21 July 2023 (*)

(Interim relief – Access to documents – Regulation (EC) No 1049/2001 – Documents related to the procedure for renewing the approval of an active substance – Documents originating from a third party – Decision to grant a third party access to the documents – Application for suspension of operation of a measure – Concept of ‘information relating to emissions into the environment’ – Regulation (EC) No 1367/2006 – Prima facie case – Urgency – Balancing of competing interests)

In Case T‑222/23 R,

Arysta Lifescience,

established in Noguères (France), represented by D. Abrahams, Z. Romata, H. Widemann and R. Spangenberg, lawyers,

applicant,

European Food Safety Authority (EFSA),

represented by D. Detken, S. Gabbi and C. Pintado, acting as Agents, and by S. Raes, J. Degrooff, and E. Kairis, lawyers,

defendant,

having regard to the order of 8 May 2023, Arysta Lifescience v EFSA (T‑222/23 R, not published),

makes the following

By its application on the basis of Articles 278 and 279 TFEU, the applicant, Arysta Lifescience, seeks the suspension of operation of the decision of the European Food Safety Authority (EFSA) of 17 February 2023 notifying it of the full disclosure of the list of co-formulants present in the formulation for representative uses of Captan 80 WG submitted in the framework of the renewal of the approval of the active substance Captan (‘the contested decision’).

Background to the dispute and forms of order sought

The applicant is a company which markets plant protection products containing the active substance Captan, in particular Captan 80 WG.

On 16 September 2022, an application for access to documents was submitted to EFSA under Regulation No 1049/2001 concerning, inter alia, the list of co-formulants present in the formulation for representative uses of Captan 80 WG, submitted in connection with the renewal of the approval of Captan (‘the information at issue’).

By letter of 13 January 2023, EFSA notified the applicant of its intention to grant access to that list.

By letter of 20 January 2023, the applicant objected to the proposed disclosure.

Following a series of exchanges with the applicant, EFSA adopted the contested decision on 17 February 2023.

By application lodged at the Court Registry on 27 April 2023, the applicant brought an action for annulment of the contested decision.

By separate document lodged at the Court Registry on 5 May 2023, the applicant brought the present application for interim measures, in which it claims that the President of the General Court should:

–order the suspension of operation of the contested decision pending delivery of the decision in the main proceedings;

–order EFSA to pay the costs.

In its observations on the application for interim measures, lodged at the Court Registry on 25 May 2023, EFSA contends that the President of the General Court should:

–dismiss the application for interim measures as unfounded;

–order the applicant to pay the costs.

Law

General conditions

In is apparent from Articles 278 and 279 TFEU read in conjunction with Article 256(1) TFEU that the judge hearing an application for interim measures may, if he or she considers that the circumstances so require, order that operation of a measure challenged before the Court be suspended or prescribe any necessary interim measures, having regard to the rules of admissibility laid down in Article 156 of the Rules of Procedure of the General Court. The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim measures are to 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’.

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

Having regard to the material in the case 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 there being any need to first hear oral argument from the parties.

According to settled 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 where one of the pleas relied on reveals the existence of a major legal or factual disagreement whose solution is not immediately obvious and therefore calls for a detailed examination which cannot be carried out by the judge hearing the application for interim measures but must be the subject of the main proceedings (see, to that effect, order of 8 April 2014, Commission v ANKO, C‑78/14 P-R, EU:C:2014:239, paragraph 15 and the case-law cited).

With a view to showing that the contested decision is, prima facie, unlawful, the applicant alleges infringement of 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) and of Article 6(1) of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13).

In the first place, the applicant claims that EFSA erred in concluding that the list of co-formulants contained information which relates to emissions into the environment within the meaning of Article 6(1) of Regulation No 1367/2006. The applicant argues that the list of co-formulants was submitted in the context of the procedure for the renewal of the approval of Captan and related to a potential formulation of a product containing that active substance. EFSA disregarded the distinction between the procedure for the approval of active substances and the procedure for the authorisation of plant protection products. Referring to the judgment of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe (C‑673/13 P, EU:C:2016:889), the applicant states that information relating to emissions into the environment may be provided only at the stage of the national authorisation procedure for plant protection products. The applicant claims that that reasoning is also applicable to information submitted during the procedure for the renewal of the approval of an active substance.

In the second place, the applicant claims that EFSA erred in finding that it was unnecessary to examine the applicability of the exception laid down in the first indent of Article 4(2) of Regulation No 1049/2001 and the possible existence of another overriding public interest in disclosure.

EFSA disputes those arguments. In the first place, relying on the judgments of 7 March 2019, Tweedale v EFSA (T‑716/14, EU:T:2019:141), and of 7 March 2019, Hautala and Others v EFSA (T‑329/17, not published, EU:T:2019:142), EFSA submits that information submitted in a procedure for the renewal of the approval of an active substance may be classified as information relating to emissions into the environment in so far as the active substance has already been authorised and has actually been used in plant protection products.

In the second place, EFSA asserts that the presence of information relating to emissions into the environment within the meaning of Article 6 of Regulation No 1367/2006 establishes an irrebuttable presumption that an overriding public interest in disclosure of that information is deemed to exist compared with the interests protected under the first indent of Article 4(2) of Regulation No 1049/2001.

In the present case, it should be observed that establishing the scope of the concept of ‘information relating to emissions into the environment’, within the meaning of Article 6(1) of Regulation No 1367/2006, is dependent on a case-by-case assessment.

In the judgment of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe (C‑673/13 P, EU:C:2016:889), in particular in paragraphs 73 to 75, the Court of Justice stated that that concept covers information on foreseeable emissions into the environment from the plant protection product or active substance in question, under normal or realistic conditions of use of that product or substance, namely the conditions under which the authorisation to place that product on the market or the approval for that product was granted and which prevail in the area where that product or substance is intended to be used. Although the placing on the market of a product or substance is not sufficient in general for it to be concluded that that product or substance will necessarily be released into the environment and that information concerning the product or substance relates to ‘emissions into the environment’, the situation is different as regards a product such as a plant protection product, and the substances which that product contains, which, in the course of normal use, are intended to be released into the environment by virtue of their very function. In that case, foreseeable emissions, under normal or realistic conditions of use, from the product in question, or from the substances which that product contains, into the environment are not hypothetical and are covered by the concept of ‘emissions into the environment’ within the meaning of the first sentence of Article 6(1) of Regulation No 1367/2006.

Those principles have been applied in several situations.

First, in the judgment of 21 November 2018, Stichting Greenpeace Nederland and PAN Europe v Commission (T‑545/11 RENV, EU:T:2018:817), in particular in paragraphs 82 to 91, the General Court drew a distinction between, on the one hand, the approval procedure for the active substance and, on the other hand, the authorisation procedure for products containing that active substance at national level. According to the General Court, an active substance must be approved at EU level before being included in plant protection products, which must, for their part, necessarily be subject to the authorisation of a Member State in order to ensure that the composition of those products meets the authorisation requirements laid down. There is still, in principle, no link between the assessment and approval of the active substance at EU level and the actual subsequent use that will be made of that substance. Approval of the active substance does not in any way include authorisation for the isolated use of that substance. Use will be made of that substance only once it is included in a plant protection product authorised for placement on the market by a Member State. Therefore, while it is true that an active substance is inevitably released into the environment at some stage of its life cycle, that is the case only via a plant protection product subject to the authorisation procedure. The General Court thus concluded that studies submitted as part of the initial approval procedure for the active substance could not be covered by the concept of ‘information relating to emissions into the environment’.

Second, in the judgments of 7 March 2019, Tweedale v EFSA (T‑716/14, EU:T:2019:141), in particular in paragraphs 83 and 119, and of 7 March 2019, Hautala and Others v EFSA (T‑329/17, not published, EU:T:2019:142), in particular in paragraphs 90 and 122, the General Court held that emissions from an active substance which has actually been used in plant protection products and is actually present in the environment cannot be classified as merely foreseeable emissions. The General Court decided that information which ‘relates to emissions into the environment’ covered toxicity and carcinogenicity studies submitted in the context of the procedure for renewal of the approval of the active substance in question, given that those studies seek to establish the toxicity, effects and other aspects of a product or substance under the most unfavourable realistic conditions which could possibly occur, and studies carried out in conditions as close as possible to normal agricultural practice and conditions which prevail in the area where that product or substance would be used.

In the present case, on the one hand, it should be observed that the information concerned by the request for access to the documents at issue is part of the dossier for renewal of the approval of the active substance Captan, which has actually been used in plant protection products and is actually present in the environment.

On the other hand, it is necessary to point out that the information at issue does not concern the potential effects of the active substance, but is a list of co-formulants submitted for representative uses of Captan 80 WG marketed by the applicant. According to Article 2(3)(c) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1), co-formulants are substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances, safeners or synergists.

It follows from the foregoing that the existing case-law does not provide a ready response to the question whether the information at issue in the present case is covered by the concept of ‘information relating to emissions into the environment’. It is therefore for the court ruling on the merits to carry out a more detailed examination of that question in the light of the particular context of the case. Without prejudging the decision of the General Court on the main action, it must be held that this plea put forward by the applicant appears, prima facie, not unfounded and therefore calls for a detailed examination, which cannot be carried out by the judge hearing the application for interim measures but must be examined in the main proceedings.

The condition relating to urgency

In order to determine whether the interim measures sought are urgent, it should be noted that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision, in order to prevent a lacuna in the legal protection afforded by the EU judicature. To attain that objective, urgency must in general be assessed in the light of the need for an interlocutory order to avoid serious and irreparable damage to the party requesting the interim measure. That party must demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable damage (see order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P-R, EU:C:2016:21, paragraph 27 and the case-law cited).

In order to show the urgency of the interim measures applied for, the applicant claims that disclosure of the information at issue would cause it serious and irreparable damage since it would allow its competitors to recreate Captan 80 WG by re-engineering. According to the applicant, once the information at issue is published and enters the public domain, it will not be possible to remove it and revert to a situation where it is confidential.

EFSA contends that the applicant has not adduced evidence to establish foreseeable and irreparable damage. First, according to EFSA, the alleged damage is purely hypothetical. The applicant has not shown that disclosure of the list of co-formulants would enable its competitors to re-engineer Captan 80 WG more easily and quickly than by relying only on information already in the public domain. EFSA observes in particular that co-formulants are not the only constituents of plant protection products. Next, EFSA argues that inasmuch as the damage alleged by the applicant is purely financial, it cannot be regarded as irreparable since it would not imperil its existence, affect substantially its market share and is not unquantifiable.

As a preliminary point, it should be observed that the applicant refers to damage that will be caused by the disclosure of purportedly confidential information. In such a case, in order to assess whether there is a risk of serious and irreparable damage, the judge hearing the application for interim measures must necessarily start from the premiss that the allegedly confidential information is indeed confidential, as claimed by the applicant (see, to that effect, order of 28 November 2013, EMA v AbbVie, C‑389/13 P(R), not published, EU:C:2013:794, paragraph 38).

Consequently, for the purpose of the present assessment of urgency, the information at issue must be regarded as being confidential.

33In the first place, as regards the foreseeability of the alleged harm, it should be observed, first of all, that in order to establish the existence of serious and irreparable damage, it is not necessary for the occurrence of the damage to be demonstrated with absolute certainty, it being sufficient to show that damage is foreseeable with a sufficient degree of probability. Nevertheless, the party seeking an interim measure is required to prove the facts forming the basis of its claim that serious and irreparable damage is likely (order of 14 December 1999, HFB and Others v Commission, C‑335/99 P(R), EU:C:1999:608, paragraph 67).

34Next, it is important to point out that the judge hearing an application for interim measures is not particularly well placed to make an informed and accurate prediction as to the manner in which the applicant’s competitors could exploit the information at issue once it has been disclosed (see, to that effect, order of 25 July 2014, Deza v ECHA, T‑189/14 R, not published, EU:T:2014:686, paragraph 91).

35In the present case, EFSA itself confirms that recreating Captan 80 WG by a process of re-engineering is technically possible by analysing the composition of the product on the market, although it asserts that that would be a long and burdensome process. It therefore cannot be ruled out that combining the information at issue with data already in the public domain may make that process faster and easier. Consequently, the occurrence of the financial damage that the applicant would sustain as a result of the information at issue being put to use in such a way by its competitors cannot be characterised as purely hypothetical.

36The argument made by EFSA, that the applicant has not shown that the information at issue would become available to its competitors, should also be rejected. Indeed, the disclosure of a document under Regulation No 1049/2001 has an erga omnes effect in that the document may be communicated to other applicants for access and any person has the right to access it (see, to that effect, judgment of 21 October, Agapiou Joséphidès v Commission and EACEA, T‑439/08, not published, EU:T:2010:442, paragraph 116). Accordingly, once the information at issue has been disclosed, it cannot be ruled out that the persons who applied for access may make it public by publishing it on the Internet. The possibility that the information at issue may be disclosed subsequently would thus contribute to weakening the applicant’s commercial position and increase the risk of serious and irreparable harm.

37In the second place, as regards the seriousness of the damage, the question of the extent to which the disclosure of allegedly confidential information causes serious damage depends on a combination of factors, such as, inter alia, the significance of the information in professional and commercial terms for the undertaking seeking to have it protected and the usefulness of that information for other market participants which are which are liable to examine and use it subsequently (order of 10 September 2013, Commission v Pilkington Group, C‑278/13 P(R), EU:C:2013:558, paragraph 42).

38In the present case, first, it is apparent from the file that the marketing of Captan 80 WG generates significant turnover for the applicant within the European Union and worldwide. It has been held, as regards more specifically damage connected with the disclosure of confidential information, that financial damage which is objectively considerable, or even not insignificant, may be considered ‘serious’, without it being necessary in every case to relate that damage to the turnover of the undertaking which fears suffering it (see, to that effect, order of 7 March 2013, EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraphs 32 and 33).

39Next, as observed in paragraph 34 above, disclosure of the information at issue is likely to facilitate the process of re-creating Captan 80 WG by a process of re-engineering.

40In the light of the foregoing, it must be found that the applicant has established, to the requisite legal standard, the seriousness of the financial damage which it risks incurring if the information at issue is disclosed.

41In the third place, as regards whether the damage is irreparable, it should be observed that damage of a pecuniary nature cannot, otherwise than in exceptional circumstances, be regarded as irreparable since, as a general rule, pecuniary compensation is capable of restoring the aggrieved person to the situation that obtained before he or she suffered the damage. Any such damage could be recouped by bringing an action for compensation on the basis of Articles 268 TFEU and 340 TFEU (see order of 10 September 2013, Commission v Pilkington Group, C‑278/13 P(R), EU:C:2013:558, paragraph 50 and the case-law cited).

42However, it should be noted that harm of a financial nature may, inter alia, be considered to be irreparable if the harm, even when it occurs, cannot be quantified (see order of 10 September 2013, Commission v Pilkington Group, C‑278/13 P(R), EU:C:2013:558, paragraph 52 and the case-law cited).

43The uncertainty of obtaining compensation for pecuniary damage if an action for damages is brought cannot in itself be regarded as a factor capable of establishing that such damage is irreparable within the meaning of the case-law of the Court of Justice. At the interlocutory stage, the possibility of subsequently obtaining compensation for pecuniary damage if an action for damages is brought following annulment of the contested measure is necessarily uncertain. Interlocutory proceedings are not intended to act as a substitute for an action for damages in order to remove that uncertainty, since their purpose is only to guarantee the full effectiveness of the final future decision that will be made in the main action (in this case an action for annulment), to which the interlocutory proceedings are an adjunct (see order of 10 September 2013, Commission v Pilkington Group, C‑278/13 P(R), EU:C:2013:558, paragraph 53 and the case-law cited).

44On the other hand, the situation is different 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 that harm by bringing an action for damages (order of 10 September 2013, Commission v Pilkington Group, C‑278/13 P(R), EU:C:2013:558, paragraph 54).

45In the present case, it must be held that an indeterminate and theoretically unlimited number of actual and potential competitors of the applicant throughout the world could obtain the information at issue following disclosure on the basis of Regulation No 1049/2001. That information, once publicly accessible, might even be obtained by competitors without the applicant being informed of that fact.

46From that point of view, having regard to the uncontrollable nature of the multiple uses that the information at issue could be put to on a global scale, EFSA’s argument – that Regulation No 1049/2001 ensures that there is respect for the applicant’s copyright within the European Union and that the information at issue cannot be used there without the applicant’s permission – is not capable of ruling out the occurrence of the alleged financial damage.

47Furthermore, having regard to the particular features of proceedings for the protection of allegedly confidential information, the applicant is not required to establish, in addition, that it would be in a position that would imperil its financial viability or that its market shares would be seriously and irreparably affected if the measures applied for were not granted (see, to that effect, order of 1 September 2015, Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 102 and the case-law cited).

48In view of the foregoing considerations, it must be found that the condition relating to urgency is satisfied in the present case, since the likelihood of the applicant suffering serious and irreparable damage has been established to the requisite legal standard.

Weighing up of interests

49According to settled case-law, the weighing up of interests requires the judge hearing an application for interim measures to determine whether or not the applicant’s interest in obtaining the measures sought outweighs the interest in the immediate application of the contested measure, by examining, more specifically, whether the possible annulment of that measure by the Court when ruling on the main application would allow the situation that would have been brought about by its immediate operation to be reversed and, conversely, whether the suspension of operation of the measure would prevent it from being fully effective in the event of the main application being dismissed (see order of 26 June 2003, Belgium and Forum 187 v Commission, C‑182/03 R and C‑217/03 R, EU:C:2003:385, paragraph 142 and the case-law cited).

50As regards more particularly the condition that the legal situation created by an interim order must be reversible, it must be observed that the purpose of the procedure for interim measures is to guarantee the full effectiveness of the future decision in the main action. Consequently, those proceedings are necessarily an adjunct to the main proceedings to which they are attached, so that the decision of the judge hearing the application for interim measures must be provisional in the sense that it cannot either prejudge the future decision in the main proceedings or deprive it of all practical effect (see order of 1 September 2015, France v Commission, T‑344/15 R, EU:T:2015:583, paragraph 47 and the case-law cited).

51In the present case, the Court will be called upon in the main proceedings to rule on whether the contested decision, by which EFSA decided to grant access to the information at issue, must be annulled owing to an infringement of Article 4(2) of Regulation No 1049/2001 and Article 6(1) of Regulation No 1367/2006. In order to maintain the effectiveness of a judgment annulling the contested decision, the applicant must be able to ensure that EFSA does not unlawfully disclose that information. A judgment ordering annulment would be rendered illusory and deprived of practical effect if the present application for interim measures were to be dismissed, since EFSA would be free to disclose the information at issue immediately, thereby effectively prejudging the future decision on the merits, namely that the action for annulment would be dismissed.

52It follows that the interest defended by the applicant must prevail over EFSA’s interest in the dismissal of the application for interim measures, a fortiori since the grant of the interim measures requested would amount to no more than maintaining the status quo for a limited period.

53It must also be observed that EFSA merely relied on the general principle of transparency and the promotion of more effective public participation in the decision-making process, without putting forward concrete evidence to establish that disclosure of the information at issue would meet an overriding need to protect public health.

54Moreover, while it is true that the person who has requested disclosure of the information at issue may invoke a right of access to the documents of the European Union’s institutions, bodies, offices and agencies under Article 15(3) TFEU, it must be found that the exercise of that right would merely be delayed if the interim measures were granted; that would entail a restriction in time on the exercise of that right, while the applicant’s right to protection of the confidentiality of that information would be reduced to nothing if the application for interim relief were dismissed. The applicant’s interest must therefore prevail over that of the party seeking access (see, to that effect, order of 1 September 2015, Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 69).

55Consequently, since all the conditions are met, the application to suspend the operation of the contested decision must be granted.

56Since this order closes the proceedings for interim measures, it is appropriate to set aside the order of 8 May 2023, Arysta Lifescience v EFSA (T‑222/23 R, not published), adopted on the basis of Article 157(2) of the Rules of Procedure, by which EFSA was ordered to suspend the operation of the contested decision until the date of the order bringing the present interim proceedings to an end.

57Pursuant to Article 158(5) of the Rules of Procedure, it is appropriate to reserve the costs.

On those grounds,

hereby orders:

1.Operation of the decision of the European Food Safety Authority (EFSA) of 17 February 2023 notifying Arysta Lifescience of the full disclosure of the list of co-formulants present in the formulation for representative uses of Captan 80 WG submitted in the framework of the renewal of the approval of the active substance Captan is suspended.

2.The costs are reserved.

3.The order of 8 May 2023, Arysta Lifescience v EFSA (T‑222/23 R) is set aside.

Luxembourg, 21 July 2023.

Registrar

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Language of the case: English.