ORDER OF THE PRESIDENT OF THE COURT OF FIRST INSTANCE 19 July 2007 * Du Pont de Nemours (France) SAS, established in Puteaux (France),

Transcription

1 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION ORDER OF THE PRESIDENT OF THE COURT OF FIRST INSTANCE 19 July 2007 * In Case T-31/07 R, Du Pont de Nemours (France) SAS, established in Puteaux (France), Du Pont Portugal Serviços, Sociedada Unipessoal L da, established in Lisbon (Portugal), Du Pont Ibérica SL, established in Barcelona (Spain), Du Pont de Nemours (Belgium) BVBA, established in Mechelen (Belgium), Du Pont de Nemours Italiana Srl, established in Milan (Italy), Du Pont De Nemours (Nederland) BV, established in Dordrecht (Netherlands), Du Pont de Nemours (Deutschland) GmbH, established in Bad Homburg vor der Höhe (Germany), Du Pont CZ s,r.o,, established in Prague (Czech Republic), Du Pont Magyarország Kereskedelmi kft, established in Budaors (Hungary), * Language of the case: English. II

2 ORDER OF CASE T-31/07 R DuPont Poland sp, z o,o., established in Warsaw (Poland), DuPont Romania Srl, established in Bucharest (Romania), DuPont (UK) Ltd, established in Stevenage (United Kingdom), Dy-Pont Agkro Ellas AE, established in Halandri (Greece), DuPont International Operations SARL, established in Grand Saconnex (Switzerland), DuPont Solutions (France) SAS, established in Puteaux, represented by D. Waelbroeck and N. Rampai, lawyers, applicants, v Commission of the European Communities, represented by L. Parpala and B. Doherty, acting as Agents, II defendant,

3 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION APPLICATION for the suspension of certain provisions of Commission Directive 2006/133/EC of 11 December 2006 amending Council Directive 91/414/EEC to include flusilazole as active substance (OJ 2006 L 349, p. 27), 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) introduces, inter alia, the Community system for the granting and withdrawal of marketing authorisation for plant protection products. 2 Article 4(1)(a) of Directive 91/414 provides that 'Member States shall ensure that a plant protection product is not authorised unless... its active substances are listed in Annex I'. II

4 ORDER OF CASE T-31/07 R 3 Active substances which are not included in Annex I to Directive 91/414 may, under certain conditions, enjoy transitional derogating measures. Article 8(2) of Directive 91/414 provides therefore that a Member State may, during a period of 12 years following the notification of this Directive, authorise the placing on the market in its territory of plant protection products containing active substances not listed in Annex I that are already on the market two years after the date of notification of this directive'. 4 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) lays down the evaluation procedure for several substances with a view to their possible inclusion in Annex I to Directive 91/414. One of those substances is flusilazole. 5 The procedure introduced by Regulation No 3600/92 begins with a notification of interest, provided for under Article 4(1) of that regulation, sent to the Commission by the producer wishing to secure the inclusion of a substance in Annex I to Directive 91/ Following the examination of the notifications of interest, Article 5(2)(b) of Regulation No 3600/92 provides that a rapporteur Member State is to be appointed in order to evaluate each of the active substances concerned. In the present case, Ireland was appointed as the rapporteur Member State with regard to flusilazole ('the rapporteur Member State'), under 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). II

5 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION 7 Once the rapporteur Member State has been appointed, Article 6(1) of Regulation No 3600/92 provides that it is for the notifiers to send to it a summary dossier' and a complete dossier', as defined in Article 6(2) and (3). 8 Article 19(1) 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 the examination by the Committee of the summary dossier and the report drawn up by the rapporteur Member State, such examination being provided for in Article 7(3), 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 to withdraw the authorisations of plant protection products containing the active substance in question, a draft decision relating to such a withdrawal, with the option of reconsidering the inclusion of the active substance in Annex I to the directive after submission of the results of additional trials or of additional information, or, finally, a draft decision to postpone inclusion of the active substance pending the submission of the results of additional trials or information. II

6 ORDER OF CASE T-31/07 R 10 Article 5(1) of Directive 91/414 provides that: 'L In the light of current scientific and technical knowledge, an active substance shall be included in Annex I for an initial period not exceeding 10 years, if it may be expected that plant protection products containing the active substance will fulfil the following conditions: (a) their residues, consequent on application consistent with good plant protection practice, do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, and the said residues, in so far as they are of toxicological or environmental significance, can be measured by methods in general use; (b) their use, consequent on application consistent with good plant protection practice, does not have any harmful effects on human or animal health or any unacceptable influence on the environment as provided for in Article 4(1)(b)(iv) and (v).' 11 Article 5(5) of Directive 91/414 provides that: '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 if there are indications that the criteria referred to in paragraphs 1 and 2 are no longer satisfied. 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 in accordance with Article 6(4).' II

7 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION 12 Article 6(1) of Directive 91/414 provides that: '1. Inclusion of an active substance in Annex I shall be decided in accordance with the procedure laid down in Article 19. The following shall also be decided in accordance with that procedure: any conditions for inclusion, amendments to Annex I, where necessary, removal of an active substance from Annex I if it no longer satisfies the requirements of Article 5(1) and (2).' 13 The adoption of a decision or directive in accordance with Article 7(3A) of Regulation No 3600/92 brings the transitional system of derogations provided for in Article 8(2) of Directive 91/414 to an end. 14 Commission Directive 2006/133/EC of 11 December 2006 amending Council Directive 91/414/EEC to include flusilazole as active substance (OJ 2006 L 349, p. 27; 'the contested directive'), which entered into force on 1 January 2007, amends Annex I of Directive 91/414 to include flusilazole. II

8 ORDER OF CASE T-31/07 R 15 Article 1 of the contested directive provides: Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive/ 16 Part A of the specific provisions in the Annex to the contested directive provides as follows: 'Only uses as fungicide on the following crops may be authorised: cereals other than rice, maize, rape seed, sugar beet, at rates not exceeding 200 g active substance per hectare per application. II

9 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION The following uses must not be authorised: air application, knapsack and hand-held applications, neither by amateur nor by professional users, home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied....' 17 Article 2 of the contested directive provides that: 'Member States shall adopt and publish by 30 June 2007 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 July ' II

10 ORDER OF CASE T-31/07 R 18 Article 3 of the contested directive provides that: '1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing flusilazole as an active substance by 30 June By that date they shall in particular verify that the conditions in Annex I to that Directive relating to flusilazole are met, with the exception of those identified in part B of the entry concerning that active substance, 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 By derogation from paragraph 1, for each authorised plant protection product containing flusilazole, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that directive and taking into account part B of the entry in Annex I to that directive concerning flusilazole. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/ EEC. Following that determination Member States shall for products containing flusilazole, where necessary, amend or withdraw the authorisation by 30 June 2008.' Background to the dispute 19 Flusilazole is a fungicide which has been used and marketed in the European Community for over 20 years. II

11 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION 20 Current authorisations for placing on the market of flusilazole-based plant protection products have been registered for use on 26 types of crop in 15 Member States 21 The substance was thus already on the market when Directive 91/414 entered into force on 25 July The applicants are engaged in the production and sale of flusilazole and of flusilazole-based plant protection products. 23 On 23 July 1993, Du Pont de Nemours (France) SA ('the notifier') notified the rapporteur Member State of its intention to secure the inclusion of flusilazole in Annex I to Directive 91/ In July 1996, the rapporteur Member State submitted its draft assessment report to the Commission, recommending that flusilazole be included in Annex I to Directive 91/914 for a 10-year duration. 25 On 17 October 1996, the Commission forwarded the draft assessment report for consultation to all Member States and then organised a wide-ranging consultation of experts from various Member States. 26 On 14 April 1997, the full report was circulated to the Member States for further consultation and to the notifier for comments and further clarification. Additional data was requested from the notifier. II

12 ORDER OF CASE T-31/07 R 27 The Committees final evaluation of the various documents on the file took place from December 1997 to January 2001, and was due to be finalised in the meeting of the Committee of 7 December On 8 November 2001, the Commission, in its draft review report, concluded that flusilazole seemed to fulfil the safety requirements under Directive 91/414, but that further studies were necessary to confirm that finding. 29 In September 2003, when all the necessary studies had been provided, the rapporteur Member State concluded that flusilazole did not pose any danger and could be included in Annex I to Directive 91/ At the beginning of October 2004, the Commission approved a proposal to include flusilazole in Annex I to Directive 91/414. However, on 8 October 2004, the Commission decided not to submit its proposal to the Committee for a vote. 31 In April 2005, a revised proposal was considered within the working group of the Committee, which recommended the inclusion of flusilazole in Annex I to Directive 91/414 for seven years only, together with a requirement that flusilazole be tested according to guidelines which were then being finalised by the Organisation for Economic Cooperation and Development (OECD), in order to improve the assessment of potential endocrine disrupting properties. II

13 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION 32 In August 2005, although the revised proposal had not been submitted to the Committee for a vote, the Commission informed the notifier that it was considering the possibility of adopting a decision of non-inclusion of flusilazole in Annex I to Directive 91/ On 10 August 2005, the rapporteur Member State informed the Commission that it did not agree with the approach taken. 34 On the 20 October 2005, the Commission informed the notifier in writing that inclusion of flusilazole in Annex I to Directive 91/414 would only cover the crops that had been scientifically tested. 35 On 3 March 2006, the Committee failed however to reach a qualified majority to approve a new Commission proposal which, this time, sought to include flusilazole in Annex I to Directive 91/414 for use restricted to cereals, oilseed rape, maize and sugar beet. 36 On 25 June 2006, under 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) and in the absence of a positive vote within the Committee, the Commission submitted to the Council a proposal for inclusion of flusilazole in Annex I to Directive 91/414 for a period of seven years and for use restricted to cereals, oilseed rape, maize and sugar beet. However, the qualified majority required for adoption of that proposal by the Council could not be achieved. II

14 ORDER OF CASE T-31/07 R 37 On 13 September 2006, the Commission then submitted an amended proposal to the Council, providing for inclusion of flusilazole in Annex I to Directive 91/414 for a period limited to 18 months. 38 On the 11 December 2006, in the absence of a decision by the Council, the Commission adopted the contested directive under the third subparagraph of Article 5(6) of Decision 1999/468, on the basis of its last proposal, that is, providing for inclusion of flusilazole in Annex I of Directive 91/414 for a period limited to 18 months and for use restricted to cereals other than rice, oilseed rape, maize and sugar beet ('the contested restrictions'). Procedure and forms of order sought 39 On 12 February 2006, the applicants lodged an application for annulment in part of the contested directive under the fourth paragraph of Article 230 EC, and an application for compensation under Article 288 EC. 40 On the same day, the applicants lodged an application for interim measures under Articles 242 EC and 243 EC, seeking suspension of enforcement of certain provisions of the contested directive and an order for other provisional measures. 41 On 28 February 2007, the Commission lodged its observations on the application for interim measures and the applicants lodged their final observations on 15 March II

15 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION 42 On 23 April 2007, the parties presented oral observations. 43 In their application for interim measures, the applicants contend that the President of the Court should: order the Commission to take appropriate measures to defer, until judgment in the main proceedings is delivered: the expiry date of the period for which flusilazole is included in Annex I of Directive 91/414, currently fixed at 30 June 2008 in the Annex to the contested directive; and the date by which the Member States have to amend or withdraw, after reevaluation, the authorisation of products containing flusilazole, also fixed at 30 June 2008 under Article 3(2) of the contested directive; order the Commission to take appropriate measures to suspend, until judgment in the main proceedings is delivered, the restriction contained in part A of the Specific Provisions of the Annex to the contested directive on the types of crops on which the use of flusilazole may be authorised by the Member States following its inclusion in Annex I to Directive 91/414/EEC, and which must be implemented by 30 June 2007; and order the Commission to pay the costs. II

16 ORDER OF CASE T-31/07 R 44 The Commission contends that the application for interim measures should be declared inadmissible or unfounded, and that the applicants should be ordered to pay the costs. Law 45 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. 46 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. Those conditions are cumulative, so that an application for interim measures must be dismissed if any one of them is absent (order of the President of the Court in Case C-268/96 P(R) SCK and FNK v Commission [1996] ECR I-4971, paragraph 30). Where appropriate, the judge hearing such an application must also weigh up the interests involved (order of the President of the Court in Case C-445/00 R Austria v Council [2001] ECR I-1461, paragraph 73). 47 Furthermore, in the context of that overall examination, the judge hearing the application enjoys a broad 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 of the President of the Court in Case II

17 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION C-149/95 P(R) Commission v Atlantic Container Line and Others [1995] ECR I-2165, paragraph 23, and Case C-364/98 P(R) Emesa Sugar v Commission [1998] ECR I-8815, paragraph 44). Arguments of the parties Admissibility 48 According to the Commission, the application for interim measures is inadmissible. 49 The Commission contends in this regard that the main action to which the application for interim relief relates is inadmissible, since, first of all, the applicants are seeking annulment of an act of general scope, in the present case, a directive, while none of them is individually concerned by that measure, and secondly, the claims in the main action for annulment of the contested restrictions are inadmissible on the ground that those restrictions were designed to form a whole and are not separable from the remainder of the directive. 50 The Commission also submits that claims for a ruling from the President of the Court of First Instance ordering the Commission to take certain measures are inadmissible, on the ground that, first of all, the Court of First Instance does not have jurisdiction to issue directions in the context of annulment actions lodged under Article 230 EC, and secondly, such directions cannot have effect inasmuch as they seek to secure an amendment of legislation in force which the Commission is not empowered to adopt without the participation of the other parties to the legislative procedure, who could oppose it. II

18 ORDER OF CASE T-31/07 R 51 According to the applicants, on the other hand, both the main action and the application for interim measures are admissible. Prima facie case 52 The applicants submit that the contested directive is unlawful since, first, by introducing the contested restrictions on the basis of a hazard assessment of flusilazole and not on the basis of a risk assessment thereof, that directive is not consistent with Directive 91/414, under which any active substance has to be assessed on the basis of a risk assessment 53 According to the applicants, the effects of flusilazole on human health and the environment had been assessed in accordance with the applicable provisions. All available evidence relating to possible concerns about its inherent toxic effects including the risk of endocrine disruption was taken into account during the assessment process. During this process, the notifier showed that there were safe uses of flusilazole, and a favourable conclusion on the safety of flusilazole, subject to certain reservations, was adopted in the Commissions draft review report of June According to the applicants, mere concerns expressed by various Member States as to the hazardous properties of flusilazole do not justify either its prohibition after 30 June 2008 or the prior withdrawal by 30 June 2007 of all authorisations of the active substance for uses other than those authorised under the contested directive. II

19 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION 55 Secondly, the contested directive infringes the precautionary principle, the application of which should only be based on a risk assessment and not on a hazard assessment 56 Thirdly, the contested directive is in breach of the principle of proportionality in that (i) the Commission has never adopted such restrictions in similar cases, (ii) the contested directive prevents Member States from making any risk management decisions, in particular in relation to other uses for which flusilazole could be authorised, and (iii) other less restrictive measures could have been adopted. 57 Fourthly, the Commission infringed the principle of equal treatment, in that other active substances whose toxicity is more evident than flusilazole's have been included in Annex I to Directive 91/414 without any restriction. 58 Fifthly, in adopting the contested directive, the Commission was in breach of its duty of sound administration, the applicants' right to be heard, the principle of legal certainty, the principle of protection of legitimate expectations and its duty to state reasons. 59 Sixthly, the contested directive is vitiated by a manifest error of assessment since the contested restrictions are founded on undocumented concerns expressed by certain Member States. II

20 ORDER OF CASE T-31/07 R 60 Finally, the contested directive is the result of a misuse of powers. 61 According to the Commission on the other hand, the contested decision is lawful 62 The Commission states, at the outset, that it alone has the power to adopt a decision on the safety of flusilazole, after following the procedure provided for under Directive 91/414. That procedure, in the present case, revealed concerns as to the effects of flusilazole on the endocrine system. In exercising its discretion, the Commission could therefore decide to authorise the marketing of flusilazole only subject to certain restrictions. 63 Secondly, the contested restrictions address the Commission's concern to apply the precautionary principle, which may be the basis not only for risk assessment, but also for risk management. 64 Thirdly, the Court of First Instances jurisdiction in appraising an act such as the contested directive is limited, since the directive is the product of complex assessments relating to technical questions. 65 As to the arguments advanced by the applicants, the Commission replies that, first of all, in relation to the restriction on uses of flusilazole, it adopted similar restrictions in other cases where the substances assessed raised doubts as to their level of harm. In the present case, that restriction was justified by the risks of endocrine disturbance established by the Commission, which, on the basis of II

21 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION Articles 5(1) and 6(1) of Directive 91/414, decided to authorise only those uses which had actually been subject to scientific testing. 66 Secondly, in relation to the restriction on limiting the duration of the inclusion of flusilazole in Annex I to Directive 91/414 to 18 months, this is aimed at requiring Member States to deal with flusilazole as a matter of priority, given the specific dangers it poses. 67 Thirdly, in relation to the principle of sound administration, the Commission contends that this principle cannot be relied on independently of a breach of another right. 68 Fourthly, concerning the right to be heard, the applicants have not shown that they were prevented from raising arguments during the assessment procedure. 69 Fifthly, in relation to the principle of legal certainty, the applicants have not indicated how this principle has been infringed. 70 Sixthly, in relation to the principle of legitimate expectations, the Commission argues in essence that the applicants have not pointed to evidence on which their expectations are based. II

22 ORDER OF CASE T-31/07 R 71 Seventhly, as regards the principle of equal treatment, the Commission contends that every active substance must be assessed independently of other active substances and when an active substance is authorised, risk mitigation measures may be adopted. 72 Eighthly, concerning breach of the duty to state reasons, the Commission states that recitals 6 and 8 of the contested directive set out the reasons why it adopted the contested restrictions. 73 Ninthly, as regards the complaint criticising it of having made a manifest error of assessment, the Commission asserts that this has not been proved. 74 Finally, in relation to misuse of powers, the Commission argues that the applicants have not indicated what is the alleged unlawful objective pursued by the Commission. Urgency 75 The applicants consider that granting their request for interim relief is a matter of urgency in order to avoid their suffering serious and irreparable damage, which is not purely financial. They claim in particular that such damage will be, first of all, the irreparable loss of their market share on the European market for triazole fungicides, secondly, the closure of their industrial plant at Cernay, and thirdly, the damage which will be suffered by farmers using flusilazole and by European agriculture as a whole. II

23 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION 76 In relation to the first head of damage alleged by the applicants, relating to the irreparable loss of their market share in the European market for triazole fungicides, the applicants claim, in essence, that, first of all, the alleged damage is imminent given that the contested directive, which effectively bans the marketing of flusilazole, will, as from 30 June 2008, result in the loss of their business, whose current net value is estimated at around EUR 84 million, calculated on the basis of the applicants' possible revenues generated by the sale of flusilazole during the 2007 to 2017 period. 77 Secondly, according to the applicants, that damage is irreversible, since (i) they do not have any substitute products to replace flusilazole on the market for triazole fungicides and (ii) the applicants competitors on the market, in particular Bayer CropScience, BASF and Syngenta, will easily snatch their market shares. While the applicants' market share in fact only amounts to around [confidential], 1 those of Bayer CropScience, BASF and Syngenta amount, respectively, to [confidential]. Moreover, (iii) flusilazole's image will be damaged by the prohibition of its use, to which the contested directive will lead in due course, with the result that purchasers will no longer order it; (iv) the official technical consultants in the Member States will remove flusilazole from their advisory programmes and, as a result, it will be extremely difficult if not impossible to re-introduce it into those programmes after a period of absence; (v) the sensitivity shown by the applicants' customers and commercial partners to questions of public health will result in a loss of confidence in the product in question; and (vi) the applicants' image in the industrial sector will also be damaged. 78 In relation to the second head of damage claimed by the applicants, relating to the closure of the plant in Cernay, which is the plant in which the applicants concentrate all their production of flusilazole for the European market, the applicants argue in 1 confidential information omitted. II

24 ORDER OF CASE T-31/07 R essence that the closure of such a plant, of which [confidential] of production is for the European market, will result in (i) the loss of 40 jobs on the site itself, (ii) the loss of dozens of jobs in undertakings which deal with flusilazole, (iii) the fact that, were the factory to be reconverted, it would be impossible to revert to the original set-up if the Court were to annul the contested directive, (iv) serious consequences for the raw material suppliers, and (v) a considerable reduction in the level of investment in research and development. 79 As regards the third head of damage claimed by the applicants, relating to the damage which would be suffered by farmers who use flusilazole and by European agriculture generally, the applicants submit (i) that there is currently no technical solution other than flusilazole for treating wood diseases in grapes, (ii) that there is no registered product able to control phomopsis in sunflower, and finally, flusilazole is the only product able to treat diseases in linseed and flax. Furthermore, in other crops, the withdrawal of flusilazole would increase the cost of protecting crops against fungal diseases. The applicants calculate the damage which European farmers would suffer to be around EUR 90 million. 80 According to the Commission, the applicants have not shown the urgency of granting their application for interim relief. 81 The Commission sets out, at the outset, a number of considerations, stating, first of all, that the damage claimed by the applicants is financial, and thus cannot be considered to be irreparable. Secondly, the applicants have not provided documents from an independent source to prove their claims. Thirdly, the applicants should have produced evidence to prove the damage that each one of them risked suffering. Fourthly, given that it is not possible to ascertain the state of regulation of flusilazole after 30 June 2008, it is only appropriate to assess the possible impact on the II

25 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION applicants of an 18-month ban on the marketing of flusilazole, and not the possible impact of a total ban. Furthermore, since the period laid down in the contested decision extends until 30 June 2007 for running down stocks, its impact can only be assessed over the period from 30 June 2007 to 30 June Fifthly, the damage alleged by the applicants is not imminent. Sixthly, the applicants have not managed to prove that, after 30 June 2008, the authorisation of the marketing of flusilazole will not be able to be renewed. 82 As for the damage alleged by the applicants, the Commission submits, as regards the loss of the applicants' business, that the criterion for calculating the net current value of the business, which relates to the applicants' possible revenues from the sale of flusilazole during the 2007 to 2017 period, is flawed. First, it is based on the erroneous premiss that the inclusion of flusilazole will not be renewed after expiry of the 18 months provided for in the contested directive, it being impossible to foresee what regulation there will be at the end of that period. Secondly, the calculation takes into account damage which, essentially, will take effect a long time after the main proceedings are over. Thirdly, for each of the years from 2007 to 2017, the applicants deduct significant sums as expenses, which are between [confidential] and [confidential]. The Commission takes the view in this respect that, if flusilazole is not marketed, there cannot be any expenses arising from marketing, administration or distribution of flusilazole itself. 83 As regards the alleged loss of market share by the applicants in the market for triazole fungicides, the Commission submits, first of all, that such a loss presupposes that flusilazole's inclusion will not be renewed after expiry of the 18 months provided for in the contested directive, which cannot be proved. II

26 ORDER OF CASE T-31/07 R 84 Secondly, even if the marketing of flusilazole were to be completely banned after 30 June 2008, the applicants should have shown that because of this, they would be exposed to a situation liable to endanger their very existence or to restrict their market shares irreversibly. In particular, they should have established that structural or legal obstacles would prevent them from returning to the market if the contested directive were ultimately annulled by the Court. 85 Thirdly, as regards the applicants' arguments that (i) suppliers will make other arrangements and so will not come back to the applicants, and (ii) technical advisers will no longer include flusilazole in their advisory programmes, any such decision being irreversible, the Commission considers that neither assertion is supported by any facts. 86 Fourthly, as regards the possibility of replacing flusilazole, the Commission submits that (i) the fungicides tebuconazole and proquinazid, which are also marketed by the applicants, may be substituted for flusilazole and (ii) even if the applicants do not have their own substitute products, they can conclude commercial agreements to distribute products of other manufacturers. 87 Fifthly, regarding the applicants' arguments that they could not return to the market, even if the contested directive were annulled, because consumers will have concerns about public health, the Commission submits that (i) if the contested decision were to be annulled, the applicants could arrange an information campaign aimed at persuading customers to revert to their product, and (ii) they have not furnished evidence showing why it would be impossible in that case to convince them to buy flusilazole again. II

27 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION 88 Sixthly, the applicants do not advance, according to the Commission, any evidence that their competitors will take over their market shares and that such loss of market share will be irreversible. 89 As regards the closure of the Cernay industrial site, the Commission argues that the applicants (i) do not provide evidence that sales made outside the Community would not be sufficient to avoid closure of that site, and (ii) invoke damages which in reality would be suffered by third parties and which would therefore not be suffered directly by the applicants. 90 As regards the damage which would be inflicted on European agriculture, the Commission considers that this has not been proved to the requisite legal standard and does not constitute damage directly suffered by the applicants. 91 Finally, regarding the possibility that the alleged damage endangers the applicants' very existence, the Commission submits that (i) the parent company to which they belong is a large undertaking which recorded a turnover of USD 27.4 billion in 2006, (ii) the alleged loss of EUR 84 million equates to around 0.22% of the entire market capitalisation of the parent company alone, and (iii) the alleged loss represents only 0.108%, that is, around one thousandth, of the groups annual turnover. 92 In their final observations of 15 March 2007, the applicants reply to the Commission s arguments. II

28 ORDER OF CASE T-31/07 R 93 First of all, the applicants again assert that the contested directive effectively prohibits marketing of flusilazole from 30 June The possibility of an extension being purely hypothetical, urgency cannot be excluded, since an application for interim relief must be assessed according to the situation at the time when it is lodged. 94 In fact, after 30 June 2008 that is, after expiry of the 18 months provided for in the contested directive marketing of flusilazole will be prohibited under the contested directive. 95 In that regard, the applicants maintain, in essence, first, that, while the Commission asserts that the procedure for extending the period of inclusion of flusilazole in Annex I to Directive 91/414 could be very rapid, it does not provide any evidence showing that definitive assessment of flusilazole would be possible in a few months, when several years have hitherto not sufficed to conduct a proper assessment, and a request for extension must normally be lodged at least two years before expiry of the authorisation of the substance in question. Secondly, the Commission has not explained how the situation could change in the 18 months in which flusilazole may still be partially marketed for the authorised uses only. Thirdly, the Commissions argument that the application for interim relief is premature, which is based on the idea that the Commission may, in principle, take a decision amending its initial decision, would lead to the situation that such an application would in reality always be deemed to be premature and could not therefore be granted, thereby making the procedure for interim relief meaningless. Fourthly, any decision made after the 18- month period would be too late to avoid the negative effects of the contested restrictions. II

29 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION 96 As far as the loss of market share is concerned, the applicants set out certain preliminary considerations in order to show that, according to the case-law of the Court of Justice and the Court of First Instance, the condition of urgency which must be satisfied for provisional measures to be ordered does not require proof that there is a risk of the applicants disappearance. According to the applicants, in order to satisfy the condition of urgency, they need only show that they are threatened with losing their market shares irreversibly. 97 As regards the irreparable nature of the alleged damage, the applicants submit that, first of all, the two products referred to by the Commission cannot be deemed to be substitutable products, given that the applicants market tebuconazole on the basis of a licence which allows them only to market it in the United States, and proquinazid on the basis of a licence which permits them to market it solely for usage on crops or against diseases other than those for which flusilazole is marketed. Secondly, before the applicants can market a new substance, they require at least 10 years to carry out studies, research and the necessary administrative procedures for its development. Thirdly, the alternative solutions envisaged by the Commission, such as parallel imports, distribution contracts concluded with other producers and marketing of generic products, are not conceivable in practice, given that (i) it would not make economic sense for a competing producer to allow the applicants to survive in the market, (ii) parallel imports are only possible for limited volumes, which are not sufficient to cover the applicants' costs, and (iii) the applicants are not active in the market for generic products, and in any event, it would also take a number of years to develop a generic product. Fourthly, the withdrawal of the marketing authorisation of flusilazole would lead to irreversible changes in the market structure, since (i), as a number of distributors have testified, the fact that a product has had its authorisation withdrawn irreparably damages its image, and (ii) the effect of consumer inertia is that consumers would not change product again for another product which they had just stopped purchasing. II

30 ORDER OF CASE T-31/07 R 98 Finally, the withdrawal of flusilazoles marketing authorisation would lead to closure of the Cernay factory, of which [confidential] of its production is for the European market Production would in fact be discontinued for nine months, which would entail costs of [confidential], since a month of stoppage entails costs of [confidential]. In addition, the estimated increase in costs per kilo of flusilazole based products sold is [confidential], being the result of the increase in the cost of raw materials per kilo if volumes supplied were reduced. The fixed costs generated by the production of flusilazole in 2006, amounting to a total of [confidential], would have to be spread over the remaining volume of flusilazole, whose production costs would thus rise by [confidential] per litre of finished product. 99 At the hearing, the Commission replied that, in relation, first of all, to the effects of the contested directive, the applicants have not provided evidence that the directive would effectively prohibit marketing of flusilazole from 30 June 2008, and, even if a decision prohibiting marketing of flusilazole were to be adopted, the withdrawal of national authorisations would result from that decision and not from the contested directive, so that the damage alleged by the applicants is only hypothetical. 100 In relation, secondly, to the irreparable nature of the damage alleged by the applicants, the Commission states that the applicants' argument is contradictory in that it refers both to the unique nature of flusilazoles properties, in order to show that it cannot be replaced by other products, and to the existence of a number of substitute products, in order to show that consumers would not go back to flusilazole if the Court of First Instance annulled the contested directive. 101 As regards the seriousness of the alleged damage, the Commission considers that the applicants cannot merely claim that they would lose market share, but that they II

31 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION must also show that such loss would cause them serious damage having regard to the size of the group to which its shareholders belong. The balance of interests 102 The applicants submit that the balance of interests is in their favour because, first, the interim measures applied for are only aimed at preserving the current situation, and secondly, flusilazole is essential to Community farmers and allows them to compete with other farmers in the world. 103 At the hearing, the applicants also asked that the damage likely to be caused to workers, companies dependent on the production of flusilazole, farmers using this active substance and European agriculture in general which they allege in their application for interim relief be assessed in the balance of interests. 104 According to the Commission, the balance of interests is in favour of rejecting the application for interim relief, because, first, the contested restrictions were designed to form a whole and cannot be separated from the rest of the contested directive without compromising the aim of the rules, which is to protect public health, and secondly, if the contested restrictions were suspended, the protection of health and the environment would be weakened. II

32 Appraisal of the President of the Court ORDER OF CASE T-31/07 R Admissibility 105 It should be borne in mind that the first paragraph of Article 104(1) of the Rules of Procedure of the Court of First Instance provides that any application to suspend the operation of any measure adopted by an institution, made pursuant to Article 242 EC, is to be admissible only if the applicant is challenging that measure in proceedings before the Court of First Instance. 106 It is clear from established case-law that, while the question of the admissibility of the main action should not, in principle, be examined in the context of proceedings for interim relief, so as not to prejudge the merits of the case, it may nevertheless be necessary, in order for an application to suspend the operation of a measure to be declared admissible, for the applicant to prove the existence of certain matters permitting the conclusion that, prima facie, the main action to which his application for interim relief relates is admissible, so as to prevent him from obtaining, by way of proceedings for interim relief, the suspension of the operation of a measure which the Court of First Instance may subsequently refuse to annul, his main action having been ruled inadmissible (order in Case C-329/99 P(R) Pfizer Animal Health v Council [1999] ECR I-8343, paragraph 89, order in Case T-37/04 R Região autónoma dos Açores v Council [2004] ECR II-2153, paragraph 108). 107 Such an examination of the admissibility of the main action is necessarily summary because the proceedings for interim relief are by nature urgent (orders in Case C-300/00 P(R) Federación de Cofradías de Pescadores and Others v Council [2000] ECR I-8797, paragraph 35, and in Região autónoma dos Açores v Council, cited in paragraph 106 above, paragraph 109). II

33 DU PONT DE NEMOURS (FRANCE) AND OTHERS v COMMISSION 108 Indeed, in the context of proceedings for interim relief, the admissibility of the main action can only be assessed on a prima facie basis, the aim being to examine whether the applicant has adduced sufficient elements which justify the a priori conclusion that the admissibility of the main action cannot be excluded. The judge hearing the interim measures action should declare that action inadmissible only where the admissibility of the main action can be wholly excluded. Otherwise, to rule on admissibility at the stage of the proceedings for interim relief, when admissibility is not, prima facie, wholly excluded, would in effect prejudge the Court of First Instances decision in the main action (orders in Case T-342/00 R Petrolessence and SG2R v Commission [2001] ECR II-67, paragraph 17; Joined Cases T-195/01 R and T-207/01 R Government of Gibraltar v Commission [2001] ECR II-3915, paragraph 47; and Região autónoma dos Açores v Council, cited in paragraph 106 above, paragraph 110). 109 In the present case, the applicants attach their application for interim relief to an annulment action, the admissibility of which is contested by the Commission. 110 Accordingly, it must be ascertained whether the evidence provided by the applicants permits the conclusion, prima facie, that the main action is not manifestly inadmissible. 111 The Commission disputes that the applicants are individually concerned by the contested directive. 112 In that regard, it must be pointed out that, at the hearing, the applicants produced a document from which it is apparent that Du Pont de Nemours (France) SA, which was mentioned in Regulation No 933/94 in its capacity as notifier, has since changed its company name, and it is now operating under the name of Du Pont de Nemours (France) SAS. The first applicant, consequently, must be regarded as the notifier. It has also participated in the assessment procedure and on that basis benefited from II

34 ORDER OF CASE T-31/07 R procedural guarantees. In those circumstances, it cannot be excluded, at first sight, that the contested directive affects the first applicant individually and that the main action which it lodged is admissible (see, to that effect, Case T-13/99 Pfizer Animal Health v Council [2002] ECR II-3305, paragraphs 99 to 105, and Case T-70/99 Alpharma v Council [2002] ECR II-3495, paragraphs 91 to 96). 113 Moreover, according to settled case-law, 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, to that effect Case C-313/90 CIRFS and Others v Commission [1993] ECR I-1125, paragraph 31; Joined Cases T-127/99, T-129/99 and T-148/99 Diputación Foral de Álava and Others v Commission [2002] ECR II-1275, paragraph 52; and Case T-374/00 Verband der freien Rohrwerke and Others v Commission [2003] ECR II-2275, paragraph 57). 114 As regards the admissibility of the claims in the main proceedings for partial annulment of the contested directive, it must be borne in mind that it is settled caselaw that partial annulment of a Community act is possible only if the elements whose annulment is sought may be severed from the remainder of the act. The Court has repeatedly ruled that that requirement of severability is not satisfied where the partial annulment of an act would have the effect of altering its substance (Case C-36/04 Spain v Council [2006] ECR I-2981, paragraphs 12 and 13; see also, to that effect, Joined Cases C-68/94 and C-30/95 France and Others v Commission [1998] ECR I-1375, paragraph 257). 115 It suffices to point out that the Commission does no more than contend that the contested restrictions are not separable from the rest of the contested directive, II