Safety and efficacy of Bacillus subtilis DSM 28343 as a feed additive for piglets

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of <i>Bacillus subtilis</i> DSM 28343 when used in feed for weaned piglets. The additive is a preparation containing viable spores of a strain of <i>B. subtilis</i>. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of a previous opinion and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. In the same opinion, the FEEDAP Panel concluded that <i>Bacillus subtilis</i> DSM 28343 is not an eye/skin irritant but should be considered as a potential respiratory sensitiser and that no conclusion could be drawn on its skin sensitisation potential. These conclusions apply also to the current application. <i>Bacillus subtilis</i> DSM 28343 at 1 × 10⁹ CFU/kg feedingstuffs has the potential to be efficacious in weaned piglets.