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关于申请人在活性物质批准审查背景下提出的用于评估烯丙苯噻唑甲基内分泌干扰特性的测试策略和时间表的声明。

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.

出版信息

EFSA J. 2023 Apr 20;21(4):e07968. doi: 10.2903/j.efsa.2023.7968. eCollection 2023 Apr.

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.

摘要

2021年7月8日,欧洲食品安全局(EFSA)根据提交的确认数据,发布了关于活性物质烯丙苯噻唑农药风险评估同行评审的结论。EFSA得出结论,根据申请人提交的确认信息,无法最终确定对人类和非靶标生物的内分泌干扰特性评估,并确定了完成评估所需的进一步数据。因此,在决策阶段,风险管理者无法得出烯丙苯噻唑仍符合《欧洲议会和欧盟理事会条例》(EC)No 1107/2009第4条规定的批准标准的结论,因此欧盟委员会决定根据该条例第21条对现有批准进行审查,并于2022年7月6日邀请申请人就EFSA结论中的调查结果提交意见,包括任何相关信息。2022年12月14日,欧盟委员会要求EFSA根据EFSA结论审议申请人提交的提案,并确认拟议的研究是否被认为足以根据欧盟委员会条例(EU)2018/605完成对该物质内分泌干扰特性的评估。本声明包含EFSA对申请人为根据欧盟委员会条例(EU)2018/605完成烯丙苯噻唑内分泌干扰特性评估而提出的测试策略和相关额外数据生成时间表的考虑。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e9c/10116401/4aa88f16368c/EFS2-21-e07968-g002.jpg

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