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Safety and efficacy of a feed additive consisting of α‐galactosidase (produced by Aspergillus tubingensis ATCC SD6740) and endo‐1,4‐β‐xylanase (produced by Trichoderma longibrachiatum CBS 139997) (Capsozyme SB Plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (Industrial Técnica Pecuaria S.A.)
Following a request from the European Commission, the EFSA 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 Capsozyme SB Plus as a zootechnical feed additive (digestibility enhancers) for chickens for f...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8666944/ https://www.ncbi.nlm.nih.gov/pubmed/34938373 http://dx.doi.org/10.2903/j.efsa.2021.6981 |
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author | Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon Durjava, Mojca Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Gropp, Jürgen Galobart, Jaume Anguita, Montserrat Pizzo, Fabiola Ortuño, Jordi |
author_facet | Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon Durjava, Mojca Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Gropp, Jürgen Galobart, Jaume Anguita, Montserrat Pizzo, Fabiola Ortuño, Jordi |
collection | PubMed |
description | Following a request from the European Commission, the EFSA 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 Capsozyme SB Plus as a zootechnical feed additive (digestibility enhancers) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying). The additive contains two enzyme ingredients (α‐galactosidase, produced by a non‐genetically modified strain of Aspergillus tubingensis; and endo‐1,4‐β‐xylanase, produced by a non‐genetically modified strain of Trichoderma longibrachiatum) and is presented in solid form. In 2020, the FEEDAP Panel issued an opinion on this product. In that assessment, the Panel considered the additive safe for the target species and the environment. The Panel concluded that the additive does not raise concern for genotoxicity but could not conclude on consumer safety due to the limitations identified in the 90‐day toxicity study. Owing to the lack of data, the Panel could not conclude on the potential of the additive as a skin or eye irritant nor as a skin sensitiser. Moreover, the Panel could not conclude on the efficacy of the additive for chickens for fattening due to the limited evidence provided. The applicant provided supplementary data to support the safety for consumers and the efficacy of the product in chickens for fattening. The FEEDAP Panel concluded that the data provided support the absence of toxicological risk for the consumer. Likewise, according to the new data submitted, the FEEDAP Panel concluded that the additive has the potential to be efficacious in chickens for fattening at the level of 14 GALU (α‐galactosidase)/18 AXC (endo‐1,4‐β‐xylanase) per kg feed, and this conclusion was extended to chickens reared for laying and extrapolated to minor poultry species for fattening/reared for laying. |
format | Online Article Text |
id | pubmed-8666944 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-86669442021-12-21 Safety and efficacy of a feed additive consisting of α‐galactosidase (produced by Aspergillus tubingensis ATCC SD6740) and endo‐1,4‐β‐xylanase (produced by Trichoderma longibrachiatum CBS 139997) (Capsozyme SB Plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (Industrial Técnica Pecuaria S.A.) Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon Durjava, Mojca Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Gropp, Jürgen Galobart, Jaume Anguita, Montserrat Pizzo, Fabiola Ortuño, Jordi EFSA J Scientific Opinion Following a request from the European Commission, the EFSA 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 Capsozyme SB Plus as a zootechnical feed additive (digestibility enhancers) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying). The additive contains two enzyme ingredients (α‐galactosidase, produced by a non‐genetically modified strain of Aspergillus tubingensis; and endo‐1,4‐β‐xylanase, produced by a non‐genetically modified strain of Trichoderma longibrachiatum) and is presented in solid form. In 2020, the FEEDAP Panel issued an opinion on this product. In that assessment, the Panel considered the additive safe for the target species and the environment. The Panel concluded that the additive does not raise concern for genotoxicity but could not conclude on consumer safety due to the limitations identified in the 90‐day toxicity study. Owing to the lack of data, the Panel could not conclude on the potential of the additive as a skin or eye irritant nor as a skin sensitiser. Moreover, the Panel could not conclude on the efficacy of the additive for chickens for fattening due to the limited evidence provided. The applicant provided supplementary data to support the safety for consumers and the efficacy of the product in chickens for fattening. The FEEDAP Panel concluded that the data provided support the absence of toxicological risk for the consumer. Likewise, according to the new data submitted, the FEEDAP Panel concluded that the additive has the potential to be efficacious in chickens for fattening at the level of 14 GALU (α‐galactosidase)/18 AXC (endo‐1,4‐β‐xylanase) per kg feed, and this conclusion was extended to chickens reared for laying and extrapolated to minor poultry species for fattening/reared for laying. John Wiley and Sons Inc. 2021-12-13 /pmc/articles/PMC8666944/ /pubmed/34938373 http://dx.doi.org/10.2903/j.efsa.2021.6981 Text en © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
spellingShingle | Scientific Opinion Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Fašmon Durjava, Mojca Kouba, Maryline López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Gropp, Jürgen Galobart, Jaume Anguita, Montserrat Pizzo, Fabiola Ortuño, Jordi Safety and efficacy of a feed additive consisting of α‐galactosidase (produced by Aspergillus tubingensis ATCC SD6740) and endo‐1,4‐β‐xylanase (produced by Trichoderma longibrachiatum CBS 139997) (Capsozyme SB Plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (Industrial Técnica Pecuaria S.A.) |
title | Safety and efficacy of a feed additive consisting of α‐galactosidase (produced by Aspergillus tubingensis ATCC SD6740) and endo‐1,4‐β‐xylanase (produced by Trichoderma longibrachiatum CBS 139997) (Capsozyme SB Plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (Industrial Técnica Pecuaria S.A.) |
title_full | Safety and efficacy of a feed additive consisting of α‐galactosidase (produced by Aspergillus tubingensis ATCC SD6740) and endo‐1,4‐β‐xylanase (produced by Trichoderma longibrachiatum CBS 139997) (Capsozyme SB Plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (Industrial Técnica Pecuaria S.A.) |
title_fullStr | Safety and efficacy of a feed additive consisting of α‐galactosidase (produced by Aspergillus tubingensis ATCC SD6740) and endo‐1,4‐β‐xylanase (produced by Trichoderma longibrachiatum CBS 139997) (Capsozyme SB Plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (Industrial Técnica Pecuaria S.A.) |
title_full_unstemmed | Safety and efficacy of a feed additive consisting of α‐galactosidase (produced by Aspergillus tubingensis ATCC SD6740) and endo‐1,4‐β‐xylanase (produced by Trichoderma longibrachiatum CBS 139997) (Capsozyme SB Plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (Industrial Técnica Pecuaria S.A.) |
title_short | Safety and efficacy of a feed additive consisting of α‐galactosidase (produced by Aspergillus tubingensis ATCC SD6740) and endo‐1,4‐β‐xylanase (produced by Trichoderma longibrachiatum CBS 139997) (Capsozyme SB Plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (Industrial Técnica Pecuaria S.A.) |
title_sort | safety and efficacy of a feed additive consisting of α‐galactosidase (produced by aspergillus tubingensis atcc sd6740) and endo‐1,4‐β‐xylanase (produced by trichoderma longibrachiatum cbs 139997) (capsozyme sb plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (industrial técnica pecuaria s.a.) |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8666944/ https://www.ncbi.nlm.nih.gov/pubmed/34938373 http://dx.doi.org/10.2903/j.efsa.2021.6981 |
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