Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1784753441977925632 |
---|---|
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. |
format | Online Article Text |
id | pubmed-9310697 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT bampidisvasileios safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT azimontigiovanna safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT bastosmariadelourdes safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT christensenhenrik safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT dusemundbirgit safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT fasmondurjavamojca safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT koubamaryline safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT lopezalonsomarta safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT lopezpuentesecundino safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT marconfrancesca safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT mayobaltasar safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT pechovaalena safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT petkovamariana safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT ramosfernando safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT sanzyolanda safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT villarobertoedoardo safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT woutersenruud safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT glandorfboet safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT svenssonkettil safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT zeljezicdavor safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT anguitamontserrat safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT brozzirosella safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT galobartjaume safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT ortunojordi safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT revezjoana safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT tarrescalljordi safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso AT pettenatielisa safetyandefficacyofafeedadditiveconsistingofendo14bxylanaseproducedbykomagataellaphaffiidsm33574xylamaxforchickensandturkeysforfatteningchickensrearedforlayingbreedingturkeysrearedforbreedingandminorpoultryspeciesforfatteningorraisedtothepointoflaybioreso |