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United Kingdom Statutory Instruments |
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You are here: BAILII >> Databases >> United Kingdom Statutory Instruments >> The Food Supplements (England) Regulations 2003 No. 1387 URL: http://www.bailii.org/uk/legis/num_reg/2003/20031387.html |
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Made | 9th May 2003 | ||
Laid before Parliament | 2nd June 2003 | ||
Coming into force | 1st August 2005 |
(2) A food supplement shall be regarded as prepacked for the purposes of these Regulations if -
(3) Other expressions used both in these Regulations and in Directive 2002/46 have the same meaning in these Regulations as they have in that Directive.
Scope of Regulations
3.
- (1) These Regulations apply to food supplements sold as food and presented as such.
(2) These Regulations do not apply to medicinal products as defined by Directive 2001/83/EC of the European Parliament and of the Council[5] on the Community code relating to medicinal products for human use.
Restriction on form in which food supplements are sold to the ultimate consumer
4.
No person shall sell any food supplement to the ultimate consumer unless it is prepacked.
Prohibitions on sale relating to composition of food supplements
5.
- (1) Subject to paragraph (3), no person shall sell a food supplement in the manufacture of which a vitamin or mineral has been used unless that vitamin or mineral -
(2) The relevant purity criteria for the purposes of paragraph (1)(b)(ii) are -
(3) In the case of a vitamin or mineral which is not listed in column 1 of Schedule 1 or is not in a form listed in Schedule 2, the prohibitions in paragraph (1) shall not apply until 1st January 2010 if -
Restrictions on sale relating to labelling etc of food supplements
6.
- (1) No person shall sell a food supplement which is ready for delivery to the ultimate consumer or to a catering establishment unless the name under which it is sold is "food supplement".
(2) Without prejudice to the Food Labelling Regulations 1996[6], no person shall sell a food supplement which is ready for delivery to the ultimate consumer or to a catering establishment unless it is marked or labelled with the following particulars -
(3) The information required by paragraph (2)(f) shall -
(4) No person shall sell any food supplement which is ready for delivery to the ultimate consumer or to a catering establishment if the labelling, presentation or advertising of that food supplement includes any mention, express or implied, that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.
Manner of marking or labelling
7.
- (1) No person shall sell any food supplement which -
unless the particulars with which it is required to be marked or labelled by virtue of regulation 6(2) appear -
save that where the sale is otherwise than to the ultimate consumer such particulars may, alternatively, appear only on the commercial documents relating to the food supplement where it can be guaranteed that such documents, containing all such particulars, either accompany the food supplement to which they relate or were sent before, or at the same time as, delivery of the food supplement, and provided always that the particulars required by regulation 5(a), (c) and (e) of the Food Labelling Regulations 1996 are also marked or labelled on the outermost packaging in which that food supplement is sold.
(2) No person shall sell any food supplement which is ready for delivery to a catering establishment and is not prepacked, unless the particulars with which it is required to be marked or labelled by virtue of regulation 6(2) appear -
(3) No person shall sell any food supplement which is ready for delivery to the ultimate consumer or to a catering establishment unless the particulars with which it is required to be marked or labelled by virtue of regulation 6(2) are easy to understand, clearly legible and indelible and, when a food is sold to the ultimate consumer, those particulars are marked in a conspicuous place in such a way as to be easily visible.
(4) No person shall sell any food supplement which is ready for delivery to the ultimate consumer or to a catering establishment if the particulars with which it is required to be marked or labelled by virtue of regulation 6(2) are in any way hidden, obscured or interrupted by any other written or pictorial matter.
Enforcement
8.
- (1) Each food authority shall enforce and execute these Regulations in its area.
(2) In this regulation "food authority" does not include -
Offences and penalties
9.
If any person contravenes regulation 4, 5, 6 or 7 he shall be guilty of an offence and liable on summary conviction to a fine not exceeding level 5 on the standard scale.
Defence in relation to exports
10.
In any proceedings for an offence under these Regulations it shall be a defence for the person charged to prove -
Application of various provisions of the Act
11.
The following provisions of the Act shall apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act or Part thereof shall be construed as a reference to these Regulations -
Signed by authority of the Secretary of State for Health
Hazel Blears
Parliamentary Under Secretary of State, Department of Health
9th May 2003
Column 1 | Column 2 |
Vitamins and minerals | Unit |
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 |
Selenium | µg |
Chromium | µg |
Molybdenum | µg |
Fluoride | mg |
Chloride | mg |
Phosphorus | mg |
2.
VITAMIN D
3.
VITAMIN E
4.
VITAMIN K
5.
VITAMIN B1
6.
VITAMIN B2
7.
NIACIN
8.
PANTOTHENIC ACID
9.
VITAMIN B6
10.
FOLIC ACID
11.
VITAMIN B12
12.
BIOTIN
13.
VITAMIN C
B. Minerals
Calcium carbonate
Calcium chloride
Calcium salts of citric acid
Calcium gluconate
Calcium glycerophosphate
Calcium lactate
Calcium salts of orthophosphoric acid
Calcium hydroxide
Calcium oxide
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 sulphate
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)
Cupric carbonate
Cupric citrate
Cupric gluconate
Cupric sulphate
Copper lysine complex
Sodium iodide
Sodium iodate
Potassium iodide
Potassium iodate
Zinc acetate
Zinc chloride
Zinc citrate
Zinc gluconate
Zinc lactate
Zinc oxide
Zinc carbonate
Zinc sulphate
Manganese carbonate
Manganese chloride
Manganese citrate
Manganese gluconate
Manganese glycerophosphate
Manganese sulphate
Sodium bicarbonate
Sodium carbonate
Sodium chloride
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 salts of orthophosphoric acid
Sodium selenate
Sodium hydrogen selenite
Sodium selenite
Chromium (III) chloride
Chromium (III) sulphate
Ammonium molybdate (molybdenum (VI))
Sodium molybdate (molybdenum (VI))
Potassium fluoride
Sodium fluoride
4.
Article 6(2) of the Directive (labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties) is already implemented in the Food Labelling Regulations 1996 (regulation 40(1) and Schedule 6, Part I, paragraph 2).
5.
The Regulations make provision as to responsibilities for enforcement (regulation 8); create offences and penalties (regulation 9) and apply certain provisions of the Food Safety Act 1990 (regulation 11). The Regulations provide a defence in relation to exports, in accordance with Articles 2 and 3 of Council Directive 89/397/EEC (OJ No. L186, 30.6.89, p.23) on the official control of foodstuffs (regulation 10).
6.
A regulatory impact assessment has been prepared and placed in the Library of each House of Parliament together with a Transposition Note setting out how the main elements of Directive 2002/46/EC are transposed in these Regulations. Copies may be obtained from the Food Labelling and Standards Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH.
[2] Functions formerly exercisable by "the Ministers" (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) are now exercisable in relation to England by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the Food Standards Act 1999 (c. 28), and paragraphs 12 and 21 of that Schedule amend respectively sections 17(1) and 48 of the 1990 Act. Functions of "the Ministers" so far as exercisable in relation to Wales were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672) as read with section 40(3) of the 1999 Act, and those functions so far as exercisable in relation to Scotland were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (c. 46) as read with section 40(2) of the 1999 Act.back
[3] OJ No. L31, 1.2.2002, p.1.back
[4] OJ No. L183, 12.7.2002, p.51.back
[5] OJ No. L311, 28.11.2001, p.67.back
[6] S.I. 1996/1499, amended by S.I. 1998/141, 1398, 2424, 1999/747, 1136, 1483, 1540, 1603, 2000/768, 2254, 3323, 2001/2294, 3442, 3775, 2002/379, 2003/474.back
[7] OJ No. L276, 6.10.90, p.40.back
© Crown copyright 2003 | Prepared 2 June 2003 |