Abstract
The vitamin B(12) (in the form of cyanocobalamin) under assessment is produced by fermentation with a genetically modified strain of Ensifer adhaerens and it is intended to be used as a nutritional additive for all animal species. In 2018, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA issued an opinion on the safety and efficacy of the product. In that assessment, the Panel could not conclude on the safety of the additive for the target species, consumers and the environment due to uncertainties on the safety of the production strain and the resulting product. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, the additive was considered to pose a risk to user safety. The applicant provided supplementary data on the identity of the production strain, its susceptibility to antibiotics and toxigenic potential, as well as on the absence of cells and recombinant DNA of the production strain in the final product. The production strain is not expected to produce any toxic compound during fermentation but harbours antimicrobial resistance genes. However, viable cells and recombinant DNA of the strain were not detected in the most concentrated form of the additive. With this new information, the FEEDAP Panel concluded that vitamin B(12) produced by E. adhaerens CNCM I-5541 (identified as SCM 2034 in the previous opinion) is safe for all animal species, the consumers and the environment. The applicant did not provide new evidence that would lead the FEEDAP Panel to reconsider previous conclusions regarding the safety for the user.