COMMON POSITION (EC) No 52/96 adopted by the Council on 18 June 1996 with a view to adopting Directive 96/. . ./EC of the European Parliament and of the Council, of . . ., amending Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (96/C 315/01)

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 (1),

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

Acting in accordance with the procedure referred to in Article 189b of the Treaty (3),

Whereas Article 4 of Council Directive 89/398/EEC (4) provides that specific provisions applicable to the groups of foodstuffs appearing in Annex I thereto must be laid down by means of specific Commission directives;

Whereas a modus vivendi was concluded on 20 December 1994 between the European Parliament, the Council and the Commission on the measures for implementing acts adopted in accordance with the procedure referred to in Article 189b of the EC Treaty (5);

Whereas the specific directives reflect the state of knowledge at the time of their adoption; whereas, therefore, any amendment to include innovations based on scientific and technical progress must, after consultation of the Scientific Committee for Food set up by Decision 95/273/EC (6), be approved in accordance with the procedure laid down in Article 13 of Directive 89/398/EEC;

Whereas a procedure must be laid down which allows the foods resulting from these technological innovations to be placed on the market on a temporary basis in order that proper benefit may be derived from the fruits of industry research pending the amendment of the specific directive concerned;

Whereas, however, on the grounds of consumer health protection, marketing authorization may be granted only after consultation of the Scientific Committee for Food;

Whereas authorization may be granted only if the product poses no danger to human health,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

In Article 4 of Directive 89/398/EEC, the following paragraph shall be added:

'1a. To enable foodstuffs intended for particular nutritional uses and resulting from scientific and technological progress to be placed on the market rapidly, the Commission may, after consulting the Scientific Committee for Food and in accordance with the procedure laid down in Article 13, authorize, for a two-year period, the placing on the market of food which does not comply with the rules as to composition laid down by the specific directives referred to in Annex I.

If necessary, the Commission may add in the authorization decision labelling rules relating to the change in composition.`.

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof.

When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Article 3

This Directive shall enter into force on the 20th 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 389, 31. 12. 1994, p. 27.

(2) OJ No C 256, 2. 10. 1995, p. 1.

(3) Opinion of the European Parliament of 11 October 1995 (OJ No C 287, 30. 10. 1995, p. 109). Council common position of 18 June 1996 (not yet published in the Official Journal) and Decision of the European Parliament of . . . (not yet published in the Official Journal).

(4) OJ No L 186, 30. 6. 1989, p. 27.

(5) OJ No C 102, 4. 4. 1996, p. 1.

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

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 20 December 1994 the Commission submitted a proposal for a Directive (1) based on Article 100a of the EC Treaty on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses.

2. The European Parliament and the Economic and Social Committee delivered their opinions on 11 October 1995 (2) and 5 July 1995 (3) respectively.

3. In the light of the opinion of the European Parliament, the Commission submitted an amended proposal on 5 December 1995 (4).

4. On 18 June 1996, the Council adopted its common position in accordance with Article 189b of the Treaty.

II. AIM

The proposal envisages a special procedure making it possible to issue temporary authorizations (for a two-year period) for the placing on the market of foodstuffs intended for dieting purposes which result from research. The introduction of such temporary authorizations will represent an advantage for the industry compared with the procedures in force, which are regarded as too cumbersome for the rapid marketing of a product resulting from technological innovations.

III. ANALYSIS OF THE COMMON POSITION

1. The European Parliament suggested four amendments, namely:

- a reference in the Directive amending Directive 89/398/EEC to the Agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning measures implementing acts (amendment 1),

- a new recital in Directive 89/398/EEC referring to the modus vivendi (amendment 7),

- the introduction of the type-IIIa committee procedure for granting temporary authorizations (amendments 5 and 6).

2. The Commission did not reproduce amendment 1 in its amended proposal. However, the Council, departing from the Commission's position, reproduced amendments 1, 5 and 6 in its common position, adopted unanimously.

3. In general, the Council's common position takes account, to a very considerable degree, of the European Parliament amendments. In some instances, though, the Council made drafting clarifications in line with the European Parliament's general approach.

4. For legal reasons the Council was unable to incorporate amendment 7, as Directive 89/398/EEC pre-dates the adoption of the Treaty on European Union.

5. The Council considers that on the whole, having incorporated three out of four European Parliament amendments, it has struck a balanced compromise enabling the rapid marketing of products resulting from technological innovations.

(1) OJ No C 389, 31. 12. 1994, p. 27.

(2) OJ No C 287, 30. 10. 1995, p. 108.

(3) OJ No C 256, 2. 10. 1995, p. 1.

(4) OJ No C 41, 13. 2. 1996, p. 13.