CFI, president, July 13, 1996, No T-76/96 R

THE PRESIDENT OF THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES

1 According to various scientific reports and articles now before the Court (see, in particular, the report of the United Kingdom's Spongiform Encephalopathy Advisory Committee entitled "Transmissible Spongiform Encephalopathies: A Summary of Present Knowledge and Research", of September 1994, hereinafter "the 1994 SEAC Report", and extracts from the periodical Nature No 380 of 28 March 1986, pages 272 to 274, and from the periodical The Lancet No 347 of 6 April 1996, pages 921 to 925), transmissible spongiform encephalopathies are a family of degenerative brain diseases characterized by the microscopic appearance of sponge-like formations in brain tissue and by the presence in that tissue, and sometimes in other tissues, of an abnormal form of a protein ° prion protein, according to the dominant theory (The Lancet, p. 916, Nature, pp. 273 to 274) ° called PrP (Protease-resistant Protein). The exact nature of the infectious agents causing transmissible spongiform encephalopathies is still unknown (Nature, p. 273). Those diseases affect a number of animal species, in particular sheep (scrapie), cattle, domestic cats and mink.

2 As far as man is concerned, according to the same sources, there are a number of forms of transmissible spongiform encephalopathies. One of them, Creutzfeldt-Jakob disease, a rare disease, occurs throughout the world, mainly in people of more than fifty or sixty years of age. In 85% of cases, it is a sporadic illness. 14% of cases show a family history. Less than 1% of cases occur through accidental transmission from person to person in medical or surgical treatment. Like the other transmissible spongiform encephalopathies, Creutzfeldt-Jakob disease is caused by an "unconventional agent" which stimulates no immune response in the host and is extremely resistant to physical and chemical treatments that destroy even the most resistant bacteria, spores, fungi and viruses. The disease appears as a rapidly progressive dementia and leads to the death of the patient, generally three to six months after the appearance of the first clinical signs. Very recently, 10 cases of a new strain of Creutzfeldt-Jakob disease have been identified in the United Kingdom in younger patients displaying atypical clinical and neurological features (The Lancet, p. 921; see paragraph 9 below).

3 Bovine spongiform encephalopathy (hereinafter "BSE"), the so-called "mad-cow disease", was identified for the first time in the United Kingdom in 1986. Since 1988, more than 160 000 confirmed cases of BSE have been identified in British herds, according to figures supplied by the United Kingdom in the fourth report, dated 24 May 1996, which it communicated to the Commission pursuant to Article 3 of Decision 96-239-EC of 27 March 1996 on emergency measures to protect against bovine spongiform encephalopathy (OJ 1996 L 78, p. 47, hereinafter "the Decision") (Annex 9 to the Commission's observations). Sporadic cases of BSE have also been declared in France, Ireland, Portugal and Switzerland. Like the other diseases in this group, BSE has a very long incubation period, spread over many years, during which it is not detectible, given the present state of knowledge.

4 BSE would appear to have its origin in the use, as cattle feed, of improperly treated sheep or bovine meat and bone meal containing the infectious agent. Changes made for commercial reasons to the rendering methods in the late 1970s and the 1980s are reported to be responsible for that situation (The Lancet, p. 915; 1994 SEAC Report, p. 27). The question whether the disease is transmitted by other pathways is under discussion. At the present time, vertical transmissibility, through the mother, or horizontal transmissibility, in particular by mere contact, has been established only in relation to certain types of transmissible spongiform encephalopathies, such as scrapie (1994 SEAC Report, pp. 24, 29 and 30).

5 As regards the question of transmissibility between species, there is much evidence that these agents come from genetically different strains which may affect different species (1994 SEAC Report, p. 24).

6 Experiments have enabled the transmissibility of some transmissible spongiform encephalopathies from one animal species to another in certain specific cases to be established (see, in particular, the 1994 SEAC Report). However, the possibility for BSE to be transmitted to man has not been proved and, according to the experts, scientific confirmation of any such transmissibility could take many months, and probably even many years.

7 However, the possibility that the agent responsible for the bovine disease is transmissible to humans has been considered following identification of BSE in the United Kingdom. Many preventive measures have therefore been introduced in that country. In particular, the Ruminant Feed Ban contained in the Bovine Spongiform Encephalopathy Order 1988 (SI 1988 No 1039, amended by SI 1991 No 2246 and SI 1996 No 962) has, since July 1988, prohibited the use of ruminant protein, suspected of being the source of the contamination, in ruminant feed. Since that period, those rules have also made it obligatory to notify any suspected case and to slaughter any suspect cattle. They impose restrictions on the movement of such cattle and provide for controls on the destruction of carcasses of those animals and an obligation to disinfect slaughterhouses. In addition, the Bovine Offal (Prohibition) Regulations 1989 (SI 1989 No 2061) have, since November 1989, prohibited the sale or use in foods destined for human consumption of certain specified bovine offal (brains, spinal cord, spleen, thymus, tonsils and intestines) which may contain the infecting agent. That prohibition was extended to the head of bovine animals (except the tongue) by the Specified Bovine Material Order 1996 (SI 1996 No 963).

8 The Community has also adopted a number of preventive measures against BSE. These include Commission Decision 94-474-EC of 27 July 1994 concerning certain protection measures relating to bovine spongiform encephalopathy and repealing Decisions 89-469-EEC and 90-200-EEC (OJ 1994 L 194, p. 96), as amended most recently by Commission Decision 95-287-EC of 18 July 1995 (OJ 1995 L 181, p. 40), which imposes in particular the following measures:

° a ban on the exportation from the United Kingdom to the other Member States of live cattle aged more than six months and of live cattle which are the offspring of cows in which BSE is suspected or confirmed;

° a ban on the exportation from the United Kingdom to the other Member States of fresh meat derived from bovine animals unless it comes from animals aged less than two-and-a-half years at slaughter or from animals which, while in the United Kingdom, have resided only on holdings on which no case of BSE has been confirmed during the previous six years or unless it consists of fresh deboned bovine meat in the form of muscle from which the adherent tissues, including obvious nervous and lymphatic tissues, have been removed;

° implementation of a proper identification system (freeze band or tattoo) and a certification system guaranteeing conformity of animals with the abovementioned requirements.

Commission Decision 92-290-EEC of 14 May 1992 concerning certain protection measures relating to bovine embryos in respect of bovine spongiform encephalopathy in the United Kingdom (OJ 1992 L 152, p. 37) also prohibits, in particular, the exportation from the United Kingdom to other Member States of bovine embryos coming from donors born after 1988 or descended from females in which BSE is suspected.

9 It was against that background that on 20 March 1996 the United Kingdom informed the Commission that additional national measures had been adopted ° providing, first, for the deboning of bovine carcasses aged more than 30 months in approved establishments and a ban on the sale or use of trimmings for human consumption; second, a ban on the use of mammalian meat and bone meal in feed for all reared animals ° following the statement issued on the same day by the Spongiform Encephalopathy Advisory Committee ("SEAC"), an independent body advising the United Kingdom Government. According to that statement, ten cases of a previously unrecognized strain of Creutzfeldt-Jakob disease had been identified by the CJD Surveillance Unit in Edinburgh in persons of less than 42 years of age.

10 Other Member States, at that time, decided to ban the import of live bovine animals and beef meat from the United Kingdom. A number of non-member countries also imposed such a ban in regard to bovine products originating in the United Kingdom or the European Union, as the case may be, or, more rarely, from one or several of the other Member States (see Annex 17 to the Commission's observations).

11 The SEAC statement of 20 March 1996, referred to above, stated that: "Although there is no direct evidence of a link, on current data and in the absence of any credible alternative, the most likely explanation at present is that these cases are linked to exposure to BSE before the introduction of the SBO Specific Bovine Offal ban in 1989. This is cause for great concern". According to SEAC, it is too early to predict the number of cases likely to arise in the future. It stressed that it was imperative that the measures in force for protecting public health be properly applied and it recommended constant checks guaranteeing the complete withdrawal of spinal cord tissue. It also recommended, in particular, that the carcasses of cattle aged more than 30 months be deboned in approved establishments monitored by the Meat Hygiene Service and that trimmings be classified as specific offal of bovine animals, and a prohibition on the use of mammalian meat and bone meal in feed for all farm animals. It concluded that if the recommendations set out above are carried out the risk from eating beef is now likely to be extremely small. SEAC confirmed these first recommendations in a second statement dated 24 March 1996. There it states that a precise measure of the risk is impossible because of a number of "interacting uncertainties, including: the magnitude of the species barrier between cattle and man; lack of data on levels of infectivity in a range of important cattle tissues, which are below the level of detectability by current assays; the uneven distribution of infectivity in any tissue; the time course for the appearance of infectivity over the duration of the incubation period; whether there is a dose below which there is no risk of infection". It repeats the recommendation concerning the prohibition on the use of mammalian meat and bone meal in feed for farmed animals, including fish and horses. It also recommends that it must not be used as fertilizer on land to which ruminants have access.

12 On receiving that information the Commission consulted the Scientific Veterinary Committee of the European Union. After hearing a report presented by Dr Will, head of the CJD Surveillance Unit, Edinburgh, it issued an opinion on 22 March 1996 in which it concluded that at that time there was no evidence that BSE was transmissible to man. However, recalling that it had always considered the possibility of such transmissibility, the Committee recognized the need to review the adequacy of the current Community measures in the light of the new information. It considered that the measures adopted by the Commission since 1990 following its opinions were important in reducing the risk of exposure of man to the BSE agent. It also recommended the adoption by the European Union of appropriate measures taking account of the provisions adopted by the United Kingdom following the SEAC's statement of 20 March 1996. It recognized that the risk of spread of the BSE agent could be further reduced by excluding from the food chain animals most likely to have been exposed to infection and, therefore, possibly harbouring infectivity. It added that, having regard to the importance of the disease, any practical measure taken by the European Community to address the incidence of disease and the possible risk of transmission was to be welcomed. Attached to that opinion is the following statement of Dr Ring, one of the members of the Committee: "On the basis of the limited scientific data, which are only based on the evaluation carried out with material from nine cattle, we cannot be confident indeed that muscle meat from cattle does not constitute a danger for transmission of BSE infection".

13 On 27 March 1996 the Commission adopted Decision 96-239-EC, Article 1 of which prohibits, "pending an overall examination of the situation", exports from the United Kingdom to the other Member States and non-member countries of:

° live bovine animals, their semen and embryos,

° meat of bovine animals slaughtered in the United Kingdom,

° products obtained from bovine animals slaughtered in the United Kingdom which are liable to enter the animal feed or human food chain, and materials destined for use in medicinal products, cosmetics or pharmaceutical products,

° mammalian-derived meat and bone-meal.

14 The Decision is based on Council Directive 90-425-EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (OJ 1990 L 224, p. 29), as amended, and in particular on Article 10 thereof, and on Council Directive 89-662-EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (OJ 1989 L 395, p. 13), as amended, and in particular on Article 9 thereof. The aforementioned articles in those two directives empowered the Commission, in the presence of "any zoonoses, diseases or other cause likely to constitute a serious hazard to animals or to human health", to adopt the necessary measures under the Standing Veterinary Committee procedure. Those same provisions require the Commission to monitor the situation and, by the same procedure, to amend or repeal the decisions taken, depending on how the situation develops.

15 The reasons given by the Commission for the Decision are as follows. First of all, it refers to the additional measures taken by the United Kingdom on 20 March 1996 as a result of the publication of new information on the recent appearance of certain atypical cases of Creutzfeldt-Jakob disease in that Member State and to the decision of other Member States to ban the entry into their territory of live bovine animals and beef and veal from the United Kingdom. It states that, under current circumstances, a risk of transmission of BSE to man cannot be excluded and that the resulting uncertainty has created serious concern among consumers. Finally, as regards exports to non-member countries, these must also be prohibited, according to the Decision, in order to prevent deflections of trade.

16 In parallel, the Commission and the Council adopted a range of support measures, linked to BSE, for the Community beef and veal market. Furthermore, the conditions for intervention were extended significantly. Some support measures concern more particularly the situation in the United Kingdom. Commission Regulation 716-96 of 19 April 1996 adopting exceptional support measures for the beef market in the United Kingdom thus provides for a programme for the slaughter and destruction of bovine animals aged more than 30 months, financed for the most part by the Community (OJ 1996 L 99, p. 14).

17 By application lodged at the Registry of this Court on 21 May 1996, The National Farmers' Union, a traders' association, and four companies operating in the cattle industry, International Traders Ferry Limited, UK Genetics, R.S. and E.M. Wright Limited and Prosper de Mulder Limited applied to the Court for the annulment of the Commission's decision. By application lodged at the Registry of this Court on 25 May 1996 the applicants applied for the operation of that decision to be suspended, under Article 185 of the EC Treaty. Except for Prosper de Mulder Limited, all of the applicants have also brought proceedings, with other undertakings, before the High Court of Justice, Queen's Bench Division, against the national measures adopted pursuant to the Commission's Decision. By an order lodged at the Registry of the Court of Justice of the European Communities on 8 May 1996, the High Court of Justice referred to that Court for a preliminary ruling pursuant to Article 177 of the Treaty a question on the validity of Article 1 of the Commission's Decision (Case C-157-96).

18 By applications lodged at the Registry of the Court of Justice on 23 and 24 May 1996, the United Kingdom of Great Britain and Northern Ireland applied for, respectively, suspension of the application of Article 1 of the Decision (Case C-108-96 R) and annulment of the Decision (Case C-180-96).

19 By a document lodged at the Registry of this Court on 29 May 1996 the Commission applied, pursuant to the third paragraph of Article 47 of the EC Statute of the Court of Justice, for a stay of the main proceedings in Case T-76-96 until delivery of the judgment of the Court of Justice in Case C-180-96 and for stay of the proceedings for interim relief in Case T-76-96 R until delivery of the interim judgment of the Court of Justice in Case C-180-96 R. Alternatively, the Commission asked the Court of First Instance to decline jurisdiction in Cases T-76-96 and T-76-96 R so that the Court of Justice might rule on those applications. By a document lodged at the Registry of this Court on 4 June 1996, the applicants submitted their observations on the aforementioned Commission applications.

20 In the meantime, the preventive measures imposed by the Decision were relaxed by Commission Decision 96-362-EC of 11 June 1996 amending Decision 96-239-EC on emergency measures to protect against bovine spongiform encephalopathy (OJ 1996 L 139, p. 17). This new decision was also adopted "pending an overall examination of the situation". As preparatory steps, the Commission had consulted the Scientific Veterinary Committee, the Scientific Committee on Cosmetology, the Scientific Committee for Food and the Committee for Proprietary Medicinal Products. On the basis of the additional information provided, the decision of 11 June 1986 in substance lifts the export ban with regard to bovine semen, which the Scientific Veterinary Committee considered in its opinion of 26 April 1996 presented "no risk of transmission of BSE". As regards other products (essentially gelatin and tallow), it makes a lifting of the export ban subject to application of certain manufacturing methods and implementation of official controls by the United Kingdom. It also requires the Commission to carry out Community inspections, in particular as regards implementation of those official controls, before exports of tallow or gelatin may be resumed. It is for the Commission, after having consulted the Member States in the framework of the Standing Veterinary Committee, to set the date on which dispatch may recommence.

21 By a document lodged at the Registry of this Court on 18 June 1996 the United Kingdom sought leave to intervene in support of the applicants in Case T-76-96 R.

22 In Case T-76-96 R, the President of this Court decided to hear oral argument from the parties and their answers to questions on 21 June 1996. At that hearing, he granted the United Kingdom leave to intervene in the proceedings for interim relief.

23 During the hearing, one of the applicants, Prosper de Mulder Limited, a tallow producer, stated that it was withdrawing its application for interim relief following the adoption of Commission Decision 96-362.

Forms of order sought

24 In their claims for interim relief, the applicants request the Court to order:

° the suspension of application of the Decision until the Court of First Instance has given judgment on the application in the main proceedings or until the Court of Justice has given its preliminary ruling in the reference made to it under Article 177 of the Treaty by the High Court of Justice on 8 May 1996;

° such further or other relief as it considers appropriate;

° that the Commission pay the costs of the interim proceedings.

In the alternative, the applicants seek partial suspension of application of the Decision as regards:

° exports to third countries;

° and-or as regards all or certain of the following products: bovine semen, bovine embryos, live calves under six months, fresh bovine meat from animals aged less than two-and-a-half years at the date of slaughter, tallow and gelatin.

At the hearing, the applicants stated that they were withdrawing their claims in so far as they related to exports of semen, following the adoption of Decision 96-362.

The Commission contends that the Court should:

° dismiss the application for interim relief;

° order the applicants to pay the costs.

Law

25 Under the combined provisions of Articles 185 and 186 of the Treaty and Article 4 of Council Decision 88-591-ECSC, EEC, Euratom of 24 October 1988 establishing a Court of First Instance of the European Communities (OJ 1988 L 319, p. 1), as amended by Council Decision 93-350-Euratom, ECSC, EEC of 8 June 1993 (OJ 1993 L 144, p. 21), and by Council Decision 94-149-ECSC, EC of 7 March 1994 (OJ 1994 L 66, p. 29), the Court of First Instance may, if it considers that circumstances so require, order that application of the contested act be suspended or prescribe any other necessary interim measures.

26 Article 104(1) of the Rules of Procedure of the Court of First Instance provides that an application to suspend operation of any measure is to be admissible only if the applicant is challenging the measure in question in proceedings before the Court of First Instance. Article 104(2) provides that applications for interim measures referred to in Articles 185 and 186 of the Treaty must state the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measures applied for. The measures sought must be provisional, in the sense that they must not prejudge the decision on the substance (see, most recently, the order of the President of the Court of First Instance of 3 June 1996 in Case T-41-96 R Bayer v Commission, not yet published in the ECR, paragraph 13).

27 In this case, it is necessary, before examining the application for suspension of the application of the Decision, first to rule on the Commission's application for a stay of these proceedings for interim relief or for a decision by this Court to decline jurisdiction in regard to the application for interim relief submitted to it.

The application for a stay of proceedings or for a decision by the Court of First Instance to decline jurisdiction

Arguments of the parties

28 The Commission has requested this Court to stay the main proceedings and the proceedings for interim relief in this case (Cases T-76-96 and T-76-96 R) pursuant to the third paragraph of Article 47 of the EC Statute of the Court of Justice and Articles 77 and 78 of the Rules of Procedure of the Court of First Instance, until the Court of Justice has ruled on the main action (Case C-180-96) and on the proceedings for interim relief (Case C-180-96 R) brought by the United Kingdom for, respectively, annulment and suspension, in whole or in part, of the same measure as the one which is the subject of the applications now before the Court of First Instance. In the alternative, the Commission has requested the Court of First Instance to decline jurisdiction in Cases T-76-96 and T-76-96 R pursuant to the abovementioned provision of Article 47 of the EC Statute of the Court of Justice and to Article 80 of the Rules of Procedure of the Court of First Instance.

29 In their written observations on those applications by the Commission, the applicants have stressed the need to give a decision on their application for interim relief as a matter of urgency, having regard to the risk of serious and irreparable damage to which they are exposed. Furthermore, the applicants contend that they have a legitimate interest in having their pleas in law and arguments relating to the effect of the Decision on their own situation examined and taken into consideration irrespective of the United Kingdom's position. Since they consider that the Court of First Instance is the appropriate body to carry out that examination, they contend that it should reject the Commission's request that it stay proceedings or decline jurisdiction.

30 In the alternative, the applicants state that if the Court of First Instance were to decide not to rule immediately on this application for interim relief, it would be appropriate for it to decline jurisdiction and to refer the file to the Court of Justice so as to enable that Court to consider their arguments and to adjudicate on their application for interim measures.

Findings of the President, as Judge hearing the application for interim relief

31 It should be observed, as a preliminary point, that the EC Statute of the Court of Justice and the Rules of Procedure of the Court of First Instance do not contain any specific provision under which the Court of First Instance may stay proceedings for interim relief or decline jurisdiction in respect of an application to suspend the operation of a measure, when a parallel application for suspension of the operation of the same measure is pending before the Court of Justice.

32 In those circumstances, the Judge hearing this application for interim relief cannot grant the Commission's application for a stay of the proceedings. The ordering of such a measure is, in principle, incompatible with the very nature and purpose of the legal remedy which proceedings for interim relief, an emergency procedure, represent. In the present case, in the absence of any specific justification put forward by the Commission, a stay of these proceedings would be inconsistent with the principle of the proper administration of justice. In that regard, it should be noted that it is, in any event, possible for the parties to appeal against the order made by the President of the Court of First Instance in these proceedings for interim relief. Furthermore, by delaying consideration of the applicants' request for interim measures, a stay of the proceedings might impair the protection of their procedural rights and legitimate interests. By virtue of Articles 185 and 186 of the Treaty, and Article 104 of the Rules of Procedure of the Court of First Instance, the applicants have the right to request in proceedings for interim relief, subject to certain conditions, the suspension of the operation of a measure whose validity they are challenging in proceedings before this Court. In the present case, the applicants claim that their rights and interests are likely to suffer grave and irreversible harm if there is not a rapid suspension of the application of the Decision, whose annulment they are, moreover, seeking in proceedings before this Court.

33 Nor is it possible for the President of the Court of First Instance to grant the Commission's request that the Court decline jurisdiction in regard to this application for interim relief, there being no specific provision enabling the Judge hearing the application for interim relief to decline jurisdiction in respect of an application to suspend the operation of a measure where a parallel application to suspend the operation of the same measure is pending before the Court of Justice. By virtue of the principle that courts must exercise the jurisdiction conferred on them, the Court of First Instance cannot, save in the cases expressly provided for in the Statute, when it has jurisdiction to hear an action under the relevant provisions of Decision 88-591, as amended, decline such jurisdiction. The third paragraph of Article 47 of the Statute provides solely for the possibility of the Court of First Instance declining jurisdiction in regard to applications for annulment. It does not refer to applications for interim measures.

34 In the present case, since the Court of First Instance has not already decided to decline jurisdiction so as to enable the Court of Justice to give judgment on the applicants' main application for the annulment of the Decision, it is not necessary to examine the effect of such declining of jurisdiction on the determination of which court has jurisdiction to hear the related application for suspension of the application of the Decision.

35 For all those reasons, the request that the Court of First Instance stay proceedings or decline jurisdiction in regard to the present application for interim relief must be rejected by the Judge hearing that application.

The application for suspension of the application of the Decision

Arguments of the parties

° Admissibility of the main application

36 The applicants maintain that they all have standing to bring proceedings since they are directly and individually affected by the Decision by reason of certain attributes which are peculiar to them or by reason of circumstances by which they are differentiated from all other persons. They rely on, in particular, the judgment of the Court of Justice in Case C-358-89 Extramet Industrie v Council [1991] ECR I-2501, paragraph 17. In this case, International Traders Ferry Limited and UK Genetics are the sole undertakings operating, respectively, in the sector for the transport of calves to other Member States and in that for the export of bovine semen and embryos from the United Kingdom. Moreover, they were committed by contracts at the time when the Decision was adopted. Finally, UK Genetics was involved in negotiating veterinary health protocols with certain non-member countries in order to obtain authorization to import bovine genetic material from the United Kingdom. R.S. and E.M. Wright Limited, whose business consists in the export of white fat heifers, is stated to be individually concerned by the Decision owing to the specialized nature of its product which is intended exclusively for the Italian market and for which there is no market in the United Kingdom.

37 The National Farmers' Union, a trade association representing the majority of farmers in England and Wales, is stated to be individually concerned by the Decision in two respects. First, it is acting on behalf of certain of its members who are themselves individually concerned by the Decision. Secondly, it has its own interest in bringing proceedings in so far as the Decision adversely affects its position as a representative body recognized by the relevant authorities as an appropriate body for consultation and negotiation in the preparation of proposals relating to the prevention of BSE.

38 The Commission, for its part, contends that the main application is manifestly inadmissible. The Decision is a measure of general scope which applies to situations determined objectively and produces its effects with regard to categories of persons viewed generally and in the abstract. In the present case, the legal position of none of the applicants is adversely affected by reason of factual circumstances which differentiate it from all other persons and distinguish it individually in the same way as an addressee.

° Prima facie case

39 According to the applicants, it is clear from the grounds on which the Decision is stated to be based that it is not intended to ensure protection against a serious danger to animal or human health but to meet "serious concern among consumers" resulting from uncertainty surrounding the risk of transmission of BSE to humans. That interpretation of the Decision is confirmed by an analysis of the context in which it was adopted.

40 The new information which led to the adoption of the Decision, which was communicated by the United Kingdom on 20 March 1996, related to the appearance of ten cases of Creutzfeldt-Jakob disease, the most likely explanation for which was, according to the SEAC statement, exposure to BSE before the introduction of the ban on specified bovine offal by the Bovine Offal (Prohibition) Regulations 1989. However, the measures necessary to ensure protection of public health against this risk had already been introduced, in particular by Decision 94-474 and Decision 92-290, and by Commission Decision 94-381-EC of 27 June 1994 concerning certain protection measures with regard to bovine spongiform encephalopathy and the feeding of mammalian derived protein (OJ 1994 L 172, p. 23), which requires Member States to prohibit the use of protein derived from mammalian tissues in the feed of ruminant species. Unlike previous decisions, Decision 96-239 was, according to the terms of a press release circulated by the Commission on the same day (annex 14 to the main application), a first step towards stabilizing the situation and reassuring consumers that beef was safe in order to safeguard the European industry internally and internationally. That press release also referred to statements made by the Commissioner responsible for agriculture and rural development to the effect that, if there should be a link between BSE and Creutzfeldt-Jakob disease, the evidence was that the risk to human health had been eliminated or at worst reduced to a minimum level following the introduction of the ban on specified bovine offal in 1989.

41 In those circumstances, the applicants maintain, first, that the defendant institution had no competence to adopt the Decision. Directives 90-425 and 89-662 empower it only to adopt measures which are intended to protect against a serious hazard to animals or to human health and which are necessary for that purpose. The applicants further contend that those directives gave it no power to impose a ban on exports from one Member State to non-member countries.

42 The applicants maintain, secondly, that adoption of the Decision was a misuse of powers in that, contrary to the aims pursued by the two directives mentioned above, on which it is based, its main purpose is not to protect against any serious hazard to public health but to reassure consumers for economic reasons.

43 Thirdly, according to the applicants, the Decision infringes the principle of proportionality: it was neither necessary nor appropriate to the aim of allaying concern among consumers or for the protection of human health, if that latter aim was indeed pursued by the contested measure, which the applicants dispute.

44 In that latter regard, the applicants claim that the preventive measures for protecting animal and human health previously adopted by both the United Kingdom and the Commission are sufficient. The new information provided by the United Kingdom on 20 March 1996 does not suggest that there is any increased risk arising from consumption of beef or beef products which had not already been taken into consideration when the previous preventive measures, based on the possible risk that BSE was transmissible to humans, were adopted. On that point, the Scientific Veterinary Committee stated, in its opinion of 22 March 1996, that there was still no certainty about whether BSE is transmissible to man. It stressed the importance of the measures already in force for reducing the risk of human exposure to the agent responsible for the disease and had recommended a brief list of improvements. Thus, in the applicants' view, the Decision has no scientific basis at all. In particular, the applicants stated at the hearing that, irrespective of the question of the efficacity of the preventive measures introduced before the adoption of the Decision, the "step" taken by the Decision, in imposing such radical measures compared with the previous preventive measures, has no logical justification. That analysis is, the applicants claim, confirmed, moreover, by the fact that the Commission did not consider it necessary either to take measures concerning products exported from the United Kingdom before the entry into force of the Decision or to extend the export ban to other Member States in which certain cases of BSE had been identified, such as France.

45 The applicants also claim that, in view of its serious breach of the principle of free movement and unity of the market and also of its catastrophic social and economic consequences for the beef and veal sector in the United Kingdom, the Decision is manifestly disproportionate, given that the Commission had available to it appropriate alternative solutions which were less restrictive, in the form of a certification system and-or labelling requirements of a nature such as to guarantee that beef or veal came from herds free from BSE and that the animals had been given feed which did not contain animal proteins.

46 As regards, more particularly, the ban on exports to non-member countries, the applicants contend that the Commission has advanced no evidence to show that the deflections of trade which it fears would be on such a scale as to justify adoption of the contested measure. The risk of fraud referred to by the defendant institution could be avoided by a more appropriate and less restrictive measure, consisting in a ban on re-imports into the European Union coupled with a proper certification system.

47 Having regard to all those considerations, the applicants claim in the alternative that the Decision is disproportionate, at least as regards the ban on exporting the products in question to non-member countries and the ban on exporting to other Member States certain of those products, such as bovine embryos, live calves under six months of age, fresh meat from bovine animals aged less than two-and-a-half years at slaughter, tallow and gelatin.

48 In those circumstances, the applicants stated, in reply to a question which the Court put to the parties at the hearing, that, contrary to the Commission's contention, the grant of the suspension which they seek would not prejudge the decision of this Court in the main proceedings. No risk of serious and irreparable damage, they maintained, would attach, during the main proceedings, to a lifting of the embargo.

49 In the oral argument which it presented at the hearing, the United Kingdom endorsed the applicants' pleas and arguments, stressing that the measures, both national and Community, already in force before the Decision was adopted were appropriate and adequate. Their application had led to a significant reduction in BSE cases in the United Kingdom. Those measures had been approved by the international veterinary forum of the World Health Organization and by the Office International des Epizooties, which had not recommended additional measures in opinions given on 3 April 1996 and 12 May 1996 respectively. The Decision, lacking any scientific justification, had a purely economic aim, namely to restore consumer confidence.

50 The United Kingdom rejects, in particular, the Commission's argument to the effect that a key objective of the Decision is not the introduction of an export ban but containment. It contends that such a measure of containment is not justified since BSE is transmitted to bovine animals through ingestion of infected feed. There is no scientific evidence that the disease is transmissible from one animal to another. On the contrary, the theory that no vertical or horizontal transmissibility is possible is borne out by the spectacular fall in BSE cases occurring after 1988 following the imposition of the ban on using animal protein in feed for bovine animals.

51 The question of protection against BSE is therefore a purely historic one since the source of the infection has been eliminated. More than 500 official checks a month and the recent on-the-spot inspections of feed for reared animals and of feed storage places have not revealed any infringements, with the exception of one particular case. Since 1990 the United Kingdom has, it states, also put into effect measures for identifying bovine animals and for determining whether they were born of a mother suspected of being infected by BSE or whether they had been in contact with a herd in which BSE cases had arisen. In those circumstances, the animals or products in respect of which the Decision introduces an export ban do not present any unacceptable risk to public health. The United Kingdom points out in this regard that a product must be regarded as safe if the risk is low or accepted, as, for example, in the case of fresh milk.

52 The Commission states, by way of a preliminary point, that, contrary to the applicants' contentions, the export bans imposed by the Decision are clearly defined as emergency and temporary measures which are subject to review, in particular on the basis of later measures to be taken by the United Kingdom. In those circumstances, the grant of the relief sought would prejudge the decision of the Court of First Instance in the main proceedings.

53 The Commission maintains, furthermore, that the Decision falls within the scope of its powers, does not constitute a misuse of powers and is in conformity with the principle of proportionality. It begins by explaining that the Decision puts into effect a policy of containment, which is universally accepted by the scientific community as a legitimate and necessary response to hazardous diseases, so as to enable them to be eradicated. That aim of protecting public health falls within the ambit of the completion of the single market, in accordance with the objectives laid down by the directives which constitute the legal basis of the Decision.

54 In this case, the new information communicated by the United Kingdom on 20 March 1996 revealed the existence of a serious risk to human health, within the meaning of the aforementioned directives. Whereas the measures previously adopted by the United Kingdom and by the Community were based on the mere hypothesis that BSE was transmissible to man, the SEAC statement indicated for the first time that the ten identified cases of Creutzfeldt-Jakob disease were very probably linked to exposure to the BSE agent before the introduction of the ban on specified offal in 1989.

55 At the hearing the Commission pointed out the difficulties of identification in relation to bovine animals, having regard to the long incubation period of the disease and to the movements of animals from one farm to another, which in practice are quite frequent. BSE detected on one farm could have been contracted on another farm through ingestion of infected feed, which would mean that all the animals on the second farm were exposed to the risk of infection. Moreover, whilst the majority of the 160 000 cases of BSE identified in the United Kingdom since 1988 are explicable by the use of animal protein in feed for bovine animals, it is not possible, in the present state of scientific information, to exclude other means of transmission. In particular, the question of maternal transmission and horizontal transmission of BSE is still open. It is the subject of continuing scientific scrutiny and review by the competent authorities. The possibility of lifting the ban on certain products such as live calves under six months of age, embryos or certain fresh bovine meat, may only seriously be envisaged in the light of the results of such a review and after the mechanisms in place for that purpose have had an opportunity to operate.

56 As regards the extension of the ban to exports to non-member countries, this is indispensable for the containment policy pursued by the Decision. It is justified by the risk of fraud and by the impossibility of guaranteeing that appropriate processing methods are followed as regards derived products imported into the Community.

57 In those circumstances, the Commission maintains that in view, on the one hand, of the risk of exposure to BSE, which is very probably transmissible to humans, and, on the other hand, of the seriousness of Creutzfeldt-Jakob disease, the Decision is in conformity with the principle of proportionality.

° Urgency

58 The applicants claim that the Decision is without precedent. Although expressed to be an emergency measure, it is unlimited in time, applies to all products of the cattle industry and entails suspension of all exports of those products from the United Kingdom.

59 They state that, if application of the Decision is not suspended, some of the applicants will disappear from the market. That is so in the case of International Traders Ferry, 80% of whose turnover is represented by the export of calves. That company has had no income since the adoption of the Decision and its bankers have refused to give it any further financial support because of the Decision. It has had to cease paying wages and salaries and can only meet its existing overheads for a limited period of three to six months. The company R.S. and E.M. Wright Limited, 94% of whose business consists in the export of white fat heifers to Italy, has also lost 94% of its income as a result of the application of the Decision.

60 UK Genetics will be forced to cease a significant part of its business and will lose its market share irrecoverably. It has built up trade in exports of semen and bovine embryos to the United States of America, Brazil, Chile, South Africa, New Zealand, Thailand and Korea, representing 38% of its turnover in the year to April 1995 and 24% in the following year.

61 The National Farmers' Union, for its part, according to the applicants, is suffering serious and irreparable harm on account of the threat posed by the Decision to the jobs and livelihoods of its members.

62 At the hearing, the applicants stated that they had taken into account the Community or national support measures taken in the beef and veal sector in assessing the damage they have suffered. Some of them, such as International Traders Ferry, have not benefited from any of those measures.

63 According to the Commission, the applicants have not demonstrated that the Decision poses a risk of serious and irreparable damage in the event that their application for suspension is refused. First, they have not taken into account the whole range of market and other support measures adopted by the Commission or by the Council to meet the crisis caused by the SEAC statement. At the hearing, the Commission stated that those measures will entail a supplementary burden for the Community budget of approximately ECU 1 500 million in 1996 and ECU 1 000 million in 1997. Second, the interim relief sought will not restore consumer confidence which has been shaken by the SEAC statements and not by the Decision. Therefore, the interim measures sought will have little practical effect on the damage allegedly suffered by the applicants. Third, the alleged damage is not serious and irreparable. It is pecuniary in nature and reflects a commercial risk accepted by operators who were already acquainted with the BSE problem.

° Balance of interests

64 The applicants, supported by the United Kingdom, contend that total or partial suspension of the application of the Decision will entail no risk for animals or public health, which are already protected by the measures put in place by the United Kingdom and by the Community before the Decision was adopted. On the other hand, some of the applicants are likely to be eliminated from the market if the present application for interim relief is dismissed.

65 The Commission states that, even assuming that the applicants are likely to suffer serious and irreparable damage, which it disputes, the nature of the damage which not only each party but also third parties are likely to suffer, and the probability of that damage occurring, must be taken into account. The protection of public health is intrinsically more important than the commercial interests described by the applicants. Furthermore, in view of the gravity of Creutzfeldt-Jakob disease, the recent cases of which are very probably linked to exposure to BSE, and the size of the population of the Community exposed to the risk of contracting the disease, the balance of interests is clearly in favour of maintaining the contested emergency measures.

Findings of the President

° Object of the application for suspension of operation

66 Having regard to the legislative context of the Decision (see paragraph 8, above) and to the amendment of that decision by Decision 96-362 (see paragraph 20, above), it is necessary to define what is, in practice, the precise object of the present application for interim measures, before examining whether the conditions for their adoption are satisfied.

67 As regards, first of all, the decision of 11 June 1996, its sole effect until now has been to lift the export ban in respect of one of the products covered by the Decision, namely bovine semen. In reply to a question, the Commission confirmed at the hearing that the export ban still applied to tallow and gelatin, since the controls to which the removal of that ban had been made subject have not yet been implemented. Moreover, the applicants stated at the hearing that the adoption of that amending decision did not in any way affect their claims in the context of the proceedings for interim relief, as regards all the products covered by the contested decision other than bovine semen.

68 It follows that, contrary to the Commission's contention in its written observations, this application for suspension of application of the Decision is not devoid of purpose as regards the ban on the export of tallow and gelatin, since the measures governing the lifting of that ban have not yet been adopted.

69 As regards, next, the delimitation of the object of the present application in the legal context of the preventive measures instituted by the Community in order to deal with the risks linked to BSE before the adoption of the Decision, it is clear from the application for interim measures that the applicants confine themselves to requesting the suspension of the application of the new export bans introduced by the Decision. They cannot, in any event, in these proceedings, call into question the body of Community rules established previously (see paragraph 8, above).

° The conditions for granting a suspension of the application of the Decision

70 In this case, it is necessary for the Judge hearing the application for interim relief to ascertain whether the three substantive conditions for granting a suspension of the application of the Decision are fulfilled, without there being any need for him first to consider the question of the admissibility of the main application. It is well settled that that question must not, in principle, be examined in proceedings for interim relief but must be reserved for the examination of the main application, save where that application appears, prima facie, to be manifestly inadmissible. To rule, at the stage of the proceedings for interim relief, on the admissibility of the main application, when its admissibility is not, prima facie, wholly excluded, would be tantamount to prejudging the Court's decision on that application (see the order of the President of the Court of Justice in Case 209-87 R EISA v Commission [1987] ECR 3453, paragraph 10, and the orders of the President of the Court of First Instance of 7 November 1995 in Case T-168-95 R Eridania and Others v Council [1995] ECR II-2817, paragraph 27, and of 22 December 1995 in Case T-219-95 R Danielson and Others v Commission, paragraph 58, not yet published in the ECR).

71 In the present case, having regard to the circumstances of the case and the arguments submitted by the applicants, appraisal of the admissibility of the action for annulment calls for a more detailed examination, which is a matter for the Court of First Instance when giving its decision on the main application and which the Judge hearing the application for interim relief cannot undertake, in the context of his brief appraisal, without prejudging that decision.

° Prima facie case

72 Following those initial observations, it is necessary, first of all, to consider whether the three pleas on which the applicants rely, alleging the Commission's lack of competence, misuse of powers and breach of the principle of proportionality, prima facie justify granting their request for suspension of the application of the Decision.

73 The first two of those pleas are based in substance on the premiss that the Decision is pursuing a purely economic aim, namely to restore consumer confidence in the European Union's beef and veal sector. Such an aim, the applicants maintain, does not rank among the objectives defined by Directives 90-425 and 89-662, which solely empower the Commission to adopt measures for the protection of public health in the field of intra-Community trade.

74 That argument is based, prima facie, on an incorrect or unduly restrictive interpretation, on the one hand, of the objectives of the Decision and, on the other hand, of the purpose and scope of Directives 90-425 and 89-662.

75 The abovementioned directives, which constitute the legal basis for the Decision, were adopted by the Council pursuant to Article 43 of the Treaty, paragraph (3) of which empowers the Council to make regulations, issue directives or take decisions in regard to the development and implementation of the common agricultural policy. They lay down a number of provisions concerning veterinary checks aimed at protecting public health and animal health in the context of the completion of the single market. Those directives illustrate the fact that the concerns associated with the protection of public health are an integral part of the common agricultural policy. It is true that the effective establishment of a single market presupposes the introduction of sufficient safeguards in relation to the protection of public health and animal health, as the Commission stated at the hearing, referring to the recitals in the preambles to the abovementioned directives (see, in particular, recitals Nos 3 to 6 in the preamble to Directive 90-425). However, consideration of the aspects relating to the protection of public health is not solely linked to the specific need to increase, or, in the present case, to restore consumer confidence so as to enable the market to function normally. It is based essentially on requirements of a higher order which have to do with the protection of human rights and which underpin the entire legal system of the Community. The protection of public health is, moreover, expressly included amongst the objectives defined in the Treaty, which states, in particular, in Article 129(1), that the Community is to contribute towards ensuring a high level of human health protection and that health protection requirements are to form a constituent part of the Community's other policies. When implementing the principle of the free movement of goods, the Community institutions must therefore take into account the requirements related in particular to the protection of the health and life of humans, which may entail, if necessary, the adoption of appropriate measures to ensure proper protection of public health.

76 In that context, Article 10 of Directive 90-425 and Article 9 of Directive 89-662 require each Member State immediately to notify the other Member States and the Commission of an outbreak of any zoonoses, diseases or other cause likely to constitute a serious hazard to animals or to human health, and authorizes the Member States and the Commission to adopt, pending the measures to be taken, interim protective measures. The fourth paragraph of each of those articles provides that, in all cases, the Commission is to review the situation at the earliest opportunity. It authorizes the Commission to adopt, in accordance with the Standing Veterinary Committee procedure, "the necessary measures for the animals and products referred to [in the directives] and, if the situation so requires, for the products derived from those animals". In the absence of any more precise particulars, those articles therefore confer on the Commission a very wide discretion in the choice of measures intended to combat a serious hazard to human health.

77 In particular, the question whether the Commission has the power, on the basis of the abovementioned articles, to adopt interim measures prohibiting the export of certain products to non-member countries must be examined in the light of the principles and aims set out above. From that point of view, there appears to be nothing which would prima facie preclude recognition of such a power, in the face of a disease which represents "a serious hazard to animals or to human health" and requires containment measures designed to prevent the spread of the disease and enable it to be eradicated, in circumstances where the Commission considers that the nature and seriousness of the risk justifies closing off the affected territory not only in regard to the other Member States, but also in regard to non-member countries in order, specifically, to ensure the effectiveness of the protection measures within the Community. At first sight, the directives in question do not, in that respect, impose any express or implied restriction or limit on the Commission's powers in connection with the Standing Veterinary Committee procedure other than those linked to the "necessary" nature of the measures adopted, in order to ensure the protection of public health in a single market. The fact, on which the applicants rely, that the titles of the directives refer to "veterinary checks applicable in intra-Community trade" should not, in principle, result in a restrictive interpretation of the powers thus conferred on the Commission in order to ensure the protection of public health in that market. It would appear to be explained solely by the fact that the directives' aim is to achieve a single market in regard to animals and products of animal origin, which entails the progressive dismantling of veterinary checks at the Community's internal frontiers in favour of checks at the place of dispatch and, consequently, a harmonization of the basic requirements relating to the safeguarding of animal health together with the conferral on the Commission of powers in regard to measures of protection (see, in particular, the fourth and tenth recitals in the preamble to Directive 90-425).

78 In that legal context, an analysis of the reasons on which the Decision is based shows, at first sight, that the emergency measures instituted aim to ensure the protection of public health against the risk of the transmissibility of BSE to humans on the ground that, under current circumstances, "a risk of transmission cannot be excluded". The fact that the measures in question are also intended to allay the concerns amongst consumers caused by the recent information issued by the SEAC regarding that risk does not in any way alter the fact that the primary objective of the Decision is indeed to protect public health in the Community, as is moreover confirmed by the measures preceding the Decision, which are set out in the recitals thereto. The Commission states, first of all, that "to protect animal and human health in the Community" it adopted a number of decisions, which it lists, instituting measures of protection against BSE. It then refers to the information which the United Kingdom Government communicated to it on 20 March 1996 concerning the additional measures taken by the United Kingdom "as a result of the publication of new information on the appearance of certain cases of Creutzfeldt-Jakob disease in that Member State". In addition, pursuing the same line of reasoning, the Commission justifies the extension of the ban on exports to non-member countries by the intention to prevent deflections of trade. At the hearing it explained in that regard that the ban on exports to non-member countries was justified in the present case by the need for a complete isolation of the territory affected by BSE. For all those reasons, the applicants' case that the Decision is pursuing a purely economic purpose appears to be contradicted not only by the actual terms of the Decision but also by the context and circumstances in which the Decision was adopted.

79 Contrary to the applicants' assertions, that conclusion is not contradicted by the Commission's press release of 27 March 1996 stating that the Commission "today adopted a series of provisional measures aimed at protecting against BSE", which would seem, rather, to confirm that the decision is intended to protect animal and public health. In any event, such a press release has no legal value and cannot under any circumstances affect the interpretation of the express and clear reasons stated for the Decision. Moreover, the Commission could legitimately decide to place more stress in its press release on aspects related to restoring consumer confidence, a matter of particular concern to the businesses affected by the crisis in the beef and veal sector.

80 By reason of its object and purpose, the Decision therefore appears to be in conformity with the directives in question. At this stage, it is not necessary to examine the question whether, prima facie, the Commission exceeded its powers, on the ground that the Decision was unnecessary for the purposes of confronting the risk constituted by BSE. It is sufficient to observe that the Decision is intended to ensure the protection of public health against a serious hazard to animals or human health, as required by the relevant provisions of those directives. Having regard to the extent to which BSE has spread within bovine livestock in the United Kingdom and to the "probability" of its transmissibility to humans, the seriousness of the risk linked to that disease appears to be manifest and is, moreover, not disputed by the applicants. They question only the Commission's competence, on the ground that that risk has not changed in nature and has already given rise to the adoption, in particular by the Commission, of earlier, appropriate preventive measures. That line of argument, which goes, rather, to the merits of the Decision, seems of little relevance to an examination of the question of the defendant institution's competence.

81 The first two pleas relied on by the applicants, alleging the Commission's lack of competence and misuse of powers, do not therefore appear, prima facie, to have any basis either in regard to the measures prohibiting exports to other Member States or those relating to exports to non-member countries.

82 In support of their third plea, the applicants rely essentially on the argument that the adoption of the Decision was not justified by the appearance of any new risk linked to BSE which had not already given rise to the adoption of appropriate measures of protection pursuant to the relevant provisions of Directives 90-425 and 89-662.

83 That argument is, at first sight, invalidated by the circumstances which gave rise to the Decision and, in particular, by the very terms of the information concerning the adoption of additional protection measures by the United Kingdom following the publication of the SEAC statement of 20 March 1996 (see paragraphs 9 to 11 above) sent to the Commission by the United Kingdom Government. In particular, the identification by the CJD Surveillance Unit in Edinburgh of ten cases of a previously unrecognized strain of that disease, for which the "most likely explanation at present" is exposure to BSE, constituted a new factor justifying the re-examination of the situation by the Commission in accordance with Article 10 of Directive 90-425 and Article 9 of Directive 89-662.

84 Although it is true that the Community preventive regime established before the adoption of the Decision was based on the assumption that BSE was transmissible to humans, that assumption was not, until then, based on any experimental or medical finding. The abovementioned statement of the SEAC refers, for the first time, to ten atypical cases of Creutzfeldt-Jakob disease, which, according to the most likely explanation, provided by the competent technical bodies, could be the result of exposure to the BSE agent. The importance and seriousness of that new factor were, moreover, taken into account by the United Kingdom, which adopted additional preventive measures in regard to the possible risk of transmissibility of BSE to humans.

85 However, the applicants argue that those new medical observations reinforcing the assumption of the transmissibility of BSE to humans do not significantly alter the facts of the problem as regards the prevention of risks linked to BSE. The most probable explanation, given by the SEAC in its statement, for the ten abovementioned cases is "exposure to BSE before the introduction of the SBO [specified bovine offal] ban in 1989" by the United Kingdom.

86 The proposition, put forward by the applicants and the United Kingdom, that any risk of transmission of the disease to the population was confined to the period before the establishment of preventive measures by the United Kingdom is not prima facie supported by any scientific finding. Even if it were accepted that the ten cases of Creutzfeldt-Jakob disease are explained, according to the most likely hypothesis, by exposure to BSE before 1989, that would not, in view in particular of the long incubation period of the disease, create any certainty as to the absence of a risk of infection linked to BSE after that date. In that regard, it is clear in particular from the article published by Dr Will and others in The Lancet (cited above, pp. 924 to 925) that exposure of the population to the BSE agent was probably greatest in the 1980s, particularly towards the end of that decade, before the introduction of a ban on specified bovine offal. That would be compatible with an incubation period of between five and ten years in those cases. However, the authors add that, if there is a causal link between the appearance of those cases and BSE then, given the potentially long and widespread exposure to the BSE agent, further cases of that new variant of Creutzfeldt-Jakob disease are likely to arise. Moreover, in its statement of 20 March 1996 the SEAC refers to the relative uncertainty of the number of cases likely to arise in the future. In its statement of 24 March 1996 it stresses the impossibility of providing a precise measure of the risk (see paragraph 11, above). The Scientific Veterinary Committee, for its part, recommends in its opinion of 22 March 1996 (see paragraph 12, above) the adoption of appropriate Community measures taking account of the provisions adopted by the United Kingdom and welcomes any measure to address the incidence of BSE and the risks of transmission.

87 Consequently, following the communication of the abovementioned information by the United Kingdom, the Commission was faced with an emergency situation caused by the confirmation, on the basis of medical findings, that there was a probable link between BSE and the appearance of a new strain of Creutzfeldt-Jakob disease, even though, according to the scientists, the ten cases identified do not provide direct evidence of the transmissibility of BSE to humans, which requires additional clinical and neuropathological observations (see The Lancet, pp. 921 and 925, the SEAC statement of 20 March 1996 and the opinion of the Scientific Veterinary Committee of the European Union of 22 March 1996).

88 In that context, having regard to the circumstances of the present case, which are characterized by the seriousness and extent of the "probable" risk, to the urgency of the situation and to the complexity of evaluating its numerous health-related and economic and social aspects, the Commission had a wide discretion, when exercising the responsibilities conferred on it, in relation to the protection of public health, by the relevant provisions of the abovementioned directives, to take the appropriate and necessary measures in accordance with the Standing Veterinary Committee procedure and after consulting the competent technical bodies (see, although in a different context, Joined Cases C-296-93 and C-307-93 France and Ireland v Commission [1996] ECR I-795, paragraphs 30 and 31.

89 At first sight, the measures introduced by the Decision do not appear to be manifestly inappropriate and disproportionate, having regard, on the one hand, to the difficulty of verifying the effective implementation of the preventive measures previously adopted by both the Community and the United Kingdom and, on the other hand, to the current lack of adequate knowledge as to the various ways in which BSE is transmitted from one animal to another.

90 In particular, it does not, prima facie, appear that the prohibition in the Ruminant Feed Ban on using ruminant protein in feed intended for bovine animals since 1988 has enabled the risks of infection to be eliminated. Although it is not disputed that this measure led to a significant fall in cases of BSE in the United Kingdom, it is nevertheless the case that, for example, during the period up to 15 September 1994 more than 12 000 cases of BSE were identified in that country amongst animals born after the entry into force of that measure (1994 SEAC Report, p. 39).

91 Furthermore, it would seem, at first sight, that the difficulties involved in the identification of bovine animals and tracing their movements from one herd to another (see, in particular, the conclusions of the Council of 29 and 30 April 1996, Annex 9 to the Commission's observations) render it impossible to draw up a list of the animals directly subject to the risk of infection either because they have been fed with contaminated products or, assuming that the disease is transmissible horizontally ° which, according to the competent technical bodies, cannot be excluded in the present state of knowledge °, because they are born of or have been in contact with animals affected by BSE. Having regard to the long incubation period, such animals may have contracted the disease without displaying the clinical signs (see, in particular, the report of the Scientific Veterinary Committee of 20 November 1995 on the confirmation of a case of Bovine Spongiform Encephalopathy (BSE) in an animal born in June 1993, Annex 12 to the Commission's observations). Moreover, as regards embryos, it is clear, at this stage, from the Opinion of the Scientific Veterinary Committee of 26 April 1996 on the risks from BSE related to trade in bovine semen and embryos (Annex 18 to the Commission's observations) noting the evidence of the transmission vertically of scrapie, that the existence of a risk of the vertical transmission of BSE cannot be ruled out, in the present state of knowledge, and requires an additional study. Finally, the question of the risk linked to the consumption of meat from an infected bovine animal is, at first sight, still not settled (see the statement by Dr Ring annexed to the Opinion of the Scientific Veterinary Committee of 22 March 1994, reproduced in paragraph 12 above).

92 In those circumstances, it does not, prima facie, appear to be the case that the Commission committed a manifest error of appraisal in its evaluation of the situation and in the choice of appropriate measures by deciding to add to the export bans already imposed by its previous decisions a ban on the export from the United Kingdom to the other Member States of live calves under six months born of cows in which BSE is not suspected; bovine embryos from cows born after 1988 and descended from cows in which BSE is not suspected; fresh bovine meat from animals aged less than two-and-a-half years at the date of slaughter or from bovine animals which, while in the United Kingdom, have resided only on holdings on which no case of BSE has been confirmed during the previous six years; and fresh deboned bovine meat in the form of muscle from which the adhered tissues, including obvious nervous and lymphatic tissues, have been removed.

93 The export bans in question constitute provisional protection. As regards bovine animals and the abovementioned products, they aim to guard against the risks linked to BSE in view of the existence of a number of uncertainties and the need to carry out investigations and detailed scientific study of the significance of the new information, while awaiting the adoption of measures intended to remove the risk of infection and, more generally, to enable BSE to be eradicated (see the sixth and seventh recitals in the preamble to the Decision). In that regard, the alternative solutions proposed by the applicants, based on a system of certification that the meat or the calves come from BSE-free herds and have not been given feed containing animal protein, do not appear, at first sight, to be such as to offer sufficient safeguards, having regard in particular to the difficulties involved in identifying and tracing animal movements and the uncertainty which exists concerning the ways in which BSE is transmitted.

94 Furthermore, the argument, submitted by the applicants at the hearing, that the manifestly disproportionate nature of the Decision is confirmed by the absence of similar measures concerning the other Member States in which cases of BSE have been detected is based, at first sight, on an incorrect appraisal of the situation in those countries, in which BSE has only appeared sporadically, and, as the Commission explained at the hearing, without being contradicted by the other parties, has led immediately to extremely rigorous preventive measures, such as the slaughter of the whole herd, when a case of BSE is identified.

95 As regards, more specifically, the extension of the ban to all exports of those products to non-member countries, it does not seem at this stage to be manifestly disproportionate in relation to the Decision's objective of protecting public health, in so far as it is intended to ensure the effectiveness of the measures of protection introduced. In that regard, the alternative, less restrictive solutions proposed by the applicants, namely a ban on reimportation together with a suitable certification system, do not prima facie make it possible to avoid the not inconsiderable risk of fraud (see the extract from the 1995 Report on the Protection of the Financial Interests of the Community, Annex 15 to the Commission's observations) or the possibility of reimportation into the Community of derived or processed products.

96 Finally, as to tallow and gelatin, suffice it to note at this stage that the decision of 11 June 1996 provided for the lifting of the ban, subject to certain conditions intended to ensure the harmlessness of those products, in accordance with the opinions issued by the competent technical bodies and on the basis of additional information facilitating a more complete evaluation of the risk.

97 For all those reasons, the pleas and arguments relied on by the applicants and by the United Kingdom do not prima facie justify suspension of the application of the Decision.

° Urgency and the balancing of interests

98 It is settled case-law that urgency must be assessed by reference to the need to make an interim order in order to avoid serious and irreparable harm being caused to the person applying for suspension of the application of a decision. In making that appraisal the Judge hearing the application for interim measures must examine whether the annulment of the decision by the Court would make it possible to reverse the situation that would be brought about by the immediate implementation of that decision and, conversely, whether the suspension requested is such as to prevent the decision from being fully effective in the event of the main application being dismissed (see, in particular, the order of the President of the Court of Justice in Joined Cases 76-89 R, 77-89 R and 91-89 R RTE and Others v Commission [1989] ECR 1141, paragraph 15).

99 As to the seriousness of the harm which they claim they are likely to suffer as a result of the Decision, the applicants refer, essentially, to the risk of being eliminated from the market or of losing market shares. The National Farmers' Union claims that its members are in danger of losing their means of existence. However, the applicants do not specify the precise effect of the Decision on those risks. They fail to take into account the part of those risks which is attributable, not to the Decision itself, but to the crisis caused in the meat and veal sector by the recent information concerning the appearance of a number of atypical cases of Creutzfeldt-Jakob disease referred to in the SEAC statement, which is the cause of the additional preventive measures adopted by the United Kingdom and of the ban by other Member States or non-member countries on the importation of bovine products from the United Kingdom, even before the adoption of the Decision on 27 March 1996.

100 In those circumstances, the Judge hearing the application for interim relief does not have sufficient information to evaluate the risks attributable to the Decision as such, or, in those circumstances, to determine the extent to which suspension of the application of the Decision would make it possible to avoid the risks alleged by the applicants.

101 Furthermore, as regards the alleged irreparable nature of the harm which they claim they will suffer, and, more particularly, the effect of the support measures adopted by both the United Kingdom and the Community on the assessment of urgency, the applicants merely maintained in general terms at the hearing that they had taken account of those support measures when evaluating the alleged risks and, in particular, that International Traders Ferry Limited had not profited from those measures. They did not produce any evidence to suggest that they will not benefit, directly or indirectly, in particular from the repercussions of the Community support measures, which, according to the Commission's explanation at the hearing, will amount to ECU 1 500 million during 1996 and ECU 1 000 million during 1997. In those circumstances, the Court does not have sufficient evidence to find that the harm alleged by the applicants is likely to be irreversible, having regard to the support measures rapidly established in response to the crisis in the beef and veal sector following the SEAC's opinion.

102 In any event, even if it were assumed that, for some of the applicants, the harm alleged is largely attributable to the Decision and reparable with difficulty ° which has not been established ° those risks must be balanced against the risks which may follow for public health if the application of the Decision is suspended.

103 In that context, it should be emphasized that the requirements linked to the protection of public health must unquestionably be given more weight than commercial or economic interests, in conformity with the Treaty's objectives of ensuring a high level of protection of human health and with the fundamental principles of Community law in that area.

104 In the present case, the greater weight given to the considerations attaching to the protection of human health is all the more necessary because Creutzfeldt-Jakob disease is fatal and a new strain of that disease linked, according to the currently most likely explanation, to BSE, has just been identified. There are still a number of uncertainties regarding the exact nature of the agent at the origin of that disease (see, in particular, the 1994 SEAC Report, p. 30, and The Lancet, p. 917), for which there is currently no effective treatment.

105 In those circumstances, having regard to the seriousness of the risk which the possible transmissibility of BSE to humans represents for the population, and to the very nature and object of the decision imposing emergency measures in order to confront that risk and the numerous uncertainties associated with it, the requirements linked to the protection of public health must in any event prevail over the economic interests of the applicants and the members of the National Farmers' Union, however serious may be the harm which they may incur and however legitimate the economic or social interests for which they seek protection.

106 It follows from all the foregoing considerations that the conditions for granting a suspension of the application of a decision are not satisfied in this case. The present application must therefore be dismissed.

On those grounds,

THE PRESIDENT OF THE COURT OF FIRST INSTANCE

hereby orders:

1. Prosper De Mulder Limited shall be removed from the list of applicants in the proceedings for interim relief.

2. The United Kingdom is given leave to intervene in support of the form of order sought by the applicants in the proceedings for interim relief.

3. The application for interim relief is dismissed.

4. The costs are reserved.

Luxembourg, 13 July 1996.