Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283
Résumé
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on the safety of calcidiol monohydrate as anovel food (NF) pursuant to Regulation (EU) 2015/2283, including its bioavailability as a metabolite ofvitamin D3when added for nutritional purposes to food supplements. The NF is produced chemically.It is proposed in food supplements up to 10lg/day for individuals≥11 years of age, includingpregnant and lactating women and up to 5lg/day in 3- to 10-year-old children. The productionprocess, composition, specifications and stability of the NF do not raise safety concerns. Animal andhuman data indicate efficient absorption. The NF contains a fraction of nanoparticles, which are fatsoluble and unlikely to reach systemic distribution. There are no concerns regarding genotoxicity.Human adult studies do not raise safety concerns. Combined intake estimates of calcidiol from the NFand calcidiol and vitamin D from the diet were below the tolerable upper intake level (UL) for vitaminD for subjects above 11 years of age. The achieved mean serum 25(OH)D concentration in adultssupplemented with 10lg NF per day remained below 200 nmol/L. The Panel concludes that the NF issafe under the proposed conditions of use and use levels for individuals≥11 years old, includingpregnant and lactating women. The applicant did not provide data on the bioavailability and safety ofthe NF in children. The combined intake estimation in children (3–10 years) is close to the UL forvitamin D. Therefore, the Panel could not conclude on the safety of consumption of the NF in children(3–10 years) at the proposed daily intake. The NF is a bioavailable source of the biologically activemetabolite of vitamin D, i.e. 1,25-dihydroxyvitamin D
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