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

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 calves for rearing. 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. 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 the target species, consumers of products derived from animals fed the additive 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 a potential respiratory sensitiser and that no conclusion could be drawn on its skin sensitisation potential. These conclusions apply also to the current application. Insufficient evidence was provided to conclude on the efficacy of the additive in calves for rearing.