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Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessme...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Kouba, Maryline, Kos Durjava, Mojca, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto Edoardo, Woutersen, Ruud, Anguita, Montserrat
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009097/
https://www.ncbi.nlm.nih.gov/pubmed/32626241
http://dx.doi.org/10.2903/j.efsa.2019.5609
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author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Anguita, Montserrat
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Anguita, Montserrat
collection PubMed
description Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessment, the additive and the production strain, a genetically modified strain of Bacillus subtilis, were characterised in full. No viable cells of the production strain were detected in the final additive, but recombinant DNA from the production strain was detected. Considering that the production strain does not carry genetic sequences of concern, the presence of DNA was considered per se of no safety concern by the Panel. The safety of the additive for the target species, consumers and environment was established, but the Panel concluded that the additive should be considered as a respiratory sensitiser. Regarding the efficacy, it was concluded that the additive has a potential to be efficacious in chickens for fattening and extended/extrapolated the conclusion to chickens reared for laying and minor poultry species for fattening. However, the Panel could not conclude on the efficacy of the additive in turkeys for fattening, reared for breeding or for breeding purposes. The Panel concluded, based on the new guidance on the efficacy for feed additives, that the conclusion on the efficacy in chickens for fattening can be extrapolated to turkeys for fattening/reared for breeding purposes. New data in turkeys for fattening would support the extrapolation. No data has been provided to support the efficacy in turkeys for breeding purposes and therefore no conclusion could be drawn. Finally, the applicant has proposed, in the current submission, a modification of the manufacturing process to remove the presence of DNA from the production strain in the final product, the removal was confirmed by analyses.
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spelling pubmed-70090972020-07-02 Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Kouba, Maryline Kos Durjava, Mojca López‐Alonso, Marta López Puente, Secundino Marcon, Francesca Mayo, Baltasar Pechová, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Anguita, Montserrat EFSA J Scientific Opinion Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessment, the additive and the production strain, a genetically modified strain of Bacillus subtilis, were characterised in full. No viable cells of the production strain were detected in the final additive, but recombinant DNA from the production strain was detected. Considering that the production strain does not carry genetic sequences of concern, the presence of DNA was considered per se of no safety concern by the Panel. The safety of the additive for the target species, consumers and environment was established, but the Panel concluded that the additive should be considered as a respiratory sensitiser. Regarding the efficacy, it was concluded that the additive has a potential to be efficacious in chickens for fattening and extended/extrapolated the conclusion to chickens reared for laying and minor poultry species for fattening. However, the Panel could not conclude on the efficacy of the additive in turkeys for fattening, reared for breeding or for breeding purposes. The Panel concluded, based on the new guidance on the efficacy for feed additives, that the conclusion on the efficacy in chickens for fattening can be extrapolated to turkeys for fattening/reared for breeding purposes. New data in turkeys for fattening would support the extrapolation. No data has been provided to support the efficacy in turkeys for breeding purposes and therefore no conclusion could be drawn. Finally, the applicant has proposed, in the current submission, a modification of the manufacturing process to remove the presence of DNA from the production strain in the final product, the removal was confirmed by analyses. John Wiley and Sons Inc. 2019-03-01 /pmc/articles/PMC7009097/ /pubmed/32626241 http://dx.doi.org/10.2903/j.efsa.2019.5609 Text en © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://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
Kouba, Maryline
Kos Durjava, Mojca
López‐Alonso, Marta
López Puente, Secundino
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Anguita, Montserrat
Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species
title Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species
title_full Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species
title_fullStr Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species
title_full_unstemmed Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species
title_short Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species
title_sort safety and efficacy of beltherm mp/ml (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009097/
https://www.ncbi.nlm.nih.gov/pubmed/32626241
http://dx.doi.org/10.2903/j.efsa.2019.5609
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