EFSA Journal最新文献

{"title":"Revised safety evaluation of the food enzyme endo-1,3(4)-β-glucanase from the non-genetically modified Cellulosimicrobium funkei strain AE-TN","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;Simone Lunardi,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9330","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9330","url":null,"abstract":"<p>The food enzyme endo-1,3(4)-β-glucanase (3-(1–3;1–4)-β-D-glucan 3(4)-glucano‑hydrolase; EC 3.2.1.6) is produced with the non-genetically modified (GM) <i>Cellulosimicrobium funkei</i> strain AE-TN by Amano Enzyme Inc. The production organism belongs to a species implicated in opportunistic infections in humans. In a previous evaluation, the Panel did not consider the food enzyme safe due to the presence of viable cells of the production strain in the food enzyme. As a follow-up, the applicant improved the quality assurance system by introducing a pressure check of the microfiltration step of the food enzyme manufacturing process and the production strain was no longer detected in new food enzyme batches. The Panel accepted the results. Based on the new data and the previous evaluation, the Panel concluded that the food enzyme endo-1,3(4)-β-glucanase produced with the non-GM <i>C. funkei</i> strain AE-TN does not give rise to safety concerns under the intended conditions of use.</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.2025.9330","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143866038","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":"Peer review of the pesticide risk assessment of the active substance buprofezin","authors":"European Food Safety Authority (EFSA),&nbsp;Fernando Álvarez,&nbsp;Maria Arena,&nbsp;Domenica Auteri,&nbsp;Sofia Batista Leite,&nbsp;Marco Binaglia,&nbsp;Anna Federica Castoldi,&nbsp;Arianna Chiusolo,&nbsp;Angelo Colagiorgi,&nbsp;Mathilde Colas,&nbsp;Federica Crivellente,&nbsp;Chloe De Lentdecker,&nbsp;Isabella De Magistris,&nbsp;Mark Egsmose,&nbsp;Gabriella Fait,&nbsp;Franco Ferilli,&nbsp;Monica Fittipaldi Broussard,&nbsp;German Giner Santonja,&nbsp;Varvara Gouliarmou,&nbsp;Katrin Halling,&nbsp;Alessio Ippolito,&nbsp;Frederique Istace,&nbsp;Samira Jarrah,&nbsp;Dimitra Kardassi,&nbsp;Aude Kienzler,&nbsp;Anna Lanzoni,&nbsp;Roberto Lava,&nbsp;Renata Leuschner,&nbsp;Alberto Linguadoca,&nbsp;Jochem Louisse,&nbsp;Christopher Lythgo,&nbsp;Oriol Magrans,&nbsp;Iris Mangas,&nbsp;Andrea Mioč,&nbsp;Ileana Miron,&nbsp;Tunde Molnar,&nbsp;Laura Padovani,&nbsp;Vincenzo Padricello,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Alexandra Piti,&nbsp;Simone Rizzuto,&nbsp;Miguel Santos,&nbsp;Rositsa Serafimova,&nbsp;Rachel Sharp,&nbsp;Csaba Szentes,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Giorgia Vianello,&nbsp;Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9392","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9392","url":null,"abstract":"<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co-rapporteur Member State Austria for the pesticide active substance buprofezin. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of buprofezin as an insecticide on ornamental plants in greenhouse via spray application. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.</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.2025.9392","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143866036","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 xylanase (produced with Komagataella phaffii DSM 25376) and β-glucanase (produced with Komagataella phaffii DSM 26469) (ENZY CARBOPLUS®) for all poultry (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;Baltasar Mayo,&nbsp;Lieve Herman,&nbsp;Montserrat Anguita,&nbsp;Nicole Bozzi Cionci,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño,&nbsp;Elisa Pettenati","doi":"10.2903/j.efsa.2025.9344","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9344","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 xylanase (produced with <i>Komagataella phaffii</i> DSM 25376) and β-glucanase (produced with <i>Komagataella phaffii</i> DSM 26469) (ENZY CARBOPLUS®) as a zootechnical feed additive (functional group: digestibility enhancers). The additive is already authorised for use in feed for chickens for fattening, chickens reared for laying, turkeys for fattening and all avian species reared for laying or breeding purposes. The applicant requested a modification of the terms of the current authorisation for chickens for fattening and reared for laying, as well as an extension of use to all poultry. The FEEDAP Panel concluded that the additive is safe for all poultry. The use of the additive is considered safe for the consumers and the environment. The FEEDAP Panel concluded that the additive is not a skin or eye irritant nor a dermal sensitiser, but it is considered a respiratory sensitiser. The Panel concluded that the additive has the potential to be efficacious as a zootechnical additive for all poultry under the proposed conditions of use.</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.2025.9344","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143866039","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 copper bilysinate for all animal species for the renewal of its authorisation (Senzyme 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;Fabiola Pizzo,&nbsp;Jordi Tarrés-Call,&nbsp;Maria Vittoria Vettori,&nbsp;Alberto Navarro-Villa","doi":"10.2903/j.efsa.2025.9356","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9356","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 copper bilysinate as nutritional feed additive for all species and categories. The additive is currently authorised for use in all animal species (3b411). The applicant has provided evidence that the additive, in powder or granule forms, complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of copper bilysinate under the current authorised conditions of use is safe for the target species, consumers and the environment. Regarding user safety, both forms of the additive are not irritant to the skin, but the powder product is an eye irritant. Both forms of the additive should be considered skin and respiratory sensitisers. Inhalation and dermal exposure are 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 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.2025.9356","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143866037","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":"Follow-up of the re-evaluation of silver (E 174) as a food additive (EFSA-Q-2023-00169)","authors":"EFSA Panel on Food Additives and Flavourings (FAF),&nbsp;Monica Andreassen,&nbsp;Gabriele Aquilina,&nbsp;Maria Lourdes Bastos,&nbsp;Polly Boon,&nbsp;Laurence Castle,&nbsp;Biagio Fallico,&nbsp;Reginald FitzGerald,&nbsp;Maria Jose Frutos Fernandez,&nbsp;Bettina Grasl-Kraupp,&nbsp;Ursula Gundert-Remy,&nbsp;Rainer Gürtler,&nbsp;Marcin Andrzej Kurek,&nbsp;Henriqueta Louro,&nbsp;Patricia Morales,&nbsp;Sabina Passamonti,&nbsp;Agnes Oomen,&nbsp;Emanuela Corsini,&nbsp;Matthew Wright,&nbsp;Peter Furst,&nbsp;Eric Gaffet,&nbsp;Katrin Loeschner,&nbsp;Jan Mast,&nbsp;Anna Undas,&nbsp;Agnieszka Mech,&nbsp;Ana Maria Rincon,&nbsp;Laura Ruggeri,&nbsp;Camilla Smeraldi","doi":"10.2903/j.efsa.2025.9316","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9316","url":null,"abstract":"<p>Silver (E 174) is a food colour that was re-evaluated by the EFSA ANS Panel (2016). The ANS Panel concluded that the information available then, was insufficient to assess the safety of silver as food additive. The major issues included limited characterisation of silver E 174 (e.g. quantity of nanoparticles) and release of ionic silver. Following a European Commission call for further data to fill the data gap, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of silver (E 174). One interested business operator (IBO) submitted limited data on particle size distribution and morphology, two genotoxicity studies and one subchronic study. The Panel concluded that the technical data submitted on physicochemical characterisation of all types of silver used as food additive E 174 were not adequate. As a result, the Panel was unable to propose changes to the EU specifications of E174 on particle size and morphology. As the additional information requested was not provided, the assessment was based solely on the submitted data. Nonetheless, given the data provided and silver insolubility in water, the Panel concluded that E174 requires risk assessment at the nanoscale following the EFSA Guidance on Risk assessment of nanomaterials to be applied in the food and feed chain, to complement the conventional risk assessment. The Panel considered that the genotoxicity data and sub-chronic toxicity data were inadequate. Consequently, the Panel could not conclude on the safety of the food additive silver E 174.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9316","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143861856","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 an essential oil derived from the leaves of Pogostemon cablin Benth. (patchouli oil) for use in all animal species (FEFANA asbl)","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;Maria de Lourdes Bastos,&nbsp;Paul Brantom,&nbsp;Andrew Chesson,&nbsp;Josef Schlatter,&nbsp;Johannes Westendorf,&nbsp;Paola Manini","doi":"10.2903/j.efsa.2025.9357","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9357","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 patchouli oil from the leaves of <i>Pogostemon cablin</i> Benth. (patchouli oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is safe up to the maximum use level in complete feed of 7.5 mg/kg for chickens for fattening, laying hens, turkeys for fattening, pigs for fattening, horses, salmonids, shrimps, rabbits, dogs, cats and ornamental fish, 24 mg/kg for piglets, 35 mg/kg for sows, 34 mg/kg for dairy cows, 60 mg/kg for veal calves (milk replacer) and 53 mg/kg for cattle for fattening, sheep and goats. These conclusions were extrapolated to other physiologically related minor species. For any other species, the additive is safe at 7.5 mg/kg complete feed. The FEEDAP Panel considered that the use level in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers were identified following the use of patchouli oil up to the highest proposed use level in feed. Regarding user safety, the essential oil under assessment should be considered as irritant to skin and eyes, and respiratory sensitiser. The use of the additive in animal feed under the proposed conditions is not expected to pose a risk to the environment. Since the leaves of <i>P. cablin</i> and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9357","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143840699","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":"Advancing EFSA's regulatory science: Updated research and innovation needs","authors":"European Food Safety Authority (EFSA),&nbsp;Stef Bronzwaer,&nbsp;Yann Devos,&nbsp;Jean-Lou C. M. Dorne,&nbsp;Bruno Dujardin,&nbsp;Antonio Fernández Dumont,&nbsp;Claudia Heppner,&nbsp;Estefanía Noriega Fernández,&nbsp;Konstantinos Paraskevopoulos,&nbsp;Carlos G. das Neves","doi":"10.2903/j.efsa.2025.e220401","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.e220401","url":null,"abstract":"<p>This editorial provides an update on research &amp; innovation (R&amp;I) needs that can support EFSA's regulatory science in the coming years. The paper presents research needs for EFSA's work in a number of domains: omics technologies; gut microbiome; new approach methodologies (NAMs); allergenicity risk assessment; aggregate exposure assessment and environmental risk assessment (ERA). In briefly describing R&amp;I needs, the document also addresses emerging challenges and opportunities. The authors acknowledge that this overview is not exhaustive and refer to earlier publications for additional R&amp;I needs, as well as to the roadmaps for a more in-depth presentation. Finally, the document calls for transdisciplinary research, reflecting on the interdependencies between human, animal, plant and environmental health. This editorial will be valuable to stakeholders, research agenda setters and funders, both public and private, in formulating calls for research and project funding related to food safety.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.e220401","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143836464","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 Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (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;Pier Sandro Cocconcelli,&nbsp;Montserrat Anguita,&nbsp;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Rosella Brozzi","doi":"10.2903/j.efsa.2025.9353","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9353","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 the authorisation of Bonvital® as a zootechnical additive for sows. Bonvital® is currently authorised for use in weaned piglets, pigs for fattening, sows, chickens for fattening, laying hens, chickens reared for laying and minor poultry species (other than those used for laying). The active agent of Bonvital® was originally identified as <i>Enterococcus faecium</i>. In a previous opinion the strain was reassigned to <i>Enterococcus lactis</i>. The applicant provided evidence that the additive currently on the market complies with the existing terms of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for the target species, consumers and the environment under the authorised conditions of use. Bonvital® in its powder form is not irritant to the skin and eyes but no conclusion is possible for the granulated form. Bonvital® should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9353","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143840588","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 subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 (GalliPro® Fit & GalliPro® Fit 10) for all poultry (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;Paul Brantom,&nbsp;Lieve Herman,&nbsp;Montserrat Anguita,&nbsp;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño,&nbsp;Rosella Brozzi","doi":"10.2903/j.efsa.2025.9361","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9361","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 a feed additive consisting of <i>Bacillus subtilis</i> DSM 32324, <i>B. subtilis</i> DSM 32325 and <i>Bacillus amyloliquefaciens</i> DSM 25840 (GalliPro® Fit 10) as a zootechnical feed additive for all poultry species. The additive in a less concentrated form (GalliPro® Fit) is already authorised for use in feed and water for drinking for poultry for fattening, reared for laying or reared for breeding. With the current application, the applicant is seeking the authorisation for use in feed and water for drinking for all poultry. In addition, the applicant is seeking the modification of the terms of the existing authorisation by introducing a new formulation with a 10-fold increased concentration of the active agents in the additive (from 3.2 × 10⁹ to 3.2 × 10¹⁰ colony forming units (CFU)/g additive). The FEEDAP Panel concluded that the additive is considered safe for the target species, including poultry species for laying and breeding, consumers and the environment at the proposed conditions of use. Both forms of the additive are non-irritant to the eyes but are considered skin and respiratory sensitisers, and any exposure through skin and respiratory tract is considered a risk. The additive has the potential to be efficacious as a zootechnical additive in all poultry at 1.6 × 10⁹ CFU/kg feed and 5.4 × 10⁸ CFU/L water for drinking.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9361","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143836466","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 Saccharomyces cerevisiae NCYC R404 for dairy cows for the renewal of its authorisation (Volac International 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;Andrey Yurkov,&nbsp;Montserrat Anguita,&nbsp;Nicole Bozzi Cionci,&nbsp;Rosella Brozzi,&nbsp;Yolanda García-Cazorla,&nbsp;Jordi Tarrés-Call,&nbsp;Piera Valeri,&nbsp;Matteo L. Innocenti","doi":"10.2903/j.efsa.2025.9342","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9342","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 the authorisation of <i>Saccharomyces cerevisiae</i> NCYC R404 as a zootechnical additive (functional group: gut flora stabilisers) for dairy cows. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence that would lead the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions on the safety of the product for the target species, consumers and the environment, for which the additive is considered to remain safe. Regarding user safety, the Panel reiterates its previous conclusions that the additive is not irritant to eyes and skin but should be considered a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. There is no need for assessing the efficacy of the additive in the context of renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9342","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143836463","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}