ORDER OF THE PRESIDENT OF THE COURT

23 January 2008 ( )

(Appeal – Application for interim measures – Application for suspension of operation – Directive 91/414/EEC – Directive 2006/132/EC – Active substance procymidone – Urgency)

In Case C‑236/07 P(R),

APPEAL pursuant to the second paragraph of Article 57 of the Statute of the Court of Justice, brought on 7 May 2007,

Sumitomo Chemical Agro Europe SAS, established in Saint-Didier-au-Mont-d’Or (France), represented by K. Van Maldegem and C. Mereu, avocats,

appellant,

the other party to the proceedings being:

Commission of the European Communities, represented by L. Parpala and B. Doherty, acting as Agents, with an address for service in Luxembourg,

defendant at first instance,

THE PRESIDENT OF THE COURT,

after hearing the Advocate General, M. Poiares Maduro,

makes the following

Order

1 By its appeal, the appellant asks the Court to set aside the order of the President of the Court of First Instance of the European Communities of 26 February 2007 in Case T-416/06 R Sumitomo v Commission, not yet published in the ECR (‘the contested order’), by which the latter dismissed the appellant’s application for interim measures seeking, first, suspension of certain provisions of Commission Directive 2006/132/EC of 11 December 2006 amending Council Directive 91/414/EEC to include procymidone as active substance (OJ 2006 L 349, p. 22, ‘the contested directive’) and, second, the adoption of certain other interim measures.

Legal context

2 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) sets out, in particular, the Community regime applicable to the grant and withdrawal of authorisations to place plant protection products on the market.

3 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 Directive 91/414 (OJ 1992 L 366, p. 10) sets out the procedure for the evaluation of a number of substances with a view to their possible inclusion in Annex I to Directive 91/414, which contains the list of active substances authorised for incorporation in plant protection products. Those substances include procymidone.

4 Article 5(4) of Directive 91/414 provides that inclusion of an active substance in Annex I may be subject to specific requirements, such as the manner of use.

5 Article 5(5) of Directive 91/414 provides:

‘On request, the inclusion of a substance in Annex I may be renewed once or more for periods not exceeding 10 years; such inclusion may be reviewed at any time … Renewal shall be granted for the period necessary to complete a review, where an application has been made for such renewal in sufficient time, and in any case not less than two years before the entry is due to lapse, and shall be granted for the period necessary to provide information requested …’

Facts of the case and the procedure before the Court of First Instance

6 The appellant, formerly Sumitomo Chemical (UK) plc, produces and distributes procymidone and procymidone-based plant protection products within the European Union. It notified the Commission of the European Communities of its wish to secure inclusion of that active substance in Annex I to Directive 91/414. In addition, the appellant was entered as a notifying producer in Annex I to Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member States for the implementation of Regulation No 3600/92 (OJ 1994 L 107, p. 8), as last amended by Commission Regulation (EC) No 2230/95 of 21 September 1995 (OJ 1995 L 225, p. 1).

7 The contested directive provides for procymidone to be included in Annex I to Directive 91/414 for use as a fungicide only on cucumbers in greenhouses (closed hydroponic systems) and plums for processing, for a period of 18 months from the date of its entry into force.

8 By application lodged with the Registry of the Court of First Instance on 29 December 2006, the appellant brought an action under the fourth paragraph of Article 230 EC for annulment of the contested directive.

9 By a separate document, lodged with the Registry on 11 January 2007, the appellant brought an application for interim measures, in which it requests the President of the Court of First Instance to:

– declare the application for interim measures to be admissible and well founded;

– suspend, until delivery of the judgment in the main proceedings, operation:

– of the period expiring on 30 June 2007 laid down by Article 3(1) of the contested directive, during which Member States may amend or withdraw existing authorisations for plant protection products containing procymidone as an active substance;

– of the following limitations and restrictions set out in the annex to the contested directive:

– expiry of the inclusion in Annex I to Directive 91/414, fixed for 30 June 2008;

– the specific provisions contained in Part A of the annex to the contested directive, relating to the crops concerned;

– of the second subparagraph of Article 3(2) of the contested directive;

– of the final paragraph of Part B of the specific provisions contained in the annex to the contested directive;

– suspend operation of Article 1 of the contested directive which provides for Annex I to Directive 91/414 to be amended and, in regard to procymidone, suspend operation of the period referred to in Article 8(2) of Directive 91/414 during which a Member State may, under certain conditions and by way of derogation, authorise the placing on the market in its territory of plant protection products containing substances not listed in Annex I to Directive 91/414, or direct the Commission to extend that period, so as to allow the Member States to continue to grant authorisations for procymidone-based products after 31 December 2006, until the date of delivery of the judgment in the main proceedings.

The contested order

10 By the contested order, the President of the Court of First Instance, having held that the damage pleaded by the appellant that was capable of establishing the urgency of its application for interim relief was pecuniary in nature, stated that the suspension of operation sought could be justified only if it appeared that, if the measure were not granted, the appellant would be placed in a situation which would endanger its very existence or irremediably affect its market shares.

11 Subsequently, the President of the Court of First Instance established whether the appellant had demonstrated adequately for legal purposes that it was impossible for it to replace procymidone with another substance having similar characteristics in order not to lose its market shares.

12 In this regard, the President of the Court of First Instance held that Annex I to Directive 91/414 could subsequently be amended in order to include crops other than those for which the use of procymidone had already been authorised. Furthermore, he held, first, that the appellant had not submitted any evidence to support the conclusion that the only way in which it could maintain its market shares would be either to sell procymidone-based products or to sell products based on another active substance which it produces and which has the same characteristics as procymidone and, second, that it had limited itself to stating that there was no generic product available to replace procymidone-based fungicides.

13 In any event, the President of the Court of First Instance stated that even if one were to accept that the appellant could not effectively replace procymidone and its procymidone-based products and that this would result in loss of its market shares, it had to be held that the appellant had not adduced any evidence capable of establishing that such a loss would cause it serious and irreparable damage.

14 With regard to the irreparable nature of the damage in question, the appellant had not demonstrated adequately for legal purposes that it would face obstacles of a structural or legal nature preventing it from recovering its market shares. With regard to the seriousness of the damage in question, the appellant, first, had relied solely on an affidavit by one of its directors and, second, also had not provided any information making it possible to appraise the financial characteristics of the group to which it is connected by virtue of its shareholders.

15 On those grounds, the President of the Court of First Instance dismissed the application for interim measures for lack of urgency.

The appeal

16 In support of its appeal concerning interim measures, the appellant puts forward two pleas in law. The first plea, alleging an incorrect application of Community law, is divided into four parts, concerning, respectively, failure to observe the rules on the burden of proof, failure to comply with the law on related companies, incorrect interpretation and application of the relevant law on plant protection products, and incorrect interpretation and application of the legislation applicable to plant protection products. The appellant’s second plea alleges a manifest distortion of the facts.

17 On 5 June 2007, the Commission lodged its response to the appeal.

Consideration of the appeal

The first part of the first plea, alleging failure to observe the rules on the burden of proof

18 In this part of the first plea, the appellant submits that the President of the Court of First Instance placed it under an obligation to prove that the options which it might have in order to prevent the alleged loss of markets were ‘impossible’ to implement. By imposing an obligation to prove impossibility, the President of the Court of First Instance effectively required the appellant to adduce evidence demonstrating with absolute and complete certainty that it would suffer serious and irreparable damage.

19 In this regard, it must be said that, as stated in paragraph 52 of the contested order, the appellant itself excluded the possibility, so far as it is concerned, of replacing procymidone-based products with other products, for a number of reasons. According to its own submissions, first, it does not have any other existing active substance capable of replacing procymidone on those markets. Second, there is no generic product available to replace procymidone-based fungicides. Third, the need to obtain the necessary authorisations prevents it from developing new substitute products in good time to reverse the changes to which the contested directive will give rise on the markets.

20 Therefore, the criticised wording of the President of the Court of First Instance in paragraph 51 of the contested order, according to which ‘it is necessary to establish whether the applicant has demonstrated adequately for legal purposes that it was impossible for it to replace procymidone with another substance’, cannot be considered, in the context of the specific assessment of the judge hearing the application for interim measures, to impose on it the obligation to prove that something was impossible, but, on the contrary, appears to take up and summarise its argument, using wording that is slightly different in order to respond to the argument.

21 In any event, the degree of proof required by the President of the Court of First Instance in the present case cannot be considered higher than that required normally, as is apparent from use of the expression ‘adequately for legal purposes’ in paragraph 51 of the contested order.

22 It must be added that the same considerations apply, in essence, to the criticism voiced by the appellant with regard to paragraph 60 of the contested order, according to which ‘it is for an applicant which invokes a loss of its market shares to demonstrate that recovery of a significant proportion of those market shares, in particular by appropriate measures of publicity, is impossible by reason of obstacles of a structural or legal nature’.

23 The President of the Court of First Instance based that assessment on the assessment in the order in Case C-471/00 P(R) Commission v Cambridge Healthcare Supplies [2001] ECR I‑2865, paragraph 111, according to which the appellant in that case had not demonstrated at all that obstacles of a structural or legal nature would prevent doctors from prescribing again the medicinal products that it marketed, therefore not allowing it to regain a significant proportion of its market shares.

24 It cannot be inferred simply from the use of the word ‘impossible’ in paragraph 60 of the contested order that the President of the Court of First Instance required the appellant to prove more than its claim that obstacles of a structural or legal nature prevented it from regaining a significant proportion of its market shares, thereby departing from the criterion laid down by the abovementioned case-law.

25 This finding is corroborated by the wording used in paragraph 68 of the contested order, where it was concluded, in terms that are almost identical to those used in the order in Commission v Cambridge Healthcare Supplies, that the appellant had not demonstrated adequately for legal purposes that it would face obstacles of a structural or legal nature preventing it from recovering its market shares.

26 In those circumstances, it cannot be held, as claimed by the appellant, that the President of the Court of First Instance changed the degree of proof required from one of proving probability to one of proving impossibility, thereby imposing on the appellant a standard of proof that is incompatible with Community law.

27 Therefore, the first part of the first plea must be dismissed as unfounded.

The second part of the first plea, alleging failure to comply with the law on related companies

28 By the second part of the first plea, the appellant criticises the assessment of the President of the Court of First Instance, in paragraphs 70, 71 and 72 of the contested order, that, in the absence of information on the financial characteristics of the group to which the appellant is connected by virtue of its shareholders, it is impossible to appraise the seriousness of any damage linked to a possible loss of its market shares.

29 The appellant submits that the assessment of the President of the Court of First Instance of the seriousness of the damage is too general and concerns both a threat to the very existence of a company and an irreparable loss of market shares. According to the appellant, the reference to the financial characteristics of the group is irrelevant in the context of an assessment of the seriousness of the damage resulting from the loss of market shares, given that that loss cannot be compensated financially.

30 In that regard, it must be stated, first, that the principal finding of the President of the Court of First Instance was that the appellant did not show that it was impossible for it to replace procymidone-based products with other products. Therefore, the President of the Court of First Instance concluded that the appellant failed to demonstrate adequately for legal purposes that loss of the possibility of marketing procymidone for crops other than those authorised by the contested directive would result in the loss of its shares of the markets in question.

31 Second, it was when considering, in the alternative, the hypothesis that the appellant could not effectively replace procymidone and its procymidone-based products and that this would result in loss of its market shares, that the President of the Court of First Instance examined whether the conditions for the damage to be serious and irreparable were fulfilled, concluding, as regards irreparability, that the appellant had not demonstrated adequately for legal purposes that it would face obstacles of a structural or legal nature preventing it from recovering its market shares. The President of the Court of First Instance thus held that the damage which the appellant relied on was not irreparable.

32 Therefore, it must be held that, even if it were accepted, as submitted by the appellant, that the President of the Court of First Instance wrongly took into consideration the financial characteristics of the group to which the appellant belongs, this cannot be enough to invalidate the assessment concerning the irremediable nature of the loss of the market shares, given that it was also not demonstrated that that damage would be irreparable.

33 In those circumstances, the second part of the first plea cannot be upheld.

The third part of the first plea, alleging incorrect interpretation and application of the relevant law on plant protection products

34 By the third part of the first plea, the appellant criticises paragraph 43 of the contested order, in which the President of the Court of First Instance held that ‘the applicant has adduced no evidence capable of establishing, first, that it enjoys data protection rights under Article 13 of Directive 91/414 and that the value of those rights will be adversely affected by the contested directive and, second, that it will lose the benefit of the investments made for the purposes of compiling a dossier on procymidone in accordance with Directive 91/414 or, a fortiori, that such damage would be serious and irreparable’.

35 According to the appellant, the President of the Court of First Instance has both misinterpreted and misapplied Directive 91/414. As a notifier of procymidone, it is automatically granted data protection rights by Article 13 of Directive 91/414.

36 Irrespective of whether or not such rights are granted automatically to a notifier, it is apparent from paragraph 43 of the contested order that, in any event, the appellant adduced no evidence capable of establishing that the value of its rights would be adversely affected by the contested directive and that it would therefore lose the benefit of the investments made for the purposes of compiling a dossier on procymidone.

37 According to consistent case-law, findings of the Court of First Instance that the applicant has not produced the necessary evidence to support its allegations or that it has not shown that the allegations are correct are findings of fact which are within the sole jurisdiction of that Court and may not be challenged on appeal, unless the Court of First Instance has distorted the clear sense of the evidence put before it (see, in particular, the order in Case C-192/03 P Alcon v OHIM [2004] ECR I‑8993, paragraph 33, and the order of 16 September 2005 in Case C‑342/04 P Schmoldt and Others v Commission, not published in the ECR, paragraph 52).

38 By its arguments, the appellant, without alleging any distortion, in fact confines itself to challenging the assessment of the facts made by the President of the Court of First Instance. That assessment is not a point of law which is subject, as such, to review by the Court of Justice on appeal (see the order in Schmoldt and Others v Commission, paragraph 53).

39 The third part of the first plea must therefore be dismissed.

The fourth part of the first plea, alleging incorrect interpretation and application of the legislation applicable to plant protection products

40 In the fourth part of the plea, the appellant submits, in essence, that the President of the Court of First Instance has wrongly held, first, that Annex I to Directive 91/414 may subsequently be amended in order to include crops other than those for which the use of procymidone has already been authorised, second, that the existence of other generic products allows the appellant to participate in parallel trade and, third, that the existence of other generic products in competition with procymidone means that the appellant can start supplying those substances instead.

41 More specifically, as regards the first complaint in this part, concerning extending the use of procymidone to crops other than those for which this active substance has already been authorised, the appellant submits that the conclusion of the President of the Court of First Instance is based exclusively on a new guidance document on the renewal or modification of entries in that annex, a first draft of which became available only a few days before the interim measures hearing.

42 However, it must be stated, first, that the contested order does not refer to any guidance document.

43 Moreover, it cannot be held, at this stage, that the interpretation of the President of the Court of First Instance, rejecting the appellant’s argument that neither Directive 91/414 nor its implementing regulations provide a legal basis for subsequent amendment to that directive, contains an error in law. Apart from the possibility, referred to by the Commission during the hearing, of subsequently amending Annex I to Directive 91/414 in accordance with Article 5(5) of that directive, the second indent of Article 6(1) of Directive 91/414 provides that the procedure for the inclusion of an active substance in Annex I also applies to amendments to Annex I where necessary.

44 Consequently, it cannot be held that the President of the Court of First Instance erred in law when he did not follow the appellant’s argument that it was not legally possible to subsequently amend Directive 91/414.

45 As regards the second and third complaints in this part, it must be noted that the President of the Court of First Instance held, first, that the appellant did not submit any evidence to support the conclusion that the only way in which it could maintain its market shares would be either to sell procymidone-based products or to sell products based on another active substance which it produces and which has the same characteristics as procymidone and, second, that it limited itself to stating that there was no generic product available to replace procymidone-based fungicides.

46 These are findings of fact, which, as noted in paragraph 37 of this order, are within the sole jurisdiction of the Court of First Instance and may not be challenged on appeal to the Court of Justice.

47 The fourth part of the first plea must accordingly be dismissed as partly inadmissible and partly unfounded. Therefore, the first plea must be dismissed in its entirety.

The second plea, alleging a manifest distortion of the facts

48 By this plea, the appellant criticises paragraph 55 of the contested order, in which the President of the Court of First Instance found that ‘the Commission stated at the hearing, without being challenged by the applicant, that, on the basis of Article 5(5) of Directive 91/414, Annex I to that directive may subsequently be amended in order to include crops other than those for which procymidone has already been authorised in the event that the applicant should submit residue studies demonstrating that the use of procymidone meets the requirements of Directive 91/414’.

49 The appellant submits, first, that it challenged, both in its written submissions and in its oral pleadings, the Commission’s argument that Directive 91/414 provides a mechanism for the inclusion in Annex I to the directive of other crops for which the use of procymidone might be authorised.

50 Second, the finding, in paragraph 55 of the contested order, that those other crops could be added to Annex I to Directive 91/414 if the appellant provided more residue studies constitutes a distortion of the facts and arguments that were submitted to the Court of First Instance, inasmuch as, according to the explanations provided by the appellant during the hearing, a complete procymidone dossier – including, in particular, residue studies – had already been submitted to the rapporteur Member State. Moreover, the appellant submits that those studies did indeed concern uses of procymidone for other crops that were not subsequently authorised by the contested measure.

51 However, it must be held that the question whether or not the appellant countered the Commission’s position regarding the existence of a mechanism to amend Annex I to Directive 91/414 cannot be considered to be an element of fact or evidence which may be the subject of a plea alleging a manifest distortion of the facts, inasmuch as it concerns the interpretation of Directive 91/414 by the President of the Court of First Instance, a review of which has indeed not revealed any errors in law in this regard, as is apparent from paragraph 42 et seq. of the present order.

52 Therefore, the second plea must be rejected as inoperative.

53 In the light of all the foregoing considerations, the appeal must be dismissed.

Costs

54 Under Article 69(2) of the Rules of Procedure, which applies to appeals by virtue of Article 118 thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the Commission has asked for costs against the appellant and the latter has been unsuccessful, the appellant must be ordered to pay the costs.

On those grounds,

THE PRESIDENT OF THE COURT

hereby orders:

1. The appeal is dismissed.

2. Sumitomo Chemical Agro Europe SAS shall pay the costs.

Luxembourg, 23 January 2008.

R. Grass V. Skouris