The Food Supplements (England) Regulations 2003

Made: 9th May 2003

Laid before Parliament: 2nd June 2003

Coming into force: 1st August 2005

The Secretary of State, in exercise of the powers conferred by sections 16(1)(a) and (e), 17(1), 26(1)(a) and (3) and 48(1) of the Food Safety Act 1990 and now vested in him , having had regard in accordance with section 48(4A) of that Act to relevant advice given by the Food Standards Agency and after consultation both as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety and in accordance with section 48(4) and (4B) of that Act, makes the following Regulations:

Title, commencement and extent

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.

Interpretation

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;

• ...

• ...

• ...

• “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—is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; andis sold in dose form;

• “preparation” includes manufacture and any form of processing or treatment, and “prepared” shall be construed accordingly;

• “Regulation (EU) No 1169/2011” means Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004;

• “sell” includes possess for sale and offer, expose or advertise for sale;

• “ultimate consumer” means any person who purchases otherwise than—for the purpose of resale;for the purposes of a catering establishment; orfor 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 regulation 2(1) of the Human Medicines Regulations 2012.

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) ..., 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 Schedule 1 to the Nutrition (Amendment) (EU Exit) Regulations 2019; and

• (b) is in a form which—

• (i) is listed in Schedule 2 to the Nutrition (Amendment) (EU Exit) Regulations 2019, 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 in EU-derived domestic legislation, assimilated direct legislation or in regulations made by the Secretary of State under regulation 3 of the Nutrition (Amendment) (EU Exit) Regulations 2019; or

• (b) in the absence of such purity criteria, generally acceptable purity criteria for the substance in question recommended by international bodies.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 Regulation (EU) No 1169/2011, 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 Schedule 1 to the Nutrition (Amendment) (EU Exit) Regulations 2019 be given using the relevant unit specified in brackets after the name of that vitamin or mineral;

• (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 point 1 of Part A of Annex XIII to Regulation (EU) No 1169/2011, be expressed also as a percentage (which may also be given in graphical form) of the relevant reference value specified in that point.

• (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—

• (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 points (a), (f), (g) and (h) of Article 9(1) Regulation (EU) No 1169/2011 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.

Enforcement

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).

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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—

• (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).

Schedule 1

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
Folate	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

A. Vitamins

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

FOLATE

• (a) pteroylmonoglutamic acid

• (b) calcium-L-methylfolate

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

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

Signed

Signed by authority of the Secretary of State for Health

Hazel Blears — Parliamentary Under Secretary of State, — Department of Health — 2003-05-09

Explanatory note

(This note is not part of the Regulations)

1These Regulations implement in England 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.

2The Regulations concern the sale (as defined in regulation 2(1)) of food supplements which are sold as food and presented as such (regulation 3). A food supplement is defined as a food sold in dose form whose purpose is to supplement the normal diet and which is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination (regulation 2(1)).

3With effect from 1st August 2005 the Regulations—aprohibit the sale of a food supplement to the ultimate consumer unless it is prepacked (regulations 4 and 2(2)),bprohibit the sale of a food supplement in the manufacture of which a vitamin or mineral has been used, unless certain compositional requirements are met, subject to a transitional provision (regulation 5 and Schedules),cprohibit the sale of a food supplement which is ready for delivery to the ultimate consumer or a catering establishment unless certain requirements as to labelling, presentation and advertising of the product are met (regulations 6 and 7).

4Article 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).

5The 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).

6A 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.

Footnotes

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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)

Ferrous bisglycinate

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

Editorial notes

Cupric carbonate

Transitional provision

12

• (1) In any proceedings for an offence under regulation 9 relating to a breach of regulation 6 or 7 consisting of a contravention of or a failure to comply with regulation 6 (3)(e), it shall be a defence to prove that—

• (a) the food supplement concerned was sold before the 31st October 2012; and

• (b) the matters constituting the alleged offence would not have constituted an offence under those Regulations if the amendments made by regulation 2(2) and (6)(b) of the Food Supplements (England) and Addition of Vitamins, Minerals and Other Substances (England) (Amendment) Regulations 2009 had not been in operation when the food was sold.

• (2) In any proceedings for an offence under regulation 9 relating to a breach of regulation 6 or 7 consisting of a contravention of, or a failure to comply with, regulation 6(3)(b), it shall be a defence to prove that—

• (a) zinc was used in the manufacture of the food supplement and the food supplement was marked or labelled before 10th February 2023; and

• (b) the matters constituting the alleged offence would not have constituted an offence under these Regulations as they had effect immediately before 10th February 2023.

• (3) In any proceedings for an offence under regulation 9 relating to a breach of regulation 6 or 7 consisting of a contravention of, or a failure to comply with, regulation 6(3)(b), it shall be a defence to prove that—

• (a) copper was used in the manufacture of the food supplement and the food supplement was marked or labelled before 10th August 2024; and

• (b) the matters constituting the alleged offence would not have constituted an offence under these Regulations as they had effect immediately before 10th August 2024.