EFSA Journal最新文献

{"title":"Safety of dried biomass powder of Chlamydomonas reinhardtii THN 6 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;Montaña Cámara,&nbsp;Torsten Bohn,&nbsp;Jacqueline Castenmiller,&nbsp;Stefaan De Henauw,&nbsp;Ángeles Jos,&nbsp;Alexandre Maciuk,&nbsp;Inge Mangelsdorf,&nbsp;Breige McNulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Alfonso Siani,&nbsp;Frank Thies,&nbsp;Margarita Aguilera-Gómez,&nbsp;Francesco Cubadda,&nbsp;Thomas Frenzel,&nbsp;Marina Heinonen,&nbsp;Helle Katrine Knutsen,&nbsp;Monika Neuhäuser-Berthold,&nbsp;Harry J. McArdle,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Alexandros Siskos,&nbsp;Henk van Loveren,&nbsp;Reinhard Ackerl,&nbsp;Maria Glymenaki,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9413","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9413","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 dried biomass powder of <i>Chlamydomonas reinhardtii</i> THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data pertained to the identity, the production process, composition, specifications, history of use, proposed uses and use levels, nutritional information, genotoxicity and allergenicity of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. The Panel concludes that, based on the available data, the safety of the NF, i.e. dried biomass powder of <i>C. reinhardtii</i> THN 6, cannot be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9413","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143889023","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-evaluation of acesulfame K (E 950) as food additive","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;Reginald 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;Monika Batke,&nbsp;Ellen Bruzell,&nbsp;James Chipman,&nbsp;Karlien Cheyns,&nbsp;Riccardo Crebelli,&nbsp;Cristina Fortes,&nbsp;Peter Fürst,&nbsp;Thorhallur Halldorsson,&nbsp;Jean-Charles Leblanc,&nbsp;Manuela Mirat,&nbsp;Oliver Lindtner,&nbsp;Alicja Mortensen,&nbsp;Matthew Wright,&nbsp;Stefania Barmaz,&nbsp;Consuelo Civitella,&nbsp;Pauline Le Gall,&nbsp;Elena Mazzoli,&nbsp;Josef Daniel Rasinger,&nbsp;Ana Rincon,&nbsp;Alexandra Tard,&nbsp;Federica Lodi","doi":"10.2903/j.efsa.2025.9317","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9317","url":null,"abstract":"<p>The present opinion deals with the re-evaluation of acesulfame K (E 950) as a food additive. Acesulfame K (E 950) is the chemically manufactured compound 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt. It is authorised for use in the European Union (EU) in accordance with Regulation (EC) No 1333/2008. The assessment involved a comprehensive review of existing authorisations, evaluations and new scientific data. Acesulfame K (E 950) was found to be stable under various conditions; at pH lower than 3 with increasing temperatures, it is degraded to a certain amount. Based on the available data, no safety concerns arise for genotoxicity of acesulfame K (E 950) and its degradation products. For the potential impurities, based on in silico data, a concern for genotoxicity was identified for 5-chloro-acesulfame; a maximum limit of 0.1 mg/kg, or alternatively, a request for appropriate genotoxicity data was recommended. Based on the synthesis of systematically appraised evidence of human and animal studies, the Panel concluded that there are no new studies suitable for identification of a reference point (RP) on adverse effects. Consequently, the Panel established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw) per day based on the highest dose tested without adverse effects in a chronic toxicity and carcinogenicity study in rats; a study considered of moderate risk of bias and one of two key studies from the previous evaluations by the Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). This revised ADI replaces the ADI of 9 mg/kg bw per day established by the SCF. The Panel noted that the highest estimate of exposure to acesulfame K (E 950) was generally below the ADI in all population groups. The Panel recommended the European Commission to consider the revision of the EU specifications of acesulfame K (E 950).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9317","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143889037","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 the extension of use of 3-fucosyllactose (3-FL) 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;Estefanía Noriega Fernández,&nbsp;Paolo Colombo,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9370","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9370","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 the safety of the extension of use of 3-fucosyllactose (3-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, produced with a genetically modified strain (<i>Escherichia coli</i> BL21 (DE3) JBT-3FL) of <i>E. coli</i> BL21 (DE3), is already authorised as ingredient in several food categories, including infant formula (IF) and follow-on formula (FOF). The applicant proposed to increase the maximum use levels of the NF in IF, FOF, food for special medical purposes (FSMP) and food supplements (FS). EFSA estimated the anticipated daily intake of the NF from the proposed extension of use in the relevant food categories. Additionally, a new intake estimate including the already authorised conditions of use in other food categories was carried out. The estimated daily intake of the NF from high consumption of IF alone at the proposed maximum use level in infants &lt; 16 weeks of age is lower than the estimated natural highest mean daily intake of 3-FL from human milk in breastfed infants. The estimated highest 95th percentile daily intake in infants from the combined exposure from the maximum authorised and proposed uses of 3-FL, is somewhat higher than the estimated intake from the already authorised uses and below the estimated highest natural mean daily intake of 3-FL from human milk in breastfed infants. The same applies to the use of the NF in FSMP and FS. Therefore, the Panel considers that the proposed extension of use does not affect the safety of the NF and concludes that the NF, 3-FL, is safe under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9370","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143884246","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 paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 (Bovacillus™) for dairy cows and other dairy ruminants (Chr. Hansen A/S)","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;Secundino López-Puente,&nbsp;Montserrat Anguita,&nbsp;Rosella Brozzi,&nbsp;Matteo L. Innocenti,&nbsp;Fabiola Pizzo,&nbsp;Jordi Ortuño","doi":"10.2903/j.efsa.2025.9426","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9426","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 Bovacillus™, a product containing viable cells of <i>Bacillus paralicheniformis</i> DSM 33902 and <i>Bacillus subtilis</i> DSM 33903, which is intended to be used as a zootechnical additive (functional group: gut flora stabiliser) in the feed of dairy cows and other dairy ruminants. The trade name is Bovacillus™, and it is intended to be commercialised in two formulations: Bovacillus™ 10, to use in feed, and WS, to use in drinking water. <i>B. paralicheniformis and B. subtilis</i> are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agents was established, and compliance with the applicable qualifications confirmed. Therefore, <i>Bacillus paralicheniformis</i> DSM 33902 and <i>Bacillus subtilis</i> DSM 33903 are presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Bovacillus™ is also considered safe for the target species, consumers and the environment. Bovacillus™ 10 and WS are not skin or eye irritants. Due to the nature of the active agents, both forms of the additive are considered respiratory and skin sensitisers. The Panel concludes that Bovacillus™ has the potential to be efficacious as a zootechnical additive when supplemented in the feed of dairy ruminants at 3.8 × 10⁸ CFU/kg complete feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9426","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143880060","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":"Commodity risk assessment of Salix caprea and Salix cinerea plants from the UK","authors":"EFSA Panel on Plant Health (PLH),&nbsp;Antonio Vicent Civera,&nbsp;Paula Baptista,&nbsp;Anna Berlin,&nbsp;Elisavet Chatzivassiliou,&nbsp;Jaime Cubero,&nbsp;Nik Cunniffe,&nbsp;Eduardo de la Peña,&nbsp;Nicolas Desneux,&nbsp;Francesco Di Serio,&nbsp;Anna Filipiak,&nbsp;Beata Hasiów-Jaroszewska,&nbsp;Hervé Jactel,&nbsp;Blanca B. Landa,&nbsp;Lara Maistrello,&nbsp;David Makowski,&nbsp;Panagiotis Milonas,&nbsp;Nikos T. Papadopoulos,&nbsp;Roel Potting,&nbsp;Hanna Susi,&nbsp;Dirk Jan van Der Gaag,&nbsp;Andrea Battisti,&nbsp;Claude Bragard,&nbsp;Christer Sven Magnusson,&nbsp;Hugo Mas,&nbsp;Daniel Rigling,&nbsp;Massimo Faccoli,&nbsp;Alžběta Mikulová,&nbsp;Fabio Stergulc,&nbsp;Olaf Mosbach-Schulz,&nbsp;Franz Streissl,&nbsp;Paolo Gonthier","doi":"10.2903/j.efsa.2025.9384","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9384","url":null,"abstract":"<p>The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘High risk plants, plant products and other objects’. This Scientific Opinion covers plant health risks posed by plants of <i>Salix caprea</i> and <i>Salix cinerea</i> imported from the United Kingdom (UK) as: (a) bundles of 1- to 2-year old cuttings/graftwood, (b) 1- to 7-year-old bare root plants, (c) 1- to 2-year-old cell grown plants and (d) 2- to 15-year-old plants in pots, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodities were evaluated against specific criteria for their relevance for this opinion. Two EU protected zone quarantine pests, i.e. <i>Bemisia tabaci</i> (European populations) and <i>Entoleuca mammata,</i> and one EU quarantine pest, i.e. <i>Phytophthora ramorum</i> (non-EU isolates), fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures described in the technical dossier from the UK were evaluated. Expert judgements were given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pests, including uncertainties associated with the assessment. The age of the plants was considered, reasoning that older trees are more likely to be infested mainly due to longer exposure time and larger size. The degree of pest freedom varies between the pests evaluated, with <i>P. ramorum</i> being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation (EKE) indicated with 95% certainty that between 9738 and 10,000 rooted <i>S. caprea</i> and <i>S. cinerea</i> plants in pots (2 to 15-year-old) per 10,000 will be free from <i>P. ramorum.</i></p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9384","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143879800","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":"Modification of the existing maximum residue level for chlormequat in oat","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;Olha Timofieieva,&nbsp;Manuela Tiramani,&nbsp;Alessia Verani,&nbsp;Elena Zioga","doi":"10.2903/j.efsa.2025.9385","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9385","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Taminco BV submitted a request to the competent national authority in Austria to modify the existing maximum residue level (MRL) for the active substance chlormequat in oat grain. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for oat. According to available livestock feeding studies, there is indication that for most of the animal matrices lower chlormequat MRLs would be sufficient to account for the current EU dietary burden. Adequate analytical methods for enforcement are available to control the residues of chlormequat and its salts (sum, expressed as chlormequat chloride) in the commodity under consideration and in animal matrices 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 resulting from the use of chlormequat chloride according to the reported agricultural practice is unlikely to present a risk to consumer health.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9385","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143879798","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 MRLs for alpha-cypermethrin and screening of the existing EU MRLs for cypermethrin","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9386","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9386","url":null,"abstract":"<p>In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to prepare a statement on the maximum residue level (MRL) proposals for alpha-cypermethrin and to perform a screening of the existing MRLs for cypermethrins based on the toxicological reference values of alpha-cypermethrin. Conversion factors based on the isomeric composition in the technical mixtures and commercial formulations of alpha-cypermethrin, zeta-cypermethrins and cypermethrins (sum of isomers) were used to recalculate MRL values proposed in the 2023 MRL review (and based on existing EU uses, import tolerances or codex maximum residue limits for cypermethrin and zeta-cypermethrin) into alpha-cypermethrin. The combined risk assessment conducted in the MRL review is expected to cover the MRLs calculated as alpha-cypermethrin in the present assessment. Moreover, a screening of the existing EU MRLs for cypermethrins considering the toxicological reference values of the more toxic alpha-cypermethrin was carried out. Two lists of MRLs, list MRL 1 expressing the residue as cypermethrin including other mixtures of constituent isomers (sum of isomers) and list MRL 2 expressing the residue as alpha-cypermethrin, are presented for further consideration by risk managers.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9386","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143879799","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 additives thiamine hydrochloride (3a820) and thiamine mononitrate (3a821) (vitamin B1) for all animal species for the renewal of their authorisation (Kaesler Nutrition 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;Anita Radovnikovic,&nbsp;Eleni Gkimprixi","doi":"10.2903/j.efsa.2025.9405","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9405","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 thiamine hydrochloride and thiamine mononitrate (vitamin B₁) for the renewal of its authorisation as nutritional feed additives for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that thiamine mononitrate and thiamine hydrochloride remain safe for all animal species, consumers and the environment. Regarding the user safety, both thiamine salts are regarded as skin and eye irritants, and skin and respiratory sensitisers. The Panel concluded there is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9405","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143879801","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-lysine sulfate produced with Corynebacterium glutamicum CGMCC 23982 for all animal species (Eppen Europa SAS)","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;Nicole Bozzi Cionci,&nbsp;Elisa Pettenati,&nbsp;Jordi Tarrés-Call","doi":"10.2903/j.efsa.2025.9346","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9346","url":null,"abstract":"<p>Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on <span>l</span>-lysine sulfate produced by fermentation with a non-genetically modified strain of <i>Corynebacterium glutamicum</i> (CGMCC 23982) when used as a nutritional additive in feed for all animal species. The active substance is <span>l</span>-lysine. The FEEDAP Panel concluded that the production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment; therefore, <span>l</span>-lysine sulfate produced with <i>C. glutamicum</i> CGMCC 23982 does not pose any safety concern associated with the production strain. <span>l</span>-Lysine sulfate produced with <i>C. glutamicum</i> CGMCC 23982 is considered safe for the target species when administered via feed. When using <span>l</span>-lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account when formulating diets. The FEEDAP Panel has concerns on the use of <span>l</span>-lysine sulfate in water for drinking. <span>l</span>-Lysine sulfate produced with <i>C. glutamicum</i> CGMCC 23982 is safe for the consumer and for the environment. With regard to user safety, the additive should be considered irritant to skin, eyes and the respiratory tract. Any exposure to the additive is a risk. <span>l</span>-lysine sulfate is considered as an efficacious source of the essential amino acid <span>l</span>-lysine for non-ruminant animal species. For the supplemental <span>l</span>-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9346","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143871571","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 additives betaine anhydrous (3a920) and betaine hydrochloride (3a925) for all animal species for the renewal of their authorisations (Orffa Additives B.V.)","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;Stefania Fusani,&nbsp;Jaume Galobart,&nbsp;Paola Manini,&nbsp;Alberto Navarro-Villa,&nbsp;Fabiola Pizzo,&nbsp;Maria Vittoria Vettori,&nbsp;Orsolya Holczknecht","doi":"10.2903/j.efsa.2025.9355","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9355","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 betaine anhydrous and betaine hydrochloride for the renewal of its authorisation. The applicant provided evidence that the additives betaine anhydrous (solid form) and betaine hydrochloride (solid form) both produced by chemical synthesis currently on the market comply with the existing conditions of authorisation. The use of betaine anhydrous and betaine hydrochloride as feed additives in animal nutrition remains safe for target species, consumers and the environment under the current authorised conditions. Regarding user safety, betaine anhydrous and betaine hydrochloride are irritant to skin and eyes. Betaine hydrochloride is also a dermal and respiratory sensitiser. Any exposure to these additives is considered a risk. These conclusions apply, in principle, to any preparations containing the active substances. There is no need for assessing the efficacy of the additives in the context of this renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9355","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143866035","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}