CELEX: 62012CJ0149
Language: en
Date: 2013-06-27 00:00:00
Title: Judgment of the Court (Eighth Chamber) of 27 June 2013.#Xeda International SA and Pace International LLC v European Commission.#Appeal — Plant protection products — Diphenylamine — Non-inclusion in Annex I to Directive 91/414/EEC — Procedure for the assessment of active substances — Withdrawal by notifier of support for inclusion of an active substance in that annex — Regulation (EC) No 1490/2002 and Regulation (EC) No 1095/2007.#Case C‑149/12 P.

JUDGMENT OF THE COURT (Eighth Chamber)
      27 June 2013 (*)
      
      (Appeal – Plant-protection products – Diphenylamine – Non-inclusion in Annex I to Directive 91/414/EEC – Procedure for the assessment of active substances – Withdrawal by notifier of support for inclusion of an active substance in that annex – Regulation (EC) No 1490/2002 and Regulation (EC) No 1095/2007)
      In Case C‑149/12 P,
      APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 21 March 2012,
      Xeda International SA, established in Saint-Andiol (France),
      
      Pace International LLC, established in Seattle (United States),
      
      represented by K. Van Maldegem, C. Mereu and N. Knight, avocats,
      appellants,
      the other party to the proceedings being:
      European Commission, represented by G. von Rintelen and P. Ondrůšek, acting as Agents, and by J. Stuyck, avocat, with an address for service in
         Luxembourg,
      
      defendant at first instance,
      THE COURT (Eighth Chamber),
      composed of E. Jarašiūnas (Rapporteur), President of the Chamber, A. Ó Caoimh and C.G. Fernlund, Judges,
      Advocate General: Y. Bot,
      Registrar: C. Strömholm, Administrator,
      having regard to the written procedure and further to the hearing on 13 December 2012,
      having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,
      gives the following
      Judgment
      1        By their appeal, Xeda International SA (‘Xeda’) and Pace International LLC (‘Pace’) seek to have set aside the judgment of
         the General Court of the European Union of 19 January 2012 in Case T‑71/10 Xeda International and Pace International v Commission (‘the judgment under appeal’), by which that court dismissed their action seeking the annulment of Commission Decision 2009/859/EC
         of 30 November 2009 concerning the non-inclusion of diphenylamine (‘DPA’) in Annex I to Council Directive 91/414/EEC and the
         withdrawal of authorisations for plant protection products containing that substance (OJ 2009 L 314, p. 79) (‘the contested
         decision’).
      
       European Union law 
      2        Article 8(2) of 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) provided that the European Commission was to implement a programme of work for the gradual examination,
         during a period of 12 years, of the active substances contained in the plant protection products that are already on the market.
         According to that article, it is decided, following examination and according to the procedure laid down in that directive,
         whether or not the examined active substance may be included in Annex I to that directive (‘Annex I’) which contains the list
         of active substances authorised for incorporation in plant protection products. That article also provides that the Member
         States are to ensure that the relevant authorisations are granted, withdrawn or varied, as appropriate, within a prescribed
         period. 
      
      3        Given the very high number of existing active substances on the market still to be evaluated, a programme in several phases
         was established. DPA is in the list of the active substances to be evaluated in the third stage of that programme, the detailed
         rules for its implementation being defined by Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed
         rules for the implementation of the second and third stages of the programme of work referred to in Article 8(2) of Directive
         91/414 (OJ 2000 L 55, p. 25) and Commission Regulation (EC) No 1490/2002 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 Council Directive 91/414
         and amending Regulation No 451/2000 (OJ 2002 L 224, p. 23). Regulation No 1490/2002 has been amended on several occasions
         and, in particular, by Commission Regulation (EC) No 1095/2007 of 20 September 2007 (OJ 2007 L 246, p. 19), which entered
         into force on 28 September 2007.
      
      4        Article 11(1) and (2) of Regulation No 1490/2002, that article being headed ‘Receipt of and access to the draft assessment
         report’, provides:
      
      ‘1.      After receiving the updated summary dossier and the draft assessment report referred to in Article 10(1), the [European Food
         Safety Authority (“EFSA”)] shall, within 30 days, acknowledge to the rapporteur Member State receipt of that report.
      
      …
      2.      The EFSA shall without delay communicate the draft assessment report to the Commission, the other Member States and the notifiers
         setting a time period of no more than two months for the submission of comments by those Member States and the notifiers.
      
      It shall collate the comments it receives, including available comments from the EFSA, and forward them to the Commission,
         Member States and the notifiers.’ 
      
      5        Article 11a of that regulation, headed ‘Examination of the draft assessment report’, provides:
      
      ‘The Commission shall, without delay, examine the draft assessment report and the recommendation by the rapporteur Member
         State and the comments received from other Member States, the EFSA and from the notifiers in accordance with Article 11(2).’
         
      
      6        Article 11b of that regulation, headed ‘Active substance with clear indications that they do not have any harmful effects’
         provides:
      
      ‘If there are clear indications that it may be expected that the active substance does not have any harmful effects on human
         or animal health or on groundwater or any unacceptable influence on the environment, as set out in Annex V, Article 12(1)(a)
         and (2)(a) shall apply.’ 
      
      7        Article 11c(1) of Regulation No 1490/2002, that article being headed ‘Consultation of the EFSA’, provides:
      
      ‘Where Article 11b does not apply, the Commission may, at any time during the evaluation, ask the EFSA to carry out a peer
         review of the full draft assessment report or to focus on specific points including points related to criteria set out in
         Annex VI. The EFSA shall organise a consultation of Member States experts including the rapporteur Member State. 
      
      Where the Commission requests the EFSA to carry out a full peer review, the EFSA shall deliver its conclusion at the latest
         six months after the request. Where the Commission does not request a full peer review, but only a conclusion on specific
         points, the period shall be reduced to three months. The submission of the conclusions shall in any event be no later than
         30 September 2008.’ 
      
      8        Article 11e of that regulation, headed ‘Withdrawal by notifier’, states:
      
      ‘Where Article 11b does not apply, the notifier may withdraw his support of the inclusion of the active substance in Annex
         I … within two months from receipt of the draft assessment report referred to in Article 11(2).’
      
      9        Article 11f of that regulation, headed ‘Active substance for which there are clear indications of harmful effects’ provides:
      
      ‘If there are clear indications that it may be expected that the active substance has harmful effects on human or animal health
         or on groundwater as set out in Annex VI, the Commission shall take a Decision on the non-inclusion of the active substance
         in Annex I …, in accordance with Article 12(1)(a) and (2)(b) of this Regulation.’
      
      10      Article 12 of Regulation No 1490/2002, headed ‘Presentation of a draft directive or draft decision’, provides:
      
      1.      The Commission shall submit to the Committee a draft review report at the latest six months after:
      (a)      receipt of the draft assessment report where Article 11b or Article 11f applies;
      (b)      receipt of the conclusion established by the EFSA where Article 11c applies; 
      (c)      receipt of a written withdrawal of the notifier’s support where Article 11e applies. 
      2.      Together with the draft review report the Commission shall submit to the Committee:
      (a)      a draft directive including the active substance in Annex I … setting out where appropriate the conditions, including the
         time limit, for such inclusion; or
      
      (b)      a draft decision addressed to the Member States requiring them to withdraw, within six months, 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 …, mentioning the reasons for the non-inclusion.
      
      …
      3.      By way of derogation from paragraph 2(b), the latest date for Member States to withdraw authorisations shall be 31 December
         2010 in the case referred to in paragraph 1(c) unless the Commission has concluded that the substance meets the criteria of
         Annex VI, if appropriate after having consulted the EFSA.’
      
      11      According to recitals 5 and 6 in the preamble to Regulation No 1095/2007, the resources of the EFSA should be used efficiently
         and the EFSA should focus on cases where the remaining doubts need to be resolved before a decision on the inclusion of the
         active substance concerned in Annex I can be taken.
      
      12      Article 3(2) of Regulation No 1095/2007 states: 
      
      ‘As regards active substances for which, at the date of entry into force of this Regulation, the draft assessment report by
         the rapporteur Member State had been sent to the EFSA but for which the EFSA had not submitted its conclusions to the Commission,
         by way of derogation from Article 11e of Regulation … No 1490/2002, Article 12(3) of that Regulation shall apply if both of
         the following conditions are satisfied: 
      
      (a)      Article 11b does not apply and one of the following cases is present:
      (i)      the active substance is not expected to meet the criteria of Annex VI of that Regulation;
      (ii)      upon being consulted by the Commission, the EFSA has concluded that the active substance does not meet the criteria of Annex
         VI of that Regulation; and
      
      (b)      the notifier informs the Commission of the withdrawal of his support of the inclusion of the active substance in Annex I …
         within two months from the entry into force of this Regulation.’
      
       Background to the dispute and the contested decision 
      13      It is apparent from the judgment under appeal that DPA is used, inter alia, as the active substance in storage aid in the
         post-harvest treatment of apples, as a scald (browning of the skin due to oxidation products which accumulate in the waxy
         surface layer) inhibitor while the apples are being stored prior to being sold. That substance is provided by Pace to Xeda
         which uses DPA to produce chemical products which it markets for post-harvest treatment of fruit and vegetables.
      
      14      On 31 May 2000, Xeda, in accordance with Article 10(2)(a) of Regulation No 451/2000, notified the Commission of its wish to
         secure the inclusion of DPA in Annex I. Under an agreement signed on 20 February 2002, Xeda transferred that notification
         to Pace.
      
      15      Following an assessment of the dossier lodged by Pace, Ireland, designated by Regulation No 1490/2002 as the rapporteur Member
         State, recommended the inclusion of DPA in Annex I, subject to certain conditions and clarifications and the production of
         data to be submitted by the notifiers, and sent its draft assessment report to EFSA on 20 June 2007.
      
      16      On 30 September 2008, EFSA delivered its report in which it expressed some concerns and pointed out some gaps in the data
         provided. In view of that report, the Commission, by letter of 24 November 2008, submitted to the Standing Committee on the
         Food Chain and Animal Health a draft review report proposing the non‑inclusion of DPA in Annex I. As that Committee did not
         deliver an opinion on the proposed measures within the prescribed time-limit, the Commission, on 25 May 2009, submitted a
         proposal relating to those measures to the Council of the European Union, which did not take a decision.
      
      17      Those are the circumstances in which the Commission adopted the contested decision which provides, in Article 1 thereof, that
         DPA is not included in Annex I and, in Article 2, that Member States must ensure that authorisations for plant protection
         products containing DPA are to be withdrawn by 30 May 2010 and that no authorisations for such products are to be granted
         or renewed from the date of publication of that decision.
      
      18      Recitals 5 and 6 in the preamble to the contested decision set out the reasons for that decision:
      
      ‘(5)      During the evaluation of [DPA], a number of concerns have been identified. In particular, it was not possible to perform a
         reliable consumer exposure assessment, as data are missing on the presence and toxicity of unidentified metabolites of the
         substance, as well as on the possible formation of nitrosamines during storage of the active substance and during processing
         of treated apples. Moreover, no data was available on the potential breakdown or reaction product of [DPA] residues in processed
         commodities. Consequently, it was not possible to conclude on the basis of the information available that [DPA] met the criteria
         for inclusion in Annex I ….
      
      (6) The Commission invited the notifier to submit its comments on the results of the peer review and on its intention or not
         to further support the substance. The notifier submitted its comments which have been carefully examined. However, despite
         the arguments put forward by the notifier, the concerns identified could not be eliminated, and assessments made on the basis
         of the information submitted and evaluated during the EFSA expert meetings have not demonstrated that it may be expected that,
         under the proposed conditions of use, plant protection products containing [DPA] satisfy in general the requirements laid
         down in Article 5(1)(a) and (b) of Directive [91/414].’
      
      
      19      In recital 10 in the preamble to the contested decision, it is stated that that decision does not prejudice the submission
         of an application pursuant to Article 6(2) of Directive 91/414 in view of a possible inclusion of DPA in Annex I thereof.
         
      
      20      Following a new application for inclusion submitted to that end, the Commission adopted, after the bringing of this appeal,
         Commission Implementing Regulation (EU) No 578/2012 of 29 June 2012 concerning the non-approval of the active substance diphenylamine,
         in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant
         protection products on the market (OJ 2012 L 171, p. 2). Under Articles 1 and 2 of Regulation No 578/2012, DPA is not approved
         and the contested decision is repealed. Recitals 7 and 11 in the preamble to that regulation state that the additional data
         and information provided did not make it possible to eliminate the specific concerns that led to the non-inclusion and that
         the contested decision was repealed ‘in the interest of clarity’. 
      
       The procedure before the General Court and the judgment under appeal 
      21      By application lodged at the General Court Registry on 18 February 2010, the appellants brought an action for annulment of
         the contested decision. 
      
      22      By the judgment under appeal, the General Court dismissed that action and ordered the appellants to pay the costs, including
         those relating to two sets of proceedings for interim measures brought by them on 22 February 2010 and 11 February 2011.
      
      23      To come to that decision, the Court rejected the four pleas in law put forward by the appellants, alleging (i) manifest errors
         of appraisal, (ii) infringement of the principle of proportionality, (iii) failure to state reasons and, (iv) infringement
         of the rights of the defence and of the principle of sound administration. Only the assessments made by the General Court
         in order to reject the first and fourth pleas are challenged in this appeal, and therefore the judgment under appeal need
         be examined only with regard to those two pleas.
      
      24      As regards the first plea, the Court rejected, in particular, the appellants’ arguments that the risk associated with the
         possible formation of nitrosamines was hypothetical and irrelevant and, in particular, rejected, in paragraphs 79 to 83 of
         the judgment under appeal, the appellants’ assertion that that concern was the principal concern, in the absence of which
         the Commission would have adopted a decision to include DPA in Annex I. 
      
      25      With regard to the fourth plea in the action, in which the appellants claimed that the notifiers were deprived of the opportunity
         to withdraw their support for the inclusion of DPA in Annex I, provided for by Article 3(2) of Regulation No 1095/2007, and
         thus did not have the benefit of a period for the withdrawal of their products longer than that provided for in Article 2
         of the contested decision, the Court inter alia rejected, in paragraphs 168 to 172 of the judgment under appeal, the appellants’
         argument that, on the date by which the notifiers could request the withdrawal of their support, namely 28 November 2007,
         the only document in their possession was the draft assessment report by the rapporteur Member State, which proposed the inclusion
         of DPA in Annex I. 
      
      26      In paragraphs 173 to 176 of the judgment under appeal, the General Court also rejected the appellants’ claim that the notifiers
         would have been in a more advantageous position if the time-limits prescribed by the applicable legislation had been complied
         with. Furthermore, in paragraphs 177 to 184 of that judgment, the General Court held that the EFSA’s alleged delay in initiating
         the consultation on the draft assessment report, which was complained of by the appellants, in no way denied to the notifiers
         the possibility of withdrawing their support, had no effect on compliance with the time‑limit for the delivery of the EFSA
         report and that, in any event, that delay had no impact on the contested decision.
      
       Forms of order sought by the parties 
      27      The appellants claim that the Court of Justice should set aside the judgment under appeal and annul the contested decision
         or, alternatively, refer the case back to the General Court to rule on their action for annulment. They claim, moreover, that
         the Commission should be ordered to pay the costs, including the costs incurred at first instance.
      
      28      The Commission contends that the Court should dismiss the appeal and order the appellants to pay the costs. However, by letter
         dated 28 November 2012 addressed to the Registry of the Court, it indicated that, because of the repeal of the contested decision
         by Regulation No 578/2012, it believed that there was no longer any need to adjudicate on this appeal.
      
       The appeal 
       Whether there is any need to adjudicate 
       Arguments of the parties
      29      At the hearing, the appellants argued that, despite the repeal of the contested decision by Regulation No 578/2012, they retained
         an interest in obtaining a declaration of illegality of that decision for five reasons. First, the decision produced legal
         effects which are not removed by that regulation. Second, it follows from the case-law that the repeal of an act does not
         constitute recognition of its illegality, that, unlike annulment, repeal does not have retroactive effect and that an applicant
         can retain an interest in seeking annulment of an act to prevent its unlawfulness recurring in the future. Third, a declaration
         of illegality in this case would have an impact on the repeal measure that, in terms of substance and procedure, is linked
         to the contested decision. Fourth, the appellants have an interest in obtaining a declaration of illegality to preserve their
         right to obtain compensation within the meaning of Article 340 TFEU. Finally, they have brought before the General Court an
         action for the annulment of Regulation No 578/2012, which, if upheld, would revive the contested decision.
      
      30      The Commission noted in particular that, if the appellants have suffered damage as a result of the withdrawal of authorisations
         enjoyed by plant protection products containing DPA, it was for them to initiate proceedings to obtain damages and not to
         seek a declaration that the contested decision is unlawful. However, the Commission stated that it would leave that issue
         to the wisdom of the Court.
      
       Findings of the Court 
      31      According to the Court’s settled case-law, the subject‑matter of the case must continue to exist, like the interest in bringing
         proceedings, until the final decision, otherwise there will be no need to adjudicate; this presupposes that the action, or
         as the case may be, the appeal, must be liable to procure an advantage to the party bringing it (see, to that effect, Joined
         Cases C‑373/06 P, C‑379/06 P and C‑382/06 P Flaherty and Others v Commission [2008] ECR I‑2649, paragraph 25, and Case C‑550/07 P Akzo Nobel Chemicals and Akcros Chemicals v Commission and Others [2010] ECR I‑8301, paragraphs 22 and 23).
      
      32      The repeal of the contested act, after the bringing of an action, does not in itself mean that the Courts of the European
         Union must declare that there is no need to adjudicate for lack of purpose or for lack of interest in bringing proceedings
         at the date of the delivery of the judgment (see, to that effect, Case C‑362/05 P Wunenburger v Commission [2007] ECR I‑4333, paragraph 47). As the appellants argue, since that repeal does not have retroactive effect, the applicant
         may in particular retain an interest in obtaining a declaration of illegality of that act for the period during which it was
         applicable and produced its effects, such a declaration retaining an interest at the very least as the basis for a possible
         action for damages (see, to that effect, Joined Cases C‑68/94 and C‑30/95 France and Others v Commission [1998] ECR I‑1375, paragraph 74).
      
      33      In the present case, it is not disputed that the contested decision produced effects before being repealed. Under Article
         2 thereof, authorisations for plant protection products containing DPA had to be withdrawn by the national authorities by
         30 May 2010. Moreover, in the context of the second and third grounds of appeal, the appellants argue, in essence, that an
         irregularity committed in the procedure for the adoption of that decision deprived them of the opportunity, offered by Article 3(2)
         of Regulation No 1095/2007, to withdraw their support for the inclusion of DPA in Annex I and, therefore, to benefit from
         a longer period for the withdrawal of their products. Accordingly, if the grounds of appeal were to be upheld, or if the examination
         of the second and third grounds of appeal were to lead to a finding of at least one such irregularity, the appeal would be
         likely to procure an advantage to the appellants in the context of an action for damages.
      
      34      Moreover, it is not disputed that the appellants have also brought an action for annulment of Regulation No 578/2012, and
         consequently, if that action were successful, the contested decision would again constitute the legal basis for the non‑inclusion
         of DPA in Annex I.
      
      35      It follows that the appeal is not devoid of purpose and that it is necessary to adjudicate.
      
       Substance 
      36      The appellants put forward three grounds in support of their appeal, alleging error of law, inconsistency in reasoning and
         distortion of evidence leading to an error of law.
      
       The first ground of appeal 
      –       Arguments of the parties
      37      By their first ground of appeal, the appellants challenge the finding of the General Court, in paragraphs 79 to 83 of the
         judgment under appeal, that the contested decision is not based primarily on considerations relating to the possible formation
         of nitrosamines. That finding is, it is alleged, vitiated by an error of law and distortion of the clear sense of the evidence.
         The evidence set out in paragraphs 81 and 82 justified a finding to the contrary, since that evidence clearly demonstrated
         that the formation of nitrosamines was the concern underlying the other two concerns, namely the presence of unidentified
         metabolites and lack of data relating to the processed products. The General Court’s conclusion that those three concerns
         are independent of each other is therefore, it is claimed, wrong and reveals an inconsistency in reasoning.
      
      38      The Commission considers that the appellants do not explain or prove how and in what way the General Court distorted the clear
         sense of the evidence. Moreover, it considers the first ground of appeal to be ineffective.
      
      –       Findings of the Court 
      39      In order to reject the appellants’ argument that the concern relating to the possible formation of nitrosamines was the principal
         concern, in the absence of which the Commission would have decided to include DPA in Annex I, the General Court held, in paragraph
         79 of the judgment under appeal, that that assertion had no basis in the contested decision nor in the EFSA report. In paragraph
         80 of that judgment, the General Court stated that, on the contrary, the three areas of concern mentioned in recital 5 in
         the preamble to that decision, namely the risk of formation of nitrosamines, the presence and toxicity of unidentified metabolites
         and the absence of data on the potential breakdown or reaction product of DPA residues in processed commodities, seemed to
         be of equal importance and that an examination of all of those concerns was appropriate in order to carry out a full and reliable
         evaluation and to eliminate any risk to the consumer.
      
      40      In paragraphs 80 to 83 of the judgment under appeal, the General Court held that that assessment was confirmed by the EFSA
         report and by a summary drawn up by the rapporteur Member State in the form of a table, the content of which the General Court
         examined. It stated, in particular, that it was apparent from that table that the question regarding the risk of formation
         of nitrosamines raised by EFSA demonstrated the relevance of an examination of that risk, not in isolation but in the wider
         context of the other concerns raised. The General Court held that it followed from those documents that, in the contested
         decision, the Commission had correctly referred to the three areas of concern and stated that the gaps in the data in respect
         of each of those concerns made it impossible to carry out a complete assessment of the risk to which consumers were exposed.
      
      41      It is clear that, contrary to what is claimed by the appellants, the General Court, on the basis of the matters referred to
         in the preceding two paragraphs, concluded not that the three concerns were independent of each other but that they were of
         equal importance and that the Commission therefore was right to find that a complete and reliable assessment, to eliminate
         any risk to consumers, could not be carried out in the absence of sufficient available data in relation to each of those concerns.
      
      42      The appellants do not state in a precise and detailed manner in what way that conclusion results from an error of law, distortion
         of the evidence or inconsistency. The appellants’ claims cannot, therefore, be answered in the context of an appeal.
      
      43      It follows that the first ground of appeal must be rejected as being unfounded.
      
       The second and third grounds of appeal
      –       Arguments of the parties
      44      In their second and third grounds of appeal, which should be examined together, the appellants criticise the reasons given
         by the General Court, in paragraphs 168 to 184 of the judgment under appeal, to justify the rejection of the plea for annulment
         based on an infringement of the rights of the defence and of the principle of sound administration, in that the notifiers
         were deprived of the possibility of withdrawing their support for the inclusion of DPA in Annex I, provided for by Article
         3(2) of Regulation No 1095/2007, and thus did not benefit from a period for the withdrawal of their products longer than that
         provided for in Article 2 of the contested decision.
      
      45      In the first place, the appellants criticise the General Court because it held, in paragraphs 168 to 174 of the judgment under
         appeal, that they had been placed in a position to withdraw their support for the inclusion of DPA in Annex I. They claim
         that, as they had not been informed of any difficulty concerning their dossier before 28 November 2007, which was the deadline
         for the withdrawal of support in accordance with Article 3(2) of Regulation No 1095/2007, attributable to the fact that the
         EFSA had sent the draft assessment report for comments with a delay of over three months, they were deprived of the possibility
         of making such a withdrawal. As a result, they had a deadline for the withdrawal of their products containing DPA, set at
         30 May 2010 by the contested decision, which was shorter than that which they would have had the benefit of had they been
         in a position to withdraw their support.
      
      46      The General Court, it is alleged, erred in its interpretation of Regulation No 1490/2002 by confusing two stages in the review
         process established by that regulation, namely that provided for in Article 11(2) thereof, during which the EFSA circulates
         the draft assessment report to the Commission, the Member States and the notifier for comments, and that provided for in Article
         11c of that regulation, according to which, at the end of that preliminary consultation, the Commission may instruct the EFSA
         to carry out a peer review, the second stage taking place only if Article 11b of that regulation does not apply, that is,
         if the case for the inclusion of the substance under evaluation in Annex I is not obvious. It is only at the end of the second
         stage that notifiers are in a position to take a fully informed decision as to whether to withdraw support for inclusion of
         the active substance in Annex I. 
      
      47      Since the EFSA had only circulated the draft assessment report as part of the basis of the first stage provided for in Article
         11(2) of Regulation No 1490/2002, the General Court erred in law in holding that it followed from two EFSA letters of 8 and
         18 October 2007 that DPA was subject to the procedure laid down in Article 11c of that regulation and that, therefore, its
         inclusion in Annex I was not obviously necessary. The General Court therefore erred in law by concluding that the appellants
         had been duly informed that there were difficulties and that they were therefore in a position to exercise their right to
         withdraw their support for inclusion of DPA in Annex I.
      
      48      According to the appellants, since these two letters were sent at a stage where no comments had yet been made by the EFSA
         or any Member State, the procedure for withdrawal of support for the inclusion of DPA in Annex I, provided for by Article
         3(2) of Regulation 1095/2007, could not yet be applicable, as this presupposes that it has first been established, at the
         end of the first stage provided for in Article 11(2) of Regulation No 1490/2002, that Article 11b thereof is not applicable.
         Those two letters in no way indicate that there were any shortcomings in their dossier and that Article 11b was not applicable.
      
      49      According to the appellants, the General Court, in paragraph 168 of the judgment under appeal, erred in law through its distortion
         of the evidence contained in those letters by interpreting the fact that the EFSA had given notice that it had organised a
         consultation of experts as evidence that the Commission had instructed it to do so pursuant to Article 11c of Regulation No 1490/2002.
         The General Court was wrong to find that the decision announced by the EFSA to organise that consultation presupposed that
         the Commission had requested the EFSA’s scientific opinion, on the view that Article 11b of that regulation was not applicable
         to DPA, and that the Commission expected to have to request the EFSA to review the draft assessment report. In fact, according
         to the appellants, the Commission did not receive that draft until 8 October 2007, under Article 11(2) of Regulation No 1490/2002,
         and the experts’ comments, including the EFSA’s own comments, only became available on 9 January 2008, so that, on the date
         of the letters in question, the stage provided for by Article 11(2) had not been completed, the procedure provided for by
         Article 11c of that regulation was not yet applicable and the appellants were not, therefore, in a position to withdraw their
         support for the inclusion of DPA in Annex I in accordance with Article 3(2) of Regulation No 1095/2007. 
      
      50      In the second place, the appellants complain that the General Court erred in its legal characterisation of the facts by finding,
         in paragraph 177 of the judgment under appeal, that the EFSA’s alleged delay in initiating the consultation on the draft assessment
         report had in no way denied to the notifiers the ‘effective enjoyment of their “right to withdraw”’. In so doing, the General
         Court distorted the clear sense of the evidence and, consequently, erred in law when assessing whether or not the appellants
         were effectively placed in a position to exercise their rights of defence.
      
      51      In particular, the General Court erroneously held, in paragraph 179 of the judgment under appeal, that the experts’ comments,
         including those of the EFSA, had been received in June 2008 whereas in fact they were received on 9 January 2008. According
         to the appellants, if the EFSA had circulated the draft assessment report without delay, they would have been in possession
         of those comments, which revealed for the first time the problems in relation to the possible formation of nitrosamines, before
         the deadline for exercising their right to withdraw their support for the inclusion of DPA in Annex I. In order to preserve
         their rights, the appellants argue, either a more adequate deadline for the submission of comments should have been set, or
         the time-limit laid down for withdrawal of support should have been deferred. 
      
      52      The Commission contends, with regard to the first complaint, that, contrary to what is claimed by the appellants, the General
         Court did not err in its interpretation of European Union legislation and that the interpretation put forward by the appellants
         is not in conformity with the objective of Regulation No 1095/2007, set out in recitals 5 and 6 in the preamble thereto, to
         use the EFSA’s resources efficiently. The Commission also challenges the appellants’ claims concerning the alleged distortion
         of evidence by the General Court which, according to the Commission, correctly interpreted the EFSA letters of 8 and 18 October
         2007.
      
      53      With regard to the second complaint, the Commission contends that the General Court did not distort the clear sense of the
         evidence that was submitted to it and that, contrary to what is claimed by the appellants, the draft assessment report had
         not been sent late by the EFSA, but in accordance with Article 11(2) of Regulation No 1490/2002.
      
      –       Findings of the Court 
      54      In order to set aside the appellants’ claims that they were deprived of the opportunity, provided for in Article 3(2) of Regulation
         No 1095/2007, to withdraw their support for the inclusion of DPA in Annex I, due to the delay in carrying out the evaluation
         process, the General Court, first, rejected the appellants’ argument that, on the date of expiry of the deadline for the withdrawal
         of support to the inclusion of a substance in Annex I, that is, on 28 November 2007, the only document available to them was
         the draft assessment report of the rapporteur Member State. In that regard, the General Court stated, in paragraph 168 of
         the judgment under appeal, that it was clear from the EFSA letter of 8 October 2007 that the notifiers had been informed of
         the fact that the EFSA had decided to organise a consultation of experts and that that stage, provided for by Article 11c
         of Regulation No 1490/2002, presupposed that the Commission had taken the view that Article 11b of that regulation was not
         applicable to DPA and that the Commission expected that it would, on the expiry of the withdrawal period, have to request
         that the EFSA review the draft assessment report.
      
      55      In paragraphs 170 to 172 of the judgment under appeal, the General Court stated, inter alia, that the proposal for the inclusion
         of DPA in Annex I made by the rapporteur Member State was not unconditional, since certain additional data and clarifications
         still had to be submitted by the notifiers, so that the notifiers had in their possession, as from 28 September 2007, and
         therefore well before the expiry of the time-limit for withdrawal of support, information to justify the existence of doubts
         that the final decision would be favourable.
      
      56      The General Court then rejected the appellants’ argument that the notifiers would have been in a more advantageous position
         if the time‑limits prescribed by the legislation had been complied with. It held, in paragraphs 173 to 176 of the judgment
         under appeal, that the EFSA had carried out a review of the draft assessment report and had submitted its conclusions in compliance
         with the various time‑limits provided for in Article 11(1) and (2), and in the second subparagraph of Article 11c(1) of Regulation
         No 1490/2002. The General Court noted that there is no provision which obliged the EFSA to begin that review or to complete
         it prior to the date of expiry of the time-limit provided for in Article 3(2) of Regulation No 1095/2007. It observed, moreover,
         that if the EFSA, having been consulted by the Commission, had come to the conclusion that DPA did not meet the criteria laid
         down in Annex VI of Regulation No 1490/2002, within the meaning of Article 3(2)(a)(ii) of Regulation No 1095/2007, it was
         not obliged to inform the notifiers of that interim conclusion and that, in any event, the fact that the notifiers were made
         aware, by means of the two EFSA letters of 8 and 18 October 2007, of the consultation of experts and of that time-limit, demonstrated
         that it was probable that the Commission would ask the EFSA to carry out a review of the draft assessment report in accordance
         with Article 11c of Regulation No 1490/2002.
      
      57      In paragraphs 177 to 180 of the judgment under appeal, the General Court found that the EFSA’s alleged delay in initiating
         the consultation on the draft assessment report in no way prevented the notifiers from exercising their right to withdraw
         their support for the inclusion of DPA in Annex I. It stated, in that regard, that no time-limit was imposed on the EFSA to
         circulate that draft to the Commission, to the Member States and to the notifier before the entry into force, on 28 September
         2007, of Regulation No 1095/2007, which provided that that report had to be sent ‘without delay’, which the EFSA did 10 days
         later, that is, on 8 October 2007. It noted that, even if the EFSA had scrupulously complied with the time‑limits prescribed
         by that regulation, from the date of its entry into force, the notifiers might have had in their possession, possibly, before
         the expiry of the time‑limit for withdrawal of support, only the comments of the Member States and of the EFSA. The General
         Court held that, as the question relating to the possible formation of nitrosamines was raised, according to the appellants,
         only after the experts’ meeting, in June 2008, the notifiers would not, in any event, have had in their possession information
         regarding that area of concern before the expiry of that time‑limit. It concluded that the notifiers had been informed, by
         the EFSA letters of 8 and 18 October 2007, of the possibility of withdrawing their support and of the entry into force of
         Regulation No 1095/2007.
      
      58      It is not apparent from the foregoing that the General Court committed the errors of law alleged by the appellants. Contrary
         to what the appellants maintain, the possibility open to the notifiers of withdrawing their support for the inclusion of an
         active substance in Annex I, in accordance with Article 3(2) of Regulation No 1095/2007, cannot depend on completion of the
         review procedure provided for in Article 11c of Regulation No 1490/2002, or even on the conclusion of the Commission or of
         the EFSA that Article 11b of that regulation does not apply or that the substance in question does not satisfy the criteria
         laid down in Annex VI thereof. As the Commission contends, the notifier may withdraw its support without awaiting the outcome
         of the formal assessment by the EFSA or the Commission, where there are no clear indications that it may be expected that
         the substance in question does not have harmful effects and where either that substance is not expected to meet the criteria,
         in Annex VI of Regulation No 1490/2002, for clear indications that a substance has harmful effects or the EFSA has already
         concluded that that substance does not meet those criteria.
      
      59      Accordingly, the General Court did not misinterpret Regulation No 1490/2002 by finding, in essence, that it was apparent from
         the EFSA letters of 8 and 18 October 2007 that the view had been taken that DPA was not covered by Article 11b of that regulation,
         but by the procedure laid down in Article 11c thereof, and consequently the notifiers could infer that the inclusion of DPA
         in Annex I was encountering difficulties.
      
      60      Furthermore, the General Court did not distort the clear sense of those letters when finding, as part of its assessment of
         the facts, which is not subject to appeal, that it could be inferred, from the fact that those letters reported a consultation
         of experts and mentioned the time-limits for withdrawal of support for the inclusion of DPA in Annex I, that DPA did not fall
         under Article 11b of Regulation No 1490/2002 and that the notifiers had been informed of the possibility of making such a
         withdrawal.
      
      61      With regard to the alleged late circulation of the draft assessment report, the General Court did not err in law or distort
         the clear sense of the evidence when it held that the question of the possible formation of nitrosamines was raised only after
         the meeting of experts, that is, in June 2008, merely taking up what was stated by the appellants in that regard, and that
         that circulation was not late under Article 11(2) of Regulation No 1490/2002, in its versions applicable both before and after
         the entry into force of amending Regulation No 1095/2007.
      
      62      Furthermore, the appellants have not in any way substantiated their complaint that the reasoning of the judgment under appeal
         is inconsistent, and that complaint must therefore be rejected as being inadmissible.
      
      63      In those circumstances, the second and third grounds of appeal must be rejected as being partly unfounded and partly inadmissible.
      
      64      Since none of the three grounds of appeal raised by the appellants in support of their appeal can be upheld, the appeal must
         be dismissed in its entirety. 
      
       Costs
      65      In accordance with Article 184(2) of the Rules of Procedure, where the appeal is unfounded, the Court is to make a decision
         as to costs. Under Article 138(1) of those Rules, which apply to the procedure on appeal by virtue of Article 184 of those
         Rules, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
         Since the appellants have been unsuccessful and the Commission has applied for costs, they must be ordered to pay the costs.
         
      
      On those grounds, the Court (Eighth Chamber) hereby:
      1.      Dismisses the appeal.
      2.      Orders Xeda International SA and Pace International LLC to pay the costs.
      [Signatures]
      * Language of the case: English.