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

Cyanocobalamin is a synthetic form of vitamin B₁₂ 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 EFSA 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 <i>Ensifer adhaerens</i> strains SCM 2034 or CICC 11008s or <i>Ensifer fredii</i> strain CMCC (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 (FEEDAP) Panel cannot conclude on the safety of the use of vitamin B₁₂ produced using <i>E. adhaerens</i> CICC 11008s and <i>E. fredii</i> CMCC (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 <i>E. adhaerens</i> SCM 2034, including the presence of antibiotic resistance genes, the absence of viable cells of the production strain or their DNA in the product, the FEEDAP Panel cannot conclude on the safety of the use of vitamin B₁₂, produced by <i>E. adhaerens</i> SCM 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 B₁₂ produced by <i>E. adhaerens</i> SCM2034 is considered to pose a risk to user safety. Vitamin B₁₂ additives produced by <i>Ensifer</i> spp. are regarded as effective in meeting animals' requirements.