Safety Assessment on the Safety and Efficacy of an Additive of Enterococcus faecium DSM 2121913, Bifidobacterium ⁠animalis spp. ⁠animalis DSM 16284 and Ligilactobacillus salivarius DSM 16351 (Biomin® C3) as a Feed Additive for Its Use in All Poultry Species for Fattening and Reared for Laying/ Breeding (RP1603)

Abstract

An application was submitted to the Food Standards Agency in June 2022 from BIOMIN GmbH (‘the applicant’) for the renewal authorisation of an additive consisting of Enterococcus faecium DSM 21913, Bifidobacterium animalis ssp. animalis DSM 16284 and Ligilactobacillus salivarius DSM 16351 (Biomin® C3), under the category of ‘zootechnical additive’ and functional group ‘gut flora stabiliser’ for its use in chickens for fattening, chickens reared for laying and minor poultry species other than laying and for the extension of use of the additive under the same category for its use in all poultry species for fattening and reared for laying/breeding. The additive is proposed to be used at a minimum inclusion rate of 1 × 108 CFU/kg in complete feed or 5 × 107 CFU/L in drinking water. The FEEDAP Panel concluded that Biomin® C3 remains safe for chickens for fattening, chickens reared for laying, and minor poultry species other than laying, as well as for consumers and the environment, under the authorized conditions of use. The Panel concluded that extending the use of the additive to all poultry for fattening and reared for laying/breeding is safe for the target species, consumers, and the environment. The additive is efficacious at a minimum inclusion level of 1 × 108 CFU/kg in complete feed and 5 × 107 CFU/L in water. The additive should be considered as a potential respiratory sensitiser but as non-irritant to eyes and skin. Conclusions could not be drawn on the potential to cause skin sensitisation. FSA/FSS has reviewed the applicant’s renewal and extension of use application, supporting documentation, and other regulators risk assessments, most notably the EFSA risk assessment opinion and consider sufficient evidence has been demonstrated to conclude without further questions or risk assessment. This document represents the opinion of the FSA and FSS.