Safety and efficacy of vitamin B12 (in the form of cyanocobalamin) produced by Ensifer spp. as a feed additive for all animal species based on a dossier submitted by VITAC EEIG

摘要

Cyanocobalamin is a synthetic form of vitamin B used in pharmaceuticals, supplements and as a food additive. It is intended to be used in feed for all animal species and categories. The European Commission asked for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of cyanocobalamin produced by fermentation with strains 2034 or 11008s or strain (B) 70000. Since relevant data were not provided by the applicant that would allow a proper identification and characterisation of the production strains, the Additives and Products or Substances used in Animal Feed ( ) Panel cannot conclude on the safety of the use of vitamin B produced using 11008s and (B) 70000 in animal nutrition for the target animals, the consumer, the user and the environment. Due to significant uncertainties on the identity and safety of the production strain 2034, including the presence of antibiotic resistance genes, the absence of viable cells of the production strain or their in the product, the Panel cannot conclude on the safety of the use of vitamin B , produced by 2034 in animal nutrition for the target species, consumers and the environment. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, vitamin B produced by 2034 is considered to pose a risk to user safety. Vitamin B additives produced by spp. are regarded as effective in meeting animals’ requirements.