Safety of a feed additive consisting of vitamin B2/riboflavin produced with Eremothecium ashbyi CCTCCM 2019833 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 of a feed additive consisting of vitamin B2/riboflavin produced with Eremothecium ashbyi CCTCCM 2019833 intended for use as a nutritional additive (functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effects) for all animal species. The characterisation, safety and efficacy of the additive have been already assessed previously; however, the FEEDAP Panel could not conclude on the safety of the additive for the target species, consumers and the users due to lack of reliable toxicological data. In the present assessment, the applicant submitted new genotoxicity and repeated dose oral toxicity studies. After the assessment of the data newly submitted, the FEEDAP Panel concluded that the use of the feed additive in animal nutrition under the conditions of use proposed is of no safety concern for the target species and the consumer. The additive is not a skin/eye irritant nor a skin sensitiser, but it is considered a respiratory sensitiser.