Dossier Complete Dossier

32. Evaluation: Which discussion will come up? PT 14 Rodenticides ANTICOAGULANTS Early discussion on the long term tests (CMR studies) Avian toxicity testing Substance identity (corn cob) Classification and Labelling ALL Compatibility with PPP dossiers

33. Evaluation: Which discussions will come up? PT 08 Wood preservatives Current ESD conservative => overestimate emission Leaching testing Assessment of Metal ions, already a discussion item for other chemicals’ programmes Passing the biodegradation criteria Substance identity (quats) Read across between substances Compatibility with PPP dossiers

34. Evaluation - Methodology The methodology for the evaluation is described in the Technical Notes for Guidance (TNsGs) and the TGD on Risk Assessment (including Emission Scenario Documents) There are some gaps and by applying the TNsGs changes have been suggested / agreed.

35. Evaluation – Methodology developments There are difficult areas: e.g. chemical identity, pheromones (guidance document), natural substances (guidance document), read across of data, leaching rates for PT08 (workshop) and 21 Methodology is translated from other areas: Existing Substances Regulation and Plant Protection Products Some remaining difficult issues: e.g. efficacy testing, metabolites

36. Evaluation - Statistics Experience from the first list was that most RMS took 6 months to check completeness. Most dossiers took more than 12 months to evaluate: in Aug. 2006: –9 (of 13) reports from RMS under PT 14 –16 (of 40) reports from RMS for PT08 “stop the clock” –Unclear chemical identity –Data gaps

37. Evaluation Peer review by the other member states Peer review by the other member states: –Documents level I, II and III are circulated –90 day commenting period for OMS, applicant and other interested parties (only public report). Comments should be submitted in writing. –The Rapporteur prepares a response-to- comments table, indicating (dis)agreement with the comments and actions. –Information is circulated via CIRCA

38. Discussions at TM and CA levels Peer review by the other member states Outstanding issues from the response-to- comments are discussed at a technical meeting. The technical meetings are prepared, chaired and followed-up by the ECB All member states and the applicants are invited to the TMs

39. Discussions at TM and CA levels Peer review by the other member states Provides consistency Provides common solutions Provides a forum for discussion Several meetings may be needed

40. Discussions at TM and CA levels C&L The Classification and labelling is performed in the TC C&L (Technical Committee for classification and labelling).

41. Discussions at TM and CA levels TM reports to the Competent Authorities meeting and the minutes of the TMs are distributed. Update of the Competent Authority Report reflecting outcome of discussions presented for the CAs. The entry of a substance onto Annex I is done via a voting committee. The legal text is a directive.

42. Annex I inclusion So is it possible at all? –Large dossier / extensive requirements –Methodology well described, but gaps are still found –25 MS plus applicant plus EEA (NO, ICE, CH) to discuss and reach a decision

43. Annex I inclusion Discussion on Sulfuryl fluoride was finished at TMI06, and voted onto Annex I at the 22 nd CA meeting (Sep. 2006) The next substances were up for final discussion at TM III 06, and Annex I entry in 2007.

44. Annex I inclusion Annex I inclusion is for a maximum of 10 years (Art. 10 / BPD) Comparative assessment Art. 14 / BPD New information The work under the BPD does not stop with Annex I inclusion.

45. Next step: Authorisation of products The BPD is a two-step Directive. The first step is Annex I inclusion under the responsibility of the Commission The second step is product authorisation under the responsibility of the Member States. Products can be authorised when they contain active substances listed in Annex I

46. Next step: Authorisation of products Product authorisation is based on the common principles in Annex VI Product authorisations will be mutually recognised according to Art. 4(1) of the BPD

47. Further information on the Review Process ECB web page: http://ecb.jrc.it/Biocides http://ecb.jrc.it/Biocides Technical Notes for Guidance on Annex I inclusion TNsG on data requirements TNsG on dossier preparation and study evaluation TNsG on product evaluation TNsGs on environmental emission scenarios TNsGs on Human Exposure TGD on Risk Assessment http://ecb.jrc.it/ http://ecb.jrc.it/ DG ENV: http://ec.europa.eu/comm/environment/biocides/index.htmhttp://ec.europa.eu/comm/environment/biocides/index.htm Basic Principles Scope/Borderline documents, manual of decisions Public version of the draft CA reports Withdrawn substances