EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/11369/2014 CIS (POOL/E4/2014/11369/11369-EN CIS.doc) […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Directive 2002/46/EC of the Euro pean Parliament and of the Council as 
regards (6 S)-5-methyltetrahydrofolic acid, glucosam ine salt used in the manufacture of 
food supplements 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Directive 2002/46/EC of the European Parliament and of the Council as 
regards (6 S)-5-methyltetrahydrofolic acid, glucosam ine salt used in the manufacture of 
food supplements 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European 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 
supplements
1, and in particular Article 4(5) thereof,  
Whereas: (1) Annex II to Directive 2002/46/EC establis hes the list of vitamin and mineral 
substances, and for each of them the forms, which may be used in the manufacture of food supplements. Commission Regulation (EC) No 1170/2009
2 has replaced Annexes 
I and II to Directive 2002/46/EC.   
(2) According to Article 14 of  Directive 2002/46/EC, provisi ons on vitamin and mineral 
substances in food supplements which may have  an effect upon public  health are to be 
adopted after consultation with the European  Food Safety Authority ('the Authority'). 
(3) Following a request for the addition of (6 S)-5-methyltetrahydrofolic acid, glucosamine 
salt as a source of folate to  the list set out in Annex II to Directive 2002/46/EC, the 
Authority adopted on 11 Septembe r 2013 a Scientific Opinion on (6 S)-5-
methyltetrahydrofolic acid, gluc osamine salt as a source of folate added for nutritional 
purposes to food supplements and the bioava ilability of folate from this source3.  
(4) It follows from the Authority ’s opinion that the use of (6 S)-5-methyltetrahydrofolic 
acid, glucosamine salt in food supplements is  not of safety concern as a source of 
folate. 
(5) The Authority noted in the conclusions set out in its opini on that given the 
manufacturing process, the sp ecifications proposed by the peti tioner, and referred to in 
                                                 
1 OJ L 183, 12.7.2002, p. 51. 
2 OJ L 314, 1.12.2009, p. 36. 
3  EFSA Journal 2013;11(10): 3358.  
EN 3   EN the opinion of the Authority, for (6 S)-5-methyltetrahydrofolic acid, glucosamine salt 
should include an indication for the absence of mycotoxins. 
(6) Following the Authority’s favourable opinion, (6 S)-5-methyltetrahydrofolic acid, 
glucosamine salt should be added to th e list set out in Annex II to Directive 
2002/46/EC. 
(7) (6S)-5-methyltetrahydrofo lic acid, glucosamine salt is a novel food ingredient the 
placing on the market of which has been  authorised by Commission Implementing 
Decision 2014/154/EU4. 
(8) Interested parties were consulted through the Advisory Group on the Food Chain and 
Animal and Plant Health and the comments provided were taken in to consideration. 
(9) Directive 2002/46/EC should therefore be amended accordingly. 
(10) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION: 
Article 1 
In Annex II to Directive 2002/46/EC the foll owing point (c) is ad ded in Heading 10 
(FOLATE) of Section A:  
‘(c) (6 S)-5-methyltetrahydrofolic acid, glucosamine salt(*) 
__________________ * The specifications for (6 S)-5-methyltetrahydrofolic acid, glucosamine salt 
must include an indication for the absence of mycotoxins.’  
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. 
                                                
 
4  Commission Implementing Decision 2014/154/EU of 19 March 2014 authorising the placing on the 
market of (6 S)-5-methyltetrahydrofolic acid, glucosamin e salt as a novel food ingredient under 
Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 85 of 21.3.2014, p. 
10).  
EN 4   EN Done at Brussels, 
 For the Commission 
 The President  José Manuel BARROSO