JUDGMENT OF 2. 3. 1982 — CASE 94/81 COMMISSION > ITALY

In Case 94/81

THE COURT, composed of: J. Menens de Wilmars President, G. Bosco and O. Due (Presidents of Chambers), A. O'Keeffe, T. Koopmans, A. Chloros and F. Grévisse, Judges, Advocate General: P. VerLoren van Themaat Registrar: P. Heim

gives the following

JUDGMENT

Facts and Issues

The facts of the case, the course of the procedure and the conclusions, submissions and arguments of the parties may be summarized as follows:

I — Facts and procedure

1. In this action the Commission is asking the Court to declare that the Italian Republic has failed to implement within the prescribed period Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Official Journal, L 262, p. 169).

2. According to the directive, the Member States must ensure that cosmetic products are put on the market only if they conform to the provisions of the directive (Article 3) and they may not, for reasons related to the requirements laid down in the directive, impede the marketing of products which comply with the requirements of the directive (Article 7). The Member States must therefore prohibit the marketing of cosmetic products containing the substances listed in Annex II to the directive (Article 4). Article 11 of the directive provides for the establishment, at a second stage, by the Council, acting on a proposal from the Commission, of lisu of permitted substances, the others remaining prohibited.

3. The directive provides (Article 14) that within 18 months of its notification the Member States are to bring into force the provisions needed in order to complv with it. That period expired on 30 January 1978.

4. By a letter dated 5 July 1979 addressed to the Ministry of Foreign Affairs of the Italian Republic, the Commission, after noting that the period for implementig the directive had expired and that it had received no communication concerning the adoption of implementing measures by the Italian Republic, expressed the opinion that the Italian Republic had failed to fulfil its obligations and, in pursuance of Article 169 of the Treaty, it invited the Italian Government to submit its observations within a period of two months. The Italian authorities replied by a letter dated 11 July 1979, in which they referred to an Italian note dated 12 April 1979 which had brought to the Commission's attention the fact that a draft law, submitted by the Italian Government and already examined by the Senate, had lapsed because of the premature dissolution of the Parliament. The assurance was given that, once the new government was constituted, it would not fail to resubmit the draft Law to the Parliament. On 19 May 1980 the Commission issued a reasoned opinion in pursuance of Article 169 of the Treaty, and invited the Italian Government to comply with that opinion within a period of two months. The response of the Italian authorities was contained in a letter dated 28 July 1980 recalling the varying fortunes with which the draft Law had met during the life of the previous legislature and pointing out that it had been resubmitted to the Parliament and again approved by the Senate. After transmission to the Chamber of Deputies, it had been entrusted to the Health Committee acting under, its legislative powers, so that its final approval might be expected very shonly.

5. The present application was lodged at the Court Registry on 24 April 1981. The Italian Government has not lodged a rejoinder. Upon hearing the repon of the Judge-Rapporteur and the views of the Advocate General the Court decided to open the oral procedure without any preparatory inquiry.

II — Conclusions of the parties

A) In its application the Commission claims that the Court should:

1) Declare that by omitting to adopt within the prescribed period the provisions needed to complv with Directive 76/768/EEC of the Council of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, the Italian Republic has failed to fulfil its obligations under the EEC Treaty;

2) Order the defendant to pay the costs.

B) The italian Government has not presented any formal conclusions.

III — Submissions and arguments of the parties

A — General observations

1. The Italian Government refers to the observations which it submitted prior to the Commission's application to the Court and contends in addition that, within the limits permitted by the legislative provisions in force, it has taken care to adopt, at the administrative level, its own measures of surveillance which are applied in the cosmetics sector by the Ministry of Health, to the principles underlying the Community directive. Whilst admitting that the subject-matter of the dispute can only be eliminated by the adoption of a law implementing the directive, the Italian Government hopes that the Court will as far as possible take into account its administrative action.

2. The Commission observes that the provisions adopted by the Italian Government are incomplete and, even as regards those points which they do cover, they do not appear to correspond faithfully to the requirements of the directive. The aim of the directive, which is to bring about complete harmonization and, as a result, the elimination of barriers to trade, is not achieved. The Commission also remarks that, leaving aside the incomplete nature of the provisions, as the Court stated in its judgment of 6 May 1980 in Case 102/79 Commission v Belgium [1980] ECR 1473, Thus, quite apart from their extremely narrow scope, the measures in question do not even constitute, according to the Commission, an appropriate implementation of the directive to which they refer. The directive requires for its implementation the creation of a legal framework within which the rights and duties of traders are stipulated in a manner consistent with the requirements of clarity and certainty.

“Mere administrative practices, which by their nature can be changed as and when the authorities please and which are not publicized widely enough, cannot ... be regarded as a proper fulfilment of the obligation imposed by Article 189 on Member States to which the directives are addressed”.

B — Observations on the measures adopted by Italy for the purpose of implementing the directive

1. The Italian Government points out that where irregularities have been found to exist the manufacturers and distributors have been given formal notice to make the packaging of their products comply with the provisions of the directive. The Commission replies that it appears, although it is not certain, that the measure adopted by the Italian Government refers to Article 6 of the directive.

2. The Italian Government also remarks that the elimination of dangerous or pharmacologically active substances contained in cosmetic products and listed in Annex II to the directive has been enforced by recourse to the procedures of seizure or warning. According to the Commission, this measure relates to the duty laid upon the Member States by Article 4 (a) of the directive. However, it is not clear whether the measure covers all or only some of the 361 substances listed in Annex II to the directive.

3. The Italian Government stresses that a ministerial order was expressly adopted on 6 June 1980 in order to prohibit the use in cosmetic products of placenta, oestrogens und progestogens. In the Commission's view, this is again a measure which concerns Annex II, in particular point 194 concerning progestogens and point 260 concerning oestrogens, whilst placenta is not mentioned in the directive.

4. According to the Italian Government another ministerial order of 15 February 1980 set limits to the use and to the content, in cosmetic products, of boric acid and its salts and derivatives, in conformity with the provisions contained in Pan I of Annex III to the directive. In the Commission's opinion, the Italian Government is referring to the duty laid upon the Member States by Article 4 (b) of the directive. Pan I of Annex III lists 29 substances, of which only that mentioned under Reference No 1 is covered by the ministerial order. Further, the directive mentions “boric acid”, whereas the ministerial order also covers its salts and derivatives. As the latter substances are not prohibited by the directive the Member States may not prohibit them.

5. The Italian Government observes, lastly, that the manufacturers and distributors concerned have frequently been called upon to prove, by way of appropriate documents, statements relating to the specific effects of their products within the confines, however, of the types of hygienic and cosmetic therapy for which the products provide. The Commission replies that this provision may refer to Article 6 (2) of the directive.

6. The Italian Government adds that Ministry of Health Circular No 60 of 11 August 1980 draws the attention of all traders in this sector to the necessity for scrupulous compliance with the rules governing cosmetic products in order, inter alia, to maintain an absolutely clear distinction between cosmetics and medicaments.

IV — Oral procedure

At the sitting on 2 December 1981, the Government of the Italian Republic, represented by G. Fienga, Avvocato dello Stato, and the Commission, represented by G. Marenco, a member of its Legal Depanment, presented oral argument.

The Advocate General delivered his opinion at the sitting on 3 Februarv 1982.

Decision

1. By application lodged at the Court Registry on 24 April 1981 the Commission of the European Communities brought an action pursuant to Article 169 of the EEC Treaty for a declaration that by not adopting within the prescribed period the provisions needed to comply with Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Official Journal 1976, L 262, p. 169), the Italian Republic has failed to fulfil its obligations under the Treaty.

2. By virtue of Article 14 of the directive the Member States were to bring into force the provisions needed to comply with the directive within 18 months of its notification. In this case that period expired on 30 January 1978.

3. The Italian Government has stated that the directive has already been the subject of measures which implement it in part. Nevertheless it does not deny that the Italian Republic has not fulfilled its obligation to implement the directive fully within the prescribed period.

4. In sum, the Italian Government justifies its omission by the need to have recourse to the legislative procedure for the purpose of implementing the directive. It prepared an appropriate draft Law which, after being approved by the Cabinet on 22 December 1977, was laid before the Parliament and approved, in turn, by the Health Committee of the Senate which transmitted it to the Chamber of Deputies for final approval. In the meantime, however, the premature dissolution of Parliament caused the draft Law to lapse. The Italian Government therefore immediately resubmitted the same draft Law to the new legislature. The draft was approved by the Health Committee of the Senate on 14 May 1980 and transmitted for approval to the 14th Standing Health Committee of the Chamber of Deputies where it is now undergoing final examination.

5. Those circumstances do not expunge the failure of the Italian Republic to fulfil its obligations, of which the Commission complains. According to established case-law of the Court a Member State may not plead provisions, practices or circumstances in its internal legal system to justify a failure to comply with obligations under Community directives.

6. It must therefore be recorded that by not adopting within the prescribed period the provisions needed to comply with Council Directive 76/768/EEC of 27 July 1976 the Italian Republic has failed to fulfil its obligations under the Treaty.

Costs

7. Article 69 (2) of the Rules of Procedure provides that the unsuccessful party is to be ordered to pay the costs. Since the defendant has been unsuccessful, it must be ordered to pay the costs.

On those grounds, THE COURT hereby:

1 Declares that by not adopting within the prescribed period the provisions needed to comply with Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, the Italian Republic has failed to fulfil its obligations under the Treaty;

2 Orders the Italian Republic to pay the costs.