Animavit® is the trade name for a feed additive based on viable cells of a strain of Bacillus subtilis. It is intended for use with piglets and pigs for fattening at a minimum dose of 2 x 109 and a maximum dose of 1 x 1010 CFU/kg complete feed. The product has not been previously authorised in the European Union. B. subtilis is a species
which EFSA recognises as being suitable for the QPS approach to the assessment of safety. This requires an assessment of toxigenic potential and resistance to relevant antibiotics. The lack of toxigenic potential was
established on the basis of the full genome sequence analysis and a series of cytotoxicity assays. The minimum inhibitory concentrations of the antibiotics tested all fell below the defined breakpoints. Consequently, the
FEEDAP Panel concludes that Animavit® is safe for the target animals, consumers and the environment. Animavit® is not irritant to skin and eyes. However, the product is a skin sensitiser and should be labelled
accordingly. Given the nature of the product and the evidence of skin sensitisation, Animavit® should be considered as also having the potential to cause sensitisation via the respiratory route. On the basis of the in vivo
studies provided, Animavit® was shown to have the potential to improve the daily weight gain of weaned piglets in three studies at the dose of 2 x109 CFU/kg feed. A further three studies with pigs for fattening showed the same effects at the same dose.