EU considers vitamin B12 approval as a standard animal feed additive

An application has been submitted under Article 4 to authorise vitamin B12, or cyanocobalamin, as a nutritional additive in feed for all animal species. The additive is produced via fermentation using a non-genetically modified strain of Ensifer adhaerens, followed by a reaction with sodium cyanide. The proposed feed additive contains a minimum purity of 96 % cyanocobalamin by weight. It is intended for use in feedingstuffs through premixtures, with recommended inclusion levels of 10 to 80 micrograms per kilogram of compound feed.

For quantification in the feed additive itself, the European Pharmacopoeia method (Eur. Ph. 0547) based on UV/VIS spectrophotometry is recommended. The Applicant also proposed this same method for determining cyanocobalamin in the additive. Meanwhile, the European Union Reference Laboratory (EURL) endorses this approach for both the feed additive and feedingstuffs.

For compound feed, the EURL advises using reversed phase high-performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV). An alternative in-house microbiological assay was suggested for premixtures and feedingstuffs but raised concerns about its practical use. The authorisation seeks to establish cyanocobalamin as a standard nutritional additive in animal feed. Approved methods for its detection include spectrophotometry for the additive and HPLC-UV for compound feed. The proposed purity and inclusion levels aim to ensure consistent nutritional benefits across animal diets.