Management of product authorization for in situ cases (IGS) 77th CA meeting – 14 March 2018 Reference : CA-March18-Doc.4.6 78th CA meeting – 28.05.2018

General overview Recall the main principles of the proposed approach Presentation of the comments received Acceptable comments that will be integrated in new version Debatable comments requiring further reflection View of the CAs on the comments Proposed next steps

The proposed approach Gather information on the concentration range of the technical active substance(s) generated by referring to standards for: Precursor(s) quality Generation process Realistic worst case condition(s) under which the IGS may be used Define the 'performance envelope' of the IGS Data in accordance with the BPR provisions should be produced by the applicant on sample(s) representing the 'performance envelope' to assess the risks and efficacy of the technical AS generated. Similar IGS BP could be grouped under a IGS BPF. Authorisation holder (AH)notifies: each product falling in the composition range of the BPF (Article 17.6) the reference to the standards used to describe the performance envelope

Comments received from CAs For inclusion in a revised version of the note Make reference to the 'generation process' instead of the 'device settings' Clarification of the concept of similarity Availability of standards? Exclude bottled biocidal products from the scope Alignment to the definitions proposed in the BPC WG recommendations Use the terminology of Article 19.2(a) – realistic worst case condition(s) of use Information submitted should be sufficient to demonstrate that the relevant criteria of Article 19 are met Deletion of the section referring to the diffusion of room disinfectant.

Comments received Further discussion/reflection with MS Information requirements for both the precursors and the technical AS should fulfil the same provisions i.e. those of Annex II, Title 1 Should catalysts be considered as precursors as they are not consumed and are therefore not part of the risk assessment of the AS? Further clarification with ECHA Demonstration of the technical equivalence of an active substance generated from a source different from the reference precursor Synergies between substance approval and product authorization when precursors are authorized

Views of the CAs Questions on the approach Information requirements for precursors when they are the biocidal products? Annex II or Annex III Should catalysts be regarded as precursors? Reference to international of national standard? (question raised at the meeting) Others? How to manage the authorisation of IGS? Case of precursors combination Precursors [A+B] placed on the market for biocidal purposes. Precursor A placed on the market for biocidal purposes. Precursors B placed on the market for non-biocidal purposes: Specification for precursor B (e.g. any relevant standard) is defined in the SPC. Only precursors B compliant with the standard could be used in the IGS. Case of orphan devices How to minimize the number of orphan devices? Communication campaign to raise awareness Current users or manufacturers to take the role of AH

Next steps Reactions in writing until 15.06.2018 to SANTE-Biocides Revision of the draft note based on the comments received. Consultation of ECHA. Presentation of a revised note at the next CA meeting. In line with the principles agreed, ECHA could describe which data requirements would be required to grant an IGS authorisation. Member States cooperation is welcome.