CELEX: 62005CJ0326
Language: en
Date: 2007-07-18
Title: Judgment of the Court (Third Chamber) of 18 July 2007.#Industrias Químicas del Vallés SA v Commission of the European Communities.#Appeal - Non-inclusion of metalaxyl in Annex I to Directive 91/414/EEC -Withdrawal of authorisations for plant protection products containing that active substance - Distortion of the clear sense of the evidence - Manifest error of appraisal.#Case C-326/05 P.

Case C-326/05 P
      Industrias Químicas del Vallés SA
      v
      Commission of the European Communities
      (Appeal – Non-inclusion of metalaxyl in Annex I to Directive 91/414/EEC – Withdrawal of authorisations for plant protection products containing that active substance – Distortion of the clear sense of the evidence – Manifest error of appraisal)
      Opinion of Advocate General Ruiz-Jarabo Colomer delivered on 30 November 2006 
      Judgment of the Court (Third Chamber), 18 July 2007 
      Summary of the Judgment
      1.     Appeals – Grounds – Distortion of the clear sense of the evidence – Findings of fact from the Court’s file substantially incorrect
            – Admissibility 
      (Art. 225 CE)
      2.     Appeals – Grounds – Distortion of the clear sense of the evidence – Definition – Clear misassessment of the evidence 
      3.     Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414
      (Council Directive 91/414, Art. 19 and Annex I)
      1.     Complaints based on findings of fact and on the assessment of those facts in a judgment under appeal are admissible on appeal
         where the appellant submits that the Court of First Instance has made findings of fact which the documents in the file show
         to be substantially incorrect or that it has distorted the clear sense of the evidence before it.
      
      (see para. 57)
      2.     There is distortion of the clear sense of the evidence where, without recourse to new evidence, the assessment of the existing
         evidence by the Court of First Instance appears to be clearly incorrect. That is the case in particular where the inferences
         drawn by the Court of First Instance from certain documents are not consistent with the meaning and implications of those
         documents read as a whole.
      
      (see paras 60, 63)
      3.     As is clear from Recitals 5, 6 and 9 in the preamble thereto, Directive 91/414 concerning the placing of plant protection
         products on the market seeks to remove barriers to intra-Community trade in those products, while maintaining a high level
         of protection of the environment and of human and animal health. In that context, if the Commission is to be able to pursue
         effectively the objective assigned to it, account being taken of the complex technical assessments which it must undertake,
         it must be recognised as enjoying a broad discretion.
      
      However, the exercise of that discretion is not excluded from review by the Court. In the context of such review the Community
         judicature must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission
         have been accurately stated and whether there has been a manifest error of appraisal or a misuse of powers.
      
      In particular, where a party claims that the institution competent in the matter has committed a manifest error of appraisal,
         the Community judicature must verify whether that institution has examined, carefully and impartially, all the relevant facts
         of the individual case, facts which support the conclusions reached.
      
      (see paras 74-77)
JUDGMENT OF THE COURT (Third Chamber)
      18 July 2007 (*)
      
      (Appeal – Non-inclusion of metalaxyl in Annex I to Directive 91/414/EEC –Withdrawal of authorisations for plant protection products containing that active substance – Distortion of the clear sense of the evidence – Manifest error of appraisal)
      In Case C‑326/05 P,
      APPEAL under Article 56 of the Statute of the Court of Justice, brought on 26 August 2005,
      Industrias Químicas del Vallés, SA, established in Mollet del Vallés (Spain), represented by C. Fernández Vicién, I. Moreno-Tapia Rivas and J. Sabater Marotias,
         abogados,
      
      appellant,
      the other party to the proceedings being:
      Commission of the European Communities, represented by B. Doherty and S. Pardo Quintillán, acting as Agents, with an address for service in Luxembourg,
      
      defendant at first instance,
      THE COURT (Third Chamber),
      composed of A. Rosas, President of the Chamber, A. Tizzano (Rapporteur), A. Borg Barthet, U. Lõhmus and A. Ó Caoimh, Judges,
      Advocate General: D. Ruiz-Jarabo Colomer,
      Registrar: M. Ferreira, Principal Administrator,
      having regard to the written procedure and further to the hearing on 27 September 2006,
      after hearing the Opinion of the Advocate General at the sitting on 30 November 2006,
      gives the following
      Judgment
      1       By its appeal, Industrias Químicas del Vallés, SA (‘IQV’) is asking the Court to set aside the judgment delivered by the Court
         of First Instance of the European Communities on 28 June 2005 in Case T‑158/03 Industrias Químicas del Vallés v Commission [2005] ECR II‑2425 (‘the judgment under appeal’), by which the Court of First Instance dismissed the action brought by IQV
         for annulment of Commission Decision 2003/308/EC of 2 May 2003 concerning the non-inclusion of metalaxyl in Annex I to Council
         Directive 91/414/EEC and the withdrawal of authorisations for plant-protection products containing this active substance (OJ
         2003 L 113, p. 8, ‘the contested decision’).
      
       Legal context
      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) establishes the Community rules governing the granting of authorisation to place plant protection products on the market
         and the withdrawal of such authorisation. Under Article 4 of Directive 91/414, Member States are to authorise the placing
         on the market only of those plant protection products of which ‘the active substances are listed in Annex I’. Article 5 of
         the directive sets out the conditions required for the inclusion of substances in that annex. Those conditions are designed
         to protect human and animal health and the environment.
      
      3       Article 6 of Directive 91/414 provides:
      ‘1.       Inclusion of an active substance in Annex I shall be decided in accordance with the procedure laid down in Article 19.
       … 
      2.       A Member State receiving an application for the inclusion of an active substance in Annex I shall without undue delay ensure
         that a dossier which is believed to satisfy the requirements of Annex II is forwarded by the applicant to the other Member
         States and to the Commission together with a dossier complying with Annex III on at least one preparation containing that
         active substance. The Commission shall refer the dossier to the Standing Committee on Plant Health referred to in Article
         19 for examination.
      
      3.       Without prejudice to the provisions of paragraph 4, at the request of a Member State, and within three to six months after
         the date of referral to the committee mentioned in Article 19, it shall be established by the procedure laid down in Article
         20 whether the dossier has been submitted in accordance with the requirements of Annexes II and III
      
      4.       If the assessment of the dossier referred to in paragraph 2 shows that further information is necessary, the Commission may
         ask the applicant to submit such information. The applicant or his authorised representative may be asked by the Commission
         to submit his remarks to it, in particular whenever an unfavourable decision is envisaged.
      
       ...’
      4       Article 8 of Directive 91/414 provides for transitional measures and derogations for active substances not listed in Annex
         I, but already on the market two years after the date of notification of that directive. The placing on the market of those
         active substances may be authorised by Member States for a provisional period of 12 years. During that transitional period,
         the active substances concerned must undergo a programme of assessment after which it may, ‘following examination by the Committee
         referred to in Article 19 of such active substance, be decided by the procedure laid down in that Article that the substance
         can be included in Annex I and under which conditions, or, in cases where the requirements of Article 5 are not satisfied
         or the requisite information and data have not been submitted within the prescribed period, that such active substance will
         not be included in Annex I’.
      
      5       That transitional period, which was initially due to expire on 26 July 2003, was extended until 31 December 2005 by Commission
         Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of 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). It was then extended – by Commission Regulation
         (EC) No 1335/2005 of 12 August 2005 amending Regulation No 2076/2002 and Decisions 2002/928/EC, 2004/129/EC, 2004/140/EC,
         2004/247/EC and 2005/303/EC as regards the time period referred to in Article 8(2) of Directive 91/414 and the continued use
         of certain substances not included in its Annex I (OJ 2005 L 211, p. 6) – until 31 December 2006, except in cases where a
         decision had been taken before that date regarding the inclusion of a particular active substance in Annex I to Directive
         91/414.
      
      6       Article 19 of Directive 91/414 provides:
      ‘Where the procedure laid down in this Article is to be followed, matters shall be referred without delay by the chairman,
         either on his own initiative or at the request of a Member State, to the Standing Committee on Plant Health ... 
      
      The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall
         deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter … 
      
      The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
      If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission
         shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified
         majority.
      
      If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed
         measures shall be adopted by the Commission.’
      
      7       Directive 91/414 also contains provisions on confidentiality. Article 13 concerns applications for authorisation to place
         on the market plant protection products containing active substances already included in Annex I to that directive, and permits
         the use of information supplied by another applicant provided that the latter has agreed to such use.
      
      8       Article 14 of Directive 91/414 provides:
      ‘Member States and the Commission shall … ensure that information submitted by applicants involving industrial and commercial
         secrets is treated as confidential if the applicant … so requests, and if the Member State or the Commission accepts that
         the applicant’s request is warranted.
      
       …’
      9       By 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’), the Commission
         implemented the assessment procedure for a number of substances, with a view to their possible inclusion in Annex I to Directive
         91/414. Metalaxyl was among those substances. 
      
      10     Article 4(1) of Regulation No 3600/92 provides that ‘[a]ny producer wishing to secure the inclusion of an active substance
         referred to in Annex I hereto … in Annex I to the Directive [91/414], shall so notify the Commission within six months of
         the date of entry into force of this Regulation’.
      
      11     Article 5 of Regulation No 3600/92 provides that:
      ‘1. The Commission shall examine with the [Standing] Committee [on Plant Health] the notifications … 
      2. Following the examination referred to in paragraph 1, decisions shall be adopted on the following, according to the procedure
         under Article 19 of the Directive [91/414], in the form of a regulation: 
      
      (a) the list of active substances adopted for assessment with a view to their possible inclusion in Annex I to Directive [91/414];
         
      
      (b) designation of a rapporteur Member State for each active substance included in the list referred to in (a). 
       … 
      4. For each substance adopted for assessment, the regulation referred to in paragraph 2 shall give: 
       … 
      - the deadline for the submission to the rapporteur Member State of the dossiers referred to in Article 6 hereof, generally
         laying down a period of 12 months for the compilation of the documents, and for the submission by any interested parties of
         technical or scientific information with regard to the potentially dangerous effects of the substance or its residues on human
         and/or animal health and/or on the environment.
      
       …’
      12     Article 6 of Regulation No 3600/92 provides:
      ‘1.       Within the time-limit referred to in the third indent of Article 5(4), the notifiers specified in the regulation referred
         to in that Article must, individually or collectively, send to the designated authority of the rapporteur Member State, for
         any given active substance: 
      
      a)       the summary dossier referred to in paragraph 2 hereof; and 
      b)       the complete dossier referred to in paragraph 3 hereof. 
       ... 
      Where for any substance the regulation as envisaged in Article 5(4) indicates several notifications, the notifiers concerned
         shall take all reasonable steps to present collectively the dossiers referred to in the first subparagraph. Where a dossier
         was not presented by all notifiers concerned, it shall mention the efforts made and the reasons why certain producers have
         not participated.
      
       ... 
      4. Where, for any given active substance, the dossiers referred to in paragraph 1 are not sent within the time-limit laid
         down in Article 5(4) or where the dossiers sent clearly do not satisfy the requirements laid down in paragraphs 2 and 3 hereof,
         the rapporteur Member State shall inform the Commission, giving the reasons pleaded by the notifiers. 
      
      5. On the basis of the report of the rapporteur Member State referred to in paragraph 4, the Commission shall present to the
         Committee a draft decision not to include the active substance in Annex I, in accordance with the final subparagraph of Article
         8(2) of the Directive [91/414], unless: 
      
      –       a new time-limit has been granted for the submission of a dossier fulfilling the requirements of paragraphs 2 and 3; a new
         time-limit will only be granted where the delay is proved to have been caused by efforts to present collective dossiers, or
         by additional efforts to be made by the notifier (or notifiers) on account of a decision to designate another rapporteur Member
         State in accordance with Article 5(5), [or by force majeure,]
      
       ...’
      13     Article 7 of Regulation No 3600/92 provides:
      ‘1.      For each active substance for which it has been designated rapporteur, the Member State shall: 
      (a)      examine the dossiers referred to in Article 6(2) and (3), … as well as any information as referred to in the third indent
         of Article 5(4) and any other available information …;
      
      (b)       immediately after examining a dossier, ensure that notifiers submit the updated summary dossier to the other Member States
         and to the Commission; 
      
      (c)       send the Commission, as quickly as possible and at the latest 12 months after receipt of a dossier as referred to in Article
         6(2) and (3), a report of its assessment of the dossier, including a recommendation: 
      
      –       to include the active substance in Annex I to the Directive, stating the conditions for its inclusion, or
      –       to remove the active substance from the market,
      ... 
      2.      From the start of the examination referred to in paragraph 1, the rapporteur Member State may request the notifiers to improve
         their dossiers, or add to them. Moreover, the rapporteur Member State may, from the start of this examination, consult with
         experts from other Member States, and may request additional technical or scientific information from other Member States
         in order to assist the evaluation. 
      
      3.       After receiving the summary dossier and the report referred to in paragraph 1, the Commission shall refer the dossier and
         the report to the [Standing] Committee [on Plant Health] for examination. 
      
      Before referring the dossier and report to the Committee, the Commission shall circulate the rapporteur’s report to the Member
         States for information … 
      
      Before the dossier and report are referred to the Committee, a consultation of experts from the Member States may be organised … 
      3A.      After the examination referred to in paragraph 3, the Commission shall … present to the Committee:
      (a)      a draft directive to include the active substance in Annex I to the Directive [91/414], setting out where appropriate the
         conditions, including the time-limit, for such inclusion;
      
      (b)      a draft decision addressed to the Member States to withdraw the authorisations of plant protection products containing the
         active substance, pursuant to the fourth subparagraph of Article 8(2) of the Directive, whereby that active substance is not
         included in Annex I to the Directive;
      
      (c)      a draft decision addressed to the Member States to suspend plant protection products containing the active substance from
         the market, with the option of reconsidering the inclusion of the active substance in Annex I to the Directive after submission
         of the results of additional trials or of additional information; or
      
      (d)      a draft decision to postpone inclusion of the active substance in Annex I to the Directive pending the submission of the results
         of additional trials or information. 
      
      4.      However, where, following the examination referred to in paragraph 3, the submission of the results of certain additional
         trials or of additional information is required, the Commission shall determine: 
      
      –       the time-limit within which the results or information concerned must be submitted to the rapporteur Member State and the
         experts designated according to paragraph 2 above, this time limit will be 25 May 2002 unless an earlier time‑limit is established
         by the Commission for a particular active substance except for the results of long-term studies, identified as being necessary
         by the rapporteur Member State and the Commission during the examination of the dossier and which are not expected to be fully
         completed by the deadline established, provided that the information submitted contains evidence that such studies have been
         commissioned and that their results will be submitted at the latest on 25 May 2003. In exceptional cases, where it has not
         been possible for the rapporteur Member State and the Commission to identify such studies by 25 May 2001, an alternative date
         may be established for the completion of such studies, provided the notifier supplies the rapporteur Member State with evidence
         that such studies have been commissioned within three months of the request to undertake the studies, and with a protocol
         and progress report of the study by 25 May 2002, 
      
      –       the time-limit within which the notifiers concerned must communicate to the rapporteur Member State and to the Commission
         their undertaking to submit the required results or information within the time-limit laid down in the first indent.
      
       ... 
      5.       The Commission shall submit to the Committee a draft decision for non-inclusion in Annex I to the Directive [91/414] in accordance
         with the final subparagraph of Article 8(2) thereof, where 
      
      –       the notifiers concerned have not communicated their undertaking to submit the required results within the time‑limit referred
         to in the second indent of paragraph 4,
      
      –       the rapporteur Member State has informed the Commission that the results referred to in the first indent of paragraph 4 have
         not been submitted within the time‑limit laid down.
      
      –        …’.
      14     Pursuant to Article 8(1) of Regulation No 3600/92, after receiving the results of the additional trials or the additional
         information, the rapporteur Member State must examine those results or the additional information, ensuring that the results
         or the additional information are sent by the notifier to the other Member States and to the Commission. Further, the rapporteur
         Member State must communicate, within six months at the latest following receipt of the results or information, a report of
         its assessment of the whole dossier including a recommendation whether or not to include the active substance in Annex I to
         Directive 91/414.
      
      15     Under Article 8(3) of Regulation No 3600/92, ‘[b]efore referring the dossier and report to the [Standing] Committee [on Plant
         Health], the Commission shall circulate the rapporteur’s report to the Member States for information and may organise a consultation
         of experts from one or several Member States’. The same provision states that ‘[t]he Commission may consult some or all of
         the notifiers of active substances on the report or parts of the report on the relevant active substance’ and, for those purposes,
         ‘[t]he rapporteur Member State shall provide the necessary technical and scientific assistance during these consultations’.
      
      16     After the examination by the Standing Committee on Plant Health, the Commission is to prepare a draft measure including the
         substance in Annex I to Directive 91/414, or concerning the non-inclusion of that substance. The draft measure is then presented
         to that Committee for approval in accordance with the procedure laid down in Article 19 of the directive.
      
       The facts and the contested decision
      17     IQV is a company governed by Spanish law, the activities of which include the production and marketing of chemical products
         and plant protection products. In particular, IQV imports metalaxyl into Spain and markets products containing that active
         substance in a number of Member States.
      
      18     In April 1995, IQV and the German undertaking Ciba Geigy AG (later Syngenta AG, ‘Syngenta’) both submitted to the Direcção-geral
         de Protecção das Culturas (Directorate general for the protection of crops, ‘the DGPC’) an application for inclusion of metalaxyl
         in Annex I to Directive 91/414. Portugal had been designated as the rapporteur Member State in respect of that active substance.
      
      19     Before making the notification required under Article 4(1) of Regulation No 3600/92, IQV and Syngenta entered into contact
         with a view to setting up a task force to compile a single collective dossier. However, Syngenta then decided not to make
         a collective notification. Consequently, Syngenta and IQV submitted separate dossiers to the Portuguese authorities, on 19
         and 26 April 1995 respectively.
      
      20     After examination of those dossiers, the DGPC considered that the dossier produced by Syngenta was complete, but that information
         was missing from the dossier lodged by IQV. Accordingly, by letter of 22 March 1996, the DGPC asked IQV to fill in the gaps
         in its dossier, in accordance with a strict timetable. 
      
      21     Over the following months, the Portuguese authorities and IQV exchanged correspondence concerning the need for IQV to provide
         the information missing from its dossier, as well as the period of time to be allowed for that purpose. 
      
      22     On 11 May 1998, Syngenta informed the DGPC that it was withdrawing from the procedure for assessing metalaxyl. IQV therefore
         remained the sole company which was party to the procedure. 
      
      23     By letter of 15 January 1999, IQV informed the Portuguese authorities that they were under an obligation to make use of all
         the information and all the documents submitted by all the notifiers and stating that, if IQV was to be asked for a complete
         dossier, an additional period of time ought to be granted to enable it to produce and summarise all the information required.
         
      
      24     By letters of 5 February and 15 March 1999 respectively, the DGPC and IQV asked the Commission for its opinion on the use
         by rapporteur Member States of studies submitted by notifiers which subsequently withdraw from the procedure for assessment
         of the active substance concerned. 
      
      25     By letter of 19 July 1999 (‘the letter of 19 July 1999’), the Commission replied to the DGPC, annexing an opinion prepared
         by the Commission Legal Service, worded as follows:
      
      ‘… 
      2. … There is no doubt that [Syngenta] has ceded its rights over the studies to the rapporteur so that the latter can use
         them in accordance with the rules governing the assessment procedure. The question which remains to be addressed, therefore,
         is whether those rules allow the rapporteur to use data after the notifier who supplied them has withdrawn from the procedure.
      
      3. The legislation is not very clear on this point … The rapporteur is to examine the dossiers submitted and … may use “all
         information”, not only that supplied by the notifiers or the interested parties.
      
      4. Both Directive 91/414 and Regulation No 3600/92 are designed to encourage the joint participation of the various producers
         in the assessment procedure … That does not alter the fact that several notifiers may participate without reaching an agreement.
         In such a case, the rapporteur is to take account of all the studies provided. Thus, the active substance is included even
         if the data supplied by one producer are incomplete, and the studies carried out by one notifier are of benefit to the producers
         as a whole even in the absence of an agreement.
      
      5. Under the system set up by Directive 91/414, inclusion of an active substance in Annex I is not linked exclusively to the
         producer who has applied for its inclusion and inclusion may even be applied for independently by a Member State. In return
         for its efforts, the undertaking which has carried out the scientific studies has the exclusive right to rely on those studies
         when the Member States authorise products containing the active substance in question … It seems therefore that, even if the
         other producers all benefit where the active substance is included thanks to studies carried out by their competitors, they
         will not be able to obtain authorisation for products containing that substance unless they carry out the studies again or
         obtain the right to use them from the author of those studies.
      
      It would be rather odd, therefore, if different rules and different rights were to apply where a notifier withdraws from the
         procedure, and paradoxical, almost, to offer a producer which abandons the market for an active substance better protection
         than a producer which is in competition on that market with the other notifiers. Moreover, the legislation makes no distinction
         between the two situations in terms of the protection offered to the studies supplied by the producers. In consequence, it
         would appear that the same set of rules must apply. 
      
      6. However, the notifier is required to give a number of guarantees to the rapporteur Member State: 
      –       it takes responsibility for submitting to the rapporteur Member State, to the other Member States, to the Commission and to
         the experts referred to in Article 7(2) (peer review), a summary dossier and, if necessary, a complete dossier in accordance
         with Article 6(1) of Regulation No 3600/92; 
      
      –       it must reply appropriately to the requests of the rapporteur Member State to improve or add to the dossier … 
      It follows that the intention of the legislature was clearly to set up a system of close cooperation between the rapporteur
         Member State and the notifier, under which the provision of technical support … and the possibility of obtaining any useful
         information … must be guaranteed by the notifier.
      
      7. In conclusion, … consideration of the matter indicates to the Commission that the withdrawal of a notifier from participation
         in the work programme should not prevent the rapporteur Member State from examining the data provided and issuing the assessment
         report, particularly where another notifier in respect of the same substance has expressed an interest in that assessment
         being completed.
      
      …’
      26     On 28 October 1999, the DGPC informed IQV that it was prepared to draw up the assessment report for metalaxyl on the basis
         of all the information available, including the information in the dossier submitted by Syngenta. It was also stated in that
         letter that if additional questions were raised during the assessment, or if additional data were required, those questions
         and requests for additional information would be addressed to IQV.
      
      27     On 26 January 2001, pursuant to Article 7 of Regulation No 3600/92, the DGPC sent the Commission its assessment report on
         metalaxyl, drawn up on the basis of the dossiers provided by IQV and by Syngenta. In the report, the DGPC stated that certain
         additional information was necessary in order to complete the assessment and that, in consequence, it was not possible at
         that stage to propose the inclusion of metalaxyl in Annex I to Directive 91/414. 
      
      28     By letters of 2 and 15 February 2001, the Portuguese authorities asked IQV to send an updated summary dossier to the Member
         States and to the Commission before 15 March 2001 and, should it be requested, a complete dossier. 
      
      29     On 26 March 2001 the Commission informed IQV that, since IQV had not sent the updated summary dossier within the time-limits
         specified, it was not possible to carry out an appropriate examination of metalaxyl and to arrive at a finding in respect
         of that substance. The Commission pointed out that, under Article 6(1) of Regulation No 3600/92, the notifiers were under
         an obligation to send both a summary dossier and a complete dossier to the competent authority of the rapporteur Member State.
         Accordingly, since those dossiers had not been sent, the Commission intended to propose the adoption of a decision not to
         include metalaxyl in Annex I to Directive 91/414.
      
      30     By letter of 4 May 2001 addressed to the Commission, IQV explained that it intended to purchase those of Syngenta’s studies
         which were protected. IQV also asked the Commission to let it know whether the Portuguese authorities had been given responsibility
         for circulating the necessary documentation to the Member States, and offered to meet the expenses of such distribution itself.
         Subsequently, in a letter of 7 June 2001 to the Commission, IQV provided the list of the studies in Syngenta’s dossier which
         were protected, and pointed out that it was unlikely that Syngenta would agree to sell those studies to IQV.
      
      31     In that letter of 7 June 2001, IQV also attempted to identify – from among the protected Syngenta studies – those which it
         would need in order to complete its own dossier. IQV explained that those studies could be replicated before the May 2002
         deadline. However, IQV asked the Commission to confirm the list so that it could be sure of being able to meet that deadline.
         On the same day, in order to compile a complete dossier, IQV contacted Syngenta with a proposal to purchase certain studies
         carried out in connection with Syngenta’s notification. 
      
      32     By letter of 11 July 2001, the Commission told IQV that it had to complete its dossier by 25 May 2002, since the Commission
         services had to arrive at a final decision regarding metalaxyl before the end of July 2003. The Commission also stated that
         if IQV did not have the complete dossier it would probably be unable to reply within a reasonable period to questions raised
         by the experts from the Member States or by the Commission.
      
      33     By letter of 26 September 2001, the DGPC informed IQV that it was not willing to circulate Syngenta’s dossier to the Member
         States and the Commission.
      
      34     By letter of 15 October 2001, the Commission informed IQV that Syngenta’s refusal to sell its studies to IQV and the Portuguese
         authorities’ refusal to circulate Syngenta’s dossier meant that it was impossible for the Commission to organise effectively
         the consultation of the experts (the ‘peer review’ mechanism) with regard to metalaxyl. 
      
      35     By letter of 1 April 2002, IQV told the Commission that it was willing to carry out all the studies necessary to obtain the
         inclusion of metalaxyl in Annex I to Directive 91/414. On 12 April 2002, IQV sent the Commission an updated summary dossier
         and confirmed its decision to compile a complete dossier.
      
      36     By letter of 6 June 2002, the Commission informed IQV that only those active substances in respect of which full data would
         be available by 31 December 2003 at the latest could have their deadline for assessment extended beyond that date. The Commission
         stated in that letter its opinion that IQV could not produce a complete dossier by that date. Accordingly, the Commission
         stated that it was forced to propose that metalaxyl should not be included in Annex I to Directive 91/414. The Commission
         pointed out, however, that IQV could file a dossier for the purpose of registering metalaxyl as a ‘new active substance’.
      
      37     By letter of 14 June 2002 to the Commission, IQV stated that it was continuing to carry out the studies necessary to fill
         the gaps identified in the report from the Portuguese authorities, and undertook to submit those studies by May 2003. Regarding
         the submission of a dossier for the registration of metalaxyl as a new active substance, IQV stated that the compilation of
         such a dossier would not be possible before the end of 2005. IQV added that since the compilation of such a dossier entailed
         a major financial investment, it could only be envisaged if the Commission guaranteed that metalaxyl would be authorised for
         a transitional period so that IQV would not lose market share during the assessment procedure.
      
      38     In June 2002 the Commission placed a draft decision not to include metalaxyl before the Standing Committee on Plant Health.
         After the Committee had approved the draft decision at its meeting of 18 and 19 October 2002, the Commission adopted the contested
         decision on 2 May 2003.
      
       The proceedings before the Court of First Instance and the judgment under appeal
      39     By application lodged at the Registry of the Court of First Instance on 9 May 2003, IQV brought an action for annulment of
         the contested decision. On the same day, IQV also applied for the suspension of application of that decision.
      
      40     By order of 5 August 2003 in Case T‑158/03 R Industrias Químicas del Vallés v Commission [2003] ECR II‑3041, the President of the Court of First Instance dismissed the application for interim measures brought by IQV. IQV then filed
         an appeal against that order. 
      
      41     By order of 21 October 2003 in Case C‑365/03 P(R) Industrias Químicas del Vallés v Commission [2003] ECR I‑12389, the President of the Court, on finding that the President of the Court of First Instance had erred in
         law in the balancing of the interests involved and that the conditions relating to a prima facie case and to urgency were
         satisfied, set aside the order of 5 August 2003 in Industrias Químicas del Vallés v Commission, and ordered the suspension of operation of the contested decision.
      
      42     By the judgment under appeal, the Court of First Instance ruled on the substance of the case and rejected the three pleas
         in law relied on by IQV. By those pleas in law, IQV alleged the incorrect application to the facts of the case of Directive 91/414
         and Regulation No 3600/92, infringement of the principle of proportionality and misuse of powers.
      
      43     Firstly, the Court of First Instance held that the Commission had not contravened either the rules relevant to the assessment
         of active substances or its own interpretation of the provisions relating to the use of studies submitted, before its withdrawal,
         by another notifier. Whatever the circumstances, IQV should have submitted to the rapporteur Member State a complete dossier
         within the time-limits laid down in Regulation No 3600/92. The Court of First Instance also held that the presumption relied
         on by the Commission – that, since IQV did not have access to the studies submitted by Syngenta, IQV would be unable to reply
         to the questions which would arise in the course of the peer review – was justified. 
      
      44     Further, the Court of First Instance considered that the contested decision did not infringe the principle of proportionality
         since, in the circumstances of the case, the withdrawal from the market of plant protection products containing metalaxyl
         represented the only means of ensuring that the objective of protecting human and animal health and the environment would
         be met. 
      
      45     Lastly, the Court of First Instance rejected the plea in law alleging misuse of powers, on the ground that IQV had not adduced
         any evidence to show that the Commission had adopted the contested decision as a result of pressure exerted by Syngenta.
      
       Proceedings before the Court of Justice and the forms of order sought by the parties 
      46     By application lodged at the Registry of the Court on 26 August 2005, IQV brought the present appeal against the judgment
         under appeal, together with a fresh application for suspension of operation of the contested decision. The latter application
         was dismissed by order of the President of the Court of 15 December 2005 in Case C‑326/05 P‑R Industrias Químicas del Vallés v Commission (not published in the ECR).
      
      47     IQV claims that the Court should:
      –       declare that the present appeal is admissible and well founded;
      –       set aside the judgment under appeal;
      –       grant the application made at first instance, seeking annulment of the contested decision;
      –       in the alternative, refer the case back to the Court of First Instance for judgment;
      –       order the Commission to pay the costs incurred both at first instance and on appeal and, if appropriate, those incurred as
         a result of the proceedings relating to interim measures.
      
      48     The Commission contends that the Court should:
      –       dismiss the appeal as inadmissible or, in the alternative, as unfounded, as regards the first to third grounds of appeal,
         the first and third parts of the fourth ground of appeal, the first part of the fifth ground of appeal, the seventh ground
         of appeal and the assertions made in paragraphs 108 and 109 of the appeal which relate to the content of certain statements
         made by the legal representative of IQV in the course of the hearing before the Court of First Instance; 
      
      –       dismiss the appeal, for the rest, as unfounded;
      –       order IQV to pay the costs.
       The appeal
      49     In its appeal, the appellant relies on seven grounds of appeal in order to have the judgment under appeal set aside and the
         contested decision annulled or, in the alternative, to have the case referred back to the Court of First Instance for a new
         ruling.
      
       The first ground of appeal
       Arguments of the parties
      50     By its first ground of appeal, the appellant submits that the Court of First Instance distorted the clear sense of the evidence
         before it in order to conclude, in paragraphs 94 and 104 of the judgment under appeal, that the Commission had not in any
         way changed, in the course of the procedure, its position as to the requirement that IQV submit a complete dossier.
      
      51     According to IQV, it is clear from the letter of 19 July 1999 – as well as from other documents, which the Court of First
         Instance did not take into account – that, initially, the Commission and the DGPC had thought it possible to carry out the
         assessment of metalaxyl not only on the basis of the dossier lodged by IQV, but also in the light of all the information available,
         including the studies submitted by Syngenta. Only subsequently did the Commission demand a complete dossier from the appellant,
         thereby changing its approach and making it impossible in practice to produce such a dossier within the period of time allowed.
      
      52     IQV alleges in particular that, by referring to a single passage in the letter of 19 July 1999, without considering the entire
         contents, the Court of First Instance misconstrued the meaning of that letter. According to IQV, a reading of the whole letter
         reveals that, in 1999, the Commission did not consider that the submission of a complete dossier by IQV was necessary, whether
         for proceeding with the assessment of metalaxyl or for the possible inclusion of that substance in Annex I to Directive 91/414.
         
      
      53     IQV adds that, in analysing the letter of 19 July 1999, the Court of First Instance did not take into account either the facts
         or the documents subsequent to that letter. On that point, IQV relies principally on a letter from the DGPC dated 28 October
         1999 (according to IQV, the only document of which it was aware at the material time) in which, on the one hand, no mention
         was made of the possibility that IQV might be asked to produce a complete dossier and, on the other, it was stated that the
         procedure would be conducted on the basis of all the information available.
      
      54     The Commission contends that this ground of appeal is inadmissible, since the appellant has not demonstrated any distortion
         of the clear sense of the evidence submitted to the Court of First Instance.
      
      55     The Commission also contends that this ground of appeal is unfounded. It maintains that it never changed its approach in the
         course of the assessment procedure: on the contrary, it always insisted that IQV submit a complete dossier. That is clear
         from the very wording of the letter of 19 July 1999, as the Court of First Instance rightly pointed out. 
      
       Findings of the Court
      56     First, the Commission’s preliminary plea of inadmissibility must be examined.
      57     In that regard, it must be pointed out that, in accordance with the case-law of the Court of Justice, complaints based on
         findings of fact and on the assessment of those facts in the judgment under appeal are admissible on appeal where the appellant
         submits that the Court of First Instance has made findings of fact which the documents in the file show to be substantially
         incorrect or that it has distorted the clear sense of the evidence before it (see, to that effect, Case C-82/01 P Aéroports de Paris v Commission [2002] ECR I‑9297, paragraph 56, and Case C‑229/05 P PKK and KNK v Council [2007] ECR I‑0000, paragraph 35).
      
      58     That is indeed the case here. The ground of appeal set out by the appellant refers in some detail to a manifest error committed
         by the Court of First Instance in its reading of the documents before it.
      
      59     In those circumstances, the first ground of appeal must be held to be admissible.
      60     As to whether the ground of appeal is well founded, it should be recalled that there is distortion of the clear sense of the
         evidence where, without recourse to new evidence, the assessment of the existing evidence appears to be clearly incorrect
         (PKK and KNK v Council, paragraph 37, and, to that effect, see also Case C‑551/03 P General Motors v Commission [2006] ECR I‑3173, paragraph 54).
      
      61     In the light of that criterion, the Court finds that the Court of First Instance relied on the content both of the letter
         of 19 July 1999 and of a letter of 28 October 1999 from the DGPC to IQV in order to conclude that the Commission had in no
         way changed its position on the need for IQV to submit a complete dossier and that, consequently, the Commission was justified
         in refusing to extend the period of time allowed for that submission.
      
      62     Thus, in paragraph 94 of the judgment under appeal, the Court of First Instance stated that ‘[t]he language of the letter
         of 19 July 1999 concerning IQV’s obligations is very clear: “[The notifier] has responsibility for submitting to the rapporteur
         Member State, the other Member States and the experts referred to in Article 7(2) (peer review) a summary dossier, and, where
         necessary, a complete dossier.” Even though the DGPC’s letter to IQV of 28 October 1999 did not repeat that passage, it is
         clear that the Commission’s position did not change at all’. In paragraph 104 of the judgment under appeal, the Court of First
         Instance added that ‘the Commission’s position on that question has not changed … The Commission did not contradict itself
         by requiring a complete dossier in 2001, since, as early as July 1999, the legal opinion addressed to the DGPC referred to
         that obligation.’ 
      
      63     However, as was pointed out by the Advocate General in points 68 to 72 of his Opinion, the inferences drawn by the Court of
         First Instance from those letters are not consistent with the meaning and implications of the letters read as a whole.
      
      64     While it is true that, according to paragraph 6 of the letter of 19 July 1999, IQV was required to submit ‘if necessary, a
         complete dossier’, the fact remains that, elsewhere in that letter, the Commission stated to the DGPC: 
      
      –       ‘[t]here is no doubt that [Syngenta] has ceded its rights over the studies to the rapporteur so that the latter can use them
         in accordance with the rules governing the assessment procedure’ (paragraph 2); 
      
      –       ‘[t]he rapporteur is to examine the dossiers submitted and … may use “all information”, not only that supplied by the notifiers
         or the interested parties’ (paragraph 3); 
      
      –       ‘[where several notifiers participate in an assessment procedure without reaching an agreement,] the rapporteur is to take
         account of all the studies provided. Thus, the active substance is included even if the data supplied by one producer are
         incomplete, and the studies carried out by one notifier are of benefit to the producers as a whole even in the absence of
         an agreement’ (paragraph 4)
      
      –       ‘[u]nder the system set up by Directive 91/414, inclusion of an active substance in Annex I is not linked exclusively to the
         producer who has applied for its inclusion and inclusion may even be applied for independently by a Member State’ (paragraph
         5);
      
      –       ‘[i]n conclusion, … consideration of the matter indicates to the Commission that the withdrawal of a notifier from participation
         in the work programme should not prevent the rapporteur Member State from examining the data provided and issuing the assessment
         report, particularly where another notifier in respect of the same substance has expressed an interest in that assessment
         being completed’ (paragraph 7).
      
      65     It is clear therefore from the terms of the letter of 19 July 1999 read as a whole that, although the Commission mentioned
         the possibility that production of a complete dossier might be required, it primarily confirmed to the Portuguese authorities
         that the assessment procedure for the active substance had to be carried out by reference to all the data available and that,
         in any event, the fact that IQV’s dossier was incomplete did not as such represent an obstacle either to proceeding with the
         assessment procedure or to the possible inclusion of metalaxyl in Annex I to Directive 91/414.
      
      66     Furthermore, the meaning of that letter is also clear from the letter sent to IQV on 28 October 1999 – after the DGPC had
         acquainted itself with the opinion of the Commission – in which the DGPC stated, without mentioning any possibility whatsoever
         that production of a complete dossier might be required, that it would take account of the dossier submitted by Syngenta and
         that only additional information could be requested from IQV. Moreover, as the Commission stated in point 5 of the grounds
         of the contested decision, the metalaxyl assessment report sent by the Portuguese authorities on 26 January 2001 was drawn
         up on the basis of information supplied by both notifiers.
      
      67     Lastly, it must also be observed that, while the Commission referred in its letter of 26 March 2001 both to the obligation
         to produce a summary dossier and to the obligation to submit a complete dossier, it indicated that the latter obligation would
         arise only ‘if requested’.
      
      68     Consequently, it must be held that the findings of fact set out in paragraphs 94 and 104 of the judgment under appeal, to
         the effect that the Commission had in no way changed its position on the need for the applicant to produce a ‘complete dossier’
         in support of its application for registration of metalaxyl, are incorrect and amount to a distortion of the clear sense of
         the evidence submitted to the Court of First Instance. 
      
      69     Accordingly, the first ground of appeal must be upheld and the judgment under appeal must be set aside, without it being necessary
         to rule on the other grounds of appeal relied on by IQV.
      
       The action before the Court of First Instance
      70     In accordance with the second sentence of the first paragraph of Article 61 of the Statute of the Court of Justice, if the
         decision of the Court of First Instance is set aside the Court of Justice may give final judgment in the matter where the
         state of the proceedings so permits.
      
      71     It is appropriate in the present case for the Court to avail itself of that possibility, since it has all the information
         necessary to rule on the substance of the case. 
      
      72     By the second and third parts of the first plea in law – which should be examined first – IQV submitted in essence that the
         Commission made a manifest error of assessment in requiring a complete dossier to be lodged before the deadline specified
         and in refusing to defer that deadline. By its contradictory behaviour, the Commission itself made it impossible for IQV to
         meet that obligation in the time allowed. 
      
      73     The Commission has maintained that it correctly assessed the facts of the case, that it correctly applied the legislation,
         and that it did not behave in a contradictory manner with regard to the need for IQV to submit a complete dossier so that
         the assessment procedure for metalaxyl could be completed.
      
      74     The Court notes however that, as is clear from Recitals 5, 6 and 9 in the preamble thereto, Directive 91/414 seeks to remove
         barriers to intra-Community trade in plant products, while maintaining a high level of protection of the environment and of
         human and animal health (see also Case C‑138/05 Stichting Zuid-Hollandse Milieufederatie [2006] ECR I‑8339, paragraph 43). 
      
      75     In that context, as the Court of First Instance rightly held in paragraph 95 of the judgment under appeal, if the Commission
         is to be able to pursue effectively the objective assigned to it, account being taken of the complex technical assessments
         which it must undertake, it must be recognised as enjoying a broad discretion.
      
      76     However, the exercise of that discretion is not excluded from review by the Court. The Court has consistently held that in
         the context of such a review the Community judicature must verify whether the relevant procedural rules have been complied
         with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error
         of appraisal or a misuse of powers (Case 98/78 Racke [1979] ECR 69, paragraph 5, and Case C‑16/90 Nölle [1991] ECR I‑5163, paragraph 12).
      
      77     In particular, where a party claims that the institution competent in the matter has committed a manifest error of appraisal,
         the Community judicature must verify whether that institution has examined, carefully and impartially, all the relevant facts
         of the individual case, facts which support the conclusions reached (see, inter alia, Case C‑269/90 Technische Universität München [1991] ECR I‑5469, paragraph 14).
      
      78     It must therefore be determined whether the contested decision was adopted in accordance with the principles set out above.
      79     On that point, it must be stated that the letters referred to above, written in 1999 by the Commission and by the DGPC, could
         well have led IQV to believe – as is clear from paragraphs 61 to 67 of the present judgment – that the assessment of metalaxyl
         would be carried out on the basis of all the information available (including the studies contained in the dossier submitted
         by Syngenta) and that the competent authorities would, if necessary, ask it to provide no more than clarification or additional
         data. Moreover, the letters from the DGPC, which are referred to in paragraph 28 of the present judgment, also bear witness
         to somewhat inconsistent behaviour on the part of the DGPC towards IQV. 
      
      80     It must accordingly be held that the appellant found itself in an unforeseen and complicated situation, account being taken
         in particular of the time and effort needed to organise the required scientific studies when the Commission asked it to produce
         a complete dossier.
      
      81     Thus, while IQV stated in its letter of 7 June 2001 that it could complete its dossier within the time allowed – that is,
         before May 2002 – if the Commission could confirm the list set out in Syngenta’s dossier of the studies necessary for that
         purpose, the Commission did no more in its letter of 11 July 2001 than emphasise that the deadline for completion of the dossier
         was 25 May 2002 and that a final decision on metalaxyl had to be adopted before the end of July 2003. It is common ground
         that the Commission never confirmed the list of studies set out in IQV’s letter of 7 June 2001.
      
      82     As emerges from the letters from IQV referred to in paragraphs 35 to 37 of the present judgment, and particularly from the
         letter of 14 June 2002, IQV nevertheless continued clearly to express its intention of submitting to the Commission the studies
         missing from its dossier, undertaking to produce them for May 2003. 
      
      83     It is common ground, however, that the Commission took no account of that undertaking in that it did not reply to the letter
         of 14 June 2002 and at the same time placed a draft decision before the Standing Committee on Plant Health for the non-inclusion
         of metalaxyl. 
      
      84     It follows that the appellant has rightly submitted that the impossibility of lodging a complete dossier before the specified
         deadline of 25 May 2002 was attributable, at least in part, to the contradictory behaviour of the competent authorities. It
         is also obvious that the Commission did not in any way take that circumstance into account when it decided to adopt the contested
         decision and to refuse to defer the deadline until May 2003, as IQV had requested. 
      
      85     That finding is not affected by the argument relied on by the Commission that the circumstances of the case precluded the
         setting of new deadlines for IQV so as to enable it to submit the missing information. As the Advocate General pointed out
         in points 77 to 84 of his Opinion, it was perfectly possible under the rules in force at the material time to defer the deadline
         for completion of the dossier, since the Commission had done so in the context of similar assessment procedures for other
         active substances. The Commission acknowledged, moreover, in the defence submitted at first instance that the deferral until
         31 December 2005 of the deadline for assessment of active substances ‘also applied to metalaxyl’.
      
      86     In addition, the Commission itself had confirmed – in the letter to IQV referred to in paragraph 36 of the present judgment
         – that it could as a general rule use any information submitted to it before 31 December 2003, in other words, at a date several
         months after the May 2003 date proposed by IQV and refused by the Commission. 
      
      87     It should be noted, furthermore, that the Commission has not disputed, even at the hearing, the absence of evidence indicating
         that the use of metalaxyl may present any risk whatsoever to public health or to the environment. 
      
      88     It follows that the Commission committed a manifest error of appraisal in refusing to grant IQV a deferral of the deadline
         for production of the studies missing from its dossier and in deciding as a consequence not to include metalaxyl in Annex
         I to Directive 91/414 on the sole ground that the appellant had failed to submit a complete dossier before that deadline.
      
      89     The contested decision is therefore vitiated by an error in law and must be annulled.
       Costs
      90     Under Article 69(2) of the Rules of Procedure, which applies to appeal proceedings by virtue of Article 118 thereof, the unsuccessful
         party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since IQV has applied
         for costs and the Commission has been unsuccessful in its pleadings, the Commission must be ordered to pay the costs of the
         present proceedings and of the proceedings at first instance, including costs relating to the proceedings for interim measures
         before both the Court of Justice and the Court of First Instance.
      
      On those grounds, the Court (Third Chamber) hereby:
      1.      Sets aside the judgment of the Court of First Instance of the European Communities of 28 June 2005 in Case T-158/03 Industrias Químicas del Vallés v Commission;
      2.      Annuls Commission Decision 2003/308/EC of 2 May 2003 concerning the non-inclusion of metalaxyl in Annex I to Council Directive
            91/414/EEC and the withdrawal of authorisations for plant-protection products containing this active substance; 
      3.      Orders the Commission of the European Communities to pay the costs of the present proceedings and of the proceedings at first
            instance, including those relating to the proceedings for interim measures before both the Court of Justice and the Court
            of First Instance.
      [Signatures]
      * Language of the case: Spanish.