EFSA Journal最新文献

{"title":"Assessment of the feed additive consisting of bentonite for ruminants, poultry and pigs for the renewal of its authorisation (Biomin 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;Jaume Galobart,&nbsp;Maria Vittoria Vettori,&nbsp;Orsolya Holczknecht,&nbsp;Jordi Ortuño,&nbsp;Fabiola Pizzo,&nbsp;Piera Valeri,&nbsp;Matteo L. Innocenti,&nbsp;Maria Dulak-Lis","doi":"10.2903/j.efsa.2025.9263","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9263","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the renewal of bentonite as a technological feed additive in the functional group of substances for reduction of the contamination of feed by mycotoxins for ruminants, poultry and pigs. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for ruminants, poultry and pigs, consumers and the environment under the authorised conditions of use. Regarding user safety, the Panel concludes that bentonite is not irritant to the skin but is irritant to the eyes and should be considered a skin and respiratory sensitiser. Any exposure is considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9263","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143439256","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":"Evaluation of confirmatory data following the Article 12 MRL review for terbuthylazine","authors":"European Food Safety Authority (EFSA),&nbsp;Giulia Bellisai,&nbsp;Giovanni Bernasconi,&nbsp;Luis Carrasco Cabrera,&nbsp;Irene Castellan,&nbsp;Monica del Aguila,&nbsp;Lucien Ferreira,&nbsp;Luna Greco,&nbsp;Samira Jarrah,&nbsp;Renata Leuschner,&nbsp;Andrea Mioč,&nbsp;Stefanie Nave,&nbsp;Hermine Reich,&nbsp;Silvia Ruocco,&nbsp;Alessia Pia Scarlato,&nbsp;Andrea Simonati,&nbsp;Marta Szot,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Alessia Verani,&nbsp;Elena Zioga","doi":"10.2903/j.efsa.2025.9231","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9231","url":null,"abstract":"<p>The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Spain to evaluate the confirmatory data that were identified for the active substance terbuthylazine in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Based on the information provided by the applicant and assessed by Spain, EFSA concludes that the tentative MRL is confirmed in sweet corn and sunflower seeds, but not in lupins/lupini beans and cotton seeds. Regarding livestock metabolism study, EFSA acknowledges that a new goat metabolism study was submitted. However, due to the shortcomings identified, the metabolism in ruminants cannot be fully depicted. Despite these deficiencies, it can be concluded that at the calculated maximum dietary burdens significant transfer of residues in bovine tissues and milk is not expected and therefore the tentative MRLs can be confirmed. The consumer risk assessment performed in the framework of the MRL review was updated using revision 3.1. of the PRIMo, considering the actual MRL values implemented in Regulation (EU) 2021/1795 and excluding the crops on which the uses are not supported by Article 12 confirmatory data (cotton seed and lupins/lupini beans). No consumer intake concerns were identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9231","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143438948","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 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;Cristina Fernàndez-Fraguas,&nbsp;Magdalena Andryszkiewicz,&nbsp;Jaime Aguilera,&nbsp;Daniele Cavanna,&nbsp;Ana Criado,&nbsp;Elsa Nielsen,&nbsp;Karin Nørby,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9229","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9229","url":null,"abstract":"<p>The food enzyme non-reducing end α-<span>l</span>-arabinofuranosidase (α-<span>l</span>-arabinofuranoside 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. The food enzyme was free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.455 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 234 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 514. A search for the homology of the amino acid sequences of the non-reducing end α-<span>l</span>-arabinofuranosidase 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":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9229","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143439205","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":"Assessment of the feed additive consisting of Lactiplantibacillus plantarum CECT 4528 for all animal species for the renewal of its authorisation (Centro Sperimentale del Latte S.r.l.)","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;Rosella Brozzi,&nbsp;Matteo L. Innocenti,&nbsp;Piera Valeri,&nbsp;Yolanda García-Cazorla","doi":"10.2903/j.efsa.2025.9247","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9247","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of <i>Lactiplantibacillus plantarum</i> CECT 4528 as a technological additive for all animal species. The applicant provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The Panel concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the additive is a preparation containing a microorganism and therefore should be considered as a skin and respiratory sensitiser. Any exposure through skin and respiratory tract is considered a risk. The additive is not an eye irritant. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9247","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143438980","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 bacillolysin from the genetically modified Bacillus amyloliquefaciens strain NPR","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;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Silvia Peluso,&nbsp;Arianna Gallo,&nbsp;Roos De Nijs,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9220","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9220","url":null,"abstract":"<p>The food enzyme bacillolysin (EC 3.4.24.28) is produced with the genetically modified <i>Bacillus amyloliquefaciens</i> strain NPR by DSM Food Specialties B.V. The production strain meets the requirements for the qualified presumption of safety (QPS) status. 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 10 food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining nine food manufacturing processes. It was estimated to be up to 6.450 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 bacillolysin to known allergens was made and no match was found. The Panel considered that the 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":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9220","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143439204","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":"Evaluation of an alkaline hydrolysis method under atmospheric pressure for Category 1 animal by-products","authors":"EFSA Panel on Biological Hazards (BIOHAZ),&nbsp;Ana Allende,&nbsp;Valeria Bortolaia,&nbsp;Sara Bover-Cid,&nbsp;Wietske Dohmen,&nbsp;Lapo Mughini-Gras,&nbsp;Laurent Guillier,&nbsp;Lieve Maria Herman,&nbsp;Liesbeth Jacxsens,&nbsp;Maarten Nauta,&nbsp;Jakob Ottoson,&nbsp;Luisa Peixe,&nbsp;Fernando Perez-Rodriguez,&nbsp;Panagiotis Skandamis,&nbsp;Elisabetta Suffredini,&nbsp;Alessandra De Cesare,&nbsp;Pablo Fernandez Escamez,&nbsp;Romolo Nonno,&nbsp;Kamela Kryemadhi,&nbsp;Angel Ortiz-Pelaez,&nbsp;Avelino Alvarez-Ordóñez","doi":"10.2903/j.efsa.2025.9272","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9272","url":null,"abstract":"<p>A new alternative method for the processing of entire bodies or body parts of pet animals (Category 1 animal by-products (ABPs)) was assessed. The method consists of an alkaline hydrolysis process under atmospheric pressure carried out in a batch system within a stainless-steel container at temperatures higher than 95.5°C for more than 14 h. Prions are the most resistant biological hazards potentially present in the material to be treated. The proposed method was assessed by the BIOHAZ Panel for its efficacy in achieving a reduction in prion infectivity by at least 6 log₁₀ to be considered equivalent to the processing method laid down in Point A Section 2 Chapter IV Annex IV of Commission Regulation (EU) No 142/2011. The application focusses on demonstrating the capacity of the alternative method to inactivate prions by providing evidence from two studies applying matrix-assisted laser desorption/ionisation time of flight (MALDI–TOF) mass spectrometry to show the absence of peptides larger than 3 kDa after the treatment. The BIOHAZ Panel considers that these studies do not provide direct or indirect experimental evidence that the quantitative reduction of prion infectivity is achieved by the alternative method. Therefore, in the absence of quantitative estimation of prion infectivity reduction, the alternative method cannot be considered equivalent to the approved alkaline hydrolysis process.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9272","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143438979","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 cyclomaltodextrin glucanotransferase from the non-genetically modified Anoxybacillus caldiproteolyticus strain AE-KCGT","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 Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Eleonora Marini,&nbsp;Jeroen Pasch,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9222","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9222","url":null,"abstract":"<p>The food enzyme cyclomaltodextrin glucanotransferase ((1-4)-α-<span>d</span>-glucan 4-α-<span>d</span>-[(1-4)-α-<span>d</span>-glucano]-transferase; EC 2.4.1.19) is produced with the non-genetically modified <i>Anoxybacillus caldiproteolyticus</i> strain AE-KCGT by Amano Enzyme Inc. 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 for adolescents, adults and the elderly in two food manufacturing processes. Subsequently, the applicant requested to extend its use to include four additional processes and revised the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of six food manufacturing processes. Dietary exposure was calculated to be up to 0.025 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 (2246 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 89,840. 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":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9222","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143404575","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":"Statement on the update of maximum residue levels (MRLs) for copper compounds in light of the EFSA scientific opinion on the re-evaluation of the health-based guidance values (HBGVs) and exposure assessment from all sources","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9271","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9271","url":null,"abstract":"<p>In compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) reviewed the maximum residue levels (MRLs) for copper compounds in light of the EFSA Scientific Committee opinion on the re-evaluation of the health-based guidance values (HBGVs) and exposure assessment from all sources. Based on the exposure calculations performed according to three different scenarios, the updated occurrence data and the residues from the new intended uses are not expected to have an impact on the chronic exposure calculations conducted under the framework of the EFSA Scientific Committee assessment. Therefore, the conclusions of the previous assessment by EFSA Scientific Committee are still valid. Since the current copper exposure is expected to cover all sources of copper, including the uses of copper as plant protection products (PPPs), it can be concluded that the authorised PPP uses for copper compounds and the new intended PPP uses present no health risk for the population, including children. Due to copper being also a micronutrient and ubiquitous in the environment, as requested in the mandate, the dietary risk assessment was performed following a different approach than the standard methodology for the dietary risk assessment of pesticide residues in the framework of setting and reviewing MRLs under Regulation (EC) No 396/2005 and in the peer review of pesticides under Regulation (EU) No 1107/2009. Therefore, all MRL proposals are suggested for further consideration by risk managers.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9271","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143404593","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 cyclomaltodextrin glucanotransferase from the non-genetically modified Anoxybacillus caldiproteolyticus strain AE-KCGT","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;Magdalena Andryszkiewicz,&nbsp;Ana Gomes,&nbsp;Natalia Kovalkovicova,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9221","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9221","url":null,"abstract":"<p>The food enzyme cyclomaltodextrin glucanotransferase ((1–4)-α-<span>d</span>-glucan 4-α-<span>d</span>-[(1–4)- α-<span>d</span>-glucano]-transferase; EC 2.4.1.19) is produced with the non-genetically modified <i>Anoxybacillus caldiproteolyticus</i> strain AE-KCGT by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in two food manufacturing processes. The dietary exposure was estimated to be up to 20.27 mg total organic solids (TOS)/kg bw per day in European populations. Genotoxicity tests did not raise safety concerns. 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 2246 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure (MoE) of at least 141 for infants, 111 for toddlers, 154 for children, 362 for adolescents, 508 for adults and 713 for the elderly. A search for the homology of the amino acid sequence of the cyclomaltodextrin glucanotransferase to known allergens was made and matches with three respiratory allergens were 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 for adolescents, adults and the elderly. The MoE is insufficient to exclude safety concerns for infants, toddlers and children.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9221","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143404592","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 vitamin B2 (98%) and vitamin B2 (80%) produced with Bacillus subtilis CGMCC 7.449 for all animal species (Chifeng Pharmaceutical Co., 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;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Baltasar Mayo,&nbsp;Nicole Bozzi Cionci,&nbsp;Rosella Brozzi,&nbsp;Jaume Galobart,&nbsp;Orsolya Holczknecht,&nbsp;Paola Manini,&nbsp;Piera Valeri,&nbsp;Maria Vittoria Vettori,&nbsp;Fabiola Pizzo","doi":"10.2903/j.efsa.2025.9249","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9249","url":null,"abstract":"<p>Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B₂ 98% and vitamin B₂ 80% in the form of riboflavin produced by fermentation with a genetically modified strain of <i>Bacillus subtilis</i> (CGMCC 7.449) as nutritional feed additives for all animal species. Viable cells and DNA of the production strain were not detected in the final products and therefore, the use of <i>B. subtilis</i> CGMCC 7.449 to produce vitamin B₂ does not raise safety concerns. The use of vitamin 98% and 80% produced with <i>B. subtilis</i> CGMCC 7.449 in animal nutrition does not represent a safety concern for the target species, consumers and for the environment. The additives are not dermal nor eye irritants but are dermal and respiratory sensitisers. Inhalation and dermal exposure are considered a risk. The additives under assessment are effective in covering the animals' requirements of vitamin B₂ when administered via feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9249","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143397175","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}