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)
Date: 2002-06-10
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, consumer protection, food inspection, foodstuff, health policy, human nutrition, labelling, marketing

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Official Journal of the European Communities

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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

of 10 June 2002

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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

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

Having regard to the opinion of the Economic and Social
Committee (2),

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

Whereas:

There is an increasing number of products marketed in
the Community as
containing concentrated
sources of nutrients and presented for supplementing the
intake of those nutrients from the normal diet.

foods

Those products are regulated in Member States by
differing national rules that may impede their free move-
ment, create unequal conditions of competition, and thus
have a direct impact on the functioning of the internal
market. It is therefore necessary to adopt Community
rules on those products marketed as foodstuffs.

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
show that this ideal situation is not being achieved for
all nutrients and by all groups of the population across
the Community.

Consumers, because of their particular lifestyles or for
other reasons, may choose to supplement their intake of
some nutrients through food supplements.

(1)

(2)

(3)

(4)

(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)

(1) OJ C 311 E, 31.10.2000, p. 207 and

C 180 E, 26.6.2001, p. 248.

(2) OJ C 14, 16.1.2001, p. 42.
(3) Opinion of the European Parliament of 14 February 2001 (OJ C
276, 1.10.2001, p. 126), Council Common Position of 3 December
2001 (OJ C 90 E, 16.4.2002, p. 1) and Decision of the European
Parliament of 13 March 2002. Council Decision of 30 May 2002.

(6)

(7)

(8)

(9)

There is a wide range of nutrients and other ingredients
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.

As a first stage, this Directive should lay down specific
rules for vitamins and minerals used as ingredients of
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
minerals laid down in this Directive.

Specific rules concerning nutrients, other than vitamins
and minerals, or other substances with a nutritional or
physiological effect used as ingredients of food supple-
ments should be laid down at a later stage, provided that
them
adequate and appropriate scientific data about
become available. Until such specific Community rules
are adopted and without prejudice to the provisions of
the Treaty, national rules concerning nutrients or other
substances with nutritional or physiological effect used
for which no
as
Community specific rules have been adopted, may be
applicable.

food supplements,

ingredients of

Only vitamins and minerals normally found in, and
consumed as part of, the diet should be allowed to be
present
in food supplements although this does not
mean that their presence therein is necessary. Contro-
versy as to the identity of those nutrients that could
potentially arise should be avoided. Therefore,
is
appropriate to establish a positive list of those vitamins
and minerals.

it

There is a wide range of vitamin preparations and
mineral substances used in the manufacture of
food
supplements currently marketed in some Member States
that have not been evaluated by the Scientific Committee
on Food and consequently are not included in the posi-
tive lists. These should be submitted to the European
Food Safety Authority for urgent evaluation, as soon as
appropriate files are presented by the interested parties.

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(11)

(12)

(13)

The chemical substances used as sources of vitamins and
minerals in the manufacture of food supplements should
be safe and also be available to be used by the body. For
this reason, a positive list of those substances should also
be established. Such substances as have been approved
by the Scientific Committee on Food, on the basis of the
said criteria,
foods
intended for infants and young children and other foods
for particular nutritional uses can also be used in the
manufacture of food supplements.

for use in the manufacture of

In order to keep up with scientific and technological
developments it is important to revise the lists promptly,
when necessary. Such revisions would be implementing
measures of a technical nature and their adoption should
be entrusted to the Commission in order to simplify and
expedite the procedure.

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
the instructions of use
use of
provided by the manufacturer will be safe for
the
consumer.

the products under

(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
based on generally acceptable scientific data, and of
intakes of those nutrients from the normal diet. Due
account
reference intake
amounts when setting maximum levels.

should also be taken of

(15)

(16)

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.

The adoption of the specific values for maximum and
minimum levels for vitamins and minerals present in
food supplements, based on the criteria set out in this
Directive and appropriate scientific advice, would be an
implementing measure and should be entrusted to the
Commission.

(17) General

and

labelling

provisions

definitions

are
contained in Directive 2000/13/EC of
the European
Parliament and of the Council of 20 March 2000 on the
approximation of the laws of the Member States relating
to the labelling, presentation and advertising of food-
stuffs (1), and do not need to be repeated. This Directive
should therefore be confined to the necessary additional
provisions.

(1) OJ L 109, 6.5.2000, p. 29.

(18)

Council Directive 90/496/EEC of 24 September 1990 on
nutrition labelling for foodstuffs (2) does not apply to
food supplements.
Information relating to nutrient
content in food supplements is essential for allowing the
consumer who purchases them to make an informed
choice and use them properly and safely. That informa-
tion should, in view of the nature of those products, be
confined to the nutrients actually present and be
compulsory.

(19) Given the particular nature of food supplements, addi-
tional means to those usually available to monitoring
bodies should be available in order to facilitate efficient
monitoring of those products.

(20)

The measures necessary for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
implementing powers
procedures for the exercise of
conferred on the Commission (3),

HAVE ADOPTED THIS DIRECTIVE:

Article 1

This Directive concerns food supplements marketed as
1.
foodstuffs and presented as such. These products shall be deliv-
ered to the ultimate consumer only in a pre-packaged form.

This Directive shall not apply to medicinal products as
2.
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).

Article 2

For the purposes of this Directive:

(a) ‘food supplements’ means foodstuffs the purpose of which
is to supplement the normal diet and which are concen-
trated sources of nutrients or other substances with a nutri-
tional 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;

(b) ‘nutrients’ means the following substances:

(i) vitamins,

(ii) minerals.

(2) OJ L 276, 6.10.1990, p. 40.
(3) OJ L 184, 17.7.1999, p. 23.
(4) OJ L 311, 28.11.2001, p. 67.

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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.

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
necessary.

Article 4

1.
Only vitamins and minerals listed in Annex I, in the forms
listed in Annex II, may be used for the manufacture of food
supplements, subject to paragraph 6.

2.
The purity criteria for substances listed in Annex II shall
be adopted in accordance with the procedure referred to in
Article 13(2), except where they apply pursuant to paragraph
3.

Article 5

1. Maximum amounts of vitamins and minerals present in
food supplements per daily portion of consumption as recom-
mended by the manufacturer shall be set, taking the following
into account:

(a) upper safe levels of vitamins and minerals established by
scientific risk assessment based on generally accepted scien-
tific data, taking into account, as appropriate, the varying
degrees of sensitivity of different consumer groups;

(b) intake of vitamins and minerals from other dietary sources.

3.
Purity criteria for substances listed in Annex II, specified
by Community legislation for their use in the manufacture of
foodstuffs for purposes other than those covered by this Direc-
tive, shall apply.

2. When the maximum levels referred to in paragraph 1 are
set, due account should also be taken of reference intakes of
vitamins and minerals for the population.

For those substances listed in Annex II for which purity
4.
criteria are not specified by Community legislation, and until
such specifications are adopted, generally acceptable purity
criteria recommended by international bodies shall be applic-
able and national rules setting stricter purity criteria may be
maintained.

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

3.
To ensure that significant amounts of vitamins and
minerals are present in food supplements, minimum amounts
per daily portion of consumption as recommended by the
manufacturer shall be set, as appropriate.

4.
The maximum and minimum amounts of vitamins and
minerals referred to in paragraphs 1, 2 and 3 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
use of vitamins and minerals not listed in Annex I, or in forms
not listed in Annex II, provided that:

1.
For the purposes of Article 5(1) of Directive 2000/13/EC,
the name under which products covered by this Directive are
sold shall be ‘food supplement’.

(a) 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,

2.
The labelling, presentation and advertising must not attri-
bute to food supplements the property of preventing, treating
or curing a human disease, or refer to such properties.

(b) the European Food Safety Authority has not given an unfa-
vourable opinion in respect of the use of that substance, or
its use in that form, in the manufacture of food supple-
ments, 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.

in
Notwithstanding paragraph 6, Member States may,
7.
compliance with the rules of the Treaty, continue to apply
existing national restrictions or bans on trade in food supple-
ments containing vitamins and minerals not included in the list
in Annex I or in the forms not listed in Annex II.

8.
Not later than 12 July 2007, the Commission shall submit
to the European Parliament and the Council a report on the
including, where
advisability of establishing specific rules,
appropriate, positive lists, on categories of nutrients or of

3. Without prejudice to Directive 2000/13/EC, the labelling
shall bear the following particulars:

(a) the names of the categories of nutrients or substances that
characterise the product or an indication of the nature of
those nutrients or substances;

(b) the portion of
consumption;

the product

recommended for daily

(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 products should be stored

out of the reach of young children.

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Article 7

Article 11

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 accor-
dance with the procedure referred to in Article 13(2).

Article 8

1.
The amount of the nutrients or substances with a nutri-
tional or physiological effect present in the product shall be
declared on the labelling in numerical form. The units to be
used for vitamins and minerals shall be those specified in
Annex I.

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

2.
The amounts of the nutrients or other substances declared
shall be those per portion of the product as recommended for
daily consumption on the labelling.

3.
Information on vitamins and minerals shall also be
expressed as a percentage of the reference values mentioned, as
the case may be, in the Annex to Directive 90/496/EEC.

Article 9

1.
The declared values mentioned in Article 8(1) and (2)
shall be average values based on the manufacturer’s analysis of
the product.

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).

2.
The percentage of the reference values for vitamins and
minerals mentioned in Article 8(3) may also be given in
graphical form.

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.

1. Without prejudice to Article 4(7), Member States shall
not, for reasons related to their composition, manufacturing
specifications, presentation or labelling, prohibit or restrict
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.

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
under this Directive.

Article 12

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,
has detailed grounds for establishing that a product referred to
in Article 1 endangers human health though it complies with
the said Directive or said acts, that Member State may tempora-
rily suspend or restrict application of the provisions in question
within its territory.
immediately inform the other
Member States and the Commission thereof and give reasons
for its decision.

It shall

2.
The Commission shall examine as soon as possible the
grounds adduced by the Member State concerned and shall
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.

If the Commission considers that amendments to this
3.
Directive or to the implementing Community acts are necessary
in order to remedy the difficulties mentioned in paragraph 1
and to ensure the protection of human health, it shall initiate
the procedure referred to in Article 13(2) with a view to
adopting those amendments. The Member State that has
adopted safeguard measures may in that event retain them until
the amendments have been adopted.

Article 13

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health instituted by
Regulation (EC) No 178/2002 (1) (hereinafter referred to as ‘the
Committee’).

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.

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

3.

The Committee shall adopt its rules of procedure.

(1) OJ L 31, 1.2.2002, p. 1.

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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 Direc-
tive by 31 July 2003. They shall forthwith inform the Commis-
sion thereof.

Those laws, regulations and administrative provisions shall be
applied in such a way as to:

(a) permit trade in products complying with this Directive,

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.

When Member States adopt these measures, they shall contain
a reference to this Directive or be accompanied by such a refer-

ence 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 publica-
tion in the Official Journal of the European Communities.

Article 17

This Directive is addressed to the Member States.

Done at Luxembourg, 10 June 2002.

For the European Parliament

The President

P. COX

For the Council

The President

J. PIQUÉ I CAMPS

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

ANNEX I

1. V i ta mi ns

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. Mi ne r a ls

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)

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

ANNEX II

A. V i t a m i n s

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

B. M i ne ra ls

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
reduced)

iron

(carbonyl+electrolytic+hydrogen

cupric carbonate

cupric citrate

cupric gluconate

cupric sulphate

copper lysine complex

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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