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Safety and efficacy of TechnoSpore(®) (Bacillus coagulans DSM 32016) for piglets, other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds

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 TechnoSpore(®) (Bacillus coagulans DSM 32016), when used as a zootechnical additive for piglets (su...

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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, Dierick, Noël, Martelli, Giovanna, Cocconcelli, Pier Sandro, Glandorf, Boet, Herman, Lieve, Prieto Maradona, Miguel, Saarela, Maria, Anguita, Montserrat, Brozzi, Rosella
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448007/
https://www.ncbi.nlm.nih.gov/pubmed/32874333
http://dx.doi.org/10.2903/j.efsa.2020.6158
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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
Dierick, Noël
Martelli, Giovanna
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Prieto Maradona, Miguel
Saarela, Maria
Anguita, Montserrat
Brozzi, Rosella
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
Dierick, Noël
Martelli, Giovanna
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Prieto Maradona, Miguel
Saarela, Maria
Anguita, Montserrat
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 TechnoSpore(®) (Bacillus coagulans DSM 32016), when used as a zootechnical additive for piglets (suckling and weaned), other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds. The bacterial species present in the additive is considered suitable for the qualified presumption of safety approach to safety assessment. The identity of the active agent was established and the lack of toxigenic potential confirmed. B. coagulans DSM 32016 did not show resistance to antibiotics of human and veterinary importance, and therefore, was presumed safe for the target species, consumers of products derived from animals Fed the additive and the environment. Since the other components of the additive did not give rise to concerns, TechnoSpore(®) was also considered safe for the target species, consumer and the environment. The additive is not a skin/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. TechnoSpore(®) showed the potential to be efficacious as a zootechnical additive in weaned piglets and chickens for fattening at 1 × 10(9) CFU/kg complete feed. This conclusion was extended to suckling piglets and extrapolated to other growing Suidae at the same physiological stage and to other birds for fattening and ornamental birds at the same use level. B. coagulans DSM 32016 included in Technospore(®) is compatible with halofuginone and diclazuril. The Panel could not conclude on the compatibility of the additive with monensin sodium, decoquinate, robenidine hydrochloride, lasalocid sodium, narasin, salinomycin sodium, maduramicin ammonium, nicarbazin and narasin/nicarbazin.
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spelling pubmed-74480072020-08-31 Safety and efficacy of TechnoSpore(®) (Bacillus coagulans DSM 32016) for piglets, other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds 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 Dierick, Noël Martelli, Giovanna Cocconcelli, Pier Sandro Glandorf, Boet Herman, Lieve Prieto Maradona, Miguel Saarela, Maria Anguita, Montserrat 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 TechnoSpore(®) (Bacillus coagulans DSM 32016), when used as a zootechnical additive for piglets (suckling and weaned), other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds. The bacterial species present in the additive is considered suitable for the qualified presumption of safety approach to safety assessment. The identity of the active agent was established and the lack of toxigenic potential confirmed. B. coagulans DSM 32016 did not show resistance to antibiotics of human and veterinary importance, and therefore, was presumed safe for the target species, consumers of products derived from animals Fed the additive and the environment. Since the other components of the additive did not give rise to concerns, TechnoSpore(®) was also considered safe for the target species, consumer and the environment. The additive is not a skin/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. TechnoSpore(®) showed the potential to be efficacious as a zootechnical additive in weaned piglets and chickens for fattening at 1 × 10(9) CFU/kg complete feed. This conclusion was extended to suckling piglets and extrapolated to other growing Suidae at the same physiological stage and to other birds for fattening and ornamental birds at the same use level. B. coagulans DSM 32016 included in Technospore(®) is compatible with halofuginone and diclazuril. The Panel could not conclude on the compatibility of the additive with monensin sodium, decoquinate, robenidine hydrochloride, lasalocid sodium, narasin, salinomycin sodium, maduramicin ammonium, nicarbazin and narasin/nicarbazin. John Wiley and Sons Inc. 2020-06-25 /pmc/articles/PMC7448007/ /pubmed/32874333 http://dx.doi.org/10.2903/j.efsa.2020.6158 Text en © 2020 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
Dierick, Noël
Martelli, Giovanna
Cocconcelli, Pier Sandro
Glandorf, Boet
Herman, Lieve
Prieto Maradona, Miguel
Saarela, Maria
Anguita, Montserrat
Brozzi, Rosella
Safety and efficacy of TechnoSpore(®) (Bacillus coagulans DSM 32016) for piglets, other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds
title Safety and efficacy of TechnoSpore(®) (Bacillus coagulans DSM 32016) for piglets, other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds
title_full Safety and efficacy of TechnoSpore(®) (Bacillus coagulans DSM 32016) for piglets, other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds
title_fullStr Safety and efficacy of TechnoSpore(®) (Bacillus coagulans DSM 32016) for piglets, other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds
title_full_unstemmed Safety and efficacy of TechnoSpore(®) (Bacillus coagulans DSM 32016) for piglets, other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds
title_short Safety and efficacy of TechnoSpore(®) (Bacillus coagulans DSM 32016) for piglets, other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds
title_sort safety and efficacy of technospore(®) (bacillus coagulans dsm 32016) for piglets, other growing suidae, chickens for fattening, other poultry for fattening and ornamental birds
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448007/
https://www.ncbi.nlm.nih.gov/pubmed/32874333
http://dx.doi.org/10.2903/j.efsa.2020.6158
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