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Safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (B‐Act(®)) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.)

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 the feed additive consisting of Bacillus licheniformis DSM 28710 (trade name: B‐Act(®)) when used i...

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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, Cocconcelli, Pier Sandro, Dierick, Noël, Glandorf, Boet, Martelli, Giovanna, Maradona, Miguel Prieto, Saarela, Maria, Galobart, Jaume, Gregoretti, Lucilla, Innocenti, Matteo L, López‐Gálvez, Gloria, Revez, Joana, Vettori, Maria Vittoria, Brozzi, Rosella
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/PMC7938357/
https://www.ncbi.nlm.nih.gov/pubmed/33732395
http://dx.doi.org/10.2903/j.efsa.2021.6449
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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
Cocconcelli, Pier Sandro
Dierick, Noël
Glandorf, Boet
Martelli, Giovanna
Maradona, Miguel Prieto
Saarela, Maria
Galobart, Jaume
Gregoretti, Lucilla
Innocenti, Matteo L
López‐Gálvez, Gloria
Revez, Joana
Vettori, Maria Vittoria
Brozzi, Rosella
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
Cocconcelli, Pier Sandro
Dierick, Noël
Glandorf, Boet
Martelli, Giovanna
Maradona, Miguel Prieto
Saarela, Maria
Galobart, Jaume
Gregoretti, Lucilla
Innocenti, Matteo L
López‐Gálvez, Gloria
Revez, Joana
Vettori, Maria Vittoria
Brozzi, Rosella
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 the feed additive consisting of Bacillus licheniformis DSM 28710 (trade name: B‐Act(®)) when used in feed for laying hens, minor poultry species for laying and for breeding purposes and ornamental birds. B. licheniformis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established, and it does not harbour acquired antimicrobial resistance genes or has toxigenic potential. Following the QPS approach, B. licheniformis DSM 28710 is presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, B‐Act(®) is also considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B‐Act(®) is considered a respiratory sensitiser. B‐Act(®) when supplemented at 1.6 × 10(9) CFU/kg complete feed has the potential to be efficacious in laying hens. Considering also that the efficacy of the product was already shown in chickens and turkeys for fattening, the Panel concludes that the additive has the potential to be efficacious in minor poultry species for laying, poultry species for breeding purposes and for ornamental birds at the same inclusion level. The conclusions on the compatibility of B‐Act(®) with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal or lower than those for chickens.
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spelling pubmed-79383572021-03-16 Safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (B‐Act(®)) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.) 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 Cocconcelli, Pier Sandro Dierick, Noël Glandorf, Boet Martelli, Giovanna Maradona, Miguel Prieto Saarela, Maria Galobart, Jaume Gregoretti, Lucilla Innocenti, Matteo L López‐Gálvez, Gloria Revez, Joana Vettori, Maria Vittoria Brozzi, Rosella 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 the feed additive consisting of Bacillus licheniformis DSM 28710 (trade name: B‐Act(®)) when used in feed for laying hens, minor poultry species for laying and for breeding purposes and ornamental birds. B. licheniformis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established, and it does not harbour acquired antimicrobial resistance genes or has toxigenic potential. Following the QPS approach, B. licheniformis DSM 28710 is presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, B‐Act(®) is also considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B‐Act(®) is considered a respiratory sensitiser. B‐Act(®) when supplemented at 1.6 × 10(9) CFU/kg complete feed has the potential to be efficacious in laying hens. Considering also that the efficacy of the product was already shown in chickens and turkeys for fattening, the Panel concludes that the additive has the potential to be efficacious in minor poultry species for laying, poultry species for breeding purposes and for ornamental birds at the same inclusion level. The conclusions on the compatibility of B‐Act(®) with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal or lower than those for chickens. John Wiley and Sons Inc. 2021-03-08 /pmc/articles/PMC7938357/ /pubmed/33732395 http://dx.doi.org/10.2903/j.efsa.2021.6449 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
Cocconcelli, Pier Sandro
Dierick, Noël
Glandorf, Boet
Martelli, Giovanna
Maradona, Miguel Prieto
Saarela, Maria
Galobart, Jaume
Gregoretti, Lucilla
Innocenti, Matteo L
López‐Gálvez, Gloria
Revez, Joana
Vettori, Maria Vittoria
Brozzi, Rosella
Safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (B‐Act(®)) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.)
title Safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (B‐Act(®)) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.)
title_full Safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (B‐Act(®)) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.)
title_fullStr Safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (B‐Act(®)) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.)
title_full_unstemmed Safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (B‐Act(®)) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.)
title_short Safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (B‐Act(®)) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.)
title_sort safety and efficacy of the feed additive consisting of bacillus licheniformis dsm 28710 (b‐act(®)) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (huvepharma n.v.)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938357/
https://www.ncbi.nlm.nih.gov/pubmed/33732395
http://dx.doi.org/10.2903/j.efsa.2021.6449
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