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Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (BioResource international, Inc.)

Following a request from the European Commission, the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the product containing endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax...

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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, Svensson, Kettil, Zeljezic, Davor, Anguita, Montserrat, Brozzi, Rosella, Galobart, Jaume, Ortuño, Jordi, Revez, Joana, Tarrés‐Call, Jordi, Pettenati, Elisa
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/PMC9310697/
https://www.ncbi.nlm.nih.gov/pubmed/35898296
http://dx.doi.org/10.2903/j.efsa.2022.7428
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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
Svensson, Kettil
Zeljezic, Davor
Anguita, Montserrat
Brozzi, Rosella
Galobart, Jaume
Ortuño, Jordi
Revez, Joana
Tarrés‐Call, Jordi
Pettenati, Elisa
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
Svensson, Kettil
Zeljezic, Davor
Anguita, Montserrat
Brozzi, Rosella
Galobart, Jaume
Ortuño, Jordi
Revez, Joana
Tarrés‐Call, Jordi
Pettenati, Elisa
collection PubMed
description Following a request from the European Commission, the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the product containing endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. 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. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the Panel concluded that Xylamax is safe for all poultry species for fattening or reared to the point of lay. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concluded that the additive is safe for the consumers. The Panel also concluded that Xylamax is not irritant to the skin but should be considered a potential eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel concluded that the additive has the potential to be efficacious at 10,000 XU/kg feed in chickens for fattening. This conclusion was extended/extrapolated to chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay.
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spelling pubmed-93106972022-07-26 Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (BioResource international, Inc.) 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 Svensson, Kettil Zeljezic, Davor Anguita, Montserrat Brozzi, Rosella Galobart, Jaume Ortuño, Jordi Revez, Joana Tarrés‐Call, Jordi Pettenati, Elisa EFSA J Scientific Opinion Following a request from the European Commission, the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the product containing endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. 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. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the Panel concluded that Xylamax is safe for all poultry species for fattening or reared to the point of lay. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concluded that the additive is safe for the consumers. The Panel also concluded that Xylamax is not irritant to the skin but should be considered a potential eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel concluded that the additive has the potential to be efficacious at 10,000 XU/kg feed in chickens for fattening. This conclusion was extended/extrapolated to chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. John Wiley and Sons Inc. 2022-07-25 /pmc/articles/PMC9310697/ /pubmed/35898296 http://dx.doi.org/10.2903/j.efsa.2022.7428 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
Svensson, Kettil
Zeljezic, Davor
Anguita, Montserrat
Brozzi, Rosella
Galobart, Jaume
Ortuño, Jordi
Revez, Joana
Tarrés‐Call, Jordi
Pettenati, Elisa
Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (BioResource international, Inc.)
title Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (BioResource international, Inc.)
title_full Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (BioResource international, Inc.)
title_fullStr Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (BioResource international, Inc.)
title_full_unstemmed Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (BioResource international, Inc.)
title_short Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (BioResource international, Inc.)
title_sort safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by komagataella phaffii dsm 33574 (xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (bioresource international, inc.)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9310697/
https://www.ncbi.nlm.nih.gov/pubmed/35898296
http://dx.doi.org/10.2903/j.efsa.2022.7428
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