Revision of the Annexes of the BPR 77th CA meeting – 14 March 2018 Reference : CA-March18-Doc.7.4 78th CA meeting - 28.05.2018

WHY? Need to implement Regulation (EC) No 2100/2017 on scientific criteria for EDs Publication of the ECHA/EFSA guidance on the identification of EDs is expected for June 2018 For increasing legal certainty, it could be verified whether the information requirements (IR) on EDs could be further aligned to the ECHA/EFSA guidance Therefore the revision: May amend the existing IR on EDs (Point 8.13.3). Is an opportunity to adapt non-EDs IR to scientific and technical progress Should take into account the huge variety of biocidal products and should therefore remain flexible enough to exempt applicants from the obligation to produce unnecessary data.

WHAT? Annexes II and III list the information required to support the approval or the authorisation of an AS or a BP. Annex IV set out the rules for data waiving. Revision of IR on EDs. Revision of IR on non-EDs: Reduction of animal testing Better protection of human and animal health Use of human data Update of data requirements for microorganisms Consistency with other parts of the BPR

HOW? Article 85 empowers the COM to adopt delegated act to adapt the Annexes II, III and IV of the BPR to scientific and technical progress.

WHEN? Proposed timing: Mid 2019: Adoption of the delegated act by COM

Questions/suggestions Before end July 2018: Opinion of CAs, industry and NGOs on the identified IR that may be subject to revision Open for other proposals provided that the reasons for the changes are duly justified.