Scientific Opinion on the safety and efficacy of vitamin B2 (80 %) as riboflavin produced by Bacillus subtilis for all animal species, based on a dossier submitted by VITAC EEIG
The additive riboflavin (80 %) is produced by fermentation of a genetically modified Bacillus subtilis strain. Neither the production strain nor its recombinant DNA was detected in the final product. Therefore, the final product does not give rise to any safety concern with regard to the genetic modification. The additive is safe for the target animals with a wide margin of safety provided that the current use levels for riboflavin are not exceeded. Setting a maximum content for riboflavin in complete feed is not considered necessary. Toxicological studies with the additive under assessment show that it has a low toxicity. The use of the additive in animal nutrition will not significantly alter the riboflavin content of food of animal origin. The FEEDAP Panel considers that the use of the additive in animal nutrition is not of safety concern for consumers. The FEEDAP Panel considers that the additive is an irritant to skin, eyes and the respiratory tract. It is unlikely to cause skin sensitisation. Workers might be exposed to a respirable dust when handling riboflavin, which should be regarded as being potentially harmful to their health. The use of the additive in animal nutrition does not pose a risk to the environment. The additive is regarded as an effective source of riboflavin in covering the animal’s requirement when administered orally.