Scientific Opinion on the safety and efficacy of Bacillus subtilis PB6 as a feed additive for weaned piglets and weaned minor porcine species

Bacillus subtilis PB6 is the trade name for a feed additive based on viable spores of a single strain of Bacillus subtilis. The additive currently is authorised for use in diets for chickens for fattening, chickens reared for laying, ducks for fattening and other minor avian species. B. subtilis is considered by EFSA to be suitable for the Qualified Presumption of Safety approach to establishing safety for the target species, consumers and the environment. The identity of the active agent in PB6 was established and the absence of toxigenic potential and resistance determinants to antibiotics demonstrated as part of a previous assessment for use with chickens for fattening. Consequently the strain is presumed safe for all animal species, consumers of the products of any animals given the additive and the environment. In the course of the previous assessment, safety for users was also examined. Evidence was provided that the additive is non-irritant to skin and eyes and is not a skin sensitiser. Given the very low dusting potential of the formulation, exposure of users via a respiratory route was also considered unlikely. Bacillus subtilis PB6 appears to have a potential to improve the production of weaned piglets. However, a minimum effective dose could no be established from the data provided. Since a minimum effective dose could not be established for a major porcine species (weaned piglets), it is not possible to extrapolate to weaned minor porcine species.