Safety and efficacy of vitamin B2 (riboflavin and riboflavin 5’‐phosphate ester monosodium salt) produced by Bacillus subtilis for all animal species based on a dossier submitted by DSM

Abstract

2Riboflavin is produced by two genetically modified Bacillus subtilis strains. Neither the production strains nor their recombinant DNA were detected in the final riboflavin products. Riboflavin 5'phosphate sodium is prepared by phosphorylation of riboflavin. The additives are safe for target animals with a wide margin of safety provided that the current use levels for riboflavin are not exceeded. Toxicological studies with the additive under assessment show that it has a low toxicity and do not indicate a genotoxic potential. The use of the additives in animal nutrition will not significantly alter the riboflavin content of food of animal origin. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the use of the additives in animal nutrition is not of safety concern for consumers. The additives containing riboflavin and riboflavin 5'-phosphate sodium are not irritant to skin and eyes. In the absence of data, the FEEDAP Panel cannot conclude on skin sensitisation. Riboflavin is a recognised photosensitiser, which may elicit skin and eye photoallergic reactions. Workers might be exposed to a respirable dust when handling riboflavin and riboflavin 5'-phosphate sodium; in the absence of data on inhalation toxicity, the FEEDAP Panel cannot conclude on a possible risk by inhalation. The use of riboflavin and riboflavin 5'-phosphate sodium in animal nutrition does not pose a risk to the environment. The additives are regarded as an effective source of riboflavin in covering the animal's requirement when administered orally.

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.)

“…The nutrient requirements/recommendations of the target species for vitamin B 2 , the background levels of vitamin B 2 in feed materials and the tolerance to overdoses of vitamin B 2 were reviewed by the FEEDAP Panel in previous opinions (EFSA FEEDAP Panel, 2014, 2016, 2018b. The Panel concluded that the use levels based on the requirement/background levels would pose no safety concerns to the target species.…”

Safety and efficacy of the feed additive consisting of Vitamin B2/Riboflavin produced by Eremothecium ashbyi CCTCCM 2019833 for all animal species (Hubei Guangji Pharmaceutical Co., Ltd)

“…The FEEDAP Panel has adopted five opinions on the use of vitamin B 2 as a feed additive. Two opinions related to the safety and efficacy of vitamin B 2 (80%) as riboflavin produced with Bacillus subtilis KCCM-10445 for all animal species (EFSA FEEDAP Panel, 2014, 2018a, an opinion on the safety and efficacy of vitamin B 2 as riboflavin and riboflavin-5 0 -phosphate ester monosodium salt, produced by either Bacillus subtilis DSM 17339 or Bacillus subtilis DSM 23984 (EFSA FEEDAP Panel, 2016), and another opinion on the safety and efficacy of vitamin B 2 (riboflavin) produced by Ashbya gossypii (EFSA FEEDAP Panel, 2018b). The last one was related to the safety and efficacy of vitamin B 2 (riboflavin 5 0 -phosphate ester monosodium salt) for all animal species when used in water for drinking (EFSA FEEDAP Panel, 2018c).…”

“…In previous assessments, the FEEDAP Panel concluded that the supplementation of feed with riboflavin could not be of concern for the consumers (EFSA FEEDAP Panel, 2014, 2016, 2018b. However, apart from riboflavin, the toxicological profile of the other components of the additive, which is a fermentation product, has not been established, and therefore, uncertainties remain as regards to the safety for the consumers of food products obtained from animals receiving the additive under assessment.…”

Safety and efficacy of vitamin B2 (riboflavin) produced by Ashbya gossypii DSM 23096 for all animal species based on a dossier submitted by BASF SE

“…Riboflavin absorption, its metabolic fate and its potential accumulation in edible tissues and eggs have been described in detail in previous opinions (EFSA FEEDAP Panel, 2014, 2016.…”