EFSA Journal最新文献

{"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}

{"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}