Commission Implementing Regulation (EU) 2024/3167 of 18 December 2024 concerning the authorisation of cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 19596 as a feed additive for all animal species
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Authorisation
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX Identification number of the feed additive Additive Composition, chemical formula, description, analytical method. Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg active substance/kg of complete feed with a moisture content of 12 % Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect 3a836 ‘Cyanocobalamin’ or ‘Vitamin B 12 ’ Additive composition: Cyanocobalamin Solid form Characterisation of the active substance: Cyanocobalamin C 63 H 88 CoN 14 O 14 P CAS number: 68-19-9 Purity: ≥ 96 % on dry basis; loss of drying 12 % Produced by fermentation with Ensifer adhaerens CGMCC 19596 Analytical method ( 1 ) For the quantification of cyanocobalamin in the feed additive: European Pharmacopoeia method (Eur. Ph. 0547) based on spectrophotometry (UV/VIS) For the quantification of cyanocobalamin in compound feed: reversed phase high performance liquid chromatography coupled to spectrophotometric detection (HPLC-UV) All animal species — — — 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated. 2. The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU/m 3 air ( 2 ) . 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment. 8 January 2035 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports ( 2 ) The exposure is calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2023;21(4):7972).
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.