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 (Text with EEA relevance) (c. 46)

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[F1 ANNEX II U.K. Vitamin and mineral substances which may be used in the manufacture of food supplements

Textual Amendments

F1 Substituted by Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements (Text with EEA relevance).

A. Vitamins U.K.

1. VITAMIN A U.K.

(a) retinol U.K.

(b) retinyl acetate U.K.

(c) retinyl palmitate U.K.

(d) beta-carotene U.K.

2. VITAMIN D U.K.

(a) cholecalciferol U.K.

(b) ergocalciferol U.K.

3. VITAMIN E U.K.

(a) D-alpha-tocopherol U.K.

(b) DL-alpha-tocopherol U.K.

(c) D-alpha-tocopheryl acetate U.K.

(d) DL-alpha-tocopheryl acetate U.K.

(e) D-alpha-tocopheryl acid succinate U.K.

(f) mixed tocopherols (1) U.K.

(g) tocotrienol tocopherol (2) U.K.

4. VITAMIN K U.K.

(a) phylloquinone (phytomenadione) U.K.

(b) menaquinone (3) U.K.

5. VITAMIN B1 U.K.

(a) thiamin hydrochloride U.K.

(b) thiamin mononitrate U.K.

(c) thiamine monophosphate chloride U.K.

(d) thiamine pyrophosphate chloride U.K.

6. VITAMIN B2 U.K.

(a) riboflavin U.K.

(b) riboflavin 5′-phosphate, sodium U.K.

7. NIACIN U.K.

(a) nicotinic acid U.K.

(b) nicotinamide U.K.

(c) inositol hexanicotinate (inositol hexaniacinate) U.K.

8. PANTOTHENIC ACID U.K.

(a) D-pantothenate, calcium U.K.

(b) D-pantothenate, sodium U.K.

(c) dexpanthenol U.K.

(d) pantethine U.K.

9. VITAMIN B6 U.K.

(a) pyridoxine hydrochloride U.K.

(b) pyridoxine 5′-phosphate U.K.

(c) pyridoxal 5′-phosphate U.K.

10. FOLATE U.K.

(a) pteroylmonoglutamic acid U.K.

(b) calcium-L-methylfolate U.K.

[F2 (c) (6 S )-5-methyltetrahydrofolic acid, glucosamine salt] U.K.

Textual Amendments

F2 Inserted by Commission Regulation (EU) 2015/414 of 12 March 2015 amending Directive 2002/46/EC of the European Parliament and of the Council as regards (6S)-5-methyltetrahydrofolic acid, glucosamine salt used in the manufacture of food supplements (Text with EEA relevance).

11. VITAMIN B12 U.K.

(a) cyanocobalamin U.K.

(b) hydroxocobalamin U.K.

(c) 5′-deoxyadenosylcobalamin U.K.

(d) methylcobalamin U.K.

12. BIOTIN U.K.

(a) D-biotin U.K.

13. VITAMIN C U.K.

(a) L-ascorbic acid U.K.

(b) sodium-L-ascorbate U.K.

(c) calcium-L-ascorbate (4) U.K.

(d) potassium-L-ascorbate U.K.

(e) L-ascorbyl 6-palmitate U.K.

(f) magnesium L-ascorbate U.K.

(g) zinc L-ascorbate U.K.

B. Minerals U.K.

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

calcium oxide

calcium L-pidolate

calcium L-threonate

calcium sulphate

[F3 calcium phosphoryl oligosaccharides]

Textual Amendments

F3 Inserted by Commission Regulation (EU) 2017/1203 of 5 July 2017 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).

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

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)

ferrous bisglycinate

ferrous L-pidolate

ferrous phosphate

[F4 ferrous ammonium phosphate

Textual Amendments

F4 Inserted by Commission Regulation (EU) No 1161/2011 of 14 November 2011 amending Directive 2002/46/EC of the European Parliament and of the Council, Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Commission Regulation (EC) No 953/2009 as regards the lists of mineral substances that can be added to foods (Text with EEA relevance).

ferric sodium EDTA]

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

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

sodium citrate

sodium gluconate

sodium lactate

sodium hydroxide

sodium salts of orthophosphoric acid

[F4 sodium sulphate

potassium sulphate]

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 (5)

selenious acid

sodium selenate

sodium hydrogen selenite

sodium selenite

chromium (III) chloride

[F5 chromium enriched yeast] (6)

Textual Amendments

F5 Inserted by Commission Regulation (EU) No 119/2014 of 7 February 2014 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 manufacture of food supplements and chromium(III) lactate tri-hydrate added to foods (Text with EEA relevance).

chromium (III) lactate trihydrate

chromium nitrate

chromium picolinate

chromium (III) sulphate

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 (7)

[F3 organic silicon (monomethylsilanetriol)] ]

(1)

[F1 alpha-tocopherol < 20 %, beta-tocopherol < 10 %, gamma-tocopherol 50-70 % and delta-tocopherol 10-30 %]

(2)

[F1 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),]

(3)

[F1 Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6.]

(4)

[F1 May contain up to 2 % of threonate.]

(5)

[F1 Selenium-enriched yeasts produced by culture in the presence of sodium selenite as selenium source and containing, in the dried form as marketed, not more than 2,5 mg Se/g. The predominant 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.]

(6)

[F1 [F5 Chromium-enriched yeast produced by culture of Saccharomyces cerevisiae in the presence of chromium(III) 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 total chromium.] ]

(7)

[F1 In the form of gel.]

Textual Amendments

F1 Substituted by Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements (Text with EEA relevance).

F5 Inserted by Commission Regulation (EU) No 119/2014 of 7 February 2014 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 manufacture of food supplements and chromium(III) lactate tri-hydrate added to foods (Text with EEA relevance).