61991J0246

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Approximation of laws ° Cosmetic products ° Packaging and labelling ° Directive 76/768 ° Exhaustive harmonization ° National legislation imposing obligations not provided for in the Directive ° Not permissible

(Council Directive 76/768, Art. 7(3))

Directive 76/768 on the approximation of the laws of the Member States relating to cosmetic products has provided exhaustively for the harmonization of national rules on the packaging and labelling of the products at issue. A Member State fails to fulfil its obligations under Directive 76/768, therefore, where its legislation exceeds the limits of the requirements laid down by Article 7(3) of the Directive regarding information, by making the marketing of cosmetic products subject to an obligation to maintain a file permanently at the disposal of the competent authorities, containing information on the nature of the product, the way in which it was manufactured and tested, its use and method of application, and on the clinical trials conducted in order to ascertain its toxicity and its tolerance by the human body.

In Case C-246/91,

Commission of the European Communities, represented by Xavier Lewis, of its Legal Service, acting as Agent, with an address for service in Luxembourg at the office of Nicola Annecchino, of its Legal Service, Wagner Centre, Kirchberg

applicant,

v

French Republic, represented by Philippe Pouzoulet, Deputy Director of the Legal Affairs Directorate at the Ministry of Foreign Affairs, acting as Agent, and Hélène Duchêne, Foreign Affairs Secretary in the same Ministry, acting as Deputy Agent, with an address for service in Luxembourg at the French Embassy, 9 Boulevard Prince-Henri,

defendant,

APPLICATION for a declaration that, by requiring a product file to be compiled, lodged and kept up-to-date, outside the framework laid down in Article 7(3) of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ 1976 L 262, p. 169), the French Republic has failed to fulfil its obligations under that directive,

THE COURT,

composed of: C.N. Kakouris, President of Chamber, acting for the President, M. Zuleeg and J.L. Murray (Presidents of Chambers), G.F. Mancini, F.A. Schockweiler, J.C. Moitinho de Almeida, F. Grévisse, M. Diez de Velasco and P.J.G. Kapteyn, Judges,

Advocate General: G. Tesauro,

Registrar: H.A. Ruehl, Principal Administrator,

having regard to the report of the Judge-Rapporteur,

after hearing the Opinion of the Advocate General at the sitting on 12 January 1993,

gives the following

Judgment

1 By application lodged at the Court Registry on 26 September 1991, the Commission of the European Communities brought an action under Article 169 of the EEC Treaty for a declaration that, by requiring a product file to be compiled, lodged and kept up-to-date, outside the framework laid down in Article 7(3) of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ 1976 L 262, p. 169, hereinafter "the Directive"), the French Republic has failed to fulfil its obligations under that directive.

2 Article 6(1) of the Directive makes the marketing of cosmetic products subject to the condition that their packaging, containers or labels bear the information specified in that provision. Under Article 7(1) of the Directive, Member States may not refuse, prohibit or restrict the marketing of any cosmetic products which meet those requirements. Nevertheless, Article 7(3) permits Member States to require that adequate and sufficient information regarding substances contained in cosmetic products be made available to the competent authority, so as to allow prompt and appropriate medical treatment in the event of difficulties.

3 Under Article 14 of the Directive, Member States must bring into force the provisions necessary to comply with the Directive by a fixed date, that is to say, so far as concerns the French Republic, by 30 January 1978.

4 According to Article L.658-3 of the French Code of Public Health, a product file must be compiled on all cosmetic products or products relating to personal hygiene before they are placed on the market. The file must be made permanently available to the competent authorities and must contain all relevant information on the nature of the product, its full formula, the way in which it was manufactured and tested, its use and method of application, and on the clinical trials conducted in order to ascertain inter alia the degree of transcutaneous toxicity and the level of cutaneous or mucous tolerance.

5 In the Commission' s view that provision exceeded the requirements of the Directive and particularly those of Article 7(3) concerning the necessary information ° regarding substances contained in cosmetic products ° to be made available so as to allow prompt and appropriate medical treatment in the event of difficulties. The Commission therefore sent the French Republic a letter of formal notice and subsequently a reasoned opinion in accordance with Article 169 of the Treaty. Since the French Republic failed to comply with the reasoned opinion, the Commission brought the present proceedings.

6 Reference is made to the Report of the Judge-Rapporteur for a fuller account of the facts of the case, the procedure and the pleas in law and arguments of the parties, which are mentioned or discussed hereinafter only in so far as is necessary for the reasoning of the Court.

7 It should be noted that, as the Court already held in its judgment in Case C-150/88 (Parfuemerie Fabrik 4711 v Provide [1989] ECR 3891, paragraph 28), the Directive has provided exhaustively for the harmonization of national rules on the packaging and labelling of cosmetic products so that a Member State cannot make the movement of cosmetic products subject to conditions other than those laid down by the Directive.

8 Furthermore, in its judgment in Case C-29/90 (Commission v Greece [1992] ECR I-1971, paragraph 13), the Court declared that making the marketing of cosmetic products dependent on the maintenance of a file containing information in addition to that required by the Directive was incompatible with the Directive.

9 Article 7(3) of the Directive provides that, for purposes of prompt and appropriate medical treatment in the event of difficulties, a Member State may require that adequate and sufficient information regarding substances contained in cosmetic products be made available to the competent authority.

10 By imposing an obligation to maintain a file permanently at the disposal of the competent authorities, containing information on the nature of the product, the way in which it was manufactured and tested, its use and method of application, and on the clinical trials conducted in order to ascertain the degree of toxicity and the relevant tolerance levels, Article L.658-3 of the French Code of Public Health exceeds the limits of the requirements laid down by the Directive.

11 Consequently, that provision conflicts with the Directive in so far as it makes the marketing of cosmetic products subject to a requirement to maintain a file containing information additional to that required by the Directive.

12 Furthermore, the French Government recognized its failure to fulfil obligations in so far as, by letter of 30 November 1992, lodged at the Court Registry on 1 December 1992, it took formal note of the interpretation of the Directive given by the Court in its judgment in Case C-29/90, mentioned above, and gave assurances to the Court that it would take the necessary steps, with respect to its domestic legislation, to give effect to that interpretation.

13 It follows that, by requiring a product file to be compiled, lodged and kept up-to-date, outside the framework laid down in Article 7(3) of the Directive, the French Republic has failed to fulfil its obligations under that directive.

Costs

14 Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs. Since the French Republic has been unsuccessful, it must be ordered to pay the costs.

On those grounds,

THE COURT

hereby:

1. Declares that, by requiring a product file to be compiled, lodged and kept up-to-date, outside the framework laid down in Article 7(3) of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, the French Republic has failed to fulfil its obligations under that directive;

2. Orders the French Republic to pay the costs.