Proposal for a directive of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements
Date: 2000-05-08
Institutions: European Commission
Subjects: approximation of laws, dietary product, human nutrition, labelling, vitamin

31.10.2000

EN

Official Journal of the European Communities

C 311 E/207

Proposal for a Directive of the European Parliament and of the Council on the approximation of
the laws of the Member States relating to food supplements

(2000/C 311 E/13)

(Text with EEA relevance)

COM(2000) 222 final (cid:151) 2000/0080(COD)

(Submitted by the Commission on 10 May 2000)

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,

Having regard to the Opinion of the Economic and Social
Committee,

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

Whereas:

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

rules

that may impede their

(2) Those products are regulated in Member States by
free
differing national
movement, may create unequal conditions of competition,
and thus have a direct impact on the functioning of the
internal market.
therefore necessary to adopt
Community
rules on those products marketed as
foodstuffs.

is

It

(3) An adequate and varied diet could, under normal circum-
stances, provide all necessary nutrients for normal devel-
opment and maintenance of a healthy life in quantities as
those
generally
acceptable scientific data. However, surveys show that
this ideal situation is not being achieved for all nutrients
and by all groups of
the
Community.

the population across

recommended

established

and

by

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

(5) In order

to ensure a high level of protection for
consumers and facilitate their choice the products that
will be put onto the market must be safe and bear
adequate and appropriate labelling.

(6) 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 plant and herbal extracts.
However, as a first stage,
this Directive should only
cover food supplements containing vitamins and minerals.

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

(8) 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 for Food, on the basis of the said
criteria, for use in the manufacture of foods intended for
infants and young children and other foods for particular
nutritional uses can also be used in the manufacture of
food supplements.

it

is

(9) In order to keep up with scientific and technological
developments
lists
important
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.

to revise

the

(10) For vitamins and minerals excessive intakes 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 consumer.

(11) For that reason, when setting those maximum safe levels,
account should be taken of the upper safe levels of the
vitamins or minerals, as established by scientific risk
assessment based on generally acceptable scientific data,
of intakes of those nutrients from the normal diet and of
the fact that for some nutrients upper safe levels may be
close
recommended for
that may be
consumption. The latter consideration is of particular
importance where generally acceptable scientific data
prove that excess intake of the vitamins and minerals
concerned cause adverse effects.

to the

level

C 311 E/208

EN

Official Journal of the European Communities

31.10.2000

(12) 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.

(13) 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.

the laws of

(14) General labelling provisions and definitions are contained
in Council Directive 79/112/EEC of 18 December 1978 on
the approximation of
the Member States
relating to the labelling, presentation and advertising of
foodstuffs for sale to the ultimate consumer (1), as last
amended
European
Parliament and of the Council (2), and do not need to
be repeated. This Directive can therefore be confined to
the necessary additional provisions.

by Directive 97/4/EC of

the

(15) Council Directive 90/496/EEC of 24 September 1990 on
nutrition labelling for foodstuffs (3) 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
in
them properly and safely. That information should,
view of
those products, be confined to
the nutrients actually present and be compulsory.

the nature of

(16) Given the particular nature of

food supplements,
additional means to those usually available to monitoring
bodies should be available in order to facilitate efficient
monitoring of those products.

(17) Since the measures necessary for the implementation of
this Directive are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of
28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission (4),
they should be adopted by use of
the regulatory
procedure provided for in Article 5 of that Decision,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

This Directive concerns food supplements marketed in

1.
pre-packaged form as foodstuffs and presented as such.

(1) OJ L 33, 8.2.1979, p. 1.
(2) OJ L 43, 14.2.1997, p. 21.
(3) OJ L 276, 6.10.1990, p. 40.
(4) OJ L 184, 17.7.1999, p. 23.

2.

This Directive does not apply to:

(a) foods for particular nutritional uses covered by Council

Directive 89/398/EEC (5);

(b) medicinal

products

covered

by

Council Directive

65/65/EEC (6).

Article 2

For the purposes of this Directive:

(a) (cid:145)food supplements(cid:146) means foodstuffs that are concentrated
sources of nutrients as specified in (b), alone or in combi-
to
nation, marketed in dose form, whose purpose is
supplement the intake of those nutrients in the normal diet;

(b) (cid:145)nutrients(cid:146) means the following substances:

(i) vitamins listed in point 1 of Annex I,

(ii) minerals listed in point 2 of Annex I;

(c) (cid:145)dose form(cid:146) means forms such as capsules, tablets, pills and
other similar forms, sachets of powder, ampoules of liquids
and drop dispensing bottles.

Article 3

shall

ensure

Member States
containing the nutrients
marketed within the Community only if
the rules laid down in this Directive.

food supplements
listed in Article 2(b) may be
they comply with

that

the

Article 4

1.
Only the vitamins and minerals listed in Annex I and the
vitamin formulations and the permitted mineral substances
listed in Annex II may be used for the manufacture of food
supplements.

2.
The criteria of purity for the substances, referred to in
paragraph 1 shall be adopted in accordance with the procedure
referred to in Article 13(2).

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

(5) OJ L 186, 30.6.1989, p. 27.
(6) OJ 22, 9.2.1965, p. 369/65.

31.10.2000

EN

Official Journal of the European Communities

C 311 E/209

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 acceptable
scientific data;

4. When the form of presentation is similar to a phar-
maceutical form as defined by pharmacopoeias, the statement
(cid:145)This is not a medicinal product(cid:146) shall appear on the label.

Article 7

The labelling of
include any
mention stating or implying that an adequate and diversified
diet cannot provide appropriate quantities of nutrients.

food supplements

shall not

(b) reference intakes of vitamins and minerals for the popu-
lation, where these are close to the upper safe levels;

Article 8

(c) intakes of vitamins and minerals from other dietary sources.

To ensure that

significant amounts of vitamins and
2.
minerals
in food supplements minimum
amounts per daily portion of consumption as recommended
by the manufacturer shall be set, as appropriate.

shall be present

The amount of

1.
listed in Article 2(b)
the nutrient(s)
present in the product shall be declared in the labelling in
numerical form. The units to be used shall be those specified
in Annex I.

2.
The amounts of the nutrient(s) declared shall be those per
portion of the product as recommended for daily consumption
on the labelling and per unit dose form, as appropriate. The
amounts declared shall be those of the product as sold.

The maximum and minimum amounts of vitamins and
3.
minerals referred to in paragraphs 1 and 2 shall be adopted in
accordance with the procedure referred to in Article 13(2).

Information on vitamins and minerals

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

Article 6

Article 9

1.
The name under which products covered by this Directive
are sold shall include the word (cid:145)supplement(cid:146) and the name of
the category of the nutrient(s) characterising the product. The
name of the category of the nutrient(s) may be completed or
replaced by the specific name of the nutrient(s) characterising
the product.

2.
The 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.

3. Without prejudice to the requirements of Directive
79/112/EEC, the labelling shall bear the following mandatory
particulars:

(a) the portion of
consumption;

the product

recommended for daily

(b) a warning as to the possible health risks, as the case may
in exceeding the recommended portion for daily

be,
consumption;

(c) a statement to the effect that food supplements should not

be used as a substitute for a diversified diet.

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

The 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, when a
product is placed on the market the manufacturer or, where a
product is manufactured in a third country, the importer, shall
notify the competent authority of each Member State where
the product is being marketed by forwarding it a model of the
label used for the product.

C 311 E/210

EN

Official Journal of the European Communities

31.10.2000

Member States may not impose this requirement, if they can
demonstrate to the Commission that notification is not
necessary in order to monitor those products efficiently in
their territory.

2. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply,
in compliance with Article 7(3) and Article 8
thereof.

Article 11

The period provided for in Article 5(6) of Decision

3.
1999/468/EC shall be three months.

1. 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 appro-
priate, with Community acts adopted in implementation of this
Directive.

2. Without prejudice to the relevant provisions of the EC
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 in implementation of 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
Directive 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
that Member State may
complies with those provisions,
temporarily suspend or restrict application of the provisions
in question within its territory. It shall immediately inform the
other Member States and the Commission thereof and give
reasons for its decision.

2.
The Commission shall examine as soon as possible the
grounds adduced by the Member State concerned and shall
the Member States within the Standing Committee
consult
its opinion without
for Foodstuffs, and shall
delay and take appropriate measures.

then deliver

to the

implementing Community acts

If the Commission considers that amendments to this
3.
Directive or
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 14

Provisions that may have an effect upon public health shall be
adopted after consultation with the Scientific Committee for
Food.

Article 15

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive by 31 May 2002. They shall forthwith inform the
Commission 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 June 2002 at the latest;

(b) prohibit trade in products which do not comply with the

Directive, from 1 June 2004 at the latest.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of
their official publication.
Member States shall determine how such reference is to be
made.

Article 16

This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

Article 13

The Commission shall be assisted by the Standing
1.
Committee for Foodstuffs instituted by Decision 69/414/EEC (1).

Article 17

This Directive is addressed to the Member States.

(1) OJ L 291, 19.11.1969, p. 9.

31.10.2000

EN

Official Journal of the European Communities

C 311 E/211

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

ANNEX I

1. Vitamins

Vitamin A ((cid:236)g RE)

Vitamin D ((cid:236)g)

Vitamin E (mg Æ-TE)

Vitamin K ((cid:236)g)

Vitamin B1 (mg)

Vitamin B2 (mg)

Niacin (mg NE)

Pantothenic acid (mg)

Vitamin B6 ((cid:236)g)

Folic acid ((cid:236)g)

Vitamin B12 ((cid:236)g)

Biotin ((cid:236)g)

Vitamin C (mg)

2. Minerals

Calcium (mg)
Magnesium (mg)
Iron (mg)
Copper ((cid:236)g)
Iodine ((cid:236)g)
Zinc (mg)
Manganese (mg)
Sodium (mg)
Potassium (mg)
Selenium ((cid:236)g)
Chromium ((cid:236)g)
Molybdenum ((cid:236)g)
Fluoride (mg)
Chloride (mg)
Phosphorus (mg)

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

ANNEX II

1. Vitamins

VITAMIN A
(cid:151) retinol
(cid:151) retinyl acetate
(cid:151) retinyl palmitate
(cid:151) beta-carotene

VITAMIN D
(cid:151) cholecalciferol
(cid:151) ergocalciferol

VITAMIN E
(cid:151) D-alpha-tocopherol
(cid:151) DL-alpha-tocopherol
(cid:151) D-alpha-tocopheryl acetate
(cid:151) DL-alpha-tocopheryl acetate
(cid:151) D-alpha-tocopheryl acid succinate

VITAMIN K
(cid:151) phylloquinone (phytomenadione)

VITAMIN B1
(cid:151) thiamin hydrochloride
(cid:151) thiamin mononitrate

VITAMIN B2
(cid:151) riboflavin
(cid:151) riboflavin 5’-phosphate, sodium

NIACIN
(cid:151) nicotinic acid
(cid:151) nicotinamide

PANTOTHENIC ACID
(cid:151) D-pantothenate, calcium
(cid:151) D-pantothenate, sodium
(cid:151) dexpanthenol

VITAMIN B6
(cid:151) pyridoxine hydrochloride
(cid:151) pyridoxine 5’-phosphate

FOLIC ACID
(cid:151) pteroylmonoglutamic acid

VITAMIN B12
(cid:151) cyanocobalamin
(cid:151) hydroxocobalamin

BIOTIN
(cid:151) D-biotin

VITAMIN C
(cid:151) L-ascorbic acid
(cid:151) sodium-L-ascorbate
(cid:151) calcium-L-ascorbate
(cid:151) potassium-L-ascorbate
(cid:151) L-ascorbyl 6-palmitate

2. Minerals
calcium carbonate
calcium chloride
calcium salts of citric acid
calcium gluconate
calcium glycerophosphate
calcium lactate

C 311 E/212

EN

Official Journal of the European Communities

31.10.2000

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))
potassium molybdate (molybdenum (VI))

potassium fluoride
sodium fluoride