Safety Assessment on the Safety and Efficacy of 25-Hydroxycholecalciferol (25-OH-D₃) Produced by a Genetically Modified Strain of <i>Saccharomyces Cerevisiae</i> SC0639 as a Feed Additive for All Ruminants (RP1317)

An application was submitted to the Food Standards Agency (FSA) in October 2021 from DSM Nutritional Products Ltd (‘the applicant’) for the new use (extension of species) of an additive containing 25-hydroxycholecalciferol (25-OH-D 3 ) produced by a genetically modified strain of Saccharomyces cerevisiae SC0639, under the category ‘nutritional additive’, functional group ‘vitamins, pro-vitamins and chemically well-defined substances having a similar effect’. The applicant seeks an extension of use from chickens for fattening, turkeys for fattening, other poultry and pigs to include all ruminants. The additive is proposed to be used at an inclusion rate of 100 µg/kg of feed (corresponding to 4000 IU vitamin D 3 /kg feed). To support the FSA and Food Standards Scotland (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 using whole genome sequencing, and upon receiving additional information, members were satisfied with the manufacturing process. Stability was determined to depend on the manufacturer and the composition of the stabilised form. The additive was also concluded to be homogeneously distributed in complete feed for turkeys. No further concerns were raised relating to identity. The ACAF concluded that the additive is safe for the target species, the consumer and the environment. The additive is not an irritant to skin or eyes but should be treated as potentially harmful if inhaled and as a potential skin sensitiser. Upon receipt of further information relating to the inclusion rate of the additive, the ACAF concluded that the inclusion of the additive demonstrates similar effects on performance parameters when compared to vitamin D 3 . The Committee therefore concluded that the additive is effective in raising serum/plasma 25-OH-D 3 levels in comparison with vitamin D 3 for ruminants when used according to the proposed conditions of use. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.