Management of product authorizations for in situ cases 77th CA meeting – 14 March 2018 Reference : CA-March18-Doc.4.6 77th CA meeting - 14.03.2018

Description of the current situation Definition of in situ generation system (IGS) Article 3(1) BPR Biocidal product used for in situ generation (first indent) Biocidal product generated in situ (second indent) Specific features of IGS Product authorization should be granted to either Precursors generating the active substance (first indent of Article 3(1)) or The active substance generated (second indent of Article 3(1)) But, the quality of the precursor(s) and the parameters in the generation process may have an effect on the composition of the AS generated Need to consider the "whole IGS" and not only precursor(s) and/or active substance(s) in isolation

Description of the current situation Considerable administrative burden and workload for Competent authorities Economic operators if each and every combination of precursors/devices/AS and uses needs to be authorised (1,5Mio) General objectives of the BPR must be met All IGS placed on the market are safe for HH and the ENV and sufficiently effective Harmonisation of the rules for improving the functioning of the internal market Timing First in situ generated substance (CIR published on 15.07.2017) will be approved on 1.1.2019(i.e. deadline for application for product authorisation)

Proposed solution: main principles Evaluation: Assessment of the maximum risks and minimum efficacy of the IGS is based on data collected on precursors and the active substance under realistic worst case condition(s) Information in the SPC sufficiently describes the parameters and boundaries of the IGS Information in the SPC is enforceable Grouping of similar IGS: The biocidal product family concept allows applicants grouping similar IGSs (i.e. IGSs having similar uses, similar composition of the AS within specified limits and similar levels of risks an efficacy)  "IGS BPF" Possibility for applicants to NOTIFY a new IGS within the boundaries of the "IGS BPF" – Article 17(6) APPLY for SBPs autorisation of one or more of the IGS covered by the "IGS BPF"- Regulation (EU) No 414/2013 COOPERATE within consortia

Proposed solution in practice Biocidal product used for in situ generation – Art 3(1) first indent Information on precursor(s) includes Variation in the composition of the precursor(s) as defined in applicable standards aiming at guaranteeing safe use Collect data on precursors on that basis and assess the risks. Information on the generation process includes Variation in use parameters as defined in applicable standard aiming at guaranteeing safe use. Description of realistic worst case condition(s) as a basis for the assessment of the IGS. Information on the active substance includes Variation in composition of the AS (the IGS BPF range) including impurities is defined via the standard(s) on precursor(s) and the generation process Collect data on a sample representing reasonable worst case condition(s) and assess the maximum risks and minimum efficacy on that basis Industry shall justify the choice of the realistic worst case condition(s) (as for any other BPF)

Proposed solution in practice Biocidal product generated in situ – Art 3(1) second indent Information on precursor(s) Variation in the composition of the precursor(s) as defined in applicable standards aiming at guaranteeing safe use (e.g. EN 973 – sodium chloride for regeneration of ion exchanger Collect data on precursors on that basis and assess the risks. Information on the generation process includes Variation in use parameters as defined in applicable standard aiming at guaranteeing safe use (e.g. DIN 19627 – ozone generation plants for water treatment). Description of realistic worst case condition(s) as a basis for the assessment of the IGS. Information on the active substance includes Variation in composition of the AS (the IGS BPF range) including impurities is defined via the standard(s) on precursor(s) and the generation process Collect data on a sample representing the reasonable worst case condition(s) and assess the maximum risks and minimum efficacy on that basis Industry shall justify the choice of the realistic worst case condition(s) (as for any other BPF) Biocidal product generated in situ

Conclusions/ next steps Today: only main principles presented Comments on CA-March18-Doc.4.6 until 06.04.2018 Next steps: Refine the approach Data requirements Clear description of the relevant standards, parameters, instructions for use, etc. in the SPC and link to labels Issue of 'orphan devices' Issue of the BP autorisation of multiple precursors Clarify the difference between precursors and active substance releaser Other issues… Technical guideline Cooperation with CAs is very much welcome Involvement of economic operators and ECHA

List of relevant documents 2017 – BPC Working Groups recommendations :In situ generated active substances – Risk assessment and implications on data requirements for active substances generated in situ and their precursors CA-Nov 15-Doc 5.5 Final-Rev 1: Harmonised classification on in situ generated active substances CA-May16-Doc 5.1 : Guidance to specify information requirements for free radicals generated in situ from ambient water or air for substance approval in the context of the BPR CA-Sept15-Doc.4.3 – Final : Compliance with and enforcement of Article 95 – The case of in situ generated active substances CA-March15-Doc.5.1-Final Revised on 23 June 2015 : Management of in situ generated active substances in the context of the BPR CA- Sept 15 – Doc.7.6 – Final : Concepts of placing and making available on the market in the context of Regulation (EU) No 528/2012