Article 1
Open ↗The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Source
Commission Implementing Regulation (EU) 2022/1160 of 5 July 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the specifications of the novel food nicotinamide riboside chloride (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/1160 of 5 July 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the specifications of the novel food nicotinamide riboside chloride (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
Open ↗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
Open ↗ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 1 (Authorised novel foods), the entry for ‘nicotinamide riboside chloride’ is replaced by the following: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data protection Specified food category Maximum levels ‘ Nicotinamide riboside chloride Food supplements as defined in Directive 2002/46/EC 300 mg/day for the adult population, excluding pregnant and lactating women 230 mg/day for pregnant and lactating women 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.’ Foods for special medical purposes as defined by Regulation (EU) No 609/2013 for the adult population, excluding pregnant and lactating women In accordance with the particular nutritional requirements of the persons for whom the products are intended 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘nicotinamide riboside chloride’ 2. The labelling of foodstuffs containing the novel food shall bear a statement that those foods should only be consumed by persons above 18 years of age excluding pregnant and lactating women. Total diet replacement for weight control as defined by Regulation (EU) No 609/2013 for the adult population, excluding pregnant and lactating women 500 mg/day Meal replacements for the adult population, excluding pregnant and lactating women 150 mg/meal (maximum 2 meals/day up to a maximum of 300 mg/day) (2) in Table 2 (Specifications), the entry for ‘nicotinamide riboside chloride’ is replaced by the following: 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: C11H15N2O5Cl 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 Mercury*: ≤ 0,1 mg/kg Cadmium*: ≤ 1 mg/kg Lead*: ≤ 0,5 mg/kg Microbiological criteria: Total Plate Count: ≤ 1 000 CFU/g Yeast and Mould: ≤ 100 CFU/g Escherichia coli : Absence in 10 g CFU: colony forming units (*) only for foods for special medical purposes, total diet replacement for weight control and meal replacements’
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