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

1By 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

2Article 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.

(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

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

4Oxon 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.

5Mitsui 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.

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

7According 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.

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

9On 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.

10On 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.

11In 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.

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

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

14Following 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.

15On 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.

16Under 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.

17On 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.

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

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

20By 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.

21At 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.

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

23On 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

24By 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.

25EFSA 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.

26By 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.

27By 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

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

The first ground of appeal

Arguments

29By 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.

30In 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.

31In 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.

32EFSA disputes those arguments.

Assessment

33It 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).

34In 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).

35It is not so in the present case.

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

37In 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.

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).

39In 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.

40As 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.

41Consequently, 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.

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

The second ground of appeal

Arguments

43By 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.

44In 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.

45In 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.

46EFSA disputes those arguments.

Assessment

67The 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.

68Apart 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.

69It 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.

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

The fifth ground of appeal

Arguments

71By 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.

72In 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.

73EFSA disputes those arguments.

Assessment

55As 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.

56Furthermore, 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).

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, <i>Gauweiler and Others</i>, C‑62/14, EU:C:2015:400, paragraph 67; of 7 February 2018, <i>American Express</i>, C‑643/16, EU:C:2018:67, paragraph 84; and of 22 November 2018, <i>Swedish Match</i>, C‑151/17, EU:C:2018:938, paragraph 35).

75By 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.

76According 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.

77Consequently, 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.

78In 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.

79The fifth plea must, therefore, be rejected.

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

Costs

81In 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.

82Under 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.

83Since 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:

The appeal is dismissed.

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.

Registrar

*

Language of the case: English.