
1 
These Regulations may be cited as the Food Supplements (England) Regulations 2003; they come into force on 1st August 2005 and extend to England only.
2 

(1) In these Regulations—
 “the Act” means the Food Safety Act 1990;
 “catering establishment” means a restaurant, canteen, club, public house, school, hospital or similar establishment (including a vehicle or a fixed or mobile stall) where, in the course of a business, food is prepared for delivery to the ultimate consumer and is ready for consumption without further preparation;
 “Directive 2002/46” means Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements;
 “dose form” means a form such as capsules, pastilles, tablets, pills, and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids or powders designed to be taken in measured small unit quantities;
 “food supplement” means any food the purpose of which is to supplement the normal diet and which—
(a) is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; and
(b) is sold in dose form;
 “preparation” includes manufacture and any form of processing or treatment, and “prepared” shall be construed accordingly;
 “sell” includes possess for sale and offer, expose or advertise for sale;
 “ultimate consumer” means any person who purchases otherwise than—
(a) for the purpose of resale;
(b) for the purposes of a catering establishment; or
(c) for the purposes of a manufacturing business.
(2) A food supplement shall be regarded as prepacked for the purposes of these Regulations if—
(a) it is ready for sale to the ultimate consumer or to a catering establishment, and
(b) it is put into packaging before being offered for sale in such a way that the food supplement cannot be altered without opening or changing the packaging.
(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.
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 on the Community code relating to medicinal products for human use.
4 
No person shall sell any food supplement to the ultimate consumer unless it is prepacked.
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—
(a) is listed in column 1 of Schedule 1; and
(b) is in a form which—
(i) is listed in Schedule 2, and
(ii) meets the relevant purity criteria.
(2) The relevant purity criteria for the purposes of paragraph (1)(b)(ii) are—
(a) the purity criteria, if any, specified by Community legislation for the use of the substance in question in the manufacture of food for purposes other than those covered by Directive 2002/46; or
(b) in the absence of such purity criteria, generally acceptable purity criteria for the substance in question recommended by international bodies.
(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—
(a) the substance in question was used in the manufacture of a food supplement which was on sale in the European Community on 12th July 2002;
(b) a dossier supporting use of the substance in question was submitted to the Commission by the Food Standards Agency or a member State other than the United Kingdom by 12th July 2005; and
(c) the European Food Safety Authority has not given an unfavourable opinion in respect of the use of that substance, or its use in that form in the manufacture 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, 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—
(a) the name of the category of any vitamin or mineral or other substance with a nutritional or physiological effect which characterises the product or an indication of the nature of that vitamin or mineral or other substance;
(b) the portion of the product recommended for daily consumption;
(c) a warning not to exceed the stated recommended daily dose;
(d) a statement to the effect that food supplements should not be used as a substitute for a varied diet;
(e) a statement to the effect that the product should be stored out of the reach of young children; and
(f) the amount of any vitamin or mineral or other substance with a nutritional or physiological effect which is present in the product.
(3) The information required by paragraph (2)(f) shall—
(a) be given in numerical form;
(b) in the case of a vitamin or mineral listed in column 1 of Schedule 1, be given using the relevant unit specified in column 2 of that Schedule;
(c) be the amount per portion of the product as recommended for daily consumption on the labelling of the product;
(d) be an average amount based on the manufacturer’s analysis of the product; and
(e) in the case of a vitamin or mineral listed in the Annex to Council Directive 90/496/EEC on nutrition labelling for foodstuffs, be expressed also as a percentage (which may also be given in graphical form) of the relevant recommended daily allowance specified in that Annex.
(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.
7 

(1) No person shall sell any food supplement which—
(a) is ready for delivery to the ultimate consumer, or
(b) is ready for delivery to a catering establishment and is prepacked,
unless the particulars with which it is required to be marked or labelled by virtue of regulation 6(2) appear—
(i) on the packaging;
(ii) on a label attached to the packaging; or
(iii) on a label which is clearly visible through the packaging,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—
(a) on a label attached to the food supplement;
(b) on a ticket or notice which is readily discernible by the intending purchaser at the place where he chooses the food supplement; or
(c) in commercial documents relating to the food supplement where it can be guaranteed that such documents either accompany the food supplement to which they relate or were sent before, or at the same time as, delivery of the food supplement.
(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.
8 

(1) Each food authority shall enforce and execute these Regulations in its area.
(2) In this regulation “food authority” does not include—
(a) the council of a district of a non-metropolitan county except where the county functions have been transferred to that council pursuant to a structural change; or
(b) the appropriate Treasurer referred to in section 5(1)(c) of the Act (which deals with the Inner Temple and the Middle Temple).
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.
10 
In any proceedings for an offence under these Regulations it shall be a defence for the person charged to prove—
(a) that the food in respect of which the offence is alleged to have been committed was intended for export to a country which has legislation analogous to these Regulations and that the food complies with that legislation; and
(b) in the case of export to a member State, that the legislation complies with the provisions of Directive 2002/46.
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—
(a) section 2 (extended meaning of “sale” etc.);
(b) section 3 (presumptions that food is intended for human consumption);
(c) section 20 (offences due to fault of another person);
(d) section 21 (defence of due diligence) as it applies for the purposes of section 8, 14 or 15;
(e) section 22 (defence of publication in the course of business);
(f) section 30(8) (which relates to documentary evidence);
(g) section 33(1) (obstruction etc. of officers);
(h) section 33(2), with the modification that the reference to “any such requirement as is mentioned in subsection (1)(b) above” shall be deemed to be a reference to any such requirement as is mentioned in that subsection as applied by paragraph (g) above;
(i) section 35(1) (punishment of offences) in so far as it relates to offences under section 33(1) as applied by paragraph (g) above;
(j) section 35(2) and (3) in so far as it relates to offences under section 33(2) as applied by paragraph (h) above;
(k) section 36 (offences by bodies corporate); and
(l) section 44 (protection of officers acting in good faith).
Signed by authority of the Secretary of State for Health
Hazel Blears
Parliamentary Under Secretary of State,
Department of Health
9th May 2003
SCHEDULE 1
Regulations 5(1) and (3) and 6(3)(b)


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
SCHEDULE 2
Regulation 5(1) and (3)
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
4 
VITAMIN K
(a) phylloquinone (phytomenadione)
5 
VITAMIN B1
(a) thiamin hydrochloride
(b) thiamin mononitrate
6 
VITAMIN B2
(a) riboflavin
(b) riboflavin 5'-phosphate, sodium
7 
NIACIN
(a) nicotinic acid
(b) nicotinamide
8 
PANTOTHENIC ACID
(a) D-pantothenate, calcium
(b) D-pantothenate, sodium
(c) dexpanthenol
9 
VITAMIN B6
(a) pyridoxine hydrochloride
(b) pyridoxine 5'-phosphate
10 
FOLIC ACID
(a) pteroylmonoglutamic acid
11 
VITAMIN B12
(a) cyanocobalamin
(b) hydroxocobalamin
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

 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