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

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 2

Treated articles 3

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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 approved AS or in Review Program Exemption for fumigation leaving no residues Transitional measure: Possibility to submit dossier on new AS until 1 Sep 2016 Treated articles 6

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 Treated articles 7

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 Treated articles 8

Products containing non-EU evaluated AS source 9

BP with non-EU evaluated AS source 10 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

Technical equivalence 11

Definition (BPR) 12 “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.

Two-tiered approach 13 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

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

Free-rider issue 15

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

The free-rider solution 17 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

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

Frame formulation vs. biocidal product family 19

Definitions 20 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.

Definitions 21 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).

Comparison 22 Frame formulationBiocidal Product Family UseSame use and same user typeSimilar use CompositionReduction of the active; Alteration in percentage of non- active substances; Replacement of pigment, dye or perfume. Elimination of an active in a multi- active product; Reduction of one or more active substances; Elimination of one or more non- active substances; Variation of one or more non- active substances; Replacement of one or more non- active substances. Risk and efficacy Same or lower risk No decrease in efficacy No adverse effect on level of risk No significant reduction in efficacy

Comparison 23 A BC DEF Frame Formulation Biocidal Product Family

Benefits of BPF to FF 24 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

Industry survey 25

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

Risk envelope approach 27 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.

Preparing for authorisation 28 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

Further clarifications 29 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

Timelines for inclusion of PT1-5 Active substances 30

Overall numbers 31 PTTotalAnnex I inclusion * * Hydrochloric acid - 1 May 2014

TM or CA discussion 32 Nonanoic acid*Perestane Sodium bromideGluteraldehyde Octanoic acidDecanoic acid Bromoacetic acidBenzoic acid Cupper sulphateMMPP DCDMHSodium hypochlorite Calcium hypochloriteActive chlorine Iodine* 1 Oct 2014

Outlook for PT Very slow progress Review programme is not expected to finish before 2025 Majority will be covered by the new BPR

Raf Bruyndonckx