Order — ECLI:EU:T:2006:102
Date: 2006-04-04
Language of the case: English
Court formation: President of the Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Agriculture and Fisheries;Environment;Plant health legislation
Concepts: Application for interim measures: suspension of operation of the contested measure and other interim measures
Procedure: Action for annulment;Application for interim measures - unfounded;Action for damages
Origin: Italy

summary dossier’ and a ‘complete dossier’ as defined in Article 6(2) and (3) of that regulation. 8 Article 19 of Directive 91/414, as amended by Council Regulation (EC) No 806/2003 of 14 April 2003 adapting to Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (qualified majority) (OJ 2003 L 122, p. 1), provides that the Commission is to be assisted by the Standing Committee on the Food Chain and Animal Health (‘the Committee’). 9 Article 7(3A) of Regulation No 3600/92, inserted by Commission Regulation (EC) No 1199/97 of 27 June 1997 amending Regulation No 3600/92 (OJ 1997 L 170, p. 19), provides that, after that examination, the Commission is to present to the Committee a draft directive to include the active substance in Annex I to Directive 91/414; a draft decision concerning the withdrawal of the authorisations of plant protection products containing the active substance; a draft decision for such a withdrawal but retaining the option of reconsidering the listing in Annex I to that directive after submission of the results of additional trials or of additional information; or a draft decision to postpone inclusion of the active substance pending the submission of the results of additional trials or information. 10 The adoption of a decision or a directive pursuant to Article 7(3A) of Regulation No 3600/92 brings to an end the transitional system of derogation under Article 8(2) of Directive 91/414. 11 Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414 to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances (OJ 2005 L 141, p. 51; ‘the contested directive’), which entered into force on 1 March 2006, amends Annex I to Directive 91/414 so as to add chlorothalonil with a purity level for hexachlorobenzene of 0.01 g/kg. 12 Article 2 of the contested directive provides: ‘Member States shall adopt and publish by 31 August 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 September 2006 …’ 13 Article 3 of the contested directive provides: ‘1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing chlorothalonil … as active [substance] by 31 August 2006. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to chlorothalonil … are met, with the exception of those identified in part B of the entries concerning those active substances, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive. 2. … Following that determination Member States shall … in the case of a product containing chlorothalonil … as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2010 at the latest …’ 14 Directive 91/414 also contains two provisions, Articles 13 and 14, grouped under the heading ‘Data requirements, data protection and confidentiality’. 15 Article 13(1) of Directive 91/414 provides: ‘… Member States shall require that applicants for authorisation of a plant protection product submit with their application: (a) a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III; and (b) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II’. 16 Article 13(3) of Directive 91/414 provides: ‘In granting authorisations, Member States shall not make use of the information referred to in Annex II for the benefit of other applicants: … (b) for a period of 10 years from first inclusion in Annex I of an active substance not on the market two years after the date of notification of this Directive; or (c) for periods not exceeding 10 years from the date of the decision in each Member State and provided for in existing national rules, concerning an active substance on the market two years after the date of notification of this Directive …’ 17 Article 13(4) of Directive 91/414 provides: ‘In granting authorisations, Member States shall not make use of the information referred to in Annex III to the benefit of other applicants: … (b) for a period of 10 years from first authorisation of the plant protection product in any Member State, where authorisation follows the inclusion in Annex I of any active substance contained in the product …’ Facts of the dispute 18 On 8 July 1993 Vischim Srl, an Italian company which produces chlorothalonil, notified the Commission that it wished to secure the inclusion of that substance in Annex I to Directive 91/414, and for that purpose submitted the dossiers provided for in Article 6(2) and (3) of Regulation No 3600/92 to the Rapporteur. The version of the active substance notified by the applicant had a purity level for hexachlorobenzene of 0.072 g/kg. 19 Sixteen other producers expressed their wish to have chlorothalonil included in Annex I to Directive 91/414, but only the applicant and ISK Biotech Europe submitted within the time-limits sufficiently complete dossiers for them to be regarded as ‘main data submitter[s]’. 20 In 1998 the chlorothalonil production activity of ISK Biotech Europe was purchased by Zeneca Agrochemicals, which later became Syngenta (‘Syngenta’). 21 The version of the active substance notified by Syngenta had a purity level for hexachlorobenzene of less than 0.01 g/kg. 22 On 31 January 2000 the Rapporteur submitted its draft assessment report, in which it concluded that more information was needed before chlorothalonil could be included in Annex I to Directive 91/414. 23 On 20 April 2000, in accordance with Article 7(3) of Regulation No 3600/92, the Commission transmitted to all Member States and to the applicant the draft assessment report for chlorothalonil, which was then reviewed by the European Community Coordination body (‘ECCO’). 24 Subsequently, the chlorothalonil dossier, the draft assessment report and the ECCO review report were sent to the Committee. At its meeting of 15 February 2005, the Committee concluded that plant protection products containing chlorothalonil satisfied the requirements of Article 5(1)(a) and (b) of Directive 91/414. 25 In February 2005 the Food and Agriculture Organisation of the United Nations (FAO) adopted a standard for chlorothalonil with a purity level for hexachlorobenzene of 0.01 g/kg, replacing the 1998 standard which had a purity level for hexachlorobenzene of 0.3 g/kg. 26 Finally, on 16 September 2005, the Commission adopted the contested directive, which includes chlorothalonil in Annex I to Directive 91/414, with a purity level for hexachlorobenzene of 0.01 g/kg. 27 In December 2005 the FAO adopted a new standard for chlorothalonil with a purity level for hexachlorobenzene of 0.04 g/kg. Procedure and forms of order sought by the parties 28 By application lodged at the Registry of the Court of First Instance on 25 November 2005, the applicant brought an action under the fourth paragraph of Article 230 EC for the partial annulment of the contested directive and the chlorothalonil review report and, in the alternative, an action for failure to act under Article 232 EC. In its application, the applicant also made a claim for compensation under Article 288 EC. 29 By separate document lodged at the Registry on 12 December 2005, the applicant brought the present application for interim measures. In that application, the applicant asks the President of the Court, pursuant to Article 105(2) of the Rules of Procedure, to rule before the Commission has submitted its observations. 30 By document lodged at the Registry on 17 January 2006, the Commission submitted its observations on the application for interim measures. 31 At the request of the President of the Court, the applicant on 30 January 2006 submitted its observations on the Commission’s observations on the application for interim measures. On 15 February 2006 the Commission filed its own observations on the applicant’s observations, and on 22 February 2006 it submitted its answer to a question asked by the President of the Court on 20 February 2006. 32 By document lodged at the Registry on 23 February 2006, the applicant made a fresh application under Article 105(2) of the Rules of Procedure. 33 By order of 24 February 2006, the President of the Court granted the applicant’s application and provisionally suspended the operation of the contested directive. 34 On 7 March 2006 oral argument was heard from the parties, and by order of that date the President of the Court cancelled the order of 24 February 2006. 35 The applicant claims that the President of the Court should: – declare the application admissible and well founded; – suspend the operation of the contested directive and the review report in so far as the inclusion of chlorothalonil in Annex I to Directive 91/414 is concerned, pending the full resolution of the dispute in the main proceedings; – order the Member States ‘not to withdraw the applicant’s chlorothalonil-based products from the national markets pending the full resolution of the dispute in the main proceedings’; – order the Commission to instruct the Member States, when reviewing existing chlorothalonil-based product registrations, to use the 20 January 2005 version of Appendix IIIA to the review report including the applicant’s studies, pending the full resolution of the dispute in the main proceedings; – order the Commission to pay the costs. 36 The Commission contends that the President of the Court should dismiss the application as inadmissible or unfounded and order the applicant to pay the costs. Law Arguments of the parties Admissibility 37 The applicant submits that the main application is admissible, first, because it was brought within the period prescribed by Article 230 EC. 38 Second, according to the applicant, the application is admissible as the contested directive is of direct and individual concern to it, both because it took part in the administrative procedure before the Commission as a notifier of chlorothalonil and a provider of data and because it enjoys intellectual property rights concerning the information provided during the assessment procedure by virtue of Article 13 of Directive 91/414. 39 The Commission disputes the admissibility of the application for annulment. In its view, the contested directive is not capable of directly affecting the applicant’s situation, so that at least one of the conditions laid down by Article 230 EC is not satisfied. Prima facie case 40 The applicant puts forward several arguments to show that the contested directive is unlawful. 41 In the first place, from a procedural point of view, the applicant submits that the contested directive is based on a scientific review report which does not correspond to the version voted on and approved by the Committee. Specifically, Appendix IIIA to the review report, listing the scientific studies used for the inclusion of chlorothalonil in Annex I, is dated 15 March 2005, whereas the Committee’s vote took place in February 2005. 42 This is a serious defect, in that the version of the review report dated March 2005 differed considerably from the previous version. To begin with, that version no longer contained the applicant’s scientific studies, thus depriving the applicant of the intellectual property rights it derives from Article 13 of Directive 91/414. 43 Next, the March 2005 version of the review report no longer described the applicant as a ‘main data submitter’, a status which was required for ensuring easy re-registration of its products after the inclusion of chlorothalonil in Annex I to Directive 91/414. 44 Finally, Appendix IIIA to the review report made no mention of the scientific studies submitted by the applicant which were used as a basis for the inclusion of chlorothalonil in Annex I to Directive 91/414. That circumstance creates a fundamental discrepancy between the conclusions of the review report and its supporting evidence 45 In the second place, on the substance, the contested directive is unlawful, first, because by including in Annex I to Directive 91/414 a different purity specification from the one studied by the Rapporteur and by failing to mention the scientific studies submitted by the applicant and examined by the Rapporteur the Commission infringed Article 95 EC and Article 5 of Directive 91/414, under which the Commission must assess active substances and list them in Annex I to that directive in ‘the light of current scientific and technical knowledge’, subject only to the ‘conditions’ set out in the implementing provisions of Article 5 of the directive. 46 Second, the Commission infringed the principle of subsidiarity, in that it assessed the technical equivalence of two notified products at Community level instead of including a less strict purity level in Annex I to Directive 91/414 and leaving it to the Member States to examine chlorothalonil-based products when re-registering them. 47 Third, by failing to mention the applicant’s scientific studies in the review report, the Commission infringed Article 13 of Directive 91/414, under which the applicant is entitled to protection for the information it submitted, which was undeniably used for the adoption of the contested directive. 48 Fourth, by excluding the applicant from the essential stages of the administrative procedure for the review of chlorothalonil and from the meetings with Syngenta, the Commission infringed Articles 6 and 7 of Regulation No 3600/92, under which the Commission and the Rapporteur are obliged to protect the rights and legitimate expectations of the notifiers and main data submitters and also to ensure that all the procedural guarantees applicable are complied with during the administrative procedure. 49 Fifth, by failing to correct manifest errors during the assessment of chlorothalonil, which were reported to the Commission by the applicant, and by failing to respond to the applicant’s letters of complaint, the Commission infringed Article 211 EC, which enshrines the principle of sound administration. 50 Sixth, the Commission did not comply with its obligation to state reasons, and breached various rights of the applicant, in particular the rights of the defence, the right to respect for legitimate expectations, and the right to equal treatment. 51 Moreover, by depriving the applicant of its right to re-register and continue to market its products in the Member States, the Commission breached the principle of proportionality and the applicant’s fundamental right to carry on its business activities, thereby interfering with its rights of property. 52 Furthermore, by creating a monopoly in favour of Syngenta without any scientific or legal justification, the Commission infringed Article 2 EC, which requires the maintenance of a high level of competition on the Community market for chlorothalonil. 53 Finally, the Commission also failed to respond to a letter of 14 April 2005 in which the applicant asked it to resolve the above issues and, more particularly, either formally to adopt the contested directive after first amending the purity level of chlorothalonil so as to bring it into line with the specification provided by the applicant, or else to refrain from adopting the contested directive in its current version and ‘have the competent evaluators decide on a different … identity … definition’. 54 The Commission considers that the contested directive is not vitiated by unlawfulness. Urgency 55 According to the applicant, the inclusion of chlorothalonil in Annex I to Directive 91/414 with a different specification from that notified by the applicant and the fact that the review report does not mention its scientific studies are liable to cause it serious and irreparable damage in connection with the withdrawal of national marketing authorisations for chlorothalonil-based products and with the inability to grant access to the data it supplied relating to chlorothalonil. 56 In particular, according to the applicant, first, if its application for suspension of operation of the contested directive is not allowed, the consequence will be that the national authorisations for marketing its product will be withdrawn. In view of the fact that the applicant makes over 80% of its chlorothalonil sales in Europe and markets only that product, its inability to continue its activities in Europe will cause it serious and irreparable damage. 57 Second, the fact that its scientific studies were not mentioned in Appendix IIIA to the review report has the consequence that those studies do not enjoy the protection of data provided for in Article 13 of Directive 91/414. As a result, the applicant cannot claim payment for the use of the data. In addition, the applicant cannot seek registration of its product from the Member States since, to do so, it would require access to Snygenta’s dossier, which would not be possible, as that undertaking is a competitor of the applicant. 58 The Commission submits, on the other hand, that the damage alleged by the applicant cannot be caused by the contested directive, since, first, the withdrawal of authorisations depends on a national measure and, second, the protection of data provided for in Article 13 of Directive 91/414 does not depend on the studies being mentioned in Appendix IIIA to the review report, as the applicant claims. 59 In any event, according to the Commission, the alleged damage is not serious enough to justify the grant of the interim measures sought. Balance of interests 60 According to the applicant, the balance of the interests at stake tilts in favour of granting the measures sought, in that they would merely maintain the status quo and not have any effect on the environment or human or animal life. By contrast, operation of the contested directive would have the consequence of endangering the applicant’s very existence. 61 The Commission replies that a suspension of operation of the contested directive would have consequences for third parties. It would entail applying the transitional scheme laid down by Directive 91/414, which expires on 31 December 2006, so that if chlorothalonil were not included again in Annex I to that directive by that date, all the authorisations would have to be withdrawn. Findings of the President of the Court 62 Under Articles 242 EC and 243 EC and Article 225(1) EC the Court of First Instance may, if it considers that circumstances so require, order that application of the contested act be suspended or prescribe any necessary interim measures. 63 Article 104(2) of the Rules of Procedure prescribes 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. Those conditions are cumulative, so that an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing the application will also, if necessary, balance the interests at stake (orders in Case C‑149/95 P(R) Commission v Atlantic Container Line and Others [1995] ECR I‑2165, paragraph 22, and Case C‑364/98 P(R) Emesa Sugar v Commission [1998] ECR I‑8815, paragraphs 43 and 47). 64 Moreover, 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 (orders in Atlantic Container Line, cited in paragraph 63 above, paragraph 23, and Emesa Sugar, cited in paragraph 63 above, paragraph 44). 65 In the present case, without it being necessary to rule on the admissibility of the main application, it must be ascertained whether the applicant has succeeded in establishing to the requisite legal standard that allowing its application for interim measures is urgent. 66 It is settled case-law that the urgency of an application for interim measures must be assessed in the light of the extent to which an interlocutory order is necessary in order to avoid serious and irreparable damage to the party seeking the adoption of the interim measure (order in Case C‑329/99 P(R) Pfizer Animal Health v Council [1999] ECR I‑8343, paragraph 94). Where the damage depends on the occurrence of several factors, it is enough that it appears to be foreseeable with a sufficient degree of probability (orders in Case C‑280/93 R Germany v Council [1993] ECR I‑3667, paragraph 34; Case C‑335/99 P(R) HFB and Others v Commission [1999] ECR I‑8705, paragraph 67; and Case T‑369/03 R Arizona Chemical and Others v Commission [2004] ECR II‑205, paragraph 71). 67 The applicant is still required, however, to prove the facts forming the basis of the claim that such serious and irreparable damage is likely (orders in HFB, cited in paragraph 66, paragraph 67, and Arizona Chemical, cited in paragraph 66, paragraph 72). 68 In the present case, the applicant alleges two heads of damage, connected, first, to the fact that the Commission took a purity level for hexachlorobenzene of 0.01 g/kg and, second, to the fact that Appendix IIIA to the review report does not contain any reference to the scientific studies it carried out. 69 With respect to the first head of damage, the applicant alleges that the contested directive will cause it four distinct forms of damage: first, the withdrawal of the national authorisations it holds; second, the withdrawal of the national authorisations held by its distributors; third, a loss of market share to Syngenta; and fourth, the endangering of its very existence. 70 As regards, first, the withdrawal of the applicant’s national authorisations, it must be stated that that could not be independent of a subsequent act adopted by each of the Member States. The withdrawal would be the consequence of a national measure adopted pursuant to Article 3 of the contested directive on the basis of a subsequent assessment of the products which were covered by the transitional scheme at the time of the entry into force of the contested directive. It should be noted in this respect that, as the parties pointed out at the hearing, the national authorities have a certain discretion in making that assessment. 71 In those circumstances, it is clear that the alleged damage depends not on the act suspension of whose operation is sought, but on the possible taking of a decision by a Member State. This damage must therefore be regarded in the present case as hypothetical and not sufficiently probable to justify the ordering of interim measures (see, to that effect, the orders in Case T‑237/99 R BP Nederland and Others v Commission [2000] ECR II‑3849, paragraphs 57 and 66, and Arizona Chemical, cited in paragraph 66 above, paragraph 91). 72 Furthermore, it must be observed that, at the hearing, the applicant itself acknowledged that it was possible that, following reviews initiated by the Rapporteur after the adoption of the contested directive, the Commission might amend it, regarding the purity level notified by the applicant as acceptable. 73 As regards, second, the withdrawal of the national authorisations of the applicant’s distributors, it should be recalled, as the Commission rightly submits, that it is settled case-law that the serious and irreparable damage relied on in an application for interim measures can be taken into account by the judge hearing the application, in his examination of the condition of urgency, only to the extent that it is liable to affect the interests of the party seeking the interim measure. It follows that the damage which the operation of the contested act may cause to a party other than the party seeking the interim measure can be taken into account, if appropriate, solely in the context of the balancing of the interests at stake (see, to that effect, the order in Pfizer Animal Health, cited in paragraph 66, paragraphs 94 to 96). 74 The second form of damage alleged by the applicant clearly relates only to third parties, namely its distributors. Consequently, even if it were established, in that it would affect the applicant’s distributors, that damage cannot justify granting the interim measures sought. 75 As regards, third, the applicant’s loss of market share, it must be pointed out that it would be caused not by the contested directive but by possible national measures withdrawing authorisations, so that its degree of probability has not been proved to the requisite legal standard. 76 Moreover, even if that damage were sufficiently probable and serious, it must be stated that the applicant has not put forward anything to show that it would be irreparable. In particular, the applicant has not shown that, if the contested directive were annulled, there would be structural or legal obstacles to prevent it from regaining its market share (see, to that effect, the order in Case C‑471/00 P(R) Commission v Cambridge Healthcare Supplies [2001] ECR I‑2865, paragraph 111). 77 As regards, fourth, the threat to the appellant’s existence, it must again be observed that that would follow not from the contested directive but from the national measure withdrawing the authorisations, so that its degree of probability has not been proved to the requisite legal standard. 78 Moreover, even if it were probable that the applicant’s existence would be imperilled by the contested directive, it must be observed that the applicant has not produced any evidence to show the seriousness of the alleged damage. 79 The threat to the applicant’s existence would be linked to the fact that it produces only chlorothalonil and 80% of its sales take place in Europe. 80 However, since it has been unable to show to the requisite legal standard that it would suffer serious and irreparable damage as a result of the loss of market share, a fortiori the applicant has been unable to show that the loss of market share would threaten its very existence. 81 Furthermore, it must be recalled that the assessment of the material situation of an applicant may take into consideration inter alia the characteristics of the group to which it is linked by way of its shareholders (orders in Case C‑12/95 P Transacciones Marítimas and Others v Commission [1995] ECR I‑467, paragraph 12; Case C‑43/98 P(R) Camar v Commission and Council [1998] ECR I‑1815, paragraph 36; and Case T‑392/02 R Solvay Pharmaceuticals v Council [2003] ECR II‑1825, paragraph 108). 82 As the applicant itself acknowledges, it is controlled by the companies Caffaro Srl and Sipcam SpA. So, even if the contested directive were the cause of the loss of 80% of the applicant’s sales, the applicant has not put forward any financial evidence to show that that loss might endanger its existence, without the group it belongs to being able to intervene to avert the alleged damage. 83 With respect to the second head of damage, linked to an alleged breach of Article 13 of Directive 91/414, the applicant claims that it is likely to suffer damage in connection with the fact that, first, other producers will not be required to pay it royalties for the use of its scientific studies and, second, it will not be able to make use of Syngenta’s data, because of the inclusion of the data in Appendix IIIA to the review report and the fact that Syngenta ‘will no doubt deny access to its [Appendix IIIA] dossier’. 84 On this point, it must be noted that, as the Commission rightly submits, any damage suffered by the applicant as described in the preceding paragraph could materialise only if the data protection granted by Article 13 of Directive 91/414 depended on the applicant’s dossier being included in Appendix IIIA to the review report. 85 In any event, in the present case, even assuming that Article 13 of Directive 91/414 requires that, in order to be covered by the protection granted by that article, the data must necessarily be published in Appendix IIIA to the review report, the applicant has not proved that the alleged damage would be irreparable. 86 As the applicant submits in its observations on the Commission’s observations, a distinction must be drawn between access to a dossier, which is necessary for registration of a product, and obtaining protection for its own dossier under Article 13 of Directive 91/414, which makes it possible to grant access to that dossier in return, if appropriate, for the payment of royalties. 87 As regards the applicant’s inability to gain access to Syngenta’s dossier, on the one hand, the applicant has merely asserted this without providing any evidence and referred to the circumstance that Syngenta is a competitor. That fact alone cannot suffice to rule out the possibility that Syngenta might be prepared to grant access to its dossier. 88 As regards the alleged loss of royalties, on the other hand, it suffices to state that this is purely financial damage. 89 It is settled case-law that, in the absence of exceptional circumstances, damage that is purely financial cannot be regarded as irreparable or even as reparable only with difficulty, since it may be the subject of subsequent financial compensation (orders in Case 141/84 R De Compte v Parliament [1984] ECR 2575, paragraph 4, and Cambridge Healthcare Supplies, cited in paragraph 76 above, paragraph 113). 90 In the present case, the applicant has not produced any evidence to show that such circumstances exist. 91 It follows from all the foregoing that the applicant has not succeeded in showing to the requisite legal standard that adoption of the interim measures sought is urgent. Consequently, without it being necessary to examine the condition of a prima facie case and balance the interests at stake, the application for interim measures must be dismissed. On those grounds, THE PRESIDENT OF THE COURT OF FIRST INSTANCE hereby orders: 1. The application for interim measures is dismissed. 2. Costs are reserved. Luxembourg, 4 April 2006. Registrar President E. Coulon B. Vesterdorf * Language of the case: English.