Safety Assessment RP222 Selenised Yeast Saccharomyces Cerevisiae CNCM I-3060 Inactivated

An application was submitted to the Food Standards Agency (FSA) in February 2021 from All-technology Ireland Ltd. (Alltech Ireland), (“the applicant”) for the authorisation of an additive containing selenised inactivated Saccharomyces cerevisiae CNCM I-3060. The application is for a modification of authorisation, in the category of ‘nutritional additives’, functional group ‘compound of trace elements’, as a source of selenium for feed. The modification proposed to increase the maximum dose of selenium content from 2000 mg Se/kg to 3500 mg Se/kg. 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. ACAF concluded that the additive can be considered safe for the target species, the consumer and the environment as long as the limits of 0.2 mg Se/kg (supplementation) and 0.5 mg Se/kg (total feed) are not exceeded. The AFFAJEG concluded that the additive should be considered as hazardous through inhalation, as well as a respiratory sensitiser, and to not be a skin sensitiser, skin irritant or eye irritant.