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)

[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.

(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.]

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).