Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for sows and suckling 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 Calsporin^® when used in feed for sows and piglets. The additive contains viable spores of a single strain of <i>Bacillus 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 previous opinions and since concerns are not expected from other components of the additive, Calsporin^® is presumed safe for all target species, consumers and the environment. In a previous opinion, the FEEDAP Panel concluded that Calsporin^® is not a dermal/eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. Use of the additive in feed for sows and suckling piglets will not introduce hazards for users not already considered. Three trials performed with sows over a complete reproductive cycle and their offspring showed positive effects on zootechnical parameters of sows and piglets. Therefore, Calsporin^® has the potential to improve one or more performance parameters of sows and suckling piglets when supplemented to both sows and suckling piglets at 3 × 10⁸ CFU/kg of complete feedingstuffs. In the view of the FEEDAP Panel, the effects observed can predominantly be traced back to the administration of the additive to pregnant/lactating sows. The proportion of effects which could be related to feeding supplemented creep feed to suckling piglets cannot be quantified.