EFSA Journal最新文献

{"title":"Safety evaluation of the food enzyme oryzin from the non-genetically modified Aspergillus sp. strain LP 4–1281","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Cristina Andreoli,&nbsp;Andrea Terron,&nbsp;Andrey Yurkov,&nbsp;Daniele Cavanna,&nbsp;Magdalena Andryszkiewicz,&nbsp;Natalia Kovalkovicova,&nbsp;Silvia Peluso,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2026.10334","DOIUrl":"10.2903/j.efsa.2026.10334","url":null,"abstract":"<p>The food enzyme oryzin (EC 3.4.21.63) is produced with the non-genetically modified <i>Aspergillus</i> sp. strain LP 4-1281 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in 14 food manufacturing processes. Since residual amounts of food enzyme–Total Organic Solids (TOS) are removed in one process, dietary exposure was calculated for the remaining 13 food manufacturing processes. It was estimated to be up to 0.446 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1218 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2731. A search for the homology of the amino acid sequence of the oryzin to known allergens was made and matches with 2 food allergens, 20 respiratory allergens and 3 contact allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13602162/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149037139","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}

{"title":"Safety and efficacy of feed additives consisting of l-lysine monohydrochloride and liquid l-lysine produced with Corynebacterium glutamicum KCCM 80368 or KCCM 80479 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;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Paul Brantom,&nbsp;Nicole Bozzi Cionci,&nbsp;Matteo Innocenti,&nbsp;Jordi Tarrés-Call,&nbsp;Joana Revez","doi":"10.2903/j.efsa.2026.10118","DOIUrl":"10.2903/j.efsa.2026.10118","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>-lysine monohydrochloride and liquid <span>l</span>-lysine produced with a genetically modified strain of <i>Corynebacterium glutamicum</i> KCCM 80368 or KCCM 80479, as nutritional and sensory additives for use in feed and water for drinking, for all animal species and categories. The <span>l</span>-lysine monohydrochloride and liquid <span>l</span>-lysine manufactured by fermentation with <i>C. glutamicum</i> KCCM 80368 or KCCM 80479 did not give rise to any safety concern regarding the genetic modifications of the production strains. No viable cells or DNA of the production strains were detected in the final products. The use of <span>l</span>-lysine monohydrochloride and liquid <span>l</span>-lysine produced with <i>C. glutamicum</i> KCCM 80368 or KCCM 80479 in feed were considered safe 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>-lysine monohydrochloride and liquid <span>l</span>-lysine in water for drinking. The use of <span>l</span>-lysine monohydrochloride and liquid <span>l</span>-lysine produced by fermentation with <i>C. glutamicum</i> KCCM 80368 or KCCM 80479 in animal nutrition were considered safe for the consumers of products from animals receiving the additives and to the environment. Regarding the user safety, the additives were not considered irritant to skin or eyes and were not considered a potential skin sensitiser. The additives were regarded as an effective source of the amino acid <span>l</span>-lysine 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":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13598811/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149037142","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}

{"title":"Safety of Cannabis sativa L. extract 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;Francesco Cubadda,&nbsp;Harry J. McArdle,&nbsp;Viviana Trezza,&nbsp;Océane Albert,&nbsp;Elisa Beneventi,&nbsp;Marcello Laganaro,&nbsp;Irene Nuin Garciarena,&nbsp;Annamaria Rossi,&nbsp;Sebastián Berrío Cruz,&nbsp;Francesca Seminati,&nbsp;Maura Magani,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2026.10319","DOIUrl":"10.2903/j.efsa.2026.10319","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 <i>Cannabis sativa</i> L. extract as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of 57%–65% w/w cannabidiol (CBD) and 9%–17% w/w of other cannabinoids. The NF is produced via supercritical CO₂ extraction followed by winterisation, decarboxylation, purification and high-vacuum distillation. It is intended to be used as an ingredient in food supplements at a maximum intake of 30 mg/day. The proposed target population is the adult 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, EFSA requested additional information on the identity, production process, compositional data, specifications, genotoxicity, reproductive and developmental toxicity and human data of the NF. The applicant did not reply to these data requests. Based on the available data, the Panel concludes that the safety of the NF cannot be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13591333/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015636","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}

{"title":"Safety of cannabidiol isolated from Cannabis sativa L. 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;Francesco Cubadda,&nbsp;Harry J. McArdle,&nbsp;Viviana Trezza,&nbsp;Océane Albert,&nbsp;Elisa Beneventi,&nbsp;Marcello Laganaro,&nbsp;Irene Nuin Garciarena,&nbsp;Annamaria Rossi,&nbsp;Sebastián Berrío Cruz,&nbsp;Francesca Seminati,&nbsp;Maura Magani,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2026.10318","DOIUrl":"10.2903/j.efsa.2026.10318","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 cannabidiol (CBD) isolated from <i>Cannabis sativa</i> L. as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of ≥ 98% w/w CBD. The NF is produced via ethanol extraction, followed by winterisation, filtration, decarboxylation and crystallisation. It is intended to be used as an ingredient in food supplements at a maximum intake of 60 mg/day. The proposed target population is the adult 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, EFSA requested additional information on the identity, production process, compositional data, specifications, genotoxicity, reproductive and developmental toxicity, and human data of the NF. The applicant did not reply to these data requests. Based on the available data, the Panel concludes that the safety of the NF cannot be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13591334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015661","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}

{"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;Francesco Cubadda,&nbsp;Harry J. McArdle,&nbsp;Viviana Trezza,&nbsp;Océane Albert,&nbsp;Elisa Beneventi,&nbsp;Marcello Laganaro,&nbsp;Irene Nuin Garciarena,&nbsp;Annamaria Rossi,&nbsp;Sebastián Berrío Cruz,&nbsp;Francesca Seminati,&nbsp;Maura Magani,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2026.10154","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10154","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 cannabidiol (CBD) obtained by chemical synthesis as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of ≥ 98% (w/w) CBD and is intended to be marketed exclusively dissolved in medium-chain triglyceride (MCT) oil in food supplements at a maximum daily dose of 2 mg. The proposed target population is the general adult population over 25 years old and excluding pregnant and lactating women. The safety of CBD in individuals taking medications cannot be established. The information provided on the production process, composition and specifications of the NF does not raise safety concerns. The NF is not considered to be nutritionally disadvantageous, and no concerns were identified with respect to genotoxicity. The applicant submitted a 90-day subchronic oral toxicity study with the NF in which the liver was identified as the key target organ, with female rats being more sensitive than males. A BMDL₁₀ of 10.5 mg/kg bw of CBD per day was derived for increased liver weight relative to body weight in female rats. In view of the remaining data gaps, including those related to reproductive and developmental toxicity, the uncertainty factor proposed in the Updated Statement on the safety of CBD published by EFSA in 2026 (i.e. 400) was applied to derive a safe intake level for cannabidiol of 0.026 mg/kg bw per day (2 mg/day for a 70-kg adult). The Panel concludes that the NF is safe under the proposed conditions of use, except for people taking medication, for whom safety could not be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10154","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148994636","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}

{"title":"Safety evaluation of the food additive rebaudioside M produced via enzymatic conversion of purified steviol glycosides leaf extracts","authors":"EFSA Panel on Food Additives and Flavourings (FAF),&nbsp;Laurence Castle,&nbsp;Monica Andreassen,&nbsp;Gabriele Aquilina,&nbsp;Maria Lourdes Bastos,&nbsp;Polly Boon,&nbsp;Biagio Fallico,&nbsp;Rex FitzGerald,&nbsp;Maria Jose Frutos Fernandez,&nbsp;Bettina Grasl-Kraupp,&nbsp;Ursula Gundert-Remy,&nbsp;Rainer Gürtler,&nbsp;Eric Houdeau,&nbsp;Marcin Kurek,&nbsp;Henriqueta Louro,&nbsp;Patricia Morales,&nbsp;Sabina Passamonti,&nbsp;José Manuel Barat Baviera,&nbsp;Gisela Degen,&nbsp;David Gott,&nbsp;Lieve Herman,&nbsp;Jean-Charles Leblanc,&nbsp;Peter Moldeus,&nbsp;Ine Waalkens-Berendsen,&nbsp;Detlef Wölfle,&nbsp;Consuelo Civitella,&nbsp;Samuele di Ciano,&nbsp;Simone Lunardi,&nbsp;Alessandra Tosato,&nbsp;Laura Ruggeri","doi":"10.2903/j.efsa.2026.10232","DOIUrl":"10.2903/j.efsa.2026.10232","url":null,"abstract":"<p>The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of a modified manufacturing process for the food additive enzymatically produced steviol glycosides (E 960c). The new process converts purified steviol glycosides extracted from <i>Stevia rebaudiana</i> leaves through enzymatic bioconversion catalysed by UDP-glucosyltransferase, UTP-glucose-1-phosphate uridylyltransferase and sucrose synthase enzymes, produced using a newly developed genetically modified strain of <i>Escherichia coli</i> (K-12 DSM 35119). The modification leads to changes in the definition of the food additive, residual protein, residual solvents and particle size. The Panel considered that the introduction of a new entry for the proposed food additive in Commission Regulation (EU) No 231/2012 would be more appropriate than amending the existing specifications for E 960c. The food additive is composed predominantly of rebaudioside M (&gt; 95%) with minor amounts of other steviol glycosides. The manufacturing process does not raise a safety concern since no viable cells nor DNA of the production strain remained in the final product; in addition, the food enzyme–total organic solid (TOS) are removed to at least 99%, and consequently, the exposure to the food enzyme–TOS can be considered negligible. The Panel considered that rebaudioside M produced by this new manufacturing process have the same physicochemical characteristics as the corresponding rebaudioside M present in E 960c(i) and (ii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the present safety assessment. The Panel concluded that there is no safety concern with respect to rebaudioside M (Reb M) produced via enzymatic conversion of purified steviol glycosides leaf extracts (95% steviol glycosides), using UDP-glucosyltransferase, UTP-glucose-1-phosphate uridylyltransferase and sucrose synthase enzymes produced by a genetically modified strain of <i>Escherichia coli</i> (named <i>E. coli</i> K-12 DSM 35119).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13583920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148988284","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}

{"title":"Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 for all terrestrial species (Dr. Bata Ltd.)","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;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Secundino López-Puente,&nbsp;Montserrat Anguita,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño","doi":"10.2903/j.efsa.2026.10307","DOIUrl":"10.2903/j.efsa.2026.10307","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 fumonisin esterase produced with the genetically modified strain <i>Komagataella phaffii</i> NCAIM (P) Y001485 as a technological feed additive (functional group: substances for reduction of the contamination of feed by mycotoxins) for all terrestrial species. Based on the data provided by the applicant in this and previous applications, the FEEDAP Panel concluded that the additive does not pose any safety concern regarding the genetically modified production strain, is safe for all terrestrial species at 360 U/kg complete feed, and its use in animal nutrition is of no concern for consumers or the environment. The additive is not irritant to skin or eyes. Due to the proteinaceous nature of the additive and the fact that the carrier is an inactivated microorganism, the additive is considered a dermal and respiratory sensitiser. Exposure by any route is considered a risk. The additive has the potential to be efficacious in all terrestrial species when added to feed at the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13579529/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148988347","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}

{"title":"Safety and efficacy of the feed additives consisting of l-isoleucine ≥ 90% and l-isoleucine ≥ 65% produced with Corynebacterium glutamicum KCCM 80388 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;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Baltasar Mayo,&nbsp;Ruud Woutersen,&nbsp;Montserrat Anguita,&nbsp;Matteo L. Innocenti,&nbsp;Joana Revez,&nbsp;Jordi Tarrés-Call,&nbsp;Elisa Pettenati,&nbsp;Joana P. Firmino","doi":"10.2903/j.efsa.2026.10293","DOIUrl":"10.2903/j.efsa.2026.10293","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>-isoleucine ≥ 90% and <span>l</span>-isoleucine ≥ 65% produced with a genetically modified strain of <i>Corynebacterium glutamicum</i> (KCCM 80388), as nutritional and sensory additives for use in feed and water for drinking, for all animal species and categories. <span>l</span>-Isoleucine ≥ 90% and <span>l</span>-isoleucine ≥ 65% manufactured by fermentation with <i>C. glutamicum</i> KCCM 80388 do not give rise to any safety concern with regard to the genetic modification of the production strain. No viable cells nor DNA of the production strain were detected in the final products. The use of <span>l</span>-isoleucine ≥ 90% and ≥ 65% produced with <i>C. glutamicum</i> KCCM 80388 in feed was considered safe 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>-isoleucine ≥ 90% and ≥ 65% in water for drinking. The use of <span>l</span>-isoleucine ≥ 90% and ≥ 65% produced by fermentation with <i>C. glutamicum</i> KCCM 80388 in animal nutrition was considered safe for the consumers of products from animals receiving the additives, and for the environment. Regarding user safety, the additives were considered not irritant to skin and are not considered skin sensitisers. <span>l</span>-Isoleucine ≥ 90% was not irritant to eyes. No conclusions could be reached on the eye irritation potential of <span>l</span>-isoleucine ≥ 65%. The additives were regarded as an effective source of the amino acid <span>l</span>-isoleucine 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":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13573628/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148967303","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}

{"title":"Safety and efficacy of a feed additive consisting of l-threonine produced using Corynebacterium glutamicum KCCM 80367 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;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Montserrat Anguita,&nbsp;Matteo L. Innocenti,&nbsp;Elisa Pettenati,&nbsp;Joana Revez,&nbsp;Jordi Tarrés-Call,&nbsp;Joana P. Firmino","doi":"10.2903/j.efsa.2026.10294","DOIUrl":"10.2903/j.efsa.2026.10294","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>-threonine produced by fermentation using the genetically modified strain of <i>Corynebacterium glutamicum</i>, KCCM 80367, as a nutritional additive in feed for all animal species and categories. In the manufacturing process used to obtain the product under assessment, the cells from the production strain are inactivated but not removed from the final product. The FEEDAP Panel concluded that the additive does not give rise to any safety concern regarding the genetic modification of the strain. DNA from the strain is present in the final product, but its presence does not raise any safety issue since the strain does not harbour any gene of concern. No viable cells of the strain were detected in the final product. The use of <span>l</span>-threonine produced using <i>C. glutamicum</i> KCCM 80367 in feed is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. The use of <span>l</span>-threonine produced using <i>C. glutamicum</i> KCCM 80367 in animal nutrition is considered safe for the consumers of products from animals receiving the additive, and to the environment. With regard to the safety of users, the additive is not irritant to skin but should be considered as a skin and respiratory sensitiser. No conclusions can be reached on its eye irritation potential. Exposure of users by inhalation and dermal routes is considered a risk. The additive <span>l</span>-threonine produced using <i>C. glutamicum</i> KCCM 80367 is regarded as an effective source of the amino acid <span>l</span>-threonine 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":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13573627/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148967249","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}

{"title":"Setting of an import tolerance for fenazaquin in teas","authors":"European Food Safety Authority (EFSA),&nbsp;Giulia Bellisai,&nbsp;Giovanni Bernasconi,&nbsp;Irene Castellan,&nbsp;Monica del Aguila,&nbsp;Lucien Ferreira,&nbsp;Renata Leuschner,&nbsp;Andrea Mioč,&nbsp;Marta Szot,&nbsp;Manuela Tiramani,&nbsp;Alessia Verani","doi":"10.2903/j.efsa.2026.10306","DOIUrl":"10.2903/j.efsa.2026.10306","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Gowan Crop Protection Limited submitted a request to the competent national authority in Germany to set an import tolerance for the active substance fenazaquin in teas imported from India. The results of the four new residue trials submitted in support of the request, together with those previously assessed during the maximum residue level (MRL) review for the same import tolerance, on the basis of which a tentative MRL of 9 mg/kg was set, are sufficient to derive an MRL for teas at the same level. The enforcement analytical method and its independent laboratory validation (ILV) submitted were found to be adequate to control fenazaquin residues in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues of fenazaquin and its toxicologically relevant plant metabolite 2-(4-tert-butylphenyl) ethanol (TBPE) resulting from the use of fenazaquin on teas imported from India according to the reported agricultural practice is unlikely to present a risk to consumer health. The consumer risk assessment for TBPE is indicative only, due to uncertainties related to missing residue data for this metabolite in commodities covered by EU-implemented Codex maximum residue limit (CXLs). Risk managers may consider either confirming the existing MRL of 9 mg/kg or lowering the value to 3 mg/kg, in line with the MRL currently in force in the country of origin.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13559795/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148929366","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}