EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1207/2022 
(POOL/E1/2022/1207/1207 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of 
the Council to allow the use of nicotinamide riboside chloride as a source of niacin in 
food for special medical purposes and total diet replacement for weight control  
(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 C ommission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Article 15 of Regulation (EU) No 609/2013 of the European Parliament and of the Council  of 
12 June 2013 on food intended for infants and young children, food for special medical 
purposes and total diet replacement for weight control1 provides that  certain types of 
substances may be added to one or more of th ose categories of food only if tho se substance s 
are included in the Union list that is set out in the Annex . 
In order to take into account  the technical progress, scientific developments or the protection 
of consumers' health , and subject to the general requirements set out in  Articles 6 a nd 9 of 
Regulation (EU) No 609/2013 , Article 16(1) of the Regulation empowers the Commi ssion to 
amend the Annex by means of delegated act s with respect to the addition of substances to the 
Union list.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission consulted the European Food Safety  Authority ( ‘the Authority’ ) on the 
matter . The Authority 's Scientific Opinion  on the extension of use of nicotinamide riboside 
chloride as a novel food pursuant to Regulation (EU) 2015/22832 constitute s the sci entific 
basis for this delegated Regulation . 
Member States ’ experts were consulted  in writing  in the context of the Expert Group on food 
intended for infants and young children, food for special medical purposes and total diet 
replacement for weight contro l3 between 22 April 2022 and 13 May 2022.   
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The Union list of substances  that may be added to the specific categories of food covered by 
the scope of Regulation (EU) No  609/2013  as set out in its Article 1(1) is updated in 
accordance with Article 16 of that Regulation and on the  basis of the above -mentioned 
Authority’s opinion  to authorise the addition of nicotinamide riboside chloride as a source of 
niacin  to those categories of food aimed at the adult populatio n, namely total diet replacement 
for weight control and food for special medical purposes . 
                                                 
1 OJ L 181, 29.6.2013, p. 35.  
2 EFSA Journal 2021;19(11):6843.  
3 Reference E02893 in the Register of Commission Expert Groups and other similar entities.   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of 
the Council to allow the use of nicotinamide riboside chloride as a source of niacin in 
food for special medical purposes and total diet replacement for weight control  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having reg ard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) No 609/2013 of the European Parliament and of the 
Council of 12 June 2013 on food intended for infants and young children, food for special 
medical purposes, and total diet replacement for weight control and repealing Council 
Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 
2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and 
Commiss ion Regulations (EC) No 41/2009 and (EC) No 953/2009 
EN 3  EN 1, and in particular Article 16(1) thereof,  
Whereas:  
(1) The Annex to Regulation (EU) No 609/2013 establishes  a Union list of substances that 
may be added to one or more of the categories of food referred to  in Article 1(1)  of 
that Regulation .  
(2) In accordance with Regulation (EU) 2015/2283 of the European Parliament and of the 
Council2, Commission Implementing Regulation (EU) 2020/163 authorised the placing 
on the market of nicotinamide riboside chloride  as a novel food for use in food 
supplements as defined in Directive 2002/46/EC of the European Parliament and of 
the Council4, for the adult population.  
(3) Following an application for extension of the use of nicotinamide riboside chloride as 
a novel food  to cover  also its use for nutritional purposes as a source of niacin , in  
particular, in food for special medical purposes  and total diet replacement for weight 
control , the Commission requested the European Food Safety Authority (‘the 
Authority’) to deliver an opinion on such extension of use in accordance with 
Regulation (EU) 2015/2283  and, following the outcome of that assessment, to evaluate 
in the context of  Regulation (EU) No 609/2013  the safety and bioavailability 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 food5. In that opinion , the Authority concluded that nicotinamide riboside 
chloride  is as safe as pure nicotinamide, for  use in food for special medical purposes 
and total diet replacement for weight control. Furthermore, the Authority  confirmed 
the bioavailability of nicotina mide, a form of niacin, from nicotinamide riboside 
chloride.  
(4) Commission Implementing Regulation (EU) 2022/11606 authorised the use of 
nicotinamide riboside chloride in, among other products,  foods for special medical 
purposes  and total diet replacement for weight control for the adult population, 
excluding pregnant and lactating women , subject to certain conditions . 
(5) The Commission considers  that the Authority’s opinion also gives sufficient grounds 
to establish that nicotinamide riboside chloride  is not of safet y concern as a source of 
niacin when used in food for sp ecial medical purposes and total diet replacement for 
weight control , under the conditions  set out in Commission Implementing Regulation 
(EU) 2022/1160 . Therefore, it is appropriate to allow the use of  nicotinamide riboside 
                                                 
1 OJ L 181, 29.6.2013, p.  35. 
2 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 Co uncil and 
Commission Regulation (EC) No 1852/2001  (OJ L 327, 11.12.2015,  p. 1)  
3 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 (E U) 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 ). 
4 Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the 
approximation o f the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 
51). 
5 Scientific opinion on the extension of use of nicotinamide riboside chloride as a novel food pursuant to 
Regulation (EU) 2015/2283 , EFSA Journal 2021;19(11):6843 . 
6 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 ).  
EN 4  EN chloride as a source of niacin in food for special medical purposes and total diet 
replacement for weight control . That substance should therefore be included in the 
Union list of substances that may be added to certain categories of food, set out in the 
Annex to Regulation (EU ) No 609/2013 . 
(6) The Annex to Regulation (EU ) No 609/2013 should therefore be amended 
accordingly , 
HAS ADOPTED THIS REGULATION:  
Article 1  
The Annex to Regulation (EU) No 609/2013 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 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For th e Commission  
 The President  
 Ursula VON DER LEYEN