COMMON POSITION (EC) No 34/97 adopted by the Council on 22 July 1997 with a view to adopting Directive 97/. . ./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 (97/C 297/01)

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 laid down in Article 189b of the Treaty (3),

Whereas Article 4 of Directive 89/398/EEC (4) provides that specific provisions applicable to the groups of foods appearing in Annex I thereto are to be laid down by means of specific Directives;

Whereas to date specific directives have been adopted for infant formulae and follow-on formulae (5), for processed cereal-based foods and baby foods intended for infants and young children (6) and for foods intended for use in energy-restricted diets for weight reduction (7); whereas there are reasons relating to public health for adopting specific provisions, in accordance with Article 4 of Directive 89/398/EEC, for dietary foods for special medical purposes and foods intended to meet the expenditure of intense muscular effort, especially for sportsmen, as referred to in Annex I to that Directive;

Whereas, in the case of the groups of low-sodium foods, including low-sodium or sodium-free dietary salts, and gluten-free foods, such products can be satisfactorily placed on the market and be efficiently monitored officially under the general provisions of Directive 89/398/EEC, provided that the conditions for the use of certain terms used to indicate the particular nutritional properties of products are defined;

Whereas the deletion of those categories from Annex I to Directive 89/398/EEC would be in line with the efforts being made to avoid unnecessarily detailed legislation;

Whereas it is not clear whether an adequate basis exists for specific provisions to be adopted for the group mentioned in point 9 of Annex I to Directive 89/398/EEC, namely the group of foods intended for persons suffering from carbohydrate-metabolism disorders (diabetes);

Whereas therefore advice should be obtained from, inter alia, the Scientific Committee for Food before a final decision is taken on the question;

Whereas it is still possible to harmonize at Community level rules applicable to other groups of foodstuffs for particular nutritional uses, in the interest of consumer protection and the free movement of such foodstuffs,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 89/398/EEC is hereby amended as follows:

1. The following Articles shall be inserted:

'Article 4a

Rules for the use of terms concerning

- the reduction or absence of sodium or salt (sodium chloride, table salt) content,

- the absence of gluten,

- which may be used to describe the products referred to in Article 1, shall be adopted in accordance with the procedure laid down in Article 13.

Article 4b

Before . . . (*), the Commission shall, after consulting the Scientific Committee for Food, present to the European Parliament and to the Council a report on the desirability of special provisions for foods for persons suffering from carbohydrate-metabolism disorders (diabetes).

In the light of the conclusions of this report, the Commission shall either, in accordance with the procedure laid down in Article 13, proceed with the preparation of the special provisions concerned or shall present, in accordance with the procedure laid down in Article 100a of the Treaty, any appropriate proposals for amendments of this Directive.

(*) Three years after the date of publication of this Directive in the Official Journal of the European Communities.`

2. Article 9 (5) shall be replaced by the following:

'5. Before . . . (*) and every three years thereafter, the Commission shall send the European Parliament and the Council a report on the implementation of this Article.

(*) Three years after the date of publication of this Directive in the Official Journal of the European Communities.`

3. Annex I shall be replaced by the following:

'ANNEX I

- Groups of foodstuffs for particular nutritional uses for which specific provisions will be laid down by specific directives (1):

1. Infant formulae and follow-on formulae

2. Processed cereal-based foods and baby foods for infants and young children

3. Food intended for use in energy-restricted diets for weight reduction

4. Dietary foods for special medical purposes

5. Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen,

- Groups of foodstuffs for particular nutritional uses for which specific provisions will be laid down by a specific directive (1), dependant on the outcome of the procedure described in Article 4b:

6. Foods for persons suffering from carbohydrate-metabolism disorders (diabetes).

(1) It is understood that products already on the market when the directive is adopted will not be affected by it.`

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive not later than . . . (8**). They shall forthwith inform the Commission thereof.

These measures shall be applied in such a way as to:

- permit trade in products complying with this Directive by . . . (9**);

- prohibit trade in products not complying with this Directive by . . . (10***).

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 of making such a reference shall be laid down by the Member States.

Article 3

This Directive shall enter into force on the day 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 C 108, 16. 4. 1994, p. 17 and OJ C 35, 8. 2. 1996, p. 17.

(2) OJ C 388, 31. 12. 1994, p. 1.

(3) Opinion of the European Parliament of 11 October 1995 (OJ C 287, 30. 10. 1995, p. 108), Council common position of 22 July 1997 and Decision of the European Parliament of . . . (not yet published in the Official Journal).

(4) OJ L 186, 30. 6. 1989, p. 27. Directive as last amended by Directive 96/84/EC (OJ L 48, 19. 2. 1997, p. 20).

(5) Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae (OJ L 175, 4. 7. 1991, p. 35). Directive as amended by Directive 96/4/EC (OJ L 49, 28. 2. 1996, p. 12).

(6) Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (OJ L 49, 28. 2. 1996, p. 17).

(7) Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (OJ L 55, 6. 3. 1996, p. 22).

(8**) 12 months after the date of publication of this Directive in the Official Journal of the European Communities.

(9***) 18 months after the date of publication of this Directive in the Official Journal of the European Communities.

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 6 April 1994 (1) the Commission submitted a proposal for a Directive 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 6 July 1994 (3) respectively.

3. On 29 January 1996 (4) the Commission forwarded to the Council its amended proposal.

4. On 22 July 1997, the Council adopted its common position in accordance with Article 189b of the Treaty.

II. OBJECTIVE

In view of the Presidency's conclusions following the European Council in Edinburgh on 11 and 12 December 1992, calling for simplification of certain Directives considered too detailed, and in the light of experience acquired since the adoption of the Directive, the Commission essentially proposed in its amended proposal to limit to five the number of categories for which specific directives relating to foodstuffs intended for particular nutritional uses must be adopted; in addition, it laid down conditions governing the use of certain terms used to indicate a particular nutritional property.

III. ANALYSIS OF THE COMMON POSITION

1. The Council has been examining this proposal for three years and, generally speaking, the text has been revised extensively during the proceedings.

The Council, departing from the Commission's position, reached its common position by taking account, on several points, of suggestions made and concerns expressed by the European Parliament.

2. Thus, the Council adopted amendment 4 (new recital) stipulating that the aim of harmonizing national provisions is, on the one hand, to protect the consumer and, on the other, to ensure free movement (this amendment was also adopted by the Commission).

3. With regard to amendments 15 and 16 (Annex I), the Council adopted only four categories of foodstuffs, as follows:

- infant formulae and follow-on formulae,

- cereal-based foods and baby foods,

- food intended for weight control diets,

- dietary foods for medical purposes.

4. The Council was consequently unable to adopt amendment 18 (adopted in part by the Commission) and the unnumbered amendment (not accepted by the Commission) concerning the following two categories of foodstuffs:

- foodstuffs for persons suffering from carbohydrate metabolism disorders (diabetes),

- gluten-free foods.

With regard to the category of foods intended for diabetics (accepted by the Commission), the Council largely took account of the European Parliament's concern by asking the Commission to submit to the European Parliament and to the Council, after consultation of the Scientific Committee for Food, a report on the desirability of laying down specific provisions for foods intended for diabetics.

In the light of the conclusions of that report, the Commission may either propose to the European Parliament and to the Council that the category be deleted from the Annex or that, in accordance with a regulatory procedure, a specific directive be adopted.

Having taken account of the objective of simplifying Community legislation, the Council did not adopt the category of gluten-free foods (this section was not adopted by the Commission). However, the Council took into consideration some of the European Parliament's wishes by laying down specific provisions on labelling (Article 4a) for gluten-free foodstuffs and low-sodium foods (amendment 17, accepted in principle by both the Commission and, in part, the Council).

5. However, the Council, taking account of the consumer protection aspect, added a category relating to foods intended to meet the expenditure of intense muscular effort, especially for sportsmen.

6. The Council was able in principle to accept the content of those amendments relating to the use of no harmful substances in foodstuffs intended for young children (amendments 9, 10 and 15/16 in part). Since pesticide residues in foodstuffs have already been regulated by specific provisions, the Council does not feel it appropriate to incorporate such references into this Directive (these amendments were not adopted by the Commission).

7. Although the Council has accepted in principle the amendment referring to the 'modus vivendi` concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty (amendment 1), it thought it superfluous to include it in the text (the Commission accepted this amendment).

8. As regards the new Article 4, which stipulates that new categories of foodstuffs intended for particular nutritional uses may be added to Annex I (amendment 5), the Council finds this amendment inappropriate since the Commission already has this possibility. Furthermore, it should be noted that the addition of new categories would not comply with the European Council's declared intention to simplify legislation in this field (the Commission did not adopt this amendment).

9. With regard to the addition of a new Annex Ia relating to allowed claims (amendment 6), the Council considers that this should, if necessary, be incorporated into more appropriate legislation (the amendment was not adopted by the Commission).

10. On the whole, having adopted several of the European Parliament's amendments and taken account of other concerns of the Parliament, the Council considers that it has found a balanced solution.

(1) OJ C 108, 16. 4. 1994, p. 17.

(2) OJ C 287, 30. 10. 1995, p. 104.

(3) OJ C 388, 31. 12. 1994, p. 1.

(4) OJ C 35, 8. 2. 1996, p. 17.