Vitamin B12 / Cyanocobalamin produced by Ensifer adhaerens CGMCC 21299

In the current application authorisation is sought under Article 4(1) for vitamin B12 / cyanocobalamin under the category/functional group 3(a), "nutritional additives/vitamins, pro-vitamins and chemically well-defined substances having similar effect", according to the classification system of Annex I of Regulation (EC) No 1831/2003. Authorisation is sought for the use of the feed additive for all animal species and categories.
According to the Applicant, vitamin B12 / cyanocobalamin is produced by fermentation with Ensifer adhaerens CGMCC 21299. The feed additive is a powder preparation containing a maximum vitamin B12 / cyanocobalamin content of 1 % mixed in a carrier. The feed additive preparation is intended to be incorporated in compound feed with no minimum or maximum contents proposed by the Applicant.
For the determination of cyanocobalamin in the feed additive preparation the Applicant proposed an in-house method based on high performance liquid chromatography coupled to spectrophotometry (HPLC-UV) while for the determination of cyanocobalamin in compound feed, the Applicant proposed a microbiological method according to USP 39-171. However, in the frame of a previous vitamin B12 evaluation, this microbiological method has triggered some NRLs concerns about its applicability for the quantification of cyanocobalamin in compound feed.
Furthermore, the EURL is aware of a ring-trial validated AOAC method based on immunoaffinity column clean-up and high performance liquid chromatography coupled to spectrophotometry (HPLC-UV) for the determination of vitamin B12 in food commodities. Within the frame of previous vitamin B12 dossiers, this chromatography method has been further verified in different feed matrices and led to acceptable performance characteristics.
Based on the performance characteristics available, the EURL recommends for official control the reversed phase liquid chromatography method coupled to spectrophotometric detection (HPLC-UV) based on the AOAC ring-trial validated method for the determination of vitamin B12 / cyanocobalamin in the feed additive preparation and compound feed.
Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.