My bookmarksSign up free

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)

Implementing Regulation (EU) 2022/1160 · Regulation · 3 articles

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 1

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

Article 2

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) 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’

Other acts of the same type
Commission Implementing Regulation (EU) 2019/317 of 11 February 2019 laying down a performance and charging scheme in the single European sky and repealing Implementing Regulations (EU) No 390/2013 and (EU) No 391/2013 (Text with EEA relevance.)Commission Implementing Regulation (EU) 2019/238 of 8 February 2019 amending Regulation (EU) No 37/2010 to classify the substance ovotransferrin as regards its maximum residue limit (Text with EEA relevance.)Commission Delegated Regulation (EU) 2019/624 of 8 February 2019 concerning specific rules for the performance of official controls on the production of meat and for production and relaying areas of live bivalve molluscs in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (Text with EEA relevance.)Commission Implementing Regulation (EU) 2019/228 of 7 February 2019 laying down technical information for the calculation of technical provisions and basic own funds for reporting with reference dates from 31 December 2018 until 30 March 2019 in accordance with Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance (Text with EEA relevance.)Commission Regulation (EU) 2019/229 of 7 February 2019 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards certain methods, the food safety criterion for Listeria monocytogenes in sprouted seeds, and the process hygiene criterion and food safety criterion for unpasteurised fruit and vegetable juices (ready-to-eat) (Text with EEA relevance.)Commission Implementing Regulation (EU) 2019/230 of 7 February 2019 correcting certain language versions of Implementing Regulation (EU) 2017/2330 concerning the authorisation of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran as feed additive for piglets and amending Regulations (EC) No 1334/2003 and (EC) No 479/2006 (Text with EEA relevance.)Commission Delegated Regulation (EU) 2019/693 of 7 February 2019 amending Delegated Regulation (EU) No 481/2014 supplementing Regulation (EU) No 1299/2013 of the European Parliament and of the Council with regard to specific rules on eligibility of expenditure for cooperation programmesCommission Regulation (EU) 2019/220 of 6 February 2019 amending Regulation (EC) No 865/2006 laying down detailed rules concerning the implementation of Council Regulation (EC) No 338/97 on the protection of species of wild fauna and flora by regulating trade thereinCommission Implementing Regulation (EU) 2019/221 of 6 February 2019 amending Regulations (EC) No 785/2007, (EC) No 379/2009, (EC) No 1087/2009, (EU) No 9/2010, (EU) No 337/2011 and Implementing Regulations (EU) No 389/2011, (EU) No 528/2011, (EU) No 840/2012, (EU) No 1021/2012, (EU) 2016/899, (EU) 2016/997, (EU) 2017/440 and (EU) 2017/896 as regards the name of the holder of the authorisation and the representative of the holder of the authorisation for certain feed additives (Text with EEA relevance.)Commission Regulation (EU) 2019/225 of 6 February 2019 amending Regulation (EC) No 748/2009 as regards the aircraft operators for which the United Kingdom is specified as administering Member State (Text with EEA relevance.)Commission Regulation (EU) 2019/226 of 6 February 2019 amending Regulation (EC) No 748/2009 on the list of aircraft operators which performed an aviation activity listed in Annex I to Directive 2003/87/EC on or after 1 January 2006 specifying the administering Member State for each aircraft operator (Text with EEA relevance.)Commission Regulation (EU) 2019/319 of 6 February 2019 amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annex XV to Commission Regulation (EU) No 142/2011 as regards health certification at import into the Union concerning transmissible spongiform encephalopathies (Text with EEA relevance.)

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

Contents

What to look at next