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)

EXPLANATORY MEMORANDUM

The framework Directive 89/107/EEC on food additives provides for the adoption of specific directives to harmonise the use of different categories of additives in foodstuffs. Directive 94/35/EC on sweeteners for use in foodstuffs sets out a list of authorised sweeteners, the foodstuffs in which they may be used and their conditions of use. The Directive was adopted in June 1994 and first amended in 1996. It now needs to be adapted in the light of recent technical and scientific developments.

The major amendments proposed with this Directive are the following:

1. Authorisation of two new sweeteners; sucralose and the salt of aspartame and acesulfame

The framework and the criteria for the authorisation of new additives are set out in Council Directive 89/107/EEC. These criteria are in summary technological need, no hazard to the health of the consumer at the level of use proposed, no misleading of the consumer and benefit to the consumer.

1.1 Sucralose

Sucralose is a sweetener manufactured by controlled chlorination of sucrose and approximately 500-600 times sweeter than sugar. It is currently approved in several other countries world wide, including Canada, Australia, Japan and the United States of America.

The Scientific Committee on Food has assessed the data on the safety of sucralose and expressed its opinion in September 2000. The Committee concluded that sucralose is acceptable as a sweetener for general food use and set an Acceptable Daily Intake (ADI) of 0-15 mg / kg body weight.

Intense sweeteners have benefits for those consumers wishing to reduce their sugar or calorie intake and for people suffering from diabetes. Authorising an additional intense sweetener has the benefit of offering consumers and food industry the possibility to choose between a wider variety of sweeteners, thus reducing the intake of the single sweeteners.

The manufacturer claims the following specific additional benefits for sucralose when compared with other sweeteners currently authorised:

- Its flavour profile indicates that it is very similar to sugar, with less side or after tastes often associated with intense sweeteners

- It is stable during high temperature processing, such as baking and pasteurisation. This will enable the food industry to produce a wider range of calorie reduced products such as baked goods and cereals. It also means that the table-top sweetener can be used by consumers at home in cooking and baking

- It blends well with sugars. This enables the production of more light products with a reduced level of sugar

- It is stable during long term storage, resulting in economic benefits for consumers and food industry

Following the opinion of the Scientific Committee on Food and the establishing of the technological need, the industry has been consulted on the expected uses of sucralose. Based on the consultations with industry, a list with the food categories and maximum usable doses for sucralose has been drawn up. Intake estimations from the producer of sucralose and two Member States indicate that the ADI for sucralose would not be exceeded with these usable doses.

1.2 Salt of aspartame and acesulfame

The salt of aspartame and acesulfame is, as the name already indicates, a salt of two already authorised sweeteners, aspartame and acesulfame K. It is manufactured from these two substances by replacing the potassium ion of acesulfame K by aspartame.

The Scientific Committee on Food has assessed the data on the safety of the salt of aspartame and acesulfame and expressed its opinion in March 2000. The Committee regarded the use of the salt of aspartame and acesulfame acceptable as an additive considering that:

- the salt represents an alternative source of aspartame and acesulfame ions to the two already permitted sources (E 951 and E 950)

- potential exposure is the same with an equivalent blend of aspartame and acesulfame K

- the use of the substance raises no additional safety considerations

The manufacturer claims the following specific benefits for the salt of aspartame and acesulfame when compared with the blend of these two substances:

- The component sweeteners cannot separate and a fixed ratio is guaranteed. This leads to more consistent product quality

- The crystals dissolve more rapidly than blends of single sweeteners. Instant products such as desserts, toppings, powder beverage mixtures and table-top sweeteners thus perform better during reconstitution

- In contrast to the blend, the salt is not hygroscopic. Aspartame acesulfame salt is thus much easier to store and to use in manufacture. It eases product handling and poses less stringent demands on packaging

- The salt has semi-cubic crystals which can be produced easily. This means that free-flowing powder of controlled particle sizes - critical for powder mixing applications - can be made

- The salt disperses easily in difficult applications, such as sugar free candy, where a blend of sweeteners is difficult to employ. This results in superior product quality

- The salt surprisingly boosts the sweetness of chewing gum and gives it a very long-lasting quality without recourse to encapsulation of the sweetener, for example with polymer coatings

- The structure of the solid salt is such that molecular sites which play a role in aspartame breakdown are blocked by the adjacent acesulfame. The resulting increased stability means that the salt can be used directly in difficult applications, such as cinnamon-flavoured gum, where aspartame is unsuitable unless protected by encapsulation

- The potassium contained in acesulfame-K is eliminated when the salt of aspartame and acesulfame salt is made. The salt thus represents a more concentrated source of sweetness, and comprises two pure sweeteners together, without the functionless presence of potassium

The use of the aspartame acesulfame salt is consequently proposed for the food categories where both aspartame and acesulfame K are authorised. The usable doses for the salt are derived from the lower of the usable doses for the two constituent parts, aspartame and acesulfame K. The maximum usable doses for aspartame and acesulfame K shall however not be exceeded by their use in combination with the salt of aspartame and acesulfame.

2. Monitoring of authorised sweeteners, reduction of the intake of cyclamates

The framework Directive on food additives, Council Directive 89/107/EEC, stipulates that all authorised food additives must be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific information.

In line with this provision, the Scientific Committee on Food has re-evaluated the safety of cyclamic acid and its sodium and calcium salts in the light of new scientific information that has become available since the previous opinion. In the new opinion expressed in March 2000, the Committee has now established a new ADI of 0-7 mg / kg bodyweight for cyclamic acid and its sodium and calcium salts, expressed as cyclamic acid. Intake studies performed in four Member States on the basis of the former temporary ADI and reviewed by the Committee showed that also this new ADI would not be exceeded.

However, recent intake data submitted by Denmark suggest that the intake of cyclamates in children could exceed the ADI. Therefore, it is proposed to reduce the maximum usable dose for cyclamates by banning or reducing its use in certain food categories.

3. In addition, it is proposed to confer on the Commission the power to decide according to the procedure laid down in Article 7 of the Directive whether a substance is a sweetener within the meaning of this Directive. This would align Directive 94/35/EC to the other two specific Directives on food additives, Directive 94/36/EC on colours for use in foodstuffs and Directive 95/2/EC on food additives other than colours and sweeteners, where similar provisions are foreseen.

I SUBSIDIARITY IMPACT STATEMENT

1. What are the objectives of the proposed measure with regard to the Community's obligations-

Directive 89/107/EEC provides for the adoption of specific directives to harmonise the use of different categories of additives in foodstuffs. Directive 94/35/EC on sweeteners for use in foodstuffs was adopted on 30 June 1994. It now needs to be adapted in the light of recent technical and scientific developments.

2. Does competence for the proposed measure lie solely with the Community or is it shared with the Member States-

Competence for the proposed measure lies solely with the Community.

3. To what extent is this a problem on a Community scale-

Harmonisation of the use of food additives at Community level was a priority for completion of the internal market. The framework Directive 89/107/EEC on food additives was adopted on 21 December 1988 and the three specific directives (colours, sweeteners, miscellaneous) in 1994 and 1995. Since then, the instruments relating to the use of additives have been the same in the fifteen Member States. This structure ensures a high level of consumer protection, offers the consumer greater freedom of choice between different foodstuffs and guarantees the free movement of foodstuffs.

Directive 94/35/EC on sweeteners for use in foodstuffs is based on the principle of the positive list. A list of authorised sweeteners is set out in the Annex to the Directive with a list of the foodstuffs in which they may be used and the conditions of use. All sweeteners not included in the list are prohibited except for those new sweeteners that are temporarily authorised by Member States for a limited period of two years.

4. What is the most effective solution taking into account the means available to the Community and the Member States-

The use of food additives should be regulated uniformly in the European Community to ensure a high level of food safety and free trade in foodstuffs within the Community.

5. What practical additional benefit will the proposed measure provide and what would be the cost of failure to take action-

The Scientific Committee on Food has evaluated two new substances to be used as sweeteners. If the Commission proposes the use of these sweeteners, they can be authorised at Community level. If the Commission does not propose the use of these substances, they can not be used in the Community.

Furthermore, the proposal foresees the reduction of the usable dose for a sweetener, for which a new Acceptable Daily Intake (ADI) has now been set, that is lower than the previously established temporary ADI. This measure aims at ensuring that the ADI for this additive is not exceeded.

6. What form of action is open to the Community-

A new Directive adopted by the European Parliament and the Council under the procedure laid down in Article 95 is needed to amend Directive 94/35/EC.

7. Is it absolutely necessary to adopt uniform rules or would a Directive establishing general principles and leaving implementation to the Member States be sufficient-

The Commission proposal is based on the principle of complete harmonisation at Community level, as prescribed by the framework directive on food additives.

2002/0152 (COD)

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 [1],

[1] OJ C [...], [...], p. [...].

Having regard to the opinion of the Economic and Social Committee [2],

[2] 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 [3],

[3] 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 [4],

[4] OJ C [...], [...], p. [...].

Whereas:

(1) European Parliament and Council Directive 94/35/EC 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.

[5] 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 Scientific Committee on Food has now established a new Acceptable Daily Intake (ADI) for cyclamic acid and its sodium and calcium salts. The opinion of the Scientific Committee on Food, in conjunction with a rigorous interpretation of intake estimations, leads 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 [6] 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.

[6] 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 [7].

[7] 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. They 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 Communities.

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' the maximum usable dose of '400 mg/l' is replaced by '350 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>

IMPACT ASSESSMENT FORM THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE TO SMALL AND MEDIUM-SIZED ENTERPRISES (SMEs)

Title of proposal

Proposal for a Directive of the European Parliament and of the Council amending Directive 94/35/EC on sweeteners for use in foodstuffs

Document reference number

SANCO/2002/1404-02

The proposal

1. Taking account of the principle of subsidiarity, why is Community legislation necessary in this area and what are its main aims-

An amendment is proposed for the positive list of sweeteners as laid down in Directive 94/35/EC. This Directive was developed according to the provisions of the framework Directive on food additives, Council Directive 89/107/EEC, which request the Commission to make a proposal on all food additives and the food categories in which the approved food additives may be used together with their maximum usable doses.

European Parliament and Council Directive 94/35/EC on sweeteners for use in foodstuffs was adopted in June 1994. The previous amendment of the Directive was adopted in December 1996. Since then, development at technical and scientific level as well as in the manufacture of foodstuffs has progressed. Therefore, a need to amend Directive 94/35/EC exists.

It is therefore necessary to introduce a proposal for an amendment to the European Parliament and Council Directive 94/35/EC modifying the positive list of sweeteners.

The impact on business

2. Who will be affected by the proposal-

- which sectors of business

All sectors of the food industry using additives for the manufacture of foodstuffs are affected

- which sizes of business (what is the concentration of small and medium-sized firms)

The range of products that can be manufactured by SME as well as by larger enterprises will be widened

- are there particular geographical areas of the Community where these businesses are found

There is a homogenous geographic distribution

3. What will business have to do to comply with the proposal-

The use of certain sweeteners in certain foodstuffs will be authorised in a lower usable dose or not be authorised any more, the production will have to be adapted accordingly

4. What economic effects is the proposal likely to have-

- on employment

- on investment and the creation of new businesses

- on the competitiveness of businesses

There will be no effect on employment. There will be an increase in competitiveness, because of improved production efficiency

5. Does the proposal contain measures to take account of the specific situation of small and medium-sized firms (reduced or different requirements etc)-

The proposal does not provide special measures for SME. All enterprises are treated equally.

Consultation

6. List the organisations which have been consulted about the proposal and outline their main views.

Associated Commission services have been formally consulted.

The European Consumers' Organisation (BEUC), the Confederation of the food and drink industries of the EU (CIAA) and the International Sweeteners Association (ISA) have been consulted. No comments were received from BEUC. CIAA and ISA support largely the proposal.