5 February 2019 (*)

(Application for interim measures — Plant protection products — Procedure for reviewing the approval of the active substance azadirachtin — Rejection of the request for confidential treatment — No prima facie case)

In Case T‑675/18 R,

Trifolio-M GmbH,

Oxon Italia SpA,

Mitsui AgriScience International SA,

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

applicants,

European Food Safety Authority (EFSA),

represented by D. Detken and S. Gabbi, acting as Agents, assisted by S. Raes, lawyer,

defendant,

Application pursuant to Articles 278 and 279 TFEU seeking the suspension of the operation of the decision of the Executive Director of the European Food Safety Authority on the assessment of the confidentiality claims made in relation to the conclusion on the Peer Review of the pesticide risk assessment of the active substance Azadirachtin of 11 September 2018 (EFSA/LA/DEC/19777743/2018),

makes the following

Background to the dispute, procedure and forms of order sought by the parties

The applicants, Trifolio-M (the ‘first applicant’), Oxon Italia (the ‘second applicant’) and Mitsui AgriScience International (the ‘third applicant’), seek the suspension of the decision of the Executive Director of the European Food Safety Authority (EFSA) on the assessment of the confidentiality claims made in relation to the conclusion on the Peer Review of the pesticide risk assessment of the active substance Azadirachtin (the ‘substance’) of 11 September 2018 (EFSA/LA/DEC/19777743/2018; the ‘contested decision’).

The first applicant is a company that markets biological plant protection products based on the substance throughout the EU.

The second applicant is a company based in Italy with expertise in the chemical and agrochemicals industries. It received its first authorisation for a substance-based product nationally in 2000, with subsequent authorisations gained in several further EU Member States.

The third applicant is an international manufacturer of agricultural chemicals. It distributes proprietary insecticides and fungicides for agriculture, horticulture and orcharding, and holds a number of European authorisations for substance-based products.

The substance is a compound extracted from the seed kernels of the Neem tree (Azadirachta indica (A.JUSS)), which mainly grows in India.

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

On 15 March 2018, EFSA approved its conclusion on the peer review of the pesticides risk assessment of the substance (the ‘conclusion on the pesticides peer review’).

On 16 March 2018, EFSA sent to the applicants its conclusion on the pesticides peer review together with the related peer review report and the addenda to the draft assessment report, setting a deadline for requests of confidentiality.

On 11 April 2018, the applicants made a request for confidential treatment related to the conclusion on the pesticides peer review, the peer review report and addendum 8 to the draft assessment report.

In its response of 17 April 2018, EFSA considered that the names of persons involved in vertebrates testing should be redacted whereas, for the remainder, the confidentiality claim should be rejected. It gave the applicants the opportunity to substantiate further their request.

On 4 June 2018, the applicants, through their legal counsel, submitted further arguments in support of their confidentiality claim.

On 27 June 2018, EFSA sent a draft decision and invited the applicants to comment.

Following the comments by the applicants, provided through their legal counsel on 5 July 2018, EFSA adopted on 19 July 2018 a decision by which it accepted the redaction of the names of persons involved in vertebrates testing and, for the remainder, rejected the confidentiality claim.

On 11 September 2018 and following the request of 27 July 2018 to review the decision of 5 July 2018, EFSA adopted the contested decision, upholding the former decision and rejecting the request for confidentiality.

According to Article 2 of the contested decision, it is to apply as from the day following the expiry of the time limit to bring ‘within two months’ an action before the General Court.

On 14 September 2018, EFSA published on its website a provisional sanitised version of the conclusion on the pesticides peer review with a disclaimer stating that the finalisation of the decision-making process on the confidentiality claims submitted by the applicants was pending.

On 19 November 2018, EFSA published a non-sanitised version of the conclusion on the pesticides peer review on its website.

By application lodged at the Court Registry on 19 November 2018, the applicants sought, in essence, annulment of the contested decision.

By a separate document, lodged at the Court Registry on the same date, the applicants brought an application for interim measures, pursuant to Articles 278 and 279 TFEU, in which they claim, essentially, that the President of the General Court should:

–suspend the operation of the contested decision;

–order EFSA to pay the costs.

Following the request of the applicants, the President of the General Court adopted, on 20 November 2018, without first hearing EFSA, an order on the basis of Article 157(2) of the Rules of Procedure of the General Court by which he ordered EFSA to suspend the operation of the contested decision and to refrain from any publication of the non-sanitised version of its conclusion on the pesticides peer review.

On the same day, EFSA withdrew from its website the non-sanitised version of its conclusion on the pesticides peer review.

In its observations on the application for interim measures, lodged at the Registry of the Court on 18 December 2018, EFSA contends, in essence, that the President of the Court should:

–reject the application for interim measures as being inadmissible, alternatively, as being unfounded;

–reserve the costs.

Law

It is apparent from reading Articles 278 and 279 TFEU together with Article 256(1) TFEU that the judge hearing an application for interim measures may, if he considers that the circumstances so require, order that the operation of a measure challenged before the General Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, since acts adopted by the institutions of the European Union are presumed to be lawful. It is therefore only exceptionally that the judge hearing an application for interim measures may order the suspension of operation of an act challenged before the Court or prescribe interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).

The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim measures must state ‘the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measure applied for’.

Thus, the judge hearing an application for interim relief may order suspension of operation of an act and other interim measures if it is established that such an order is justified, prima facie, in fact and in law, and that it is urgent in so far as, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, and consequently an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing an application for interim relief is also required to undertake, when necessary, a weighing of the competing interests (see order of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 21 and the case-law cited).

In the context of that overall examination, the judge hearing the application for interim measures has a wide discretion and remains free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).

In addition, according to the second sentence of Article 156(4) of the Rules of Procedure, applications for interim measures ‘shall contain all the evidence and offers of evidence available to justify the grant of interim measures’.

Thus, an application for interim measures must be sufficient in itself to enable the defendant to prepare its observations and the judge hearing the application to rule on it, as necessary, without any other supporting information, since the essential elements of fact and law on which the application is based must be found in the actual text of that application (see order of 6 September 2016, Inclusion Alliance for Europe v Commission, C‑378/16 P-R, not published, EU:C:2016:668, paragraph 17 and the case-law cited).

Lastly, although the application for interim measures can be supplemented, on specific points, by references to documents annexed thereto, those documents cannot compensate for a failure to set out the essential elements in that application. It is not the task of the judge hearing the application for interim measures to seek, in place of the party concerned, those matters contained in the annexes to the application for interim measures, in the main application or in the annexes to the latter which might support the application for interim measures. Imposing such an obligation on the judge hearing the application for interim measures would, moreover, render redundant Article 156(5) of the Rules of Procedure, which provides that the application for interim measures must be made by a separate document (see order of 20 June 2014, Wilders v Parliament and Others, T‑410/14 R, not published, EU:T:2014:564, paragraph 16 and the case-law cited).

As regards the examination of whether it is urgent to grant interim measures in order to prevent the disclosure of allegedly confidential information, it should be noted that that assessment, relating to the question whether there is a risk of serious and irreparable harm to the interests of the party seeking interim relief, overlaps to some extent with the assessment of the existence of a prima facie case linked to the confidential nature of the information, as claimed by the party seeking those measures (orders of 12 June 2018, Nexans France and Nexans v Commission, C‑65/18 P(R), EU:C:2018:426, paragraph 15, and of 23 November 2017, Nexans France and Nexans v Commission, T‑423/17 R, not published, EU:T:2017:835, paragraph 46).

Consequently, it is only when, first, the applicant for interim measures alleges that the information whose publication he wishes provisionally to prevent constitutes business secrets or is covered by professional secrecy and, second, that allegation satisfies the condition that there is a prima facie case, that the judge hearing an application for interim measures is in principle required, when examining the condition of urgency, to start from the premiss that the information constitutes business secrets or is covered by professional secrecy (order of 12 June 2018, Nexans France and Nexans v Commission, C‑65/18 P(R), EU:C:2018:426, paragraph 21).

It is therefore not sufficient, for the purposes of being granted interim measures, to have claimed that the information which is to be disclosed is confidential if such a claim does not satisfy the condition relating to a prima facie case (order of 12 June 2018, Nexans France and Nexans v Commission, C‑65/18 P(R), EU:C:2018:426, paragraph 22).

In those circumstances, it is necessary to examine first of all whether the condition relating to a prima facie case is satisfied.

Having regard to the material in the case file, the President of the General Court considers that he has all the information necessary to rule on the present application for interim measures without there being any need first to hear oral argument from the parties.

The condition relating to a prima facie case

As regards the condition relating to the existence of a prima facie case, it should be recalled that that condition is satisfied where at least one of the pleas in law put forward by the applicant for interim measures in support of the main action appears, at first sight, to be not unfounded. This is the case where one of the pleas relied on reveals the existence of major legal or factual disagreement the solution to which is not immediately obvious and therefore calls for a detailed examination that cannot be carried out by the judge hearing the application for interim measures but must be the subject of the main proceedings (see, to that effect, orders of 3 December 2014, Greece v Commission, C‑431/14 P-R, EU:C:2014:2418, paragraph 20 and the case-law cited, and of 1 March 2017, EMA v MSD Animal Health Innovation and Intervet international, C‑512/16 P(R), not published, EU:C:2017:149, paragraph 59 and the case-law cited).

As regards disputes concerning interim protection for information alleged to be confidential, the judge hearing the application for interim measures — if he is not to disregard the intrinsically ancillary and provisional nature of proceedings for interim measures — may, as a rule, conclude that there is no prima facie case only in the case where the information in question is obviously not confidential (see order of 1 March 2017, EMA v MSD Animal Health Innovation and Intervet international, C‑512/16 P(R), not published, EU:C:2017:149, paragraph 60 and the case-law cited).

In the present case, the applicants put forward, in essence, five pleas.

By their first plea, the applicants allege that EFSA made a manifest error in its assessment of the applicants’ confidentiality claim. The applicants further claim that EFSA’s argument is that ‘all components mentioned in the EFSA conclusion [on the pesticides peer review] are well known from available open literature’, though the applicants had shown in their letter to EFSA dated 27 July 2018 that this is not the case.

In that regard it must be recalled that according to the settled case-law recalled in paragraphs 28 and 29 above, it is not the task of the judge hearing the application for interim measures to seek, in place of the party concerned, the essential elements of fact and law on which the application is based in the annexes to the application for interim measures, in the main application or in the annexes to the latter which might support the application for interim measures.

The applicants fail, first, to indicate to which ‘components mentioned in the EFSA conclusion’ they refer. Second, they fail to indicate in which instance the EFSA had argued that all such components are ‘well known’. Third, the applicants do not provide in the actual text of their application for interim measures the essential elements of fact on which their claim of confidentiality of the components is based. Instead, they make a general, unspecific reference to the document ‘Annex R 15’. Fourth, in order to assess whether information can be considered as confidential it is, at first sight, decisive whether that information is available from open sources and not whether that information is ‘well known’.

For all those reasons the first plea, cannot, prima facie, succeed.

By their second plea, the applicants submit that EFSA misinterpreted 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) and failed to confer confidential treatment on the composition and concentration of the applicants’ plant extract components.

43In that respect they argue, in the first place, that some of the specific grounds for confidential treatment pursuant to paragraph 2 of Article 63 of Regulation No 1107/2009 are met. In the second place, they seem to argue that in any event the confidentiality claim is supported by paragraph 1 of Article 63 of Regulation No 1107/2009.

44Paragraphs 1 and 2 of Article 63 of Regulation No 1107/20091 read as follows:

‘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.’

45More specifically, the applicants argue, in the first place, that their claim of confidentiality is supported by Article 63(2)(a), (b), (c), and (f) of Regulation No 1107/2009.

46However, prima facie, none of these claims can succeed.

47With regards to Article 63(2)(a) of Regulation No 1107/2009, the applicants contend that the method of manufacture, within the meaning of that provision would be revealed by indicating ‘the exact composition and purity profile of the applicants’ active substance’.

48In that respect, it must be stressed that the applicants fail to demonstrate the accuracy of the starting point of their arguments. In fact, they fail to demonstrate that in one of the documents referred to in paragraph 9 above ‘the exact composition and purity profile of the applicants’ active substance’ would be disclosed.

49Furthermore, it is noteworthy to recall that Article 63(2)(a) of Regulation No 1107/2009 refers to the disclosure ‘of the method of manufacture’ as such and does not refer to the disclosure of information which may allow drawing inferences as to the method of manufacture utilised.

50Finally, the applicants do not give any explanation as to their assertion that by disclosing ‘the exact composition and purity profile of the applicants’ active substance’ the method of manufacture would be revealed.

51Such an explanation would have been all the more necessary since EFSA explained already in its decision of 19 July 2018, confirmed by the contested decision, that if a compound is chemically synthesised, the impurities may allow drawing inferences as to the manufacturing process utilised but that this does not, however, apply in the instant case, since the substance in question is a plant extract.

52Regarding the claim of an infringement of Article 63(2)(b) of Regulation No 1107/2009, it must be stressed that the applicants simply mention that provision without giving any further explanation as to their claim. In the absence of any element adduced by the applicants in the request for interim relief to support their claim of an infringement of Article 63(2)(b) of Regulation No 1107/2009, the judge hearing an application for interim measures cannot assess that claim.

53With respect to Article 63(2)(c) of Regulation No 1107/2009 the applicants submit that this provision is infringed ‘since the composition and concentration of the applicants’ plant extract components are reported in the results of the five batch analysis of the active substance that was submitted by the applicants as part of their dossier’.

54In that respect, it is noteworthy that the applicants do not indicate in which one of the documents referred to in paragraph 9 above the ‘composition and concentration of the applicants’ plant extract components are reported’.

55However, without any such information as regards the facts material to their claim it is difficult to assess this claim.

56Furthermore, according to the settled case-law recalled in paragraphs 28 and 29 above, it is not the task of the judge hearing the application for interim measures to seek, in place of the party concerned, the relevant information in the annexes to the application for interim measures, in the main application or in the annexes to the latter.

57In addition, if the applicants’ claim should be understood, as suggested by EFSA, as related to the data contained in Appendix A to the conclusion on the pesticides peer review, it must be recalled that the applicants did not provide this document as an annex to their request for interim relief.

58In any event, and for the sake of completeness, it appears to be incorrect to affirm that the ‘composition and concentration of the applicants’ plant extract components’ are reported in Appendix A, which was provided by EFSA in its observations. In fact, it follows from Appendix A that only the mean content of the active substances is reported. Furthermore, as it is highlighted in the annex to the contested decision, ‘the exact composition is not made available to the public’ and ‘the fraction of substance not biologically active (the part of material composed by non-relevant impurities), which represents a substantial amount of the active substance, remain[s] unidentified and is not disclosed.’

59With respect to the alleged infringement of Article 63(2)(f) of Regulation No 1107/2009, the applicants simply state that ‘since the composition and concentration of the applicants’ plant extract components are integral parts of the active substance, which is itself part of the plant protection product formulation, they fall in the scope of Article 63(2)(f) [of Regulation No 1107/2009] relating to “information on the complete composition of the plant protection product”.’

60However, since Article 63(2)(f) of Regulation No 1107/2009 protects against the disclosure of the ‘complete composition’ of the plant protection product, the claim of an infringement of that provision cannot be upheld as the applicants themselves do not affirm that the ‘complete composition’ of their products would be disclosed.

61In the second place, the applicants seem to rely on Article 63(1) of Regulation No 1107/2009 in so far as they argue, though in the part of their application dedicated to the condition of ‘urgency’, that the disclosure of the ‘specific components and concentration levels’ of their products would enable competitors to benefit from their know how and thus obtain an unfair advantage, depriving the applicants of the fruits of their investments in research and development.

62It must be noted that the applicants, again, do not indicate in which one of the documents referred to in paragraph 9 above the ‘specific components and concentration levels’ of their products are reported.

63However, without such information it is difficult to assess the applicants’ claim.

64If the applicants’ claim should be understood as related to the data contained in Appendix A to the conclusion on the pesticides peer review, it should be recalled that the applicants did not provide this document as an annex to their request for interim relief.

65In any event and for the sake of completeness, it is important to recall that Appendix A to the conclusion on the pesticides peer review, which was provided by EFSA in its observations, does not appear to reveal the ‘specific components and concentration levels’ of the applicants’ products. In fact, as it follows, at first sight, from Appendix A, only the mean content of the active substances are reported. As it is highlighted in the annex to the contested decision, ‘the exact composition is not made available to the public’ and ‘the fraction of substance not biologically active (the part of material composed by non-relevant impurities), which represents a substantial amount of the active substance, remain[s] unidentified and is not disclosed.’

66In the absence of any specific explanation on how competitors could utilise the reported mean concentration of the various active substances contained in the products of the applicants, the starting point of the applicants’ argument seems to be too weak to provide ‘verifiable evidence’ in the meaning of Article 63(1) of Regulation No 1107/2009 to support their claim that the disclosure of the information in question might undermine their commercial interests.

67For all those reasons the second plea, cannot, prima facie, succeed.

68By their third plea, the applicants claim a breach of the duty to state reasons.

69In support of this plea, the applicants contend that the contested decision is substantially the same as the draft decision of 27 June 2018 despite the comments provided by the applicants in the letter of 5 July 2018.

70Prima facie, the third plea cannot succeed.

71It is settled case-law that the statement of reasons must be appropriate to the measure at issue and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted that measure in such a way as to enable the persons concerned to ascertain the reasons for it and to enable the competent court to exercise its power of review. The requirements to be satisfied by the statement of reasons depend on the circumstances of each case, in particular the content of the measure in question, the nature of the reasons given and the interest which the addressees of the measure, or other parties to whom it is of direct and individual concern, may have in obtaining explanations. 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, now Article 296 TFEU, must be assessed with regard not only to its wording but also to its context and all the legal rules governing the matter in question (judgments of 1 February 2007, Sison v Council, C‑266/05 P, EU:C:2007:75, paragraph 80, and of 10 September 2008, Williams v Commission, T‑42/05, EU:T:2008:325, paragraph 94).

72Accordingly, the fact, alleged by the applicants, that the contested decision is substantially the same as the draft decision of 27 June 2018 is, in principle, devoid of any relevance to demonstrate a breach of the obligation to state reasons.

73Furthermore, it appears, at first blush, that EFSA explains, in the annexes to its decision of 19 July 2018 and to the contested decision, in length and in detail the reasons for not accepting the applicants’ claims for confidentiality, enabling the applicants to ascertain the reasons for the decisions taken and the court to exercise its power of review.

74By their fourth plea, the applicants claim a breach of the principle of uniform application of EU law.

75In that respect, the applicants argue that the information for which they claim a confidential treatment was considered to be confidential in the procedure which resulted in the inclusion of azadirachtin as active substance by Commission Implementing Directive 2011/44/EU of 13 April 2011, amending Council Directive 91/414/EEC to include azadirachtin as active substance and amending Commission Decision 2008/941/EC (OJ 2001 L 200, p. 43). It would be contrary to the principle of uniform application of EU law if now this information is no longer considered to be confidential.

76Prima facie, the fourth plea cannot succeed.

77In fact, as it was held in paragraph 74 of the order of 25 October 2018, JPMorgan Chase and Others v Commission (T‑420/18 R, not published, EU:T:2018:724), a request for confidentiality must, a priori, be assessed on its own merits. Thus, a reasoning based exclusively on analogy cannot suffice to establish a prima facie case.

78In any event, it appears that the applicants cannot validly rely on the principle of uniform application of EU law in the given circumstances. In that respect it is sufficient to recall that EFSA took the contested decision several years after the Commission had accorded confidential treatment and that the applicants do not dispute that the applicable legal framework has changed since then.

79By their fifth plea, the applicants claim a breach of the principle of proportionality.

80In that respect, they argue that there is no prevailing public interest in disclosure and that accordingly the requested confidential treatment can be granted as occurred in the procedure which resulted in the Implementing Directive 2011/44/EU.

81Prima facie, the fifth plea cannot succeed.

82According to settled case-law of the Court, the principle of proportionality requires that acts of the EU institutions should be suitable for attaining the legitimate objectives pursued by the legislation at issue and should not go beyond what is necessary to achieve those objectives (judgment of 16 June 2015, Gauweiler and Others, C‑62/14, EU:C:2015:400, paragraph 67 and the case-law cited).

83As EFSA rightly points out, the principles of openness and transparency embodied in Articles 38 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) form an essential pillar of EFSA’s activities in food safety matters and confidentiality constitutes the exception, as expressly stated in Article 39 of the same regulation.

84It appears thus, at first sight, that it cannot be asserted that the disclosure of the information in question would go beyond what is necessary to achieve the objectives pursued by EFSA.

85Since the applicants have not raised against the contested decision complaints other than the five pleas examined in paragraphs 37 to 84 above, it follows from all of the foregoing that the application for interim measures must be dismissed because there is no prima facie case, without there being any need to examine the condition relating to urgency or the balance of interests.

86Since the present order terminates the proceedings for interim measures, it is necessary to cancel the order of 20 November 2018, Trifolio-M and Others v EFSA (T‑675/18 R), adopted on the basis of Article 157(2) of the Rules of Procedure, under which EFSA had been ordered, in particular, to refrain from any publication of the non-sanitised version of its conclusion on the pesticides peer review.

87Pursuant to Article 158(5) of the Rules of Procedure and given that EFSA has published in the EFSA Journal, on 19 November 2018 and thus before the expiry of the time limit to bring an action to challenge the contested decision, the non-sanitised version of its conclusion on the pesticides peer review, it appears appropriate that each party should bear its own costs related to the proceedings for interim relief.

On those grounds,

hereby orders:

1.The application for interim measures is dismissed.

2.The order of 20 November 2018, Trifolio-M and Others v EFSA, (T‑675/18 R) is cancelled.

3.Each party shall bear its own costs.

Luxembourg, 5 February 2019

Registrar

Language of the case: English