Hugues KENIGSWALD European Chemicals Agency

1. Preliminary draft guidance on the data requirements and assessment of applications for renewal of approval of active substances under BPR Hugues KENIGSWALD European Chemicals Agency March 2019

2. The guidance should be regarded as a proposal open for discussion on how to address the information requirements for the applicants and the assessment of the eCAs.

3. Major points of the guidance

4. A data gap analysis should be performed by the applicant before dossier submission, considering any changes in the information requirements and the evaluation of active substances since the time of the initial approval or previous renewal. Although there is no obligation for the applicant to resubmit data submitted at the initial approval or previous renewal, the whole data package should be available to the eCA how to retrieve and access the whole data package might be technically challenging.

5. Renewal Document: In this document, the applicant should describe the status prior to evaluation and preparation of the Draft Renewal Assessment Report, with the purpose to: early in the process identify data gaps that need to be fulfilled at dossier submission, and identify areas on which the subsequent evaluation must be focussed. justify why new information is needed in specific sections explain why the conclusions of previous assessment(s) of the active substance remain valid in other sections.

6. Renewal Assessment Report: The CAR CLH report template should be used. Any new / revised text from previous CAR should be highlighted. The list of new studies should be included also in RAR indicating which studies were accepted and used in the risk assessment by the eCA.

7. Criteria for full evaluation: The eCA should conduct a full evaluation unless: ED assessment is already available No new data available or new data without impact on outcome of risk assessment No need for re-assessment of previously submitted data or any re-assessment has no impact on outcome of risk assessment. Need to define what full evaluation means: assessment of exclusion criteria, setting of reference values and outcome of exposure assessment. Full evaluation is not re-assessment of all endpoints!

8. Assessment of data available from article 95 applications: ECHA proposes that the eCAshould investigate whether there are data available in Article 95 applications which could be relevant for risk assessment and classification and labelling, only in case they lead to more conservative conclusions.

9. Assessment of data available from article 95 applications: eCAs are concerned since: evaluation of these data is not foreseen and covered by the fee paid by the RNL applicant. Has to be clarified how and when the RNL applicant will be informed for the existence of art.95 data and their possible impact on the RNL of approval.

10. Assessment of data requested in BPC opinion and data submitted at Product Authorisation on the AS: ECHA proposes these data to be considered by the eCA. eCA indicate that these data : can also be retrieved by the applicant. should be used only if lead to more conservative conclusions (or animal testing is avoided).

11. Key questions on renewal of approval Comments received from DE, BE, DK, SE, AT, MT.

12. 1. Interpretation of article 13(2) about the data requirements to be submitted by the applicant: Most eCAsagree to request from the applicant to: bring the scientific risk assessment to the current methodologies and practices and assess in detail whether the conclusions of the previous assessment remain valid and submit the whole data package from initial or previous approval and the renewal.

13. 2.Should new guidance documents be followed in the assessment of renewal of approval? eCAs agree. Proposal to scan for guidance gaps and develop any missing guidance to avoid problems encountered in the review programme in the past.

14. 3a. Could changes be allowed in the reference products / uses? 3b. Need of overview of actual uses and products in the market? eCAs agree. BE and DE question whether assessment of representative product in the CAR is needed since many real products are already authorised. Divergent views by the eCAs. Need to focus on identifying one safe use.

15. 3c. Should dummy products still be accepted as reference products even at the stage of renewal ?   eCAsagree that normally no dummy products should be accepted at the renewal of approval.

16. 4. Can changes be accepted on the specifications of the active substance, and under which justification and the data requirements for applicant. eCAsagree that normally no changes should be allowed, nevertheless, flexibility on acceptance of changes on specifications should be allowed too. Need to agree the way forward when:new manufacturing location with different specifications, new 5 batch analysis not equivalent to reference specification, changes in tox properties of impurities, new specification leads to removal of relevant impurities, changes to more refined analytical methods detecting more impurities.

17. 5. Whether and to what extent re-assessment of old data should be done by the applicant and / or by the eCA. Most eCAssupport that: re-evaluation should be done in the light of current knowledge and methodologies in risk assessment. Re-evaluation should focus on key studies. If revision of the evaluation is needed, the applicant should provide detailed information (study summaries and reports need in IUCLID, revised exposure calculations and risk characterisation in the draft RAR).

18. 6. Should literature review for all endpoints be requested under RNL? eCAs are supportive in general with the notion that: more guidance/practice should be developed on this issue on the assessment of relevance and reliability (proposal to use EFSA guidance on literature review after modifying it for biocides); this task will create considerable increase in the workload for the eCAwith possibly limited additional improvement of safety level.

19. 7. Define the extent of the evaluation in case the substance meets the exclusion criteria. Is this possible to limit the re-assessment and focus on the risks mitigation measures and the assessment of the conditions for derogation? eCAs note that for hazard assessment, all data needs to be assessed against criteria for classification under CLP. Reference values, NOAELS, LC50 values, etc. still need to be set, which requires assessment of the studies.

20. Thank you! Subscribe to our news at echa.europa.eu/subscribe Follow us on Twitter @EU_ECHA Follow us on Facebook Facebook.com/EUECHA