Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 94/35/EC on sweeteners for use in foodstuffs (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

EXPLANATORY MEMORANDUM

1. Procedure

On 11 July 2002, the Commission adopted a proposal for a European Parliament and Council Directive amending Directive 94/35/EC on sweeteners for use in foodstuffs [1]. The proposal was sent to the European Parliament and Council on the same day. The Economic and Social Committee issued its opinion supporting the Commission proposal on 11 December 2002.

[1] COM(2002) 375 final, 11 July 2002.

On 10 April 2003, the European Parliament has in first reading given a favourable opinion on the proposal. The Parliament adopted 8 amendments, 2 of which were accepted by the Commission.

2. Objective of the Commission proposal

The Commission proposal aims at adapting Directive 94/35/EC on sweeteners for use in foodstuffs to recent technical and scientific developments. To this end it foresees:

- To authorise two new sweeteners, sucralose and the salt of aspartame and acesulfame, after favourable opinions by the Scientific Committee on Food.

- To reduce the intake of an already authorised sweetener, cyclamate, following an opinion of the SCF lowering the ADI (Acceptable Daily Intake) for this substance. Since soft drinks contribute to a large extent to the intake of sweeteners, and there are indications that the ADI could be exceeded, the Commission proposed a reduction of the maximum permitted use dose of cyclamates in soft drinks from 400 to 350 mg/l.

- To confer on the Commission the power to decide whether a substance should be considered as a sweetener according to the Directive.

- To clarify the meaning of the food category 'fine bakery wares for special nutritional uses' that is not interpreted in a homogeneous manner by Member States.

3. Commission opinion on the amendments adopted by the European Parliament

In total, the European Parliament adopted 8 amendments to the Commission proposal. Out of these 8 amendments, 2 can be accepted by the Commission without changes: Amendment 1 concerning the recital number 3 on cyclamates and amendment 6 concerning article 2 on the transposition of the Directive. The Commission refuses amendments 2, 3, 4, 5, 12rev and 13 (merged) and 9.

The Commission had agreed to an amendment of the Parliament tabled for the Plenary requesting to reduce the maximum permitted dose of cyclamates for soft drinks to 250 mg/l and to extend this reduction to milk and juice based drinks. This amendment fell when amendment 9 requesting a value of 100 mg/l for these food categories was adopted by Parliament. In line with its position expressed in the Plenary, the Commission now proposes to reduce the dose of cyclamates to 250 mg/l in soft drinks and to extend this reduction to milk and juice based drinks.

4. Conclusion

Having regard to Article 250 paragraph 2 of the EC Treaty, the Commission modifies its proposal as follows.

2002/0152 (COD)

Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 94/35/EC on sweeteners for use in foodstuffs

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 [2],

[2] OJ C ..., ..., p. ...

Having regard to the opinion of the European Economic and Social Committee [3],

[3] OJ C ..., ..., p. ...

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 laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption [4],

[4] OJ L 40, 11.2.1989, p. 27. Directive as amended by European Parliament and Council Directive 94/34/EC (OJ L 237, 10.9.1994, p. 1).

Acting in accordance with the procedure laid down in Article 251 of the Treaty [5],

[5] OJ C ..., ..., p. ...

Whereas:

(1) European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs [6] lays down a list of sweeteners that may be used in the Community and their conditions of use.

[6] OJ L 237, 10.9.1994, p. 3. Directive as amended by European Parliament and Council Directive 96/83/EC (OJ L 48, 19.2.1997, p. 16).

(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.

(3) The opinion of the Scientific Committee on Food concerning the Acceptable Daily Intake (ADI) for cyclamic acid and its sodium and calcium salts and recent studies on the intake of cyclamate lead to a reduction of the maximum usable doses of cyclamic acid and its sodium and calcium salts.

(4) The food additives concerned comply with the general criteria laid down in Annex II to Directive 89/107/EEC.

(5) It is desirable that when a decision is taken on whether a particular substance is a sweetener, the consultation of the Standing Committee on the Food Chain and Animal Health procedure is followed.

(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 of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [7] 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] OJ L 31, 1.2.2002, p. 1.

(7) The provisions of Directive 94/35/EC should be adapted to take account of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [8].

[8] OJ L 184, 17.7.1999, p. 23.

(8) Directive 94/35/EC should therefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 94/35/EC is amended as follows:

(1) Article 4 is replaced by the following:

"Article 4

1. It may be decided in accordance with the procedure referred to in Article 7(2) whether a substance is a sweetener within the meaning of Article 1(2).

2. Where there are differences of opinion as to whether sweeteners can be used in a given foodstuff under the terms of this Directive, it may be decided in accordance with the procedure referred to in Article 7 (2) whether that foodstuff is to be considered as belonging to one of the categories listed in the third column of the Annex."

(2) Article 7 is replaced by the following:

"Article 7

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 (1) of Regulation (EC) No 178/2002 (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 three months.

3. The Committee shall adopt its rules of procedure."

(3) The Annex is 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 by [...] at the latest. The purpose of those laws, regulations and administrative provisions shall be to:

- authorise, by ... [9] at the latest, the marketing and the use of products which comply with this Directive;

[9] Twelve months from the date of entry into force of this Directive

- ban, by ... * at the latest, the marketing and the use of products which do not comply with this Directive

Member States shall forthwith inform the Commission thereof.

When Member States adopt those provisions, they shall contain a reference to this Directive or 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 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX

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

(1) The category 'fine bakery products for special nutritional uses' shall be renamed 'fine bakery products, energy-reduced or with no added sugar';

(2) For E 951 aspartame the following category is added:

'- Cornets and wafers, for ice cream, with no added sugar // 1000 mg/kg'

(3) For E 952 cyclamic acid and its sodium and calcium salts:

(a) for the category 'water-based flavoured drinks, energy-reduced or with no added sugar' and 'milk- and milk-derivative-based or fruit-juice-based drinks, energy-reduced or with no added sugar' the maximum usable dose of '400 mg/l' is replaced by ' 250 mg/l';

(b) the following categories and maximum usable doses are 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 // 1500 mg/kg

- Breath-freshening micro-sweets, with no added sugar // 2500 mg/kg

- Edible ices, energy-reduced or with no added sugar // 250 mg/kg'

(4) The following tables are added:

>TABLE POSITION>