(Action for annulment – Action for damages – Directive 91/414

ORDER OF THE COURT OF FIRST INSTANCE (Second Chamber)

17 June 2008 (*)

(Action for annulment – Action for damages – Directive 91/414/EEC – Plant protection products – Opinion of the European Food Safety Authority – Non-actionable measure – Preparatory measure – Inadmissibility)

In Case T‑311/06,

FMC Chemical SPRL, established in Brussels (Belgium),

Arysta Lifesciences SAS, established in Noguères (France),

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

applicants,

supported by

European Crop Protection Association (ECPA), established in Brussels, represented by D.Waelbroeck and N.Rampal, lawyers,

intervener,

v

European Food Safety Authority (EFSA), represented initially by A.Cuvillier and D.Detken, and subsequently by A.Cuvillier and S.Gabbi, acting as Agents,

defendant,

supported by

Commission of the European Communities, represented by B.Doherty, acting as Agent,

intervener,

APPLICATION for (i) annulment of the opinion of EFSA of 28 July 2006 on the assessment of the active substance carbofuran under Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L230, p.1), and (ii) compensation for the damage sustained,

THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES (Second Chamber),

composed of I.Pelikánová, President, K.Jürimäe (Rapporteur) and S.Soldevila Fragoso, Judges,

Registrar: E.Coulon,

makes the following

Order

Legal context

Directive 91/414/EEC

1Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L230, p.1) establishes the Community rules applicable to the granting and the withdrawal of authorisation to place plant protection products on the market.

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 …’.

3Article 5(1) of Directive 91/414 describes the conditions for inclusion of an active substance in Annex I to the directive.

4Under Article 8(2) of Directive 91/414, active substances which are not included in Annex I to that directive may, subject to certain conditions, be covered by derogating transitional arrangements. Article 8(2) of Directive 91/414 thus 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’. However, Article 8(2) of Directive 91/414 provides that, within that 12-year period, ‘the Commission shall commence a programme of work for the gradual examination of these active substances’.

Regulation (EC) No451/2000

5Commission Regulation (EC) No451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Directive 91/414 (OJ 2000 L55, p.25), as amended by Commission Regulation (EC) No1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414 (OJ 2002 L224, p.23), organises the procedure for the evaluation of various active substances with a view to their possible inclusion in Annex I to Directive 91/414. Those substances include carbofuran.

6The procedure introduced by Regulation No451/2000 begins with a notification of interest, provided for under Article 4 of the regulation, which is to be sent to the rapporteur Member State (designated in Annex I to Regulation No451/2000) by any producer who wishes to secure the inclusion of a substance in Annex I to Directive 91/414.

7The evaluation proper of the active substances is governed by Article 8 of Regulation No451/2000, as amended by Article 20 of Regulation No1490/2002. Article 8(1) of Regulation No451/2000 provides:

‘The rapporteur Member State shall evaluate and report only on those active substances for which at least one dossier has been determined to be complete … It shall send a draft report of its assessment of the dossier to the European Food Safety Authority … as quickly as possible …

At the same time, the rapporteur Member State shall make a recommendation to the Commission either:

–to include the active substance in Annex I to [Directive 91/414], stating the conditions for inclusion, or

–not to include the active substance in Annex I to [Directive 91/414], stating the reasons for the non-inclusion.

…’

8Article 8(7) of Regulation No451/2000 provides:

‘The [European Food Safety Authority] shall evaluate the rapporteur’s draft assessment report and deliver its opinion on whether the active substance can be expected to meet the safety requirements of [Directive 91/414] to the Commission at the latest one year after receipt of the rapporteur Member State draft assessment report. Where appropriate, the [European Food Safety Authority] shall give its opinion on the available options claimed to meet the safety requirements. …’

9Article 8(8) of Regulation No451/2000 provides:

‘At the latest six months after receipt of the [European Food Safety Authority] opinion referred to in paragraph 7, the Commission shall submit the draft review report. Without prejudice to any proposal it may submit with a view to amending the Annex to Directive 79/117/EEC, and on the basis of the finalised review report it shall submit to the Committee:

(a)a draft directive to include the active substance in Annex I to [Directive 91/414], setting out where appropriate the conditions, including the time-limit, for such inclusion, or

(b)a draft decision addressed to the Member States to withdraw the authorisations of plant protection products containing the active substance, pursuant to the fourth subparagraph of Article 8(2) of [Directive 91/414], whereby that active substance is not included in Annex I to [Directive 91/414], mentioning the reasons for the non-inclusion.

…’

Background to the dispute

10The applicants – FMC Chemical SPRL and Arysta Lifesciences SAS, manufacturers and distributors within the European Union of carbofuran and carbofuran-based plant protection products – notified the Commission that they wished to secure the inclusion of the active substance carbofuran in Annex I to Directive 91/414, and then sent a dossier to the Kingdom of Belgium, as rapporteur Member State, on 26 and 30 April 2002 respectively. On 3 August 2004, the European Food Safety Authority (EFSA) received the Kingdom of Belgium’s draft assessment report, which recommended that carbofuran should not be included in Annex I to Directive 91/414. On 28 July 2006, EFSA delivered to the Commission its opinion (updated and published on its internet site on 28 August 2006), entitled ‘Conclusion regarding the peer review of the pesticide risk assessment of the active substance carbofuran’ (‘the contested measure’). On 13 June 2007, the Commission adopted Decision 2007/416/EC concerning the non-inclusion of carbofuran in Annex I to Directive 91/414 and the withdrawal of authorisations for plant protection products containing that substance (OJ 2007 L156, p.30).

Procedure and forms of order sought by the parties

11By application lodged at the Registry of the Court of First Instance on 7 November 2006, the applicants brought an action for annulment of the contested measure and for compensation for the damage sustained.

12By separate documents lodged at the Registry of the Court of First Instance on 17 November 2006, the applicants made two applications for interim measures, registered under numbers T‑311/06RI and T‑311/06RII respectively, seeking (i) suspension of operation of the contested measure and (ii) an order directing the European Commission not to propose any measures related to the non-inclusion of carbofuran in Annex I to Directive 91/414, in particular, at the meeting of the Committee on 23 and 24 November 2006.

13By order of 1 March 2007 in Joined Cases T‑311/06RI, T‑311/06RII, T‑312/06R and T‑313/06R FMC Chemical and Others v EFSA (not published in the ECR), the President of the Court of First Instance rejected the applications for interim measures.

14By document lodged at the Registry of the Court of First Instance on 15 December 2006, the Commission applied for leave to intervene in support of EFSA. By order of the President of the Fifth Chamber of the Court of First Instance of 9 February 2007, the Commission was granted leave to intervene.

15By document lodged at the Registry of the Court of First Instance on 12 February 2007, the European Crop Protection Association (ECPA) applied for leave to intervene in support of the applicants. By order of the President of the Fifth Chamber of the Court of First Instance of 3 May 2007, ECPA was granted leave to intervene.

16By separate document lodged at the Registry of the Court of First Instance on 25 January 2007, EFSA raised an objection of inadmissibility under Article 114(1) of the Rules of Procedure of the Court of First Instance. The applicants lodged their observations on that objection on 27 March 2007. The Commission and ECPA lodged their statements in intervention, limited to admissibility, on 6 March and 19 June 2007 respectively.

17The applicants claim that the Court of First Instance should:

–declare the application admissible and well founded, or, in the alternative, reserve its decision on admissibility pending its decision on the substance;

–annul the contested measure;

–order EFSA and/or the Commission, in accordance with Articles 64 and 65 of the Rules of Procedure, to produce the proposal for the non-inclusion of carbofuran in Annex I to Directive 91/414;

–declare Article 20 of Regulation No1490/2002 illegal and inapplicable vis-a-vis the applicants and the review of their carbofuran dossiers;

–order EFSA to compensate the applicants for the damage sustained as a result of the contested measure, and reserve the fixing of the amount of compensation either by agreement between the parties or by the Court in the absence of such agreement;

–order EFSA to pay the costs.

18EFSA contends that the Court should:

–dismiss the application as inadmissible;

–order the applicants to pay the costs incurred by the Commission.

19The Commission contends that the Court should:

–dismiss the application as inadmissible;

–dismiss in its entirety the application for measures of organisation of procedure.

20ECPA claims that the Court should:

–declare the application admissible in its entirety;

–order EFSA to pay the costs, including those relating to ECPA’s intervention.

Law

21Under Article 114(1) of the Rules of Procedure, if a party so requests, the Court of First Instance may make a decision on admissibility without going into the substance of the case. Under Article 114(3), the remainder of the proceedings is to be oral, unless the Court of First Instance decides otherwise.

22In the present case, since it has sufficient information from the case-file, the Court will make a decision without opening the oral procedure.

Admissibility of the application for annulment

Arguments of the parties

23EFSA, supported by the Commission, pleads the inadmissibility of the application for annulment. In support of its objection of inadmissibility, EFSA submits that, on account of the very nature of EFSA, its acts cannot be the subject of proceedings under the fourth paragraph of Article 230EC, and that its opinion in relation to the assessment of the active substance carbofuran is not a measure that can be contested under that article.

24First of all, as regards its own nature, EFSA submits, first, that Article 230EC does not contain any reference to acts of European agencies or bodies other than the institutions mentioned in that provision. EFSA cannot therefore be regarded as one of the institutions mentioned in Article 230EC.

25Second, EFSA notes that, unlike other regulations establishing Community agencies, Regulation (EC) No178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing EFSA and laying down procedures in matters of food safety (OJ 2002 L31, p.1) does not provide for Article 230EC to be applicable to acts of the agency thus established, namely EFSA.

26Third, and lastly, EFSA submits that, in view of the limited nature of its powers, the legislature acted correctly in not bringing the acts of EFSA within the scope of Article 230EC.

27Next, as regards the nature of the contested measure, EFSA denies that that measure is capable of being challenged. First, EFSA notes that its findings constitute a procedural step in an ongoing decision-making process, which does not entail any change in the applicants’ legal position. Specifically, the contested measure is a preliminary step in the procedure enabling the Commission to adopt a final, binding decision.

28In that regard, EFSA points out that its role in that decision-making process is to give an opinion on the draft assessment of the rapporteur Member State and on whether the active substance can be expected to meet the safety requirements of Directive 91/414. It is on the basis of that opinion that the Commission must submit to the Committee either a draft directive to include the active substance in Annex I to Directive 91/414, or a draft decision addressed to the Member States, withdrawing the authorisations of plant protection products containing the active substance in question. EFSA refers, in that regard, to a brief review of the ‘milestones’ of the active substances peer review procedure and, specifically, to Article 8(1), (5), (7) and (8) of Regulation No451/2000.

29Second, EFSA notes that the contested measure is not a measure the legal effects of which are binding on and capable of affecting the applicants’ interests by bringing about a distinct change in their legal position. The only final decisions provided for in the legislation at issue that are capable of affecting the applicants’ legal position, and thus fulfil the requirements of Article 230EC, are the directives, or the decisions addressed to the Member States by the Commission.

30In their application and observations on the objection of inadmissibility, the applicants are concerned to demonstrate (i) that EFSA is one of the institutions whose acts may be challenged in proceedings for annulment in accordance with Article 230EC, and (ii) that the contested measure is an actionable measure for the purposes of Article 230EC.

31As regards, first of all, the question whether EFSA’s acts are open to judicial review pursuant to Article 230EC, the applicants point out, first, that, if the Court were to uphold EFSA’s argument that it is not an institution against which proceedings can be brought and whose acts may be subject to judicial review, EFSA would avoid any accountability for its acts with regard to the pesticide risk assessment of the active substances contained in plant protection products.

32Second, the applicants claim that EFSA’s statutes – contained in Regulation No178/2002 – provide that the Court of Justice is to have jurisdiction in disputes based on EFSA’s acts; in consequence, according to the applicants, EFSA’s acts are open to challenge under Article 230EC.

33Third, the applicants submit that, in a letter of 19 May 2004 to the Council, the Commission and the Parliament, EFSA itself admitted that ‘[a]ll [its] acts [were] … potentially subject to judicial review’.

34Fourth, and lastly, the applicants submit that the mere fact that the defendant is not listed in Article 230EC does not prevent the Court of First Instance from holding that its acts can be challenged on the basis of that article.

35Next, as regards the legal nature of the contested measure, the applicants take the view, first, that the title of the contested measure – ‘EFSA Conclusion Report’ – does not preclude it from being an actionable measure for the purposes of Article 230EC. In that regard, the applicants recall the case-law according to which the action for annulment must be available in the case of all measures adopted by the institutions, whatever their nature or form, which are intended to have legal effects (Case 22/70 Commission v Council [1971] ECR263).

36Second, the applicants submit that the contested measure produces legal effects. The applicants put forward two arguments in support of that assertion.

37Firstly, there is an incontrovertible causal link between the EFSA opinion and the subsequent measures taken by the Commission, the latter having no discretion in respect of those measures. In the applicants’ view, the Commission has no power to adopt a measure for inclusion or non-inclusion in Annex I to Directive 91/414 without having first obtained EFSA’s opinion. This is clearly demonstrated by the word ‘shall’ and the expression ‘on the basis of’ used in Article 8(8) of Regulation No451/2000.

38Secondly, according to the applicants, the EFSA opinion is the final and binding step in the administrative assessment of the active substances. The Court has acknowledged in that regard, in Joined Cases C‑154/04 and C‑155/04 Alliance for Natural Health and Others [2005] ECRI‑6451, that an action for annulment can be brought against such a decision in similar situations.

39Furthermore, the EFSA opinion is, according to the applicants, the culmination of a special procedure similar to the one in the case which gave rise to the judgment in Joined Cases 8/66 to 11/66 Cimenteries CBR and Others v Commission [1967] ECR75. The fact that it may be challenged follows from the obiter dictum in the judgment of the Court of Justice in Case 60/81 IBM v Commission [1981] ECR2639, paragraph 11, to the effect that an intermediary act may be challenged if it is ‘the culmination of a special procedure distinct from that intended to permit the Commission or the Council to take a decision on the substance of the case’. According to the applicants, the procedure applicable to EFSA’s review is separate from the procedure for the assessment of active substances by the rapporteur Member State and by the Commission, in so far as EFSA is subject to Regulation No178/2002 and, accordingly, must comply with specific rules applicable to its internal procedures.

40Finally, the administrative nature of EFSA’s procedures and the possibility of judicial review are recognised in Regulation (EC) No1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ 2004 L338, p.4). According to the applicants, EFSA plays the same role in the plant protection products sector as in that of products intended to come into contact with food. It follows that the contested measure is part of an administrative procedure that is different from the legislative procedure culminating in the decision not to include a substance in Annex I. It must, therefore, be open to judicial review.

41ECPA points out, first, that EFSA’s task of making the scientific assessment of applications for the inclusion of active substances in Annex I to Directive 91/414 is a typical example of the Commission’s delegation of powers to an internal body. In the context of that task of assisting the Commission, EFSA has been granted the power to adopt decisions having binding effects on third parties. In the opinion of ECPA, such a delegation of powers is possible only if it does not impede judicial review of the decisions of the authority to which those powers have been delegated. The delegated entity is subject to the same conditions for the exercise of its powers as those applicable to the institutions under the control of which it acts, so far as the review of the legality of its acts is concerned.

42Second, according to ECPA, the Commission has no discretion whatsoever and must, on the basis of the EFSA opinion, propose the inclusion of the active substance in Annex I where it is concluded that safe uses exist, or non-inclusion where no safe uses can be identified. That follows from the wording of (i) Article 8(8) of Regulation No451/2000; (ii) Article 5 of Directive 91/414, which imposes an obligation to propose the inclusion of an active substance in Annex I where the risk assessment is positive; and (iii) Article 8(2) of Directive 91/414, according to which the active substance may not be included in Annex I to Directive 91/414 where the requirements of Article 5 of the directive are not satisfied.

Findings of the Court

43It is settled case-law that only measures the legal effects of which are binding on the applicant and capable of affecting his interests by bringing about a distinct change in his legal position are acts or decisions against which proceedings for annulment may be brought. As regards, specifically, acts or decisions drawn up in a procedure involving several stages, only measures definitively laying down the position of the institution on the conclusion of that procedure are, in principle, measures against which proceedings for annulment may be brought. It follows that preliminary measures or measures of a purely preparatory nature are not measures against which proceedings for annulment may be brought (IBM v Commission, cited in paragraph 39 above, paragraphs 9 and 10; order in Case T‑426/04 Tramarin v Commission [2005] ECRII‑4765, paragraph 25; and order of the President of the Court of First Instance of 24 March 2006 in Case T‑454/05R Sumitomo Chemical Agro Europe and Philagro France v Commission, not published in the ECR, paragraph 50).

44In the present case, the contested measure is an opinion delivered by EFSA pursuant to Article 8(7) of Regulation No451/2000.

45Article 8 of Regulation No451/2000 describes the evaluation procedure for active substances notified by interested parties in accordance with Article 4 of that regulation, and defines the respective roles in that evaluation of the Member States, EFSA and the Commission. It can be seen from Article 8 that the procedure for the evaluation of active substances is made up of successive stages, and at every such stage the Member States, EFSA and the Commission are each assigned a specific role.

46First of all, under Article 8(1) of Regulation No451/2000, the Member State designated rapporteur Member State is to make an initial assessment of the dossier lodged by the notifiers and to draw up a draft assessment report which it has to send to EFSA.

47Next, after circulating the draft assessment report to the Member States and, if appropriate, organising a consultation of experts pursuant to Article 8(5) of Regulation No451/2000, EFSA is to evaluate the draft assessment report in accordance with Article 8(7) and to deliver its opinion on whether the active substance can be expected to meet the safety requirements of Directive 91/414 to the Commission at the latest one year after receipt of the draft assessment report.

48Finally, under Article 8(8) of Regulation No451/2000, at the latest six months after receipt of the EFSA opinion referred to in Article 8(7), the Commission is to draw up a draft review report. On the basis of the finalised review report, it is then to submit to the Committee either a draft directive to include the active substance in Annex I, or a draft decision addressed to the Member States to withdraw the authorisations of plant protection products containing the active substance, whereby that active substance is not included in Annex I to Directive 91/414. The directive or decision is then to be adopted in accordance with the procedure provided for in Article 19 of Directive 91/414.

49It follows that the procedure for the evaluation of active substances contained in plant protection products under Article 8 of Regulation No451/2000 comprises three successive stages: (i) the drawing-up of a draft assessment report by the rapporteur Member State; (ii) the adoption by EFSA of an opinion on whether the active substance can be expected to meet the safety requirements; and (iii) the preparation by the Commission of a finalised review report, which is submitted to the Committee together with a draft directive or decision. Only the directive or the decision produces binding legal effects capable of affecting the interests of the notifiers.

50Thus, the contested measure must be regarded as a preliminary step in the procedure for the inclusion or the non-inclusion of active substances in Annex I to Directive 91/414 and, in consequence, it is not a measure against which proceedings for annulment may be brought.

51That conclusion is not affected by the arguments put forward by the applicants and ECPA. First, as regards the applicants’ argument that the title of a measure cannot preclude it from being open to challenge, suffice it to note that, while the applicants correctly refer to the judgment in Commission v Council, cited in paragraph 35 above – in which the Court of Justice, at paragraph 42, held that an action for annulment should be available in the case of all measures adopted by the institutions, whatever their nature or form, which are intended to have legal effects – it is nevertheless incumbent on the applicants to show that the contested measure is intended to produce such effects, and in the present case they have failed to do so.

52Second, the applicants’ argument that the contested measure produces binding legal effects must also be rejected. According to the applicants, since the Commission is not empowered to adopt a decision not to include, or to include, the substance in question in Annex I to Directive 91/414 without first obtaining the opinion of EFSA, it has no discretion whatsoever. Although, admittedly, the Commission adopts its decision not to include, or to include, the substance in question in Annex I to Directive 91/414 after obtaining the opinion of EFSA, note must be taken of the fact that there is nothing in Regulation No451/2000 to suggest that the Commission is obliged to comply with EFSA opinions in substantive terms and therefore has no discretion.

53As regards the parallel argument of ECPA relating to the wording of Article 8(8) of Regulation No451/2000, and also of Article 5 and Article 8(2) of Directive 91/414, this too must be rejected. ECPA effectively infers from the wording of those provisions that the Commission has no discretion whatsoever and that it must, on the basis of the EFSA opinion, propose the inclusion of the active substance in Annex I where it is concluded that safe uses exist, or the non-inclusion of that substance where no safe uses can be identified.

54However, it must be noted, in the first place, that Article 8(8) of Regulation No451/2000 provides that, after receiving the EFSA opinion, the Commission is to draw up a draft review report and that, on the basis of the finalised review report, it is to submit a draft directive or decision to the Committee. It does not follow from that provision that the Commission is bound by the EFSA opinion.

55In the second place, contrary to ECPA’s contention, Article 5 of Directive 91/414 merely describes the conditions to be fulfilled in order for an active substance to be included in Annex I to Directive 91/414 and does not contain any indication that would support the conclusion that the Commission may not depart from the EFSA opinion.

56Similarly, and in the third place, Article 8(2) of Directive 91/414 merely confirms that, in order for a substance to be included in Annex I, it must fulfil the conditions of Article 5. It does not follow from Article 8(2) of Directive 91/414 that the Commission must adhere to the EFSA opinion.

57Third, the applicants claim that the contested measure concludes the administrative stage of the evaluation of the active substance in question and may, as such, be the subject of an action for annulment. In that regard, firstly, the applicants rely on the judgment in Alliance for Natural Health and Others, cited in paragraph 38 above, which recognised the possibility of bringing an action against a final decision of EFSA refusing an application for modification of a positive list of vitamins and minerals within the meaning of Article 4 of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ 2002 L183, p.51).

58However, in Alliance for Natural Health and Others, cited in paragraph 38 above (at paragraph 88), the Court of Justice merely mentioned the possibility of an action for the annulment of a final decision refusing an application for modification of positive lists – without specifying that that decision is actually adopted by EFSA – or of an action for damages against EFSA, and in no way confirms that an action for annulment may be brought against a final decision of EFSA.

59Furthermore, Article 8(7) and (8) of Regulation No451/2000 does not provide that EFSA is empowered to adopt a ‘final decision’. Accordingly, in the light of the judgment in Alliance for Natural Health and Others, cited in paragraph 38 above, it cannot be held that the contested measure concludes the administrative stage of the evaluation of the active substance in question and, as such, may be the subject of an action for annulment.

60Secondly, as regards the applicants’ argument that the EFSA opinion is the final stage in a special procedure similar to that referred to in Cimenteries CBR and Others v Commission, cited in paragraph 39 above, it must be borne in mind that, in that case, the Court was called upon to rule on the admissibility of an action for annulment brought against the act of the Commission whereby, under Article 15(6) of Council Regulation No17 of 6 February 1962: First Regulation implementing Articles [81EC] and [82EC] (OJ, English Special Edition 1959-62, p.87), the Commission had withdrawn the benefit of an exemption from a fine in respect of a notified agreement, after a preliminary examination at the end of which the Commission had reached the conclusion that that agreement was contrary to Article 81EC.

61However, it must be held that the procedure laid down in Regulation No451/2000, under which EFSA adopted the measure being contested in the present case, is in no way comparable – whether with regard to its purpose, its successive stages or the institutions involved in it – to the procedure laid down in Regulation No17, which resulted in the Commission’s adoption of the measure at issue in the judgment referred to.

62Thirdly, as regards the applicants’ argument based on the judgment in IBM v Commission, cited in paragraph 39 above, according to which a provisional measure is one against which proceedings for annulment may be brought if it is the culmination of a special procedure distinct from that which enabled the Commission to take a decision on the substance of the case, it must be noted that the Court stated as follows in paragraphs 10 and 11 of that judgment:

‘10In the case of acts or decisions adopted by a procedure involving several stages, in particular where they are the culmination of an internal procedure, … in principle an act is open to review only if it is a measure definitively laying down the position of the Commission or the Council on the conclusion of that procedure, and not a provisional measure intended to pave the way for the final decision.

11It would be otherwise only if acts or decisions adopted in the course of the preparatory proceedings not only bore all the legal characteristics referred to above but in addition were themselves the culmination of a special procedure distinct from that intended to permit the Commission or the Council to take a decision on the substance of the case.’

63The applicants claim that EFSA’s review procedure is separate from the procedure for the assessment of active substances by the rapporteur Member State and the Commission, in so far as EFSA is subject to Regulation No178/2002 and, accordingly, must comply with specific rules applicable to its internal procedures. Those arguments are not persuasive in the light of the criteria laid down in IBM v Commission, cited in paragraph 39 above. There is in fact nothing in Regulation No178/2002 to suggest that the contested measure is the culmination of a special procedure conducted before EFSA and not part of the ordinary procedure laid down in Directive 91/414 for the purposes of the adoption by the Commission of an act which lays down its final position.

64Moreover, only the Commission directive or decision may be regarded as the final stage in the procedure for the evaluation of active substances contained in plant protection products. As noted in paragraph 49 above, that evaluation procedure comprises three successive stages. Since the contested measure relates to the second stage in that procedure, it is not the culmination of a special procedure as referred to in IBM v Commission, cited in paragraph 39 above.

65Fourth, the applicants’ argument relating to the provisions of Regulation No1935/2004 must be rejected. Article 14 of that regulation merely provides for an administrative review by the Commission of the measures which EFSA adopts in exercise of the powers conferred upon it by that regulation.

66Fifth, and finally, as regards the argument put forward by ECPA that EFSA’s task is a typical example of delegation to an internal body of the power to adopt decisions having binding effects on third parties, meaning that the decisions of the delegated entity are subject to judicial review, it follows from the case-law that powers cannot be presumed to have been delegated and that, even when empowered to delegate its powers, the delegating authority must take an express decision to that effect (Case 9/56 Meroni v HighAuthority [1957-1958] ECR 133, at page 151). Contrary to the contention of ECPA, Article 8(7) of Regulation No451/2000, as amended by Article 20 of Regulation No1490/2002, does not in any way mean that the power to adopt binding decisions has been delegated to EFSA. On the contrary, that provision, in conjunction with Article 8(8) of Regulation No451/2000, provides that the Commission is to draw up a review report after receiving the opinion of EFSA on whether the active substance can be expected to meet the safety requirements of Directive 91/414; on the basis of that report, the Commission is to submit a draft decision or directive to the Committee. It must therefore be concluded that the Commission has not delegated to EFSA the power to adopt decisions having binding effects on third parties.

67Having regard to the foregoing, it must be held that the applicants have not produced evidence enabling it to be established to the requisite legal standard that the contested measure produces binding legal effects capable of affecting their interests by bringing about a distinct change in their legal position.

68The application for annulment must therefore be declared inadmissible, and there is no need to rule on EFSA’s contention that the Court of First Instance has no jurisdiction to rule on an application under the fourth paragraph of Article 230EC for the annulment of one of EFSA’s acts.

Admissibility of the plea of illegality

Arguments of the parties

69EFSA pleads the inadmissibility of the applicants’ plea of illegality in respect of Article 20 of Regulation No1490/2002, pursuant to which – according to the applicants – EFSA was retroactively and illegally involved in the procedure for the evaluation of the active substances. EFSA maintains that, since the plea of illegality is subordinate to the main plea in law and the latter is inadmissible, the plea of illegality is itself inadmissible.

70The applicants submit that, since the contested measure produces legal effects on them, the plea of illegality is admissible.

Findings of the Court

71It has been consistently held that the possibility afforded by Article 241EC of pleading the inapplicability of a regulation or measure of general application which forms the legal basis for the contested implementing measure does not constitute an independent right of action and recourse may be had to it only as an incidental plea, so that if the main action is inadmissible so also is the plea of illegality (Case 33/80 Albini v Council andCommission [1981] ECR2141, paragraph 17; order in Joined Cases T‑54/00 and T‑73/00 Federación de Cofradías de Pescadores de Guipúzcoa and Others v Council [2001] ECR II‑2691, paragraph 82; and order in Case T‑386/04 Eridania Sadam and Others v Commission[2005] ECR II‑2531, paragraph 51).

72Since the application for annulment is inadmissible, the plea of illegality must also be declared inadmissible.

Admissibility of the claim for damages

Arguments of the parties

73EFSA pleads the inadmissibility of the claim for damages in so far as the contested measure has no legal effects.

74The applicants submit that, to the extent that the contested measure produces legal effects and the claim for damages is based on that measure, the claim for damages is admissible.

75The applicants submit also, without further explanation, that the claim for damages is not based solely on the unlawfulness of the contested measure but also on the damage suffered as a result of the unlawful requests by EFSA for supplementary data, the retroactive application of deadlines and the frustration of legitimate expectations.

Findings of the Court

76According to settled case-law, for the Community to incur non-contractual liability, within the meaning of the second paragraph of Article 288EC, as a result of the unlawful conduct of its bodies, a set of conditions must be satisfied, namely, the unlawfulness of the alleged conduct of the institutions, the reality of the damage and the existence of a causal link between the alleged conduct and the damage complained of (Case 26/81 Oleifici Mediterranei v EEC [1982] ECR3057, paragraph 16; Case T‑175/94 International Procurement Services v Commission [1996] ECR II‑729, paragraph 44; and order of the Court of First Instance of 8 September 2006 in Case T‑92/06 Lademporiki and Parousis & Sia v Commission, not published in the ECR, paragraph 10).

77Furthermore, according to the first paragraph of Article 21 of the Statute of the Court of Justice, applicable to the Court of First Instance by virtue of the first paragraph of Article 53 of the Statute, and Article 44(1)(c) of the Rules of Procedure of the Court of First Instance, the application must state the subject-matter of the proceedings and contain a summary of the pleas in law on which it is based. According to the case-law, that statement must be sufficiently clear and precise to enable the defendant to prepare its defence and the Court to rule on the application, if necessary, without any further information (Case T‑387/94 Asia Motor France and Others v Commission [1996] ECR II‑961, paragraph 106, and Case T‑113/96 Dubois et Fils v Council and Commission [1998] ECR II‑125, paragraph 29).

78In that regard, it follows from the case-law that, in the context of an action for damages, a claim for an unspecified form of damages is not sufficiently concrete and must therefore be regarded as inadmissible (Case 5/71 Zuckerfabrik Schoeppenstedt v Council [1971] ECR975, paragraph 9, and Joined Cases T‑79/96, T‑260/97 and T‑117/98 Camar and Tico v Commission and Council [2000] ECR II‑2193, paragraph 181).

79However, the Court has accepted that, in special circumstances, it is not essential to specify the exact extent of the damage in the application and to state the amount of compensation sought (see, to that effect, Case T‑64/89 Automec v Commission [1990] ECR II‑367, paragraphs 75 to 77, and order in Case T‑91/05 Sinara Handel v Counciland Commission [2007] ECR II‑245, paragraphs 110 to 116). It has also held in that regard that the applicant must establish, or at least indicate, the existence of any such circumstances in the application (order in Case T‑262/97 Goldstein v Commission [1998] ECR II‑2175, paragraph 25).

80By the claim for damages in the present case, compensation is sought in relation to three separate forms of damage: (i) the loss of profit which the applicants suffered as a result of their clients’ stated intention to reduce or stop their purchases of the active substance in question; (ii) the non-material damage that resulted from the damage to the applicants’ reputation following the adoption of the contested measure; and (iii) the actual damage associated with the additional costs which the applicants incurred following the requests for data made by EFSA at an advanced stage in the evaluation procedure.

81The Court finds, however, that the applicants have not quantified the damage which they consider themselves to have suffered or put forward any facts at all that would enable the extent of that damage to be assessed. In their pleadings they have merely claimed, in abstract and general terms, damage suffered ‘in undertaking, with EFSA’s strong encouragement, the cost of performing studies agreed at the 19 May 2005 EFSA evaluation meeting’, ‘the lost profits deriving from their customers’ and distributors’ stated intention to reduce or stop purchasing carbofuran’ and ‘immaterial damages resulting from the bad reputation that the contested measure has brought to the image of the company vis-à-vis the marketplace, both within and outside the [European Union]’. It must be held, therefore, that the applicants have failed to provide evidence that would enable the reality of the purported damage to be verified with the requisite accuracy or the amount of that damage to be assessed, albeit only approximately.

82Furthermore, it must be observed that the applicants do not explain why they failed to carry out an assessment, even approximately, of the damage purportedly suffered. At most, they state, as regards the three forms of damage in relation to which they seek compensation, that ‘[t]hese damages are very difficult to quantify and may very well not be quantifiable such that they may need to be fixed ex aequo et bono in the course of the proceedings’. Such claims, lacking any explanation, manifestly cannot be regarded as sufficient justification for the total absence of any assessment of that damage.

83Therefore, having regard to the first paragraph of Article 21 of the Statute of the Court of Justice, applicable to the Court of First Instance by virtue of the first paragraph of Article 53 of the Statute, and Article 44(1)(c) of the Rules of Procedure of the Court of First Instance, the claim for damages must be declared inadmissible.

Measures of organisation of procedure

Arguments of the parties

84In its objection of inadmissibility, EFSA, supported by the Commission, maintains that the applicants’ request for the production of documents should be rejected. In support of the form of order thus sought, EFSA asserts that the applicants should have provided the Court with at least minimum information indicating the utility of those documents for the purposes of the proceedings, which they failed to do, and that, since all the pleas in support of their application are inadmissible, it is unnecessary to examine the request for the production of documents.

85In their observations on the objection of inadmissibility, the applicants submit that the purpose of the requests for documents is to demonstrate the sine qua non link between the contested measure and the proposal and adoption of the non-inclusion decision.

Findings of the Court

86According to the case-law, in order to enable the Court to determine whether it is conducive to the proper conduct of the procedure to order the production of certain documents, the party requesting production must identify the documents requested and provide the Court with at least minimum information indicating the utility of those documents for the purposes of the proceedings (see, to that effect, Case C‑185/95P Baustahlgewebe v Commission [1998] ECR I‑8417, paragraphs 92 and 93, and Joined Cases T‑45/98 and T‑47/98 Krupp Thyssen Stainless and Acciai speciali Terni v Commission [2001] ECR II‑3757, paragraphs 30 and 31).

87In the present case, the Court considers that the application for annulment is inadmissible, as the contested measure must be regarded as a preliminary step in the procedure leading to the inclusion or non-inclusion of the active substance in Annex I to Directive 91/414. That finding is based on an analysis of the procedure referred to in Article 8 of Regulation No451/2000, and the Court’s reasoning is in no way dependent on the content of the measure adopted by the Commission at the conclusion of the procedure laid down by that article.

88It follows that the request for production of documents must be rejected, as the utility of those documents for the purposes of the proceedings has not been demonstrated.

Costs

89Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Furthermore, under the first subparagraph of Article 87(4) of the Rules of Procedure, the Member States and institutions which have intervened in the proceedings are to bear their own costs. Finally, under the third subparagraph of Article 87(4) of the Rules of Procedure, the Court of First Instance may order an intervener to bear his own costs.

90Since EFSA has applied only for the applicants to be ordered to pay the costs incurred by the Commission, and not EFSA’s own costs, it must be ordered to bear its own costs. Equally the applicants and the interveners must be ordered to bear their own costs.

On those grounds,

THE COURT OF FIRST INSTANCE (Second Chamber)

hereby orders:

1.The action is dismissed.

2.FMC Chemical SPRL, Arysta Lifesciences SAS, the European Food Safety Authority (EFSA), the European Crop Protection Association (ECPA) and the Commission shall each bear their own costs.

Luxembourg, 17 June 2008.

* Language of the case: English.