EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
SANCO/11565/2011 Rev. 1 (POOL/E4/2011/11565/11565R1-EN.doc) […](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending Directive 2002/46/EC of the European Parliament and of the Council, 
Regulation (EC) No 1925/2006 of the European Parliame nt and of the Council and 
Commission Re
gulation (EC) No 953/2009 as re gards the lists of mineral substances that 
can be added to foods 
(Text with EEA relevance) 
  
EN 1   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending Directive 2002/46/EC of the European Parliament and of the Council, 
Regulation (EC) No 1925/2006 of the Europe an Parliament and of the Council and 
Commission Regulation (EC) No 953/2009 as regar ds the lists of mineral substances that 
can be 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 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,  
Having regard to Regulation (EC) No 1925/2006 of the European Parliament and of the 
Council of 20 December 2006 on the addition of v itamins and minerals and of certain other 
substances to foods2, and in particular Article 3(3) thereof, 
Having regard to Directive 2009/39/EC of the Eu ropean Parliament and the Council of 6 May 
2009 on foodstuffs intended for particular nutritional uses3, and in particular Article 4(3) 
thereof,  
After consulting the European Food Safety Authority (EFSA), 
Whereas: (1) Annex II to Directive 2002/46/EC establis hes the list of vitamin and mineral 
substances which may be used for the manufacture of food supplements. Commission 
Regulation (EC) No 1170/2009 has replaced Annexes I and II of Directive 2002/46/EC. Modifications to the list pr ovided under Annex II of Directive 
2002/46/EC as modified by that  Regulation are to be adopted in compliance with the 
requirements laid down in Article 4 of th at Directive and in accordance with the 
procedure referred to in  its Article 13(3).  
(2) Annex II to Regulation (EC) No 1925/2006 estab lishes the list of vitamin and mineral 
substances which may be added to food. 
                                                
 
1 OJ L 183, 12.7.2002, p. 51. 
2 OJ L 404, 30.12.2006, p. 26. 
3 OJ L 124, 20.5.2009, p. 21.  
EN 2   EN (3) The Annex to Regulation (EC) No 953/2009 esta blishes the list of substances that may 
be added for specific nutritional purposes in foods for particular nutritional uses. 
(4) New mineral substances have been eval uated by the EFSA for use in food. The 
substances for which the EFSA expressed a favourable opinion should be added to the 
lists in those acts. 
(5) Interested parties were consulted through the Advisory Group on the Food Chain and 
Animal and Plant Health and the provided  comments were taken into consideration. 
(6) Directive 2002/46/EC, Regulation (EC)  No 1925/2006 and Regulation (EC) No 
953/2009 should therefore be amended accordingly. 
(7) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health, and neither the European 
Parliament nor the Council has opposed them,  
HAS ADOPTED THIS REGULATION: 
Article 1 
Point B of Annex II to Directive 2002/46/EC is amended as follows: 
(a) the following entries are inserted after the entry "ferrous phosphate" 
"ferrous ammonium phosphate 
ferric sodium EDTA" 
(b) the following entries are inserted afte r the entry "sodium salts of orthophosphoric 
acid": 
"sodium sulphate potassium sulphate".  
Article 2 
Point 2 of Annex II to Regulation (EC) No 1925/2006 is amended as follows: 
(a) the following entries are inserted after the entry "ferrous sulphate" 
"ferrous ammonium phosphate ferric sodium EDTA"  
EN 3   EN (b) the following entry is inserted after the entry "chromium (III) sulphate and its 
hexahydrate": 
"chromium picolinate". 
Article 3 
Category 2 (Minerals) of the Annex to Regulation (EC) No 953/2009 is amended as follows: 
(a) the following entries are inserted after the entry "ferrous sulphate" 
"ferrous ammonium 
phosphate x  
ferric sodium EDTA x "
 
(b) the following entry is inserted after the entry "chromium (III) sulphate and its 
hexahydrate": 
"chromium picolinate x "
 
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 . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
 For the Commission 
 José Manuel BARROSO  The President