Safety and efficacy of feed additives consisting of Vitamin B2 (98%) and Vitamin B2 (80%) as riboflavin produced by Bacillus subtilis KCCM 10445 for all animal species (Hubei Guangji Pharmaceutical Co. Ltd.)

Abstract

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 98% and vitamin B2 80% in the form of riboflavin produced by fermentation with a genetically modified strain of Bacillus subtilis (KCCM 10445) as nutritional additives in feed and water for drinking for all animal species. The production strain harbours antimicrobial resistance genes. With the data available the Panel is not in the position to confirm the correspondence between the strain deposited under accession number KCCM 10445 and the strain under the current assessment. The production strain and its recombinant DNA were not detected in the final products. Therefore, the additives do not pose any safety concern associated with the genetic modification of the production strain. The additives are safe for the target species, the consumer and the environment. Vitamin B2 80% is not hazardous by inhalation. In the absence of data, no conclusions on the possible risk by inhalation of vitamin B2 98% can be reached. Neither vitamin B2 98% nor vitamin B2 80% are irritant to skin or eyes. In the absence of data, no conclusions on the skin sensitisation potential of the additives can be reached. The additives under assessment are effective in covering the animals’ requirements for vitamin B2 when administered via feed and/or water for drinking.

Keywords

• Vitamin B2/Riboflavin
• Bacillus subtilis
• nutritional additive
• vitamins
• safety
• efficacy