ORDER OF THE VICE-PRESIDENT OF THE COURT

23 May 2019 ( )

(Appeal — Order for interim relief — Regulation (EC) No 1107/2009 — Plant protection products — Review procedure for the evaluation of the active substance azadirachtin — Request for confidential treatment — Rejection — Absence of any prima facie case)

In Case C‑163/19 P(R),

APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 22 February 2019,

Trifolio-M GmbH, established in Lahnau (Germany),

Oxon Italia SpA, established in Pero (Italy),

Mitsui AgriScience International SA/NV, established in Brussels (Belgium),

represented by C. Mereu and S. Englebert, avocats,

appellants,

the other party to the proceedings being:

European Food Safety Authority (EFSA), represented by D. Detken and S. Gabbi, acting as Agents, and S. Raes, advocaat,

defendant at first instance

THE VICE-PRESIDENT OF THE COURT,

after hearing the Advocate General, M. Szpunar,

makes the following

Order

1 By their appeal, Trifolio-M GmbH, Oxon Italia SpA and Mitsui AgriScience International SA/NV request the Court of Justice to set aside the order of the President of the General Court of the European Union of 5 February 2019, Trifolio-M and Others v EFSA (T‑675/18 R, not published, ‘the order under appeal’, EU:T:2019:64), by which the General Court, first, dismissed their application for suspension of operation of Decision EFSA/LA/DEC/19777743/2018 of the Executive Director of the European Food Safety Authority (EFSA) of 11 September 2018 (‘the contested decision’) concerning applications for confidential treatment of the conclusions of the peer review of the food risk assessment related to pesticide residues of the active substance azadirachtin (‘the conclusions of the review’), and, second, annulled its order of 20 November 2018, Trifolio-M and Others v EFSA (T‑675/18 R).

Legal context

2 Article 63 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1) provides:

‘1. A person requesting that information submitted under this Regulation is to be treated as confidential shall provide verifiable evidence to show that the disclosure of the information might undermine his commercial interests, or the protection of privacy and the integrity of the individual.

2. Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerned:

(a) the method of manufacture;

(b) the specification of impurity of the active substance except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant;

(c) results of production batches of the active substance including impurities;

(d) methods of analysis for impurities in the active substance as manufactured except for methods for impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant;

(e) links between a producer or importer and the applicant or the authorisation holder;

(f) information on the complete composition of a plant protection product;

(g) names and addresses of persons involved in testing on vertebrate animals.

...’

The background to the dispute, procedure before the General Court and order under appeal

3 Trifolio-M is a company which markets, throughout the European Union, biological plant protection products based on the active substance azadirachtin.

4 Oxon Italia is a company established in Italy which has expertise in the chemical and agrichemical sectors. It received its first national authorisation in 2000 for a product based on that substance and subsequently obtained authorisations in various other Member States of the European Union.

5 Mitsui AgriScience International is an international manufacturer of agricultural chemical products. It distributes protected insecticides and fungicides intended for agriculture, horticulture and arboriculture and holds a number of European authorisations covering products based on that substance.

6 The active substance azadirachtin is a compound extracted from the seed of the neem tree (Azadirachta Indica (A.JUSS)), which grows mainly in India.

7 According to the appellants, plant protection products containing that substance are used as insecticides and acaricides in fruit and vegetable crops and are also suitable for organic farming.

8 On 15 March 2018, EFSA approved the conclusions of the review.

9 On 16 March 2018, EFSA sent those conclusions to the appellants, together with the peer review report and the addenda to the draft assessment report, setting a time limit for any requests for confidential treatment.

10 On 11 April 2018, the appellants submitted a request for confidential treatment in respect of the conclusions of the review, the peer review report and Annex 8 to the draft assessment report.

11 In its reply of 17 April 2018, EFSA stated its view that the names of the persons involved in tests on vertebrates should be redacted and that the request for confidential treatment was to be dismissed as to the remainder. It gave the appellants the opportunity of substantiating their request.

12 On 4 June 2018, the appellants put forward other arguments in support of their request for confidential treatment.

13 On 27 June 2018, EFSA sent a draft decision to the appellants and requested them to submit their observations.

14 Following the observations submitted by the appellants on 5 July 2018, EFSA, on 19 July 2018, adopted a decision by which it agreed to redact the names of the persons involved in the tests on vertebrates and rejected the request for confidential treatment as to the remainder.

15 On 11 September 2018, following the request of 27 July 2018 for review of the decision of 5 July 2018, EFSA adopted the contested decision, confirming the earlier decision and rejecting the request for confidential treatment.

16 Under Article 2 thereof, the contested decision becomes applicable on the day following the expiry of the ‘two-month’ time limit laid down for bringing an action before the General Court.

17 On 14 September 2018, EFSA published on its website a provisionally redacted version of the conclusions of the review together with a non-liability clause stating that the requests for confidential treatment submitted by the appellants were still under consideration.

18 On 19 November 2018, EFSA published an unredacted version on its website.

19 By application lodged on the same day at the Registry of the General Court, the appellants sought, in essence, annulment of the contested decision.

20 By separate document, also lodged at the Registry of the General Court on the same day, the appellants, on the basis of Articles 278 and 279 TFEU, requested the President of the General Court to suspend the implementation of the contested decision and order EFSA to pay the costs.

21 At the request of the appellants, the President of the General Court, on 20 November 2018, without first hearing EFSA, adopted an order under Article 157(2) of the Rules of Procedure of the General Court ordering EFSA to suspend the implementation of the contested decision and to refrain from publishing the unredacted version of the conclusions of the review.

22 On the same day, EFSA removed the unredacted version of the conclusions of the review from its website.

23 On 5 February 2019, the President of the General Court, by the order under appeal, dismissed the appellants’ application for interim relief and rescinded his order of 20 November 2018, Trifolio-M and Others v EFSA (T‑675/18 R).

Forms of order sought and procedure before the Court of Justice

24 By their appeal, the appellants claim, in essence, that the Court should:

– set aside the order under appeal and suspend that order pursuant to Article 160(7) of the Rules of Procedure of the Court of Justice;

– reinstate the order of the President of the General Court of 20 November 2018, Trifolio-M and Others v EFSA (T‑675/18 R);

– suspend the operation of the contested decision;

– order any other interim relief deemed appropriate;

– order EFSA to pay a penalty per day of publication of the full version of the contested decision on its website after the delivery of this order;

– in the alternative, remit the case to the President of the General Court; and

– order EFSA to pay the costs.

25 EFSA contends that the Court should:

– dismiss the appeal; and

– order the appellants to pay the costs of the present appeal, those of the interim proceedings in Case T‑675/18 R and the court fees which it has incurred.

26 By separate document lodged at the Registry of the Court of Justice on 25 February 2019, the appellants applied, pursuant to Articles 278 and 279 TFEU and Article 160(7) of the Rules of Procedure of the Court, for a stay of execution and other interim relief seeking, in essence, suspension of the order under appeal and of the contested decision and the grant of other interim relief.

27 By order of 7 March 2019, Trifolio-M and Others v EFSA (C‑163/19 P(R)-R, not published, EU:C:2019:187), the Vice-President of the Court suspended the operation of the contested decision until adoption of the present order and ordered EFSA to refrain from publishing the conclusions of the review and to remove them immediately from its website.

The appeal

28 The appellants put forward five grounds of appeal in support of their appeal.

The first ground of appeal

Arguments

29 By their first ground of appeal, the appellants submit that, in paragraphs 38 to 40 of the order under appeal, the President of the General Court distorted the evidence which they submitted to the Court in their application for interim relief and that that distortion led him to err in law.

30 In particular, the appellants claim that, contrary to the finding of the President of the General Court in paragraph 40 of the order under appeal, it is abundantly clear that all the information enabling him to rule on their application for interim relief and enabling EFSA to submit a detailed defence was duly stated in that application, in particular in paragraphs 13, 26 and 42 to 44 thereof.

31 In addition, in the opinion of the appellants, the President of the General Court committed a serious error of assessment in failing to make a distinction between the public nature of the information at issue and the fact that it is widely known.

32 EFSA disputes those arguments.

Assessment

33 It should be noted that the Court of Justice has consistently held that, where the General Court has established or assessed the facts, the Court of Justice has jurisdiction, under Article 256 TFEU, solely to review the legal characterisation of those facts and the conclusions in law drawn from them. The assessment of the facts is not, therefore, other than in cases where the evidence produced before the General Court has been distorted, a question of law which is subject, as such, to review by the Court of Justice (see, inter alia, judgment of 10 November 2016, DTS Distribuidora de Televisión Digital v Commission, C‑449/14 P, EU:C:2016:848, paragraph 43).

34 In addition, according to the settled case-law of the Court of Justice, that distortion must be obvious from the documents in the Court’s file, without any need to carry out a new assessment of the facts and the evidence (judgment of 9 November 2017, TV2/Danmark v Commission, C‑649/15 P, EU:C:2017:835, paragraph 50 and the case-law cited).

35 It is not so in the present case.

36 The appellants have not shown that the President of the General Court manifestly distorted the evidence which they submitted to him.

37 In that regard, the mere allegation of distortion of the evidence by the President of the General Court and/or the fact that EFSA was able to submit detailed observations in response to the application for interim relief made by the appellants cannot suffice to establish the existence of such distortion.

38 Furthermore, such an application must be sufficiently clear and specific in itself to enable the defendant to prepare its observations and the judge hearing the application to rule on it, where necessary, without other supporting information, the essential elements of fact and law on which it is founded being set out in a coherent and comprehensible fashion in the actual text of the application for interim relief (orders of the President of the Court of 30 April 2010, Ziegler v Commission, C‑113/09 P(R), not published, EU:C:2010:242, paragraph 13, and of the Vice-President of the Court of 7 March 2013, EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraph 39).

39 In the present case, those requirements have not been satisfied, since, as the President of the General Court correctly pointed out in paragraph 40 of the order under appeal, the appellants did not, in their application for interim relief, including in paragraphs 13, 26 and 42 to 44 of that application, identify with the requisite level of clarity and precision, the essential elements of fact on which their application for confidential treatment is based.

40 As regards the assessment by the President of the General Court regarding the public nature of the information at issue or the fact that it was widely known, it is sufficient to note that, contrary to the appellants’ submissions, it is clear from paragraphs 38 and 40 of the order under appeal that the President of the General Court did not confuse those two factors.

41 Consequently, the President of the General Court, in paragraphs 38 to 40 of the order under appeal, neither distorted the evidence adduced before him nor committed any serious error of assessment.

42 In those circumstances, the first ground of appeal must be rejected.

The second ground of appeal

Arguments

43 By their second ground of appeal, the appellants submit that, in paragraphs 49 to 51 of the order under appeal, the President of the General Court misinterpreted Article 63(2)(a) of Regulation No 1107/2009.

44 In particular, they argue that, by taking the view that their situation is not covered by that provision and by failing to accept their assertion that the combined disclosure of the components concerned and the concentrations of those components in the active substance at issue was to be regarded as falling within the scope of that provision, the President of the General Court erred in law.

45 In the view of the appellants, the ground set out in paragraph 49 of the order under appeal, which states that Article 63(2)(a) of Regulation No 1107/2009 refers to disclosure of ‘the manufacturing process’ and does not refer to the disclosure of information enabling conclusions to be drawn as to the method of manufacture used, is incorrect.

46 EFSA disputes those arguments.

Assessment

47 It must be borne in mind that, according to the actual wording of Article 63(2)(a) of Regulation No 1107/2009, that provision refers to disclosure of ‘the manufacturing process’.

48 Accordingly, apart from the fact that paragraph 49 of the order under appeal is a ground included for the sake of completeness, the President of the General Court cannot be criticised for finding that that provision refers to that disclosure as such and does not refer to that of the information enabling conclusions to be drawn as to the method of manufacture used.

49 Moreover, in so far as, as is clear from paragraph 50 of the order under appeal, the appellants’ line of argument was based on the assertion that ‘the exact composition and purity of [their] active substance’ reveals the manufacturing process, without that assertion having been duly substantiated, the President of the General Court did not err in law when he rejected that argument.

50 Consequently, the interpretation made by the President of the General Court of Article 63(2)(a) of Regulation No 1107/2009 is not vitiated by an error of law.

51 It follows that the second ground of appeal must be rejected.

The third ground of appeal

Arguments

52 By their third ground of appeal, the appellants submit that, by criticising them, in paragraphs 54, 57 and 62 of the order under appeal, for not having specified, in their application for interim relief, the document containing the information at issue or produced Annex A to the conclusions of the review, when that document was available in the main action, the President of the General Court erred in law and in procedure.

53 The appellants submit that the President of the General Court ought to have examined their application for interim relief in the light of their main action or allowed them to lodge a new version of their application for interim relief, including the additional information which the President considered was necessary for the purpose of assessing the ground in question.

54 EFSA disputes those arguments.

Assessment

55 As has been pointed out in paragraph 38 of the present order, the essential elements of law and of fact on which an application for interim relief is based must be stated coherently and comprehensibly in the actual text of that application.

56 Furthermore, in view of the rapidity which, by its nature, characterises the interim relief procedure, it is reasonable to require the party seeking interim relief to submit, save in exceptional circumstances, all the evidence available in support of the application when that application is made, so that the judge hearing the application for interim relief may assess, on that basis, the merits of the application (orders of the President of the Court of 11 November 2011, Nencini v Parliament, C‑530/10 P(R), not published, EU:C:2011:729, paragraph 29; of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 56; and of the Vice-President of the Court of 6 September 2016, Inclusion Alliance for Europe v Commission, C‑378/16 P-R, not published, EU:C:2016:668, paragraph 18).

57 A request for interim relief which fails to set out the facts and evidence which should be included as essential elements of the conditions for the grant of the interim relief sought and which could be set out in that application does not meet those requirements, since the applicant was not unable to rely on them when that application was made (order of the Vice-President of the Court of 6 September 2016, Inclusion Alliance for Europe v Commission, C‑378/16 P-R, not published, EU:C:2016:668, paragraph 19).

58 With regard, inter alia, to the prima facie case, such an omission cannot be remedied by a mere reference to the application in the main proceedings without any explanation as to the factual and legal grounds which would, on the face of it, warrant the grant of the interim relief sought (see, to that effect, orders of the President of the Court of 10 June 1988, Sofrimport v Commission, 152/88 R, EU:C:1988:296, paragraph 12; of 12 October 2000, Greece v Commission, C‑278/00 R, EU:C:2000:565, paragraph 27; and of the Vice-President of the Court of 6 September 2016, Inclusion Alliance for Europe v Commission, C‑378/16 P-R, not published, EU:C:2016:668, paragraph 20).

59 Consequently, the President of the General Court cannot be criticised for finding that the appellants had not provided him with the facts enabling him to assess their plea concerning an infringement of Article 63 of Regulation No 1107/2009, on the ground that their application for interim relief did not contain the information necessary in that regard, or for having refrained from examining that request in the light of their application in the main proceedings.

60 With regard to the appellants’ argument that the President of the General Court ought to have allowed them to lodge a new and supplemented version of their application for interim relief, it must be recalled that the President of the General Court alone is the judge of the possible need to supplement the information which he has available to him in the cases before him (see, inter alia, order of 22 November 2018, Valencia Club de Fútbol v Commission, C‑315/18 P(R), EU:C:2018:951, paragraph 57).

61 It must be held that, in the present case, none of the evidence adduced by the appellants supports the conclusion that the President of the General Court exceeded the limits of his discretion.

62 If the fact that the President of the General Court attaches particular importance to the lack of evidence necessary for the examination of an application for interim relief were to suffice, as such, for the applicant to be able to insist that it be allowed to supplement its application, the President of the General Court would in practice be bound, whenever he had doubts as to the probative value or sufficiency of the evidence submitted in support of the urgency of an application for interim relief, to invite the applicant to respond to those doubts, which would be manifestly incompatible with both the nature of proceedings for interim relief and the discretion enjoyed by the judge hearing the application for such relief within such proceedings (see, to that effect, order of the President of the Court of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 61).

63 It follows from the foregoing considerations that, in paragraphs 54, 57 and 62 of the order under appeal, the President of the General Court erred neither in law nor in procedure.

64 In those circumstances, the third ground of appeal must be rejected.

The fourth ground of appeal

Arguments

65 By their fourth ground of appeal, the appellants allege that the President of the General Court erred in law, in paragraphs 75 to 78 of the order under appeal, by failing to recognise that there is ‘virtual identity’ between Article 14 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) and Article 63 of Regulation No 1107/2009 and by failing to accept the appellants’ arguments based on an analogous interpretation of those provisions.

66 EFSA disputes those arguments.

Assessment

67 The appellants’ line of argument, which is based on the premiss that the relevant provisions of Directive 91/414 are identical to those of Regulation No 1107/2009 and that they must therefore be applied uniformly, cannot be accepted.

68 Apart from the fact that such identity is not in any way established, it is not apparent from the provisions of Regulation No 1107/2009 that an application for confidential treatment made under those provisions must, as a matter of principle, be treated in the same way as an application for confidential treatment made under the provisions of Directive 91/414.

69 It follows that, in paragraphs 76 and 77 of the order under appeal, the President of the General Court did not err in law by holding that, prima facie, the appellants’ arguments could not succeed, since such a request for confidential treatment must a priori be examined individually as to its merits.

70 Consequently, the fourth ground of appeal must be rejected.

The fifth ground of appeal

Arguments

71 By their fifth ground of appeal, the appellants submit that, by interpreting Articles 38 and 39 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1) as meaning that, having regard to the derogating nature of Article 39, the disclosure of the information at issue did not go beyond the objectives pursued by EFSA, the President of the General Court erred in law in the application of the principle of proportionality.

72 In their view, a more detailed examination of those provisions and that information leads, on the contrary, to the conclusion that data for which confidential treatment has been requested and justified should not be published without a valid reason.

73 EFSA disputes those arguments.

Assessment

74 As the President of the General Court recalled in paragraph 82 of the order under appeal, according to the settled case-law of the Court of Justice, the principle of proportionality requires that acts of the EU institutions be appropriate for achieving the legitimate objectives pursued by the legislation in question and do not go beyond what is necessary in order to achieve those objectives (judgments of 16 June 2015, Gauweiler and Others, C‑62/14, EU:C:2015:400, paragraph 67; of 7 February 2018, American Express, C‑643/16, EU:C:2018:67, paragraph 84; and of 22 November 2018, Swedish Match, C‑151/17, EU:C:2018:938, paragraph 35).

75 By virtue of Article 38(1)(c) of Regulation No 178/2002, EFSA is to ensure that its activities are conducted in broad transparency and, without prejudice to Articles 39 and 41 of that regulation, is to publish the information on which its opinions are based without delay.

76 According to the wording of Article 39(1) of Regulation No 178/2002, by way of derogation from Article 38 of that regulation, EFSA is not to divulge to third parties confidential information that it receives for which confidential treatment has been requested and justified, with the exception of information which, if the circumstances so require, must be made public in order to protect public health.

77 Consequently, it follows from the wording of those provisions that, in principle, EFSA is to publish the information on which it bases its opinions and that, by way of derogation from that principle, it does not disclose to third parties confidential information that it receives where confidential treatment of that information, excluding any information that must be made public in order to protect public health, has been requested and has been justified.

78 In those circumstances, by holding, in paragraphs 83 and 84 of the order under appeal, that, in accordance with the actual wording of Article 39 of Regulation No 178/2002, confidential treatment is an exception and that it therefore appeared, prima facie, that it could not be claimed that the disclosure of the information in question goes beyond what is necessary to achieve the objectives pursued by EFSA, the President of the General Court did not err in law in the application of the principle of proportionality.

79 The fifth plea must, therefore, be rejected.

80 In the light of all of the foregoing, the appeal must be dismissed in its entirety.

Costs

81 In accordance with Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is unfounded, the Court is to make a decision as to the costs.

82 Under Article 138(1) of those rules, applicable to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs, if they have been applied for in the successful party’s pleadings.

83 Since EFSA has applied for costs against the appellants and the appellants have been unsuccessful, they should be ordered to pay the costs incurred in the present appeal proceedings and the interim proceedings in Case C‑163/19 P(R)-R.

On those grounds, the Vice-President of the Court hereby orders:

1. The appeal is dismissed.





2. Trifolio-M GmbH, Oxon Italia SpA and Mitsui AgriScience International SA/NV shall pay the costs of the present appeal and those of the interim proceedings in Case C‑163/19 P(R)-R.





Luxembourg, 23 May 2019.





A. Calot Escobar R. Silva de Lapuerta