EFSA Journal最新文献

{"title":"Plain Language Summary of the European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2022–2023","authors":"","doi":"10.2903/j.efsa.2025.p230301","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.p230301","url":null,"abstract":"","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.p230301","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143555058","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":"The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2022–2023","authors":"European Food Safety Authority,&nbsp;European Centre for Disease Prevention and Control","doi":"10.2903/j.efsa.2025.9237","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9237","url":null,"abstract":"<p>This report presents the main findings of the 2022–2023 harmonised antimicrobial resistance (AMR) monitoring in <i>Salmonella</i> spp., <i>Campylobacter jejuni</i> and <i>Campylobacter coli</i> from humans and food-producing animals (broilers, laying hens and fattening turkeys, fattening pigs and cattle under 1 year of age) and derived meat. For animals and meat, AMR data on indicator commensal <i>Escherichia coli</i>, presumptive extended-spectrum beta-lactamase (ESBL)-/AmpC beta-lactamase (AmpC)−/carbapenemase (CP)-producing <i>E. coli</i> and the occurrence of methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) are also analysed. Generally, resistance differed greatly between reporting countries and antimicrobials. A high proportion of <i>Salmonella</i> spp. and <i>Campylobacter</i> isolates from humans and animals were resistant to commonly used antimicrobials (ampicillin, tetracycline and sulfonamides) in human and veterinary medicine, although <i>Salmonella</i> isolates from laying hens exhibited lower resistance. In humans, increasing trends in resistance to ciprofloxacin, one of two critically important antimicrobials (CIA) for human treatment, were observed in poultry-associated <i>Salmonella</i> serovars and in <i>Campylobacter</i>, in several reporting countries. Combined resistance to CIA was however observed in a low proportion of isolates except for some <i>Salmonella</i> serovars and <i>C. coli</i> from humans and animals in some countries. In imported fresh meat of broilers and turkeys sampled at border control posts, resistance to third-generation cephalosporins was observed respectively at very high and moderate levels in <i>Salmonella</i> and indicator <i>E. coli</i>. While CP-producing <i>Salmonella</i> isolates were not detected in animals in 2022–2023, five human cases of CP-producing <i>Salmonella</i> were reported in 2022 and six cases in 2023 (the majority harbouring <i>bla</i>_OXA-48 or <i>bla</i>_OXA-48-like genes). Detection of CP-producing <i>E. coli</i> isolates (carrying <i>bla</i>_OXA-48, <i>bla</i>_OXA-181, <i>bla</i>_OXA-244, <i>bla</i>_NDM-5 and <i>bla</i>_VIM-1 genes) in broilers, fattening turkeys, fattening pigs, cattle under 1 year of age and meat from pigs by seven member states (MSs) in 2022 and 2023, requires a thorough follow-up. The temporal trend analyses in key outcome indicators (complete susceptibility and prevalence of ESBL-/AmpC- producing <i>E. coli</i>) showed an encouraging progress in reducing AMR in food-producing animals in several EU MSs over the last 10 years.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9237","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143555055","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":"Nutritional safety and suitability of a specific protein hydrolysate derived from sources of skimmed cow's milk and whey protein concentrates and used in infant and follow-on formula manufactured from hydrolysed protein by Healthcare Reckitt B.V.","authors":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA),&nbsp;Torsten Bohn,&nbsp;Montaña Cámara,&nbsp;Jacqueline Castenmiller,&nbsp;Stefaan de Henauw,&nbsp;Karen-Ildico Hirsch-Ernst,&nbsp;Angeles Jos,&nbsp;Alexandre Maciuk,&nbsp;Inge Mangelsdorf,&nbsp;Breige McNulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Alfonso Siani,&nbsp;Frank Thies,&nbsp;Laurence Castle,&nbsp;Mary Fewtrell,&nbsp;Hildegard Przyrembel,&nbsp;Ariane Titz,&nbsp;Dominique Turck","doi":"10.2903/j.efsa.2025.9278","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9278","url":null,"abstract":"<p>The European Commission (EC) requested the European Food Safety Authority to evaluate the nutritional safety and suitability of a specific protein hydrolysate derived from sources of skimmed cow's milk (including non-fat) and whey protein concentrates for use in infant and follow-on formula manufactured by Healthcare Reckitt B.V. Healthcare Reckitt B.V. submitted a dossier to the EC seeking an amendment to Regulation (EU) 2016/127 regarding the protein sources permissible in the manufacture of infant and/or follow-on formula. The protein hydrolysate under evaluation is sufficiently characterised with respect to the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 2.3 g/100 kcal and consumed as the sole source of nutrition for 3 months led to growth that is similar to an infant formula manufactured from intact cow's milk protein with a protein content of 1.9 g/100 kcal. Data on adverse events and tolerance of the formula did not raise any concerns. No experimental data have been provided on the nutritional safety and suitability of this protein source in follow-on formula. Given that follow-on formula is consumed with complementary foods and the protein source is nutritionally safe and suitable in an infant formula that can be the sole source of nutrition of young infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow-on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow-on formula, as long as the formula in which it is used contains a minimum of 2.3 g/100 kcal protein and complies with the compositional criteria of Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9278","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143555057","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 enzyme glucose oxidase from the non-genetically modified Aspergillus tubingensis strain GOX","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;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Jaime Aguilera,&nbsp;Magdalena Andryszkiewicz,&nbsp;Francesco Pesce,&nbsp;Eleonora Marini,&nbsp;Ana Criado,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9290","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9290","url":null,"abstract":"<p>The food enzyme glucose oxidase (β-<span>d</span>-glucose: oxygen 1-oxidoreductase, i.e. EC 1.1.3.4) is produced with the non-genetically modified <i>Aspergillus tubingensis</i> strain GOX by DSM Food Specialties. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 1.555 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 2000 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 1286. A search for the homology of the amino acid sequence of the glucose oxidase to known allergens was made, and one match with a contact allergen was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. 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":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9290","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143533596","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":"BIOHAZ scientific opinion on the equivalence of an alternative heat treatment process of feathers and down","authors":"EFSA Panel on Biological Hazards (BIOHAZ),&nbsp;Ana Allende,&nbsp;Avelino Alvarez-Ordóñez,&nbsp;Valeria Bortolaia,&nbsp;Sara Bover-Cid,&nbsp;Wietske Dohmen,&nbsp;Laurent Guillier,&nbsp;Lieve Herman,&nbsp;Liesbeth Jacxsens,&nbsp;Lapo Mughini-Gras,&nbsp;Maarten Nauta,&nbsp;Jakob Ottoson,&nbsp;Luisa Peixe,&nbsp;Fernando Perez-Rodriguez,&nbsp;Panagiotis Skandamis,&nbsp;Elisabetta Suffredini,&nbsp;John Griffin,&nbsp;Pablo Fernández Escámez,&nbsp;Carolina Baptista,&nbsp;Sandra Correia,&nbsp;Alessandra De Cesare","doi":"10.2903/j.efsa.2025.9270","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9270","url":null,"abstract":"<p>The European Commission requested EFSA to provide a scientific opinion on the equivalence between the heat treatment process of feathers and down with dry heat to a temperature of 100°C for 30 min and the treatment set up in Commission Regulation (EU) No 142/2011, in terms of inactivation of relevant pathogens. To be considered at least equivalent to the methods in the legislation, the alternative method should be able to reduce the concentration of <i>Enterococcus faecalis</i> or <i>Salmonella</i> Senftenberg by at least 5 log₁₀ and the infectious titre of <i>Anelloviridae</i> and <i>Circoviridae</i> by at least 3 log₁₀. An extensive literature search (ELS) was conducted to identify studies in which the log₁₀ reduction or the D value of the indicators were determined after dry heating in matrices with low moisture/water activity. The ELS did not provide any study on the inactivation of <i>E. faecalis</i> by dry heating. For <i>S</i>. Senftenberg, there was no clear data demonstrating a 5 log₁₀ reduction. For <i>Anelloviridae</i> and <i>Circoviridae</i> there was limited evidence and only one study reported 1 log₁₀ reduction after 30 min at 120°C. Given the available data and sources of uncertainty, it is not possible to conclude on a 5 log₁₀ reduction of <i>E. faecalis</i> using the proposed method due to lack of evidence. Similarly, a comparable reduction of <i>S.</i> Senftenberg cannot be concluded due to conflicting evidence. For <i>Anelloviridae</i> and <i>Circoviridae,</i> it was not possible to conclude that a 3 log₁₀ reduction is achieved with the proposed method, as only one study on dry heat was retrieved, which did not demonstrate such a reduction. Therefore, based on data available to date, applying dry heat to feathers and down at 100°C for 30 min cannot be considered equivalent to the treatment specified in the Regulation, in terms of inactivation of relevant pathogens.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9270","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530070","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 an extension of use of the food enzyme triacylglycerol lipase from the genetically modified Trichoderma reesei strain RF10625","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;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Daniele Cavanna,&nbsp;Roos Anna de Nijs,&nbsp;Giulio Di Piazza,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9283","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9283","url":null,"abstract":"<p>The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the genetically modified <i>Trichoderma reesei</i> strain RF10625 by AB Enzymes GmbH. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of five food manufacturing processes. As the food enzyme–total organic solids (TOS) are removed from the final foods in one food manufacturing process, the dietary exposure to the food enzyme–TOS was estimated only for the remaining four processes. It was calculated to be up to 0.197 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1000 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 5076. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9283","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143513539","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":"Scientific Opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006","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;Karen Ildico Hirsch-Ernst,&nbsp;Ángeles Jos,&nbsp;Inge Mangelsdorf,&nbsp;Breige McNulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Alfonso Siani,&nbsp;Frank Thies,&nbsp;Leonard Matijević,&nbsp;Silvia Valtueña Martinez,&nbsp;Alexandre Maciuk","doi":"10.2903/j.efsa.2025.9276","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9276","url":null,"abstract":"<p>The Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the safety of monacolins from red yeast rice (RYR), which have been placed under Union scrutiny in Part C of Annex III in accordance with Article 8(4) of Regulation (EC) No 1925/2006. The NDA Panel reviewed the additional scientific data submitted during the period of scrutiny, which included analytical data on the composition of RYR supplements, the intake of monacolins from other dietary sources, in vitro bioaccessibility and cytotoxicity data of monacolins vs. other statins, nutrivigilance/post-marketing data, case reports and clinical studies. Based on the new nutrivigilance data provided, the NDA Panel reiterates the concerns of the ANS Panel (EFSA ANS Panel, 2018) that exposure to monacolin K from RYR at intake levels as low as 3 mg/day could lead to severe adverse effects on the musculoskeletal system, including rhabdomyolysis, and on the liver. The NDA Panel concludes that the data submitted by interested parties during the Union scrutiny period do not allow establishing the safety of monacolins in RYR supplements below 3 mg/day or to identify a daily intake of monacolins from RYR in food supplements that does not raise safety concerns for the general population or vulnerable subgroups thereof.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9276","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143513529","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 an extension of use of the food enzyme non-reducing end α-l-arabinofuranosidase from the non-genetically modified Aspergillus tubingensis strain ARF","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;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Laura Sanmartín,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9291","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9291","url":null,"abstract":"<p>The food enzyme non-reducing end α-<span>l</span>-arabinofuranosidase (α-<span>l</span>-arabinofura‑noside non-reducing end α-<span>l</span>-arabinofuranosidase, EC 3.2.1.55) is produced with the non-genetically modified <i>Aspergillus tubingensis</i> strain ARF by DSM Food Specialties B.V. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in five food manufacturing processes. Subsequently, the applicant requested to extend its use to include two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. The dietary exposure was calculated to be up to 0.458 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (234 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 511. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9291","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143513530","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 enzyme 6-Phytase from the genetically modified Trichoderma reesei strain AR-766","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;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Cristina Fernandez-Fraguas,&nbsp;Daniele Cavanna,&nbsp;Ana Criado,&nbsp;Simone Lunardi,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9226","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9226","url":null,"abstract":"<p>The food enzyme 6-Phytase (<i>myo</i>-inositol-hexakisphosphate 6-phosphohydrolase; EC 3.1.3.26) is produced with the genetically modified <i>Trichoderma reesei</i> strain AR-766 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in four food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in the production of distilled alcohol, dietary exposure was calculated only for the remaining three food manufacturing processes. It was estimated to be up to 0.071 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 947 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 13,338. A search for the homology of the amino acid sequence of the 6-Phytase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. 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":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9226","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143513538","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-arginine produced with Corynebacterium glutamicum KCCM 80387 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;Nicole Bozzi Cionci,&nbsp;Matteo L. Innocenti,&nbsp;Ruud Woutersen,&nbsp;Jordi Tarrés-Call","doi":"10.2903/j.efsa.2025.9258","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9258","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>-arginine produced with <i>Corynebacterium glutamicum</i> KCCM 80387 as a nutritional feed additive for all animal species (category: nutritional additive; functional group: amino acids, their salts and analogues; and category: sensory additives; functional group: flavouring compounds). The production strain <i>C. glutamicum</i> KCCM 80387 is a genetically modified strain and raises no safety concerns. The FEEDAP Panel concluded that the additive does not pose any safety concern with regard to the production strain. The use of <span>l</span>-arginine produced by fermentation with <i>C. glutamicum</i> KCCM 80387 in feed as nutritional additive or as flavouring compound is safe for the target species. The FEEDAP Panel has concerns on the use of <span>l</span>-arginine in water for drinking. The use of <span>l</span>-arginine produced by fermentation with <i>C. glutamicum</i> KCCM 80387 in animal nutrition is considered safe for the consumers and for the environment. As regards the safety for the user, <span>l</span>-arginine produced with <i>C. glutamicum</i> KCCM 80387 is not irritant to skin, and not a dermal sensitiser but is irritant to the eyes and respiratory tract. The additive <span>l</span>-arginine produced by fermentation with <i>C. glutamicum</i> KCCM 80387 is regarded as an efficacious source of the essential amino acid <span>l</span>-arginine for non-ruminant nutrition. For the supplemental <span>l</span>-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen. <span>l</span>-Arginine is also considered efficacious when used as a flavouring compound in animal nutrition.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9258","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143497074","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}