Report of the Judge-Rapporteur in Case C-246/91

I — Legal framework

A — The relevant Community legislation

Council Directive 76/768 of 27 July 1976 (hereinafter the Directive) is concerned with the approximation of the laws of the Member States relating to cosmetic products. Its aim is to determine, at Community level, the rules with which the composition, labelling and packaging of cosmetic products must comply. The purpose of the approximation was to eliminate the barriers to trade resulting from the differing requirements laid down by the Member States, especially in the sphere of the protection of public health.

Article 2 of the Directive provides that cosmetic products put on the market must not be liable to cause damage to human health when they are applied under normal conditions of use. According to Article 3 of the Directive, the Member States are to take all necessary measures to ensure that only cosmetic products which conform to the provisions of the Directive and its annexes may be put on the market. Article 4 prohibits the marketing of cosmetic products containing substances listed in the annexes to the Directive.

Article 7 of the Directive provides that:

B — The relevant national legislation

Article L.658-3 of the French Public Health Code provides that:

Failure to compile a file does not cause the marketing of the product for which the file should have been compiled to be prohibited. However, Article L.658-10 of the Public Health Code provides that:

According to Article 1 of Decree No 77-1558 of 28 December 1977, the person responsible for putting any cosmetic product on the market is required to inform the Prefect of the Département in which he has his address or registered office of the place where he lodged the file prescribed in Article L.658-3 of the Public Health Code.

II — Facts and procedure

The Commission considered that legislation to be contrary to Community law and on 7 October 1986 sent the French Republic a letter before action pursuant to Article 169 of the EEC Treaty.

The French Republic replied by letter of 1 April 1987 in which it maintained in particular that Article L.658-3 of the Public Health Code was in conformity with the Community legislation. After studying those observations, the Commission, by reasoned opinion of 2 August 1988 delivered pursuant to Article 169 of the Treaty, found that Article L.658-3 of the Public Health Code was incompatible with the Directive.

By letter of 30 January 1989, the French Government announced a draft Law the object of which was, in particular, to bring the French legislation into conformity with the Directive. By letter of 26 March 1990, the French Government justified its action by explaining that, by carrying out consultations on a draft Council directive amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, the Commission had implicitly acknowledged that in its present state the Community legislation did not afford the high level of protection required by Article 100a of the Treaty.

The Commission's application was registered at the Court Registry on 26 September 1991. The written procedure followed its normal course. Upon hearing the report of the Judge-Rapporteur and the views of the Advocate General, the Court decided to open the oral procedure without any preparatory inquiry.

III — Forms of order sought by the parties

The Commission claims that the Court should:

The French Republic contends that the Court should:

IV — Pleas in law and arguments of the parties

The Commission states that the Directive exhaustively harmonizes the national rules on the packaging and labelling of cosmetic products. It is therefore clear from the scheme of the Directive, as interpreted by the Court, that a Member State may not subject the marketing of cosmetic products to conditions other than those laid down in the Directive.

The French legislation at issue requires the compilation of a file containing, on the one hand, certain particulars which, under the Directive, must appear in any event on the product's packaging, container or label and, on the other hand, information additional to that required by the Directive.

The compilation of the file and the information it is required to contain go beyond the provisions of Article 7(3) of the Directive relating to the information necessary for prompt and appropriate medical treatment in the event of difficulties. Only the information regarding the full formula required by Decree No 77-1588 could be justified for the purposes of such treatment.

As regards the requirement for additional information and formalities before the cosmetic product is marketed, the Commission states that it seems difficult to maintain that the compilation of a file which contains, in part, information which is already provided for in Article 6(1) of the Directive could contribute to the protection of public health.

With regard to the judgment in Provide, cited above, the Commission states that the Court has ruled that the requirement of additional indications were not permitted where they were designed to protect consumers. However, it follows from this that the requirement of additional information also cannot be permitted where it is intended to protect public health, especially since the very aim of the directive is to protect human health.

As for the Community control measures, the Commission would emphasize that, according to the Court, the appropriate controls must henceforth be carried out and the protection measures taken in accordance with the scheme laid down by the harmonizing directive.

As for the proposal for a Council directive, the Commission states that that proposal refers only to a file in the Community whereas the French legislation at issue requires a file to be compiled and maintained in France before a cosmetic product is marketed in France. Furthermore, there are differences between the requirements of Decree No 77-1588 and those of Article 7a of the proposal for a directive.

The French Government states first of all that, according to the Court's case-law, two conditions must be satisfied before there can be total harmonization precluding reliance upon Article 36 of the Treaty: first, the measures necessary to guarantee the protection of human health must be harmonized; secondly, procedures for checking that they are observed must be established. However, neither the provisions of the Directive nor the judgment in Provide, cited above, state that the Directive has brought about total harmonization in the sphere of cosmetic products, in particular with regard to the protection of human health.

With regard to the first of those conditions, the French Government considers that in the judgment in Provide, cited above, the Court was only concerned to determine whether the Directive had harmonized packaging and labelling rules exhaustively. The French Government also points out that the Advocate General drew an analogy between the Directive and Council Directive 79/112/EEC. The judgment did not relate to the whole of the Member States' legislation on the composition of cosmetic products.

According to the French Government, it cannot be considered that the Directive exhaustively harmonized, in Article 4 and the Annexes, the information relating to the composition of cosmetic products. The system created by the Directive has several lacunae since the safety of a cosmetic product is the responsibility of the manufacturer, who is free to put the product on the market without any prior authority.

The French Government also observes that the Directive does not lay down any measures on the organization of Community procedure for monitoring compliance with the harmonization measures. Article 3 of the Directive does not contemplate the organization of monitoring by the Community. The requirements laid down in Article 6 of the directive are concerned only with product labelling and Article 12 of the directive only provides for safeguard measures.

According to the French Government, the file provided for by the decree at issue is of considerable advantage as far as the protection of public health is concerned. If an untoward event should occur the file would make it possible to take the swift decision which is necessary in the field of public health. It would also make it possible to clarify the sphere of manufacturer's responsibilities, guarantee that quality standards are maintained from one production run to the next and, lastly, would enable experts to monitor changes in the product in the course of its marketing.

The French Government states that by virtue of points 5, 8, 9 and 10 of Article 2 of Decree No 77-1558 it can be made sure that cosmetic products are not likely to harm human health under normal conditions of use. Points 1, 2, 3, 4, 6, 11, 12 and 13 of Article 2 of the decree do not duplicate the labelling requirements of Article 6 of the directive. Point 5 of Article 2 of the decree implements Article 1(2) of and Annex 1 to the Directive.

In the French Government's view, the file protects the consumer by enabling the national authorities to identify manufacturers and importers and carry out inspections on their premises and by requiring that a qualified person be responsible for compiling information which will enable the quality of products to be guaranteed. The administrative constraints which are imposed on manufacturers are minimal since the procedure instituted by Decree No 77-558 is declaratory in nature.

V — Continuation of the written procedure

The written procedure closed on 23 March 1992.

By judgment of 18 March 1992 the Court held that by making the marketing of cosmetic products dependent on the lodging with the competent national authorities of a declaration containing information other than that which a Member State may require under Article 7(3) of Council Directive 76/768 of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products and by requiring that any manufacturer or person responsible for the marketing of a cosmetic product should keep at the seat of his undertaking in Greece a file for each product manufactured or imported containing all particulars relating to the composition, properties and description of the product, to the formal record of the manufacture and inspection of each batch and to the method adopted for such inspection, the Hellenic Republic has failed to fulfil its obligations under Directive 76/768.

By letter of 30 November 1992, registered at the Court Registry on 1 December 1992, the French Government informed the Court that it had noted the interpretation given to the Directive in the aforesaid judgment of 18 March 1992 and assured the Court that it would draw the necessary inferences so far as its domestic legislation was concerned.

1 Language of the case: French.

2 OJ 1976 L 262, p. 169.

3 Decree No 77-1558 of 28 December 1977 on the compilation of the file and the forwarding of information prior to the putting on the market of a cosmetic product or a personal hygiene product (Official Journal of the French Republic of 25 January 1978, p. 497).

4 OJ 1991 C 52, p. 6.

5 Case C-150/88 Parfümerie-Fabrik 4711 v Provide [1989] ECR 3891.

6 Case 148/78 Ministero Pubblico v Ratti [1979] ECR 1692, paragraph 36.

7 Case 251/78 Denkavit Füttermittel v Minister für Ernährung, Landwirtschaft und Forsten [1979] ECR 3369, paragraph 14.

8 Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (OJ 1979 L 33, p. 1). Opinion of Advocate General Darmon [1989] ECR 3902, paragraph 16.

9 Judgment of 18 March 1992 in Case 29/90 Commission v Hellenic Republic [1992] ECR I-1971.