ChromaDex given green light to expand novel vitamin B3 ingredient within EU

NR was authorised as a novel food in 2017 for supplementation at a daily dose of 300mg, after a positive opinion from the European Food Standards Agency (EFSA).

However, biotech developer, ChromaDex, submitted a further request in March 2020 to expand NR’s commercial use and to seek protection for the proprietary data of a study lodged with the petition.

Positive opinion

The authority returned a positive scientific opinion earlier this month, following a favourable safety assessment that deemed the extension of use conditions appropriate in the foods outlined, with effect from July 25th​.

Changes to the novel food regulations allow NR inclusion in foods for special medical purposes and as a dietary replacement in weight control management at levels of 500mg per day for adults, excluding pregnant and lactating women.

Demands for protection of supporting material were, however, declined by the authority. The opinion indicated that the human study evaluating the safety and dose-dependent effects of NR supplementation was not needed for the assessment or overall decision-making process and, as such, should not be protected in according with EU regulations (Article 27(1) of Regulation 2015/2281).

EU regulations

The original EFSA assessment on the safety of NR as a meal replacement for the general population concluded that 300mg per day was below the established nicotinamide ‘Upper Level’ (UL) for adults and therefore considered safe, with the exception of pregnant and lactating women.

The current scientific opinion supports these initial findings and asserts there are also sufficient grounds to establish NR in the prescribed format; it states that the ingredient “fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2282​”.

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