Amended proposal for a Directive of the European Parliament and of the Council amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs (presented by the Commission in application of Article 250(2) of the EC Treaty)
Date: 2002-09-03
Institutions: European Commission
Subjects: advertising, approximation of laws, consumer information, foodstuff, labelling, packaging

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Amended proposal for a Directive of the European Parliament and of the Council amending
Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs (1)

(2002/C 331 E/35)

(Text with EEA relevance)

COM(2002) 464 final — 2001/0199(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 3 September 2002)

(Amendments are indicated by underlining/strikeout in the text)

A. Principles

EXPLANATORY MEMORANDUM

1.
In September 2001 the Commission submitted the proposal for a European Parliament and Council
Directive amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs
COM(2001) 433 — 2001/0199(COD) with a view to its adoption under the codecision procedure
provided for in Article 251 of the Treaty establishing the European Community.

On 11 June 2002 the European Parliament adopted a number of amendments at first reading. The
Commission then indicated its position on each amendment, specifying which amendments it could
accept and which it could not.

Subsequently the Commission drafted this amended proposal.

2.
The modifications incorporate the amendments accepted as such by the Commission, as well as the
new provisions resulting from the amendments which were accepted in principle though worded
differently.

B. Presentation of the modifications

1. Amendments accepted as such

— Amendment 2

This amendment adds mixtures of mushrooms to the other mixtures (fruits or vegetables) whose labelling
must not necessarily respect the rule of descending order of weight and specifies that this option applies
only in the case of mixtures used in proportions which are likely to vary. These details are useful and
reduce the risks of uncertainty both for the manufacturer and the consumer.

The Commission accepts this amendment.

— Amendment 6

The main purpose of this amendment is to abolish the labelling derogation provided for in the proposal in
respect of ingredients consisting of preparations of sauces or mustards constituting less than 5 % of the
finished product in foodstuffs.

The purpose of this provision in the initial proposal was to avoid overly long lists of ingredients.

The amendment removes this advantage but thus reduces the possibilities of ingredients being omitted
from the labelling, hence increasing the degree of consumer information. Besides,
this amendment
improves the wording of the text.

The Commission accepts this amendment.

(1) OJ C 332 E, 27.11.2001, p. 257.

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2. Amendments accepted in principle but not as regards the wording

— Amendment 7, part two

This amendment makes it incumbent on the European Food Safety Authority to establish criteria for
updating the Annex and to review it at regular two-yearly intervals.

In fact, the amendment of the Annex with a view to updating it, which is indeed necessary, is a matter for
the legislator, after consulting the Authority at scientific level.

Thus the Commission can accept the principle of regular review of the list annexed to the proposal.

— Amendment 11

This amendment requires the Commission to issue detailed guidelines for the interpretation of the annex to
the proposal.

The Commission cannot accept this amendment as it stands but considers it useful that the Directive
include a provision requiring that technical details be added to the list of allergenic ingredients,
if
necessary.

C. Rejected amendments

— Amendment 13

As regards ingredients used in small quantities (less than 5 % of the finished product), this amendment
eliminates the possibility of not strictly respecting the descending order of weight when enumerating them
in the list of ingredients.

This flexibility as regards presentation in the labelling is however technically justified,
obligation to list all the ingredients, including those used in minute quantities.

in view of the

Hence this amendment is not acceptable.

— Amendment 14

This amendment eliminates the possibility of not repeating an ingredient used several times in the
preparation of a foodstuff, both as a simple ingredient and as an ingredient of a compound ingredient.

Hence the elimination of this flexibility is not acceptable.

— Amendment 5

This amendment eliminates the possibility of not indicating the composition of compound ingredients
used in small quantities (less than 5 % of the finished product) when the composition of the compound
ingredient is defined in current Community legislation, which indicates the composition in line with the
sales name. The products potentially concerned by this derogation are chocolates, fruit juices, fruit jams,
jellies, marmalades and chestnut purée.

This derogation does not apply either to additives or to allergenic substances.

The purpose of the derogation is to avoid uselessly lengthening the lists of ingredients while maintaining
consistency with the proposal's objectives.

Hence this amendment is not acceptable.

— Amendment 7, part one

This amendment exempts processing aids derived from allergenic ingredients
requirement on the grounds that these substances are eliminated during the manufacturing process.

from the labelling

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However, residues may be present in the finished products and allergic reactions may occur even in the
presence of simple residues or traces of allergenic substances.

Hence this part of amendment 7 is not acceptable.

— Amendments 8, 9 and 10

These amendments add the named ingredients to the list in the Annex.

However, the list proposed by the Commission is based on the available scientific data and should be
extended only on the basis of objective scientific criteria.

The Commission, with a view to updating the list in the future, has invited the Scientific Committee on
Food to prepare a rapid procedure for amending the list (comitology). It will also raise the question as to
the necessity of adding these ingredients to the list.

Hence these amendments are not acceptable.

Pursuant to Article 250(2) of the EC Treaty, the Commission amends the proposal as described above.

The amendments to the Commission’s initial proposal are shown as follows: deleted passages are struck
through and new or amended passages are indicated in bold and underlined characters.

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

consumers are

ensured that

(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 adver-
certain substances need not
tising of
appear in the list of ingredients.

foodstuffs (1)

(1) OJ L 109, 6.5.2000, p. 29. Directive amended by Commission

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

allergies or

(3) Certain ingredients contained in foodstuffs are the cause
of
in the
Community, and some of those allergies or intolerances
constitute a danger to the health of those concerned.

in consumers

intolerances

(4) The Scientific Committee for Food (SCF) has stated that
the incidence of food allergy is such as to affect the lives
of many people, causing conditions ranging from very
mild to potentially fatal.

(5) The SCF has acknowledged that common food allergens
include cow's milk, fruits, legumes (especially peanuts and
tree nuts,
soybeans), eggs, crustaceans,
fish, vegetables
the Umbelliferae family),
foods of
(celery and other
it has also noted that adverse
wheat and other cereals;
food
reactions to food additives may occur and that
additive avoidance is often difficult since not all
food
additives may be included in labelling.

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

variety of processed foods.

(7) Even if

labelling, which is intended for consumers in
general, must not be regarded as the only means of
information, taking over the role of 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
about the composition of foodstuffs.

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(8) The list of allergenic substances includes those foodstuffs
and ingredients recognised as causing hypersensitivity and
likely to benefit
from an exemption under Directive
2000/13/EC. In order to keep up with the development
of scientific knowledge, it is important to be able to revise
this list rapidly, when necessary. Such revisions should
take the form of implementing measures of a technical
nature, and their adoption should be entrusted to the
Commission in order
to simplify and accelerate the
procedure.

(9) To provide all consumers with better information and to
protect the health of certain consumers, it should be made
ingredients all
obligatory to include in the list of
ingredients present in the foodstuff and,
in the case of
ingredients known to be allergenic, to declare them by
including in alcoholic
their specific name in all cases,
drinks, with no possibility of using the name of
the
category to which they belong or, in the case of additives,
of an exemption from the obligation of
their being
included in the list of ingredients.

(10) In order to prevent the risk of labelling becoming too
complex and difficult
to read, procedures are needed
which make it possible to avoid excessively long lists of
ingredients while still ensuring that the above-mentioned
objectives are achieved. In order to take account of the
technical constraints associated with the manufacture of
foodstuffs, it is also necessary to authorise greater flexi-
bility with regard to the listing of ingredients used in very
small quantities.

(11) Directive 2000/13/EC should be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2000/13/EC is amended as follows:

1. Article 6 is amended as follows:

(b) as regards the products referred to in Article 2,
paragraph 1, of Council Regulation (EEC) No
1601/91 (**), under the procedure laid down in
Article 13 of the said Regulation;

(c) as regards the products referred to in Article 1,
paragraph 2, of Council Regulation (EEC) No
1576/89 (***), under the procedure laid down in
Article 14 of the said Regulation;

(d) as regards other products, under the procedure laid
down in Article 20, paragraph 2, of this Directive.

___________

(*) OJ L 179, 14.7.1999, p. 1.
(**) OJ L 149, 14.6.1991, p. 1.
(***) OJ L 160, 12.6.1989, p. 1.’

(b) The second sub-paragraph of paragraph 5 is amended as

follows:

(i) The fourth indent is replaced by the following text:

foodstuff,
in the list of

‘— where fruits,or 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
under the designation “fruits”, or “vegetables”
or “mushrooms” followed by a phrase such as
“in varying proportions”, immediately followed
by a
fruits, or vegetables or
mushrooms present and a phrase such as “in
the
varying
list of
mixture
ingredients,
first
sub-paragraph, on the basis of the total weight
the fruits, or vegetables or mushrooms
of
present,’

in accordance with the

proportions”;
shall be

included in the

in such cases,

list of

the

(a) The following paragraph 3a is inserted:

(ii) The following sixth and seventh indents are added:

‘3a. Without prejudice to the rules to be established
in application of paragraph 3, the presence of one or
more of the ingredients listed in Annex IIIa in a drink
referred to in paragraph 3 shall be mentioned, unless
the
included under
concerned is/are
its/their specific name(s) in the name under which the
drink is sold. This indication shall comprise the term
“contains”, followed by the name of the ingredient(s)
concerned.

ingredient(s)

Where necessary, detailed rules
paragraph may be adopted:

for

applying this

(a) as regards the products referred to in Article 1,
paragraph 2, of Council Regulation (EC) No
1493/99 (*), under
the procedure laid down in
Article 75 of the said Regulation;

‘— ingredients constituting less than 5 % of

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

— 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 composition, and in so far as they
constitute less than 5 % 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, or
the
“contains
following
least one of
ingredients:
. . .:” where at least one
of no more than three ingredients is present
in the finished product.’

at
. . .,

. . .,

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(c) Paragraph 8 is amended as follows:

(i) The

following sentence

is

added to the

first

sub-paragraph:

‘However, where the ingredients of the compound
ingredient are already listed as single ingredients in
the list of ingredients, repetition is not compulsory,
as long as an explanatory note, placed near the list
of
ingredients, clearly informs the purchaser that
they are present in the foodstuff as single ingredients
and as ingredients of the compound ingredient.’

(ii) The

second sub-paragraph is

replaced by the

following text:

The list in Annex IIIa shall be reexamined and,
(11)
where necessary, updated, every two years, and for the
first time two years after the entry into force of this
Directive, on the basis of
the most recent scientific
knowledge.

To this end Annex IIIa may be amended, in compliance
with the procedure referred to in Article 20(2), after
obtaining the opinion of
the European Food Safety
Authority issued on the basis of Article 29 of Regu-
lation (EC) No 178/2002 of the European Parliament
and of the Council (1).

Where necessary,
the list in Annex IIIa may be the
technical guidelines for its interpretation,
subject of
Annex IIIa may be amended in compliance with the
procedure referred to in Article 20(2).’

referred to under
‘However,
sub-paragraph shall not be compulsory:

the

list

the

first

2. In Annex I,

and
‘vegetables’, and the corresponding definitions, are deleted.

‘crystallised fruit’

the designations

(a) where

the

the

composition of

compound
is defined in current Community
ingredient
legislation, and in so far as the compound
ingredient constitutes
the
finished product; however, this provision shall
not apply to additives, subject to paragraph 4(c);

than 5 % of

less

(b) for

thecompound ingredients

consisting of
mixtures of spices and/or herbs that constitute
listed
less than 2 % of
below, with the exception of additives, subject
to paragraph 4(c);

the finished product,

(i) preparations of sauces or mustards consti-
tuting less than 5 % of the finished product,

(ii) mixtures of spices and/or herbs constituting

less than 2 % of the finished product;

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

(d) The following paragraphs 10 and 11 areis added:

The provisions of paragraph 4(c)(ii) and (iii),
‘(10)
paragraph 6 (second sub-paragraph,
first indent) and
paragraph 8 (second sub-paragraph) shall not apply to
the ingredients listed in Annex IIIa.

3. Annex IIIa, the text of which is appended to this Directive,

is inserted.

Article 2

Member States shall bring into force, by 31 December 2003 at
the latest, the laws, regulations and administrative provisions
necessary to:

— permit, by 1 January 2004 at the latest, the sale of products

that comply with this Directive,

— prohibit, as from 1 January 2005, products that do not
comply with this Directive; any products that do not
comply with this Directive but have been placed on the
market or labelled prior to this date may, however, be sold
while stocks last.

They shall forthwith inform the Commission thereof.

When these provisions are adopted by the Member States, they
shall contain a reference to this Directive or be accompanied
by such a reference on the occasion of their official publi-
cation. Member States shall determine how such reference is
to be made.

Article 3

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

Article 4

This Directive is addressed to the Member States.

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

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ANNEX

‘ANNEX IIIa

INGREDIENTS REFERRED TO IN ARTICLE 6, PARAGRAPHS 3a AND 10

Cereals containing gluten 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 dairy products (including lactose)

Nuts and nut products

Sesame seeds and products thereof

Sulphite at concentrations of at least 10 mg/kg’