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Safety and efficacy of Levucell(®) SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for all pigs
Following a request from the European Commission, the EFSA 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 Levucell(®) SB when used in feed for suckling piglets, pigs for fattening and minor porcine sp...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009061/ https://www.ncbi.nlm.nih.gov/pubmed/32626080 http://dx.doi.org/10.2903/j.efsa.2019.5535 |
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author | Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria 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 Woutersen, Ruud Brozzi, Rosella |
author_facet | Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria 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 Woutersen, Ruud Brozzi, Rosella |
collection | PubMed |
description | Following a request from the European Commission, the EFSA 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 Levucell(®) SB when used in feed for suckling piglets, pigs for fattening and minor porcine species. Levucell(®) SB is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae currently authorised as a zootechnical additive for weaned piglets, sows, chickens for fattening and minor poultry species for fattening. The applicant is now seeking authorisation as a zootechnical additive for use with all pigs. In the context of a previous opinion, the identity of the strain was confirmed, and according to the Qualified Presumption of Safety (QPS) approach to safety assessment, it was presumed safe for the target species, consumers of products from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, Levucell(®) SB is also considered safe for the target species, including all pigs, consumers and the environment. Levucell(®) is not a skin or eye irritant or a skin sensitiser. Inhalation exposure is unlikely. Encapsulation used in the existing coated forms is not expected to introduce hazards for users. In previous opinions, Levucell(®) SB was found to have the potential to be efficacious in sows and weaned piglets at the dose of 1 × 10(9) colony forming units (CFU)/kg complete feedingstuffs. Since the dose proposed for use with all pigs is the same as that demonstrated to be effective in weaned piglets and sows, and it can be reasonably assumed that the mode of action is the same, the conclusion on efficacy for weaned piglets and sows can be extrapolated to all pigs. Therefore, the FEEDAP Panel concludes that Levucell(®) SB has the potential to be efficacious in all pigs at 1 × 10(9) CFU/kg feedingstuffs. |
format | Online Article Text |
id | pubmed-7009061 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70090612020-07-02 Safety and efficacy of Levucell(®) SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for all pigs Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria 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 Woutersen, Ruud Brozzi, Rosella EFSA J Scientific Opinion Following a request from the European Commission, the EFSA 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 Levucell(®) SB when used in feed for suckling piglets, pigs for fattening and minor porcine species. Levucell(®) SB is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae currently authorised as a zootechnical additive for weaned piglets, sows, chickens for fattening and minor poultry species for fattening. The applicant is now seeking authorisation as a zootechnical additive for use with all pigs. In the context of a previous opinion, the identity of the strain was confirmed, and according to the Qualified Presumption of Safety (QPS) approach to safety assessment, it was presumed safe for the target species, consumers of products from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, Levucell(®) SB is also considered safe for the target species, including all pigs, consumers and the environment. Levucell(®) is not a skin or eye irritant or a skin sensitiser. Inhalation exposure is unlikely. Encapsulation used in the existing coated forms is not expected to introduce hazards for users. In previous opinions, Levucell(®) SB was found to have the potential to be efficacious in sows and weaned piglets at the dose of 1 × 10(9) colony forming units (CFU)/kg complete feedingstuffs. Since the dose proposed for use with all pigs is the same as that demonstrated to be effective in weaned piglets and sows, and it can be reasonably assumed that the mode of action is the same, the conclusion on efficacy for weaned piglets and sows can be extrapolated to all pigs. Therefore, the FEEDAP Panel concludes that Levucell(®) SB has the potential to be efficacious in all pigs at 1 × 10(9) CFU/kg feedingstuffs. John Wiley and Sons Inc. 2019-01-16 /pmc/articles/PMC7009061/ /pubmed/32626080 http://dx.doi.org/10.2903/j.efsa.2019.5535 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 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 Woutersen, Ruud Brozzi, Rosella Safety and efficacy of Levucell(®) SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for all pigs |
title | Safety and efficacy of Levucell(®)
SB (Saccharomyces cerevisiae
CNCM I‐1079) as a feed additive for all pigs |
title_full | Safety and efficacy of Levucell(®)
SB (Saccharomyces cerevisiae
CNCM I‐1079) as a feed additive for all pigs |
title_fullStr | Safety and efficacy of Levucell(®)
SB (Saccharomyces cerevisiae
CNCM I‐1079) as a feed additive for all pigs |
title_full_unstemmed | Safety and efficacy of Levucell(®)
SB (Saccharomyces cerevisiae
CNCM I‐1079) as a feed additive for all pigs |
title_short | Safety and efficacy of Levucell(®)
SB (Saccharomyces cerevisiae
CNCM I‐1079) as a feed additive for all pigs |
title_sort | safety and efficacy of levucell(®)
sb (saccharomyces cerevisiae
cncm i‐1079) as a feed additive for all pigs |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009061/ https://www.ncbi.nlm.nih.gov/pubmed/32626080 http://dx.doi.org/10.2903/j.efsa.2019.5535 |
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