Dataset Information

Statement concerning the review of the approval of the active substance ipconazole.

ABSTRACT: In October 2021, the European Commission asked EFSA to provide scientific and technical assistance in accordance with Article 21(2) of Regulation (EC) No 1107/2009 and to deliver a statement on the information submitted by the applicant taking into consideration the assessment of the rapporteur Member State (RMS) in the context of the review of the approval of the active substance ipconazole. The current statement contains a summary of the main findings of the assessment of the risks posed to birds from use of ipconazole and whether the requirements regarding negligible exposure for humans (dietary and non-dietary exposure) set out in point 3.6.4 of Annex II to Regulation (EC) No 1107/2009 may be considered satisfied. The identified concerns are presented.

SUBMITTER: European Food Safety Authority (EFSA)

PROVIDER: S-EPMC9412245 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Statement concerning the review of the approval of the active substance ipconazole.

EFSA journal. European Food Safety Authority 20220826 8

In October 2021, the European Commission asked EFSA to provide scientific and technical assistance in accordance with Article 21(2) of Regulation (EC) No 1107/2009 and to deliver a statement on the information submitted by the applicant taking into consideration the assessment of the rapporteur Member State (RMS) in the context of the review of the approval of the active substance ipconazole. The current statement contains a summary of the main findings of the assessment of the risks posed to bi ...[more]

PMID: 36052015

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Project description:Flupyradifurone is a novel butenolide insecticide, first approved as an active substance for use in plant protection products by Commission Implementing Regulation (EU) 2015/2084. Following concerns that this substance may pose high risks to humans and the environment, the French authorities, in November 2020, asked the Commission to restrict its uses under Article 69 of Regulation (EC) No 1107/2009. To support this request, competent Authorities from France cited a series of literature papers investigating its hazards and/or exposure to humans and the environment. In addition, in June 2020, the Dutch Authorities notified the Commission, under Article 56 of Regulation (EC) No 1107/2009, of new information on flupyradifurone on the wild bee species Megachile rotundata. This notification is also referred to in the French notification on flupyradifurone. Consequently, the EFSA PPR Panel was mandated to quantify the likelihood of this body of evidence constituting proof of serious risks to humans or the environment. Therefore, the EFSA PPR Panel evaluated the likelihood of these studies indicating new or higher hazards and exposure to humans and the environment compared to previous EU assessments. A stepwise methodology was designed, including: (i) the initial screening; (ii) data extraction and critical appraisal based on the principles of OHAT/NTP; (iii) weight of evidence, including consideration of the previous EU assessments; (iv) uncertainty analysis, followed, whenever relevant, by an expert knowledge elicitation process. For the human health, only one study was considered relevant for the genotoxic potential of flupyradifurone in vitro. These data did not provide sufficient information to overrule the EU assessment, as in vivo studies already addressed the genotoxic potential of flupyradifurone. Environment: All available data investigated hazards in bee species. For honey bees, the likelihood of the new data indicating higher hazards than the previous EU assessment was considered low or moderate, with some uncertainties. However, among solitary bee species - which were not addressed in the previous EU assessment - there was evidence that Megachile rotundata may be disproportionately sensitive to flupyradifurone. This sensitivity, which may partially be explained by the low bodyweight of this species, was mechanistically linked to inadequate bodily metabolisation processes.

Project description:Acetamiprid is a pesticide active substance with insecticidal action currently under the third renewal (AIR3) of the Commission implementing regulation (EU) No 844/2012. Following concerns that this substance may pose high risks to humans and the environment, the French authorities asked the Commission to restrict its uses under Article 69 of Regulation (EC) No 1107/2009. To support this request, competent Authorities from France cited a series of literature papers investigating its hazards and/or exposure to humans and the environment. Consequently, the EFSA PPR Panel was mandated to advise on the likelihood that body of evidence would constitute proof of serious risks to humans or the environment. Therefore, the EFSA PPR Panel evaluated the likelihood of these studies indicating new or higher hazards and exposure to humans and the environment compared to previous EU assessments.A stepwise methodology was designed, including: (i) the initial screening; (ii) the data extraction and critical appraisal based on the principles of OHAT/NTP; (iii) the weight of evidence, including consideration of the previous EU assessments; (iv) the uncertainty analysis, followed, whenever relevant, by an expert knowledge elicitation process. For human health, no conclusive evidence of higher hazards compared to previous assessment was found for genotoxicity, developmental toxicity, neurotoxicity including developmental neurotoxicity and immunotoxicity. However, due to the lack of adequate assessment of the current data set, the PPR Panel recommends conducting an assessment of endocrine disrupting properties for acetamiprid in line with EFSA/ECHA guidance document for the identification of endocrine disruptors. For environment, no conclusive, robust evidence of higher hazards compared to the previous assessment was found for birds, aquatic organisms, bees and soil organisms. However, the potential of high inter-species sensitivity of birds and bees towards acetamiprid requires further consideration.

Dataset Information

Statement concerning the review of the approval of the active substance ipconazole.

Publications

Statement concerning the review of the approval of the active substance ipconazole.

Similar Datasets

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