Explanatory Memorandum to COM(2002)375 - Amendment of Directive 94/35/EC on sweeteners for use in foodstuffs - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2002)375 - Amendment of Directive 94/35/EC on sweeteners for use in foodstuffs. |
|---|---|
| source | COM(2002)375  |
| date | 11-07-2002 |
The major amendments proposed with this Directive are the following:
Contents
- 1. Authorisation of two new sweeteners; sucralose and the salt of aspartame and acesulfame
- 1.1 Sucralose
- 1.2 Salt of aspartame and acesulfame
- 2. Monitoring of authorised sweeteners, reduction of the intake of cyclamates
- I SUBSIDIARITY IMPACT STATEMENT
- 1. What are the objectives of the proposed measure with regard to the Community's obligations-
- 2. Does competence for the proposed measure lie solely with the Community or is it shared with the Member States-
- 3. To what extent is this a problem on a Community scale-
- 4. What is the most effective solution taking into account the means available to the Community and the Member States-
- 5. What practical additional benefit will the proposed measure provide and what would be the cost of failure to take action-
- 6. What form of action is open to the Community-
- 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 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.
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.
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.
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.
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.
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.
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.