Common Position (EC) No 18/2002 of 3 December 2001 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements (Text with EEA relevance)
Date: 2001-12-03
Institutions: Council of the European Union
Subjects: approximation of laws, food additive, food inspection, foodstuff, foodstuffs legislation, marketing

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 18/2002

adopted by the Council on 3 December 2001

with a view to adopting Directive 2002/. . ./EC of the European Parliament and of the Council of
. . . on the approximation of the laws of the Member States relating to food supplements

(2002/C 90 E/01)

(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,

opment and maintenance of a healthy life, in quantities
those established and recommended by
which meet
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.

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:

(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.

(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 on to 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 plants and herbal extracts.

rules

that may impede their

(2) Those products are regulated in Member States by
differing national
free
movement, 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-

(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, Council
Common Position of 3 December 2001 and Decision of
the
European Parliament of
(not yet published in the Official
Journal).

. . .

(7) As a first stage, this Directive should lay down specific
rules for vitamins and minerals used as ingredients of
food
containing
vitamins 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.

supplements.

supplements

Food

used

effect

ingredients

of
as
should be laid down at a later

(8) Specific rules concerning nutrients, other than vitamins
and minerals, or other substances with a nutritional or
food
physiological
supplements
stage,
provided that adequate and appropriate scientific data
about
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 physio-
logical effect used as ingredients of food supplements, for
which no Community specific rules have been adopted,
may be applicable.

available. Until

them become

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(9) 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. Controversy as to
the identity of those nutrients that could potentially arise
should be avoided. Therefore it is appropriate to establish
a positive list of those vitamins and minerals.

(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.

(10) 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 for Food and
consequently are not included in the positive lists. These
should be submitted to the Scientific Committee for Food
for urgent evaluation, as soon as appropriate files are
presented by the interested parties.

(11) 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

(12) 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

is

(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 consumer.

(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
those nutrients from the normal diet. Due
intakes of
account
intake
taken of
amounts when setting maximum levels.

should also be

reference

(16) The adoption of the specific values for maximum and
in
minimum levels for vitamins and minerals present
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 labelling provisions and 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 foodstuffs (1), and do not
need to be repeated. This Directive should therefore be
confined to the necessary additional provisions.

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

for

HAVE ADOPTED THIS DIRECTIVE:

Article 1

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

(1) OJ L 109, 6.5.2000, p. 29.
(2) OJ L 276, 6.10.1990, p. 40.
(3) OJ L 184, 17.7.1999, p. 23.

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This Directive shall not apply to medicinal products as
2.
defined by Council Directive 65/65/EEC of 26 January 1965 on
the approximation of provisions laid down by Law, Regulation
or Administrative Action relating to proprietary medicinal
products (1) and Council Directive 92/73/EEC of 22 September
1992 widening the
scope of Directives 65/65/EEC and
75/319/EEC on the approximation of provisions laid down
by Law, Regulation or Administrative Action relating to
medicinal products and laying down additional provisions on
homeopathic medicinal products (2).

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.

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

1.
in the
Only vitamins and minerals listed in Annex I,
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.

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

4.
For those substances listed in Annex II for which purity
criteria are not specified by Community legislation, and until

(1) OJ 22, 9.2.1965, p. 369. Directive as last amended by Directive

93/39/EEC (OJ L 214, 24.8.1993, p. 22).

(2) OJ L 297, 13.10.1992, p. 8.

such specifications are adopted, generally acceptable purity
criteria
shall be
applicable and national rules setting stricter purity criteria
may be maintained.

international bodies

recommended by

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

6.
By way of derogation from paragraph 1 and until . . . (*),
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:

(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,

(b) the Scientific Committee for Food has not given an unfa-
vourable opinion in respect of the use of that substance, or
its use
food
supplements, on the basis of a dossier supporting use of
the
submitted to the
Commission by the Member State not later than . . . (**).

in the manufacture of

in question to be

substance

in that

form,

7.
in
Notwithstanding paragraph 6, Member States may,
compliance with the rules of the Treaty, continue to apply
restrictions or bans on trade in food
existing national
supplements 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 . . . (***), the Commission shall submit to
the European Parliament and the Council a report on the
advisability of establishing specific rules,
including, where
appropriate, positive lists, on categories of nutrients or of
substances with a nutritional or physiological effect other
than those referred to in paragraph 1, accompanied by any
proposals
to this Directive which the
Commission deems necessary.

amendment

for

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
scientific data,
the
varying degrees of sensitivity of different consumer groups;

taking into account, as appropriate,

(*) The end of the seventh year as from the date of entry into force

of this Directive.
(**) Eighteen months after

Directive.

the date of entry into force of

this

(***) Five years after the date of entry into force of this Directive.

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

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.

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

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’.

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 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.

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.

for

Rules
accordance with the procedure referred to in Article 13(2).

implementing this Article may be specified in

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).

The amounts of

substances
2.
declared shall be those per portion of the product as recom-
mended for daily consumption on the labelling.

the nutrients or other

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

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 on 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
in their
product on the market
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

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.

Article 8

1.
The amount of the nutrients or substances with a nutri-
tional or physiological effect present in the product shall be

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.

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Article 12

Article 14

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
complies with the said Directive or said acts, that Member
State may 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
on Foodstuffs, and shall
its opinion without
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.

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
forthwith inform the
Commission thereof.

. . . (*). They

shall

by

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 . . . (**) at the latest;

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

Directive, from . . . (***) 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 13

Article 16

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

This Directive shall enter into force on the day of its publi-
cation in the Official Journal of the European Communities.

Article 17

This Directive is addressed to the Member States.

Done at . . .

For the European Parliament

The President

For the Council

The President

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

(*) The last day of the month, one year after the date of entry into

force of this Directive.

(**) The first day of the month following the end of the first year to
have expired after the date of entry into force of this Directive.
(***) First day of the month following the end of the third year to have
expired after the date of entry into force of this Directive.

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VITAMINS AND MINERALS WHICH MAY BE USED IN THE MANUFACTURE OF FOOD SUPPLEMENTS

ANNEX I

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)

folic acid (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)

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VITAMIN AND MINERAL SUBSTANCES WHICH MAY BE USED IN THE MANUFACTURE OF FOOD
SUPPLEMENTS

ANNEX II

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

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

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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

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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

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 11 May 2000 the Commission submitted to the Council a proposal for a Directive of the
European Parliament and of the Council, based on Article 95 of the Treaty, on the approximation
of the laws of the Member States relating to food supplements (1).

2. The Economic and Social Committee delivered its opinion on 19 October 2000 (2).

3. The European Parliament delivered its opinion on 14 February 2001 (3).

4. On the occasion of

the 38
amendments adopted, and forwarded an amended proposal (4) to the Council on 21 March 2001,
following the abovementioned European Parliament opinion.

the Commission accepted 16 of

the European Parliament vote,

5. On 3 December 2001 the Council adopted its Common Position in accordance with Article 251 of

the Treaty.

II. OBJECTIVE

The marketing of numerous products in Community territory over recent years, in particular as ‘food
supplements’, has led to an increase in the number of national rules governing such products, and in
the Commission's opinion this has created barriers to free movement. After consulting widely with the
parties concerned, the Commission concluded that it was necessary to adopt Community rules in that
area, inter alia, in connection with its food safety activities.

The text of the Common Position aims to harmonise Member States' national legislations on the basis
of the following elements:

— definition of the concept of food supplement,

— establishment of a list of vitamins and minerals which may be used in the manufacture of a food

supplement in the forms determined in a second list,

— determination of the procedures for derogation from and amendment of the aforementioned lists,

— establishment of quantities of vitamins and mineral salts present in food supplements,

— establishment of appropriate standards as regards labelling, presentation and advertising,

— introduction of safeguard measures in the event of a risk to public health.

III. ANALYSIS OF THE COMMON POSITION

A. General remarks

In general, the Council has followed the Commission's amended proposal. It has accepted, either in
whole or in substance, the 16 amendments adopted at first reading by the European Parliament as
set out by the Commission in its amended proposal.

The other European Parliament amendments which were not incorporated into the Commission's
amended proposal have also been omitted by the Council. However,
the idea expressed in
amendments 39, 49 and 32 rev., according to which some vitamins and substances currently
marketed but not covered by the Annexes should undergo scientific evaluation, has been taken
into account to some extent in Article 4(6) (see section B(b)).

(1) OJ C 311 E, 31.10.2000, p. 207.
(2) OJ C 14, 16.1.2001, p. 42.
(3) 6096/01 Codec 119 Denleg 5.
(4) OJ C 180 E, 26.6.2001, p. 248.

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B. Main innovations introduced by the Council

1. The main innovations introduced by the Council relate to:

— the setting of quantities of food supplements,

— authorisation of the placing on the market of existing food supplements,

— the revision of the Directive;

(a) setting of quantities of food supplements:

Article 5, in conjunction with recital 14, ensures a balanced approach guaranteeing both the
safety of such supplements and due regard for reference intakes for the population;

(b) authorisation of existing food supplements not listed in Annexes I or II:

Article 4(6) and (7), in conjunction with Article 15 on the text's entry into force, aims to allay
the concern of participants in this market by laying down clear procedures and time limits for
all current supplements not listed in Annexes I or II to the text, thereby reassuring both industry
and the consumer;

(c) Directive revision clause:

Article 4(8) establishes an amendment procedure after a period of five years, which will enable
the Commission usefully to take stock of the implementation of the Directive, particularly with
regard to its scope, and to propose amendments if necessary.

2. Furthermore, the Council has considered that the obligation to provide information when a
product is placed on the market, as provided for in Article 10, is ultimately the responsibility of
the Member States.

Finally,
it has introduced a clause providing for the possibility of the participation of the
Standing Committee on Foodstuffs in order to specify the procedures for implementing
Articles 7 and 8 on the labelling, presentation and advertising of food supplements.

IV. CONCLUSIONS

The Council considers that the Common Position responds to a large extent to the basic wishes
expressed by the European Parliament, while at the same time taking sufficient account of the
concern expressed by Member States,
inter alia, with regard to public health and/or Community
harmonisation. The Council considers that the Common Position achieves a good balance between
the prerequisites for the proper functioning of the single market and consumer protection/information.