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Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) for poultry (Kemin Europa N.V.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) as a zootechnical feed additive for poultry. The production strain is genetically modified....

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Autores principales: 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, Glandorf, Boet, Brantom, Paul, Anguita, Montserrat, Galobart, Jaume, Manini, Paola, Ortuño, Jordi, Pettenati, Elisa, Pizzo, Fabiola, Tarrés, Jordi, Revez, Joana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9301927/
https://www.ncbi.nlm.nih.gov/pubmed/35873724
http://dx.doi.org/10.2903/j.efsa.2022.7439
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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
Glandorf, Boet
Brantom, Paul
Anguita, Montserrat
Galobart, Jaume
Manini, Paola
Ortuño, Jordi
Pettenati, Elisa
Pizzo, Fabiola
Tarrés, Jordi
Revez, Joana
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
Glandorf, Boet
Brantom, Paul
Anguita, Montserrat
Galobart, Jaume
Manini, Paola
Ortuño, Jordi
Pettenati, Elisa
Pizzo, Fabiola
Tarrés, Jordi
Revez, Joana
collection PubMed
description Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) as a zootechnical feed additive for poultry. The production strain is genetically modified. No viable cells nor recombinant DNA of the production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the production strain. The FEEDAP Panel concluded that Xygest™ HT is considered safe for chickens for fattening at 30,000 U/kg and in laying hens at 45,000 U/kg, with a wide margin of safety. These conclusions can be extended to chickens reared for laying/breeding and extrapolated to all poultry species for fattening and reared for laying/breeding and to ornamental birds. The conclusions on laying hens are extrapolated to all laying poultry species. The use of Xygest™ HT in animal nutrition is of no concern for consumer safety and this feed additive is considered safe for the environment. The Panel also concluded that Xygest™ HT is not irritant to the eyes and skin but should be considered a dermal and a respiratory sensitiser. The Panel concluded that the additive Xygest™ HT has a potential to be efficacious for laying hens under the proposed conditions of use and this conclusion can also be extrapolated to all laying poultry species. The Panel could not conclude on the efficacy of the product for chickens for fattening due to insufficient data.
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spelling pubmed-93019272022-07-22 Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) for poultry (Kemin Europa N.V.) 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 Glandorf, Boet Brantom, Paul Anguita, Montserrat Galobart, Jaume Manini, Paola Ortuño, Jordi Pettenati, Elisa Pizzo, Fabiola Tarrés, Jordi Revez, Joana EFSA J Scientific Opinion Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) as a zootechnical feed additive for poultry. The production strain is genetically modified. No viable cells nor recombinant DNA of the production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the production strain. The FEEDAP Panel concluded that Xygest™ HT is considered safe for chickens for fattening at 30,000 U/kg and in laying hens at 45,000 U/kg, with a wide margin of safety. These conclusions can be extended to chickens reared for laying/breeding and extrapolated to all poultry species for fattening and reared for laying/breeding and to ornamental birds. The conclusions on laying hens are extrapolated to all laying poultry species. The use of Xygest™ HT in animal nutrition is of no concern for consumer safety and this feed additive is considered safe for the environment. The Panel also concluded that Xygest™ HT is not irritant to the eyes and skin but should be considered a dermal and a respiratory sensitiser. The Panel concluded that the additive Xygest™ HT has a potential to be efficacious for laying hens under the proposed conditions of use and this conclusion can also be extrapolated to all laying poultry species. The Panel could not conclude on the efficacy of the product for chickens for fattening due to insufficient data. John Wiley and Sons Inc. 2022-07-21 /pmc/articles/PMC9301927/ /pubmed/35873724 http://dx.doi.org/10.2903/j.efsa.2022.7439 Text en © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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
Glandorf, Boet
Brantom, Paul
Anguita, Montserrat
Galobart, Jaume
Manini, Paola
Ortuño, Jordi
Pettenati, Elisa
Pizzo, Fabiola
Tarrés, Jordi
Revez, Joana
Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) for poultry (Kemin Europa N.V.)
title Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) for poultry (Kemin Europa N.V.)
title_full Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) for poultry (Kemin Europa N.V.)
title_fullStr Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) for poultry (Kemin Europa N.V.)
title_full_unstemmed Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) for poultry (Kemin Europa N.V.)
title_short Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) for poultry (Kemin Europa N.V.)
title_sort safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by komagataella phaffii atcc pta‐127053 (xygest™ ht) for poultry (kemin europa n.v.)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9301927/
https://www.ncbi.nlm.nih.gov/pubmed/35873724
http://dx.doi.org/10.2903/j.efsa.2022.7439
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