62005CC0326_EN
Opinion of the Advocate-General
Opinion of the Advocate-General
1. Industrias Químicas del Valles SA (‘IQV’) is appealing against the judgment of the Court of First Instance of 28 June 2005 (2) dismissing the action 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 (3) (‘the contested decision’).
2. An unwieldy bundle of pleas reveals the tension between, on the one hand, compliance with the deadlines which the Commission has fixed with a view to ensuring that access to Annex I to Council Directive 91/414 (4) is managed somewhat methodically and, on the other, the essential aim of that legislation, which takes precedence over other aspects in order to make sure that any substance which promotes the development of the chemical industry without endangering human health or the environment is registered.
I – Relevant legal background
A – Directive 91/414
3. Directive 91/414 concerns the authorisation, placing on the market, use and control of plant protection products (Article 1(1)), and approves only those which contain active substances (5) listed in Annex I thereto (Article 4(1)); an active substance may be so included if, in the light of current scientific and technical knowledge, it does not have any harmful effects on health or any unacceptable influence on the environment (Article 5(1)). (6)
4. However, the Member States are permitted, during a period of not more than 12 years, to authorise the distribution of plant protection products containing substances not listed in Annex I provided that those substances were already on the market two years after the date of notification of the directive (Article 8(2), first subparagraph), as is the case with metalaxyl. That period, which expired on 26 July 2003, was extended until 31 December 2005, except in cases where a decision to include or not to include a particular substance in Annex I had been taken before that date. (7)
5. During that transitional period, the Commission set up a programme of work for the gradual examination of those active substances (Article 8(2), second subparagraph, of Directive 91/414) and for deciding, following the relevant assessment, to include them in Annex I to Directive 91/414 or, in cases where the requirements under Article 5 are not satisfied or the requisite information and data have not been submitted within the prescribed period, not to include them (Article 8(2), fourth subparagraph).
B – Commission Regulation (EEC) No 3600/92
1. Initial notification
6. Regulation No 3600/92 lays down the procedures for implementing the programme. (8) They begin with an expression of interest, notified within six months of the date of entry into force of that regulation by any producer wishing to secure the inclusion in Annex I to Directive 91/414 of one of the active substances described in Annex I to the regulation, one of which is metalaxyl (Article 4(1)). Collective dossiers may be submitted, (9) in order to avoid duplication of work, and in particular to avoid experiments involving vertebrate animals (recital 9).
7. Once the applications have been examined, a rapporteur Member State is designated. Applications in respect of metalaxyl were assigned to Portugal, (10) which allocated the task to the Direcção-Geral de Protecção das Culturas (Directorate‑General for the Protection of Crops, ‘the DGPC’).
2.
Procedure before the rapporteur Member State
8. The notifiers are required to show that the substance is not harmful to health or the environment (Article 6(2)(b) of Regulation No 3600/92, (11) read in conjunction with Article 5 of Directive 91/414). To that end, they had to send to the rapporteur Member State, by 31 October 1995, (12) individually or collectively, a summary dossier and a complete dossier, with a copy to the experts of other Member States – selected by the Commission with a view to a possible subsequent consultation – and, if so requested, to the competent national authorities (Article 6(1) of Regulation No 3600/92, read in conjunction with Article 7(2) thereof). (13) Article 6(2) and (3) of Regulation No 3600/92 specify the content of those dossiers.
9. The Commission, on being informed accordingly by the rapporteur Member State, may, under the fourth subparagraph of Article 8(2) of Regulation No 91/414, refuse to include the substance if the documentation is not sent within the period allowed or if the requirements laid down are not met, although an extension may be granted where the delay is caused by efforts to present collective dossiers, or by adjustments in the light of a change of rapporteur Member State, or by force majeure (Article 6(4), and Article 6(5), opening words and first indent). (14)
10. If the procedure continues, the rapporteur Member State is to examine the dossiers, ensuring that notifiers submit the summary dossier, duly updated, to the other Member States and to the Commission (Article 7(1)(a) and (b)); it may request the notifiers to improve or add to their dossiers, and it may ask for additional technical or scientific information from other Member States (Article 7(2)). (15)
11. Lastly, the rapporteur Member State is to prepare and send to the Commission – as quickly as possible and at the latest 12 months after receipt of the dossiers – an assessment, together with a recommendation for: (i) inclusion of the active substance in Annex I to Directive 91/414; or (ii) withdrawal of the active substance from the market; or (iii) suspension of the placing on the market of that active substance, pending additional trials or additional information specified in the report; or (iv) postponement of any decision pending submission of the results of additional trials or additional information (Article 7(1)(c)).
3. Examination by the Standing Committee on Plant Health and the Commission proposal
12. The Commission is then to refer the summary dossier and the report to the Standing Committee on Plant Health (‘the Committee’), (16) but beforehand, if it considers it expedient, it is to organise a consultation of national experts (peer review) and to consult some or all of the notifiers on the content of the report (Article 7(3)). (17)
13. The Committee is to examine the documentation and the Commission is to place before it either a draft decision withdrawing the authorisations for plant protection products containing the active substance or a draft directive including the active substance in Annex I to Directive 91/414. The Commission may also suggest suspending such products from the market or postponing any decision until after submission of the results of additional trials or of further information (Article 7(3A) (18) ).
14. If the last option is selected, the Commission is to fix a deadline, which was to be 25 May 2002 (unless an earlier deadline had been fixed 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 could not be fully completed by the deadline established, provided that it had been shown that such studies had been commissioned and that their results would 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 that the notifier supplies the rapporteur Member State with evidence that such studies were 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. After that, submission of new studies is not accepted (Article 7(4)). (19)
15. If the deadlines are not respected, the Commission is to submit to the Committee, in accordance with Article 8(2) of Directive 91/414, a draft decision for non-inclusion of the active substance in Annex I thereto (Article 7(5)).
16. If the interested party is diligent and fulfils its obligations within the time allowed, similar steps are taken – as laid down in Article 8 of Regulation No 3600/92 (20) – until a decision is taken as to whether to include the active substance in Annex I to Directive 91/414; if it is decided not to, the corresponding authorisations are withdrawn.
C –
Economy of effort and data protection
17. In laying down the rules to govern authorisations to place a product on the market, Directive 91/414 provides that a Member State to which an application is made in respect of an active substance already authorised in another Member State must avoid the repetition of tests and analyses if the agricultural, plant health and environmental and climatic conditions are comparable (Article 10(1) of Directive 91/414).
18. However, applicants must provide documents proving that the requirements laid down have been satisfied, and the Member States may not make use of that information for the benefit of other applicants, unless this has been agreed (Article 13(1)(a), read in conjunction with Article 13(3)(a), of Directive 91/414).
19. In any event, the holders of previous authorisations and the new applicant must reach agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals. For the same purpose, where data is requested with a view to inclusion in Annex I of an active substance already on the market two years after notification of the Directive, the Member States are to encourage data holders to cooperate. Where an agreement cannot be reached, the national authorities are to oblige the sharing of the data if the persons concerned are located in their territory, determining both the procedure and the reasonable balance of the interests of the parties concerned (Article 13(7), last three subparagraphs).
20. Directive 91/414 requires the Commission and the Member States to ensure that industrial and commercial secrets are treated as confidential if this is requested by an applicant for authorisation of a plant protection product or by an applicant wishing to have an active substance included in Annex I to the directive, provided that the request is warranted (Article 14, first paragraph), although that confidentiality does not cover the information listed in the second paragraph of Article 14.
II – Background to the appeal
A – The facts in the case which are relevant to the appeal
21. From the judgment under appeal (paragraphs 20 to 50) and from the documents annexed to the appeal, the following facts emerge.
22. IQV, which has its seat in Spain, has been importing metalaxyl since February 1994 and markets it in Italy, Greece and Portugal, as well as in Spain. Ciba Geigy AG (which later became Novartis AG, then Syngenta AG, ‘Syngenta’) also marketed products containing metalaxyl (paragraphs 20 and 21).
23. Both undertakings notified the Commission of their intention to initiate the procedure for the inclusion of metalaxyl in Annex I to Directive 91/414 and, having failed in their attempt to compile a collective dossier, submitted separate dossiers to the DGPC on 19 April 1995 and 26 April 1995, respectively (paragraphs 21 and 22).
24. After a preliminary examination of the documents submitted, the DGPC formed the view that the dossier submitted by IQV, unlike that submitted by Syngenta, was incomplete and informed the company accordingly on 22 March 1996. It later told IQV exactly which studies still needed to be carried out, and the company undertook to provide them by June 1998 (paragraphs 23 to 25).
25. On 11 May 1998 Syngenta informed the rapporteur Member State that it was withdrawing from the assessment procedure for metalaxyl, and requested the return of the summary dossier and the complete dossier it had submitted (paragraph 26). (21)
26. On 15 January 1999, IQV – now making the application on its own – informed the DGPC that, in its opinion, the documents and information submitted by Syngenta should be used, and requested deferral of the deadline in case the use of that material was refused and it, IQV, was asked for a complete dossier. On 5 February 1999 and 15 March 1999 respectively, IQV and the DGPC asked the Commission for its opinion on the use of dossiers submitted by notifiers which withdraw from the procedure. At the same time, the Commission was informed that the dossier submitted by IQV was incomplete and that additional time would be necessary in order for the gaps to be filled (paragraphs 28 and 29).
27. On 19 July 1999 the Commission replied to the DGPC, enclosing the following opinion from the Commission’s Legal Service (paragraph 30 of the appeal, and Annex VI thereto): (22)
‘...
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 …
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. Those rules, known as ‘data protection’, cover both the data relating to the active substances (Annex II data) and that relating to the product (Annex III data). 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 during preparation of its assessment report and, later, during the examination of that report by the Commission in accordance with Article 7(2) of Regulation No 3600/92.
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.
However, before beginning – or continuing – the work, it is appropriate and reasonable for the rapporteur Member State to examine, together with the notifier concerned, and with the aim of economising on the resources required of them both, the guarantees which the latter may provide that it will meet its obligation to supply the technical and administrative contribution described in point 6 above, which is necessary in order to complete the assessment and to take a decision at Community level.’
28. IQV had no knowledge of the above document. Relying on that document, the DGPC informed IQV on 28 October 1999 that it was prepared to draw up the assessment report on the basis of all the information available, including the data in the dossier supplied by Syngenta. The DGPC stated, however, that if additional questions arose or additional data were required, it would address itself to IQV. On 26 January 2001 the assessment report was sent to the Commission. The report stated that certain additional information was required and, accordingly, did not recommend the inclusion of metalaxyl in Annex I to Directive 91/414 (paragraphs 31 and 32).
29. In February 2001, the DGPC asked IQV to send to the Member States and the Commission, before 15 March 2001, an updated summary dossier and, should it be requested, a complete dossier. Since IQV did not do so within the time allowed, the Commission informed the company that it was not possible to carry out an appropriate examination of metalaxyl and arrive at a finding in respect of that substance. Accordingly, the Commission intended to recommend that metalaxyl should not be included in Annex I to Directive 91/414 (paragraphs 34 and 35).
30. From that moment, IQV considered the options of replicating certain studies or buying them from Syngenta, but the purchase fell through. It then asked the Commission whether Portugal would be given responsibility for circulating the documentation to the Member States. The Commission did not rule out the possibility, but the Portuguese authorities were not prepared to do it. Finally, in October 2001, the Commission informed IQV that, owing to those two refusals, it was impossible for it to consult the national experts with regard to metalaxyl (paragraphs 36 to 42).
31. March 2002 marked the beginning of an exchange of letters in which the Commission informed IQV that not only the difficulty in obtaining a complete dossier by 31 December 2003, but also the lack of circumstances justifying deferral of the deadline, prompted it to recommend that metalaxyl should not be included in Annex I to Directive 91/414. (23) IQV again expressed its willingness to carry out all the studies necessary, provided that it was granted a new transitional period (paragraphs 43 to 47).
32. At its meeting of 18 and 19 October 2002, the Standing Committee on Plant Health approved a draft decision not to include metalaxyl in Annex I to Directive 91/414 because IQV did not have the documentation necessary for a detailed assessment and for replying to questions raised by the Member States. On 2 May 2003, the Commission adopted the contested decision (paragraphs 49 and 50).
33. By that decision, the Commission refused to include metalaxyl in Annex I to Directive 91/414 (Article 1) and required the Member States not to grant or renew the corresponding authorisations, and to withdraw those already issued (Article 2). In the statement of reasons prefacing that decision, it is explained that IQV had failed to submit a complete dossier, since it was prevented from completing it within a reasonable period, nor did it have access to the dossier submitted by Syngenta, so it was unable to submit information needed for an appropriate assessment. In those circumstances, there was no means of ensuring that, under the proposed conditions of use, plant protection products containing metalaxyl would not have any harmful effect on health or on the environment (recital 7).
B – The forms of order sought and the arguments adduced at first instance
34. On 9 May 2003 IQV brought an action before the Court of First Instance for annulment of the contested decision.
35.
In support of its action, the applicant put forward three pleas in law: the first plea alleged that the contested decision measure reflects an incorrect and inconsistent interpretation of Directive 91/414 and Regulation No 3600/92; the second plea alleged that it infringes the principle of proportionality; the third plea, which is irrelevant to this appeal, related to misuse of powers.
36. In the first plea, the challenge focused on: (1) the need for a complete dossier from each of the notifiers; (2) the requirement that it be submitted within the time-limit laid down in Article 6(1) of Regulation No 3600/92; (3) the inconsistency of the Commission’s letter of 19 July 1999; and (4) the weakness of the presumption that the company would be unable to answer the experts’ questions during the peer review.
37. The Commission contested those arguments, which the Court of First Instance rejected in their entirety.
C – The grounds of the judgment under appeal
1. The need for a complete dossier from each of the notifiers (paragraphs 71 to 78)
38. After establishing that IQV and Syngenta acted separately, the Court of First Instance stated that the existence of two separate notifications means that a complete dossier is required from each notifier. It follows from Article 6(1) and (2)(b) and Article 7(1)(b) of Regulation No 3600/92 that each notifier has an obligation to prepare a summary dossier and a complete dossier, and IQV’s responsibilities are not affected by Syngenta’s withdrawal from the procedure. That obligation is not called into question by the fact that Regulation No 3600/92 evinces a preference for the submission of collective dossiers. Moreover, Article 13(7) of Directive 91/414 applies only to authorisations for plant protection products and the burden of proving that the active substance is not harmful lies with the interested party.
2. The requirement that a complete dossier be submitted within the time-limit laid down (paragraphs 88 to 100)
39. The legislation lays down specific time-limits for submitting the documentation and completing the procedure, and the Commission may extend those time-limits only in ‘exceptional’ cases. That possibility does not arise in IQV’s case since it knew, at least as early as 3 May 1997, that its dossier was incomplete and, from July 1998, it was aware of Syngenta’s withdrawal. The allegations concerning the difficulty for IQV of complying with the time-limits are irrelevant since, in its letter of 19 July 1999, the Commission made it clear that the notifier ‘takes responsibility for submitting to the rapporteur Member State, to the other Member States, to the Commission and to the experts ... a summary dossier and, if necessary, a complete dossier’ and, even though the DGPC’s letter of 28 October 1999 did not quote that extract, ‘it is clear that the Commission’s position did not change at all’.
40. The Commission did not manifestly exceed the limits of its discretion by refusing to grant the extension. An indefinite extension of the time-limit would thwart the objective pursued by Directive 91/414 of ensuring a high level of protection of health and the environment. It is true that deadlines have been deferred for other substances, but never beyond 31 December 2003, whereas some of IQV’s studies were not complete until September 2004.
3. The inconsistency of the Commission’s letter of 19 July 1999 (paragraphs 104 and 105)
41. The Commission did not contradict itself by requiring a complete dossier in 2001, since a reference to that obligation was made in the legal opinion of 19 July 1999 addressed to the DGPC, setting out an interpretation compatible with Regulation No 3600/92.
4. IQV’s inability to reply to the questions (paragraphs 110 to 115)
42. The Commission was correct in pointing out that, without access to Syngenta’s studies, IQV was not in a position to answer the experts’ questions on those studies. Recital 7 of the contested decision mentions that there was not enough information to carry out the assessment.
43. IQV failed on a number of occasions to meet procedural deadlines, thereby helping to bring that situation upon itself; and it should be added that not all the essential studies missing from its dossier were in Syngenta’s dossier. In its letter of 4 May 2001, IQV itself acknowledged the difficulty of replying to the Member States’ questions without access to Syngenta’s studies.
5. The principle of proportionality (paragraphs 133 to 139)
44. The objective of Directive 91/414 is to protect health and the environment in accordance with the precautionary principle and the case-law upholding the primacy of such protection over economic interests. The contested decision is not a manifestly inappropriate means of attaining that objective, since IQV was unable, without Syngenta’s studies, to clarify any doubts which might have been raised during the peer review or, consequently, to prove that metalaxyl was not harmful.
45. In a statement before the Court of First Instance, IQV maintained that only two analyses remained to be covered in its own studies and those of Syngenta (provided by the time the contested decision was adopted), but at the hearing it admitted that only draft reports had been completed by then (May 2003), not conclusive studies.
III – The appeal
46. IQV relies on seven grounds of appeal.
47. By the first ground of appeal, IQV alleges that the Court of First Instance distorted the clear sense of the Commission’s letter to the DGPC of 19 July 1999, by holding in paragraph 94 of the judgment (and by a reference in paragraph 104) that the Commission made it clear in that letter that the notifier was required to submit both a summary dossier and a complete dossier. According to IQV, such an analysis implies a fragmentary approach to the letter, disregards its context and takes no account of subsequent events, which reveal that the Commission and the Portuguese authorities had initially thought it possible to assess metalaxyl on the basis of all the information available, including the studies submitted by Syngenta. Only later did the Commission change its mind and ask for a complete dossier, thereby changing its original approach and making it impossible for the dossier to be prepared within the period of time allowed.
48. By its second ground of appeal, IQV alleges that the Court of First Instance erred in law by rejecting the argument that there was no obligation to prepare a complete dossier on the basis of a passage in the legal opinion of 19 July 1999, which, as stated in the judgment itself, was not quoted by the Portuguese authorities in their reply to IQV. According to IQV, not only is such an approach at odds with the principle of sound administration – in accordance with which the Commission must accept the verdict of the body to which has delegated a task – it also gives the Commission the power to adopt measures which limit rights, on the basis of documents of which the addressees of those measures are unaware.
49. By its third ground of appeal, IQV alleges infringement of the Community case-law relating to the precautionary principle and the principle of proportionality, which, in order to prevent potential risks to health, requires solid evidence on the basis of which there can be a reasonable doubt that a substance is harmless. The Court of First Instance should have realised that the decision not to include metalaxyl in Annex I to the Directive was not based on such evidence but on procedural considerations, especially the desire to finish the ass essment procedure as quickly as possible. In those circumstances, the harm caused to individual rights far outweighs the advantages for the general interest.
50. By its fourth ground of appeal, IQV alleges other errors of law, in the interpretation and application of the relevant legal framework:
(1) IQV complains that the Court of First Instance confuses the terms ‘complete dossier’ and ‘additional information’, whereas they are quite separate, since they relate to different stages of the assessment procedure.
(2) IQV then alleges to be incorrect the argument that, where there are multiple notifiers, each must compile a complete dossier, since it is inconsistent not only with recital 7 and Article 7(1) and (2) of Regulation No 3600/92, but also with the aim of avoiding duplication of experiments with vertebrate animals.
(3) IQV also rejects the view that Articles 13 and 14 of Directive 91/414 do not apply to procedures for the assessment of active substances.
(4) Lastly, IQV criticises the limited role attributed by the judgment to the rapporteur Member State in the stages following submission of its opinion, since the rapporteur Member State is meant to disseminate the information in its possession and to give the interested parties technical assistance so that they can reply to the questions put by the Commission.
51. By the fifth ground of appeal, IQV criticises the judgment for holding that the Commission was right to refuse to defer the deadline for the assessment of metalaxyl. In that regard, the Court of First Instance relied on two false premisses: (i) that the applicant had requested an indefinite delay, whereas in fact it had undertaken to complete the long-term studies by September 2004, and (ii) that deferrals for other active substances respected the deadline of 31 December 2003, an assertion which contradicts paragraph 90 of the judgment, where it is acknowledged that the transitional period for authorisation to place on the market plant protection products containing active substances was extended until 31 December 2005.
52. The sixth ground of appeal focuses on paragraphs 110 et seq. of the judgment under appeal, which contain an excessive – almost contradictory – account of IQV’s presumed inability to reply to the experts’ questions on Syngenta’s studies. For the Court of First Instance, not all the essential studies missing from IQV’s dossier were in Syngenta’s dossier, which was also incomplete, a fact not mentioned in the contested decision, which states that ‘assessment of metalaxyl could only proceed on the basis of the dossier submitted by Syngenta’.
53. By the final ground of appeal, it is alleged that the Court of First Instance committed certain irregularities in its examination of IQV’s observations in the Report for the Hearing prepared by the Judge-Rapporteur, since most of the points made are not addressed in the judgment under appeal and no reason is given for that omission. IQV also alleges unequal treatment in that, while the Commission had the opportunity to contest those observations in writing after the hearing, IQV was not granted the right to reply. (24)
IV – Analysis of the appeal
54. IQV bases its appeal on seven grounds, some procedural and others substantive. The first group comprises the first, sixth and seventh grounds of appeal and the second group comprises the remaining grounds.
A – The procedural pleas
55. The three arguments put forward by IQV in respect of the conduct of the Court of First Instance in the proceedings before it refer to different stages in the procedure: the assessment of the evidence (first ground), the argumentation followed and inferences drawn in the judgment (sixth and seventh grounds).
1. The sixth ground of appeal
56. By its sixth ground of appeal, IQV complains of a contradiction in paragraph 110 of the judgment under appeal, where it is stated that IQV was not in a position to answer the experts’ questions because it did not have access to Syngenta’s dossier, while in paragraph 112 it is stated that essential studies were missing from Syngenta’s dossier, an assertion that does not appear in the contested decision.
57. However, there is no such contradiction, and that ground of appeal is therefore unfounded and must be rejected.
58. The fact that IQV could not make use of the other company’s studies does not mean that they were complete; if those studies were necessary for evaluating metalaxyl, it means that those compiled by the appellant were insufficient, not that Syngenta’s studies approached perfection.
59. Moreover, in legal proceedings held to establish the disputed facts and to determine the applicable law, by settling the dispute in a reasoned manner, there was nothing to prevent the Court of First Instance altering some of the Commission’s factual assessments, since such a discretion accrues to its judicial competence in an action for annulment.
2. The seventh ground of appeal
60. By this ground of appeal, IQV complains that many of its observations in the Report for the Hearing drawn up by the Judge-Rapporteur were not taken into account, and no reason was given for that omission. It adds that, in breach of the principle of equality of arms in the proceedings, the Commission was permitted to refute those observations in writing, instead of being compelled to do so orally during the hearing, which deprived the appellant of the opportunity to rebut the Commission’s arguments.
61. That second aspect of the ground of appeal is inadmissible, since it merely points to a procedural irregularity, without explaining the extent to which that deviation put IQV at a disadvantage in relation to the Commission, depriving it of a proper defence. It is a rhetorical protest, marginal to the nature of these proceedings, which are not designed to reopen the debate order to define the scope of the case, after the Report for the Hearing has been heard, (25) but to draw the attention of the Court of First Instance to possible ambiguities or inaccuracies showing that the court called upon to decide the case has not fully grasped the inferences to be drawn from that debate.
62. Thus the first part of the ground of appeal is unfounded. The Report for the Hearing is a document addressed exclusively to the other Members of the Court hearing the case, which does not have to contain an exhaustive description of the facts and allegations; a summary account is adequate. By definition, its lacunae or errors cannot constitute an independent infringement of the rights of the defence, nor can the fact that the observations reported therein are not addressed in the judgment, because the Report for the Hearing is not part of that decision. The parties do not participate in this internal procedure in order to exercise their rights of defence, but rather to cooperate with a multilingual body in order to specify the subject-matter of the dispute, in the interests of the proper administration of justice.
3. The first ground of appeal
63. However, more weight can be attributed to the first ground of appeal, by which IQV claims that the Court of First Instance made a biased and partial interpretation of the opinion of the Commission’s Legal Service, enclosed with the letter of 19 July 1999, thereby distorting its content.
64. IQV maintains that it failed to meet the deadlines because the Commission changed its mind and asked it for a complete dossier in 2001, even though, two years previously – in the aforementioned opinion – it had taken a different approach.
65. In response to that argument, the Court of First Instance stated (paragraphs 94 and 104) that the Commission did not change its mind, since, according to that document, the notifier has responsibility for submitting a summary dossier, and, where appropriate, a complete dossier. However, that assertion does not fully reflect reality and disregards – as is pointed out in the appeal – the linguistic context in which the opinion was issued, no account being taken of subsequent events.
66. It should be pointed out that the Commission drew up that opinion in order to dispel any doubts as to whether use should be made, in the assessment procedure, of the studies of a notifier who subsequently withdraws. According to the opinion, the applicable provisions do not provide a clear solution to the problem (point 3), although they encourage joint submissions and the studies of one notifier may benefit everybody, even if no agreement has been reached, so that the active substance may be registered even though the data supplied by one producer are incomplete (point 4). Under the system established by Directive 91/414, that registration is not linked exclusively to the person who seeks it; in the absence of interested undertakings, access to Annex I may be granted to national authorities (point 5). It is true that each notifier takes responsibility for submitting a summary dossier and a complete dossier and for cooperating with the rapporteur Member State (point 6), but it is equally true that the withdrawal of one of the notifiers from the programme of work does not preclude the rapporteur Member State from making use of its studies in order to issue the assessment report, if other notifiers wish to continue, although it may also examine the guarantees which they may provide to supply the necessary technical and administrative contribution (point 7).
67. Thus a detailed analysis of the opinion does not support the inference, drawn by the Court of First Instance, that, in the circumstances of the case, there was no doubt, as far as the Commission was concerned, that the notifier who wishes to complete the dossier is required, if necessary, to reproduce the dossier of the undertaking which withdraws. The appraisal of that document in the judgment under appeal is regrettable; it has taken an isolated sentence out of context in order to make a deduction belied by a thorough reading, and adulterated its true meaning.
68. That interpretation of the opinion (a document of which IQV was unaware) coincides with the meaning attributed to it in October 1999 by the DGPC, when it informed IQV that it intended to prepare the assessment on the basis of all the available information, including the information in Syngenta’s dossier, although it might also request any relevant further information.
69. I am not unaware of the case-law of the Court of Justice to the effect that the Court has no competence to assess the facts, (26) which lies within the exclusive jurisdiction of the Court of First Instance. (27) However, where the documents in the file show that the Court of First Instance has made findings which are substantially inaccurate and those inaccuracies are ‘obvious and easily ascertainable’, (28) or where there is an irregularity which has altered (‘distorted’) the clear sense of the evidence submitted to it, (29) the Court of Justice may legitimately intervene on appeal, because there has been misuse of the power of the Court of first Instance to establish the facts to which the law must be applied.
70. That error, as I explain below, has flawed the reasoning of the judgment under appeal, leading it to reach a mistaken conclusion, and the first ground of appeal should therefore be upheld, to the extent that I shall indicate in due course.
B – The substantive grounds of appeal
71. The other part of the appeal, which is not sufficiently consistent and rather confused, is composed of four grounds of appeal (the second to the fifth), in which IQV employs various arguments which probably amount to a single line of argument since, when all is said and done, what is being disputed is the interpretation given by the Court of First Instance to Directive 91/414 and the related provisions, when it approved the Commission’s refusal to register metalaxyl because the appellant had not submitted a complete dossier within the time-limit and because it was unable to use Syngenta’s documentation. That is why the appeal criticises the arguments in the judgment under appeal in respect of that obstacle (fourth ground), which support the Commission’s position on this point – disregarding the opinion of 19 July 1999 and the subsequent response of the Portuguese authorities (second ground) – in order to adopt a formalistic decision, more concerned with the duration of the assessment procedure than with determining whether metalaxyl is a danger to health and the environment (third and fourth grounds).
1. The procedure for assessing active substances
72. Directive 91/414 represented the needle on weighing scales on which two purely Community objectives are placed: firstly, the removal of barriers to trade in plant products and the improvement of plant production and, secondly, the protection of human and animal health and the environment. (30) The latter aim is served by Article 4(1)(a), which only permits trade in plant protection products containing substances listed in Annex I to Directive 91/414, whereas the other objective is covered by the first subparagraph of Article 8(2), which allows Member States to authorise, during a transitional period, products containing active substances not listed in Annex I that are already on the market. The second, third and fourth subparagraphs of Article 8(2) seek to reconcile the two aims, (31) by designing a programme of work for the examination of those substances (the procedural details being laid down in Regulation No 3600/92), which culminates in their inclusion in the Annex, or in a refusal to include them because the necessary information and data have not been provided or, even if they have been provided, because it has not been demonstrated that the substances are harmless. (32)
73. The provisions of Regulation No 3600/92 must be understood in this light, especially those which require the undertakings concerned to submit documentation establishing that the substances are harmless.
74. Directive 91/414 (the second and fourth subparagraphs of Article 8(2)) and Regulation No 3600/92 (Articles 6(1) and 7(2)) require producers interested in having a substance included in Annex I to provide the necessary information, so that, if they do not do so, they suffer the consequences. However, we must not lose a sense of perspective, by rushing to the conclusion that those consequences always arise when the notifier is unable to submit all the documentation. That would be the natural outcome in a procedure for the authorisation of an activity subject to a permit, such as, for example, the sale of plant protection material. However, it is not so obvious in a procedure which, far from being concerned with the authorisation of rights, pursues the general interest in maintaining a high level of protection of health and the environment. It is therefore not a question of directly benefiting undertakings which manufacture certain active substances, but of providing citizens with a guarantee that those substances are harmless, by means of a procedure in which the undertakings who hope to profit if the outcome is favourable openly cooperate.
75. That view explains why, if several companies seek registration of the same substance, they are encouraged to act jointly (recital 9 and Article 6(1), (2)(a) and (5), first indent) and why, where they participate individually, the rapporteur Member State issues its report on the basis of all the documentation, irrespective of who has supplied it (recital 6 and Article 7(1) of Regulation No 3600/92), even if it has been another Member State (Article 7(2) of the Regulation). It also explains the opinion of the Commission’s Legal Service of 19 July 1999, according to which it is possible for applications for registration to be made directly by national authorities, without the intercession of producers (Article 6(5), second indent, of Regulation No 3600/92), and is fully consonant with the observations made in that document concerning the use of information provided by an undertaking which, after initiating the procedure for registration of the substance, discontinues and withdraws from the procedure, without prejudice to the rules relating to the protection of that data (33) and the obligation of the remaining notifiers to make a technical and administrative contribution to the completion of the procedure, so that a decision can be taken on whether or not to include the active substance in Annex I to Directive 91/414.
76. It is therefore not at all strange that, three months after receiving the legal opinion of 19 July 1999, the DGPC notified IQV that it would issue its assessment on the basis of all the data available, including the data supplied by Syngenta, and asked it to be prepared in case new queries arose or further information was requested. Nor is it surprising that, in reliance on that information, IQV did not complete its dossier, which everyone knew was incomplete, and simply waited in case it was asked for that additional cooperation.
2. The time-limits for notifiers to submit dossiers
77. Directive 91/414 lays down various time-limits, but they are not peremptory. In providing for the possibility of successive extensions, the Community legislature confirms that view.
78.
First of all, the transitional period during which the Member States could authorise the placing on the market of plant protection products containing active substances not listed in Annex I, which originally expired on 26 July 2003, was extended, first until 31 December 2005 and then until 31 December 2006. (34)
79. In the assessment procedure for those substances, the time-limit for submitting the summary and completed dossiers in respect of some substances – amongst them metalaxyl – expired on 30 April 1995, but was extended until 31 October 1995. (35) The same thing happened with the deadlines for the interested parties to supply further information or additional evidence, which was fixed as 25 May 2002 in Article 7(4), first indent, of Regulation No 3600/92 and could, in certain circumstances, be deferred until 25 May 2003. (36)
80. Moreover, Regulation No 3600/92 (Article 6(5), first indent) provides that, where the aforementioned dossiers are not submitted by the deadline, this is to be deferred if the delay has been caused by efforts to present collective dossiers or by force majeure,
81. No other interpretation is possible since, as I have said, what is being protected is not the individual benefit of the undertakings seeking to have an active substance included in Annex I to Directive 91/414, but the general interest, which requires the free circulation of those substances and of plant protection products within Community territory, without any harm to the environment or to human or animal health. Accordingly, if a product of that kind containing a substance not listed in Annex I to Directive 91/414 was being marketed, with the relevant authorisations, in a Member State at the time when that legislation was notified, what is of vital concern is to establish that such a substance is harmless, not the precise date on which that is done; consequently, if the deadline specified is not met, through no fault of the notifier (force majeure) or because the notifier has followed the procedure preferred by the legislation (collective dossiers), the deferral must be granted.
82. As it is, I consider that in the present case both reasons are present. To begin with, at the preliminary stage of the procedure, IQV attempted to act jointly, but was unsuccessful because Syngenta withdrew; it then tried to obtain Syngenta’s studies and analyses but was unable to. Furthermore, in the light of the letter sent to it by the rapporteur Member State in October 1999, IQV could reasonably have believed that it would not to be asked to complete its dossier, (37) but only to provide the studies and additional information needed for the assessment after all the documentation in the procedure had been examined, without excluding the documentation submitted by Syngenta. In those circumstances, the request made in February 2001 that IQV should send the Member States and the Commission, by 15 March 2001, an updated summary dossier and, if so requested, a complete dossier, is an event which, although not quite covered by the concept of force majeure, is similar, since it was unforeseeable and beyond IQV’s power of decision, factors which made that request impossible to fulfil.
83. In short, the Court of First Instance has committed the errors of law alleged in the appeal by denying the significance of the reply given to IQV in October 1999 by the DGPC, as the Commission’s alter ego (second ground); by attaching greater importance to strict observance of time-limits than to attainment of the objectives of Directive 91/414 (third ground), aims which it disregards through an interpretation of the procedures laid down in Regulation No 3600/92 which reflects neither the wording nor the spirit of that legislation (fourth ground); and, lastly, by holding that the Commission was right to refuse to grant IQV a deferral of the deadline (fifth ground).
84. In the light of those considerations, my examination of the substantive grounds of appeal, together with the first ground, discloses the advisability of setting aside the judgment under appeal, because, by distorting the clear sense of the opinion of 19 July 1999 (first ground), the Court of First Instance renders the position of the rapporteur Member State wholly ineffective (second ground), wrongly authorises the Commission’s refusal to grant a deferral, errs in law by denying that it was the Commission which prevented IQV from being able to meet the deadline (fifth ground), and thus thwarts the intentions of the Community legislature (third ground).
V –  The ruling of the Court of Justice on the action
85. Once the judgment under appeal has been set aside, the Court of Justice may give final judgment in the matter, pursuant to the first paragraph of Article 61 of the EC Statute of the Court of Justice, because the state of the proceedings so permits.
86. The decision to set aside the judgment must, as IQV claims, uphold the application and annul the contested decision. However, it need not implicitly entail the inclusion of metalaxyl in Annex I to Directive 91/414 and may, given the circumstances on the basis of which the appeal is successful, merely declare the annulment, returning the administrative procedure to the point at which the appellant must be granted an additional period of time within which to supply the information missing from its own dossier and from Syngenta’s dossier, that information being necessary for the adoption of a decision on metalaxyl.
VI – Costs in the two sets of proceedings
87. The outcome which I suggest requires that the Commission be ordered to pay the costs of the proceedings at first instance, in accordance with the first subparagraph of Article 87(2) of the Rules of Procedure of the Court of First Instance.
88. The Commission must also bear the costs of this appeal, pursuant to the first paragraph of Article 122, in combination with the first subparagraph of Article 69(2), of the Rules of Procedure of the Court of Justice.
VII –  Conclusion
89. In the light of the foregoing considerations, I propose that the Court of Justice:
(1) uphold the first five grounds of appeal relied on by IQV in its appeal against the judgment of 28 June 2005 of the Court of First Instance of the European Communities in Case T-158/03 Industrias Químicas del Vallés
v Commission ;
(2) set aside that judgment;
(3) uphold the application brought by Industrias Químicas del Vallés SA and annul 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, returning the administrative procedure to the point at which that company must be granted an additional period of time within which to supply the information missing from its own dossier and from Syngenta’s dossier, that information being necessary for the adoption of a decision on metalaxyl;
(4) order the Commission of the European Communities to pay the costs of the present proceedings, as well as those incurred in the proceedings at first instance.
(1) .
(2)  –	Case T-158/03 Industrias Químicas del Vallés
v Commission [2005] ECR
II-2425.
(3)  –	OJ 2003 L 113, p. 8.
(4)
Directive of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1).
(5)  –	‘Active substances’ are chemical elements, their compounds, micro-organisms and viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products (Article 2(3) and (4)).
(6)  –	The protection of health and the environment is the inspiration for this Directive, both in its preamble (ninth and tenth recitals) and in its provisions (Article 5(1) and Article 4(1)(b)(iv) and (v)).
(7)  –	Article 1 of Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Directive 91/414 and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these substances (OJ 2002 L 319, p. 3). A further extension, until 31 December 2006, was granted in Commission Regulation (EC) No 1335/2005 of 12 August 2005 (OJ 2005 L 211, p. 6).
(8)  –	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 Council Directive 91/414/EEC (OJ 1992 L 366, p. 10).
(9)  –	Article 6(1), (2)(a) and (5), first indent, refer indirectly to this possibility.
(10)  –	Annex I to Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member States for the implementation of Commission Regulation (EEC) No 3600/92 (OJ 1994 L 107, p. 8).
(11)  –	In accordance with Commission Regulation (EC) No 2266/2000 of 12 October 2000 amending Regulation (EEC) No 3600/92 (OJ 2000 L 259, p. 27).
(12)  –	A time-limit fixed, in accordance with Article 5 of Regulation No 3600/92, by Commission Regulation (EC) No 2230/95 of 21 September 1995 amending Regulation (EC) No 933/94 (OJ 1995 L 225, p. 1), in which 30 April 1995 had been established (Article 2).
(13)  –	The wording of Article 7(2) derives from Commission Regulation (EC) No 1199/97 of 27 June 1997 amending Regulation (EEC) No 3600/92 (OJ 1997 L 170, p. 19).
(14)  –	This first indent is the wording of Commission Regulation (EC) No 491/95 of 3 March 1995 amending Regulations No 3600/92 and Regulation No 933/94 (OJ 1995 L 49, p. 50).
(15)  –	Paragraph amended by Regulation No 1199/97, cited in footnote 13.
(16)  –	This Committee has been replaced by the Standing Committee on the Food Chain and Animal Health (Article 62(2), second subparagraph, of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1)).
(17)  –	In the version of Regulation (EC) No 2266/2000, cited above.
(18)  –	Incorporated by Regulation (EC) No 1199/97.
(19)  –	In accordance with Regulation No 2266/2000.
(20)  –	As amended by Regulation No 2266/2000.
(21)  –	Syngenta withdrew from the procedure because it was seeking registration of metalaxyl-M, a substance with characteristics very similar to those of metalaxyl.
(22)
The translation is mine.
(23)  –	Subject to the possibility that a dossier could be filed for the purpose of registering metalaxyl as an active substance (paragraphs 46 and 47).
(24)  –	It completes the appeal with a protest, not formulated as a plea in law, regarding paragraph 137 of the judgment at first instance, which contains a statement (‘at the hearing [the applicant] admitted that only draft reports rather than definitive studies had been completed by the date of adoption of the contested decision in May 2003’) which the appellant considers is the result of a drafting error or a misunderstanding, because the studies in question had been completed by that time. In support of this assertion, it proposed two measures of inquiry: the inclusion in the file of those studies and of the transcription of the hearing which took place before the Court of first Instance on 8 December 2004. However, as that transcription demonstrated the truth of the extract in the judgment under appeal, at the appeal hearing, in reply to a question put to him, the representative of Industrial Químicas del Vallés withdrew the complaint.
(25)  –	The judgment in Case C-161/97 P Kernkraftwerke Lippe-Ems
v Commission
[1999] ECR I‑2057 pointed out that the Judge-Rapporteur’s report presents in summary form the elements of fact and law in the case and the pleas and arguments of the parties, and it is open to the parties before or during the hearing to ask for corrections to be made or to express reservations (paragraph 58).
(26)  –	The judgment in Case C-283/90 P Vidrányi
v Commission
[1991] ECR I-4339, paragraphs 10 and 11, is the first in a long line of judgments which point out that appeals are limited to a review of the interpretation and application of legal provisions and any ruling on the facts is precluded.
(27)  –	This was stated in Case C-136/92 P Commission
v Brazzelli Lualdi and Others
[1994] ECR I-1981, paragraph 49.
(28)  –	The words of Advocate General La Pergola in the Opinion in Case C-46/98 P EFMA
v Council [2000] ECR I-7079, point 11.
(29)  –	Case C-237/98 P Dorsch Consult
v Council and Commission
[2000] ECR I-4549, paragraphs 35 and 36.
(30)  –	The judgment in Case C-174/05 Zuid-Hollandse Milieufederatie and Natuur en Milieu
[2006] ECR I-2443, paragraph 30, refers to both objectives.
(31)  –	I agree with Advocate General Sharpston who, in the Opinion in Case C-138/05 Stichting Zuid-Hollandse Milieufederatie
[2006] ECR I-8339, argues that the leeway afforded to Member States under the various transitional provisions contained in Article 8 of Directive 91/414 cannot undermine the objective of protecting the environment and health (points 46 and 76).
(32)  –	This assessment may therefore lead to the withdrawal or variation of the authorisations granted pursuant to the first subparagraph of Article 8(2), if risks are perceived which preclude registration of the substance in Annex I to Directive 91/414, in accordance with the fourth subparagraph of Article 8(2). See to that effect the judgment cited in footnote 30, especially paragraph 22.
(33)  –	Ar ticles 13 and 14 of Directive 91/414 govern the requirement for data, its protection and confidentiality; they apply to the procedure for evaluating substances, as is apparent from Article 7(1)(d) of Regulation No 3600/92. However, the combined interpretation of those two provisions shows that those who possess information needed to include an active substance in Annex I may be required to supply it (the penultimate subparagraph of Article 13(3)), unless it is subject to confidential treatment under Article 14.
(34)  –	Point 3 and footnote 7 of this Opinion.
(35)  –	As I pointed out in point 7 and footnote 12.
(36)  –	This is apparent from Article 7(4) of Regulation No 3600/92, in the wording of Regulation No 2266/2000, which I have transcribed in part in point 13 of this Opinion.
(37)  –	Above all, because, as the Court of First Instance itself acknowledges (paragraph 94 of the judgment), the only passage in the opinion referring to the obligation to submit the dossiers (point 6) was not repeated in the letter from the Portuguese authorities.