Court of Justice of the European Communities (including Court of First Instance Decisions)

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1. Actions for failure to fulfil obligations ° Pre-litigation procedure ° Letter of formal notice ° Delimitation of the subject-matter of the dispute ° Reasoned opinion ° Detailed statement of complaints
(EC Treaty, Art. 169)
2. Actions for failure to fulfil obligations ° Examination by the Court as to whether the action is well founded ° Situation to be taken into consideration ° Situation at the expiry of the period laid down in the reasoned opinion
(EC Treaty, Art. 169)
3. Approximation of laws ° Procedure for the provision of information in the field of technical standards and regulations ° Member States' obligation to communicate all draft technical regulations to the Commission ° Concept of technical regulation ° Regulations concerning the quality of waters intended for molluscs ° Inclusion ° Conditions
(Council Directive 83/189, Art. 8)
4. Approximation of laws ° Procedure for the provision of information in the field of technical standards and regulations ° Member States' obligation to communicate all draft technical regulations to the Commission ° Concept of technical regulation ° Compulsory technical specifications concerning production methods and procedures for medicinal products ° Included
(Council Directive 83/189, Art. 1(1) and (5) and Art. 8)

1. 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.
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.
2. In an action under Article 169 of the Treaty, 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 the Court cannot take account of any subsequent changes.
3. Where national regulations concerning certain aspects of the quality of the waters intended for edible lamellibranch molluscs stipulate that only molluscs grown in waters complying with the technical specifications it lays down may be marketed, they must be regarded as technical regulations subject to the notification requirement under Article 8 of Directive 83/189 laying down a procedure for the provision of information in the field of technical standards and regulations.
4. It is plain from Article 1(1) of Directive 83/189 laying down a procedure for the provision of information in the field of technical standards and regulations, as amended by Directive 88/182, that the concept of technical specification includes production methods and procedures for medicinal products as defined in Article 1 of Directive 65/65 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products.
Accordingly, a national regulation introducing new compulsory technical specifications for the marketing of proprietary medicinal products made from cattle organs and tissues constitutes a technical regulation within the meaning of Article 1(5) of Directive 83/189, and should be notified to the Commission in accordance with Article 8 thereof.

In Case C-289/94,
Commission of the European Communities, represented by Antonio Aresu, of its Legal Service, acting as Agent, with an address for service in Luxembourg at the office of Carlos Gómez de la Cruz, also of its Legal Service, Wagner Centre, Kirchberg,
applicant,
v
Italian Republic, represented by Umberto Leanza, Head of the Legal Department at the Ministry of Foreign Affairs, acting as Agent, assisted by Pier Giorgio Ferri, Avvocato dello Stato, with an address for service in Luxembourg at the Italian Embassy, 5 Rue Marie-Adélaďde,
defendant,
APPLICATION for a declaration that, by issuing four Ministry of Health Decrees, namely Nos 256 and 257 of 1 August 1990 and those of 1 September 1990 and 7 June 1991, without notifying them to the Commission at the draft stage, the Italian Republic failed to fulfil its obligations under Articles 8 and 9 of 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), as amended by Council Directive 88/182/EEC of 22 March 1988 (OJ 1988 L 81, p. 75),
THE COURT (Sixth Chamber),
composed of: C.N. Kakouris, President of the Chamber, G.F. Mancini and H. Ragnemalm (Rapporteur), Judges,
Advocate General: D. Ruiz-Jarabo Colomer,
Registrar: D. Louterman-Hubeau, Principal Administrator,
having regard to the Report for the Hearing,
after hearing oral argument from the parties at the hearing on 28 March 1996,
after hearing the Opinion of the Advocate General at the sitting on 25 April 1996,
gives the following
Judgment

1 By application lodged at the Court Registry on 24 October 1994, the Commission of the European Communities brought an action under Article 169 of the EC Treaty for a declaration that, by issuing four Ministry of Health Decrees, namely Nos 256 and 257 of 1 August 1990 and those of 1 September 1990 and 7 June 1991, without notifying them to the Commission at the draft stage, the Italian Republic failed to fulfil its obligations under Articles 8 and 9 of 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), as amended by Council Directive 88/182/EEC of 22 March 1988 (OJ 1988 L 81, p. 75).
2 The Italian Ministry of Health published in the Gazzetta Ufficiale della Repubblica Italiana ("GURI") the four following ministerial decrees:
° Ministerial Decree No 256 of 1 August 1990 amending the Ministerial Decree of 27 April 1978 concerning the microbiological, biological, chemical and physical characteristics of zones inhabited by natural deposits and beds of edible lamellibranch molluscs and of zones intended for the cultivation of molluscs, for the purpose of classifying them as approved, conditional and prohibited zones (GURI, Ordinary Supplement No 211 of 10 September 1990);
° Ministerial Decree No 257 of 1 August 1990 amending the Ministerial Decree of 5 October 1978 concerning the microbiological, chemical and biological characteristics of edible lamellibranch molluscs by reference to their intended use. Detailed rules for the sampling of edible molluscs which may be subject to analysis at different stages of production and marketing (GURI, Ordinary Supplement No 211 of 10 September 1990);
° Decree of 1 September 1990 concerning the methods of analysis for determining the presence of biotoxic algae in bivalve molluscs and for the qualitative and quantitative determination of phytoplankton populations in sea waters intended for the cultivation of molluscs (GURI No 218 of 18 September 1990);
° Decree of 7 June 1991 on measures concerning proprietary medicinal products made from cattle organs and tissues (GURI No 135 of 11 June 1991).
3 The Commission takes the view that those four decrees should have been notified to it at the draft stage in accordance with Article 8(1) of Directive 83/189, as amended by Directive 88/182 ("Directive 83/189"), which requires Member States to communicate any draft technical regulation to the Commission immediately, save where such regulation merely transposes the full text of an international or European standard, and to make a brief statement of the grounds which make the enactment of such a technical regulation necessary. The Commission is to notify the draft to the other Member States immediately.
4 The words "technical regulation", referred to in Article 8, are defined in Article 1(5) of Directive 83/189 as follows:
"... technical specifications, including the relevant administrative provisions, the observance of which is compulsory, de jure or de facto, in the case of marketing or use in a Member State or a major part thereof, except those laid down by local authorities."
5 Article 9(3) of Directive 83/189 provides:
"Paragraphs 1, 2 and 2(a) shall not apply in those cases where, for urgent reasons relating to the protection of public health or safety, the protection of health and life of animals or plants, a Member State is obliged to prepare technical regulations in a very short space of time in order to enact and introduce them immediately without any consultations being possible. The Member State shall give, in the communication referred to in Article 8, the reasons which warrant the urgency of the measures taken. The Commission shall take appropriate action in cases where improper use is made of this procedure."
6 Article 10 of Directive 83/189 provides:
"Articles 8 and 9 shall not apply where the Member States fulfil their obligations as arising out of Community directives and regulations; the same shall apply in the case of obligations arising out of international agreements which result in the adoption of uniform technical specifications in the Community."
7 The Commission took the view that the decrees at issue were technical regulations which should have been referred to it at the draft stage in accordance with Article 8 of Directive 83/189 and, by letters of 12 March 1991 and 12 February 1992, gave the Italian Government formal notice to submit its observations.
8 By telex messages of 18 April 1991 and 31 March 1992 respectively, the Italian Government replied that the decrees had not been notified because of the need to update the system for monitoring the quality of shellfish-breeding waters and molluscs intended for human consumption, following the appearance of toxic algae, and also because of the urgency of the matter.
9 Notwithstanding those explanations, the Commission sent two reasoned opinions to the Italian Republic on 2 December 1991 and 23 October 1992 respectively, reminding it that, under Article 9(3) of Directive 83/189, not even the existence of urgent reasons relieved the Italian Government of the obligation to notify the decrees at the draft stage, and requesting it to take the necessary compliance measures within two months.
10 The Italian Republic did not reply to the two reasoned opinions, or take any action thereon.
11 It is in those circumstances that the Commission has brought this action.
Admissibility
12 The Italian Republic makes three pleas in law that the action is inadmissible.
The first plea
13 The Italian Republic argues that the letters of formal notice sent to it were couched in general and inadequate terms. The Commission merely stated generally and in the abstract that the decrees at issue were technical regulations, without either explaining or demonstrating the reasons which had led it to that conclusion. The Italian Government maintains that it was not, therefore, placed in a position to know, at that stage, the pleas on which the action was based and to prepare its defence in an appropriate manner.
14 The Commission replies that, during the pre-litigation procedure, the Italian Government did not at any time call into question the view that the decrees at issue were in the nature of technical regulations. It had the opportunity to challenge the applicability of Directive 83/189, but preferred to take that for granted and stress rather the urgency in order to justify the absence of prior notification of the decrees in question.
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.
18 The first plea of inadmissibility must therefore be dismissed.
The second plea
19 The Italian Government complains that the Commission did not take account, at any stage of the pre-litigation procedure, of the Italian Republic' s subsequent adoption of Legislative Decree No 530 of 30 December 1992 (GURI, Ordinary Supplement of 11 January 1993), designed to implement Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs (OJ 1991 L 268, p. 1). That decree was notified to the Commission, which issued a detailed opinion on 27 January 1993.
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).
21 In this case, Decree No 530 was adopted after the expiry of the time-limit laid down by the reasoned opinion of 2 December 1991.
22 The second plea of inadmissibility must therefore also be dismissed.
The third plea
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.
25 It follows that the third plea of inadmissibility must also be dismissed, and that the action is admissible.
Substance
26 The Commission argues that the reasons of urgency invoked by the Italian Republic in its replies to the letters of formal notice cannot justify the total failure to communicate the decrees in issue at the draft stage. Admittedly, Article 9(3) of Directive 83/189 enables Member States to derogate from the standstill periods in the earlier paragraphs of that article for urgent reasons relating to the protection of public health or safety or the protection of health and life of animals or plants. However, the existence of such reasons does not relieve Member States of the obligation to communicate the draft decrees in question, since the second sentence of Article 9(3) provides: "The Member State shall give, in the communication referred to in Article 8, the reasons which warrant the urgency of the measures taken". In this case, neither the draft decrees nor the reasons for their urgent adoption were communicated to the Commission, and it accordingly considers that the Italian Republic has failed to fulfil its obligations under Articles 8 and 9 of Directive 83/189.
27 In its defence and its rejoinder, the Italian Republic no longer invokes the reasons of urgency which it raised and expounded in its replies to the letters of formal notice in order to justify the lack of notification.
28 Therefore, contrary to what the Commission maintains, there is no need to examine whether, by not indicating to the Commission the reasons justifying the urgent adoption of the contested decrees, the Italian Republic failed to fulfil its obligations under Article 9 of Directive 83/189.
29 It is, however, necessary to determine whether, as the Italian Republic maintains, the four decrees at issue are not covered by the notification requirement imposed by Article 8 of Directive 83/189, either because they do not constitute technical regulations within the meaning of Article 1(5), or because they are intended to transpose Community directives and fall under Article 10 of Directive 83/189.
Ministerial Decree No 256 of 1 August 1990
30 In the first place, the Italian Republic considers that Decree No 256 does not fall within the scope of Directive 83/189, since the provisions it contains do not constitute technical regulations within the meaning of Article 1(5) of the directive. The decree concerns the quality of the waters intended for the cultivation of edible lamellibranch molluscs and not the characteristics required for their marketing.
31 That argument must be rejected.
32 Although Decree No 256 does concern certain aspects of the quality of the waters intended for edible lamellibranch molluscs, it nevertheless establishes, as the Commission has rightly pointed out, a very close correlation between the quality of waters used for such cultivation and the marketing of lamellibranch molluscs for human consumption. Thus, only molluscs grown in waters complying with the technical specifications laid down by Decree No 256 may be marketed. Compliance with those specifications, which are binding, thus has a direct impact on the marketing of the molluscs, with the result that Decree No 256 must be regarded as a technical regulation subject to the notification requirement under Article 8 of Directive 83/189.
33 Secondly, the Italian Republic argues that, since they concern water quality, the provisions of Decree No 256 refer to a matter governed by Council Directive 79/923/EEC of 30 October 1979 on the quality required of shellfish waters (OJ 1979 L 281, p. 47), which is referred to in the preamble to the decree. The Italian Government therefore considers that, pursuant to Article 10 of Directive 83/189, it was not required to notify that decree.
34 That argument by the Italian Government cannot be accepted either.
35 Decree No 256 is intended only to update Articles 4 and 6 of the Ministerial Decree of 27 April 1978, referred to above, concerning the quality of shellfish waters, following the appearance of certain toxic micro-algae in certain Italian coastal areas on the Adriatic Sea. Since that new environmental situation presented risks for the consumer, the Italian Republic wished to adopt protective and preventive measures by, in particular, intensifying the sampling of water and molluscs to preclude any risk of contamination. Far from replacing the Decree of 27 April 1978, Decree No 256 merely brought it up to date by establishing more detailed and intensive surveillance criteria and methods for shellfish waters.
36 As for Directive 79/923, its scope is far wider than that of Decree No 256. Not only does it provide for the strengthening of sampling procedures and periodic monitoring of shellfish waters following the appearance of new toxic micro-algae, but it establishes a general programme for the progressive reduction of water pollution and a complex system for the classification of waters intended for the cultivation of molluscs. Those objectives are only partially pursued by Decree No 256, the scope of which is much more limited.
37 Decree No 256 does not therefore constitute a measure transposing Directive 79/923 such as to justify application of Article 10 of Directive 83/189, and it did therefore have to be notified to the Commission pursuant to Article 8 of the latter directive.
Decree No 257 of 1 August 1990 and the Decree of 1 September 1990
38 The Italian Republic argues that Directive 91/492, cited above, was adopted on 15 July 1991, prior to the dispatch by the Commission on 2 December 1991 of the reasoned opinion concerning Decree No 257 of 1 August 1990 and the Decree of 1 September 1990. It therefore considers that those two decrees were transformed into provisions implementing Directive 91/492, and that it was therefore relieved of the obligation to notify them, pursuant to Article 10 of Directive 83/189.
39 That argument cannot be accepted.
40 Decree No 257 merely amended, for reasons identical to those which led to the adoption of Decree No 256, Article 8 of the Ministerial Decree of 5 October 1978, referred to above, concerning the microbiological, chemical and biological characteristics of molluscs.
41 As for the Ministerial Decree of 1 September 1990, it established a new method of analysis for determining the presence of toxic micro-algae in bivalve molluscs and in waters intended for the cultivation of molluscs.
42 Like Decree No 256, therefore, those two decrees had a limited purpose, consisting in preventing the appearance of new toxic micro-algae by strengthening existing methods of analysis and introducing new ones.
43 Directive 91/492 for its part contains much wider provisions on the marketing not only of bivalve molluscs but also of marine gastropods, tunicates and echinoderms. It lays down new requirements for all stages of gathering, handling, storing, transporting and distributing molluscs, and also introduces a system of registration and marking to allow the origin of each batch to be identified for health purposes.
44 Moreover, the absence of a direct link between Directive 91/492 and the two decrees in question is confirmed by the Italian Government' s assertion that that directive was transposed into Italian law by means of Legislative Decree No 530 of 30 December 1992, referred to above, which, as it says itself, constitutes the only measure for the implementation of Directive 91/492 and in respect of which the Commission sent a detailed opinion on 27 January 1993 criticizing that decree in that it applied to another toxin (NSP) not referred to in Directive 91/492.
45 Since they do not constitute measures transposing Directive 91/492 such as to justify application of Article 10 of Directive 83/189, Decree No 257 of 1 August 1990 and the Decree of 1 September 1990 had to be notified to the Commission pursuant to Article 8 of the latter directive.
The Decree of 7 June 1991
46 According to the Italian Government, the Decree of 7 June 1991, which lays down measures concerning proprietary medicinal products made from cattle organs and tissues, is a response to fears aroused by the spread of infectious cattle diseases (especially bovine spongiform encephalopathy, commonly known as "mad cow disease"). In order to exclude viruses or specific pathogenic agents from those proprietary medicinal products, the Italian authorities preferred to require additional documentation and analyses going beyond what was submitted in support of applications for marketing authorization at the relevant time, rather than deciding upon a general suspension of those authorizations.
47 The Italian Government considers that such measures fall within the competences of Member States under Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20). Those competences comprehend the possibility of Member States suspending or revoking marketing authorizations and requiring additional documentation in support of the initial application for marketing authorization.
48 In reply to a written question from the Court, the Italian Government has argued that the extension by Directive 88/182 of the scope of Directive 83/189 to the production methods and procedures for medicinal products within the meaning of Directive 65/65 cannot alter or reduce the scope of the special system in the highly sensitive sector governed by the latter directive, and, in particular, that it may not affect national authorities' powers of inspection and verification under the special system for registering proprietary medicinal products.
49 The Italian Government therefore considers that only national measures concerning proprietary medicinal products which fall outside the scope of Directive 65/65 are subject to the information procedure laid down by Directive 83/189.
50 Those arguments cannot be accepted.
51 It is plain from Article 1(1) of Directive 83/189 that the concept of technical specification includes production methods and procedures for medicinal products as defined in Article 1 of Directive 65/65.
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.

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

On those grounds,
THE COURT (Sixth Chamber)
hereby rules:
1. By adopting four Ministry of Health Decrees, namely No 256 of 1 August 1990, No 257 of 1 August 1990 and those of 1 September 1990 and 7 June 1991, without notifying them to the Commission at the draft stage, the Italian Republic failed to fulfil its obligations under Article 8 of 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, as amended by Council Directive 88/182/EEC of 22 March 1988.
2. The Italian Republic is ordered to pay the costs.