Scientific Opinion on safety and efficacy of vitamin B12 (cyanocobalamin) produced by Ensifer adhaerens when used as a feed additive for all animal species based on a dossier submitted by Lohamnn Animal Health

Abstract

The product under consideration is vitamin B12 (cyanocobalamin) produced by Ensifer adhaerens. There are uncertainties regarding the genetic basis of the antibiotic resistance found in the production strain and regarding the possible presence of its DNA in the product. However, the product under assessment is extensively purified ensuring that the active substance represents more than 99 % on a dry matter basis and that the remainder is almost exclusively attributable to substance-related impurities. Taking into account the extensive purification process, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers it unlikely that any remnants of DNA from the production strain would remain in the final product to an extent that would give rise to any safety concerns. The use of vitamin B12 produced by E. adhaerens as a nutritional additive is safe for the target animals. Its use in animal nutrition does not give rise to safety concerns for consumers. In the absence of data, the FEEDAP Panel considers it prudent to assume that vitamin B12 is an irritant to skin and eyes, is a skin sensitiser and is hazardous by inhalation. The use of vitamin B12 produced by E. adhaerens in animal nutrition does not pose a risk to the environment. Vitamin B12 produced by E. adhaerens is regarded as effective in meeting animals’ requirements when administered orally.