Commission of the European Communities v Italian Republic.
Date: 1996-09-17
15 It should be noted that, under Article 169 of the Treaty, the Commission may not bring an action before the Court for a declaration that a Member State has failed to fulfil its obligations until it has given that Member State the opportunity of submitting its observations. The Court has consistently held that, at the pre-litigation stage of proceedings for failure of a State to fulfil its obligations, the purpose of the letter of formal notice is to delimit the subject-matter of the dispute and to indicate to the Member State, which is invited to submit its observations, the factors enabling it to prepare its defence (Case 274/83 Commission v Italy [1985] ECR 1077, paragraph 19; Case 229/87 Commission v Greece [1988] ECR 6347, paragraphs 11 and 12).
16 Although the reasoned opinion provided for in Article 169 of the Treaty must contain a coherent and detailed statement of the reasons which led the Commission to conclude that the State in question failed to fulfil one of its obligations under the Treaty, the letter of formal notice is not subject to such strict requirements of precision, since, of necessity, it cannot contain anything more than an initial brief summary of the complaints. There is therefore nothing to prevent the Commission from setting out in detail in the reasoned opinion the complaints which it already made more generally in the letter of formal notice (see, in particular, Commission v Italy, cited above, paragraph 21).
17 In this case, the formal letters of 12 March 1991 and 12 February 1992 sufficiently identified the alleged failure of the Italian Republic to fulfil its obligations, consisting in the adoption of the decrees at issue containing technical regulations without first notifying them to the Commission at the draft stage, as required by Directive 83/189. Those letters thus informed the Italian Government of the nature of the complaints against it and gave it the opportunity to submit its defence, which it did by the two telex messages of 18 April 1991 and 31 March 1992.
20 The Court has consistently held that the question whether a Member State has failed to fulfil its obligations must be determined by reference to the situation in the Member State as it stood at the end of the period laid down in the reasoned opinion, and that the Court cannot take account of any subsequent changes (Case C-133/94 Commission v Belgium [1996] ECR I-0000, paragraph 17).
23 The Italian Government maintains that, at the very least, two of the decrees at issue, namely Decree No 257 of 1 August 1990 and the Decree of 1 September 1990, were not subject to the notification requirement under Article 10 of Directive 83/189. Those two decrees also fell within the scope of Directive 91/492, of which they became the implementing measures, so that the reasoned opinion concerning them issued by the Commission on 2 December 19910, after the adoption of Directive 91/492, became wholly irrelevant. To require the suspension of the two decrees at issue and then their notification at the draft stage would amount to preventing a Member State from maintaining in force rules on health safeguards in accordance with a directive which had already been published, but the period for whose implementation had not yet expired.
24 Such an argument is not capable of affecting the admissibility of the present action. The question whether the Italian Republic was relieved of the obligation to notify the two decrees in question pursuant to Article 10 of Directive 83/189 is a matter which goes to the substance of the dispute.
52 Accordingly, the Decree of 7 June 1991 introducing new compulsory technical specifications for the marketing of proprietary medicinal products made from cattle organs and tissues does constitute a technical regulation within the meaning of Article 1(5) of Directive 83/189, and should have been notified to the Commission.
53 It must therefore be held that, by adopting the four decrees at issue without notifying them to the Commission at the draft stage, the Italian Republic failed to fulfil its obligations under Article 8 of Directive 83/189.