EN    EN EN 
  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2009) final 
Draft 
COMMISSION REGULATION 
of 
amending Directive 2002/46/EC and Regulati on (EC) No 1925/2006 as regards the lists 
of vitamins and minerals and their forms th at can be added to foods, including food 
supplements 
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
amending Directive 2002/46/EC and Regulati on (EC) No 1925/2006 as regards the lists 
of vitamin and minerals and their forms that  can be added to foods, including food 
supplements 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
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, 
After consulting the European Food Safety Authority, Whereas: 
(1) Annexes I and II to Directive 2002/46/EC establish the lists of vitamins and minerals, 
and for each of them the forms, that ma y be used for the manufacture of food 
supplements. Modifications to these lists ar e 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) Annexes I and II to Regulation (EC) No 1925/ 2006 establish the lists of vitamins and 
minerals, and for each of them the forms, that may be added to food. Modifications to these lists are to be adopted in compliance with the requirements laid down in Article 
3 of that Regulation and in accordance with the procedure referred to in its Article 
14(3). 
(3) New vitamin and mineral forms have been  evaluated by the European Food Safety 
Authority. The substances which have receive d a favourable scientif ic opinion and for 
which the requirements laid down in Direct ive 2002/46/EC and in Regulation (EC) No 
1925/2006 are complied with should be added to  the respectiv e lists in those acts. 
                                                
 
1 OJ L 183, 12.7.2002, p. 51. 
2 OJ L 404, 30.12.2006, p. 26.  
EN 3   EN (4) Interested parties were consulted and the provided comments were taken into 
consideration. 
(5) Following the scientific evaluation by the European Food Safety Authority, it is 
appropriate to introduce speci fications for some vitamin and mineral substances for 
their identification. 
(6) Directive 2002/46/EC and Regulation (EC) No 1925/2006 shoul d 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 Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annexes I and II to Directive 2002/46/EC are replaced respectively by the texts in Annex I 
and II to this Regulation. 
Article 2 
Regulation (EC) No 1925/2006 is amended as follows: 
(1) In Annex I, the word "BORON" is  added in the list in point 2.  
(2) Annex II is replaced by the text  in Annex III 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 
 Androulla VASSILIOU  Member of the Commission  
EN 4   EN ANNEX I  
"ANNEX I 
Vitamins and minerals which may be used  in the manufacture of food supplements 
1. Vitamins 
Vitamin A (µg RE) Vitamin D (µg) Vitamin E (mg α-TE) 
Vitamin K (µg) Vitamin B1 (mg) Vitamin B2 (mg) Niacin (mg NE) Pantothenic acid (mg) Vitamin B6 (mg) Folic acid (µg)* Vitamin B12 (µg) Biotin (µg) Vitamin C (mg) 
2. Minerals 
Calcium (mg) Magnesium (mg) Iron (mg) Copper (µg) Iodine (µg) Zinc (mg) Manganese (mg) Sodium (mg) Potassium (mg)  
EN 5   EN Selenium (µg) 
Chromium (µg) Molybdenum (µg) Fluoride (mg) Chloride (mg) Phosphorus (mg) Boron (mg) Silicon (mg) _________________________________________________________________ * Folic acid is the term included in Annex I of Commission Directive 
2008/100/EC of 28 October 2008 amendi ng Council Directive 90/496/EEC on 
nutrition labelling for foodstuffs as re gards recommended daily allowances, 
energy conversion factors and definitions  for nutrition labelling purposes and 
covers all forms of folates."  
EN 6   EN ANNEX II  
"ANNEX II 
Vitamin and mineral substances which may be used in the manufacture of food 
supplements 
A. Vitamins 
1. VITAMIN A 
(a) retinol (b) retinyl acetate (c) retinyl palmitate (d) beta-carotene 
2. VITAMIN D 
(a) cholecalciferol (b) ergocalciferol 
3. VITAMIN E 
(a) D-alpha-tocopherol (b) DL-alpha-tocopherol (c) D-alpha-tocopheryl acetate 
(d) DL-alpha-tocopheryl acetate 
(e) D-alpha-tocopheryl acid succinate (f) mixed tocopherols* (g) tocotrienol tocopherol** 
4. VITAMIN K 
(a) phylloquinone (phytomenadione) (b) menaquinone*** 
5. VITAMIN B1 
(a) thiamin hydrochloride (b) thiamin mononitrate  
EN 7   EN (c) thiamine monophosphate chloride 
(d) thiamine pyrophosphate chloride 
6. VITAMIN B2 
(a) riboflavin (b) riboflavin 5'-phosphate, sodium 
7. NIACIN 
(a) nicotinic acid (b) nicotinamide (c) inositol hexanicotinate  (inositol hexaniacinate) 
8. PANTOTHENIC ACID 
(a) D-pantothenate, calcium (b) D-pantothenate, sodium (c) dexpanthenol (d) pantethine 
9. VITAMIN B6 
(a) pyridoxine hydrochloride (b) pyridoxine 5'-phosphate 
(c) pyridoxal 5'-phosphate 
10. FOLATE 
(a) pteroylmonoglutamic acid (b) calcium-L-methylfolate 
11. VITAMIN B12 
(a) cyanocobalamin (b) hydroxocobalamin (c) 5'-deoxyadenosylcobalamin (d) methylcobalamin  
EN 8   EN 12. BIOTIN 
(a) D-biotin 
13. VITAMIN C 
(a) L-ascorbic acid (b) sodium-L-ascorbate (c) calcium-L-ascorbate**** (d) potassium-L-ascorbate (e) L-ascorbyl 6-palmitate (f) magnesium L-ascorbate (g) zinc L-ascorbate 
B. Minerals 
calcium acetate calcium L-ascorbate calcium bisglycinate calcium carbonate calcium chloride calcium citrate malate 
calcium salts of citric acid 
calcium gluconate calcium glycerophosphate calcium lactate calcium pyruvate calcium salts of orthophosphoric acid calcium succinate calcium hydroxide calcium L-lysinate calcium malate  
EN 9   EN calcium oxide 
calcium L-pidolate calcium L-threonate calcium sulphate magnesium acetate magnesium L-ascorbate magnesium bisglycinate magnesium carbonate magnesium chloride magnesium salts of citric acid magnesium gluconate magnesium glycerophosphate magnesium salts of  orthophosphoric acid 
magnesium lactate magnesium L-lysinate magnesium hydroxide magnesium malate 
magnesium oxide 
magnesium L-pidolate magnesium potassium citrate magnesium pyruvate magnesium succinate magnesium sulphate magnesium taurate magnesium acetyl taurate ferrous carbonate ferrous citrate  
EN 10   EN ferric ammonium citrate 
ferrous gluconate ferrous fumarate ferric sodium diphosphate ferrous lactate ferrous sulphate ferric diphosphate (ferric pyrophosphate) ferric saccharate elemental iron (carbonyl+elec trolytic+hydrogen reduced) 
ferrous bisglycinate ferrous L-pidolate ferrous phosphate iron (II) taurate cupric carbonate cupric citrate cupric gluconate cupric sulphate 
copper L-aspartate 
copper bisglycinate copper lysine complex copper (II) oxide sodium iodide sodium iodate potassium iodide potassium iodate zinc acetate zinc L-ascorbate  
EN 11   EN zinc L-aspartate 
zinc bisglycinate zinc chloride zinc citrate zinc gluconate zinc lactate zinc L-lysinate zinc malate zinc mono-L-methionine sulphate zinc oxide zinc carbonate zinc L-pidolate zinc picolinate zinc sulphate manganese ascorbate manganese L-aspartate manganese bisglycinate 
manganese carbonate 
manganese chloride manganese citrate manganese gluconate manganese glycerophosphate manganese pidolate manganese sulphate sodium bicarbonate sodium carbonate sodium chloride  
EN 12   EN sodium citrate 
sodium gluconate sodium lactate sodium hydroxide sodium salts of orthophosphoric acid potassium bicarbonate potassium carbonate potassium chloride potassium citrate potassium gluconate potassium glycerophosphate potassium lactate potassium hydroxide potassium L-pidolate potassium malate potassium salts of orthophosphoric acid L-selenomethionine 
selenium enriched yeast***** 
selenious acid sodium selenate sodium hydrogen selenite sodium selenite chromium (III) chloride chromium (III) lactate trihydrate chromium nitrate chromium picolinate chromium (III) sulphate  
EN 13   EN ammonium molybdate (molybdenum (VI)) 
potassium molybdate (molybdenum (VI)) sodium molybdate (molybdenum (VI)) calcium fluoride potassium fluoride sodium fluoride sodium monofluorophosphate boric acid sodium borate choline-stabilised orthosilicic acid silicon dioxide silicic acid****** __________________________________________________________________ * alpha-tocopherol <20%, beta-tocoph erol <10%, gamma-tocopherol 50 – 70% 
and delta-tocopherol 10 - 30% 
** Typical levels of individual  tocopherols and tocotrienols: 
– 115 mg/g alpha-tocopherol (101 mg/g minimum) 
– 5 mg/g beta-tocopherol (<1 mg/g minimum) 
– 45 mg/g gamma-tocopherol (25 mg/g minimum) 
– 12 mg/g delta-tocopherol  (3 mg/g minimum) 
– 67 mg/g alpha-tocotrienol (30 mg/g minimum) 
– <1 mg/g beta-tocotrienol (<1 mg/g minimum) 
– 82 mg/g gamma-tocotrienol (45 mg/g minimum) 
– 5 mg/g delta-tocotrienol (<1 mg/g minimum). 
*** Menaquinone occurring principally as menaquinone-7 and, to a minor extent, 
menaquinone-6. 
**** May contain up to 2% of threonate.  *****Selenium-enriched yeasts produced by culture in the pres ence of sodium 
selenite as selenium source and containi ng, in the dried form as marketed, not 
more than 2.5 mg Se/g. The predominan t organic selenium species present in 
the yeast is selenomethionine (between  60 and 85% of the total extracted 
selenium in the product). The content of other organic selenium compounds 
including selenocysteine shall not exceed  10% of total extracted selenium. 
Levels of inorganic selenium normally shall not exceed 1% of total extracted 
selenium.  
EN 14   EN ******In the form of gel."  
EN 15   EN ANNEX III  
"ANNEX II 
VITAMIN FORMULATIONS AND MINE RAL SUBSTANCES WHICH MAY BE 
ADDED TO FOODS 
1. Vitamin formulations 
VITAMIN A 
retinol retinyl acetate retinyl palmitate beta-carotene VITAMIN D cholecalciferol ergocalciferol VITAMIN E D-alpha-tocopherol DL-alpha-tocopherol D-alpha-tocopheryl acetate 
DL-alpha-tocopheryl acetate 
D-alpha-tocopheryl acid succinate VITAMIN K phylloquinone (phytomenadione) menaquinone* VITAMIN B1 thiamin hydrochloride thiamin mononitrate VITAMIN B2 riboflavin  
EN 16   EN riboflavin 5'-phosphate, sodium 
NIACIN nicotinic acid nicotinamide PANTOTHENIC ACID D-pantothenate, calcium D-pantothenate, sodium dexpanthenol VITAMIN B6 pyridoxine hydrochloride pyridoxine 5'-phosphate pyridoxine dipalmitate FOLIC ACID pteroylmonoglutamic acid calcium-L-methylfolate VITAMIN B12 cyanocobalamin 
hydroxocobalamin 
BIOTIN D-biotin VITAMIN C L-ascorbic acid sodium-L-ascorbate calcium-L-ascorbate potassium-L-ascorbate L-ascorbyl 6-palmitate  
EN 17   EN 2. Mineral substances 
calcium carbonate 
calcium chloride calcium citrate malate calcium salts of citric acid calcium gluconate calcium glycerophosphate calcium lactate calcium salts of orthophosphoric acid calcium hydroxide calcium malate calcium oxide calcium sulphate magnesium acetate magnesium carbonate magnesium chloride magnesium salts of citric acid 
magnesium gluconate 
magnesium glycerophosphate magnesium salts of  orthophosphoric acid 
magnesium lactate magnesium hydroxide magnesium oxide magnesium potassium citrate magnesium sulphate ferrous bisglycinate ferrous carbonate  
EN 18   EN ferrous citrate 
ferric ammonium citrate ferrous gluconate ferrous fumarate ferric sodium diphosphate ferrous lactate ferrous sulphate ferric diphosphate (ferric pyrophosphate) ferric saccharate elemental iron (carbonyl + electrolytic + hydrogen reduced) cupric carbonate cupric citrate cupric gluconate cupric sulphate copper lysine complex sodium iodide 
sodium iodate 
potassium iodide potassium iodate zinc acetate zinc bisglycinate zinc chloride zinc citrate zinc gluconate zinc lactate zinc oxide  
EN 19   EN zinc carbonate 
zinc sulphate manganese carbonate manganese chloride manganese citrate manganese gluconate manganese glycerophosphate manganese sulphate sodium bicarbonate sodium carbonate sodium citrate sodium gluconate sodium lactate sodium hydroxide sodium salts of orthophosphoric acid selenium enriched yeast** sodium selenate 
sodium hydrogen selenite 
sodium selenite sodium fluoride potassium fluoride potassium bicarbonate potassium carbonate potassium chloride potassium citrate potassium gluconate potassium glycerophosphate  
EN 20   EN potassium lactate 
potassium hydroxide potassium salts of orthophosphoric acid chromium (III) chloride and its hexahydrate chromium (III) sulphate and its hexahydrate ammonium molybdate (molybdenum (VI)) sodium molybdate (molybdenum (VI)) boric acid sodium borate _________________________________________________________________ * Menaquinone occurring principally as menaquinone-7 and, to a minor extent, 
menaquinone-6.  
** Selenium-enriched yeasts produced by culture in the presence of sodium 
selenite as selenium source and containi ng, in the dried form as marketed, not 
more than 2.5 mg Se/g. The predominan t organic selenium species present in 
the yeast is selenomethionine (between  60 and 85% of the total extracted 
selenium in the product). The content of other organic selenium compounds 
including selenocysteine shall not exceed  10% of total extracted selenium. 
Levels of inorganic selenium normally shall not exceed 1% of total extracted 
selenium."