EU approves high-purity vitamin B12 feed additive for animal nutrition
A new feed additive containing vitamin B12 (cyanocobalamin) has been assessed for use in animal nutrition. The product, made through fermentation with a non-genetically modified bacterial strain, meets a minimum purity of 96%. Authorities have now outlined the recommended testing methods for its safe and accurate measurement in feed.
The feed additive is produced using Ensifer adhaerens CGMCC 19596, a non-GM strain, ensuring a high-purity cyanocobalamin content. Its authorisation is sought under Article 4 of EU regulations, specifically for nutritional use in animal feed. The vitamin is intended for incorporation into feedingstuffs via premixtures, with recommended levels between 10 and 80 micrograms per kilogram of compound feed.
The European Union Reference Laboratory (EURL) has reviewed multiple testing approaches. For the feed additive itself, the European Pharmacopoeia method (Eur. Ph. 0547) is recommended. Meanwhile, for compound feed, reversed phase liquid chromatography with UV detection (HPLC-UV) is advised, based on an AOAC-validated ring-trial method. These methods have shown reliable performance, with repeatability deviations between 9.0% and 10.8%, and intermediate precision deviations from 10.1% to 10.8%. An in-house microbiological assay was proposed for detecting cyanocobalamin in premixtures and feedingstuffs. However, concerns about its practical use have been raised. The EURL has concluded that no further validation is required for the recommended methods, as current protocols meet the necessary standards.
The EU’s Implementing Regulation (EU) 2024/3167 now formally endorses the European Pharmacopoeia method for the feed additive and HPLC-UV for compound feed. These decisions provide clear guidelines for manufacturers and laboratories, ensuring consistent and accurate measurement of cyanocobalamin in animal nutrition. The approved methods will support the additive’s safe and regulated use across the EU.
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