Safety of benfotiamine as a Novel food pursuant to Regulation (EU) 2015/2283 and the bioavailability of benfotiamine as a source of thiamin in the context of Directive 2002/46/EC on food supplements.

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 the safety of benfotiamine as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and on the bioavailability of benfotiamine as a source of thiamin in the context of Directive 2002/46/EC. The NF, which is produced by chemical synthesis, is proposed to be used in food supplements for adults at a maximum intake of 300 mg/day. The Panel notes that the identity of the NF has not been sufficiently demonstrated, including the possible presence of small particles and nanoparticles. The Panel also notes that the data provided were insufficient to demonstrate that the manufacturing process is reproducible and capable of consistently producing a product with the proposed characteristics. No conclusion could be drawn on the microbiological stability of the NF over the proposed shelf life. The information provided indicates that the bioavailability of thiamin from benfotiamine may be higher than that from water-soluble forms of thiamin and thus benfotiamine may be used as a source of thiamin. Owing to the insufficient characterisation of the NF, unresolved uncertainties regarding small particles, including nanoparticles, the lack of adequate information on its metabolic fate, bioaccumulation and long-term effects, and the limitations of the submitted toxicological data, the Panel concludes that the safety of benfotiamine as a NF cannot be established under the proposed conditions of use. The Panel also concludes that the higher bioavailability of benfotiamine compared with authorised or natural sources of thiamin has not been quantified to an extent that would allow the derivation of a conversion factor for labelling purposes.