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Assessment of the application for renewal of authorisation of Yea‐Sacc(®) (Saccharomyces cerevisiae) for horses

Yea‐Sacc(®) is an additive based on a live preparation of a strain of Saccharomyces cerevisiae intended for use as a zootechnical additive (digestibility enhancer). The current assessment is performed in the context of the renewal of the authorisation of the feed additive; however, the applicant pro...

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Autores principales: Bampidis, Vasileios, Azimonti, Giovanna, de Lourdes 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 Edoardo, Woutersen, Ruud, Anguita, Montserrat, Galobart, Jaume, Holczknecht, Orsolya, Manini, Paola, Tarrés‐Call, Jordi, Pettenati, Elisa, Pizzo, Fabiola
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008869/
https://www.ncbi.nlm.nih.gov/pubmed/32626206
http://dx.doi.org/10.2903/j.efsa.2019.5918
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author Bampidis, Vasileios
Azimonti, Giovanna
de Lourdes 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 Edoardo
Woutersen, Ruud
Anguita, Montserrat
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Tarrés‐Call, Jordi
Pettenati, Elisa
Pizzo, Fabiola
author_facet Bampidis, Vasileios
Azimonti, Giovanna
de Lourdes 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 Edoardo
Woutersen, Ruud
Anguita, Montserrat
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Tarrés‐Call, Jordi
Pettenati, Elisa
Pizzo, Fabiola
collection PubMed
description Yea‐Sacc(®) is an additive based on a live preparation of a strain of Saccharomyces cerevisiae intended for use as a zootechnical additive (digestibility enhancer). The current assessment is performed in the context of the renewal of the authorisation of the feed additive; however, the applicant proposed also to lower (6.5 × 10(8) colony forming unit (CFU)/kg of complete feedingstuff) the minimum dose of the additive when used in feed for horses. The additive is produced in a powder (Yea‐Sacc(®)) and in a prills (Yea‐Sacc(®)_TS) forms. The Panel considered that the additive currently on the market complies with the existing conditions of authorisation. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the production strain has been confirmed, safety for the target species, consumer and the environment were presumed. Both formulations are non‐irritant to skin, Yea‐Sacc(®)_TS is non‐irritant to the eye while Yea‐Sacc(®) is a moderate irritant. Both formulations should be considered skin sensitisers and because of their high proteinaceous nature, they should be considered as potential respiratory sensitisers. The applicant submitted two efficacy studies: the FEEDAP Panel concluded that in the first study inconsistent results were observed for the two lower doses which are considered microbiologically equivalent. The second study demonstrated that Yea‐Sacc(®) at the level of 7.5 × 10(8) resulted in a better digestion of organic matter which may be explained by increases in digestibility of the fibre. Based on the data provided, the FEEDAP Panel cannot conclude on the efficacy of Yea‐sacc(®) when used as a feed additive in horses at the proposed level (6.5 × 10(8) CFU/kg complete feed).
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spelling pubmed-70088692020-07-02 Assessment of the application for renewal of authorisation of Yea‐Sacc(®) (Saccharomyces cerevisiae) for horses Bampidis, Vasileios Azimonti, Giovanna de Lourdes 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 Edoardo Woutersen, Ruud Anguita, Montserrat Galobart, Jaume Holczknecht, Orsolya Manini, Paola Tarrés‐Call, Jordi Pettenati, Elisa Pizzo, Fabiola EFSA J Scientific Opinion Yea‐Sacc(®) is an additive based on a live preparation of a strain of Saccharomyces cerevisiae intended for use as a zootechnical additive (digestibility enhancer). The current assessment is performed in the context of the renewal of the authorisation of the feed additive; however, the applicant proposed also to lower (6.5 × 10(8) colony forming unit (CFU)/kg of complete feedingstuff) the minimum dose of the additive when used in feed for horses. The additive is produced in a powder (Yea‐Sacc(®)) and in a prills (Yea‐Sacc(®)_TS) forms. The Panel considered that the additive currently on the market complies with the existing conditions of authorisation. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the production strain has been confirmed, safety for the target species, consumer and the environment were presumed. Both formulations are non‐irritant to skin, Yea‐Sacc(®)_TS is non‐irritant to the eye while Yea‐Sacc(®) is a moderate irritant. Both formulations should be considered skin sensitisers and because of their high proteinaceous nature, they should be considered as potential respiratory sensitisers. The applicant submitted two efficacy studies: the FEEDAP Panel concluded that in the first study inconsistent results were observed for the two lower doses which are considered microbiologically equivalent. The second study demonstrated that Yea‐Sacc(®) at the level of 7.5 × 10(8) resulted in a better digestion of organic matter which may be explained by increases in digestibility of the fibre. Based on the data provided, the FEEDAP Panel cannot conclude on the efficacy of Yea‐sacc(®) when used as a feed additive in horses at the proposed level (6.5 × 10(8) CFU/kg complete feed). John Wiley and Sons Inc. 2019-12-19 /pmc/articles/PMC7008869/ /pubmed/32626206 http://dx.doi.org/10.2903/j.efsa.2019.5918 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
de Lourdes 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 Edoardo
Woutersen, Ruud
Anguita, Montserrat
Galobart, Jaume
Holczknecht, Orsolya
Manini, Paola
Tarrés‐Call, Jordi
Pettenati, Elisa
Pizzo, Fabiola
Assessment of the application for renewal of authorisation of Yea‐Sacc(®) (Saccharomyces cerevisiae) for horses
title Assessment of the application for renewal of authorisation of Yea‐Sacc(®) (Saccharomyces cerevisiae) for horses
title_full Assessment of the application for renewal of authorisation of Yea‐Sacc(®) (Saccharomyces cerevisiae) for horses
title_fullStr Assessment of the application for renewal of authorisation of Yea‐Sacc(®) (Saccharomyces cerevisiae) for horses
title_full_unstemmed Assessment of the application for renewal of authorisation of Yea‐Sacc(®) (Saccharomyces cerevisiae) for horses
title_short Assessment of the application for renewal of authorisation of Yea‐Sacc(®) (Saccharomyces cerevisiae) for horses
title_sort assessment of the application for renewal of authorisation of yea‐sacc(®) (saccharomyces cerevisiae) for horses
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008869/
https://www.ncbi.nlm.nih.gov/pubmed/32626206
http://dx.doi.org/10.2903/j.efsa.2019.5918
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