EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10292/2020 
(POOL/E1/2020/10292/10292 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Directive 2002/46/EC of the European Parliament and of the Council as 
regards magnesium citrate malate and nicotinamide riboside chloride used in the 
manufacture of food supplements and as regards the units of measurement used for 
copper  
(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 2  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Directive 2002/46/EC of the European Parliament and of the Council as 
regards magnesium citrate malate and nicotinamide riboside chloride used in the 
manufacture of food supplements and as regards the units of measurement used for 
copper  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the E uropean Union,  
Having regard to Directive 2002/46/EC of the European Parliament and of the Council of 
10 June 2002 on the approximation of the laws of the Member States relating to food 
supplements1, and in particular Article 4(5) thereof,  
Whereas:  
(1) Annex es I and  II to Directive 2002/46/EC list the vitamin s and mineral s and their 
forms , which may be used in the manufacture of food supplements.  
(2) Pursuant  to Article 14 of Directive 2002/46/EC, provisions on vitamin and mineral 
substances in food supplements that may have an effect upon public health are to be 
adopted after consultation with  the European Food Safety Authority (‘the Authority’).  
(3) Pursuant to Article 14(1) and 14(3)(a) of Regulation (EC) 178/2002  of the European 
Parliament and of the Council of 2 8 January 2002 laying down the general principles 
and requirements of food law, establishing the European Food Safety Authority and 
laying down procedures in matters of food safety2 food shall not be placed on the 
market if it is unsafe with regard to  the normal conditions of use of the food by the 
consumer.  
(4) Following a request  from the European Commission to deliver an opinion on  
nicotinamide riboside chloride as a novel food including the safety of its use in food 
supplements as a source of niacin  and th e bioavailability of nicotinamide, a form of 
niacin, from this source, in the context of Directive 2002/46/EC , on 4 July 2019 the 
Authority adopted  a scientific opinion on the safety of nicotinamide riboside chloride 
as a novel food ingredient for use as a  source of niacin in food supplements3. 
(5) It follows from that opinion that the use of nicotinamide riboside chloride in food 
supplements is not of safety concern  provided that certain limitations  are respected  
which are set out in the approval of this substance by Commission Regulation  (EU) 
2020/16 .4 
                                                 
1 OJ L 183, 12.7.2002, p.  51.  
2 OJ L 31, 1.2.2002, p. 1 –24. 
3 EFSA Journal 2019;17(8):5775  
4 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  
EN 3  EN (6) Based on  the Authority’s favourable opinion  and on the authorisation as a novel food 
ingredient as set out in Commission Regulation  (EU) 2020/16 , nicotinamide ribo side 
chloride should be included in  the list set out in Annex  II to Directive 2002/46/EC.  
(7) Pursuant to Article 8 of Regulation (EU) 2015/22835, magnesium citrate malate was 
included in the Union list of authorised novel foods provided for in the Annex to 
Implementing Regulation (EU) 2017/2470 .6 This listing provides that magnesium 
citrate malate is authorised exclusively as a novel food ingredient for the use in food 
supplements as defined in Directive 2002/46/EC.  
(8) Following a request  from the European Commission to deliver an opinion  on the 
nutrient source , magnesium citrate malate , the Authority adopted a s cientific opinion 
on the bioavailability of magnesium from magnesium citrate malate when  added for 
nutritional purposes to food s upplements7. The Authority concluded that magnesium 
citrate malate is a source from which magnesium is bioavailable. The assessment of 
the bioavailability of a nutrient source is of relevance to its safety assessment as 
explained by the Authority  in its guidance  document “Guidance on safety evaluation 
of sources of nutrients and bioavailability of nutrient from the source s”8. The 
Authority explains  that its approach to evaluating the bioavailability of a nutrient 
source is by using comparative studies that consider the bioavailability of the chemical 
forms of the nutrient that are already on the positive  lists in the relevant legislation.  
The Authority further explains that  the classification of the bioavailability of a nutrient 
source  as being equivalent, higher or lowe r than a reference source  has implications 
for the safety of the source at the proposed uses and use levels and with respect to 
relevant health -based guidance values, such as the tolerable upper intake level ( UL) 
for the  nutrient itself . 
(9) The Authority in its above -mentioned guidance document, explain s that the evaluat ion 
of the safety of a nutrient source does not include an assessment  of the nutritional, 
physiological function or safety of the nutrient  per se , in line wi th the relevant legal 
basis for this evaluation.  The Authority , however explained that if the proposed uses 
and use levels of the source were likely to reach the UL for that nutrient, it would 
consider this  in its safety assessment. The Authority, in its s cientific opinion on the 
bioavailability of magnesium citrate malate, noted t hat at th e proposed maximum use 
levels for  magnesium citrate malate, the existing UL for magnesium in food 
supplements, water, or added to food and beverages (2 50mg per day) was  exceeded. 
Directive 2002/46/EC recognises that excessive intake of vitamins and minerals may 
result in adverse effects and therefore necessitate the setting of maximum safe levels 
for them in food supplements, as appropriate. Those maximum levels should be set 
taking into account the UL of the vitamin or mineral, as established by scientific risk 
assessment based on generally acceptable scientific dat a, and intakes of the nutrient 
                                                                                                                                                         
European Parliament and of the Council and amending Commission Implementing Regulation (EU) 
2017/2470 , OJ L 7, 13.1.2020, p. 6 . 
5 Regulation (EU) 2015/2283 of the Parliament and of the Council of 25 November 2015  on novel foods, 
amendin g 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 , OJ L 327, 11.12.2015, p. 1.  
6 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 ).  
7 EFSA Journal 2018;16(12):5484  
8 EFSA Journal 2018;16(6):5294   
EN 4  EN from the normal diet. It is to be noted that in 2001, t he Scientific Committee  on Food9 
set the UL for magnesium based on a mild, transient laxative effect  which is easily 
reversible and to which the body can easily adapt within days . On the basis of 
generally acceptable scientific data, the reported adverse effects from the intake of 
magnesium when used in the manufacture of food supplements are not considered to 
be of a severe nature that would necessitate the setting of a maximum safe level for the 
use of magnesium citrate malate  at the proposed use levels in food supplements . 
How ever, this situation could be revised  as scientific information becomes available 
that would demonstrate the  need to establish a harmonised maximum safe level for 
magnesium. Furthermore, until such limits are set at EU level, national rules 
governing the use of magnesium in the manufacture of food supplements may be 
applied on the basis of the criteria laid down in Article 5 of Directive 2002/ 46/EC . 
(10) Based on the Authority’s favourable opinion on the bioavailability of magnesium from 
magnesium citrate malate, and on its  authorisation as a novel food ingredient as set out 
in Implementing Regulation (EU) 2017/2470, m agnesium citrate malate should be 
included in  the list set out in  Annex II to Directive 2002/46/EC .  
(11) Pursuant to  Article 8(1)  and (3) of Directive 2002/46/EC, the amount of copper 
present in a food supplement is to be declared on the labelling in numerical form using 
the units  of measur ement  specified in Annex I to Directive 2002/46/EC . Pursuant to 
Article 8(3) of Directive 2002/46/EC , the information on this substance is also to be 
expressed as a percentage of the references  values set out in Annex XIII to Regulation 
(EU) 1169/2011  of the European Parliament and  of the Council . Pursuant to  Annex I 
to Directive 2002/46/EC, t he unit s of measurement  for copper required for  labelling 
purposes for food supplements are ‘µg’, whereas those required for copper pursuant to  
Regulation (EU ) 1169/2011  are ‘mg’. For reasons of consistency and clarity, the unit s 
of measurement  for copper in Annex I to Directive 2002/46/EC should also be ‘mg’.  
Since the modification of the unit s of measurement  for copper  is not liable to have an 
effect on human h ealth, it is not necessary to seek the opinion of the Authority.   
(12) The Advisory Group on the Food Chain and Animal and Plant Health  was consulted 
and its comments were taken into consideration.   
(13) In order to avoid disruptions in trade, sufficient time should  be given to allow 
producers  to comply with the new unit s of measurement  for copper. Moreover, in the 
absence of safety concerns, the marketing of existing stocks of copper should be 
allowed after the date of application of Article 1 of  this Regulation, un til those stocks 
are exhausted.  
(14) Directive 2002/46/EC should therefore be amended accordingly.  
(15) The measures provided for in this Regulation are in acc ordance with the opinion of the 
Standing  Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex I  to Directive 2002/46/EC  is amended in accordance with the Annex to this 
Regulation.   
                                                 
9 http://www.efsa.europa.eu/sites/default/files/efsa_rep/blobserver_assets/ndatolerableuil.pdf   
EN 5  EN Article 2  
Annex II to Directive 2002/46/EC is amended in accordance with the Annex to this 
Regulation.  
Article 3 
Products placed on the market or labelled prior to …/…/ …  [Office of publication: please add 
date eighteen  months after date of publication in the OJ ] and that do  not comply with point 1 
of the Annex to this Regulation may be marketed after that date until the existing stocks ru n 
out. 
Article 4 
This Regulation shall enter into force on the twentieth day following  that of its publication in 
the Official Journal of the European Union .  
Article 1 shall apply from …/…/… [Office of publication: please add date eighteen  months 
after publication ]. 
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