EFSA Journal最新文献

{"title":"Safety evaluation of the food enzyme mannan endo-1,4-β-mannosidase from the non-genetically modified Aspergillus niger strain AE-HCM","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;Andrew Chesson,&nbsp;Lieve Heman,&nbsp;Jaime Aguilera,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Natalia Kovalkovicova,&nbsp;Giulio di Piazza,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9488","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9488","url":null,"abstract":"<p>The food enzyme mannan endo-1,4-β-mannosidase (1,4-β-<span>d</span>-mannan mannanohydrolase; EC 3.2.1.78) is produced with the non-genetically modified microorganism <i>Aspergillus niger</i> strain AE-HCM by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in three food manufacturing processes. Dietary exposure was calculated to be up to 0.568 mg total organic solids (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 728 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1282. A search for the homology of the amino acid sequence of the mannan endo-1,4-β-mannosidase to known allergens was made and a match with a respiratory allergen was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9488","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144264620","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 endo-1,4-β-xylanase from the genetically modified Trichoderma reesei strain DP-Nzd72","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;Ana Criado,&nbsp;Cristina Fernández-Fraguas,&nbsp;Simone Lunardi,&nbsp;Valentina Tokić,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9485","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9485","url":null,"abstract":"<p>The food enzyme endo-1,4-β-xylanase (4-β-<span>d</span>-xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified <i>Trichoderma reesei</i> strain DP-Nzd72 by Genencor International B.V. 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 three food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining food manufacturing process. It was estimated to be up to 0.017 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 1000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 58,824. A search for the homology of the amino acid sequence of the endo-1,4-β-xylanase 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 that 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 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9485","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144264619","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 glucan 1,4-α-maltohydrolase from the genetically modified Escherichia coli strain MLAVSC","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;Jaime Aguilera Entrena,&nbsp;Cristina Fernández-Fraguas,&nbsp;Silvia Peluso,&nbsp;Valentina Tokić,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9483","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9483","url":null,"abstract":"<p>The food enzyme glucan 1,4-α-maltohydrolase (4-α-<span>d</span>-glucan α-maltohydrolase, EC 3.2.1.133) is produced with the genetically modified <i>Escherichia coli</i> strain MLAVSC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes. Since residual amounts of food enzyme total organic solids (TOS) are removed in one food manufacturing process, dietary exposure was calculated for the remaining two processes. It was estimated to be up to 0.172 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 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 5814. A search for the homology of the amino acid sequence of the glucan 1,4-α-maltohydrolase to known allergens was made and matches with three respiratory allergens and one injected allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9483","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144264543","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 triacylglycerol lipase from the genetically modified Komagatella phaffii strain LALL-LI2","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;Daniele Cavanna,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9486","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9486","url":null,"abstract":"<p>The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified <i>Komagatella phaffii</i> strain LALL-LI2 by Danstar Ferment AG. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure was estimated to be up to 0.071 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the triacylglycerol lipase 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 that 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 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9486","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144264542","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":"Efficacy of a feed additive consisting of ponceau 4R for its use in baits for freshwater fish (GIFAP)","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;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Alberto Navarro-Villa,&nbsp;Maria Vittoria Vettori","doi":"10.2903/j.efsa.2025.9462","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9462","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of ponceau 4R. Ponceau 4R is intended to be used as a sensory additive (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs) in baits for freshwater fish up to a maximum content of 15 mg/kg in complementary feed. Ponceau 4R is intended to be incorporated in fishing baits in order to colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not intended for use in aquaculture. The characterisation of the additive, its safety and its efficacy were evaluated in a previous opinion of the Panel. In that opinion, the Panel concluded that the use of ponceau 4R in the preparation of baits for freshwater fish under the proposed conditions of use is of no concern for the target animals, for the consumer and the environment. Regarding the user safety, the additive is not skin irritant but should be considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the eye irritation potential of the additive. Finally, in the previous opinion, the Panel concluded that in absence of data no conclusion could be reached on the efficacy of ponceau 4R in freshwater fish baits. Based on the new data submitted by the applicant, the Panel concluded that ponceau 4R has the potential to be efficacious in colouring fishing baits under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9462","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144244589","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 grain and flour from perennial intermediate wheatgrass (Thinopyrum intermedium) 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;Harry J. McArdle,&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;Monika Neuhäuser-Berthold,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Alexandros Siskos,&nbsp;Henk van Loveren,&nbsp;Ruth Roldán-Torres,&nbsp;Fabio Alfieri,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9467","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9467","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 grain and flour from perennial intermediate wheatgrass (IWG) (<i>Thinopyrum intermedium</i>) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, composed primarily of carbohydrates, proteins and water, is produced by cultivating the IWG plant and subsequently processing it to yield either grains or flour. The target population proposed by the applicant is the general population and the NF is proposed as a food ingredient in several food products. Considering the nutritional profile of the NF and the proposed conditions of use, its consumption is considered not nutritionally disadvantageous, and the Panel considers that no toxicological studies are required on this NF. The microbiological analyses for several batches of the NF revealed high microbial counts regarding total aerobic microbial count, Enterobacteriaceae, yeasts and moulds, highlighting excessive variability in the hygiene conditions along the production process. The NF has the same potential as wheat, barley and rye to trigger IgE-mediated allergic reactions in cereal-allergic individuals and/or adverse reactions in individuals with coeliac disease under the proposed conditions of use. The Panel notes that, due to the high microbial loads observed in both IWG grain and flour batches, the microbiological quality of the NF is compromised. The potential presence of Enterobacteriaceae and opportunistic pathogen <i>Pantoea</i> species, such as <i>P. agglomerans</i>, and further released compounds could pose safety concerns. Moreover, the provided stability data do not support a 12-month shelf-life for the NF. Based on the available data, the Panel concludes that the safety of the NF, grain and flour from perennial intermediate wheatgrass (<i>Thinopyrum intermedium</i>) cannot be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9467","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144244960","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 Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 (Microsaf®) for chickens for fattening, other poultry for fattening and ornamental birds (S.I. Lesaffre)","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;Baltasar Mayo,&nbsp;Montserrat Anguita,&nbsp;Nicole Bozzi Cionci,&nbsp;Rosella Brozzi,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño,&nbsp;Piera Valeri,&nbsp;Yolanda García-Cazorla","doi":"10.2903/j.efsa.2025.9465","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9465","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 Microsaf® when used as a feed additive for chickens for fattening, other poultry for fattening and ornamental birds. The product under assessment is based on viable cells/spores of <i>Bacillus velezensis</i> NRRL B-67647, <i>Bacillus pumilus</i> NRRL B-67648 and <i>Bacillus licheniformis</i> NRRL B-67649. The three bacterial species are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strains was clearly established, no acquired antimicrobial resistance determinants of concern were detected and the lack of toxigenic potential was corroborated, the FEEDAP Panel considered the use of the active agents safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, the Panel concluded that Microsaf® is also considered safe for the target species, consumers and the environment. Regarding user safety, the additive is not irritant to the skin or eyes provided it is formulated with only calcium carbonate. The additive should be considered skin and respiratory sensitisers, and any exposure via skin or respiratory tract is considered a risk. The FEEDAP Panel concludes that the additive has the potential to improve the zootechnical performance of chickens for fattening at a proposed minimum inclusion level of 3 × 10⁷ total CFU/kg of complete feedingstuffs. These results are extrapolable to other poultry for fattening and ornamental birds. Microsaf® is compatible with diclazuril, narasin, maduramicin ammonium, salinomycin sodium, monensin sodium, robenidine hydrochloride and the combination narasin/nicarbazin, lasalocid and halofuginone.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9465","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144244962","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":"Re-assessment of the risks to public health related to the genotoxicity of styrene present in plastic food contact materials","authors":"EFSA Panel on Food Contact Materials (FCM),&nbsp;Lambré Claude,&nbsp;Riccardo Crebelli,&nbsp;Maria Da Silva,&nbsp;Konrad Grob,&nbsp;Evgenia Lampi,&nbsp;Maria Rosaria Milana,&nbsp;Marja Pronk,&nbsp;Mario Ščetar,&nbsp;Georgios Theodoridis,&nbsp;Els Van Hoeck,&nbsp;Nadia Waegeneers,&nbsp;Claudia Bolognesi,&nbsp;Emma Di Consiglio,&nbsp;Marcel Mengelers,&nbsp;Zainab Al Harraq,&nbsp;Irene Muñoz Pilar,&nbsp;Sandra Rainieri,&nbsp;Gilles Rivière","doi":"10.2903/j.efsa.2025.9473","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9473","url":null,"abstract":"<p>The EFSA Panel on Food Contact Materials (FCM) was requested by the European Commission to re-evaluate the potential genotoxicity of styrene after oral exposure and its safety for use in plastic FCM with a specific migration limit (SML) of 40 μg/kg food. A rigorous assessment of the in vivo genotoxicity studies (i) provided by third parties, (ii) identified by a targeted literature search and (iii) reported in the 2019 IARC Monograph was performed. All studies were assessed for reliability and relevance and the results integrated in the weight of evidence. The results provided by reliable in vivo oral genotoxicity studies, covering different genetic endpoints and target tissues, including liver, the primary site of metabolism, demonstrated that the oral administration of styrene in mice and rats up to the maximum tolerated dose (300 and 500 mg/kg body weight (bw), respectively) did not induce genotoxic effects. The Panel concluded that there was no evidence that styrene is genotoxic following oral exposure. For substances demonstrated to be non-genotoxic, according to the EFSA Note for Guidance for FCM, an SML up to 50 μg/kg food would not be of safety concern. Consequently, the use of styrene in the manufacture of FCM respecting the SML of 40 μg/kg food proposed by the European Commission is not of safety concern.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9473","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144244968","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":"Plain Language Summary of the Re-assessment of the risks to public health related to the genotoxicity of styrene present in plastic food contact materials","authors":"","doi":"10.2903/j.efsa.2025.p230601","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.p230601","url":null,"abstract":"","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.p230601","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144244979","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 Lacticaseibacillus huelsenbergensis DSM 115424 for all animal species (Lactosan GmbH & Co. KG)","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;Matteo L. Innocenti,&nbsp;Yolanda García-Cazorla","doi":"10.2903/j.efsa.2025.9458","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9458","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on <i>Lacticaseibacillus huelsenbergensis</i> DSM 115424 when used as a technological additive to improve ensiling of all fresh plant material for all animal species at a proposed minimum concentration of 1 × 10⁸ colony forming units (CFU)/kg fresh plant material. The bacterial species <i>L. huelsenbergensis</i> is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established, and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, inhalation and dermal exposure are considered a risk. One preparation of the additive containing whey powder as a carrier was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that <i>L. huelsenbergensis</i> DSM 115424 has the potential to improve the production of silage prepared from all fresh plant materials at a minimum concentration of 1 × 10⁸ CFU/kg fresh material.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9458","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144244961","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}