Judgment of the Court of 26 February 2002. - Commission of the European Communities v Boehringer Ingelheim Vetmedica GmbH and C. H. Boehringer Sohn. - Appeal - Veterinary medicinal products - Partial annulment of Commission Regulation (EC) No 1312/96 in so far as, in fixing the maximum residue limits for clenbuterol chlorhydrate, it further specifies the permissible therapeutic indications for that substance - Possibility for the Commission, in fixing the maximum residue limits of veterinary medicinal products, to take into account Directive 96/22/EC concerning the prohibition on the use of certain substances. - Case C-32/00 P.



European Court reports 2002 Page I-01917



Summary

Parties

Grounds

Decision on costs

Operative part



Keywords

Agriculture - Uniform legislation - Maximum residue limits of veterinary medicinal products in foodstuffs of animal origin - Procedure for establishing limits - Regulation No 2377/90 - Possibility for the Commission to include references to the therapeutic indications permitted for clenbuterol

(Council Regulation No 2377/90, Annex III; Commission Regulation No 1312/96; Council Directive 96/22)

Summary

$$The references to the permitted therapeutic indications for clenbuterol which appear in Annex III to Regulation No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as amended by Regulation No 1312/96, must be regarded as merely declaratory, and not having, in themselves, the character of legislation.

In the first place, those references cannot be understood as having the object or effect of laying down a prohibition on the marketing and use of clenbuterol, subject to the therapeutic indications mentioned by them, which is independent of the prohibition laid down by Directive 96/22. Nor can those references be understood as having the object or effect of placing a limitation on the validity of the maximum residue limits (MRLs) established for clenbuterol in the context of Regulation No 2377/90. The Commission did not therefore need authorisation from Regulation No 2377/90 in order to be able to insert references to the permitted therapeutic indications for clenbuterol in Annex III to that regulation, as amended by Regulation No 1312/96, for the purposes of recalling the relevant provisions of Directive 96/22.

The Court of First Instance therefore erred in law by holding that the Commission could not lawfully base the limitation of the validity of the MRL established for clenbuterol on the provisions of Directive 96/22, when, first, the references to permitted therapeutic indications for clenbuterol did not have the object or effect of limiting the validity of the MRL established by Regulation No 1312/96, and, second, no provision prohibited the Commission from inserting in Annex III to Regulation No 2377/90, as amended by Regulation No 1312/96, a reminder of the effects of the provisions of Directive 96/22 in relation to the permitted therapeutic uses of clenbuterol.

( see paras 53-57 )

Parties

In Case C-32/00 P,

Commission of the European Communities, represented by X. Lewis, acting as Agent, with an address for service in Luxembourg,

appellant,

APPEAL against the judgment of the Court of First Instance of the European Communities (Second Chamber) of 1 December 1999 in Joined Cases T-125/96 and T-152/96 Boehringer v Council and Commission [1999] ECR II-3427, seeking to have that judgment set aside in part,

the other parties to the proceedings being:

Boehringer Ingelheim Vetmedica GmbH,

C.H. Boehringer Sohn,

established in Ingelheim am Rhein (Germany), represented by D. Waelbroeck and D. Fosselard, avocats, with an address for service in Luxembourg,

applicants at first instance,

Council of the European Union,

defendant at first instance in Case T-125/96 and intervener at first instance in Case T-152/96,

Fédération Européenne de la Santé Animale (Fedesa), established in Brussels (Belgium), represented by A. Vandencasteele and D. Brinckman, avocats, with an address for service in Luxembourg,

Stichting Kwaliteitsgarantie Vleeskalverensector (SKV), established in The Hague (Netherlands), represented by G. van der Wal, advocaat, and L. Parret, avocat, with an address for service in Luxembourg,

interveners at first instance,

and

United Kingdom of Great Britain and Northern Ireland,

intervener at first instance

in Case T-125/96,

THE COURT,

composed of: G.C. Rodríguez Iglesias, President, P. Jann, F. Macken and N. Colneric (Presidents of Chambers), A. La Pergola (Rapporteur), J.-P. Puissochet, M. Wathelet, R. Schintgen and V. Skouris, Judges,

Advocate General: D. Ruiz-Jarabo Colomer,

Registrar: R. Grass,

having regard to the report of the Judge-Rapporteur,

after hearing the Opinion of the Advocate General at the sitting on 4 October 2001,

gives the following

Judgment

Grounds

1 By application lodged at the Registry of the Court of Justice on 7 February 2000, the Commission of the European Communities brought an appeal pursuant to Article 49 of the EC Statute of the Court of Justice against the judgment of the Court of First Instance of 1 December 1999 in Joined Cases T-125/96 and T-152/96 Boehringer v Council and Commission [1999] ECR II-3427 (the contested judgment), seeking to have that judgment set aside in part.

Legal background

2 On 26 June 1990, the Council adopted Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ 1990 L 224, p. 1).

3 Under Regulation No 2377/90, the Commission is to establish a maximum residue limit (hereinafter MRL), defined in Article 1(1)(b) of that regulation as the maximum concentration of residue resulting from the use of a veterinary medicinal product which may be accepted by the Community to be legally permitted or recognised as acceptable in or on a food.

4 Regulation No 2377/90 provides that, after assessment of the risks which they represent for public health, pharmacologically active substances used in veterinary medicinal products are to be included in one of the four lists set out in Annexes I to IV. Annex I concerns substances in respect of which an MRL may be established, and Annex II those in respect of which it does not appear to be necessary to establish an MRL. Annex III concerns substances which may, under certain conditions, be given a provisional MRL, and Annex IV concerns substances in respect of which no MRL can be established, by reason of their hazardous nature.

5 Article 6(1) of Regulation No 2377/90 provides:

In order to obtain the inclusion in Annex I, II, or III of a new pharmacologically active substance which is:

- intended for use in veterinary medicinal products for administration to food-producing animals, and

- intended to be placed on the market of one or more Member States which have not previously authorised the use of the substance concerned in food-producing animals,

the person responsible for marketing shall submit an application to the Commission. ...

6 From the expiry of the transitional period laid down in Article 14 of Regulation No 2377/90, the administration to food-producing animals of veterinary medicinal products containing pharmacologically active substances which are not mentioned in Annexes I, II, or III is, in principle, prohibited within the Community.

7 According to Article 15 of Regulation No 2377/90, no provision of that regulation is in any way to prejudice the application of Community legislation prohibiting the use in livestock farming of certain substances having a hormonal action or the measures taken by Member States to prevent the unauthorised use of veterinary medicinal products.

8 On 29 April 1996, the Council adopted Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ 1996 L 125, p. 3).

9 According to the sixth recital in the preamble to Directive 96/22, the improper use of beta-agonists can be a serious risk to human health, so that, in the interests of the consumer, the holding, administering to animals of any species and the placing on the market for that purpose of beta-agonists should be prohibited.

10 To that end, Article 2(b) of Directive 96/22 provides that Member States are to prohibit the placing on the market of beta-agonists for administering to animals the flesh and products of which are intended for human consumption for purposes other than those provided for in point 2 of Article 4.

11 Article 3 of Directive 96/22 provides:

Member States shall prohibit:

(a) the administering to a farm ... animal ... of beta-agonists;

(b) the holding, except under official control, of animals referred to in (a), on a farm, the placing on the market or slaughter for human consumption of farm animals ... which contain the substances referred to in (a) or in which the presence of such substances has been established, unless proof can be given that the animals in question have been treated in accordance with Articles 4 or 5;

...

(d) the placing on the market of meat of the animals referred to in (b);

(e) the processing of the meat referred to in (d).

12 In accordance with point 2 of the first paragraph of Article 4 of Directive 96/22, the Member States may, by way of derogation from Articles 2 and 3, authorise the administering for therapeutic purposes of authorised veterinary medicinal products containing (inter alia) beta-agonists for certain categories of bovines, equidae and pets.

13 Article 1(2)(b) of Directive 96/22 defines therapeutic treatment as the administering - under Article 4 of this directive - to an individual farm animal of an authorised substance to treat, after examination by a veterinarian, a fertility problem ... and, in the case of beta-agonists, to induce tocolysis in cows when calving and to treat respiratory problems and to induce tocolysis in equidae raised for purposes other than meat production.

14 On 8 July 1996, the Commission adopted Regulation (EC) No 1312/96 amending Annex III to Regulation No 2377/90 (OJ 1996 L 170, p. 8).

15 Following the amendment made by Regulation No 1312/96, Annex III to Regulation No 2377/90 fixes provisional MRLs for a particular beta-agonist substance, clenbuterol chlorhydrate (clenbuterol), specifying, under its heading Other provisions, first, the expiry date of those MRLs, namely 1 July 2000, and, second, the therapeutic indications authorised for that substance, namely, in the case of bovines, solely for inducing tocolysis in cows when calving and, in the case of equidae, for inducing tocolysis and treating respiratory ailments.

16 In that respect, Regulation No 1312/96 states, in the seventh recital in its preamble, that Directive [96/22] prohibits the use of clenbuterol in all farm animals with the exception of some specific therapeutic purposes in equidae and in cows.

Facts and procedure before the Court of First Instance

17 The facts underlying the dispute, as described in paragraphs 3, 4, 36 and 37 of the contested judgment, are the following.

18 Boehringer Ingelheim Vetmedica GmbH (hereinafter BI Vetmedica) develops and markets veterinary medicinal products. It is a wholly owned subsidiary of C.H. Boehringer Sohn (hereinafter Boehringer), which is one of the leading 20 pharmaceutical companies in the world.

19 BI Vetmedica is one of the two pharmaceutical undertakings in the European Union with produce and market veterinary medicinal products containing a beta-agonist substance, namely clenbuterol, for treating respiratory problems of commercial animals, that is to say animals intended for marketing and the flesh and products of which are consumed by humans. According to its own statements before the Court of First Instance, BI Vetmedica's market share accounts for about 99% of sales of veterinary medicinal products containing clenbuterol in the European Union.

20 On 20 July 1994, on the basis of Regulation No 2377/90, BI Vetmedica applied to the Commission for the establishment of MRLs for clenbuterol as regards bovines and equidae. In an opinion dated 3 January 1996, the Committee for Veterinary Medicinal Products recommended, for reasons of scientific methodology, the adoption of provisional MRLs, expiring on 1 July 2000. It was following that request that the Commission adopted Regulation No 1312/96.

21 In those circumstances, on 9 August 1996, BI Vetmedica and Boehringer brought an action before the Court of First Instance, registered as Case T-125/96, claiming inter alia that the Court should:

- annul Articles 1, 2, 3 and 4 of Directive 96/22/EC in so far as they prohibited the placing on the market of veterinary medicinal products containing beta-agonists intended to be administered for therapeutic purposes to animals the flesh and products of which were intended for human consumption;

- order the Community to make good the damage suffered by them as a result of the adoption of the contested measure.

22 On 27 September 1996, BI Vetmedica and Boehringer brought a second action before the Court of First Instance, registered as Case T-152/96, claiming inter alia that the Court should:

- declare, in accordance with Article 184 of the EC Treaty (now Article 241 EC), that Directive 96/22/EC, in so far as it prohibited the placing on the market of veterinary medicinal products containing beta-agonists for administration for therapeutic purposes to farm animals, was illegal and therefore could not serve to justify the restrictions contained in Regulation No 1312/96;

- annul Regulation No 1312/96 in so far as it restricted the validity of the MRLs established for clenbuterol to certain specific therapeutic purposes.

23 By order of 13 June 1997 in Case T-125/96, the Court of First Instance granted leave to intervene, on the one hand, to the Fédération Européenne de la Santé Animale (Fedesa) and the United Kingdom of Great Britain and Northern Ireland, in support of the forms of order sought by BI Vetmedica and Boehringer and, on the other, to Stichting Kwaliteitsgarantie Vleeskalverensector (SKV) and the Commission, in support of the form of order sought by the Council. By an order of the same date in Case T-152/96, the Court granted Fedesa leave to intervene in support of BI Vetmedica and Boehringer, and SKV and the Council leave to intervene in support of the Commission.

The contested judgment

24 Having examined the question of the legality of Directive 96/22 in paragraphs 59 to 141 of the contested judgment, the Court of First Instance concluded, in paragraph 142, that the four pleas in law relied upon by BI Vetmedica and Boehringer for the purposes of establishing the illegality of Directive 96/22 had to be rejected as unfounded.

25 Consequently, the Court of First Instance concluded, in paragraph 143 of the contested judgment, that the claim by BI Vetmedica and Boehringer in Case T-125/96 for the partial annulment of Directive 96/22 had to be declared unfounded in any event, without there being any need to rule on the objection of inadmissibility raised by the Council.

26 Similarly, in paragraph 146 of the contested judgment, noting that it had already held that Directive 96/22 did not infringe any of the rules of law relied upon by BI Vetmedica and Boehringer, the Court of First Instance held that the claim for compensation brought by them in Case T-125/96, being based on the alleged infringement of those rules, must be dismissed as unfounded in any event, without there being any need to rule on the objection of inadmissibility raised by the Council.

27 As regards the action, in Case T-152/96, brought by BI Vetmedica and Boehringer for the annulment of Regulation No 1312/96, the Court of First Instance first concluded, in paragraphs 173 and 175 of the contested judgment, that it was admissible.

28 On the substance, the Court of First Instance then held, in paragraph 176 of the contested judgment, that the two pleas in law relied upon BI Vetmedica and Boehringer in support of that action were underpinned by a single objection, to the effect that Directive 96/22 was unlawful.

29 The Court of First Instance went on to hold, in paragraph 180 of the contested judgment, that since the various pleas in law raised by BI Vetmedica and Boehringer for the purpose of establishing the illegality of Directive 96/22 had been dismissed, their objection of illegality had to be dismissed as unfounded in any event, without there being any need to rule on the submission by the Commission and the Council that the objection was inadmissible.

30 In those circumstances, the Court of First Instance held, in paragraph 181 of the contested judgment, that the two pleas on which BI Vetmedica and Boehringer based their action for the annulment of Regulation No 1312/96 therefore also had to be dismissed as unfounded, in so far as they were based on the alleged illegality of Directive 96/22.

31 Finally, in paragraphs 182 to 197 of the contested judgment, the Court of First Instance examined a third plea in law, raised by Fedesa in its statement in intervention and by BI Vetmedica and Boehringer in their replies to the written questions of the Court, to the effect that the Commission exceeded the power conferred upon it by Regulation No 2377/90 by limiting the validity of the MRLs for a veterinary medicinal product to certain specified therapeutic indications.

32 The Court of First Instance found in particular, in paragraph 186 of the contested judgment, that, by virtue of Regulation No 2377/90, the procedure for fixing MRLs, which might be provisional, for a pharmacologically active substance depended solely on the question whether residues of the substance in question, at the proposed level, constituted a risk to the health of consumers. It also stated, in paragraph 187 of that judgment, that that regulation did not make the inclusion of a substance in one of the nnexes I to III of the regulation subject to the condition that the product containing that substance had to be capable of being directly used and marketed.

33 In that respect, in paragraphs 188 to 191 of the contested judgment, the Court of First Instance referred in the following terms to its judgment in Case T-120/96 Lilly Industries v Commission [1998] ECR II-2571 (the Lilly judgment):

188 In that respect, the Court has already held, in Lilly, that the procedure for the establishment of an MRL under Regulation No 2377/90 is independent of, and distinct from, the procedures for the issue of the marketing authorisations laid down in Directive 81/851 and Regulation No 2309/93 (see paragraph 88 of the Lilly judgment).

189 The Court has also pointed out (in paragraph 89 of the Lilly judgment) that those two measures, which govern respectively the issue of national and Community authorisations for the marketing of veterinary medicines, expressly provide that marketing authorisation for a product will be refused where its use is prohibited under other provisions of Community law (see point 3 of the first paragraph of Article 11 of Directive 81/851 and point 3 of the first paragraph of Article 33 of Regulation No 2309/93).

190 However, Regulation No 2377/90 contains no provision authorising the Commission to take account of a ban on marketing in refusing to establish an MRL (paragraph 90 of the Lilly judgment).

191 The Court concluded (at paragraph 92 of the Lilly judgment) that the Commission was not legally entitled to base its decision refusing to establish an MRL for somidibove, a recombinant bovine somatotrophin (BST), on the existence of the moratorium on BST.

34 In paragraph 192 of the contested judgment, the Court of First Instance held that, similarly, under the procedure for establishing an MRL for clenbuterol pursuant to Regulation No 2377/90, the Commission was not legally entitled to base the limitation on the validity of that MRL on the provisions of Directive 96/22.

35 In paragraph 194 of the contested judgment, the Court of First Instance emphasised that the procedure for establishing an MRL laid down by Regulation No 2377/90 is strictly limited to the determination of the threshold below which residues of a given product, present in or on foodstuffs, may be regarded as posing no danger to human health. The Court explained in the same paragraph that, if the institutions nevertheless considered that they had other reasons for prohibiting the marketing of the product in question, they were under a duty to act by the appropriate means, as they did in this case by adopting Directive 96/22.

36 In paragraph 196 of the contested judgment, the Court of First Instance stated:

Furthermore, there is no provision in Regulation No 2377/90 authorising the Commission to limit the MRLs of a veterinary medicinal product permissible in foodstuffs of animal origin to certain therapeutic indications. Nor can such a limitation be justified by the requirements inherent in safeguarding public health on which Regulation No 2377/90 is based. Those requirements are limited to determining the maximum permissible threshold for the concentration of residues of a substance in food intended for human consumption, whatever the therapeutic indication in respect of which that substance was prescribed. It is self-evident that residues of a pharmacologically active substance which are present in food of animal origin are neither more nor less dangerous for health, at a certain level of concentration, according to whether that substance was administered in respect of a particular therapeutic indication. It follows that the MRLs for a given pharmacologically active substance cannot be determined by reference to the therapeutic properties or indications of that substance, which may be numerous (see, by analogy, Case C-293/97 The Queen v Secretary of State for the Environment and MAFF ex parte Standley and Others [1999] ECR I-2603, paragraph 34).

37 In paragraph 197 of the contested judgment, the Court of First Instance added that Regulation No 1312/96 prejudges the measures to be taken by Member States to prevent unauthorised use of veterinary medicinal products, in breach of Article 15(2) of Regulation No 2377/90, since the limits to the validity of the MRLs for clenbuterol which it imposes would continue to exist even in the event of annulment, withdrawal or amendment of the relevant provisions of Directive 96/22.

38 The Court of First Instance concluded, in paragraph 198 of the contested judgment, that, by limiting the validity of the MRLs established for clenbuterol to certain specified therapeutic indications for bovines and equidae, in Regulation No 1312/96, the Commission exceeded its powers under Regulation No 2377/90.

39 Therefore, in paragraph 199 of the contested judgment, the Court of First Instance held that Regulation No 1312/96 had to be annulled in so far as it restricted the validity of the MRLs which it established for clenbuterol to certain specified therapeutic indications for bovines and equidae.

40 In those circumstances, the Court of First Instance gave judgment:

1. Cases T-125/96 and T-152/96 are joined for the purposes of this judgment.

2. Commission Regulation ... No 1312/96 ... is annulled, in so far as it restricts the validity of the MRLs which it establishes for clenbuterol to certain specified therapeutic indications for bovines and equidae.

3. For the rest, the applications are dismissed.

4. In Case T-125/96, the applicants and Fédération Européenne de la Santé Animale (Fedesa), as regards its intervention, are ordered to bear their own costs and those of the Council. The United Kingdom, the Commission and Stichting Kwaliteitsgarantie Vleeskalverensector (SKV) are ordered to bear their own costs.

5. In Case T-152/96, the Commission is ordered to bear its own costs and to pay one-half of the costs of the applicants and Fedesa, the other half to be borne by them. The Council and SKV are ordered to bear their own costs.

The appeal

41 The Commission, in its appeal, and SKV, in its statement in intervention, claim that the Court of Justice should:

- set aside that part of the contested judgment which annuls Regulation No 1312/96 in so far as it restricts the validity of the MRLs which it establishes for clenbuterol to certain therapeutic indications for bovines and equidae;

- dismiss the action for annulment of Regulation No 1312/96 lodged by BI Vetmedica and Boehringer in Case T-152/96 as unfounded;

- order BI Vetmedica and Boehringer to pay the costs of the appeal;

- order BI Vetmedica and Boehringer to pay the costs incurred at first instance in relation to the action for annulment in Case T-152/96.

42 BI Vetmedica, Boehringer and Fedesa contend that the Court should:

- dismiss the appeal as unfounded;

- order the Commission to pay the costs of the appeal;

- order the Commission to pay the whole of the costs incurred by them at first instance for the purposes of the action for annulment in Case T-152/96.

The new plea by BI Vetmedica and Boehringer based on the adoption of Regulation (EC) No 2391/2000

43 After the closure of the written procedure, BI Vetmedica and Boehringer raised, on the basis of Article 42(2) of the Rules of Procedure of the Court of Justice, a new plea in law based on the adoption, on 27 October 2000, of Commission Regulation (EC) No 2391/2000 amending Annexes I, II and III to Regulation No 2377/90 (OJ 2000 L 276, p. 5).

44 BI Vetmedica and Boehringer have argued that, since Regulation No 2391/2000, which enters clenbuterol in Annex I to Regulation No 2377/90, no longer mentions the therapeutic indications allowed for that substance, it should be inferred that the Commission decided thenceforward to comply with the contested judgment and that the line of argument developed by the Commission in its appeal is thus called into question.

45 In that respect it should be noted, in so far as the new plea raised by BI Vetmedica and Boehringer must be regarded as raising an objection based on the loss of an interest in bringing an action, that the adoption of Regulation No 2391/2000, which establishes inter alia the definitive MRLs applicable to clenbuterol as from 27 December 2000, does not remove the interest in deciding the question of the legality of Regulation No 1312/96, especially with a view to determining the legal effects of that latter regulation during the period from 7 September 1996 until 1 July 2000, in which it established the provisional MRLs applicable to clenbuterol.

The plea alleging error of law vitiating the contested judgment

46 In support of its appeal, the Commission raises a first plea in law based on the argument that the Court of First Instance erred in law by holding that the Commission had exceeded its powers by restricting the validity of the MRLs established by Regulation No 1312/96.

47 In the first part of this plea, the Commission argues that the error of law by the Court of First Instance lies in the fact that, in paragraphs 188 to 190, the contested judgment took as the starting point for its analysis the reasoning, which the Commission maintains is erroneous, used in paragraphs 88 to 90 of the Lilly judgment, which led the Court of First Instance to draw equally erroneous inferences in the remainder of the contested judgment. In the second part of the same plea, the Commission maintains that the Court of First Instance also erred in law in paragraph 187 of the contested judgment, by holding that Article 6(1) of Regulation No 2377/90 did not make the inclusion of a substance in one of the Annexes I to III to that regulation subject to the condition that the product containing that substance must be directly used and marketed.

48 In relation to the first part of the first plea, the Commission argues in particular that the Court of First Instance erred in law by holding, in paragraph 190 of the contested judgment with reference to paragraph 90 of the Lilly judgment, that Regulation No 2377/90 did not contain any provision authorising the Commission to take account of a marketing prohibition in order to refuse to establish an MRL.

49 The Commission argues in that respect that, contrary to the statement which appears in paragraph 192 of the contested judgment, it could lawfully, in the context of the procedure for establishing an MRL for clenbuterol pursuant to Regulation No 2377/90, take into consideration all prohibitions or restrictions concerning the marketing of that substance, such as those laid down by Directive 96/22.

50 SKV states in its statement in intervention that it supports in particular the argument of the Commission that the Court of First Instance took a wrong view on the relations between the various Community legislative measures in question, which did not take into account the need to ensure the coherence of those measures. SKV therefore contends that the Court of First Instance was wrong in finding fault with the Commission for referring to Directive 96/22 in Regulation No 1312/96, thereby denying the importance for Community legislation to be transparent and coherent.

51 In that respect, it is first necessary to analyse the legal significance of the references to therapeutic indications which appear under the heading Other provisions of Annex III to Regulation No 2377/90, as amended by Regulation No 1312/96.

52 It can be seen by comparing those references with the wording of the seventh recital in the preamble to Regulation No 1312/96 that the former are intended solely as a reminder that, by virtue of Directive 96/22, the use of clenbuterol is prohibited on all reared animals, save for certain specific therapeutic purposes in relation to equidae and bovines.

53 Furthermore, an implementing regulation must, if possible, be given an interpretation consistent with the basic regulation (Case C-90/92 Dr Tretter v Hauptzollamt Stuttgart-Ost [1993] ECR I-3569, paragraph 11; Case C-61/94 Commission v Germany [1996] ECR I-3989, paragraph 52). In this case, an analysis of Regulation No 1312/96 in the light of the provisions of Regulation No 2377/90, which constitutes its legal basis, confirms that those references must be regarded as merely declaratory, and not having, in themselves, the character of legislation.

54 In the first place, those references cannot be understood as having the object or effect of laying down a prohibition on the marketing and use of clenbuterol, subject to the therapeutic indications mentioned by them, which is independent of the prohibition laid down by Directive 96/22. In that respect, it should be pointed out that it follows from Article 15 of Regulation No 2377/90 that the provisions of that regulation cannot prejudice Community and national measures relating to the use of certain unauthorised substances.

55 Nor, moreover, can those references be understood as having the object or effect of placing a limitation on the validity of the MRLs established for clenbuterol in the context of Regulation No 2377/90. It should be noted in that respect that the only limitation on the validity of an MRL envisaged by Regulation No 2377/90 concerns the indication of the limited duration of its validity where the substance in question is entered in Annex III to that regulation.

56 In the light of that analysis, it must be held that, as the Commission maintains in the first part of its first plea, it did not need authorisation from Regulation No 2377/90 in order to be able to insert references to the permitted therapeutic indications for clenbuterol in Annex III to that regulation, as amended by Regulation No 1312/96, for the purposes of recalling the relevant provisions of Directive 96/22. Just as no provision of Regulation No 2377/90 required the Commission to insert those references in that annex, their presence not being legally necessary, there was no provision in that regulation prohibiting it from doing so.

57 It follows that the Court of First Instance erred in law in paragraph 192 of the contested judgment by holding, in the light of the considerations set out in paragraphs 190 and 191 of that judgment, that the Commission could not lawfully base the limitation of the validity of the MRL established for clenbuterol on the provisions of Directive 96/22, when, first, the references to permitted therapeutic indications for clenbuterol did not have the object or effect of limiting the validity of the MRL established by Regulation No 1312/96, and, second, no provision prohibited the Commission from inserting in Annex III to Regulation No 2377/90, as amended by Regulation No 1312/96, a reminder of the effects of the provisions of Directive 96/22 in relation to the permitted therapeutic uses of clenbuterol.

58 Since the first part of the first plea in the appeal is well founded, it is not necessary to examine either the second part of the first plea or the second plea in the appeal, claiming that the reasoning followed by the Court of First Instance in the contested judgment was contradictory, incomplete and erroneous.

59 It follows from the above that points 2 and 5 of the operative part of the contested judgment must be set aside.

The substance of the action

60 In accordance with Article 54 of the EC Statute of the Court of Justice, as the state of the proceedings so permits, the Court will itself give judgment on the substance of the dispute.

61 It should be observed as a preliminary point that the Commission is appealing against the contested judgment only in so far as it refers to Case T-152/96, and that the Court of Justice therefore has to rule in this judgment only on the application, made to the Court of First Instance by BI Vetmedica and Boehringer in Case T-152/96, for partial annulment of Regulation No 1312/96.

62 In that application, BI Vetmedica and Boehringer raised three pleas in law.

63 The Commission's appeal calls into question only the part of the contested judgment relating to Case T-152/96 in which the Court of First Instance sets out, in paragraphs 182 to 199, the reasoning which constitutes the necessary support for the decision to annul Regulation No 1312/96 in part, which it pronounces in point 2 of the operative part of the judgment.

64 The Commission's appeal does not therefore call into question either the part of the contested judgment relating to Case T-152/96 in which the Court of First Instance holds the action for partial annulment brought by BI Vetmedica and Boehringer against Regulation No 1312/96 to be admissible, or the part in which the Court of First Instance rejects the first two pleas raised by them. Nor have BI Vetmedica and Boehringer, or Fedesa, challenged that latter part of the contested judgment, as they could have done by means of a cross-appeal in their responses.

65 The Court of Justice therefore has to rule only on the plea that, when adopting Regulation No 1312/96, the Commission exceeded the power conferred upon it under Regulation No 2377/90 by limiting the validity of the MRLs for clenbuterol to certain specific therapeutic indications.

66 That plea must be rejected as unfounded because, for the reasons stated in paragraphs 51 to 57 of this judgment, the Commission could lawfully insert in the amendment of Annex III to Regulation No 2377/90 effected by Regulation No 1312/96 references with mere declaratory value relating to the therapeutic indications permitted for clenbuterol by virtue of Directive 96/22.

67 It follows from the above that the action for annulment of Regulation No 1312/96 must be dismissed.

Decision on costs

Costs

68 Under Article 122 of the Rules of Procedure, where the appeal is well founded and the Court of Justice itself gives final judgment in the case, the Court is to make a decision as to costs.

69 Under Article 69(2) of the Rules of Procedure, which applies to appeal proceedings by virtue of Article 118, the unsuccessful party is to be ordered to pay the costs if they are applied for in the successful party's pleadings. Since BI Vetmedica and Boehringer have been unsuccessful, they must be ordered to bear their own costs and also to pay the whole of the costs incurred by the Commission both before the Court of First Instance in Case T-152/96 and before the Court of Justice.

70 Under the first subparagraph of Article 69(4) of the Rules of Procedure, also applicable to the procedure on appeal by virtue of Article 118, Member States and institutions which intervene in the proceedings are to bear their own costs. Pursuant to that provision, the Council must bear the costs which it has incurred in the proceedings before the Court of First Instance in Case T-152/96.

71 Under the third subparagraph of Article 69(4) of the Rules of Procedure, also applicable to the procedure on appeal by virtue of Article 118, the Court may order an intervener other than a State or institution to bear its own costs. Pursuant to that provision, it is appropriate to order Fedesa and SKV to bear the costs which they have incurred both in the proceedings before the Court of First Instance in Case T-152/96 and in those before the Court of Justice.

Operative part

On those grounds,

THE COURT

hereby:

1. Sets aside points 2 and 5 of the operative part of the judgment of the Court of First Instance of 1 December 1999 in Joined Cases T-125/96 and T-152/96 Boehringer v Council and Commission;

2. Dismisses the action for annulment brought by Boehringer Ingelheim Vetmedica GmbH and C.H. Boehringer Sohn against Commission Regulation No 1312/96 of 8 July 1996 amending Annex III to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin;

3. Orders Boehringer Ingelheim Vetmedica GmbH and C.H. Boehringer Sohn, both in the proceedings before the Court of First Instance in Case T-152/96 and in those before the Court of Justice, to bear their own costs and to pay the whole of the costs incurred by the Commission of the European Communities;

4. Orders the Council of the European Union to bear the costs which it has incurred in the proceedings before the Court of First Instance in Case T-152/96;

5. Orders the Fédération Européenne de la Santé Animale (Fedesa) and the Stichting Kwaliteitsgarantie Vleeskalverensector (SKV) to bear the costs which they have incurred both in the proceedings before the Court of First Instance in Case T-152/96 and in those before the Court of Justice.