Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo‐1,4‐β‐xylanase (Beltherm MP/ML), produced by a genetically‐modified Bacillus subtilis strain, as a zootechnical additive for laying hens, minor poultry spec...

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Autores principales:	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Noël Dierick, Lieve Herman, Giovanna Martelli, Jaume Galobart, Montserrat Anguita
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	zootechnical additives digestibility enhancers xylanase Beltherm safety efficacy Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
Acceso en línea:	https://doaj.org/article/92789aedfc544e229d7bbd0b76d397f1
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spelling	oai:doaj.org-article:92789aedfc544e229d7bbd0b76d397f12021-12-02T17:55:57ZSafety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)1831-473210.2903/j.efsa.2021.6906https://doaj.org/article/92789aedfc544e229d7bbd0b76d397f12021-11-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6906https://doaj.org/toc/1831-4732Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo‐1,4‐β‐xylanase (Beltherm MP/ML), produced by a genetically‐modified Bacillus subtilis strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panel concluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panel concluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panel concluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panel concluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panel could not conclude on the efficacy of the product for the target species for which the application was made.EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca Fašmon DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenNoël DierickLieve HermanGiovanna MartelliJaume GalobartMontserrat AnguitaWileyarticlezootechnical additivesdigestibility enhancersxylanaseBelthermsafetyefficacyNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 11, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	zootechnical additives digestibility enhancers xylanase Beltherm safety efficacy Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
spellingShingle	zootechnical additives digestibility enhancers xylanase Beltherm safety efficacy Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Noël Dierick Lieve Herman Giovanna Martelli Jaume Galobart Montserrat Anguita Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)
description	Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo‐1,4‐β‐xylanase (Beltherm MP/ML), produced by a genetically‐modified Bacillus subtilis strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panel concluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panel concluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panel concluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panel concluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panel could not conclude on the efficacy of the product for the target species for which the application was made.
format	article
author	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Noël Dierick Lieve Herman Giovanna Martelli Jaume Galobart Montserrat Anguita
author_facet	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Noël Dierick Lieve Herman Giovanna Martelli Jaume Galobart Montserrat Anguita
author_sort	EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
title	Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)
title_short	Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)
title_full	Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)
title_fullStr	Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (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‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)
title_sort	safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by bacillus subtilis lmg s‐27588 (beltherm mp/ml) for laying hens, minor poultry species and all avian species (puratos nv)
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/92789aedfc544e229d7bbd0b76d397f1
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Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)

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