C-23/00

COUNCIL v BOEHRINGER

OPINION OF ADVOCATE GENERAL RUIZ-JARABO COLOMER delivered on 4 October 2001 1

1. The Council of the European Union is and to rule on the objection of inadmis- seeking to have a judgment of the Court of sibility raised by it in Case T-125/96. It is First Instance partially set aside, on the not, however, seeking an order for costs ground that it failed to examine the objec- against the defendants. tion of inadmissibility raised by the Council in a case in which two undertakings were seeking annulment of a directive and com- pensation for the damage resulting there- from. 2

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3. Boehringer Ingelheim Vetmedica GmbH raised an objection of inadmissibility pur- ('BI Vetmedica') is practically the only suant to Article 114 of the Rules of Pro- pharmaceutical company within the Euro- cedure. Two years later, by an order of pean Union to produce and market veterin- 19 November 1998, the Court of First ary medicinal products containing a beta- Instance decided to join the objection of agonist, namely clenbuterol, for the treat- inadmissibility to an examination of the ment of respiratory disorders in animals merits of the case. intended for human consumption. It accounts for about 97% of sales of the veterinary medicinal products affected by the prohibition on the marketing and administering of beta-agonists laid down in Directive 96/22. 6. On 8 July 1996 the Commission adopted Regulation (EC) No 1312/96, 5in which it established provisional maximum residue limits for clenbuterol in foodstuffs of animal origin, but exclusively for the therapeutic purposes authorised under Directive 96/22/EC, namely, in the case of The adoption of that directive meant that, bovines, solely for inducing tocolysis in with effect from 1 July 1997 (the date on cows when calving and, in the case of which Member States were to have adapted equines, for inducing tocolysis and treating their domestic laws), BI Medica was unable respiratory ailments. to market in those States its veterinary medicines containing clenbuterol for ani- mals intended for human consumption, except for the therapeutic purposes listed in Article 4(2).

Realising that the application for the par- dismissed in turn. For that reason, in tial annulment of Regulation No 1312/96 paragraph 143, the Court of First Instance in Case T-152/96 was essentially based on declared the claim for annulment of Direc- the plea of illegality raised against Directive tive 96/22 unfounded and considered that 96/22, the partial annulment of which there was no need to rule on the objection formed part of the subject-matter of the of inadmissibility raised by the Council. action in Case T-125/96, and that the arguments used by the applicants to chal- lenge the legality of that directive were substantially the same in both cases, the Court of First Instance deemed it appropri- ate to rule on the issue, common to both The claim for compensation was based on cases, of the legality of Directive 96/22, an alleged breach of the rules of law relied before examining the outstanding questions on by the applicants. Since the Court of of admissibility and substance raised by First Instance had already held that Direc- each of them. tive 96/22 did not infringe any of those rules, it dismissed the claim as unfounded, adding that there was no need to rule on the objection of inadmissibility raised by the Council.

9. For the purpose of establishing the 10. In its operative part, the judgment illegality of Directive 96/22, the applicants annulled Commission Regulation (EC) raised four pleas in law: breach of the No 1312/96 in so far as it restricted the principle of proportionality; breach of the validity of the maximum residue limits principles of legal certainty and protection established for clenbuterol to certain spec- of legitimate expectations; breach of the ified therapeutic indications for bovines principle of sound administration; and and equines, and for the rest dismissed the infringement of Article 43 of the EC Treaty applications. on the ground of failure to comply with the requirement to consult the European Par- liament further when the text finally adopted, taken as a whole, differed materially from the text on which it had already been consulted. II. The Appeal

damage in Case T-125/96 and against the The Stichting Kwaliteitsgarantie Vlees- plea of illegality raised in the context of the kalverensector (SKV) and the Commission, application for partial annulment of Regu- which intervened before the Court of First lation No 1312/96 in Case T-152/96. Instance in support of the forms of order However, it is lodging an appeal since it sought by the Council, lodged a response considers that the Court of First Instance but not a rejoinder. erred in law by failing to examine the objection of inadmissibility raised on the ground of the applicants' lack of locus standi. 13. Since none of the parties submitted an application setting out its reasons for wishing to be heard, the Court of Justice decided, in accordance with the provisions of Article 120 of the Rules of Procedure, to In their response, BI Vetmedica, Boehringer dispense with the hearing. and the Fédération de la santé animale (Fedesa), which in the proceedings before the Court of First Instance was granted leave to intervene in support of the forms of order sought by those undertakings, main- tained that the Council's appeal was mani- 14. For the purposes of an analysis of the festly inadmissible, in particular since it did legal questions to which this case gives rise, not comply with the conditions laid down I shall deal with the admissibility of the in the second paragraph of Article 49 of the appeal as a preliminary issue. I shall then EC Statute of the Court of Justice, given look at the merits of the case in the that the Council had been successful. following order: I shall examine the objec- tion of inadmissibility raised before the Court of First Instance in the action for annulment of Directive 96/22 and then the objection of inadmissibility raised in the action for compensation for damage; and, 12. The President of the Court of Justice lastly, I shall express my view on the authorised the Council to prepare a suc- admissibility of the application for annul- cinct reply dealing only with that issue. ment.

the first being that the fact that it has been 17. The Council contends that its appeal is successful prevents it from appealing, in admissible and claims that the form of accordance with Article 49 of the Statute of order sought in the document in which it the Court of Justice. Since the application claimed that the action for annulment was was held to be unfounded, as the Council inadmissible, and which it submitted in contended it should be, the Council cannot accordance with Article 114(1) of the Rules maintain, for the purpose of seeking to of Procedure of the Court of First Instance, have the judgment set aside, that it was was not granted. It submits that, according unsuccessful in its submissions. to the fourth paragraph of Article 230 EC, a private individual does not have locus standi to institute proceedings for annul- ment of a directive, so that, if the Court of First Instance is satisfied that the contested act is in the nature of a directive, there is no need to proceed with its examination of the act since the action is inadmissible in any The second reason is that the application event. The Council states, last, that it does does not satisfy the requirements of not claim to restrict the discretion of the Article 225 EC, Article 51 of the Statute Court of First Instance to organise its and Article 112(1)(c) of the Rules of Pro- procedure, but that it seeks a determination cedure of the Court of Justice, since the of the question of the applicants' locus appellant confines itself to reproducing the standi and a decision as to the stage at arguments that it put forward before the which such a matter should be considered. Court of First Instance. It does not identify the error of law in the judgment. Nor does it cite the provision that has been infringed.

However, those characteristics, which dis- tinguish the present appeal from the vast majority of appeals to the Court of Justice, 21. Second, because, under the first para- do not mean that the Council's appeal graph of Article 49 of the Statute, an should be declared manifestly inadmissible, appeal may be brought, inter alia, against as BI Vetmedica, Boehringer and Fedesa a decision of the Court of First Instance propose. disposing of a procedural issue concerning a plea of inadmissibility.

23. On that point, there is only one preced- ent which seems to me to be relevant to this case. France was the first Member State to In the judgment, the Court of Justice make use of the third paragraph of allowed the appeal, annulled the judgment Article 49 of the Statute of the Court of of the Court of First Instance and, giving Justice. It did so because it disagreed with final judgment in the matter, dismissed the the Court of First Instance, which, after application for annulment lodged by Com- reserving its decision for the final judg- africa Spa and Dole Fresh Fruit Europe Ltd ment, dismissed the Commission's objec- & Co. as inadmissible. tion that the action was inadmissible on the ground that the applicants lacked locus standi. In that case, the Court of First Instance had expressly declared the action admissible and, after considering the sub- stance of the matter, dismissed it as unfounded. 8 25. Third, there is a further argument for declaring the Council's appeal admissible. Under the third paragraph of Article 49 of the Statute of the Court of Justice, with the Advocate General Mischo emphasised the exception of cases relating to disputes novelty of the appeal in points 5 to 16 of between the Community and its servants, his Opinion 9and pointed out that it did an appeal may be brought not only by not appear to seek to set aside, in whole or Member States which did not intervene in in part, the decision of the Court of First the proceedings at first instance but also by Instance within the meaning of Article 113(1) the Community institutions, which are in of the Rules of Procedure of the Court of the same position as Member States or Justice. institutions which intervened at first instance. Since the Council would have been able to lodge the present appeal 8 — Case C-73/97 P France v Coafrica and Others [1999] ECR without having been a party at first I-185. instance, there are even more compelling 9 — Opinion in Case C-73/97 P France v Comafrica and Others, cited in footnote 7 above. reasons why it should be able to do so

28. Although the Court of First Instance upheld its claims and did not annul Direc- First, the Council does not merely repro- tive 96/22, the Council considers that that duce the arguments put forward at first outcome was only apparently successful instance, since it does not claim in the and has appealed against the judgment, appeal that the objection was well founded: seeking a declaration that the Court of First the ground on which it relies is the Court of Instance committed a fundamental error of First Instance's failure to rule on the law by not dealing with the objection of objection; and, for obvious reasons, that inadmissibility based on the applicants' omission could not be addressed by the lack of locus standi when it should have parties prior to pronouncement of the done so. The Council maintains that by not judgment under appeal. ruling on the right of a natural or legal person to seek the annulment of a directive before proceeding to examine the substance of the case, the Court of First Instance did not act in accordance with either the letter or the spirit of the fourth paragraph of Second, the Council has identified the error Article 230 EC and that the decision is of law as the Court of First Instance's inconsistent with its own case-law. omission to resolve the objection of inad- Whether or not the applicant has locus missibility before dealing with the sub- standi is a preliminary issue which must be stance of the case. evaluated before the substance of a case is

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SKV further states that, although the Court of First Instance, for reasons of procedural 29. BI Vetmedica and Boehringer contend efficiency, proceeded to deal with the that, under the general principle of pro- legality of Directive 96/22 before turning cedural law whereby the Court is master of to issues of admissibility and substance, it both procedure and evidence, 10 the Court was not entitled to ignore the objection of of First Instance has a wide discretion to inadmissibility raised by the Council, tak- organise the procedure in accordance with ing into account the questions of principle the characteristics of each case and of the raised in this case. connexity of the issues raised. This dis- cretion includes the power to proceed to the substance of a case before investigating the admissibility of the application, pro- vided that this course of action seems The Commission, which agrees with the preferable for reasons of procedural econ- Council, further maintains that if the lack omy or for any other reason. In this specific of jurisdiction of the Court of First Instance case, they consider that it was necessary, in to take cognisance of an action determines the interest of the sound administration of that the application is devoid of purpose justice and in order to facilitate the proper and that it must be dismissed, the inadmis- conduct of the proceedings, to rule on the sibility of the application is a ground for legality of Directive 96/22 before examin- finding that the Court has no jurisdiction to ing the admissibility of the application, hear the case. The admissibility of an application is not at the discretion of the parties, since a bar to proceeding with the 10 — They cite the Opinion of Advocate General Cosmas in Case C-199/92 P Hüls v Commission [1999] ECR I-4287, case is mandatory and the Court is under point 48.

since the former was the central issue in no jurisdiction to deal with the substance of Cases T-125/96 and T-152/96. To seek to the proceedings. Proof of that assertion lies limit the discretion of the Court of First in the fact that the persons with a right of Instance, as the Council does in its appeal, access to the Community Courts are is equivalent to attacking the principle of defined in the Treaty (Articles 226 EC to separation of powers between institutions 228 EC for actions for failure to fulfil laid down in the EC Treaty. Fedesa fully obligations under the Treaty; Article 230 EC supports the respondents' arguments. for actions for annulment; Article 232 EC for actions for failure to act; or Article 236 EC for actions by officials) and in the Statute (Article 37 for inter- vention; and Articles 49 and 50 for appeals), not in the Rules of Procedure. 30. As the respondents and Fedesa claim, Second, lack of locus standi is one of the the Court of First Instance does indeed have absolute bars to proceeding with an action a wide discretion to organise the procedure. which the Court of First Instance may at Thus, to take some examples, Article 64 of any time consider of its own motion. its Rules of Procedure regulates the meas- ures of organisation of procedure which, pursuant to Article 49, may be prescribed at any stage of the proceedings; Article 51 establishes the grounds on which cases may be referred to the various differently-con- It is true that under Article 114(4) of its stituted benches; and Article 50 confers on Rules of Procedure the Court of First the President the power to order that two Instance may decide on such an application or more cases be joined on account of the or reserve its decision for the final judg- connection between them. ment. In that regard, the Court of Justice has held that it is for the Court of First Instance to decide whether or not the proper administration of justice justifies immediate adjudication upon an objection of inadmissibility or postponement of such However, I do not believe that those adjudication until final judgment. n discretionary powers are sufficiently wide to extend to the preliminary issues regu- lated exhaustively in Articles 111 to 114 of the Rules of Procedure, or that they include the power to refrain from expressly resolv- ing an objection of inadmissibility raised by However, to my mind that does not mean one of the parties. that the Court of First Instance can address the substance of the case before resolving the issue of the alleged lack of locus standi. To take the opposite approach, which is precisely what it did in the judgment which the Court of Justice is asked to set aside, 31. That view is based on a number of seems to me to prejudge the locus standi reasons. First, the locus standi of the applicant to bring an action is a require- ment which must be satisfied if the case is 11 _ Case C-126/90 P Bocos Vietano v Commission [1991] to proceed: where it is not, the Court has ECR I-781, paragraph 6.

32. With a view to determining whether the judgment under appeal should be set aside, I have reviewed the cases of the Court of Justice and those of the Court of First Instance in which an objection of inadmissibility had been reserved for final Among this group I encountered one case judgment, in order to ascertain how each which departed from the general rule. The Court has acted in that regard. I shall Commission raised a plea of inadmissibility examine the two groups of cases separately. by means of a separate document and the Court made an order joining the plea to the main proceedings 20 without stating what the plea was or making any further refer- ence to it. 33. In the 30 cases to have come before the Court of First Instance which I have examined, I have found that, as a general rule, the Court refers to the objection of inadmissibility before dealing with the substance of the case, whether it is alleged that the applicant lacks of locus standi, 12 In any event, in accordance with the case- that the action is out of time, 13 that the law of the Court of First Instance, among contested measure is not open to chal- the absolute bars to proceeding with an lenge, 14 that the applicant has no interest action, the existence of which it may in bringing the action, 15 that the contested consider at any time, even of its own

12 — Joined Cases T-528/93, T-542/93, T-543/93 and T-546/93 16 — C a s e T-167/97 Skrikas v Parliament [1998] ECR-SC Métropole Télévision and Others v Commission [1996) I-A-287,II-857. ECR II-649. 17 — C a s e T-112/95 Dethlefs and Others v Council and 13 — Joined Cases T-374/94, T-375/94, T-384/94 and T-388/94 Commission (1998) ECR II-3819. European Night Services and Others v Commission [19981 18 — Case T-72/99 Meyer v Commission [2000] ECR II-2521. ECR II-3141; and Case T-37/97 Forges de Clabecq v Commission [1999] ECR II-859. 19 — Case T-37/92 BEUC and NCC v Commission [1994] ECR II-285. 14 — Case T-3/93 Air France v Commission [1994] ECR II-121. 20 — Order in Case T-136/95 Industria del Frio Auxiliar 1 5 — J o i n e d Cases T-369/94 and T-85/95 DIR International Conservera v Commission [1998] ECR II-3301, paragraph Film and Others v Commission [1998] ECR II-357. 22.

motion, are those relating to the require- paragraph of Article 230 EC, 25 that the ments of admissibility of actions laid down applicant has no interest in bringing the in t h e f o u r t h p a r a g r a p h of action, 26 that the Court of Justice has no Article 230 EC. 21 jurisdiction to hear the case, 27 that no prior complaint was lodged (in staff cases), 28 that there is no harmful act, 29 or that the action cannot be directed against the defendant. 30 On one occasion, moreover, despite analysing the plea of inadmissibil- ity, the Court of Justice decided that the question whether the objection of inadmis- sibility was well founded must be deter- mined together with the substantive issues

21 — Case T-239/94 EISA v Commission [1997] ECR II-1839, paragraph 26; Case T-100/94 Michailidis and Others v the rule. In Van Reenen v Commission 32 Commission [1998] ECR II-3115, paragraph 49; Case the Commission claimed that the appli- T-114/96 Biscuiterie-confiserie LOR and Cofiserie du Tech v Commission [1999] ECR II-913, paragraph 24; cation was out of time and the Second Case T-194/95 Area Cova and Others v Council [1999] ECR II-2271, paragraph 22; and Case T-12/96 Area Cova v Council [1999] ECR II-2301, paragraph 21. 22 — Case C-279/94 Commission v Italy [1997] ECR I-4743; 25 — Case 22/70 Commission v Council [1971] ECR 263; Case and Case C-35/96 Commission v Italy [1998] ECR I-3851. C-213/88 Luxembourg v Parliament [1991] ECR I-5643; 23 — Case 15/59 Société métallurgique de Knutange v High Case C-316/91 Parliament v Council [1994] ECR I-625; Authority [I960] ECR 1; Joined Cases 25/65 and 26/65 Case C-135/93 Spain v Commission [1995] ECR I-1651; Símet and Others v High Authority [1967] ECR 113; Case and Case C-25/94 Commission v Council [1996] ECR 79/71 Heinemann v Commission [1972] ECR 579; Case I-1469. 11/72 Giordano v Commission [1973] ECR 417; and Case 159/86 Canters v Commission [1988] ECR 4859. 26—Joined Cases 177/73 and 5/74 Reinarz v Commission [1974] ECR 819; Case 4/74 Scuppa v Commission [1975] 24 — Case 106/63 Toepfer v Commission [1965] ECR 405; ECR 919; and Case 167/86 Rousseau v Court of Auditors

This was proposed to the Full Court I-3525; and Case C-65/90 Parliament v Council [1992] ECR I-4593. Py Advocate General Tesauro in his Opinion. 32 — Case 189/73 [1975] ECR 445.

Chamber of the Court of Justice held that, question of admissibility and the substance since the action clearly lacked any foun- of the action, it was appropriate to proceed dation, there was no need to give a ruling directly to consideration of the substance of on the objection of inadmissibility. 33 In the case. 37 Last, in Bocos Viciano v Com- Giry v Commission 34 the Commission put mission 38 the Commission claimed that the forward, as reasons why the action should appeal was inadmissible owing to a pro- not be admitted, the failure to lodge a prior cedural irregularity in the way in which the administrative complaint and the absence application had been submitted and men- of interest in bringing the action. The same tioned up to five omissions.

35. None of the above decisions, taken in had been taken, either expressly or by isolation or in combination, provides implication. On this occasion the Third grounds for interpreting Article 92(2) of Chamber considered, without stating its the Rules of Procedure of the Court of reasons, that it was appropriate to deter- Justice and Article 113 of the Rules of mine the substance of the case and to Procedure of the Court of First Instance as determine subsequently whether it was still meaning that the possibility of considering necessary to rule on the objections of at any time, of its own motion, whether inadmissibility. 36 In Tradax v Commission there exists any absolute bar to proceeding (Case 64/82 [1984] ECR 1359) the Com- with an action may be understood as an mission claimed that the action was inad- option of the Court. On the contrary, in my missible because, inter alia, it was directed view, the emphasis should be placed on the against a measure which was not suscep- fact that this examination may be carried tible of review within the meaning of out by the Court of its own motion and at Article 230 EC.

34 —Joined Cases 126/75, 34/76 and 92/76 [1977] ECR 1937. 35 — Advocate General Capotorti, on the other hand, undertook a detailed examination of the objections to admissibility in 37 — In his Opinion, Advocate General Sir Gordon Slynn did his Opinion and proposed that they be rejected. examine the grounds of inadmissibility put forward by the 36 — Advocate General Verloren Van Themaat examined both Commission. objections and concluded that they should be rejected. 38 — Cited in footnote 11 above.

(b) The objection of inadmissibility of the action for compensation raised before the Court of First Instance and the failure to 39. In the present proceedings, the United determine that objection which gave rise to Kingdom claims that the Council's appeal the appeal should be dismissed in so far as it relates to paragraph 146 of the judgment. It contends that the special nature of the directive does not mean that it cannot give rise to the non-contractual liability of the Commu- nity. Although it is the national authorities 37. In paragraph 6 of its application, under that incorporate the rule into their domestic the heading 'Background', the Council law, and although that legislation is the quotes paragraph 146 of the judgment immediate source of the damage to indi- under appeal, where the Court of First viduals, it cannot be precluded at the outset Instance held that there was no need to rule that the origin of the liability may lie in the on the objection of inadmissibility because Community act. For this reason it disagrees Directive 96/22 would not be annulled. The with the Council's argument that individ- Council merely observes that this is the uals lack locus standi if the act which can only point in the entire judgment at which allegedly give rise to non-contractual lia-

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41. There are a number of reasons. First, it is settled case-law that the action for c o m p e n s a t i o n p r o v i d e d for by Articles 235 EC and 288 EC was intro- duced as an autonomous form of action with a particular purpose to fulfil within However, the Court has consistently held the system of actions and subject to con- that the Community's non-contractual lia- ditions on its use dictated by its specific bility cannot be incurred through the nature, so that the fact that the action for adoption of a legislative measure involving annulment is declared inadmissible does a choice of economic policy unless a not automatically mean that the action for sufficiently flagrant violation of a superior compensation is inadmissible.39 The con- rule of law for the protection of the ditions of admissibility of both actions are individual has occurred. Thus in a legis- therefore not the same. lative context characterised by a wide margin of discretion, which is essential for

39 — Case C-87/89 Sonito and Others v Commission [1990] ECR I-1981, paragraph 14; and order in Case C-257/93 40 — Case C-146/91 KYDEP v Council and Commission [1994] Van Parijs and Others v Council and Commission [1993] ECR 1-4199, paragraph 19, and Case C-104/97 P Atlanta v ECR I-3335, paragraph 14. European Community [1999] ECR I-6983, paragraph 65.

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the implementation of the common agri- conditions are satisfied, may give rise to a cultural policy, such liability can therefore declaration that the Community has be incurred only if the institution concerned incurred non-contractual liability. has manifestly and gravely disregarded the limits on the exercise of its powers. 41

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45. In support of its claim that the action is Member States are to implement a direc- inadmissible, the Council submits that tive; and when the application for annul- u n d e r the f o u r t h p a r a g r a p h of ment of Directive 96/22 was lodged at first Article 230 EC a natural or legal person instance that period had not yet expired. may only institute proceedings for annul- ment of a decision addressed to that person or one which, although in the form of a regulation or a decision addressed to another person, is of direct and individual concern to the person in question. Those measures which are open to challenge are distinguished by the fact that they are not SKV claims that if an individual were of general application or normative in allowed to seek annulment of a directive, nature, since, even where an action against the interpretation of Article 230 EC would a regulation is admitted, the measure in be stretched to the point of exceeding the question is in reality a disguised decision. A permitted limits of the system of judicial further requirement is that the persons to protection laid down in the Treaty. Fur- whom the measure is addressed or those to thermore, the characteristics of directives whom it is of direct and individual concern are such that judicial protection for indi- be affected in legal terms owing to a factual viduals is always possible in each State once situation which applies to them and distin- they have been incorporated into domestic guishes them from other persons. law.

47. There is no doubt that, as already seen, the fourth paragraph of Article 230 EC restricts the locus standi of natural and legal persons to seek annulment of a Community measure. As the Court of First Instance has recently held, that paragraph makes no provision, for the benefit of individuals, for a direct action before the Community judicature challenging a direc- tive. 42

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certain substances listed exhaustively; and 51. BI Vetmedica and Boehringer claim in order for those provisions to be appli- that they are individually concerned by cable in the Member States, they must be those provisions, which, they allege, are incorporated into the internal legal order aimed at a closed category of undertakings by means of national implementing meas- made up of those holding the necessary ures. authorisations, including themselves, and that there is a specific link between that closed category of undertakings and the content of the decision. Furthermore, Directive 96/22 affected the specific rights of BI Vetmedica and Boehringer, recog- 49. It is settled case-law that the general nised by the authorisations, to manufacture application, and thus the legislative nature, and market veterinary medicinal products of a measure is not called in question by the containing clenbuterol. The effect which fact that it is possible to determine more or the measure has on those undertakings is less precisely the number or even the such that it distinguishes them from all identity of the persons to whom it applies other producers, because, in addition, they at any given time, as long as it is established are practically the sole manufacturers of that such application takes effect by virtue the prohibited medicines. of an objective legal or factual situation defined by the measure in question in relation to its purpose. 45

52. Since the judgment in Plaumann v Commission, 48 the Court of Justice has held that a decision addressed to a Member 50. In addition to classifying a directive as State is of direct and individual concern to a. measure of general application, 46 the natural or legal persons only if that Court of Justice has also held that although decision affects them by reason of certain in principle it is binding only on the parties attributes which are peculiar to them, or by to whom it is addressed, namely the reason of circumstances in which they are Member States, a directive constitutes a differentiated from all other persons, and form of indirect regulatory or legislative by virtue of these factors distinguishes them measure. 47 individually just as in the case of the person addressed. 49

legislative measure of general application, 53. BI Vetmedica and Boehringer further aimed in a universal and abstract manner at maintain that the impugned provisions of a wide range of economic operators Directive 96/22 directly affect their legal involved in activities connected with the situation, since no discretion is left to the raising of livestock for human consump- Member States, which were required tion, varying from undertakings which simply to prohibit any use whatsoever of market substances with hormonal and the products in question, with the excep- tireostatic effects and beta-agonists to those tion of their application for the therapeutic with livestock farms, including those which purposes restrictively defined in market meat products and also veterinary Article 4(2). surgeons. The directive cannot therefore be regarded as having concerned a specific number of persons at the time when it was adopted.

The Court's case-law shows that, for a Even if that were the position, however, person to be directly concerned by a and the directive had to be regarded as Community measure, the latter must being aimed at a closed category of iden- directly affect the legal situation of the tifiable undertakings at the time when it individual and leave no discretion to the was adopted, the fact that the Member addressees of that measure who are States were given more than one year to entrusted with the task of implementing implement it meant that there was no it, such implementation being purely auto- reason why some undertakings should not matic and resulting from Community rules have ceased to carry on those activities and without the application of other intermedi- others begun to do so before the period in ate rules. 50 It must be borne in mind, question had expired. moreover, that a directive may not of itself

54. For the reasons stated, I consider that Therefore, a directive such as the contested the application for annulment submitted by directive, which requires the Member BI Vetmedica and Boehringer is inadmiss- States to prohibit the marketing of certain ible. substances for administering to animals for human consumption, for other than thera- peutic purposes, cannot of itself, before the national implementing measures have been adopted, directly affect the legal position of the appellant undertakings within the meaning of the fourth paragraph of Article 230 EC. Directive 96/22 leaves the Member States a certain discretion when III. Costs implementing it, since they may authorise the prohibited substances to be adminis- tered for therapeutic purposes to certain animals and in certain circumstances. If the use of such substances is allowed in those 55. Under Article 122 of the Rules of terms, the conditions set out in Article 6, Procedure, the Court of Justice is to make which refers in turn to two other directives, a decision as to costs where the appeal is will have to be satisfied. Where those uses well founded and the Court itself gives final are authorised a register must be set up, in judgment in the case. which the responsible veterinarians must record the treatment carried out. Last, the Council reserves the possibility to adopt transitional measures necessary for the

51 — See Case 152/84 Marshall [1986] ECR 723, paragraph 48; Case 80/86 Kolpinghms Nijmegen (1987] ECR 3969, Since the Council has not applied for costs, paragraph 9; Case C-91/92 Faccini Dori |1994| ECR each of the parties must be ordered to bear I-3325, paragraph 25; and Case C-192/94 El Corte Inglés [1996] ECR I-1281, paragraph 15. its own costs.

(3) dismiss the remainder of the appeal;

(4) order the parties to bear their own costs.

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