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关于地下水代谢物RH - 2651在活性物质虫酰肼确证数据评估中的相关性声明。

Statement on the relevance of the groundwater metabolite RH-2651 in the assessment of confirmatory data on the active substance tebufenozide.

出版信息

EFSA J. 2021 Nov 17;19(11):e06920. doi: 10.2903/j.efsa.2021.6920. eCollection 2021 Nov.

DOI:10.2903/j.efsa.2021.6920
PMID:34868370
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8596960/
Abstract

In 2018, the risk assessment for tebufenozide in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009 concluded that based on the submitted data, the metabolite RH-2651 has to be considered as a relevant groundwater metabolite since the absence of genotoxic potential was not fully demonstrated. Following further considerations during the decision-making process, the European Commission asked EFSA on 14 July 2021 to provide its scientific view on the genotoxic potential of the metabolite RH-2651 following consideration of new experimental data submitted by the applicant under Article 21(2) of Regulation (EC) No 1107/2009. Based on the available data, it is concluded that metabolite RH-2651 does not have genotoxic potential and therefore is not automatically considered a relevant groundwater metabolite.

摘要

2018年，根据91/414/EEC指令第6(1)条及(EC) No 1107/2009法规第6(f)条批准后要求提供的确认性数据，对虫酰肼进行的风险评估得出结论：基于所提交的数据，代谢物RH - 2651必须被视为一种相关的地下水代谢物，因为其无遗传毒性潜力并未得到充分证明。在决策过程中的进一步审议之后，欧盟委员会于2021年7月14日要求欧洲食品安全局在审议申请人根据(EC) No 1107/2009法规第21(2)条提交的新实验数据后，就代谢物RH - 2651的遗传毒性潜力提供科学意见。基于现有数据，得出结论：代谢物RH - 2651没有遗传毒性潜力，因此不会自动被视为相关的地下水代谢物。

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