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Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Add...

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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, Aquilina, Gabriele, Brantom, Paul, Dierick, Noël, Anguita, Montserrat, Rychen, Guido
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/PMC7009285/
https://www.ncbi.nlm.nih.gov/pubmed/32626242
http://dx.doi.org/10.2903/j.efsa.2019.5610
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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
Aquilina, Gabriele
Brantom, Paul
Dierick, Noël
Anguita, Montserrat
Rychen, Guido
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
Aquilina, Gabriele
Brantom, Paul
Dierick, Noël
Anguita, Montserrat
Rychen, Guido
collection PubMed
description Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has requested for the authorisation in new species/categories. The Panel considered that the new use would not introduce hazards that have not already been considered. Therefore, it was concluded that the additive is safe for the consumers and the environment. Considering the safety for the user, the Panel concluded that the additive, in either form, is not toxic by inhalation or irritant for skin or eye but it is considered a potential respiratory sensitiser. The Panel could not conclude on the dermal sensitisation potential of the additive. In a trial with weaned piglets, the animals tolerated well a 200‐fold the level recommended in feed by the applicant; therefore, the Panel concluded that the additive is safe for weaned piglets, pigs for fattening and minor porcine species at the recommended level. Based on the data provided to support the efficacy of the additive in weaned piglets and pigs for fattening, the Panel concluded that the additive has the potential to be efficacious at the recommended level in those species/categories. The conclusions on the safety and efficacy for weaned piglets and pigs for fattening were extrapolated to minor porcine species.
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spelling pubmed-70092852020-07-02 Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for piglets, pigs for fattening and other porcine 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 Aquilina, Gabriele Brantom, Paul Dierick, Noël Anguita, Montserrat Rychen, Guido EFSA J Scientific Opinion Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has requested for the authorisation in new species/categories. The Panel considered that the new use would not introduce hazards that have not already been considered. Therefore, it was concluded that the additive is safe for the consumers and the environment. Considering the safety for the user, the Panel concluded that the additive, in either form, is not toxic by inhalation or irritant for skin or eye but it is considered a potential respiratory sensitiser. The Panel could not conclude on the dermal sensitisation potential of the additive. In a trial with weaned piglets, the animals tolerated well a 200‐fold the level recommended in feed by the applicant; therefore, the Panel concluded that the additive is safe for weaned piglets, pigs for fattening and minor porcine species at the recommended level. Based on the data provided to support the efficacy of the additive in weaned piglets and pigs for fattening, the Panel concluded that the additive has the potential to be efficacious at the recommended level in those species/categories. The conclusions on the safety and efficacy for weaned piglets and pigs for fattening were extrapolated to minor porcine species. John Wiley and Sons Inc. 2019-03-05 /pmc/articles/PMC7009285/ /pubmed/32626242 http://dx.doi.org/10.2903/j.efsa.2019.5610 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
Aquilina, Gabriele
Brantom, Paul
Dierick, Noël
Anguita, Montserrat
Rychen, Guido
Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for piglets, pigs for fattening and other porcine species
title Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for piglets, pigs for fattening and other porcine species
title_full Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for piglets, pigs for fattening and other porcine species
title_fullStr Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for piglets, pigs for fattening and other porcine species
title_full_unstemmed Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for piglets, pigs for fattening and other porcine species
title_short Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for piglets, pigs for fattening and other porcine species
title_sort safety and efficacy of beltherm mp/ml (endo‐1,4‐beta‐xylanase) as a feed additive for piglets, pigs for fattening and other porcine species
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009285/
https://www.ncbi.nlm.nih.gov/pubmed/32626242
http://dx.doi.org/10.2903/j.efsa.2019.5610
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