Revision of the technical annexes of the BPR 77th CA meeting – 14 March 2018 Reference : CA-September18-Doc.7.6 80th CA meeting - 28.09.2018

Overview Comments received on CA-May18-Doc7.4 Objectives and scope Description of the proposed changes Your input is required on: Transitional provisions Historical human data Next steps Q&A

Comments Inputs received from: 4 Member States 0 Stakeholders Efficacy Structure of chapter 8.12, Title 1, Annex II Annex III, recital 2, 7th para : pre-submission consultation _____________________________________ Annex III, title 1, new point 2.6: clarification structure of BPF Historical human data DE proposes: - To rearrange the data requirements of point 8,12 into three main points which are intended to cover the existing data requirements. To further address the requirements for applicants regarding the pre-submission stage. Our understanding is that the DE authorities want to make the organisation of a pre-submission meeting a condition for the validation of applications - To introduce a wording to ensure that the size of the BPF will remain under manageable size (not taken up)

Objectives and scope Main drivers for amendments: Entering into force of endocrine disruptor criteria To adapt the annexes to technical and scientific progress Reduction of animal testing Better protection of human and animal health Improve consistency of the BPR Annexes Streamline the requirements for micro-organisms Covers Annexes II and III of the BPR Adapt to progress on nanos (tbc for November) Legal basis: empowerment in Article 85 BPR

Description of the proposed changes Annexes II and III – Title I Effectiveness (Section 6) Mirror the explanation in the efficacy guidance Vol II Toxicological profiles (Section 8) Improve the testing strategy by favoring in vitro tests against in vivo Include new tests for better information on toxicological profiles (irritation,neurotox, genotox..) Include testing strategies and methods for the determination of EDs properties Ecotoxicological studies (Section 9) Include testing strategy and methods for the determination of EDs properties

Description of the proposed changes Annexes II and III – Title II Alignment to the PPP endpoints for micro-organisms Streamline certain provisions on micro-organisms

Transitional provisions: your views Balance between Apply the new rules asap to better protect human and animal health and the environment Expectations at the time of submission Elements to consider Dossiers already submitted: which provisions will apply? Update more important (EDs, genotox, reprotox,…) than others Applicable asap with cut-off date(s) regardless of the submission process Applicable before the cut-off date(s) by applicants on a voluntary basis

Historical human data: your views Current provisions: Tests on humans for generating toxicological data shall not be performed for the purposes of the BPR. (Efficacy data exempted) Existing human data may be considered (see e.g. point 8.12 of Annex II) But not to lower the safety margins resulting from animal testing (point 1.1.3 of Annex IV) The aims of the current wording is to protect human against deliberate exposure to biocides

Historical human data: your views (II) Current situation: Human data generated for the purposes of assessing non-biocidal applications is available (e.g. iodine in the context of medicinal product) Human data generated after exposure to biocidal products/PPPs placed on the market is available (e.g. biomonitoring studies) Member States experience with the use of human data? Which types of human data could be considered to reduce the safety margins of tests conducted on animals or which types of human data should not be considered to reduce the safety margins of tests conducted on animals for ethical reasons The aims of the current wording is to protect human against deliberate exposure to biocides

Next step: the delegated act is discussed with the expert group Future actions Comments on the draft annexes + views on HHD and transitional provisions: deadline 19/10/2018 Based on input COM will start drafting the delegated act (core text and annexes) Next step: the delegated act is discussed with the expert group

Q&A The floor is yours…