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

vitamin B2, riboflavin, nutritional additive, safety, efficacy, genetically modified microorganism
First published in the EFSA Journal
16 January 2014
4 December 2013
Scientific Opinion


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.

Panel members at the time of adoption

Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf
Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal 2014;12(1):3531
Question Number
On request from
European Commission
The full opinion will be published in accordance with article 8(6) of Regulation (EC) No 1831/2003 once the decision on confidentiality, in line with article 18(2) of the Regulation, will be received from the European Commission.