REGUL ATIONS 
COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/16 
of 10 Januar y 2020 
author ising the placing on the mark et of nicotinamide riboside chlor ide 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) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regar d to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) 
No 1852/2001 (1), and in particular Article 12 thereof, 
Whereas: 
(1) Regulation (EU) 2015/2283 provides that only novel foods author ised and included in the Union list may be placed 
on the mark et within the Union. 
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implemen ting Regulation (EU) 2017/2470 (2) 
establishing a Union list of author ised novel foods was adopt ed. 
(3) Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draf t implementing act 
author ising placing on the Union mark et of a novel food and on the updating of the Union list. 
(4) On 10 May 2018, the compan y ChromaDex Inc. (‘the Applicant’) made a request to the Commission to place 
nicotinamide riboside chlor ide on the Union mark et as a novel food within the meaning of Article 10(1) of 
Regulation (EU) 2015/2283. The application request ed for nicotinamide riboside chlor ide to be used as a source of 
niacin in food supplements intended for the general adult population at the maximum use levels of 300 mg/da y. 
Further more, the application requested for nicotinamide riboside to be also added to the list of niacin forms 
specifi ed in Annex II of Directive 2002/46/EC of the European Parliament and of the Council (3) as a source of niacin. 
(5) The Applicant also made a request to the Commission for the protection of propr ietar y data for a number of studies 
submitted in suppor t of the application namely , an in vitro study evaluating the metabolism of nicotinamide riboside 
in blood (Study No 160312) (4); an oral 7-da y dose range finding toxicity study in juvenile dogs (StudyNo 
(1)OJ L 327, 11.12.2015, p. 1. 
(2)Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance 
with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72). 
(3)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the 
Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51). 
(4)Keystone Bioanalytical Inc., The Metabolism of Nicotinamide Riboside in Human Blood (Study No 160312), 10 Januar y 2018, 
unpublished. EN Offi cial Jour nal of the European Union L 7/6                                                                                                                                              13.1.2020   17-921) (5); a hER G screening assa y (Study No 20151223) (6); a 28-da y repeat-dose oral toxicity study in juvenile 
dogs (Study No 17-940) (7); a 90-da y repeated -dose oral toxicity study in Sprague–Dawle y rats (Study 
No S14022) (8); a reproductive toxicity study (Study No G10959) (9); and a developmental toxicity study in rats 
(Study No G10957) (10). 
(6) The Commission consulted the European Food Safet y Author ity (‘Author ity’) on 8 October 2018, asking it to 
provid e a scientific opinion on the safety of nicotinamide riboside as a novel food in accordance with Article 10(3) 
of Regulation (EU) 2015/2283, and on the assessment for the intended use as a food supplement. 
(7) On 4 July 2019, the Author ity adop ted the scientific opinion on the ‘Safe ty of nicotinamide riboside chlor ide as a 
novel food pursuant to Regulation (EU) 2015/2283 and bioa vailability of nicotinamide from this source, in the 
conte xt of Directive 2002/46/EC’ (11). That scientifi c opinion is in line with the requirements of Article 11 of 
Regulation (EU) 2015/2283. 
(8) In its opinion, the Author ity concluded that nicotinamide riboside chloride is safe when used in food supplements at 
the maximum level of 300 mg/da y for the general adult population, excl uding pregnant and lactating women, and at 
the maximum level of 230 mg/da y for pregnant and lactating women. 
(9) The opinion of the Author ity gives suffi cient grounds to establish that nicotinamide riboside chlor ide under the 
assessed conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283. 
(10) The Auth ority considered that, in elaborating its opinion on nicotinamide riboside chlor ide as a novel food, data 
from the in vitro study evaluating the metabolism of nicotinamide riboside in blood (Study No 160312) served as a 
basis to assess the bioavai lability of nicotinamide, while data from five toxicity studies (an oral 7-da y dose range 
finding toxicity study in juvenile dogs (Study No 17-921); a 28-da y repeat-dose oral toxicity study in juvenile dogs 
(Study No 17-940); a 90-da y repeated -dose oral toxicity study in Sprague–Da wley rats (Study No S14022); a 
reproductive toxicity study (Study No G10959); and a developmental toxicity study in rats (Study No G10957)) 
served as a basis to assess the safety of nicotinamide riboside chlor ide. Theref ore, it is considered that the 
conclusions on the safety of nicotinamide riboside chlor ide could not have been reached without the data from the 
unpublished repor ts of those studies. 
(11) The Commission request ed the applicant to further clarify the justification provi ded with regard to their propr ietar y 
claim over the in vitro study evaluating the metabolism of nicotinamide riboside in blood and the five toxicity 
studies, and to clarify their claim to an excl usive right of reference to these studies, as refer red to in Article 26(2)(b) 
of Regulation (EU) 2015/2283. 
(12) The Applicant declared that, at the time the application was submitted , it held ownership and propr ietar y excl usive 
right of referen ce to these studies, and that theref ore third parties cannot lawfully access or use these studies or refer 
to that data. 
(13) The Commission assessed all the information provided by the Applicant and considered that the Applicant has 
suffi ciently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 
2015/2283. Theref ore, the in vitro study evaluating the metabolism of nicotinamide riboside in blood and the five 
toxicity studies contained in the Applicant’s file should not be used by the Auth ority for the benefi t of a subsequent 
applicant for a period of five years from the date of entr y into force of this Regulation. According ly, the placing on 
the mark et within the Union of nicotinamide riboside chlor ide should be restr icted to the Applicant for that period. 
(5)Exper imur , Oral 7-Da y Dose Range Finding Toxicity Study in Juvenile Dogs (Study No 17-921), 27 November 2017, unpublished. 
(6)IPS Therapeutique, Inc., Evaluation of the effec ts of Nicotinamide Riboside Chlor ide on the human potassium channel using human 
embr yonic kidney (HEK) 293 cells transfect ed with a human ether -a-go-go-relat ed gene (hER G), 25 March 2016, unpublished. 
(7)Exper imur , Oral 28-Da y Toxicity Study in Juvenile Dogs (Study No 17-940), 20 Febr uary 2018, unpublished. 
(8)Syngene International Limited, Comparative 90-Da y Oral Toxicity Study in Sprague Dawle y Rats (Study No S14022), 12 May 2015, 
unpublished. 
(9)Advinus Therapeutics Limit ed, Nicotinamide riboside chlor ide: one generation reproduction toxicity study through diet in Sprague- 
Dawley rats (Study No G10959), 21 November 2016, unpublished. 
(10)Advinus Therapeutics Limited, Nicotinamide riboside chlor ide: embr yo-fetal developmental toxicity study in Sprague-Dawle y rats by 
oral route (Study No G10957), 30 September 2016. 
(11)EFSA Journal 2019;17(8):5775. EN Offi cial Jour nal of the European Union 13.1.2020                                                                                                                                              L 7/7   (14) However , restr icting the author isation of nicotinamide riboside chlor ide and of the reference to the studies contained 
in the Applicant’s file for the sole use of the Applicant does not prevent other applicants from applying for an 
author isation to place on the market the same novel food provid ed that, their application is based on legally 
obtained information suppor ting the author isation under this Regulation. 
(15) The Directive 2002/46/EC lays down requirements on food supplements. The use of nicotinamide riboside chlor ide 
should be author ised without prejudice to the requirements of that Directive. 
(16) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
1. Nicotinamide riboside chloride as specifi ed in the Annex to this Regulation shall be included in the Union list of 
author ised novel foods established in Implementing Regulation (EU) 2017/2470. 
2. For a period of five years from the date of entr y into force of this Regulation only the initial Applicant: 
— Com pany: ChromaDex Inc.; 
— Address: 10900 Wilshire Boulevard Suit e 600, Los Ang eles, CA 90024 USA, 
is author ised to place on the mark et within the Union the novel food refer red to in paragraph 1, unless a subsequent 
applicant obtains author isation for the novel food without reference to the data protect ed pursuant to Article 2 of this 
Regulation or with the agreement of ChromaDex Inc. 
3. The entr y in the Union list refer red to in paragraph 1 shall include the conditions of use and labelling requirements 
laid down in the Annex. 
4. The author isation provid ed for in this Article shall be without prejudice to the provi sions of Directive 2002/46/EC. 
Article 2 
The studies contained in the application file on the basis of whic h the novel food referred to in Article 1 has been assessed 
by the Author ity, claimed by the Applicant as propr ietar y and without whic h the novel food could not have been 
author ised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entr y into 
force of this Regulation without the agreement of ChromaDex Inc. 
Article 3 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation. 
Article 4 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 10 Januar y 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 7/8                                                                                                                                              13.1.2020   ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: 
(1) the following entr y is inser ted in Table 1 (Author ised 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 chlor­
ide Specif ied food categor y Maximum levels The designation of the novel 
food on the labelling of the 
foodstuffs containing it shall 
be “Nicotinamide riboside 
chloride”  Auth orised on 20 Febr uary 
2020. This inclusion is based 
on propr ietar y scientific evi-
dence and scientifi c data pro-
tected in accordance with Arti-
cle 26 of Regulation (EU) 
2015/2283. 
Applicant: ChromaDex Inc., 
10900 Wilshire Boulevard 
Suite 600, Los Ange les, CA 
90024 USA. Dur ing the period 
of data protection, the novel 
food is author ised for placing 
on the mark et within the Union 
only by ChromaDex Inc. unless 
a subsequent applicant obtains 
author isation for that novel 
food without reference to the 
propr ietar y scientific evidence 
or scientifi c data protect ed in 
accordance with Article 26 of 
Regulation (EU) 2015/2283 or 
with the agreement of Chroma­
Dex Inc. 
End date of the data prot ection: 
20 Febr uary 2025.’ Food Supplements as defined 
in Directive 2002/46/EC 300 mg/da y for the general 
adult population, excluding 
pregnant and lactating women 
230 mg/da y for pregnant and 
lactating women   EN Offi cial Jour nal of the European Union 13.1.2020                                                                                                                                              L 7/9   (2) the following entr y is inser ted in Table 2 (Specif ications) in alphabetical order:                                                                
Author ised Novel Food Specification 
‘Nicotinamide riboside chlor ide Descr iption/Def inition: 
The novel food is a synthetic form of nicotinamide riboside. 
The novel food contains ≥ 90 % nicotinamide riboside chlor ide, predominantly in its β form, the remaining compo nents being residual 
solvents, reaction by-products and degradation products. 
Nicotinamide riboside chlor ide: 
CAS number: 23111-00-4 
EC number: 807-820-5 
IUPAC name: 1-[(2R,3R,4S,5R)-3,4-dih ydro xy-5-(hy droxymethyl )oxolan-2-yl]p yridin-1-ium-3-carbo xamide;ch loride 
Chemical formula: C11H15N2O5Cl 
Molecular weight: 290,7 g/mol 
Character istics/Composition: 
Colour: Whit e to light brown 
Form: Powder 
Identif ication: Conf orms by NMR (nuclear magnetic resonance) 
Nicotinamide riboside chlor ide: ≥ 90 % 
Water conte nt: ≤ 2 % 
Residual solv ents: 
Aceton e: ≤ 5 000 mg/kg 
Methanol: ≤ 1 000 mg/kg 
Aceton itrile: ≤ 50 mg/kg 
Methyl tert-butyl ether : ≤ 500 mg/kg 
Reaction by-products: 
Methyl acetat e: ≤ 1 000 mg/kg 
Acetamide: ≤ 27 mg/kg 
Acetic acid: ≤ 5 000 mg/kg 
Heavy metals : 
Arsenic: ≤ 1 mg/kg 
Microbiological criter ia: 
Total Plate Count : ≤ 1 000 CFU/g 
Yeast and Mould: ≤ 100 CFU/g 
Escher ichia coli: Absence in 10 g’   EN Offi cial Jour nal of the European Union L 7/10                                                                                                                                            13.1.2020