Common Position (EC) No 16/2003 of 20 February 2003 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 amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs (Text with EEA relevance)
Date: 2003-02-20
Institutions: Council of the European Union
Subjects: advertising, approximation of laws, consumer information, foodstuff, labelling, packaging, public health

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COMMON POSITION No 16/2003

adopted by the Council on 20 February 2003

with a view to the adoption of a Directive of the European Parliament and of the Council
amending Council Directive 2000/13/EC as regards ingredients present in foodstuffs

(2003/C 102 E/02)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

cause of allergies or intolerances in consumers, and some
of those allergies or intolerances constitute a danger to the
health of those concerned.

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 European Economic and
Social Committee (2),

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

Whereas:

(1)

In order to achieve a high level of health protection for
consumers and to guarantee their right to information, it
appropriately
must be
through the
informed as regards foodstuffs,
listing of all ingredients on labels.

are
inter alia,

ensured that

consumers

(2) By virtue of Article 6 of 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 (4), certain substances need not appear in the
list of ingredients.

(3) When used in the production of

foodstuffs and still
present, certain ingredients or other substances are the

(1) OJ C 332 E, 27.11.2001, p. 257.
(2) OJ C 80, 3.4.2002, p. 35.
(3) Opinion of the European Parliament of 11 June 2002 (not yet
published in the Official
Journal), Council Common Position of
20 February 2003 and Decision of the European Parliament of
. . . (not yet published in the Official Journal).

(4) The Scientific Committee on Food set up by Article 1 of
Commission Decision 97/579/EC (5), has stated that the
incidence of food allergies is such as to affect the lives
of many people, causing conditions ranging from very
mild to potentially fatal.

(5) The said Committee has acknowledged that common food
allergens include cow's milk,
legumes (especially
peanuts and soybeans), eggs, crustaceans, tree nuts, fish,
vegetables (celery and other foods of
the Umbelliferae
family), wheat and other cereals.

fruits,

(6) The most common food allergens are found in a wide

variety of processed foods.

(7) The said Committee has also noted that adverse reactions
to food additives may occur and that the avoidance of
food additives is often difficult since not all of them are
invariably included on the labelling.

(8)

It is necessary to provide that additives, processing aids
and other substances with allergenic effect covered by
Article 6(4)(a) of Directive 2000/13/EC are subject
to
labelling
information to
appropriate
consumers suffering from food allergy.

to give

rules,

(9) Even if
labelling, which is intended for consumers in
is not to be regarded as the only medium of
general,
information acting as substitute for the medical estab-
lishment, it is nevertheless advisable to assist consumers
who have allergies or intolerances as much as possible by
providing them with more comprehensive information on
the composition of foodstuffs.

(10) The list of allergenic substances should include those
foodstuffs, ingredients and other substances recognised as
causing hypersensitivity.

(4) OJ L 109, 6.5.2000, p. 29; Directive as amended by Commission

(5) OJ L 237, 28.8.1997, p. 18; Decision as amended by Decision

Directive 2001/101/EC (OJ L 310, 28.11.2001, p. 19).

2000/443/EC (OJ L 179, 18.7.2000, p. 13).

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(11) In order to provide all consumers with better information
and to protect the health of certain consumers, it should
be made obligatory to include in the list of ingredients all
ingredients and other substances present in the foodstuff.
In the case of alcoholic beverages, it should be mandatory
to include in the labelling all ingredients with allergenic
effect present in the beverage concerned.

(12) In order to take account of

the technical constraints
involved in the manufacture of foodstuffs, it is necessary
to authorise greater flexibility with regard to the listing of
ingredients and other
substances used in very small
quantities.

(13) In order to keep up with the development of scientific
knowledge and progress as regards technological means
of removing the allergenicity in ingredients and other
substances and in order to protect consumers against
new food allergens and avoid unnecessary obligations on
it is important to be able to revise the list of
labelling,
ingredients
rapidly, when necessary by including or
deleting certain ingredients or substances. The revision
should be based on scientific criteria determined by the
European Food Safety Authority set up by Regulation (EC)
No 178/2002 of
the
Council (1) and take the form of implementing measures
of a technical nature, the adoption of which should be
entrusted to the Commission in the interest of simplifying
and
the
Commission should,
if necessary, draw up technical
guidelines for the interpretation of Annex IIIa.

the European Parliament and of

Furthermore,

accelerating

procedure.

the

(14) Directive 2000/13/EC should therefore be

amended

accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2000/13/EC is hereby amended as follows:

1. Article 6 shall be amended as follows:

(a) paragraph 1 shall be replaced by the following:

Ingredients shall be listed in accordance with this

‘1.
Article and Annexes I, II, III and IIIa.’;

(b) the following paragraph shall be inserted:

‘3a. Without prejudice to the rules for labelling to be
established pursuant to paragraph 3, any ingredient, as
defined in paragraph 4(a) and listed in Annex IIIa, shall
be indicated on the labelling where it
in
beverages referred to in paragraph 3. This indication

is present

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

shall comprise the word “contains” followed by the
name of the ingredient(s) concerned. However, an indi-
cation is not necessary when the ingredient is already
included under its specific name in the list of ingredients
or in the name under which the beverage is sold.

Where necessary, detailed rules for the presentation of
the indication referred to in the first subparagraph may
following
accordance with
be
procedures:

adopted

the

in

(a) as regards the products referred to in Article 1(2) of
Council Regulation (EC) No 1493/99 of 17 May
1999 on the common organisation of the market
in wine (*), under the procedure laid down in Article
75 of that Regulation;

(b) as regards the products referred to in Article 2(1) of
Council Regulation (EEC) No 1601/91 of 10 June
1991 laying down general rules on the definition,
description and presentation of aromatised wines,
aromatised wine-based drinks and aromatised wine-
product cocktails (**), under
the procedure laid
down in Article 13 of that Regulation;

(c) as regards the products referred to in Article 1(2) of
Council Regulation (EEC) No 1576/89 of 29 May
1989 laying down general rules on the definition,
description and presentation of spirit drinks (***),
under the procedure laid down in Article 14 of
that Regulation;

(d) as regards other products, under the procedure laid

down in Article 20(2) of this Directive.

___________

(*) OJ L 179, 14.7.1999, p. 1; Regulation as last
amended by Regulation (EC) No 2585/2001 (OJ
L 345, 29.12.2001, p. 10).

(**) OJ L 149, 14.6.1991, p. 1; Regulation as last
amended by Regulation (EC) No 2061/96 of the
(OJ L
European Parliament and of the Council
277, 30.10.1996, p. 1).

(***) OJ L 160, 12.6.1989, p. 1; Regulation as last
amended by Regulation (EC) No 3378/94 of the
European Parliament and of the Council
(OJ L
366, 31.12.1994, p. 1).’;

(c) the following point shall be added to paragraph 4(c):

‘(iv) substances which are not additives but are used in
the same way and with the same purpose as
processing aids
in the
still present
finished product, even if in altered form.’;

and are

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(d) the second subparagraph of paragraph 5 shall be

amended as follows:

(c) where the compound ingredient is a foodstuff for
which a list of ingredients is not required under
Community legislation.’;

(i) the fourth indent shall be replaced by the following:

(f)

the following paragraphs shall be added:

foodstuff,
in the list of

‘— where fruit, vegetables or mushrooms, none of
which significantly predominates in terms of
weight and which are used in proportions that
are likely to vary, are used in a mixture as
they may be
ingredients of
a
ingredients
grouped together
“vegetables” or
under the designation “fruit”,
“in
“mushrooms”
varying proportions”,
immediately followed by
the fruit, vegetables or mushrooms
a list of
present;
the mixture shall be
in such cases,
included in the list of ingredients in accordance
with the first subparagraph, on the basis of the
total weight
vegetables or
mushrooms present,’;

followed by

the phrase

fruit,

the

of

(ii) the following indents shall be added:

‘— ingredients constituting less than 2 % of

the
finished product may be listed in a different
order after the other ingredients,

composition,

its nature or

— where ingredients which are similar or mutually
substitutable are likely to be used in the manu-
facture or preparation of a foodstuff without
altering its
its
perceived value, and in so far as they constitute
less than 2 % of the finished product, they may
be referred to in the list of ingredients by means
of the phrase “contains . . . and/or . . .”, where at
least one of no more than two ingredients is
present in the finished product. This provision
shall not apply to additives or to ingredients
listed in Annex IIIa.’;

(e) the second subparagraph of paragraph 8 shall be

replaced by the following:

‘The list referred to in the first subparagraph shall not be
compulsory:

(a) where the composition of the compound ingredient
is defined in current Community legislation, and in
so far as the compound ingredient constitutes less
than 2 % of
this
provision shall not apply to additives, subject to
paragraph 4(c),

the finished product; however,

(b) for compound ingredients consisting of mixtures of
spices and/or herbs that constitute less than 2 % of
the finished product, with the exception of additives,
subject to paragraph 4(c),

6

of

the
the

2,
and

paragraph

paragraph

Notwithstanding

second
‘10.
second
subparagraph
subparagraph of paragraph 8, any ingredient used in
production of a foodstuff and still present
in the
finished product, even if in altered form, and listed in
Annex IIIa or originating from an ingredient listed in
Annex IIIa shall be indicated on the label with a clear
reference to the name of this ingredient.

The indication referred to in the first subparagraph shall
not be required if the name under which the foodstuff is
sold clearly refers to the ingredient concerned.

in the finished product, even if

Notwithstanding paragraph 4(c)(ii),
(iii) and (iv), any
substance used in production of a foodstuff and still
present
in altered
form, and originating from ingredients listed in Annex
IIIa shall be considered as an ingredient and shall be
indicated on the label with a clear reference to the
name of the ingredient from which it originates.

The list

11.
in Annex IIIa shall be systematically
re-examined and, where necessary, updated on the
basis of the most recent scientific knowledge. The first
re-examination shall take place at the latest on . . . (*).

Updating could also be effected by the deletion from
Annex IIIa of ingredients for which it has been scien-
tifically established that it is not possible for them to
cause adverse reactions.

To this end, Annex IIIa may be amended, in compliance
with the procedure referred to in Article 20(2), after an
opinion has been obtained from the European Food
Safety Authority issued on the basis of Article 29 of
Regulation (EC) No 178/2002 (**).

interpretation of

Where necessary, technical guidelines may be issued for
the
in
compliance with the procedure referred to in Article
20(2).

in Annex IIIa,

the

list

___________
(**) OJ L 31, 1.2.2002, p. 1.’;

2.

in the second subparagraph of Article 19,
‘Standing
Committee on Foodstuffs set up by Council Decision
69/414/EEC (1)’ shall be replaced by ‘Standing Committee
on the Food Chain and Animal Health set up by Regulation
(EC) No 178/2002’;

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

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3. the footnote, ‘OJ L 291, 29.11.1969, p. 9’, shall be deleted;

They shall forthwith inform the Commission thereof.

4.

5.

in Article 20(1) ‘Standing Committee on Foodstuffs’ shall be
replaced by ‘Standing Committee on the Food Chain and
Animal Health’;

the designations

in Annex I,
and
‘vegetables’, and the corresponding definitions, shall be
deleted;

‘crystallised fruit’

6. Annex IIIa, the text of which is set out in the Annex to this

Directive, shall be inserted.

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

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 2

Article 3

1. Member States shall bring into force, by . . . (*) the laws,
regulations and administrative provisions necessary to:

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

— permit, as from . . . (*), the sale of products that comply

with this Directive;

Article 4

This Directive is addressed to the Member States.

— prohibit, as from . . . (**), the sale of products that do not
comply with this Directive; any products which do not
comply with this Directive but which have been placed
on the market or
to this date may,
labelled prior
however, be sold while stocks last.

. . .

For the European Parliament

The President

For the Council

The President

(*) 12 months from the date of entry into force of this Directive.
(**) 24 months from the date of entry into force of this Directive.

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ANNEX

‘ANNEX IIIa

Ingredients referred to in Article 6(3a), (10) and (11)

Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof

Crustaceans and products thereof

Eggs and products thereof

Fish and products thereof

Peanuts and products thereof

Soybeans and products thereof

Milk and products thereof (including lactose)

Nuts i.e. Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occi-
dentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera),
Macadamia nut and Queensland nut (Macadamia ternifolia) and products thereof

Celery and products thereof

Mustard and products thereof

Sesame seeds and products thereof

Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2.’

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 7 September 2001 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, Council amending
Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs (1).

2. The Economic and Social Committee delivered its opinion on 16 January 2002 (2).

3. The European Parliament adopted a number of amendments on 11 June 2002 (3).

4. Following the European Parliament opinion, the Commission forwarded an amended proposal (4) to

the Council on 4 September 2002.

5. On 20 February 2003, the Council adopted its Common Position in accordance with Article 251 of

the Treaty.

II. OBJECTIVE

In the White Paper on Food Safety, the Commission had announced the intention to propose an
amendment to the Directive 2000/13/EC, especially with regard to the possibility of not indicating the
components of compound ingredients which form less than 25 % of the final product. This possibility
was introduced into Community legislation more than 20 years ago with the objective of avoiding
inordinately long lists of ingredients.

However, as food production has become more complex and the consumption of processed foods
more widespread, consumers have repeatedly expressed the wish to be better informed about the
foodstuffs they purchase, and specifically about their composition.

Moreover, the need was recognised to address the problem of food allergies, an issue which comes
under food safety and health, by providing the consumers with information on the presence of
allergenic ingredients.

The proposal aims therefore at providing the consumer with more comprehensive information about
the composition of food products and alcoholic beverage, particularly in order to make obligatory
listing ingredients susceptible to cause allergies or intolerances.

III. ANALYSIS OF THE COMMON POSITION

A. General remarks related to the European Parliament's amendments

1. The Council has followed the Commission's amended proposal. It has accepted — either word
by word or in substance — the four Parliament's amendments as set out by the Commission in
its amended proposal.

2. The Council has also taken into account most of the other European Parliament amendments.

(a) Three other European Parliament amendments (i.e. amendments 8, 9 and 14), which were
not incorporated into the Commission's amended proposal, have been accepted by the
Council;

(b) As regards two other amendments (i.e. amendments 5 and 13), the Council, rather than
deleting the relevant provision, has preferred to limit the derogation by lowering the level
below which the derogation applies from 5 to 2 %.

3. As regards amendment 10, the Council, like the Commission, considers that this question could

be raised in the context of the future updating of the list.

(1) OJ C 332 E, 27.11.2001, p. 257.
(2) OJ C 80, 3.4.2002, p. 35.
(3) Doc. 9840/02 (not yet published in the Official Journal).
(4) OJ C 331 E, 31.12.2002, p. 188.

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B. Main innovations introduced by the Council

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

— coverage of certain substances which are not additives but are used in the same way and
with the same purpose as processing aids and are still present in the finished product (see
proposal for a new paragraph 4(c)(iv) of Article 6 in Directive 2000/13/EC),

— obligation to indicate the ingredients originating from an ingredient listed in Annex IIIa with
a clear reference to the name of this ingredient's, unless the name under which the foodstuff
is sold clearly refers to the ingredient concerned (see proposal for a new paragraph 10 of
Article 6 in Directive 2000/13/EC).

2. Other modifications have been made, of a purely technical nature and aiming at clarifying the

text of the Directive.

IV. CONCLUSIONS

The Council considers that the Common Position responds to a large extent to the main 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.