COMMON POSITION (EC) No 55/96 adopted by the Council on 25 June 1996 with a view to adopting Directive 96/. . ./EC of the European Parliament and of the Council, of . . ., amending Directive 94/35/EC on sweeteners for use in foodstuffs (96/C 315/04)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee (1),

Acting in accordance with the procedure referred to in Article 189b of the Treaty (2),

Having regard to 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), and in particular Article 3 (2) thereof,

Whereas since the adoption of Directive 94/35/EC (4) there have been many technical developments in the field of sweeteners;

Whereas the Directive should be adapted to take account of these developments;

Whereas the Scientific Committee for Food set up by Commission Decision 95/273/EC (5) was consulted before the adoption of provisions liable to have an effect on public health,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

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

1. the following paragraph shall be added to Article 1:

'5. This Directive shall also apply to the corresponding foodstuffs intended for particular nutritional uses in accordance with Directive 89/398/EEC.` 2. Article 2 shall be amended as follows:

(a) paragraph 3 shall be replaced by the following:

'3. Sweeteners may not be used in food for infants and young children as referred to in Directive 89/398/EEC, including food for infants and young children who are not in good health, unless so laid down in specific provisions.` (b) the following paragraph shall be added:

'5. In the Annex quantum satis means that no maximum level is specified. However, sweeteners shall be used in accordance with good manufacturing practice, at a dose level not higher than is necessary to achieve the intended purpose and provided that they do not mislead the consumer.`.

3. The following Article shall be added:

'Article 2 (a) Without prejudice to other Community provisions, the presence of a sweetener in a foodstuff is permissible:

- in compound foodstuffs with no added sugar or energy-reduced, in compound dietary foodstuffs intended for a low-calorie diet and in compound foodstuffs with a long shelf-life, other than those mentioned in Article 2 (3), to the extent that the sweetener is permitted in one of the ingredients of the compound foodstuff,

or

- if the foodstuff is destined to be used solely in the preparation of a compound foodstuff which conforms to this Directive.`

4. The category 'Vitamins and dietary preparations` in the Annex shall be renamed 'Food supplements/diet integrators based on vitamins and/or mineral elements, syrup-type or chewable`.

5. The table in the Annex shall be supplemented by the table in the Annex to this Directive.

Article 2

Member States shall, where necessary, amend their laws, regulations and administrative provisions in order to:

- authorize trade in products not conforming to this Directive, by [. . .] (*) at the latest,

- prohibit trade in products not conforming to this Directive from [. . .] (**). 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.

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 reference on the occasion of their official publication. The methods for making such reference shall be laid down by Member States.

Article 3

This Directive shall enter into force on the seventh 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 . . .

For the European Parliament The President For the Council The President

(1) OJ No C 174, 17. 6. 1996, p. 1.

(2) Opinion of the European Parliament of 12 March 1996 (OJ No C 96, 1. 4. 1996, p. 24), Council common position of 25 June 1996 (not yet published in the Official Journal) and Decision of the European Parliament of . . . (not yet published in the Official Journal).

(3) OJ No L 40, 11. 2. 1989, p. 27. Directive as last amended by Directive 94/34/EC (OJ No L 237, 10. 9. 1994, p. 1).

(4) OJ No L 237, 10. 9. 1994, p. 3.

(5) OJ No L 167, 18. 7. 1995, p. 22.

(*) 12 months after the date of adoption of this Directive.

(**) 18 months after the date of adoption of this Directive.

ANNEX

Note:

1. For the substance E 952, cyclamic acid and its Na and Ca salts, maximum usable doses are expressed in free acid.

2. For the substance E 954, saccharin and its Na, K and Ca salts, maximum usable doses are expressed in free imide.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 20 October 1995 the Commission submitted a proposal for a Directive, based on Article 100a of the EC Treaty, on sweeteners for use in foodstuffs.

2. The European Parliament, the Economic and Social Committee and the Committee of the Regions delivered their opinions on 12 March 1996 (1) and 27 March 1996 (2) respectively. The European Parliament approved the Commission proposal with no amendments.

3. The Council adopted its common position in accordance with Article 189b of the Treaty on 25 June 1996.

II. OBJECTIVE

Directive 94/35/EC was adopted on 21 June 1994. It has its origins in Directive 89/107/EEC providing for the adoption of specific directives to harmonize the use of various categories of additives in foodstuffs. The objective of the proposal is to adapt Directive 94/35/EC to technical and scientific developments.

III. ANALYSIS OF THE COMMON POSITION

1. Generally speaking, the common position corresponds to the Commission proposal. However, the Council has recast the text so as to achieve concordance between the Directive on sweeteners and the Directives on the other additives and also to take into account technical and scientific developments in the European Community.

All the amendments to the proposal were accepted by the Commission.

2. The Council has broadened the scope of the Directive to include foodstuffs intended for particular nutritional uses in accordance with Directive 89/398/EEC (Article 1 (5)).

3. Nevertheless, taking into account the need to protect infants and young children as referred to in Directive 89/398/EEC, the Council has stipulated that sweeteners may not be used in food intended for these groups of persons (Article 2 (3)).

4. As regards compound foodstuffs in which the presence of a sweetener is permissible (Article 2 (a)), the Council has emphasized that this provision would apply without prejudice to other Community provisions. In order to reduce as far as possible the use of sweeteners in the products concerned, the Council has also restricted the scope of the provision by stipulating that the presence of a sweetener is permissible only in:

- compound foodstuffs with no added sugar or energy-reduced,

- compound dietary foodstuffs intended for a low-calorie diet,

- compound foodstuffs with a long shelf-life.

5. In the case of the additives acesulfame K (E 950), aspartame (E 951), saccharin and its Na, K and Ca salts (E 954) and neohesperidine DC (E 959), the Council has stipulated that breakfast cereals must have a fibre content of more than 15 % and contain at least 20 % bran. The Council has included some clarification, bearing in mind production methods and the desire to reduce the significance of certain categories of foodstuffs, and has amended the definitions of the terms 'energy-reduced beer`, 'cornets and wafers with no added sugar for ice-cream` and 'Feinkostsalat`.

The Council has added to the list 'spirit drinks containing less than 15 % alcohol by volume`. This product has existed on the market for a long time.

Finally, the Council has not included 'energy-reduced fruit wine` drinks as these drinks are not produced within the European Union.

6. Concerning acesulfame (E 950), the Council added to the list 'energy-reduced tablet-form confectionery`. This product has existed on the market for a long time.

7. With regard to the additive 'aspartame` (E 951), the Council added the phrase 'strongly flavoured freshening throat pastilles with no added sugar`. This product has existed on the European Union market for a long time.

8. As regards the additive 'cyclamic acid and its Na and Ca salts` (E 952), the Council preferred to reduce its use to three categories of foodstuffs. At the same time, the Council decided to reduce the usable doses for these three categories.

9. Finally, as regards the additive 'neohesperidine DC`, the Council wanted to lay down the same rules for the use of this additive as for other similar additives, and accordingly added the following foodstuffs:

- spirit drinks containing less than 15 % alcohol by volume,

- cornets and wafers with no added sugar for ice-cream,

- energy-reduced beer,

- complete formulae and nutritional supplements for use under medical supervision,

- snacks: certain flavours of ready-to-eat, prepacked, dry, savoury starch products and coated nuts.

10. On the whole, the Council took into account the main thrust of the proposal approved by the European Parliament and clarified the text in order to take account of present and future production, and considers that it has reached a balanced compromise.

(1) OJ No C 96, 1. 4. 1996, p. 24.

(2) OJ No C 174, 17. 6. 1996, p. 1.