ORDER OF THE PRESIDENT OF THE COURT OF FIRST INSTANCE
11 December 2007 (*)
(Application for interim relief – Directive 91/414/EEC – Application for suspension of operation of a measure – Admissibility – No urgency)
In Case T‑349/07 R,
FMC Chemical SPRL, established in Brussels (Belgium),
Satec Handelsgesellschaft mbH, established in Elmshorn (Germany),
Belchim Crop Protection NV, established in Londerzeel (Belgium),
FMC Foret, SA, established in Sant Cugat de Valles (Spain),
F&N Agro Slovensko spol. s.r.o., established in Bratislava (Slovakia),
F&N Agro Ceská republika spol. s.r.o., established in Prague (Czech Republic),
F&N Agro Polska sp. z o.o., established in Warsaw (Poland),
FMC Corp., established in Philadelphia, Pennsylvania (United States),
represented by C. Mereu and K. Van Maldegem, lawyers,
applicants,
v
Commission of the European Communities, represented by L. Parpala and B. Doherty, acting as Agents,
defendant,
APPLICATION for suspension of the operation of Commission Decision 2007/415/EC of 13 June 2007 concerning the non-inclusion of carbosulfan in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ 2007 L 156, p. 28) 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
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 carbosulfan – to which the present proceedings relate – a carbamate insecticide used against insects in all developmental forms. It is used in agriculture to control both soil and above-ground pests. In the Community market, the most important crops for carbosulfan are maize, oilseed rape, fruit and vegetables, cotton and sugar beet.
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 Kingdom of Belgium for carbosulfan, 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 FMC Chemical SPRL, FMC Foret, SA, F&N Agro Ceská republika spol. s.r.o., F&N Agro Slovensko spol. s.r.o. and F&N Agro Polska sp. z o.o. are subsidiaries of FMC Corp., a chemical undertaking serving agricultural, industrial and consumer markets, which manufactures and markets crop and plant protection products, and especially insecticides – like carbosulfan – and herbicides.
22 The six abovementioned applicants (‘the FMC applicants’) are the leading manufacturer worldwide of carbosulfan, an important product in their insecticide portfolio. In the Community, they hold national marketing authorisations for plant protection products containing carbosulfan, but they do not always sell these products directly to farmers. Their sales are mostly achieved through formulation and distribution companies, which sell the products under a number of brand names, all protected by trade marks held by FMC Corp. They also sell formulated plant protection products to distribution companies for own-label packaging and sale.
23 Satec Handelsgesellschaft mbH is FMC Chemical’s main carbosulfan customer in the Community. It holds a number of national marketing authorisations for plant protection products. Belchim Crop Protection NV specialises in the marketing of carbamate-based plant protection products, that is to say containing carbosulfan and carbofuran. It holds no national marketing authorisations for plant protection products, but sells a range of such products. A significant part of its sales is constituted by sales of the FMC applicants’ carbosulfan-based products.
24 On 29 August 2000 FMC Chemical notified the Commission of its wish to secure the inclusion of carbosulfan in Annex I to the Directive. The Commission accepted the notification and listed FMC Chemical among the ‘notifying producers’. FMC Chemical submitted its summary and complete dossiers to the Kingdom of Belgium, the rapporteur Member State. After the submission of additional studies by FMC Chemical, the rapporteur Member State considered the dossier to be complete and proceeded to assess it, pursuant to Article 8 of Regulation No 451/2000.
25 On 11 August 2004 the Kingdom of Belgium forwarded its draft assessment report to EFSA. The draft assessment report recommended that carbosulfan should not be included in Annex I to the Directive on the ground that a substantial amount of essential information was missing. On 17 August 2004 copies of the draft assessment report were sent by EFSA to the Member States. Subsequently, in 2004 and 2005, it was the subject of peer review by the Member States and EFSA. In particular, an EFSA evaluation meeting took place on 19 May 2005.
26 The applicants allege – and the Commission denies – that EFSA and the Kingdom of Belgium agreed on the occasion of the meeting of 19 May 2005 that additional data were needed and that, pursuant to Article 8(5) of Regulation No 451/2000, new studies could be submitted within four weeks of the meeting. In any event, over the period from 18 June 2005 to 2 November 2006, FMC Chemical lodged a number of scientific documents relating to the assessment of carbosulfan with the Kingdom of Belgium and EFSA. Most of the additional data were not taken into consideration in the peer review of carbosulfan by the Member States and EFSA.
27 On 28 July 2006 EFSA submitted to the Commission its ‘conclusion regarding the peer review of the pesticide risk assessment of the active substance carbosulfan’. Then the Member States and the Commission examined the issue within the Standing Committee on the Food Chain and Animal Health. On 24 November 2006 the Commission finalised its review report for carbosulfan in which it proposed that carbosulfan not be included in Annex I to the Directive.
28 Finally, in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, the Commission adopted on 13 June 2007 Decision 2007/415/EC concerning the non-inclusion of carbosulfan in Annex I to the Directive and the withdrawal of authorisations for plant protection products containing that substance (OJ 2007 L 156, p. 28; ‘the contested decision’), the operative part of which is worded as follows:
‘Article1
Carbosulfan shall not be included as active substance in Annex I to [the] Directive …
Article2
Member States shall ensure that:
(a) authorisations for plant protection products containing carbosulfan are withdrawn by 13 December 2007;
(b) no authorisations for plant protection products containing carbosulfan 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 13 December 2008 at the latest.
Article 4
This Decision is addressed to the Member States.’
29 The contested decision states by way of justification for not including carbosulfan as an active substance in Annex I to the Directive that, during the evaluation of that active substance, a number of concerns were identified, namely (i) the presence of metabolites having a hazardous profile, which led to concerns about the exposure of consumers and the possible risk of groundwater contamination, (ii) the presence in the technical material, at levels which raised concerns, of relevant impurities, at least one of which was carcinogenic, and (iii) possible risks to birds and mammals, aquatic organisms, bees, non-target arthropods, earthworms, and non-target soil micro-organisms and plants (recital 5).
30 Despite the arguments put forward by FMC Chemical, 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 carbosulfan satisfied in general the conditions laid down in the Directive (recital 6).
Procedure and forms of order sought
31 By application lodged at the Registry of the Court of First Instance on 7 September 2007, the applicants brought an action for annulment of the contested decision.
32 By separate document, lodged at the Court Registry on 1 October 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.
33 In its written observations lodged at the Court Registry on 23 October 2007, the Commission contends that the President of the Court should:
– dismiss the application for interim measures;
– order the applicants to pay the costs.
34 On 12 November 2007 the President of the Court asked the applicants certain questions. The applicants replied within the time-limit set.
Law
35 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.
36 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).
37 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).
38 Having regard to the documents in the case, and in particular the applicants’ 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
39 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 14 paragraphs, whereas the main application contains 100 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.
40 The Commission adds that none of the applicants other than FMC Chemical 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 carbosulfan 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.
41 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. FMC Chemical, as the notifier of carbosulfan, 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 of the President of the Court of First Instance of 19 July 2007 in Case T-31/07 R Du Pont de Nemours (France) and Others v Commission, not yet published in the ECR, paragraph 113, and the case-law cited).
42 Furthermore, each of the applicants other than FMC Chemical (save for Belchim Crop Protection) 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 carbosulfan-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 13 December 2007 as a direct result of the contested decision. As for Belchim Crop Protection, its right to market carbosulfan for FMC Chemical will be adversely affected.
43 Finally, FMC Corp. holds trade marks protecting its carbosulfan-based plant protection products. These longstanding trade marks will be rendered redundant as a result of the contested decision.
Findings of the President of the Court
44 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.
45 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).
46 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 45 above, paragraph 35).
47 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).
48 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.
49 It is to be noted first of all that the Commission, while contesting that the applicants other than FMC Chemical are entitled to bring the main proceedings, expressly acknowledges that FMC Chemical is so entitled. Indeed, since FMC Chemical, in its capacity as notifier of carbosulfan, 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 FMC Chemical and that the main application made by it is admissible (Du Pont de Nemours (France) and Others v Commission, cited in paragraph 41 above, paragraph 112).
50 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 Rohrwerkeand 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, the judgment of the Court of First Instance of 9 July 2007 in Case T-282/06 Sun Chemical Group and Others v Commission, not yet published in the ECR, paragraph 52).
51 It must be stated, however, that while the case-law referred to in paragraph 50 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.
52 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).
53 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.
54 In the present context, it must therefore be examined whether the applicants other than FMC Chemical appear prima facie to be manifestly not entitled to apply to the Court for annulment, in the main proceedings, of the contested decision.
55 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.
56 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 FMC Chemical, 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, carbosulfan, 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.
57 The possibility remains however that, in certain circumstances, the provisions of this 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).
58 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 57 above, paragraph 20; Unión de Pequeños Agricultores v Council, cited in paragraph 57 above, paragraph 36; and Case C-236/02 P Commission v Jégo-Quéré [2004] ECR I‑3425, paragraph 45).
59 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 Arnaudand 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).
60 In the present case, it seems that, far from being individually distinguished by attributes peculiar to them, the applicants other than FMC Chemical are affected in the same way as all the other vendors and users of carbosulfan 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 FMC Chemical. 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.
61 So far as concerns the fact that the applicants other than FMC Chemical and Belchim Crop Protection hold national marketing authorisations for carbosulfan, 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 carbosulfan 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.
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 FMC Chemical 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). The same is true of the mere contractual right conferred on Belchim Crop Protection consisting in the power to distribute carbosulfan-based products for FMC Chemical.
63 In so far as the applicants plead damage to the worth of the trade marks held by FMC Corp., it is true that in Codorníu v Council, cited in paragraph 57 above (paragraph 21), the Court of Justice held that the Spanish proprietor of the trade mark Gran Cremant de Codorniu, which had traditionally used that mark, was individually concerned by a provision of a general nature under which only French and Luxembourg producers were entitled to use the term ‘crémant’, given that the provision prevented that proprietor from using its mark. However, that is not the situation here. While it is apparent from the documents adduced by the applicants that FMC Corp. is the proprietor of the trade marks Marshal, Alize, Sheriff, Cartel, SPI, Posse and Belfort, there is nothing to indicate that the use by FMC Corp. of those marks may, as such, be affected by a prohibition on the marketing of the active substance carbosulfan, in particular as, far from being registered specifically for carbosulfan, the marks relate to pesticides or pharmaceutical products in the generic sense. FMC Corp. may therefore, in any event, continue to use them for products which do not contain carbosulfan and in order to prevent other undertakings from using signs liable to be confused with them.
64 Finally, the line of argument that the applicants other than FMC Chemical form part of a closed class of undertakings condemned to losing their marketing authorisations by 13 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 45 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.
65 It follows from the foregoing that the contested decision cannot, prima facie, be considered to be of individual concern to the applicants other than FMC Chemical. 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.
66 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.
67 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 45 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).
68 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 lacks proper foundation in that it does not take account of relevant scientific data which FMC Chemical 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 carbosulfan, although that procedure had already begun.
69 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 FMC Chemical.
Urgency
Arguments of the parties
70 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 carbosulfan-based products on 13 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 their main products. Finally, the contested decision will damage the reputation on the market of the applicants’ longstanding trade marks.
71 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 41 above.
72 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).
73 As regards the case in point, the applicants assert that the imminence of the damage is evident 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 FMC applicants by 13 December 2007, which will cause them damage. This inevitable effect also stems from the nature of the relevant market, where no long-term supply contracts are concluded and there is no brand loyalty. On the contrary, since the market is characterised by similarity in prices and one-year contracts, distributors will immediately change supplier if the FMC applicants are no longer able to supply an interesting portfolio of products. Thus, following the negative EFSA opinion and the announcement at the end of 2006 that the contested decision was going to be adopted, sales of carbosulfan for 2007 have already dropped compared with sales in 2006.
74 In the applicants’ submission, the withdrawal of the national marketing authorisations and registrations for plant protection products will result in the loss of all of the FMC applicants’ market shares and customers for carbosulfan. In this connection, they rely on the Phillips McDougall report (annexed to the application for interim measures) according to which carbosulfan manufactured and sold by the FMC applicants (including their formulation and distribution companies) accounted for over [confidential] (1) % of the product sold in the Community in 2005, the remainder being sold by distributors who obtained supplies from alternative sources.
75 So far as concerns the substitutability of carbosulfan, 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 carbosulfan. 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, because the applicants are faced by powerful competitors capable of offering not only direct replacement products, but also an overall product portfolio, particularly in the fruit and vegetables sector, with the larger companies capable of meeting all pest, weed and disease control requirements.
76 With regard to the products competing with carbosulfan, the applicants produce a table which contains a list of numerous active substances, including alpha-cypermethrin, bifenthrin and cypermethrin. Furthermore, they mention four substances as likely replacement products, namely chlorpyrifos, dimethoate, ethoprophos and fosthiazate, which are included in Annex I to the Directive and marketed by powerful companies, such as Bayer and Syngenta. The latter have considerable financial resources which will enable them to capture the market lost by the FMC applicants, the replacements for carbosulfan on the Community market being low cost products with a broad spectrum.
77 In this context, the applicants submit, however, that most of the products competing with carbosulfan in the Community have different efficacy with regard to the control of certain pests, and that any active ingredient may not be a suitable replacement in all carbosulfan’s authorised applications, inter alia because of technical problems linked to the development of pest resistance on a total shift to other chemical classes.
78 The FMC applicants state with regard to the possibility of carbosulfan’s being replaced by products from their own portfolio that they do not have any product whose sale could replace that of carbosulfan in the same markets.
79 Referring to the Phillips McDougall report, they add that the retrieval of sales of carbosulfan following its withdrawal, should it be reinstated on the market, will be very difficult to achieve, given that the product portfolio of the FMC applicants is far more limited than that of the major companies in the industry.
80 There are still other reasons why the FMC applicants will not be able to re-enter the markets with new products. Their products containing carbosulfan are mostly in the form of granules which need to be applied with a specific applicator, calibrated especially for this product use. Once a farmer has decided to switch to a ready-treated seed application, it is most unlikely that he will return to granule-applied products, as his equipment will become obsolete and the cost of replacement would not be justifiable. Hence, an interruption in the supply of products containing carbosulfan will result in the irrevocable loss of carbosulfan’s shares of the market in question.
81 Pointing out that carbosulfan has been safely used in the Community for over 30 years, the applicants fear a loss of carbosulfan’s reputation and destruction of the value of the trade marks held by FMC Corp. The contested decision will seriously damage confidence in the FMC applicants on the Community market, which is particularly sensitive to health and environmental issues. Carbosulfan thus risks being regarded as a dangerous substance and the FMC applicants as undertakings manufacturing and selling products harmful to health and the environment. In this connection, they refer to correspondence which FMC Chemical has received from its distributors and customers throughout the Community.
82 The applicants further assert that, if carbosulfan had in fact been included in Annex I to the Directive, Article 13 of the Directive would have permitted FMC Chemical, as the notifier, to refuse its competitors and customers access to data obtained – at great cost – for the purpose of carbosulfan’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 carbosulfan’s not being included in Annex I to the Directive, FMC Chemical 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 submit that the importance of carbosulfan sales in the operations of the FMC applicants and the damage that they have already started suffering are apparent from the table and documents annexed to the application for interim measures. The table and documents demonstrate that sales in the Community of products containing carbosulfan amounted to USD [confidential] million for the 2006 calendar year, whereas anticipated sales for 2007 are significantly lower. These figures show that EFSA’s adverse opinion of July 2006 has already had a significant negative impact upon the sales of the FMC applicants. All of those sales in the Community will be lost because of the withdrawal of national registrations by 13 December 2007.
84 In addition, carbosulfan sales outside the Community amount to USD [confidential] million. Phillips McDougall estimates that carbosulfan sold by the FMC applicants accounts for about [confidential] % of this total. In the case of sales outside the Community, losses can be anticipated for several reasons. First of all, certain third countries mimic the Community rules, so that a substance which is not included in Annex I to the Directive will also be prohibited in those countries. The applicants estimate that around USD [confidential] million of sales (of which USD [confidential] million is attributed to the FMC applicants) may be lost if carbosulfan is prohibited in the Community. In this context, the applicants mention the Middle East and Africa, which are important markets for the FMC applicants.
85 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, which means that the substance in question is then subject to a prior consent procedure in the event of export out of the Community. If carbosulfan were indeed to be subject to this procedure, that is likely to make sales more difficult.
86 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 effectively make it more difficult to market products treated with carbosulfan. In any event, in order to avoid a prohibitive limit being set, the FMC applicants will have to submit costly tests to the regulatory authorities in the Community in defence of higher MRLs.
87 The applicants conclude by submitting that, overall, the gravity of the damage that will be suffered by the FMC applicants if the contested decision is not suspended must be assessed in the light of the reputation which they have built with carbosulfan since the mid 1970s, of the customer base and turnover which they have carefully built over a long period of time, and of the investments which they have made in carbosulfan, the reputation of the trade marks relating to the product and the defence of the product throughout the Community review process.
88 As regards Satec Handelsgesellschaft and Belchim Crop Protection, the applicants assert that they 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, this loss may be compensated for by increased sales of replacement products, but the applicants have provided no data enabling it to be assessed to what extent the sales of carbosulfan can be replaced by sales of other products.
91 In any event, the damage that can be taken into consideration is very small compared to the FMC applicants’ resources, in that it amounts to only less than [confidential] % of the turnover of the FMC group. 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 The Commission observes that the FMC applicants assess their sales in the Community of products containing carbosulfan as amounting to USD [confidential] million in 2006 and that their sales in third countries amount to about USD [confidential] million (that is to say [confidential] % of USD [confidential] million). Consequently, only about [confidential] % of their sales of carbosulfan have been made in the Community. As regards sales in third countries, the FMC applicants plead a loss of USD [confidential] million.
93 Even if a loss of USD [confidential] million were accepted – disregarding any compensatory sales of substitute products and accepting the assessed losses in third country markets – that loss should be weighed against the turnover of FMC Corp., the group’s parent company. The turnover achieved by the latter in 2006 in respect of agricultural products alone amounts to USD 767 million.
94 The Commission points out that the total turnover of FMC Corp., taking all products together, amounted in 2006 to USD 2.347 billion, which the applicants have confirmed in response to a question from the President of the Court. The Commission concludes therefrom that the claimed loss of USD [confidential] million is only [confidential] % of the FMC group’s total turnover.
95 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. On the other hand, the letters from customers which the applicants have relied upon attest, first, the special value of carbosulfan and the absence of perfect substitute products and, second, the FMC applicants’ excellent reputation.
96 Finally, the Commission contends that the FMC applicants already sell substances capable of being substitutes for carbosulfan, that is to say alpha-cypermethrin, cypermethrin and bifenthrin, pointing out that income from the sale of bifenthrin exceeds that generated by carbosulfan. In addition, the FMC applicants could, in accordance with an element of their commercial strategy, obtain substitute products from other producers such as Nippon Soda Co., BASF and Bayer CropScience.
97 The Commission draws the conclusion that urgency is not established in the present case.
Findings of the President of the Court
98 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 of the President of the Court of First Instance of 7 June 2007 in Case T-346/06 R IMS v Commission, not yet published in the ECR, 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).
99 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).
100 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.
101 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 72 above, paragraph 107; and in Du Pont de Nemours (France) and Others v Commission, cited in paragraph 41 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 99 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).
102 It is in the light of those considerations that examination is required of the reasons put forward by the applicants to establish that FMC Chemical 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 FMC Foret, F&N Agro Ceská republika, F&N Agro Slovensko, F&N Agro Polska, FMC Corp., Satec Handelsgesellschaft and Belchim Crop Protection must be excluded from that examination (see paragraph 65 above).
103 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 41 above, paragraphs 196 and 203 and the case-law cited).
104 So far as concerns the situation of FMC Chemical, it is not in dispute that the overall turnover of the group to which it belongs amounted to USD 2.347 billion in 2006. According to the applicants, the gravity of the damage is established, in particular, by the fact that the FMC applicants’ sales in the Community of products containing carbosulfan, which amounted to USD [confidential] million in 2006, would be lost if operation of the contested decision were not suspended and that the loss of sales of carbosulfan outside the Community would amount, for the FMC applicants, to USD [confidential] million.
105 It follows that, according to these figures, the annual loss caused to the FMC applicants by the contested decision on the Community market would amount to less than 1% of the turnover of their group.
106 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. As has been held above (paragraphs 65 and 102), only matters concerning FMC Chemical can be taken into consideration when establishing urgency. The data presented in the application for interim measures relate to the sales made by the six FMC applicants and do not enable the pertinent figures for FMC Chemical to be identified, whereas those figures should have been set out in the text of the application for interim measures itself (see paragraph 67 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 FMC Chemical.
108 For the sake of completeness, a rough assessment of the annual loss caused on the Community market by the contested decision to FMC Chemical alone would yield an estimate lower than that of 1% of the turnover of the FMC 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 the applicants have not established that the interim measure sought would, if granted, prevent the authorities of the countries concerned from prohibiting the marketing of carbosulfan 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 carbosulfan 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, Pfizer Animal Health v Council, cited in paragraph 101 above, paragraph 160).
110 Nor is the applicants’ invocation of Article 5 of the Rotterdam Convention (see paragraph 85 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 FMC Chemical foreseeable and quantifiable damage in a given third country while the main proceedings are continuing. Whilst 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), carbosulfan has just been entered in Parts 1 and 2 of Annex I to Regulation No 304/2003, which implements the Rotterdam Convention, suffice it to state that, as provided by Article 13(6)(a) of Regulation No 304/2003, the only consequence of its entry is to impose, in the case of export of carbosulfan, an obligation to obtain the explicit consent of the importing country. The applicants have neither established that the third countries to which FMC Chemical intends to export carbosulfan would refuse to consent to its import nor provided figures in this regard. In any event, the prohibition on the import of carbosulfan would be the direct consequence not of the contested decision, but of a decision taken solely by the authorities of the third country concerned (see paragraph 109 above). Consequently, the applicants have not shown that the mechanism under the Rotterdam Convention will result directly and inevitably in losses of sales of carbosulfan-based products on the market of specified third countries.
111 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 effectively make it more difficult to market products treated with carbosulfan and would oblige the FMC applicants to submit costly tests to the regulatory authorities in the Community in defence of higher MRLs, so as to avoid a prohibitive limit being set.
112 As regards the alleged adverse effects of new MRLs on trade with third countries, it need merely be pointed out that it will be for the third countries in question alone to decide whether or not carbosulfan-based products should be imported (see paragraph 109 above).
113 Likewise, on the Community market, while the contested decision could in fact result in the setting of new MRLs for carbosulfan, the damage allegedly suffered because of those MRLs would not be a direct consequence of the contested decision. The Community procedure for setting MRLs is independent of the decision not to include carbosulfan in Annex I to the Directive. Nor have the applicants proved to the required legal standard that the non-inclusion of carbosulfan 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 carbosulfan.
114 It follows that the applicants’ contentions concerning the issue of MRLs lack foundation for the purpose of proving that the damage allegedly caused to FMC Chemical by the contested decision is serious.
115 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 carbosulfan’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.
116 It follows from the foregoing that none of the reasons put forward to establish that the damage suffered by FMC Chemical would be serious can be upheld.
117 These findings are sufficient to conclude that the damage caused to FMC Chemical by the contested decision would in any event amount to less than 1% of the turnover of the FMC group and cannot therefore be regarded as serious, and it is not even necessary to rule on the extent to which that damage could be reduced by the sale of substitute products.
118 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 they have acquired a reputation with carbosulfan since the mid 1970s, that they have carefully built their customer base and turnover over a long period of time, that they have made substantial investments in carbosulfan and that they have longstanding trade marks of repute relating to carbosulfan whose value will be destroyed by the contested decision. 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.
119 As regards the alleged destruction of the trade marks, it need merely be recalled that they are all registered in the name of FMC Corp. alone (see paragraph 22 above). As has been held above (paragraphs 65 and 102), any damage caused to FMC Corp. cannot be taken into account when considering urgency, as urgency must be established in respect of FMC Chemical alone. Besides, there seems to be nothing to prevent the applicants from continuing to use the trade marks as such (see paragraph 63 above).
120 Furthermore, the applicants have not proved to the required legal standard that the damage assessed approximately above can be regarded as irreparable.
121 While the applicants contend that they are liable to lose the market shares and the reputation that have been acquired by carbosulfan in the Community, they have not established that it would be impossible for FMC Chemical 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 carbosulfan to regain its previous position.
122 First, the applicants themselves note that, from a technical point of view, it will not be possible to obtain perfect, seamless substitutability for carbosulfan, that the replacement of carbosulfan may in particular bring about the development of pest resistance and that most of the other products have different efficacy from carbosulfan. Second, they observe that the broad spectrum of activity and relatively low cost of carbamate insecticides are factors making their use attractive to farmers. Finally, they have expressly drawn attention to the correspondence received by FMC Chemical from a number of customers and distributors in Europe who stress carbosulfan’s importance and efficacy.
123 It follows that carbosulfan’s qualities appear to be highly appreciated by the applicants’ customers and that no perfect substitute product exists. These factors support the view that it would be possible for carbosulfan 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.
124 Moreover, the applicants themselves state that the market in question is characterised by the absence of long-term supply contracts and of brand loyalty and by similarity in prices, with distributors tending to change supplier rapidly. Such characteristics do not justify the conclusion that there are structural obstacles on the market concerned preventing FMC Chemical from regaining any market shares lost because of the contested decision, but tend rather to show that it would be at least partially possible to regain such shares (see, to this effect, Sumitomo Chemical Agro Europe v Commission, cited in paragraph 101 above, paragraph 64).
125 While the applicants assert that they are competing with powerful undertakings which have considerable financial resources enabling them, thanks to their complete product portfolio, to capture the market lost because of the contested decision, they do no more than conclude therefrom that the retrieval of sales of carbosulfan, should it be reinstated on the market, will be ‘far more difficult to achieve’. This is a mere supposition which not only is not backed up by any evidence or principle founded on experience, but is contradicted by the findings made in paragraphs 122 to 124 above. The same is true of the assertions that it is unlikely that the FMC applicants will be able to re-enter the market in question, given that their carbosulfan-based products in the form of granules need to be applied with a specific applicator, calibrated especially for this product use, and once a farmer has decided to switch to a ready-treated seed application he will not return to granule-applied products.
126 Finally, the results of the survey of the FMC applicants’ customers relating to the possibility of carbosulfan’s returning to the market (annexed to the application for interim measures) do not lead to the conclusion that all possibility of carbosulfan’s regaining the market shares lost is categorically ruled out. According to this study (consisting of a single page) the regaining of market shares appears only difficult to achieve. Furthermore, the representativeness of the responses appearing in the study seems extremely poor, given that it mentions only one customer, namely Satec Handelsgesellschaft, one of the applicants in these proceedings for interim measures, which can hardly be classified as an objective source of information.
127 It follows that, while recapture by carbosulfan of the market shares lost because of the contested decision may, financially and economically, be quite onerous, such a return to the market, including restoration of carbosulfan’s reputation, does not appear impossible (see, to this effect, Pfizer Animal Health v Council, cited in paragraph 101 above, paragraphs 161 to 165).
128 The damage allegedly suffered by FMC Chemical on account of the contested decision cannot therefore be regarded as irreparable.
129 It follows from all of the foregoing that the applicants have not shown, as matters now stand, that FMC Chemical would suffer serious and irreparable damage if suspension of operation of the contested decision were not granted.
130 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.
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, 11 December 2007.