JUDGMENT OF THE COURT OF FIRST INSTANCE (Second Chamber)
1 December 1999 (1)
(Directive prohibiting the use of beta-agonists in stockfarming - Regulation limiting the validity of maximum residue limits of veterinary medicinal products to certain therapeutic purposes - Action for annulment - Admissibility - Principle of proportionality)
In Joined Cases T-125/96,
Boehringer Ingelheim Vetmedica GmbH
and
C.H. Boehringer Sohn,
companies incorporated under German law, established in Ingelheim am Rhein (Germany), represented by Denis Waelbroeck and Denis Fosselard, of the Brussels Bar, with an address for service in Luxembourg at the Chambers of Ernest Arendt, 8-10 Rue Mathias Hardt,
applicants,
supported by
Fédération Européenne de la Santé Animale (Fedesa), an association incorporated under Belgian law, established in Brussels, represented by Alexandre Vandencasteele, of the Brussels Bar, with an address for service in Luxembourg at the Chambers of Ernest Arendt, 8-10 Rue Mathias Hardt,
and
United Kingdom of Great Britain and Northern Ireland, represented by Lindsey Nicoll, of the Treasury Solicitor's Department, acting as Agent, and by David Lloyd Jones, Barrister, of the Bar of England and Wales, with an address for service in Luxembourg at the Embassy of the United Kingdom, 14 Boulevard Roosevelt,
interveners,
v
Council of the European Union, represented by Moyra Sims-Robertson and Ignacio Díez Parra, Legal Advisers, acting as Agents, with an address for service in Luxembourg at the office of Alessandro Morbilli, Manager of the Legal Affairs Directorate of the European Investment Bank, 100 Boulevard Konrad Adenauer,
defendant,
supported by
Stichting Kwaliteitsgarantie Vleeskalverensector (SKV), a foundation incorporated under Netherlands law, established in The Hague, represented by Gerard van der Wal, advocate before the Hoge Raad der Nederlanden, and Laura Paret, of the Brussels Bar, with an address for service in Luxembourg at the Chambers of Aloyse May, 31 Grand-Rue,
and
Commission of the European Communities, represented by Xavier Lewis, of its Legal Service, acting as Agent, with an address for service in Luxembourg at the office of Carlos Gómez de la Cruz, also of its Legal Service, Wagner Centre, Kirchberg,
interveners,
APPLICATION for the partial annulment of Council Directive 96/22/EC of 29 April 1996 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) together with a claim for compensation,
and T-152/96,
Boehringer Ingelheim Vetmedica GmbH
and
C.H. Boehringer Sohn,
applicants,
supported by
Fedesa,
intervener,
v
Commission of the European Communities,
defendant,
supported by
SKV
and
Council of the European Union,
interveners,
APPLICATION for the partial annulment of Commission Regulation (EC) No 1312/96 of 8 July 1996 amending Annex III of Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximumresidue limits of veterinary medicinal products in foodstuffs of animal origin (OJ 1996 L 170, p. 8),
THE COURT OF FIRST INSTANCE
OF THE EUROPEAN COMMUNITIES (Second Chamber),
composed of: A. Potocki, President, C.W. Bellamy and A.W.H. Meij, Judges,
Registrar: B. Pastor, Principal Administrator,
having regard to the written procedure and further to the hearing on 12 May 1999,
gives the following
Factual and legislative background
- bronchospasmolysis action (dilation of the bronchial tracts in order to ease breathing in the event of an infection of the upper respiratory tracts);
- cardiac stimulation of equines and bovines;
- induction of tocolysis in cows when calving (relaxation of the uterus to facilitate parturition).
'The question arises as to whether control of the misuse of beta-agonists would be substantially improved by their total prohibition, including for therapeutic uses. The broad consensus among those charged with control in the Member States is that the misuse of beta-agonists has become a serious problem and that a prohibition would greatly ease the difficulty of proving illegal intent. While normally reluctant to propose removal from the market of a product with therapeutic uses, the Commission has come to the conclusion that a total ban on beta-agonists, except for the therapeutic treatment of horses and pet animals, would be a significant help to control. In taking this view, the Commission is influenced also by indications that replacement products are generally available for therapeutic purposes.
'Member States shall ensure that the owners or keepers of food-producing animals can provide proof of purchase, possession and administration of veterinary medicinal products containing the substances set out in Article 1(5) [these include beta-agonists in particular] [...]
In particular, Member States may require the maintenance of a record giving at least the following information:
(a) date;
(b) identity of the veterinary medicinal product;
(c) quantity;
(d) name and address of the supplier of the medicinal product;
(e) identification of the animals treated.
'Member States shall take all measures necessary to ensure that only persons empowered under their national legislation in force possess or have under their control veterinary medicinal products or substances which may be used as veterinary medicinal products that have anabolic [...] properties.
Member States shall maintain a register of producers and dealers permitted to be in possession of active substances which may be used in the manufacture of veterinary medicinal products having the properties referred to in the first subparagraph. Such persons must maintain detailed records of all dealings in substances which may be used in the manufacture of veterinary medicinal products and keep these records available for inspection by the competent authorities for a period of at least three years.
'(5) whereas the results of an enquiry conducted by the Commission in the Member States from 1990 to 1992 show that beta-agonists are widely available in the livestock-rearing sector, leading to their illegal use;
(6) whereas the improper use of beta-agonists can be a serious risk to human health; whereas, 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;
(7) whereas, however, the administering of medicinal products based on beta-agonists may be authorised for well-defined therapeutic purposes, in the case of certain categories of bovine animals, equidae and pets;
(8) whereas, moreover, it is necessary to ensure that all consumers are able to acquire meat and foodstuffs derived therefrom under the same conditions of supply and that those products correspond as closely as possible to their concerns and expectations; whereas, given consumer sensitivity, this can only bring about an increase in the consumption of the products in question;
(9) whereas the prohibition on the use of hormonal substances for fattening purposes should continue to apply; whereas the use of certain substances for therapeutic or zootechnical purposes may be authorised but must be strictly controlled in order to prevent any misuse.
'(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).
'2. the administering for therapeutic purposes of authorised veterinary medicinal products containing:
(i) allyl trenbolone, administered orally, or beta-agonists to equidae and pets, provided they are used in accordance with the manufacturer's instructions;
(ii) beta-agonists, in the form of an injection to induce tocolysis in cows when calving.
Such substances must be administered by a veterinarian or, in the case of the veterinary medicinal products referred to in (i), under his direct responsibility; treatment must be registered by the veterinarian responsible, who shall record at least the details referred to in point 1.
Farmers shall be prohibited from holding veterinary medicinal products containing beta-agonists which may be used for induction purposes in the treatment of tocolysis.
- Annex I, for substances in respect of which an MRL may be established (see Article 2);
- Annex II, for substances in respect of which it does not appear to be necessary to establish an MRL (see Article 3);
- Annex III, for substances already used on the date of the entry into force of Regulation No 2377/90, or, by way of exception, which are not yet used, in respect of which it is not possible definitively to establish an MRL but which, providing their residues at the level proposed present no hazard for human health, may be given a provisional MRL (see Article 4);
- Annex IV, for substances in respect of which no MRL can be established, by reason of their hazardous nature (see Article 5).
'Whereas, in order to allow for the completion of scientific studies, clenbuterol hydrochloride should be inserted into Annex III to Regulation (EEC) No 2377/90;
Whereas Council 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, prohibits the use of clenbuterol in all farm animals with the exception of some specific therapeutic purposes in equines and in cows;
[...]
Whereas the measures provided for in this regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products.
Procedure
Forms of order sought by the parties in Case T-125/96
- annul Articles 1, 2, 3 and 4 of Directive 96/22/EC in so far as they prohibit 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 are 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;
- order the parties to produce to the Court, within a reasonable period from the date of the judgment, the figures corresponding to the amount of compensation agreed on between the parties;
- in the absence of any such agreement, order the parties to produce to the Court, within the same period, details of the sums claimed;
- order that interest at the annual rate of 8% be paid on the amount payable from the date of judgment;
- order the Council to pay the costs.
- dismiss the application as manifestly inadmissible or, in the alternative, as unfounded;
- order the applicants to pay the costs.
Forms of order sought by the parties in Case T-152/96
- declare, in accordance with Article 184 of the EC Treaty (now Article 241 EC), that Directive 96/22/EC, in so far as it prohibits the placing on the market of veterinary medicinal products containing beta-agonists for administration for therapeutic purposes to farm animals, is illegal and therefore cannot serve to justify the restrictions contained in Regulation No 1312/96;
- annul Regulation No 1312/96 in so far as it restricts the validity of the MRLs established for clenbuterol to certain specific therapeutic purposes;
- order the Commission to pay the costs.
- dismiss the application as inadmissible or, in the alternative, as unfounded;
- order the applicants to pay the costs.
- dismiss the plea of illegality raised against Directive 96/22 as inadmissible or, in the alternative, as unfounded;
- dismiss the application as inadmissible or, in the alternative, as unfounded;
- order the applicants to pay the costs.
Preliminary observations concerning the subject-matter of the dispute and the procedure
The legality of Directive 96/22
The first plea, alleging breach of the principle of proportionality
Arguments of the parties
Findings of the Court of First Instance
The second plea, alleging breach of the principles of legal certainty and protection of legitimate expectations
Arguments of the applicants
Findings of the Court of First Instance
The third plea, alleging breach of the principle of sound administration
Arguments of the applicants
Findings of the Court of First Instance
The fourth plea, alleging infringement of Article 43 of the Treaty
Arguments of the parties
Findings of the Court of First Instance
The claim for annulment in Case T-125/96
The claim for compensation in Case T-125/96
The claim for annulment in Case T-152/96
Admissibility
Arguments of the parties
Findings of the Court of First Instance
- The interest of BI Vetmedica in bringing an action
- The question whether BI Vetmedica is individually concerned
- The question whether BI Vetmedica is directly concerned
- Boehringer's capacity to bring an action
Substance
Arguments of the parties
Findings of the Court of First Instance
'the maximum concentration of residue resulting from the use of a veterinary medicinal product (expressed in mg/kg or microgrammes/kg on a fresh weight basis) which may be accepted by the Community to be legally permitted or recognised as acceptable in or on a food.
It is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the acceptable daily intake (ADI), or on the basis of a temporary ADI that utilises an additional safety factor. It also takes into account other relevant public health risks as well as food technology aspects.
Costs
203. As to SKV, the Court considers that it is proper to apply the second subparagraph of Article 87(4) of the Rules of Procedure and order SKV to bear its own costs.
On those grounds,
THE COURT OF FIRST INSTANCE (Second Chamber)
hereby rules:
1. Cases T-125/96 and T-152/96 are joined for the purposes of this judgment.
2. Commission Regulation (EC) No 1312/96 of 8 July 1996 amending Annex III of 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 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 equines.
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.
Potocki
|
Delivered in open court in Luxembourg on 1 December 1999.
H. Jung A. Potocki
Registrar President
1: Language of the case: English.