Scientific Opinion on the safety and efficacy of BioPlus 2B ( Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750) as a feed additive for sows

The European Food Safety Authority was asked to deliver a scientific opinion on the safety and efficacy of the product BioPlus 2B (Bacillus licheniformis and Bacillus subtilis) when used as a feed additive for sows. This product is already authorised for use in piglets, pigs for fattening, turkeys for fattening, calves and for sows from two weeks before farrowing and during lactation. The current application regards an extension of use to cover the whole reproduction period of sows, from mating to the end of lactation at the dose of 1.28 x 109 CFU/kg feed. The safety of this additive for the target animals, the consumer, the user and the environment has been established and will not be affected by the proposed extension of use. Consequently, the FEEDAP Panel considered only the efficacy of the additive for the benefit of piglets during the total reproductive period of sows. Three trials were provided covering at least one reproductive cycle. Although, one study showed reduction in piglet mortality, numbers of weaned piglets and litter weight at weaning were unaffected in all studies. Therefore, the FEEDAP Panel finds insufficient evidence of any benefit when sows are treated with BioPlus 2B over the entire reproductive period.