Safety and efficacy of GalliPro® Fit (Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840) for all poultry species for fattening or reared for laying/breeding
Following a request from the European Commission, the 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 GalliPro® Fit (Bacillus subtilis DSM 32324, B. subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840) when used as a zootechnical additive in feed and water for drinking for all poultry species for fattening or reared for laying/breeding. The two bacterial species present in the additive are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agents was established and the lack of toxigenic potential confirmed. The strains did not show resistance to relevant antibiotics. Therefore, the additive was presumed safe for the target species, consumers and the environment. In the absence of data, no conclusions could be drawn on the skin/eye irritancy or skin sensitisation of the additive. Due to the proteinaceous nature of the active agents, the additive was considered a respiratory sensitiser. The Panel concluded that GalliPro® Fit is compatible with diclazuril, decoquinate and halofuginone. However, the data provided did not allow to conclude on the compatibility of the additive with other coccidiostats. The Panel concluded that the additive has a potential to be efficacious in chickens for fattening at 1.6 × 109CFU/kg feed and at 5.4 × 108CFU/L water for drinking. The conclusion was extrapolated to all other poultry species for fattening or reared for laying/breeding. The results from the study in turkeys support this conclusion.