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Safety and efficacy of a feed additive consisting of guanidinoacetic acid (Creamino®) for turkeys for fattening and reared for breeding (Alzchem Trostberg GmbH)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-11 DOI: 10.2903/j.efsa.2025.9349
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Jaume Galobart, Jordi Ortuño Casanova, Maria Vittoria Vettori, Jordi Tarrés-Call, Alberto Navarro-Villa
{"title":"Safety and efficacy of a feed additive consisting of guanidinoacetic acid (Creamino®) for turkeys for fattening and reared for breeding (Alzchem Trostberg 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;Jordi Ortuño Casanova,&nbsp;Maria Vittoria Vettori,&nbsp;Jordi Tarrés-Call,&nbsp;Alberto Navarro-Villa","doi":"10.2903/j.efsa.2025.9349","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9349","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 the safety and efficacy of guanidinoacetic acid (GAA) when used as zootechnical additive in feed and water for drinking for turkeys for fattening and turkeys reared for breeding, and a preparation of GAA when used in feed for the same target species. The FEEDAP Panel concluded that GAA at 1200 mg/kg complete feed or 600 mg/L water is safe for turkeys for fattening and turkeys reared for breeding. There is no concern on consumer safety resulting from the use of GAA for turkeys at the proposed conditions of use. GAA is not toxic by inhalation, not irritant to skin and eyes and not a dermal sensitiser. The FEEDAP Panel concluded that the use of GAA as feed additive is not expected to pose a risk to the environment. The use of the additive under assessment in animal nutrition at the proposed conditions of use has the potential to be efficacious in turkeys for fattening and turkeys reared for breeding. The above conclusions apply to both the active substance GAA and the preparation of GAA.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9349","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143818601","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}
引用次数: 0
Safety and efficacy of the feed additive consisting of clinoptilolite of sedimentary origin for all animal species for the renewal of its authorisation (ZEOCEM, a.s.)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-11 DOI: 10.2903/j.efsa.2025.9364
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Jaume Galobart, Orsolya Holczknecht, Fabiola Pizzo, Anita Radovnikovic, Maria Vittoria Vettori, Angelica Amaduzzi
{"title":"Safety and efficacy of the feed additive consisting of clinoptilolite of sedimentary origin for all animal species for the renewal of its authorisation (ZEOCEM, 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;Jaume Galobart,&nbsp;Orsolya Holczknecht,&nbsp;Fabiola Pizzo,&nbsp;Anita Radovnikovic,&nbsp;Maria Vittoria Vettori,&nbsp;Angelica Amaduzzi","doi":"10.2903/j.efsa.2025.9364","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9364","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 the assessment of the application for renewal of authorisation of clinoptilolite of sedimentary origin as a technological feed additive (binder and anticaking agents) for all animal species. The applicant provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concludes that clinoptilolite of sedimentary origin remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive is not a skin nor an eye irritant but should be considered a skin and respiratory sensitiser. 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":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9364","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143818603","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}
引用次数: 0
Assessment of the feed additive consisting of Saccharomyces cerevisiae CBS 493.94 (Yea-Sacc®) for dairy cows, minor dairy ruminant species, cattle for fattening and minor ruminant species for fattening for the renewal of its authorisation (ALL-TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland])
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-11 DOI: 10.2903/j.efsa.2025.9354
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Jaume Galobart, Matteo L. Innocenti, Rosella Brozzi
{"title":"Assessment of the feed additive consisting of Saccharomyces cerevisiae CBS 493.94 (Yea-Sacc®) for dairy cows, minor dairy ruminant species, cattle for fattening and minor ruminant species for fattening for the renewal of its authorisation (ALL-TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland])","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;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Rosella Brozzi","doi":"10.2903/j.efsa.2025.9354","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9354","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 a preparation of dried cells of <i>Saccharomyces cerevisiae</i> CBS 493.94 (Yea-Sacc®) as a zootechnical additive for dairy cows, minor dairy ruminant species, cattle for fattening and minor ruminant species for fattening. The feed additive is marketed in two solid forms (Yea-Sacc® C and Yea-Sacc® TS) differing by the granulometry. The applicant provided evidence that the additive currently in the market complies with the existing terms of the authorisation. The Panel concluded that the additive remains safe for the target species, consumers and the environment. Regarding the safety for the user, Yea-Sacc® TS is non-irritant to the skin or eyes while Yea-Sacc® C is not irritant to the skin but irritant to the eyes. The additive in both formulations 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 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":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9354","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143818604","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}
引用次数: 0
Efficacy of a feed additive consisting of guanidinoacetic acid (Creamino®) for weaned piglets and pigs for fattening in water for drinking (Alzchem Trostberg GmbH)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-11 DOI: 10.2903/j.efsa.2025.9350
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Jaume Galobart, Maria Vittoria Vettori, Alberto Navarro-Villa
{"title":"Efficacy of a feed additive consisting of guanidinoacetic acid (Creamino®) for weaned piglets and pigs for fattening in water for drinking (Alzchem Trostberg 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;Alberto Navarro-Villa","doi":"10.2903/j.efsa.2025.9350","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9350","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 the efficacy of guanidinoacetic acid (GAA; Creamino®), intended for use as zootechnical additive (functional group: other zootechnicals – improvement of performance parameters) for weaned piglets and pigs for fattening in water for drinking. The additive is already authorised for use in feed and water for chickens for fattening and chickens reared for laying/breeding and only for feed in weaned piglets and pigs for fattening. In the previous opinion, the Panel concluded that the additive is safe for chickens for fattening, chickens reared for laying/breeding, piglets and pigs for fattening, the consumer, users and the environment under the proposed conditions of use. In the current submission, the applicant submitted considerations to support the authorisation of GAA in water for drinking for weaned piglets and pigs for fattening. The FEEDAP Panel reiterates it previous conclusion that the use of GAA in feed and water for drinking of weaned piglets and pigs for fattening has the potential to be efficacious in improving the zootechnical performance of the target animals under the proposed conditions of use (600–1200 mg GAA/kg complete feed; 200–600 mg GAA/L water).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9350","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143818602","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}
引用次数: 0
Assessment of the feed additive neohesperidine dihydrochalcone for piglets, pigs for fattening, calves, sheep, fish and dogs for the renewal of its authorisation (HealthTech Bio Actives S.L.U.)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-10 DOI: 10.2903/j.efsa.2025.9358
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Maria de Lourdes Bastos, Paul Brantom, Andrew Chesson, Josef Schlatter, Johannes Westendorf, Maria Dulak-Lis, Paola Manini
{"title":"Assessment of the feed additive neohesperidine dihydrochalcone for piglets, pigs for fattening, calves, sheep, fish and dogs for the renewal of its authorisation (HealthTech Bio Actives S.L.U.)","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;Maria Dulak-Lis,&nbsp;Paola Manini","doi":"10.2903/j.efsa.2025.9358","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9358","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 the renewal of the authorisation of neohesperidine dihydrochalcone as a sensory feed additive for piglets and pigs for fattening, calves, sheep, fish and dogs. The additive is already authorised for use in calves, sheep, fish, dogs and certain categories of pigs (2b959). The applicant provided evidence that the additive currently in the market complies with the existing conditions of the authorisation and that the production process has not been modified. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for the target species, consumers and the environment. Neohesperidine dihydrochalcone is not irritant to skin and eyes and is not a skin sensitiser. Exposure through inhalation is likely. The present application for renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive, and therefore, there is no need for re-assessing the efficacy.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9358","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143809683","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}
引用次数: 0
Safety of a feed additive consisting of Sepiolitic clay for all animal species (MYTA S.A.)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-10 DOI: 10.2903/j.efsa.2025.9365
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Vasileios Bampidis, Montserrat Anguita, Orsolya Holczknecht, Matteo L. Innocenti, Jordi Ortuño
{"title":"Safety of a feed additive consisting of Sepiolitic clay for all animal species (MYTA S.A.)","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;Vasileios Bampidis,&nbsp;Montserrat Anguita,&nbsp;Orsolya Holczknecht,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño","doi":"10.2903/j.efsa.2025.9365","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9365","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of Sepiolitic clay as a technological feed additive for all animal species. In 2022, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of the same additive. The Panel concluded that Sepiolitic clay used as a feed additive is safe for the consumers and the environment, and efficacious as a binder and anticaking agent in feed for all animal species under the proposed conditions of use. The additive was not considered an eye or skin irritant. However, it was considered a respiratory and dermal sensitiser. Due to the dusting potential and its silica content, the additive was considered a risk by inhalation. Regarding the target species, in the previous Opinion, the Panel concluded that the additive was safe for dairy ruminants and growing <i>Suidae</i> at the recommended use level (20,000 mg/kg feed), for chickens for fattening at 10,000 mg/kg feed and for salmonids at 17,600 mg/kg feed. No conclusion could be drawn for all other species/categories. Based on the tolerance studies in chickens for fattening and trout evaluated in the current assessment, and the ones in weaned piglets and dairy cows previously assessed, the Panel concluded that the inclusion of Sepiolitic clay at the maximum recommended level of 20,000 mg/kg complete feed is safe for all animal species.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9365","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143809681","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}
引用次数: 0
Safety and efficacy of a feed additive consisting of capsaicin for all animal species (XP Chemistries AB)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-10 DOI: 10.2903/j.efsa.2025.9340
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Maria Bastos, Georges Bories, Paul Brantom, Jürgen Gropp, Ruud Woutersen, Jaume Galobart, Paola Manini, Fabiola Pizzo, Maria Vittoria Vettori, Andrew Chesson
{"title":"Safety and efficacy of a feed additive consisting of capsaicin for all animal species (XP Chemistries AB)","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 Bastos,&nbsp;Georges Bories,&nbsp;Paul Brantom,&nbsp;Jürgen Gropp,&nbsp;Ruud Woutersen,&nbsp;Jaume Galobart,&nbsp;Paola Manini,&nbsp;Fabiola Pizzo,&nbsp;Maria Vittoria Vettori,&nbsp;Andrew Chesson","doi":"10.2903/j.efsa.2025.9340","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9340","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 capsaicin as a sensory feed additive for all animal species (flavouring compounds). The additive is specified to have a purity of at least 98% with a ratio of <i>(E)-</i>capsaicin (<i>trans</i>-capsaicin) to <i>(Z)-</i>capsaicin (<i>cis-</i>capsaicin) of ≥ 6:1. The FEEDAP Panel concludes that the additive capsaicin is safe at the recommended maximum use level proposed by the applicant (6.5 mg/kg complete feed) for use in all poultry species, all porcine species, all bovines, ovines, caprines, cervids and camelids, all equids, leporids, salmonids and minor fin fish species, dogs, ornamental birds and ornamental fish. For cats and other species not considered above, 5.3 mg/kg complete feed is considered safe. The use of capsaicin as a feed additive is considered safe for consumers and the environment. Capsaicin is a skin and respiratory irritant and is assumed to be an eye irritant. It is not a dermal sensitiser. Any exposure of users is considered a risk. The Panel concluded that the additive has the potential to be efficacious as a flavouring additive in feed for all animal species under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9340","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143809682","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}
引用次数: 0
Safety evaluation of the food enzyme alternansucrase from the genetically modified Escherichia coli strain EBASSC
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-09 DOI: 10.2903/j.efsa.2025.9331
EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L. M. Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Magdalena Andryszkiewicz, Daniele Cavanna, Giulio Di Piazza, Cristina Fernàndez-Fraguas, Natalia Kovalkovičová, Silvia Peluso, Yi Liu
{"title":"Safety evaluation of the food enzyme alternansucrase from the genetically modified Escherichia coli strain EBASSC","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;Giulio Di Piazza,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Natalia Kovalkovičová,&nbsp;Silvia Peluso,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9331","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9331","url":null,"abstract":"<p>The food enzyme alternansucrase (sucrose:1,6(1,3)-α-<span>d</span>-glucan 6(3)-α-<span>d</span>-glucosyltransferase; EC 2.4.1.140) is produced with the genetically modified <i>Escherichia coli</i> strain EBASSC by Advanced Enzyme Technologies Ltd. The production strain of the food enzyme contains a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in the processing of sugars for the production of maltose alternan gluco-oligosaccharides. Two sets of dietary exposure estimates were made, using the default or more specific input factors. The refined dietary exposure was estimated to be up to 0.586 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 500 mg TOS/kg bw per day, the mid-dose tested, which when compared with the refined exposure estimate, results in a margin of exposure of at least 853. A search for the homology of the amino acid sequence of the alternansucrase 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 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9331","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143801445","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}
引用次数: 0
Evaluation of a fluidised catalytic cracking co-processing method for the production of renewable fuels using Category 3 animal fat and used cooking oils
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-09 DOI: 10.2903/j.efsa.2025.9337
EFSA Panel on Biological Hazards (BIOHAZ), Ana Allende, Valeria Bortolaia, Sara Bover-Cid, Wietske Dohmen, Laurent Guillier, Lieve Herman, Liesbeth Jacxsens, Maarten Nauta, Lapo Mughini-Gras, Jakob Ottoson, Luisa Peixe, Fernando Perez-Rodriguez, Panagiotis Skandamis, Elisabetta Suffredini, Alessandra De Cesare, Pablo Fernandez Escamez, John Griffin, Kamela Kryemadhi, Angel Ortiz-Pelaez, Avelino Alvarez-Ordóñez
{"title":"Evaluation of a fluidised catalytic cracking co-processing method for the production of renewable fuels using Category 3 animal fat and used cooking oils","authors":"EFSA Panel on Biological Hazards (BIOHAZ),&nbsp;Ana Allende,&nbsp;Valeria Bortolaia,&nbsp;Sara Bover-Cid,&nbsp;Wietske Dohmen,&nbsp;Laurent Guillier,&nbsp;Lieve Herman,&nbsp;Liesbeth Jacxsens,&nbsp;Maarten Nauta,&nbsp;Lapo Mughini-Gras,&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;John Griffin,&nbsp;Kamela Kryemadhi,&nbsp;Angel Ortiz-Pelaez,&nbsp;Avelino Alvarez-Ordóñez","doi":"10.2903/j.efsa.2025.9337","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9337","url":null,"abstract":"<p>An alternative processing method for the production of renewable fuels from rendered animal fats, pretreated using standard processing methods 1–5 or method 7 and used cooking oils, derived from Category 3 animal by-products, was assessed. The alternative method is based on a fluidised catalytic cracking co-processing treatment with a preheat stage by at least 145°C and a pressure of at least 1.4 barg for at least 13 s, followed by a reactor stage by at least 500°C for 2 s. The applicant selected the use of spores of pathogenic bacteria as primary indicators without carrying out a full hazard identification, which is acceptable as per previous EFSA evaluations. The EFSA BIOHAZ Panel considers that the application and supporting literature contain sufficient evidence to support that the alternative method can achieve a reduction of at least 12 log<sub>10</sub> of <i>C. botulinum</i> spores and 5 log<sub>10</sub> of the spores of other pathogenic bacteria. The Hazard Analysis and Critical Control Point plan contained some inadequacies: the reception of raw materials should be considered a prerequisite (with acceptance criteria) rather than a critical control point and quantitative limits for temperature and holding time at the reactor should be defined. The information provided by the applicant suggests that appropriate corrective actions are in place for dealing with risks associated with interdependent processes and with the intended end use of the products. The applicant also considers as part of the alternative processing method the operation under an unplanned shutdown. EFSA only assesses the alternative processing methods under normal operating conditions. Thus, the procedures under an unplanned shutdown were not assessed as part of the alternative processing method. Overall, the alternative method under evaluation is considered equivalent to the processing methods currently approved in the Commission Regulation (EU) No 142/2011.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9337","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143801447","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}
引用次数: 0
Safety of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-09 DOI: 10.2903/j.efsa.2025.9341
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Jaume Galobart, Fabiola Pizzo
{"title":"Safety of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland 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;Jaume Galobart,&nbsp;Fabiola Pizzo","doi":"10.2903/j.efsa.2025.9341","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9341","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 the safety of a feed additive consisting of dicopper chloride trihydroxide intended for use as a nutritional additive (functional group: compounds of trace elements) for all animal species. Regarding the safety for the user, in the previous assessment, the FEEDAP Panel concluded that the additive is hazardous by inhalation, it is irritant to skin and eye and a skin and respiratory sensitiser. For the current assessment, arguments have been provided by the applicant in support of the safety of the additive for the users exposed by inhalation. The FEEDAP Panel concluded that dicopper chloride trihydroxide is irritant to skin, eyes and the respiratory system and should be considered a skin and respiratory sensitiser. Any exposure is considered a risk.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9341","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143801889","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}
引用次数: 0
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