Scientific Opinion on the safety and efficacy of Calsporin® (Bacillus subtilis) as a feed additive for piglets

Calsporin® is a microbial feed additive based on a single strain of Bacillus subtilis . The applicant is seeking authorisation for the use of the product with piglets at a proposed dose of 3 × 108 CFU/kg complete feedingstuff. The additive is currently authorised for use with chickens for fattening. The identity of the active agent was established in the previous application and belongs to a bacterial species whose safety EFSA considers can be assessed using the QPS approach. The strain is susceptible to antibiotics and evidence was previously provided to demonstrate a lack of toxigenic potential. Thus the product strain meets the qualifications attached to this group of bacilli, and the additive can be presumed safe for the target species, consumers and the wider environment. Five feeding trials are reported, each made with piglets given the additive at the proposed dose compared to matched groups fed the same diet without the additive. A significant improvement in feed to gain ratio and increase in final body weight and average daily gain in animals given the additive compared to control animals was seen in three trials. Consequently, Calsporin® can be considered as effective at the proposed dose.