CELEX: 62008CO0517
Language: en
Date: 2010-04-15 00:00:00
Title: Order of the Court (Second Chamber) of 15 April 2010. # Makhteshim-Agan Holding BV and Others v European Commission. # Appeal - Directive 91/414/EEC - Non-inclusion of endosulfan in Annex I to that directive - Withdrawal of marketing authorisations - Appeal manifestly unfounded. # Case C-517/08 P.

ORDER OF THE COURT (Second Chamber)
      15 April 2010 (*)
      
      (Appeal – Directive 91/414/EEC – Non-inclusion of endosulfan in Annex I to that directive – Withdrawal of marketing authorisations – Appeal manifestly unfounded)
      In Case C‑517/08 P,
      APPEAL under Article 56 of the Statute of the Court of Justice, lodged on 19 November 2008,
      Makhteshim-Agan Holding BV, established in Amsterdam (Netherlands),
      
      Alfa Agricultural Supplies SA, established in Athens (Greece),
      
      Aragonesas Agro SA, established in Madrid (Spain),
      
      represented by C. Mereu and K. Van Maldegem, avocats,
      appellants,
      the other parties to the proceedings being:
      European Commission, represented by L. Parpala and N.B. Rasmussen, acting as Agents, with an address for service in Luxembourg,
      
      defendant at first instance,
      Bayer CropScience AG, established in Monheim am Rhein (Germany),
      
      applicant at first instance,
      European Crop Protection Association (ECPA), established in Brussels (Belgium), represented by D. Waelbroeck, avocat,
      
      Kingdom of Spain,
      
      interveners at first instance,
      THE COURT (Second Chamber),
      composed of J.N. Cunha Rodrigues, President of the Chamber, P. Lindh (Rapporteur), A. Rosas, U. Lõhmus and A. Arabadjiev,
         Judges,
      
      Advocate General: V. Trstenjak,
      Registrar: R. Grass,
      after hearing the Advocate General,
      makes the following
      Order
      1        By their appeal, Makhteshim-Agan Holding BV, Alfa Agricultural Supplies SA and Aragonesas Agro SA (‘the appellants’) seek
         the setting aside of the judgment of the Court of First Instance of the European Communities (now ‘the General Court’) in
         Case T‑75/06 Bayer CropScience and Others v Commission [2008] ECR II‑2081 (‘the judgment under appeal’), by which it dismissed their action for annulment of Commission Decision
         2005/864/EC of 2 December 2005 concerning the non-inclusion of endosulfan in Annex I to Council Directive 91/414/EEC and the
         withdrawal of authorisations for plant protection products containing this active substance (OJ 2005 L 317, p. 25, ‘the contested
         decision’).
      
       Legal context
       Directive 91/414/EEC
      2        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, and corrigendum, OJ 1992 L 170, p. 40), as amended by Council Regulation (EC) No 806/2003 of 14 April 2003 (OJ 2003
         L 122, p. 1, ‘Directive 91/414’), lays down the Community rules applicable to the granting of authorisation to place plant
         protection products on the market and to the withdrawal of such authorisation. It is a requirement of that directive that
         Member States should authorise those products only if the active substance which they contain is included in Annex I thereto.
      
      3        Article 2 of Directive 91/414, entitled ‘Definitions’, provides:
      
      ‘For the purposes of this Directive the following definitions shall apply:
      ...
      2.      “residues of plant protection products”
      one or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment
         and resulting from the use of a plant protection product, including their metabolites and products resulting from their degradation
         or reaction.
      
      ...’
      4        Article 5(1) of that directive is worded as follows:
      
      ‘In the light of current scientific and technical knowledge, an active substance shall be included in Annex I for an initial
         period not exceeding 10 years, if it may be expected that plant protection products containing the active substance will fulfil
         the following conditions:
      
      (a)      their residues, consequent on application consistent with good plant protection practice, do not have any harmful effects
         on human or animal health or on groundwater or any unacceptable influence on the environment, and the said residues, in so
         far as they are of toxicological or environmental significance, can be measured by methods in general use;
      
      (b)      their use, consequent on application consistent with good plant protection practice, does not have any harmful effects on
         human or animal health or any unacceptable influence on the environment as provided for in Article 4(1)(b)(iv) and (v).’
      
      5        Article 8(2) of Directive 91/414 also provides that, after the latter’s adoption, the Commission of the European Communities
         is to commence a programme of work for the gradual examination of the active substances which are not listed in Annex I to
         that directive within a 12-year period. That programme may require interested parties to submit all requisite data to the
         Commission and the Member States within a certain period.
      
      6        Article 19 of Directive 91/414 provides that the Commission is to be assisted by the Standing Committee on the Food Chain
         and Animal Health (‘the Committee’).
      
      7        Article 1 of Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article
         8(2) of Directive 91/414 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), as amended by
         Commission Regulation (EC) No 1335/2005 of 12 August 2005 (OJ 2005 L 211, p. 6), extended the abovementioned time period of
         12 years until 31 December 2006 for the active substances which were assessed in the framework of Commission Regulation (EEC)
         No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of
         work referred to in Article 8(2) of Directive 91/414 (OJ 1992 L 366, p. 10), as amended by Commission Regulation (EC) No 2266/2000
         of 12 October 2000 (OJ 2000 L 259, p. 27, ‘Regulation No 3600/92’).
      
      8        Finally, Article 6 of Directive 91/414 provides for the possibility of the inclusion of an active substance in Annex I to
         that directive.
      
       Regulation No 3600/92
      9        Regulation No 3600/92 regulates the procedure for the assessment of a number of substances with a view to their possible inclusion
         in Annex I to Directive 91/414. One of the substances listed in Annex I to Regulation No 3600/92 is endosulfan.
      
      10      That regulation provides, in particular, that for each substance, a Member State is to be designated rapporteur by regulation.
      
      11      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), as amended by Commission
         Regulation (EC) No 2230/95 of 21 September 1995 (OJ 1995 L 225, p. 1, ‘Regulation No 933/94’), designated the active substances
         which should be assessed in the framework of Regulation No 3600/92, designated a Member State to act as rapporteur in respect
         of each substance and laid down the deadline for the submission to that Member State of the dossiers referred to in Article
         6 of the latter regulation.
      
      12      With regard to endosulfan, 31 October 1995 was the date laid down in Article 2(2) of Regulation No 933/94. It is clear, moreover,
         from Annex I to that regulation that the Kingdom of Spain was designated as the rapporteur for that substance.
      
      13      Article 7(3) of Regulation No 3600/92 provides that, after receiving the summary dossier drawn up by the producers of the
         active substance whose inclusion in Annex I to Directive 91/414 is sought and the assessment report drawn up by the rapporteur
         Member State, the Commission is to refer that dossier and that report to the Committee for examination.
      
      14      Article 7(3A)(d) of that regulation provides that, after the examination by the Committee, the Commission may present to the
         latter a draft decision to postpone inclusion of the active substance in Annex I to Directive 91/414, pending the submission
         of the results of additional trials or information.
      
      15      It is clear from Article 8(3) of the same regulation that, in the light of the outcome of the additional trials or the additional
         information, the Commission may present to the Committee a draft decision concerning the inclusion or the non-inclusion of
         the active substance in Annex I to that directive.
      
       The facts giving rise to the dispute and the contested decision
      16      AgrEvo GmbH (now Bayer CropScience AG), Makhteshim-Agan Holding BV, Alfa Agricultural Supplies SA and Aragonesas Agro SA are
         companies whose business includes the production and marketing of endosulfan and plant protection products based on that substance,
         which is used in the manufacture of pesticides. Those companies wished to obtain the inclusion of endosulfan in Annex I to
         Directive 91/414 in the context of the procedure laid down in Article 8(2) of that directive. In July 1993 they notified their
         application for that purpose.
      
      17      By the deadline of 31 October 1995 laid down by Article 2(2) of Regulation No 933/94, only AgrEvo GmbH and Makhteshim-Agan
         International Coordination Center had submitted dossiers on endosulfan in accordance with Article 6 of Regulation No 3600/92.
         Those two companies combined their efforts within a group called the ‘Endosulfan task force’ (‘the task force’).
      
      18      During February 2000, the rapporteur Member State sent the Commission a draft assessment report in which it concluded that
         the decision on the inclusion of endosulfan in Annex I to Directive 91/414 should be deferred pending receipt and examination
         of the additional information. That draft report was communicated to the task force and to the Member States.
      
      19      Considering that certain additional information was needed for the examination of endosulfan and under Article 7(3A)(d) of
         Regulation No 3600/92, on 21 November 2001 the Commission adopted Decision 2001/810/EC concerning the decision on the possible
         inclusion of certain active substances into Annex I to Directive 91/414 (OJ 2001 L 305, p. 32). In accordance with that decision,
         the deadline for submission of new data concerning endosulfan was postponed until 25 May 2002 and that for the submission
         of certain long-term studies until 31 May 2003.
      
      20      In May 2002, the task force provided new data. In July 2002, the task force entered into discussions with the rapporteur Member
         State concerning the possibility of notifying studies relating to a different formulation of endosulfan. The product originally
         took the form of wettable powder (‘WP’) or emulsifiable concentrate (‘EC’). The new product took the form of a capsule suspension
         (‘CS’). At a meeting on 17 July 2002, the representatives of that Member State stated that they could not accept the new dossier.
         The Commission too did not give its approval.
      
      21      In May 2003, the task force submitted the long-term studies, to which they had added new data, that is to say, they submitted
         a new dossier concerning the ‘CS formulation’ (‘the CS dossier’).
      
      22      On 17 May 2004, a tripartite meeting was held between the Commission, the rapporteur Member State and the task force (‘the
         tripartite meeting’). At that meeting, the Commission stated that it planned to propose to the Committee that endosulfan should
         not be included in Annex I to Directive 91/414. It invited the task force to submit its comments before 21 June 2004, while
         making it clear that no new studies could be accepted, since the deadline of 31 May 2003 had passed.
      
      23      By letter of 25 June 2004 addressed to the Commission, the representatives of the task force objected to the way in which
         the evaluation of endosulfan had been conducted. They also sought authorisation to produce a number of technical explanations
         and presented additional arguments and new studies.
      
      24      By letter of 12 July 2004, the Commission asked the rapporteur Member State not to take into account the new studies submitted
         by the task force. A copy of that letter was sent to that task force.
      
      25      On 2 December 2005, the Commission adopted the contested decision, which was notified under document number C(2005) 4611.
         The Commission noted, in particular in recital 8 in the preamble thereto, the following factors:
      
      ‘During the evaluation of [endosulfan], a number of areas of concern have been identified. This was in particular the case
         concerning its environmental fate and behaviour as the route of degradation of the active substance is not completely clear
         and unknown metabolites were found in soil degradation, water/sediment degradation and mesocosm studies. ... In addition exposure
         of operators under indoor conditions has not been considered to be sufficiently addressed with the available information.
         Moreover endosulfan is volatile, its main metabolite is persistent and it has been found in monitoring results of regions
         where the substance was not used. Consequently, as these concerns remain unsolved, assessments made on the basis of the information
         submitted have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products
         containing endosulfan satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414 …’
      
       The action before the General Court and the judgment under appeal
      26      By application lodged at the Registry of the General Court on 27 February 2006, Bayer CropScience AG, Makhteshim-Agan Holding
         BV, Alfa Agricultural Supplies SA and Aragonesas Agro SA (‘the applicants’) brought an action for annulment of the contested
         decision.  The European Crop Protection Association (ECPA) intervened in support of their claims. The Kingdom of Spain intervened
         in support of the form of order sought by the Commission.
      
      27      The applicants put forward three pleas in law supporting the claim for annulment. The first plea alleged procedural flaws,
         unfairness of the evaluation procedure and breach of the principle of protection of legitimate expectations. The second alleged,
         first, infringement of Article 95(3) EC and, secondly, infringement of Article 5(1) of Directive 91/414. The third alleged
         breach of certain general principles of European Union law, including the principle of equal treatment (eighth branch).
      
      28      Without formally raising an objection of inadmissibility, the Commission, supported by the Kingdom of Spain, expressed doubts
         as to the applicants’ interest in bringing proceedings and contested the locus standi of certain of the applicants.
      
      29      With regard to locus standi, the Commission argued that although Bayer CropScience was individually concerned by the contested decision, since it had
         taken part in the administrative procedure, that was not true of the other three applicants which, consequently, could not
         be regarded as individually concerned by that decision.
      
      30      On that point, the General Court responded that, in so far as Bayer CropScience AG was entitled to bring proceedings, there
         was no need to consider whether the other applicants had standing to bring proceedings.
      
      31      On the substance, the General Court dismissed the action.
      
      32      It first answered the first plea in law and the second branch of the second plea, alleging infringement of Article 5(1) of
         Directive 91/414. It then replied to the first branch of the second plea and, finally, to the third plea.
      
      33      In the context of its response to the first plea and to the second branch of the second plea, the General Court first examined
         whether the Commission was entitled, on 12 July 2004, to refuse to examine certain data or studies which it considered had
         been presented out of time. In paragraph 74 of the judgment under appeal, it considered that the question whether the procedural
         time-limits were applicable ought to be examined first, since it related to the general framework of assessment for the present
         case.
      
      34      In order to answer that question, the General Court, in paragraph 80 of the judgment under appeal, examined the circumstances
         in which the Commission might have been under an obligation to postpone the deadline for presenting studies or data. In paragraph
         88 of that judgment, it pointed out that in Case C‑326/05 P Industrias Químicas del Vallés v Commission [2007] ECR I‑6557, the Court held that the Commission had made a manifest error of assessment in refusing to grant to a company
         a deferral of the deadline for submission of a complete initial dossier, because the fact that it was impossible for that
         company to comply with the deadlines was attributable, at least in part, to the contradictory behaviour of the competent authorities.
      
      35      The General Court, in paragraph 89 of the judgment under appeal, inferred from that case-law that an extension of the deadlines
         is possible if the party concerned was in a situation of force majeure which prevented it from complying with the procedural time-limits, a situation which might obtain if the impossibility of
         complying with those time-limits was attributable, at least in part, to contradictory behaviour on the part of the competent
         authorities.
      
      36      The General Court therefore began to examine whether the applicants had been placed, as a result of contradictory behaviour
         on the part of the assessors, in a situation of force majeure which had prevented them from complying with the legislative time-limits. To do so, it carried out an examination of seven
         issues in respect of which it examined whether there had been contradictory behaviour on the part of the authorities which
         had deprived the applicants of the possibility of providing information before the expiry of the legislative deadlines.
      
      37      In paragraph 206 of the judgment under appeal, the General Court considered that that examination had not brought to light
         any manifest error of assessment on the part of the Commission or an infringement of the rights of the defence or the frustration
         of any legitimate expectation. It concluded that the applicants were not in a situation of force majeure which prevented them from complying with the procedural deadlines. It therefore rejected the first plea and the second branch
         of the second plea.
      
      38      The General Court, having considered that the arguments alleging infringement of Article 95 EC had been confused with those
         put forward in the context of the first plea and the second branch of the second plea, rejected the first branch of the second
         plea. Similarly, the General Court considered that there had been no breach of the principle of proportionality, or the principle
         of the protection of legitimate expectations and of legal certainty, or the prohibition against acting ultra vires, or the duty to undertake a diligent and impartial assessment, or the prohibition against a misuse of powers, or the rights
         of the defence, or the principle of the excellence and independence of scientific opinions, or the principle of equal treatment,
         or the principle of lex specialis, or the principle of estoppel or nemini licet venire contra factum proprium, and rejected the third plea.
      
       Forms of order sought by the parties
      39      The appellants claim that the Court should:
      
      –        set aside the judgment under appeal;
      –        annul the contested decision or,
      –        alternatively, refer the case back to the General Court for judgment; and
      –        order the Commission to pay the costs, including the costs before the General Court.
      40      The Commission claims that the Court should dismiss the appeal and order the appellants to pay the costs.
      
      41      The European Crop Protection Association (ECPA) intervened without stating whether it supported the appeal.
      
       The appeal
      42      Under Article 119 of its Rules of Procedure, where an appeal is, in whole or in part, clearly inadmissible or clearly unfounded,
         the Court may at any time dismiss the appeal in whole or in part by reasoned order without opening the oral procedure.
      
       The locus standi of the appellants
      43      The Commission contests the locus standi of the appellants. It submits that they did not participate in the task force and that they are no more concerned by the contested
         decision than other producers of endosulfan. The Commission also states that the third applicant company before the General
         Court was Alfa Georgika Efodia AEVE, whereas the second appellant is Alfa Agricultural Supplies SA.
      
      44      The Commission considers that, inasmuch as, on the one hand, the General Court did not rule on the issue of the admissibility
         of the action of the three appellants and as, on the other hand, Bayer CropScience AG did not bring an appeal, any examination
         of the action to set aside the judgment under appeal must be preceded by an examination of its pleas relating to the locus standi of the appellants. On that basis, it points out that it is settled case-law that inadmissibility constitutes a ground involving
         a question of public policy which may, and even must, be raised of its own motion by the Community judicature.
      
      45      The Commission submits that the appellants never had locus standi at first instance and that they cannot therefore challenge the contested decision by indirect means.
      
      46      As to whether Makhteshim-Agan Holding BV and Makhteshim-Agan International Coordination Center are, as claimed, identical,
         the Commission points out that the statement of the Makhteshim Group’s legal adviser was made only in connection with the
         appeal.
      
      47      The appellants submit that, in appeals and as regards admissibility, the Court has jurisdiction only to examine whether the
         appeal was brought within the time-limits and whether it is limited to points of law. Examination of the locus standi of the appellants would require the Court to carry out an assessment of the facts which it has no jurisdiction to do. They
         take the view that, having had the status of parties to the dispute before the General Court, they are entitled to bring an
         appeal.
      
      48      If the Court should consider that it has jurisdiction to rule on the locus standi of the appellants, then the latter refer to their pleadings before the General Court. They point out that Makhteshim-Agan
         Holding BV and Makhteshim-Agan International Coordination Center do not have separate legal personalities, for the latter
         is merely an agency of the former.
      
      49      Last, they claim that it is Alfa Agricultural Supplies SA which was one of the applicants and which is one of the appellants.
      
      50      It is common ground that the General Court dismissed as unfounded the action brought by the appellants, without ruling on
         the standing of those parties to apply for the annulment of the contested decision.
      
      51      Those parties have therefore been unsuccessful in their submissions before the General Court for the purpose of the second
         paragraph of Article 56 of the Statute of the Court of Justice.
      
      52      There is no doubt that Makhteshim-Agan Holding BV and Aragonesas Agro SA are the same parties as those whose actions were
         dismissed before the General Court. With regard to Alfa Agricultural Supplies SA, the second appellant, it is clear from the
         application for annulment brought before the General Court and from the pleadings presented before that court that that company
         was the third applicant before the General Court.
      
      53      Accordingly, it follows from the second paragraph of Article 56 of the Statute of the Court of Justice that Makhteshim-Agan
         Holding BV, Alfa Agricultural Supplies SA and Aragonesas Agro SA may bring an appeal before the Court of Justice against the
         judgment under appeal.
      
      54      With regard to the admissibility of the action for annulment brought before the General Court, the Court, in an appeal before
         it under Article 56 of its Statute, may rule, if necessary of its own motion, whether there is an absolute bar to proceeding
         arising from disregard of the conditions as to admissibility laid down in Article 230 EC (see Case C‑298/00 P Italy v Commission [2004] ECR I‑4087, paragraph 35, and Case C‑362/06 P Sahlstedt and Others v Commission [2009] ECR I‑0000, paragraph 22).
      
      55      It is clear from the fifth recital in the preamble to the contested decision that Makhteshim-Agan Holding BV sent the notification
         seeking the inclusion of endosulfan in Annex I to Directive 91/414. It is therefore entitled to seek annulment of that decision.
      
       Substance
      56      The appellants point out that it is clear from the eighth recital in the preamble to the contested decision that the inclusion
         of endosulfan in Annex I to Directive 91/414 was refused on the ground that the Commission identified several areas of concern.
         Among those areas, that decision refers to the discovery of an unknown metabolite (‘the metabolite of the metabolite’) in
         soil degradation and water degradation studies for the substance, to the failure sufficiently to address the exposure of operators
         in indoor conditions and to the discovery of the existence of the metabolite of endosulfan in regions where that substance
         had not been used.
      
      57      The appellants consider that the General Court rightly held that the essential question to be resolved was whether the applicants
         were in a situation of force majeure which had prevented them from complying with the procedural time-limits, and whether that impediment was attributable to
         contradictory behaviour on the part of the competent authorities.
      
      58      The appellants nevertheless state that the General Court made several errors in interpreting the relevant legal framework
         applicable to their situation and concluded, wrongly, that the competent authorities had not placed them in a situation of
         force majeure which had prevented them from complying with the procedural time-limits. Those errors were made in particular with regard
         to the issue of the metabolite of the metabolite, the operator exposure issue and the issue of the classification of endosulfan
         as a persistent organic pollutant (‘a POP’) and a persistent, bioaccumulable and toxic substance (‘a PBT’). Moreover, the
         General Court erred in law by holding that the procedural rights enjoyed by the appellants, in particular the principle of
         equal treatment, had not been infringed.
      
       The first ground of appeal, concerning the issue of the metabolite of the metabolite
      59      The appellants criticise the General Court for deciding that they had not been prevented from resolving the problem of the
         metabolite of the metabolite within the legislative deadlines on account of the behaviour of the competent authorities. They
         put forward four heads of challenge, namely, that they were not informed in good time of that problem, that the guidelines
         were retroactively applied without their having the right to be heard, that the threshold of 10% was wrongly applied and that
         they had identified a safe use for endosulfan.
      
      –       The first head of challenge 
      60      The appellants criticise the General Court for distorting the evidence which was presented to it by considering that they
         had been informed of the problem raised by the existence of the metabolite of the metabolite at an early stage in the procedure.
         They claim that the General Court confused the issue of the metabolites, which is concerned with the metabolite of endosulfan
         or endosulfan sulfate, and the issue of the metabolites of the metabolites, that is to say, the metabolite of endosulfan sulfate,
         and confused aspects relating to the rates of degradation of the metabolites with aspects relating to the routes of degradation.
         According to the appellants, although the metabolite of the metabolite was actually identified in May 2002, first, it was
         not until January 2004 that the evaluators first expressed their concerns regarding that metabolite of the metabolite and,
         secondly, before that date, the appellants were not aware that that issue was important. 
      
      61      The Commission claims that the appellants fail to show how the General Court committed an error of interpretation, first,
         between the issue of the metabolite and that of the metabolite of the metabolite and, secondly, between the rates and the
         routes of degradation. In the Commission’s view, the General Court was right to consider that the applicants were informed
         of the need to examine the routes of degradation of endosulfan from the start of 2000 at the latest. Moreover, those issues
         were discussed at length before the General Court.
      
      62      It should be pointed out that it is clear from Article 225 EC and the first paragraph of Article 58 of the Statute of the
         Court of Justice that an appeal lies on points of law only. The General Court thus has exclusive jurisdiction to find and
         appraise the relevant facts and evidence. The finding of those facts and the appraisal of that evidence thus do not, save
         where they distort the evidence, constitute a point of law which is subject, as such, to review by the Court of Justice on
         appeal (see Case C‑136/92 P Commission v Brazzelli Lualdi and Others [1994] ECR I‑1981, paragraphs 48 and 49, and Case C‑214/05 P Rossi v OHIM [2006] ECR I‑7057, paragraph 26 and case-law cited).
      
      63      It was without distorting the evidence presented to it that, in paragraph 113 et seq. of the judgment under appeal, the General
         Court pointed out that it was clear from the documents before it that various comments and requests for data made before 2004
         referred to the evaluators’ concern with understanding the degradation route of endosulfan and its metabolites, as well as
         the rate of degradation. The General Court also relied in particular on the draft assessment report of December 1999 and on
         the minutes of a meeting of 25 August 2001 which referred to the issue of the relevance from the toxicity point of view of
         metabolites other than the metabolite of endosulfan.
      
      64      It seems that, by claiming that the General Court confused, on the one hand, the issue of the metabolites with that of the
         metabolites of the metabolites and, on the other hand, aspects relating to the rates of degradation of the metabolites with
         aspects relating to the routes of degradation, the appellants do no more, in fact, than challenge the appraisal of the facts
         carried out by the General Court in considering that the applicants had been informed at an early stage in the procedure of
         the issue of the metabolites of the metabolite of endosulfan and of the need to clarify the routes of degradation of that
         substance, and that they had had the opportunity to present solutions within the deadlines. It follows that this head of challenge
         is inadmissible.
      
      –       The second head of challenge
      65      The appellants complain that the General Court contradicted itself. It considered that the draft guidelines on the relevance
         of metabolites in groundwater prepared by the Commission could not entail any self-imposed limitation on the Commission’s
         discretion and that the lawfulness of the decision must be assessed, not in the light of that draft, but in the light of the
         provisions of Directive 91/414. In addition, it contradicted itself by stating that the applicants could have submitted, from
         November 2001, studies relating to the criteria set out in those draft guidelines. In any event, the applicants found themselves
         in an uncertain situation concerning the issue of the metabolites of the metabolites.
      
      66      The Commission considers that the General Court rightly held that the draft guidelines could not entail any self-imposed limitation
         on the Commission’s discretion. Relying on a contradiction would constitute a distortion of the findings made by the General
         Court.
      
      67      It is clear from paragraph 119 of the judgment under appeal that the General Court stated that the draft guidelines could
         not entail any self-imposed limitation on the Commission’s discretion and that the lawfulness of the contested decision must
         be assessed not in the light of those guidelines, but in the light of the provisions of Directive 91/414. In paragraphs 121
         and 122 of the judgment under appeal, the General Court added, without contradicting itself, that the two problems in respect
         of which the applicants complained that they had been belatedly confronted with the draft guidelines were already contained
         in Annex II to that directive. It follows that this head of challenge is manifestly unfounded.
      
      –       The third head of challenge
      68      The appellants complain that the General Court misinterpreted statutory provisions by considering that Directive 91/414 authorised
         the evaluators to examine the behaviour of products derived from the metabolites of an active substance whereas, in their
         view, that directive allows a 10% threshold to be set only for the metabolites of the substance and not for metabolites of
         the metabolites.
      
      69      The Commission argues that the appellants have not based their claims on any legal analysis of the relevant provisions and
         rely on mere assertions. Furthermore, the General Court rightly stated that it is Directive 91/414 itself which authorises
         the evaluators to examine the behaviour of products derived from metabolites.
      
      70      In paragraph 127 of the judgment under appeal, the General Court pointed out, first, that Article 5(1)(a) of Directive 91/414
         provides that a substance is to be included in Annex I to that directive on condition that the residues of plant protection
         products containing that substance, consequent on application consistent with good plant protection practice, ‘do not have
         any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, and the
         said residues, in so far as they are of toxicological or environmental significance, can be measured by methods in general
         use’. Secondly, Article 2(2) of that directive defines the terms ‘residues of plant protection products’ as ‘one or more substances
         present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting
         from the use of a plant protection product, including their metabolites and products resulting from their degradation or reaction’.
      
      71      In the light of those definitions, it seems that the General Court rightly decided, first, that ‘metabolites and products
         resulting from their degradation or reaction’ must be understood as products resulting from the degradation of the active
         substances in the broad sense and include both metabolites and metabolites of the metabolites and, secondly, that the evaluators
         therefore made no error in seeking to clarify the route of degradation of the metabolite of the metabolite of endosulfan and
         in applying to it the 10% threshold. It follows that this head of challenge is manifestly unfounded.
      
      –       The fourth head of challenge
      72      The appellants complain that the General Court rejected their arguments concerning the solutions which they had proposed to
         address the concerns relating to the metabolites of the metabolites and which were rejected as out of time by the Commission.
         Those solutions consisted in a new formulation (the CS dossier), a reduced application rate (revised good agricultural practices
         (‘the revised GAP’)) and limited glasshouse use.
      
      73      With regard to the CS dossier, the General Court allegedly distorted the evidence presented to it by finding that the applicants
         had provided no explanation making it possible to understand why they had not submitted that dossier before the deadline.
         Furthermore, the General Court erred in law by considering that the assurances provided by the rapporteur Member State had
         not given rise to a legitimate expectation.
      
      74      As regards the revised GAP, the appellants submit that they were presented in order to address the concern regarding the metabolite
         of the metabolite. However, the applicants could not present the revised GAP before that problem arose. Therefore, by deciding
         that the revised GAP should have been presented earlier, the General Court erred in law by failing to recognise the manifest
         error of assessment made by the evaluators, who refused to take into account the revised GAP.
      
      75      As regards glasshouse use, the appellants complain that the General Court considered that that method had been presented out
         of time, although that only occurred so that the problem of the metabolite of the metabolite could be addressed. The General
         Court also committed an error of law by considering that a glasshouse is not an enclosed space, contrary to the specific wording
         of Annex II to Directive 91/414. That finding led the General Court to decide that, even if the solution consisting in glasshouse
         use had been examined, that examination would not have led to a different decision.
      
      76      The Commission claims that the General Court rightly decided that the new solutions had been presented out of time without
         its agreement and that, with the aim of addressing the problem raised by the existence of the metabolite of the metabolite
         which had been reported to the applicants as from 1999, their presentation in 2004 was out of time. 
      
      77      It is settled case-law that complaints directed against grounds included in a decision of the General Court purely for the
         sake of completeness cannot lead to that decision being set aside and are therefore nugatory (Joined Cases C‑189/02 P, C‑202/02 P,
         C‑205/02 P to C‑208/02 P and C‑213/02 P Dansk Rørindustri and Others v Commission [2006] ECR I‑5425, paragraph 148, and the order of 23 February 2006 in Case C‑171/05 P Piau v Commission, paragraph 86).
      
      78      The appellants state in paragraphs 33, 43 and 48 of the appeal that the new formulation (the CS dossier), the reduced application
         rate (the revised GAP) and the limited glasshouse use are solutions which the applicants had presented with a view to resolving
         the problem raised by the existence of the metabolite of the metabolite and that those solutions were rejected by the Commission
         on the ground that they had been presented out of time although that problem had been raised by the evaluators at an advanced
         stage of the procedure, which did not allow the applicants to present those solutions within the deadlines.
      
      79      It follows from paragraph 64 of this order that the General Court, after establishing and appraising the facts, considered
         that the applicants had been informed at an early stage in the procedure of the problem raised by the existence of the metabolites
         of the metabolite of endosulfan and of the need to clarify the routes of degradation of that substance and that they had had
         the opportunity to present solutions within the deadlines.
      
      80      It follows that those heads of challenge are directed against grounds of the judgment under appeal that were stated purely
         for the sake of completeness and, therefore, even on the assumption that they are well founded, they cannot lead to the setting
         aside of that judgment, which is justified on other grounds. Consequently, those heads of challenge must be rejected as ineffective
         (see Case C‑273/05 P OHIM v Celltech [2007] ECR I‑2883, paragraphs 56 and 57).
      
       The second ground of appeal, concerning operator exposure
      81      The appellants claim that the operator exposure issue, which had been regarded as settled, re-emerged after the tripartite
         meeting and was then taken into account as a decisive ground for the non-inclusion of endosulfan in Annex I to Directive 91/414.
      
      82      The appellants complain, first, that the General Court, on the one hand, considered that the re-emergence out of time of that
         issue did not frustrate the legitimate expectations on which the applicants were entitled to rely and did not constitute a
         case of force majeure, and, on the other hand, concluded that the Commission had not infringed the rights of the defence and the right of the applicants
         to be heard by depriving them of the possibility of presenting other data. Indeed, according to the appellants, the General
         Court was mistaken as to the role of the rapporteur Member State. 
      
      83      The appellants complain, secondly, that the General Court failed to answer the question whether the applicants ought to have
         been allowed to submit studies after the tripartite meeting.
      
      84      Thirdly, the appellants submit that the General Court erred in law by considering that the issue of operator exposure under
         outdoor conditions was only secondary in relation to the issue of the metabolite of the metabolite whereas the question of
         operator exposure concerned the use of endosulfan in outdoor conditions. However, if the question of operator exposure in
         indoor conditions had been resolved, endosulfan could have been included in Annex I to Directive 91/414 for that use.
      
      85      Lastly, the appellants argue that the General Court erred in law by not finding that the competent authorities had made a
         manifest error of assessment by refusing to extend the procedural deadlines and by not accepting the revised GAP and glasshouse
         use of endosulfan which would have resolved the issue of operator exposure.
      
      86      The Commission argues that the rapporteur Member State’s attitude did not give rise to a legitimate expectation on which the
         applicants could rely. It points out, in that regard, that that Member State’s opinion was not binding. It adds that the issue
         of the metabolites of the metabolites was relevant for the use of endosulfan in both indoor and outdoor conditions, contrary
         to the appellants’ statements.
      
      87      In paragraph 161 of the judgment under appeal, the General Court pointed out, on the one hand, that it was clear from the
         minutes of the tripartite meeting that even though the rapporteur Member State referred in those minutes to an identified
         safe use of endosulfan, additional data concerning glasshouse workers and bystanders still had to be submitted and, on the
         other hand, that the applicants had then submitted new calculations which were ultimately considered insufficient. The General
         Court rightly inferred, in paragraph 164 of that judgment, that the expression of a view by the rapporteur Member State could
         not give rise to certainty on the part of the applicants that the issue of operator exposure had been resolved in so far as
         the adoption of a final position on that issue was deferred until additional data had been received.
      
      88      Furthermore, the General Court, in paragraph 165 of the judgment under appeal, considered that it was clear from the facts
         which it had established, on the one hand, that the applicants had had a number of opportunities to submit studies and that
         they could have submitted arguments after the tripartite meeting and, on the other hand, that a disagreement as to substance
         arose between the Commission and the applicants concerning the elimination of risk for operators. In the light of those findings,
         the General Court was able to infer that that disagreement could not be equated with an infringement of the right to a fair
         hearing and that the applicants had been in a position to resolve, within the deadlines, the issue of operator exposure, including
         by means of the revised GAP and glasshouse use.
      
      89      Finally, the appellants’ third head of challenge, in so far as it is concerned with the issue of the date of the appearance
         of the metabolite of the metabolite, is directed against a ground of the judgment under appeal that was stated purely for
         the sake of completeness, as indicated in paragraph 79 of this order. Consequently, that head of challenge must be rejected
         as ineffective.
      
      90      It follows from those considerations that this ground of appeal is manifestly unfounded and must be rejected.
      
       The third ground of appeal, concerning the classification of endosulfan as a POP or a PBT
      91      The appellants claim, in the first place, that the General Court considered that the classification of endosulfan as a POP
         or a PBT was not incompatible with Article 5(1) of Directive 91/414 without examining the applicants’ arguments that that
         classification was insufficient to prevent the inclusion of that substance in Annex I to that directive. The General Court
         wrongly concluded that the Commission could reasonably have taken into account criteria relating to POPs and to PBTs in its
         evaluation on the basis of that directive. The General Court did not examine their arguments concerning the differences between
         the concepts of hazard and risk.
      
      92      The appellants state that, even assuming that the Commission could reasonably have taken into account criteria relating to
         POPs and to PBTs in its evaluation, the applicants had presented a document dealing with that issue, which the authorities
         dismissed on the ground that it had been presented out of time. The General Court failed to respond to those arguments.
      
      93      Lastly, the appellants criticise the General Court for having erred in law by considering that the competent authorities had
         not made a manifest error of assessment in refusing to examine the safe uses of endosulfan, such as glasshouse use, on the
         ground that they had been presented out of time. However, those safe uses would have resolved the problem connected with the
         classification of that substance as a POP or a PBT.
      
      94      The Commission asserts that the contested decision is based solely on Directive 91/414. Furthermore, the appellants do not
         explain how such a classification could preclude endosulfan from having harmful effects within the meaning of Article 5(1)
         of that directive.
      
      95      It seems that, contrary to what is stated in the ground of appeal, the General Court did not conclude that the Commission
         could reasonably take into account POPs or PBTs in its evaluation of endosulfan under Directive 91/414. On the contrary, after
         pointing out in paragraph 183 of the judgment under appeal that the classification of endosulfan as a POP or PBT, which is
         covered by another directive, had been taken into account in the course of the evaluation procedure and that the Commission
         could not argue that it had adopted the contested decision independently of that classification, the General Court held that,
         even given the existence of that consideration, the eighth recital in the preamble to that decision – in that it referred
         to the fact that endosulfan was volatile and that its main metabolite had been found in the monitoring results for regions
         where the substance was not used – was not incompatible with the criteria set out in Article 5(1)(a) of Directive 91/414,
         and rightly decided that the classification of endosulfan as a POP or PBT did not preclude that substance from having harmful
         effects within the meaning of that provision.
      
      96      Moreover, by deciding, in paragraph 186 of the judgment under appeal, that the applicants’ arguments concerning the difference
         between risk and hazard were irrelevant, the General Court necessarily answered those arguments.
      
      97      Finally, as regards the third head of challenge, it must be concluded that it is identical to that already set out at paragraph
         78 of this order, and that it concerns the solutions which the applicants had presented with a view to resolving the problem
         raised by the existence of the metabolite of the metabolite and which were rejected by the Commission on the ground that they
         had been presented out of time although, according to the applicants, that problem had been raised by the evaluators at an
         advanced stage of the procedure, which did not allow them to present those solutions within the deadlines. This head of challenge
         must therefore be declared irrelevant on the grounds set out in paragraphs 79 and 80 of this order.
      
      98      It follows from those considerations that this ground of appeal is in part ineffective and in part manifestly unfounded and
         must be rejected.
      
       The fourth ground of appeal, alleging breach of the principle of equal treatment
      99      The appellants complain that the General Court rejected the applicants’ arguments to the effect that endosulfan was afforded
         less favourable treatment than that applied to other substances.
      
      100    The appellants claim, first, that the General Court, in paragraph 235 of the judgment under appeal, ruled that their arguments
         were inadmissible because they were abstract, although the appellants provided specific examples.
      
      101    The General Court then erred in law by concluding that the principle of equal treatment did not apply, for the Commission
         had broad discretion or the procedures at issue were complex. However, that principle was applicable in this case, since the
         other active substances cited in the application were subject to the same legal framework and to the same evaluation procedure.
      
      102    Last, the General Court wrongly held that the conditional inclusion of fenarimol in Annex I to Directive 91/414 was equivalent
         to the phase-out period for endosulfan although those two measures are not equivalent.
      
      103    With regard to those points, the Commission considers that the General Court rightly decided that the applicants failed to
         establish that the differences in the evaluation processes for other substances were not objectively justified.
      
      104    It is apparent that, in paragraphs 237 and 242 of the judgment under appeal, the General Court considered that, having regard
         to the specific nature of each examination procedure, which makes comparisons extremely difficult, and to the Commission’s
         discretion in that field, the appellants, which merely listed other substances to which another approach had been applied,
         without explaining why they ought to have been treated in the same way as endosulfan, failed to establish that the differences
         in treatment in the way in which the evaluation procedures subject to comparison were conducted were not objectively justified.
         Moreover, at paragraph 240 of the judgment under appeal, the General Court restricted itself to describing the treatment finally
         given, respectively, to fenarimol and to endosulfan.
      
      105    Consequently, contrary to the statements in the ground of appeal relied on, the General Court neither concluded that the principle
         of equal treatment did not apply since the Commission has broad discretion nor stated that the conditional inclusion of a
         substance in Annex I to Directive 91/414 was equivalent to a phase-out period for another substance. It follows that that
         ground has no factual basis.
      
      106    In the light of all those considerations, the appeal must be dismissed without its being necessary to rule on the locus standi of Alfa Agricultural Supplies SA and Aragonesas Agro SA.
      
       Costs
      107    In accordance with Article 69(2) and (4) of the Rules of Procedure, applicable to the appeal procedure under Article 118 of
         those rules, first, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful
         party’s pleadings and, secondly, the Court may decide that an intervener is to bear its own costs. Since the Commission applied
         for the appellants to be ordered to pay the costs and their pleas were unsuccessful, they must be ordered to pay the costs.
         Moreover, the European Crop Protection Association is to bear its own costs.
      
      On those grounds, the Court (Second Chamber) hereby:
      1.      Dismisses the appeal;
      2.      Orders Makhteshim-Agan Holding BV, Alfa Agricultural Supplies SA and Aragonesas Agro SA to pay the costs;
      3.      Orders the European Crop Protection Association to bear its own costs.
      [Signatures]
      * Language of the case: English.