Safety and efficacy of a feed additive consisting of vitamin B12 (cyanocobalamin) produced by fermentation with Ensifer adhaerensCGMCC 19596 for all animal species (Hebei Huarong Pharmaceutical Co. ltd).

Abstract

The vitamin B12 (in the form of cyanocobalamin) under assessment is produced by fermentation with Ensifer adhaerens CGMCC 19596 and it is intended to be used as a nutritional additive for all animal species. Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of cyanocobalamin, produced by fermentation with E. adhaerens CGMCC 19596. Cyanocobalamin produced by other strains of E. adhaerens is already authorised for use in animal species. ■■■■■ However no viable cells nor DNA of the production strain were detected in the additive. Therefore, cyanocobalamin produced by E. adhaerens CGMCC 19596 does not raise safety concerns as regards to the production strain. The FEEDAP Panelconcluded that cyanocobalamin produced by fermentation with E. adhaerens CGMCC 19596 is considered safe for all animal species. The use of cyanocobalamin in animal nutrition is of no concern for consumer safety. Cyanocobalamin is non-irritant to skin and non-irritant to eyes. No conclusions could be drawn on the potential of the additive to be a skin sensitiser. The potential endotoxin activity of the additive is unlikely to represent a hazard for users. The use of the additive under assessment in animal nutrition is considered safe for the environment. Cyanocobalamin produced by E. adhaerens CGMCC 19596 is effective in meeting animal's nutritional requirements when administered via feed.