Cyanocobalamin, a form of vitamin B12, is widely used as a nutritional additive for various animal species. Understanding what cyanocobalamin is made from involves exploring its production process, which primarily relies on fermentation using specific microorganisms.
The vitamin B12 (in the form of cyanocobalamin) under assessment is typically produced via fermentation. But what is cyanocobalamin made from specifically? The process often involves genetically modified strains of microorganisms like Ensifer adhaerens. This fermentation method allows for the large-scale production of cyanocobalamin.
In the past, concerns have been raised regarding the safety of cyanocobalamin produced in this manner. One key area of scrutiny involves the safety of the production strain itself.
Previously, the FEEDAP Panel of EFSA (European Food Safety Authority) expressed reservations due to uncertainties about the safety of the Ensifer adhaerens strain and the resulting cyanocobalamin product. These concerns stemmed from issues like high endotoxin content, potential inhalation risks during handling, and reported skin and eye irritation.
However, subsequent data has addressed some of these concerns. The applicant provided additional information regarding the identity of the production strain, its susceptibility to antibiotics, and its potential for toxicity. They also demonstrated the absence of viable cells and recombinant DNA from the Ensifer adhaerens strain in the final cyanocobalamin product.
Importantly, while the production strain may harbor antimicrobial resistance genes, tests confirmed that viable cells and recombinant DNA of the strain were not detectable in the final, concentrated form of the additive.
Based on this new evidence, the FEEDAP Panel revised its assessment and concluded that vitamin B12 produced by E. adhaerens CNCM I‐5541 (SCM 2034) is safe for all animal species, consumers, and the environment. This determination highlights the importance of thorough safety evaluations and ongoing research in the production of animal feed additives.
It is important to note that while cyanocobalamin itself is now considered safe, the initial safety concerns regarding handling and potential user risks remain. The applicant did not provide new evidence that would lead the FEEDAP Panel to reconsider previous conclusions regarding the safety for the user. Therefore, appropriate safety measures should still be taken when handling concentrated forms of cyanocobalamin.
In summary, cyanocobalamin is typically made from fermentation processes using genetically modified microorganisms, particularly Ensifer adhaerens. While initial concerns regarding the safety of the production strain were raised, further research and data have led to the conclusion that cyanocobalamin produced in this manner is safe for its intended uses in animal feed. However, users should still adhere to safety precautions during handling due to potential irritancy.
