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

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 cons...

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Autor principal:	European Food Safety Authority (EFSA)
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	tebufenozide pesticide insecticide peer review risk assessment Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
Acceso en línea:	https://doaj.org/article/1b02721c33e84bd9bac465694b983264
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spelling	oai:doaj.org-article:1b02721c33e84bd9bac465694b9832642021-12-02T17:55:57ZStatement on the relevance of the groundwater metabolite RH‐2651 in the assessment of confirmatory data on the active substance tebufenozide1831-473210.2903/j.efsa.2021.6920https://doaj.org/article/1b02721c33e84bd9bac465694b9832642021-11-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6920https://doaj.org/toc/1831-4732Abstract 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.European Food Safety Authority (EFSA)Wileyarticletebufenozidepesticideinsecticidepeer reviewrisk assessmentNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 11, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	tebufenozide pesticide insecticide peer review risk assessment Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
spellingShingle	tebufenozide pesticide insecticide peer review risk assessment Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 European Food Safety Authority (EFSA) Statement on the relevance of the groundwater metabolite RH‐2651 in the assessment of confirmatory data on the active substance tebufenozide
description	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.
format	article
author	European Food Safety Authority (EFSA)
author_facet	European Food Safety Authority (EFSA)
author_sort	European Food Safety Authority (EFSA)
title	Statement on the relevance of the groundwater metabolite RH‐2651 in the assessment of confirmatory data on the active substance tebufenozide
title_short	Statement on the relevance of the groundwater metabolite RH‐2651 in the assessment of confirmatory data on the active substance tebufenozide
title_full	Statement on the relevance of the groundwater metabolite RH‐2651 in the assessment of confirmatory data on the active substance tebufenozide
title_fullStr	Statement on the relevance of the groundwater metabolite RH‐2651 in the assessment of confirmatory data on the active substance tebufenozide
title_full_unstemmed	Statement on the relevance of the groundwater metabolite RH‐2651 in the assessment of confirmatory data on the active substance tebufenozide
title_sort	statement on the relevance of the groundwater metabolite rh‐2651 in the assessment of confirmatory data on the active substance tebufenozide
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/1b02721c33e84bd9bac465694b983264
work_keys_str_mv	AT europeanfoodsafetyauthorityefsa statementontherelevanceofthegroundwatermetaboliterh2651intheassessmentofconfirmatorydataontheactivesubstancetebufenozide
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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

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