1 By application lodged at the Court Registry on 15 June 1999, the Commission of the European Communities brought an action under Article 226 EC for a declaration that, by adopting the Order of 9 November 1994 concerning rubber materials and rubber articles entering into contact with foodstuffs, food products and beverages (Journal Officiel de la République Française of 2 December 1994, p. 17029; the 1994 Order) without expressly providing for recognition of technical rules, standards and manufacturing processes lawfully followed in the other Member States and recognition of the results of the related checks and tests carried out by an inspectorate or a laboratory officially recognised in another Member State, the French Republic has failed to fulfil its obligations under Article 30 of the EC Treaty (now, after amendment, Article 28 EC). Relevant provisions
2 Article 1 of the 1994 Order provides that rubber materials and rubber articles that are held for sale, offered for sale or sold for contact with foodstuffs, food products and beverages and rubber materials and rubber articles brought into contact with those foodstuffs, food products and beverages must meet the requirements of that Order.
3 The first sentence of the second paragraph of Article 2 of the 1994 Order provides: Synthetic polymers used in manufacturing the materials and articles referred to in Article 1 must be produced only from monomers, base materials and modifying agents listed in Table B of Annex I.
4 The first paragraph of Article 4 states: In the manufacture of the rubber materials and rubber articles referred to in Article 1, only the additives which are listed in Annex II may be added to the polymers designated in Article 2 of this Order.
5 Finally, Article 5 provides: Where appropriate, the substances named in Annex II are to be accompanied by quantified data concerning adherence to specific purity criteria or to purity criteria recognised as being equivalent, and which have been set by the authorities of the Member States of the European Communities or of the Contracting Parties to the Agreement on the European Economic Area. Facts and procedure
6 On 18 November 1993 the French authorities notified to the Commission, pursuant to Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ 1983 L 109, p. 8), a draft order concerning rubber materials and rubber articles entering into contact with foodstuffs, food products and beverages.
7 Since the Commission took the view that certain provisions of the notified draft were liable to hinder intra-Community trade, it delivered a detailed opinion on 20 February 1994 in which it stated that the draft should expressly provide, first, for recognition of technical rules, standards and manufacturing processes lawfully followed in the other Member States or the other Contracting Parties to the Agreement on the European Economic Area of 2 May 1992 (OJ 1994 L 1, p. 3) and, second, for recognition of the results of checks and tests, and the related certificates, of an inspectorate or a laboratory officially recognised by another Member State or another Contracting Party to the EEA Agreement, offering suitable and adequate guarantees from the technical and professional point of view and from the point of view of their independence.
8 By letter of 9 August 1994 the French authorities replied that the approach suggested by the Commission did not appear justified.
9 Indeed, the French authorities adopted the 1994 Order, which reproduces the provisions of the notified draft, without taking account of the observations made by the Commission, and forwarded it to the Commission on 5 January 1995.
10 The French authorities kept to their position in the course of a number of bilateral meetings and in a note delivered to the Commission on 15 January 1996.
11 On 3 December 1997 the Commission delivered a reasoned opinion pursuant to Article 169 of the EC Treaty (now Article 226 EC) in which it stated that, by adopting the 1994 Order without taking account of the proposals put forward by the Commission, the French Republic had failed to fulfil its obligations under Article 30 et seq. of the Treaty. The Commission also called on the French Government to adopt the measures necessary to comply with the reasoned opinion within two months from its notification.
12 In response to the reasoned opinion, the French authorities forwarded to the Commission, by letter of 18 February 1998, a note in which they proposed the insertion in the 1994 Order of a clause for the mutual recognition of monomers, base materials, modifying agents and additives, as defined in Articles 2 and 4 of that Order.
13 By letter of 15 April 1998, the Commission suggested to the French authorities that they alter the clause envisaged in such a way as to allow full application of the principle of mutual recognition.
14 The French authorities replied by letter of 4 June 1998 that they were keeping to the wording of the clause which they had proposed inserting in the 1994 Order, because they considered that each Member State had to be able to ensure, first, that it took account of public health requirements and, second, that it carried out an assessment of the risks, in particular the toxicological risks, before permitting a substance to be marketed.
15 Finding that the French Republic had not complied with the reasoned opinion within the period laid down, the Commission brought the present action before the Court of Justice.
16 The Commission claims that the Court should declare that, by adopting the 1994 Order, the French Republic has failed to fulfil its obligations under Article 30 of the Treaty and order the French Republic to pay the costs.
17 As a preliminary plea, the French Government disputes the admissibility of the action and accordingly asks the Court to dismiss it. Admissibility
18 In the French Government's submission, the Commission has amalgamated the procedure under Article 169 of the Treaty and the preventive notification mechanism provided for in Directive 83/189.
19 It considers that this amalgamation undermines several fundamental legal principles.
20 First, the Commission could not replace the stage of the letter of formal notice with a detailed opinion without affecting the three procedural levels provided for by Article 169 of the Treaty and thus infringing the hierarchy of legal rules.
21 Second, the Commission failed to observe the distinction between preparatory documents and opinions on the one hand and measures of a binding nature on the other. That distinction would be illusory if a detailed opinion of the Commission created obligations for Member States or draft regulations were treated as regulations.
22 Finally, the Commission's standpoint undermines the audi alteram partem rule in so far as application of the procedure under Directive 83/189 results in the formal-notice stage being eliminated.
23 The Commission contends that the action is admissible.
24 In its submission, while Article 169 of the Treaty requires observance of a pre-litigation stage, it does not specify the form which measures adopted by the Commission during that stage must take.
25 The Commission accepts that it has become established practice for the first measure taken at the pre-litigation stage to be a letter of formal notice, which must set out briefly the complaints made against the Member State concerned.
26 However, since the term letter of formal notice is not used in Article 169 of the Treaty, no particular form is required for the first measure at the pre-litigation stage.
27 Consequently, there is nothing to prevent a detailed opinion delivered under Article 9(1) of Directive 83/189 from being regarded as equivalent to a letter of formal notice, since the detailed opinion contains at least a succinct statement of the Commission's complaints regarding the failure by a Member State to fulfil one of its obligations.
28 The Commission points out that Case C-184/96 Commission v France [1998] ECR I-6197, like the present case, involved a detailed opinion and not a letter of formal notice. However, the French Government, which was party to the case, raised no objection in that respect and the Court impliedly accepted that approach.
29 In its rejoinder, the French Government maintains that, by definition, draft legislation does not create legally binding provisions. A draft thus cannot in itself amount to an infringement of an obligation deriving from the Treaty or secondary law. Moreover, the fact that, first, the notifying Member State may respond in the participatory procedure under Directive 83/189 and alter or withdraw the draft regulation notified by it and, second, the Commission may impose a standstill period of 12 months with a view to harmonisation shows that an infringement cannot be identified at that stage.
30 Nor does the fact that that procedural point was not raised by the French Government in Case C-184/96 prevent it from being raised in the present case or, a fortiori, prevent the Court, which does not consider the question automatically, from examining it in the present case upon application by the defendant.
31 As the Court held in its order in Case C-341/97 Commission v Netherlands [2000] ECR I-6611, at paragraph 17, it follows from the function assigned to the pre-litigation stage of proceedings for failure of a State to fulfil its obligations that the purpose of the letter of formal notice is, first, 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 C-289/94 Commission v Italy [1996] ECR I-4405, paragraph 15) and, second, to enable the Member State to comply before proceedings are brought before the Court (Case C-365/97 Commission v Italy [1999] ECR I-7773, paragraphs 23 and 24).
32 Also, in order for a letter of formal notice to be issued, a prior failure by the Member State concerned to fulfil an obligation owed by it must be alleged (Commission v Netherlands, cited above, paragraph 18).
33 However, it is clear that, at the time when a detailed opinion under Directive 83/189 is delivered, the Member State to which it is addressed cannot have infringed Community law, since the measure exists only in draft form (Commission v Netherlands, paragraph 19).
34 The contrary view would result in the detailed opinion constituting a conditional formal notice whose existence would be dependent on the action taken by the Member State concerned in relation to the opinion. The requirements of legal certainty, which are inherent in any procedure capable of becoming contentious, preclude such incertitude (Commission v Netherlands, paragraph 20).
35 Accordingly, the action must be dismissed as inadmissible.