Statement on the active substance flupyradifurone
Abstract 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 authoritie...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
EFSA Panel on Plant Protection Products and their Residues (PPR) [verfasserIn] Antonio Hernandez Jerez [verfasserIn] Paulien Adriaanse [verfasserIn] Philippe Berny [verfasserIn] Tamara Coja [verfasserIn] Sabine Duquesne [verfasserIn] Andreas Focks [verfasserIn] Marina Marinovich [verfasserIn] Maurice Millet [verfasserIn] Olavi Pelkonen [verfasserIn] Silvia Pieper [verfasserIn] Aaldrik Tiktak [verfasserIn] Christopher Topping [verfasserIn] Anneli Widenfalk [verfasserIn] Martin Wilks [verfasserIn] Gerrit Wolterink [verfasserIn] Maj Rundlöf [verfasserIn] Alessio Ippolito [verfasserIn] Alberto Linguadoca [verfasserIn] Laura Martino [verfasserIn] Martina Panzarea [verfasserIn] Andrea Terron [verfasserIn] Annette Aldrich [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2022 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: EFSA Journal - Wiley, 2018, 20(2022), 1, Seite n/a-n/a |
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| Übergeordnetes Werk: |
volume:20 ; year:2022 ; number:1 ; pages:n/a-n/a |
| Links: |
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| DOI / URN: |
10.2903/j.efsa.2022.7030 |
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| Katalog-ID: |
DOAJ014889870 |
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| 520 | |a Abstract 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. | ||
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| 700 | 0 | |a Paulien Adriaanse |e verfasserin |4 aut | |
| 700 | 0 | |a Philippe Berny |e verfasserin |4 aut | |
| 700 | 0 | |a Tamara Coja |e verfasserin |4 aut | |
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| 700 | 0 | |a Andreas Focks |e verfasserin |4 aut | |
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| 700 | 0 | |a Maurice Millet |e verfasserin |4 aut | |
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| 700 | 0 | |a Aaldrik Tiktak |e verfasserin |4 aut | |
| 700 | 0 | |a Christopher Topping |e verfasserin |4 aut | |
| 700 | 0 | |a Anneli Widenfalk |e verfasserin |4 aut | |
| 700 | 0 | |a Martin Wilks |e verfasserin |4 aut | |
| 700 | 0 | |a Gerrit Wolterink |e verfasserin |4 aut | |
| 700 | 0 | |a Maj Rundlöf |e verfasserin |4 aut | |
| 700 | 0 | |a Alessio Ippolito |e verfasserin |4 aut | |
| 700 | 0 | |a Alberto Linguadoca |e verfasserin |4 aut | |
| 700 | 0 | |a Laura Martino |e verfasserin |4 aut | |
| 700 | 0 | |a Martina Panzarea |e verfasserin |4 aut | |
| 700 | 0 | |a Andrea Terron |e verfasserin |4 aut | |
| 700 | 0 | |a Annette Aldrich |e verfasserin |4 aut | |
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10.2903/j.efsa.2022.7030 doi (DE-627)DOAJ014889870 (DE-599)DOAJ2026fb11ae334358b13bed9af2651f11 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Plant Protection Products and their Residues (PPR) verfasserin aut Statement on the active substance flupyradifurone 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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. flupyradifurone butenolide insecticides genotoxicity uncertainty analysis environmental risk assessment Nutrition. Foods and food supply Chemical technology Antonio Hernandez Jerez verfasserin aut Paulien Adriaanse verfasserin aut Philippe Berny verfasserin aut Tamara Coja verfasserin aut Sabine Duquesne verfasserin aut Andreas Focks verfasserin aut Marina Marinovich verfasserin aut Maurice Millet verfasserin aut Olavi Pelkonen verfasserin aut Silvia Pieper verfasserin aut Aaldrik Tiktak verfasserin aut Christopher Topping verfasserin aut Anneli Widenfalk verfasserin aut Martin Wilks verfasserin aut Gerrit Wolterink verfasserin aut Maj Rundlöf verfasserin aut Alessio Ippolito verfasserin aut Alberto Linguadoca verfasserin aut Laura Martino verfasserin aut Martina Panzarea verfasserin aut Andrea Terron verfasserin aut Annette Aldrich verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 1, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:1 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7030 kostenfrei https://doaj.org/article/2026fb11ae334358b13bed9af2651f11 kostenfrei https://doi.org/10.2903/j.efsa.2022.7030 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2022 1 n/a-n/a |
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10.2903/j.efsa.2022.7030 doi (DE-627)DOAJ014889870 (DE-599)DOAJ2026fb11ae334358b13bed9af2651f11 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Plant Protection Products and their Residues (PPR) verfasserin aut Statement on the active substance flupyradifurone 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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. flupyradifurone butenolide insecticides genotoxicity uncertainty analysis environmental risk assessment Nutrition. Foods and food supply Chemical technology Antonio Hernandez Jerez verfasserin aut Paulien Adriaanse verfasserin aut Philippe Berny verfasserin aut Tamara Coja verfasserin aut Sabine Duquesne verfasserin aut Andreas Focks verfasserin aut Marina Marinovich verfasserin aut Maurice Millet verfasserin aut Olavi Pelkonen verfasserin aut Silvia Pieper verfasserin aut Aaldrik Tiktak verfasserin aut Christopher Topping verfasserin aut Anneli Widenfalk verfasserin aut Martin Wilks verfasserin aut Gerrit Wolterink verfasserin aut Maj Rundlöf verfasserin aut Alessio Ippolito verfasserin aut Alberto Linguadoca verfasserin aut Laura Martino verfasserin aut Martina Panzarea verfasserin aut Andrea Terron verfasserin aut Annette Aldrich verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 1, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:1 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7030 kostenfrei https://doaj.org/article/2026fb11ae334358b13bed9af2651f11 kostenfrei https://doi.org/10.2903/j.efsa.2022.7030 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2022 1 n/a-n/a |
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10.2903/j.efsa.2022.7030 doi (DE-627)DOAJ014889870 (DE-599)DOAJ2026fb11ae334358b13bed9af2651f11 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Plant Protection Products and their Residues (PPR) verfasserin aut Statement on the active substance flupyradifurone 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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. flupyradifurone butenolide insecticides genotoxicity uncertainty analysis environmental risk assessment Nutrition. Foods and food supply Chemical technology Antonio Hernandez Jerez verfasserin aut Paulien Adriaanse verfasserin aut Philippe Berny verfasserin aut Tamara Coja verfasserin aut Sabine Duquesne verfasserin aut Andreas Focks verfasserin aut Marina Marinovich verfasserin aut Maurice Millet verfasserin aut Olavi Pelkonen verfasserin aut Silvia Pieper verfasserin aut Aaldrik Tiktak verfasserin aut Christopher Topping verfasserin aut Anneli Widenfalk verfasserin aut Martin Wilks verfasserin aut Gerrit Wolterink verfasserin aut Maj Rundlöf verfasserin aut Alessio Ippolito verfasserin aut Alberto Linguadoca verfasserin aut Laura Martino verfasserin aut Martina Panzarea verfasserin aut Andrea Terron verfasserin aut Annette Aldrich verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 1, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:1 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7030 kostenfrei https://doaj.org/article/2026fb11ae334358b13bed9af2651f11 kostenfrei https://doi.org/10.2903/j.efsa.2022.7030 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2022 1 n/a-n/a |
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10.2903/j.efsa.2022.7030 doi (DE-627)DOAJ014889870 (DE-599)DOAJ2026fb11ae334358b13bed9af2651f11 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Plant Protection Products and their Residues (PPR) verfasserin aut Statement on the active substance flupyradifurone 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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. flupyradifurone butenolide insecticides genotoxicity uncertainty analysis environmental risk assessment Nutrition. Foods and food supply Chemical technology Antonio Hernandez Jerez verfasserin aut Paulien Adriaanse verfasserin aut Philippe Berny verfasserin aut Tamara Coja verfasserin aut Sabine Duquesne verfasserin aut Andreas Focks verfasserin aut Marina Marinovich verfasserin aut Maurice Millet verfasserin aut Olavi Pelkonen verfasserin aut Silvia Pieper verfasserin aut Aaldrik Tiktak verfasserin aut Christopher Topping verfasserin aut Anneli Widenfalk verfasserin aut Martin Wilks verfasserin aut Gerrit Wolterink verfasserin aut Maj Rundlöf verfasserin aut Alessio Ippolito verfasserin aut Alberto Linguadoca verfasserin aut Laura Martino verfasserin aut Martina Panzarea verfasserin aut Andrea Terron verfasserin aut Annette Aldrich verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 1, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:1 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7030 kostenfrei https://doaj.org/article/2026fb11ae334358b13bed9af2651f11 kostenfrei https://doi.org/10.2903/j.efsa.2022.7030 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2022 1 n/a-n/a |
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10.2903/j.efsa.2022.7030 doi (DE-627)DOAJ014889870 (DE-599)DOAJ2026fb11ae334358b13bed9af2651f11 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Plant Protection Products and their Residues (PPR) verfasserin aut Statement on the active substance flupyradifurone 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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. flupyradifurone butenolide insecticides genotoxicity uncertainty analysis environmental risk assessment Nutrition. Foods and food supply Chemical technology Antonio Hernandez Jerez verfasserin aut Paulien Adriaanse verfasserin aut Philippe Berny verfasserin aut Tamara Coja verfasserin aut Sabine Duquesne verfasserin aut Andreas Focks verfasserin aut Marina Marinovich verfasserin aut Maurice Millet verfasserin aut Olavi Pelkonen verfasserin aut Silvia Pieper verfasserin aut Aaldrik Tiktak verfasserin aut Christopher Topping verfasserin aut Anneli Widenfalk verfasserin aut Martin Wilks verfasserin aut Gerrit Wolterink verfasserin aut Maj Rundlöf verfasserin aut Alessio Ippolito verfasserin aut Alberto Linguadoca verfasserin aut Laura Martino verfasserin aut Martina Panzarea verfasserin aut Andrea Terron verfasserin aut Annette Aldrich verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 1, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:1 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7030 kostenfrei https://doaj.org/article/2026fb11ae334358b13bed9af2651f11 kostenfrei https://doi.org/10.2903/j.efsa.2022.7030 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2022 1 n/a-n/a |
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EFSA Panel on Plant Protection Products and their Residues (PPR) @@aut@@ Antonio Hernandez Jerez @@aut@@ Paulien Adriaanse @@aut@@ Philippe Berny @@aut@@ Tamara Coja @@aut@@ Sabine Duquesne @@aut@@ Andreas Focks @@aut@@ Marina Marinovich @@aut@@ Maurice Millet @@aut@@ Olavi Pelkonen @@aut@@ Silvia Pieper @@aut@@ Aaldrik Tiktak @@aut@@ Christopher Topping @@aut@@ Anneli Widenfalk @@aut@@ Martin Wilks @@aut@@ Gerrit Wolterink @@aut@@ Maj Rundlöf @@aut@@ Alessio Ippolito @@aut@@ Alberto Linguadoca @@aut@@ Laura Martino @@aut@@ Martina Panzarea @@aut@@ Andrea Terron @@aut@@ Annette Aldrich @@aut@@ |
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Statement on the active substance flupyradifurone |
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Abstract 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. |
| abstractGer |
Abstract 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. |
| abstract_unstemmed |
Abstract 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. |
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Statement on the active substance flupyradifurone |
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https://doi.org/10.2903/j.efsa.2022.7030 https://doaj.org/article/2026fb11ae334358b13bed9af2651f11 https://doaj.org/toc/1831-4732 |
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Antonio Hernandez Jerez Paulien Adriaanse Philippe Berny Tamara Coja Sabine Duquesne Andreas Focks Marina Marinovich Maurice Millet Olavi Pelkonen Silvia Pieper Aaldrik Tiktak Christopher Topping Anneli Widenfalk Martin Wilks Gerrit Wolterink Maj Rundlöf Alessio Ippolito Alberto Linguadoca Laura Martino Martina Panzarea Andrea Terron Annette Aldrich |
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10.2903/j.efsa.2022.7030 |
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2024-07-04T00:52:13.897Z |
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| score |
7.3967133 |