EN EN
EUROPEAN
COMMISSION
Brussels, XXX
SANCO/10722/2013 CIS 
(POOL /E4/2013/10722/10722 -EN 
CIS.doc)
[…](2013) XXX draft
COMMISSION REGULATION (EU) No …/..
of XXX
amending Directive 2002/46/EC of the European Pa rliament and of the Council and 
Regulation (EC) No 1925/2006 of the European Parliament and of the Council as 
regards chromium enriched yeast used for the manufacture of food supplements and 
chromium(III) lactate tri -hydrate added to foods 
(Text with EE A relevance)EN 2 ENCOMMISSION REGULATION (EU) No …/..
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 chromium enriched yeast used for the manufact ure of food supplements and 
chromium(III) lactate tri -hydrate added to foods 
(Text with EEA relevance)
THE EUROPEAN COMMI SSION,
Having regard to the Treaty  on the Functioning of the European Union ,
Having regard to Directive 2002/46/EC of the European Par liament and of the Council of 
10June 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,
After consulting the European Food Safet y Authority (EFSA) ,
Whereas:
(1) Annex II toDirective 2002/46/EC estab lishes the list of vitamin and mineral 
substances which may be used in the manufacture of food supplements .Commission 
Regulation (EC) No 1170/20093has replaced Annexes I and II to Directive 
2002/46/EC. Annex II to Directive 2002/46/EC has been amended by Commission 
Regulation (EC) No 1161/20114.
(2) According to Article 14 of Directive 2002/46/EC, provisions on vitamin and mineral 
substances in food supplements which mayhave an effect upon public health are to be 
adopted after consultation with EFSA .
  
1OJ L 183, 12.7.2002, p. 51 .
2OJ L 404, 30.12.2006, p. 26.
3OJ L 314, 1.12.2009, p. 36.
4OJ L 296, 15.11.2011, p. 29.EN 3 EN(3) On 31 O ctober 2012 ,EFSA adopted a scientific opinion on ChromoPrecise® cellular 
bound chromium yeast added for nutritional purposes as a source of chromium in food 
supplements and the bioavailability of chromium from this source .5
(4) EFSA stressed that the conclusi ons set out in its opinion appl yonly to 
ChromoPrecise® chromium y east and not to other chromium -enriched yeasts . 
Furthermore it considered that the specifications for ChromoPrecise® chromium y east 
should include specifications for loss on dry ing and for c hromium(VI) maximum 
content.
(5) If follows from the opinion adopted by EFSA on 31 October 2012 that the use of 
ChromoPrecise® chromium y east in food supplements is not of safety concern ,
provided that certain conditions detailed in the opinion are respected.
(6) Annex II toRegulation (EC) No 1925/2006 establishes the list of vitamin and mineral 
substances which may be added to food s.
(7) 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 EFSA .
(8) On 13 September 2012 EFSA adopted a scientific opinion on chromium(III) lactate 
tri-hydrate as a source of chromium (III) added for nutritional purposes to foodstuff.6
(9) It follows from the opinion adopted b y EFSA on 13 September 2012 that the addition 
of chromium(III) lactate tri -hydrate to food is not of safet y concern , provided certain 
conditions detailed in the opinion are respected.
(10) Substances for which EFSA expressed a favourable opinion should be added to the 
lists set out in Annex II to Directive 2002/46/EC and 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 con sideration.
(12) Directive 2002/46/EC and Regulation (EC) No 1925/2006 should therefore be 
amended accordingl y.
(13) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health and nei ther the European 
Parliament nor the Council has opposed them,
  
5EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on 
Chromop recise® cellular bound chromium ye ast added for nutritional purposes as a source of 
chromium in food supplements and the bioavailabilit of chromium form this source. EFSA Journal 
2012; 10(11):2951.
6EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on 
chromium(III) lactate tri -hydrate as a source of chromium added for nutritional purposes to foodstuff. 
EFSA Journal 2012; 10(10):2881.EN 4 ENHAS ADOPTED THIS REGULATION:
Article 1
Inpoint B of Annex II to Directive 2002/46/EC ,the following entry isinserted after the entry  
"chromium(III) chloride ":
"chromium enriched yeast(*).
___________________
* Chromium -enriched yeasts produced b y culture in the presence of chromium 
chloride as a source of chromium and containing, in the dried form as 
marketed, 230 -300 mg of chromium/kg. The content of chromium(VI) shall 
not exceed 0.2% of to tal chromium. "
Article 2
In point 2 of Annex II to Regulation (EC) No 1925/2006 , the following entry is inserted after 
the entry "chromium picolinate ":
"chromium(III) lactate tri -hydrate ".
Article 3
This Regulation shall enter into force on the twentieth d ayfollowing 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