Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiae DBVPG 48 SF (BioCell®) for horses, pigs and ruminants (Mazzoleni S.p.A.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae 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(9) CFU/kg complete feed for horses, 4 × 10(8) CFU/kg complete feed for dairy cows and minor dairy species, 4 × 10(9) 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(9) CFU/kg complete feed for sows and minor porcine species for reproduction. Saccharomyces cerevisiae 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.