Safety Assessment on the Safety and Efficacy of <i>Bacillus Velezensis</i> ATCC PTA-6737 (PB6) as a Feed Additive for Weaned Piglets, Weaned Minor Porcine Species, Sows and All Pig species. (RP1512)

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in April 2022 from Kemin Europa N.V. (‘the applicant’) for the renewal and new use (extension of species) to all pig species of an additive containing Bacillus velezensis ATCC PTA-6737 under the category ‘zootechnical’, functional group ‘gut flora stabiliser’. The additive is proposed to be used at a minimum content of 1 x 10 7 CFU/kg complete feedingstuff in piglets (weaned), minor porcine species (weaned) and in growing pigs, and at a minimum content of 1 x 10 8 CFU/kg complete feedingstuff in sows and minor reproductive porcine species. To support the FSA and FSS in evaluating the dossier, the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly identified and characterised, and that it is stable for 18 months at room temperature, for 6 months as part of a mineral premix and a finished mash feed, and for 3 months after pelleting when held at a maximum of 90°C for 45 seconds. Homogeneity was also demonstrated. The ACAF concluded that the additive is presumed safe for the target species, the consumer and the environment due to its Qualified Presumption of Safety (QPS) status. The additive is not an irritant to skin or eyes but should be treated as a potential skin and respiratory sensitiser. The ACAF concluded that the additive is efficacious in weaned piglets at a dose of 1 x 10 7 CFU/kg complete feed. The Committee also concluded that the additive has the potential to be efficacious in sows and minor reproductive species at a dose of 1 x 10 8 CFU/kg complete feed. The Committee could not accept the applicant’s specific request for extrapolation from piglets to all growing pigs due to lack of evidence for efficacy when fed at the lower dose (1 x 10 7 CFU/kg) proposed in pigs. However, given the presence of three significant piglet trials and three significant sow trials the Committee was satisfied that the studies provided supported efficacy in all pigs when the higher dose of 1 x 10 8 CFU/kg was utilised for pigs in the fattening phase. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.