EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11505/2016 
(POOL/E1/2016/11505/11505 -EN.doc)  
[…](2016) XXX  draft 
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Directive 2002/46/EC of the European Parliament and of the Council and 
Regulation (EC) No 1925/2006 of the European Parliament and of the Council as 
regards organic silicon (monomethylsilanetriol) and calcium phosphoryl 
oligosaccharides (POs -Ca®) added to foods and used in the manufacture of food 
supplements  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Directive 2002/46/EC of the European Parliament and of the Council and 
Regulation (EC) No 1925/2006 of the European Parliament and of the Council as 
regards organic silicon (monomethylsilanetriol) and calcium phosphoryl 
oligosaccharides (POs -Ca®) added to  foods and 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 Cou ncil 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,  
Having regard to Regulation (EC) No 1925/2006  of the European Parliament and of the 
Council of 20 December 2006 on the addition of vitamins and minerals and of certain other 
substances to foods2, and in particular Article 3(3) thereof,  
Whereas:  
(1) Annex II to Directive 2002/46/EC establishes the list of vitamin and mineral 
substances, which may be used in the manufacture of food supplements.  
(2) According to Article 14 of Directive 2002/46/EC, provisions on vitamin and mineral 
substances in food supple ments which may have an effect upon public health are to be 
adopted after consultation with  the European Food Safety Authority (‘the Authority’).  
(3) Annex II to Regulation (EC) No 1925/2006 establishes the list of vitamin and mineral 
substances, and for each of them the forms, which may be added to foods.  
(4) According to Article 3(3) of Regulation (EC) No 1925/2006, modifications to the list 
provided in Annex II to that Regulation are to be adopted taking account of the 
opinion of the Authority.  
(5) Following a req uest for the addition of organic silicon as a source of silicon to the list 
set out in Annex II to Directive 2002/46/EC, on 9 March 2016 the Authority adopted a 
Scientific Opinion on the safety of organic  silicon (monomethylsilanetriol ; MMST ) as 
a novel fo od ingredient for use as a source of silicon in food supplements and 
bioavailability of orthosilicic acid from the source3. 
(6) It follows from that opinion that the use of organic silicon (monomethylsilanetriol ) in 
food supplements is not of a safety concern as a source of silicon , provided that certain 
conditions are respected . 
                                                 
1 OJ L 183, 12.7.2002, p.  51.  
2 OJ L 404, 30.12.2006, p.  26.  
3 EFSA Journal 2016;14(4):4436   
EN 3   EN (7) Taking into account  the Authority’s favourable opinion,  organic sili con 
(monomethylsilanetriol ) should be included in  the list set out in Annex II to Directive 
2002/46/EC.  
(8) Following a request for the addition of calcium phosphoryl oligosaccharides (POs -
Ca®) as a source of calcium to the list set out in Annex II to Directive 2002/46/EC and 
to the list set out in Annex II to Regulation (EU) No 1925/2006, on 26 April 2016 the 
Authority ado pted a Scientific Opinion on safety of calcium phosphoryl 
oligosaccharides (POs -Ca®) as a source of calcium added for nutritional purposes to 
food, food supplements and foods for special medical purposes4. 
(9) It follows from t hat opinion that the addition of calcium phosphoryl oligosaccharides 
(POs -Ca®) to food and its use in food supplements is not of a safety concern as a 
source of calcium , provided that certain conditions are respected.  
(10) Taking into account  the Authority’s favourable opinion, calcium phospho ryl 
oligosaccharides (POs -Ca®) should be included in  the list set out in Annex II to 
Directive 2002/46/EC  and in the list set out in Annex II to Regulation (EC) No 
1925/2006 . 
(11) Interested parties were consulted through the Advisory Group on the Food Chain and 
Animal and Plant Health and the comments provided were taken into consideration.  
(12) Directive 2002/46/EC and Regulation (EC) No 1925/2006 should therefore be 
amended accordingly.  
(13) The measures provided for in this Regulation are in accordance with the opin ion of 
the Standing  Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex II to Directive 2002/46/EC  is amended in accordance with the Annex to this 
Regulation.   
Article 2  
Annex II to Regulation (EC) No 1925 /2006  is am ended in accordance with the Annex to this 
Regulation.  
Article 3 
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  
                                                 
4 EFSA Journal 2016;14(6):4488   
EN 4   EN  Jean -Claude JUNCKER