C-316/96

COMMISSION v ITALY

OPINION OF ADVOCATE GENERAL FENNELĽY delivered on 23 October 1997 *

1. The present infringement proceedings — Council Directive 93/54/EEC of 24 June concern the transposition into Italian law of 1993 amending Directive 91/67/EEC two pairs of Council Directives broadly concerning the animal health conditions speaking in the field of animal health. The governing the placing on the market of Commission has withdrawn its claim in aquaculture animals and products (here­ respect of one of the Directives, while Italy inafter 'Directive 93/54/EEC); 2 has not contested its failure to transpose two of the others, but has done so in respect of the fourth measure.

— Council Directive 93/113/EC of 14 December 1993 concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition I — Pre-litigation proceedings (hereinafter 'Directive 93/113/EC); 3 and

— Council Directive 93/114/EC of 14 December 1993 amending Directive 70/524/EEC concerning additives in feedingstuffs (hereinafter 'Directive 2. The Directives at issue in the present pro­ 93/114/EC). 4 ceedings are the following:

— Council Directive 93/53/EEC of 24 June 3. Following the adoption of a Ministerial 1993 introducing minimum Community Decree of 29 January 1997, 5 the Commis­ measures for the control of certain sion withdrew its claim as regards Directive fish diseases (hereinafter 'Directive 93/53/EEC); 1 2 — Ibid., p. 34. 3 — OJ 1993L 334, p. 17. 4 — Ibid., p. 24. * Original language: English. 5 — Gazzetta Ufficiale dello Stato Italiano (hereinafter 'GURI') 1 — OJ 1993 L 175, p. 23. No 92 of 21 April 1997, p. 29.

93/54/EEC, which will therefore not be dealt European Community ('the Treaty') by with in the remainder of this Opinion. sending a letter of formal notice on 20 Janu- ary 1995, inviting the Italian Government to send it a complete table of the national pro- visions which, in the latter's view, ensured the transposition of the Directives. By letter of 27 February 1995, Italy informed the Commission that the Directives had all been 4. Article 20(1) of Directive 93/53/EEC included in the annual 'Community law' for reads as follows: 1994, and that the necessary implementing provisions had been drafted, pending the adoption of this law. As there was no further communication from Italy in this regard, the Commission sent a reasoned opinion on 22 January 1996, concluding that Italy had failed in its obligations under the Treaty and 'Member States shall bring into force the the Directives, and setting a further two- laws, regulations and administrative provi- month deadline for compliance. By letter of sions necessary to comply with this Direc- 15 March 1996, Italy informed the Commis- tive before 1 July 1994. They shall forthwith sion that the implementation of Directives inform the Commission thereof.' 93/53/EEC and 93/54/EEC was imminent, and that the legislative office of the depart- ment responsible in the Ministry of Health had transmitted the sole implementing provi- sion for the remaining Directives to the For Directive 93/113/EC, the deadlines for department responsible for European Union transposition set by Article 8 were 1 January policies. 1995 as regards Article 7 (concerning the imposition of labelling requirements), and 1 October 1994 as regards the other provi- sions. Article 2 of Directive 93/114/EC set the deadline for transposition at 1 October 1994. In each case, the Member States were required to include a reference to the Directive in the national provisions, or in the official publication in which they were announced. 6. The present proceedings were initiated by an application lodged at the Court on 26 September 1996. The Commission relies upon the obligation of the Member States, in accordance with Articles 189 and 5 of the Treaty, to comply with deadlines set by Directives and argues that this obligation is 5. In the absence of any indication that the not fulfilled unless all the provisions of the Directives had been transposed into Italian relevant Directives have been transposed into law, the Commission opened the pre- the law of the Member State. As Italy has litigation stage of the procedure provided by not communicated the provisions transpos- Article 169 of the Treaty establishing the ing these Directives to it, the Commission

— Directive 93/113/EC should be consid- ered fully implemented in Italy. In accordance with Article 3, on 20 Decem- 7. Italy's defence, broken down by Direc- ber 1994 Italy forwarded to the Commis- tive, is as follows: sion a list of enzymes and micro- organisms and their preparations permitted for use in animal nutrition, which was subsequently included in the Community list of such products drawn up by the Commission and published on 11 September 1996. 7 In the meantime, in conformity with Article 2, Italy has tem- porarily admitted the use and marketing — the national provisions to implement of the products on the Ust sent to the Directive 93/53/EEC will be adopted as Commission in December 1994, subject soon as possible. Italy also contended in to a number of restrictions introduced at its written pleadings that the Directive the Commission's behest. The corrected had been partially transposed into Italian list of permitted products was notified to law by a Ministerial Order of 2 Septem- all the regional health representative ber 1996, which contains provisions con- offices ('assessorati regionali della Sanità') cerning viral haemorrhagic septicaemia and professional associations and organi- and infectious hematopoietic necrosis in zations by means of a ministerial circular farm fish, though this plea was in effect of 26 July 1995, and has since been abandoned at the hearing. In a letter reg- replaced by the Commission list. The istered at the Court on 27 August 1997, labelling obligations of Article 7 have Italy drew the Court's attention to the been implemented in part by Presidential adoption, on 3 July 1997, of Presidential Decree N o 228 of 1 March 1992, 8 which Decree N o 263, 6 which in its view transposes different Community Direc- ensured the transposition of Directive tives concerning additives in animal 93/53/EEC. While indicating at the hear- ing that the withdrawal of its claim in

9. The situation regarding the Commission's complaint in respect of Directive 93/113/EC is somewhat more complicated, and it becomes necessary to examine briefly certain of its substantive provisions. The basic Com- II — Analysis of the Commission com- munity rule in this area, which was laid plaints down in Article 3(1) of Council Directive 70/524/EEC of 23 November 1970 concern- ing additives in feeding-stuffs, 10 is that 'only those additives which are listed in Annex I [to the Directive] may be incorporated in feeding-stuffs and only subject to the requirements set out therein'. By way of derogation from this provision, Article 2(1) of Directive 93/113/EC requires Member States 'temporarily [to] allow the use and 8. Italy has not contested the complaint marketing of enzymes, micro-organisms and regarding its failure to bring into force their preparations in animal nutrition within within the deadline set the requisite provi- their territory, provided that, on the basis of sions to comply with Directive 93/53/EEC, the information available, the products do and the Commission has not withdrawn its not present a danger to human or animal complaint in this regard. Whatever the con- health, and that they are included in the list tent of Presidential Decree N o 263 of 3 July established by virtue of Article 3' of this 1997, it follows from the established case-law Directive. Article 3 required the Member of the Court that 'the question whether a States to forward to the Commission before Member State has failed to fulfil its obliga- 1 November 1994 a Ust of the enzymes, tions must be determined by reference to the micro-organisms and preparations (hereinaf- situation in the Member State as it stood at ter, for convenience, 'products') it permitted the end of the period laid down in the rea- on the basis of Article 2, while those request- soned opinion, and the Court cannot take ing the inclusion of a given product on the account of any subsequent changes', 9 other Ust were to transmit the dossiers justifying

inclusion to the Commission and the Mem- not complied with, and a large part of Italy's ber States by 1 January 1996. 11 pleadings was devoted to demonstrating that it had complied with the substantive obliga- tions imposed by Articles 2 and 3. At the hearing, however, the Commission clarified that its complaint in regard to this Directive concerned Italy's failure to bring into force 10. O n the basis of this information, the the necessary provisions to transpose Commission was under an obligation to Articles 2 and 7. In its view, the adoption publish, before 31 March 1996, a provisional and communication to the relevant authori- list of the products then permitted in the ties of the ministerial circular of 26 July 1995 Member States (Article 4(3)), and then, establishing the Italian list of permitted before 1 January 1997, a definitive Commu- products, upon which Italy relies, does not nity list of permitted products (Article 5). constitute a proper transposition of Article 2. Article 7 sets out quite detailed labelling Similarly, the Commission argues that nei- requirements for different categories of ther the circular nor Presidential products. Decree N o 228 of 1 March 1992 constitutes a sufficient transposition of the labelling requirements of Article 7; in particular, Article 7 introduces new requirements and criteria for products not covered by the 1992 Decree. The Commission adds that, in any 11. As noted above, the Commission only case, Italy failed to communicate any trans- published the provisional list of permitted position measures to it, as it was required to products in September 1996. It was also do by Article 8(2) of the Directive. unable to meet the deadline of 1 January 1997 for the adoption of the definitive list; as a result, Council Directive 97/40/EC of 25 June 1997 amending Directive 93/113/EC concerning the use and marketing of enzymes, micro-organisms and their prepa- rations in animal nutrition 12 extended the 13. In respect of Article 2, Italy has accused deadline to 1 July 1998. the Commission of being excessively formal- istic. The national list it forwarded to the Commission in December 1994 was provi- sional in character, pending the adoption of the definitive Community list of permitted 12. The Commission did not specify during products; furthermore, a national transposi- the written procedure which aspects of tion was no longer indispensable following Directive 93/113/EC it considered Italy had the publication of the consolidated national lists by the Commission in September 1996.

provisions to comply with Article 2 by 26 July 1995 on which Italy relies does not 1 October 1994; it appears from the case-file create a sufficiendy clear legal situation in its that it had not done so before the expiry of territory as regards the marketing and use of the deadline set by the Commission's rea- the listed products and, hence, does not con- soned opinion, in March 1996, nor had it stitute a proper fulfilment of its transposition done so by the date of the oral hearing. Even obligations under Article 8(1) of Directive if it were a proper defence, which I doubt, I 93/113/EC as regards Article 2. N o r does the do not accept that the Commission is being publication in the ' C ' series of the Official 'excessively formalistic'. A failure properly Journal of the European Communities, which to transpose Article 2 could, in my view, is reserved for Information and Notices, of a have important practical consequences, for consolidated list of products permitted in the example, for producers or potential users of Member States correct this situation at the such products who wish to market or use a national level or dispense the Member States given product in Italy, and who would only from their duty to transpose Article 2. have the circular to justify their activities in the face of the general prohibition laid down in Article 3(1) of Council Directive 70/524/EEC, which has, presumably, been enacted into Italian law.

I - 7238

COMMISSION v ITALY

III — Conclusion

17. In view of the foregoing, I would recommend to the Court that it:

(1) Declare that, by failing to bring into force within the deadlines set the laws, regulations and administrative provisions necessary to comply with Council Directive 93/53/EEC of 24 June 1993 introducing minimum Community mea- sures for the control of certain fish diseases, Council Directive 93/113/EC of 14 December 1993 concerning the use and marketing of enzymes, micro- organisms and their preparations in animal nutrition, and Council Directive 93/114/EC of 14 December 1993 amending Directive 70/524/EEC concerning additives in feedingstuffs, the Italian Republic has failed to comply with its obligations under these Directives and the Treaty;

(2) Order the Italian Republic to pay the costs.