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Document 02002L0046-20220930
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)Text with EEA relevance
Consolidated text: 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)Text with EEA relevance
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)Text with EEA relevance
02002L0046 — EN — 30.09.2022 — 009.001
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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 (OJ L 183 12.7.2002, p. 51) |
Amended by:
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Official Journal |
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No |
page |
date |
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L 94 |
32 |
1.4.2006 |
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REGULATION (EC) No 1137/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 October 2008 |
L 311 |
1 |
21.11.2008 |
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L 314 |
36 |
1.12.2009 |
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L 296 |
29 |
15.11.2011 |
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L 39 |
44 |
8.2.2014 |
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L 68 |
26 |
13.3.2015 |
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L 173 |
9 |
6.7.2017 |
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L 83 |
1 |
10.3.2021 |
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)
Article 1
Article 2
For the purposes of this Directive:
‘food supplements’ means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms 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 and powders designed to be taken in measured small unit quantities;
‘nutrients’ means the following substances:
vitamins,
minerals.
Article 3
Member States shall ensure that food supplements may be marketed within the Community only if they comply with the rules laid down in this Directive.
Article 4
By way of derogation from paragraph 1 and until 31 December 2009, Member States may allow in their territory the use of vitamins and minerals not listed in Annex I, or in forms not listed in Annex II, provided that:
the substance in question is used in one or more food supplements marketed in the Community on the date of entry into force of this Directive,
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, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than 12 July 2005.
Article 5
Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following into account:
upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups;
intake of vitamins and minerals from other dietary sources.
Article 6
Without prejudice to Directive 2000/13/EC, the labelling shall bear the following particulars:
the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances;
the portion of the product recommended for daily consumption;
a warning not to exceed the stated recommended daily dose;
a statement to the effect that food supplements should not be used as a substitute for a varied diet;
a statement to the effect that the products should be stored out of the reach of young children.
Article 7
The labelling, presentation and advertising of food supplements shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.
Rules for implementing this Article may be specified in accordance with the procedure referred to in Article 13(2).
Article 8
Rules for implementing this paragraph may be specified in accordance with the procedure referred to in Article 13(2).
Article 9
Further rules for implementing this paragraph with regard in particular to the differences between the declared values and those established in the course of official checks shall be decided upon in accordance with the procedure referred to in Article 13(2).
Rules for implementing this paragraph may be adopted in accordance with the procedure referred to in Article 13(2).
Article 10
To facilitate efficient monitoring of food supplements, Member States may require the manufacturer or the person placing the product on the market in their territory to notify the competent authority of that placing on the market by forwarding it a model of the label used for the product.
Article 11
Article 12
Article 13
The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Article 14
Provisions that may have an effect upon public health shall be adopted after consultation with the European Food Safety Authority.
Article 15
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 2003. They shall forthwith inform the Commission thereof.
Those laws, regulations and administrative provisions shall be applied in such a way as to:
permit trade in products complying with this Directive, from 1 August 2003 at the latest;
prohibit trade in products which do not comply with the Directive, from 1 August 2005 at the latest.
When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be adopted by the Member States.
Article 16
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 17
This Directive is addressed to the Member States.
ANNEX I
Vitamins and minerals which may be used in the manufacture of food supplements
1. Vitamins
Vitamin A (μg RE)
Vitamin D (μg)
Vitamin E (mg a-TE)
Vitamin K (μg)
Vitamin B1 (mg)
Vitamin B2 (mg)
Niacin (mg NE)
Pantothenic acid (mg)
Vitamin B6 (mg)
Folic acid (μg) ( 3 )
Vitamin B12 (μg)
Biotin (μg)
Vitamin C (mg)
2. Minerals
Calcium (mg)
Magnesium (mg)
Iron (mg)
Copper (mg)
Iodine (μg)
Zinc (mg)
Manganese (mg)
Sodium (mg)
Potassium (mg)
Selenium (μg)
Chromium (μg)
Molybdenum (μg)
Fluoride (mg)
Chloride (mg)
Phosphorus (mg)
Boron (mg)
Silicon (mg)
ANNEX II
Vitamin and mineral substances which may be used in the manufacture of food supplements
A. Vitamins
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
(f) mixed tocopherols ( 4 )
(g) tocotrienol tocopherol ( 5 )
4. VITAMIN K
(a) phylloquinone (phytomenadione)
(b) menaquinone ( 6 )
5. VITAMIN B1
(a) thiamin hydrochloride
(b) thiamin mononitrate
(c) thiamine monophosphate chloride
(d) thiamine pyrophosphate chloride
6. VITAMIN B2
(a) riboflavin
(b) riboflavin 5′-phosphate, sodium
7. NIACIN
(a) nicotinic acid
(b) nicotinamide
(c) inositol hexanicotinate (inositol hexaniacinate)
(d) nicotinamide riboside chloride
8. PANTOTHENIC ACID
(a) D-pantothenate, calcium
(b) D-pantothenate, sodium
(c) dexpanthenol
(d) pantethine
9. VITAMIN B6
(a) pyridoxine hydrochloride
(b) pyridoxine 5′-phosphate
(c) pyridoxal 5′-phosphate
10. FOLATE
(a) pteroylmonoglutamic acid
(b) calcium-L-methylfolate
(c) (6S)-5-methyltetrahydrofolic acid, glucosamine salt
11. VITAMIN B12
(a) cyanocobalamin
(b) hydroxocobalamin
(c) 5′-deoxyadenosylcobalamin
(d) methylcobalamin
12. BIOTIN
(a) D-biotin
13. VITAMIN C
(a) L-ascorbic acid
(b) sodium-L-ascorbate
(c) calcium-L-ascorbate ( 7 )
(d) potassium-L-ascorbate
(e) L-ascorbyl 6-palmitate
(f) magnesium L-ascorbate
(g) zinc L-ascorbate
B. Minerals
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
calcium phosphoryl oligosaccharides
magnesium acetate
magnesium L-ascorbate
magnesium bisglycinate
magnesium carbonate
magnesium chloride
magnesium citrate malate
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
ferrous ammonium phosphate
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
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 ( 8 )
selenious acid
sodium selenate
sodium hydrogen selenite
sodium selenite
chromium (III) chloride
chromium enriched yeast ( 9 )
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 ( 10 )
organic silicon (monomethylsilanetriol)
( 1 ) OJ L 311, 28.11.2001, p. 67.
( 2 ) OJ L 31, 1.2.2002, p. 1.
( 3 ) Folic acid is the term included in Annex I of Commission Directive 2008/100/EC of 28 October 2008 amending Council Directive 90/496/EEC on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions for nutrition labelling purposes and covers all forms of folates.
( 4 ) alpha-tocopherol < 20 %, beta-tocopherol < 10 %, gamma-tocopherol 50-70 % and delta-tocopherol 10-30 %
( 5 ) Typical levels of individual tocopherols and tocotrienols:
( 6 ) Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6.
( 7 ) May contain up to 2 % of threonate.
( 8 ) 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.
( 9 ) 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.
( 10 ) In the form of gel.