Safety Assessment on the Safety and Efficacy of an Additive of 25-Hydroxycholecalciferol (Bio D® 1.25%) as a Feed Additive for Poultry for Fattening, Other Poultry (Layers, Broiler, Breeders), Ornamental Birds and All Pigs (RP1335)

An application was submitted to the Food Standards Agency (FSA) in November 2021 from Huvepharma NV (‘the applicant’) for the authorisation of 25-hydroxycholecalciferol (Bio D ® 1.25%) as a feed additive under the category of ‘nutritional’ additives, functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. The additive contains a minimum of 1.25% 25-hydroxycholecalciferol and seeks authorisation for a modification of its production process using Pseudonocardia autotrophica M301 (DSM 32858) as a production organism, and to be used at a maximum dose of: 100 µg/kg, 80 µg/kg, 50 µg/kg of complete feed with 12% moisture in poultry for fattening, other poultry and pigs, respectively; 50 µg/kg, 40 µg/kg, 25 µg/kg in drinking water in poultry for fattening, other poultry and pigs, respectively. The FSA/FSS concluded the additive and production strain were correctly identified. It is not a dusty product, however the particle size distribution was not characterised fully. The additive is stable for 24 months at room temperature and acceptably stable in premixtures and feed. Stability during pelleting could not be determined. Homogeneity in feed was demonstrated. The presence of live cells from the production organism in the final form of the product could not be ruled out. The FSA/FSS cannot conclude on the safety of the additive Bio D ® 1.25% for the target species and consumers as currently formulated when produced by P. autotrophica M301 (DSM 32858). The additive is not a skin irritant or sensitiser and is not an eye irritant. The additive has a low dusting potential which would limit exposure through inhalation, however, uncertainties remain on its particle size distribution. Conclusions could not be drawn on the systemic toxicity potential of the additive, and the presence of live cells from the production strain in the final product could not be ruled out. These factors pose a concern for the safety for the user/worker. The additive can be considered safe for the environment. 25-hydroxycholecalciferol can be considered efficacious for the target species at the proposed doses of inclusion. Conclusions on chickens for fattening can be extrapolated to ornamental birds. This Safety Assessment represents the opinion of the FSA and FSS.