C-32/00

COMMISSION v BOEHRINGER

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

1. The Commission of the European Com- 1. Facts munities is seeking to have set aside in part a judgment of the Court of First Instance 2 annulling Regulation (EC) No 1312/96 3 ('Regulation No 1312/96') in so far as, by 2. Council Regulation (EEC) No 2309/93 5 fixing the maximum limits of clenbuterol ('Regulation No 2309/93') establishes a residue in foodstuffs of animal origin, it centralised procedure for the grant of further specifies the therapeutic indications marketing authorisations for veterinary for which Member States may authorise the medicinal products; under Article 31(3)(b) administration of veterinary medicinal of that regulation, such medicinal products products containing that substance. The intended for administration to food-pro- Court of First Instance held that by acting ducing animals require a statement of the in that way the Commission had exceeded maximum residue limit which may be its powers under Regulation (EEC) accepted by the Community in accordance No 2377/90 4 ('Regulation No 2377/90'). with Regulation No 2377/90. Article 34(2) of that regulation provides that the refusal of marketing authorisation is to constitute a prohibition on the placing on the market of the veterinary medicinal product con- cerned throughout the Community.

residue not representing any toxicological provides that Member States are to ensure hazard for human health as expressed by that the placing on the market of beta- the acceptable daily intake. agonists for administering to animals intended for human consumption is pro- hibited. Under Article 4(2) Member States may authorise the administering for thera- peutic purposes of veterinary medicinal products containing allyl trenbolone or Annex I sets out the pharmacologically beta-agonists to equidae, bovines and pets. active substances for which maximum residue levels have been fixed; Annex II those not subject to maximum residue levels; Annex III those used in veterinary medicinal products for which provisional maximum residue levels have been fixed; and Annex IV those for which no maxi- mum levels can be fixed. 6. BI Vetmedica is practically the only pharmaceutical company within the Euro- pean Union to produce and market veterin- ary medicinal products containing a beta- agonist, namely clenbuterol, for the treat- 4. In accordance with Article 7 of Regu- ment of respiratory disorders in animals lation No 2377/90, Boehringer Ingelheim intended for human consumption. It Vetmedica GmbH ('BI Vetmedica') applied accounts for about 97% of sales of the to the Commission on 20 July 1994 for the veterinary medicinal products affected by establishment of maximum residue limits, the prohibition on the marketing and as regards bovines and equidae, of clen- administering of beta-agonists laid down buterol hydrochloride, a chemical com- in Directive 96/22. pound in the category of beta-agonist substances. In an opinion of 3 January 1996, the Committee for Veterinary Medicinal Products recommended, for rea- sons of scientific methodology, the adop- tion of provisional limits, expiring on 1 July 2000.

8. On 8 July 1996, the Commission declared the application admissible. In adopted Regulation (EC) No 1312/96, paragraphs 180 and 181 it dismissed the which brought clenbuterol hydrochloride allegation of illegality, and also the two within the scope of Annex III to Regulation pleas on which the applicants based their No 2377/90. It established provisional action, as unfounded. maximum residue limits ('MRLs') and the therapeutic indications for which, pursuant to Directive 96/22/EC, Member States could authorise the administering of vet- erinary medicinal products containing that substance, which are, in the case of bov- 11. The Court of First Instance went on to ines, solely the induction of tocolysis in examine whether the Commission had cows when calving and, in the case of exceeded the power conferred upon it by equines, the induction of tocolysis and the Regulation No 2377/90 by specifying the treatment of respiratory ailments. permissible therapeutic indications, in addi- tion to fixing the maximum limits for clenbuterol residues in bovines and equi- dae. That argument had been put forward by the Fédération de la santé animale (Fedesa) in its statement in intervention 9. BI Vetmedica and C H . Boehringer Sohn and by the applicants in their replies to the Ltd ('Boehringer') (the latter being the sole written questions put to them during the owner of the former and one of the leading procedure. 20 pharmaceutical companies in the world) lodged an application with the Court of First Instance on 27 September 1996 in which they raised an objection of illegality against Directive 96/22, claiming that it could not serve as justification for the 12. The Court of First Instance held, in restrictions in Regulation No 1312/96, paragraph 196 of the judgment, that there which they requested the Court of First was no provision in R e g u l a t i o n Instance to annul. 7 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 could such a limitation be justified by the requirements inherent in safeguarding public health on which Regulation II. The judgment of the Court of First No 2377/90 is based. Those requirements Instance were limited to determining the maximum permissible threshold for the concentration of residues of a substance in food intended for human consumption, whatever the 10. In paragraph 173 of the judgment therapeutic indication in respect of which that substance was prescribed. It was self- under appeal, the Court of First Instance evident that residues of a pharmacologi- cally active substance which were present 7 — This application gave rise to Case T-152/96 Boehringer v in food of animal origin were neither more Coywjiíssioii. nor less dangerous for health, at a certain

They request the Court of Justice to dismiss 14. In its application, which was lodged at the appeal as unfounded and to order the the Court of Justice on 7 February 2000, Commission to bear both the costs of these the Commission put forward two grounds proceedings and the costs which they of appeal. First, it alleged that the Court of incurred at first instance. First Instance had erred in law in finding that the Commission had exceeded its powers; and, second, it claimed that the reasoning used to support that conclusion was contradictory, incomplete and wrong. The Stichting Kwaliteitsgarantie Vlees- 16. Since none of those concerned sub- kalverensector (SKV), which had been mitted an application setting out its reasons granted leave at first instance to intervene for wishing to be heard, the Court of in support of the forms of order sought by Justice decided, in accordance with the Commission, submitted a response on Article 120 of the Rules of Procedure, to 18 April 2000 in which it fully supports the dispense with the hearing.

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cerned. Furthermore, owing to the fact that they were set to expire on 1 July 2000. If it does not require any measure to adapt it new parameters for clenbuterol had not to national law, the regulation imposes a been set, BI Vetmedica would have been in direct obligation on the traders concerned. a worse position than if the therapeutic That finding places BI Vetmedica in the indications had been maintained, since the same position as the person to whom a use of the substance would have been decision is addressed. completely prohibited, for all purposes.

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Second, the fact that the Court of First with the judgment under appeal before the Instance declares an action by an individual Court of Justice gave judgment. against a regulation admissible and then annuls it does not necessarily mean that the act was deemed to be an individual decision. In paragraph 162 of the judgment under appeal the Court of First Instance states that the provisions of Regulation 24. I do consider, however, that the Com- No 1312/96 apply to objectively deter- mission was obliged to act when the period mined situations and produce legal effects for which it had fixed the provisional with respect to categories of persons envis- maximum residue limit for clenbuterol in aged in general and abstract terms, namely bovines and equidae expired, that is, on the pharmaceutical undertakings which 1 July 2000. Had it not done so, Article 13 produce clenbuterol and those who pre- of Regulation No 2377/90, on an a scribe and use that substance. By its nature contrario interpretation, would have and scope, therefore, Regulation allowed the Member States to prohibit or No 1312/96 is legislative in character and impede the movement on their territory of does not constitute a decision within the foodstuffs of animal origin with residues of meaning of Article 249 EC. clenbuterol, since neither Annex I nor Annex III had made provision for any maximum residue limit for that substance, nor did it appear in Annex II.

Nor, third, can it be maintained, and the Commission cannot be thought to have seriously intended it, that it is only necess- ary to have recourse to the second para- 25. For the reasons stated, I consider that graph of Article 53 of the Statute when the the fact that the Commission adopted Court of First Instance has declared that a Regulation No 2391/00 does not mean regulation is inapplicable to a specific that it no longer has an interest in pursuing dispute, in accordance with Article 241 EC. its appeal. The two provisions differ considerably in scope, since the Statute envisages the annul- ment of a regulation, which takes effect erga omnes, whereas Article 241 EC on the objection of illegality refers to its inappli- cability inter partes.

27. BI Vetmedica and Boehringer argue that, as stated in the third recital of the preamble to Regulation No 2377/90, the The Commission states that the Court of maximum residue limits are intended to First Instance made the same error in protect public health. For that reason the another judgment delivered some months Court of First Instance was correct to state, previously, 11againstwhich France lodged in paragraph 186 of the judgment under an appeal; the case is now pending. 12 appeal, that the procedure for fixing MRLs, which may be provisional, for a pharmaco- logically active substance depends solely on the question whether residues of the sub- stance in question, at the proposed level, constitute a risk to the health of consumers.

30. Second, Article 14 of Regulation 28. I am able to accept that the procedure No 2377/90 prohibits the administration for the establishment of maximum residue to food-producing animals in the Commu- limits for veterinary products in foodstuffs nity of veterinary medicinal products con- of animal origin laid down in Regulation taining pharmacologically active sub- No 2377/90 is autonomous and distinct stances which are not mentioned in Annex- from the procedures for the grant of auth- es I, II or III, except in the case of auth- orisation to market veterinary medicinal orised clinical trials which do not cause products regulated by Directive 81/851 and foodstuffs obtained from livestock partici- by Regulation No 2309/93. It is sufficient pating in such trials to contain residues to establish that they are governed by which constitute a hazard to human health. completely different rules. However, that evidence does not lead me to argue that the Commission can fix those limits, in appli- cation of Regulation No 2377/90, in a manner divorced from reality, without taking into account the legal and scientific background of each specific case. If in Regulation No 1312/96 the Commis- sion had fixed the maximum residue limit for clenbuterol without specifying the therapeutic indications in which that sub- stance could be administered to animals, in accordance with Directive 96/22, the rule would have been incomplete, since, in the 29. First, Article 6(1) of Regulation absence of that information, those to whom No 2377/90 lays down two conditions for it was addressed would have been lawfully the inclusion in Annex I, II or III of a entitled to believe that, in application of pharmacologically active substance, Article 14, the administration of clenbute- namely that it is used in veterinary medici- rol for indiscriminate purposes, provided nal products for animals intended for the that the residues did not exceed the maxi- production of food and that it is marketed mum level fixed, was not precluded, since it in one or more Member States which have appeared in Annex III until 1 July 2000.

31. It is common ground that Directive maximum limits or clenbuterol in rooa- 96/22 prevents the administration in the stuffs of animal origin and at the same time Community of clenbuterol to bovines and specified the therapeutic indications for equidae while allowing the Member States which Member States could authorise the to authorise the administration of medici- administration of medicinal products con- nal products containing that substance, taining the substance, in accordance with subject to certain conditions, for certain Directive 96/22, not only did it not exceed very restricted therapeutic purposes. the powers which it exercised under Regu- Article 11 supplements the protection of lation No 2377/90, but it ensured the Community consumers by prohibiting the coherence of that measure, which was importation from non-member countries of intended to protect public health. animals or their meat to which any of the prohibited substances have been adminis- tered, unless they were administered in compliance with the provisions and requirements laid down in Articles 4, 5 and 7; and it is Article 4 that establishes the 33. I consider, therefore, that the Court of indications for which administration to First Instance erred in law in finding, in bovines and equidae of medicinal products paragraph 192 of the judgment under based on clenbuterol may be authorised by appeal, that, under the procedure for Member States. establishing an MRL for clenbuterol pur- suant to Regulation No 2377/90, the Com- mission was not legally entitled to base the limitation on the validity of that MRL on the provisions of Directive 96/22, and that the first ground of appeal is well founded. It cannot be maintained, therefore, as the respondents claim, that if the maximum residue limits are confined to the uses authorised within the Union there will be a lacuna in health protection, but that the fixing of those limits, specifying at the same time the therapeutic indications for which the medical products may be administered C. Second ground of appeal: the errors in to animals, guarantees coherent and com- the reasoning prehensive consumer protection, since it ensures that the maximum residue limits do not vary, irrespective of whether the meat was produced in the Community or comes from a non-member country. 34. The Commission claims that the line of argument followed by the Court of First Instance is contradictory, because it recog- nises the position of the Council, defined in Directive 96/22, which completely pro- hibits some therapeutic indications of clen- buterol and not others, and at the same 32. When the Commission adopted Regu- time states, in paragraph 196 of the judg- lation No 1312/96, which established the ment, that the requirements inherent in

safeguarding public health on which Regu- 37. The respondents disagree with the lation No 2377/90 is based are limited to Commission's view, and I agree with them. 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 sub- stance was prescribed. With that example, the Commission pro- ceeds from the idea of the non-complying Member State, namely the State which has ignored the provisions of Directive 96/22. However, Community law has provided a specific mechanism to deal with a situation 35. I do not believe that the reasoning of that nature, namely an action for failure followed by the Court of First Instance is to act under Articles 226 EC and 227 EC, contradictory, as the Commission main- without the Commission being empowered tains. I agree with the respondents and to adopt preventive legislation. Fedesa that the alleged contradictions are not in fact contradictions and that the Court of First Instance merely distinguished the therapeutic uses of clenbuterol from the illegal use of massive doses used as a growth agent. 38. Finally, the Commission claims that the reasoning in the judgment is wrong where, in paragraph 192, the Court of First Instance stated that the Commission was not legally entitled to base the limitation on the validity of the maximum residue limit 36. The Commission goes on to argue that on the provisions of Directive 96/22, when the reasoning is incomplete, because it does it is a well-known fact that it based it on not examine any of the consequences Regulation No 2377/90. harmful to human health which might arise, if the therapeutic indications for which the administering of products based on clenbuterol can be authorised could not be included in Regulation No 1312/96. It gives the example of Member State A, which does not apply the partial prohib- 39. The respondents again disagree and ition on the use of the compound and contend that if the Commission had not which allows it to be administered to calves based itself on Directive 96/22 it would not for the treatment of the bronchial tubes. have referred to that directive. Article 13 of Regulation No 2377/90 pre- vents Member State B from prohibiting beef whose content of that substance is within the maximum limits of residues fixed in Regulation No 1312/96 imported from Member State A from entering the 40. I agree with the Commission that the food chain. reasoning preceding the resolution of the

43. Third, it is also incorrect to state, in The only limitation in that provision is paragraph 187 of the judgment, that temporal in nature, since the limits were Article 6(1) of Regulation No 2377/90 fixed provisionally and expired on 1 July does not make the inclusion of a substance 2000. It does not make sense to state that in one of the Annexes (I to III) thereto the validity of those limits was restricted to subject to the condition that the product certain therapeutic indications, since, first, containing that substance must be capable from the aspect of public health, if residues of being directly used and marketed: the

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word 'directly' is not to be found in that specifying the therapeutical indications for provision, and two conditions must both be which Member States may authorise the satisfied if a pharmacologically active sub- use of medicinal products containing that stance is to be included in one of those substance, at the time when the maximum annexes, namely it must be for use in residue limits for clenbuterol were fixed, veterinary medicinal products applied to prejudged the measures to be taken by animals intended for the production of Member States to prevent unauthorised use food and it must be placed on the market of veterinary medicinal products. in one or more Member States which have not previously authorised the use of the substance in those animals.

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MRLs established for clenbuterol to certain unfounded and must therefore be dis- specified therapeutic indications for bov- missed. ines and equidae, the Commission had exceeded its powers under Regulation No 2377/90.

V. Costs

IV. The action for annulment

49. Article 122 of the Rules of Procedure provides that where the appeal is well 47. Under the second sentence of the first founded and the Court of Justice itself paragraph of Article 54 of the Statute, if gives final judgment in the case, it is to the Court of Justice sets aside the decision make a decision as to costs. under appeal, it may itself give final judg- ment in the matter, where the state of the proceedings so permits. That provision should be applied in the present case.

(1) set aside the judgment of the Court of First Instance of 1 December 1999 in so far as it annuls Regulation No 1312/96 on the ground that, by limiting the validity of the MRLs established for clenbuterol to certain specified therapeutic indications for bovines and equidae, the Commission exceeded its powers under Regulation No 2377/90.

(2) dismiss the application of BI Vetmedica and Boehringer for annulment of Regulation No 1312/96.

(3) order BI Vetmedica and Boehringer to pay the costs incurred by the Commission and SKV in both sets of proceedings.

(4) order Fedesa to bear its own costs in both sets of proceedings.

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