Search

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 Bacillus subtilis. 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 9 108 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 tofeeding supplemented creep feed to suckling piglets cannot be quantified. [ABSTRACT FROM AUTHOR]

The additive B-Act® is a preparation containing viable spores of a strain of Bacillus licheniformis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1.6 × 109 colony-forming unit (CFU)/kg complete feedingstuffs. B. licheniformis is considered by EFSA to be suitable for the qualified presumption of safety approach for establishing safety. As the identity of the active agent was established and the lack of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance were demonstrated, the additive is presumed safe for the target species, consumers and the environment. In the absence of data, no conclusion can be drawn on the skin/eye irritation or skin sensitisation potential. The dustiness of the preparations tested indicated a potential for users to be exposed via inhalation. B-Act® should be considered to have the potential to be a respiratory sensitiser. B-Act® at the recommended dose 1.6 × 109 CFU/kg feed has some potential to improve the feed to gain ratio of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. licheniformis DSM 28710 is compatible with decoquinate, diclazuril, halofuginone, nicarbazin, robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, monensin sodium, narasin and salinomycin sodium. [ABSTRACT FROM AUTHOR]