Corte di giustizia UE n. 451/2013

62012CJ0149_EN [OSCURATO:PERSONA] part [OSCURATO:PERSONA] C‑149/12 P, APPEAL under [OSCURATO:PERSONA] 56 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], brought on 21 March 2012, [OSCURATO:PERSONA] SA, established in Saint-Andiol (France), [OSCURATO:PERSONA] LLC, established in Seattle ([OSCURATO:PERSONA]), represented by K. [OSCURATO:PERSONA], C. Mereu and N. Knight, avocats, appellants, the other party to the proceedings being: [OSCURATO:PERSONA], represented by G. von Rintelen and P. Ondrůšek, acting as Agents, and by J. Stuyck, avocat, with an address for service in Luxembourg, defendant at first instance, [OSCURATO:PERSONA] ([OSCURATO:PERSONA]), composed of E. Jarašiūnas (Rapporteur), President of the [OSCURATO:PERSONA], A. Ó Caoimh and C.G. Fernlund, Judges, [OSCURATO:PERSONA]: Y. Bot, Registrar: C. Strömholm, Administrator, having regard to the written procedure and further to the hearing on 13 December 2012, having decided, after hearing the [OSCURATO:PERSONA], to proceed to judgment without an Opinion, gives the following [OSCURATO:PERSONA] 1. By their appeal, [OSCURATO:PERSONA] SA (‘[OSCURATO:PERSONA]’) and [OSCURATO:PERSONA] LLC (‘[OSCURATO:PERSONA]’) seek to have set aside the judgment of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 19 January 2012 in [OSCURATO:PERSONA] T‑71/10 [OSCURATO:PERSONA] and [OSCURATO:PERSONA] v [OSCURATO:PERSONA] (‘the judgment under appeal’), by which that court dismissed their action seeking the annulment of [OSCURATO:PERSONA] 2009/859/EC of 30 November 2009 concerning the non-inclusion of diphenylamine (‘DPA’) in Annex I to [OSCURATO:PERSONA] 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ 2009 L 314, p. 79) (‘the contested decision’). [OSCURATO:PERSONA] law 2. [OSCURATO:PERSONA] 8(2) of [OSCURATO:PERSONA] 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1) provided that the [OSCURATO:PERSONA] was to implement a programme of work for the gradual examination, during a period of 12 years, of the active substances contained in the plant protection products that are already on the market. According to that article, it is decided, following examination and according to the procedure laid down in that directive, whether or not the examined active substance may be included in Annex I to that directive (‘Annex I’) which contains the list of active substances authorised for incorporation in plant protection products. That article also provides that the [OSCURATO:PERSONA] are to ensure that the relevant authorisations are granted, withdrawn or varied, as appropriate, within a prescribed period. 3. Given the very high number of existing active substances on the market still to be evaluated, a programme in several phases was established. DPA is in the list of the active substances to be evaluated in the third stage of that programme, the detailed rules for its implementation being defined by [OSCURATO:PERSONA] (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the programme of work referred to in [OSCURATO:PERSONA] 8(2) of [OSCURATO:PERSONA] 91/414 (OJ 2000 L 55, p. 25) and [OSCURATO:PERSONA] (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in [OSCURATO:PERSONA] 8(2) of [OSCURATO:PERSONA] 91/414 and amending [OSCURATO:PERSONA] 451/2000 (OJ 2002 L 224, p. 23). [OSCURATO:PERSONA] 1490/2002 has been amended on several occasions and, in particular, by [OSCURATO:PERSONA] (EC) No 1095/2007 of 20 September 2007 (OJ 2007 L 246, p. 19), which entered into force on 28 September 2007. 4. [OSCURATO:PERSONA] 11(1) and (2) of [OSCURATO:PERSONA] 1490/2002, that article being headed ‘Receipt of and access to the draft assessment report’, provides: ‘1. After receiving the updated summary dossier and the draft assessment report referred to in [OSCURATO:PERSONA] 10(1), the [[OSCURATO:PERSONA] (“EFSA”)] shall, within 30 days, acknowledge to the rapporteur [OSCURATO:PERSONA] receipt of that report. … 2. The EFSA shall without delay communicate the draft assessment report to the [OSCURATO:PERSONA], the other [OSCURATO:PERSONA] and the notifiers setting a time period of no more than two months for the submission of comments by those [OSCURATO:PERSONA] and the notifiers. It shall collate the comments it receives, including available comments from the EFSA, and forward them to the [OSCURATO:PERSONA], [OSCURATO:PERSONA] and the notifiers.’ 5. [OSCURATO:PERSONA] 11a of that regulation, headed ‘Examination of the draft assessment report’, provides: ‘[OSCURATO:PERSONA] shall, without delay, examine the draft assessment report and the recommendation by the rapporteur [OSCURATO:PERSONA] and the comments received from other [OSCURATO:PERSONA], the EFSA and from the notifiers in accordance with [OSCURATO:PERSONA] 11(2).’ 6. [OSCURATO:PERSONA] 11b of that regulation, headed ‘Active substance with clear indications that they do not have any harmful effects’ provides: ‘If there are clear indications that it may be expected that the active substance does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, as set out in Annex V, [OSCURATO:PERSONA] 12(1)(a) and (2)(a) shall apply.’ 7. [OSCURATO:PERSONA] 11c(1) of [OSCURATO:PERSONA] 1490/2002, that article being headed ‘Consultation of the EFSA’, provides: ‘[OSCURATO:PERSONA] 11b does not apply, the [OSCURATO:PERSONA] may, at any time during the evaluation, ask the EFSA to carry out a peer review of the full draft assessment report or to focus on specific points including points related to criteria set out in Annex VI. The EFSA shall organise a consultation of [OSCURATO:PERSONA] experts including the rapporteur [OSCURATO:PERSONA]. [OSCURATO:PERSONA] the [OSCURATO:PERSONA] requests the EFSA to carry out a full peer review, the EFSA shall deliver its conclusion at the latest six months after the request. [OSCURATO:PERSONA] the [OSCURATO:PERSONA] does not request a full peer review, but only a conclusion on specific points, the period shall be reduced to three months. The submission of the conclusions shall in any event be no later than 30 September 2008.’ 8. [OSCURATO:PERSONA] 11e of that regulation, headed ‘Withdrawal by notifier’, states: ‘[OSCURATO:PERSONA] 11b does not apply, the notifier may withdraw his support of the inclusion of the active substance in Annex I … within two months from receipt of the draft assessment report referred to in [OSCURATO:PERSONA] 11(2).’ 9. [OSCURATO:PERSONA] 11f of that regulation, headed ‘Active substance for which there are clear indications of harmful effects’ provides: ‘If there are clear indications that it may be expected that the active substance has harmful effects on human or animal health or on groundwater as set out in Annex VI, the [OSCURATO:PERSONA] shall take a [OSCURATO:PERSONA] on the non-inclusion of the active substance in Annex I …, in accordance with [OSCURATO:PERSONA] 12(1)(a) and (2)(b) of this [OSCURATO:PERSONA].’ 10. [OSCURATO:PERSONA] 12 of [OSCURATO:PERSONA] 1490/2002, headed ‘Presentation of a draft directive or draft decision’, provides: 1. [OSCURATO:PERSONA] shall submit to the [OSCURATO:PERSONA] a draft review report at the latest six months after: (a) receipt of the draft assessment report where [OSCURATO:PERSONA] 11b or [OSCURATO:PERSONA] 11f applies; (b) receipt of the conclusion established by the EFSA where [OSCURATO:PERSONA] 11c applies; (c) receipt of a written withdrawal of the notifier’s support where [OSCURATO:PERSONA] 11e applies. 2. Together with the draft review report the [OSCURATO:PERSONA] shall submit to the [OSCURATO:PERSONA]: (a) a draft directive including the active substance in Annex I … setting out where appropriate the conditions, including the time limit, for such inclusion; or (b) a draft decision addressed to the [OSCURATO:PERSONA] requiring them to withdraw, within six months, the authorisations of plant protection products containing the active substance, pursuant to the fourth subparagraph of [OSCURATO:PERSONA] 8(2) of [OSCURATO:PERSONA] [91/414], whereby that active substance is not included in Annex I …, mentioning the reasons for the non-inclusion. … 3. By way of derogation from paragraph 2(b), the latest date for [OSCURATO:PERSONA] to withdraw authorisations shall be 31 December 2010 in the case referred to in paragraph 1(c) unless the [OSCURATO:PERSONA] has concluded that the substance meets the criteria of Annex VI, if appropriate after having consulted the EFSA.’ 11. According to recitals 5 and 6 in the preamble to [OSCURATO:PERSONA] 1095/2007, the resources of the EFSA should be used efficiently and the EFSA should focus on cases where the remaining doubts need to be resolved before a decision on the inclusion of the active substance concerned in Annex I can be taken. 12. [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] 1095/2007 states: ‘As regards active substances for which, at the date of entry into force of this [OSCURATO:PERSONA], the draft assessment report by the rapporteur [OSCURATO:PERSONA] had been sent to the EFSA but for which the EFSA had not submitted its conclusions to the [OSCURATO:PERSONA], by way of derogation from [OSCURATO:PERSONA] 11e of [OSCURATO:PERSONA] … No 1490/2002, [OSCURATO:PERSONA] 12(3) of that [OSCURATO:PERSONA] shall apply if both of the following conditions are satisfied: (a) [OSCURATO:PERSONA] 11b does not apply and one of the following cases is present: (i) the active substance is not expected to meet the criteria of Annex VI of that [OSCURATO:PERSONA]; (ii) upon being consulted by the [OSCURATO:PERSONA], the EFSA has concluded that the active substance does not meet the criteria of Annex VI of that [OSCURATO:PERSONA]; and (b) the notifier informs the [OSCURATO:PERSONA] of the withdrawal of his support of the inclusion of the active substance in Annex I … within two months from the entry into force of this [OSCURATO:PERSONA].’ Background to the dispute and the contested decision 13. It is apparent from the judgment under appeal that DPA is used, inter alia, as the active substance in storage aid in the post-harvest treatment of apples, as a scald (browning of the skin due to oxidation products which accumulate in the waxy surface layer) inhibitor while the apples are being stored prior to being sold. That substance is provided by [OSCURATO:PERSONA] to [OSCURATO:PERSONA] which uses DPA to produce chemical products which it markets for post-harvest treatment of fruit and vegetables. 14. On 31 May 2000, [OSCURATO:PERSONA], in accordance with [OSCURATO:PERSONA] 10(2)(a) of [OSCURATO:PERSONA] 451/2000, notified the [OSCURATO:PERSONA] of its wish to secure the inclusion of DPA in Annex I. [OSCURATO:PERSONA] an agreement signed on 20 February 2002, [OSCURATO:PERSONA] transferred that notification to [OSCURATO:PERSONA]. 15. Following an assessment of the dossier lodged by [OSCURATO:PERSONA], [OSCURATO:PERSONA], designated by [OSCURATO:PERSONA] 1490/2002 as the rapporteur [OSCURATO:PERSONA], recommended the inclusion of DPA in Annex I, subject to certain conditions and clarifications and the production of data to be submitted by the notifiers, and sent its draft assessment report to EFSA on 20 June 2007. 16. On 30 September 2008, EFSA delivered its report in which it expressed some concerns and pointed out some gaps in the data provided. In view of that report, the [OSCURATO:PERSONA], by letter of 24 November 2008, submitted to the [OSCURATO:PERSONA] on the [OSCURATO:PERSONA] and [OSCURATO:PERSONA] a draft review report proposing the non‑inclusion of DPA in Annex I. As that [OSCURATO:PERSONA] did not deliver an opinion on the proposed measures within the prescribed time-limit, the [OSCURATO:PERSONA], on 25 May 2009, submitted a proposal relating to those measures to the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], which did not take a decision. 17. Those are the circumstances in which the [OSCURATO:PERSONA] adopted the contested decision which provides, in [OSCURATO:PERSONA] 1 thereof, that DPA is not included in Annex I and, in [OSCURATO:PERSONA] 2, that [OSCURATO:PERSONA] must ensure that authorisations for plant protection products containing DPA are to be withdrawn by 30 May 2010 and that no authorisations for such products are to be granted or renewed from the date of publication of that decision. 18. Recitals 5 and 6 in the preamble to the contested decision set out the reasons for that decision: ‘(5) During the evaluation of [DPA], a number of concerns have been identified. In particular, it was not possible to perform a reliable consumer exposure assessment, as data are missing on the presence and toxicity of unidentified metabolites of the substance, as well as on the possible formation of nitrosamines during storage of the active substance and during processing of treated apples. Moreover, no data was available on the potential breakdown or reaction product of [DPA] residues in processed commodities. Consequently, it was not possible to conclude on the basis of the information available that [DPA] met the criteria for inclusion in Annex I …. (6) [OSCURATO:PERSONA] invited the notifier to submit its comments on the results of the peer review and on its intention or not to further support the substance. The notifier submitted its comments which have been carefully examined. However, despite the arguments put forward by the notifier, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted and evaluated during the EFSA expert meetings have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing [DPA] satisfy in general the requirements laid down in [OSCURATO:PERSONA] 5(1)(a) and (b) of [OSCURATO:PERSONA] [91/414].’ 19. In recital 10 in the preamble to the contested decision, it is stated that that decision does not prejudice the submission of an application pursuant to [OSCURATO:PERSONA] 6(2) of [OSCURATO:PERSONA] 91/414 in view of a possible inclusion of DPA in Annex I thereof. 20. Following a new application for inclusion submitted to that end, the [OSCURATO:PERSONA] adopted, after the bringing of this appeal, [OSCURATO:PERSONA] (EU) No 578/2012 of 29 June 2012 concerning the non-approval of the active substance diphenylamine, in accordance with [OSCURATO:PERSONA] (EC) No 1107/2009 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] concerning the placing of plant protection products on the market (OJ 2012 L 171, p. 2). [OSCURATO:PERSONA] 1 and 2 of [OSCURATO:PERSONA] 578/2012, DPA is not approved and the contested decision is repealed. Recitals 7 and 11 in the preamble to that regulation state that the additional data and information provided did not make it possible to eliminate the specific concerns that led to the non-inclusion and that the contested decision was repealed ‘in the interest of clarity’. The procedure before the [OSCURATO:PERSONA] and the judgment under appeal 21. By application lodged at the [OSCURATO:PERSONA] on 18 February 2010, the appellants brought an action for annulment of the contested decision. 22. By the judgment under appeal, the [OSCURATO:PERSONA] dismissed that action and ordered the appellants to pay the costs, including those relating to two sets of proceedings for interim measures brought by them on 22 February 2010 and 11 February 2011. 23. To come to that decision, the [OSCURATO:PERSONA] rejected the four pleas in law put forward by the appellants, alleging (i) manifest errors of appraisal, (ii) infringement of the principle of proportionality, (iii) failure to state reasons and, (iv) infringement of the rights of the defence and of the principle of sound administration. Only the assessments made by the [OSCURATO:PERSONA] in order to reject the first and fourth pleas are challenged in this appeal, and therefore the judgment under appeal need be examined only with regard to those two pleas. 24. As regards the first plea, the [OSCURATO:PERSONA] rejected, in particular, the appellants’ arguments that the risk associated with the possible formation of nitrosamines was hypothetical and irrelevant and, in particular, rejected, in paragraphs 79 to 83 of the judgment under appeal, the appellants’ assertion that that concern was the principal concern, in the absence of which the [OSCURATO:PERSONA] would have adopted a decision to include DPA in Annex I. 25. With regard to the fourth plea in the action, in which the appellants claimed that the notifiers were deprived of the opportunity to withdraw their support for the inclusion of DPA in Annex I, provided for by [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] 1095/2007, and thus did not have the benefit of a period for the withdrawal of their products longer than that provided for in [OSCURATO:PERSONA] 2 of the contested decision, the [OSCURATO:PERSONA] inter alia rejected, in paragraphs 168 to 172 of the judgment under appeal, the appellants’ argument that, on the date by which the notifiers could request the withdrawal of their support, namely 28 November 2007, the only document in their possession was the draft assessment report by the rapporteur [OSCURATO:PERSONA], which proposed the inclusion of DPA in Annex I. 26. In paragraphs 173 to 176 of the judgment under appeal, the [OSCURATO:PERSONA] also rejected the appellants’ claim that the notifiers would have been in a more advantageous position if the time-limits prescribed by the applicable legislation had been complied with. Furthermore, in paragraphs 177 to 184 of that judgment, the [OSCURATO:PERSONA] held that the EFSA’s alleged delay in initiating the consultation on the draft assessment report, which was complained of by the appellants, in no way denied to the notifiers the possibility of withdrawing their support, had no effect on compliance with the time‑limit for the delivery of the EFSA report and that, in any event, that delay had no impact on the contested decision. Forms of order sought by the parties 27. The appellants claim that the [OSCURATO:PERSONA] of Justice should set aside the judgment under appeal and annul the contested decision or, alternatively, refer the case back to the [OSCURATO:PERSONA] to rule on their action for annulment. They claim, moreover, that the [OSCURATO:PERSONA] should be ordered to pay the costs, including the costs incurred at first instance. 28. [OSCURATO:PERSONA] contends that the [OSCURATO:PERSONA] should dismiss the appeal and order the appellants to pay the costs. However, by letter dated 28 November 2012 addressed to the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], it indicated that, because of the repeal of the contested decision by [OSCURATO:PERSONA] 578/2012, it believed that there was no longer any need to adjudicate on this appeal. The appeal Whether there is any need to adjudicate Arguments of the parties 29. At the hearing, the appellants argued that, despite the repeal of the contested decision by [OSCURATO:PERSONA] 578/2012, they retained an interest in obtaining a declaration of illegality of that decision for five reasons. First, the decision produced legal effects which are not removed by that regulation. Second, it follows from the case-law that the repeal of an act does not constitute recognition of its illegality, that, unlike annulment, repeal does not have retroactive effect and that an applicant can retain an interest in seeking annulment of an act to prevent its unlawfulness recurring in the future. Third, a declaration of illegality in this case would have an impact on the repeal measure that, in terms of substance and procedure, is linked to the contested decision. Fourth, the appellants have an interest in obtaining a declaration of illegality to preserve their right to obtain compensation within the meaning of [OSCURATO:PERSONA] 340 TFEU. Finally, they have brought before the [OSCURATO:PERSONA] an action for the annulment of [OSCURATO:PERSONA] 578/2012, which, if upheld, would revive the contested decision. 30. [OSCURATO:PERSONA] noted in particular that, if the appellants have suffered damage as a result of the withdrawal of authorisations enjoyed by plant protection products containing DPA, it was for them to initiate proceedings to obtain damages and not to seek a declaration that the contested decision is unlawful. However, the [OSCURATO:PERSONA] stated that it would leave that issue to the wisdom of the [OSCURATO:PERSONA]. Findings of the [OSCURATO:PERSONA] 31. According to the [OSCURATO:PERSONA] settled case-law, the subject‑matter of the case must continue to exist, like the interest in bringing proceedings, until the final decision, otherwise there will be no need to adjudicate; this presupposes that the action, or as the case may be, the appeal, must be liable to procure an advantage to the party bringing it (see, to that effect, [OSCURATO:PERSONA] C‑373/06 P, C‑379/06 P and C‑382/06 P Flaherty and Others v [OSCURATO:PERSONA] [2008] ECR I‑2649, paragraph 25, and [OSCURATO:PERSONA] C‑550/07 P [OSCURATO:PERSONA] and [OSCURATO:PERSONA] v [OSCURATO:PERSONA] and Others [2010] ECR I‑8301, paragraphs 22 and 23). 32. The repeal of the contested act, after the bringing of an action, does not in itself mean that the Courts of the [OSCURATO:PERSONA] must declare that there is no need to adjudicate for lack of purpose or for lack of interest in bringing proceedings at the date of the delivery of the judgment (see, to that effect, [OSCURATO:PERSONA] C‑362/05 P Wunenburger v [OSCURATO:PERSONA] [2007] ECR I‑4333, paragraph 47). As the appellants argue, since that repeal does not have retroactive effect, the applicant may in particular retain an interest in obtaining a declaration of illegality of that act for the period during which it was applicable and produced its effects, such a declaration retaining an interest at the very least as the basis for a possible action for damages (see, to that effect, [OSCURATO:PERSONA] C‑68/94 and C‑30/95 France and Others v [OSCURATO:PERSONA] [1998] ECR I‑1375, paragraph 74). 33. In the present case, it is not disputed that the contested decision produced effects before being repealed. [OSCURATO:PERSONA] 2 thereof, authorisations for plant protection products containing DPA had to be withdrawn by the national authorities by 30 May 2010. Moreover, in the context of the second and third grounds of appeal, the appellants argue, in essence, that an irregularity committed in the procedure for the adoption of that decision deprived them of the opportunity, offered by [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] 1095/2007, to withdraw their support for the inclusion of DPA in Annex I and, therefore, to benefit from a longer period for the withdrawal of their products. Accordingly, if the grounds of appeal were to be upheld, or if the examination of the second and third grounds of appeal were to lead to a finding of at least one such irregularity, the appeal would be likely to procure an advantage to the appellants in the context of an action for damages. 34. Moreover, it is not disputed that the appellants have also brought an action for annulment of [OSCURATO:PERSONA] 578/2012, and consequently, if that action were successful, the contested decision would again constitute the legal basis for the non‑inclusion of DPA in Annex I. 35. It follows that the appeal is not devoid of purpose and that it is necessary to adjudicate. Substance 36. The appellants put forward three grounds in support of their appeal, alleging error of law, inconsistency in reasoning and distortion of evidence leading to an error of law. The first ground of appeal – Arguments of the parties 37. By their first ground of appeal, the appellants challenge the finding of the [OSCURATO:PERSONA], in paragraphs 79 to 83 of the judgment under appeal, that the contested decision is not based primarily on considerations relating to the possible formation of nitrosamines. That finding is, it is alleged, vitiated by an error of law and distortion of the clear sense of the evidence. The evidence set out in paragraphs 81 and 82 justified a finding to the contrary, since that evidence clearly demonstrated that the formation of nitrosamines was the concern underlying the other two concerns, namely the presence of unidentified metabolites and lack of data relating to the processed products. [OSCURATO:PERSONA] conclusion that those three concerns are independent of each other is therefore, it is claimed, wrong and reveals an inconsistency in reasoning. 38. [OSCURATO:PERSONA] considers that the appellants do not explain or prove how and in what way the [OSCURATO:PERSONA] distorted the clear sense of the evidence. Moreover, it considers the first ground of appeal to be ineffective. – Findings of the [OSCURATO:PERSONA] 39. In order to reject the appellants’ argument that the concern relating to the possible formation of nitrosamines was the principal concern, in the absence of which the [OSCURATO:PERSONA] would have decided to include DPA in Annex I, the [OSCURATO:PERSONA] held, in paragraph 79 of the judgment under appeal, that that assertion had no basis in the contested decision nor in the EFSA report. In paragraph 80 of that judgment, the [OSCURATO:PERSONA] stated that, on the contrary, the three areas of concern mentioned in recital 5 in the preamble to that decision, namely the risk of formation of nitrosamines, the presence and toxicity of unidentified metabolites and the absence of data on the potential breakdown or reaction product of DPA residues in processed commodities, seemed to be of equal importance and that an examination of all of those concerns was appropriate in order to carry out a full and reliable evaluation and to eliminate any risk to the consumer. 40. In paragraphs 80 to 83 of the judgment under appeal, the [OSCURATO:PERSONA] held that that assessment was confirmed by the EFSA report and by a summary drawn up by the rapporteur [OSCURATO:PERSONA] in the form of a table, the content of which the [OSCURATO:PERSONA] examined. It stated, in particular, that it was apparent from that table that the question regarding the risk of formation of nitrosamines raised by EFSA demonstrated the relevance of an examination of that risk, not in isolation but in the wider context of the other concerns raised. [OSCURATO:PERSONA] held that it followed from those documents that, in the contested decision, the [OSCURATO:PERSONA] had correctly referred to the three areas of concern and stated that the gaps in the data in respect of each of those concerns made it impossible to carry out a complete assessment of the risk to which consumers were exposed. 41. It is clear that, contrary to what is claimed by the appellants, the [OSCURATO:PERSONA], on the basis of the matters referred to in the preceding two paragraphs, concluded not that the three concerns were independent of each other but that they were of equal importance and that the [OSCURATO:PERSONA] therefore was right to find that a complete and reliable assessment, to eliminate any risk to consumers, could not be carried out in the absence of sufficient available data in relation to each of those concerns. 42. The appellants do not state in a precise and detailed manner in what way that conclusion results from an error of law, distortion of the evidence or inconsistency. The appellants’ claims cannot, therefore, be answered in the context of an appeal. 43. It follows that the first ground of appeal must be rejected as being unfounded. The second and third grounds of appeal – Arguments of the parties 44. In their second and third grounds of appeal, which should be examined together, the appellants criticise the reasons given by the [OSCURATO:PERSONA], in paragraphs 168 to 184 of the judgment under appeal, to justify the rejection of the plea for annulment based on an infringement of the rights of the defence and of the principle of sound administration, in that the notifiers were deprived of the possibility of withdrawing their support for the inclusion of DPA in Annex I, provided for by [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] 1095/2007, and thus did not benefit from a period for the withdrawal of their products longer than that provided for in [OSCURATO:PERSONA] 2 of the contested decision. 45. In the first place, the appellants criticise the [OSCURATO:PERSONA] because it held, in paragraphs 168 to 174 of the judgment under appeal, that they had been placed in a position to withdraw their support for the inclusion of DPA in Annex I. They claim that, as they had not been informed of any difficulty concerning their dossier before 28 November 2007, which was the deadline for the withdrawal of support in accordance with [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] 1095/2007, attributable to the fact that the EFSA had sent the draft assessment report for comments with a delay of over three months, they were deprived of the possibility of making such a withdrawal. As a result, they had a deadline for the withdrawal of their products containing DPA, set at 30 May 2010 by the contested decision, which was shorter than that which they would have had the benefit of had they been in a position to withdraw their support. 46. [OSCURATO:PERSONA], it is alleged, erred in its interpretation of [OSCURATO:PERSONA] 1490/2002 by confusing two stages in the review process established by that regulation, namely that provided for in [OSCURATO:PERSONA] 11(2) thereof, during which the EFSA circulates the draft assessment report to the [OSCURATO:PERSONA], the [OSCURATO:PERSONA] and the notifier for comments, and that provided for in [OSCURATO:PERSONA] 11c of that regulation, according to which, at the end of that preliminary consultation, the [OSCURATO:PERSONA] may instruct the EFSA to carry out a peer review, the second stage taking place only if [OSCURATO:PERSONA] 11b of that regulation does not apply, that is, if the case for the inclusion of the substance under evaluation in Annex I is not obvious. It is only at the end of the second stage that notifiers are in a position to take a fully informed decision as to whether to withdraw support for inclusion of the active substance in Annex I. 47. Since the EFSA had only circulated the draft assessment report as part of the basis of the first stage provided for in [OSCURATO:PERSONA] 11(2) of [OSCURATO:PERSONA] 1490/2002, the [OSCURATO:PERSONA] erred in law in holding that it followed from two EFSA letters of 8 and 18 October 2007 that DPA was subject to the procedure laid down in [OSCURATO:PERSONA] 11c of that regulation and that, therefore, its inclusion in Annex I was not obviously necessary. [OSCURATO:PERSONA] therefore erred in law by concluding that the appellants had been duly informed that there were difficulties and that they were therefore in a position to exercise their right to withdraw their support for inclusion of DPA in Annex I. 48. According to the appellants, since these two letters were sent at a stage where no comments had yet been made by the EFSA or any [OSCURATO:PERSONA], the procedure for withdrawal of support for the inclusion of DPA in Annex I, provided for by [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] 1095/2007, could not yet be applicable, as this presupposes that it has first been established, at the end of the first stage provided for in [OSCURATO:PERSONA] 11(2) of [OSCURATO:PERSONA] 1490/2002, that [OSCURATO:PERSONA] 11b thereof is not applicable. Those two letters in no way indicate that there were any shortcomings in their dossier and that [OSCURATO:PERSONA] 11b was not applicable. 49. According to the appellants, the [OSCURATO:PERSONA], in paragraph 168 of the judgment under appeal, erred in law through its distortion of the evidence contained in those letters by interpreting the fact that the EFSA had given notice that it had organised a consultation of experts as evidence that the [OSCURATO:PERSONA] had instructed it to do so pursuant to [OSCURATO:PERSONA] 11c of [OSCURATO:PERSONA] 1490/2002. [OSCURATO:PERSONA] was wrong to find that the decision announced by the EFSA to organise that consultation presupposed that the [OSCURATO:PERSONA] had requested the EFSA’s scientific opinion, on the view that [OSCURATO:PERSONA] 11b of that regulation was not applicable to DPA, and that the [OSCURATO:PERSONA] expected to have to request the EFSA to review the draft assessment report. In fact, according to the appellants, the [OSCURATO:PERSONA] did not receive that draft until 8 October 2007, under [OSCURATO:PERSONA] 11(2) of [OSCURATO:PERSONA] 1490/2002, and the experts’ comments, including the EFSA’s own comments, only became available on 9 January 2008, so that, on the date of the letters in question, the stage provided for by [OSCURATO:PERSONA] 11(2) had not been completed, the procedure provided for by [OSCURATO:PERSONA] 11c of that regulation was not yet applicable and the appellants were not, therefore, in a position to withdraw their support for the inclusion of DPA in Annex I in accordance with [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] 1095/2007. 50. In the second place, the appellants complain that the [OSCURATO:PERSONA] erred in its legal characterisation of the facts by finding, in paragraph 177 of the judgment under appeal, that the EFSA’s alleged delay in initiating the consultation on the draft assessment report had in no way denied to the notifiers the ‘effective enjoyment of their “right to withdraw”’. In so doing, the [OSCURATO:PERSONA] distorted the clear sense of the evidence and, consequently, erred in law when assessing whether or not the appellants were effectively placed in a position to exercise their rights of defence. 51. In particular, the [OSCURATO:PERSONA] erroneously held, in paragraph 179 of the judgment under appeal, that the experts’ comments, including those of the EFSA, had been received in June 2008 whereas in fact they were received on 9 January 2008. According to the appellants, if the EFSA had circulated the draft assessment report without delay, they would have been in possession of those comments, which revealed for the first time the problems in relation to the possible formation of nitrosamines, before the deadline for exercising their right to withdraw their support for the inclusion of DPA in Annex I. In order to preserve their rights, the appellants argue, either a more adequate deadline for the submission of comments should have been set, or the time-limit laid down for withdrawal of support should have been deferred. 52. [OSCURATO:PERSONA] contends, with regard to the first complaint, that, contrary to what is claimed by the appellants, the [OSCURATO:PERSONA] did not err in its interpretation of [OSCURATO:PERSONA] legislation and that the interpretation put forward by the appellants is not in conformity with the objective of [OSCURATO:PERSONA] 1095/2007, set out in recitals 5 and 6 in the preamble thereto, to use the EFSA’s resources efficiently. [OSCURATO:PERSONA] also challenges the appellants’ claims concerning the alleged distortion of evidence by the [OSCURATO:PERSONA] which, according to the [OSCURATO:PERSONA], correctly interpreted the EFSA letters of 8 and 18 October 2007. 53. With regard to the second complaint, the [OSCURATO:PERSONA] contends that the [OSCURATO:PERSONA] did not distort the clear sense of the evidence that was submitted to it and that, contrary to what is claimed by the appellants, the draft assessment report had not been sent late by the EFSA, but in accordance with [OSCURATO:PERSONA] 11(2) of [OSCURATO:PERSONA] 1490/2002. – Findings of the [OSCURATO:PERSONA] 54. In order to set aside the appellants’ claims that they were deprived of the opportunity, provided for in [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] 1095/2007, to withdraw their support for the inclusion of DPA in Annex I, due to the delay in carrying out the evaluation process, the [OSCURATO:PERSONA], first, rejected the appellants’ argument that, on the date of expiry of the deadline for the withdrawal of support to the inclusion of a substance in Annex I, that is, on 28 November 2007, the only document available to them was the draft assessment report of the rapporteur [OSCURATO:PERSONA]. In that regard, the [OSCURATO:PERSONA] stated, in paragraph 168 of the judgment under appeal, that it was clear from the EFSA letter of 8 October 2007 that the notifiers had been informed of the fact that the EFSA had decided to organise a consultation of experts and that that stage, provided for by [OSCURATO:PERSONA] 11c of Regul ation No 1490/2002, presupposed that the [OSCURATO:PERSONA] had taken the view that [OSCURATO:PERSONA] 11b of that regulation was not applicable to DPA and that the [OSCURATO:PERSONA] expected that it would, on the expiry of the withdrawal period, have to request that the EFSA review the draft assessment report. 55. In paragraphs 170 to 172 of the judgment under appeal, the [OSCURATO:PERSONA] stated, inter alia, that the proposal for the inclusion of DPA in Annex I made by the rapporteur [OSCURATO:PERSONA] was not unconditional, since certain additional data and clarifications still had to be submitted by the notifiers, so that the notifiers had in their possession, as from 28 September 2007, and therefore well before the expiry of the time-limit for withdrawal of support, information to justify the existence of doubts that the final decision would be favourable. 56. [OSCURATO:PERSONA] then rejected the appellants’ argument that the notifiers would have been in a more advantageous position if the time‑limits prescribed by the legislation had been complied with. It held, in paragraphs 173 to 176 of the judgment under appeal, that the EFSA had carried out a review of the draft assessment report and had submitted its conclusions in compliance with the various time‑limits provided for in [OSCURATO:PERSONA] 11(1) and (2), and in the second subparagraph of [OSCURATO:PERSONA] 11c(1) of [OSCURATO:PERSONA] 1490/2002. [OSCURATO:PERSONA] noted that there is no provision which obliged the EFSA to begin that review or to complete it prior to the date of expiry of the time-limit provided for in [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] 1095/2007. It observed, moreover, that if the EFSA, having been consulted by the [OSCURATO:PERSONA], had come to the conclusion that DPA did not meet the criteria laid down in Annex VI of [OSCURATO:PERSONA] 1490/2002, within the meaning of [OSCURATO:PERSONA] 3(2)(a)(ii) of [OSCURATO:PERSONA] 1095/2007, it was not obliged to inform the notifiers of that interim conclusion and that, in any event, the fact that the notifiers were made aware, by means of the two EFSA letters of 8 and 18 October 2007, of the consultation of experts and of that time-limit, demonstrated that it was probable that the [OSCURATO:PERSONA] would ask the EFSA to carry out a review of the draft assessment report in accordance with [OSCURATO:PERSONA] 11c of [OSCURATO:PERSONA] 1490/2002. 57. In paragraphs 177 to 180 of the judgment under appeal, the [OSCURATO:PERSONA] found that the EFSA’s alleged delay in initiating the consultation on the draft assessment report in no way prevented the notifiers from exercising their right to withdraw their support for the inclusion of DPA in Annex I. It stated, in that regard, that no time-limit was imposed on the EFSA to circulate that draft to the [OSCURATO:PERSONA], to the [OSCURATO:PERSONA] and to the notifier before the entry into force, on 28 September 2007, of [OSCURATO:PERSONA] 1095/2007, which provided that that report had to be sent ‘without delay’, which the EFSA did 10 days later, that is, on 8 October 2007. It noted that, even if the EFSA had scrupulously complied with the time‑limits prescribed by that regulation, from the date of its entry into force, the notifiers might have had in their possession, possibly, before the expiry of the time‑limit for withdrawal of support, only the comments of the [OSCURATO:PERSONA] and of the EFSA. [OSCURATO:PERSONA] held that, as the question relating to the possible formation of nitrosamines was raised, according to the appellants, only after the experts’ meeting, in June 2008, the notifiers would not, in any event, have had in their possession information regarding that area of concern before the expiry of that time‑limit. It concluded that the notifiers had been informed, by the EFSA letters of 8 and 18 October 2007, of the possibility of withdrawing their support and of the entry into force of [OSCURATO:PERSONA] 1095/2007. 58. It is not apparent from the foregoing that the [OSCURATO:PERSONA] committed the errors of law alleged by the appellants. Contrary to what the appellants maintain, the possibility open to the notifiers of withdrawing their support for the inclusion of an active substance in Annex I, in accordance with [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] 1095/2007, cannot depend on completion of the review procedure provided for in [OSCURATO:PERSONA] 11c of [OSCURATO:PERSONA] 1490/2002, or even on the conclusion of the [OSCURATO:PERSONA] or of the EFSA that [OSCURATO:PERSONA] 11b of that regulation does not apply or that the substance in question does not satisfy the criteria laid down in Annex VI thereof. As the [OSCURATO:PERSONA] contends, the notifier may withdraw its support without awaiting the outcome of the formal assessment by the EFSA or the [OSCURATO:PERSONA], where there are no clear indications that it may be expected that the substance in question does not have harmful effects and where either that substance is not expected to meet the criteria, in Annex VI of [OSCURATO:PERSONA] 1490/2002, for clear indications that a substance has harmful effects or the EFSA has already concluded that that substance does not meet those criteria. 59. Accordingly, the [OSCURATO:PERSONA] did not misinterpret [OSCURATO:PERSONA] 1490/2002 by finding, in essence, that it was apparent from the EFSA letters of 8 and 18 October 2007 that the view had been taken that DPA was not covered by [OSCURATO:PERSONA] 11b of that regulation, but by the procedure laid down in [OSCURATO:PERSONA] 11c thereof, and consequently the notifiers could infer that the inclusion of DPA in Annex I was encountering difficulties. 60. Furthermore, the [OSCURATO:PERSONA] did not distort the clear sense of those letters when finding, as part of its assessment of the facts, which is not subject to appeal, that it could be inferred, from the fact that those letters reported a consultation of experts and mentioned the time-limits for withdrawal of support for the inclusion of DPA in Annex I, that DPA did not fall under [OSCURATO:PERSONA] 11b of [OSCURATO:PERSONA] 1490/2002 and that the notifiers had been informed of the possibility of making such a withdrawal. 61. With regard to the alleged late circulation of the draft assessment report, the [OSCURATO:PERSONA] did not err in law or distort the clear sense of the evidence when it held that the question of the possible formation of nitrosamines was raised only after the meeting of experts, that is, in June 2008, merely taking up what was stated by the appellants in that regard, and that that circulation was not late under [OSCURATO:PERSONA] 11(2) of [OSCURATO:PERSONA] 1490/2002, in its versions applicable both before and after the entry into force of amending [OSCURATO:PERSONA] 1095/2007. 62. Furthermore, the appellants have not in any way substantiated their complaint that the reasoning of the judgment under appeal is inconsistent, and that complaint must therefore be rejected as being inadmissible. 63. In those circumstances, the second and third grounds of appeal must be rejected as being partly unfounded and partly inadmissible. 64. Since none of the three grounds of appeal raised by the appellants in support of their appeal can be upheld, the appeal must be dismissed in its entirety. Costs 65. In accordance with [OSCURATO:PERSONA] 184(2) of the Rules of Procedure, where the appeal is unfounded, the [OSCURATO:PERSONA] is to make a decision as to costs. [OSCURATO:PERSONA] 138(1) of those Rules, which apply to the procedure on appeal by virtue of [OSCURATO:PERSONA] 184 of those Rules, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the appellants have been unsuccessful and the [OSCURATO:PERSONA] has applied for costs, they must be ordered to pay the costs. [OSCURATO:PERSONA] part On those grounds, the [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) hereby: 1. Dismisses the appeal. 2. [OSCURATO:PERSONA] SA and [OSCURATO:PERSONA] LLC to pay the costs.