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Safety and efficacy of a feed additive consisting of a tincture derived from the leaves of Ocimum basilicum L. (basil tincture) for use in all animal species (FEFANA asbl) 从罗勒叶中提取的酊剂(罗勒酊剂)用于所有动物的饲料添加剂的安全性和有效性(FEFANA asbl)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-07-30 DOI: 10.2903/j.efsa.2025.9543
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Maria de Lourdes Bastos, Emilio Benfenati, Paul Brantom, Andrew Chesson, Josef Schlatter, Johannes Westendorf, Paola Manini
{"title":"Safety and efficacy of a feed additive consisting of a tincture derived from the leaves of Ocimum basilicum L. (basil tincture) for use in all animal species (FEFANA asbl)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Maria de Lourdes Bastos,&nbsp;Emilio Benfenati,&nbsp;Paul Brantom,&nbsp;Andrew Chesson,&nbsp;Josef Schlatter,&nbsp;Johannes Westendorf,&nbsp;Paola Manini","doi":"10.2903/j.efsa.2025.9543","DOIUrl":"10.2903/j.efsa.2025.9543","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the leaves of <i>Ocimum basilicum</i> L. (basil tincture) when used as a sensory additive in feed and in water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.79%. Basil tincture contains on average 0.187% (w/w) total polyphenols (of which 0.0247% are flavonoids). Methyleugenol (0.0006%) and estragole (0.00005%) were detected in the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of basil tincture is very unlikely to induce adverse effects in long-living and reproductive animals and is of no safety concern for species for fattening at the following concentrations in complete feed: 65 mg/kg for chickens for fattening, 97 mg/kg for laying hens, 87 mg/kg for turkeys for fattening, 140 mg/kg for pigs for fattening, 116 mg/kg for piglets, 170 mg/kg for sows, 291 mg/kg for veal calves, 256 mg/kg for cattle for fattening, sheep/goats and horses, 166 mg/kg for dairy cows, 102 mg/kg for rabbits, 292 mg/kg for salmonids, 307 mg/kg for dogs, 256 mg/kg for cats and 500 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to induce adverse effects at 65 mg/kg complete feed. No safety concerns were identified for the consumer and the environment from the use of the additive in animal feed. Regarding user safety, basil tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to methyleugenol and estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the leaves of <i>O. basilicum</i> are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was necessary.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9543","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725727","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}
引用次数: 0
Safety and efficacy of the feed additives l-histidine and l-histidine monohydrochloride monohydrate produced with Corynebacterium glutamicum KCCM 80389 for all animal species (CJ Europe GmbH) 用谷氨酰胺棒状杆菌KCCM 80389生产的饲料添加剂l-组氨酸和l-组氨酸一水合物的安全性和有效性(CJ Europe GmbH)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-07-30 DOI: 10.2903/j.efsa.2025.9535
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Jaume Galobart, Matteo L. Innocenti, Maria Vittoria Vettori, Joana Revez
{"title":"Safety and efficacy of the feed additives l-histidine and l-histidine monohydrochloride monohydrate produced with Corynebacterium glutamicum KCCM 80389 for all animal species (CJ Europe GmbH)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Montserrat Anguita,&nbsp;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Maria Vittoria Vettori,&nbsp;Joana Revez","doi":"10.2903/j.efsa.2025.9535","DOIUrl":"10.2903/j.efsa.2025.9535","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of <span>l</span>-histidine and <span>l</span>-histidine monohydrochloride monohydrate produced with a genetically modified strain of <i>Corynebacterium glutamicum</i> (KCCM 80389) as nutritional and sensory feed additives for all animal species and categories. <span>l</span>-Histidine and <span>l</span>-histidine monohydrochloride monohydrate manufactured by fermentation with <i>C. glutamicum</i> KCCM 80389 do not give rise to any safety concern regarding the genetic modifications of the production strain. No viable cells or DNA of the production strain were detected in the final products. The FEEDAP Panel concluded that the use of <span>l</span>-histidine and <span>l</span>-histidine monohydrochloride monohydrate produced with <i>C. glutamicum</i> KCCM 80389 in feed raises no safety concerns for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the species. The FEEDAP Panel had concerns on the use of <span>l</span>-histidine and <span>l</span>-histidine monohydrochloride monohydrate in water for drinking. The FEEDAP Panel concluded that the use of <span>l</span>-histidine and <span>l</span>-histidine monohydrochloride monohydrate produced by fermentation with <i>C. glutamicum</i> KCCM 80389 in animal nutrition are safe for the consumers of products from animals receiving the additive, and to the environment. Regarding the user safety, the additives are not considered irritant to skin or eyes and are not considered potential skin sensitisers. The additives were regarded as effective sources of the amino acid <span>l</span>-histidine for all non-ruminant species. To be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9535","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725739","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}
引用次数: 0
Safety and efficacy of a feed additive consisting of a tincture derived from the leaves or the aerial parts of Mentha × piperita L. (peppermint tincture) for use in all animal species (FEFANA asbl) 由薄荷叶或薄荷根部提取的酊剂(薄荷酊剂)组成的用于所有动物物种的饲料添加剂的安全性和有效性(FEFANA asbl)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-07-30 DOI: 10.2903/j.efsa.2025.9544
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Maria de Lourdes Bastos, Emilio Benfenati, Paul Brantom, Andrew Chesson, Josef Schlatter, Johannes Westendorf, Paola Manini
{"title":"Safety and efficacy of a feed additive consisting of a tincture derived from the leaves or the aerial parts of Mentha × piperita L. (peppermint tincture) for use in all animal species (FEFANA asbl)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Maria de Lourdes Bastos,&nbsp;Emilio Benfenati,&nbsp;Paul Brantom,&nbsp;Andrew Chesson,&nbsp;Josef Schlatter,&nbsp;Johannes Westendorf,&nbsp;Paola Manini","doi":"10.2903/j.efsa.2025.9544","DOIUrl":"10.2903/j.efsa.2025.9544","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the leaves or aerial parts of <i>Mentha</i> × <i>piperita</i> L. (peppermint tincture) when used as a sensory additive in feed and in water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.85%. Peppermint tincture contains on average 0.095% (w/w) total polyphenols (of which 0.0247% are flavonoids). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of peppermint tincture is safe at the proposed use level of 500 mg/kg complete feed for ornamental fish. For the other species the calculated safe concentrations in complete feed are: 64 mg/kg for chickens for fattening, 95 mg/kg for laying hens, 86 mg/kg for turkeys for fattening, 138 mg/kg for pigs for fattening, 115 mg/kg for piglets, 168 mg/kg for sows, 287 mg/kg for veal calves, 253 mg/kg for cattle for fattening, sheep/goats and horses, 164 mg/kg for dairy cows, 101 mg/kg for rabbits, 289 mg/kg for salmonids, 303 mg/kg for dogs and 253 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 64 mg/kg complete feed. The use of peppermint tincture at the proposed conditions of use is considered safe for the consumers and the environment. Regarding user safety, the additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Any exposure is considered a risk. Since the leaves of <i>Mentha</i> × <i>piperita</i> L. are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was necessary.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9544","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725423","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}
引用次数: 0
Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283 根据法规(EU) 2015/2283,合成大麻二酚作为新型食品的安全性
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-07-30 DOI: 10.2903/j.efsa.2025.9527
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Helle Katrine Knutsen, Rosangela Marchelli, Harry J. McArdle, Peter Moldeus, Monika Neuhäuser-Berthold, Josef Rudolf Schlatter, Alexandros Siskos, Viviana Trezza, Henk van Loveren, Océane Albert, Elisa Beneventi, Areti Favata, George E. N. Kass, Marcello Laganaro, Maura Magani, Irene Nuin Garciarena, Anna Maria Pieger, Annamaria Rossi, Karen Ildico Hirsch-Ernst
{"title":"Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283","authors":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA),&nbsp;Dominique Turck,&nbsp;Torsten Bohn,&nbsp;Montaña Cámara,&nbsp;Jacqueline Castenmiller,&nbsp;Stefaan De Henauw,&nbsp;Ángeles Jos,&nbsp;Alexandre Maciuk,&nbsp;Inge Mangelsdorf,&nbsp;Breige McNulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Alfonso Siani,&nbsp;Frank Thies,&nbsp;Margarita Aguilera-Gómez,&nbsp;Francesco Cubadda,&nbsp;Thomas Frenzel,&nbsp;Marina Heinonen,&nbsp;Helle Katrine Knutsen,&nbsp;Rosangela Marchelli,&nbsp;Harry J. McArdle,&nbsp;Peter Moldeus,&nbsp;Monika Neuhäuser-Berthold,&nbsp;Josef Rudolf Schlatter,&nbsp;Alexandros Siskos,&nbsp;Viviana Trezza,&nbsp;Henk van Loveren,&nbsp;Océane Albert,&nbsp;Elisa Beneventi,&nbsp;Areti Favata,&nbsp;George E. N. Kass,&nbsp;Marcello Laganaro,&nbsp;Maura Magani,&nbsp;Irene Nuin Garciarena,&nbsp;Anna Maria Pieger,&nbsp;Annamaria Rossi,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9527","DOIUrl":"10.2903/j.efsa.2025.9527","url":null,"abstract":"<p>Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on synthetic cannabidiol as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is subject of the application is <i>trans</i>-cannabidiol (CBD), produced by chemical synthesis and proposed to be used in food supplements at a level of 30 mg/day. The target population is the general population, excluding pregnant and lactating women. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data concerned the identity, the production process, the compositional data, the specifications, the genotoxicity, the reproductive and developmental toxicity and the human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. synthetic cannabidiol, cannot be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9527","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144725665","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}
引用次数: 0
Updated peer review of the pesticide risk assessment of the active substance metalaxyl-M (amendment of approval conditions) 更新原料药甲甲酰基- m农药风险评估同行评审(修订批准条件)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-07-29 DOI: 10.2903/j.efsa.2025.9573
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, Monica Fittipaldi Broussard, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, 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, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza
{"title":"Updated peer review of the pesticide risk assessment of the active substance metalaxyl-M (amendment of approval conditions)","authors":"European Food Safety Authority (EFSA),&nbsp;Fernando Álvarez,&nbsp;Maria Arena,&nbsp;Domenica Auteri,&nbsp;Sofia Batista Leite,&nbsp;Marco Binaglia,&nbsp;Anna Federica Castoldi,&nbsp;Arianna Chiusolo,&nbsp;Angelo Colagiorgi,&nbsp;Mathilde Colas,&nbsp;Federica Crivellente,&nbsp;Chloe De Lentdecker,&nbsp;Isabella De Magistris,&nbsp;Mark Egsmose,&nbsp;Gabriella Fait,&nbsp;Franco Ferilli,&nbsp;Monica Fittipaldi Broussard,&nbsp;German Giner Santonja,&nbsp;Varvara Gouliarmou,&nbsp;Katrin Halling,&nbsp;Alessio Ippolito,&nbsp;Frederique Istace,&nbsp;Samira Jarrah,&nbsp;Dimitra Kardassi,&nbsp;Aude Kienzler,&nbsp;Anna Lanzoni,&nbsp;Roberto Lava,&nbsp;Renata Leuschner,&nbsp;Alberto Linguadoca,&nbsp;Jochem Louisse,&nbsp;Christopher Lythgo,&nbsp;Oriol Magrans,&nbsp;Iris Mangas,&nbsp;Andrea Mioč,&nbsp;Ileana Miron,&nbsp;Tunde Molnar,&nbsp;Laura Padovani,&nbsp;Vincenzo Padricello,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Simone Rizzuto,&nbsp;Miguel Santos,&nbsp;Rositsa Serafimova,&nbsp;Rachel Sharp,&nbsp;Csaba Szentes,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Giorgia Vianello,&nbsp;Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9573","DOIUrl":"10.2903/j.efsa.2025.9573","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, Belgium, and co-rapporteur Member State, Greece, for the pesticide active substance metalaxyl-M 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 for the amendment to the conditions of approval of metalaxyl-M as a fungicide seed treatment for sunflower and spinach seeds intended to be sown in field and on the basis of data submitted to update the specified level of an impurity in the technical active substance. This assessment was updated following a request from the Commission to integrate the risk assessment for birds and mammals with the application of refined good agricultural practices (GAPs). 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":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9573","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717031","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}
引用次数: 0
Guidance on the use of read-across for chemical safety assessment in food and feed 食品和饲料中化学品安全评估中解读使用指南
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-07-28 DOI: 10.2903/j.efsa.2025.9586
EFSA Scientific Committee, Susanne Hougaard Bennekou, Ana Allende, Angela Bearth, Josep Casacuberta, Laurence Castle, Tamara Coja, Amélie Crépet, Thorhallur Halldorsson, Laurentius (Ron) Hoogenboom, Pikka Jokelainen, Helle Knutsen, Konstantinos Koutsoumanis, Claude Lambré, Søren Nielsen, Dominique Turck, Antonio Vicent Civera, Roberto Edoardo Villa, Holger Zorn, Emilio Benfenati, Romualdo Benigni, Qasim Chaudhry, Lucian Farcal, George Kass, Alexis Nathanail, Alicia Paini, Rositsa Serafimova
{"title":"Guidance on the use of read-across for chemical safety assessment in food and feed","authors":"EFSA Scientific Committee,&nbsp;Susanne Hougaard Bennekou,&nbsp;Ana Allende,&nbsp;Angela Bearth,&nbsp;Josep Casacuberta,&nbsp;Laurence Castle,&nbsp;Tamara Coja,&nbsp;Amélie Crépet,&nbsp;Thorhallur Halldorsson,&nbsp;Laurentius (Ron) Hoogenboom,&nbsp;Pikka Jokelainen,&nbsp;Helle Knutsen,&nbsp;Konstantinos Koutsoumanis,&nbsp;Claude Lambré,&nbsp;Søren Nielsen,&nbsp;Dominique Turck,&nbsp;Antonio Vicent Civera,&nbsp;Roberto Edoardo Villa,&nbsp;Holger Zorn,&nbsp;Emilio Benfenati,&nbsp;Romualdo Benigni,&nbsp;Qasim Chaudhry,&nbsp;Lucian Farcal,&nbsp;George Kass,&nbsp;Alexis Nathanail,&nbsp;Alicia Paini,&nbsp;Rositsa Serafimova","doi":"10.2903/j.efsa.2025.9586","DOIUrl":"10.2903/j.efsa.2025.9586","url":null,"abstract":"<p>Read-across is a method used in chemical risk assessment to predict the toxicological properties of a target substance by using data from structurally and mechanistically similar substances, known as source substances. EFSA's Scientific Committee has developed an approach for using read-across in food and feed risk assessment. This method provides a step-by-step guide to applying read-across as part of a weight-of-evidence evaluation for individual substances. It includes an explanation of the key aspects to consider at each step of the read-across workflow, i.e. problem formulation, target substance characterisation, source substance identification, source substance evaluation, data gap filling, uncertainty assessment, conclusion and reporting. It highlights the importance of clarity, impartiality and quality to derive transparent and reliable read-across conclusions. A particular emphasis is placed on the analysis of uncertainty and whether the overall uncertainty can be lowered to tolerable levels by using standardised approaches, and/or additional data from new approach methodologies (NAMs). The guidance outlines methods to integrate data from NAMs to support read-across in the relevant steps, improving the robustness of the assessment. The ultimate goal is to equip risk assessors and applicants with a comprehensive framework to carry out read-across assessments systematically and transparently, thereby supporting the safety evaluation of chemicals in the food and feed chain.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9586","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144714613","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}
引用次数: 0
Safety assessment of the process Starlinger recoSTAR PET iV+ used to recycle post-consumer PET into food contact materials Starlinger recoSTAR PET iV+将消费后PET回收为食品接触材料的过程的安全性评估
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-07-28 DOI: 10.2903/j.efsa.2025.9574
EFSA Panel on Food Contact Materials (FCM), Claude Lambré, Riccardo Crebelli, Maria da Silva, Koni Grob, Maria Rosaria Milana, Marja Pronk, Gilles Rivière, Mario Ščetar, Georgios Theodoridis, Els Van Hoeck, Nadia Waegeneers, Vincent Dudler, Constantine Papaspyrides, Maria de Fátima Tavares Poças, Remigio Marano, Evgenia Lampi
{"title":"Safety assessment of the process Starlinger recoSTAR PET iV+ used to recycle post-consumer PET into food contact materials","authors":"EFSA Panel on Food Contact Materials (FCM),&nbsp;Claude Lambré,&nbsp;Riccardo Crebelli,&nbsp;Maria da Silva,&nbsp;Koni Grob,&nbsp;Maria Rosaria Milana,&nbsp;Marja Pronk,&nbsp;Gilles Rivière,&nbsp;Mario Ščetar,&nbsp;Georgios Theodoridis,&nbsp;Els Van Hoeck,&nbsp;Nadia Waegeneers,&nbsp;Vincent Dudler,&nbsp;Constantine Papaspyrides,&nbsp;Maria de Fátima Tavares Poças,&nbsp;Remigio Marano,&nbsp;Evgenia Lampi","doi":"10.2903/j.efsa.2025.9574","DOIUrl":"10.2903/j.efsa.2025.9574","url":null,"abstract":"<p>The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process Starlinger recoSTAR PET iV+ (EU register number RECYC333). The input is hot washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, with no more than 5% PET from non-food consumer applications. The flakes are dried and crystallised (step 2), melted in an extruder and crystallised (step 3) and treated in a solid-state polycondensation (SSP) reactor under high temperature and vacuum (step 4). Having examined the challenge test provided, the Panel concluded that all three steps are critical in determining the decontamination efficiency of the process, the SSP being the most relevant for decontamination. The operating parameters to control the efficiency are the pressure, the temperature, the residence time and the gas flow rate. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of a contaminant substance. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature or below, with or without hot-fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens, and such uses are not covered by this evaluation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9574","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144714776","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}
引用次数: 0
Pest categorisation of Coccus viridis 病毒球菌病虫害的分类
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-07-25 DOI: 10.2903/j.efsa.2025.9582
EFSA Panel on Plant Health (PLH), Antonio Vicent Civera, Paula Baptista, Anna Berlin, Elisavet Chatzivassiliou, Jaime Cubero, Nik Cunniffe, Eduardo de la Peña, Nicolas Desneux, Francesco Di Serio, Anna Filipiak, Paolo Gonthier, Beata Hasiów-Jaroszewska, Hervé Jactel, Blanca B. Landa, Lara Maistrello, David Makowski, Panagiotis Milonas, Nikos T. Papadopoulos, Roel Potting, Hanna Susi, Dirk Jan van der Gaag, Alex Gobbi, Virag Kertesz, Andrea Maiorano, Antigoni Akrivou, Dimitrios Papachristos, Oresteia Sfyra
{"title":"Pest categorisation of Coccus viridis","authors":"EFSA Panel on Plant Health (PLH),&nbsp;Antonio Vicent Civera,&nbsp;Paula Baptista,&nbsp;Anna Berlin,&nbsp;Elisavet Chatzivassiliou,&nbsp;Jaime Cubero,&nbsp;Nik Cunniffe,&nbsp;Eduardo de la Peña,&nbsp;Nicolas Desneux,&nbsp;Francesco Di Serio,&nbsp;Anna Filipiak,&nbsp;Paolo Gonthier,&nbsp;Beata Hasiów-Jaroszewska,&nbsp;Hervé Jactel,&nbsp;Blanca B. Landa,&nbsp;Lara Maistrello,&nbsp;David Makowski,&nbsp;Panagiotis Milonas,&nbsp;Nikos T. Papadopoulos,&nbsp;Roel Potting,&nbsp;Hanna Susi,&nbsp;Dirk Jan van der Gaag,&nbsp;Alex Gobbi,&nbsp;Virag Kertesz,&nbsp;Andrea Maiorano,&nbsp;Antigoni Akrivou,&nbsp;Dimitrios Papachristos,&nbsp;Oresteia Sfyra","doi":"10.2903/j.efsa.2025.9582","DOIUrl":"10.2903/j.efsa.2025.9582","url":null,"abstract":"<p>The EFSA Panel on Plant Health performed a pest categorisation of <i>Coccus viridis</i> (Hemiptera: Coccidae), the green coffee scale, for the territory of the European Union (EU), following the commodity risk assessment of <i>Jasminum polyanthum</i> from Uganda, in which <i>C</i>. <i>viridis</i> was identified as a pest of possible concern to the EU. <i>Coccus viridis</i> is distributed in tropical and subtropical areas of the Americas, Africa, Asia and Oceania. In the EU, <i>C. viridis</i> occurs on the Azores and Madeira Islands (Portugal). It is a polyphagous pest, feeding on plant species belonging to more than 200 genera from 72 plant families, primarily on coffee (<i>Coffea arabica</i>), guava (<i>Psidium guajava</i>) and cacao (<i>Theobroma cacao</i>) plants. Hosts that are grown in the EU include <i>Apium graveolens</i>, <i>Citrus</i> spp., <i>Eriobotrya japonica</i>, <i>Eucalyptus camaldulensis</i>, <i>Mangifera indica</i>, <i>Pyrus communis</i> and some ornamental plants. Plants for planting, fruits, vegetables and cut flowers provide potential pathways for entry into the EU. Climatic conditions and availability of host plants in southern and central EU countries would allow this species to establish and spread. However, since little is known about the pest-specific temperature requirements, and considering its tropical and subtropical origin, there is uncertainty about its ability to establish outdoors in central EU. Nevertheless, establishment could occur in greenhouses and on indoor plantings in such areas. Introduction and spread of <i>C. viridis</i> would likely have an economic impact in the EU, but there is uncertainty on the magnitude. This insect is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. Phytosanitary measures are available to reduce the likelihood of entry and further spread. While the magnitude of impact in the EU is associated with uncertainty, all criteria assessed by EFSA for consideration as a potential quarantine pest are met<i>.</i></p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9582","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144705534","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}
引用次数: 0
Safety and efficacy of a feed additive consisting of copper lysinate sulfate for all animal species (Phytobiotics Futterzusatzstoffe GmbH) 由硫酸铜组成的饲料添加剂对所有动物的安全性和有效性(Phytobiotics Futterzusatzstoffe GmbH)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-07-25 DOI: 10.2903/j.efsa.2025.9555
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Georges Bories, Jürgen Gropp, Jaume Galobart, Paola Manini, Fabiola Pizzo, Maria Vittoria Vettori, Anita Radovnikovic, Alberto Navarro-Villa
{"title":"Safety and efficacy of a feed additive consisting of copper lysinate sulfate for all animal species (Phytobiotics Futterzusatzstoffe GmbH)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Georges Bories,&nbsp;Jürgen Gropp,&nbsp;Jaume Galobart,&nbsp;Paola Manini,&nbsp;Fabiola Pizzo,&nbsp;Maria Vittoria Vettori,&nbsp;Anita Radovnikovic,&nbsp;Alberto Navarro-Villa","doi":"10.2903/j.efsa.2025.9555","DOIUrl":"10.2903/j.efsa.2025.9555","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper lysinate sulfate as nutritional feed additive for all animal species. The additive has not yet been authorised in the EU. The FEEDAP Panel concluded that the additive copper lysinate sulfate is safe for all animal species and categories at the respective maximum authorised total copper levels in feed. In the absence of reliable deposition data, the FEEDAP Panel could not conclude on the safety of the additive for the consumer. In the absence of data, the FEEDAP Panel could not conclude on the eye irritation potential of the additive. The Panel concluded that the additive is not a skin irritant and thus it should be considered a skin and respiratory sensitiser; inhalation and dermal exposure are considered a risk. The FEEDAP Panel concluded that the use of the additive under the proposed conditions of use is safe for the environment. The Panel was not in the position to conclude on the efficacy of the additive at the maximum authorised inclusion level.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9555","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144705448","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}
引用次数: 0
Safety assessment of the process EREMA VACUNITE (EREMA Vacurema Basic and Polymetrix SSP V-LeaN) used to recycle post-consumer PET into food contact materials EREMA VACUNITE (EREMA Vacurema Basic和Polymetrix SSP V-LeaN)工艺用于回收消费后PET到食品接触材料的安全性评估
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-07-25 DOI: 10.2903/j.efsa.2025.9575
EFSA Panel on Food Contact Materials (FCM), Claude Lambré, Riccardo Crebelli, Maria da Silva, Koni Grob, Maria Rosaria Milana, Marja Pronk, Gilles Rivière, Mario Ščetar, Georgios Theodoridis, Els Van Hoeck, Nadia Waegeneers, Vincent Dudler, Constantine Papaspyrides, Maria de Fátima Tavares Poças, Vasiliki Sfika, Emmanouil Tsochatzis, Evgenia Lampi
{"title":"Safety assessment of the process EREMA VACUNITE (EREMA Vacurema Basic and Polymetrix SSP V-LeaN) used to recycle post-consumer PET into food contact materials","authors":"EFSA Panel on Food Contact Materials (FCM),&nbsp;Claude Lambré,&nbsp;Riccardo Crebelli,&nbsp;Maria da Silva,&nbsp;Koni Grob,&nbsp;Maria Rosaria Milana,&nbsp;Marja Pronk,&nbsp;Gilles Rivière,&nbsp;Mario Ščetar,&nbsp;Georgios Theodoridis,&nbsp;Els Van Hoeck,&nbsp;Nadia Waegeneers,&nbsp;Vincent Dudler,&nbsp;Constantine Papaspyrides,&nbsp;Maria de Fátima Tavares Poças,&nbsp;Vasiliki Sfika,&nbsp;Emmanouil Tsochatzis,&nbsp;Evgenia Lampi","doi":"10.2903/j.efsa.2025.9575","DOIUrl":"10.2903/j.efsa.2025.9575","url":null,"abstract":"<p>The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process EREMA VACUNITE (EREMA Vacurema Basic and Polymetrix SSP V-LeaN) (EU register number RECYC332). The input is hot caustic/surfactant-washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, with no more than 5% PET from non-food consumer applications. The flakes are first decontaminated in a ■■■■■ flake reactor under ■■■■■ (step 2), then extruded, pelletised and ■■■■■ (step 3). The ■■■■■ pellets are ■■■■■ (step 4) and submitted to solid-state polycondensation (SSP) in a ■■■■■ reactor at ■■■■■ under ■■■■■ and ■■■■■ (step 5). Having examined the challenge tests provided, the Panel concluded that steps 2 and 5 are critical for determining the decontamination efficiency of the process. The operating parameters to control the performance of steps 2 and 5 are temperature, pressure and residence time as well as ■■■■■ for step 5. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of a contaminant substance. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature or below, with or without hot-fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9575","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144705450","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}
引用次数: 0
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