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

2. 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

3. 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
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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)

4. 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

5. 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

6. 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

7. 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

8. 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 of Annex IV)
The aims of the current wording is to protect human against deliberate exposure to biocides

9. 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

10. 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

11. Q&A
The floor is yours…