62007TO0031_EN
Parties
Grounds
Operative part
Parties
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),
DuPont CZ s.r.o.,
established in Prague (Czech Republic),
DuPont Magyarország Kereskedelmi kft,
established in Budaors (Hungary),
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. Rampal, lawyers,
applicants,
v
Commission of the European Communities,
represented by L. Parpala and B. Doherty, acting as Agents,
defendant,
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
Grounds
Legal context
1. Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230 p.1) 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’.
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 91/414.
6. 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).
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.
10. Article 5(1) of Directive 91/414 provides that:
‘1. 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).’
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.
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.
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 2007.
…’
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 2007. 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 13.
2. 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.
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 1993.
22. 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 91/414.
24. 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.
27. The Committee’s 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 2001.
28. 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 91/414.
30. 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.
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 91/414.
33. 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.
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 2007.
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 re-evaluation, 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.
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 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 II‑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.
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 Commission’s draft review report of June 2004.
54. 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.
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.
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 Instance’s 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 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.
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.
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 applicant’s 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 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 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 2008. 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.
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.
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 group’s annual turnover.
92. In their final observations of 15 March 2007, the applicants reply to the Commission’s arguments.
93. First of all, the applicants again assert that the contested directive effectively prohibits marketing of flusilazole from 30 June 2008. 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 Commission’s 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.
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 applicant’s 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.
98. Finally, the withdrawal of flusilazole’s 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 flusilazole’s 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 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.
Appraisal of the President of the Court
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, paragraph 106 above, paragraph 109).
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 Instance’s 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, 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 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 case-law 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, without however providing evidence permitting the conclusion that, at first sight, the partial annulment applied for would have the effect of altering its substance.
116. In the present case, the applicants submit that the purpose of their application is not to secure annulment of the contested directive, which is a directive adopted with a view to including flusilazole in Annex I to Directive 91/414, but to secure inclusion of that substance without the contested restrictions, which they consider to be scientifically unjustified and unlawful.
117. 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 conclusion, prima facie, that the admissibility of the main action cannot be excluded. The judge hearing the interim measures action should thus declare that action inadmissible only where the admissibility of the main action can be wholly excluded.
118. However, the Commission’s claims do not allow the judge hearing the application for interim relief to reach a conclusion on whether or not the contested provisions are separable from other provisions of the contested directive, and the admissibility of the claims in the main proceedings cannot therefore, prima facie, be excluded.
119. It must also be borne in mind that the Court of Justice has also held that the question whether partial annulment would alter the substance of the contested measure is an objective criterion, and not a subjective criterion linked to the policy pursued by the authority which adopted the measure at issue (see, to that effect, Case C-239/01 Germany
v Commission
[2003] ECR I‑10333, paragraph 37).
120. The Commission’s policy objective in adopting a directive including flusilazole in Annex I to Directive 91/414, but attaching a number of restrictions to that inclusion, cannot therefore be taken into account for the purposes of determining whether partial annulment of the contested directive would alter the substance of the contested measure.
121. In addition, it must be noted that, in any event, flusilazole was an authorised substance prior to 30 June 2007. The effect of the contested directive is to authorise the substance for a certain period subject to certain restrictions on use. However, if the applicants could seek only annulment of the measure in full, as the Commission implies, and not only annulment of the contested restrictions, such an action would lead to flusilazole’s prohibition, as the applicants would no longer benefit from its inclusion in Annex I to Directive 91/414. Such an action would evidently have no practical advantage for them.
122. Accordingly, if the Commission’s argument were upheld, the applicants could seek neither annulment of the measure in full, nor its partial annulment, and could not, therefore, protect themselves against any serious and irreparable damage resulting from the contested directive. The Commission’s argument cannot therefore succeed at this stage.
123. In the light of the foregoing, it must be held that, prima facie, there are no grounds for concluding, in the present case, that the admissibility of the main action is clearly excluded.
124. In relation to the admissibility of the application for interim relief, which the Commission contests on the ground that the application seeks to secure an order from the President of the Court of First Instance giving directions to the Commission, it should be pointed out that what the applicants are actually seeking to secure by their application for interim relief is the suspension of enforcement of certain provisions of the contested directive.
125. In any event, the applicants do not base their application for interim relief only on Article 242 EC, but also on Article 243 EC.
126. On the basis of Article 243 EC, the judge hearing the application for interim relief may prescribe any necessary interim measures. In particular, he may issue, on a provisional basis, appropriate directions to the Commission (see, to that effect, the order in Case 118/83 R Muratori
v Commission
[1983] ECR 2583, paragraph 53).
127. It must therefore be held that, on the basis of the evidence submitted by the parties, the application for interim measures is admissible.
Prima facie case
128. It must be noted that at least some of the pleas relied on by the applicants appear, at first sight, to be relevant and, in any event, not entirely unfounded. This is the case, in particular, for the first and second pleas.
129. Those two pleas advanced by the applicants rely on a common argument based, in essence, on the distinction between the concept of risk, on the one hand, and that of hazard, on the other.
130. The Court of First Instance has already had occasion to hold, in a similar sector also falling within the common agricultural policy within the meaning of Article 37 EC, that ‘risk’ constitutes a function of the probability that use of a product or a procedure will adversely affect the interests safeguarded by the legal order. ‘Hazard’ (‘danger’) is commonly used in a broader sense and describes any product or procedure capable of having an adverse effect on human health ( Pfizer Animal Health
v Council, paragraph 112 above, paragraph 147).
131. The Court went on to state that the purpose of a risk assessment is to assess the degree of probability of a certain product or procedure having adverse effects on human health and the seriousness of those potential effects (see, to that, effect, Pfizer Animal Health
v Council, paragraph 112 above, paragraph 148).
132. By their first plea, the applicants argue that the assessment procedure established by Directive 91/414, as set out in Article 5 thereof, is based on a risk assessment. They state that none of the plant protection products falling within the rules at issue have dangerous properties and the objective of the legislation in question is to manage the risk inherent in the marketing of such products.
133. As the applicants submit, under Article 5 of Directive 91/414, inclusion of an active substance in Annex I to that directive is excluded unless, in the light of current scientific and technical knowledge, it may be expected that a plant protection product containing the active substance will be safe. In other words, even if a substance is hazardous, it may still, at first sight, be included in Annex I to Directive 91/414, provided that it meets a standard of risk that is legally acceptable when the appropriate instructions on use are followed.
134. The Commission does not appear to contest the fact that Directive 91/414 requires an evaluation of the risks connected with the substances whose marketing has to be authorised. It in fact submits that the contested directive, which is based on Directive 91/414, is based on an assessment of the risks which come to light following the scientific tests carried out during the analysis of flusilazole.
135. In addition, by their second plea, the applicants argue that the precautionary principle, relied in the present case by the Commission itself, is also based on an assessment of risk and not on an assessment of hazards.
136. In particular, the applicants rely on the case-law of the Court of First Instance that the precautionary principle can apply only in situations in which there is a risk, notably to human health, which, although it is not founded on mere hypotheses that have not been scientifically confirmed, has not yet been fully demonstrated ( Pfizer Animal Health v Council, paragraph 112 above, paragraph 146).
137. In this regard, as the Commission correctly states, it must be borne in mind that the Court of Justice has already held that, where a Community authority is called upon, in the performance of its duties, to make complex assessments, it enjoys a wide measure of discretion, the exercise of which is subject to a limited judicial review in the course of which the Community judicature may not substitute its assessment of the facts for the assessment made by the authority concerned. Thus, in such cases, the Community judicature must restrict itself to examining the accuracy of the findings of fact and law made by the authority concerned and to verifying, in particular, that the action taken by that authority is not vitiated by a manifest error or a misuse of powers and that it did not clearly exceed the bounds of its discretion (order of the President of the Court in Case C-471/00 P(R) Commission
v Cambridge Healthcare Supplies
[2001] ECR I‑2865, paragraph 96).
138. It follows from the foregoing that, in order to reply to the two pleas in question, the Court may have to rule on whether the Commission exceeded its discretion in adopting the contested directive.
139. In that regard, the applicants state that the Commission had concluded, initially, on the basis of a series of scientific studies provided by the notifier at the request of the Commission itself, that flusilazole was safe and could be included in Annex I to Directive 91/414 for a period of 10 years, even if that inclusion had to be coupled with certain restrictions. It was only after the Committee had examined the Commission’s initial draft that the latter was amended, on several occasions, until it was finally adopted by the Commission. The Commission based its reasons for those amendments on the risks inherent in endocrine disturbance potentially attributable to flusilazole.
140. However, as the applicants submit, such reasoning appears, at first sight, to cast doubt on the risk assessment previously conducted.
141. Furthermore, the doubts cast on the results of the Commission’s assessment report and the various supplementary studies seem, at first sight, to be due only to the concerns that were expressed by certain Member States within the Committee, as is apparent from recital 7 of the contested directive, and the reasons why the Commission considered that those concerns should take precedence over the evidence which it had gathered over a number of years of assessment are not clearly stated.
142. In the light of the foregoing, if the Commission did in fact err in basing the contested directive on an assessment of hazards and thereby infringed both Directive 91/414 and the precautionary principle, the possibility that such error could affect the lawfulness of the contested directive cannot be excluded.
143. It follows that the applicants’ two pleas – alleging, essentially, breach of Directive 91/414, in that the contested directive is not based on a risk assessment, and breach of the precautionary principle, pleas which, because of their complexity, require an in-depth examination which cannot be conducted by the judge hearing the application for interim relief – cannot, at first sight, be considered to be wholly unfounded. Since the requirement for a prima facie case has been satisfied, it is clear that the President of the Court of First Instance is justified in examining the other conditions for granting interim measures.
Urgency
144. According to settled case-law, the urgency of an application for interim relief must be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable damage to the party seeking the relief (see the order in Pfizer Animal Health
v Council, paragraph 106 above, paragraph 94, and the case-law cited). Where damage depends on the occurrence of a number of factors, it is enough for that damage to be foreseeable with a sufficient degree of probability (order of the President of the Court of First Instance in Case T-369/03 R Arizona Chemical and Others v Commission
[2004] ECR II-205, paragraph 71; see also, to that effect, the orders of the Court of Justice in Case C-280/93 R Germany
v Council
[1993] ECR I-3667, paragraphs 32 to 34, and of the President of the Court of Justice of 14 December 1999 in Case C-335/99 P(R) HFB and Others
v Commission
[1999] ECR I-8705, paragraph 67).
145. However, the applicant is still required to prove the facts which are deemed to show the probability of serious and irreparable damage ( Arizona Chemical and Others v Commission, paragraph 144 above, paragraph 72; see also, to that effect, HFB and Others
v Commission, paragraph 144 above, paragraph 67).
146. In the present case, the applicants invoke damage on three heads, comprising, first, loss of market share in the market in question, secondly, the closure of the Cernay industrial site, and thirdly, the damage that would be caused to farmers using flusilazole and to European agriculture as a whole.
147. It must be borne in mind, at the outset, that the serious and irreparable damage alleged, which the application for interim relief seeks to avoid, can be taken into account by the judge hearing the application for relief, in the context of his examination of the urgency requirement, only to the extent that it is likely to be caused to the interests of the party seeking the relief. It follows that the damage which enforcement of the contested measure is likely to cause to a party other than that seeking relief can only be taken into consideration, if appropriate, by the judge hearing the application, when weighing up the interests before him (order of the President of the Court of First Instance of 2 August 2006 in Case T-69/06 R Aughinish Alumina
v Commission, not published in the ECR, paragraph 80; see also, to that effect, orders of the President of the Court of First Instance in Case T‑13/99 R Pfizer Animal Health
v Council  [1999] ECR II‑1961, paragraph 136, and of 1 February 2006 in Case T‑417/05 R Endesa
v Commission, not published in the ECR, paragraph 64).
148. Therefore, the arguments advanced by the applicant to prove the existence of the third head of damage likely to be caused to farmers using flusilazole and to European agriculture in general will be taken into account only when the various interests are weighed up.
149. Therefore, it is necessary to examine the alleged damage comprising closure of the Cernay industrial site and the applicant’s loss of market share in the markets concerned.
150. In that regard, it is appropriate to reject, at the outset, the Commission’s arguments which, first, maintain that the applicants’ interpretation of the provisions of the contested directive to the effect that flusilazole will be banned after 30 June 2008 is flawed, second, contest the imminence of the alleged damage because it cannot be ascertained at the present time whether flusilazole will be completely banned after 30 June 2008 on the ground that the Commission may propose an amendment of the legislation in force, third, contend that any damage will only become apparent after judgment in the main proceedings has been delivered, and finally, argue that the scope of the damage should be assessed only according to its effects between 30 June 2007 and 30 June 2008.
151. In fact, as the applicants correctly submit, in the legislation’s present form, flusilazole will be partially banned from 30 June 2007 and completely banned from 30 June 2008. It is in the light of this ban that the judge hearing the application for interim relief has to make his ruling and not in the light of a hypothetical amendment of the legislation which might be proposed by the Commission. The damage relied on is in fact imminent to the extent that, after 30 June 2007, the applicants will be unable to run down their stocks for use on crops other than those set out in the contested directive, and the damage will start to be felt from 1 July 2007, well before any judgment is delivered in the main proceedings.
152. It must be added, for the sake of completeness, that the applicants’ arguments as to the practical impossibility of amending the legislation in force before 30 June 2008 given the need to lodge a request for renewal within two years of the expiry of flusilazole’s inclusion in Annex I to Directive 91/414, which the timeframes laid down in the contested directive would make impossible, cannot be dismissed at first sight.
153. The Commission’s explanations in this regard, relating to the scope of Article 5(5) of Directive 91/414, to the effect that there is a distinction between the legal situation governed by the first sentence of that provision and that governed by the second sentence thereof, and that the two-year period does not apply in the present case, appear at the very least to be cryptic and lacking conviction.
154. The Commission maintains, in essence, first, that, as is confirmed by recital 11 of the contested directive, there is nothing to prevent a request for renewal from being introduced by the applicants or by any other interested party. Second, it argues that the first sentence of Article 5(5) of Directive 91/414 introduces a general power to renew entries and ends with the possibility for national authorities to revise such entries if there are, inter alia, safety problems, while the second sentence supplements that provision and is directed at the specific case of substances which are subject to review and whose inclusion may expire before such review has been completed. According to the Commission, since review of an active substance must be carried out on the initiative of the public authorities and not of a player in the market, the review, and therefore the second sentence of Article 5(5) of Directive 91/414, does not apply in the case of a request for renewal of an entry.
155. It seems at first sight, however, that the request referred to in the first sentence of Article 5(5) of Directive 91/414 cannot be distinguished from the application mentioned in the second sentence thereof. The possibility of a review in fact seems to be inherent in a request for renewal for the purposes of the procedural rules laid down in Article 6 of the directive. The second paragraph of Article 6(4) of Directive 91/414 in fact seems at first sight to provide that those rules are to apply to requests for renewal falling within Article 5(5) of the directive.
156. Accordingly, it seems at first sight that the two-year period referred to in Article 5(5) of Directive 91/414 is applicable in the case of a renewal of an entry such as the one in question in the present case.
157. It must be borne in mind that that timeframe of at least two years for submitting a request for renewal cannot be adhered to in the present case, having regard, on the one hand, to the date of entry into force of the contested directive, that is 1 January 2007, and, on the other, the date laid down in the contested directive for the expiry of flusilazole’s inclusion in Annex I to Directive 91/414, that is, 30 June 2008.
158. It must also be pointed out that the first subparagraph of Article 3(2) of the contested directive provides that for each authorised plant protection product containing flusilazole, Member States are to re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414, 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.
159. However, it must be borne in mind that re-evaluation will, at first sight, only be for products authorised by Directive 91/414.
160. Re-evaluation cannot therefore, at first sight, lead to any expansion of the list of authorised uses under Directive 91/414, contrary to what the Commission implies, but could, on the other hand, result in new restrictions or a total ban on flusilazole-based plant protection products.
161. This brief examination of the current legal context cannot therefore, at first sight, lead to exclusion of the substance of the applicants’ arguments, and therefore, rule out the imminence of the damage which threatens them.
Closure of the Cernay industrial site
162. The applicants claim that the adoption of the contested directive, inasmuch as it effectively prohibits them from marketing flusilazole, will cause the Cernay industrial site to be closed.
163. The applicants submit in this regard that they have three industrial sites in Europe, including one located at Cernay. Cernay is the only site where the applicants produce flusilazole. [Confidential] of the production of flusilazole at the Cernay site is for sale within the Community.
164. It must be pointed out, however, that it is apparent from the applicants’ written pleadings that other substances appear to be produced at the Cernay site. A loss of [confidential] of production certainly cannot be deemed to be small-scale, even if, as the Commission submits, other markets outside the Community are open to the applicants. However, the applicants have not provided any evidence enabling the impact of such a loss on the totality of production at the site in question to be measured, but have merely supplied evidence concerning the business connected with the production of flusilazole.
165. In those circumstances, it must be concluded that the applicants have not proven to the requisite legal standard that the loss of [confidential] of production of flusilazole at the Cernay site will lead to its closure as a result of the ban on marketing flusilazole to which the contested directive will lead.
166. Even if the applicants managed to prove that the adoption of the contested directive would lead to closure of the Cernay industrial site, they have not provided evidence that such closure would cause them serious and irreparable damage.
167. In fact, the applicants contend that the closure of the Cernay industrial site will result in, first, the loss of 40 jobs on the site itself, second, the loss of dozens of jobs in undertakings dealing with flusilazole, third, were the factory to be reconverted, the impossibility of reverting to the original set-up if the Court were to annul the contested directive, fourth, serious consequences for raw material suppliers, and fifth, a considerable reduction in the level of investment in research and development.
168. However, in the light of the case-law referred to in paragraph 147 above, it must be pointed out that, first, the loss of 40 jobs at the Cernay site itself, second, the loss of dozens of jobs in undertakings dealing with flusilazole, and third, the serious consequences for raw material suppliers, do not constitute damage caused to the applicants’ interests and consequently can only be taken into account in the context of weighing up the relevant interests.
169. It must be borne in mind, however, that if those difficulties irremediably damaged the applicants’ production or the production cycle of flusilazole, they could still be taken into account in the examination of the urgency requirement.
170. It is not sufficiently clear, however, from the applicants’ written pleadings that this is the case here. They in fact only claim, in essence, that there would be an increase in costs if the Cernay plant had to limit its production of flusilazole for export to non-member countries, but not that it would be technically impossible to restart production of this substance in the event that a judgment upheld their application in the main proceedings.
171. It is therefore not appropriate to have regard to this in the context of the assessment of urgency.
172. In addition, the applicants have not provided any evidence to their claims relating to the significant reduction in the level of research and development investment or the fact that it would be impossible to reconvert the Cernay factory subsequently if the Court of First Instance were to annul the contested directive.
173. It follows that the applicants have not succeeded in establishing that the possible closure of the site at Cernay would cause them serious and irreparable damage.
The damage arising from the alleged loss of market share
174. It is clear from well-established case-law that damage of a purely pecuniary nature cannot, save in exceptional circumstances, be regarded as irreparable or even as being reparable only with difficulty, if it can ultimately be the subject of financial compensation (order of the President of the Third Chamber of the Court of Justice in Case 141/84 R De Compte
v Parliament
[1984] ECR 2575, paragraph 4, order of the President of the Court of First Instance in Case T-392/02 R Solvay Pharmaceuticals
v Council
[2003] ECR II-1825, paragraph 106; see also, to that effect, order in Commission
v Cambridge Healthcare Supplies, paragraph 137 above, paragraph 113).
175. Under that principle, the suspension sought could be justified only if it appeared that, if the measure were not granted, the applicant would be placed in a situation which would endanger its very existence or irremediably affect its market share (see, to that effect, orders in Pfizer Animal Health
v Council, paragraph 112 above, paragraph 138, and Solvay Pharmaceuticals
v Council, paragraph 173 above, paragraph 107).
176. In the present case, the applicants do not claim that the contested directive will endanger their very existence. However, they submit that the contested directive will irremediably affect their market shares.
177. It must therefore be ascertained, in accordance with established case-law, whether the loss of market share alleged by the applicants has been established to the requisite legal standard and whether such loss is shown to be irreversible.
178. It must be pointed out that the Commission does not dispute the fact that the contested directive will have the effect of preventing the applicant from marketing flusilazole from 30 June 2007, for crops other than those set out in that directive, and from 30 June 2008, for all crops, unless, in the meantime, an amendment to the legislation in force is adopted.
179. In relation to the irreversible nature of the loss of market share by the applicants on the European market for triazole fungicides, the applicants submit that, first of all, they do not have substitute products to replace flusilazole on the market for triazole fungicides.
180. It must be pointed out in that regard that the applicants have provided sufficient evidence that the two substitute substances referred to by the Commission cannot reasonably be considered to be an alternative to flusilazole on the European market for triazole fungicides. It is in fact apparent (i) that tebuconazole is a substance [confidential] for the purposes of combating soya rust fungus, and (ii) that proquinazid is designed to combat a different type of disease and is not or is not yet authorised in the majority of the Member States. It must therefore be considered that the applicants are correct in submitting that flusilazole is the only substance in the range of their products belonging to the group of triazole fungicides, and that they do not produce any substitute fungicide able to replace flusilazole which could be used on the crops or for the diseases currently treated with that substance.
181. Furthermore, it is not reasonable, as the Commission submits, to expect the applicants to conclude commercial agreements to distribute the products of other producers, which would result in their having to depend on the will of their competitors to avoid losing market share.
182. Secondly, the competitive situation, as described by the applicants and which the Commission does not seriously dispute, shows a high degree of competition between the various undertakings present in that market and it cannot be excluded, with a sufficiently high degree of probability, that the applicants’ competitors, in particular Bayer CropScience, BASF and Syngenta, will take up their market shares.
183. The applicants in fact have a market share of around [confidential], while the market shares of BASF, Bayer CropScience and Syngenta amount to [confidential], [confidential] and [confidential] respectively.
184. However, as the evidence advanced by the applicants shows, even if flusilazole satisfies a precise technical need and has a significant market share for certain crops or in certain countries, it is not disputed that a number of triazole products sold by those three undertakings compete with it directly in those sectors and could provide an immediate substitute.
185. It must therefore be held that the applicants are correct in maintaining that they are exposed to a very high risk that they will lose their market shares following the entry into force of the contested restrictions.
186. In addition, first, as the letters from the applicants’ distributors annexed by the applicants to their written pleadings show, it is likely that the ban on the applicants’ products will damage flusilazole’s image, since, in particular, there are other competing products on the market and it cannot be excluded that this could very probably result in loss of interest on the part of buyers.
187. Secondly, as the letters of the applicants’ distributors also show, the official technical consultants in the Member States will inevitably remove flusilazole from their advisory programmes, given that flusilazole will be prohibited, and it is therefore likely that it will be very difficult to re-introduce it into those programmes after a period of absence.
188. Thirdly, it is apparent, as is clear from the letters and report of dmrkynetec Ltd, also annexed by the applicants to their written pleadings, that the sensitivity of the end-users of the products, that is farmers, customers and the applicants’ commercial partners, to questions of public health will result in their loss of confidence in flusilazole. It must therefore be considered that the applicants’ claims that it will be extremely difficult to re-build that confidence after a period of prohibition of flusilazole – the duration of which may well be for several years – are sufficiently probable.
189. Fourth, it cannot be excluded that the applicants’ image in the industrial sector in question, which is characterised by intense competition between a small number of large undertakings, will also be damaged.
190. It must indeed be noted in this regard, as the Commission correctly contends, that if the Court of First instance were to annul the contested directive, the applicants could arrange a press and publicity campaign to regain their lost market shares.
191. Nevertheless, conducting a publicity campaign possibly several years after flusilazole has disappeared does not offer the applicants any guarantee that they will be able to recover, even partially, the lost market shares, as is shown by the report of dmrkynetec Ltd produced by the applicants.
192. It must be stated in this regard that, contrary to what the Commission asserts, the absence of any public health problem resulting from the use of flusilazole since it was put on the market, is not in itself capable, in the course of such a campaign, of reversing the very negative effect which a measure prohibiting this active substance is likely to have.
193. It is also settled case-law that if the implementation of a measure whose annulment is sought in the main action may cause irreversible market developments on a market on which the applicant is already present, the losses which would thereby ensue for the applicant, though financial in nature, may nevertheless exceptionally be regarded as irreparable for the purposes of granting interim relief (see the order of the Court of First Instance in Case T-139/91 R Comafrica and Dole Fresh Fruit Europe v Commission
[2001] ECR II-2415, paragraph 94 and the case-law cited).
194. In the present case, the market in question would probably experience irreversible changes.
195. In those circumstances, it cannot be excluded that at least a part of the damage which would be suffered by the applicants in the light of the loss of their market shares may be irreversible.
196. As regards the gravity of the damage arising from a loss of market share, it should be pointed out that, where the applicant is an undertaking, the gravity of material damage should be assessed in the light of, in particular, the size of that undertaking (order of the president of the Court of First Instance in T-195/05 R Deloitte Business Advisory
v Commission [2005] ECR II-3485, paragraph 156; see, to that effect, order of the President of the Court of Justice in Cases C-51/90 R and C-59/90 R Comos Tank and Others
v Commission
[1990] ECR I-2167, paragraphs 26 and 31, and in Case T-201/04 R Microsoft
v Commission
[2004] ECR II-4463, paragraph 257). In addition, for the purposes of assessing the economic circumstances of an applicant, consideration may be given, in particular, to the characteristics of the group to which it belongs by virtue of its shareholding structure ( Solvay Pharmaceuticals
v Council, paragraph 174 above, paragraph 108; see also, to that effect, orders of the President of the Court of Justice in Case C-12/95 P Transacciones Marítimas and Others
v Commission
[1995] ECR I-467, paragraph 12, and in Case C-43/98 P(R) Camar
v Commission and Council [1998] ECR I-1815, paragraph 36).
197. In the present case, the Commission contends that the loss of market shares that the applicants would suffer would in any event only have a very limited impact on their turnover, having regard to the group to which they belong. The Commission advances in this respect a number of arguments to show that the financial loss w hich this group could suffer would in no way endanger its existence.
198. It must be borne in mind in this regard that the applicants do not submit that their existence would be endangered by the contested directive. They assert, rather, that loss of market share alone, if proved, constitutes serious and irreparable damage according to the case-law, and that it is therefore not appropriate to examine the extent to which the loss of market shares is likely to damage the group to which they belong.
199. It should be recalled that the interim relief sought could be justified only if it appeared that, if the measure were not granted, the applicants would be placed in a situation which would endanger their very existence or irremediably affect their market shares (order in Pfizer Animal Health
v Council, paragraph 146 above, paragraph 138, and Solvay Pharmaceuticals
v Council, paragraph 174 above, paragraph 107).
200. It is therefore not necessary for the applicants to show that their existence is endangered where they invoke the risk of a loss of market share.
201. The applicants must show, however, that the damage which they allege will occur constitutes serious damage.
202. Admittedly, in the present case, the financial impact of the loss of the applicants’ business connected to the marketing of flusilazole cannot be considered to be such as to endanger the existence of the very group to which they belong. However, an assessment of the gravity of the irreversible loss of market share cannot be based, as the Commission maintains, only on the accounting value of the business which generates the market shares and on the loss of such value to the group.
203. Indeed, it should be recalled that, when considering the characteristics of the group, it is necessary to assess all the factual circumstances of the case (see, to that effect, Aughinish Alumina v Commission, paragraph 147 above, paragraphs 69 to 78).
204. Furthermore, the judge hearing an application for interim relief must determine in the light of the circumstances of the individual case whether immediate implementation of the measure which is the subject of the application for suspension of operation may cause the applicant serious and immediate damage which no subsequent decision could repair (orders of the President of the Court of First Instance in Case T-306/01 R Yusuf and Al Barakaat International Foundation v Council and Commission
[2002] ECR II‑2387, paragraph 93, and in Case T-47/03 R Sison
v Council
[2003] ECR II‑2047, paragraph 30).
205. It must be pointed out, in the present case, that the applicants have been on the market for over 20 years and benefit from authorisations to put on the market flusilazole-based plant protection products registered for use on 26 types of crops in 15 Member States. Furthermore, it is not disputed that the other products marketed by the applicants enjoy a reputation on the market which could be significantly damaged by a total ban on flusilazole from 30 June 2008. The loss of the applicants’ market shares, which were built up owing to their know-how, investment in research and development, and by building up a customer base over a number of years on a market characterised by fierce competition, must, in the light of these circumstances, be considered to be likely to cause it serious damage. The fact that such a loss only has limited impact on the group’s turnover is not sufficient to discount the seriousness of the damage in the circumstances of the present case.
The balance of interests
206. When, in the context of an application for interim measures in which it is submitted that the applicant is at risk of suffering serious and irreparable damage, the judge hearing the application weighs up the various interests at issue, he must determine whether the possible annulment of the contested decision by the court giving judgment in the main action would make it possible to reverse the situation that would be brought about by its immediate implementation and, conversely, the extent to which the suspension of its operation would be such as to prevent the objectives pursued by the contested decision if the main application were to be dismissed (order of the President of the Court of First Instance in Case T-114//0606 R Globe
v Commission
[2006] ECR II‑2627, paragraph 147; see also, to that effect, order of the President of the Court of Justice in Joined Cases C-182/03 R and C-217/03 R Belgium and Forum 187
v Commission
[2003] ECR I‑6887, paragraph 142).
207. It must be recalled in that regard that, as a rule, there can be no question but that the requirements of the protection of public health must take precedence over economic considerations (see order of the President of the Court of First Instance in Case T-70/99 R Alpharma
v Council
[1999] ECR II‑2027, paragraph 152 and the case-law cited).
208. In the present case, however, the reasons put forward by the Commission for adopting the contested directive lie in the potential risks posed by flusilazole to endocrine disturbance. Nevertheless, it must be borne in mind that the Commission had itself given to understand, throughout the assessment procedure, that on the basis of the scientific tests performed and on the basis of the information and studies provided by the notifier at the Commission’s request, flusilazole was safe.
209. In fact, on the basis of that assessment, the Commission had proposed including flusilazole in Annex I to Directive 91/414. The initial measures submitted to the Committee provided for a 7-year limitation to the period of inclusion so that the Member States would give priority to re-evaluating plant protection products containing flusilazole that are already on the market.
210. As is apparent from recital 8 of the contested directive, it was only after examination by the Committee and the Council that the Commission amended its proposal, on the basis of concerns expressed by certain Member States, as it considered that further restrictions were necessary to reduce the risk to a level which could be deemed acceptable and in accordance with the high level of protection sought in the Community.
211. As a result, the Commission also introduced a number of restrictions to its initial proposal, including limiting the inclusion period to 18 months instead of seven years as originally proposed.
212. As the Committee had not issued its opinion through its president within the prescribed period, the Commission submitted to the Council a proposal containing the contested restrictions. By the date of expiry of the period laid down in Directive 91/414, the Council had neither adopted the proposed implementing measure nor expressed its opposition to that proposal. The Commission was thus able to adopt the proposal with the contested restrictions.
213. In that context, it must be borne in mind that, first, flusilazole has been produced and marketed by the applicants for over 20 years.
214. Secondly, it is not established, on the basis of the parties’ written pleadings, that its use has been the cause of harm to public health.
215. Thirdly, the assessment of flusilazole was carried out over more than 13 years, during which the Commission’s position was unchanged as to the substance’s innocuousness and it was only after having proposed its inclusion in Annex I to Directive 91/414 for a period of 10 years that, following discussions within the Committee, the Commission proposed limiting that period of inclusion to seven years, before finally reducing it to 18 months.
216. Fourthly, flusilazole was finally judged to be sufficiently safe to be authorised for use on certain crops, the prohibition on its use on other crops appearing to be due only to concerns expressed by certain Member States.
217. It must also be pointed out that, without prejudice to what was stated in paragraph 159 above, the Commission itself does not discount the possibility that inclusion in Annex I to Directive 91/414, from which flusilazole benefits, may be extended to other crops in the future.
218. However, without the judge hearing the application replacing the Commission in the assessment of technical considerations which, by nature, are complicated, it must be borne in mind that the applicants merely request that a situation be preserved that has existed for a number of years.
219. It must be pointed out, at this stage, that it is apparent, first, that the Commission was unable to conduct properly all the required assessments in the 15-year timeframe it was accorded to this end, which, to the detriment of the applicants, led to an incomplete assessment, and second, that although the effects of flusilazole on certain crops are still unknown, the plant protection products using this active substance have nevertheless been authorised by the Member States for more than 15 years without, at first sight, any measure of prohibition or protection being considered necessary with regard to the applicants’ products.
220. It follows that a measure to suspend the enforcement of the contested restrictions pending the decision in the main proceedings does not, in the present case, seem more likely to compromise health than the absence of measures taken at both Community and national levels over more than 15 years, in particular when no proven harmful effect of flusilazole has been complained of and safe uses have, on the contrary, been identified both by the rapporteur Member State and the review Committee.
221. In addition, it must be borne in mind, first, that Article 4(5) of Directive 91/414 allows authorisations granted to plant protection products to be reviewed at any time if there are indications that any of the requirements referred to in Article 4(1) are no longer satisfied, including the requirement that, in the light of current scientific and technical knowledge, those products have no harmful effect on human or animal health, directly or indirectly, or on groundwater and that they have no unacceptable influence on the environment.
222. Second, Article 11(1) of Directive 91/414 provides that where a Member State has valid reasons to consider that a product which it has authorised or is bound to authorise under Article 10 of the directive constitutes a risk to human or animal health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory. In such a case, it must immediately inform the Commission and the other Member States of such action and give reasons for its decision.
223. It seems that, should the need arise, protective measures could therefore be taken, pursuant to Directive 91/414 if the contested restrictions were suspended pending delivery of the judgment in the main proceedings.
224. Furthermore, enforcement of the contested directive is likely to have a significant adverse effect not only on the applicants, but also on third parties. In particular, even if the applicants have not managed to show, at first sight, as was held in paragraphs 162 to 173 above, that the contested directive could lead to closure of their industrial site at Cernay, it may be reasonably expected that the consequences of an irreversible reduction in the applicants’ market shares will be considerable. In particular, the probable reduction of staff at that industrial site or an effect on undertakings dealing with flusilazole cannot be excluded.
225. In addition, the applicants claim that farmers using flusilazole and European agriculture in general will be affected, in particular because, first of all, there is currently no technical solution other than flusilazole for treating wood diseases in grapes, second, 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.
226. However, the Commission merely contests those arguments by contending that they contradict those made by the applicants for the purposes of disputing the substitutability of flusilazole for other competing products.
227. It suffices to point out, in this regard, that the fact that flusilazole has unique properties vis-à-vis certain crops clearly does not exclude the possibility that it can be replaced by other substances on the market for triazole fungicides as regards other crops. The Commission’s argument therefore cannot be upheld.
228. It must therefore be held that the balance of interests involved is in favour of granting the interim relief sought.
229. In the light of the foregoing, it must be held that the conditions for granting the interim relief sought have been satisfied in the present case.
230. Accordingly, it is appropriate to suspend, until judgment is delivered in the main proceedings, first, the expiry of flusilazole’s inclusion in Annex I to Directive 91/414, 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, if necessary, after review, the authorisation of flusilazole-containing products, also fixed at 30 June 2008 under the second subparagraph of Article 3(2) of the contested directive, and second, 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, namely cereals other than rice, oilseed rape, maize and sugar beet.
(1) .
(1) 	 – confidential information omitted.
Operative part
On those grounds,
THE PRESIDENT OF THE COURT OF FIRST INSTANCE
hereby orders:
1. The expiry of the period for which flusilazole is included in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, fixed at 30 June 2008 in the Annex to Commission Directive 2006/133/EC of 11 December 2006 amending Council Directive 91/414/EEC to include flusilazole as active substance, is suspended until judgment is delivered in the main proceedings;
2. The date by which the Member States have to amend or withdraw, if necessary, after review, the authorisation of products containing flusilazole, also fixed at 30 June 2008 under the second subparagraph of Article 3(2) of Directive 2006/133, is suspended until judgment is delivered in the main proceedings;
3. The restriction contained in part A of the Specific Provisions of the Annex to Directive 2006/133 on the types of crops on which the use of flusilazole may be authorised by the Member States, namely cereals other than rice, oilseed rape, maize and sugar beet, is suspended until judgment is delivered in the main proceedings;
4. Costs are reserved.
Luxembourg, 19 July 2007.