Safety Assessment on the Safety and Efficacy of <i>Bacillus licheniformis</i> DSM 28710 (B-Act®) as a Feed Additive for Piglets, Pigs for Fattening, Minor Growing Porcine Species and All Reproductive Porcine Species (RP2163)

An application was submitted to the Food Standards Agency (FSA) in December 2023 from Huvepharma NV (‘the applicant’) for the new authorisation of an additive consisting of viable spores of Bacillus licheniformis DSM 28710 (B-Act ® ) under the category ‘zootechnical additives’, functional group ‘gut flora stabilisers’. The additive is currently authorised in Great Britain (GB) for use in all avian species at a minimum dose of 1.6 x 10 9 CFU/kg feed, and the applicant is seeking authorisation for a new use in piglets, pigs for fattening and minor growing porcine species at a proposed minimum dose of 1.6 x 10 9 CFU/kg complete feed, and in all reproductive swine species at a proposed minimum dose of 3.2 x 10 9 CFU/kg complete feed. The FSA/FSS concluded that the additive and the active agent were correctly identified and characterised. The additive is stable in mash and pelleted pig feed at 25 °C/60% RH for 3 months, and at 40 °C/75% RH for 4 weeks. The additive is stable during pelleting at 105 °C with a retention time of 45 seconds, and is capable of homogenous distribution in mash and pelleted pig feed. The FSA/FSS do not agree with the minimum dose (1.6 x 10 9 CFU/kg feed) proposed by the applicant in the conditions of use for pigs for fattening and minor growing porcine species. B. licheniformis DSM 28710 is suitable for the EFSA Qualified Presumption of Safety (QPS) approach and the additive is safe for the target species, consumer and the environment. B-Act ® is a potential respiratory sensitiser and hazardous at any level of exposure. The additive is non-irritating to eyes and skin but is a presumed skin sensitiser. Measures to minimise skin and respiratory exposure are recommended. To support the FSA and Food Standards Scotland (FSS) in evaluating the dossier, the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to provide advice on the efficacy data provided by the applicant. Following advice from ACAF, the FSA/FSS concluded that B-Act ® has the potential to be efficacious in piglets and other minor porcine species at the same developmental stage at a minimum dose of 1.6 x 10 9 CFU/kg feedingstuffs. B-Act ® has the potential to be efficacious in lactating sows, by means of benefit in the piglets, at a minimum dose of 3.2 x 10 9 CFU/kg feedingstuffs, and this conclusion can be extrapolated to all reproductive porcine species. Based on the demonstration of potential efficacy in weaned piglets and sows, B-Act ® has the potential to be efficacious in pigs for fattening and other minor fattening porcine species at the higher dose of 3.2 x 10 9 CFU/kg feedingstuffs. This safety assessment represents the opinion of the FSA and FSS.