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12.7.2002 EN Official Journal of the European Communities L 183/51

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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE (6) There is a wide range of nutrients and other ingredients
EUROPEAN UNION, that might be present in food supplements including, but

not limited to, vitamins, minerals, amino acids, essential
fatty acids, fibre and various plants and herbal extracts.

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission (1),

(7) As a first stage, this Directive should lay down specific
Having regard to the opinion of the Economic and Social rules for vitamins and minerals used as ingredients of
Committee (2), food supplements. Food supplements containing vita-

mins or minerals as well as other ingredients should also
be in conformity with the specific rules on vitamins and

Acting in accordance with the procedure laid down in Article minerals laid down in this Directive.
251 of the Treaty (3),

Whereas:

(1) There is an increasing number of products marketed in (8) Specific rules concerning nutrients, other than vitamins
the Community as foods containing concentrated and minerals, or other substances with a nutritional or
sources of nutrients and presented for supplementing the physiological effect used as ingredients of food supple-
intake of those nutrients from the normal diet. ments should be laid down at a later stage, provided that

adequate and appropriate scientific data about them
become available. Until such specific Community rules

(2) Those products are regulated in Member States by are adopted and without prejudice to the provisions of
differing national rules that may impede their free move- the Treaty, national rules concerning nutrients or other
ment, create unequal conditions of competition, and thus substances with nutritional or physiological effect used
have a direct impact on the functioning of the internal as ingredients of food supplements, for which no
market. It is therefore necessary to adopt Community Community specific rules have been adopted, may be
rules on those products marketed as foodstuffs. applicable.

(3) An adequate and varied diet could, under normal
circumstances, provide all necessary nutrients for normal
development and maintenance of a healthy life in quanti-
ties which meet those established and recommended by
generally acceptable scientific data. However, surveys (9) Only vitamins and minerals normally found in, and
show that this ideal situation is not being achieved for consumed as part of, the diet should be allowed to be
all nutrients and by all groups of the population across present in food supplements although this does not
the Community. mean that their presence therein is necessary. Contro-

versy as to the identity of those nutrients that could
potentially arise should be avoided. Therefore, it is

(4) Consumers, because of their particular lifestyles or for appropriate to establish a positive list of those vitamins
other reasons, may choose to supplement their intake of and minerals.
some nutrients through food supplements.

(5) In order to ensure a high level of protection for consu-
mers and facilitate their choice, the products that will be
put on to the market must be safe and bear adequate
and appropriate labelling. (10) There is a wide range of vitamin preparations and

mineral substances used in the manufacture of food
(1) OJ C 311 E, 31.10.2000, p. 207 and supplements currently marketed in some Member States

C 180 E, 26.6.2001, p. 248. that have not been evaluated by the Scientific Committee
(2) OJ C 14, 16.1.2001, p. 42. on Food and consequently are not included in the posi-
(3) Opinion of the European Parliament of 14 February 2001 (OJ C

276, 1.10.2001, p. 126), Council Common Position of 3 December tive lists. These should be submitted to the European
2001 (OJ C 90 E, 16.4.2002, p. 1) and Decision of the European Food Safety Authority for urgent evaluation, as soon as
Parliament of 13 March 2002. Council Decision of 30 May 2002. appropriate files are presented by the interested parties.

 

L 183/52 EN Official Journal of the European Communities 12.7.2002

(11) The chemical substances used as sources of vitamins and (18) Council Directive 90/496/EEC of 24 September 1990 on
minerals in the manufacture of food supplements should nutrition labelling for foodstuffs (2) does not apply to
be safe and also be available to be used by the body. For food supplements. Information relating to nutrient
this reason, a positive list of those substances should also content in food supplements is essential for allowing the
be established. Such substances as have been approved consumer who purchases them to make an informed
by the Scientific Committee on Food, on the basis of the choice and use them properly and safely. That informa-
said criteria, for use in the manufacture of foods tion should, in view of the nature of those products, be
intended for infants and young children and other foods confined to the nutrients actually present and be
for particular nutritional uses can also be used in the compulsory.
manufacture of food supplements.

(19) Given the particular nature of food supplements, addi-
tional means to those usually available to monitoring

(12) In order to keep up with scientific and technological bodies should be available in order to facilitate efficient
developments it is important to revise the lists promptly, monitoring of those products.
when necessary. Such revisions would be implementing
measures of a technical nature and their adoption should (20) The measures necessary for the implementation of this
be entrusted to the Commission in order to simplify and Directive should be adopted in accordance with Council
expedite the procedure. Decision 1999/468/EC of 28 June 1999 laying down the

procedures for the exercise of implementing powers
conferred on the Commission (3),

(13) Excessive intake of vitamins and minerals may result in
adverse effects and therefore necessitate the setting of
maximum safe levels for them in food supplements, as
appropriate. Those levels must ensure that the normal
use of the products under the instructions of use
provided by the manufacturer will be safe for the HAVE ADOPTED THIS DIRECTIVE:

consumer.

Article 1
(14) When maximum levels are set, therefore, account should

be taken of the upper safe levels of the vitamins and
minerals, as established by scientific risk assessment 1. This Directive concerns food supplements marketed as
based on generally acceptable scientific data, and of foodstuffs and presented as such. These products shall be deliv-
intakes of those nutrients from the normal diet. Due ered to the ultimate consumer only in a pre-packaged form.
account should also be taken of reference intake
amounts when setting maximum levels. 2. This Directive shall not apply to medicinal products as

defined by Directive 2001/83/EC of the European Parliament
and of the Council of 6 November 2001 on the Community
code relating to medicinal products for human use (4(15) Food supplements are purchased by consumers for ).

supplementing intakes from the diet. In order to ensure
that this aim is achieved, if vitamins and minerals are
declared on the label of food supplements, they should
be present in the product in a significant amount. Article 2

For the purposes of this Directive:
(16) The adoption of the specific values for maximum and

minimum levels for vitamins and minerals present in (a) ‘food supplements’ means foodstuffs the purpose of which
food supplements, based on the criteria set out in this is to supplement the normal diet and which are concen-
Directive and appropriate scientific advice, would be an trated sources of nutrients or other substances with a nutri-
implementing measure and should be entrusted to the tional or physiological effect, alone or in combination,
Commission. 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

(17) General labelling provisions and definitions are taken in measured small unit quantities;
contained in Directive 2000/13/EC of the European
Parliament and of the Council of 20 March 2000 on the (b) ‘nutrients’ means the following substances:
approximation of the laws of the Member States relating
to the labelling, presentation and advertising of food- (i) vitamins,
stuffs (1), and do not need to be repeated. This Directive (ii) minerals.
should therefore be confined to the necessary additional
provisions.

(2) OJ L 276, 6.10.1990, p. 40.
(3) OJ L 184, 17.7.1999, p. 23.

(1) OJ L 109, 6.5.2000, p. 29. (4) OJ L 311, 28.11.2001, p. 67.

 

12.7.2002 EN Official Journal of the European Communities L 183/53

Article 3 substances with a nutritional or physiological effect other than
those referred to in paragraph 1, accompanied by any proposals
for amendment to this Directive which the Commission deems

Member States shall ensure that food supplements may be necessary.
marketed within the Community only if they comply with the
rules laid down in this Directive.

Article 5

Article 4 1. Maximum amounts of vitamins and minerals present in
food supplements per daily portion of consumption as recom-

1. Only vitamins and minerals listed in Annex I, in the forms mended by the manufacturer shall be set, taking the following
listed in Annex II, may be used for the manufacture of food into account:
supplements, subject to paragraph 6.

(a) upper safe levels of vitamins and minerals established by
scientific risk assessment based on generally accepted scien-

2. The purity criteria for substances listed in Annex II shall tific data, taking into account, as appropriate, the varying
be adopted in accordance with the procedure referred to in degrees of sensitivity of different consumer groups;
Article 13(2), except where they apply pursuant to paragraph
3. (b) intake of vitamins and minerals from other dietary sources.

3. Purity criteria for substances listed in Annex II, specified 2. When the maximum levels referred to in paragraph 1 are
by Community legislation for their use in the manufacture of set, due account should also be taken of reference intakes of
foodstuffs for purposes other than those covered by this Direc- vitamins and minerals for the population.
tive, shall apply.

3. To ensure that significant amounts of vitamins and
4. For those substances listed in Annex II for which purity minerals are present in food supplements, minimum amounts
criteria are not specified by Community legislation, and until per daily portion of consumption as recommended by the
such specifications are adopted, generally acceptable purity manufacturer shall be set, as appropriate.
criteria recommended by international bodies shall be applic-
able and national rules setting stricter purity criteria may be 4. The maximum and minimum amounts of vitamins and
maintained. minerals referred to in paragraphs 1, 2 and 3 shall be adopted

in accordance with the procedure referred to in Article 13(2).
5. Modifications to the lists referred to in paragraph 1 shall
be adopted in accordance with the procedure referred to in
Article 13(2).

Article 6

6. By way of derogation from paragraph 1 and until 31
December 2009, Member States may allow in their territory the 1. For the purposes of Article 5(1) of Directive 2000/13/EC,
use of vitamins and minerals not listed in Annex I, or in forms the name under which products covered by this Directive are
not listed in Annex II, provided that: sold shall be ‘food supplement’.

(a) the substance in question is used in one or more food 2. The labelling, presentation and advertising must not attri-
supplements marketed in the Community on the date of bute to food supplements the property of preventing, treating
entry into force of this Directive, or curing a human disease, or refer to such properties.

(b) the European Food Safety Authority has not given an unfa- 3. Without prejudice to Directive 2000/13/EC, the labelling
vourable opinion in respect of the use of that substance, or shall bear the following particulars:
its use in that form, in the manufacture of food supple-
ments, on the basis of a dossier supporting use of the (a) the names of the categories of nutrients or substances that
substance in question to be submitted to the Commission characterise the product or an indication of the nature of
by the Member State not later than 12 July 2005. those nutrients or substances;

7. Notwithstanding paragraph 6, Member States may, in (b) the portion of the product recommended for daily
compliance with the rules of the Treaty, continue to apply consumption;
existing national restrictions or bans on trade in food supple-
ments containing vitamins and minerals not included in the list (c) a warning not to exceed the stated recommended daily
in Annex I or in the forms not listed in Annex II. dose;

(d) a statement to the effect that food supplements should not
8. Not later than 12 July 2007, the Commission shall submit be used as a substitute for a varied diet;
to the European Parliament and the Council a report on the
advisability of establishing specific rules, including, where (e) a statement to the effect that the products should be stored
appropriate, positive lists, on categories of nutrients or of out of the reach of young children.

 

L 183/54 EN Official Journal of the European Communities 12.7.2002

Article 7 Article 11

The labelling, presentation and advertising of food supplements 1. Without prejudice to Article 4(7), Member States shall
shall not include any mention stating or implying that a not, for reasons related to their composition, manufacturing
balanced and varied diet cannot provide appropriate quantities specifications, presentation or labelling, prohibit or restrict
of nutrients in general. trade in products referred to in Article 1 which comply with

this Directive and, where appropriate, with Community acts
adopted in implementation of this Directive.

Rules for implementing this Article may be specified in accor-
dance with the procedure referred to in Article 13(2).

2. Without prejudice to the Treaty, in particular Articles 28
and 30 thereof, paragraph 1 shall not affect national provisions
which are applicable in the absence of Community acts adopted

Article 8 under this Directive.

1. The amount of the nutrients or substances with a nutri-
tional or physiological effect present in the product shall be Article 12
declared on the labelling in numerical form. The units to be
used for vitamins and minerals shall be those specified in
Annex I. 1. Where a Member State, as a result of new information or

of a reassessment of existing information made since this Direc-
tive or one of the implementing Community acts was adopted,

Rules for implementing this paragraph may be specified in has detailed grounds for establishing that a product referred to
accordance with the procedure referred to in Article 13(2). in Article 1 endangers human health though it complies with

the said Directive or said acts, that Member State may tempora-
2. The amounts of the nutrients or other substances declared rily suspend or restrict application of the provisions in question
shall be those per portion of the product as recommended for within its territory. It shall immediately inform the other
daily consumption on the labelling. Member States and the Commission thereof and give reasons

for its decision.

3. Information on vitamins and minerals shall also be 2. The Commission shall examine as soon as possible the
expressed as a percentage of the reference values mentioned, as grounds adduced by the Member State concerned and shall
the case may be, in the Annex to Directive 90/496/EEC. consult the Member States within the Standing Committee on

the Food Chain and Animal Health, and shall then deliver its
opinion without delay and take appropriate measures.

Article 9
3. If the Commission considers that amendments to this
Directive or to the implementing Community acts are necessary

1. The declared values mentioned in Article 8(1) and (2) in order to remedy the difficulties mentioned in paragraph 1
shall be average values based on the manufacturer’s analysis of and to ensure the protection of human health, it shall initiate
the product. the procedure referred to in Article 13(2) with a view to

adopting those amendments. The Member State that has
Further rules for implementing this paragraph with regard in adopted safeguard measures may in that event retain them until
particular to the differences between the declared values and the amendments have been adopted.
those established in the course of official checks shall be
decided upon in accordance with the procedure referred to in
Article 13(2).

Article 13

2. The percentage of the reference values for vitamins and
minerals mentioned in Article 8(3) may also be given in 1. The Commission shall be assisted by the Standing
graphical form. Committee on the Food Chain and Animal Health instituted by

Regulation (EC) No 178/2002 (1) (hereinafter referred to as ‘the
Committee’).

Rules for implementing this paragraph may be adopted in
accordance with the procedure referred to in Article 13(2).

2. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

Article 10
The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

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 3. The Committee shall adopt its rules of procedure.
authority of that placing on the market by forwarding it a
model of the label used for the product. (1) OJ L 31, 1.2.2002, p. 1.

 

12.7.2002 EN Official Journal of the European Communities L 183/55

Article 14 ence on the occasion of their official publication. The methods
of making such reference shall be adopted by the Member

Provisions that may have an effect upon public health shall be States.
adopted after consultation with the European Food Safety
Authority.

Article 16
Article 15 This Directive shall enter into force on the day of its publica-

Member States shall bring into force the laws, regulations and tion in the Official Journal of the European Communities.
administrative provisions necessary to comply with this Direc-
tive by 31 July 2003. They shall forthwith inform the Commis- Article 17
sion thereof.

This Directive is addressed to the Member States.
Those laws, regulations and administrative provisions shall be
applied in such a way as to:
(a) permit trade in products complying with this Directive, Done at Luxembourg, 10 June 2002.

from 1 August 2003 at the latest;
(b) prohibit trade in products which do not comply with the

Directive, from 1 August 2005 at the latest. For the European Parliament For the Council

When Member States adopt these measures, they shall contain The President The President
a reference to this Directive or be accompanied by such a refer- P. COX J. PIQUÉ I CAMPS

ANNEX I

Vitamins and minerals which may be used in the manufacture of food supplements

1. Vi tamins 2. Minera ls

Vitamin A (µg RE) Calcium (mg)

Vitamin D (µg) Magnesium (mg)
Iron (mg)

Vitamin E (mg α-TE)
Copper (µg)

Vitamin K (µg) Iodine (µg)
Vitamin B1 (mg) Zinc (mg)
Vitamin B2 (mg) Manganese (mg)
Niacin (mg NE) Sodium (mg)

Pantothenic acid (mg) Potassium (mg)
Selenium (µg)

Vitamin B6 (mg)
Chromium (µg)

Folic acid (µg)
Molybdenum (µg)

Vitamin B12 (µg) Fluoride (mg)
Biotin (µg) Chloride (mg)
Vitamin C (mg) Phosphorus (mg)

 

L 183/56 EN Official Journal of the European Communities 12.7.2002

ANNEX II

Vitamin and mineral substances which may be used in the manufacture of food supplements

A. Vitamins 12. BIOTIN

1. VITAMIN A (a) D-biotin

(a) retinol
13. VITAMIN C

(b) retinyl acetate
(a) L-ascorbic acid

(c) retinyl palmitate
(b) sodium-L-ascorbate

(d) beta-carotene
(c) calcium-L-ascorbate

2. VITAMIN D (d) potassium-L-ascorbate

(a) cholecalciferol (e) L-ascorbyl 6-palmitate

(b) ergocalciferol B. Minera ls

3. VITAMIN E calcium carbonate
calcium chloride

(a) D-alpha-tocopherol
calcium salts of citric acid

(b) DL-alpha-tocopherol
calcium gluconate

(c) D-alpha-tocopheryl acetate
calcium glycerophosphate

(d) DL-alpha-tocopheryl acetate
calcium lactate

(e) D-alpha-tocopheryl acid succinate
calcium salts of orthophosphoric acid

4. VITAMIN K calcium hydroxide
calcium oxide

(a) phylloquinone (phytomenadione)
magnesium acetate

5. VITAMIN B1 magnesium carbonate

(a) thiamin hydrochloride magnesium chloride

(b) thiamin mononitrate magnesium salts of citric acid
magnesium gluconate

6. VITAMIN B2 magnesium glycerophosphate

(a) riboflavin magnesium salts of orthophosphoric acid

(b) riboflavin 5’-phosphate, sodium magnesium lactate
magnesium hydroxide

7. NIACIN magnesium oxide
(a) nicotinic acid magnesium sulphate
(b) nicotinamide ferrous carbonate

ferrous citrate
8. PANTOTHENIC ACID ferric ammonium citrate

(a) D-pantothenate, calcium ferrous gluconate
(b) D-pantothenate, sodium ferrous fumarate
(c) dexpanthenol ferric sodium diphosphate

ferrous lactate
9. VITAMIN B6 ferrous sulphate

(a) pyridoxine hydrochloride ferric diphosphate (ferric pyrophosphate)
(b) pyridoxine 5’-phosphate ferric saccharate

elemental iron (carbonyl+electrolytic+hydrogen
10. FOLIC ACID reduced)

(a) pteroylmonoglutamic acid cupric carbonate
cupric citrate

11. VITAMIN B12 cupric gluconate
(a) cyanocobalamin cupric sulphate
(b) hydroxocobalamin copper lysine complex

 

12.7.2002 EN Official Journal of the European Communities L 183/57

sodium iodide sodium gluconate
sodium iodate sodium lactate
potassium iodide sodium hydroxide
potassium iodate sodium salts of orthophosphoric acid
zinc acetate potassium bicarbonate
zinc chloride potassium carbonate
zinc citrate potassium chloride
zinc gluconate potassium citrate
zinc lactate potassium gluconate
zinc oxide potassium glycerophosphate
zinc carbonate potassium lactate
zinc sulphate potassium hydroxide
manganese carbonate potassium salts of orthophosphoric acid
manganese chloride sodium selenate
manganese citrate sodium hydrogen selenite
manganese gluconate sodium selenite
manganese glycerophosphate chromium (III) chloride
manganese sulphate chromium (III) sulphate
sodium bicarbonate ammonium molybdate (molybdenum (VI))
sodium carbonate sodium molybdate (molybdenum (VI))
sodium chloride potassium fluoride
sodium citrate sodium fluoride