Statement concerning the testing strategy and timelines proposed by the applicant for the assessment of the endocrine disruption properties of acibenzolar‐S‐methyl in the context of the review of the approval of the active substance

Abstract

On 8 July 2021, EFSA published a Conclusion on the peer review of the pesticide risk assessment for the active substance acibenzolar‐S‐methyl in light of confirmatory data submitted. EFSA concluded that based on the confirmatory information submitted by the applicant, the assessment of endocrine‐disrupting properties could not be finalised for humans and non‐target organisms and identified further data deemed necessary to finalise the assessment. Consequently, during the decision‐making stage it could not be concluded by risk managers that acibenzolar‐S‐methyl still meets the approval criteria laid down in Article 4 of Regulation (EC) No 1107/2009 and therefore the European Commission decided to launch a review of the existing approval in accordance with Article 21 of that Regulation and on 6 July 2022 invited the applicant to submit comments on the findings in the EFSA Conclusion including any relevant information. On 14 December 2022, the European Commission requested EFSA to consider the proposal as submitted by the applicant in light of the EFSA Conclusion and to confirm whether the proposed studies are considered sufficient to complete the assessment of the endocrine disrupting properties of the substance in line with Commission Regulation (EU) 2018/605. The current statement contains EFSA's considerations as regards the testing strategy and associated timelines for additional data generation proposed by the applicant to complete the assessment of the endocrine disrupting properties of acibenzolar‐S‐methyl in line with Commission Regulation (EU) 2018/605.