Pub Date : 2024-09-17DOI: 10.2903/j.efsa.2024.8996
European Food Safety Authority (EFSA), Giulia Bellisai, Giovanni Bernasconi, Luis Carrasco Cabrera, Irene Castellan, Monica del Aguila, Lucien Ferreira, Luna Greco, Samira Jarrah, Renata Leuschner, Andrea Mioč, Stefanie Nave, Hermine Reich, Silvia Ruocco, Alessia Pia Scarlato, Marta Szot, Anne Theobald, Manuela Tiramani, Alessia Verani
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance cycloxydim in pome fruits, apricots/peaches, peas (with pods), maize/corn, sugar beet roots and milk (sheep). The data submitted in support of the request were found to be sufficient to derive MRL proposals for pome fruits, peas (with pods), maize/corn and sugar beet roots while for apricots, peaches and sheep milk no changes to the existing MRLs were considered necessary. Adequate analytical methods for enforcement are available to control the residues of cycloxydim according to the current enforcement residue definition in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of cycloxydim according to the reported agricultural practices is unlikely to present a risk to consumer health.
{"title":"Modification of the existing maximum residue levels for cycloxydim in various crops","authors":"European Food Safety Authority (EFSA), Giulia Bellisai, Giovanni Bernasconi, Luis Carrasco Cabrera, Irene Castellan, Monica del Aguila, Lucien Ferreira, Luna Greco, Samira Jarrah, Renata Leuschner, Andrea Mioč, Stefanie Nave, Hermine Reich, Silvia Ruocco, Alessia Pia Scarlato, Marta Szot, Anne Theobald, Manuela Tiramani, Alessia Verani","doi":"10.2903/j.efsa.2024.8996","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8996","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance cycloxydim in pome fruits, apricots/peaches, peas (with pods), maize/corn, sugar beet roots and milk (sheep). The data submitted in support of the request were found to be sufficient to derive MRL proposals for pome fruits, peas (with pods), maize/corn and sugar beet roots while for apricots, peaches and sheep milk no changes to the existing MRLs were considered necessary. Adequate analytical methods for enforcement are available to control the residues of cycloxydim according to the current enforcement residue definition in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of cycloxydim according to the reported agricultural practices is unlikely to present a risk to consumer health.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8996","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142245056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-16DOI: 10.2903/j.efsa.2024.8889
EFSA Panel on Plant Health (PLH), Claude Bragard, Paula Baptista, Elisavet Chatzivassiliou, Francesco Di Serio, Paolo Gonthier, Josep Anton Jaques Miret, Annemarie Fejer Justesen, Christer Sven Magnusson, Panagiotis Milonas, Juan A. Navas-Cortes, Stephen Parnell, Roel Potting, Philippe Lucien Reignault, Emilio Stefani, Hans-Hermann Thulke, Wopke Van der Werf, Antonio Vicent Civera, Jonathan Yuen, Lucia Zappalà, Jean-Claude Grégoire, Andrea Battisti, Chris Malumphy, Massimo Faccoli, Virag Kertesz, Matteo Marchioro, Isabel Martinez, Giacomo Ortis, Davide Rassati, Enrico Ruzzier, Alan MacLeod
The EFSA Panel on Plant Health performed a group pest categorisation for the EU territory of non-EU Scolytinae (Coleoptera: Curculionidae) on non-coniferous hosts, which total 6495 known species. Most species attack apparently healthy, weakened or dead trees, either feeding on the phloem (‘bark beetles’ subgroup) or on fungi inoculated into the sapwood (‘ambrosia beetles’ subgroup). Smaller subgroups feed and reproduce in seeds and fruits, or in herbaceous plants. Some species are polygynous, the males initiate a gallery or a chamber on or in a new host and attract females. Others are monogamous, and the females initiate the new galleries. Many species respond to primary volatile attractants emitted by the hosts, and some produce aggregation pheromones that attract conspecifics of both sexes. The species attacking living hosts are often associated with fungi that contribute to weakening the host defences and provide nutrients to the insects. Some are inbreeding; the males in the offspring mate with their sisters and rarely leave their natal tree. The larvae of all species develop and pupate within their hosts. Based on catalogues and other published data, a database was constructed providing information on hosts, feeding and reproductive habits, geographic distribution and the Köppen–Geiger climate types in countries where species occur. The Scolytinae were screened to exclude species in the following categories: (i) 708 species attacking conifers; (ii) 127 species present in at least four EU Member States and (iii) 440 species occurring in areas with climatic conditions not occurring in the EU. Among the remaining 5220 species, 88 species known for their mobility, occupying at least two landmasses separated by geographical barriers and some of which had impact levels documented in literature, were extracted. They were grouped into four subcategories: (i) 12 species with high impact on plant health; (ii) 16 species with low or doubtful impact; (iii) 48 species with no impact; (iv) 12 species with no impact and which had never been recorded as ‘introduced’ in the consulted catalogues but occurring on at least two landmasses. All 88 species could enter the EU with wood or wood products, or with plants for planting, and could establish because host plants are available, and climate is suitable in parts of the EU. Control measures to inhibit introduction are available. There is considerable uncertainty regarding the potential impact of many species. Methods for the reliable identification of many species are lacking. For some species of non-EU Scolytinae on non-coniferous hosts, all criteria assessed by EFSA for consideration as potential quarantine pest are met. Nevertheless, the Panel was not able to develop a method to discriminate confidently between species that clearly meet the criteria for potential quarantine pest status and those that do not.
{"title":"Pest categorisation of non-EU Scolytinae on non-coniferous hosts","authors":"EFSA Panel on Plant Health (PLH), Claude Bragard, Paula Baptista, Elisavet Chatzivassiliou, Francesco Di Serio, Paolo Gonthier, Josep Anton Jaques Miret, Annemarie Fejer Justesen, Christer Sven Magnusson, Panagiotis Milonas, Juan A. Navas-Cortes, Stephen Parnell, Roel Potting, Philippe Lucien Reignault, Emilio Stefani, Hans-Hermann Thulke, Wopke Van der Werf, Antonio Vicent Civera, Jonathan Yuen, Lucia Zappalà, Jean-Claude Grégoire, Andrea Battisti, Chris Malumphy, Massimo Faccoli, Virag Kertesz, Matteo Marchioro, Isabel Martinez, Giacomo Ortis, Davide Rassati, Enrico Ruzzier, Alan MacLeod","doi":"10.2903/j.efsa.2024.8889","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8889","url":null,"abstract":"<p>The EFSA Panel on Plant Health performed a group pest categorisation for the EU territory of non-EU Scolytinae (Coleoptera: Curculionidae) on non-coniferous hosts, which total 6495 known species. Most species attack apparently healthy, weakened or dead trees, either feeding on the phloem (‘bark beetles’ subgroup) or on fungi inoculated into the sapwood (‘ambrosia beetles’ subgroup). Smaller subgroups feed and reproduce in seeds and fruits, or in herbaceous plants. Some species are polygynous, the males initiate a gallery or a chamber on or in a new host and attract females. Others are monogamous, and the females initiate the new galleries. Many species respond to primary volatile attractants emitted by the hosts, and some produce aggregation pheromones that attract conspecifics of both sexes. The species attacking living hosts are often associated with fungi that contribute to weakening the host defences and provide nutrients to the insects. Some are inbreeding; the males in the offspring mate with their sisters and rarely leave their natal tree. The larvae of all species develop and pupate within their hosts. Based on catalogues and other published data, a database was constructed providing information on hosts, feeding and reproductive habits, geographic distribution and the Köppen–Geiger climate types in countries where species occur. The Scolytinae were screened to exclude species in the following categories: (i) 708 species attacking conifers; (ii) 127 species present in at least four EU Member States and (iii) 440 species occurring in areas with climatic conditions not occurring in the EU. Among the remaining 5220 species, 88 species known for their mobility, occupying at least two landmasses separated by geographical barriers and some of which had impact levels documented in literature, were extracted. They were grouped into four subcategories: (i) 12 species with high impact on plant health; (ii) 16 species with low or doubtful impact; (iii) 48 species with no impact; (iv) 12 species with no impact and which had never been recorded as ‘introduced’ in the consulted catalogues but occurring on at least two landmasses. All 88 species could enter the EU with wood or wood products, or with plants for planting, and could establish because host plants are available, and climate is suitable in parts of the EU. Control measures to inhibit introduction are available. There is considerable uncertainty regarding the potential impact of many species. Methods for the reliable identification of many species are lacking. For some species of non-EU Scolytinae on non-coniferous hosts, all criteria assessed by EFSA for consideration as potential quarantine pest are met. Nevertheless, the Panel was not able to develop a method to discriminate confidently between species that clearly meet the criteria for potential quarantine pest status and those that do not.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8889","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142234961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-10DOI: 10.2903/j.efsa.2024.8988
European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Galini Mavriou, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance Bacillus velezensis strain RTI301 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. velezensis strain RTI301 as a fungicide for the control of soil-borne diseases in greenhouses (permanent) and walk-in tunnels (non-permanent) and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified.
{"title":"Peer review of the pesticide risk assessment of the active substance Bacillus velezensis RTI301","authors":"European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Galini Mavriou, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza","doi":"10.2903/j.efsa.2024.8988","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8988","url":null,"abstract":"<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance <i>Bacillus velezensis</i> strain RTI301 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of <i>B. velezensis</i> strain RTI301 as a fungicide for the control of soil-borne diseases in greenhouses (permanent) and walk-in tunnels (non-permanent) and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8988","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142165649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.2903/j.efsa.2024.8989
European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Galini Mavriou, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance Bacillus subtilis strain RTI477 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. subtilis strain RTI477 as a fungicide for the control of soil-borne diseases in greenhouses (permanent) and walk-in tunnels and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified.
{"title":"Peer review of the pesticide risk assessment of the active substance Bacillus subtilis strain RTI477","authors":"European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Galini Mavriou, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza","doi":"10.2903/j.efsa.2024.8989","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8989","url":null,"abstract":"<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance <i>Bacillus subtilis</i> strain RTI477 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of <i>B. subtilis</i> strain RTI477 as a fungicide for the control of soil-borne diseases in greenhouses (permanent) and walk-in tunnels and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8989","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142165548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.2903/j.efsa.2024.8985
EFSA Panel on Food Additives and Flavourings (FAF), Monica Andreassen, Gabriele Aquilina, Maria Lourdes Bastos, Polly Boon, Biagio Fallico, Reginald FitzGerald, Maria Jose Frutos Fernandez, Bettina Grasl-Kraupp, Ursula Gundert-Remy, Rainer Gürtler, Eric Houdeau, Marcin Kurek, Henriqueta Louro, Patricia Morales, Sabina Passamonti, José Manuel Barat Baviera, Gisela Degen, David Gott, Lieve Herman, Jean-Charles Leblanc, Peter Moldeus, Ine Waalkens-Berendsen, Detlef Wölfle, Consuelo Civitella, Jaime Aguilera Entrena, Agnieszka Mech, Salvatore Multari, Laura Ruggeri, Camilla Smeraldi, Alexandra Tard, Sam Vermeiren, Laurence Castle
The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of curdlan as a new food additive used as firming and gelling agent, stabiliser, thickener. Curdlan is a high molecular weight polysaccharide consisting of β-1,3-linked glucose units, produced by fermentation from Rhizobium radiobacter biovar 1 strain NTK-u. The toxicological dataset consisted of sub-chronic, chronic and carcinogenicity, reproductive and developmental toxicity studies as well as genotoxicity. In vivo data showed that curdlan is not absorbed as such but is extensively metabolised by the gut microbiota into CO2 and other innocuous compounds. Curdlan was not genotoxic and was well-tolerated with no overt organ-specific toxicity. Effects observed at very high doses of curdlan, such as decreased growth and increased cecum weight, are common for indigestible bulking compounds and therefore considered physiological responses. In a combined three-generation reproductive and developmental toxicity study, decreased pup weight was observed during lactation at 7500 mg curdlan/kg body weight (bw) per day, the highest dose tested. The Panel considered the observed effects as treatment-related and adverse, although likely secondary to nutritional imbalance and identified a conservative no observed adverse effect level (NOAEL) of 2500 mg/kg bw per day. Despite the limitations noted in the dataset, the Panel was able to conclude applying the margin of exposure (MOE) approach. Given that curdlan and its break-down products are not absorbed and that the identified adverse effect is neither systemic nor local, no adjustment factor was deemed necessary. Thus, an MOE of at least 1 was considered sufficient. The highest exposure estimate was 1441 mg/kg bw per day in toddlers at the 95th percentile of the proposed maximum use level exposure assessment scenario. The Panel concluded that there is no safety concern for the use of curdlan as a food additive at the proposed uses and use levels.
{"title":"Safety evaluation of curdlan as a food additive","authors":"EFSA Panel on Food Additives and Flavourings (FAF), Monica Andreassen, Gabriele Aquilina, Maria Lourdes Bastos, Polly Boon, Biagio Fallico, Reginald FitzGerald, Maria Jose Frutos Fernandez, Bettina Grasl-Kraupp, Ursula Gundert-Remy, Rainer Gürtler, Eric Houdeau, Marcin Kurek, Henriqueta Louro, Patricia Morales, Sabina Passamonti, José Manuel Barat Baviera, Gisela Degen, David Gott, Lieve Herman, Jean-Charles Leblanc, Peter Moldeus, Ine Waalkens-Berendsen, Detlef Wölfle, Consuelo Civitella, Jaime Aguilera Entrena, Agnieszka Mech, Salvatore Multari, Laura Ruggeri, Camilla Smeraldi, Alexandra Tard, Sam Vermeiren, Laurence Castle","doi":"10.2903/j.efsa.2024.8985","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8985","url":null,"abstract":"<p>The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of curdlan as a new food additive used as firming and gelling agent, stabiliser, thickener. Curdlan is a high molecular weight polysaccharide consisting of β-1,3-linked glucose units, produced by fermentation from <i>Rhizobium radiobacter biovar</i> 1 strain NTK-u. The toxicological dataset consisted of sub-chronic, chronic and carcinogenicity, reproductive and developmental toxicity studies as well as genotoxicity. In vivo data showed that curdlan is not absorbed as such but is extensively metabolised by the gut microbiota into CO<sub>2</sub> and other innocuous compounds. Curdlan was not genotoxic and was well-tolerated with no overt organ-specific toxicity. Effects observed at very high doses of curdlan, such as decreased growth and increased cecum weight, are common for indigestible bulking compounds and therefore considered physiological responses. In a combined three-generation reproductive and developmental toxicity study, decreased pup weight was observed during lactation at 7500 mg curdlan/kg body weight (bw) per day, the highest dose tested. The Panel considered the observed effects as treatment-related and adverse, although likely secondary to nutritional imbalance and identified a conservative no observed adverse effect level (NOAEL) of 2500 mg/kg bw per day. Despite the limitations noted in the dataset, the Panel was able to conclude applying the margin of exposure (MOE) approach. Given that curdlan and its break-down products are not absorbed and that the identified adverse effect is neither systemic nor local, no adjustment factor was deemed necessary. Thus, an MOE of at least 1 was considered sufficient. The highest exposure estimate was 1441 mg/kg bw per day in toddlers at the 95th percentile of the proposed maximum use level exposure assessment scenario. The Panel concluded that there is no safety concern for the use of curdlan as a food additive at the proposed uses and use levels.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8985","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142165381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-05DOI: 10.2903/j.efsa.2024.8891
EFSA Panel on Plant Health (PLH), Claude Bragard, Paula Baptista, Elisavet Chatzivassiliou, Francesco Di Serio, Paolo Gonthier, Josep Anton Jaques Miret, Annemarie Fejer Justesen, Alan MacLeod, Christer Sven Magnusson, Panagiotis Milonas, Juan A. Navas-Cortes, Stephen Parnell, Roel Potting, Emilio Stefani, Wopke Van der Werf, Antonio Vicent Civera, Jonathan Yuen, Lucia Zappalà, Matteo Crotta, Ewelina Czwienczek, Ciro Gardi, Agata Kaczmarek, Virag Kertesz, Andrea Maiorano, Olaf Mosbach-Schulz, Marco Pautasso, Giuseppe Stancanelli, Franz Streissl, Anastasia Terzidou, Hans-Hermann Thulke
In accordance with the EFSA Strategy 2027 outlining the need for fit-for-purpose protocols for EFSA generic scientific assessments, the EFSA Panel on Plant Health (PLH Panel) developed standard protocols to harmonise the problem formulation process and outputs for mandates addressing recurrent scientific questions. Three types of recurring EFSA plant health mandates require generic scientific assessments: (i) pest categorisation; (ii) commodity risk assessment for the purpose of derogation to provisions of the EU plant health law and (iii) quantitative pest risk assessment. The three standard protocols are tailored to the appropriate level of detail and build on the existing guidance documents laying out the methods for conducting risk assessment in the plant health domain. To develop a standard protocol for pest categorisation, the PLH Panel adapted the latest version of the standard template reporting the evidence needs and the assessment questions to conclude whether a pest fulfils the criteria for being considered a potential quarantine pest for the EU. To develop a standard protocol for commodity risk assessment, the PLH Panel adapted the procedure and standard templates used for commodity risk assessment of high risk plants. To develop a standard protocol for quantitative pest risk assessments (qPRA), the Panel reviewed the existing guidance document on qPRA and the qPRAs published by the PLH Panel. The hierarchy of assessment questions and sub-questions used were identified and extracted. Based on this, a hierarchically organised IT-tool was formulated as protocol for the planning and documentation of future qPRAs.
{"title":"Standard protocols for plant health scientific assessments","authors":"EFSA Panel on Plant Health (PLH), Claude Bragard, Paula Baptista, Elisavet Chatzivassiliou, Francesco Di Serio, Paolo Gonthier, Josep Anton Jaques Miret, Annemarie Fejer Justesen, Alan MacLeod, Christer Sven Magnusson, Panagiotis Milonas, Juan A. Navas-Cortes, Stephen Parnell, Roel Potting, Emilio Stefani, Wopke Van der Werf, Antonio Vicent Civera, Jonathan Yuen, Lucia Zappalà, Matteo Crotta, Ewelina Czwienczek, Ciro Gardi, Agata Kaczmarek, Virag Kertesz, Andrea Maiorano, Olaf Mosbach-Schulz, Marco Pautasso, Giuseppe Stancanelli, Franz Streissl, Anastasia Terzidou, Hans-Hermann Thulke","doi":"10.2903/j.efsa.2024.8891","DOIUrl":"10.2903/j.efsa.2024.8891","url":null,"abstract":"<p>In accordance with the EFSA Strategy 2027 outlining the need for fit-for-purpose protocols for EFSA generic scientific assessments, the EFSA Panel on Plant Health (PLH Panel) developed standard protocols to harmonise the problem formulation process and outputs for mandates addressing recurrent scientific questions. Three types of recurring EFSA plant health mandates require generic scientific assessments: (i) pest categorisation; (ii) commodity risk assessment for the purpose of derogation to provisions of the EU plant health law and (iii) quantitative pest risk assessment. The three standard protocols are tailored to the appropriate level of detail and build on the existing guidance documents laying out the methods for conducting risk assessment in the plant health domain. To develop a standard protocol for pest categorisation, the PLH Panel adapted the latest version of the standard template reporting the evidence needs and the assessment questions to conclude whether a pest fulfils the criteria for being considered a potential quarantine pest for the EU. To develop a standard protocol for commodity risk assessment, the PLH Panel adapted the procedure and standard templates used for commodity risk assessment of high risk plants. To develop a standard protocol for quantitative pest risk assessments (qPRA), the Panel reviewed the existing guidance document on qPRA and the qPRAs published by the PLH Panel. The hierarchy of assessment questions and sub-questions used were identified and extracted. Based on this, a hierarchically organised IT-tool was formulated as protocol for the planning and documentation of future qPRAs.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11375420/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-04DOI: 10.2903/j.efsa.2024.8984
European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Galini Mavriou, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Finland, and co-rapporteur Member State, Croatia, for the pesticide active substance amidosulfuron and the assessment of confirmatory data following the Article 12 MRL review are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of amidosulfuron as a post-emergence herbicide on winter cereals, spring cereals, flax and grass/pasture (all field uses). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.
{"title":"Peer review of the pesticide risk assessment of the active substance amidosulfuron","authors":"European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Galini Mavriou, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza","doi":"10.2903/j.efsa.2024.8984","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8984","url":null,"abstract":"<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Finland, and co-rapporteur Member State, Croatia, for the pesticide active substance amidosulfuron and the assessment of confirmatory data following the Article 12 MRL review are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of amidosulfuron as a post-emergence herbicide on winter cereals, spring cereals, flax and grass/pasture (all field uses). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8984","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142137676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-29DOI: 10.2903/j.efsa.2024.8987
European Food Safety Authority (EFSA), Giulia Bellisai, Giovanni Bernasconi, Luis Carrasco Cabrera, Irene Castellan, Monica del Aguila, Lucien Ferreira, Luna Greco, Samira Jarrah, Renata Leuschner, Andrea Mioč, Stefanie Nave, Hermine Reich, Silvia Ruocco, Alessia Pia Scarlato, Marta Szot, Anne Theobald, Manuela Tiramani, Alessia Verani
According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance difenoconazole. To assess the occurrence of difenoconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Council Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.
根据(EC) No 396/2005法规第12条,欧洲食物安全局(EFSA)审查了目前在欧洲一级为农药活性物质苯醚甲环唑制定的最大残留限量(MRL)。为评估苯醚甲环唑在植物、加工商品、轮作作物和牲畜中的残留发生情况,欧洲食品安全局考虑了在理事会指令 91/414/EEC 框架内得出的结论、食品法典委员会制定的最高残留限量以及成员国和英国报告的欧洲授权(包括支持残留的数据)。根据对现有数据的评估,提出了最高残留限量建议,并进行了消费者风险评估。监管框架要求的一些信息缺失,可能对消费者造成急性风险。因此,消费者风险评估仅被视为指示性的,欧洲食品安全局提出的一些最大残留限量建议仍需风险管理者进一步考虑,还应考虑减少消费者接触的措施。
{"title":"Review of the existing maximum residue levels for difenoconazole according to Article 12 of Regulation (EC) No 396/2005","authors":"European Food Safety Authority (EFSA), Giulia Bellisai, Giovanni Bernasconi, Luis Carrasco Cabrera, Irene Castellan, Monica del Aguila, Lucien Ferreira, Luna Greco, Samira Jarrah, Renata Leuschner, Andrea Mioč, Stefanie Nave, Hermine Reich, Silvia Ruocco, Alessia Pia Scarlato, Marta Szot, Anne Theobald, Manuela Tiramani, Alessia Verani","doi":"10.2903/j.efsa.2024.8987","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8987","url":null,"abstract":"<p>According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance difenoconazole. To assess the occurrence of difenoconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Council Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8987","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142100478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-22DOI: 10.2903/j.efsa.2024.8986
European Food Safety Authority (EFSA), Antoine Messéan, Fernando Álvarez, Yann Devos, Ana M. Camargo
Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2022 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Overall, the 2022 PMEM report provides no evidence of adverse effects of maize MON 810 cultivation. It shows a high level of compliance with refuge requirements by Spanish and Portuguese farmers growing maize MON 810, but uncertainty remains on compliance in areas where the clustered surface of maize MON 810 farms exceeds 5 ha. There are no signs of practical resistance to Cry1Ab in the field in corn borer populations collected in north-eastern Spain in 2022, although a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information retrieved through farmer questionnaires in Spain and from the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Uncertainties remain on whether ‘very highly’ and ‘extremely’ sensitive non-target lepidoptera are potentially exposed to harmful amounts of MON 810 pollen. EFSA notes that several recommendations made in the frame of the assessment of previous PMEM reports remain unaddressed and identified additional shortcomings in the 2022 PMEM report that require further consideration by the consent holder in future annual PMEM reports. Particularly, EFSA emphasises the urgent need to increase the sensitivity of the insect resistance monitoring strategy and implement mitigation measures to ensure that the exposure of non-target lepidoptera to maize MON 810 pollen is reduced to levels of no concern.
{"title":"Assessment of the 2022 post-market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU","authors":"European Food Safety Authority (EFSA), Antoine Messéan, Fernando Álvarez, Yann Devos, Ana M. Camargo","doi":"10.2903/j.efsa.2024.8986","DOIUrl":"10.2903/j.efsa.2024.8986","url":null,"abstract":"<p>Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2022 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Overall, the 2022 PMEM report provides no evidence of adverse effects of maize MON 810 cultivation. It shows a high level of compliance with refuge requirements by Spanish and Portuguese farmers growing maize MON 810, but uncertainty remains on compliance in areas where the clustered surface of maize MON 810 farms exceeds 5 ha. There are no signs of practical resistance to Cry1Ab in the field in corn borer populations collected in north-eastern Spain in 2022, although a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information retrieved through farmer questionnaires in Spain and from the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Uncertainties remain on whether ‘very highly’ and ‘extremely’ sensitive non-target lepidoptera are potentially exposed to harmful amounts of MON 810 pollen. EFSA notes that several recommendations made in the frame of the assessment of previous PMEM reports remain unaddressed and identified additional shortcomings in the 2022 PMEM report that require further consideration by the consent holder in future annual PMEM reports. Particularly, EFSA emphasises the urgent need to increase the sensitivity of the insect resistance monitoring strategy and implement mitigation measures to ensure that the exposure of non-target lepidoptera to maize MON 810 pollen is reduced to levels of no concern.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11340014/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-16DOI: 10.2903/j.efsa.2024.8977
European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Galini Mavriou, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance 1-methylcyclopropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council for an amendment in approval conditions. The current approval of 1-methylcyclopropene includes the specific provision ‘Only uses as plant growth regulator for post-harvest storage in sealable warehouse may be authorised’. The applicant AgroFresh Holding France SAS submitted, in accordance with Article 7 of Reg. (EC) 1107/2009, an application to remove this specific provision in order to allow member states to authorise the use of products containing 1-methylcyclopropene on outdoor crops pre-harvest. The conclusions were reached on the basis of the evaluation of the representative use(s) of 1-methylcyclopropene as a plant growth regulator via spray application on pome fruit. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.
报告了欧洲食品安全局(EFSA)在对报告员成员国荷兰主管当局对农药活性物质 1-甲基环丙烯进行的初步风险评估进行同行审查后得出的结论。同行审查的背景是欧洲议会和理事会第 1107/2009 号条例(EC)所要求的批准条件修正案。目前对 1-甲基环丙烯的批准包括 "仅可批准作为植物生长调节剂用于收获后在可密封仓库中的储存 "的具体规定。申请人 AgroFresh Holding France SAS 根据 (EC) 1107/2009 号法规第 7 条的规定提交了一份申请,要求取消这一特殊规定,以允许成员国授权将含有 1-甲基环丙烯的产品用于收获前的室外作物。该结论是根据对 1-甲基环丙烯作为植物生长调节剂通过喷洒应用于梨果的代表性用途的评估得出的。提出了适合用于监管风险评估的可靠终点。列出了监管框架要求的缺失信息。对发现的问题进行了报告。
{"title":"Peer review of the pesticide risk assessment of the active substance 1-methylcyclopropene","authors":"European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Galini Mavriou, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza","doi":"10.2903/j.efsa.2024.8977","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8977","url":null,"abstract":"<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance 1-methylcyclopropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council for an amendment in approval conditions. The current approval of 1-methylcyclopropene includes the specific provision ‘Only uses as plant growth regulator for post-harvest storage in sealable warehouse may be authorised’. The applicant AgroFresh Holding France SAS submitted, in accordance with Article 7 of Reg. (EC) 1107/2009, an application to remove this specific provision in order to allow member states to authorise the use of products containing 1-methylcyclopropene on outdoor crops pre-harvest. The conclusions were reached on the basis of the evaluation of the representative use(s) of 1-methylcyclopropene as a plant growth regulator via spray application on pome fruit. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8977","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141991709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}