Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) as a feed additive for dogs

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Calsporin^® when used in feed for dogs. 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. This approach 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, including dogs, and for the environment. In a previous opinion, the Panel also concluded that the additive is not a dermal/eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. The use of the additive in dogs is considered unlikely to introduce hazards for users of the product not already considered as part of the first assessment. Therefore, the conclusions reached apply to the current application. Four studies were supplied aiming at investigating the effects of the supplementation of Calsporin^® to the faecal consistency of dogs. Overall, there is a small but significant increase in faecal dry matter content and benefits seen in a subjective assessment of faecal consistency. However, the biological relevance of changes of this magnitude for the animal is questionable, as are the practical benefits for the owner.