Calcidiol monohydrate: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children: 10 μg/day for children from 11 years of age and adults 5 μg/day for children from 3 to 10 years of age

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘calcidiol (calcifediol) monohydrate (vitamin D)’. 2. The labelling of food supplements containing the novel food shall bear a statement that they should not be consumed by infants and children under 3 years of age/children under 11 years of age, depending on the age group the product is intended for.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

The novel food is calcidiol monohydrate (25-hydroxycholecalciferol monohydrate). The novel food contains the monohydrate form of the major circulating metabolite of vitamin D3 in the body and is a source of 1,25-dihydroxyvitamin D, the biologically active form of vitamin D.

Conversion factor: 1 μg calcidiol = 2,5 μg vitamin D3 for doses up to 10 μg/day.

The production process of the novel food starts with a yeast fermentation which results in a mixture of sterols, with trienol being the major sterol obtained. After the fermentation, purification and several chemical steps follow. The chemical steps include saponification and extraction, where the trienol is isolated from the biomass. This is followed by a hydroxylation step to separate the trienol from the other sterols. Trienol is then epoxidised and subsequently reduced to give 25-hydroxydehydrocholesterol. A photoreaction follows, to obtain a mixture of 25-hydroxy-previtamin D3, 25-hydroxy-tachysterol and 25-hydroxy-lumisterol. Thereafter, the 25-hydroxy-previtamin D3 is thermally isomerised to ‘“Calcidiol”’ and recrystallized to obtain the novel food of the required purity.

The novel food is intended to be placed on the market as a diluted form ‘“0,25 % w/w”’, containing 0,250-0,275 % w/w of calcidiol (anhydrous). The novel food needs to be placed on the market in a preparation guaranteeing its stability.

Chemical name according to IUPAC:

(1S,3Z)-3-[(2E)-2-[(1R,3αS,7αR)-1-[(2R)-6-hydroxy-6-methylheptan-2-yl]-7α-methyl-2,3,3α,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol; hydrate

CAS Number: 63283-36-3 (Calcifediol monohydrate)

Empirical formula: C27H44O2.H2O

Molecular weight: 418,7 g/mol

Characteristics/composition:

25(OH)D3.H2O: 97,0-100 %

Total related substances: ≤ 1,5 %, of which: Δ22-25(OH)D3: ≤ 0,5 %; Lumisterol (): ≤ 0,5 %; pre-25(OH)D3 (): ≤ 0,5 %; Tachysterol (): ≤ 0,5 %; trans-Vitamin D3 (): ≤ 0,5 %

Other impurities: ≤ 0,10 %

Water content: 3,8-5,0 %

Acetone: ≤ 1 000 mg/kg

Isopropanol: ≤ 10 mg/kg

Heavy metals:

Arsenic: ≤ 1 mg/kg

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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