Order of the President of the Court of First Instance of 5 August 2003. Industrias Químicas del Vallés SA v Commission of the European Communities. Interlocutory proceedings

Ordonnance du Tribunal

Case T-158/03 R

Industrias Químicas del Vallés, SA
v
Commission of the European Communities

«(Proceedings for interim relief – Application for suspension of operation – Prima facie case – Urgency – Balancing of interests)»

Order of the President of the Court of First Instance, 5 August 2003     

Summary of the Order

1.. Applications for interim measures – Conditions governing admissibility – Application – Procedural requirements – Failure to produce documents – Regularisation
(Art. 242 EC; Rules of Procedure of the Court of First Instance, Arts 44(3) to (6) and 104(3))

2.. Applications for interim measures – Suspension of operation of a measure – Conditions for granting – Balancing of all the interests involved – Priority to be given to protection of public health over economic considerations – Account taken of a lack of diligence on the part of the applicant
(Art. 242 EC; Rules of Procedure of the Court of First Instance, Art. 104(2))

1. Failure to attach the documents referred to in Article 44(3) and (5) of the Rules of Procedure of the Court of First Instance to an application for interim relief, as required by Article 104(3) of those rules, does not automatically make the application inadmissible. Given the express reference in Article 104(3) to Article 44, the principles set out in that latter provision should also apply in the context of an application for interim relief, particularly those set out in Article 44(6), whereby if the application does not comply with the obligations laid down in Article 44 (3) to (5), the Registrar must set the applicant a reasonable time-limit within which to put its application in order. see paras 43-45

2. Where, in the context of an application for suspension, the judge hearing the application, being informed that there is a risk that the applicant may suffer serious and irreparable damage, weighs up the various interests at issue, he must consider whether the annulment of the contested decision by judgment in the main action would make it possible to reverse the situation that would have been brought about by its immediate implementation, and conversely whether suspension of the operation of that decision might prevent its being fully effective in the event of the main application being dismissed. The judge hearing the application for interim relief must also balance the respective interests of the parties in order to assess whether it is necessary to award interim relief in order to avoid serious and irreparable damage to the applicant. In that regard, it must be remembered that, in principle, the requirements of the protection of public health must unquestionably be given precedence over economic considerations. Where a party has contributed to the creation of the damage complained of, by reason of possible negligence or omission, that may prevent the balance of interests from leaning in favour of the party in default. see paras 105-107, 110

ORDER OF THE PRESIDENT OF THE COURT OF FIRST INSTANCE
5 August 2003 (1)

((Interlocutory proceedings – Application for suspension of operation – Prima facie case – Urgency – Weighing of interests))

In Case T-158/03 R,

Industrias Químicas del Vallés, SA, established in Barcelona (Spain), represented by C. Fernández Vicién, P. González-Espejo and J. Sabater Marotias, lawyers,

applicant,

v

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

defendant,

APPLICATION for an order suspending the operation of Commission Decision 2003/308/EC of 2 May 2003 concerning the non-inclusion of metalaxyl in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance (OJ 2003 L 113, p. 8),

THE PRESIDENT OF THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES

makes the following

Order
Relevant provisions

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 in particular the Community system for the granting and withdrawal of authorisation for plant protection products. Article 4 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. The conditions for the inclusion of active substances in Annex I are laid down in Article 5 of Directive 91/414. Inclusion is not possible unless, in the light of current scientific and technical knowledge, it may be expected that plant protection products containing the active substance will fulfil certain conditions ensuring that they are harmless.

2 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. That period of 12 years, which expired on 26 July 2003, was extended in the case of some substances until 31 December 2005 by Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that directive and the withdrawal of authorisations for plant protection products containing these substances (OJ 2002 L 319, p. 3).

3 Article 8(2) of Directive 91/414 also provides that during that transitional period the active substances concerned must be subjected to an evaluation programme, at the end of which they may either be included in Annex I to Directive 91/414 or not be included in it if those substances do not meet the safety requirements set out in Article 5 of Directive 91/414 or the information and data needed for the evaluation have not been submitted within the prescribed period. Lastly Article 8(2) of Directive 91/414 provides that the details of the programme are to be set out in a Commission regulation.

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 Council Directive 91/414/EEC concerning the placing of plant protection products on the market (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 metalaxyl, used in the manufacture of fungicides for the control of several diseases affecting crops.

5 The procedure introduced by Regulation No 3600/92 begins with a notification of interest, provided for under Article 4(1) of that regulation, which reads [a]ny producer wishing to secure the inclusion of an active substance referred to in Annex I hereto, or any salts, esters or amines thereof, in Annex I to [Directive 91/414], shall so notify the Commission within six months of the date of entry into force of this regulation.

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 Portugal was appointed as the rapporteur Member State with regard to metalaxyl, 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 Commission Regulation (EEC) No 3600/92 (OJ 1994 L 107, p. 8).

7 Once the rapporteur Member State has been appointed notifiers must send it a summary dossier and a complete dossier as defined in Article 6(2) and (3) of Regulation No 3600/92. Article 6(2)(b) of Regulation No 3600/92, as amended by Regulation (EC) No 2266/2000 of 12 October 2000 (OJ 2000 L 259, p. 27), provides it has to be demonstrated by the notifier that, on the basis of the information submitted for one or more preparations for a limited range of representative uses, the requirements of Directive [91/414] in relation to the criteria referred to in Article 5 thereof can be met.

8 Article 6(1) of Regulation No 3600/92 provides that the next stage in the procedure is for the notifiers to send the summary dossier and the complete dossier to the rapporteur Member State within a time-limit to be set by the Commission. In the case of metalaxyl the time-limit for submitting the dossiers was set at 30 April 1995 under Regulation No 933/94, and extended until 30 October 1995 by Commission Regulation (EC) No 2230/95 of 21 September 1995 amending Regulation No 933/94 (OJ 1995 L 225, p. 1). Article 6(1) of Regulation No 3600/92 also provides that the notifiers must also send the summary dossier and the complete dossier to experts of other Member States accepted by the Commission with a view to further consultation.

9 The rapporteur Member State then examines the summary dossier and the complete dossier and, under Article 7(1)(b) of Regulation No 3600/92, must immediately after examining a dossier, ensure that notifiers submit the updated summary dossier to the other Member States and to the Commission. Article 7(2) of Regulation No 3600/92, as amended by Commission Regulation (EC) No 1199/97 of 27 June 1997 (OJ 1997 L 170, p. 19) provides that from the start of its examination the rapporteur Member State may request the notifiers to improve their dossiers, or add to them and may ... consult with experts from other Member States, and may request additional technical or scientific information from other Member States in order to assist the evaluation.

10 The rapporteur Member State must then prepare and send a report on its assessment of the dossiers to the Commission within 12 months of the receipt of a dossier, under Article 7(1)(c) of Regulation No 3600/92. That report must contain in particular a recommendation to include the active substance concerned in Annex I to Directive 91/414.

11 The report sent by the rapporteur Member State to the Commission may then be referred for consultation to experts of the Member States, and the Commission may consult one or more notifiers under Article 7(3) of Regulation No 3600/92, as amended by Regulation No 1199/97. Article 7(3), as amended by Article 62(2) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1), also provides that that report will then be examined by the Standing Committee on the Food Chain and Animal Health ( the Committee).

12 Article 7(3A) of Regulation No 3600/92, as added by Regulation No 1199/97, provides that following that examination the Commission is to present to the Committee either a draft directive to include the active substance in Annex I to the directive, or a draft decision to withdraw the authorisations of plant protection products containing the active substance, or a draft decision to suspend plant protection products containing the active substance from the market, with the option of reconsidering the inclusion of the active substance in Annex I to that directive after submission of the results of additional trials or of additional information, or lastly a draft decision to postpone inclusion of the active substance pending the submission of the results of additional trials or information.

13 However, Article 7(4), first indent, of Regulation No 3600/92, as amended by Regulation No 2266/2000, provides that, if it appears, following the Committee's examination, that it is necessary to have the results of certain trials or additional information, the Commission is to set a time-limit by which those results or that information must be submitted. The provision states: this time-limit will be 25 May 2002 unless an earlier time-limit is established by the Commission for a particular active substance except for the results of long-term studies, identified as being necessary by the rapporteur Member State and the Commission during the examination of the dossier and which are not expected to be fully completed by the deadline established, provided that the information submitted contains evidence that such studies have been commissioned and that their results will be submitted at the latest on 25 May 2003. In exceptional cases, where it has not been possible for the rapporteur Member State and the Commission to identify such studies by 25 May 2001, an alternative date may be established for the completion of such studies, provided the notifier supplies the rapporteur Member State with evidence that such studies have been commissioned within three months of the request to undertake the studies, and with a protocol and progress report of the study by 25 May 2002.

14 Article 7(5) of Regulation No 3600/92 provides that the Commission shall submit to the Committee a draft decision for non-inclusion in Annex I to the Directive. In accordance with the final subparagraph of Article 8(2) thereof, where: ...

─ the rapporteur Member State has informed the Commission that the results referred to in the first indent of paragraph 4 have not been submitted within the time-limit laid down the rapporteur Member State has informed the Commission that the results referred to in the first indent of paragraph 4 have not been submitted within the time-limit laid down

.

15 Article 8 of Regulation No 3600/92, as amended by Regulation No 2266/2000, provides that after receiving the results of the additional trials or the additional information, the rapporteur Member State must finalise its examination, ensure that the summary of the additional trials and the results of those trials or the additional information are sent by the notifier to the other Member States and to the Commission, and communicate as quickly as possible, and within six months at the latest following receipt of the results or information, a report of its assessment of the whole dossier including a recommendation whether or not to include the active substance in Annex I to Directive 91/414.

16 Under Article 8(3) of Regulation No 3600/92, as amended by Regulation No 2266/2000, once the Commission has received the report drawn up by the rapporteur Member State it must refer it to the Committee for examination, following further examination by the experts of the Member States, where appropriate. After that examination the Commission finally submits a draft decision to the Committee on whether or not the substance should be included in Annex I to Directive 91/414.

Facts and procedure

17 The applicant, Industrias Químicas del Vallés, SA ( IQV or the applicant) is a Spanish undertaking whose activities include the production and marketing of phytosanitary products, animal feed and chemicals. Since February 1994 IQV has imported metalaxyl into Spain and marketed products containing that active substance in Italy, Spain, Greece and Portugal, and also in nine other States outside the European Community.

18 The applicant and Syngenta AG (formerly Ciba Geigy AG, then Novartis AG, Syngenta), another undertaking which was at the time marketing products containing metalaxyl, each notified the Commission of their intention to submit a dossier with a view to the inclusion of that substance in Annex I to Directive 91/414. Syngenta and the applicant then submitted a dossier to the Portuguese authorities on 19 April 1995 and 26 April 1995 respectively, that is to say, before the 31 October 1995 deadline set by the Regulation No 2230/95.

19 After studying those documents, the Portuguese authorities considered that the dossier submitted by Syngenta was substantially complete, but that the one submitted by IQV was not. IQV was informed of this and undertook to complete its dossier according to a timetable approved by the Portuguese authorities. In particular, on 12 April 1996, IQV indicated to the Portuguese authorities that most of the information identified as missing would be available by the end of June 1996. On 27 May 1996 the Portuguese authorities informed IQV that they agreed to the time-limit for the submission of the information still to be supplied, stressing at the same time the need to set a time-limit for the submission of certain other information.

20 On 3 June 1997 the Portuguese authorities informed IQV that its dossier could still not be regarded as complete and indicated what information was missing.

21 On 30 September 1997 IQV informed the Portuguese authorities that it should be possible to provide most of the information required within nine months.

22 On 11 May 1998 Syngenta informed the Portuguese authorities that it was withdrawing from the procedure for the evaluation of metalaxyl. Syngenta also requested, on 15 May 1998, that the dossiers it had submitted during the procedure should be returned to it. IQV was therefore the only undertaking participating in the procedure for the evaluation of metalaxyl, but it had not yet completed its dossier at that stage.

23 On 27 July 1998 IQV was informed of Syngenta's withdrawal from the procedure for the evaluation of metalaxyl.

24 By letter of 19 July 1999 the Commission informed the Portuguese authorities that, in its view, the fact that a notifier had withdrawn from the procedure for the examination of an active substance did not preclude the Member State responsible for investigating the dossier from taking into account all the information available to it, including the information provided by that notifier. On 28 August 1999 the Portuguese authorities informed IQV that they were prepared to draw up an assessment report on metalaxyl on the basis of all the available information, including the dossier provided by Syngenta. The Portuguese authorities stated, however, that if additional information were required the relevant requests would be addressed to IQV.

25 On 26 January 2001 the Portuguese authorities sent the Commission their assessment report on metalaxyl, drawn up on the basis of the dossiers sent by Syngenta and IQV. In their report the Portuguese authorities stated that certain additional information was required in order to complete the evaluation of that substance and that it was not possible for them at that stage to propose the inclusion of the substance in Annex I to Directive 91/414.

26 By letters of 2 and 15 February 2001 Portugal requested IQV to send to the Member States and the Commission, before 15 March 2001, an updated summary dossier and, in case it was asked for it, a complete dossier concerning metalaxyl, under Article 7(1)(b) of Regulation No 3600/92.

27 On 26 March 2001 the Commission informed IQV that since the latter had not sent the updated summary dossier within the required time-limit it would not be possible for the Commission and the Member States to carry out an appropriate examination and to reach a conclusion on metalaxyl, which meant that it was considering proposing a decision not to include metalaxyl in Annex I to Directive 91/414.

28 On 7 June 2001 IQV contacted Syngenta with a proposal to buy the studies it needed in order to compile a complete dossier.

29 In a letter dated 11 July 2001 the Commission let it be known that if IQV did not have the complete dossier it could probably not reply within a reasonable period to the questions that would be raised concerning metalaxyl, and a final decision needed to be taken before July 2003.

30 On 10 September 2001 Syngenta sent a letter to IQV in which it informed the latter that it was not willing to sell it the studies that were carried out in order to submit its dossier on metalaxyl.

31 On 26 September 2001 the Portuguese authorities informed IQV that they were not willing to circulate the dossier to the Member States and the Commission in place of IQV.

32 On 15 October 2001 the Commission informed IQV that, due to Syngenta's refusal to give it access to its dossier and the Portuguese authorities' refusal to copy and circulate the dossier, it was impossible for it to hold consultations with experts from the Member States concerning metalaxyl and it therefore had to decide to prepare a draft decision not to include that substance in Annex I to Directive 91/414.

33 On 8 March 2002 the Commission again informed IQV that since the Portuguese authorities had considered that it was not their responsibility to reply to questions raised during the examination by the national experts it would not be possible to carry out that examination effectively. The Commission therefore informed IQV that it saw no other solution than to propose that metalaxyl should not be included in Annex I.

34 On 12 April 2002 IQV sent the Commission an updated summary dossier and confirmed its decision to prepare a new complete dossier.

35 By a letter of an unspecified date in May 2002 the Commission informed IQV that only those active substances in respect of which full information was available by 31 December 2003 at the latest could have their deadline for evaluation extended beyond the end of 2003. Since, in the Commission's view, it was clear that IQV's complete dossier would not be ready by that date and since Syngenta's withdrawal from the notification process did not warrant metalaxyl being treated any differently from other active substances, the Commission stated that it was forced to propose that metalaxyl should not be included in Annex I to Directive 91/414.

36 At its meeting on 18 and 19 October 2002 the Committee approved the draft decision not to include metalaxyl in Annex I to Directive 91/414.

37 On 2 May 2003 the Commission adopted Decision 2003/308/EC concerning the non-inclusion of metalaxyl in Annex I to Council Directive 91/414/EEC (OJ 2003 L 113, p. 8, the contested decision). That decision was published in the Official Journal of the European Union of 7 May 2003.

38 By application lodged at the Registry of the Court of First Instance on 9 May 2003 the applicant brought an action for annulment of the contested decision.

39 By a separate document lodged at the Registry of the Court of First Instance on the same day, the applicant brought an application to suspend the operation of the contested decision.

40 On 21 May 2003 the Commission submitted its observations on the application for interim relief.

41 On 27 June 2003 the parties stated their views at a hearing.

Law

Admissibility

42 In its observations the Commission, although it does not formally plead that the application for interim relief is inadmissible, points out that the application is not accompanied by the documents referred to in Article 44(3) and (5) of the Rules of Procedure of the Court of First Instance, that is to say, the certificates of the lawyers representing IQV, the statutes of that company and proof that the authority granted to its lawyers had been properly conferred. The Commission defers to the assessment of the judge hearing the application for interim relief regarding the possible impact such unavailability may have on the admissibility of the application.

43 The Court observes in that regard that under Article 104(3) of the Rules of Procedure the documents referred to in Article 44(3) and (5) of those rules must be attached to an application for interim measures. In the present case, the application for interim relief is not accompanied by those documents.

44 However, in the context of an action relating to the substance of a case, the Rules of Procedure do not state that failure to attach to the application the documents referred to in Article 44(3) and (5) of the Rules of Procedure automatically means that the application is inadmissible. Under Article 44(6) of the Rules of Procedure, if an application does not comply with the requirements set out in Article 44(3) to (5) of those rules the Registrar must prescribe a reasonable period within which the application must be put in order. If the application is not put in order the Court of First Instance is to decide whether the failure to comply with these conditions renders the application formally inadmissible.

45 In view of the express reference in Article 104(3) of the Rules of Procedure to Article 44(3) and (5) of those Rules, the same principles should apply in the context of an application for interim relief. In the present case the Registrar has requested the applicant to put its application in order and the applicant has produced the documents referred to in Article 44(3) and (5) of the Rules of Procedure within the prescribed time-limits. The application for interim relief is therefore admissible.

The application for interim relief

46 Article 104(2) of the Rules of Procedure provides that an application for interim relief must state 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 suspension of operation must be dismissed if any one of them is absent (order of the President of the Court of Justice of 14 October 1996 in Case C-268/96 P(R) SCK and FNK v Commission [1996] ECR I-4971, paragraph 30). The judge hearing an application for interim relief must also weigh up the interests involved (order of the President of the Court of Justice of 23 February 2001 in Case C-445/00 R Austria v Council [2001] ECR I-1461, paragraph 73).

47 The measure sought must furthermore be provisional inasmuch as it must not prejudge the points of law or fact in issue or neutralise in advance the effects of the decision subsequently to be given in the main action (order of the President of the Court of Justice of 19 July 1995 in Case C-149/95 P(R) Commission v Atlantic Container Line and Others [1995] ECR I-2165, paragraph 22).

48 In the context of his 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 within which the need to order interim measures must be analysed and assessed (order of the President of the Court of Justice in Commission v Atlantic Container Line and Others, cited above, paragraph 23).

49 The judge hearing the application for interim relief considers that in the present case it is appropriate to consider first of all whether the condition relating to urgency is satisfied before considering, if appropriate, whether the conditions relating to a prima facie case and the weighing of interests are also met.

Urgency

─ Arguments of the parties

50 The applicant points out, by way of introduction, that under Article 2(a) of the contested decision Member States must ensure that authorisations for plant protection products containing metalaxyl are withdrawn within a period of six months from the date of adoption of the [contested] decision, which means that Member States may withdraw their authorisations at any time between 2 May and 2 November 2003.

51 The applicant also points out that metalaxyl-M, the product marketed by Syngenta, is the active isomer of conventional metalaxyl, that preparations manufactured on the basis of both substances are used in the same doses and on the same crops, that 80% of the studies undertaken to evaluate metalaxyl-M are the same as the studies undertaken to evaluate metalaxyl, that certain official documents drawn up by international organisations refer to metalaxyl-M as a substitute chemical compound for metalaxyl, and lastly that their prices are very similar. The applicant infers from this that they are active substances that can be substituted perfectly well and that it is highly likely that if products containing metalaxyl were withdrawn they would be replaced by products containing metalaxyl-M. This would be all the more likely since Syngenta would engage in promotion campaigns that would emphasise that substitutability and would contribute to the replacement of one product by the other and a loss of confidence in metalaxyl on the part of the end consumer and distributors. IQV would therefore lose its market share and would be unable to win back its customers. The irreversibility of that loss of market share would be due, among other things, to the particular sensitivity consumers have when it comes to matters of public health and the loss of confidence that would be caused by withdrawal of a product as a result of a decision by the government, even if withdrawal was not on public health grounds. Implementation of the contested decision would also lead, in the case of IQV, to an irreparable loss of confidence on the part of its strategic partners and a loss of prestige within the industry in which it operates. The applicant considers that the economic damage to it would amount to a loss of over 30% of its pre-tax profits and a drop in sales which would have an impact, that would be more difficult to assess, on the marketing of other products in its range.

52 The Commission refutes those arguments. First, it is unlikely that the national authorities will withdraw products containing metalaxyl immediately the contested decision is adopted. Such withdrawal would be more likely to occur at the end of the period of six months provided for in that decision. Next, Article 3 of the contested decision allows Member States the option to grant a longer period of grace for selling products containing metalaxyl, which might extend to 18 months.

53 Lastly, as regards the loss of prestige IQV would suffer, the Commission considers that the applicant has provided no details in this respect.

54 The Commission also considers that the other types of damage pleaded by the applicant, namely, loss of customers and market shares, loss of strategic partners, loss of a little over 30% of its profits and a drop in sales of other products in its range, are of a purely financial nature and the applicant has submitted no specific evidence of how serious or irreparable they are.

55 First, the fact that certain products containing metalaxyl-M could replace products containing metalaxyl and the existence of Syngenta's promotion campaigns do not provide specific evidence for assessing the precise consequences of operation of the contested decision not being suspended, in view of the time-limits set by that decision for actually withdrawing from the market and selling stocks of products containing metalaxyl.

56 Second, other substances could replace both metalaxyl and metalaxyl-M, so that any replacement of products containing metalaxyl would not necessarily be to Syngenta's benefit. Moreover, the replacement of metalaxyl by metalaxyl-M could result from certain intrinsic qualities of metalaxyl-M, such as the fact that it causes less harm to groundwater. Thus, even if there were a loss of customers and a drop in the applicant's market share the applicant would not have proved either that these were linked to the implementation of the contested decision or that they were serious and irreparable. Moreover, if the applicant were to prepare a fresh dossier on metalaxyl and were to have that dossier approved it could start marketing its products again. The applicant has not proved that if it took the appropriate measures it would not be possible for it to recover its market shares. Nor has the applicant provided specific evidence of a loss of confidence on the part of some of its partners.

57 Also, as regards the applicant's assertions relating to the destruction of a large share of its business, the Commission observes that it has not been established that the applicant's auditor was independent, the applicant does not state either which products would suffer a 30% drop or what proportion would be sales outside the Community, the applicant has not proved that such loss would jeopardise its very existence, and lastly an undertaking operating in a highly-regulated market where the public authorities can intervene in an emergency is required to take appropriate precautions and, in the present case, to protect itself from a potential paralysis of sales of products containing metalaxyl by building up reserves or by diversifying its business.

58 Lastly, the Commission points out that the applicant has not provided specific evidence of how the ban on metalaxyl could have effects on the marketing of other products in its range.

─ Findings of the President

59 As the Court has consistently held, the urgency of an application to suspend the operation of a measure must be assessed in relation to the necessity for an order granting interim relief in order to prevent serious and irreparable damage being occasioned to the party seeking suspension. It is therefore sufficient, particularly where whether the loss occurs depends on the occurrence of a number of factors, for the damage to be foreseeable at this stage with a sufficient degree of probability (see, in particular, the order of the Court of Justice of 29 June 1993 in Case C-280/93 R Germany v Council [1993] ECR I-3667, paragraphs 22 and 34, and the order 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).

60 Article 2 of the contested decision provides that Member States shall ensure that: (a) authorisations for plant protection products containing metalaxyl are withdrawn within a period of six months from the date of adoption of the present decision; (b) from the date of adoption of the present decision, no authorisations for plant protection products containing metalaxyl are granted or renewed under the derogation provided for in Article 8(2) of Directive 91/414/EEC.

61 The effects of the bans provided for in Article 2 of the contested decision are moderated by Article 3 of that decision, which, in conjunction with Article 4(6) of Directive 91/414, permits Member States to grant a period of grace of up to 18 months from the date on which the contested decision was adopted for the disposal, storage, placing on the market and use of existing stocks. However, that period of grace is not only purely optional, it is also limited by its purpose since it applies only to placing on the market existing stocks.

62 Furthermore, the option proposed by the Commission during the administrative procedure that IQV should start the procedure for evaluation of metalaxyl again and apply for its inclusion in Annex I to Directive 91/414 as a new substance does not appear at present to be an alternative that would allow the effects of the contested decision to be avoided. IQV has contended, and has not been contradicted by the Commission on this point, that that procedure could take between two and three years in total, which would mean that even if it was successful it would end with a decision that would be too late to offset the effects of the contested decision immediately.

63 Consequently, as the contested decision was adopted on 2 May 2003, IQV will in principle, by 3 November 2003 at the latest, be unable to sell products containing metalaxyl and will, if Member States agree, at best be able to sell stocks of preparations containing that substance which have already been produced.

64 It is appropriate therefore first of all to determine whether IQV is therefore at risk of suffering serious damage, and second, if appropriate, to determine whether that damage is irreparable.

65 As regards whether any damage exists, IQV is only likely to lose market shares if it is impossible for it to replace metalaxyl with another substance in the manufacture of its preparations, in particular with metalaxyl-M. IQV contends in that regard, and has not been contradicted by the Commission on this point, that metalaxyl-M is an isomer of metalaxyl which can easily be replaced, in particular since preparations based on both those substances are applied in the same doses and to the same crops. IQV points out also that the prices of those two substances are very similar. Metalaxyl-M appears at first sight to be capable of being substituted for metalaxyl. It does not appear, however, that it could necessarily be used by IQV in order to make up for the withdrawal of metalaxyl. Metalaxyl-M is in fact produced by Syngenta, a competitor of IQV, which holds industrial property rights in the substance. Syngenta is therefore, on the face of it, in a position to make its sales of metalaxyl-M to IQV subject to conditions that are very commercially disadvantageous, which is likely to be reflected in the selling price of IQV's preparations and, hence, to affect their commercial competitiveness.

66 The question therefore arises whether substances other than metalaxyl-M can be used as a substitute for metalaxyl. In its observations the Commission considered that a number of other substances could replace metalaxyl for certain uses. They are, in particular, propamocarb hydrochloride, azoxystrobin, Bordeaux mixture and fluoroimide, which are used to combat diseases caused by phytophthora infestans affecting potato crops, and dithianon, iprovalicarb, tolyfluanid, azoxystrobin and Bordeaux mixture, which are used to combat diseases caused by plasmopara viticola in wine-producing crops. At the hearing the Commission listed other substances it regarded as being potential substitutes for metalaxyl. In answer to a question at the hearing from the judge hearing the application for interim relief, the Commission acknowledged, however, that even accepting the fact that those substances could replace metalaxyl, their use by IQV would require the latter first to obtain a marketing authorisation, which would take at least a year. Consequently, even if those substances could be substituted for metalaxyl, IQV would certainly not be in a position to use them within a short enough time to avoid the effects of the contested decision.

67 It is probable therefore that if operation of the decision were not suspended IQV would be likely to lose market shares because it would be unable to market its products. It is therefore appropriate to determine whether such damage would be irreparable.

68 In that regard, it is clear from established case-law that, save in exceptional circumstances, pecuniary damage cannot be regarded as irreparable or even as reparable only with difficulty since it may be the subject of subsequent financial compensation (order of the President of the Third Chamber of the Court of Justice of 3 July 1984 in Case 141/84 R De Compte v Parliament [1984] ECR 2575, paragraph 4, order of the President of the Court of Justice of 11 April 2001 in Case C-471/00 P(R) [2001] Commission v Cambridgeshire Healthcare Supplies [2001] ECR I-2865, paragraph 113 and order of the President of the Court of First Instance of 11 April 2003 in Case T-392/02 R Solvay Pharmaceuticals v Council [2003] ECR II-1825, paragraph 106).

69 According to that principle, the suspension of operation sought would only be justified if it were clear that in the absence of such a measure the applicant would be in a situation likely to endanger its very existence or to alter irreparably its market shares (orders of the President of the Court of First Instance of 30 June 1999 in Case T-13/99 R Pfizer Animal Health v Council [1999] ECR II-1961, paragraph 138 and Solvay Pharmaceuticals v Council, cited above, paragraph 107).

70 In the present case, the applicant has at no time shown, or even really pleaded, the danger that implementation of the contested decision would represent for its existence. At the hearing the applicant did say that failure to suspend the operation of the decision would endanger the existence of two of its subsidiaries in Italy and Portugal. It did not, however, adduce any evidence in support of that assertion. Nor did it show that it would be impossible for it to support those two subsidiaries financially or that the possible bankruptcy of those companies would endanger its own existence.

71 The applicant pleaded instead the loss of market shares that it would suffer as a result of implementation of the contested decision. In response, the Commission pointed out that, according to case-law, an applicant who pleads a loss of its market shares must show that it is impossible for it to regain a significant proportion of those market shares following the putting into place, in particular, of appropriate publicity measures due to obstacles of a structural or legal nature (order in Commission v Cambridge Healthcare Supplies, cited above, paragraphs 110 and 111).

72 In the present case, there are several factors to indicate that it would be difficult for IQV to regain its market shares once they have been lost as a result of implementation of the contested decision.

73 First, IQV's market shares would probably be lost to a great extent to Syngenta. IQV has adduced evidence to show that Syngenta has embarked upon a trade policy based on the similarity between metalaxyl and metalaxyl-M. In that regard, IQV stated in particular that Syngenta's product based on metalaxyl-M, Ridomil MZ Gold, had the same name as its own product based on metalaxyl, Ridomil. IQV also stated that products based on metalaxyl-M had the same composition as products based on metalaxyl. Contrary to what the Commission states in its observations, this is specific evidence indicating that consumers are encouraged to perceive those products in a similar way and, therefore, it shows the likelihood of the danger of IQV losing market shares to Syngenta. Syngenta is a company belonging to a powerful group which can therefore use major publicity measures in order to counter or even anticipate the publicity measures which IQV could deploy in order to regain its market shares following the possible annulment of the contested decision. For the same reasons, Syngenta doubtless has considerable financial resources that would enable it to conduct an aggressive trade and pricing policy in order to retain any customers it may have gained as a result of the contested decision. Nor should the particular sensitivity of the health sectors to decisions to withdraw a plant protection product be totally overlooked either, even if the product is withdrawn without any danger to health being associated with it.

74 There is therefore various evidence on file indicating that implementation of the contested decision is likely to enable IQV's competitors, in particular Syngenta, to gain some of its market shares, a significant number of which might never have been diverted if it had not been for that decision, and then retain a significant number of its customers despite the fact that the contested decision may have been annulled. Such a situation might cause irreversible market developments on a market on which the applicant is already present, developments which might, according to case-law, constitute irreparable damage (see, to that effect, the orders of the President of the Court of First Instance of 16 June 1992 in Joined Cases T-24/92 R and T-28/92 R Langnese-Iglo and Schöller Lebensmittel v Commission [1992] ECR II-1839, paragraph 29, of 17 January 2001 in Case T-342/00 R Petrolessence and SG2R v Commission [2001] ECR II-67, paragraph 48, and of 12 September 2001 in Case T-139/01 R Comafrica and Dole Fresh Fruit Europe v Commission [2001] ECR II-2415, paragraph 94).

75 It is also appropriate to take into account the Commission's argument that metalaxyl-M has certain qualities which distinguish it from metalaxyl, in particular the fact that weaker doses of it may be used in preparations and that it has less impact on groundwater. Therefore, the Commission contends, it is not impossible that some of IQV's customers might decide to change from metalaxyl to metalaxyl-M due to the qualities the latter possesses and not due to implementation of the contested decision. That contention does not, however, alter in the present case the fact that a large share of IQV's customers might turn to Syngenta solely as a result of the contested decision. Indeed, the fact of customers changing from using metalaxyl to using metalaxyl-M as a result of its qualities tends to some extent to increase the irreparable nature of the damage, since it is difficult to assess sufficiently accurately the size of the market share lost by the applicant as a result of the free play of competition and that lost as a result of implementation of the decision (see, by analogy, the order of the President of the Court of First Instance of 7 July 1998 in Case T-65/98 R Van den Bergh Foods v Commission [1998] ECR II-2641, paragraph 65). Damage that cannot be assessed may be regarded as irreparable (see the order of the President of the Court of Justice of 23 May 1990 in Joined Cases C-51/90 R and C-59/90 R Comos-Tank and Others v Commission [1990] ECR I-2167, paragraph 24, and the order of the President of the Court of First Instance of 21 March 1997 in Case T-41/97 R Antillean Rice Mills v Council [1997] ECR II-447, paragraph 47).

76 It must therefore be concluded that the applicant has demonstrated that there is a risk of an irreversible alteration of its market shares. Since the urgency condition is met it is appropriate to consider the applicant's arguments concerning the existence of a prima facie case.

Prima facie case

─ Arguments of the parties

77 In its application for interim relief the applicant states that it relies in its application in the main proceedings on three pleas: infringement of Directive 91/414 and Regulation No 3600/92, infringement of the principle of proportionality and, lastly, misuse of powers.

78 The applicant submits, first of all, that Directive 91/414 requires that in the context of the procedure for assessing a plant protection product every effort should be made to ensure that the producers concerned submit collective dossiers, particularly in order to limit the number of tests on vertebrate animals. By deciding during the course of the proceedings to depart from its original interpretation and to require IQV to submit a complete dossier on metalaxyl the Commission infringed the ninth recital in the preamble to, and Article 6(1) of, Regulation No 3600/92, and the 18th recital in the preamble to, and Article 13(7)(b) of, Directive 91/414. The Commission also infringed the interpretation it had itself given of those provisions when it had requested the rapporteur Member State to continue the assessment of metalaxyl on the basis of Syngenta's complete dossier.

79 In the second plea IQV submits that the contested decision infringes the principle of proportionality in so far as it is not adequate in order to attain its objective of a scientific assessment of the active plant protection substances since it excludes one of them from the market without a prior scientific assessment. The applicant also contends, in a second part, that the Commission could have used less restrictive methods to achieve the same objective; in particular, it could have asked the Portuguese authorities to distribute the dossier to the Member States and leave it to IQV to answer questions raised by Member States, or it could have extended the time-limit for submission of the dossier after making clear to IQV the content of the studies required for assessing metalaxyl. Lastly, the contested decision has caused much more harm to IQV's rights than it has produced advantages for the public interest.

80 In the third plea the applicant submits that the Commission misused its powers by pursuing an objective which was different from that contained in Directive 91/414, in the present case the objective of including permitted active substances in Annex I to Directive 91/414 in the light of their toxicological and ecotoxicological properties and, on the other hand, not excluding from the market safe active substances, provided there are studies for assessing them and provided one or more undertakings have expressed a wish to bear the costs involved in including substances in Annex I to Directive 91/414. The Commission excluded metalaxyl without any scientific grounds for so doing, perhaps under pressure from the multinational Syngenta.

81 In answer to the applicant's first plea, the Commission contends that it is for the author of a notification to demonstrate, inter alia, that the active substance which it is asking to be included in Annex I to Directive 91/414 does not have certain harmful effects on human or animal health, groundwater and the environment. According to the Commission, IQV, on the one hand, had not been able to produce within a reasonable time the information required merely on the basis of the assessment report and, on the other hand, in view of Syngenta's refusal to sell it its studies, was not in a position to submit the information required in order to assess metalaxyl on a number of points, and therefore to answer the many questions which the assessment by experts from the Member States would probably have raised.

82 The Commission also disputes the applicant's second plea. It notes first of all that the contested decision is suitable for achieving the objective of Directive 91/414 in so far as Article 8(2) of the directive provides that a decision may be taken not to include a substance in Annex I to the directive where the notifier fails to submit the requisite information within the prescribed period. Second, in response to the applicant's argument that there are less restrictive methods of achieving the same objective, the Commission points out that the objective of Directive 91/414 is to obtain an adequate assessment of the active substances in question on the basis of the information submitted by the notifier. It is therefore the notifier who must provide all the necessary information. Moreover, IQV had a more than reasonable period prior to the adoption of the contested decision within which to submit that information. Third, in response to the applicant's argument that the contested decision has caused more harm to its individual rights than it has produced advantages for the public interest, the Commission notes that it was Directive 91/414 itself which made the interests of the producers concerned subordinate to the public interest by laying down strict requirements with regard to proof.

83 Lastly, in response to the applicant's third plea, the Commission contends that it adopted the contested decision in accordance with the relevant Community rules. Syngenta is not the only undertaking which derives advantage from metalaxyl not being included in Annex I to Directive 91/414. The correspondence attached to the file shows that there was no conflict between the judgment given on IQV's dossier when it was submitted to the rapporteur Member State and the Commission's final decision.

─ Findings of the President

84 In order to establish the existence of a prima facie case, the judge hearing the application for interim relief must consider whether, having regard to the factual and legal circumstances of the case, the pleas in law and supporting arguments adduced by the applicant in support of his action on the merits are of a serious nature (order of the President of the Court of First Instance of 1 December 1994 in Case T-353/94 R Postbank v Commission [1994] ECR II-1141, paragraph 27).

85 In the first plea the applicant argues that the requirement to submit a complete dossier conflicts with the ninth recital in the preamble to, and Article 6(1) of, Regulation No 3600/92 and with the 18th recital in the preamble to, and Article 13(7)(b) of, Directive 91/414.

86 The ninth recital in the preamble to Regulation No 3600/92 states: in order to avoid duplication of work, and in particular experiments involving vertebrate animals, specific provisions have to be provided to stimulate producers to submit collective dossiers. Article 6(1) of Regulation No 3600/92 provides in that regard: where for any substance the regulation as envisaged in Article 5(4) indicates several notifications, the notifiers concerned shall take all reasonable steps to present collectively the dossiers referred to in the first subparagraph.

87 That article requires producers concerned with the inclusion of the same active substance in Annex I to Directive 91/414 to try to reach agreement in order to submit a joint notification. However, at first sight it cannot be inferred directly from this that where, as in the present case, the undertakings have not been able to reach agreement in order to submit a joint notification the Commission and the rapporteur Member State are then deprived of the right to require those undertakings to submit, in pursuance of the legislation, a complete file or studies which have already been produced by other undertakings and which would involve duplication of studies on vertebrate animals. Article 6(2) of Regulation No 3600/92 states that it is for the notifier to prove that the active substance in respect of which it is submitting a dossier meets the requirements of Article 5 of Directive 91/414. It is to be inferred from this that that obligation is incumbent on any producer who has submitted a notification, even in principle if it has not been able to reach agreement with the other undertakings concerned in order to submit a joint notification, even if the only notifier has submitted a complete dossier and has subsequently withdrawn and, finally, even if the points which the rapporteur Member State or the Commission consider it necessary to prove involve duplication of studies on vertebrate animals. The inevitable conclusion is therefore that it does not appear at this stage on the basis of the arguments set out in the application for interim relief that the Commission and the Member States cannot in the present case, as a result of Article 6(1), last subparagraph, of Regulation No 3600/92, request the distribution of a summary dossier and where appropriate a complete dossier, under Article 6(1), second subparagraph of Regulation No 3600/92. Nor does it appear at this stage on the basis of the arguments contained in the application for interim relief that Article 6(1), last subparagraph, of Regulation No 3600/92 would prevent the rapporteur Member State from carrying out his duty to ensure that the notifier distributes an updated summary dossier to the other Member States and the Commission immediately after examining a dossier, in pursuance of Article 7(1)(b) of Regulation No 3600/92.

88 Moreover, at first sight it does not appear that the applicant can rely on the preamble to, and Article 13(7)(b) of, Directive 91/414 either. Article 13(7)(b) of Directive 91/414 requires a producer wishing to obtain authorisation to market a plant protection product to reach agreement with holders of previous authorisations in order to share information and thus avoid unnecessary testing on vertebrate animals. However, that requirement applies to applications for authorisation which are not submitted under the derogating arrangement contained in Article 8(2) of Directive 91/414, the first phase of which is provided for in Regulation No 3600/92, and which is the only phase at issue in the present case. The applicant's arguments on this point do not therefore appear promising.

89 Nor can one at first sight regard as well-founded the applicant's argument that the requirement of a complete dossier after the rapporteur Member State has submitted its assessment report conflicts with the interpretation of the Commission, which had requested the rapporteur Member State to prepare the assessment report on metalaxyl on the basis of the dossier submitted by Syngenta. It appears that in that argument the applicant considers that the Commission and the rapporteur Member State encouraged it to have legitimate expectations that it would not have to produce a complete document at a later date, by agreeing that the assessment report should be prepared on the basis of all the information available to the rapporteur Member State, including Syngenta's dossier.

90 It may be observed in that regard that no one may rely on infringement of the principle of protection of legitimate expectations in the absence of specific, unconditional and concurring assurances which the administration has given him (see in particular Case T-381/00 Wasmeier v Commission [2002] ECR-SC I-A-125 and II-677, paragraph 106). In the present case, the Portuguese authorities did in fact send the applicant a letter on 28 August 1999 stating that they would draw up the assessment report on metalaxyl on the basis of the dossier submitted by Syngenta in particular. However, that letter makes clear that if additional information is required it will be requested from the applicant, the only undertaking still concerned by the inclusion of metalaxyl in Annex I to Directive 91/414. That letter did not therefore, at first sight, exclude the possibility that the applicant might be asked to provide a summary dossier or a complete dossier at a later date, under Article 6(1) and Article 7(1)(b) of Regulation No 3600/92. Therefore, at first sight, the applicant was not entitled to entertain legitimate expectations that the procedure normally applying would be set aside in the later phases of the examination of metalaxyl.

91 The applicant's first plea does not therefore appear, prima facie and solely on the basis of the information submitted at this stage by the applicant, to justify annulment of the contested decision. It is therefore appropriate to consider the second plea submitted by the applicant, alleging infringement of the principle of proportionality.

92 It is settled case-law that by virtue of the principle of proportionality laid down in the third paragraph of Article 5 EC the measures adopted by Community institutions must not exceed what is appropriate and necessary for attaining the objective pursued (Case 15/83 Denkavit Nederland [1984] ECR 2171, paragraph 25, Case T-260/94 Air Inter v Commission [1997] ECR II-997, paragraph 144, and Case T-216/96 Conserve Italia v Commission [1999] ECR II-3139, paragraph 101). Also, in order to establish whether a provision of Community law complies with the principle of proportionality, it must be ascertained whether the means which a Community institution employs are suitable for the purpose of achieving the desired objective and whether they do not go beyond what is necessary to achieve it (see, in particular, Case C-233/94 Germany v Parliament and Council [1997] ECR I-2405, paragraph 54).

93 The applicant disputes, in the first part, whether the contested decision is necessary and appropriate for achieving the objective of Directive 91/414 and Regulation No 3600/92, which is that a substance should not be excluded from the market without a scientific assessment.

94 From a reading of Articles 4 to 10 of Directive 91/414 and the whole of Regulation No 3600/92, it would indeed appear that one of the objectives of those two measures is to provide for a procedure for the scientific assessment of certain active substances with a view to authorising them or prohibiting them within the Community. Article 8(2) of Directive 91/414, however, provides expressly that if the information required for the assessment of an active substance tested during the transitional phase has not been submitted within the prescribed period that substance cannot be included in Annex I to Directive 91/414. The purpose of that directive is therefore not only that a complete scientific assessment should be made of the active substance in question but also that the assessment should be conducted within the maximum period allowed under Directive 91/414, failing which the substance may be withdrawn from the market.

95 In the present case, it is clear from recital 7 in the preamble to the contested decision that the Commission decided not to include metalaxyl in Annex I to Directive 91/414 because, in its own words, since IQV did not have access to [Syngenta's] dossier, [IQV] was [not] in a position [either] to submit information in relation to matters arising from evaluation of it [or] to complete its own dossier within a reasonable period. According to the Commission, it was therefore not possible to organise an efficient peer review of metalaxyl. That statement of reasons does not show clearly whether the contested decision was adopted because a complete assessment of metalaxyl was no longer legally possible before the expiry of the prescribed period or whether that decision was adopted for other reasons, possibly relating to the Commission's wish to close as quickly as possible a dossier whose examination it might, however, have had the power to prolong. In the light of that ambiguous statement of reasons, the judge hearing the application for interim relief is not, without conducting a full analysis of the circumstances of the case, in a position to consider as manifestly unfounded the applicant's arguments that the contested decision is not appropriate to meet the objective of a scientific assessment of the plant protection products within the prescribed period.

96 Second, as regards the applicant's argument that there were less restrictive methods of achieving the objective laid down in Directive 91/414 and Regulation No 3600/92, it is appropriate to consider whether, at first sight, at the time the contested decision was adopted the Commission actually had any alternative courses of action that would have enabled it to assess metalaxyl fully and in a scientific manner within the time-limits set by the relevant legislation whilst causing less harm to IQV's interests.

97 In its application for interim relief the applicant argues that the less restrictive methods which the Commission could have used would have been, for example, to entrust to the rapporteur Member State the task of distributing the dossier to the other Member States whilst leaving IQV to answer any questions that might arise, or to allow IQV to reconstitute its dossier within a reasonable period and extend the time-limit for submitting it.

98 With regard to the first option, it is clear from the documents before the Court that the Portuguese authorities refused to undertake distribution of the complete dossier in place of the applicant. In the absence of any provision in Regulation No 3600/92 clearly requiring the Member State to carry out such distribution, it does not at first sight appear that the Commission had the power to compel the rapporteur Member State to undertake the task itself in place of the applicant.

99 With regard to the second option, in particular extension of the period for submitting a dossier to the Commission, it is clear from the documents before the Court that the Committee met on 18 and 19 October 2002. By those dates it was no longer possible for the applicant to submit, before the time-limit of 25 May 2002 imposed by Article 7(4) of Regulation No 3600/92, the results of any additional studies that might have subsequently been required by the Committee. It is clear in that regard from the dossier that certain studies, the need for which had been indicated since the submission of the assessment report by the rapporteur Member State, would not in any event have been available until September 2004 at the earliest. Consequently, it does not seem on the face of it that the Commission really had any option at that date apart from proposing to the Committee a decision not to include metalaxyl in Annex I to Directive 91/414, and that impossibility does not affect the validity of the reasons why the meeting of the Committee did not take place earlier.

100 On the basis of the preceding information, it seems therefore that the alternative solutions proposed by the applicant required an amendment of Regulation No 3600/92. As that regulation was adopted by the Commission itself, it cannot be precluded in principle that at that stage it was possible for the Commission to adopt a special regulation in order to extend the time-limit for submission of the studies needed for the assessment of metalaxyl and thus allow IQV to try to obtain authorisation of that substance before 31 December 2005. That alternative would need to remain an exception, however, since it raises delicate issues relating, in particular, as it is a measure having general scope, to observance of the principle of equal treatment and legal protection of third parties, and also to the public interest that attaches to the implementation of a regulatory measure. IQV did not at that stage put forward any evidence which would on the face of it impose such a duty on the Commission. The issues are, however, delicate issues of principle which require close consideration and which cannot be resolved in the context of an application for interim relief.

101 It is also necessary to take into account the fact that Regulation No 3600/92 is an instrument which is complex in its application, the relevant provisions of which have been amended on several occasions and which has not expressly taken account of the situation in which the applicant is placed, namely of being the only undertaking supporting the inclusion of an active substance in Annex I to Directive 91/414, after the other producer concerned, the only producer to have submitted an essentially complete dossier, withdrew from the procedure in question, although the rapporteur Member State agreed to continue the examination procedure on the basis of that dossier. Consequently, resolution of the issues raised by the application requires a close study of the factual and legal background to that situation, which should be carried out once both parties have put their case. The judge hearing the application for interim relief considers therefore that the pleas submitted by the applicant cannot be rejected as being manifestly unfounded at the stage at which the application for interim relief is being considered. It is therefore necessary to weigh up the interests at issue.

Weighing of interests

─ Arguments of the parties

102 The applicant contends that suspension of the operation of the contested decision would not harm human or animal life or the environment since withdrawal of metalaxyl is justified by the incomplete nature of the applicant's dossier. The applicant also points out that metalaxyl has not caused any problems during the years in which it has been marketed and that it has recently been successfully reassessed in the United States and Canada. In addition, by Commission Directive 2002/64/EC of 15 July 2002 amending Directive 91/414 to include cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl-M and picolinafen as active substances (OJ 2002 L 189, p. 27), metalaxyl-M was included in Annex I to Directive 91/414, since it is a natural substitute for metalaxyl and the studies required for its assessment represent 80% of the studies needed for the assessment of metalaxyl.

103 On the other hand, the applicant argues, failure to suspend the operation of the contested decision would have very serious consequences for it and for certain undertakings located outside the European Union which market products treated with metalaxyl within the Union.

104 The Commission disputes that argument. In its opinion IQV has not proved that it would suffer any damage. However, suspending operation of the contested decision would endanger the Commission's interest that the procedures applicable under the Community legislation should be observed. Suspension of the operation of the contested decision would also affect the interest represented by the rules governing the authorisation of plant protection products, which require that products whose risks to health have not been assessed must not be authorised. The Commission also has an interest in IQV being treated in the same way as any other notifier which has not submitted a complete dossier within the prescribed time-limit. Although not speaking on behalf of the Portuguese authorities, the Commission also argues that those authorities could be harmed if the contested decision were suspended. Lastly, the Commission argues that the effects on imports into the Community of products containing metalaxyl do not stem from the contested decision but from a later stage which involves consultation of the World Trade Organisation's Committee on Sanitary and Phytosanitary Measures. That procedure does not necessarily make it impossible to import products containing metalaxyl into the Community because importers could ask for tolerance limits to be set on imports.

─ Findings of the President

105 Where, in the context of an application for suspension, the judge hearing the application, being informed that there is a risk that the applicant may suffer serious and irreparable damage, weighs up the various interests at issue, he must consider whether the annulment of the contested decision by judgment in the main action would make it possible to reverse the situation that would have been brought about by its immediate implementation, and conversely whether suspension of the operation of that decision might prevent its being fully effective in the event of the main application being dismissed (orders of the President of the Court of Justice of 26 June 2003 in Joined Cases C-182/03 R and C-217/03 R Belgium and Forum 187 v Commission [2003] ECR I-6887, paragraph 142, and in Commission v Atlantic Container Line and Others, cited above, paragraph 50).

106 The judge hearing the application for interim relief must also balance the respective interests of the parties in order to assess whether it is necessary to award interim relief in order to avoid serious and irreparable damage to the applicant (order of the President of the Court of First Instance of 23 November 1990 in Case T-45/90 R Speybrouck v Parliament [1990] ECR II-705, paragraph 36).

107 In that regard, it must be remembered that, in principle, the requirements of the protection of public health must unquestionably be given precedence over economic considerations (see in particular the order of the Court of Justice of 12 July 1996 in Case C-180/96 R United Kingdom v Commission [1996] ECR I-3903, paragraph 93; the orders of the President of the Court of Justice of 11 April 2001 in Case C-459/00 P (R) Commission v Trenker [2001] ECR I-2823, paragraph 109 and Case C-474/00 P (R) Commission v Bruno Farmaceutici and Others [2001] ECR I-2909, paragraph 112; and the order in Solvay Pharmaceuticals v Council, cited above, paragraph 122).

108 In the present case the contested decision was taken not because of the specific and identified risks which metalaxyl might have for health but because of the incomplete nature of the information submitted by the applicant in order for metalaxyl to be assessed. The assessment report by the rapporteur Member State stated that it was necessary to continue to assess the effects of metalaxyl on groundwater. The Commission confirmed at the hearing, however, that it was not pleading that this active substance posed a serious risk for human health or the environment. Moreover, metalaxyl-M, which, as was stated above, is an active substance that is very similar to metalaxyl, has been included in Annex I to Directive 91/414. There is therefore reason to consider that suspension of the operation of the contested decision is not on the face of it likely to create serious risks for the protection of human health.

109 Going on to consider the applicant's financial interest, it is appropriate to take into account the damage caused it by the contested decision, due in particular to the likelihood that the applicant will suffer an irreversible loss of market shares as a result of it (see paragraph 76 above). In that regard, the applicant stated in its application that the gross margin on its sales of products containing metalaxyl represents over 30% of its pre-tax profits. However, as the Commission points out, that figure does not show the share of those sales which are made within the Community, the only area in which authorisation to market metalaxyl will be withdrawn under the contested decision. The applicant markets metalaxyl-based products in nine States outside the Community, which, even in the absence of a detailed assessment, tends to relativise the size of the loss it will suffer.

110 It is also necessary in the present case to ascertain to what extent the applicant has contributed to creating this damage, in particular through possible negligence or failure to take action. Indeed, failure to act may prevent the balance of interests from being in favour of the party in default (order of the President of the Court of Justice of 22 April 1994 in Case C-87/94 R Commission v Belgium [1994] ECR I-1395, paragraph 41).

111 In that regard, it is clear from the documents before the Court that the applicant submitted its dossier to the Portuguese authorities on 26 April 1995 and that from the beginning of 1996 onwards those authorities clearly indicated to it that its dossier was incomplete, and identified those studies that were missing or incomplete. Syngenta, for its part, had no apparent difficulties in essentially completing its dossier within the prescribed time-limits, and IQV has given no reasons to justify on the face of it failure to submit the complete dossier, as required by Article 6(1) of Regulation No 3600/92.

112 The letters the applicant attached to its application state that following the submission of its incomplete dossier it informed the Portuguese authorities on several occasions that it was in the process of completing it. In its letter of 30 September 1997 IQV estimated in particular that it would probably need another nine months in order to submit the majority of the missing information. On 27 July 1998, however, the date on which IQV was notified that Syngenta was withdrawing from the assessment procedure in question, IQV had still not submitted a complete dossier to the Portuguese authorities.

113 Moreover, once the applicant had been notified of Syngenta's withdrawal on 27 July 1998 it should in principle have been alerted of the risk for the rest of the procedure if it did not have a complete dossier at its disposal. Certainly, by letter of 28 August 1999 the Portuguese authorities told the applicant that the dossier was to be prepared on the basis of the dossier submitted by Syngenta. However, the Portuguese authorities stated fairly clearly in that letter that any future questions would be directed to IQV. That letter does not therefore seem at that stage to have provided the precise, unconditional and concurring assurances needed under the case-law (see in particular Wasmeier v Commission, cited above, paragraph 106), so that the applicant could have a legitimate expectation that it would not be asked for the complete dossier at a later date. IQV could not at that time, therefore, exclude the possibility that it would be asked for a summary dossier and a complete dossier under Article 6(1) and Article 7(1)(b) of Regulation No 3600/92. On 2 February 2001, when the rapporteur Member State asked IQV to produce a complete dossier IQV had not yet finalised it. Consequently, in view of this failure to submit a complete dossier before it was formally asked to do so by the rapporteur Member State and in the absence of objective factors to justify that failure to take action, it appears that the applicant contributed to a large extent to creating the damage with which it is now confronted.

114 It is necessary also to ascertain whether any other possible failures on the part of the Commission or the rapporteur Member State are likely to affect the significance of the fact that the applicant appears to have contributed to a large extent to creating the damage it is likely to suffer. In that connection, it seems, according to the Commission, that Syngenta submitted an essentially complete dossier on 19 April 1995. In their letters to the Commission of 28 May and 27 July 1998 the Portuguese authorities none the less stated that that dossier was considered by them to be complete. Consequently, assuming that that had been the case since 19 April 1995, the rapporteur Member State was required in principle to submit its assessment report by 20 April 1996 at the latest, that is to say, within the period of 12 months laid down in Article 7(1)(c) of Regulation No 3600/92. However, that assessment report was not submitted until 26 January 2001, which was nearly five years after the time-limit laid down in Article 7(1)(c) of Regulation No 3600/92 had expired. It should also be noted that on the date the report of the rapporteur Member State should have been submitted Syngenta had not yet withdrawn its dossier, which it did not do until two years later, on 11 May 1998. Consequently, on that date the procedure for the assessment of metalaxyl could perhaps have continued, and possibly been completed, before Syngenta's withdrawal. The rapporteur Member State therefore also seems to have contributed to a large extent to creating the situation in which IQV is now placed.

115 However, without prejudging the consequences of that possible irregularity as regards the main proceedings, its contribution to creating the damage the applicant is likely to suffer is not sufficient in the present case to exempt the applicant entirely from its duty to limit in advance the extent of that damage. IQV was aware at that time of the fact that a decision was to be taken in principle before 26 July 2003, since Regulation No 2076/2002 extending that time-limit to 31 December 2005 was not adopted until 20 November 2002. Consequently, the delay on the part of the rapporteur Member State clearly contributed to increasing an urgent situation which should have been anticipated as one of the undertaking's business risks and which, therefore, also accentuated the measures that IQV needed to take in order to limit it, especially since IQV operates in a highly regulated field, which requires it to protect itself against the harmful consequences of possible intervention by the public authorities by adopting an appropriate policy (see, by analogy, order of the President of the Court of Justice of 11 April 2001 in Case C-479/00 P(R) Commission v Gerot Pharmazeutika [2001] ECR I-3121, paragraph 97).

116 It is also necessary to take account of the fact that suspension of the operation of the contested decision would directly affect the general interest of the Commission that the Community legislation, in particular Regulation No 3600/92, should be applied.

117 Finally, IQV contends that implementation of the contested decision would affect the interests of certain producers using metalaxyl who are located outside the Community, by creating a trade barrier on entry to the Community for products containing that substance. However, even if the judge hearing the application for interim relief is entitled to take into account the interests of third parties at the stage of weighing up interests, it is not apparent from the documents before the Court in the present case that IQV enjoys a special status which enables it to state what is in fact the interest of those producers, who have not intervened in the present case. At any event, even assuming the ban on importing products treated with metalaxyl stems directly from the contested decision, which has not been shown by the applicant, the latter has not proved either that those producers are unable to treat their products with the metalaxyl substitutes that may be available at their place of treatment and, in particular, metalaxyl-M. Naturally, this may result in additional cost for them, but this has not been evaluated by the applicant. It is therefore impossible for the judge hearing the application for interim relief to estimate to what extent the interests of those third parties might possibly be affected.

118 In the light of all this evidence the balance of interests is against suspending operation of the measure and the application for interim relief must therefore be dismissed.

On those grounds,

THE PRESIDENT OF THE COURT OF FIRST INSTANCE

hereby orders:

1. The application for interim relief is dismissed.

2. The costs are reserved.

Luxembourg, 5 August 2003.

H. Jung

B. Vesterdorf

Registrar

President

1 – Language of the case: Spanish. Top

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