# Scientific opinion on the characterisation of Ensifer adhaerens CGMCC 19596 used in the production of the feed additive consisting of vitamin B12 (cyanocobalamin) for all animal species (Hebei Huarong Pharmaceutical Co., ltd.)

## TL;DR

This paper concludes that a strain of Ensifer adhaerens used to produce vitamin B12 is not genetically modified, addressing previous uncertainties.

## Contribution

The paper provides new evidence confirming that the bacterial strain Ensifer adhaerens CGMCC 19596 is not genetically modified.

## Key findings

- The production strain Ensifer adhaerens CGMCC 19596 is confirmed to be non-genetically modified.
- The feed additive vitamin B12 produced with this strain does not pose safety concerns.
- Supplementary data resolved previous uncertainties about the strain's genetic modification status.

## Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the characterisation of the feed additive consisting of vitamin B12 (cyanocobalamin) produced by fermentation with Ensifer adhaerens (CGMCC 19596). The additive is intended to be used as a nutritional additive for all animal species. In a previous opinion, the FEEDAP Panel could not conclude on the characterisation of the production strain, due to uncertainties on whether the production strain E. adhaerens CGMCC 19596 was genetically modified. However, since viable cells and DNA were not detected in the product, the FEEDAP Panel concluded that vitamin B12 (cyanocobalamin), produced with E. adhaerens CGMCC 19596 would not raise safety concerns as regards the production strain. In the present submission, the applicant provided supplementary information regarding the origin and history of modifications of the strain. Based on the data provided, the FEEDAP Panel concluded on the characterisation of the production strain E. adhaerens CGMCC 19596, which can be considered not to be genetically modified.