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

JUDGMENT OF THE GENERAL COURT (Second Chamber)

3 June 2015 (*)

(Action for annulment — Plant protection products — Publication of documents relating to the inclusion of an active substance — Refusal of the request for confidential treatment of certain information — Contested act not attributable to the defendant — Inadmissibility)

In Case T‑578/13,

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,

ACTION for the annulment of the decision, notified by letter of the European Food Safety Authority (EFSA) of 8 October 2013, to publish certain parts of documents in respect of which the applicants had requested confidentiality,

THE GENERAL COURT (Second Chamber),

composed of M.E. Martins Ribeiro (Rapporteur), President, S. Gervasoni and L. Madise, Judges,

Registrar: L. Grzegorczyk, Administrator,

having regard to the written procedure and further to the hearing on 23 September 2014,

gives the following

Judgment

 Legal context

 Directive 91/414

1        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) lays down the EU rules governing authorisation for the placing of plant protection products on the market. Under Article 3(1) of Directive 91/414, Member States are to prescribe that, in principle, plant protection products may not be placed on the market and used in their territory, unless they have authorised the product in accordance with that Directive. Under Article 4(1)(a) of Directive 91/414, Member States are to ensure that a plant protection product is not authorised unless, in particular, its active substances are listed in Annex I to that directive.

2        As provided in Article 6(2), (3) and (5) of Directive 91/414:

‘2.       A Member State receiving an application for the inclusion of an active substance in Annex I shall without undue delay ensure that a dossier which is believed to satisfy the requirements of Annex II is forwarded by the applicant to the other Member States and to the Commission together with a dossier complying with Annex III on at least one preparation containing that active substance. The Commission shall refer the dossier to the Standing Committee on Plant Health referred to in Article 19 for examination.

3.      Without prejudice to the provisions of paragraph 4, at the request of a Member State, and within three to six months after the date of referral to the committee mentioned in Article 19, it shall be established by the procedure laid down in Article 20 whether the dossier has been submitted in accordance with the requirements of Annexes II and III.

…

5.       The procedure concerning the submission and appraisal of applications for inclusion in Annex I and setting or varying any conditions for inclusion shall be adopted in accordance with the procedure laid down in Article 21.’

3        Article 14 of the Directive, which concerns the protection of industrial and commercial secrets, reads as follows:

‘Member States and the Commission shall, without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment, ensure that information submitted by applicants involving industrial and commercial secrets is treated as confidential if the applicant wishing to have an active substance included in Annex I or the applicant for authorisation of a plant protection product so requests, and if the Member State or the Commission accepts that the applicant’s request is warranted.

Confidentiality shall not apply to:

–        the names and content of the active substance or substances and the name of the plant protection product,

–        the name of other substances which are regarded as dangerous under Directives 67/548/EEC and 78/631/EEC,

–        physico-chemical data concerning the active substance and plant protection product,

–        any ways of rendering the active substance or plant protection product harmless,

–        a summary of the results of the tests to establish the substance’s or product’s efficacy and harmlessness to humans, animals, plants and the environment,

–        recommended methods and precautions to reduce handling, storage, transport, fire or other hazards,

–        methods of analysis referred to in Articles 4(1)(c) and (d) and 5 (1),

–        methods of disposal of the product and of its packaging,

–        decontamination procedures to be followed in the case of accidental spillage or leakage,

–        first aid and medical treatment to be given in the case of injury to persons.

If the applicant subsequently discloses previously confidential information, he shall be required to inform the competent authority accordingly.’

 Regulation No 178/2002

4        Article 22(2) 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), provides:

‘The Authority shall provide scientific advice and scientific and technical support for the Community’s legislation and policies in all fields which have a direct or indirect impact on food and feed safety. It shall provide independent information on all matters within these fields and communicate on risks.’

5        Article 23 of Regulation No 178/2002 provides:

‘The tasks of the Authority shall be the following:

…

(j)      to ensure that the public and interested parties receive rapid, reliable, objective and comprehensible information in the fields within its mission;

…

(l)       to undertake any other task assigned to it by the Commission within its mission.’

6        Article 39(1) of Regulation No 178/2002, entitled ‘Confidentiality’, provides that:

‘By way of derogation from Article 38, the Authority shall not divulge to third parties confidential information that it receives for which confidential treatment has been requested and justified, except for information which must be made public if circumstances so require, in order to protect public health.’

7        Article 46(1) of the regulation reads as follows:

‘The Authority shall have legal personality. In all Member States it shall enjoy the widest powers granted by law to legal persons. In particular, it may acquire and dispose of movable and immovable property and institute legal proceedings.’

 Regulation No 1107/2009

8        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) replaced Directive 91/414 with effect from 14 June 2011 (see Articles 83 and 84 of Regulation No 1107/2009).

9        However, in accordance with Article 80(1)(a) of Regulation No 1107/2009, Directive 91/414 is to continue to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of Directive 91/414 before 14 June 2011.

10      The second subparagraph of Article 12(1) of Regulation No 1107/2009 provides:

‘The Authority shall make the draft assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63, that certain parts of the draft assessment report be kept confidential.’

11      Article 63(1) of Regulation No 1107/2009 states that:

‘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.’

 Regulation No 188/2011

12      Under Article 1 of Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market two years after the date of notification of that Directive (OJ 2011 L 53, p. 51), that regulation lays down ‘detailed rules for the submission and appraisal of applications for inclusion in Annex I to Directive 91/414/EEC of active substances which were not on the market on 26 July 1993’.

13      Article 7 of Regulation No 188/2011 provides:

‘1.      The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant and the other Member States within 30 days from its receipt. …

2.      The Authority shall 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/EEC.

It shall grant a period of two weeks to the applicant to request confidential treatment.’

14      Article 9(1) of that regulation provides:

‘The Commission shall, at the latest six months after receipt of the conclusion of the Authority, submit to the Standing Committee on the Food Chain and Animal Health, hereinafter “the Committee”, a draft review report to be finalised at its meeting.’

15      Article 10 of Regulation No 188/2011 reads as follows:

‘The finalised review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of Directive 91/414/EEC, shall be made available to the public.’

16      Article 11(6) of Regulation No 188/2011, which is entitled ‘Transitional measures’, reads as follows:

‘By way of derogation from paragraph 5, for applications for which the draft assessment report had been submitted to the Commission and the Authority by 31 December 2009 at the latest, Articles 2 to 6 and the first subparagraph of Article 7(1) shall not apply. In such cases, the following procedure shall apply.

By 18 April 2011, the rapporteur Member State shall request the applicant to inform that Member State and the Authority, within 1 month, in case the applicant considers that information that had not been submitted for the preparation of the draft assessment report and that might influence the outcome of the assessment, is available, specifying the nature of that information and its possible influence on the assessment.

Within 2 months from receiving the reply of the applicant, the Authority shall decide whether that information might influence the outcome of the assessment. If so, the Authority shall, without undue delay, ask the rapporteur Member State to request the submission of that information by the applicant. The rapporteur Member State shall update the draft assessment report where appropriate in the light of that information.

The Authority shall set a period of up to 6 months for the rapporteur Member State to prepare and submit to the Commission that updated draft assessment report, with a copy to the Authority. It shall at the same time inform the applicant that the draft assessment report has been submitted and request him to immediately forward to the Authority, the other Member States and the Commission the updated dossiers, where applicable. …’

 Background to the proceedings

17      On 22 August 2002, the first applicant, Luxembourg Pamol (Cyprus) Ltd, a subsidiary of the second applicant, Luxembourg Industries Ltd, a company developing, producing and selling, inter alia, herbicides, fungicides and insecticides, applied to the French Republic, in accordance with Article 6(2) of Directive 91/414, for the inclusion in Annex I to that directive of the active substance ‘potassium phosphonates’(‘the substance at issue’), which was formerly called ‘potassium phosphite’.

18      On 2 September 2003, the Commission adopted Decision 2003/636/EC recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of potassium phosphite, acequinocyl and cyflufenamid in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (OJ 2003 L 221, p. 42), by which it confirmed that the dossier submitted by the first applicant could be regarded as satisfying, in principle, the data and information requirements set out in Annexes II and III to Directive 91/414.

19      On 1 February 2005, the Member State designated as rapporteur, the French Republic, which was responsible for the detailed examination of the dossier, submitted a draft assessment report for review by the Member States and the European Food Safety Authority (‘EFSA’).

20      Following a general agreement between the Commission and EFSA on the conduct of peer reviews, EFSA conducted such a review of the draft assessment report for the substance at issue, and of the comments on that draft, by consulting technical experts from a number of Member States.

21      In response to a letter of 15 February 2005 asking them, on behalf of EFSA, to remove sensitive data from the draft assessment report before its disclosure to third parties, the applicants sent, by letter of 9 March 2005, a version of the draft assessment report in which the data that they considered to be sensitive had been deleted. EFSA thereupon informed them by e-mail of 16 March 2005 that their requests for the removal of parts of text would be examined.

22      By e-mail of 6 May 2010, EFSA informed the applicants of its intention to publish the draft assessment report for the substance at issue on its website and asked them to check the dossiers that had been prepared in accordance with the proposals made in 2005 for the removal of sensitive data. By letter of 3 June 2010, the applicants sent a version of the draft assessment report in which the data they considered to be sensitive had been deleted. On 4 October 2010, EFSA published the draft assessment report on its website.

23      After the entry into force of Regulation No 188/2011 and in accordance with Article 11(6) of that regulation, EFSA asked the rapporteur Member State, by letter of 7 July 2011, to request the applicants to send it information that had not been submitted for the preparation of the draft assessment report and might influence the outcome of the assessment. The rapporteur Member State drafted an addendum to the draft assessment report including information that had not been submitted earlier for the preparation of that draft. In October 2011, EFSA sent the addendum to the Member States and to the applicants, asking the latter to provide additional information so that the risk assessment could be finalised.

24      By e-mail of 19 November 2012, EFSA sent the applicants a copy of its conclusions on the risk assessment for the substance at issue, to enable them to request the removal of confidential information before the document was published on EFSA’s website. By e-mail of 26 November 2012, the applicants informed EFSA that they were not submitting any requests for confidentiality with regard to those conclusions.

25      On 16 December 2012, EFSA submitted to the Commission its conclusions on the risk assessment of the substance at issue, used as a pesticide. Those conclusions were examined, together with the draft assessment report, by the Member States and by the Commission within the Standing Committee on the Food Chain and Animal Health.

26      On 11 January 2013, EFSA asked the applicants to indicate whether it was necessary to delete certain information in the documents making up the peer review of the assessment report, and the final addendum, for the substance at issue (‘the contested documents’). By letter of 25 February 2013, the applicants submitted numerous confidentiality requests. EFSA refused most of those requests by e-mail of 29 March 2013, in which it pointed out the non-confidential nature of, inter alia: information on the composition of the substance at issue; the analysis method for that substance; the analysis methods for residues; the scientific information on the basis for the evaluation and risk assessments performed; and information already in the public domain.

27      By e-mail to EFSA dated 5 April 2013, the second applicant objected to the refusal of the confidentiality requests and requested a meeting with the responsible EFSA officials.

28      After preparing, on 15 March 2013, the draft review provided for in Article 9 of Regulation No 188/2011, the Commission approved the substance at issue by Implementing Regulation (EU) No 369/2013 of 22 April 2013 approving the active substance potassium phosphonates, in accordance with Regulation No 1107/2009 (OJ 2013 L 111, p. 39).

29      By letter of 13 May 2013, in view of the disagreement with the applicants and their request that the confidentiality requests be reconsidered, EFSA asked the Commission to take a position as to whether those requests were justified, making reference to the fact that, since the peer review for the substance at issue had been conducted in accordance with the rules and procedures laid down in Regulation No 188/2011, those requests had to be considered in accordance with Article 14 of Directive 91/414. By e-mail of the same date, EFSA informed the applicants that, since those requests for confidentiality were being considered in accordance with Article 14 of Directive 91/414, they had been sent to the Commission for consultation.

30      By e-mail of 14 June 2013 to EFSA and to the Commission, the lawyer for the second applicant stated as follows:

‘… We are … grateful for the confirmation that the publication of the Documents is on hold pending the decision on the validity of our client’s confidentiality claims. However, we are uncertain as to the procedure that will be followed, in particular as regards the authority that will decide in this matter and the timeline within which this will be done. Whilst your May 13 letter states that EFSA has referred the matter to the European Commission, the same letter also says that “EFSA will provide a full response” to our letter. Can you please clarify this point? Our client would also like to receive a procedural guarantee that the Documents will not be published before you inform us of the decision and give our client a chance to respond (as was verbally stated during a telephone call with Mr H[.] F[.] on 25 April 2013).

Furthermore, although the rationale behind our confidentiality claims is set out in the letter from our client’s consultant dated 25 February 2013, and [in] our subsequent letter of 5 April 2013, our client is convinced that a prior meeting is necessary in order to fully explain its position and to enable the Commission and EFSA to make an informed decision. In particular, a meeting would prevent the risk of any misunderstanding which might lead EFSA and/or the Commission to wrongly conclude that our client’s claims for confidentiality are unjustified …’

31      On 8 July 2013, the Commission sent EFSA a response to its letter of 13 May 2013, stating, inter alia:

‘… I would like to emphasise that according to Article 80(1) of Regulation (EC) No 1107/2009, the former legislation, Directive 91/414/EEC continues to apply, with respect to the procedures and the conditions for the approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. This is the case for [the substance at issue] where such decision was adopted on 2 September 2003.

Therefore, Article 7(2) of Regulation (EU) No 188/2011 applies in the case of [the substance at issue], and the sanitisation shall follow the principles applied by EFSA in similar cases in the past, for reasons of consistency.

I understand that the sanitisation of the draft Assessment Report — except for the Final Addendum — [was] finalised on the basis of the applicant’s comments submitted before 10 March 2005. There was no reason not to apply the same principles to the Final Addendum to this report.

The principles applied by EFSA in the sanitisation (as also set out in the “general guidance on information that may be removed …”) and communicated to the applicant for [the substance at issue] on 15 February 2005 reflects a common understanding of EFSA and the Commission of the provisions of Article 14 of Directive 91/414/EEC.

We consider that the peer review report should be covered by the provisions of Directive 91/414/EEC, as for all other documents produced during the same assessment.’

32      By e-mail dated 19 July 2013, the lawyer for the applicants summarised a telephone conversation with Dr R., a member of the Commission staff, as follows:

‘…

–        Dr R[.] confirmed that EFSA sought the Commission’s view on confidentiality claims submitted by Luxembourg Industries and related correspondence, and that the authorities have been in discussion. Whilst the matter has not yet been finalised, the Commission has clarified its position, namely that EFSA should apply its own guidance on the redaction of confidential data (which the Commission has never criticised) to all active substances, including [the substance at issue], in a consistent fashion. This suggests that the Commission is not in disagreement with EFSA’s stance, although clarification is needed.

–        As Directive 91/414 does not set out a formal procedure for resolving differences of opinion on confidentiality claims, no specific deadline is foreseen for finalising the decision on publication. However, in accordance with “good administrative practice”, the decision will be made within a reasonable period of time. Since the Commission was simply consulted on the issue, without there being a request for official advice, Dr R[.] believes the final decision will be communicated by EFSA.

–        Whilst Dr R[.] would be happy to clarify the Commission’s position at a meeting with Luxembourg Industries, he has no availability until September. Additionally, he believes that a meeting with EFSA would be more helpful as it has been driving the process and is likely to finalise the decision on publication.

–        …’

33      On 26 July 2013, the second applicant sent an e-mail to EFSA, worded as follows:

‘… In the absence of follow-up communication from EFSA and the European Commission, we should be grateful for information on the status of [progress on] your investigation into this matter and clarification on what procedure is being followed and the anticipated timeline.

Additionally we hereby reiterate our client’s request for a meeting with EFSA at your earliest convenience. So far neither EFSA nor the European Commission has responded to our request for a meeting to fully explain our client’s position and to enable the Commission and EFSA to make an informed decision. In that regard we remain convinced that a meeting held in accordance with principles of good administration would prevent the risk of any misunderstanding that might lead EFSA and/or the Commission to wrongly conclude that our client’s claims for confidentiality are unjustified …’

34      By letter of 8 October 2013, EFSA informed the applicants that the Commission had provided it with a response as to whether their requests for confidentiality were justified. In addition, it stated:

‘… I would like to emphasise that according to Article 80(1) of Regulation (EC) No 1107/2009, the former legislation, Directive 91/414/EEC continues to apply, with respect to the procedures and the conditions for the approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. This is the case for [the substance at issue] where such decision was adopted on 2 September 2003.

Therefore, Article 7(2) of Regulation (EU) No 188/2011 applies in the case of [the substance at issue], and the sanitisation shall follow the principles applied in similar cases in the past for reasons of consistency and equal treatment.

The principles applied in the sanitisation (as also set out in the “general guidance on information that may be removed …”) and communicated to the applicant for [the substance at issue] on 15 February 2005 reflect a common understanding of EFSA and the Commission of the provisions of Article 14 of Directive 91/414/EEC.

Since according to the provisions of Article 14 this is a matter in the responsibility of the European Commission, a meeting with EFSA is not considered to be relevant.

EFSA will now proceed with the publication on [its] website of the Peer Review Report and Final Addendum … as they have been prepared and sent to your attention on 29 March 2013.’

35      By letter of 15 October 2013 to EFSA and to the Commission, the second applicant complained about the way in which the requests for confidentiality had been handled by the Commission and EFSA. In particular, it complained that EFSA and the Commission had ignored its requests for a meeting. EFSA had simply informed it, by letter of 13 May 2013, that the matter had been referred to the Commission for consultation in accordance with Article 14 of Directive 91/414. The second applicant added that, during a telephone conversation on 19 July 2013 (see paragraph 32 above), the Commission had taken the view that, failing any official request by EFSA, the latter was the authority responsible for the final version of the response to the requests for confidentiality and, accordingly, ‘the natural partner’ with which to discuss them. The second applicant went on to state that it had never received clarification regarding the procedure followed to assess the requests for confidentiality. It had received conflicting information from EFSA and the Commission as to which authority would take the final decision. Lastly, the second applicant again insisted on the urgency of a meeting with both authorities. It maintained that, at the very least, the Commission should agree to holding a meeting, given that, according to the letter of 8 October 2013 (see paragraph 34 above), it was the authority responsible for publication.

 Procedure and forms of order sought

36      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 to publish certain parts of the contested documents in respect of which the applicants had requested confidentiality, as notified by EFSA’s letter of 8 October 2013 (‘the contested decision’).

37      By separate document lodged at the Court Registry on the same day, the applicants submitted an application for interim relief in which they claimed, inter alia, that the President of the Court should suspend operation of the contested decision.

38      By order of 8 November 2013, the President of the Court granted suspension of operation of the contested decision, in accordance with Article 105(2) of the Rules of Procedure, pending the decision on the application for interim relief.

39      By document lodged at the Court Registry on 17 January 2014, the Commission raised a preliminary plea of inadmissibility pursuant to Article 114 of the Rules of Procedure.

40      By order of 13 February 2014 (Luxembourg Pamol (Cyprus) and Luxembourg Industries v Commission, T‑578/13 R, EU:T:2014:103), the President of the General Court ordered, inter alia, suspension of operation of the contested decision and reserved the costs.

41      On 10 March 2014, the applicants submitted their observations on the preliminary plea of inadmissibility.

42      Upon hearing the Report of the Judge-Rapporteur, the General Court (Second Chamber) decided to open the oral procedure, limited to the question of the admissibility of the application.

43      The parties put oral arguments and gave their answers to the questions put by the Court at the hearing of 23 September 2014.

44      The applicants claim that the Court should:

–        declare the action admissible and well founded;

–        annul the contested decision;

–        order the Commission to pay the costs;

–        order ‘such other or further measures as justice may require’.

45      The Commission contends that the Court should:

–        dismiss the action as inadmissible;

–        order the applicants to pay the costs.

46      The applicants submit, in their observations on the plea of inadmissibility, that the Court should reject the plea of inadmissibility.

 Law

47      The Commission submits that the application brought against it, seeking annulment of the contested decision, is manifestly inadmissible. That decision is not attributable to the Commission, but is an act of EFSA.

48      In the first place, it should be noted that, if the contested decision was notified by EFSA, the applicants designated the Commission as the party against whom the application was made.

49      First of all, it must be recalled that, under Article 44(1)(b) of the Rules of Procedure, an application of the kind referred to in Article 21 of the Statute of the Court of Justice of the European Union is to state the designation of the party against whom it is made.

50      According to the case-law, the mistaken designation in the application of a defendant other than the body responsible for adopting the contested measure does not render the application inadmissible, if the latter contains information which makes it possible to identify unambiguously the party against whom it is made, such as the designation of the contested measure and the body responsible for it. In such a case, the body responsible for the contested measure must be considered to be the defendant, even though it was not mentioned in the introductory part of the application (see order of 16 October 2006 in Aisne et Nature v Commission, T‑173/06, EU:T:2006:320, paragraph 17 and case-law cited).

51      In the present case, the designation of the Commission in the application was not an error on the applicants’ part. It is clearly apparent from the contents of the application and the applicants’ observations on the plea of inadmissibility that they intended to bring the action expressly against the Commission. The applicants take the view that the contested decision is an act of the Commission. It follows that the party designated as the defendant in the application must be taken into account and, if necessary, the appropriate conclusions must be drawn from that designation as regards the admissibility of the application (see, to that effect, order in Aisne et Nature v Commission, cited in paragraph 50 above, EU:T:2006:320, paragraph 18).

52      It is necessary, therefore, to examine the admissibility of the application brought against the Commission.

53      In that regard, it should be pointed out that, in principle, an application for annulment must be made against the author of the contested measure. However, in certain cases, the General Court has held that measures adopted pursuant to delegated powers were ascribable to the delegating institution, to which it fell to defend the measure in question. That is, in particular, the case when the author of the measure exercises a merely advisory competence or the measure annulment of which is sought was conditional upon the prior agreement of the delegating institution (see, to that effect, order of 5 December 2007 in Schering-Plough v Commission and EMEA, T‑133/03, EU:T:2007:365, paragraphs 22 and 23; judgment of 21 October 2010 in Agapiou Joséphidès v Commission and EACEA, T‑439/08, EU:T:2010:442, paragraph 34, and order of 4 June 2012 in Elti v Delegation of the European Union to Montenegro, T‑395/11, EU:T:2011:274, paragraphs 62 and 63).

54      In addition, as regards measures or decisions adopted by a procedure involving several stages, a measure may, in principle, be the subject of an application for annulment only if it is a measure definitively laying down the position of the institution concerned on the conclusion of the procedure, and not a preliminary or purely preparatory measure (see, to that effect, judgment of 11 November 1981 in IBM v Commission, 60/81, ECR, EU:C:1981:264, paragraphs 9 and 10).

55      In the second place, it should also be pointed out that, under Article 46(1) of Regulation No 178/2002, EFSA is to have legal personality and, under Article 22(2) of that regulation, has as its mission, inter alia, to provide scientific advice and scientific and technical support for the Union’s policies and legislation in all fields which have a direct or indirect impact on food and feed safety. Article 23(l) of Regulation No 178/2002 provides that EFSA is to undertake ‘any other task assigned to it by the Commission within its mission’.

56      Although the General Court has held that an opinion given by EFSA under Article 8(7) of Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC (OJ 2000 L 55, p. 25) must be held to be a preliminary step in the procedure for the inclusion or non-inclusion of active substances in Annex I to Directive 91/414 and, in consequence, was not a measure against which proceedings for annulment may be brought (see, to that effect, orders of 17 June 2008 in Dow AgroSciences v EFSA, T‑397/06, EU:T:2008:208, paragraphs 41 and 47, and FMC Chemical and Arysta Lifesciences v EFSA, T‑311/06, EU:T:2008:205, paragraphs 44 and 50), it is also settled case-law that EFSA is a body, office or agency, within the meaning of Article 263(1) TFEU whose acts intended to produce legal effects vis-à-vis third parties must be amenable to proceedings for annulment (see, to that effect, judgment of 12 December 2012 in Evropaïki Dynamiki v EFSA, T‑457/07, EU:T:2012:671, paragraph 24).

57      In the third place, as regards the legal base of the decision to publish the contested documents, it should be recalled that while Regulation No 1107/2009 replaced Directive 91/414 with effect from 14 June 2011, Directive 91/414 continues to apply, under Article 80(1)(a) of Regulation No 1107/2009, as regards the procedure and the conditions for approval in respect of active substances for which a decision was adopted in accordance with Article 6(3) of Directive 91/414 before 14 June 2011. As set out at paragraph 18 above, the Commission had adopted such a decision on 2 September 2003, with the result that the conditions of Article 80(1)(a) of Regulation No 1107/2009 are satisfied in the present case.

58      In the present case, as regards the subject-matter of the present proceedings, it must be stated that, according to the application, the applicants seek the annulment of the ‘Commission Decision of 8 October 2013 … whereby [it] decided to make public certain parts of the [contested documents] in respect of which the applicants had claimed confidentiality’. The applicants submit that EFSA’s letter of 8 October 2013 was merely the means by which the decision adopted by the Commission was notified to them.

59      First of all, it is not disputed that it was by an e-mail of 29 March 2013 (see paragraph 26 above) that EFSA rejected the requests for confidentiality made by the applicants. It is apparent from that e-mail that it was EFSA which had considered their requests, accepted those that it considered to be valid and rejected others. It is also apparent from that e-mail that EFSA had said that it would not publish the contested documents before 15 April 2013, except with the applicants’ agreement. It may therefore be concluded, with regard to the procedure that led to the publication of the draft assessment report on 4 October 2010, that, if the applicants had not disputed the rejection of those requests, EFSA would have published the contested documents on the basis of its own assessment of the requests for confidentiality submitted by the applicants, without seeking any type of intervention by the Commission.

60      Next, it must be held that, inasmuch as, by its letter of 8 October 2013, EFSA informed the applicants of the imminent publication of the contested documents on its website, that letter informed the applicants of the decision taken, by EFSA, on the publication of those documents, a decision which had been adopted on the basis of Article 7(2) of Regulation No 188/2011. The decision to publish the contested documents means, in addition, that a position was taken on the requests for confidentiality at issue, in accordance with Article 14 of Directive 91/414, as is clear from the letter of 8 October 2013 in which EFSA states that the documents will be published in the version transmitted to the applicants on 29 March 2013, namely, in the version resulting from the assessment undertaken by EFSA, in which the information allegedly confidential was not redacted.

61      Finally, it is important to point out that, in essence, the applicants’ application is directed against the decision to publish, to the extent that the latter relates to passages containing information that the applicants consider confidential, thus refusing the requests for confidentiality. It is therefore necessary to consider whether the Commission is the true author of that decision or whether that decision can, at least, be attributed to the Commission, taking into account, inter alia, the respective competences of EFSA and the Commission and the wording of the letter of 8 October 2013 and of the context of the contested decision.

62      First, it is necessary to consider the Commission’s argument that its contribution was merely a preparatory step before EFSA’s decision was adopted and cannot, therefore, be the subject of an application for annulment.

63      In that regard, it must be pointed out that a member of staff of the Commission had already observed, in the course of the telephone conversation with the applicants’ lawyer referred to in the e-mail of 19 July 2013 (see paragraph 32 above), that EFSA had merely consulted the Commission, and that, failing any official request by EFSA, he thought that the final decision would be notified by EFSA. Furthermore, the applicants have themselves noted, in paragraph 93 of the application, that the Commission, in breach of Article 14 of Directive 91/414, was simply consulted, unofficially, by EFSA to assist the latter in deciding whether the requests for confidentiality were justified.

64      It must be pointed out that the wording of the Commission’s letter of 8 July 2013 (see paragraph 31 above) is not capable of substantiating the argument that it was the Commission that decided on the requests for confidentiality. More specifically, it is clear from that letter that the Commission’s intervention did not consist of an assessment of the various requests for confidentiality that had been rejected by EFSA (see the e-mail of 29 March 2013), but merely of clarification as to the legal provisions applicable in the case and in recommendations made to EFSA. While the applicants had based their requests for confidentiality on Article 63 of Regulation No 1107/2009, the Commission considered that the peer review report and all the other documents produced in the course of the same assessment had to be covered by the provisions of Directive 91/414 and that, therefore, it was necessary to apply Article 7(2) of Regulation No 188/2011. The Commission recommended to EFSA that it should observe the principles it had applied in the past to similar cases and apply to the final addendum the same principles as had been applied to the draft assessment report, recalling that the principles EFSA applied to the redaction of confidential data reflected their common understanding of Article 14 of Directive 91/414. However, while, in its letter, the Commission indicated to EFSA the legislation and principles applicable to the requests for confidentiality at issue, the fact remains that the Commission did not apply that legislation and those principles in order to determine those claims itself.

65      As regards the letter of 8 October 2013 (see paragraph 34 above), it must be recalled that, in that letter, EFSA told the applicants that the Commission had provided it with a reply on the question whether the requests for confidentiality were justified. Next, EFSA repeated, almost verbatim, several paragraphs of the Commission’s letter of 8 July 2013 on the legislation and the principles applicable in the case. While EFSA had, inter alia, confirmed that the question raised, under Article 14 of Directive 91/414, concerned the responsibility of the Commission, that observation does not in any way support a conclusion that the Commission determined the requests for confidentiality.

66      It must be emphasised that the author of the letter of 8 October 2013 was not the Commission but EFSA, which referred to the Commission’s reply and drew inferences from it. However, the assessment by EFSA of the Commission’s reply is not capable of altering the legal nature of that reply, which contained information and recommendations, and was not a decision rejecting the requests for confidentiality lodged by the applicants.

67      It follows that it must be held that the author of the contested decision is EFSA, that body having decided to publish the contested documents in a version in which the allegedly confidential information, in respect of which it had carried out its assessment on 29 March 2013 (see paragraph 26 above), was not redacted, and refusing the requests for confidentiality made by the applicants.

68      In the second place, it must be examined whether the contested decision may be attributed to the Commission, even though the Commission was not its author.

69      As is clear from the case-law cited at paragraph 53 above, in certain cases the General Court has held that measures adopted pursuant to delegated powers were attributable to the delegating institution and that was the case, in particular, when the author of the measure exercised a merely advisory competence or the measure of which annulment was sought was conditional upon the prior agreement of the delegating institution.

70      At the hearing, the Commission contended that those conditions were not met in the present case, EFSA having adopted the contested decision on the basis of its own competence.

71      First, the Commission states that, after the establishment of EFSA by Regulation No 178/2002, it delegated to EFSA the assessment of claims of confidentiality. It added that, since the entry into force of Regulation No 188/2011, Article 7(2) of that Regulation has been the legal base of that delegation of powers.

72      The applicants dispute the argument that Article 7(2) of Regulation No 188/2011 includes such a delegation of powers.

73      It must be pointed out that, according to settled case-law, in interpreting a provision of EU law, it is necessary to consider not only its wording but also its context and the objectives of the rules of which it is part (see judgments of 7 June 2005 in VEMW and Others, C‑17/03, ECR, EU:C:2005:362, paragraph 41 and case-law cited, and 26 October 2010 in Germany v Commission, T‑236/07, ECR, EU:T:2010:451, paragraph 44 and case-law cited).

74      It is in the light of those principles that the question whether Article 7(2) of Regulation No 188/2011 provides for the delegation to EFSA of the power to determine requests for confidentiality and, if so, whether EFSA has the power to decide on those requests in its own name or whether its decision-making power is conditional upon the prior agreement of the Commission.

75      First, it is necessary to reject the applicants’ argument that, by virtue of Article 11(6) of Regulation No 188/2011, Article 7 of that regulation does not apply to claims in respect of which, as in the present case, a draft assessment report was submitted to the Commission and EFSA by 31 December 2009 at the latest. Article 11(6) excludes only the application of the first subparagraph of Article 7(1), and does not refer to Article 7(2) of Regulation No 188/2011, which therefore remains applicable.

76      Next, as regards the wording of the provision at issue, it must be observed that Article 7(2) of Regulation No 188/2011 authorises EFSA to publish draft assessment reports, with the exception 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.

77      The Commission submits that Article 7(2) of Regulation No 188/2011 refers only to the assessment of the merits of requests for confidentiality, as provided for by Article 14 of Directive 91/414, whereas the applicants consider that Article 7(2) refers also to the Commission’s competence to decide on those claims, provided for by Article 14 of Directive 91/414.

78      In that regard, it must be pointed out that, if Article 14 of Directive 91/414, on the one hand, confers powers on the Commission and to the Member States and, on the other hand, lays down criteria for the assessment of the merits of requests for confidentiality, the wording of Article 7(2) of Regulation No 188/2011 nevertheless supports the conclusion that that paragraph merely refers to the criteria as to the merits and not to the rule regarding competence laid down in Article 14 of Directive 91/414. Article 7(2) of Regulation No 188/2011 refers to confidential treatment that ‘has been requested and justified by the applicant in accordance with Article 14 of Directive 91/414/EEC’ and, hence, to the requirements that a claim for confidentiality must satisfy, without mentioning the conferring of powers provided for by that article. Moreover, Article 7(2) of Regulation No 188/2011 does not provide for any intervention by the Commission. In particular, it is EFSA, and not the Commission, that grants the applicant a period of two weeks in order to request confidential treatment. Thus, it must be held that requests for confidentiality are among those questions closely linked to the publication of the draft assessment report that EFSA decides in its own right.

79      As regards, next, the legislative context of and the objectives pursued by the legislation at issue, the Commission explained, at the hearing, that it was guided by the choices made in Regulation 1107/2009 in entrusting EFSA with the task of deciding, in its own right, on requests for confidentiality, in accordance with Article 7(2) of Regulation No 188/2011.

80      In view of the foregoing, it must be held that it is clear from the wording and scheme of Article 12 of Regulation No 1107/2009, read in conjunction with Article 63 of that regulation, that it is EFSA that is competent to adopt a decision on a request for confidentiality. In particular, Article 12(1) of Regulation No 1107/2009 provides that EFSA is to make the draft assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63 of the regulation, that certain parts of the draft assessment report be kept confidential. It is also clear, as follows from the fact that Article 63 of Regulation No 1107/2009 lays down the conditions for confidential treatment of information submitted by the parties concerned, but does not determine which authority makes the decision to grant confidential treatment, that EFSA’s competence, provided for by Article 12 of that regulation, to publish the draft assessment report, includes the power to rule on requests for confidentiality.

81      Although Regulation No 1107/2009 repealed Directive 91/414 with effect from 14 June 2011, on 25 February 2011 the Commission adopted Regulation No 188/2011 laying down detailed rules for the implementation of Directive 91/414, on the basis that that directive continued to apply to certain active substances after 14 June 2011 (see paragraph 57 above). As regards the publication of the assessment report, the Commission established, in adopting Regulation No 188/2011, a legislative framework that is, in essence, largely identical to that provided for by Article 12 of Regulation No 1107/2009. In common with that Article 12, Article 7(2) of Regulation No 188/2011 provides that EFSA is to make the draft assessment report available to the public, but that it is to grant the applicant a period of two weeks to request confidential treatment.

82      Given the similarities between Article 12 of Regulation No 1107/2009 and Article 7(2) of Regulation No 188/2011, Article 12 may be taken into account when interpreting the legislative context and the objectives pursued by Article 7(2) and, more specifically, in making the finding that, in adopting that article, the Commission intended to delegate to EFSA the power to decide on all aspects of the publication of the draft assessment report, including requests for confidentiality, in the same way as is provided for by Article 12 of Regulation No 1107/2009.

83      Therefore, it is apparent from both the wording and scheme of Article 7(2) of Regulation No 188/2011, that that article authorises EFSA to determine, in its own right, requests for confidentiality. In particular, that decision-making power is not conditional upon the prior agreement of the delegating institution, namely, the Commission. Furthermore, in its letter of 8 July 2013, as is clear from the considerations set out in paragraph 64 above, the Commission merely made recommendations regarding general principles for the assessment of requests for confidentiality, without itself deciding on the applicant’s requests for confidentiality and, in particular, without giving prior agreement to EFSA to reject those claims.

84      It follows that the conditions enabling, in accordance with the case-law cited in paragraph 53 above, a decision to be attributed to the delegating institution, that is not the author of that decision are not fulfilled in the present case.

85      Second, that finding cannot be called into question by the applicants’ argument that Regulation No 188/2011 merely establishes the detailed rules for the implementation of Directive 91/414, so that Article 7(2) of Regulation No 188/2011 cannot constitute a delegation of competence to EFSA and the Commission is bound by the conferral of powers in Article 14 of Directive 91/414.

86      Even if such an argument could be accepted, it would not affect the finding that it was indeed EFSA that adopted the contested decision, in its own name, without relying on an advisory competence or a competence conditional upon the prior agreement of the Commission.

87      Third, the applicants’ argument invoking, in essence, the right to an effective remedy cannot succeed either. At the hearing, the applicants submitted that if they had had to direct their action against EFSA, they could have challenged only the last step in EFAS’s procedure, namely, the publication of the contested documents. If the applicants could bring their application only after publication, they argued, that application could not prevent the disclosure of their industrial and commercial secrets with the result that their judicial protection would be inadequate. It must, however, be held that the decision to publish the contested documents, including the information for which the applicants requested confidential treatment, already constituted a challengeable act, without its being necessary to wait for the implementation of that act. Hence, it is not necessary to attribute the contested decision to the Commission in order to ensure effective judicial protection.

88      Nor, furthermore, does the ambiguity arising from the reference made by EFSA, in its letter of 8 October 2013, to the Commission’s responsibility under Article 14 of Directive 91/414 for requests for confidentiality justify attribution of the contested decision to the Commission, the Commission not being responsible for that ambiguity. The Commission never acted in a manner that could have given grounds for believing that it was the author of the contested decision.

89      In the light of the forgoing, it must be held that, because EFSA’s decision cannot be attributed to the Commission, the action must be dismissed as inadmissible.

 Costs

90      Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. As the applicants have been unsuccessful, they must be ordered to pay the costs, including those relating to the interim proceedings, in accordance with the form of order sought by the Commission.

On those grounds,

THE GENERAL COURT (Second Chamber)

hereby:

1.      Dismisses the action as inadmissible;

2.      Orders Luxembourg Pamol (Cyprus) Ltd and Luxembourg Industries Ltd to pay the costs, including those relating to the interim proceedings.

Delivered in open court in Luxembourg on 3 June 2015.

[Signatures]

* Language of the case: English.

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