Commission Implementing Regulation (EU) 2020/16 of 10 January 2020 authorising the placing on the market of nicotinamide riboside chloride as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
1. Nicotinamide riboside chloride as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
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Company: ChromaDex Inc.;
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Address: 10900 Wilshire Boulevard Suite 600, Los Angeles, CA 90024 USA,
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of ChromaDex Inc.
3. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.
4. The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
The studies contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the Applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of ChromaDex Inc.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
the following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data Protection
‘Nicotinamide riboside chloride
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Nicotinamide riboside chloride”
Authorised on 20 February 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: ChromaDex Inc., 10900 Wilshire Boulevard Suite 600, Los Angeles, CA 90024 USA. During the period of data protection, the novel food is authorised for placing on the market within the Union only by ChromaDex Inc. unless a subsequent applicant obtains authorisation for that 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 ChromaDex Inc.
End date of the data protection: 20 February 2025.’
Food Supplements as defined in Directive 2002/46/EC
300 mg/day for the general adult population, excluding pregnant and lactating women
230 mg/day for pregnant and lactating women
(2)
the following entry is inserted in Table 2 (Specifications) in alphabetical order:
Authorised Novel Food
Specification
‘Nicotinamide riboside chloride
Description/Definition:
The novel food is a synthetic form of nicotinamide riboside.
The novel food contains ≥ 90 % nicotinamide riboside chloride, predominantly in its β form, the remaining components being residual solvents, reaction by-products and degradation products.
Nicotinamide riboside chloride:
CAS number: 23111-00-4
EC number: 807-820-5
IUPAC name: 1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]pyridin-1-ium-3-carboxamide;chloride
Chemical formula: C 11 H 15 N 2 O 5 Cl
Molecular weight: 290,7 g/mol
Characteristics/Composition:
Colour: White to light brown
Form: Powder
Identification: Conforms by NMR (nuclear magnetic resonance)
Nicotinamide riboside chloride: ≥ 90 %
Water content: ≤ 2 %
Residual solvents:
Acetone: ≤ 5 000 mg/kg
Methanol: ≤ 1 000 mg/kg
Acetonitrile: ≤ 50 mg/kg
Methyl tert-butyl ether: ≤ 500 mg/kg
Reaction by-products:
Methyl acetate: ≤ 1 000 mg/kg
Acetamide: ≤ 27 mg/kg
Acetic acid: ≤ 5 000 mg/kg
Heavy metals:
Arsenic: ≤ 1 mg/kg
Microbiological criteria:
Total Plate Count: ≤ 1 000 CFU/g
Yeast and Mould: ≤ 100 CFU/g
Escherichia coli : Absence in 10 g’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
