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

on the Wiley Online Library

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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 in vivo 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.

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