Safety and efficacy of a feed additive consisting of riboflavin-5'-phosphate ester monosodium salt (vitamin B2) (from riboflavin 98%, produced by Bacillus subtilis KCCM 10445) for all animal species (Hubei Guangji Pharmaceutical Co. Ltd)

Abstract

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of vitamin B₂ in the form of riboflavin-5'-phosphate ester monosodium salt. The additive is manufactured by chemical synthesis from riboflavin 98%, produced by fermentation with a genetically modified strain of Bacillus subtilis (KCCM 10445). Riboflavin 98% has been previously evaluated by the FEEDAP Panel for its use as feed additive for all animal species. Since the additive under assessment contains the phosphate ester monosodium salt of a riboflavin (98%) preparation already considered safe, the FEEDAP Panel concluded that the addition of the salt does not add any toxicological property to the final additive. Therefore, the additive is safe for the target species, the consumer and the environment. The additive is not a skin/eye irritant and it is not considered a respiratory sensitiser. Riboflavin is a known photosensitiser which may elicit skin and eye photoallergic reactions. The additive under assessment is effective in covering the animals' requirements for vitamin B2 when administered via feed and/or water for drinking.

Keywords: Bacillus subtilis; efficacy; nutritional additive; safety; vitamin B2/riboflavin; vitamins.