(Application for interim measures – Directive 91/414
Tribunal de Justicia de la Unión Europea

(Application for interim measures – Directive 91/414

Fecha: 20-Oct-2005

ORDER OF THE PRESIDENT OF THE COURT OF FIRST INSTANCE

24 March 2006 (*)

(Application for interim measures – Directive 91/414/EEC – Admissibility)

In Case T‑454/05R,

Sumitomo Chemical Agro Europe SAS, established in Saint-Didier-au-Mont-d’Or (France),

Philagro France SAS, established in Saint-Didier-au-Mont-d’Or,

represented by K.Van Maldegem and C.Mereu, lawyers,

applicants,

v

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

defendant,

APPLICATION for, first, suspension of the operation of a decision allegedly contained in a letter from the Commission of 20 October 2005 and, second, grant of certain interim measures regarding the administrative procedure conducted before the Commission for the inclusion of procymidone in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L230, p.1),

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

makes the following

Order

Legal context

1Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1) lays down, in particular, the Community regime applicable to authorisation to place plant protection products on the market and withdrawal of such authorisation.

2Article 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’.

3Active substances which are not included in Annex I to Directive 91/414 qualify, under certain conditions, for a transitional derogation. Article 8(2) of Directive 91/414 provides 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 12-year period, which expired on 26 July 2003, was extended for certain substances until 31 December 2006 by Commission Regulation (EC) No 1335/2005 of 12 August 2005 amending Regulation (EC) No 2076/2002 and Decisions 2002/928/EC, 2004/129/EC, 2004/140/EC, 2004/247/EC and 2005/303/EC as regards the time period referred to in Article 8(2) of Directive 91/414 and the continued use of certain substances not included in its Annex I (OJ 2005 L 211, p. 6).

4Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Directive 91/414 (OJ 1992 L 366, p. 10) sets out the procedure for assessment of a number of substances with a view to their possible inclusion in Annex I to Directive 91/414. Procymidone is among those substances.

5The procedure established by Regulation No 3600/92 begins with the sending of a notification of interest, as provided for in Article 4(1) of the regulation, to the Commission by a producer wishing to secure the inclusion of a substance in Annex I to the directive.

6Article 5(2)(b) of Regulation No 3600/92 provides that, after examination of the notifications of interest, a rapporteur Member State is designated for the assessment of each of the active substances concerned. In the case in point, the French Republic was designated as the rapporteur Member State for procymidone, 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).

7Once the rapporteur Member State has been designated, each notifier is to send to it, in accordance with Article 6(1) of Regulation No 3600/92, a ‘summary dossier’ and a ‘complete dossier’, as defined in Article 6(2) and (3) of that regulation.

8The summary dossier and the complete dossier are sent by notifiers to the rapporteur Member State within a period laid down by the Commission. In the case of procymidone, the deadline for lodging those dossiers was set at 30 April 1995 by Regulation No 933/94, and then extended to 31 October 1995 by Commission Regulation (EC) No 2230/95 of 21 September 1995 amending Regulation No 933/94 (OJ 1995 L 225, p. 1). In accordance with Article 6(1) of Regulation No 3600/92, notifiers are also to send the summary dossier and complete dossier to experts from other Member States accepted by the Commission, with a view to their possible subsequent consultation.

9Article 19 of Directive 91/414, as amended by Council Regulation (EC) No 806/2003 of 14 April 2003 adapting to Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (qualified majority) (OJ 2003 L 122, p. 1), provides that the Commission is to be assisted by the Standing Committee on the Food Chain and Animal Health (‘the Committee’).

10Article 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 L170, p. 19), provides that after that examination the Commission is to present to the Committee (a) a draft directive to include the active substance in Annex I to Directive 91/414, (b) a draft decision to withdraw the authorisations of plant protection products containing the active substance, (c) a draft decision to suspend such products from the market, 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 (d) a draft decision to postpone inclusion of the active substance in Annex I pending the submission of the results of additional trials or of additional information.

Facts

11Sumitomo Chemical Agro Europe SAS (‘the first applicant’) notified the Commission that it wished to secure the inclusion of procymidone in Annex I to Directive 91/414, a step which had the effect of listing it among the ‘notifying producers’ in Annex I to Regulation No 933/94, as last amended by Regulation No 2230/95.

12Philagro France SAS (‘the second applicant’), a French subsidiary of the first applicant, distributes plant protection products containing procymidone in France, holding marketing authorisations for them.

13The first applicant submitted a dossier on procymidone to the rapporteur Member State before the deadline of 30 April 2005 set by Regulation No 933/94.

14Following the adoption of Commission Regulation (EC) No 2266/2000 of 12October 2000 amending Regulation No 3600/92 (OJ 2000 L 259, p. 27), the first applicant revised its dossier lodged in 1995, which originally included use data on 33 different crops requiring examination or authorisation at Community level, so as to submit use data only on plums, tomatoes, peppers, cucumbers and witloof chicory by way of representative uses for the purpose of the inclusion of procymidone in Annex I to Directive 91/414.

15In July 2004 the rapporteur Member State proposed that procymidone be included in Annex I to Directive 91/414. The Commission then put forward a draft directive concerning the inclusion of procymidone in Annex I to Directive 91/414 and a draft review report which was submitted to the Legislation Working Group of the Committee on 15 April 2005. The draft directive proposed that procymidone be included in Annex I to Directive 91/414 as a fungicide, without limitations as to uses or crops.

16By letter of 4 August 2005, the Commission informed the first applicant that it was considering not including procymidone in Annex I to Directive 91/414, stating that ‘it [did] not seem possible to conclude that it [could] be expected that, under the proposed conditions of use, plant protection products containing procymidone would satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414’. In its letter, the Commission invited the first applicant ‘to comment on these areas of concern remaining after the evaluation’.

17The first applicant replied to the Commission by letters of 1, 5, 9 and 27 September and 15 October 2005, requesting the Commission to reconsider its position and to propose the inclusion of procymidone in Annex I to Directive 91/414.

18By letters of 9 and 27 September 2005, the applicants also asked the Commission for access to all documents relating to the review of procymidone in respect of the period from January to the end of September 2005.

19The Director-General of the Health and Consumer Protection Directorate-General of the Commission replied to all the abovementioned letters from the applicants by letter of 20 October 2005 (‘the contested measure’). The letter stated:

‘In order to possibly resolve some of the pending decisions on substances of the first stage of the review programme, I would be grateful if you could send us by 14 November 2005 a proposal for highly detailed conditions of use and risk mitigation measures for your substance. In any event, you should also be aware that an inclusion into Annex I of Directive 91/414…, if this were to be the option followed, would at most cover the supported uses that have been the subject of the EU evaluation.’

20As regards the timetable, the letter confirmed that ‘studies submitted after the fixed deadlines [could], at this stage of the process, no longer be examined as they would jeopardise a timely decision making’.

21By the contested measure the Commission, on the basis of Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), (i) refused to grant access to the documents requested by the applicants in their letters of 9 and 27 September 2005 and (ii), while acknowledging that procymidone had been placed before the Legislation Working Group of the Committee at its meetings of 14 and 15 February, 14 and 15 April, 2 and 3 June, 14 and 15 July and 22 and 23 September 2005, refused to supply the minutes of those meetings.

Procedure and forms of order sought

22By application lodged at the Registry of the Court of First Instance on 20 December 2005, the applicants brought proceedings on the basis of the fourth paragraph of Article 230 EC for annulment of the contested measure and, in the alternative, on the basis of Article 232 EC for failure to act, seeking a declaration that the Commission had failed to comply with its obligation, first, to correct manifest errors and, secondly, to propose to the Committee the unconditional inclusion of procymidone in Annex I to Directive 94/414. Finally, the applicants sought damages on the basis of Article 288 EC.

23By separate document lodged at the Registry on 23 January 2006, the applicants made the present application for interim measures. In this application, they requested the President of the Court of First Instance to give his decision, on the basis of Article 105(2) of the Rules of Procedure of the Court of First Instance, before the Commission submitted its observations.

24By document lodged at the Registry on 2 February 2006, the Commission submitted its observations on the application for interim measures.

25By a document of the same day the Commission requested that certain documents be removed from the file, and the applicants lodged their observations on this request on 10 February 2006.

26By document lodged at the Registry on 7 February 2006, the applicants requested a measure of organisation of procedure and offered further evidence, as a result of which they amended the form of order sought by them. The Commission lodged observations on that request on 21 February 2006.

27At the invitation of the President of the Court of First Instance, on 10 February 2006 the applicants lodged their observations on the Commission’s observations regarding the application for interim measures. On 21 February 2006 the Commission lodged its own observations on the applicants’ observations.

28As a result of the document lodged at the Registry on 7 February 2006, the applicants claim that the President of the Court of First Instance should:

–declare the present application admissible and well founded;

–suspend operation of the contested measure as far as the limited inclusion of procymidone in Annex I to Directive 91/414 is concerned, pending the full resolution of the dispute in the main proceedings;

–suspend the draft Commission directive amending Directive 91/414 to include procymidone as an active substance and any vote upon it, pending the full resolution of the dispute in the main proceedings;

–order the Commission to further extend the time period referred to in Article 8(2) of Directive 91/414 as regards procymidone, so as to allow Member States to continue granting authorisations for procymidone-based products after 31 December 2006, pending the full resolution of the dispute in the main proceedings and until a new decision is taken on the inclusion of procymidone in Annex I to Directive 91/414;

–order the Commission to pay the costs.

29The Commission contends that the President of the Court of First Instance should dismiss the application as inadmissible or as unfounded and order the applicants to pay the costs.

30By document lodged at the Registry on 22 February 2006, the applicants made a further request for interim relief under Article 105(2) of the Rules of Procedure, seeking an order requiring the Commission to withdraw the draft directive from the agenda of the 3 March 2006 meeting of the Committee.

Law

Arguments of the parties

31The Commission submits, first, that the claims seeking an order requiring the Commission to extend the period referred to in Article 8(2) of Directive 91/414 as regards procymidone are inadmissible, because the Court does not have jurisdiction to issue orders to the Commission.

32Second, the claims seeking suspension of the operation of the contested measure are also inadmissible because it is not a challengeable act for the purposes of the fourth paragraph of Article 230 EC.

33The applicants observe that an application for suspension of the operation of a measure is admissible if the applicant has challenged that act in an action before the Court and the action is prima facie admissible. In the applicants’ submission, the main action seeking annulment of the contested measure is admissible, first, because it was brought within the time-limit laid down by the fourth paragraph of Article 230 EC and, second, because the contested measure was addressed to the first applicant and its affiliates, which include the second applicant.

34In any event, in the applicants’ submission, the issue of the admissibility of the main application must not, in principle, be examined in proceedings relating to an application for interim measures, so as not to prejudge the decision on the substance.

35The applicants further contend that the Commission’s position would have the effect of preventing judicial review of the legality of acts of the Commission.

36So far as concerns the Commission’s argument that the Court does not have jurisdiction to issue orders to the Commission, the applicants maintain that they do not claim that the Court should order the Commission to adopt a specific act, but to refrain from submitting the contested measure for a vote within the Committee. The other measures are necessary only to ensure that suspension of the operation of the contested measure has practical effect.

37The applicants add that an action for annulment may be brought against the contested measure, first, because Regulation No 1049/2001 is not relevant, second, because the contested measure is a final act which terminates the administrative phase provided for by Directive 91/414, during which the applicants have certain rights and procedural guarantees, and third, because the ability to bring an action for annulment against a measure depends not on its form but on its capacity to produce legal effects.

Findings of the President of the Court

38Since the parties’ written observations contain all the information necessary for deciding the application for interim measures, there is no need to hear oral argument from the parties.

39By virtue of, first, Articles 242 EC and 243 EC and, second, 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.

40Article 104(2) of the Rules of Procedure provides that applications 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. These conditions are cumulative, so that applications for interim measures must be dismissed if one of them is not fulfilled. The court hearing the application will also, where appropriate, balance the competing interests (orders in Case C-149/95 P(R) Commission v Atlantic Container Line and Others [1995] ECR I‑2165, paragraph 22, and in Case C‑364/98 P(R) Emesa Sugar v Commission [1998] ECR I‑8815, paragraph 43).

41Also, in the context of that overall examination the court hearing the application has a wide discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of Community law imposing a pre-established scheme of analysis within which the need to order interim measures must be analysed and assessed (Commission v Atlantic Container Line and Others, paragraph 23, and EmesaSugar v Commission, paragraph 44).

42Having regard to the Commission’s claims for dismissal of the present application as manifestly inadmissible, it is appropriate in the present case to begin by considering the application’s admissibility.

43The first subparagraph of Article 104(1) of the Rules of Procedure provides that an 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.

44In the present case, as mentioned in paragraph 22 above, the applicants have brought proceedings for annulment of the contested measure, on the basis of Article 230 EC, for a declaration of failure to act on the basis of Article 232 EC and for damages on the basis of Article 288 EC. Nevertheless, it is apparent from the application for interim measures that it is an adjunct to the main action solely in so far as that action seeks annulment of the contested measure on the basis of Article 230 EC.

45The Commission disputes that the main action for annulment is admissible.

46It is settled case-law that the admissibility of the main action should not, in principle, be examined in proceedings relating to an application for interim measures so as not to prejudge the substance of the case. However, where it is contended that the main action from which the application for interim measures is derived is manifestly inadmissible, it may be necessary to establish certain grounds supporting the conclusion that such an action is prima facie admissible. Thus, in order for an application for interim measures to be declared admissible, the applicant must establish certain grounds supporting the conclusion that the substantive action from which his application is derived is prima facie admissible, so as to prevent him from obtaining, by way of proceedings for interim relief, the benefit of interim measures to which he could not be entitled if his action were declared inadmissible when examined as to its merits (orders in Case 376/87 R Distrivet v Council [1988] ECR209, paragraph 21, and in Case T-236/00 R Stauner and Others v Parliament and Commission [2001] ECRII‑15, paragraph 42).

47It must accordingly be determined whether the applicants have established, in their application for interim measures, certain grounds supporting the conclusion that, prima facie, the main action for annulment is not manifestly inadmissible.

48In the applicants’ submission, the main action challenging the contested measure is admissible, first, because it was brought within the time-limit laid down by the fourth paragraph of Article 230 EC, second, because the contested measure was addressed to the first applicant and its affiliates, which include the second applicant, and finally, because the contested measure is a challengeable act for the purposes of Article 230 EC.

49With regard to that final reason, the applicants maintain that the contested measure is a challengeable act in that it brought to an end the administrative procedure before the Commission, in the course of which they had certain rights and procedural guarantees.

50It is to be remembered that only measures which produce binding legal effects such as to affect the interests of an applicant by bringing about a distinct change in his legal position constitute acts or decisions which may be the subject of an action for annulment. In the specific case of acts or decisions adopted by a procedure involving several stages, in principle an action for annulment may be brought only against measures which definitively establish the position of the institution concerned upon the conclusion of the procedure. This means that preliminary or purely preparatory measures cannot be the subject of an action for annulment (judgment in Case 60/81 IBM v Commission [1981] ECR2639, paragraphs 9 and 10, and order in Case T-55/01 R Asahi Vet v Commission [2001] ECRII‑1933, paragraphs 61 and 62).

51In the present case, the contested measure is contained in the Commission’s letter of 20 October 2005.

52The initial point should be made that, in their observations on the Commission’s observations, the applicants themselves ‘acknowledge that the contested [measure] is not a final act in so far as their request for access to documents is concerned’.

53Next, it should, first, be noted that, according to the contested measure itself, the request for information which it contains ‘should in no way be considered as a commitment [on the part of the Commission] nor a presumption for a favourable decision as regards [the substance manufactured by the applicants]’. The contested measure states in addition that ‘at this stage, no final position is taken and the Commission reserves its rights to propose the necessary measures to the Member States’.

54Second, as the Commission rightly submits, a definitive decision regarding the outcome of the review procedure envisaged in Article 8(2) of Directive 91/414 must necessarily follow the vote by the Committee and take the form of one of the measures provided for in Article 7(3A) of Regulation No 3600/92 as amended by Regulation No 1199/97.

55The content and the form of the contested measure therefore show prima facie that it merely provided non-binding particulars regarding the Commission’s future conduct of the procedure and the Commission did not give commitments or define its position.

56Third, it must be stated with regard to the case-law of the Court of First Instance referred to by the applicants in this connection that they are wrong in relying on the judgment of 28 June 2005 in Case T-158/03 Industrias Químicas del Vallés v Commission, not yet published in the ECR, given that, in that case, the contested decision was specifically a decision adopted on the basis of Article 7(3A) of Regulation No 3600/92 as amended by Regulation No 1199/97.

57Fourth, the applicants submit that the contested measure would deny them certain procedural guarantees provided for during the administrative phase as governed by Directive 91/414 and the implementing regulations. In their submission, the contested measure brings the administrative phase to a close, first, because it is addressed to them and relates to the examination of their dossier and, second, because it defines the Commission’s position with regard to the inclusion of procymidone in Annex I to Directive 91/414.

58However, the mere fact that the contested measure is addressed to the applicants is not sufficient to establish that it brings the administrative phase to a close. The applicants themselves indeed observe, first, that proposal of a draft directive to the Committee simultaneously represents the conclusion of the administrative procedure and ‘the first step’ of the legislative procedure and, second, that ‘the purpose of the administrative procedure under Directive 91/414 is to result in measures of individual application, i.e., a decision not including – or a directive including – the active substance in Annex I to Directive 91/414’.

59Nor, as held in paragraphs 53 and 55 above, does the contested measure define the Commission’s position.

60Accordingly, the applicants have not adduced evidence or arguments from which it may be concluded that the contested measure brings the administrative phase to a close and thus denies them the procedural guarantees provided for by Directive 91/414 and the implementing regulations.

61In addition, the applicants refer to procedural guarantees provided for by Directive 91/414 and the implementing regulations without adducing evidence or arguments capable of proving that the contested measure would be liable to impair them.

62Having regard to the foregoing, it must be found that, at this stage, the applicants have not adduced evidence or arguments proving to the required legal standard that the contested measure produces binding legal effects such as to affect their interests by bringing about a distinct change in their legal position.

63Consequently it does not appear, at this stage, that the applicants have adduced evidence or argumentsfrom which it may be concluded that the action for annulment is not prima facie manifestly inadmissible.

64It follows that, in accordance with the case-law recalled in paragraph 46 above, the application for interim measures must be held inadmissible and be dismissed.

On those grounds,

THE PRESIDENT OF THE COURT OF FIRST INSTANCE

hereby orders:

1.The application for interim measures is dismissed.

2.Costs are reserved.

Luxembourg, 24 March 2006.

E. Coulon

B. Vesterdorf

Registrar

President


* Language of the case: English.

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