Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiae DBVPG 48 SF (BioCell®) for horses, pigs and ruminants (Mazzoleni S.p.A.).
Abstract: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of DBVPG 48 SF (BioCell®) as a zootechnical feed additive for horses, pigs and ruminants. The product, manufactured in three formulations (microsphere, micropellet and powder), is intended for use in complete feed at a minimum inclusion level of 3 × 10 CFU/kg complete feed for horses, 4 × 10 CFU/kg complete feed for dairy cows and minor dairy species, 4 × 10 CFU/kg complete feed for calves, cattle for fattening, minor growing and fattening ruminants, piglets and pigs for fattening and minor porcine species and 6 × 10 CFU/kg complete feed for sows and minor porcine species for reproduction. is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was conclusively established and, therefore, the use of the additive in animal nutrition is considered safe for the target species, the consumer and the environment. The additive, in any formulation, is not irritant to the eyes and skin but should be considered a respiratory sensitiser. The Panel cannot conclude on the skin sensitisation potential of the additive. The Panel concluded that the additive has the potential to be efficacious at the proposed conditions of use for horses, dairy ruminants and all pigs. However, the Panel was not in the position to conclude on the efficacy of the additive for calves, and neither for cattle for fattening, minor growing and fattening ruminants.
© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
Publication Date: 2023-04-20 PubMed ID: 37089174PubMed Central: PMC10116400DOI: 10.2903/j.efsa.2023.7971Google Scholar: Lookup
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Summary
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The research article discusses the safety and effectiveness of the Saccharomyces cerevisiae DBVPG 48 SF feed additive (BioCell®) for different animals including horses, pigs, and ruminants, concluding it’s safe and potentially effective for specific animal groups.
Research Details
The research was carried out following a request from the European Commission and was conducted by the European Food Safety Authority (EFSA). The product evaluated is made in three different formulations: microsphere, micropellet, and powder. It is intended to be used in complete feed for horses, pigs, dairy cows, minor dairy species, calves, cattle for fattening, piglets, pigs for fattening, and minor porcine species at various minimum inclusion levels.
- 3 × 10 CFU/kg complete feed for horses
- 4 × 10 CFU/kg complete feed for dairy cows and minor dairy species
- 4 × 10 CFU/kg complete feed for calves, cattle for fattening, minor growing and fattening ruminants, piglets and pigs for fattening and minor porcine species
- 6 × 10 CFU/kg complete feed for sows and minor porcine species for reproduction
Findings
The EFSA concluded that BioCell was safe for the target species, the environment, and consumers since the identity of the strain is conclusively established.
- The use of BioCell in animal feeds did not cause irritation to the eyes or skin.
- BioCell might sensitize the respiratory system, although the panel did not draw a conclusion on the potential for skin sensitization.
Efficacy Conclusions
The research also examined the efficacy of BioCell under the proposed conditions of use.
- The panel concluded that BioCell has the potential to be effective for horses, dairy ruminants, and all pig categories.
- However, the EFSA panel could not draw conclusions on the effectiveness of the supplement for calves, cattle for fattening, and minor growing and fattening ruminants.
The results of the EFSA’s examination support future use of BioCell as a zootechnical feed additive in regulated contexts and industries.
Cite This Article
APA
Bampidis V, Azimonti G, Bastos ML, Christensen H, Durjava M, Dusemund B, Kouba M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brantom P, Dierick N, Anguita M, Brozzi R, Galobart J, Innocenti ML, Navarro-Villa A, Ortuño J, Pizzo F, Revez J.
(2023).
Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiae DBVPG 48 SF (BioCell®) for horses, pigs and ruminants (Mazzoleni S.p.A.).
EFSA J, 21(4), e07971.
https://doi.org/10.2903/j.efsa.2023.7971 Publication
Researcher Affiliations
References
This article includes 10 references
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