Safety of vitamin B2 product confirmed

A new additive has been assessed by the European Food Safety Authority as a safe and effective source of riboflavin (vitamin B2) in animal feeds

A feed additive – containing riboflavin and riboflavin 5’-phosphate sodium – is an effective source of riboflavin in covering the animal’s requirement when administered orally, concluded the European Food Safety Authority (EFSA) Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) based on the assessment of a dossier submitted by DSM.

Riboflavin is produced by two genetically modified Bacillus subtilis strains. Neither the production strains nor their recombinant DNA was detected in the final riboflavin products. Riboflavin 5’-phosphate sodium is prepared by phosphorylation of riboflavin.

FEEDAP found that the additives are safe for target animals with a wide margin of safety provided that the current use levels for riboflavin are not exceeded. Toxicological studies with the additive reveal it has a low toxicity and there is no indication of genotoxic potential.

The use of the additives in animal nutrition will not significantly alter the riboflavin content of food of animal origin.

FEEDAP considers that the use of the additives in animal nutrition is not of safety concern for consumers. The additives containing riboflavin and riboflavin 5’-phosphate sodium are not irritant to skin and eyes. In the absence of data, the panel was unable to conclude on skin sensitisation. Riboflavin is a recognised photosensitizer, it states, which may elicit skin and eye photoallergic reactions. Workers might be exposed to a respirable dust when handling riboflavin and riboflavin 5’-phosphate sodium. In the absence of data on inhalation toxicity, the FEEDAP panel was unable to reach a conclusion on a possible risk by inhalation.

The use of riboflavin and riboflavin 5’-phosphate sodium in animal nutrition does not pose a risk to the environment, the panel concluded.