Scientific Opinion on the safety and efficacy of Calsporin® (Bacillus subtilis) for turkeys for fattening, ducks, geese, pigeons and other game birds for meat production, ducks, geese, pigeons, game birds, ornamental and sporting birds for rearing to point of lay, turkeys reared for breeding and chickens reared for laying
Calsporin® is a feed additive based on a strain of Bacillus subtilis. The applicant is seeking authorisation for the use of the product in feeds for turkeys for fattening, ducks, geese, pigeons and other game birds for meat production, ducks, geese, pigeons, game birds, ornamental and sporting birds for rearing to point of lay, and turkeys reared for breeding at the dose of 3 x 108 CFU/kg feed, and for chickens reared for laying at the dose of 5 x 108 CFU/kg feed. EFSA has been requested to deliver an opinion on the safety of the product for target animals, consumers, users and the environment, and on its efficacy. The identity of the active agent was established in a previous assessment and belongs to a bacterial species whose safety EFSA considers can be assessed using the QPS approach. Thus, the product strain meets the qualifications of this group of bacilli and the additive can be presumed safe for the target species, consumers and environment. Three trials conducted with turkeys showed a significant increase in final body weight in birds given the additive at the proposed dose compared to control animals. Consequently, Calsporin® can be considered as efficacious for turkeys for fattening at the dose of 3 x 108 CFU/kg feed. Since the efficacy of Calsporin® for chickens and turkeys for fattening was established, it can be assumed to be efficacious with chickens reared for laying and turkeys reared for breeding at the proposed doses. As the mechanism of action of the additive can be reasonably assumed to be the same as in the major species, and as the proposed dose is the same, efficacy for the minor avian species can be presumed at the dose of 3 x 108 CFU/kg feed. The compatibility of Calsporin® was demonstrated with aut horised coccidiostats.