WP on the implementation of the Biocidal product family concept :

1. CA-March29-Doc.4.7.a WP on the implementation of the Biocidal product family concept: agreed recommendations in a nutshell

2. Article 3(1)(s) of the BPR ‘biocidal product family’ means a group of biocidal products having: (i) similar uses; (ii) the same active substances; (iii) similar composition with specified variations; and (iv) similar levels of risk and efficacy. In order to define whether a BPF meets the BPR definition of family with regards to similarity, further criteria had to be developed for assessment of “similar uses”, “similar composition with specified variations” and “similar levels of risk and efficacy”. WP on the implementation of the Biocidal product family concept was established.

3. CG mandate to the WP on the implementation of the Biocidal product family concept* Objectives to discuss issues already identified as relevant when defining the structure of the family (as well as any other relevant issues identified during the discussions) to provide a recommendation to the Commission on the elements that need to be updated or further addressed in the “Implementing the new concept of biocidal product families” (CA-Nov14-Doc.5.8-Final.rev31).“ *agreed during the CG-24 September 2017 available: /CircaBC/echa/Biocides CoordinationGroup_public/Library/Summary records/Summary records WP-BPF

4. The composition of the WP • MSs • ASOs: • UEAPME (SMEs) • AISE • CEFIC • TheCommission • ECHA

5. To clarify similarity concept several documents were developed and agreed by the WP experts: • similar uses • Similarity of uses (including automated tool in the form of matrix) (iii) similar composition with specified variations • Definition of similar composition • Grouping of co-formulants in BPF (iv) similar levels of risk and efficacy • Similarity concept – Risk and efficacy • In addition WP experts agreed on the general documents: • Best practices for BPF pre-submission meetings • Splitting of families for ongoing applications WP deliverables All WP recommendations were agreed in the WP by consensus

6. Decision tree for assessment of similarity ! Only products fulfilling all similarity criteria in Article 3(1)(s) of the BPR will be accepted to stay in the same BPF

7. Similar composition with specified variations Article 3(1)(s)(iii) of the BPR - I(V) Similar composition with specified variations Grouping of co-formulants Definition of similar composition Approach which may be used by the applicant to consider specified variations within a similar composition Applicants shall follow the agreed approach

8. Similar composition with specified variations Article 3(1)(s)(iii) of the BPR - II(V) Definition of similar composition “Backbone composition” should be established within a BPF “Each individual member of the BPF should contain the same basic set of ingredients, which is essentialto formulateall products within the biocidal product family. Individual products may still contain additional ingredients to comply with the needs for some envisaged individual uses.” • Refers to: co-formulants needed to formulate any individual product in the BPF (e.g. binders, solvents etc). • Does not referto: easily exchangeable co-formulants (e.g., parfumes, pigments, dyes, etc) • Exceptions can be made: • For carrier – based products as defined in CA-Nov16-Doc.4.3-Final • For concentrates which only consist of the active substance itself

9. Similar composition with specified variations Article 3(1)(s)(iii) of the BPR - III(V) Examples Definitionof similar composition Example 1: A BPF with CMIT/MIT as active substance, including glycol based, water based and powder based formulations. It should be evaluated whether the solvents meet the criteria defined in the document on grouping of co-formulants. Depending on the outcome, the family should be either split into two families (solvent based and powder based) or into three families, glycol based, water based and powder based. Example 2: A BPF with Isopropyl alcohol, including products with 50-70% of the active substance and different additives where the composition is added with water up to 100% and including wipes impregnated with the same formulations. In this case the exception for carrier-based products could apply and wipes would be accepted as part of the BPF (providing that similar uses and similar level of risk and efficacy are satisfied).

10. Similar composition with specified variations Article 3(1)(s)(iii) of the BPR - IV(V) Grouping of co-formulants Applicants, when appropriate, are allowed to group co-formulants having the same function, provided that they: • have the same impact on the classification (i.e. resulting in the same hazard and precautionary statements) for the whole formulation • have the same impact on the level of risk and efficacy of the formulation. • concentration range for group (metaSPC level) Cmin>0 and Cmax=defined • for members of the group can be range from C=0=>Cmax.

11. Similar composition with specified variations Article 3(1)(s)(iii) of the BPR - V(V) Example Grouping of co-formulants

12. Similar uses Article 3(1)(s)(i) of the BPR - I(I) Similarity of uses Criteria to assess whether a pair of uses within a BPF is similar are included in a decision tree An automated tool in the form of a matrixhas been developed to assist on the application of the criteria Some flexibility is possible in order to avoid unnecessary submissions: • in each family a maximum of two pairs of uses that are a priory considered as "non-similar“ is allowed.

13. Similar levels of risk and efficacy Article 3(1)(s)(iv) of the BPR - I(V) Similarity concept – Risk and efficacy Based on the definition of “a core” composition at family level Assessment is based on the worst case composition for and which might be different for each area • Efficacy Risk Every use in the metaSPCs must be assessed

14. Similar levels of risk and efficacy Article 3(1)(s)(iv) of the BPR - II(V) To be used where the efficacy or a safe use cannot be supported over the whole composition range of the core To be used where the inclusion of an additional group of products to the core would significantly restrict the overall authorisation Similarity concept – Risk and efficacy Subsets To address different levels Risk • Risk and Efficacy • Efficacy Extension could require complete assessment with the worst composition different from the one of the core Extensions triggering a complete re‑assessment of all BPF parameters independent from the core assessment are not acceptable

15. Similar levels of risk and efficacy Article 3(1)(s)(iv) of the BPR - III(V) Example Similarity concept - a core including more than one meta-SPC • The BPF applied for includes only RTU products (10-20 % active substance dissolved in 70-85 % solvent). The products are available with different combinations of pigments, perfumes and dyes (PPD). • These PPD (2.5-5 %) include a substance of concern (SoC, e.g. a preservative) which triggers a hazard-phrase (e.g. EUH 208 Contains SoC1…). These products are presented in meta SPC 1.

16. Similar levels of risk and efficacy Article 3(1)(s)(iv) of the BPR - IV(V) Example Similarity concept - a core including more than one meta-SPC • Additionally, products are placed on the market which have the same active substance, solvent and PPD content. However, these PPD include a different SoC (e.g. another preservative) which triggers a different hazard-phrase (e.g. EUH 208 Contains SoC2…). These products are presented in meta SPC 2. • The core composition (see table columns in orange) is based on the largest variations (smallest min. value and largest max. value of all the meta SPCs) of each ingredient. In this case the core composition also represents the overall Level 1 family composition range. The products with different PPD combinations cannot be presented in one meta-SPC because of different H-phrases which must be entered in chapter 3 of the SPC. However, as long as all the products can be covered by the same core assessment (e.g. because the sensitising preservatives are similar) a separate application which would be in a large part redundant should be avoided.

17. Similar levels of risk and efficacy Article 3(1)(s)(iv) of the BPR –V(V) Similarity concept – Risk and efficacy Limitations of possible number of subset and extensions MS can accept the inclusion of subsets and extensions in a BPF In general not more than three refinements per family (via subsets and/or extensions) are allowed Subsets considered as necessary in order to support para. 77 of Annex VI of the BPR are allowed and would not be included as part of these three refinements

18. Best practices for pre-submission Annex III(2) of the BPR - I(I) Best practices for eCA agreement and pre-submission meetings Applicants has obligation to initiate a pre-submission consultation with eCA/rMS • Step 1: • Applicant contacts CAs regarding signing an eCA agreement (“the sooner the better”) • eCA agreement is singed (for UA) Step 2: Pre-submission meeting How to organise? What to discuss? When?

19. Splitting of families - I(II) Splitting of families for ongoing applications Document do not introduce new requirements, but clarify several aspectsif in the context of the assessment of a biocidal product family it was considered that similar criteria are not met Applicable for on-going applicationsas of 28 September 2018 • If during the assessment it would be considered that some similarity criteria are not met, the affected uses/products would not be authorised since the definition of the biocidal product family (Article 3(s) of the BPR) would not be met. Expected that this document would not be necessary for applications submitted once the new similarity criteria would be applicable

20. Splitting of families - II(II) Splitting of families for ongoing applications Equal treatment of applicants should be ensured – should not be an advantage for applications resulting from splitting of a BPF compared to applications where the BPF had been correctly structured from beginning Timelines Other considerations Fees IT issues • fees from MSs are decided at National level. • ECHA fees: In case of UA procedures, the fee Regulation does not foresee any reduction when a new application is submitted. A new application for a product or product family will be treated as a new application in terms of fees. • The applicant may choose the most suitable product authorisation procedure for the application of the new product(s) or product family authorisation. • NA UA • submission of the initial application for the original BPF warrants that all the existing products initially covered by that BPF can benefit from the provisions of Article 89 of the BPR regarding the transitional period • No modification of sequence of tasks will be made in R4BP3 • The duration of every step for new applications will be decided by the eCA

21. Documents agreed by the CG

22. Documents tabled for agreement in the CG

23. Next steps Documents agreed by the WPshould be agreed by the CG Based on the outcome of the discussion the document CA-Nov14-Doc.5.8-Final.rev31 will be updated accordingly. CA will decide on the date of applicability of the updated CA document

24. ECHA Thanks all experts having contributed to the development of the WP recommendations