Common Position (EC) No 57/2003 of 25 June 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 94/35/EC on sweeteners for use in foodstuffs
Date: 2003-06-25
Institutions: Council of the European Union
Subjects: animal nutrition, foodstuff, foodstuffs legislation, marketing, sweetener

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 57/2003

adopted by the Council on 25 June 2003

with a view to the adoption of a Directive 2003/. . ./EC of the European Parliament and of the
Council of . . . amending Directive 94/35/EC on sweeteners for use in foodstuffs

(2003/C 277 E/01)

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 European Economic and
Social Committee (2),

the Scientific Committee on Food,
After consultation of
pursuant to Article 6 of Council Directive 89/107/EEC of 21
December 1988 on the approximation of
the
Member States concerning food additives authorised for use
in foodstuffs intended for human consumption (3),

the laws of

Acting in accordance with the procedure laid down in Article
251 of the Treaty (4),

Whereas:

(1) Directive 94/35/EC of the European Parliament and of the
for use in
Council of 30 June 1994 on sweeteners
foodstuffs (5) lays down a list of sweeteners that may be
used in the Community and their conditions of use.

(2) Since 1996, two new sweeteners, sucralose and the salt of
aspartame and acesulfame, have been found acceptable for
use in food by the Scientific Committee on Food.

(1) OJ C 262 E, 29.10.2002, p. 429.
(2) OJ C 85, 8.4.2003, p. 34.
(3) OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive
94/34/EC of the European Parliament and of the Council (OJ L
237, 10.9.1994, p. 1).

(4) Opinion of the European Parliament of 10 April 2003 (not yet
published in the Official
Journal), Council Common Position of
25 June 2003 and Decision of the European Parliament of . . .
(not yet published in the Official Journal).

(5) OJ L 237, 10.9.1994, p. 3. Directive as amended by Directive

96/83/EC (OJ L 48, 19.2.1997, p. 16).

(3) The opinion of

the Scientific Committee on Food on
cyclamic acid and its sodium and calcium salts (which led
to the establishment of a new Acceptable Daily Intake
(ADI)) and recent studies on the intake of cyclamates lead
to a reduction of the maximum usable doses of cyclamic
acid and its sodium and calcium salts.

adapted to take

(4) The designation of certain food categories in Directive
94/35/EC should be
into account
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 (6)
and of specific Directives adopted for some groups of
foodstuffs
I of Council Directive
89/398/EEC (7).

in Annex

listed

(5) The use of

food additives concerned complies with the
to Directive

general criteria laid down in Annex II
89/107/EEC.

food law,

establish procedures

(6) Articles 53 and 54 of Regulation (EC) No 178/2002 of the
European Parliament and of
the Council of 28 January
2002 laying down the general principles and requirements
establishing the European Food Safety
of
Authority and laying down procedures in matters of food
safety (8)
emergency
measures in relation to food of Community origin or
imported from a third country. They allow the Commission
to adopt such measures in situations where food is likely to
constitute a serious risk to human health, animal health or
the environment and where such risk cannot be contained
satisfactorily by measures taken by the Member State(s)
concerned.

taking

for

(7) The measures necessary for implementation of Directive
94/35/EC should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures
implementing powers
exercise of
conferred on the Commission (9).

the

for

(6) OJ L 183, 12.7.2002, p. 51.
(7) OJ L 186, 30.6.1989, p. 27. Directive as last amended by Directive
1999/41/EC of the European Parliament and of the Council (OJ L
172, 8.7.1999, p. 38).
(8) OJ L 31, 1.2.2002, p. 1.
(9) OJ L 184, 17.7.1999, p. 23.

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(8) Directive

94/35/EC

should

therefore

be

amended

accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 94/35/EC is hereby amended as follows:

1. Article 4 shall be replaced by the following:

‘Article 4

It may be decided in accordance with the procedure laid
down in Article 7:

— where there are differences of opinion as to whether
sweeteners can be used in a given foodstuff under the
terms of this Directive, whether that foodstuff is to be
considered as belonging to one of the categories listed in
the third column of the Annex,

— whether a food additive listed in the Annex and auth-
orised at “quantum satis” is used in accordance with the
criteria referred to in Article 2 and

The Committee shall adopt its rules of procedure.

3.
___________

(*) OJ L 31, 1.2.2002, p. 1.
(**) Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (OJ L 184,
17.7.1999, p. 23).’;

4. The Annex shall be amended in accordance with the Annex

to this Directive.

Article 2

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive in order to:

— authorise trade in and use of products conforming with this

Directive by . . . (*) at the latest,

— prohibit trade in and use of products not conforming with
this Directive by . . . (**) at the latest; however, products
placed on the market or labelled before that date which
do not comply with this Directive may be marketed until
stocks are exhausted.

— whether a substance is a sweetener within the meaning

of Article 1(2).’

They shall forthwith inform the Commission thereof.

2. A third indent shall be added to Article 5(2):

‘— salt of aspartame and acesulfame: “contains a source of

phenylalanine” ’

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

3. Article 7 shall be replaced by the following:

‘Article 7

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health set up
pursuant to Article 58 of Regulation (EC) No 178/2002 (*),
hereinafter referred to as “the Committee”.

Article 3

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

Article 4

This Directive is addressed to the Member States.

2. Where reference is made to this Article, Articles 5 and
7 of Decision 1999/468/EC (**), shall apply, having regard
of the provisions of Article 8 thereof.

Done at . . .

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

For the European Parliament

The President

For the Council

The President

(*) 12 months after the entry into force of this Directive.
(**) 18 months after the entry into force of this Directive.

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The Annex to Directive 94/35/EC is hereby amended as follows:

ANNEX

1.

In the third column of the tables the following categories of foodstuffs shall be renamed:

(a) Instead of ‘Complete formulae for weight control intended to replace total daily food intake or an individual
meal’ to read ‘Foods intended for use in energy-restricted diets for weight reduction as referred to in Directive
1996/8/EC (*)’;

(b) Instead of ‘Complete formulae and nutritional supplements for use under medical supervision’ to read ‘Dietary

foods for special medical purposes as defined in Directive 1999/21/EC (**)’;

(c) Instead of ‘Liquid food supplements/dietary integrators’ to read ‘Food supplements as defined in Directive

2002/46/EC (***) supplied in a liquid form’;

(d) Instead of

‘Solid food supplements/dietary integrators’

to read ‘Food supplements as defined in Directive

2002/46/EC supplied in a solid form’;

(e) Instead of ‘Food supplements/dietary integrators based on vitamins and/or mineral elements, syrup-type or
chewable’ to read ‘Food supplements as defined in Directive 2002/46/EC, based on vitamins and/or mineral
elements and supplied in a syrup-type or chewable form’;

2. The following footnotes shall be added after the tables:

‘

(*) Commission Directive 1996/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for

weight reduction (OJ L 55, 6.3.1996, p. 22).

(**) Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91,

7.4.1999, p. 29).

(***) 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 (OJ L 183, 12.7.2002, p. 51).’;

3. For E 951 ‘Aspartame’ the following category shall be added under ‘Confectionery’:

‘— Essoblaten

1 000 mg/kg’

4. For E 952 ‘cyclamic acid and its sodium and calcium salts’:

(a) for the following categories of

foodstuffs, the maximum usable dose of

‘400 mg/l’ shall be replaced by

‘250 mg/l’:

— Water-based flavoured drinks, energy-reduced or with no added sugar;

— Milk- and milk derivative-based or fruit-juice-based drinks, energy-reduced or with no added sugar.

(b) the following categories of foodstuffs and maximum usable doses shall be deleted:

‘— Confectionery with no added sugar

500 mg/kg

— Cocoa- or dried-fruit-based confectionery, energy-reduced or with no added sugar

500 mg/kg

— Starch-based confectionery, energy-reduced or with no added sugar

— Chewing gum with no added sugar

— Breath-freshening micro-sweets, with no added sugar

— Edible ices, energy-reduced or with no added sugar

500 mg/kg

1 500 mg/kg

2 500 mg/kg

250 mg/kg’;

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5. The following tables shall be added:

‘EC No

Name

Foodstuffs

Maximum
usable dose

E 955

Sucralose

Non-alcoholic drinks

— Water-based flavoured drinks, energy-reduced or with no

300 mg/l

added sugar

— Milk- and milk-derivative-based or fruit-juice-based drinks,

300 mg/l

energy-reduced or with no added sugar

Desserts and similar products

— Water-based flavoured desserts, energy-reduced or with no

400 mg/kg

added sugar

— Milk- and milk-derivative-based preparations, energy-reduced

400 mg/kg

or with no added sugar

— Fruit- and vegetable-based desserts, energy-reduced or with

400 mg/kg

no added sugar

— Egg-based desserts, energy-reduced or with no added sugar

400 mg/kg

— Cereal-based desserts, energy-reduced or with no added sugar

400 mg/kg

— Fat-based desserts, energy-reduced or with no added sugar

400 mg/kg

— “Snacks”: certain flavours of ready to eat, pre-packed, dry,

200 mg/kg

savoury starch products and coated nuts

Confectionery

— Confectionery with no added sugar

1 000 mg/kg

— Cocoa- or dried-fruit-based confectionery, energy-reduced or

800 mg/kg

with no added sugar

— Starch-based confectionery, energy-reduced or with no added

1 000 mg/kg

sugar

— Cornets and wafers, for ice cream, with no added sugar

800 mg/kg

— Essoblaten

800 mg/kg

— Cocoa-, milk-, dried-fruit- or fat-based sandwich spreads,

400 mg/kg

energy-reduced or with no added sugar

— Breakfast cereals with a fibre content of more than 15 %, and
containing at least 20 % bran, energy-reduced or with no
added sugar

400 mg/kg

— Breath-freshening micro-sweets with no added sugar

2 400 mg/kg

— Strongly flavoured freshening throat pastilles with no added

1 000 mg/kg

sugar

— Chewing gum with no added sugar

— Energy-reduced tablet form confectionery

— Cider and Perry

3 000 mg/kg

200 mg/kg

50 mg/l

— Drinks consisting of a mixture of a non-alcoholic drink and

250 mg/l

beer, cider, perry, spirits or wine

— Spirit drinks containing less than 15 % alcohol by volume

250 mg/l

— Alcohol-free beer or with an alcohol content not exceeding

250 mg/l

1,2 % vol

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EC No

Name

Foodstuffs

Maximum
usable dose

— “Bière de table/Tafelbier/Table beer” (original wort content

250 mg/l

less than 6 %) except for “Obergäriges Einfachbier”

— Beers with a minimum acidity of 30 milli-equivalents

250 mg/l

expressed as NaOH

— Brown beers of the “oud bruin” type

— Energy-reduced beer

250 mg/l

10 mg/l

— Edible ices, energy-reduced or with no added sugar

320 mg/kg

— Canned or bottled fruit, energy-reduced or with no added

400 mg/kg

sugar

— Energy-reduced jams, jellies and marmalades

— Energy-reduced fruit and vegetable preparations

— Sweet-sour preserves of fruit and vegetables

— Feinkostsalat

400 mg/kg

400 mg/kg

180 mg/kg

140 mg/kg

— Sweet-sour preserves

and semi-preserves of

fish and

120 mg/kg

marinades of fish, crustaceans and molluscs

— Energy-reduced soups

— Sauces

— Mustard

— Fine bakery products for special nutritional uses

45 mg/l

450 mg/kg

140 mg/kg

700 mg/kg

— Foods intended for use in energy-restricted diets for weight

320 mg/kg

reduction as referred to in Directive 1996/8/EC

— Dietary foods for special medical purposes as defined in

400 mg/kg

Directive 1999/21/EC

— Food supplements as defined in Directive 2002/46/EC

240 mg/l

supplied in a liquid form

— Food supplements as defined in Directive 2002/46/EC

800 mg/kg

supplied in a solid form

— Food supplements as defined in Directive 2002/46/EC, based
on vitamins and/or mineral elements and supplied in a
syrup-type or chewable form

2 400 mg/kg

EC No

Name

Foodstuffs

Maximum
usable dose (*)

E 962

Salt of
aspartame-
acesulfame

Non-alcoholic drinks

— Water-based flavoured drinks, energy-reduced or with no

350 mg/l (a)

added sugar

— Milk- and milk-derivative-based or fruit-juice-based drinks,

350 mg/l (a)

energy-reduced or with no added sugar

Desserts and similar products

— Water-based flavoured desserts, energy-reduced or with no

350 mg/kg (a)

added sugar

— Milk- and milk-derivative-based preparations, energy-reduced

350 mg/kg (a)

or with no added sugar

— Fruit- and vegetable-based desserts, energy-reduced or with

350 mg/kg (a)

no added sugar

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EC No

Name

Foodstuffs

Maximum
usable dose (*)

— Egg-based desserts, energy-reduced or with no added sugar

350 mg/kg (a)

— Cereal-based desserts, energy-reduced or with no added sugar

350 mg/kg (a)

— Fat-based desserts, energy-reduced or with no added sugar

350 mg/kg (a)

— “Snacks”: certain flavours of ready to eat, prepacked, dry,

500 mg/kg (b)

savoury starch products and coated nuts

Confectionery

— Confectionery with no added sugar

500 mg/kg (a)

— Cocoa- or dried-fruit-based confectionery, energy-reduced or

500 mg/kg (a)

with no added sugar

— Starch-based confectionery, energy-reduced or with no added

1 000 mg/kg (a)

sugar

— Essoblaten

1 000 mg/kg (b)

— Cocoa-, milk-, dried-fruit or

fat-based sandwich spreads,

1 000 mg/kg (b)

energy-reduced or with no added sugar

— Breakfast cereals with a fibre content of more than 15 %, and
containing at least 20 % bran, energy-reduced or with no
added sugar

1 000 mg/kg (b)

— Breath-freshening micro-sweets with no added sugar

2 500 mg/kg (a)

— Chewing gum with no added sugar

— Cider and perry

2 000 mg/kg (a)

350 mg/l (a)

— Drinks consisting of a mixture of a non-alcoholic drink and

350 mg/l (a)

beer, cider, perry, spirits or wine

— Spirit drinks containing less than 15 % alcohol by volume

350 mg/l (a)

— Alcohol-free beer or with an alcohol content not exceeding

350 mg/l (a)

1,2 % vol

— “Bière de table/Tafelbier/Table beer” (original wort content

350 mg/l (a)

less than 6 %) except for “Obergäriges Einfachbier”

— Beers with a minimum acidity of 30 milli-equivalents

350 mg/l (a)

expressed as NaOH

— Brown beers of the “oud bruin” type

— Energy-reduced beer

350 mg/l (a)

25 mg/l (b)

— Edible ices, energy-reduced or with no added sugar

800 mg/kg (b)

— Canned or bottled fruit, energy-reduced or with no added

350 mg/kg (a)

sugar

— Energy-reduced jams, jellies and marmalades

1 000 mg/kg (b)

— Energy-reduced fruit and vegetable preparations

350 mg/kg (a)

— Sweet-sour preserves of fruit and vegetables

— Feinkostsalat

200 mg/kg (a)

350 mg/kg (b)

— Sweet-sour preserves

and semi-preserves of

fish and

200 mg/kg (a)

marinades of fish, crustaceans and molluscs

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EC No

Name

Foodstuffs

— Energy-reduced soups

— Sauces

— Mustard

Maximum
usable dose (*)

110 mg/l (b)

350 mg/kg (b)

350 mg/kg (b)

— Fine bakery products for special nutritional uses

1 000 mg/kg (a)

— Foods intended for use in energy-restricted diets for weight

450 mg/kg (a)

reduction as referred to in Directive 1996/8/EC

— Dietary foods for special medical purposes as defined in

450 mg/kg (a)

Directive 1999/21/EC

— Food supplements as defined in Directive 2002/46/EC

350 mg/l (a)

supplied in a liquid form

— Food supplements as defined in Directive 2002/46/EC

500 mg/kg (a)

supplied in a solid form

— Food supplements as defined in Directive 2002/46/EC, based
on vitamins and/or mineral elements and supplied in a
syrup-type or chewable form

2 000 mg/kg (a)

(*) Maximum usable doses for the salt of aspartame-acesulfame are derived from the maximum usable doses for its constituent parts,
aspartame (E951) and acesulfame-K (E950). The maximum usable doses for both aspartame (E951) and acesulfame-K (E950) are
not to be exceeded by use of the salt of aspartame-acesulfame, either alone or in combination with E950 or E951. Limits in this
column are expressed either as (a) acesulfame-K equivalents or (b) aspartame equivalents.’

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 11 July 2002 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, amending Directive
94/35/EC on sweeteners for use in foodstuffs (1).

2. The Economic and Social Committee and the European Parliament gave their opinion on this

proposal respectively on 11 December 2002 (2) and 10 April 2003 (3).

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

the Council on 19 May 2003.

4. On 25 June 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 94/35/EC, with a view to update and revise the list of sweeteners for use
in foodstuffs.

Therefore, in the light of the latest technical and scientifical developments, the proposal mainly aims at
authorising two new sweeteners (sucralose and salt of aspartame and acesulfame) and monitoring
authorised sweeteners (reduction of the intake of cyclamates).

III. ANALYSIS OF THE COMMON POSITION

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

1. The Council has accepted –– either word by word or in substance –– the two European Parliament's
amendments (i.e. amendments 1 and 6) as set out in the Commission's amended proposal. It has
however changed the deadline for the prohibition of use of products not conforming with the
Directive to 18 months after the entry into force;

2. Furthermore, the Council has followed the Commission's amended proposal in reducing the auth-
orised levels for cyclamates for water-based drinks as well as drinks based on milk or fruit-juice as
proposed by the European Parliament, to 250 mg/l. While this level is greater than the 100 mg/l
proposed by the European Parliament, the Commission has undertaken in a minutes statement to
keep under review the maximum usable doses of these substances, taking account inter-alia of
information on intakes from Member States;

3. As regards the other amendments, the Council, like the Commission, considers that some of the
questions addressed by these amendments could be raised in the context of the future updating of
the legislation (5).

(1) OJ C 262 E, 29.10.2002, p. 429.
(2) OJ C 85, 8.4.2003, p. 34.
(3) Doc. 8306/03.
(4) Doc. 9753/03.
(5) See draft minutes statement by the Commission: ‘The Commission undertakes to examine within a period of four
years the sucralose consumption study results provided by the Member States in accordance with the procedures
followed for the report on food additive consumption submitted in October 2001’.

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B. Main innovations introduced by the Council

1. The main innovations introduced by the Council with regard to the Commission's amended

proposal relate to:

— clarification of the wording of Article 4 of Directive 94/35/EC, notably as regards the use of a

food additive listed in the Annex and authorised at ‘quantum satis’ (Article 1(1)),

— labelling obligation as regards salt of aspartame and acesulfame (Article 1(2)),

— simplification of the layout of the table in the Annex related to the maximum usable dose for
salt of aspartame-acesulfame, in order to indicate the limits either as acesulfame-K equivalents or
as aspartame equivalents.

2. Other modifications have been made, of a purely technical nature and aiming at clarifying the text
of the Directive (notably concerning the renaming of certain categories and foodstuffs in the Annex,
following the adoption of a certain number of Directives since 1994).

IV. CONCLUSIONS

The Council considers that the Common Position ensures further harmonisation while taking into
account the main concerns expressed by the European Parliament, notably with a view to protecting
public health and providing better consumer information.