62007TO0326_EN
Parties
Grounds
Operative part
Parties
In Case T‑326/07 R,
Cheminova A/S,
established in Harboøre (Denmark),
Cheminova Agro Italia Srl,
established in Rome (Italy),
Cheminova Bulgaria EOOD,
established in Sofia (Bulgaria),
Agrodan, SA,
established in Madrid (Spain),
Lodi SAS,
established in Grand-Fougeray (France),
represented by C. Mereu and K. Van Maldegem, lawyers,
applicants,
v
Commission of the European Communities,
represented by B. Doherty and L. Parpala, acting as Agents,
defendant,
APPLICATION for suspension of the operation of Commission Decision 2007/389/EC of 6 June 2007 concerning the non-inclusion of malathion in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ 2007 L 146, p. 19) pending the full resolution of the dispute in the main proceedings,
THE PRESIDENT OF THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES
makes the following
Order
Grounds
Legal context
1. Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1; ‘the Directive’) establishes the Community system for the granting and withdrawal of marketing authorisation for plant protection products.
2. The ninth recital in the preamble to the Directive states that the provisions governing marketing authorisation for plant protection products must ensure a high standard of protection, which, in particular, must prevent authorisation of the marketing of plant protection products whose risks to health, groundwater and the environment have not been the subject of appropriate research. This recital also states that the objective of improving plant production must not be prejudicial to the protection of human health and the environment.
3. Article 2 of the Directive defines plant protection products as being, inter alia, active substances intended to destroy undesired plants. Active substances are defined in this article as substances or micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products.
4. Article 4(1) of the Directive provides that the Member States are to ensure that a plant protection product is not authorised unless its active substances are listed in Annex I to the Directive.
5. Active substances which are not included in Annex I to the Directive may under certain conditions benefit from a system of transitional derogation. Under Article 8(2) of the Directive, a Member State could, during a period of 12 years following the notification of the Directive, authorise the placing on its national market of plant protection products containing active substances not listed in Annex I that were already on the market two years after the date of notification of the Directive, that is to say on 25 July 1993. The Commission was to commence a programme of work for the gradual examination of those active substances. Subsequently, it could be decided whether or not the substance would be included in Annex I to the Directive. The Member States were to ensure that the relevant authorisations would be granted, withdrawn or varied, as appropriate.
6. In accordance with those provisions, the Commission commenced a programme of work for the gradual examination of active substances, in the context of which interested parties wishing to secure the inclusion of such a substance in Annex I had to submit all requisite data to the Commission and the Member States within a specified period.
7. Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of the Directive (OJ 2002 L 366, p. 10) set out the evaluation procedure for an initial series of substances with a view to their possible inclusion in Annex I to the Directive.
8. Subsequently, by Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of the Directive (OJ 2000 L 55, p. 25), the Commission provided for the evaluation of a second and a third series of active substances with a view to their possible inclusion in Annex I to the Directive.
9. The active substances in the second series include malathion – to which the present proceedings relate – an antiparasitic product used principally in agriculture against various insects on a vast range of agricultural and horticultural products and against mosquitoes, flies and household insects.
10. The procedure established by Regulation No 451/2000 began with a notification of interest, provided for in Article 4(1) thereof, which had to be sent by 31 August 2000 at the latest to the rapporteur Member State designated in Annex I to the regulation, that is to say the Republic of Finland for malathion, by the producer wishing to secure the substance’s inclusion in Annex I to the Directive.
11. By virtue of Article 6(1) of Regulation No 451/2000, each notifier had the task of sending to the rapporteur Member State a summary dossier and a complete dossier, as defined in Article 6(2) and (3) of the regulation.
12. The time-limit for the submission of those dossiers and of relevant information which could contribute to the evaluation of the active substances was set at 30 April 2002, by virtue of Article 5(4)(c) and (d) of Regulation No 451/2000, in conjunction with Article 2 of Commission Regulation (EC) No 703/2001 of 6 April 2001 laying down the active substances of plant protection products to be assessed in the second stage of the work programme referred to in Article 8(2) of the Directive and revising the list of Member States designated as rapporteurs for those substances (OJ 2001 L 98, p. 6).
13. As set out in Article 7(1) of Regulation No 451/2000, the rapporteur Member State was required to report to the Commission on the completeness of the dossiers, at the latest six months after the receipt of all dossiers for an active substance. In the case of active substances for which a dossier was considered to be complete, the rapporteur Member State then evaluated the dossier.
14. In accordance with Article 8(1) of Regulation No 451/2000 as originally drafted, the rapporteur Member State had to submit to the Commission as quickly as possible, and at the latest 12 months after the dossier had been considered to be complete, a report on its assessment of the dossier, containing a recommendation to include, or not to include, the active substance in Annex I to the Directive.
15. Article 8 of Regulation No 451/2000 was amended by Article 20 of Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of the Directive and amending Regulation No 451/2000 (OJ 2002 L 224, p. 23), in that an additional procedural element was introduced.
16. Thus, the rapporteur Member State had to send a draft report of its assessment of the dossier to the European Food Safety Authority (EFSA) as quickly as possible and at the latest 12 months after the dossier had been determined to be complete, at the same time recommending the Commission to include, or not to include, the active substance in Annex I to the Directive (Article 8(1) of Regulation No 451/2000). At this stage of the procedure, whilst the submission of new studies was not in principle accepted, the rapporteur Member State could request the notifiers to submit further data which were necessary to clarify the dossier (Article 8(2) of Regulation No 451/2000).
17. EFSA then had to circulate the rapporteur Member State’s draft assessment report to the other Member States and could organise a consultation of experts (peer review). At this stage of the procedure the submission of new studies was not accepted; however, the rapporteur Member State, with the agreement of EFSA, could request the notifiers to submit within specified periods further data considered by the rapporteur Member State or EFSA necessary to clarify the dossier (Article 8(5) of Regulation No 451/2000).
18. EFSA had to evaluate the rapporteur Member State’s draft assessment report and deliver its opinion on whether the active substance could be expected to meet the safety requirements of the Directive to the Commission one year after receipt of the draft assessment report at the latest. Where appropriate, EFSA could give its opinion on the available options claimed to meet the safety requirements (Article 8(7) of Regulation No 451/2000).
19. Six months after receipt of the EFSA opinion at the latest, the Commission was required to propose, as the case may be, a decision refusing the inclusion of the active substance in Annex I to the Directive and designed to secure the withdrawal, by the Member States, of marketing authorisations for plant protection products containing that substance, or a directive including the substance in Annex I to the Directive (Article 8(8) of Regulation No 451/2000).
20. The final measure had to be adopted in accordance with the ‘comitology’ procedure prescribed by Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23) in conjunction with Article 19 of the Directive and Article 2(b) of Regulation No 1490/2002, that is to say following an opinion from the Standing Committee on the Food Chain and Animal Health.
Facts
21. The applicant Cheminova A/S is a Danish company which was founded in 1938 and is engaged principally in the manufacture and sale of plant protection products. It sells to the market in two ways: either it sells its products directly to customers on the Community market using its own national authorisations or it chooses to sell via subsidiaries ­– such as Cheminova Agro Italia Srl, Cheminova Bulgaria EOOD and Agrodan, SA, which are applicants in the present case – or customers. In the latter case, the subsidiaries and customers may also hold national authorisations. The applicants also sell to customers in non-Community markets, in particular to North America and Africa. Cheminova A/S, Cheminova Agro Italia, Cheminova Bulgaria and Agrodan (‘the four Cheminova applicants’) belong to a group the parent company of which is Auriga Industries A/S, a company that does not have an independent business activity.
22. The applicant Lodi SAS is a French company which specialises in the manufacture and sale of insecticides. It holds marketing authorisations in France for a number of malathion-based products.
23. On 24 August 2000 Cheminova A/S notified the Commission of its wish to secure the inclusion of malathion in Annex I to the Directive. The Commission accepted the notification and listed Cheminova A/S among the ‘notifying producers’. Cheminova A/S submitted its summary and complete dossiers to the Republic of Finland, the rapporteur Member State, identifying four crop uses for review: apples, strawberries, alfalfa and ornamentals (greenhouse plants). On 28 October 2002 the Republic of Finland informed the Commission that the dossier submitted by Cheminova A/S was complete.
24. The Republic of Finland evaluated malathion and, without having requested Cheminova A/S to submit further scientific data to it, forwarded its draft assessment report to EFSA on 2 February 2004 with a view to peer review. This draft assessment report – which recommended the inclusion of malathion in Annex I to the Directive whilst limiting its use to ornamentals in greenhouses – was the subject of peer review by the Member States and EFSA. The review lasted from 2 February 2004 to 13 January 2006, without EFSA or the Republic of Finland requesting Cheminova A/S to submit further scientific data. During the period from 4 April to 24 November 2005, Cheminova A/S, acting on its own initiative, sent scientific documents relating to malathion to the Republic of Finland and EFSA.
25. On 13 January 2006 EFSA submitted to the Commission its ‘conclusion regarding the peer review of the pesticide risk assessment of the active substance malathion’. Then the Member States and the Commission examined the issue within the Standing Committee on the Food Chain and Animal Health. On 17 March and 31 July 2006 Cheminova A/S forwarded further scientific documents relating to malathion to the Commission. On 29 September 2006 the Commission finalised its review report for malathion in which it proposed that malathion not be included in Annex I to the Directive.
26. Finally, in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, the Commission adopted on 6 June 2007 Decision 2007/389/EC concerning the non-inclusion of malathion in Annex I to the Directive and the withdrawal of authorisations for plant protection products containing that substance (OJ 2007 L 146, p. 19; ‘the contested decision’), the operative part of which is worded as follows:
‘ Article 1
Malathion shall not be included as an active substance in Annex I to [the] Directive …
Article 2
Member States shall ensure that:
(a) authorisations for plant protection products containing malathion are withdrawn by 6 December 2007;
(b) no authorisations for plant protection products containing malathion are granted or renewed from the date of publication of this Decision.
Article 3
Any period of grace granted by Member States in accordance with the provisions of Article 4(6) of [the] Directive … shall be as short as possible and shall expire on 6 December 2008 at the latest.
Article 4
This Decision is addressed to the Member States.’
27. The contested decision states by way of justification for not including malathion as an active substance in Annex I to the Directive that, during the evaluation of that active substance, some concerns were identified, namely the fact that the genotoxicity of isomalathion could not be excluded and the effects of certain toxicologically relevant metabolites, with the result that it could not be concluded on the basis of the information available that malathion met the criteria for inclusion in Annex I to the Directive (recital 5).
28. Thus, the contested decision explains that, due to the presence in the technical material of isomalathion, an impurity that contributes significantly to the toxicity profile of malathion and the genotoxicity of which cannot be excluded, a conclusion could not be drawn regarding the risk to operators, workers and bystanders. It also states that on the basis of the available information it had not been demonstrated that the estimated exposure of consumers resulting from the acute and chronic intake of edible crops was acceptable, due to the insufficient information on the effects of certain toxicologically relevant metabolites (recital 5).
29. Despite the arguments put forward by Cheminova A/S (between 4 April 2005 and 31 July 2006) in respect of isomalathion and the metabolites, the Commission took the view that the concerns could not be eliminated. It considered that assessments made on the basis of the information submitted and evaluated during the EFSA expert meetings had not demonstrated that it could be expected that, under the proposed conditions of use, plant protection products containing malathion satisfied in general the requirements laid down in the Directive (recital 6).
Procedure and forms of order sought
30. By application lodged at the Registry of the Court of First Instance on 30 August 2007, the applicants brought an action for annulment of the contested decision.
31. By separate document, lodged at the Court Registry on 5 September 2007, they brought the present application for interim measures, in which they claim that the President of the Court of First Instance should:
– suspend the operation of the contested decision;
– grant all interim relief measures as necessary;
– order the Commission to pay the costs.
32. In its written observations lodged at the Court Registry on 24 September 2007, the Commission contends that the President of the Court should:
– dismiss the application for interim measures;
– order the applicants to pay the costs.
33. On 31 October 2007 the President of the Court asked the parties certain questions. The parties replied within the time-limit set.
Law
34. Under Articles 242 EC and 243 EC in conjunction with Article 225(1) EC, the Court of First Instance may, if it considers that circumstances so require, order that application of the act contested before it be suspended or prescribe any necessary interim measures.
35. Article 104(2) of the Rules of Procedure of the Court of First Instance provides that an application for interim measures must state the subject-matter of the proceedings, the circumstances giving rise to urgency, and the pleas of fact and law establishing a prima facie case for the interim measures applied for. Thus, the judge hearing the application may order suspension of operation of an act and interim measures if it is established that such an order is justified, prima facie, in fact and in law and that it is urgent in so far as, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, so that an application for interim measures must be dismissed if any one of them is not satisfied (order in Case C‑268/96 P(R) SCK and FNK
v Commission
[1996] ECR I-4971, paragraph 30). Where appropriate, the judge hearing the application must also weigh up the interests involved (see the order in Case C‑445/00 R Austria
v Council
[2001] ECR I‑1461, paragraph 73, and the case cited).
36. In addition, in the context of that overall examination, the judge hearing the application has a wide discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of Community law imposing a pre-established scheme of analysis within which the need to order interim measures must be analysed and assessed (order in Case C-149/95 P(R) Commission
v Atlantic Container Line and Others
[1995] ECR I‑2165, paragraph 23, and order of 3 April 2007 in Case C-459/06 P(R) Vischim
v Commission, not published in the ECR, paragraph 25).
37. Having regard to the documents in the case, and in particular the parties’ replies to the questions asked, the President of the Court considers that he has all the material needed in order to rule on the present application for interim measures and that it is not expedient first to hear oral argument from the parties.
Admissibility
Arguments of the parties
38. The Commission submits that the application for interim measures is inadmissible because it does not meet the formal requirements in Article 104(2) and (3) of the Rules of Procedure. It essentially does no more than refer to the very voluminous text of the application in the main proceedings and it is virtually impossible to understand the criticisms of the contested decision from it alone. The pleas put forward in the application for interim measures in order to establish a prima facie case are presented in only nine paragraphs, whereas the main application contains 88 paragraphs devoted to the pleas for annulment. However, pleas which have not been set out in the application for interim measures itself should not be taken into consideration by the judge hearing that application.
39. The Commission adds that none of the applicants other than Cheminova A/S is individually concerned, for the purposes of the fourth paragraph of Article 230 EC, by the contested decision, which is a measure of general application addressed to the Member States alone. Those other applicants are simply vendors or users of the product in question. As is apparent from three lists annexed to the Commission’s observations, there are many companies apart from those other applicants which use malathion or are authorised to sell it. Consequently the action and, therefore, the application for interim measures should be declared inadmissible so far as concerns those applicants.
40. In the applicants’ submission, the main application is admissible under the fourth paragraph of Article 230 EC because it is directed against a measure which produces binding legal effects that are of direct and individual concern to the applicants. Cheminova A/S, as the notifier of malathion, is without doubt entitled to bring the main proceedings. Where admissibility must be established for one and the same application lodged by a number of applicants and the application is admissible in respect of one of them, there is no need to consider whether the other applicants are entitled to bring proceedings (see the order in Case T-31/07 R Du Pont de Nemours (France) and Others
v Commission
[2007] ECR II-0000, paragraph 113, and the case-law cited).
41. Furthermore, each of the applicants other than Cheminova A/S is entitled to bring the main proceedings as they each hold national authorisations, granted to them by the competent Member State authorities, for the marketing of malathion-based plant protection products. As no other business may now obtain such a marketing authorisation, these applicants form part of a closed class of businesses. All of their authorisations will be withdrawn by 6 December 2007 as a direct result of the contested decision.
Findings of the President of the Court
42. By virtue of Article 104(1) of the Rules of Procedure, an application for interim measures is admissible only if it is made by a party to a case that is before the Court. This rule implies that the main action, to which the application for interim measures relates, can in fact be examined by the Court.
43. It is settled case-law that in principle the admissibility of the main action should not be examined in proceedings for interim measures so as not to prejudge the case in the main proceedings. Nevertheless, where it is contended that the main action to which the application for interim measures relates is manifestly inadmissible, it may prove necessary to establish whether there are any grounds for concluding prima facie that the main action is admissible (orders in Case C‑300/00 P(R) Federación de Cofradías de Pescadores de Guipúzcoa and Others
v Council
[2000] ECR I-8797, paragraph 34; in Case T-236/00 R Stauner and Others
v Parliament and Commission
[2001] ECR II‑15, paragraph 42; and in Case T‑155/02 R VVG International and Others
v Commission
[2002] ECR II‑3239, paragraph 18).
44. Such examination of the admissibility of the main action is necessarily summary because proceedings for interim measures are by nature urgent ( Federación de Cofradías de Pescadores de Guipúzcoa and Others v Council, cited in paragraph 43 above, paragraph 35).
45. In the context of an application for interim measures, the admissibility of the main action can be assessed only on a prima facie basis, the aim being to examine whether the applicant has adduced sufficient evidence or arguments justifying the prima facie conclusion that the admissibility of the main action cannot be excluded. The judge hearing the application for interim measures should declare that application inadmissible only where admissibility of the main action can be wholly excluded. To rule, at the stage of the proceedings for interim measures, on the admissibility of the main action, when its admissibility is not, prima facie, wholly excluded, would be tantamount to prejudging the Court of First Instance’s decision in respect of that action (orders in Case T-342/00 R Petrolessence and SG2R v Commission
[2001] ECR II-67, paragraph 17; in Joined Cases T-195/01 R and T-207/01 R Government of Gibraltar
v Commission
[2001] ECR II-3915, paragraph 47; and in Case T-37/04 R Região autónoma dos Açores
v Council
[2004] ECR II‑2153, paragraph 110).
46. In the present case, the Commission disputes that the main action is admissible. It must therefore be ascertained whether evidence or arguments exist which nevertheless permit the prima facie conclusion that the main action is admissible.
47. It is to be noted first of all that the Commission, while contesting that the applicants other than Cheminova A/S are entitled to bring the main proceedings, expressly acknowledges that Cheminova A/S is so entitled. Indeed, since Cheminova A/S, in its capacity as notifier of malathion, did participate in the procedure for the assessment of an active substance provided for by the Directive and benefits from the procedural guarantees provided for by the relevant legislation, it cannot be excluded, at first sight, that the contested decision is of direct and individual concern, within the meaning of the fourth paragraph of Article 230 EC, to Cheminova A/S and that the main application made by it is admissible ( Du Pont de Nemours (France) and Others
v Commission, cited in paragraph 40 above, paragraph 112).
48. In those circumstances, since one and the same main application is involved, there is prima facie no need to consider whether the other applicants are entitled to bring proceedings (see, to this effect, Case C-313/90 CIRFS and Others
v Commission
[1993] ECR I‑1125, paragraph 31; Joined Cases T-447/93 to T‑449/93 AITEC and Others
v Commission
[1995] ECR II‑1971, paragraph 82; and Case T-374/00 Verband der freien Rohrwerke and Others
v Commission
[2003] ECR II‑2275, paragraph 57). That case-law, founded on considerations relating to economy of procedure, is justified by the fact that, even if one or other of those applicants were not entitled to bring proceedings, the Court should nevertheless consider the substance of the pleas for annulment put forward in their entirety (see, to this effect, Case T-282/06 Sun Chemical Group and Others v Commission
[2007] ECR II-0000, paragraph 52).
49. It must be stated, however, that while the case-law referred to in paragraph 48 above is, where relevant, to be taken into consideration in the main proceedings, it cannot apply so far as concerns the issue of assessing urgency in proceedings for interim measures.
50. In accordance with settled case-law, urgency must be assessed in relation to the necessity for an order granting interim relief in order to prevent serious and irreparable damage to the party requesting the relief. That party must furnish proof that he cannot await the conclusion of the main action without personally suffering damage which would have serious and irreparable effects for him (orders in Case 142/87 R Belgium
v Commission  [1987] ECR 2589, paragraph 23, and in Case C-356/90 R Belgium
v Commission
[1991] ECR I‑2423, paragraphs 20 and 23).
51. It follows that only a party who is entitled to bring the main action to which the application for interim measures relates can be permitted to establish urgency by submitting that he would personally suffer serious and irreparable damage if the interim relief sought were not granted. In the absence of such a restriction it would be sufficient, in order to obtain interim relief, for undertakings concerned by a Community measure to join forces and collectively bring an action for annulment – accompanied by an application for interim measures – which would be brought by applicants only one of whom would be entitled to bring proceedings for the purposes of the fourth paragraph of Article 230 EC while the others could only show themselves to be the victim of serious and irreparable damage.
52. In the present context, it must therefore be examined whether the applicants other than Cheminova A/S appear prima facie to be manifestly not entitled to apply to the Court for annulment, in the main proceedings, of the contested decision.
53. As provided in the fourth paragraph of Article 230 EC, any natural or legal person may institute proceedings against a decision which, although in the form of a regulation or a decision addressed to another person, is of direct and individual concern to the former.
54. As regards the question whether the contested decision, which is addressed only to the Member States (Article 4 of the contested decision), is, prima facie, of individual concern to the applicants other than Cheminova A/S, it must be stated first that that decision constitutes prima facie an act of general application in that it applies to objectively determined situations and entails legal effects in respect of categories of persons envisaged in a general and abstract manner. Articles 1 to 3 of the contested decision concern an active substance, malathion, and economic operators who hold marketing authorisations that are referred to in a general and abstract manner. Accordingly, in light of those provisions and subject to the existence of characteristics which are peculiar to them, those economic operators are prima facie affected by the contested decision in the same manner and placed in an identical situation.
55. The possibility remains however that, in certain circumstances, the provisions of a measure of general application may be of individual concern to some of them (Case C-358/89 Extramet Industrie
v Council
[1991] ECR I-2501, paragraph 13; Case C-309/89 Codorníu
v Council
[1994] ECR I-1853, paragraph 19; and Case C-50/00 P Unión de Pequeños Agricultores
v Council
[2002] ECR I‑6677, paragraph 36).
56. In accordance with settled case-law, natural or legal persons other than the person to whom a measure is addressed can claim that the measure is of individual concern to them, within the meaning of the fourth paragraph of Article 230 EC, only if it affects them by reason of certain attributes peculiar to them, or by reason of a factual situation which differentiates them from all other persons and distinguishes them individually in the same way as the addressee would be (Case 25/62 Plaumann
v Commission
[1963] ECR 95, 107; Codorníu
v Council, cited in paragraph 55 above, paragraph 20; Unión de Pequeños Agricultores
v Council, cited in paragraph 55 above, paragraph 36; and Case C-236/02 P Commission
v Jégo-Quéré
[2004] ECR I‑3425, paragraph 45).
57. The possibility of determining more or less precisely the number or even the identity of the persons to whom a measure applies by no means implies that it must be regarded as being of individual concern to them, as long as it is established that such application takes effect by virtue of an objective legal or factual situation defined by the measure in question (order in Case C-131/92 Arnaud and Others
v Council
[1993] ECR I-2573, paragraph 13; order in Case C‑409/96 P Sveriges Betodlares and Henrikson
v Commission
[1997] ECR I‑7531, paragraph 37; and Case T-138/98 ACAV and Others
v Council
[2000] ECR II‑341, paragraph 64).
58. In the present case, it seems that, far from being individually distinguished by attributes peculiar to them, the applicants other than Cheminova A/S are affected in the same way as all the other vendors and users of malathion in the same situation. The contested decision contains nothing tangible to support the conclusion that it was adopted having regard to the particular situation of the applicants other than Cheminova A/S. It seems therefore that it is solely by reason of their objective position as economic operators covered by the contested decision that those applicants might claim to be affected by it. An effect of that kind is not sufficient for individual concern within the meaning of the fourth paragraph of Article 230 EC. None of the arguments to the contrary put forward by the applicants allows this assessment to be called into question.
59. So far as concerns the fact that the applicants other than Cheminova A/S hold national marketing authorisations for malathion, suffice it to state that the mere existence of such marketing rights, which is potentially called into question by the contested decision, is not capable of individually distinguishing the holder of the right where it is not in dispute that the right is granted, pursuant to a general and abstract rule, to objectively determined economic operators (see, to this effect, the order in Case T-94/04 EEB and Others
v Commission
[2005] ECR II‑4919, paragraphs 53 to 55). The Commission has demonstrated, by adducing three lists as annexes to its observations, that numerous undertakings other than the applicants exist which sell and use malathion too and which therefore have marketing rights in the same way as the applicants. In response to a question asked by the President of the Court, the applicants did not dispute that those undertakings referred to by the Commission are present on the market.
60. In response to a question asked by the President of the Court, the applicants also adduced letters which granted the applicants other than Cheminova A/S access to data held by the latter and were intended to help them to obtain national marketing authorisations for malathion. Referring to the judgment in Case T-13/99 Pfizer Animal Health v Council
[2002] ECR II‑3305, at paragraph 98, the applicants submit that those letters conferred specific rights comparable to the right on which the applicant undertaking could rely in Codorníu
v Council, cited in paragraph 55 above (paragraph 21).
61. It need merely be observed in relation to those submissions that the letters in question granting access had neither the aim nor the effect of conferring upon the undertakings to which they were sent the specific legal position that was held by Cheminova A/S. As they merely facilitated the grant of national marketing authorisations for malathion, their effect cannot exceed that of those authorisations themselves. As has already been held in paragraph 59 above, those authorisations are not such as to distinguish individually the applicants other than Cheminova A/S. The reference to Pfizer Animal Health
v Council, cited in paragraph 60 above, is inapposite, given that the application in that case was declared admissible only in light of a series of factors constituting a particular procedural situation which differentiated the applicant, inter alia its status of person responsible for first putting the product concerned int o circulation ( Pfizer Animal Health
v Council, paragraphs 97, 98 and 105). That is not true of the procedural situation of the applicants other than Cheminova A/S.
62. Even if the contested decision were capable of producing different effects according to the particular vendor or user concerned, that fact would not be sufficient to demonstrate that the applicants other than Cheminova A/S have attributes peculiar to them or are in a factual situation which differentiates them from the economic operators referred to in the lists adduced by the Commission. The applicants have not explained in the application for interim measures to what extent their marketing rights would be specially affected by the adverse consequences of the contested decision in a manner that would distinguish them from any other operator in the category in question (see, to this effect, the order of 11 September 2007 in Case T-28/07 Fels-Werke and Others
v Commission, not published in the ECR, paragraph 63).
63. Finally, the line of argument that the applicants other than Cheminova A/S form part of a closed class of undertakings condemned to losing their marketing authorisations by 6 December 2007 must also be rejected. It is settled case-law that, in order for the existence of such a class to be a factor capable of distinguishing the persons in question individually in relation to a measure of general application, the institution adopting the contested measure must have been under an obligation to take account, at the time of adoption of the measure, of the particular circumstances of those persons (see Federación de Cofradías de Pescadores de Guipúzcoa and Others
v Council and Commission, cited in paragraph 43 above, paragraph 46 and the case-law cited; Case T-489/93 Unifruit Hellas
v Commission
[1994] ECR II‑1201, paragraph 25; order in Case T-60/96 Merck and Others
v Commission
[1997] ECR II‑849, paragraph 58; and Case T‑166/99 Andres de Dios and Others
v Council
[2001] ECR II‑1857, paragraph 54). Here, no such obligation was imposed on the Commission for the adoption of the contested decision.
64. It follows from the foregoing that the contested decision cannot, prima facie, be considered to be of individual concern to the applicants other than Cheminova A/S. These applicants are thus not entitled to put forward their own individual situation in order to establish urgency. Nor, therefore, are they entitled to bring the present application for interim measures.
65. In so far as the Commission submits that the application for interim measures does not meet the formal requirements in Article 104(2) and (3) of the Rules of Procedure, it is to be recalled that, under that provision, an application for the adoption of interim measures is to state, inter alia, the pleas of fact and law establishing a prima facie case for the measures applied for, and is to be made by a separate document and in accordance with the provisions of Articles 43 and 44 of the Rules of Procedure.
66. It is well established case-law that an application for interim measures must be sufficient in itself to enable the defendant to prepare his observations and the judge hearing the application to rule on it, where appropriate, without other supporting information, the essential elements of fact and law on which it is founded having to be set out in a coherent and comprehensible fashion in the text of the application for interim measures itself (orders in Stauner and Others
v Parliament and Commission, cited in paragraph 43 above, paragraph 34; in Case T-306/01 R Aden and Others
v Council and Commission
[2002] ECR II‑2387, paragraph 52; in Case T-175/03 R Schmitt
v EAR
[2003] ECR-SC I‑A‑175 and II‑883, paragraph 18; and in Case T-85/05 R Dimos Ano Liosion and Others
v Commission
[2005] ECR II‑1721, paragraph 37).
67. In the present case, while the application for interim measures may in fact be regarded as incomplete so far as concerns the pleas put forward to establish a prima facie case, it nevertheless contains details which enable the President of the Court to examine the pleas. It is made clear that the applicants essentially submit that the contested decision is unfounded in that it does not take account of relevant scientific data which Cheminova A/S submitted to the competent authorities at the appropriate time. In addition, they put forward a plea of illegality in respect of Regulation No 1490/1992 in that it retroactively permitted the involvement of EFSA in the assessment procedure for malathion, although that procedure had already begun.
68. In those circumstances, the application for interim measures cannot be considered to fail to comply with the conditions prescribed by Article 104(2) of the Rules of Procedure. It follows that this application is admissible so far as concerns Cheminova A/S.
Urgency
Arguments of the parties
69. In the applicants’ submission, the urgency for granting the present application stems from the fact that the contested decision will cause them serious and irreversible damage. This damage is constituted by the loss of their authorisations to sell malathion-based products on 6 December 2007 at the latest, the loss of customers, and the irreparable loss of share in the relevant markets which will be taken over by competing companies which are very powerful and already present on the market. Furthermore, the contested decision will destroy irrevocably the image of the key products of the four Cheminova applicants. Finally, the contested decision will damage the reputation on the market of the applicants’ other longstanding trade marks.
70. So far as concerns the burden of proof resting upon them, the applicants submit, referring to the order in Case C-365/03 P(R) Industrias Químicas del Vallés
v Commission
[2003] ECR I‑12389, at paragraph 6, that it is sufficient for them to show that they will ‘probably’ suffer serious and irreparable damage, because they ‘might find it difficult to offer’ alternative products to their clients and would ‘run the risk’ of suffering an irreparable loss of market shares given the conditions of competition on the market. They add that this understanding of the requisite standard of proof has been confirmed by the order in Du Pont de Nemours (France) and Others v Commission, cited in paragraph 40 above.
71. Nor do the applicants have to demonstrate that they would probably go bankrupt if operation of the contested decision were not suspended, it being sufficient for them to establish that, if such a measure were not granted, they would be placed in a situation which would ‘irremediably affect [their] market share’ (orders in Case T‑392/02 R Solvay Pharmaceuticals
v Council
[2003] ECR II-1825, paragraph 107, and in Case T-158/03 R Industrias Químicas del Vallés
v Commission
[2003] ECR II-3041, paragraph 69), or their ‘position in the market’ or their reputation would be affected (order in Case T-169/00 R Esedra
v Commission
[2000] ECR II‑2951, paragraph 45).
72. As regards the case in point, the applicants state that Cheminova A/S manufactures three different types of plant protection products: insecticides, herbicides and fungicides. Within the insecticides market, it markets various active substances, including, in particular, malathion, chlorpyriphos and dimethoate.
73. The principal markets in Europe on which Cheminova A/S sells malathion, through its subsidiaries Cheminova Agro Italia and Agrodan, are Italy and Spain. Cheminova A/S also sells malathion-based products to Cheminova Bulgaria and its Polish and United Kingdom subsidiaries. For other States in the Community, Cheminova A/S sells its products directly to customers.
74. It is clear that the damage is imminent and irreparable in nature from the fact that, by virtue of the contested decision, Member States will have to withdraw the marketing authorisations for plant protection products held by the four Cheminova applicants on 6 December 2007 at the latest. The withdrawal of those authorisations will result in the irremediable loss of the entirety of the applicants’ market shares and customers for malathion. Their share of the Community malathion market is estimated at approximately [ confidential ]. (1)
75. So far as concerns the substitutability of malathion, no two active substances are the same from a technical point of view. In the absence of perfect substitutability, the applicants’ customers will need to take the technical attributes of the replacement product into account before deciding upon it instead of malathion. From a legal point of view, the applicants must have a national authorisation for the use/sale of a replacement substance. Since it takes time to obtain such authorisations, it is likely that in the meantime the market will have been occupied by competing companies. The introduction of a new active substance by the applicants would take approximately 10 years of research and development, and financially would be very onerous. From a commercial point of view, the applicants cannot reasonably be expected to distribute the products of other producers. From a structural point of view, the relevant market is characterised by strong competition, the applicants being faced by powerful competitors capable of offering not only direct replacement products, but products for all pest, weed and disease control requirements.
76. With regard to the products competing with malathion, the applicants produce a table containing 22 likely substitute substances – including chlorpyrifos and abamectin – which are marketed by powerful companies such as Dow, Bayer, DuPont, Syngenta and BASF. Those companies have, first, branded and well-established products that cater for the needs of the customers to whom the applicants can no longer sell malathion-based products and, second, considerable funding resources for any publicity material that is necessary to accompany those sales. They can therefore capture the market lost by the four Cheminova applicants and consolidate that capture.
77. In this context, the applicants refer to statements by customers of Cheminova A/S indicating that the principal products to which those clients would turn in the absence of malathion would be chlorpyrifos, phosmet and dimethoate.
78. As regards the possibility of malathion returning to the market, the applicants refer to a survey of some of its principal customers. The nine replies received from customers based in six Member States of the Community bear out the probability that the loss of market share and customers will be irremediable.
79. So far as concerns the possibility of the four Cheminova applicants making up for the loss of malathion-based products by replacing them with other products from their portfolio, they contend that such substitution will be possible only in respect of chlorpyrifos-ethyl and dimethoate.
80. However, their chlorpyrifos-based and dimethoate-based products cannot be considered to be substitute products for the malathion-based products. They do not have the necessary national authorisations in each Member State in which they are currently active. In this context, a table shows the lack of overlap with dimethoate-based and chlorpyrifos-based products in Spain, their principal Community market. Thus, only [ confidential ] % of the product applications lost will be theoretically recoverable in Spain through sales of substitute products in the applicants’ own portfolio. This figure corresponds to [ confidential ] % of the turnover in respect of malathion achieved by the applicant Agrodan.
81. Pointing out that malathion has been safely used in the Community market for approximately 40 years, the applicants add that the contested decision affects their general reputation and confidence in malathion. These will be seriously damaged in a market which is particularly sensitive to health and environmental issues, with serious consequences involving difficulties not only in commercial relationships with customers but also with persons who have invested as shareholders. In particular, Cheminova A/S is the holder of the Fyfanon®™ trade mark, registered since 1969, which has represented the core of its malathion business for approximately 40 years. Cheminova A/S holds further relevant malathion trade marks, the reputation and goodwill of which will be reduced to nothing by the contested decision.
82. The applicants further assert that, if malathion had in fact been included in Annex I to the Directive, Article 13 of the Directive would have permitted Cheminova A/S, as the notifier, to refuse its competitors and customers access to data obtained – at great cost – for the purpose of malathion’s inclusion. Normally, access of those competitors and customers to the data – which are necessary for obtaining national authorisations for the plant protection product in question – would be given only in return for a payment calculated to compensate the notifier for the costs which he has borne. As a result of malathion’s not being included in Annex I to the Directive, Cheminova A/S will suffer harm consisting in a denial of the benefit of the data protection rights resulting from such inclusion.
83. As regards the gravity of the damage caused by the contested decision, the applicants state that the turnover of the applicant Cheminova A/S, including that of the applicants Cheminova Agro Italia, Cheminova Bulgaria and Agrodan, represents approximately [ confidential ] % of the total turnover of the entire group for 2006. According to the applicants, it is apparent from the Deloitte & Touche report annexed to the application for interim measures that sales of malathion in the 2006 calendar year amounted to almost EUR [ confidential ] million, representing [ confidential ] % of total sales of the four Cheminova applicants. [ confidential ] % of these sales were made on the Community market. Sales in countries affected by the contested decision totalled nearly EUR [ confidential ] million in 2006, representing [ confidential ] % of total malathion sales.
84. They explain that sales within the Community will be lost because of the withdrawal of national authorisations. With regard to sales in third countries, the Deloitte & Touche report reveals damage on several bases. Certain third countries follow Community rules, so that refusal to include an active substance in Annex I to the Directive results in the substance being prohibited in those countries, a fact which is confirmed by the Phillips McDougall report (annexed to the application for interim measures). In addition, in accordance with Article 5 of the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade (OJ 2003 L 63, p. 29), the parties thereto are obliged to give notification of prohibitions within 90 days of their adoption. Such notification may result in the substance being listed in Annex III to the Convention, with the effect that the substance in question is then subject to a prior consent procedure in the event of export out of the Community. The Commission has prepared such a notification.
85. Furthermore, a non-inclusion decision such as the contested decision is usually followed by the setting of new maximum residue limits (‘MRLs’) for the substance concerned in products of plant origin. The setting of such MRLs would in practice be equivalent to a prohibition of imports into the Community of crops or products treated with malathion outside the Community. In any event, the uncertainty about MRLs is sufficient to provoke doubts in the minds of non-Community customers, as evidenced by an e-mail received from Fundecitrus, a citrus-grower organisation in Brazil. Deloitte & Touche have taken these factors into consideration when calculating the consequential losses due to lost non-Community sales of malathion.
86. Deloitte & Touche have also calculated a loss of profit resulting from expected growth in the ‘oilseed rape project’: Cheminova A/S had envisaged supplying the oilseed rape sector with malathion by 2009 and the ‘oilseed rape project’ was expected to increase significantly the sales and profits achieved with malathion-based products. Deloitte & Touche have assessed this loss of profit at more than EUR [ confidential ] million until 2011.
87. Taking account of all the matters of fact required to assess the gravity of the damage, Deloitte & Touche have calculated the total loss for the four Cheminova applicants as a consequence of the contested decision to be almost EUR [ confidential ] million.
88. As regards the applicant Lodi, the applicants assert that it too would sustain serious and irreparable damage if the interim measure sought were not granted.
89. The Commission contends that the damage pleaded by the applicants is purely financial. Such damage generally cannot be regarded as irreparable since it can ultimately be the subject of financial compensation.
90. So far as concerns the gravity of the damage alleged, the Commission acknowledges that the contested decision will result in a loss of sales, income and market share for the applicants. However, market share is not an end in itself: it can be of benefit to undertakings only in so far as it brings them profits. In order to assess whether or not the loss of a market share is serious, it should, therefore, be translated into money terms, taking account of the size of the undertaking as a whole. In the present case, a large proportion of the sales of malathion made by the four Cheminova applicants are not affected by the contested decision, given that only [ confidential ] % of their sales of malathion are made on the Community market.
91. The loss that can be taken into consideration amounts to only [ confidential ] % of sales of the Cheminova group for the next three years. Such damage cannot be classified as serious. The Commission refers in this regard to the order in Joined Cases C‑51/90 R and C-59/90 R Comos-Tank and Others
v Commission
[1990] ECR I‑2167.
92. In the Commission’s submission, the applicants are wrong to take account of losses of sales and income after 2010 in calculating damage. Those losses are too distant to justify the interim relief sought. In addition, the applicants mix sales made on the Community market with those made on markets outside the Community. The contested decision has effects only on the Community market and not in third countries.
93. With regard to whether the damage pleaded is irreparable, the Commission observes that the applicants should have shown that obstacles of a structural or legal nature would prevent them from regaining a significant proportion of their market shares with the aid, in particular, of appropriate publicity measures. They provide no such evidence, but merely assert that competitors hold large market shares. However, this fact is not, in itself, an obstacle of a structural nature standing in the way of the applicants’ regaining their market shares.
94. The application for interim measures is, moreover, contradictory so far as concerns the active substances which could replace malathion. The two reports adduced by the applicants in support of their case come to diametrically opposite results. Also, the statements from customers relied upon to show that the return of malathion to the market will hardly be possible do not in any way justify the applicants’ pessimistic interpretation of them. On the contrary, such a return appears entirely realistic.
95. Furthermore, the applicants have acknowledged that the substances which might replace malathion cannot be a perfect substitute. This shows that, if malathion were reintroduced onto the market, it could regain its market share thanks to its inherent characteristics. Consequently, the Commission submits that the applicants have not established insurmountable obstacles which would prevent them from regaining a significant proportion of the market.
96. The Commission draws the conclusion that urgency is not established in the present case.
Findings of the President of the Court
97. In accordance with settled case-law, urgency must be assessed in relation to the necessity for an order granting interim relief in order to prevent serious and irreparable damage to the party requesting the relief. It does not have to be established with absolute certainty that the damage is imminent; it is sufficient that the damage, particularly when it depends on the occurrence of a number of factors, should be foreseeable with a sufficient degree of probability (see the order in Case T-346/06 R IMS
v Commission
[2007] ECR II-0000, paragraphs 121 and 123, and the case-law cited). However, the party invoking damage is required to prove the facts forming the basis of its claim that serious and irreparable damage is likely (orders in Case C-335/99 P(R) HFB and Others
v Commission
[1999] ECR I-8705, paragraph 67; in Case T-151/01 R Duales System Deutschland
v Commission
[2001] ECR II-3295, paragraph 188; and in Case T-34/02 R B v Commission
[2002] ECR II‑2803, paragraph 86).
98. It is also well-established case-law that damage of a purely financial nature cannot, save in exceptional circumstances, be regarded as irreparable or even as being reparable only with difficulty since normally it can be the subject of subsequent financial compensation (orders in Case C-471/00 P(R) Commission
v Cambridge Healthcare Supplies
[2001] ECR I‑2865, paragraph 113, and in Case T-339/00 R Bactria
v Commission
[2001] ECR II‑1721, paragraph 94).
99. The interim measure sought is justified only if it appears that, without such a measure, the applicant would be in a position that could imperil its existence before final judgment in the main action (order in Case T-181/02 R Neue Erba Lautex
v Commission
[2002] ECR II‑5081, paragraph 84). Since imminent disappearance from the market does constitute damage that is both irremediable and serious, adoption of the interim measure sought appears justified in such a situation.
100. While account has also been taken of the fact that, if the measure sought were not granted, the applicant’s market share would be irremediably affected (orders in Case T-13/99 R Pfizer Animal Health
v Council
[1999] ECR II‑1961, paragraph 138; in Solvay Pharmaceuticals
v Council, cited in paragraph 71 above, paragraph 107; and in Du Pont de Nemours (France) and Others
v Commission, cited in paragraph 40 above, paragraph 175), it must be pointed out that this situation can be placed on an equal footing with that of the risk of disappearance from the market and justify adoption of the interim measure sought only if the irremediable effect on market share is also of a serious nature. It is therefore not sufficient that a market share, however minimal, may be irremediably lost; on the contrary it is necessary for that market share to be sufficiently large. An applicant who invokes the loss of such a market share must demonstrate, furthermore, that regaining a significant proportion of it, in particular by appropriate publicity measures, is impossible by reason of obstacles of a structural or legal nature (see, to this effect, Commission
v Cambridge Healthcare Supplies, cited in paragraph 98 above, paragraphs 110 and 111, and the order of the President of the Court of First Instance of 26 February 2007 in Case T-416/06 R Sumitomo Chemical Agro Europe
v Commission, not published in the ECR, paragraphs 59 and 60).
101. It is in the light of those considerations that examination is required of the reasons put forward by the applicants to establish that Cheminova A/S will suffer serious and irreparable damage if suspension of the operation of the contested decision is not ordered. It is to be remembered that the arguments relating to the applicants Lodi, Cheminova Agro Italia, Cheminova Bulgaria and Agrodan must be excluded from that examination (see paragraph 64 above).
102. It should be determined, first of all, whether the damage pleaded may be classified as serious in the light, in particular, of the size and turnover of the undertaking and of the characteristics of the group to which it belongs (see Comos-Tank and Others
v Commission, cited in paragraph 91 above, paragraph 26, and Du Pont de Nemours (France) and Others
v Commission, cited in paragraph 40 above, paragraphs 196 and 203 and the case-law cited).
103. The applicants state that the average turnover over 2004, 2005 and 2006 of the group to which Cheminova belongs was DKK 5.248 billion, that is to say more than EUR 700 million. According to the applicants, the gravity of the damage is established, inter alia, by the fact that sales of malathion in 2006 amounted to almost EUR [ confidential ] million, ‘equalling [ confidential ] % of the total sales of the Cheminova applicants’. They specify that ‘[ confidential ] % of these sales were made on the EU market’.
104. It follows that, according to the figures put forward by the applicants, the annual loss caused by the contested decision on the Community market would amount to less than 1% of the turnover of their group.
105. However, the evidential value of the information upon which this figure of less than 1% is founded is significantly weakened by the fact that the figures supplied by the applicants must be qualified, for two reasons.
106. First, the percentages mentioned in the application for interim measures were calculated by reference to the sales achieved by the four Cheminova applicants, whereas they should have been calculated by reference to the – larger – sales of the group to which those applicants belong. Second, as has been held above (paragraphs 64 and 101), only matters concerning Cheminova A/S can be taken into consideration when establishing urgency. The data presented in the application for interim measures relate to the four Cheminova applicants and do not enable the pertinent figures for Cheminova A/S to be identified, whereas those figures should have been set out in the text of the application for interim measures itself (see paragraph 66 above).
107. It follows that the figures supplied by the applicants concerning the damage suffered on the Community market do not appear sufficiently precise to establish urgency for Cheminova A/S.
108. For the sake of completeness, a rough assessment of the annual loss caused on the Community market by the contested decision to Cheminova A/S alone would yield an estimate considerably lower than that of less than 1% of the turnover of the Cheminova group.
109. In so far as the applicants plead that a reduction in their sales in States that are not members of the Community will result from the contested decision because certain third countries follow Community rules, it must be stated that such behaviour is not alleged as regards the United States and Canadian markets, on which, according to the Deloitte & Touche report, the applicants sell [ confidential ] % of their malathion-based products. According to that report itself, those two markets will probably not be affected at all by malathion’s not being included in Annex I to the Directive. Consequently, the alleged negative impact of the contested decision on sales in third countries is already considerably reduced, according to the information provided by the applicants themselves.
110. As regards the other countries in which the applicants claim to market malathion-based products, they have not established that the interim measure sought would, if granted, prevent the authorities of the countries concerned from prohibiting the marketing of malathion in their territory. Accordingly, they have not shown that suspension of the operation of the contested decision would be liable to prevent the alleged damage from materialising. In any event, such a prohibition on the marketing of malathion would be the direct consequence not of the contested decision, but of a decision taken by the authorities of each third country in the exercise of their absolute discretion (see, to this effect, the order in Pfizer Animal Health
v Council, cited in paragraph 100 above, paragraph 160).
111. Nor is the applicants’ invocation of Article 5 of the Rotterdam Convention (see paragraph 84 above) capable of establishing to the required legal standard that the obligation owed by the Community under that provision to give notification and provide information may cause Cheminova A/S foreseeable and quantifiable damage in a given third country while the main proceedings are continuing. While the applicants have pointed out that, by virtue of Commission Regulation (EC) No 1376/2007 of 23 November 2007 amending Annex I to Regulation (EC) No 304/2003 of the European Parliament and of the Council concerning the export and import of dangerous chemicals (OJ 2007 L 307, p. 14), malathion has just been entered in Part 1 of Annex I to Regulation No 304/2003, which implements the Rotterdam Convention, suffice it to state that, as provided by Article 7(1) of Regulation No 304/2003, the only consequence of its entry is to impose an obligation to provide information vis-à-vis any countries of import. Consequently, the applicants have not shown that the mechanism under the Rotterdam Convention will result directly and inevitably in losses of sales of malathion-based products on the market of specified third countries. On the contrary, they have acknowledged, in response to a question asked by the President of the Court, that it is for the third country alone to decide whether or not the products concerned should be imported.
112. The applicants further submit that a non-inclusion decision, such as the contested decision, is usually followed by the setting of new MRLs for the substance concerned in products of plant origin, which would in practice be equivalent to a prohibition of imports into the Community of crops or products treated with malathion outside the Community and provoke doubts in the minds of customers from third countries. In response to a question asked by the President of the Court, the applicants stated that the link between the contested decision and the setting of MRLs would affect the sale in third countries of malathion-based products.
113. As regards the alleged adverse effects of new MRLs on trade with third countries, it is common ground that the applicants sell [ confidential ] % of their malathion-based products on the United States and Canadian markets. According to the Deloitte & Touche report itself, those two markets will probably not be affected at all by MRL issues. So far as concerns the other markets, it need merely be pointed out that it will be for the third countries in question alone to decide whether or not malathion-based products should be imported (see paragraphs 110 and 111 above).
114. Likewise, on the Community market, while the contested decision could in fact result in the setting of new MRLs for malathion, the damage allegedly suffered because of those MRLs would not be a direct consequence of the contested decision. As the applicants have acknowledged, the Community procedure for setting MRLs is independent of the decision not to include malathion in Annex I to the Directive. Nor have the applicants proved to the required legal standard that the non-inclusion of malathion in Annex I to the Directive would inevitably, because of new, more stringent, MRLs, effectively prohibit imports into the Community of products treated with that substance. They have in particular not set out the reasons that would prevent the Community legislature from setting, with a view to facilitating international trade, import tolerances permitting the import of foodstuffs and products of plant origin affected by the former MRLs for malathion.
115. It follows that the applicants’ contentions concerning the issue of MRLs lack foundation for the purpose of proving that the damage allegedly caused to Cheminova A/S by the contested decision is serious.
116. In so far as the applicants refer to an ‘oilseed rape project’ under which Cheminova A/S had envisaged supplying malathion to the oilseed rape sector, expecting to increase significantly the sales and profits achieved with its malathion-based products, suffice it to note that the loss of profit pleaded in this context is founded purely on hopes, the application for interim measures referring to no supply contract, or preliminary supply agreement, that has been signed concerning implementation by Cheminova A/S of this project, the carrying out of which was allegedly compromised by the contested decision. The ‘oilseed rape project’ has not therefore yet become sufficiently concrete to be capable of being regarded as secured by Cheminova A/S.
117. The damage pleaded in relation to the ‘oilseed rape project’ must therefore be classified as hypothetical. Damage which is purely hypothetical, in that it depends on the occurrence of future and uncertain events, cannot justify granting interim measures ( Government of Gibraltar
v Commission, cited in paragraph 45 above, paragraph 101, and order in Case T-422/03 R Enviro Tech Europe and Enviro Tech International v Commission
[2004] ECR II‑469, paragraph 65). Consequently, the applicants’ contentions in this context also cannot establish that the damage allegedly caused to Cheminova A/S by the contested decision is serious.
118. As regards the damage caused by the denial of data protection rights allegedly conferred by Article 13 of the Directive, the applicants failed in the application for interim measures to quantify this element of the damage resulting from malathion’s not being included in Annex I to the Directive, but they did not submit that it would be impossible to quantify it. The assertion relating to the protection of data must therefore also be rejected.
119. It follows from the foregoing that none of the reasons put forward to establish that the damage suffered by Cheminova A/S would be serious can be upheld.
120. Furthermore, this damage, assessed approximately at less than 1% of the turnover of the Cheminova group (see paragraph 108 above) must also be the subject of deductions, given that the applicants have conceded their ability to compensate for a proportion of their sales of malathion-based products by the sale of other products which they manufacture or which they are authorised to market, specifying that [ confidential ] % of the product applications lost would be capable of being recovered in Spain through sales of substitute products in the applicants’ own portfolio.
121. These findings are sufficient to conclude that the damage caused to Cheminova A/S by the contested decision would in any event amount to significantly less than 1% of the turnover of the Cheminova group and cannot therefore be regarded as serious, and it is not even necessary to identify each of the substitute products or the deductions to be made, which would indeed be impossible in the absence of figures relating to Cheminova A/S alone.
122. This conclusion is not called into question by an assessment of the circumstances as a whole relied upon by the applicants, in particular the fact that Cheminova A/S began producing malathion in 1968 under the trade mark Fyfanon®™, became the principal manufacturer of malathion in 1991, has thus been present on the malathion market for approximately 40 years and has marketing authorisations for malathion-based plant protection products for numerous uses in 10 Member States of the Community. These historical considerations cannot be taken into consideration since they disclose no economic and financial figures which could be taken into account to assess damage liable to justify the grant of an interim measure.
123. Furthermore, the applicants have not proved to the required legal standard that the damage assessed approximately above can be regarded as irreparable.
124. Suffice it to state that, while the applicants contend that they are liable to lose the market shares and the reputation that have been acquired by malathion in the Community, they have not succeeded in establishing to the required legal standard that it would be impossible for Cheminova A/S to regain the reputation and the market shares lost, should the contested decision be annulled on conclusion of the main proceedings. The material in the file for the present application does not demonstrate that those losses would be irremediable and that it would not be possible for malathion to regain its previous position.
125. First, the applicants themselves note that, from a technical point of view, it will not be possible to obtain perfect, seamless substitutability for malathion. Second, they observe that one of the key benefits of malathion is that it has a broad spectrum of activity and can be sold to the farmer at a relatively low cost. Finally, they have expressly drawn attention to the statements of three bodies representing their customers in Europe which stress the importance of malathion, the necessity for its inclusion among the range of chemical tools to combat harmful insects and avoid the development of resistance, and the detrimental economic consequences of malathion’s not being included in Annex I to the Directive.
126. It follows that malathion’s qualities appear to be highly appreciated by the applicants’ customers and that no perfect substitute product exists. These factors also support the view that it would be possible for malathion to return to the market should operation of the contested decision not be suspended and the contested decision be annulled by the judgment in the main proceedings.
127. This conclusion is confirmed by the results of a survey of some of the applicants’ principal customers relating to the possibility of malathion’s returning to the market following a fresh authorisation for it. None of the customers questioned categorically ruled out all possibility that malathion would regain the market shares lost.
128. One of the nine customers unreservedly accepted the possibility that malathion would return to the market. While another customer stated that such a return appeared difficult because part of the market would have been taken by other products, the evidential value of this response is weakened by the fact that it was provided by the applicant Lodi, which can hardly be classified as an objective source of information in that it submits in the present proceedings specifically that it will be impossible for malathion to regain its previous position. A third customer replied that if the substitute products and malathion were comparable in terms of efficacy and price, it would be difficult to imagine farmers’ using malathion again. This customer added, however, that it would resume selling malathion if it returned to the market. The other customers envisaged the return of malathion to the market subject to conditions relating the product’s effectiveness and the competitiveness of its price.
129. The applicants have not stated that malathion is less effective than the substitute products which will have taken the market shares lost because of the contested decision. As regards price level, the applicants themselves have referred to a relatively high profit margin on certain of their malathion-based products, namely [ confidential ] %, a fact which could enable them to reduce prices in order to support the re-entry of those products onto the market.
130. It follows that, while recapture by malathion of the market shares lost because of the contested decision may, financi ally and economically, be quite onerous, such a return to the market, including restoration of malathion’s reputation, does not appear impossible (see, to this effect, the order in Pfizer Animal Health
v Council, cited in paragraph 100 above, paragraphs 161 to 165).
131. The damage allegedly suffered by Cheminova A/S on account of the contested decision cannot therefore be regarded as irreparable, and there is no need to examine the other questions, in particular of substitutability, raised in the context of urgency.
132. It follows from all of the foregoing that the applicants have not shown, as matters now stand, that Cheminova A/S would suffer serious and irreparable damage if suspension of operation of the contested decision were not granted.
133. Consequently, the application for interim measures must be dismissed for lack of urgency, without any need to examine whether the other conditions governing suspension of the contested decision’s operation are met.
(1) .
(1)
–	Confidential data omitted.
Operative part
On those grounds,
THE PRESIDENT OF THE COURT OF FIRST INSTANCE
hereby orders:
1. The application for interim measures is dismissed.
2. Costs are reserved.
Luxembourg, 4 December 2007.