1. Product Authorisation Workshop on REACH and EU Biocidal Product Legislation in practice (Experiences from EU Industry) INT MARKT 48493 Belgrade, Serbia Raf Bruyndonckx 1 June 2012 Procedures and Requirements

2. Outline General principles Procedures Application Data requirements Fees Role of industry associations 2

3. Cefic 3 Cefic – European Chemical Industry Council Membership 28 national chemical federations > 600 companies > 20 affiliated sector associations Horizontal - vertical EU Policy Centre: REACH, International trade, energy and climate change, HSE, logistics, R&I … 104 Sector Groups

4. EBPF 4 European Biocidal Products Forum Sector group of Cefic Regulatory developments of EU biocides legislation AS producers & BP formulators 70 members: companies, associations, federations Recognised stakeholder & observer Implementation BPD: AS evaluation – BP authorisation New Regulation

5. EBPF – European Biocidal Products Forum General Assembly Management Committee General Issues Advocacy Team Communication Issues Team Data Sharing WG Product Authorisation WG Sustainable Use WG Dietary RA ISG Sector-Specific Issues Disinfectants WG Insecticides WG Rodenticides WG RDDG Best Practice WG

6. BPR - New era starting Sep 2013 Updated EU biocides law applicable 1 Sep 2013 Regulation – directly applicable to all EU Same principles, improved procedures – mutual recognition, changes to products New concepts – EU authorisation, product family Extended scope – treated articles European Chemicals Agency 6

7. Abbreviations BPDBiocidal Product Directive 98/8/EC BPRBiocidal Product Regulation ASactive substance BPbiocidal product PTproduct type PAproduct authorisation MRmutual recognition LoAletter of access MSmember state(s) 7

8. Product Authorisation General Principles 8

9. General principles 9 Authorisation is required before placing on the market Authorisation is granted for max. 10 years Authorisation can be granted if all conditions are fulfilled: AS is approved for relevant PT + AS source is on positive list The product is effective No unacceptable effects on target organism (resistance) No unacceptable effects on HH, ENV or animal health Chemical identity is known (impurities/residues) Phys-chem properties acceptable for transport and use

10. General principles 10 A BP cannot be authorised for use by general public if: It is classified acute tox. (dermal, oral, inhalation); It is classified CMR 1 or 2; It has PBT properties; It has endocrine disrupting properties or It has developmental neurotoxic or immunotoxic effects

11. General principles 11 Dossier elements: AS data: LoA or complete dossier BP data: complete dossier (or LoA) Assessment of hazard, risk (through relevant exposure) and efficacy Draft Summary of the biocidal Product Characteristics (SPC)

12. SPC – the ID card of a BP 12 Trade name Authorisation holder – authorisation number Date of authorisation & expiry date Manufacturer of BP and AS Qualitative and quantitative composition Type of formulation – categories of users Instructions for use and safe disposal

13. Product Authorisation Procedures 13

14. Different procedures 14 (National) authorisation – provisional authorisation Mutual recognition (in parallel or in sequence) BPR: Union authorisation Coordination by ECHA, evaluation by MS, decision by COM Simplified authorisation procedure Parallel trade authorisation “Same product” authorisation

15. Timelines 15 2 years to submit dossier 2 years to grant, amend or withdraw authorisations 3 months for completeness check 12 months for first authorisation 2 months to apply for mutual recognition 4 months to recognise first authorisation 3 months to resolve diverging opinions

16. 31/12/10 1/01/07 1/01/09 8/09/06 3 months completeness check (01/01 to 31/03/09) 2 months application for mutual recognition (01/04 to 31/05/10) 12 months 1 st evaluation and authorisation (01/04/09 to 31/03/10) 4 months recognition of 1 st authorisation (01/06 to 30/09/10) 3 months (01/10 to 31/12/10) † † No application/notification (30/06/09) Failed completeness check (30/09/09) Timelines 16

17. Union authorisation - scope 17 Valid across all MS at once Similar conditions of use across the Union - guidance Excluded: Art 5 – PTs 14, 15, 17, 20 and 21 Sep 2013: new AS - PTs 1, 3, 4, 5, 18 and 19 Jan 2017: PTs 2, 6 and 13 Jan 2020: all categories Assessment report by 31 Dec 2017

18. 18 Conditions: AS in Annex I (BPR), no SoC, no nano, no PPE, sufficiently efficient No requirement for a LoA to AS dossier Submission to the Agency Evaluation by a MS within 90 days Once authorised, notification to other MS is sufficient – no MR Simplified authorisation procedure

19. “Same product” authorisations 19 Identical products Existing practice (NL, FI, CH, SE, DK, PT, BE, IT...) Mutual recognition within a MS between companies Faster procedures Principle in BPR, follow-up regulation

20. Product Authorisation Application 20

21. R4BP 21 Register for Biocidal Products Electronic database – “EU catalogue of products” Application form – Applicant & product Decision and assessment report BPR: Electronic submissions – no more paper Central communication and process management tool Covers both AS and BP

22. R4BP 22

23. Product Authorisation Data requirements 23

24. General outline 24 Data on the active substance(s) – LoA to Annex I dossier Substances of concern Data on the biocidal product Use description – exposure assessment Analytical methods Properties/Effect/hazard assessment (PC, TOX, ENV) Risk assessment Efficacy

25. 25

26. Data waiving 26 A data requirement is not relevant to the product and/or the intended use A study cannot be performed because the test is not feasible The outcome of a study can be accurately predicted based on a scientific argumentation The outcome of the study is in no way relevant to the risk assessment, classification and labelling or intended use

27. Principle approach 27 Collate info on components - AS and SoC Start with detailed use description Derive possible exposure (exclude specific routes) Properties/Effect/hazard assessment Risk assessment – Risk reduction measures Efficacy

28. Availability of data 28 Active substance dossier (LoA required) Co-formulants: REACH – MSDS Public literature

29. Product Authorisation Fees 29

30. Fees 30 Broad variation across MS First authorisation: 10.000 – 50.000 Euro Changes: 500 – 25.000 Euro Renewal: 500 – 50% of original fee Annual fee: fixed or related to sales

31. Role of industry associations 31

32. Role of industry associations 32 General representation of industry Endeavour to be recognised stakeholder Consensus driven position taking Competition law considerations No specific role regarding data sharing

33. Useful sources of information 33 Note for guidance to applicants for PA and MR - linklink EU Evaluation Manual - linklink TNsG on data requirements – linklink TNsG on product evaluation – linklink Joint Research Centre – biocides section - linklink

34. Raf Bruyndonckx +32 2 676 7366 rbr@cefic.be