Order of the President of the Court of First Instance of 30 June 1999. – Alpharma Inc. v Council of the European Union.

BIB.ORDER

T-70/99 R61999B00700017.000120301208859T

ORDER OF 30. 6. 1999 — CASE T-70/99 R

ALPHARMA V COUNCIL

Order of the President of the Court of First Instance

30 June 1999^(*)

In Case T-70/99 R,

Alpharma Inc., a company constituted in accordance with the law of the United States of America, established in Fort Lee, United States, represented by Gavin Robert, Solicitor, and Bernard van de Walle de Ghelcke, of the Brussels Bar, with an address for service in Luxembourg at the Chambers of Freddy Brausch, 11 Rue Goethe,

applicant,

Council of the European Union, represented by John Carbery, Moyra Sims and Jorge Monteiro, 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

Commission of the European Communities, represented by Peter Oliver and Theofanis Christoforou, Legal Advisers, and Francesco Ruggeri Laderchi, of its Legal Service, acting as Agents, with an address for service in Luxembourg at the office of Carlos Gómez de la Cruz, of its Legal Service, Wagner Centre, Kirchberg,

Republic of Finland, represented by Holger Rotkirch, Director of the Legal Service in the Ministry of Foreign Affairs, and Tuula Pynnä, Legal Adviser in the same Ministry, acting as Agents, with an address for service in Luxembourg at the Finnish Embassy, 2 Rue Heinrich Heine,

and

Kingdom of Sweden, represented by Anders Kruse, Adviser in the Ministry of Foreign Affairs, acting as Agent, with an address for service in Luxembourg at the Swedish Embassy, 2 Rue Heinrich Heine,

interveners,

APPLICATION for suspension of the operation of Council Regulation (EC) No 2821/98 of 17 December 1998 amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 70/524/EEC concerning additives in feedingstuffs (OJ 1998 L 351, p. 4) or for other interim measures,

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

makes the following

Order

Legislative framework

1On 23 November 1970 the Council adopted Directive 70/524/EEC concerning additives in feedingstuffs (OJ, English Special Edition 1970 (III), p. 840, hereinafter ‘Directive 70/524’). That directive, which has been amended several times, lays down, in Annex I thereto, a list of additives the incorporation of which in feedingstuffs is authorised at Community level for an indeterminate period, together with the conditions attaching to their incorporation. In Annex II, it lists substances whose use could be authorised in the Member States for a period of five years.

2Article 2 of the initial version of Directive 70/524 defined additives as ‘substances which, when incorporated in feedingstuffs, are likely to affect their characteristics or livestock production’.

3Article 7(1) of Directive 70/524, in the version resulting from Council Directive 84/587/EEC of 29 November 1984 amending Directive 70/524 (OJ 1984 L 319, p. 13, hereinafter ‘Directive 84/587’), a provision which has subsequently been amended, states:

‘Amendments to be made to annexes on account of the growth of scientific and technical knowledge shall be adopted in accordance with the procedure laid down in Article 23.’

4The regime established by Directive 70/524 was substantially modified by Council Directive 96/51/EC of 23 July 1996 amending Directive 70/524 (OJ 1996 L 235, p. 39, hereinafter ‘Directive 96/51’). Article 2 of Directive 96/51 provides that the Member States are to bring into force the laws, regulations and administrative provisions necessary to comply with Article 1(4) thereof, in so far as it enacts new Articles 6(1), 9d(2), 9e(3), 9f, 9g, 9h, 9i, 9j, 9n and 9o of Directive 70/524, and Article 1(10), (12), (19) and (20) thereof on 1 April 1998 and with its other provisions on 1 October 1999.

5In particular, Article l(3)(i) of Directive 96/51 provides for the replacement of Article 2(a) of Directive 70/524 by the following wording:

‘(a)additives: substances or preparations used in animal nutrition in order to:
—
affect favourably the characteristics of feed materials or of compound feedingstuff s or of animal products; or
—
satisfy the nutritional needs of animals or improve animal production, in particular by affecting the gastro-intestinal flora or the digestibility of feedingstuffs; or
—
introduce into nutrition elements conducive to attaining particular nutritional objectives or to meeting the specific nutritional needs of animals at a particular time; or
—
prevent or reduce the harmful effects caused by animal excretions or improve the animal environment;
(aa)“micro-organisms”: micro-organisms forming colonies;
(aaa)additives subject to authorisation linked to the person responsible for putting them into circulation: the additives listed in Part I of Annex C;
(aaaa)other additives: additives not subject to authorisation linked to the person responsible for putting them into circulation and referred to in Part II of Annex C’.

6Article 9g of Directive 70/524, as inserted by Article 1(4) of Directive 96/51, provides:

‘1.Additives as referred to in Article 2(aaa) [additives subject to authorisation linked to the person responsible for putting them into circulation: the additives listed in Part I of Annex C] included in Annex I before 1 January 1988 shall be provisionally authorised as from 1 April 1998 and transferred to Chapter I of Annex B with a view to their re-evaluation as additives linked to a person responsible for putting them into circulation.
2.With a view to their re-evaluation, the additives as referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorisation; such applications, accompanied by the monographs and the identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorisation was granted or by his successor or successors, via the Member State acting as rapporteur, to the Commission, sending copies to the other Member States, which shall acknowledge receipt thereof.
...
4.Member States shall ensure that the person responsible for putting an additive as referred to in paragraph 1 into circulation submits, as provided for in Article 4 and not later than 30 September 2000, the dossier referred to in Article 4 with a view to re-evaluation. Where he fails to do so, the authorisation of the additive in question shall be withdrawn through the adoption of a regulation in accordance with the procedure laid down in Article 23 and it shall be deleted from the list in Chapter I of Annex B.
...’

7Article 11 of Directive 70/524, in the version thereof resulting from the replacement of its original wording by that contained in Article 1(1) of Directive 84/587, as amended by Article 1(7) of Directive 96/51, provides:

‘1.Where a Member State, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, has detailed grounds for establishing that the use of one of the additives authorised or its use in conditions which may be specified constitutes a danger to animal or human health or the environment although it complies with the provisions of this directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving reasons for its decision.
2.The Commission shall, as soon as possible, examine the grounds cited by the Member State concerned and consult the Member States within the Standing Committee for Feedingstuffs; it shall then deliver its opinion without delay and take the appropriate measures.
3.Should the Commission consider that amendments to the directive are necessary in order to mitigate the difficulties mentioned in paragraph 1 and to ensure the protection of human or animal health or the environment, it shall initiate the procedure laid down in Article 24 with a view to adopting those amendments; the Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force.’

8Article 23 of Directive 70/524, as inserted by Article 1(1) of Directive 84/587 and last amended by Annex I to the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded (OJ 1994 C 241, p. 21, hereinafter ‘the Act of Accession’), provides:

‘1.Where the procedure laid down in this article is to be followed, matters shall be referred without delay by the chairman, either on his own initiative or at the request of a Member State, to the Standing Committee for Feedingstuffs, hereinafter called “the Committee”.
2.The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time-limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that article. The chairman shall not vote.
3.The Commission shall adopt the measures and implement them forthwith where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority.
If the Council has not adopted any measures within three months of the proposal being submitted to it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures.’

9Article 24 of Directive 70/524, as inserted by Article 1(1) of Directive 84/587 and last amended by Annex I to the Act of Accession, provides:

‘1.Where the procedure laid down in this article is to be followed, matters shall be referred to the [Standing] Committee [for Feedingstuffs] without delay by the chairman, either on his own initiative or at the request of a Member State.
2.The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion within two days. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that article. The chairman shall not vote.
3.The Commission shall adopt the measures and implement them forthwith where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority.
If the Council has not adopted any measures within 15 days of the proposal being submitted to it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures.’

10The Standing Committee for Feedingstuffs referred to in Articles 23 and 24 of Directive 70/524 was established by Council Decision 70/372/EEC of 20 July 1970 setting up a Standing Committee for Feedingstuffs (OJ, English Special Edition 1970 (II), p. 534). It consists of representatives of the Member States with a representative of the Commission as chairman.

11Decision 76/791/EEC of 24 September 1976 establishing a Scientific Committee for Animal Nutrition (OJ 1976 L 279, p. 35) set up under the auspices of the Commission a Scientific Committee for Animal Nutrition (hereinafter ‘the SCAN’). That decision was repealed by Commission Decision 97/579/EC of 23 July 1997 setting up scientific committees in the field of consumer health and food safety (OJ 1997 L 237, p. 18), which provides, in Article 2(1) and (3):

‘1.The scientific committees shall be consulted in the cases laid down by Community legislation. The Commission may also decide to consult them on other questions of particular relevance to consumer health and food safety.
...
3.At the Commission's request, the scientific committees shall provide scientific advice on matters relating to consumer health and food safety...’

12The Annex to Decision 97/579 defines the competence of the SCAN as covering ‘scientific and technical questions concerning animal nutrition, its effect on animal health, on the quality and health of products of animal origin, and concerning the technologies applied to animal nutrition’.

13In addition, Article 8(1) of Directive 70/524, as amended by Directive 96/51, provides:

‘The Scientific Committee for Animal Nutrition established by Commission Decision 76/791/EEC [of 24 September 1976] shall be responsible for assisting the Commission, at the latter's request, on all scientific questions relating to the use of additives in animal nutrition.’

Facts

14Defined in general terms, an antibiotic is a substance of biological or synthetic origin, specifically acting at an essential stage of the metabolism of bacteria (antibacterial agents) or fungi (antifungal agents).

15Antibiotics are used, both in humans and in animals, to treat various bacterial diseases. In animals, antibiotics may be used for therapeutic or prophylactic purposes or as growth promoters.

16It is common knowledge, moreover, that bacteria exposed to antibiotics may develop resistance to those antibiotics. The term ‘antibiotic resistance’ refers, therefore, to the ability of a bacterium to live in the presence of an antibiotic which should, in normal circumstances, prevent its replication or kill it. Once a bacterium has developed resistance to an antibiotic, treatment with that antibiotic will be ineffective. In addition, if a bacterium becomes resistant to one member of an antibiotic class, it may also be resistant to other antibiotics from the same class; this phenomenon is called ‘cross-resistance’.

17Recent years have seen a relative decline in the development of effective new antimicrobial chemotherapeutic agents designed to combat certain pathogens. In that regard, bacteria of the Enterococcus faecium (E. faecium) species have developed a resistance to all authorised antibiotics, including vancomycin. Scientists are agreed that there exists a real danger that antibiotics may become ineffective both in the short term and in the long term, that fewer new remedies are being developed and that permanent resistance to various remedies is becoming entrenched.

18The Copenhagen recommendations on antimicrobial resistance, a report of a conference on the microbial threat held in Copenhagen in September 1998 at the instigation of the European Union Directors-General/Chief Medical Officers, states (on p. 7): ‘Resistance to antimicrobial agents is a major public health problem in Europe.’

19Bacitracin zinc is an antibiotic used both as a growth promoter for livestock and in human medicine. This dual-use antibiotic is produced by Alpharma Inc. and marketed in the Community under the trade name ‘Albac’.

20When administered on a regular basis to livestock, bacitracin zinc promotes growth, in particular by enhancing the functioning of the animal's intestinal flora and reducing the incidence of digestive problems.

21Bacitracin zinc was authorised as an additive in feedingstuffs under the procedure initially laid down by Directive 70/524 and was thus listed in Annex I. Since a new use for bacitracin zinc was provisionally authorised by Commission Directive 94/41/EC of 18 July 1994 amending Directive 70/524 (OJ 1994 L 209, p. 18), it was also listed in Annex II to Directive 70/524. That authorisation covering chickens for fattening and pigs was extended to 17 July 1999 by Commission Regulation (EC) No 2786/98 of 22 December 1998 concerning the modification of the period of authorisations of additives referred to in Article 9i(l) of Council Directive 70/524 (OJ 1998 L 347, p. 25, hereinafter ‘Regulation No 2786/98’).

22In addition, bacitracin zinc has, since 1 April 1998, been subject to a re-evaluation procedure pursuant to Directive 96/51.

23Since 1986 the Kingdom of Sweden has prohibited the use of all antibiotics as animal growth promoters. Article 151(1) of the Act of Accession, read in conjunction with Title VII, E(4), of Annex XV thereto, provided that the Kingdom of Sweden was to be authorised to maintain in force until 31 December 1998 its pre-accession legislation with regard to the restriction or prohibition of the use in feedingstuffs of additives classed as antibiotics. The Kingdom of Sweden was also afforded the option of submitting, before 31 December 1998, requests for adaptation of Directive 70/524, which were to be accompanied by a detailed scientific statement of reasons. A decision on requests for adaptation submitted by the Kingdom of Sweden was to be adopted before 31 December 1998 ‘in accordance with the procedure laid down in Article 7 of Directive 70/524’. Pursuant to those provisions, the Kingdom of Sweden submitted to the Commission on 2 February 1998 requests for adaptation of Directive 70/524 accompanied by detailed scientific statements of reasons with regard to eight antibiotic substances, including bacitracin zinc.

24On 17 December 1998 the Council adopted Regulation (EC) No 2821/98 amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 70/524 (OJ 1998 L 351, p. 4, hereinafter ‘the contested regulation’), which removed bacitracin zinc from the list in Annex B to Directive 70/524.

25The operative part of the contested regulation reads as follows:

‘Article 1
The entries in Annex B to Directive 70/524/EEC for the following antibiotics shall be deleted:
—
bacitracin zinc,
...
Article 2
The Commission shall re-examine the provisions of this regulation before 31 December 2000 on the basis of the results given by
—
the different investigations concerning the induction of resistances by the use of the antibiotics concerned,
and
—
the surveillance programme of microbial resistance in animals which have received antibiotics, to be carried out in particular by the persons responsible for putting the additives concerned into circulation.
Article 3
This regulation shall enter into force on the day of its publication in the Official Journal of the European Communities.
It shall apply from 1 January 1999.
However, where, on the date on which this regulation enters into force, a Member State has not banned, in accordance with Community law, one or more of the antibiotics referred to in Article 1 of this regulation, such antibiotic or antibiotics shall remain authorised in that Member State until 30 June 1999.’

26In recital 22 in the preamble to the contested regulation the Council states:

‘Whereas bacitracin zinc, a cyclic polypeptide, is also used in human medicine mainly for topical treatment of infections of the skin and mucosal surfaces; whereas publications show that it could possibly be used for the treatment of vancomycin-resistant enterococci, which represent a clinical problem in human medicine; whereas selected resistances from the use of bacitracin zinc as a feed additive inevitably increase the reservoir of resistances to bacitracin zinc; whereas the percentage of Enterococcus faecium resistant to bacitracin zinc is higher in chickens which have received bacitracin zinc than in chickens which have not received it; whereas these resistances could be transferred from animals to humans and reduce the effectiveness of bacitracin zinc used as a human medicinal product; whereas the effectiveness of bacitracin zinc in human medicine should therefore be preserved.’

27Recitals 23 to 27 in the preamble state:

‘(23)Whereas according to the conclusions of the World Health Organisation conference held in Berlin in October 1997, the Economic and Social Committee of the European Union, the International Office of Epizootics and the conference on antibiotic resistance held in Copenhagen in September 1998, antibiotic resistance must henceforth be regarded as a major, complex problem of international dimensions; whereas, in the sense of the recommendations arising from these conferences, it is desirable to set up a system of general surveillance of antimicrobial resistance resulting from the use of antibiotics; whereas, furthermore, the phenomena of resistance encountered not only in hospitals but also in the general population should be addressed;
(24)Whereas medicinal products belonging to new classes of antibiotics are not ready to be approved in the immediate future; whereas it is therefore imperative to preserve the effectiveness of those human medicinal products which are still effective;
(25)Whereas one of the ways of achieving that aim, along with others relating to use of human medicinal products, is not to increase the reservoir of resistances in animals, especially where such resistances could be transferred to humans, thereby reducing the effectiveness of human medicinal products; whereas numerous scientific data demonstrate such a transfer not only for the organisms responsible for zoonoses but also for commensals;
(26)Whereas one of the ways of preventing such a phenomenon, which originates in the use in livestock farming of antibiotics administered either as a veterinary medicinal product or as a feed additive, is no longer to authorise the use of antibiotics authorised as human medicinal products or known to select cross-resistance to antibiotics used in human medicine as additives, restricting the use of such substances for fundamental reasons to human medicine;
(27)Whereas, for the sake of protecting human health, the authorisations for the antibiotics bacitracin zinc, spiramycin, virginiamycin and tylosin phosphate should be withdrawn’.

28The programme of surveillance of microbial resistance in animals which have received antibiotics, referred to in Article 2 of the contested regulation and introduced following the adoption of Commission Directive 97/6/EC of 30 January 1997 amending Directive 70/524 (OJ 1997 L 35, p. 11), has been conducted under the auspices of the Commission since April 1998. That programme, involving the industry concerned, the Commission and six Member States, is being carried out by the persons responsible for putting the additives concerned into circulation. Its aim is to gauge, over a period of two years, the prevalence of resistance in animal enterococci, or the degree of sensitivity of those enterococci, to seven antibiotics used in locations with different practices as regards the use of feedingstuffs.

29In addition, the Scientific Steering Committee within the Commission's Directorate-General for Consumer Policy and Consumer Health Protection (DG XXIV) established a Multidisciplinary Scientific Steering Committee on Antibiotic Resistance in March 1998. The remit of that steering committee is to conduct a broad review of the literature and output of other institutions relating to the use of antibiotics and the development of resistance in the areas of human pharmaceuticals, veterinary pharmaceuticals and feed additives.

30Lastly, recital 23 in the preamble to the contested regulation refers to the World Health Organisation (WHO) conference held in Berlin in October 1997 on ‘The Medical Impact of the Use of Antimicrobials in Food Animals’. In the report of that conference, the WHO recommended that the use of any antimicrobial agent for growth promotion in animals should be terminated if it is used in human therapeutics.

Procedure

31By application lodged at the Registry of the Court of First Instance on 11 March 1999, Alpharma Inc. (hereinafter ‘Alpharma’ or ‘the applicant’) brought an action under the fourth paragraph of Article 173 of the EC Treaty (now, after amendment, the fourth paragraph of Article 230 EC) for the annulment of the contested regulation.

32On 14 April 1999 the Council raised, pursuant to Article 114 of the Rules of Procedure, an objection to the admissibility of the application for annulment.

33By separate document lodged at the Registry of the Court of First Instance on the same day, Alpharma also applied, pursuant to Articles 185 and 186 of the EC Treaty (now Articles 242 EC and 243 EC), for suspension of operation of the contested regulation pending judgment in the main action, and for the adoption of such other measures as may be considered necessary or appropriate.

34By letter of 25 March 1999, the Republic of Finland applied for leave to intervene in support of the form of order sought by the defendant in the proceedings for interim relief.

35By application lodged at the Registry of the Court of First Instance on 30 March 1999, the Commission applied for leave to intervene in support of the form of order sought by the defendant in the proceedings for interim relief.

36By letter of 8 April 1999, the Kingdom of Sweden applied for leave to intervene in support of the form of order sought by the defendant in the proceedings for interim relief.

37Those applications for leave to intervene were served, in accordance with Article 116(1) of the Rules of Procedure, on the applicant and the defendant, which submitted their observations within the time-limits prescribed.

38By order of 14 April 1999 the President of the Court of First Instance allowed the intervention of the Republic of Finland, the Kingdom of Sweden and the Commission in Case T-70/99 R and granted, at the stage of the proceedings for interim relief, the applicant's request for confidential treatment vis-à-vis the parties granted leave to intervene.

39Each of the parties granted leave to intervene lodged its observations within the period prescribed.

40The parties presented oral argument at the hearing on 26 April 1999.

Law

41Under 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), the Court may, if it considers that circumstances so require, order the operation of the contested act to be suspended or prescribe any necessary interim measures.

42Article 104(2) of the Rules of Procedure provides that applications for interim measures must state the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the measures applied for. Those requirements are cumulative, so that an application for suspension of operation must be dismissed if either of them is not met (order of the President of the Court of First Instance of 15 July 1998 in Case T-73/98 R Prayon-Rupel v Commission [1998] ECR II-2769, paragraph 25). In addition, the Court hearing an application for interim relief must balance the interests at stake (order of 12 July 1996 in Case C-l80/96 R United Kingdom v Commission [1996] ECR I-3903, paragraph 44).

Arguments of the parties

Admissibility

43Whilst the Council does not formally plead the inadmissibility of the application for interim measures, it nevertheless asserts, supported by the Commission, that the claim in the main proceedings is inadmissible. It considers, in essence, that the contested regulation is not of individual concern to the applicant within the meaning of the fourth paragraph of Article 173 of the Treaty. The Commission points out in this regard that an unlimited number of persons may currently produce and market bacitracin zinc, that other undertakings are currently producing and lawfully marketing it, and that there is nothing to prevent the other producers from applying for and receiving a new authorisation linked to the person responsible for putting the additive into circulation, in accordance with Directive 70/524, as amended by Directive 96/51.

44The applicant asserts, by contrast, that its main action is admissible because it was the only undertaking to submit before 1 October 1998, in accordance with Article 9g(2) of Directive 70/524, an application for authorisation linked to the person responsible for putting the additives into circulation, with a view to re-evaluation of the additives referred to in Chapter I of Annex B to that directive. Therefore, it is currently the only company which can be affected by the prohibition on bacitracin zinc after 1 October 1999, the date on which the new system established by Directive 96/61 enters into force. Moreover, it is apparent from Chapter I of Annex B to Directive 70/524, as amended by Directive 96/51, that authorisation will be linked to the person responsible from 1 October 1999, so that generic copies will be prohibited as from that date.

45Furthermore, even though other undertakings may submit dossiers before 30 September 2000 with a view to approval as persons responsible for putting additives into circulation, in accordance with Article 9g(4) of Directive 70/524, the applicant considers that it is not possible for such an application to be made in respect of bacitracin zinc because the marketing of that antibiotic additive is prohibited by the contested regulation from 1 July 1999 at the latest.

The existence of a prima facie case

46The applicant puts forward a number of pleas to establish a prima facie case for the grant of the interim measures sought.

47First, it claims that neither Article 11(3) of Directive 70/524 (see paragraph 7 above) nor the Act of Accession (see paragraph 23 above) can provide a correct legal basis for the contested regulation so far as concerns withdrawal of the authorisation of bacitracin zinc. In particular, the Act of Accession refers to Article 7 of Directive 70/524, a provision which was repealed by Article 1(4) of Directive 96/51.

48The choice of legal basis dictates the choice of procedure for withdrawing authorisation of an additive. In so far as the contested regulation bans spiramycin, virginiamycin and tylosin phosphate, it is based on Article 11(3) of Directive 70/524, a provision which refers to the emergency procedure set out in Article 24 of that directive. However, that emergency procedure contrasts with the normal procedure for withdrawing authorisation of an additive governed by Article 23 of Directive 70/524, under both the former version of Article 7 and Article 9m as inserted by Directive 96/51. The applicant accordingly maintains that, by failing to adhere to the periods laid down by Article 23 of Directive 70/524, the institutions have denied it the benefit of those periods. Furthermore, the speed with which the procedure was carried out deprived the Standing Committee for Feedingstuffs and the Council of the opportunity to consider fully all the scientific evidence in relation to bacitracin zinc.

49Second, the Council manifestly erred in its assessment. According to the second indent of the first paragraph of Article 9m of Directive 70/524, as inserted by Directive 96/51, a regulation withdrawing authorisation in respect of an additive may be adopted if one of the conditions for its authorisation referred to in Article 3a of Directive 70/524 is no longer met. Under Article 3a(e), Community authorisation of an additive is to be granted only if ‘for serious reasons concerning human or animal health its use must not be restricted to medical or veterinary purposes’. It has not been established that there are serious reasons concerning human or animal health for restricting the use of bacitracin zinc to medical or veterinary purposes.

50The precautionary principle, to which reference is made in recital 29 in the preamble to the contested regulation, was improperly applied in the case of bacitracin zinc. In particular, the institutions failed to carry out an objective risk assessment before the contested regulation was adopted. The applicant states in this regard that, even if there is resistance to bacitracin zinc in animals which is transferable to humans, a view which it expressly contests on the basis of the expert's report of Professor Casewell annexed to the application for interim measures, the consequence for human health is negligible, as is confirmed by an expert whose report is likewise annexed to the application. The use of bacitracin zinc in human medicine is limited to topical treatment of minor external infections, which can be combated with other medicinal products. Its use is all the more insignificant in that it cannot be injected because of its nephrotoxicity. Accordingly, the need to preserve the use which is made of bacitracin zinc in human medicine provided no justification at all for withdrawing authorisation for it.

51The applicant also notes that, in contrast to the case of the other three banned antibiotics, no scientific appraisal was carried out or commissioned before the decision to withdraw authorisation in respect of bacitracin zinc, that interested parties, of which it was one, were not involved in the examination of the possible options and that no cost/benefit assessment appears to have been carried out.

52Third, the Council infringed the principle of proportionality, the principle of the protection of legitimate expectations and its right to be heard.

53The principle of proportionality was infringed because the ban on bacitracin zinc will result in the use of alternative antibiotics which are used in human medicine. Furthermore, rather than banning bacitracin zinc, the human use of that antibiotic could have been controlled.

54The principle of the protection of legitimate expectations was also infringed, because the contested regulation was adopted when the surveillance programme concerning microbial resistance in animals which have received antibiotics was in the course of being implemented, the Multidisciplinary Scientific Committee on Antimicrobial Resistance had not yet completed its work and an immediate ban was not justified by any new information.

55Finally, it maintains that, as the world's leading manufacturer of bacitracin zinc and its only producer for human use, it should have been given the opportunity to submit its observations on the proposed ban.

56Fourth and last, the Council gave insufficient reasons in the contested regulation for the withdrawal of authorisation in respect of bacitracin zinc. In particular, the contested regulation fails to explain why a ban is necessary, when bacitracin zinc is currently used in human medicine to an insignificant extent and is unlikely to be used in the future for that purpose because of its toxic effects. Furthermore, Regulation No 2786/98, which extends the temporary authorisation of bacitracin zinc for administration in higher doses to chickens and pigs up until 17 July 1999, that is to say 17 days after the entry into force of the ban in all the Member States, states that bacitracin zinc ‘does not adversely affect human or animal health or the environment, nor harm the consumer’. That statement, in an act adopted only five days after the contested regulation, shows that the withdrawal of bacitracin zinc is not based on a lawful statement of reasons.

57The Council, supported by the Commission, the Republic of Finland and the Kingdom of Sweden, submits that the condition relating to a prima facie case is not satisfied.

58First of all, the contested regulation is not vitiated by a procedural defect. As is apparent from its preamble, it has a dual legal basis, namely Article 151 of the Act of Accession, in conjunction with Title VII, E(4), of Annex XV thereto, on the one hand, and Article 11 of Directive 70/524, on the other.

59The Council observes that Title VII, E(4), of Annex XV to the Act of Accession states that any decision to adapt Community rules must be adopted ‘in accordance with the procedure laid down in Article 7 of Directive 70/524’, which was, at that time, the provision governing the authorisation or withdrawal of additives. In the version then in force, resulting from Directive 84/587, Article 7 of Directive 70/524 provided that the procedure to be followed was that laid down in Article 23 of the directive. The Council points out in that regard that, because of the special status accorded to an act of accession, the subsequent amendment of secondary legislation referred to in such primary law cannot have the effect of rendering the relevant provision of the act of accession ineffective or inapplicable.

60Thus, in accordance with the relevant provisions of the Act of Accession, the procedure to be followed for the withdrawal of authorisation in respect of bacitracin zinc was that set out in Article 23 of Directive 70/524, while the application of the safeguard provisions in Article 11 of that directive meant that the procedure under Article 24 thereof had to be followed for the withdrawal of authorisation in respect of the other antibiotics. Both of those provisions require the Commission to refer the matter to the Standing Committee for Feedingstuffs and the only differences between them are the periods within which that committee must deliver its opinion and the Council is required to act.

61It is not an infringement of an essential procedural requirement within the meaning of Article 173 of the Treaty to combine the application of the procedures under Articles 23 and 24 of Directive 70/524. First, the discretion conferred by Article 23(3) of that directive does not preclude the Chairman of the Standing Committee for Feedingstuffs from asking the committee to deliver its opinion within two days, as Article 24(3) provides. Second, the three-month time-limit imposed on the Council under Article 23 is a maximum period within which it is required to take a decision. Thus, when the proposed regulation was before the Council in the present case, the latter was under no obligation whatsoever to wait for the three-month period to elapse before adopting the measure withdrawing authorisation in respect of bacitracin zinc. In any event, the time-limits laid down by Articles 23 and 24 of Directive 70/524 are not procedural guarantees for the benefit of natural or legal persons.

62The Council goes on to state that it acted in a precautionary manner, since the contested regulation was adopted in order to prevent all actual and foreseeable risks to public health from the dual use of antibiotic substances. The political decision was made in the present case by striking a balance between, first, the maintenance, pending scientific studies, of the status quo with respect to a product used as a growth promoter in animal husbandry, primarily in order to enhance growth and reap quicker and better profits for the farming community, and secondly, the withdrawal of authorisation in respect of the four substances for mandatory reasons related to public health. In that context, it points out that growth promoters other than bacitracin zinc, which do not have dual use, are still authorised. Therefore, in deciding to withdraw authorisation in respect of bacitracin zinc, the Community chose in favour of protecting the overriding interest of public health, on the basis of the evidence before it and following an assessment of the possible dangers to public health.

63The Council and the Commission note that, where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent (Case C-157/96 The Queen v MAFF and Another ex parte National Farmers' Union and Others [1998] ECR I-2211, paragraph 63, and Case T-199/96 Bergaderm and Goupil v Commission [1998] ECR II-2805, paragraph 66).

64In that context, the Commission states that, in the light of the recommendations of the WHO and other authoritative bodies, such as the Health Council of the Netherlands, there are grounds for believing that the continued use of bacitracin zinc as a growth promoter poses a grave threat to human health, a situation which empowers the Community institutions to ban that substance. It points out that the fact that the scale of the risk has not yet been clearly established is irrelevant, because the Community institutions are not required to wait until the extent of the risk has been quantified before taking protective measures. On the contrary, they are required to intervene in good time to protect human health once a potential risk is established through a qualitative assessment. In the present case, the applicant has failed to show that the Commission erred in finding that there was uncertainty as to the existence of risks to human health.

65The Commission states, furthermore, that bacitracin zinc is currently used in human medicine and could possibly be used for the treatment of vancomycin-resistant enterococci, that resistance selected from the use of bacitracin zinc as an additive inevitably increases the reservoir of resistance to that substance and that there is evidence of increased resistance in animals which have received it, that resistances could be transferred from animals to man and that this could reduce the effectiveness of the use of bacitracin zinc in human medicine.

66With regard to that last point, the Commission produced at the hearing a document indicating that a laboratory received authorisation from the United States health authorities in May 1997 to place bacitracin on the market, under the trade name Maciim, for intramuscular use.

67The Council also denies any breach of the principle of proportionality, as formulated in paragraph 96 of the judgment in Case C-180/96 United Kingdom v Commission [1998] ECR I-2265. In matters concerning the common agricultural policy, the Community legislature has a discretionary power, so that the legality of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate to the objective pursued (Case C-331/88 The Queen v MAFF and Another ex parte Fedesa and Others [1990] ECR I-4023, paragraphs 13 and 14). On the basis of the scientific evidence available, the Community institutions did not act in a manifestly inappropriate manner. Moreover, the Kingdom of Sweden submits, in the light of experience in that country following the banning of antibiotic growth promoters in 1986, that it is possible to raise animals without growth-promoting antibiotics whilst retaining proper health conditions.

68The Council states that the institutions are all the more justified in adopting protective measures without having to wait until the reality and seriousness of the risks become fully apparent where a substance which could have adverse effects on human health is not indispensable for the well-being of animals and alternative products are available.

69Nor can the applicant's argument set out in paragraph 53 above be accepted. The alleged increase in the use of alternative products for veterinary purposes would constitute a serious infringement of Article 3a(d) of Directive 70/524.

70The Council considers, moreover, that the applicant's proposal concerning the imposition of stricter controls in connection with the use of the substance in human medicine entirely misses the point behind the Community action. In particular, the possibility of using bacitracin zinc for treating patients with vancomycin-resistant enterococci is increasingly becoming a reality, to the point that it could become a reserve antibiotic. The overriding principle of the WHO, adhered to by the Community, is that antibiotic substances used in human medicine should not be used as animal growth promoters. Although bacitracin is not yet fully used as a drug of last resort for humans, it is nevertheless already in use in human medicine and belongs to a class of drugs with potentially useful effects. The very objective of the contested regulation is to prevent its actual and potential use from being impaired by non-essential use in animals.

71The Council maintains that there has been no breach of the principle of the protection of legitimate expectations either. Referring in that regard to the judgment in Joined Cases T-481/93 and T-484/93 Exporteurs in Levende Varkens and Others v Commission [1995] ECR II-2941, it denies having given the applicant any precise assurance giving rise to a justified expectation that the use of bacitracin zinc as a growth promoter would be authorised indefinitely in accordance with Directive 70/524. As a prudent and discriminating trader in the pharmaceuticals sector, the applicant had been aware, in particular on the basis of the Act of Accession, that there could be no legal guarantee that the Community would not act as it did.

72The Council disputes the existence of any right to be heard in the context of the procedure under which a legislative act of general application is adopted. In any event, the Commission took account of the views which the applicant submitted in response to the Swedish adaptation provisions, in August 1998, and in response to the document drawn up by the Health Council of the Netherlands. Furthermore, the Commission responded positively to the applicant's request for a meeting at which it could restate its views. However, it was not swayed by the arguments put forward by the applicant.

73As regards the plea alleging infringement of Article 190 of the EC Treaty (now Article 253 EC), the Council points out that the contested regulation contains a preamble with 35 recitals and that recital 22 is specifically devoted to bacitracin zinc, its current and potential use in human medicine, the resistances already recorded in animals and the possibility that those resistances could be transferred from animals to humans. The Commission adds that Regulation No 2786/98 entered into force and was published before the contested regulation, which therefore amended the former by implication.

Urgency

74The applicant claims that, if the operation of the contested regulation is not suspended, its animal health business within the European Union will soon be eliminated. Its turnover from the sale of animal health products in Europe amounts to EUR (...),⁽²⁾ of which EUR (...) are attributable to sales of Albac.

75The applicant submits that it will suffer serious and irreparable damage which is difficult to assess in financial terms by reason of: loss of turnover during the period leading up to the actual ban on bacitracin zinc; loss of earnings from 1 July 1999; permanent loss of its market share in the European Union; lasting prejudice to its reputation and product; long-term loss of know-how and experience; severance of the existing distribution network; damage to its market; increased costs at its factory in Oslo; and effects generated by the ban outside the Community.

76In order to establish the imminence and the extent of the harm to which it is exposed, the applicant relies on a number of documents annexed to its application, namely a report drawn up by Alpharma's Director for Europe, the Middle East and Africa containing estimates of financial losses and loss of market share caused by the ban on the use of bacitracin zinc in the Community (hereinafter ‘the Berntsen report’), a file containing correspondence from the applicant's distributors in Europe and a letter from the Director of Brakke Consulting Inc. Europe, a firm of consultants operating in the animal health sector (hereinafter ‘the Brakke letter’).

—Loss of turnover during the period leading up to the ban

77Relying on the Berntsen report and the Brakke letter, the applicant points out that sales will decrease in the period from January to July 1999 both within and outside the Community.

—Loss of earnings from 1 July 1999

78The applicant relies on the Berntsen report, which indicates the projected loss of earnings from the sale of bacitracin zinc for the period from 1999 to 2009. It states that its sales of bacitracin zinc would have almost doubled between 1999 and 2009 and that, in revenue terms, the loss of earnings is likely to be more than double at the end of that period. Those estimates are, moreover, conservative because, except for certain specific circumstances relating to Austria, Denmark and the Netherlands, the figures assume only an annual average growth in turnover of 8% and an annual price increase of 2%. However, over the last four years turnover from sales of Albac has increased by an average of (...)% annually, in both volume and value. Demand for Albac would also have been assisted in the future because, from 1 October 1999, sales of generic bacitracin zinc would no longer have been authorised within the European Union, as a result of the application of the rules.

—Permanent loss of market share in the Community

79The Berntsen report, confirmed by the Brakke letter, gives an estimate of the current market share of bacitracin zinc produced by the applicant in the animal feed market in all the Member States and in the Community, and of the shares of other substances not produced by the applicant, namely: virginiamycin, avilamycin and flavomycin for the broiler and turkey segment; tylosin, virginiamycin, salinomycin, avilamycin and flavomycin for the swine segment; and virginiamycin and flavomycin for the calf segment.

80The applicant maintains that, without interim relief, the market shares currently held by it will be permanently lost to competing products. The Brakke letter bears out and amplifies that analysis. In addition, the Berntsen report contains an estimate of the market shares of authorised substances after the contested regulation has taken effect. The restructuring of the market recorded after the ban on avoparein in January 1997 corroborates that analysis. Moreover, the applicant's current competitors are already preparing to turn the ban on bacitracin zinc to their advantage.

—Permanent damage to market reputation

81The applicant, relying on the Brakke letter, asserts that it will never be able to repair the damage caused by the ban to its reputation, which is closely associated with the success of Albac, and to the reputation currently enjoyed by its product. It points out that some distributors will exert pressure on their suppliers not to buy meat from animals fed with bacitracin zinc even after the ban has been lifted.

—Permanent damage caused by loss of expertise

82Since, on the one hand, the business of developing, producing and selling feed additive is complex and technical and, on the other, the applicant has a highly qualified and experienced team to run its Albac operation in Europe, the applicant is convinced that the effect of the ban will be to break up that team and make it almost impossible for it, after the Court has dealt with the merits of the case, to regain a level of knowledge and experience such as that of the experts it currently employs. That conviction is borne out by the case study on avoparein contained in the Berntsen report.

—Damage caused to distribution

83The applicant states that the teams in the various Member States responsible for the distribution of bacitracin zinc, with which it has long-standing contractual ties, will be either dismantled or redeployed, with ensuing losses of know-how. Furthermore, the personal relationships built up between marketing specialists and customers, crucial for the commercial success of a product, will probably be lost because of the ban. In addition, each of the applicant's distributors will suffer, directly and indirectly, significant financial loss due to their inability to market Albac, as is clear from the file containing correspondence from the applicant's European distributors.

84As the distribution contracts which it has entered into will have to be terminated because of the ban, each of the distributors will attempt to replace bacitracin zinc with relatively comparable products, such as probiotics, organic acids, acidifiers and immunostimulators. The applicant anticipates that those products will be distributed on an exclusive basis so that, as the Brakke letter points out, it is more than likely that the applicant's access to its current distribution chain will be precluded after a period of two years. Even if distributors can also market products competing with Albac, that is likely to reduce their interest and investment in the success of Albac, making the retrieval of its current market position unlikely.

—Loss of customers

85Assuming that the contested regulation is annulled, the applicant maintains that it will be able to recover only a limited proportion of its customers, in particular because of the change in the system for feeding poultry, which would have been given therapeutic treatment in the meantime. The Brakke letter bears out that analysis.

—Increased production costs and the Oslo factory

86The applicant's plant and the Skøyen facility in Oslo (hereinafter ‘the Oslo factory’) currently produce (...) kg of bacitracin zinc per year. That production is for sale worldwide, including the Community, but excluding the United States where bacitracin is produced at another of its factories. The applicant states that, during the fermentation process needed to produce bacitracin zinc, a broth containing the active ingredient is held in a tank following the necessary time in the main fermenter. From that holding tank a specified amount of the broth is diverted for use in the production of ‘human grade’ bacitracin. Some (...)% of the active ingredient is removed from that extract and the remainder returned to the holding tank for use in the production of Albac. The Oslo facility also produces approximately (...) kg of human grade bacitracin per year. With that production, the capacity of the Oslo facility is fully utilised.

87From 1 July 1999 bacitracin zinc will be produced for sale in markets outside the Community and human grade bacitracin will be produced for sale in markets worldwide. Production at the Oslo factory will have to be reduced as a result by (...) kg of active ingredient per year, that is to say approximately (...)% of capacity.

88The Berntsen report forecasts that, following the Community ban, the unit production costs for a kilogram of bacitracin zinc at the Oslo factory will increase by (...)%, because of the increased level of fixed costs (salaries and overheads).

89The Berntsen report also describes the effect of the ban on the profitability of the factory and shows that, at current unit cost levels and current average sales prices, the applicant will lose a substantial amount of revenue and be faced with substantial unabsorbed overheads which will exacerbate the loss of gross profit.

90A revised profit and loss statement, following the Community ban, is also set out in the report. That statement takes account of revised figures for unit production and operational costs. Taking those factors into account, it is projected that in 1999 the Oslo factory will show a significant overall loss.

91In those circumstances, production could admittedly be transferred to the United States, but that decision would entail making the Oslo factory workforce redundant, involve significant costs and not enable demand to be satisfied in full. Besides, a period of up to three years would be needed to obtain the necessary approvals from the United States Food and Drugs Administration for human grade bacitracin.

92Another possibility would be to continue production at the Oslo factory but with reduced output. The increase in certain costs could then be passed on to purchasers of Albac and measures could be taken at the Oslo factory to downsize and to reduce overheads. Those measures would result in a reduction in staff at the factory and the applicant anticipates that (...) employees there (...) would be likely to be made redundant. While those measures would enable the Oslo factory to show a net profit (operating income), they would jeopardise the future of the factory and the undertaking's future growth. In particular, the departure of the sales staff, who are skilled specialists, could not be made good and would jeopardise the ability of the undertaking to retrieve its market share if the ban is subsequently lifted.

93Finally, spare capacity at the Oslo factory could be utilised to produce a new product, but that possibility presupposes not only that the product will be developed but also that it will obtain authorisation and be a commercial success.

—Consequences of the ban outside the Community

94The applicant claims that, as a result of the Community ban, non-member countries, including countries which are candidates for accession, could ban bacitracin zinc. It points out that, when avoparcin was banned in the Community, Hungary, Poland, Romania, the Czech Republic, Bulgaria and Ukraine fell into line with that ban. Furthermore, following the Community ban, Korea, Japan and Thailand decided to impose one themselves. In the present case, measures banning the use of bacitracin zinc in animal feed have already been adopted in Poland, Romania and Bulgaria and are about to be adopted in the Czech Republic. In particular, the announcement of the ban by the Polish authorities stated that it was ‘with reference to the [contested] regulation’. The applicant sells Albac in all those countries. In addition, a possible ban is currently being considered by the New Zealand and Australian authorities.

95Annual production of bacitracin zinc at the Oslo factory would therefore have to be cut further, thereby worsening the financial results of that operation which are already forecast to deteriorate as a result of the ban in the Community. The Berntsen report contains the financial analyses in that regard.

96Finally, it is apparent from the Brakke letter that ‘the loss of registration in the home country of Alpharma, where Albac is manufactured, automatically results in the inability of Alpharma to obtain a Free Sale Certificate required for registration and import permits in many Asian, African and Latin American countries. This is a problem unique to Alpharma, which automatically causes a uniquely [European Union] ban to have major international repercussions.’

97The Council disputes that the condition relating to urgency is met. In its view, the applicant has not demonstrated that the damage allegedly caused to the Oslo factory and to its animal health business by the entry into force of the contested regulation would be irreparable and endanger the very existence of that plant and business, or that it would result in irreparable harm to the applicant and endanger its very existence (see, in particular, order of the President of the Court of First Instance of 10 May 1994 in Case T-88/94 R Société Commerciale des Potasses et de l'Azote and Entreprise Minière et Chimique v Commission [1994] ECR II-263, paragraph 44).

98The Council notes as a preliminary point that the applicant operates in more than 50 countries, employs staff at 33 sites in 21 countries and manufactures and markets speciality human pharmaceutical and animal health products. It currently has five manufacturing facilities in the United States, four in Norway (including the Oslo factory), one in Denmark and one in Indonesia. It employs approximately 2600 people worldwide. In addition, it claims to be the largest manufacturer of generic liquid and topical pharmaceuticals in the United States, the leading Nordic producer of international finished pharmaceuticals, a dominant worldwide supplier of general important specific antibiotics, a leading producer of animal health additives and the largest producer of fish vaccines worldwide. As regards, more specifically, its Animal Health Division outside the European Union, it claims to have a dominant position in the United States and a strong and growing international presence in Latin America and Asia. In view of its size, its international presence and the diversity of its products, the Council considers that the applicant's contentions concerning the impact of the ban on its business are not realistic.

99First of all, while it is not in dispute that the applicant will cease to sell bacitracin zinc in the Community, it has not been demonstrated that the Community ban will necessarily bring to an end its animal health business either within or outside the European Union. The Council maintains that the alleged damage within the European Union is grossly overestimated and exaggerated, because the projected loss of sales in 1999-2009 is based on the growth rates for 1997-98, years in which the applicant took over the market share held by a product which had been withdrawn from the market.

100In addition, the Council denies that the ban affects the applicant's reputation. Information relating to products used in the feeding of animals, in particular poultry, is not made available to the general public and therefore has no impact on purchasing decisions by the final consumer.

101The Council also considers that it has not been demonstrated that the expected reduction in sales of the product will give rise to direct irreparable consequences for employment at the Oslo factory or for the workforce currently responsible for producing and marketing the banned product. In that regard, if there is a risk that the undertaking may not function properly without certain key employees, the Council expresses surprise that the applicant may decide to make some of its staff redundant, especially as the factory manufactures the banned product for the global market other than the United States. The applicant should be able to retain those employees for a few months, even if they have less work, in view of the problems which the departure of some of them might entail.

102Second, the Council points out that damage of a purely financial nature cannot in principle be regarded as irreparable, or reparable only with difficulty, if it can ultimately be the subject of financial compensation (order of 1 October 1997 in Case T-230/97 R Comafrica and Dole Fresh Fruit Europe v Commission [1997] ECR II-1589). In the present case, the applicant has failed to show that the alleged damage to the Oslo factory and to its animal health business is such as to place its very existence in jeopardy. That would be the case if the applicant's activities were limited to the manufacture of Albac and the entire market for that product were suddenly to disappear because of the contested regulation. However, on the basis of information placed on the Internet by the applicant, production at the Oslo factory is not limited to bacitracin zinc as a feed additive. It produces ‘animal grade’ bacitracin zinc for markets other than those of the European Union and United States, ‘animal grade’ bacitracin zinc for therapeutic use, ‘human grade’ bacitracin zinc and other antibiotic products. In addition, the applicant is currently developing new products which could be produced by the Oslo factory.

103Furthermore, harm resulting from decisions adopted by non-member countries to ban bacitracin zinc cannot be taken into account.

104Finally, the Council produced at the hearing a copy of the press release dated 14 December 1998 which the applicant issued following the adoption of the contested regulation.

Balance of interests

105The applicant, relying on the order of the President of the Court of Justice of 19 July 1995 in Case C-149/95 P(R) Commission v Atlantic Container Line and Others [1995] ECR I-2165, paragraph 50, submits that annulment of the contested regulation by the court adjudicating on the substance will not make it possible to reverse the situation brought about by the immediate operation of the regulation, and that suspension of its operation will not prevent it from being fully effective in the event of the main application being dismissed.

106First of all, the damage which the Community ban will cause to the applicant will be so severe that it will be unable to reverse the fortunes of its animal health business in Europe should the contested regulation be annulled: that business would be destroyed before the Court gave judgment in the main proceedings.

107The applicant then points to the differences between the present case and the case which gave rise to the order of 12 July 1996 in United Kingdom v Commission, cited above, where the United Kingdom had applied for suspension of operation of the Commission decision intended to protect public health against bovine spongiform encephalopathy. In particular, the risk to human health in United Kingdom v Commission lay in the transmission of a fatal disease affecting humans for which there was no known cure at the time, while the risk invoked in the present case is a possible build-up of resistance to a medicinal product which has no significant actual or potential use in human medicine. There is no life-threatening disease for which bacitracin zinc is prescribed. The applicant states in that regard that the use of bacitracin zinc is necessarily limited because of its nephrotoxicity. For that reason it is not effective as a treatment for infections caused by vancomycin-resistant enterococci, contrary to the statement in recital 22 in the preamble to the contested regulation. Moreover, alternative products are available in respect of its current use. It is clear from scientific literature as well as its current use and its manner of prescription that it is very little used today. Thus, the authorisation of bacitracin zinc as an additive in feedingstuffs presents no risk to human health. In any event, it is not established that the use of bacitracin zinc in feedingstuffs may lead to increased resistance to that antibiotic in humans — the evidence of over 40 years of experience and the expert's report annexed to the application suggest the contrary.

108Furthermore, unlike the cases relating to bovine spongiform encephalopathy, where new data had established that there was a risk of transmission of a fatal and incurable disease, in the present case there is no new evidence showing a serious risk that bacitracin zinc is harmful. Moreover, the temporary authorisation for the administration of bacitracin zinc in a higher dose was granted in 1994 and has been renewed on four occasions, the last time only a few days after the adoption of the contested regulation. Also, the period from 1 January 1999 to 30 June 1999 set to enable stocks of antibiotics affected by the ban to be sold demonstrates the relative lack of urgency found by the Council itself.

109Furthermore, the applicant claims that the very fact of maintaining the ban on bacitracin zinc presents a serious risk to human health because, as Professor Hellig has explained in his expert's report annexed to the application for interim measures, it is likely that the ban on the use of bacitracin zinc in animal feed will lead to the increased use of alternative antibiotics which also have important uses in humans. In addition, antibiotic residues could be left in food by alternative antibiotics and there would be a higher risk of meat contamination caused by intestinal wall breakage in poultry during processing.

110Finally, a less radical measure than the withdrawal of authorisation could have been adopted, in particular regulation of the ‘over the counter’sale of bacitracin zinc for human use.

111According to the Council, the balance of interests militates in favour of the maintenance of the contested regulation, inasmuch as the interest in having the contested measure maintained is not readily comparable to the applicant's interest in having its operation suspended (order of 12 July 1996 in United Kingdom v Commission, cited above, paragraph 90, and order of the President of the Court of Justice of 24 September 1996 in Joined Cases C-239/96 R and C-240/96 R United Kingdom v Commission [1996] ECR I-4475). Even if it were acknowledged that there may be damage to the applicant's interests, that damage cannot outweigh the serious harm to public health which is liable to be caused by suspension of the contested decision, and which could not be remedied if the main action were subsequently dismissed (order of 12 July 1996 in United Kingdom v Commission, cited above, paragraph 92). Any possible damage to the applicant's commercial interests cannot outweigh the potentially serious harm to public health which could be caused by permitting the routine use of bacitracin zinc as a growth promoter to continue.

112The parties intervening in support of the form of order sought by the Council endorse those arguments.

Findings of the Court

Admissibility

113In accordance with the second paragraph of Article 104(1) of the Rules of Procedure, an application for the adoption of interim measures is admissible only if it is made by a party to a case before the Court of First Instance. That rule is not a mere formality; it presupposes that the main action which is accompanied by the application for interim measures is capable of being properly considered by the Court.

114It is settled case-law that, in principle, the issue of the admissibility of the main action should not be examined in proceedings for interim relief, so as not to prejudge the Court's decision on the substance of the case. It may nevertheless appear necessary, when, as in this case, it is contended that the main application to which the application for interim measures relates is manifestly inadmissible, to establish whether there are any grounds for concluding prima facie that the main application is admissible (see, in particular, the orders of the President of the Court of Justice of 27 January 1988 in Case 376/87 R Distrivet v Council [1988] ECR 209, paragraph 21, and of 13 July 1988 in Case 160/88 R Fédération Européenne de la Santé Animale and Others v Council [1988] ECR 4121, paragraph 22; orders of the President of the Court of First Instance of 15 March 1995 in Case T-6/95 R Cantine dei Colli Bevici v Commission [1995] ECR II-647, paragraph 26, and of 22 December 1995 in Case T-219/95 R Danielsson and Others v Commission [1995] ECR II-3051, paragraph 58; order of the President of the Fifth Chamber of the Court of First Instance of 28 April 1999 in Case T-11/99 R Van Parys and Others v Commission [1999] ECR II-1355, paragraph 50).

115The fourth paragraph of Article 173 of the Treaty gives individuals the right to challenge any decision which, although in the form of a regulation, is of direct and individual concern to them. The particular purpose of that provision is to prevent the Community institutions from being able, simply by choosing to use the form of a regulation, to preclude an individual from bringing an action against a decision which concerns him directly and individually and thus to make it clear that the nature of a measure cannot be changed by the form chosen (see, in particular, Case T-47/95 Terres Rouges and Others v Commission [1997] ECR II-481, paragraph 39).

116In the present case, the contested regulation withdraws four specified antibiotics from the list in Annex B to Directive 70/524 and prohibits their sale in all the Member States of the Community with effect, pursuant to Article 3, from 1 January 1999 or 1 July 1999. As is apparent from recital 27 in the preamble to the contested regulation, the reason for the withdrawal of authorisation for the four antibiotics is the protection of human health; it is therefore aimed not only at the manufacturers of the products concerned but also at those using them and, more generally, at the entire population of the European Union. That regulation is therefore in the form of a measure having general application within the meaning of Article 189 of the EC Treaty (now Article 249 EC).

117However, the fact that a provision is, by its nature and scope, of a legislative nature does not prevent it from being of individual concern to natural or legal persons if it affects them by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons and, by virtue of those factors, distinguishes them individually just as in the case of the addressee of a decision (Case C-309/89 Codorniu v Council [1994] ECR I-1853, paragraph 19, and order of 26 March 1999 in Case T-114/96 Biscuiterie-Confiserie LOR and Confiserie du Tech v Commission [1999] ECR II-913, paragraph 30).

118It suffices in that regard to note in the context of the present proceedings, first, that the applicant is in a special situation, since it is the sole producer of bacitracin zinc in the European Economic Area and its leading supplier there, and second, that it risks being adversely affected by the contested regulation by reason of its position as the only undertaking which, before 1 October 1998, lodged a new application for authorisation with a view to the re-evaluation of bacitracin zinc as an additive linked to a person responsible for putting it into circulation, in accordance with Article 9g(2) of Directive 70/524, as inserted by Article 1 of Directive 96/51.

119Moreover, it is common ground that the contested regulation is of direct concern to the applicant.

120Consequently, there are important factors prompting the Court to conclude that the contested regulation may be of direct and individual concern to the applicant and that the applicant may thus be entitled to seek its annulment under the fourth paragraph of Article 173 of the Treaty. Consequently, the present application for interim measures must be declared admissible.

The existence of a prima facie case

121The parties disagree fundamentally as to the circumstances in which the competent authorities may, as a precautionary step, adopt a measure withdrawing authorisation in respect of an antibiotic the effect of which is to prohibit the sale of that product in the Community.

122The applicant maintains that the precautionary principle was improperly applied in the case of bacitracin zinc, since the institutions involved failed to carry out an objective assessment of the risk before the contested regulation was adopted. It states in this regard that, even if there were resistance to bacitracin zinc in animals and that resistance were transferable to humans, which is not the case, the impact on human health would be negligible because of the extremely limited use of that antibiotic in human medicine.

123The Council, by contrast, maintains that the principal objective of the contested regulation, in withdrawing authorisation for four antibiotics, was to ensure the protection of human health against the actual and potential risks of increased antimicrobial resistance in human medicine resulting from the regular use of antibiotics in the raising of animals. That measure must, it contends, be seen as a precautionary safeguard which can be reviewed in the light of the investigations and the surveillance programme. The Council, supported by the Commission and the intervening Member States, considers, in essence, that, where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent. In the present case, although the experts are unable to quantify the health risk, reports such as those of the WHO, the House of Lords Select Committee and the Health Council of the Netherlands, together with the Copenhagen recommendations on antimicrobial resistance, reveal the justification and the need for the adoption of measures to put an end to the use of antimicrobial agents as growth promoters for livestock where those agents are or could be used as a drug for human use.

124It must be observed in that regard that, if the Court were in fact to find that the Council was mistaken in its interpretation of the criteria for the application of the precautionary principle, such a finding would constitute, in the circumstances of this case, a crucial factor for the purposes of assessing the extent of the risk to human health which may justify the withdrawal of authorisation in respect of bacitracin zinc as an additive in animal feed.

125The arguments which the applicant has advanced regarding this issue accordingly require very thorough examination, which cannot be undertaken in the context of these proceedings for interim relief.

126It follows that the applicant's plea alleging, in essence, that the precautionary principle has been contravened cannot, prima facie, be regarded as wholly unfounded and justifies consideration by the Court of the other conditions for the grant of interim relief.

Urgency and the balancing of interests

127It is settled case-law that the urgency of an application for interim measures must be assessed in relation to the necessity for an interim order to prevent serious and irreparable damage to the party applying for those measures. It is for the party seeking suspension of operation of an act to prove that it cannot wait for the outcome of the main proceedings without suffering damage that would entail serious and irreparable consequences (order in Prayon-Rupel v Commission, cited above, paragraph 36).

128It is likewise well-established case-law that damage of a purely pecuniary nature cannot, save in exceptional circumstances, be regarded as irreparable or even as being reparable only with difficulty, if it can ultimately be the subject of financial compensation (order of the President of the Court of Justice of 18 October 1991 in Case C-213/91 R Abertal and Others v Commission [1991] ECR I-5109, paragraph 24, and order 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 42).

129Under those principles, the suspension sought could be justified, in the circumstances of the present case, only if it appeared that, in the absence of such relief, the applicant would be placed in a situation which could endanger its very existence or irremediably affect its market share.

130In order to determine whether the operation of the contested regulation is likely to endanger the applicant's existence, it is necessary to ascertain the effects which it may have, first, on the Oslo factory, and second, on the applicant's financial viability.

131It must be stated at the outset that the operation of the contested regulation will not cause all production of Albac to cease or inevitably lead to the closure of the Oslo factory.

132Since the effect of the contested regulation is to ban the sale of bacitracin zinc used as an additive in animal feed in the Community, the applicant will be able to continue to produce Albac for sale in markets outside the Community. In that regard, the value of sales of Albac in the Member States of the Community, calculated on the basis of the figures set out in the table on page 6 of the Berntsen report, accounted for (...)% of the total value of sales of Albac worldwide in 1998, and not (...)% as indicated on page 4 of the Berntsen report; sales of Albac outside the Community therefore accounted for (...)% of the total value of sales. Total turnover from sales of Albac worldwide in 1998 amounted to EUR (...), of which EUR (...) were attributable to Community sales.

133Next, the applicant alleges that the decrease in production of bacitracin zinc which will be caused by the operation of the contested regulation and, therefore, the decrease in sales of that product will inevitably lead to an increase in its unit production costs. However, while the Oslo factory might well show a loss in 1999 because of the inability to market Albac in the Community, as is apparent from the financial projections contained in the Berntsen report, reorganisation measures and steps to reduce overheads, such as those recommended by the applicant itself, could enable a net profit (operating income) to be shown (Berntsen report, p. 15), so that closure of the factory will not be an inevitable result of the operation of the contested regulation. However, on the assumption that the applicant is forced to make highly qualified staff, (...), redundant in order to protect the financial position of the Oslo factory, that factory will nevertheless continue to produce Albac for sale in markets other than those of the Member States, so that redundancies of such staff could only make it more difficult to regain market share in the Community, in the event that the Court finds for the applicant in the main action.

134Furthermore, the Council has stated, without challenge from the applicant, that the latter also produces substances in its Oslo factory other than that banned in the Community, namely ‘animal grade’ bacitracin zinc for therapeutic use, ‘human grade’ bacitracin zinc and other antibiotic products. The manufacture of those products for sale worldwide is not affected by the operation of the contested regulation either.

135Accordingly, since a decision not to grant suspension will not inevitably lead to the discontinuance of production of bacitracin zinc for animal feed or to the cessation of the other production activities at the Oslo factory, it must be held that the operation of the contested regulation will not result in the factory's closure.

136As regards the further question whether the inability to sell Albac in the Community prejudices the applicant's financial viability, it should be noted that, since the ban on that product is limited to the Community, the applicant will still be able to market it outside the Community after 1 July 1999. Having regard to the results recorded in 1998 (see paragraph 132 above), it is possible that sales of Albac will enable it to realise (...)% of the turnover achieved by it from sales of that product in 1998.

137Furthermore, it was stated at the hearing, in reply to a question from the Court, that turnover from sales of Albac throughout the world accounted for 5% of the applicant's total turnover.

138Consequently, the financial harm which the applicant will suffer will not prevent it from continuing to pursue its activities pending judgment in the main action.

139As to the effect which that prohibition will have on market share, a distinction must be drawn between markets outside the Community and the Community market.

140The applicant claims that sales of Albac in countries which are not Member States of the Union will decrease as a result of the Community legislation. The Court considers that such an argument can only be validly relied on to establish urgency in ordering suspension of the contested act in so far as an order for suspension would be liable to prevent the alleged damage from materialising. As it is, the applicant has not in any way shown that the interim relief, if granted, would prevent the countries concerned from banning the sale of bacitracin zinc in their territory. Furthermore, in so far as the banning of bacitracin zinc in the Community has actually led to a reduction, or even a prohibition, of sales of that product in other countries, such damage is not a direct consequence of the contested regulation, resulting instead from decisions taken by the competent national authorities with a view to ensuring, in their absolute discretion, the protection of human health. In those circumstances, it is for the applicant to bring proceedings before the national courts for a review of the legality of the decisions which are causing it to sustain the commercial damage alleged.

141The applicant further claims that it is in danger of losing the market shares acquired by its product in the Community. However, those market shares cannot be regarded as irremediably compromised. Even if the share of the Community market held by bacitracin zinc is lost to competing products from 1 July 1999, there is nothing in the documents before the Court to justify the conclusion that it would be impossible for the product in issue to regain its previous position.

142It should be noted in that regard, first, that the ban is not definitive in nature, since, according to Article 2 of the contested regulation, its provisions are to be re-examined before 31 December 2000 on the basis of the results of the various investigations concerning the development of resistance following the use of the antibiotics concerned and the surveillance programme concerning microbial resistance in animals which have received antibiotics.

143Furthermore, Alpharma has an excellent reputation in the animal feed industry, as a producer of high quality products (Brakke letter, p. 4). Sales of Albac in 13 Member States increased by an average of (...)% per year, in value and in volume, during the period from 1994 to 1998 (Berntsen report, p. 7). In addition, on the assumption that the contested regulation had not been adopted, the Berntsen report indicates that sales would have increased in volume by 8% per year during the period from 1999 to 2009. It follows, first, that doubt cannot be cast on the applicant's reputation as a whole merely because of the ban on the sale of Albac, which is just one of the products manufactured by it, and second, that, given the commercial success with Community stock farmers which bacitracin zinc has enjoyed in the past and is anticipated for the future, the view cannot be taken that the applicant will no longer be able to regain the share of the Community market which bacitracin zinc for use in animal feed held before the ban, should the contested regulation be annulled by the Court.

144In addition, even if one of the effects of the operation of the contested regulation will be, following its possible annulment by the Court, to prevent the distribution of Albac in the Member States through the applicant's current distribution network, the applicant does not claim that it will never be able to secure distribution of its product in the Member States. Accordingly, even if significant financial commitments had to be entered into, the applicant would not be prevented from selling its product in the Community again, should the Court find in its favour in the main action.

145Furthermore, assuming that the ban on the use of Albac in animal feed, as provided for by the contested regulation, gives rise to a negative reaction on the part of retailers and consumers, suspension of operation of that regulation could not re-establish the product's reputation any more than it would be reestablished, in the future, by the annulment of the regulation on completion of the main proceedings or, as the case may be, a lifting of the ban by the Commission before 31 December 2000 following the re-examination of the regulation on the basis of the results of the studies referred to in Article 2 thereof.

146Finally, the serious and irreparable damage alleged, which suspension of operation of a contested act is intended to avoid, can be taken into account by the Court hearing an application for interim measures, in its consideration of the criterion of urgency, only in so far as it may be caused to the interests of the party seeking the interim relief. It follows that the damage, if any, which the operation of the contested act may cause to a party other than the party seeking the interim relief can be taken into consideration by the Court hearing the application for interim measures only when balancing the interests at stake. Consequently, the possible damage to the distributors of Albac established in the various Member States, pleaded by the applicant, is to be taken into account only when that factor is considered for the purposes of suspension of operation.

147Having regard to all the foregoing, it must be concluded that the applicant has not succeeded in showing that it would suffer serious and irreparable damage if operation of the contested regulation were not suspended.

148In any event, even if the applicant succeeded in establishing beyond any doubt the existence of serious and irreparable damage, the Court would still be required, in the context of the present application, to weigh the interest of the applicant in obtaining suspension of the ban on the sale of bacitracin zinc in the Community against the interest of the other parties in securing its continuance in force.

149In the context of its examination of an application for interim measures, the Court is required to determine whether the possible annulment of the contested act by the Court hearing the main action would allow the situation brought about by its immediate implementation to be reversed and, conversely, whether suspension of the operation of that act would be such as to prevent its 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 of 11 May 1989 in Joined Cases 76/89 R, 77/89 R and 91/89 R RTE and Others v Commission [1989] ECR 1141, paragraph 15, the order of 12 July 1996 in United Kingdom v Commission, cited above, paragraph 89, and the order of the President of the Court of First Instance of 21 March 1997 in Case T-41/97 R Antillean Rice Mills v Council [1997] ECR II-447, paragraph 42).

150Such a balancing of interests favours the maintenance of the contested regulation in any event, inasmuch as the interest in having the contested regulation maintained is not readily comparable to the interest of the applicant in having it suspended.

151Damage to commercial and social interests of the kind that would be sustained by the applicant and by the distributors of Albac established in the various Member States with whom it is contractually linked cannot outweigh the damage to public health which would be liable to be caused by suspension of the contested regulation, and which could not be remedied if the main action were subsequently dismissed.

152In the light of that consideration, there can be no question but that the requirements of the protection of public health must take precedence over economic considerations (order of 12 July 1996 in United Kingdom v Commission, cited above, paragraph 93; judgment in Case C-183/95 Affish v Rijksdienst Keuring Vee en Vlees [1997] ECR I-4315, paragraph 43; and order of 15 September 1998 in Case T-136/95 Industria del Frio Auxiliar Conservera v Commission [1998] ECR II-3301, paragraph 58).

153In addition, it has been held that, where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent (judgments in National Farmers' Union and Others, cited above, paragraph 63, and United Kingdom v Commission, cited above, paragraph 99; judgment in Bergaderm and Goupil v Commission, cited above, paragraph 66).

154In the present case, without in any way prejudging the assessment to be made by the Court concerning the pleas raised by the applicant in the main action, it must be observed that the stated objective of the withdrawal of authorisation in respect of bacitracin zinc is to combat the risks of increased antimicrobial resistance in human medicine resulting from the regular use of that antibiotic in the raising of animals. Consequently, that risk of increased antimicrobial resistance in human medicine is based on the assumption that bacteria resistant to bacitracin zinc in animals are transmissible to humans.

155The documents before the Court substantiate that assumption.

156Thus, in the report of the conference held in Berlin in October 1997 on ‘The Medical Impact of the Use of Antimicrobials in Food Animals’, the WHO stated (p. 1):

‘Certain antimicrobials used for treatment or growth promotion in agriculture are also used for disease control in humans. Others select for cross-resistance in bacteria to antimicrobials used in human medicine. Microbiological and clinical evidence is mounting that resistant bacteria or resistance determinants might be passed from animals to humans, resulting in infections that are more difficult to treat. With an increase in the prevalence and distribution of antimicrobial-resistant infections in hospitals and the community, the question has been raised as to how this escalation of resistance could have been influenced by the use of antimicrobials in livestock production.
The magnitude of the medical and public health impact of antimicrobial use in food animal production is not known. Despite the uncertainty, however, there is enough evidence to cause concern. It is unrefuted that the use of antimicrobials leads to the selection of resistant bacteria and that the scope of the emerging problem depends, among other things, on duration of exposure to and concentration of the antimicrobial.’

157In the same report, the WHO recommended that the use of any antimicrobial agent for growth promotion in animals should be terminated if it is used in human therapeutics.

158In the report of the Health Council of the Netherlands of September 1998, the Committee on Antimicrobial Growth Promoters made the following recommendation: ‘As soon as possible [terminate] the use of substances which confer resistance to (related) antibiotics currently used to treat patients suffering from bacterial infections. These include the antimicrobial growth promoters avoparein, tylosin and spiramycin. This recommendation also applies to antimicrobial growth promoters for which related compounds will be available for human therapy in the long term, and cross-resistance has been established (virginiamycin, avilamycin and bacitracin)’ (pp. 19 and 20).

159Page 42 of that report states:

‘Bacitracin and everninomycin are two “new” antibiotics under development for the treatment of patients with VRE [vancomycin-resistant enterococcus] and MRSA [methicillin-resistant Staphyllococcus aureus] infections which are currently generating a great deal of interest. In the past, the use of bacitracin in humans has been confined to topical use in the treatment of patients with infections of the skin or the mucous membrane. Recently, though, it has entered experimental use for the treatment of patients infected by VRE (Chia J.K., Nakata M.M., Park S.S. et ai, Use of Bacitracin Therapy for Infection due to Vancomycin-resistant Enterococcus faecium, Clin Inf Dis 1995; 21:1520). However, this antibiotic is additionally used as a growth promoter in livestock farming. In the United States, relatively low resistance rates (up to 17 per cent) have so far been found in staphylococci, streptococci and enterococci... Nevertheless, if this substance is used as a growth promoter, the possibility of resistance increasing cannot be excluded.’

160The report also states:

‘Bacitracin and everninomycin have recently been introduced for the treatment of patients infected by VRE [vancomycin-resistant enterococcus] or MRSA [methi-cillin-resistant Staphyllococcus aureus]. However, bacitracin is used as a growth promoter, while everninomycin is closely related to the growth promoter avilamycin, so the possibility of problems arising in the future as a result of developing resistance to these agents cannot be excluded’ (pp. 62 and 63).

161Finally, the Committee on Antimicrobial Growth Promoters ‘believes that the use of antimicrobial growth promoters which also have or may in the future have therapeutic medical or veterinary applications should be terminated as soon as possible... [and that] antimicrobial growth promoters which are related to antibiotics with such (potential) applications should also be withdrawn from use’ (p. 64).

162In its application for interim measures and at the hearing, the applicant claimed that, unlike resistance to the other three antibiotics banned by the contested regulation, resistance to bacitracin zinc was chromosome-mediated and not plasmid-mediated, so that transfer of that resistance from one bacterial species to another and from animals to humans was unlikely.

163In that regard, it should be stated that acquired resistance of a bacterium to antibiotics, which is different from natural resistance, is the result of either chromosomal mutation or the acquisition of one or more genes which make the bacterium resistant. The Council and the Commission challenge the view that resistance to bacitracin zinc cannot be transferred to humans. They contend, in particular, that resistance which resides on a chromosome could be mediated by transferable genetic elements, such as the transposons. At the hearing, Professor P. Courvalin, giving evidence on behalf of the defendant, stated that a resistance mechanism could not be said always to be chromosomal.

164Accordingly, since the applicant's assertion has been scientifically challenged by the Community institutions, it cannot be considered proven that resistance of bacteria to bacitracin zinc cannot be transmitted from animals to humans.

165In those circumstances, since it is not impossible, according to the sources quoted, that bacteria which have become resistant due to the feeding to livestock of antibiotic additives such as bacitracin zinc may be transmissible from animals to humans, the risk of increased antimicrobial resistance in human medicine on account of the use of bacitracin zinc in animal feed cannot be ruled out. If increased antimicrobial resistance in human medicine were to occur, the potential consequences for public health would be very serious, since, if they developed resistance, certain bacteria could no longer be effectively combated by human medicines capable of being used for that purpose, including bacitracin. In that regard, it is apparent from the case-file that bacitracin could be used in the future to combat resistant bacteria (report of the Health Council of the Netherlands, pp. 42 and 65; study submitted by Sweden to the Commission in February 1998, cited in paragraph 11 of the Commission's statement in intervention). At the hearing, Professor F. Baquero confirmed this analysis in his evidence on behalf of the Commission. Finally, that substance was authorised in 1997 by the United States health authorities for use by injection, as is apparent from a document produced to the Court on the day of the hearing.

166In those circumstances, without prejudging the examination by the Court of the assessment of the extent of the risk, which must be established by the institutions concerned when adopting a precautionary measure, the mere existence of the risk so identified is enough in itself to justify taking into account, in the balancing of interests, the protection of human health. Consequently, the applicant cannot found an argument on the differences between the present case and that which gave rise to the order of 12 July 1996 in United Kingdom v Commission, since the fact that the fatal nature of the disease transmissible to humans and the grave hazard to human health were taken into account in that case does not mean that measures cannot be adopted by the Community institutions in the absence of any serious factor of that kind.

167It follows, in the light of all the foregoing, that the criteria for ordering suspension of operation of the contested regulation are not satisfied in the present case. This application must therefore be dismissed.

On those grounds,

THE PRESIDENT OF THE COURT OF FIRST INSTANCE

hereby orders:

1.The application for interim measures is dismissed.
2.The costs are reserved.