ORDER OF THE PRESIDENT OF THE GENERAL COURT
13 February 2014 (*)
(Application for interim measures – Procedure for placing plant protection products on the market – Publication of documents relating to the inclusion of an active substance – Rejection of the request for confidential treatment of certain information – Application for suspension of operation of a measure – Admissibility – Urgency – Prima facie case – Weighing up of the interests involved)
In Case T‑578/13 R,
Luxembourg Pamol (Cyprus) Ltd, established in Nicosia (Cyprus),
Luxembourg Industries Ltd, established in Tel-Aviv (Israel),
represented by C. Mereu and K. Van Maldegem, lawyers,
applicants,
v
European Commission, represented by G. von Rintelen and P. Ondrůšek, acting as Agents,
defendant,
APPLICATION for suspension of the operation of the Commission’s decision, communicated to the applicants by letter of the European Food Safety Authority (EFSA) of 8 October 2013, rejecting their request for confidential treatment of certain information contained in the peer review report and final addendum thereto concerning the inclusion of the active substance potassium phosphonates submitted by the applicants pursuant to 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 Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Directive 91/414 as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that directive (OJ 2011 L 53, p. 51),
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Background to the dispute
1 The present order for interim measures forms part of a legal framework established by 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), 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 Directives 79/117/EEC and 91/414 (OJ 2009 L 309, p. 1) and Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Directive 91/414 as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that directive (OJ 2011 L 53, p. 51).
2 Directive 91/414 seeks to harmonise the rules for the evaluation and approval of plant protection products and their active substances in the European Union (‘EU’). It provides that a plant protection product may be marketed in a Member State only if, inter alia, after being evaluated at EU level in the light of the criteria laid down in Directive 91/414, its active substance has been included in Annex I to the directive.
3 In the present case, the first applicant, Luxembourg Pamol (Cyprus) Ltd – a subsidiary of the second applicant, Luxembourg Industries Ltd, which develops, produces and sells, inter alia, herbicides, fungicides and insecticide – submitted an application to the French Republic in August 2002 for the inclusion, pursuant to Article 6(2) of Directive 91/414, of the active substance ‘potassium phosphonates’ (‘the substance at issue’) in Annex I to that directive.
4 By decision of 2 September 2003, the Commission of the European Communities confirmed, pursuant to Article 6(3) of Directive 91/414, that the dossier submitted by the first applicant could be regarded as satisfying the data and information requirements of Annexes II and III to Directive 91/414.
5 The French Republic, as designated Rapporteur Member State, was tasked with the detailed examination of the dossier. On 1 February 2005, it submitted a draft assessment report for review by the Member States and the European Food Safety Authority (EFSA).
6 EFSA is a European agency established by 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). The principal mission of EFSA, which has legal personality, is to provide scientific advice and scientific and technical support for the EU’s legislation and policies in all fields which have a direct or indirect impact on food and feed safety. It is to provide independent information on all matters within these fields and ensure that the public receives rapid, reliable, objective and comprehensible information in the fields within its mission.
7 Following an agreement between the Commission and EFSA concerning peer review, EFSA organised such a review for the draft assessment report on the substance in question, via consultation of technical experts from a number of Member States.
8 In response to a letter of 15 February 2005, in which they were requested, on behalf of EFSA, to remove sensitive data from the draft assessment report in advance of its release to third parties, the applicants sent a version of the draft assessment report in which they had removed data which they considered to be sensitive. EFSA informed the applicants by way of reply that the requests for deletion of text would be carefully examined.
9 In 2010, EFSA informed the applicants that it intended to make the draft assessment report for the substance at issue publicly available on its website and asked them to check the files that had been prepared following the proposals made for the removal of sensitive data in 2005. By letter of 3 June 2010, the applicants sent a version of the draft assessment report in which they had removed data which they considered to be sensitive. On 4 October 2010, EFSA made the draft assessment report publicly available on its website.
10 Following the entry into force of Regulation No 188/2011, and in accordance with Article 11(6) of that regulation, EFSA, in July 2011, asked the Rapporteur Member State to request the submission by the applicants of information that had not been submitted for the preparation of the draft assessment report and that might influence the outcome of the assessment. As a consequence, the Rapporteur Member State prepared an addendum to the draft assessment report which included information that had not been previously submitted for the preparation of that report. In October 2011, EFSA circulated the addendum to the Member States and the applicants and asked the latter to submit additional information to enable the risk assessment to be finalised.
11 By e‑mail of 19 November 2012, EFSA sent to the applicants a copy of its conclusions on the risk assessment for the substance at issue so as to enable them to request the removal of confidential information prior to publication on the EFSA website. By e‑mail of 26 November 2012, the applicants informed EFSA that they would not be submitting any request for confidential treatment concerning those conclusions.
12 On 16 December 2012, EFSA submitted to the Commission its conclusions on the review of the pesticide risk assessment of the substance at issue. Those conclusions were reviewed, together with the draft assessment report, by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health.
13 On 11 January 2013, EFSA requested the applicants to indicate whether some information in the peer review report and the final addendum for the substance at issue (‘the contested documents’) should be removed. By letter of 25 February 2013, the applicants submitted a number of requests for confidential treatment. The majority of those requests were rejected by EFSA’s e‑mail of 29 March 2013, in which it claimed that information concerning the following inter alia, was not confidential: the content of the substance at issue, the method of analysis for that substance and methods of analysis for residues, scientific information on the basis of the evaluation and risk assessments performed and information that is already in the public domain.
14 In view of the disagreement with the applicants, EFSAS – which is required under Article 7(2) of Regulation No 188/2011 to publish the draft assessment report with the exception of confidential information within the meaning of Article 14 of Directive 91/414 – requested the Commission, by letter of 13 May 2013, to give a decision as to whether the applicants’ requests for confidential treatment were justified. By letter of the same date, EFSA informed the applicants that those issues of confidentiality had been referred to the Commission for consultation.
15 The Commission replied to EFSA by letter of 8 July 2013. In essence, the Commission referred to the principles on which EFSA had already relied in similar cases in the past and confirmed that those principles, as summarised in the ‘General Guidance on information that may be removed from draft assessment reports before provision to third parties’, attached to the letter of 15 February 2005 (see paragraph 8 above), reflected the common understanding of EFSA and the Commission of the provisions of Article 14 of Directive 91/414.
16 By letter of 8 October 2013, EFSA informed the applicants that the Commission had answered its question as to whether their requests for confidential treatment were justified and indicated, in response to the applicant’s request to discuss the matter at a meeting with EFSA, that, in accordance with Article 14 of Directive 91/414, that question fell within the responsibility of the Commission, with the result that such a meeting was not deemed appropriate. EFSA also indicated in that letter that it intended to proceed with the publication of the partially redacted version of the contested documents, which had been sent to the applicants on 29 March 2013 (see paragraph 13 above).
Procedure and forms of order sought by the parties
17 By application lodged at the Registry of the General Court on 6 November 2013, the applicants brought an action for annulment of the Commission’s decision rejecting their confidentiality claims, communicated by EFSA’s letter of 8 October 2013 (‘the contested decision’). In support of their action, the applicants claim that the Commission incorrectly assessed its claims, in breach of Article 14 of Directive 91/414, Article 339 TFEU, Article 7 of the Charter of Fundamental Rights of the European Union and Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’).
18 By separate document lodged at the Court Registry on the same day, the applicants brought the present application for interim relief, in which it claims, in essence, that the President of the Court should:
– suspend the operation of the contested decision with immediate effect, pursuant to Article 105(2) of the Rules of Procedure of the General Court, pending the Court’s ruling on the present application for interim relief or, in any event, the main application;
– suspend the operation of the contested decision with effect from the date of its entry into force;
– grant any other interim measures deemed appropriate and hold a hearing if necessary;
– order the Commission to pay the costs.
19 By order of 8 November 2013, the President of the General Court granted the suspension of operation requested by the applicants, in accordance with Article 105(2) of the Rules of Procedure.
20 In its observations on the application for interim relief, which were lodged at the Court Registry on 20 November 2013, the Commission contends, in essence, that the President of the Court should:
– terminate suspension of the operation of the contested decision ordered on 8 November 2013;
– dismiss the application for interim relief;
– order the applicants to pay the costs.
21 The applicants replied to the Commission’s observations by a pleading lodged on 6 December 2013. The Commission adopted a final position on that pleading in a pleading of 16 December 2013. In response to a measure of organisation of procedure, the applicants, on 28 January 2014, provided further information for the file in the present application for interim measures.
Law
22 It is apparent from a reading of Articles 278 TFEU and 279 TFEU in conjunction with Article 256(1) TFEU that the judge hearing applications for interim relief may, if he considers that the circumstances so require, order suspension of operation of a measure that is being challenged before the General Court or order any interim measures necessary, in accordance with Article 104 of the Rules of Procedure of the General Court.
23 Having regard to the material in the file, the President of the General Court considers that he has all the information needed to rule on the present application for interim measures, without it being necessary first to hear oral argument from the parties. In the circumstances of the present case, it is appropriate to examine, first of all, the issues of admissibility raised by the Commission.
Admissibility
24 According to the Commission, the application for interim relief is inadmissible for two reasons: first, it does not meet the formal requirements applying to applications for interim measures laid down in Article 104(2) and (3) of the Rules of Procedure, and, second, it is inadmissible in so far as the application in the main proceedings, to which it is attached, should be dismissed as being manifestly inadmissible.
25 As regards the first plea of inadmissibility, the Commission argues that the applicants do not specifically identify what information should be treated as confidential, the application for interim measures being extremely vague on this point. It adds that the application refers to documents annexed to the application in the main proceedings, which were not made available to the Commission in good time. As a consequence, the Commission has been denied the right properly to defend and prepare its observations on the application for interim measures effectively.
26 It should be recalled in this regard that an application for interim relief must be sufficiently clear and precise, in itself, to enable the defendant to prepare its observations and the judge hearing the application to give a ruling, if necessary, without other supporting information. Accordingly, the essential facts and points of law on which such an application must be based have to be set out in a coherent and comprehensible fashion in the actual application for interim measures, which may be supported and supplemented on specific points by references to extracts from documents annexed to the application (see, to that effect, order of the President of the Court of 29 July 2010 in Case T‑252/10 R Cross Czech v Commission, not published in the ECR, paragraph 10 and the case-law cited, and order of the President of the Court of Justice of 30 April 2010 in Case C‑113/90 P(R) Ziegler v Commission, not published in the ECR, paragraph 13).
27 With regard to the present application for interim measures, it is apparent that it sets out, over 28 pages, the legal and factual background, a prima facie case, urgency and the weighing up of the different interests involved. As regards the documents at issue, the applicants state, at paragraph 16 of the application for interim measures, that they have requested confidential treatment in respect of the following categories of data: (i) protected know-how relating to scientific expertise deployed in compiling the dossier on the substance at issue; (ii) information on the method of manufacture; (iii) information on the substance at issue, including the specification of impurities, starting materials and product, as well as methods of analysis for impurities in the substance as manufactured; (iv) names and details of the authors of vertebrate animal studies; (v) information on the results of the 5-batch analysis; and (vi) personal data.
28 In order to expand upon those claims for confidentiality by category, the applicants refer to the application in the main proceedings annexed to their application for interim measures. Moreover, they mention voluminous contested documents, including a version of these partially redacted by EFSA (see paragraph 16 above) attached as Annex A1 to the application in the main proceedings. The applicants also refer to their claims for confidentiality identifying the contested document which were submitted by letter of 25 February 2013 (see paragraph 13 above), attached as Annex A3 to the application in the main proceedings, and to a list setting out a large body of specific supporting evidence, also forming part of that annex.
29 Accordingly, it cannot be claimed that the applicants have failed to set out, in their application for interim measures, the specific information in respect of which they seek confidential treatment. Indeed, they were required to heed the Practice Directions to parties before the General Court (OJ 2012 L 68, p. 23), which sets the maximum number of pages for applications for interim measures at 25, leaving the applicants with no option other than to summarise in the application their confidentiality claims by category and to refer to the annexes in respect of the considerable volume of specific data claimed to be confidential.
30 The judge hearing the application for interim measures can therefore only conclude, in the light of the particular circumstances of the case, that the indication of the subject-matter of the proceedings, the summary of the pleas in law relied on to justify the suspension of operation sought, including the summary of the six categories of data claimed to be confidential, are sufficient for the body of the application for interim relief to satisfy the criteria set out in Articles 104(3) and 44(1)(c) of the Rules of Procedure. The Commission’s doubts as to whether the application is sufficiently precise will be examined when the substance of the application is considered.
31 Inasmuch as the applicants refer to documents annexed not to the application for interim measures but only to the application in the main proceedings, to which the interim application is attached, the President considers that it would be formalistic to refuse to take account of those documents for the specific purposes of the present interim proceedings. Indeed, it should be noted that the applicants sent those documents by fax, which may explain why, in view of their extraordinary volume (over 900 pages), they were lodged only once, annexed to the application in the main proceedings. Moreover, the President has easy, rapid access to the documents in question. Lastly, the procedural position is that the parties, agents and lawyers are the same and the action in the main proceedings and the application for interim measures were lodged on the same day (see, to that effect and by analogy, Case T‑37/91 ICI v Commission [1995] ECR II‑1901, paragraph 47, and Case T‑351/03 Schneider Electric v Commission [2007] ECR II‑2237, paragraph 95 and 96). In any event, Annexes A1 and A3, at issue, were subsequently also added to the case-file in the proceedings for interim measures, at the request of the President, in order to complete that file.
32 It is true that the Commission was not in a position to express a view on the documents annexed to the application in the main proceedings when it prepared its observations of 20 November 2013, because that application had not yet been served on it at that time. However, it must be noted that, after a defect in the application had been cured, it was received, together with the annexes thereto, by the Commission on 6 December 2013. Consequently, the Commission was in a position to take those documents into account for the purpose of its pleading of 16 December 2013; in any event, the Commission did not request the Court to grant an extension of the period for lodging that pleading. It is therefore apparent that the taking into account, by the judge hearing the application for interim measures, of the documents annexed to the application in the main proceedings to which the applicants have referred in the application for interim measures is not liable to undermine the principle of audi alteram partem or to have an adverse effect on the expeditiousness required in interim proceedings, with the result that it would be formalistic to refuse to take account of those documents. It is in the context of the examination of the condition requiring urgency that it will be necessary to determine whether the reference to those documents may provide appropriate support for and supplement the application for interim measures on those specific points.
33 It follows that the first plea alleging inadmissibility cannot be accepted.
34 In support of the second plea alleging inadmissibility, the Commission argues that the action brought against it in the main proceedings for annulment of EFSA’s letter of 8 October 2013 is manifestly inadmissible. That letter, it submits, cannot be imputed to the Commission and is an act of EFSA, whose administrative acts producing legal effects vis-à-vis third parties may be challenged by an action for annulment. Under Article 7(2) of Regulation No 188/2011, the task falls to EFSA to make the draft assessment report available to the public, excluding any information in respect of which confidential treatment has been requested and justified by the applicant in accordance with Article 14 of Directive 91/414. Since the latter provision provides a role for the Commission, EFSA sought its view on the applicants’ requests for confidential treatment. As the Commission did not accept the justification provided in support of those requests, EFSA adopted the letter of 8 October 2013 on that basis.
35 In that regard, it is settled case-law that the admissibility of the action in the main proceedings must not, in principle, be examined in the proceedings for interim measures. However, where a plea alleging that the action in the main proceedings is manifestly inadmissible is raised, the party seeking interim measures must provide evidence on the basis of which it may be concluded, prima facie, that that action, to which the application for interim measure is an adjunct, is admissible, so that that party will not be able, by means of the interim proceedings, to obtain suspension of operation of a measure which the Court will subsequently decline to annul, its action being dismissed as inadmissible after examination of the substance of the claim in the main proceedings. Such an examination of the admissibility of the action in the main proceedings by the judge hearing applications for interim measures is necessarily summary, in view of the urgent nature of interim proceedings (see the order of the President of the Court of 29 August 2013 in Case T‑5/13 R Iran Liquefied Natural Gas v Council, not published in the ECR, paragraph 26 and the case-law cited).
36 Accordingly, in interim proceedings, the admissibility of the main action may be assessed only on a prima facie basis and the judge hearing the application for interim measures should declare that action inadmissible only if the admissibility of the corresponding main action can be wholly excluded. Otherwise, to rule, at the stage of the proceedings for interim relief, on the admissibility of the main action, when its admissibility is not, prima facie, wholly excluded, would be tantamount to prejudging the Court’s decision in the main proceedings (order in Iran Liquefied Natural Gas v Council, paragraph 27 and the case-law cited).
37 In the present case, it should be recalled, first, that EFSA had asked the Commission, by letter of 13 May 2013, to consider whether the applicants’ requests for confidential treatment were justified, while at the same time informing the applicants, by letter of the same date, that the issues of confidentiality had been referred to the Commission for consultation, and, second, that the Commission’s letter of reply to EFSA of 8 July 2013 referred to principles of confidentiality reflecting the common understanding of EFSA and the Commission of the provisions of Article 14 of Directive 91/414 (see paragraphs 14 and 15 above). Next, in its letter of 8 October 2013, EFSA informed the applicants of the Commission’s response to their requests for confidential treatment, stating that the question whether those requests were confidential came, in accordance with Article 14 of Directive 91/414, within the responsibility of the Commission (see paragraph 16 above).
38 In the light of those forms of words chosen by EFSA, it would not appear to be manifestly incorrect to interpret its letter of 8 October 2013 as meaning that, while it was its decision to proceed with the substantive publication of the documents in question on its website, it nevertheless considered itself bound by the Commission’s rejection of the applicants’ requests for the omission of information which they classified as confidential. Moreover, such an interpretation does not appear to be at odds with the provisions applicable.
39 While Article 7(2) of Regulation No 188/2011 authorises EFSA to publish the contested documents, that provision precludes publication of any information in respect of which confidential treatment has been requested and justified by the applicant ‘in accordance with Article 14 of Directive 91/414’. With regard to an application for inclusion of an active substance in Annex I to that directive, the first subparagraph of Article 14 of Directive 91/414 provides that the Commission is required to ensure that secret information provided by the applicant is treated as confidential if the applicant so requests and if ‘the Commission accepts that the applicant’s request is warranted’.
40 It would therefore appear that Article 14 of Directive 91/414 – a higher ranking legal provision than Regulation No 188/2011, which simply lays down detailed rules for the implementation of that directive – empowers the Commission, not EFSA, in so far as concerns the inclusion of an active substance in Annex I to that directive, to give a final decision on the protection of information purported to be confidential. It does not appear, prima facie, that it can be clearly ruled out that, when publishing such information, EFSA must respect the Commission’s decision on the request for confidential treatment submitted by the economic operator concerned.
41 That conclusion is not invalidated by the Commission’s argument that the only reason why EFSA’s role was not acknowledged by Directive 91/414 is that EFSA had not yet been established when that directive was adopted. If the legislature had shared the Commission’s view, there would have been nothing to prevent it from amending Article 14 of Directive 91/414 by entrusting EFSA with a more important role alongside the Commission or instead of it. While it is true that, in the meantime, EFSA has been entrusted with such a role under Articles 12 and 63 of Regulation No 1107/2009, that regulation appears to be irrelevant for the purposes of the present case, since Article 80(1)(a) of Regulation No 1107/2009 provides that Directive 91/414 is to continue to apply with respect to the procedure and the conditions for authorisation of the substance at issue. Although it had the opportunity to do so, the legislature has not amended the applicable procedure.
42 In the light of the foregoing, it must be held that, prima facie, there are no grounds for concluding that the main proceedings are inadmissible, in so far as they seek the annulment of the contested decision. It follows that the second plea alleging inadmissibility must also be rejected.
43 It is therefore necessary to proceed with the examination of the substance of the application for interim measures.
Substance
44 Article 104(2) of the Rules of Procedure of the General Court provides that applications for interim relief 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, suspension of the operation of an act and other interim measures may be ordered by the judge hearing the application 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 on the main action. Those conditions are cumulative, with the result that applications for interim measures must be dismissed if any one of those conditions is not satisfied (order of the President of the Court of Justice in Case C‑268/96 P(R) SCK and FNK v Commission [1996] ECR I‑4971, paragraph 30).
45 In the context of that overall examination, the judge hearing the application for interim measures enjoys a broad discretion and is 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 preestablished scheme of analysis within which the need to order interim measures must be assessed (orders of the President of the Court of Justice in Case C‑149/95 P(R) Commission v Atlantic Container Line and Others [1995] ECR I‑2165, paragraph 23, and the order of 3 April 2007 in Case C‑459/06 P(R) Vischim v Commission, not published in the ECR, paragraph 25). Where appropriate, the judge hearing the application must also weigh up the interests involved (order of the President of the Court of Justice in Case C‑445/00 R Austria v Council [2001] ECR I‑1461, paragraph 73).
46 In the circumstances of the present case, it is appropriate to examine first of all whether the condition requiring there to be a prima facie case is satisfied.
Whether there is a prima facie case
47 According to established case-law, the condition relating to the establishment of a prima facie case 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, prima facie, not unfounded. That is the case, inter alia, where one of the pleas relied on reveals the existence of difficult legal issues 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, or where the discussion of issues by the parties reveals that there is a major legal disagreement whose resolution is not immediately obvious (see, to that effect, the order of the Vice-President of the Court of Justice in Case C‑278/13 P(R) Commission v Pilkington Group [2013] ECR, paragraph 67 and the case-law cited).
48 In the present case, the applicants contend that the contested decision is unlawful on the basis, inter alia, that the Commission misapplied Article 14 of Directive 91/414, which protects the confidentiality of business secrets covered by professional secrecy, which is a fundamental right enshrined in Article 339 TFEU, Article 7 of the Charter of Fundamental Rights and Article 8 of the ECHR. By the contested decision, they argue, the Commission rigidly implemented its policy on transparency and confidentiality under Directive 91/414, without having regard to the specific circumstances of the present case.
49 The applicants point out that Article 14 of Directive 91/414 does not define industrial and commercial secrets but lists what is not confidential, including the names and content of active substances and the name of the plant protection product, physico-chemical data concerning the active substance and plant protection product, a summary of the results of the tests to establish the product’s efficacy and harmlessness to humans, animals, plants and the environment, and methods of analysis.
50 According to the applicants, it is the ‘General Guidance on information that may be removed from draft assessment reports before provision to third parties’ (see paragraph 15 above) which lists the following as confidential data or information of commercial interest: (i) the identity and content of impurities in technical material, including the nature and content of inactive isomers; (ii) the corresponding analytical methods; (iii) batch analysis reports; and (iv) company know-how, including product registration strategies, pursuant to Article 4(2) of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43). Also to be taken into account is the ‘successor’ to Article 14 of Directive 91/414, namely Article 63 of Regulation No 1107/2009, which codified the administrative practice summarised in the ‘Guidelines’ referred to above and thus reflected a common understanding that certain data on the content of the active substance, in particular as regards impurities, and physic-chemical data concerning the active substance constitute industrial or commercial secrets which attract confidential treatment. Such information covered by professional secrecy should be given protection by the EU Courts.
51 With regard to the requests for confidential treatment submitted in the present case, the applicants point out that EFSA rejected the majority of them, in particular all the claims relating to their company know-how or registration strategy, on the ground that the content of the substance at issue and the method of analysis for that substance are not confidential (see paragraph 13 above), thereby ignoring the finer distinctions necessary for the protection of data on certain impurities and the corresponding analytical methods. Moreover, EFSA claimed that methods of analysis for residues, scientific information for the basis of the evaluation and risk assessments performed are not confidential. Thus, scientific information forming the basis of the evaluation and risk assessments are the endpoints of studies.
52 In so far as EFSA refused to protect information that is already in the public domain, the applicants point out that they are not in any way seeking to keep public information, as such, confidential. They simply want to keep confidential [confidential]. This relates to the applicants’ protected know-how, which the abovementioned ‘Guidelines’ themselves treat as confidential.
53 The applicants state that that know-how, deployed in devising and executing a business plan, is a business secret, disclosure of which would give their competitors access to methods and expertise relating to the registration of the substance at issue. The information in respect of which they are seeking confidentiality reveals, [confidential]. Since EFSA intends to publish studies which were deemed unacceptable and were therefore to be repeated by the applicants the latter object to the publication of those studies, which have not been published or used for the evaluation of the product. By giving the applicants’ competitors instant and free access to those studies and to the approaches that were not accepted by EFSA, such disclosure will enable them to save time and resources.
54 The Commission claims that the applicants’ arguments are vague and general. It is of the view that the applicants should have explained, in the application for interim measures, how EFSA’s refusal to treat certain information as confidential could specifically and effectively undermine the interest protected by Article 4 of Regulation No 1049/2001. Instead of doing so, the applicants contend that they do not understand on what grounds studies which were not used for the evaluation of the product should be disclosed. In the Commission’s view, that is not the appropriate test for the purpose of answering the question whether the disclosure of information undermines commercial interests. When the applicants state that they are not seeking to keep public information confidential, but to keep confidential [confidential], they fail to identify the specific information at which their request for confidential treatment is directed.
55 The Commission adds that the dossier submitted for inclusion of the substance at issue is characterised by the fact that the applicants [confidential]. [confidential].
56 With regard to [confidential], the applicants submit that information made available to the public concerning the risk assessment of the substance at issue does not, in itself, shed light on how the data in question was used. The fact that [confidential] does not disclose the scientific arguments put forward by the applicants to justify the use and adequacy to meet data requirements for the registration dossier on the substance at issue.
57 It should be noted, as regards the contested documents, that the applicants state at paragraphs 16 and 32 of their application for interim measures that they claimed confidentiality, pursuant to Article 14 of Directive 91/414, in respect of the following categories:
– their protected know-how relating to scientific expertise deployed in compiling the dossier on the substance at issue – in other words, the registration strategy for that substance, disclosure of which would undermine their commercial interests;
– information on the method of manufacture;
– information on the substance at issue, including the specification of its impurities, starting material and product, as well as methods of analysis for impurities in the substance as manufactured;
– the names and details of authors of vertebrate animal studies;
– information on the results of the 5-year batch analysis;
– personal data.
58 Those requests for confidential treatment by category refer to the contested documents annexed to the application in the main proceedings as Annex A1, which comprises approximately 900 pages. Those requests were given concrete expression by the request for confidential treatment identifying those documents submitted by the applicants on 25 February 2013 (see paragraph 13 above), which was annexed as Annex A3 to the application in the main proceedings, along with a list of approximately 300 specific items of supporting documentary evidence covering 40 pages, also included in Annex A3.
59 That list of supporting documentary evidence consists of a table identifying – in the contested documents – the items, pages and sections referred to, along with the reasons why the information in question should be treated as confidential. By way of example, the ‘comments on the assessment report’ at pages 3 and 5 (1/7 and 3/7) sets out the observations of the Kingdom of the Netherlands on the draft assessment report and section B1-B5 in column 2 of the table contain information on the active substance which is deemed to be confidential under Article 63(2)(b) of Regulation No 1107/2009.
60 On reading those procedural documents, it is apparent that the requests for confidential treatment at issue in the main proceedings, with the exception of those relating to the names and details of authors of studies and personal data, relate to physico-chemical, biological and pharmaceutical data. Accordingly, those requests – and the contrary argument advocated by the Commission – raise complex scientific and technical issues. That is particularly the case with regard to whether [confidential] may be classified as confidential, in so far as such a strategy, consisting in [confidential], may be regarded as a scientific invention used for the purpose of the registration dossier on the substance at issue.
61 The question whether the Commission erred in rejecting the majority of the requests for confidential treatment of a scientific nature thus calls for a thorough, in-depth examination which it will be necessary to carry out in the main proceedings, especially as that examination will relate to a considerable volume of information that is claimed to be confidential (see paragraph 58 above) and the legal issue raised by the claim of confidentiality in respect of certain information in the dossier submitted for the assessment of an active substance that is required in order to obtain authorisation to place a plant protection product manufactured on the basis of that substance on the market has not yet been deliberated by the EU Courts and therefore raises unexplored issues.
62 The question whether the names and details of authors of studies and personal data are confidential cannot be examined in isolation to any useful purpose by the judge hearing the application for interim measures and should be answered on the basis of the Court’s assessment, in the main proceedings, of the substantive data capable of constituting economic and scientific secrets. It appears that only the names, details and personal data pertaining to such secrets merit protection.
63 Lastly, with regard to the relevant legal rules for the examination to be carried out by the court hearing the substantive application, it is not possible, prima facie, to reject as manifestly incorrect the applicants’ argument that, first, the ‘General Guidance on information that may be removed from draft assessment reports before provision to third parties’ reflects the common understanding of EFSA and the Commission of Article 14 of Directive 91/414 and, second, Article 63 of Regulation No 1107/2009 should be taken into account for the purpose of interpreting Article 14 of Directive 91/414, in so far as, even though Regulation No 1107/2009 is not applicable to the present case, Article 63 codified administrative practice. It does not appear, prima facie, that the application of those provisions would clearly have the consequence of dismissing the applicants’ main action.
64 In the light of the foregoing considerations, it must be concluded, without prejudice to the merits of the arguments put forward by the Commission, which will be considered by the Court when it adjudicates upon the substance, that the present case raises complex untested questions which cannot, prima facie, be considered to be manifestly of no relevance, while their resolution calls for thorough examination within the main proceedings.
65 Accordingly, it must be held that there is a prima facie case.
The weighing up of the interests
66 It is settled case-law that the weighing up of the various interests involved requires the judge hearing the application for interim measures to determine whether or not an applicant’s interest in obtaining interim measures sought outweighs the interest in immediate application of the contested measure by examining, more specifically, whether annulment of that measure by the Court when ruling on the main application would allow the situation which would have been brought about by its immediate operation to be reversed, and, conversely, whether suspension of its operation would prevent it from being fully effective in the event of the main application being dismissed (see order of the President of the Court of 11 March 2013 in Case T‑462/12 R Pilkington Group v Commission [2013] ECR, paragraph 28 and the case-law cited).
67 As regards the condition that the legal situation created by an interim relief order must be reversible, it must be recalled that the purpose of the procedure for interim relief is merely to guarantee the full effectiveness of the future decision on the main action. Consequently, such a procedure is merely ancillary to the main action, to which it is an adjunct, and accordingly the decision made by the judge hearing an application for interim measures is by its nature interim in the sense that it must not either prejudge the future decision on the substance of the case or render it illusory by depriving it of effectiveness (see Pilkington Group v Commission, paragraph 29 and the case-law cited).
68 It necessarily follows that the interest defended by a party to interim relief proceedings does not merit protection where that party’s request is that the judge hearing the application should adopt a decision which, far from being a merely interim measure, serves to prejudge the future decision on the main action and to render it illusory by depriving it of its effectiveness. Moreover, for that very reason an application for interim measures in which the judge hearing the application was asked to order the disclosure of allegedly confidential information held by the Commission was declared to be inadmissible inasmuch as an order acceding to such an application might have nullified in advance the effects of the decision to be delivered subsequently on the main action (see Pilkington Group v Commission, paragraph 30 and the case-law cited).
69 In the present case, the Court will be called upon to rule, in the main proceedings, on whether the contested decision – by which the Commission rejected the applicants’ requests for confidential treatment, thereby permitting publication on EFSA’s website of purportedly confidential information contained in the documents at issue – must be annulled, on the grounds, inter alia, of disregard for the confidential nature of that information in so far as its publication would constitute infringement of Article 14 of Directive 91/414, Article 339 TFEU, Article 7 of the Charter of Fundamental Rights and Article 8 of the ECHR. In that regard, it is obvious that, in order to protect the effectiveness of a judgment annulling the contested decision, the applicants must be able to ensure that the Commission will not allow the unlawful publication by EFSA of that information. A judgment ordering annulment would be rendered illusory and would be deprived of effectiveness if this application for interim measures were to be dismissed, since the consequence of that dismissal would be that EFSA would be free immediately to publish the information at issue and therefore de facto to prejudge the future decision in the main action, namely that the action for annulment would be dismissed.
70 It follows that the interest defended by the applicants must prevail over the Commission’s interest in the dismissal of the application for interim measures, a fortiori where the grant of the interim measures requested amounts to no more than maintaining, for a limited period, the status quo which has existed for a number of years, bearing in mind that the Commission, far from claiming that publication of the documents at issue in full is necessary to meet an overriding need to protect public health or the specific interests of given economic operators, has merely referred to the general principle of transparency, the right of access by the public to the documents of the institutions and EFSA’s mandate of ensuring that the public and interested parties receive information swiftly in the fields within its competence.
Urgency
71 It should be noted, first, that it has been held that there is a prima facie case here. It follows that the lodging of both the main action and the application for interim measures cannot be construed as a delaying tactic on the part of the applicants, intended to abuse their right to the protection of confidential information and to delay the publication of the documents at issue for no legitimate reason. Moreover, after the various interests involved had been weighed up, it became apparent that the interest defended by the applicants must prevail over the Commission’s interest.
72 The President of the Court is of the view that the considerations set out above must have a bearing on the assessment of urgency (see, to that effect, Austria v Council, paragraph 110).
73 In order to demonstrate urgency, the applicants submit that the products based on the substance at issue currently occupy [confidential] in their product range. Luxembourg Industries has been selling the products in [confidential] during the past decade, as well as to customers in [confidential] under different brand names since 2010 and 2013, respectively. As the only fungicide, as opposed to fertiliser, based on the substance at issue in the EU, the applicants anticipate that the products based on the substance at issue will become the strongest pillar of the company, whose commercial success will determine the applicants’ future.
74 The applicants claim that disclosure of the business secrets contained in the documents at issue would give rise to immediate and irreversible damage by granting their competitors, especially those in the fertiliser industry, instant, irreversible and free access to their registration strategy for the substance at issue, which those competitors would be able to replicate at no cost, as well as to studies and approaches that were not accepted by EFSA, which they would be able to avoid, thus saving time and resources. As regards the issue of fertilisers, the applicants state that because of the multiple names (phosphonates, phosphites) under which the substance at issue is known and the common confusion with the fertiliser phosphate, which is also based on the element phosphorous, producers and distributors of the substance at issue are currently able to market fungicides as fertilisers and circumvent the stringent and costly regulatory requirements for fungicides, whilst exploiting the commercial advantage associated with claims relating to pesticides. As the Member States are about to bring such circumvention to an end, the applicants’ competitors will need to register their products as plant protection products as soon as possible, in order to be able to continue to market their products within the EU. In that process, access to the applicants’ registration strategy would give them a significant competitive advantage by revealing the roadmap to rapid, cost-effective dossier preparation, which competitors will be able to replicate at virtually no cost.
75 Referring to certificates produced by their auditors, which are annexed to the application for interim measures, the applicants state that the turnover derived from products based on the substance at issue for 2013 was [confidential], which represents approximately [confidential] of their global group turnover. They add that, by analogy with the success of the substance at issue in markets abroad, they anticipate growth in sales figures based on commitments from customers in the EU to buy such products, and a net value [confidential]. Publication of confidential information will, therefore, trigger irreversible changes in the market for the substance at issue and products based on that substance by enabling competitors to secure rapid, cost-effective authorisation for their own products. Accordingly, the immediate implementation of the contested decision would not only reduce the applicants’ turnover but also frustrate their business plans.
76 The applicants claim that, on the basis of their experience and common marketing knowledge, disclosure of confidential know-how, giving access to the results of intensive research and development efforts and thus enabling their numerous competitors to reduce their selling price (which need not incorporate those costs), could have the effect of reducing the applicants’ market volume of products based on the substance at issue by [confidential], following registration of competing products as pesticides. Foreseeable harm of such magnitude is clearly serious.
77 According to the applicants, publication of the documents at issue would make commercially valuable data freely available to their competitors, who would be able to secure the registration of their products as pesticides in a rapid and cost-effective manner by using the applicants’ know-how in the form of the registration strategy for the substance at issue. Consequently, the competitors would enjoy an unfair competitive advantage over the applicants in the market for the substance at issue. In the event that the action in the main proceedings were successful, the applicants would be unable to recoup both their losses and their investments, including research and development costs in the sum of [confidential] in addition to [confidential] invested in the construction of a new production plant. The contested decision would therefore have a serious and irremediable effect on the applicants’ turnover and market share, as well as on market conditions relating to the substance at issue.
78 Lastly, the applicants submit that, if the harm alleged were to occur, they may be unable to identify or quantify it with sufficient precision, with the result that it will be impossible to make good the harm by bringing an action for damages. It would be impossible to identify the number and status of all the persons who would acquire knowledge of the information published and to assess the actual impact which publication of that information might have on the applicants’ commercial and financial interests.
79 By way of reply, the Commission states that, instead of explaining in the application for interim measures how EFSA’s refusal to treat certain information as confidential could specifically and effectively undermine their commercial interests, the applicants simply put forward extremely vague and general arguments. Moreover, the damage alleged, which is based on the occurrence of future and uncertain events, is entirely hypothetical and cannot, therefore, justify the grant of the interim measures sought. In any event, the applicants have failed to show that, without such measures, they would be in a position that could imperil their existence or that, by reason of obstacles of a structural or legal nature, it would be impossible for them to regain, in particular by appropriate publicity measures, a significant proportion of the market share which they claim they might lose.
80 It should be noted in this regard that it has been consistently held that urgency must be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable harm to the party seeking the interim relief. It does not have to be established with absolute certainty that the damage is imminent. It is sufficient to show that damage is foreseeable with a sufficient degree of probability. However, the party invoking damage is nevertheless required to prove the facts forming the basis of its claim that serious and irreparable damage is likely (see, to that effect, Commission v Pilkington Group, paragraphs 36 and 37).
81 Where an undertaking seeks interim measures in order to prevent the publication of information which that party claims is covered by the obligation of professional secrecy, the extent to which disclosure of such information will cause serious and irreparable harm depends on a combination of factors, such as, inter alia, how significant the information is in commercial and professional terms for the undertaking providing the information and its usefulness for other market participants which are liable to examine and use it subsequently (see, to that effect, Commission v Pilkington Group, paragraph 42, and the order of the VicePresident of the Court of Justice of 28 November 2013 in Case C‑389/13 P(R) EMA v Abbvie, not published in the ECR, paragraph 42).
82 In the present case, since the harm alleged would arise as a result of the publication of information claimed to be confidential, it should be noted that, for the purpose of assessing the existence of serious and irreparable harm, the President is required to start from the premiss that the information alleged to be confidential is in fact confidential, as claimed by the applicants in their action in the main proceedings and in their application for interim relief (see, to that effect, Commission v Pilkington Group, paragraph 38).
83 Moreover, as the applicants have themselves acknowledged, the harm alleged is of an economic and financial nature in that it is claimed that it will adversely affect their production and marketing activities. With regard to the seriousness of such harm, it has been held that financial harm which is objectively significant may be considered to be ‘serious’ without it being necessary to measure it systematically against the turnover of the undertaking which fears that it may suffer that harm (see, to that effect, order of the Vice-President of the Court of Justice in Case C‑551/12 P(R) EDF v Commission [2013] ECR, paragraphs 32 and 33).
84 In the present case, the harm alleged by the applicants resides in the fact that, if the information claimed to be confidential were to be published on the EFSA website, any subsequent annulment of the contested decision, on grounds of infringement of Article 339 TFEU and the fundamental right to the protection of professional secrecy, would not reverse the effects of publication of that information. All of the applicants’ competitors, in particular those active in the fertiliser market, would have immediate access to the information in question and be able to exploit it freely, whereas the applicants would be denied effective judicial protection if the information at issue were to be disclosed before the resolution of the main action.
85 It must held that the harm thus alleged by the applicants is sufficiently serious. If, as a starting point, it is assumed that the information in question – contained in a dossier submitted for the assessment of an active substance that is necessary for the purpose of obtaining authorisation to place a plant protection product manufactured on the basis of that substance on the market – was covered by professional secrecy, publication of that information would necessarily cause the applicants significant harm, since it is specific commercial information relating to matters such as (i) information reflecting the applicants’ scientific know-how, obtained as a result of heavy investment in research and development and deployed to develop their strategy for the registration of the substance at issue, (ii) information on the method of manufacturing that substance, the specification of impurities, starting materials and product, as well as methods of analysis for impurities in the substance as manufactured, (iii) information on the results of a number of analyses, (iv) the names and details of authors of animal studies, and (v) personal data relating to the scientific information set out above (see, to that effect, Commission v Pilkington Group, paragraph 47). Moreover, the applicants have demonstrated that they had invested a great deal in developing the substance at issue and the products based on that substance form a significant part of their product range.
86 In any event, it should be recalled that, first, it has been established that there is a prima facie case here, as the requests for confidential treatment submitted by the applicants raise complex technical and scientific questions calling for an in-depth examination, which will need to be carried out in the main proceedings (see paragraphs 60 to 62 above). Second, it has been noted that it must be assumed, for the purposes of the interim relief proceedings, that all the information to which those requests relate is confidential.
87 Information of an economic nature may be regarded as confidential only where its disclosure is liable seriously to prejudice the commercial and financial interests of the person who is the proprietor of the information, that is to say, cause serious harm to that person’s interests (see, to that effect, Case T‑198/03 Bank Austria Creditanstalt v Commission [2006] ECR II‑1429, paragraph 71, and Case T‑474/04 Pergan Hilfsstoffe für industrielle Prozesse v Commission [2007] ECR II‑4225, paragraph 65). Accordingly, the assessment of whether publication of the information at issue – complex and presumed to be confidential – would cause the applicants ‘simple’ or ‘serious’ harm is not a matter that may be considered separately from an in-depth examination to be carried out by the Court when ruling on the main application. In view of his ancillary role vis-à-vis that of the Court adjudicating on the substance, the judge hearing the application for interim measure is therefore required to assume, for the purposes of the present proceedings, not only that the information at issue is confidential but also that the harm which may be caused to the applicants as a result of such publication is serious.
88 As a consequence, there is no need to examine the various figures provided by the applicants to demonstrate the serious of the harm alleged (see paragraph 83 above), figures which the Commission considers to be inadequate for the purpose of establishing that the applicants would suffer serious harm or would find themselves in a position that could imperil their existence if the interim measures were not granted.
89 With regard to the claim that the harm alleged is irreparable, it is clear that annulment by the Court of the contested decision could not reverse the effects of the publication on EMSA’s website of a version of the documents at issue containing information claimed to be confidential, since knowledge of such information obtained by persons consulting the site cannot be withdrawn.
90 Moreover, it is firmly established case-law that such harm of a financial nature is considered to be irreparable if it cannot be quantified, that is to say, where it is already clear, when the assessment is carried out by the judge hearing the application for interim measures, that, in view of its nature and the manner in which it will foreseeably occur, the harm alleged, should it occur, may not be adequately identified or quantified and that, in practice, it will not therefore be possible to make good such harm by bringing an action for damages under Articles 268 TFEU and 340 TFEU (see, to that effect, EDF v Commission, paragraph 60, and Commission v Pilkington Group, paragraphs 52 and 54).
91 With regard to the publication on the internet of the data at issue in the present case, namely specific scientific and commercial information concerning, inter alia, the registration strategy and method of manufacture of the substance at issue, the methods of analysis for impurities in that substance and the results of a number of analyses relating thereto, it is clear that that information would be particularly useful to the applicants’ competitors within the EU and that the number of its competitors could not be confined to undertakings established within the EU that are currently in competition with the applicants. Indeed, EFSA’s website may be accessed the world over, with the result that undertakings established in nonmember countries may, depending on how useful the information at issue may be for them, be prompted to compete with the applicants within the EU by taking advantage of that information.
92 It should be added that EFSA’s website can be accessed by an unlimited number of persons. Consequently, it is obviously impossible to identify the number and status of persons – be they competitors, suppliers or customers of the applicants, or members of the general public – who could acquire knowledge of the information at issue that has entered the public domain and exploit it in a way that is detrimental to the applicants. If that information were published in the internet, the applicants’ general position would be one of vulnerability and they could expect all kinds of harm.
93 It is therefore impossible to assess the actual impact which publication of the information claimed to be confidential might have on the applicants’ economic and financial interests. It follows that the harm which they might suffer as a result of publication of that information on the internet cannot be adequately quantified.
94 In the light of the foregoing considerations, it must be held that the condition relating to urgency is met in the present case, since the likelihood that the applicants will suffer serious and irreparable harm has been established to the requisite legal standard.
95 As a consequence, since all the requisite conditions have been met, the application for interim measures must be granted in so far as it seeks suspension of the operation of the contested decision. Moreover, in order to ensure that the suspension of operation has the practical effect sought, the Commission must be ordered to ensure that EFSA does not publish a version of the documents at issue that is more detailed than the redacted version included in the applicants’ letter of 25 February 2013, as set out in Annex A3 to the application in the main proceedings.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1) Operation of the Commission’s decision communicated to Luxembourg Pamol (Cyprus) Ltd and Luxembourg Industries Ltd by letter of the European Food Safety Authority (EFSA) of 8 October 2013 rejecting their request for confidential treatment of certain information contained in the peer review report and final addendum thereto concerning the inclusion of the active substance potassium phosphonates is suspended.
2) The European Commission shall ensure that EFSA does not publish a version of the peer review report and final addendum thereto concerning the inclusion of the active substance potassium phosphonates that is more detailed than the redacted version included in the letter of Luxembourg Pamol (Cyprus) Ltd and Luxembourg Industries of 25 February 2013, as set out in Annex A3 to the application in the main proceedings.
3) The costs are reserved.
Luxembourg, 13 February 2014.