Safety Assessment RP641 Bacillus Velezensis DSM 15544

An application was submitted to the Food Standards Agency (FSA) in March 2021 from Asahi Biocycle Co., Ltd (“the applicant”) for the authorisation of an additive (Calsporin ®) containing a minimum 1x1010 CFU/g of Bacillus velezensis DSM 15544, under the category of ‘zootechnical’ additives, functional group ‘gut flora stabilisers’. The application is for a request of extension of authorisation from chickens for fattening and laying hens to all other poultry and avian species for fattening, laying and breeding. The additive Calsporin® was fully characterised and no major causes for concern were identified by the Joint Expert Group On Animal Feed And Feed Additives (AFFAJEG) in the identity, production, characterisation or conditions of use sections. To support the FSA and Food Standards Scotland (FSS) in evaluating the dossier, the Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. The AFFAJEG concluded that the additive can be considered safe for the target species, the consumer and the environment, due to the Qualified Presumption of Safety (QPS) status of the microorganism Bacillus velezensis DSM 15544. The additive should be considered as a potential respiratory sensitiser and irritant. The Group concluded that it is possible to extrapolate conclusions on efficacy from the original authorisation in chickens for fattening and laying hens and, therefore, the additive has the potential to be efficacious in other poultry, sporting and game birds, exotic and ornamental birds for rearing, fattening, egg production or breeding, when used at a minimum concentration of 3x108 CFU/kg feed in complete feedstuff (with moisture content of 12%). The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.