Directive 2003/115/EC of the European Parliament and of the Council of 22 December 2003 amending Directive 94/35/EC on sweeteners for use in foodstuffs
Date: 2003-12-22
Institutions: Council of the European Union, European Parliament
Subjects: food consumption, foodstuff, foodstuffs legislation, labelling, marketing, sweetener

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Official Journal of the European Union

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DIRECTIVE 2003/115/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Directive 94/35/EC on sweeteners for use in foodstuffs

of 22 December 2003

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission (1),

(5)

(6)

Having regard to the opinion of the European Economic and
Social Committee (2),

After consultation of
the Scientific Committee on Food,
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)

(2)

(3)

(4)

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

Since 1996, two new sweeteners, sucralose and the salt
of aspartame and acesulfame, have been found accep-
table for use in food by the Scientific Committee on
Food.

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.

The designation of certain food categories in Directive
94/35/EC should be adapted to take into account Direc-
tive 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 supple-
ments (6) and of specific directives adopted for some
groups of foodstuffs listed in Annex I to Council Direc-
tive 89/398/EEC (7).

(1) OJ C 262 E of 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 (OJ C 277 E, 18.11.2003, p. 1) and position of the Euro-
pean Parliament of 22 October 2003 (not yet published in the Offi-
cial 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).

(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).

The use of the food additives concerned complies with
the general criteria laid down in Annex II to Directive
89/107/EEC.

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 of
food law, establishing the European
Food Safety Authority and laying down procedures in
matters of food safety (8) establish procedures for taking
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.

(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 for the exercise of implementing powers
conferred on the Commission (9).

(8)

Directive 94/35/EC should therefore be amended accord-
ingly,

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, and

(8) OJ L 31, 1.2.2002, p. 1.
(9) OJ L 184, 17.7.1999, p. 23.

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— whether a food additive listed in the Annex and
authorised at “quantum satis” is used in accordance with
the criteria referred to in Article 2.’;

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

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

phenylalanine”.’;

3. Article 7 shall be replaced by the following:

‘Article 7

The Commission shall be assisted by the Standing
1.
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”.

2. Where reference is made to this Article, 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.

(*) 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

By 29 January 2006 at the latest, the Commission shall submit
a report to the European Parliament and the Council outlining
the progress made in the re-evaluations of additives under way
and setting out a provisional calendar for future re-evaluations,
especially those for sucralose and salt of aspartame-acesulfame.
These re-evaluations shall be carried out on the basis of
consumer data supplied by the Member States and shall take
account of the effects of additives on vulnerable population
groups.

Article 3

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

— authorise trade in and use of products conforming with this

Directive by 29 January 2005 at the latest,

— prohibit trade in and use of products not conforming with
the latest; however,
this Directive by 29 July 2005 at
products placed on the market before that date which do
not comply with this Directive may be marketed until 29
January 2006.

They shall forthwith inform the Commission thereof.

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.

Article 4

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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 22 December 2003.

For the European Parliament

The President

P. COX

For the Council

The President

A. MATTEOLI

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Official Journal of the European Union

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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 96/8/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 chew-
able’ 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 96/8/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

500 mg/kg

— Chewing gum with no added sugar

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

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

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 added sugar

300 mg/l

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

300 mg/l

added sugar

Desserts and similar products

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

400 mg/kg

— Milk- and milk-derivative-based preparations, energy-reduced or with no added sugar

400 mg/kg

— Fruit- and vegetable-based desserts, energy-reduced or with no added sugar

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

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

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

400 mg/kg

400 mg/kg

400 mg/kg

400 mg/kg

— "Snacks": certain flavours of ready to eat, pre-packed, dry, savoury starch products and

200 mg/kg

coated nuts

Confectionery

— Confectionery with no added sugar

1 000 mg/kg

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

800 mg/kg

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

1 000 mg/kg

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

— Essoblaten

800 mg/kg

800 mg/kg

— Cocoa-, milk-, dried-fruit- or fat-based sandwich spreads, energy-reduced or with no

400 mg/kg

added sugar

— Breakfast cereals with a fibre content of more than 15 %, and containing at least 20 %

400 mg/kg

bran, energy-reduced or with no added sugar

— Breath-freshening micro-sweets with no added sugar

— Strongly flavoured freshening throat pastilles with no added sugar

— Chewing gum with no added sugar

— Energy-reduced tablet form confectionery

— Cider and Perry

2 400 mg/kg

1 000 mg/kg

3 000 mg/kg

200 mg/kg

50 mg/l

— Drinks consisting of a mixture of a non-alcoholic drink and beer, cider, perry, spirits or

250 mg/l

wine

— Spirit drinks containing less than 15 % alcohol by volume

— Alcohol-free beer or with an alcohol content not exceeding 1,2 % vol

250 mg/l

250 mg/l

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Official Journal of the European Union

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EC No

Name

Foodstuffs

Maximum usable dose

— 'Bière de table/Tafelbier/Table beer' (original wort content less than 6 %) except for

250 mg/l

'Obergäriges Einfachbier'

— Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH

— Brown beers of the 'oud bruin' type

— Energy-reduced beer

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

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

— Energy-reduced jams, jellies and marmalades

— Energy-reduced fruit and vegetable preparations

— Sweet-sour preserves of fruit and vegetables

— Feinkostsalat

250 mg/l

250 mg/l

10 mg/l

320 mg/kg

400 mg/kg

400 mg/kg

400 mg/kg

180 mg/kg

140 mg/kg

— Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and

120 mg/kg

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 reduction as referred to in

320 mg/kg

Directive 1996/8/EC

— Dietary foods for special medical purposes as defined in Directive 1999/21/EC

400 mg/kg

— Food supplements as defined in Directive 2002/46/EC supplied in a liquid form

240 mg/l

— Food supplements as defined in Directive 2002/46/EC supplied in a solid form

800 mg/kg

— Food supplements as defined in Directive 2002/46/EC, based on vitamins and/or

2 400 mg/kg

mineral elements and supplied in a syrup-type or chewable form

E 962

Salt of aspartame-
acesulfame1 (*)

Non-alcoholic drinks

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

350 mg/l (a)

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

350 mg/l (a)

added sugar

Desserts and similar products

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

350 mg/kg (a)

— Milk- and milk-derivative-based preparations, energy-reduced or with no added sugar

350 mg/kg (a)

— Fruit- and vegetable-based desserts, energy-reduced or with no added sugar

350 mg/kg (a)

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EC No

Name

Foodstuffs

Maximum usable dose

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

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

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

350 mg/kg (a)

350 mg/kg (a)

350 mg/kg (a)

— 'Snacks': certain flavours of ready to eat, prepacked, dry, savoury starch products and

500 mg/kg (b)

coated nuts

Confectionery

— Confectionery with no added sugar

500 mg/kg (a)

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

500 mg/kg (a)

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

1 000 mg/kg (a)

— Essoblaten

1 000 mg/kg (b)

— Cocoa-, milk-, dried-fruit or fat-based sandwich spreads, energy-reduced or with no

1 000 mg/kg (b)

added sugar

— Breakfast cereals with a fibre content of more than 15 %, and containing at least 20 %

1 000 mg/kg (b)

bran, energy-reduced or with no added sugar

— Breath-freshening micro-sweets with no added sugar

— Chewing gum with no added sugar

— Cider and perry

2 500 mg/kg (a)

2 000 mg/kg (a)

350 mg/l (a)

— Drinks consisting of a mixture of a non-alcoholic drink and beer, cider, perry, spirits or

350 mg/l (a)

wine

— Spirit drinks containing less than 15 % alcohol by volume

— Alcohol-free beer or with an alcohol content not exceeding 1,2 % vol

350 mg/l (a)

350 mg/l (a)

— 'Bière de table/Tafelbier/Table beer' (original wort content less than 6 %) except for

350 mg/l (a)

'Obergäriges Einfachbier'

— Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH

350 mg/l (a)

— Brown beers of the 'oud bruin' type

— Energy-reduced beer

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

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

— Energy-reduced jams, jellies and marmalades

— Energy-reduced fruit and vegetable preparations

— Sweet-sour preserves of fruit and vegetables

— Feinkostsalat

350 mg/l (a)

25 mg/l (b)

800 mg/kg (b)

350 mg/kg (a)

1 000 mg/kg (b)

350 mg/kg (a)

200 mg/kg (a)

350 mg/kg (b)

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Official Journal of the European Union

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EC No

Name

Foodstuffs

Maximum usable dose

— Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and

200 mg/kg (a)

molluscs

— Energy-reduced soups

— Sauces

— Mustard

— Fine bakery products for special nutritional uses

110 mg/l (b)

350 mg/kg (b)

350 mg/kg (b)

1 000 mg/kg (a)

— Foods intended for use in energy-restricted diets for weight reduction as referred to in

450 mg/kg (a)

Directive 1996/8/EC

— Dietary foods for special medical purposes as defined in Directive 1999/21/EC

— Food supplements as defined in Directive 2002/46/EC supplied in a liquid form

— Food supplements as defined in Directive 2002/46/EC supplied in a solid form

450 mg/kg (a)

350 mg/l (a)

500 mg/kg (a)

— Food supplements as defined in Directive 2002/46/EC, based on vitamins and/or

2 000 mg/kg (a)

mineral elements and supplied in a syrup-type or chewable form

(*) 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) espartame equivalents.’