Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces cerevisiae MUCL 39885) for dairy cows and horses.
Abstract: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of the product Biosprint ( MUCL 39885) as a feed additive for dairy cows and horses. is considered by EFSA to have qualified presumption of safety (QPS) status. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel confirms that the use of Biosprint under the current authorised conditions of use is safe for the target species, the consumers and the environment. The additive is considered as a potential skin and eye irritant and skin/respiratory sensitiser. There is no need to assess the efficacy of Biosprint in the context of the renewal of the authorisation.
© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Publication Date: 2019-11-28 PubMed ID: 32626192PubMed Central: PMC7008807DOI: 10.2903/j.efsa.2019.5915Google Scholar: Lookup
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- Journal Article
Summary
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This research article summarises a review carried out by the European Food Safety Authority (EFSA) regarding the renewal of authorisation of Biosprint, a feed additive for dairy cows and horses, confirming its safety for the animals, consumers and environment.
Objective of the research
- The main objective of this research was to deliver a scientific opinion on the renewal of authorisation for the product Biosprint (Saccharomyces cerevisiae MUCL 39885) as an animal feed additive for dairy cows and horses. This product review was requested by the European Commission and conducted by EFSA.
Product Safety
- EFSA recognizes Biosprint holds a Qualified Presumption of Safety (QPS) status. This means the product is presumed to be safe for the specific uses it has been authorized for, unless new evidence demonstrates otherwise.
- The data provided by the applicant showed that the feed additive complies with the conditions under which it was authorized, which is fundamental for its reauthorization.
- The use of Biosprint under its currently authorised conditions is declared safe for the target species, the consumers of the animals’ products, and the environment, according to the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP).
Potential Risks
- Although Biosprint is safe to use as a feed additive, it is considered as a potential skin and eye irritant, as well as a possible skin/respiratory sensitiser. Therefore, it should be handled with caution to avoid direct contact.
Efficacy Assessment
- In the context of the renewal of the authorisation, there was no requirement to assess the efficacy of Biosprint. The focus was primarily on evaluating its safety according to the current conditions of use.
Cite This Article
APA
Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Kouba M, Kos Durjava M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Anguita M, Galobart J, Holczknecht O, Manini P, Tarrés-Call J, Pettenati E, Pizzo F.
(2019).
Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces cerevisiae MUCL 39885) for dairy cows and horses.
EFSA J, 17(11), e05915.
https://doi.org/10.2903/j.efsa.2019.5915 Publication
Researcher Affiliations
References
This article includes 9 references
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- EFSA FEEDAP Panel. Safety and efficacy of Biosprint® (Saccharomyces cerevisiae) as a feed additive for sows. EFSA Journal 2009;7 (2):970, 9 pp.
- EFSA FEEDAP Panel. Scientific Opinion on the safety and efficacy of Biosprint® (Saccharomyces cerevisiae) as a feed additive for dairy cows. EFSA Journal 2010;8(7):1662, 8 pp.
- EFSA FEEDAP Panel. Scientific Opinion on the safety and efficacy of Biosprint® (Saccharomyces cerevisiae) as a feed additive for horses. EFSA Journal 2010;8(7):1659, 10 pp.
- EFSA FEEDAP Panel. Scientific Opinion on the safety and efficacy of Biosprint® (Saccharomyces cerevisiae) for piglets. EFSA Journal 2010;8(10):1864, 9 pp.
- EFSA FEEDAP Panel. Guidance on the renewal of the authorization of feed additives. EFSA Journal 2013;11(10):3431, 8 pp.
- EFSA FEEDAP Panel. Scientific Opinion on the safety and efficacy of Biosprint® (Saccharomyces cerevisiae MUCL 39885) for minor ruminant species for meat and milk production. EFSA Journal 2015;13(7):4199, 8 pp.
- EFSA FEEDAP Panel. Guidance on the characterisation of microorganisms used as feed additives or as production organisms. EFSA Journal 2018;16(3):5206, 24 pp.
Citations
This article has been cited 3 times.- Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Fašmon Durjava M, Kouba M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Martelli G, Anguita M, Galobart J, Manini P, Tarrés-Call J, Pettenati E, Pizzo F. Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiaeMUCL 39885 (Biosprint(®)) for cats and dogs (Prosol S.p.A.).. EFSA J 2021 Jul;19(7):e06699.
- Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Fašmon Durjava M, Kouba M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Anguita M, Galobart J, Manini P, Pettenati E, Tarrés-Call J, Pizzo F. Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiaeMUCL 39885 (Biosprint(®)) for all pigs (other than sows and weaned piglets) and other minor porcine species (Prosol S.p.A.).. EFSA J 2021 Jul;19(7):e06698.
- Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Kos Durjava M, Kouba M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Anguita M, Galobart J, Holczknecht O, Manini P, Tarrés-Call J, Pettenati E, Pizzo F. Assessment of the application for renewal of authorisation of Biosprint(®) (Saccharomyces cerevisiae MUCL 39885) as a feed additive for weaned piglets.. EFSA J 2020 Nov;18(11):e06284.
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