Scientific Opinion on the safety and efficacy of Bacillus subtilis PB6 (Bacillus subtilis) as a feed additive for laying hens and minor poultry species for laying
Bacillus subtilis PB6 is the trade name for a feed additive based on viable spores of a strain of Bacillus subtilis. This species is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. This approach requires the identity of the active agent to be established and the absence of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance to be demonstrated. No evidence of toxigenic potential or of resistance to antibiotics of human and veterinary importance was found as judged by the current guidelines. Consequently, the strain of B. subtilis in the additive is presumed safe for target animals, consumers and the environment. This conclusion covers the use of the additive in feed for laying hens and minor poultry species for laying. Use of the additive in feed for laying hens and minor poultry species will not introduce hazards for users not already considered. All four trials made with laying hens showed some evidence of a beneficial effect of the additive on egg production when used at a minimum dose of 1 × 108 colony-forming units (CFU)/kg complete feed, by increasing laying rate or average egg weight. The FEEDAP Panel concludes that Bacillus subtilis PB6 shows some potential to be efficacious in laying hens. This conclusion on efficacy for laying hens can be extended to minor poultry species raised for laying when the additive is used at the same minimum dose.