EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1208/2022 
(POOL/E1/2022/1208/1208 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of 
the Council as regards nicotinamide riboside chloride added to foods  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 2  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of 
the Council as regards nicotinamide riboside chloride added to foods  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to  Regulation (EC) No 1925/2006 of the European Parliament and of t he 
Council of 20 December 2006 on the addition of vitamins and minerals and of certain other 
substances to foods1, and in particular Article 3(3) thereof,  
Whereas:  
(1) Annexes I and II to Regulation (EC) No 1925/2006 establish the list of vitamin and 
mineral substances, and for each of them the forms, which may be added to foods.  
(2) Commission Implementing Regulation (EU) 2020/162 authorised the placing on the 
market of nicotinamide riboside chloride  as a novel food for use in food s upplements 
as defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the 
Council3, for the adult population.  
(3) As the initial authorisation of this substance as a novel food as set out in Regulation 
(EU) 2020/16 concerned only food supplements, the substance has been included in 
the list set out in Annex II to Directive 2002/46/EC4 by Commission Regulation (EU) 
2021/4185. Following an application for extension of the use of nicotinamide riboside 
chloride as a novel food to cover also its use for nutritional pu rposes as a source of 
niacin , in particular, in meal replacements, t he Commission requested the European 
Food Safety Authority (‘the Authority’)  to deliver an opinion on such extension of use 
in accordance with Regulation (EU) 2015/22836 and, following the  outcome of that 
                                                 
1 OJ L 404, 30.12.2006, p. 26.  
2 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 (OJ L 7, 13.1.2020, p. 6 ). 
3 Directive 2002/46/EC of the E uropean Parliament and of the Council of 10 June 2002 on the 
approximation of the laws of the Member State s relating to food supplements (OJ L 183, 12.7.2002, p. 
51). 
4 Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on t he 
approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 
51). 
5 Commission Regulation (EU) 2021/418 of 9 March 2021 amending Directive 2002/46/EC of the 
European Parliament and of the Council as regards nicoti namide riboside chloride and magnesium 
citrate malate used in the manufacture of food supplements and as regards the units of measurement 
used for copper (OJ L 83, 10.3.2021, p. 1).  
6 Regulation (EU) 2015/2283 of the Parliament and of the Council of 25 Nov ember 2015 on novel foods, 
amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing  
EN 3  EN assessment, to evaluate in the context of  Regulation (EC) No 1925/2006 , the safet y 
and bio -availability of that substance when added to the foods in question . On 14 
September 2021 , the Authority adopted  a scientific opinion on the  extension of use of 
nicotinamide riboside chloride as a novel food .7 
(4) It follows from that opinion that the use of nicotinamide riboside chloride in foods is 
not of safety concern  as a source of niacin provided that certain conditions  are 
fulfilled.  Those conditions are set out in the authorisation  of this substance by 
Commission Implementing Regulation  (EU) 2022/1160 .8 
(5) In accordance with Article 3(1) of Regulation (EC) No 1925/2006 , only vitamins 
and/or minerals listed in Annex I, in the form listed in Annex II to th at act may be 
added to foods. Based on  the Authority’s favourable opinion  and on the authorisation 
as a novel food as set out in Commission Regulation  (EU) 2022/1160 , nicotinamide 
riboside chloride should be included in  in Annex  II to Regulation (EC) No 1925/2006  
as a form of niacin . 
(6) The Advisory Group on the Food Chain and Animal and Plant Health  was consulted 
and its comments were taken into consideration . 
(7) Regulation (EC) No 1925/2006 should therefore be amended accordingly.  
(8) The measu res provided for in this Regulation are in acc ordance with the opinion of the 
Standing  Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex I I to Regulation (EC) No 1925/2006  is amended in accordance with the Annex to t his 
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 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  
                                                                                                                                                         
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation 
(EC) No 1852/2001 (OJ L 327, 11.1 2.2015, p. 1).  
7 EFSA Journal 2021;19(11):6843 . 
8 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 , (OJ L 179, 6.7.2022, p. 25 ).