Safety of beta-nicotinamide mononucleotide (β-NMN) pursuant the regulation (EU) 2015/2283 and the bioavailability of nicotinamide from this source in the context of Directive 2002/46/EC.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on beta-nicotinamide mononucleotide (β-NMN) as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF consists of chemically synthesised β-NMN and is intended for use in food supplements as a source of niacin up to 300 mg/day. The target population is adults, excluding pregnant and lactating women. The identity, production process, composition and specifications of the NF do not raise safety concerns. A human intervention study comparing the relative bioavailability of β-NMN and nicotinamide in equimolar amounts supported the use of a conversion factor (CF) of 1. On this basis, the proposed maximum intake corresponds to 109.7 mg/day of nicotinamide. This amount is approximately five times the population reference intake (PRI) of niacin for adults but remains below the upper level (UL) of 900 mg/day for nicotinamide. No concerns were identified regarding genotoxicity. In a 90-day repeated dose oral toxicity study in rats, effect on reproductive organs were observed and the no observed adverse effect level (NOAEL) of 400 mg/kg bw per day identified, resulting in a margin of exposure (MoE) of 93. The available human study did not raise safety concerns. Based on the nature and the metabolic fate of the NF, the proposed use levels and the available human data, the calculated MoE was considered sufficient. The Panel concludes that the NF is safe under the proposed conditions of use for the adult population, excluding pregnant and lactating women and that the NF constitutes a bioavailable source of nicotinamide, a form of niacin.