Xeda International and Pace International v Commission [2012] EUECJ T-71/10 (19 January 2012)

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Plant protection products - Active substance diphenylamine - Non-inclusion in Annex I to Directive 91/414/EEC - Withdrawal of authorisations of plant protection products containing that substance - Action for annulment - Locus standi - Admissibility - Proportionality - Article 6(1) of Directive 91/414 - Rights of the defence - Article 3(2) of Regulation (EC) No 1095/2007

1 The first applicant, Xeda International SA ('Xeda'), manufactures and markets chemical products in the sector of post-harvest treatment of fruit and vegetables, based on diphenylamine ('DPA'), an active substance with which it is supplied by the second applicant, Pace International LLC ('Pace'), under an exclusive supply agreement.

2 Xeda has registrations for the marketing of the plant protection products Xedamine 20, Xedamine 20 EC and Xeda Aerosol 88 in Italy, France, Spain and Greece.

3 DPA is a man-made chemical product developed for agricultural use. As an intermediate for the production of antioxidants, it is used 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.

4 DPA is one of the 84 active substances (Part B) evaluated in the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1) As regards those active substances, the time limit for the submission of complete dossiers was set at 25 May 2003 by Article 10(4) of Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414 (OJ 2000 L 55, p. 25). However, Article 10(3) stated that the detailed rules concerning the submission of dossiers relating to those substances were to be established subsequently by a regulation of the Commission of the European Communities. Against that background, the Commission adopted Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414 and amending Regulation No 451/2000 (OJ 2002 L 224, p. 23).

5 The list of active substances in the third stage of the programme of work is contained in Annex I to Regulation No 1490/2002. That annex designates Ireland as the Rapporteur Member State ('RMS') which has to submit a draft assessment report ('DAR') on DPA to the European Food Safety Authority ('EFSA') with a view to its possible inclusion in Annex I to Directive 91/414.

6 In accordance with Article 10(2)(a) of Regulation No 451/2000, on 31 May 2000 Xeda notified the Commission of its wish to secure the inclusion of DPA in Annex I to Directive 91/414.

7 By letter of 23 June 2000 the Commission acknowledged receipt of the notification, registered under reference XED-FR-001. Another manufacturer, Cerexagri SA (formerly Elf Atochem Agri SA), submitted a separate notification for the same active substance, under reference ELF-FR-003.

8 Under an agreement signed on 20 February 2002 with Pace, Xeda transferred its notification for DPA to Pace; the Commission was informed thereof by letter of 15 May 2002, received on 24 May 2002, to which was annexed, inter alia, the aforementioned agreement.

9 By agreement concluded on 24 January 2003 Pace and Cerexagri formed the Task Force '[DPA] Data Development Consortium' ('DDDC')', in order to pool their efforts to assemble the data required for the evaluation of DPA. On 15 May 2003 the company Compliance Services International was appointed DDDC's sole representative for the purpose of the evaluation of DPA. On the same day and by agreement, Pace and Cerexagri transferred their respective notifications to DDDC (within which Xeda was defined as an 'affiliate' of Pace), in order to submit a joint dossier. The Commission was informed of these developments by letters of 15 and 19 May 2003, respectively.

10 On 30 November 2004, within the deadline laid down by Article 7(1) of Regulation No 1490/2002 for active substances in Part B of Annex 1 to that regulation, Pace and Cerexagri jointly submitted their dossier (complete and in summary) to the RMS, within the framework of the DDDC, requesting an assessment of the use of DPA in apple-growing. The representative usage notified was that of an emulsifiable concentrate, No Scald DPA 31 EC, applied to the apples by the post-harvest and pre-storage dripping or drenching method.

12 Following the assessment of the dossier in question and in accordance with Article 10(1) of Regulation No 1490/2002, the RMS recommended the inclusion of DPA in Annex I to Directive 91/414, subject to certain conditions, clarifications and data to be submitted by the notifiers, identified in Annex II to that regulation as being Ceraxgri and Compliance Services International, and sent its DAR to the EFSA on 20 June 2007, for review by the latter.

13 On 8 October 2007 the EFSA sent the DAR issued by the RMS to the Member States, the Commission and Cerexagri - the latter being classified by the RMS as the initial notifier of DPA, in the same capacity as Pace, and as constituting the contact point for the Commission with the notifiers - with a view to the consultation of experts provided for by Article 11(2) of Regulation No 1490/2002 which commenced on the same date.

14 In the EFSA letter sending the DAR to Cerexagri, the notifiers were invited to submit any comments on the conclusions in the DAR as a contribution to the consultation of experts, by 7 December 2007 at the latest. They were further informed of the possibility of withdrawing their support for the inclusion of DPA in Annex I to Directive 91/414 in accordance with Article 11e of Regulation No 1490/2002, by the same date.

15 By letter of 18 October 2007 the EFSA informed Cerexagri that, contrary to what was stated in its earlier letter, the request to withdraw support for the inclusion of DPA had to be submitted to the Commission and to the EFSA by 28 November 2007 at the latest, in accordance with Article 3 of Commission Regulation (EC) No 1095/2007 of 20 September 2007 amending Regulation (EC) No 1490/2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414 and Regulation (EC) No 2229/2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414 (OJ 2007 L 246, p. 19).

16 The comments received from the Member States on the DAR, and the EFSA comments on it submitted in a table of 9 January 2008, were assessed by the RMS and presented in a table ('the Reporting Table') drawn up on 5 February 2008. On the basis of that table, the EFSA drew up, on 28 February 2008, an evaluation table identifying the missing data which was to be submitted by the notifiers and the matters of concern to be discussed by the experts.

17 On 11 May 2008 the notifiers submitted a position paper on the study on metabolism by J.L. Gray, entitled 'The Metabolism of ¹⁴C-Diphenylamine in stored apples - Nature of the Residue in Plants' ('the Gray study'), previously submitted to the RMS within the complete dossier ('the position paper on the Gray study'). The aim of the position paper on the Gray study was to address concerns regarding the failure of the Gray study to identify metabolites present in DPA at levels greater than 0.625 mg/kg. That report was distributed to the experts' meeting which took place from 3 to 6 June 2008 to discuss the evaluation of DPA and additional data submitted by the applicants.

18 At the end of that meeting, in the report of the 'PRAPeR expert meeting', it was concluded firstly, that since the analysis carried out by the Gray study was based on 0, 2, 12, 24 and 40 weeks of apple cold storage treated with DPA after harvest, it did not provide a continuous picture on the presence of metabolites. Secondly, it was pointed out that the reference storage period of 24 weeks could vary according to retail market practices and end consumer habits. The period could therefore be shorter, namely 12 weeks, or even longer and extend to 40 weeks. Finally, it was concluded that the identity of three unidentified metabolites should be clarified, since they were present in significant amounts. It was also stated that the natural presence of nitrites or of nitrates in apples could not be ruled out, but that the significant level at which the formation of nitrosamines could occur was not known. On the other hand, the section of the DAR relating to the physico^_chemical properties of DPA mentioned the possible formation of nitrosamines in the case of tank mixing (mixing of several active substances in a tank before they are applied for plant health purposes). Similarly, that section of the report relating to residues stated that further data were required on the probability of the formation of nitrosamines in metabolism or in apple processing. Thus, additional information was required from the notifiers in order to identify the unknown metabolites, and also information which was lacking on the nature of DPA degradation products in processed commodities.

19 The EFSA conclusions, the notifiers' comments thereon, the RMS's response and the experts' comments were summarised in an evaluation table of 23 September 2008.

20 On 30 September 2008 the EFSA delivered its report, which it submitted to the Commission, in the form of 'Conclusion regarding the peer review of the pesticide risk assessment of the active substance [DPA]' ('the EFSA Conclusion Report').

21 In essence, concerning, firstly, the identity and physical, chemical and technical properties of DPA, the EFSA concluded that, except for the lack of full specification of the primary substance (the minimal purity of the substance could not be established on the basis of the available data) and the fact that the notifiers confirmed that certain tank mixes might result in the formation of nitrosamines, the assessment of the dossier revealed no critical areas of concern. However, data gaps were identified with regard to spectra for impurities, evidence to demonstrate that the DPA level remains stable when stored in opened containers and emulsion stability at the minimum use in concentration.

22 Secondly, the EFSA pointed out that, given the structure of DPA and indications of the possible formation of nitrosamines in tank mixing, the notifiers were asked to supply data concerning metabolism or processed commodities and on the possible presence of nitrosamines in apples, since the experts' meeting had been unable to rule out the natural presence of nitrates/nitrites in apples. According to the EFSA, this data gap is linked to the gaps regarding the identification of the metabolites in apples and the nature of the residues in processed commodities.

23 As regards the presence of residues in stored apples, the EFSA concluded, first, that, although DPA was the major residue, the information provided was insufficient, first of all, to clarify the identity of the metabolites present at levels exceeding 0.05 mg/kg where the apples were treated at N rate, next, to rule out the potential for the presence or formation of nitrosamines during apple metabolism or processing and, finally, to define the nature of residues in processed commodities. Accordingly, an analysis of the radioactive residue risk could only be proposed on a provisional basis.

24 With regard, secondly, to processed commodities, the EFSA pointed out that no study that investigated the potential breakdown or reactions of DPA residues had been provided. The EFSA concluded that, even if, as the notifiers maintained, apples destined for commercial processing are not treated with DPA, the possibility of apples treated with DPA and purchased by final consumers being processed in household preparations was not taken into account. It thus identified a new data gap on the nature of the residues in processed commodities. As for the study submitted on the level of residues in processed commodities, an inconsistency was noted by the experts' meeting on the level of residues in wet and dried apple pomace.

25 Consequently, the EFSA Conclusion Report identified four critical areas of concern, namely:

26 By letter of 1 October 2008, received by the notifiers on 16 October 2008, and also sent by e-mail on 1 October 2008, the Commission invited them to submit comments on the EFSA Conclusion Report within four weeks of receipt of that letter.

27 By a letter dated 11 November 2008 the RMS submitted its comments on the EFSA Conclusion Report. By e-mail of 14 November 2008, in response to an express request from the Commission sent by e-mail on 13 November 2008, the notifiers informed the Commission, that they had no comments to make on the EFSA Conclusion Report.

28 By letter of 24 November 2008 the Commission submitted to the Standing Committee on the Food Chain and Animal Health a draft review report proposing the non-inclusion of DPA in Annex I to Directive 91/414.

29 By letter of 17 December 2008 the notifiers responded to the EFSA Conclusion Report by submitting comments to the Commission. They stated, inter alia, that they would undertake to initiate a study on DPA metabolism in order to identify the three unidentified metabolites in stored apples and also a processing study.

30 The Standing Committee on the Food Chain and Animal Health met on 26 February 2009 and finalised the draft review report. However, it did not deliver an opinion on the proposal for a Commission Decision within the time limit laid down by Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23).

31 On 25 May 2009 the Commission sent its draft review report to the Council of the European Union. The Council likewise did not issue an opinion within the time limit laid down by Decision 1999/468.

32 On 30 November 2009, after having received the notifiers' comments, the Commission adopted Decision 2009/859/EC concerning the non-inclusion of [DPA] in Annex I to Directive 91/414 and the withdrawal of authorisations for plant protection products containing that substance (OJ 2009 L 314, p. 79; 'the contested decision').

33 Recitals 5 and 6 of the preamble to the contested decision set out the reasons for the non-inclusion of DPA.

34 In recital 5 it is pointed out, first of all, that, during the evaluation of DPA, a number of concerns were identified. In particular, it is stated that it was not possible to perform a reliable consumer exposure assessment, owing to the insufficiency of available data for determining 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 were 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 to Directive 91/414.

35 In recital 6 of the contested decision, it was concluded that, despite the notifier's comments on the results of the peer review, submitted at the request of the Commission, the concerns set out in recital 5 of the contested decision persisted. Similarly, assessments made on the basis of the information submitted and evaluated during EFSA expert meetings had not demonstrated that, under the proposed conditions of use, plant protection products containing DPA satisfied in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414.

36 Consequently, in recital 7 of the preamble to the contested decision, it is concluded that DPA should not be included in Annex I to the aforementioned directive. Further, in recital 8 of the preamble to the contested decision, it is stated that measures should be taken to ensure that authorisations granted for plant protection products containing DPA are withdrawn and are not renewed, and that no new authorisations for such products are granted. Finally, in recital 9 in the preamble to the contested decision, it is stated that any period of grace granted by a Member State for the disposal, storage, placing on the market and use of existing stocks of such products should be limited to 12 months, ensuring that plant protection products containing DPA remain available to farmers for 18 months from the adoption of that decision.

37 Furthermore, in recital 10 of the preamble to the contested decision, it is stated that the decision is adopted without prejudice to the submission of an application brought in accordance with Article 6(2) of Directive 91/414, the detailed implementation rules of which have been established in Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Directive 91/414 as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but not included in Annex I (OJ 2008 L 15, p. 9), in view of a possible inclusion of DPA in its Annex I.

39 On 27 May 2010, in accordance with the procedure laid down in Article 13 of Regulation No 33/2008, the applicants submitted a new dossier for the inclusion of DPA in Annex I to Directive 91/414, under the accelerated assessment procedure.

40 The RMS examined the notification and produced, on 26 November 2010, an additional report to the DAR, proposing the inclusion of DPA.

41 By application lodged at the Court Registry on 18 February 2010, the applicants brought the present action.

42 By a separate document lodged at the Registry on 22 February 2010, Xeda lodged, under Articles 278 TFEU and 279 TFEU, an application for interim relief, seeking suspension of the operation of the contested decision and the adoption of appropriate interim measures.

43 By order of 30 April 2010 in Case T-71/10 R Xeda International v Commission, not published in the ECR, the President of the General Court dismissed that application and reserved the costs.

44 Since the composition of the Chambers of the Court was changed, the Judge Rapporteur was assigned to the Fifth Chamber, to which the present case was, accordingly, allocated.

45 By letter lodged at the Court Registry on 14 January 2011, the applicants requested the Court's permission, under Article 64 of the Court's Rules of Procedure, to produce a document which was annexed to that letter.

46 By decision of the President of the Fifth Chamber of the Court of 24 January 2011, the document produced by the applicants was added to the case file, in accordance with Article 7(2) of the instructions to the Registrar of the General Court, and the Commission was invited to submit comments on that document.

47 By a document lodged at the Registry on 11 February 2011, pursuant to Article 109 of the Rules of Procedure, Xeda brought a second application for interim relief seeking suspension of operation of the contested decision pending a ruling on the new dossier concerning DPA under the accelerated assessment procedure.

48 By order of the President of the Court of 8 April 2011 in Case T-71/10 R-II Xeda International v Commission, not published in the ECR, the application for interim relief was dismissed and costs were reserved.

49 Upon hearing the report of the Judge-Rapporteur, the Court decided to open the oral procedure.

50 The parties presented oral argument and replied to the oral questions put by the Court at the hearing on 13 July 2011.

51 At the hearing, the Court invited the Commission, pursuant to Article 64 of the Rules of Procedure, to produce the letter mentioned in the last paragraph of the EFSA letter of 18 October 2007 (see paragraph 15 above, produced as an annex to the defence) within the period of 10 days, that is by 25 July 2011. The Court also invited the applicants to inform it, within the period of 10 days from receipt of that letter, whether it had already been notified to them by the EFSA during the evaluation procedure.

52 By document lodged at the Court Registry on 19 July 2011, the Commission lodged the document requested by the Court.

53 By document lodged at the Court Registry on 28 July 2011, the applicants confirmed that the notifier Cerexagri had received, during the evaluation procedure, a copy of the document lodged by Commission following the hearing and had submitted comments in that regard.

54 By decision of the President of the Fifth Chamber of the Court of 4 August 2011 the oral procedure was closed.

57 The Commission considers that Xeda's action is inadmissible, since it claims that Xeda withdrew the notification initially lodged in respect of DPA, within the meaning of Regulation No 451/2000, by formally transferring it to Pace. Xeda was therefore not listed in Annex II to Regulation No 1490/2002 as a notifier for DPA, in the same capacity as Compliance Services International, representing Pace, and Cerexagri.

58 In that regard, it is clear that the Commission does not dispute the admissibility of the action as regards Pace, which must be regarded as having standing to bring proceedings under the fourth paragraph of Article 263 TFEU. The initial notification aimed at the inclusion of DPA in Annex I to Directive 91/414 carried out by Xeda under Article 10(1) of Regulation No 451/2000 was sent on to Pace. Thereafter, Pace and Cerexagri sent their respective notifications for the inclusion of DPA to DDDC and submitted a joint dossier to the RMS for the evaluation of DPA, within DDDC. It follows that the contested decision whereby the Commission refused to include DPA in Annex I to Directive 91/414 is of direct and individual concern to Pace, as the author of the notification of DPA under Article 10(1) of Regulation No 451/2000 aimed at that inclusion (see, to that effect, Case T-326/07 Cheminova and Others v Commission [2009] ECR II-2685, paragraph 66).

59 It must therefore be concluded that the action brought by Pace is admissible.

60 According to settled case-law, which the Commission confirmed at the hearing that it did not challenge, since one and the same application is involved, there is no need to consider whether the other applicants are entitled to bring proceedings (see Cheminova and Others v Commission, paragraph 58 above, paragraph 68 and case-law cited).

61 Consequently, for reasons of procedural economy, there is no need to examine separately Xeda's standing to bring proceedings or to rule on the other arguments put forward by the Commission in respect of the admissibility of this action.

63 In support of their action, the applicants put forward four pleas in law alleging, first, manifest errors of appraisal, second, infringement of the principle of proportionality, third, failure to state the grounds and, fourth, infringement of the rights of the defence and of the principle of sound administration.

64 The applicants claim that the contested decision is vitiated by manifest errors of appraisal, in that it is based, essentially, on concerns which are hypothetical and not scientifically proven, and founded on factors which are irrelevant to the evaluation of DPA or insufficient to permit the conclusion that DPA should not be included in Annex I to Directive 91/414.

65 First, it is clear that the non-inclusion of DPA in Annex I to Directive 91/414 is based, in recitals 5 and 6 of the preamble to the contested decision, on the EFSA Conclusion Report, which constitutes the scientific basis for the contested decision.

66 It is stated in recital 5 of the preamble to the contested decision that the EFSA conclusion identified 'a number of concerns' and that 'it was not possible to perform a reliable consumer exposure assessment' because of the insufficiency of the available data or the absence of data submitted in relation to those concerns.

67 Those concerns were identified by the Commission in recital 5 as follows. First, the Commission cites 'the presence and toxicity of unidentified metabolites of [DPA] or the possible formation of nitrosamines during storage of [DPA] and during processing of treated apples'. Next, the Commission mentions 'the potential breakdown or reaction product of [DPA] residues in processed commodities'. The conclusion drawn in recital 5 is that 'it was not possible to conclude, on the basis of the information available, that [DPA] met the criteria for inclusion in Annex I to Directive 91/414'.

68 According to recital 6 of the preamble to the contested decision, it was concluded that the identified concerns persisted in spite of the comments submitted by the notifier on the results of the peer review, that the assessments made on the basis of the information submitted and evaluated during EFSA expert meetings had not demonstrated that, under the proposed conditions of use, plant protection products containing DPA satisfied the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414 and that, consequently, DPA should not be included in Annex I to Directive 91/414.

69 In order to assess whether the concerns identified in the contested decision and, in particular, the concern relating to the possible formation of nitrosamines are merely hypothetical and are founded on criteria which are irrelevant or insufficient to justify a non-inclusion decision, as claimed by the applicants, it must be recalled that Directive 91/414, as is clear from the fifth, sixth and ninth recitals of the preamble thereto, aims to remove barriers to intra-Community trade in plant protection products, while maintaining a high level of protection of the environment and of human and animal health (see, to that effect, Case T-75/06 Bayer CropScience and Others v Commission [2008] ECR II-2081, paragraph 81 and case-law cited). In that context, if the Commission is to be able to pursue effectively the objective assigned to it, account being taken of the complex technical assessments which it must undertake, it must be recognised as enjoying a broad discretion (see Case C-326/05 P Industrias Químicas del Vallés v Commission [2007] ECR I-6557, paragraphs 74 and 75, and Bayer CropScience and Others v Commission, paragraph 82).

70 The exercise of that discretion is not, however, excluded from judicial review. According to settled case-law, in the context of such a review the courts of the European Union must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of appraisal of the facts or a misuse of powers (see Bayer CropScience and Others v Commission, paragraph 83 and case-law cited).

71 In particular, where a party claims that the institution competent in the matter has made a manifest error of appraisal, the courts of the European Union must examine whether that institution has examined, carefully and impartially, all the relevant facts of the individual case which support the conclusions reached (Case C-269/90 Technische Universität München [1991] ECR I-5469, paragraph 14, and Bayer CropScience and Others v Commission, paragraph 69 above, paragraph 84).

72 In the light of those considerations the Court must assess, in turn, the arguments of the applicants concerning, first, the claim that the risk associated with the possible formation of nitrosamines is hypothetical and irrelevant, which risk is further claimed to be the main reason for the adoption of the contested decision and, secondly, the insufficiency of data on the presence and toxicity of unidentified metabolites and the absence of studies relating to the processing of products containing DPA.

- The ground of complaint that the risk associated with the possible formation of nitrosamines is hypothetical and irrelevant

73 The applicants claim, firstly, a manifest error of appraisal in that the non-inclusion of DPA is founded principally on the concern relating to the possible formation of nitrosamines, which is claimed to be a purely hypothetical conclusion with no relation to the evaluation of DPA and, in particular, to the representative use notified to the competent authorities.

74 In that regard, it must be recalled that Article 5(1)(b) of Directive 91/414 provides that, before a substance can be included in Annex I to that directive, it must be possible to expect that, in the light of current scientific and technical knowledge, plant protection products containing that active substance will fulfil the following conditions:

75 It follows from that provision, interpreted in combination with the precautionary principle that, in the domain of human health, the existence of solid evidence which, while not resolving scientific uncertainty, may reasonably raise doubts as to the safety of a substance, justifies, in principle, the refusal to include that substance in Annex I to Directive 91/414. The precautionary principle is designed to prevent potential risks (Case T-229/04 Sweden v Commission [2007] ECR II-2437, paragraph 161, and Cheminova and Others v Commission, paragraph 58 above, paragraph 166).

76 However, it is also clear from the case-law that a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has not been scientifically verified (Case T-13/99 Pfizer Animal Health v Council [2002] ECR II-3305, paragraph 143).

77 Although they may not take a purely hypothetical approach to risk and may not base their decisions on a 'zero-risk', the European Union institutions must nevertheless take account of their obligation under the first subparagraph of Article 152(1) EC to ensure a high level of human health protection, which, to be compatible with that provision, does not necessarily have to be the highest that is technically possible (Case C-284/95 Safety Hi-Tech [1998] ECR I-4301, paragraph 49, and Pfizer Animal Health v Council, paragraph 152).

78 Consequently, if it is not to adopt arbitrary measures, which cannot in any event be rendered legitimate by the precautionary principle, the competent public authority must ensure that any measures that it takes, even preventive measures, are based on as thorough a scientific risk assessment as possible, account being taken of the particular circumstances of the case at issue. Notwithstanding the existing scientific uncertainty, the scientific risk assessment must enable the competent public authority to ascertain, on the basis of the best available scientific data and the most recent results of international research, whether matters have gone beyond the level of risk that it deems acceptable for society. That is the basis on which the authority must decide whether preventive measures are called for (Pfizer Animal Health v Council, paragraph 162).

79 In the present case, it is clear that, firstly, the applicants' assertion that the concern relating to the possible formation of nitrosamines was the principal concern, in the absence of which the Commission would have adopted a decision to include DPA in Annex I to Directive 91/414, cannot be accepted. In the light of the wording of recital 5 of the preamble to the contested decision, it is evident that the possible formation of nitrosamines during storage of DPA and during the processing of products treated with DPA is cited as an issue which was secondary to the concern relating to the presence and toxicity of unidentified metabolites. Moreover, beyond the other concerns, reference is made to the absence of data on the potential breakdown or reaction product of DPA residues in processed commodities. Similarly, there is no basis for the applicants' claim that the three concerns were not all of equal importance. It should be observed that, as stated by the Commission, the EFSA Conclusion Report does not in any way establish a hierarchy of importance of the concerns raised, if indeed the claims were based on that document.

80 On the contrary, the three areas of concern seem to be of equal importance, and it was appropriate to examine all those concerns in order to carry out a full and reliable evaluation and thereby to eliminate any risk to the consumer. Both the EFSA Conclusion Report and the reporting table confirm that interpretation.

81 First, as stated in paragraph 22 above, the EFSA Conclusion Report states that, given the structure of DPA and indications on the possible formation of nitrosamines in the case of tank mixing, the notifiers were asked to examine whether there was a probability of formation of nitrosamines in metabolism or under processing. The EFSA Conclusion Report states, further, that the experts' meeting could not exclude the natural presence of nitrates/nitrites in apples, but that the significant level at which at which the formation of nitrosamines could be induced was not known. That report adds further that the data gap concerning the presence of nitrosamines was linked to the gaps on the identification of metabolites in apples and the nature of residues in processed apples. It must be observed, lastly, that that report states the importance of an assessment on a case-by-case basis, for all tank mixes, since some of them might result in the formation of nitrosamines.

82 Next, in reply to the EFSA question whether the RMS had considered the possibility of the formation of nitrosamines in metabolism and during processing the Reporting Table states in column 3(5) 'apple metabolism study and processing' of the section relating to residues, that the answer was in the negative and that the notifiers had provided no data on that point. Consequently, the question of the formation of nitrosamines raised by the EFSA in that context demonstrates the relevance of an examination of that risk, not in isolation, but in the wider context of the other concerns raised.

83 It follows from those documents that in the contested decision the Commission correctly referred, to the three concerns by taking the view, in accordance with the scientific opinion of the DPA peer review, that the data gaps found to exist in respect of each of those three concerns made it impossible to complete the consumer exposure risk assessment.

84 The applicants claim, further, that since nitrosamines are metabolites formed by the combination of amines, such as DPA, and nitrates or nitrites which may be present in fields treated with fertiliser, they cannot be formed when DPA is applied to apples as a post-harvest treatment, since that is done indoors, where there is no contact with fertilisers. Even though, having regard to the notified representative use of DPA, the absence of outside contact was confirmed both by the DAR and by the EFSA Conclusion Report, it remains the case that that argument of the applicants does not address the issue of the behaviour of DPA residues or the possible degradation of DPA into nitrosamines where apples are subject to household processing. Those issues will be examined in relation to the errors of appraisal allegedly committed by the Commission in respect of the conclusions drawn from the insufficiency of data on unidentified metabolites and the absence of data on the processing of apples treated with DPA.

85 Next, as regards the applicants' arguments relating to the irrelevance of tank mix tests for the purposes of DPA evaluation, the Court must examine, on the basis of the information provided by the applicants on preparations containing DPA, of which they are proprietors at national level, and of the representative use notified for the purposes of the DPA evaluation, whether the Commission was correct to take the view that there was a probability that those products would be mixed with other active substances or preparations and therefore a risk of formation of nitrosamines.

86 It is clear, in that regard, that, according to the label produced by the Commission, submitted by Cerexagri in 2004 in relation to the notification for the No Scald DPA 31 EC product, as authorised in the United Kingdom, that product must not be combined with calcium chloride or other products without first consulting with the producer's technicians. Likewise, the No Scald DPA 31.8 EC product label, authorised in Greece, states that it must not be combined with other preparations. Nonetheless, it must be observed that, as stated by the Commission, the No Scald DPA 31 product label, authorised in Italy, also produced by Cerexagri in the dossier, provides, in the 'Compatibility' section, that that product is compatible with other products normally used post-harvest and that in the case of mixing with other preparations, the longest waiting period is to be respected before it is placed on the market.

87 Further, concerning the Xeda products, it must be observed that, although some marketing authorisations issued by the competent national authorities and some labels affixed to those products rule out any mixing with other preparations, others state that the products in question are compatible with other preparations or with certain products or fungicides. For example, in respect of the Xedamine 20 product authorised in Italy, in the 'Compatibility' section, the label expressly provides that that product is compatible with other fungicides authorised for the post-harvest treatment of apples and that, in the case of mixing with other preparations, the longest waiting period is to be respected before it is placed on the market. On the other hand, the approvals issued by the French Ministry of Agriculture, Fisheries and Food for the same product, and for the Xedamine Aerosol 88 product, refer, among toxicological risks, to the 'danger of cumulative effects'. Likewise, the marketing authorisation issued by the Greek Ministry of Agriculture for the Xedamine-20 EC product, and the label of that product, state that it should not be combined with other preparations in order to avoid loading the apples with residues. As regards the Italian label of the Xedamine Aerosol product, it provides that that product is compatible with the Xedazol Aerosol product.

88 Lastly, it is clear from the letter of 17 December 2008 which the notifiers sent to the Commission, that on the labels affixed to their products 'no tank mixes will be stated'. The Commission could therefore reasonably deduce from that statement that the labels affixed to the products notified in the dossier did not exclude tank mixes, especially when that was apparent, as set out in paragraph 86 above, from certain product labels provided by the notifiers themselves, as authorised in Italy.

89 Under Article 16 of Directive 91/414 on the requirements applicable as to labelling the packaging of plant protection products, and in particular Article 16(1)(k), the labelling of such products must specify the uses for which they have been authorised and the agricultural, plant health and environmental conditions under which they may be used or should not be used. Since the system of marketing authorisation, both at national level and at European Union level, is a system of positive authorisation, only uses for which the product has previously been authorised can be stated on the label, as the parties stated in their written replies to questions from the Court.

90 However it is clear that, in accordance with recital 19 of the preamble to Directive 91/414, that directive complements European Union provisions on the classification, packaging and labelling of pesticides, and, together with those provisions, considerably improves the protection of users of plant protection products. Consequently, as the Commission stated in its answers to questions from the Court, while labelling is essential to provide information and instructions on the correct use of a plant protection product, that information is without prejudice to that required by Directive 91/414.

91 In that regard, it must be observed that under point 2.9 of Annex III to Directive 91/414, information relating to the physical and chemical compatibility of a substance with other products, including plant protection products with which its use is to be authorised, is required, unless justification acceptable to the competent authorities is produced, certifying that that information would not be necessary owing to the nature of the product or to its proposed uses.

92 In the present case, the fact that the notifiers stated within their dossier that the physical and chemical compatibility of the product with tank mixes was not at issue, since the product defended within their summary dossier was not labelled for that use, cannot constitute an acceptable justification for failure to submit the required data in respect of DPA's compatibility, given that some of their products did not rule out mixing with other preparations. Moreover, the explanation provided by the notifiers was contradicted by the labels supplied to the Commission by Cerexagri. In addition, it must be observed that the notifiers themselves stated during the evaluation of DPA that it was regular practice to mix it with a fungicide and/or calcium salt. Consequently, the applicants' claim that the tank mix test was of no relevance to the evaluation of DPA, taking into account the notified representative use and the explanations provided within the notifiers' summary dossier, cannot be accepted.

93 In any event, it must be recalled that the applicants have expressly accepted that the formation of nitrosamines was not ruled out in the case of tank mixes and confirmed that the existence of this risk in the case of tank mixes of DPA with other substances was scientifically established.

94 The applicants' contention that the monitoring authorities accepted that the representative use submitted by the notifiers did not involve the addition of nitrites or nitrates during processing cannot eliminate the risk of the formation of nitrosamines, since, in the absence of evidence to the contrary, the natural presence of nitrates in apples and the possibility that the applicants' products may be mixed with other preparations containing those substances cannot be ruled out.

95 It follows from the foregoing, as rightly stated by the Commission, that data relating to tank mixes were relevant and necessary in order to complete the risk assessment and, without such data, the existence of the associated risk, namely the possible formation of nitrosamines, could justifiably be inferred.

96 It follows that the Commission did not commit a manifest error of appraisal by basing the contested decision on the insufficiency of data on the possible formation of nitrosamines during storage of DPA and that this ground of complaint must be rejected.

- The ground of complaint relating to the absence of studies relating to processing and the insufficiency of data relating to unidentified metabolites

97 The applicants claim that the contested decision is vitiated by a manifest error of appraisal, in that it is based on the lack of data on the nature of the degradation products of DPA which might occur in treated commodities, during household processing using apples, to justify non-inclusion of that active substance in Annex I to Directive 91/414.

98 The applicants further submit that the contested decision is vitiated by a manifest error of appraisal in that it bases the refusal to include DPA in Annex I to Directive 91/414 on the lack of data on the presence and toxicity of unidentified metabolites.

99 Firstly, as regards the manifest error of appraisal relating to the degradation of DPA which could occur in treated commodities during household processing of apples, it must be observed, at the outset, that the fact that the RMS did not regard the absence of data on that point as being a matter of concern is of no relevance. As emphasised by the Commission, the assessment of the RMS is binding neither on the EFSA nor on the Commission (see, to that effect, Cheminova and Others v Commission, paragraph 58 above, paragraph 209). Further, as stated in paragraph 65 above, it is the EFSA Conclusion Report and not the DAR which constitutes the scientific basis for the contested decision. It is clear that the notifiers did not submit comments on the EFSA Conclusion Report when the opportunity to do so was given to them.

100 Next, it must be recalled that the EFSA Conclusion Report refers to that absence of data among the critical areas of concern, making finalisation of the evaluation of risk to the consumer impossible. Consequently, as stated by the Commission, it follows from that report that, even though apples intended for industrial processing are generally not treated with DPA, it cannot be ruled out that apples purchased by consumers may be used in household preparations. It must further be observed that Annexes II and III to Directive 91/414 include, in points 6.6 and 8.2 respectively, the data relating to the 'effects of industrial processing and/or household preparation on the nature and magnitude of residues' among the data required in dossiers submitted to the competent authorities for the inclusion of an active substance in Annex I to that directive and the obtaining of the consequent authorisation of the plant protection product containing that substance. It is initially specified, in the 'Introduction' to Annexes II and III to Directive 91/414, that there is no need to provide certain information which would not be necessary owing to the nature of the product or its proposed uses, provided that a justification which is acceptable to the competent authorities is provided by the notifiers.

101 In the present case, while the notifiers produced a study on processing, that study related to the level of residues in apples subject to industrial processing, treated with DPA. As regards that study, both the experts' meeting and the EFSA, in its Conclusion Report, found differences between the levels of residue observed in wet and dried apple pomace (see paragraph 24 above). As regards studies on household processing, the applicants have accepted that the notifiers had not provided such data within their dossier, considering that such data was not relevant, because only apples intended for direct human consumption, with no prior industrial processing, are treated with DPA.

102 It is however clear that that assertion does not cover the possibility raised by the experts' meeting that apples purchased by consumers might be subject to household processing. That is all the more important given that apples are widely consumed by all age groups of the population, including the most vulnerable, such as babies, in various forms and culinary preparations (raw, cooked, as a compote or as juice) and that they are therefore likely to undergo processing. Since apples treated with DPA contain residues at significant levels, studies on the nature of those residues ought to have been produced by the notifiers, both on raw apples and on processed apples. As regards the studies on the metabolism of raw apples produced by the notifiers, those were not capable of responding to a concern of that kind.

103 Further, it must be recalled that the burden of proof as regards the safety of the active substance lies with the notifier (Bayer CropScience and Others v Commission, paragraph 69 above, paragraph 85). Contrary to what is claimed by the applicants, the fact that the issue of the nature of residues in processed products was raised for the first time by the EFSA by way of comment on the DAR, as an unresolved issue requiring discussion by the experts, cannot affect its relevance to the risk assessment. The notifiers, although made aware of that issue in the course of the evaluation, did not provide the necessary clarification. Accordingly, the EFSA found in its Conclusion Report that further information was necessary in the present case and categorised the absence of studies relating to household processing among the critical areas of concern. As well as declaring on 14 November 2008 that they had no comments on the EFSA Conclusion Report, the notifiers subsequently, stated to the Commission in their letter of 17 December 2008 that they would shortly supply a study on the nature of residues in processed products, in order to address the concerns raised.

104 It follows that the Commission did not err in including that factor among the causes of concern justifying the decision of non-inclusion.

105 Secondly, as regards the alleged manifest error of appraisal relating to the absence of data on the possible formation of metabolites, it must be recalled that, as the applicants have themselves stated in their reply, the notifiers' dossier did not identify all metabolites. Further, that finding was made in the Reporting Table, in the section relating to residues, to which the applicants also refer in their application.

106 It must be recalled that Article 2(2) of Directive 91/414 defines the terms 'residues of plant protection products' broadly, as 'one or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites and products resulting from their degradation or reaction'.

107 It must further be observed that Annex II to Directive 91/414 on the requirements for the dossier to be submitted for the inclusion of an active substance in Annex I to that directive requires the identification of degradation and reaction products and of metabolites in treated plants or products (Part A, point 6(1)). Moreover, Annex III of that directive on the requirements for the dossier for the authorisation of a plant protection product containing that substance has, first, in point 8.1, a reference to information required in the case of post-harvest treatment relating to 'breakdown of residues during storage' and, second, in point 8.2, a reference to information relating to 'effects of industrial processing and/or household preparation on the nature and magnitude of residues'.

108 In the present case, the notifiers produced, within their full dossier, in the section relating to residues, a study on metabolites in apples undertaken by Kim-Kang in 1993 and completed in 1994, entitled 'Metabolism of ¹⁴C-diphenylamine in stored apples - Nature of the residue in plants' ('the Kim-Kang study').

109 The examination of that study by the Joint Meetings of the Food and Agricultural Organisation of the United Nations (FAO) and the World Health Organisation (WHO) on Pesticides Residues ('JMPR') disclosed that 'the unidentified non-polar metabolites found in the study were not related to either 4-aminobiphenyl, 2-aminobiphenyl, or N-nitrosodiphenylamine'. The last of those three substances is, according to the applicants, the nitrosamine which is the most likely to be degenerated from DPA, when it comes into contact with nitrates or nitrites.

110 Further, the notifiers submitted to the RMS, as part of the data relating to residues, the Gray study, carried out in 2005, designed to study the metabolism of DPA in apples during storage. That study, referenced in volume 3 of the DAR, disclosed that DPA was the main residue present in all samples taken at various times of storage, and that six other residue fractions were present, the components of some of which were identified in the study. The Gray study demonstrated that there were six metabolites present during storage, three of which were not identified, namely the metabolites coded 1, 2 and 3. However, in the position paper on the Gray study the relevance of the identification of those three metabolites was discounted taking into account the normal storage time for apples, which was well below 40 weeks, and not greater than five months. That position paper stated, inter alia, that 'although the unidentified metabolites 1, 2 and 3 did constitute a significant portion of 'TRR' (total radioactive residues) at week 40 [of storage], apples are generally held in cold storage 24 weeks or less. Therefore these metabolites are not likely to be present in apples subjected to cold storage up to and including the longest expected interval of 5 months, and, not being present, will not have any dietary impact'. Further, the position paper on the Gray study states that 'the presence of metabolite 3 at 12 weeks is dubious and, as such, should not be included in the formation/decline curve for that metabolite'. Accordingly, the conclusion of that position paper was that the identities of those metabolites was not relevant.

111 However, it must be observed that it follows from point 3.1 of the evaluation table in relation to residues - which refers to points 3(3) and 3(5) of the RMS Reporting Table - and from the report of the experts' meeting, that it was not sufficient to submit studies on the presence of metabolites of DPA, but that those metabolites had to be identified, since, at N rate of application of DPA to apples, their level exceeded the maximum application rate of 0.05 mg/g prescribed by good plant protection practice and, consequently, the rate above which identification of the metabolites was required.

112 It is clear that the Gray study confirms that the three unidentified metabolites were present in significant proportions at week 40, while metabolite 3 could be present at a much earlier stage, namely in week 12 of apple storage. Further, no information was supplied on the proportions of metabolites present between the 24th and 40th weeks of storage. In addition, no evidence was provided by the notifiers to establish that the generally employed storage time for apples was 24 weeks, to provide some safeguard against metabolites being present, or that apples will not be consumed in the period between the 24th and 40th weeks.

113 In those circumstances, it cannot be held that the justification offered by the position paper on the Gray study is sufficient to address the concern relating to unidentified metabolites. Further, the applicants' argument that both the rate of application of DPA used for the purposes of that study, and the storage time employed were excessive by comparison with good plant protection practices and commercial practices is ineffective. Even if the results obtained in the Gray study are overstated, the notifiers submitted no other data reflecting market practices which would have served to eliminate the concern relating to unidentified metabolites.

114 As regards the Kim-Kang study, cited as one of the studies supplied by the notifiers within Volume 2 (Annex A) of the DAR, which the applicants dispute was taken into consideration by the RMS for the purposes of the DPA evaluation, it is clear that the applicants make reference to it, within their action, only indirectly via an assessment of a conclusion drawn from that study by the JMPR at a meeting of the FAO and WHO which took place on 20 and 29 September 2001 (see paragraph 109 above). According to that assessment, the unidentified non-polar metabolites were not related to, in particular, N-nitrosodiphenylamine, which, according to the applicants, is the nitrosamine most likely to be degenerated from DPA. However, a reference to that assessment also fails to address the issue of the identification of metabolites.

115 It cannot be deduced from that finding alone, nor from the conclusions of the more recent Gray study, that the notifiers' dossier contained the information required to eliminate the concern relating to the toxicity of unknown metabolites present in DPA, so as to rule out any risk of the formation of nitrosamines. In that regard, it must be observed that, in their letter of 17 December 2008, the notifiers informed the Commission that they intended to commission a new study on the unknown metabolites in order to prove the absence of nitrosamines in DPA and that the use of DPA on apples carries no risk. Accordingly, the notifiers seemed to accept, at that stage, that the studies produced within their dossier did not make it possible to eliminate the concern relating to nitrosamines.

116 Further, it must be observed that, for the purposes of the procedure of evaluation of active substances at European Union level as established by Directive 91/414 and Regulations Nos 451/2000, 1490/2002, 1095/2007 and 33/2008, only the conclusions of the EFSA, which can arrange a consultation of experts, are taken into account by the Commission. Accordingly, the JMPR conclusions, relied on by the applicants to support the relevance of the Kim-Kang study, are in no way binding on the Commission in its assessment. As stated by the Commission in its rejoinder, the JMPR can only make scientific evaluations concerning the toxicological and residue behaviour of active substances for the purpose of the setting of international maximum residue levels of pesticides in food and feed by the Codex Alimentarius Commission. Those recommendations, made within a procedure distinct from that for the inclusion of active substances in Annex I to Directive 91/414, cannot be compared to the EFSA conclusions, which constitute the scientific basis of the contested decision

117 It follows that, even if, contrary to what was concluded in recital 5 of the preamble to the contested decision, the notifiers did supply data on the presence of metabolites, that data was not sufficient to make it possible to determine their degree of toxicity or potential harmfulness.

118 As regards the report produced by the notifiers as evidence supposedly to prove the absence of nitrosamines in stored apples treated with DPA, titled 'An investigation into the storage stability of metabolites, specifically to prove the presence or absence of nitrosamines, in stored apples treated with ¹⁴C-Diphenylamine', it must be observed that that report was drawn up in relation to a study commenced on 2 October 2009 and completed on 10 February 2010.

119 It must therefore be observed that, although the notifiers had stated to the Commission, by letter of 17 December 2008, that they expected to be able to submit a study aimed at the identification of the three unknown metabolites in stored apples, the report in question is of no relevance to the evaluation procedure under consideration since it was submitted to the Commission after the adoption of the contested decision.

120 It follows that the applicants have not proved that the Commission committed a manifest error of appraisal by relying on the insufficiency of data on the toxicity of the metabolites and by concluding that the lack of exact knowledge of the nature and behaviour of those metabolites made it impossible to carry out a reliable evaluation of consumer exposure risk.

122 In those circumstances, it must be concluded that the Commission did not commit a manifest error of appraisal by basing its decision on the insufficiency of data concerning the risk of formation of nitrosamines in conjunction with tank mixes, and unidentified metabolites, and the absence of data relating to processing.

123 In the light of the foregoing, the first plea must be rejected in its entirety.

124 The applicants claim that the contested decision is disproportionate, since the Commission could have chosen other, less restrictive measures which would have achieved the desired objectives without imposing on them the allegedly disproportionate burden of having to lose their authorisations issued at national level, being unable to sell their DPA products and being compelled to re-submit a dossier for the examination of that same active substance, in accordance with Regulation No 1095/2007.

125 The less restrictive measures advocated by the applicants consisted in the adoption of a decision under Article 6(1) of Directive 91/414, allowing the inclusion of DPA in Annex I to that directive subject to compliance with certain conditions, such as the submission of confirmatory data on the metabolites and studies relating to processing, and/or with additional restrictions on use (for example, only for unprocessed use, and/or limited to a 24-week storage period).

126 It must be first be recalled that, according to settled case-law, the principle of proportionality, which is one of the general principles of European Union law, requires that measures adopted by the institutions must not exceed the limits of what is appropriate and necessary in order to attain the legitimate objectives pursued by the legislation in question; where there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (Case 137/85 Maizena and Others [1987] ECR 4587, paragraph 15; Pfizer Animal Health v Council, paragraph 76 above, paragraph 411, and Cheminova and Others v Commission, paragraph 58 above, paragraph 194).

127 It follows that, within the context of judicial review of the application of that principle, in view of the broad discretion which the Commission enjoys in adopting decisions relating to the inclusion of active substances in Annex I to Directive 91/414, the lawfulness of a measure can be affected only if the measure is manifestly inappropriate in relation to the objective which it is intended to attain (Bayer CropScience and Others v Commission, paragraph 69 above, paragraph 224).

128 In the present case, the contested decision is based on Directive 91/414, which has the objective, firstly, of removing barriers to intra-Community trade in plant protection products, and of improving plant production and, secondly, of protecting human and animal health and the environment. In those circumstances, it must be examined whether the contested decision is manifestly inappropriate to attain the objective envisaged by the re-evaluation system implemented by that directive, namely the protection of human and animal health and of the environment (see, to that effect, Cheminova and Others v Commission, paragraph 58 above, paragraph 196).

129 The applicants claim that the Commission often proposes and adopts directives for the inclusion of active substances subject to the submission of additional data, at the national or European Union level, in order to address concerns raised in the original evaluation process.

130 In that regard, the applicants refer to examples of active substances in respect of which notifiers were given a time-limit prior to inclusion of those substances in Annex I to Directive 91/414, in order to clarify aspects of the assessment, where the concerns raised were similar to those in the present case.

131 As regards, firstly, the active substances referred to by the applicants as examples of the application of Article 6(1) of Directive 91/414, it must be observed, as is clear from Commission Directive 2005/72/EC of 21 October 2005 amending Directive 91/414 to include chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram as active substances (OJ 2005 L 279, p. 63) (recital 5), Commission Directive 2008/44/EC of 4 April 2008 amending Directive 91/414 to include benthiavalicarb, boscalid, carvone, fluoxastrobine, Paecilomyces lilacinus and prothioconazole as active substances (OJ 2008 L 94, p. 13) (recital 9), Commission Directive 2008/116/EC of 15 December 2008 amending Directive 91/414 to include aclonifene, imidacloprid and metazachlore as active substances (OJ 2008 L 337, p. 86) (recital 4) and Commission Directive 2009/11/EC of 18 February 2009 amending Directive 91/414 to include bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad as active substances (OJ 2009 L 48, p. 5) (recital 4), in relation to those substances, that the Commission has recourse to that provision only where the active substances being assessed could be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414 (see, to that effect, Cheminova and Others v Commission, paragraph 58 above, paragraph 216).

132 By contrast, in the present case, it was concluded, on the completion of peer review, that DPA did not satisfy those requirements, in light of the fact that it posed various risks which were not sufficiently set out in the notifiers' dossier. Consequently, that provision was not applicable.

133 Secondly, and to the extent that the applicant's argument can be understood as meaning that the Commission should have authorised the inclusion of DPA subject to the attachment of conditions in accordance with Article 5(4) of Directive 91/414, it must be recalled that, contrary to Article 6(1) of that directive, the effect of that provision is to permit the inclusion of substances which do not satisfy the requirements of Article 5(1) of that directive by imposing certain restrictions which eliminate the problematic uses of the substance at issue (see, to that effect, Sweden v Commission, paragraph 75 above, paragraph 169, and Cheminova and Others v Commission, paragraph 58 above, paragraph 200).

134 Since Article 5(4) of Directive 91/414 is to be regarded as a limitation on Article 5(1) of that directive, it must be interpreted in the light of the precautionary principle. Consequently, before including a substance in Annex I to that directive, it must be established beyond a reasonable doubt that the restrictions on the use of the substance involved make it possible to ensure that use of that substance will be in accordance with the requirements laid down in Article 5(1) of Directive 91/414 (Sweden v Commission, paragraph 75 above, paragraph 170).

135 However, the applicants do not state by what means the conditions and/or restrictions which the Commission could have imposed on the Member States, involving the use of DPA being restricted solely to non-processed or commercially processed apples and/or limited to a 24-week storage period, would have guaranteed a use of DPA in accordance with the requirements of Article 5(1) of Directive 91/414. In any event, a decision permitting the inclusion of DPA in Annex I to Directive 91/414 subject to the production of data at Member State level, as is suggested by the applicants, is not capable of eliminating the problematic uses of the substance at issue (see, to that effect, Cheminova and Others v Commission, paragraph 58 above, paragraph 201).

136 In fact, compliance with the restrictions proposed by the applicants would be very difficult, since, as stated by the Commission, it would be impossible to guarantee that apples treated with DPA were not processed by consumers or that they were not consumed after 24 weeks, especially when some labels affixed to the applicants' products recommend a longer storage period in certain circumstances, namely in cases of the mixing of DPA products with other substances.

137 Further, it must be observed that the contested decision is also not disproportionate in being based on the absence of sufficient information to allow a conclusion that there were no risks of the kind defined in Article 5(1) of Directive 91/414, in light of the fact that the objectives of protection of human and animal health and of the environment pursued by Directive 91/414 militate against a deferral of the decision to include or not to include the active substance at issue in Annex I to Directive 91/414 being left to the discretion of the producers of the active substance in question and the fact that, in any event, it is possible for those producers to have the active substance re-examined by means of the procedure provided for in Article 6(2) of Directive 91/414 (see, to that effect, Bayer CropScience and Others v Commission, paragraph 69 above, paragraph 228).

138 Thirdly, even if the applicants' argument concerning examples of decisions adopted on the basis of Article 6(1) of Directive 91/414 can be understood as essentially a claim of a breach of the principle of equal treatment, which has allegedly led the Commission to adopt a disproportionate decision, it must be recalled that that principle requires that comparable situations must not be treated differently and that different situations must not be treated in the same way, unless such treatment is objectively justified (see, to that effect, Case 106/83 Sermide [1984] ECR 4209, paragraph 28; Case C-174/89 Hoche [1990] ECR I-2681, paragraph 25, and Case T-38/02 Groupe Danone v Commission [2005] ECR II-4407, paragraph 453).

139 However it must be held that, having regard in particular to the specific nature of each review procedure, which makes comparisons extremely difficult, and also to the Commission's discretion as to the way in which it conducts investigations of such a technical and complex nature, which has been referred to several times already, the applicants have failed to establish that the differences in the way in which the evaluation procedures subject to comparison took place were not objectively justified (see, to that effect, Bayer CropScience and Others v Commission, paragraph 69 above, paragraph 242).

140 Consequently, the active substances referred to by the applicants are not comparable to the evaluation of DPA, even though the concerns raised display similarities with the present procedure.

141 In any event, it is clear that the Guidance document, on which the applicants rely, listing the active substances included in Annex I to Directive 91/414 notwithstanding the fact that those substances raised concerns allegedly comparable to those in the present case, is not intended to produce legally binding effects. As is stated in the preamble to that document, it was produced by the Commission Services in co-operation with the Member States with the aim of providing straightforward guidance to notifiers in respect of whom a decision for inclusion in Directive 91/414 was adopted, in relation to data required in order to confirm that the evaluated active substances have no harmful effects.

142 Accordingly, it must be concluded that in adopting the contested decision the Commission did not infringe the principle of proportionality.

The third plea in law: the inadequacy of the statement of reasons for the contested decision

143 The applicants claim that the contested decision is based on other areas of concern which were mentioned in the EFSA Conclusion Report in order to justify the decision not to include DPA. However, those alleged areas of concern were not mentioned in the contested decision in such a way as to enable the applicants to know that they formed part of the grounds of that decision. The applicants state therefore that all such other concerns relied upon by the Commission were not supported by an adequate statement of reasons.

144 It must be observed that, according to settled case-law, the statement of reasons required by Article 253 EC must be appropriate to the act at issue and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted the measure in question in such a way as to enable the persons concerned to ascertain the reasons for the measure and to enable the competent court to exercise its power of review. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons meets the requirements of Article 253 EC must be assessed with regard not only to its wording but also to its context and to all the legal rules governing the matter in question (see, to that effect, Case C-5/01 Belgium v Commission [2002] ECR I-11991, paragraph 68; Case C-501/00 Spain v Commission [2004] ECR I-6717, paragraph 73, and judgment of 5 March 2009 in Case C-479/07 France v Council, not published in the ECR, paragraph 49).

145 It must be observed that, in the present case, the applicants appear to maintain that, since the contested decision is based, implicitly, on the concerns which were mentioned in the EFSA Conclusion Report, it is vitiated by a failure to state reasons in relation to them.

146 It is however clear in the present case, as stated in paragraph 67 above, that the contested decision does adequately set out the concerns which were identified during the evaluation and which led the Commission to reject the inclusion of DPA in Annex I to Directive 91/414. The Commission concludes that the reported insufficiency of data in relation to those concerns made it impossible to conclude that DPA met the criteria for inclusion.

147 In the light of the foregoing, it must be concluded that the contested decision contains an adequate statement of reasons, having regard to the requirements laid down by the case-law referred to in paragraph 144 above.

148 Further, given that this plea in law appears to have been raised only on the assumption that the non-inclusion of DPA in Annex I to Directive 91/414 was based on grounds other than those set out in the contested decision and that there is nothing to suggest that to be the case, this plea must be rejected as manifestly unfounded.

The fourth plea in law: infringement of the rights of the defence and the principle of sound administration

149 In support of their fourth plea in law, the applicants claim that the notifiers were deprived of the possibility of exercising the 'right to withdraw' their support for the inclusion of DPA in Annex I to Directive 91/414, provided for by Article 3(2) of Regulation No 1095/2007, in return for the possibility of being entitled to a extended period for the withdrawal of authorisations for their products - namely until 31 December 2010 - longer than that provided for in Article 2 of the contested decision, until 30 May 2010. The loss of that right was due to the delay in the evaluation procedure, delay entirely attributable to the Commission as the body with overall responsibility for the transitional programme of work under Article 8(2) of Directive 91/414, and to the fact that, on the date by which the notifiers could have indicated their intention to withdraw support for the review of DPA, namely 28 November 2007 at the latest, they were in possession of one document only, the DAR of the RMS, which recommended the inclusion of DPA in Annex I to Directive 91/414 and did not raise any of the concerns identified in recital 5 of the preamble to the contested decision.

150 As regards the infringement of the applicants' rights of defence, it must be recalled that, according to settled case-law, observance of the right to a fair hearing is, in all proceedings initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of European Union law which must be guaranteed even in the absence of any rules governing the procedure in question (Case C-135/92 Fiskano v Commission [1994] ECR I-2885, paragraph 39, and Case T-228/02 Organisation des Modjahedines du peuple d'Iran v Council [2006] ECR-4665, paragraph 91).

151 In the present case, the first point to note is that the contested decision adversely affects Pace since it refuses to grant its request to have DPA included in Annex I to Directive 91/414.

152 Accordingly, it is first necessary to examine, in the light of the applicable legislative framework and the circumstances of the present case, whether the notifiers, of which Pace is one, were deprived of the possibility of requesting the withdrawal of their support for the inclusion of DPA.

153 It must first be recalled that Regulation No 1490/2002 was amended by Regulation No 1095/2007. In particular, Article 1 of Regulation No 1095/2007 amended Articles 11 and 12 of Regulation No 1490/2002, respectively relating to the evaluation by the EFSA and the submission of a draft directive or draft decision by the Commission on the conclusion of that evaluation.

154 In that regard, it must be recalled that, under the first subparagraph of Article 11(1) of Regulation No 1490/2002, as originally worded, '[a]fter receiving the updated summary dossier and the [DAR] referred to in Article 10(1), the EFSA shall, within 30 days, acknowledge receipt of the report to the rapporteur Member State'. Under Article 11(2), '[t]he EFSA shall circulate the rapporteur's [DAR] to the Member States and may organise a consultation of experts including from the [RMS]'.

155 In accordance with Article 11(4) of Regulation No 1490/2002, in its original version, '[t]he EFSA shall evaluate the rapporteur's [DAR] and deliver its opinion on whether the active substance can be expected to meet the safety requirements of Directive 91/414 ... to the Commission at the latest one year after receipt of the [RMS] [DAR]' Under that same provision, '[w]here appropriate, the EFSA shall give its opinion on the available options claimed to meet the safety requirements'.

156 As regards Article 12 of Regulation No 1490/2002, in its original version, that provided that, '[a]t the latest six months after receipt of the EFSA opinion referred to in Article 11(4) the Commission shall submit a draft review report'. The Commission is to submit to the Committee, as appropriate, 'a draft directive to include the active substance in Annex I to Directive 91/414 ..., setting out where appropriate the conditions, including the time limit, for such inclusion; or a draft decision addressed to the Member States to withdraw the [marketing] authorisations of plant-protection products containing that substance, pursuant to the fourth subparagraph of Article 8(2) of Directive 91/414 ..., whereby that active substance is not included in Annex I to [that] Directive ... mentioning the reasons for the non-inclusion'.

157 It is apparent from reading recital 5 of the preamble to Regulation No 1095/2007 that the Commission is now not obliged to consult the EFSA in order to obtain a detailed scientific opinion in relation to obvious cases, in other words, where there are clear indications that a substance does not have harmful effects, or, on the other hand, in order to obtain confirmation that an active substance is clearly harmful where there are clear indications that it has harmful effects. The Commission can therefore decide to include or not include the substance at issue, as appropriate, in Annex I to Directive 91/414 immediately following the DAR examination.

158 It must however be noted that the DAR is always sent to the EFSA, which then immediately sends the DAR to the Commission, the Member States and the notifiers for their comments, then assembles the comments received and adds its own, where necessary, and sends everything back to the Commission, the Member States and the notifiers. Lastly, the EFSA makes the DAR available to persons with an interest for consultation.

159 The objective pursued by that amendment of the evaluation procedure is efficient use of EFSA resources, which, according to recital 6 of the preamble to Regulation No 1095/2007, should henceforth focus on the examination of active substances in relation to which doubts need to be resolved before a decision on their inclusion in Annex I to Directive 91/414 can be taken. Accordingly, in order to speed up the procedure further, recital 7 of the preamble to that regulation states that it should be possible 'to grant a longer withdrawal period in cases where there are such remaining doubts and notifiers agree to withdraw their support of the inclusion of the active substance'. Recital 7 also states that 'this procedure should only apply to cases where there are no clear indications that the substance has harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment'.

160 It must be recalled, in that regard, that the criteria for clear indications that an active substance has no such effects were set out in Annex V of Regulation No 1490/2002, which was added by Regulation No 1095/2007 to follow Annex IV of Regulation No 1490/2002.

161 Article 11b of Regulation No 1490/2002, as replaced by Regulation No 1095/2007, provides:

162 Conversely, Annex VI of Regulation No 1490/2002, also added by Regulation No 1095/2007 to follow Annex IV of Regulation No 1490/2002, as amended, lays down the criteria for clear indications that an active substance has harmful effects.

163 Moreover, under Article 11c of Regulation No 1490/2002, as replaced by Regulation No 1095/2007:

164 Further, Article 11e of Regulation No 1490/2002, on the notifier's withdrawal of support for inclusion, is worded as follows:

165 Article 12 of Regulation No 1490/2002, as replaced by Regulation No 1095/2007, states as follows:

166 In accordance with Article 3(2) of Regulation No 1095/2007 on transitional provisions for Regulation No 1490/2002 :

167 It must be observed that Regulation No 1095/2007 entered into force on the seventh day following the date of its publication in the Official Journal of the European Union, that is to say 28 September 2007. On that date, the EFSA had received the DAR of the RMS, but had not yet submitted its conclusions to the Commission. Firstly, it must be recalled that procedural rules are of direct application (see, to that effect, Cheminova and Others v Commission, paragraph 58 above, paragraphs 79 and 80). Secondly, it is clear that Article 3(2) of Regulation No 1095/2007 is applicable, as a transitional provision, to the present case, which fact was, moreover, brought to the knowledge of one of the notifiers, Cerexagri, by the EFSA letter of 18 October 2007. In that letter, it is also stated that the notifiers had received the DAR from the RMS by, at the latest, 28 September 2007, a date which corresponds to the date when Regulation No 1095/200 entered into force.

168 Further, it is clear from the EFSA letter of 8 October 2007, produced by the Commission in response to the Court's request at the hearing, referred to in the abovementioned letter of 18 October 2007, that the notifiers had been informed of the fact that the EFSA had decided to organise a consultation of experts. The comments of the notifiers on the DAR were obtained as a contribution to that consultation. However, that stage, provided for by Article 11c of Regulation No 1490/2002 as amended, presupposes that the Commission has requested the scientific opinion of the EFSA, on the view that Article 11b was not applicable to DPA and that the Commission expected that it would, on the expiry of the withdrawal period, have to request that the EFSA review the DAR.

169 However, the applicants claims that the notifiers' rights of defence were infringed, since, on the date by which they could request the withdrawal of their support of the inclusion of DPA, namely by 28 November 2007, the only document in their possession was the DAR by the RMS, which proposed the inclusion of DPA in Annex I to Directive 91/414. In the absence of grounds to suspect that there might be a negative decision at that stage, the applicants assert that the notifiers were deprived of the possibility of requesting withdrawal, as provided for by Article 3(2) of Regulation No 1095/2007.

170 It must be observed, in that regard, that the proposal for the inclusion of DPA made by the RMS in the DAR was not unconditional, but accompanied by the conditions stated in section 4 of the DAR. The notifiers had therefore to supply certain additional data and clarifications, which were not included in the studies produced within the dossier, as is clear, in particular, from points 4.2, 4.5 and 4.7 of that document. That data was required in order to determine, inter alia, the physical and chemical properties of DPA (point 4.2), the nature of DPA residues in industrially processed apples intended for consumption (point 4.5.2) and the unidentified metabolites (point 4.7).

171 The fact that the abovementioned data gaps were pointed out to the notifiers at that stage, even though those gaps did not, ultimately, prevent the RMS from proposing the inclusion of DPA in Annex I to Directive 91/414, demonstrates that, contrary to the applicants' claims, the notifiers had in their possession, as from 28 September 2007, and therefore well before the expiry of the time-limit for withdrawal, information to justify the existence of doubts that the final decision would be favourable. Further, having regard to the clarifications requested by the RMS, the applicants cannot claim that it could be concluded, at that stage, that DPA was clearly incapable of having harmful effects on human health.

172 In the event that the notifiers did not provide the required clarifications, as in this case, they could expect that the EFSA would issue its conclusions with concerns being raised in relation to the persisting gaps. Consequently, the notifiers should have exercised the required due diligence and should not have discounted at the outset the foreseeable possibility that Article 11b of Regulation No 1490/2002 might not be applicable.

173 The applicants claim nonetheless that the notifiers would have been in a more advantageous position if the time-limits prescribed by the legislation applicable to the evaluation of DPA had been complied with. However, contrary to the applicants' claim, the EFSA could not commence its review immediately after the DAR was sent to it by the RMS, namely on 20 June 2007, since the EFSA was obliged, in accordance with Article 11(1) and (2) of Regulation No 1490/2002, in the earlier version applicable at that time, to acknowledge receipt of the DAR within a period of 30 days, then to send the DAR to the Member States while organising a possible consultation of experts. In the present case, the EFSA sent the DAR to the Member States, to the Commission and to the notifiers on 8 October 2007 and set, for the Member States and the notifiers, in accordance with Article 11(2) of Regulation No 1490/2002, as amended by the then in force Regulation No 1095/2007, a time-limit of two months within which to submit comments, expiring on 7 December 2007.

174 Further, it is clear that there is no provision which obliges the EFSA either to begin its review of the DAR at a precise date prior to the date of expiry of the time-limit prescribed for the withdrawal of support of the inclusion of a substance under Article 3(2) of Regulation No 1095/2007, or moreover to complete it before that date. In addition, if the EFSA, having been consulted by the Commission, had come to the conclusion that DPA did not satisfy the criteria laid down in Annex VI of Regulation No 1490/2002, for the purposes of Article 3(2)(a)(ii) of Regulation No 1095/2007, the EFSA was also not obliged to inform the notifiers of that interim conclusion, contrary to what is asserted by the applicants in their letter of 28 July 2011. In any event, the fact that the notifiers were made aware, by means of two letters, dated 8 and 18 October 2007, sent to them by the EFSA, of the consultation of experts commenced on October 2007 and of the time-limit attached to the right to request the withdrawal of support of the inclusion of DPA demonstrates that DPA was not one of the clear cases where the Commission could submit a draft decision or directive directly to the committee, under Article 12(1)(a) of Regulation No 1490/2002 as amended, but that it was probable that the Commission would ask the EFSA to carry out a review of the DAR within the meaning of Article 11c of that regulation.

175 It is apparent from the second subparagraph of Article 11c(1) that the EFSA was to deliver its conclusion within a period of six months after notification of the Commission's request for the full review of the DAR and, in any event, by no later than 30 September 2008.

176 In the present case, the EFSA delivered its Conclusion Report on that date and therefore did not infringe the time-limits prescribed by the legislation, as claimed by the applicants.

177 Similarly, the alleged delay in initiating the consultation on the DAR by the EFSA, which is complained of by the applicants, in no way denied to the notifiers the effective enjoyment of their 'right to withdraw'.

178 While the EFSA waited until 8 October 2007, in other words more than three months, to send the DAR and initiate the consultation, it is in the present case clear that, before the entry into force of Regulation No 1095/2007, no time-limit applied to that communication. From the date of the entry into force of that regulation, namely 28 September 2007, the EFSA had to communicate the report 'without delay' to the Commission, the Member States and the notifiers and to set a maximum time-limit of two months for the submission of comments by the Member States and the notifiers, which the EFSA did ten days later, in other words on 8 October 2007, setting a time-limit expiring on 7 December 2007. Even in the scenario advocated by the applicants, had the EFSA scrupulously complied with the time-limits prescribed by Regulation No 1095/2007, 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 the exercise of the 'right to withdraw', only the comments of the Member States on the DAR and, possibly, those of the EFSA.

179 However, according to the applicants, the question relating to the possible formation of nitrosamines was actually raised only after the experts' meeting, in June 2008. Consequently, in light of the fact that the risks associated with DPA, and therefore the probability that a negative decision would be adopted, were, according to the applicants, in reality only raised after the expiry of the prescribed time-limit for the withdrawal of support for that substance, the notifiers would not, in any event, have had in their possession information on the concern relating to the possible formation of nitrosamines within the prescribed period for the withdrawal of support for the inclusion of DPA.

180 Moreover, as is clear from recital 6 of the preamble to the contested decision, the Commission did inform the notifiers of the possibility of withdrawing support for the inclusion of DPA. By letters of 8 and 18 October 2007 the EFSA informed the notifiers of the possibility of withdrawing their notification, and had, in any event, drawn their attention to the entry into force of Regulation No 1095/2007, thereby enabling them to identify the provision and time-limit applicable in the present case.

181 It follows that the rights of defence of the notifiers, and therefore of Pace, were respected throughout the procedure prior to the adoption of the contested decision. In that regard, the applicants cannot confuse a failure to respect the rights of the defence with the failure to obtain the desired result through the exercise of those rights. The fact that the applicants consider that the comments submitted answer all concerns as to the harmfulness of DPA does not thereby demonstrate that the Commission infringed their rights of defence by taking the view, when the contested decision was adopted, that 'it [was] not possible to conclude, on the basis of the information available, that [DPA] met the criteria for inclusion in Annex I to Directive 91/414' (see, to that effect, Cheminova and Others v Commission, paragraph 58 above, paragraph 247).

182 Even if the EFSA had not fulfilled its obligation under Article 11(2) of Regulation No 1490/2002, as amended, to communicate the DAR without delay, that consideration would affect the legality of the contested decision only if it was established that the content of that decision would have differed if that irregularity had not occurred (see, to that effect, Joined Cases 209/78 to 215/78 and 218/78 van Landewyck and Others v Commission [1980] ECR 3125, paragraph 47, and Case T-279/02 Degussa v Commission [2006] ECR II-897, paragraph 416).

183 To the extent that the applicants claim that the EFSA delay in initiating the consultation was attributable to the Commission, it must be observed that the fact that the Commission did not ensure that the EFSA complied with its obligation to communicate the DAR without delay, under Article 11(2) of Regulation No 1490/2002, as amended, cannot be regarded as an infringement of the principle of sound administration on the part of the Commission (see, to that effect, Cheminova and Others v Commission, paragraph 58 above, paragraph 226).

184 In the present case, and in light of the foregoing, it must be concluded that the alleged delay on the part of the EFSA in initiating the consultation had no effect on compliance with the time-limit for the delivery of its Conclusion Report. In any event, that delay has no impact on the contested decision.

185 Under those circumstances, the fourth plea must be rejected and, consequently, the action must be dismissed in its entirety.

186 Under Article 87(2) of the Rules of Procedure, 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 applicants have been unsuccessful and the Commission has applied for costs, the applicants must be ordered to bear their own costs and to pay those of the Commission, including the costs relating to the proceedings for interim measures.

2. Orders Xeda International SA and Pace International LLC to bear their own costs and to pay those of the European Commission, including the costs relating to the proceedings for interim measures.

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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Xeda International and Pace International v Commission [2012] EUECJ T-71/10 (19 January 2012) URL: http://www.bailii.org/eu/cases/EUECJ/2012/T7110.html Cite as: [2012] EUECJ T-71/10

Court of Justice of the European Communities (including Court of First Instance Decisions)