Commission Implementing Regulation (EU) 2024/1052 of 10 April 2024 authorising the placing on the market of calcidiol monohydrate as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2024/1052
• Articles: 5

Article 1

1.   Calcidiol monohydrate is authorised to be placed on the market within the Union.

Calcidiol monohydrate shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company DSM Nutritional Products Ltd.  ( 27 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 1 May 2024, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of DSM Nutritional Products Ltd.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of DSM Nutritional Products Ltd.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 ( Authorised novel foods ), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘ Calcidiol monohydrate

Specified food category

Maximum levels

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.

Authorised on 1 May 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: DSM Nutritional Products Ltd., Wurmisweg 576, 4303 Kaiseraugst, Switzerland. During the period of data protection, the novel food calcidiol monohydrate is authorised for placing on the market within the Union only by DSM Nutritional Products Ltd., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of DSM Nutritional Products Ltd.

End date of the date protection: 1 May 2029.’

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

(2)

in Table 2 ( Specifications ), the following entry is inserted:

Authorised Novel Food

Specification

‘ Calcidiol monohydrate

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 D 3 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 D 3 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 D 3 , 25-hydroxy-tachysterol and 25-hydroxy-lumisterol. Thereafter, the 25-hydroxy-previtamin D 3 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: C 27 H 44 O 2 .H 2 O

Molecular weight: 418,7 g/mol

Characteristics/composition:

25(OH)D 3 .H 2 O: 97,0-100 %

Total related substances: ≤ 1,5 %, of which: Δ 22 -25(OH)D 3 : ≤ 0,5 %; Lumisterol  ( 1 ) : ≤ 0,5 %; pre-25(OH)D 3

( 2 ) : ≤ 0,5 %; Tachysterol  ( 3 ) : ≤ 0,5 %; trans-Vitamin D 3

( 4 ) : ≤ 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

( 1 )   9b,10a-Cholesta-5,7-diene-3b,25-diol (25(OH)).

( 2 )   Cholesta-5,7-diene-3b,25-diol.

( 3 )   (6E)-9,10-Secocholesta-5(10),6,8-triene-3b,25-diol (iso-25(OH)).

( 4 )   (5E,7E)-9,10-Secocholesta-5,7,10(19)-triene-3b,25-diol.’