COMMON POSITION (EC) No 6/96

adopted by the Council on 22 December 1995

with a view to adopting Regulation (EC) No . . ./96 of the European Parliament and of the Council laying down a Community procedure for flavouring substances used or intended for use in foodstuffs

(96/C 59/03)

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),

Having consulted the Scientific Committee for Food,

Acting in accordance with the procedure laid down in Article 189b of the Treaty (3),

Whereas Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (4) provides for the adoption by the Council of the appropriate provisions concerning flavouring substances;

Whereas the appropriate provisions apply without prejudice to the general framework established by Directive 88/388/EEC;

Whereas differences between national laws relating to flavourings hinder the free movement of foodstuffs; whereas they may create conditions of unequal competition, thereby directly affecting the establishment or functioning of the internal market;

Whereas national laws relating to flavourings for use in foodstuffs should take account primarily of human health requirements but also, as far as health protection allows, of economic and technical needs;

Whereas, in order to achieve the free movement of foodstuffs, the approximation of those laws is necessary;

Whereas, the Community measures envisaged by this Regulation are not only necessary but also indispensable for the attainment of the stated objectives; whereas these objectives cannot be achieved by Member States individually;

Whereas it is necessary to establish general criteria for the use of flavouring substances;

Whereas, on the basis of the most recent scientific advice, it is necessary to lay down a list of flavouring substances which may be used in foodstuffs;

Whereas this list must be open-ended and capable of being amended in the light of scientific and technical developments;

Whereas it may be necessary for health reasons to adopt conditions of use for certain flavouring substances;

Whereas flavouring substances which are actually used in the Member States and the use of which cannot be challenged by any of the latter pursuant to the general rules of the Treaty should initially be listed in a register; whereas such registration does not come under Article 7 of Directive 88/388/EEC and does not, therefore, call for the intervention of the Scientific Committee for Food at this stage;

Whereas, however, a safeguard clause must enable a Member State to take the necessary measures where a flavouring substance is likely to constitute a danger of public health;

Whereas, in keeping with Article 214 of the Treaty, it is necessary to protect intellectual property linked to the development and production of flavouring substances,

HAVE ADOPTED THIS REGULATION:

Article 1

1. This Regulation lays down the procedure for the establishment of rules in respect of the flavouring substances referred to in the third, fourth, fifth and sixth indents of Article 5 (1) of Directive 88/388/EEC. This Regulation shall apply without prejudice to the other provisions of Directive 88/388/EEC.

2. This Regulation shall apply to flavouring substances used or intended for use in or on foodstuffs to impart odour and/or taste, as defined in Article 1 (2) (b) of Directive 88/388/EEC.

3. This Regulation shall apply without prejudice to specific directives permitting flavouring substances covered by this Regulation to be used for purposes other than those mentioned in Article 1 (2).

Article 2

1. The flavouring substances shall comply with the general use criteria referred to in the Annex.

2. A list of flavouring substances the use of which is authorized to the exclusion of all others shall be drawn up in accordance with Articles 3, 4 and 5.

Article 3

1. Within a period of one year of the entry into force of this Regulation, the Member States shall notify to the Commission a list of the flavouring substances which may, in accordance with Directive 88/388/EEC, be used in foodstuffs marketed on their territory. Such notification shall contain any useful information regarding:

(a) the nature of such flavouring substances, such as the chemical formula, the CAS number, the EINECS number, the IUPAC nomenclature, their origin and, if necessary, the conditions for their use;

(b) the foodstuffs in which such flavouring substances are chiefly used;

(c) compliance with the criteria, and the reasons for those criteria, provided for in Article 4 of Directive 88/388/EEC, at the level of each Member State.

2. On the basis of the notification provided for in paragraph 1, and following Commission scrutiny of the notification, in the light of subparagraph (c), flavouring substances the legal use of which in one Member State must be recognized by the other Member States shall be entered in a register which shall be adopted in accordance with the procedure laid down in Article 7 within a year of the end of the notification period provided for in paragraph 1. If necessary, this register may comprise conditions of use.

3. If, on the basis of a detailed notification and in the light of fresh data or a re-evaluation of existing data since the establishment of the register referred to in paragraph 2, a Member State notes that a flavouring substance may constitute a danger to public health, it may suspend or restrict the use of such substance on its territory. It shall immediately inform the Commission and the other Member States thereof, stating the reasons for its decision.

The Commission shall examine as soon as possible the reasons invoked by the Member State concerned and shall consult the Standing Committee on Foodstuffs set up by Decision 69/414/EEC (1). The Commission shall then deliver its opinion.

If the Commission considers that amendments to the register of flavouring substances are necessary to ensure protection of human health, it shall initiate the procedure provided for in Article 7 with a view to adopting such amendments. The State which adopted the safeguard measures may maintain them until the entry into force of such amendments.

Article 4

1. In order to check whether the flavouring substances contained in the register referred to in Article 3 comply with the general use criteria given in the Annex, a programme for the evaluation of these flavouring substances shall be adopted in accordance with the procedure laid down in Article 7 within 10 months of the register being adopted.

This programme shall define in particular:

- the order of priorities according to which the flavouring substances are to be examined, taking into account their uses,

- the time limits,

- the flavouring substances which are to be the subject of scientific cooperation.

2. The persons responsible for placing the flavouring substances on the market shall forward the data necessary for the evaluation to the Commission, if necessary at the latter's request.

3. If it is apparent, following the evaluation, that a flavouring substance does not comply with the general use criteria given in the Annex, that substance shall be deleted from the register in accordance with the procedure laid down in Article 7.

Article 5

1. After completion of the evaluation programme provided for in Article 4, the list of flavouring substances referred to in Article 2 (2) shall be adopted in accordance with the procedure laid down in Article 8 within five years of adoption of the evaluation programme provided for in Article 4.

2. The use of a new flavouring substance not included in the register provided for in Article 3 (2) may be authorized in accordance with the procedure laid down in Article 7. To that end, it shall first be included in this programme in accordance with the procedure laid down in Article 7. It shall be evaluated on the basis of the place allocated to it in the evaluation programme referred to in Article 4 (1).

Article 6

1. This Regulation shall apply without prejudice to the Community provisions authorizing the use, in certain foodstuffs, of certain categories of flavouring substances as defined in Article 1 of Directive 88/388/EEC.

2. However, flavouring substances of these categories must conform with the general use criteria set out in the Annex.

Article 7

1. The Commission shall be assisted by the Standing Committee on Foodstuffs.

2. Matters shall be referred to the Committee by its Chairman either on his own initiative or at the request of the representative of a Member State.

3. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

The Commission shall adopt the intended measures where they are in accordance with the opinion of the Committee.

If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

If the Council has not acted within three months of referral to it, the proposed measures shall be adopted by the Commission.

Article 8

In the case referred to in Article 5 (1), the procedure referred to in Article 7 shall apply, it being understood that if the Council has not acted within three months of referral to it, the proposed measures shall be adopted by the Commission save where the Council has decided against the said measures by a simple majority.

Article 9

Member States may not prohibit, restrict or obstruct the marketing or the use in foodstuffs of flavouring substances if these comply with the provisions of this Regulation.

Article 10

The provisions intended to align existing Community acts on this Regulation shall be adopted in accordance with the procedure laid down in Article 7.

Article 11

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at . . .

For the European Parliament

The President

For the Council

The President

(1) OJ No C 1, 4. 1. 1994, p. 22.

(2) OJ No C 195, 18. 7. 1994, p. 4.

(3) Opinion of the European Parliament of 5 May 1994 (OJ No C 205, 25. 7. 1994, p. 398), Council common position of . . . (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 184, 15. 7. 1988, p. 61. Directive as amended by Directive 91/171/EEC (OJ No L 42, 15. 2. 1991, p. 25).

(1) OJ No L 291, 19. 11. 1969, p. 9.

ANNEX

GENERAL CRITERIA FOR THE USE OF FLAVOURING SUBSTANCES REFERRED TO IN ARTICLE 2 (1)

1. The use of flavouring substances may be authorized provided that:

- they present no risk to the health of the consumer, in accordance with the scientific assessment provided for in Article 7 of Directive 88/388/EEC,

- their use does not mislead the consumer.

2. To assess the possible harmful effects of a flavouring substance, the latter must be subjected to appropriate toxicological evaluation. When a flavouring substance contains or consists of a genetically modified organism within the meaning of Article 2 (1) and (2) of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (1), Articles 11 to 18 will not be applicable. However, the evaluation of the safety of this flavouring substance must take into account environmental safety as provided for in the said Directive.

3. All flavouring substances must be kept under constant supervision and must be re-evaluated whenever necessary.

(1) OJ No L 117, 8. 5. 1990, p. 15. Directive as last amended by Directive 94/15/EC (OJ No L 103, 22. 4. 1994, p. 20).

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 1 December 1993, the Commission submitted a proposal based on Article 100a of the EC Treaty (1) relating to a Community procedure for flavouring substances used in foodstuffs.

2. Following the European Parliament's opinion, delivered on 5 May 1994 (2), the Commission (3) submitted an amended proposal.

3. The Economic and Social Committee delivered its opinion on 27 April 1994 (4).

4. On 22 December 1995, the Council adopted a common position on the amended proposal in accordance with the procedure laid down in Article 189b of the Treaty.

II. AIM

5. In order to deal with the situation created by completion of the internal market, the proposal aims to establish a common positive list of flavouring substances used in foodstuffs and to lay down evaluation criteria and procedures for the establishment of such a list.

The proposal is an important step at Community level in terms of progress in the agri-foodstuffs sector, the proper functioning of the internal market, and consumer protection.

III. ANALYSIS OF THE COMMON POSITION

6. The Council has examined the proposal, and in general the text has been considerably altered during the discussions. The text on the one hand reflects a balance between diverging positions and on the other takes account of the European Parliament's wishes on a number of points, especially the establishment of a positive list of flavouring substances the use of which is authorized to the exclusion of all others (amendment 5). The Commission has accepted all the modifications to the initial proposal adopted by the Council.

7. As regards the scope, the Council has adopted the Commission's amended proposal (Article 1).

8. In accordance with amendment 5, the general criteria for evaluating flavouring substances are to be found in the enacting terms (Article 2 (1)). Moreover, the Council has adopted the principle of amendment 5 by stipulating in a recital that, in keeping with Article 214 of the Treaty, it is necessary to protect intellectual property linked to the development and manufacture of flavouring substances.

However, the Council and the Commission were unable to adopt the part of amendment 5 concerning submission of a draft list to the European Parliament as they felt that the list of flavouring substances should not be established until the Scientific Committee for Food had been consulted and the list had been formally adopted by the Commission under a committee procedure.

9. The common position considerably strengthens the procedures for establishing the positive list (Articles 3, 4 and 5). The common position contains the following points:

first stage:

- notification to the Commission by the Member States of the substances which may be used in their territory (Article 3 (1)),

- within a year following the end of the notification period, adoption by the Commission, in accordance with a type IIIa committee procedure, is to adopt a register comprising all substances notified by the Member States (Article 3 (2)),

- within 10 months of the adoption of the register, a programme for the evaluation of the substances contained in the register is to be adopted (Article 4).

During this stage Member States may suspend or restrict the use of any given flavouring substance within the framework of a specific safeguard clause (Article 3 (3)).

second stage:

- within five years of adoption of the evaluation programme, the Commission is to adopt the positive list in accordance with a type IIIb committee procedure (Article 8).

10. The common position considerably strengthens the provisions regarding the procedures for taking the decision on the establishment of the register and the positive list. The decision on the establishment of the register will be taken by a type IIIa committee procedure. The positive list will be adopted in accordance with a type IIIb committee procedure (Articles 7 and 8).

11. The Council adopted the provisions which stipulate that the Regulation is to apply without prejudice to the Community provisions authorizing the use, in certain foodstuffs, of certain categories of flavouring substances as defined in Article 1 of Directive 88/388/EC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production.

12. The Council then included a provision whereby Member States may not prohibit, restrict or obstruct the marketing or the use of flavouring substances in foodstuffs if they comply with the provisions of the Regulation (Article 9). The Council also decided that the provisions intended to align existing Community acts on the Regulation should be adopted in accordance with a type IIIa committee procedure (Article 10).

13. As regards the European Parliament's amendments 3 and 6 relating to genetically modified organisms, the common position adopts the principle of those amendments by stipulating that evaluation of the safety of substances containing such an organism must take into account environmental safety as provided for in Directive 90/220/EEC (Annex).

However, there was a part of amendment 6 which the Council and the Commission were unable to adopt as they felt that all flavouring substances should fall within the scope of the proposed Regulation.

14. The Council has included the principle of the European Parliament's amendments 4, 5, 7 and 8 in its common position by specifying (in the Annex) that flavouring substances:

- must present no risk to the health of the consumer (amendment 8),

- must be kept under constant supervision and be reevaluated whenever necessary (amendment 5),

- must not mislead the consumer (amendment 8),

- may be authorized only after consultation of the Scientific Committee for Food (amendments 4 and 7).

15. Having adopted the EP amendments which were accepted by the Commission and having taken into account the points raised by the EP, the Council considers that on the whole it has achieved a fair balance between positions which differed markedly at the outset.

(1) OJ No C 1, 4. 1. 1994, p. 22.

(2) OJ No C 205, 25. 7. 1994, p. 398.

(3) OJ No C 171, 24. 6. 1994, p. 6.

(4) OJ No C 195, 18. 7. 1994, p. 4.