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Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets. The additive is t...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Durjava, Mojca Fašmon, 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, Dierick, Noël, Martelli, Giovanna, Galobart, Jaume, Anguita, Montserrat, Revez, Joana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7934070/
https://www.ncbi.nlm.nih.gov/pubmed/33727969
http://dx.doi.org/10.2903/j.efsa.2021.6456
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author Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Durjava, Mojca Fašmon
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
Dierick, Noël
Martelli, Giovanna
Galobart, Jaume
Anguita, Montserrat
Revez, Joana
author_facet Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Durjava, Mojca Fašmon
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
Dierick, Noël
Martelli, Giovanna
Galobart, Jaume
Anguita, Montserrat
Revez, Joana
collection PubMed
description Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets. The additive is to be used in to sows in order to have benefits in piglets and to all porcine species at any developmental stage at 10 IU/kg feed. This additive consists of endo‐1,4‐β‐xylanase produced by a genetically modified strain of Bacillus subtilis (LMG S‐15136). In a previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for the users regarding the potential of the additive as dermal sensitiser and on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. In the absence of new information, the FEEDAP Panel retained its previous conclusion that the additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a dermal sensitiser. The applicant provided new efficacy data and complementary information regarding a previous study. Based on the previously assessed data and the newly submitted ones, the Panel concludes that although the additive has a potential to be efficacious as a zootechnical additive in sows during the lactation period at the level of 10 IU/kg feed, the data are considered not sufficient to conclude on a beneficial effect on the performance of the litters.
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spelling pubmed-79340702021-03-15 Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV) Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Durjava, Mojca Fašmon 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 Dierick, Noël Martelli, Giovanna Galobart, Jaume Anguita, Montserrat Revez, Joana EFSA J Scientific Opinion Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets. The additive is to be used in to sows in order to have benefits in piglets and to all porcine species at any developmental stage at 10 IU/kg feed. This additive consists of endo‐1,4‐β‐xylanase produced by a genetically modified strain of Bacillus subtilis (LMG S‐15136). In a previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for the users regarding the potential of the additive as dermal sensitiser and on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. In the absence of new information, the FEEDAP Panel retained its previous conclusion that the additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a dermal sensitiser. The applicant provided new efficacy data and complementary information regarding a previous study. Based on the previously assessed data and the newly submitted ones, the Panel concludes that although the additive has a potential to be efficacious as a zootechnical additive in sows during the lactation period at the level of 10 IU/kg feed, the data are considered not sufficient to conclude on a beneficial effect on the performance of the litters. John Wiley and Sons Inc. 2021-03-05 /pmc/articles/PMC7934070/ /pubmed/33727969 http://dx.doi.org/10.2903/j.efsa.2021.6456 Text en © 2021 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
Durjava, Mojca Fašmon
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
Dierick, Noël
Martelli, Giovanna
Galobart, Jaume
Anguita, Montserrat
Revez, Joana
Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV)
title Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV)
title_full Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV)
title_fullStr Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV)
title_full_unstemmed Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV)
title_short Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV)
title_sort safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by bacillus subtilis lmg s‐15136 (belfeed b mp/ml) for sows in order to have benefits in piglets and for all porcine species (beldem, a division of puratos nv)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7934070/
https://www.ncbi.nlm.nih.gov/pubmed/33727969
http://dx.doi.org/10.2903/j.efsa.2021.6456
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