EU evaluates cyanocobalamin as a feed additive for animal nutrition

A new assessment has been carried out for the use of vitamin B12, or cyanocobalamin, as a feed additive. The substance is intended for incorporation in animal feed through premixtures. Its minimum purity is set at 96% by weight. The applicant initially proposed the European Pharmacopoeia method (Eur. Ph. 0547) for determining cyanocobalamin in the feed additive. The European Union Reference Laboratory (EURL) supports this method for official control of the additive itself.

For the analysis of cyanocobalamin in compound feed, the EURL instead recommends reversed phase high performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV). This aligns with Commission Implementing Regulation (EU) 2024/3167, which also endorses HPLC-UV for quantification in compound feed. Additionally, the AOAC method, involving immunoaffinity column clean-up and HPLC-UV, has been validated for vitamin B12 in feedingstuffs, with repeatability and intermediate precision values between 9.0–10.8% and 10.1–10.8% respectively.

The proposed use of cyanocobalamin in feedingstuffs would see levels ranging from 10 to 80 micrograms per kilogram of compound feed. Authorisation is being sought under Article 4 for its role as a nutritional additive in animal feed. The assessment confirms the suitability of HPLC-UV for testing cyanocobalamin in compound feed. The European Pharmacopoeia method remains the preferred choice for controlling the additive itself. The findings support the proposed authorisation for its use in animal nutrition.