Product Authorisation

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

2. Outline • Treated Articles • Products containing non-EU evaluated AS source • Technical equivalence • Free-rider issue • Frame formulation vs. biocidal product family • Timelines for inclusion of PT1-5 AS

3. Treated articles

6. Treated articles • Definition: "treated article" means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products • A TA shall not be placed on the market only if it is treated with or incorporates approvedAS or in Review Program • Exemption for fumigation leaving no residues • Transitional measure: • Possibility to submit dossier on new AS until 1 Sep 2016

7. Treated articles • Labelling: Instructions for use where necessary to protect HH/ENV - Upon request by consumer, provide information on biocidal treatment, within 45 days • Specific labelling is required if: • a claim is made regarding the biocidal properties of the TA, or • the conditions associated with the approval of the active substance(s) so require

8. Treated articles Specific labelling: • a statement that the TA incorporates biocidal products; • where substantiated, the biocidal property attributed to the TA; • the name of all active substances contained in the biocidal products; • the name of all nanomaterials contained in biocidal products, followed by the word "nano" in brackets; • any relevant instructions for use

9. Products containing non-EU evaluated AS source

10. BP with non-EU evaluated AS source • No (limited) recognition of evaluations performed outside the scope of the EU biocides legislation • Under BPD and BPR, responsibility for compliance is with the person placing on the market • No system of Only Representative • Art 95 of BPR: importer of a BP needs to be listed as source for the AS

11. Technical equivalence

12. Definition (BPR) • “Technical equivalence" means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out.

13. Two-tiered approach • Tier I • Evaluation of analytical data • Method of manufacturing • Specification of purity • Identity of impurities • Tier II • Available test data - initial screening testing • Guidance under development

14. TE assessment • BPD: performed by Member State • AS evaluation – Annex I inclusion • Product authorisation – new source • BPR: performed by ECHA • Procedures and guidance under development

15. Free-rider issue

16. The free-rider issue • While defended, any actor can place an AS on the market during the transitional period • Transitional period is taking longer than expected • 2010 –> 2014 -> 2025 -> ??? • Complying companies are put at a disadvantage

17. The free-rider solution • As of 1 Sep 2013, companies placing on the market: • An AS, or • a BP containing an AS • Need to comply with the data requirements • LoA • New complete dossier • From 2015, BP can only contain an AS from a compliant source

18. The free-rider solution • Discussions regarding implementation ongoing: • Evaluation of new dossiers • Re-import of AS from EU source

19. Frame formulationvs.biocidal product family

20. Definitions Frame formulation – BPD Specifications for a group of biocidal products having the same use and user type. This group of products must contain the same active substances of the same specifications, and their compositions must present only variations from a previously authorised biocidal product, which do not affect the level of risk associated with them and their efficacy. In this context, a variation is the allowance of a reduction in the percentage of the active substance and/or an alteration in percentage composition of one or more non-active substances and/or the replacement of one or more pigments, dyes, perfumes by others presenting the same or lower risk, and which do not decrease the efficacy.

21. Definitions Biocidal Product Family – BPR a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products; a reduction in the percentage of one or more active substances may be allowed, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. The classification, hazard and precautionary statements for each product shall be the same (exception for a concentrate for professional use and ready-to-use products obtained through dilution).

22. Comparison

23. Comparison A C B F E D Frame Formulation Biocidal Product Family

24. Benefits of BPF to FF • One application - one authorisation for whole family • Mutual recognition of a BPF • 30 day notification period before placing on the market of existing products in a family or changing pigment, dye or perfume • No limit on the number of products in a BPF • Broad variation on composition possible across a BPF

25. Industry survey

26. Setting up a BPF • Group products according to active substances • Divide active substance groups according to use • Determine if a BPF can be formed from these sub-groups using classification, efficacy and hazard profiles • Check for overlaps between the groups – can two groups be joined into one?

27. Risk envelope approach The risk envelope approach is a concept that exploits the idea that within a group of biocidal products and use patterns or for a product with multiple use patterns (i.e. product-types), there will be certain use patterns which represent the worst-case or critical situation in each area of risk assessment. The assessment of these worst-case/critical products/uses will cover all other situations where the use pattern is less critical or the same.

28. Preparing for authorisation • Decision on representative worst case(s), e.g.: • High active concentration, or multiple actives • Worst hazard profile • Major commercial product • Broad use spectrum/exposure scenario • Establish testing programme – minimum to support BPF • Explore read-across and data-waiving

29. Further clarifications • Transitional arrangements: are all members of a BPF considered as an existing product, even if some are not? • Mutual recognition: MS can request for derogations – will they apply to all members of a BPF? • Very little experience yet with FF – need for clear guidance regarding BPF

30. Timelines for inclusion of PT1-5 Active substances

31. Overall numbers * Hydrochloric acid - 1 May 2014

32. TM or CA discussion

33. Outlook for PT 1-5 • Very slow progress • Review programme is not expected to finish before 2025 • Majority will be covered by the new BPR

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