Safety Assessment RP24-25-26 Saccharomyces Cerevisiae MUCL39885 - 4B1710

An application was submitted to the Food Standards Agency in January 2021 from PROSOL, S.p.A, Italy (“the applicant) for the authorisation of an additive (Biosprint®) containing Saccharomyces cerevisiae MUCL 39885 cells, under the category of ‘zootechnical’ additives, functional group ‘gut flora stabilisers’. The additive contains only Saccharomyces cerevisiae MUCL 39885 cells and is proposed to be supplied at a minimum dose of 3x109 colony forming units (CFU)/kg of complete feedstuff for all pigs other than sows and suckling piglets, and a minimum of 7x1010 of complete feedstuff for cats and dogs. It aims to improve the faecal consistency of the target animals. To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. A comprehensive literature review, an independent scientific evaluation and a cytotoxicity by MTT test were evaluated by AFFAJEG, and it was concluded that the additive is safe for the proposed target species, consumers and the environment. The additive should be considered a skin and respiratory sensitiser and a potential skin and eye irritant for users. AFFAJEG concluded that the existing efficacy data in piglets and sows could be extrapolated to all pigs and minor porcine species other than suckling piglets, weaned piglets and sows, and that the additive is efficacious for improving faecal consistency at the proposed doses of 3x109 CFU/g. Three long-term efficacy studies in dogs and one for cats were evaluated by AFFAJEG, which concluded that the additive can be considered efficacious for improving faecal consistency in both species at the proposed dose of 7x1010 CFU/g. The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.