8 May 2019 (*)

(Interim measures — Biocidal products — Active substance empenthrin — Non-approval — Application for suspension of operation of a measure — No urgency)

In Case T‑734/18 R,

Sumitomo Chemical (UK) plc,

Tenka Best, SL,

represented by K. Van Maldegem, lawyer, and V. McElwee, Solicitor,

applicants,

European Commission,

represented by L. Haasbeek and R. Lindenthal, acting as Agents,

defendant,

supported by

Kingdom of Belgium,

represented by L. Van den Broeck and P. Cottin, acting as Agents, and by A. Poppe and E. Jacubowitz, lawyers,

intervener,

APPLICATION pursuant to Articles 278 and 279 TFEU seeking the suspension of the operation of Commission Implementing Decision (EU) 2018/1251 of 18 September 2018 not approving empenthrin as an existing active substance for use in biocidal products of product-type 18 (OJ 2018 L 235, p. 24),

makes the following

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

1The first applicant, Sumitomo Chemical (UK) plc, distributes the biocidal active substance known as empenthrin (‘the substance at issue’). Empenthrin is a broad-spectrum insecticide used to control flying insects, including moths and other pests that damage textiles.

2The second applicant, Tenka Best, SL, manufactures biocidal products containing the substance at issue which it markets under the applicable systems in several EU Member States and in non-EU Member States. Its supplier of the substance at issue is the first applicant.

3The dispute concerns Commission Implementing Decision (EU) 2018/1251 of 18 September 2018 not approving empenthrin as an existing active substance for use in biocidal products of product-type 18 (OJ 2018 L 235, p. 24; ‘the contested decision’).

4The substance at issue was the subject of review as part of the 10-year work programme established by Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ 1998 L 123, p. 198).

5In that context, the first applicant submitted, on 28 March 2002, a notification and, on 26 April 2006, a complete dossier to the Rapporteur Member State, in this case, the Kingdom of Belgium.

6Although the dossier was accepted, in January 2007, as being, in principle, complete, the procedure could be finished only in 2018 by means of the adoption of the contested decision.

7On 13 December 2018 the applicants lodged at the Registry of the General Court an action seeking the annulment of the contested decision.

8On 23 December 2018, by a separate document, lodged at the Court Registry on that date, the applicants brought an application for interim measures in which they claim, in essence, that the President of the General Court should:

–suspend the operation of the contested decision with immediate effect, in accordance with Article 157(2) of the Rules of Procedure of the General Court;

–grant any other interim measures deemed appropriate and hold an oral hearing as needed;

–order the European Commission to pay the costs.

9In its observations on that application for interim measures, lodged at the Registry of the General Court on 21 January 2019, the Commission contends that the President of the General Court should:

–reject the application for interim measures;

–reserve the costs.

10On 25 March 2019 the applicants submitted a request that certain information should not be disclosed to the public.

11By a measure of organisation of procedure of 27 March 2019, the President of the General Court sent a question to the applicants to be answered in writing, and the applicants replied on 8 April 2019.

12By decision of the President of the General Court of 9 April 2019, the Kingdom of Belgium was granted leave to intervene in support of the forms of order sought by the Commission.

13By a measure of organisation of procedure of 9 April 2019, the President of the General Court sent a question to the Commission to be answered in writing, and the Commission replied on 15 April 2019.

14On 16 April 2019 the Kingdom of Belgium lodged its statement in intervention, on which the applicants stated their position on 2 May and the Commission on 3 May 2019.

Law

15It is apparent from reading Articles 278 and 279 TFEU together with Article 256(1) TFEU that the judge hearing an application for interim measures may, if he considers that the circumstances so require, order that the operation of a measure challenged before the General Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, since acts adopted by the institutions of the European Union are presumed to be lawful. It is therefore only exceptionally that the judge hearing an application for interim measures may order the suspension of operation of an act challenged before the Court or prescribe interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).

16Article 156(4) of the Rules of Procedure provides that applications for interim measures must state ‘the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measure applied for’.

17Thus, the judge hearing an application for interim relief may order suspension of operation of an act and other interim measures if it is established that such an order is justified, prima facie, in fact and in law, and that it is urgent in so far as, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, and consequently an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing an application for interim relief is also required to undertake, when necessary, a weighing of the competing interests (see order of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P‑R, EU:C:2016:142, paragraph 21 and the case-law cited).

18In the context of that overall examination, the judge hearing the application for interim measures has a wide discretion and remains free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).

19Having regard to the material in the case file, the President of the General Court considers that he has all the information necessary to rule on the present application for interim measures without there being any need first to hear oral argument from the parties.

20In the circumstances of this case, it is appropriate to examine, first, whether the condition relating to urgency is satisfied.

21In 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 Courts. To attain that objective, urgency must, generally, be assessed in the light of the need for an interlocutory order to avoid serious and irreparable harm 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 harm (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).

22Further, it must be recalled that, in accordance with settled case-law, when suspension of the operation of a European Union act is sought, the grant of the interim measures requested is justified only where the act at issue constitutes the decisive cause of the alleged serious and irreparable harm (see order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P‑R, EU:C:2016:21, paragraph 45 and the case-law cited).

23In addition, according to well-established case-law, there is urgency only if the serious and irreparable harm feared by the party seeking the interim measures is so imminent that its occurrence can be foreseen with a sufficient degree of probability. That party remains, in any event, required to prove the facts that form the basis of its claim that such harm is likely, it being clear that purely hypothetical harm, based on future and uncertain events, cannot justify the granting of interim measures (see order of 16 February 2017, Gollnisch v Parliament, T‑624/16 R, not published, EU:T:2017:94, paragraph 25 and the case-law cited).

24In accordance with settled case-law, 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 prevailed before he suffered the damage. Any such damage could be remedied by the applicant’s bringing an action for compensation on the basis of Articles 268 and 340 TFEU (see order of 23 April 2015, Commission v Vanbreda Risk & Benefits, C‑35/15 P(R), EU:C:2015:275, paragraph 24 and the case-law cited).

25Where the harm alleged is financial in nature, the interim measures sought are justified if it appears that, in the absence of those measures, the applicant would be in a position that would imperil its financial viability before final judgment is given in the main action, or if its market share would be affected substantially in the light of, inter alia, the size and turnover of its undertaking and, where appropriate, the characteristics of the group to which it belongs (see order of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P‑R, EU:C:2014:1749, paragraph 46 and the case-law cited).

26Moreover, according to the second sentence of Article 156(4) of the Rules of Procedure, an application for interim measures ‘shall contain all the evidence and offers of evidence available to justify the grant of interim measures’.

27Thus, an application for interim measures must, of itself, enable the defendant to prepare its observations and the judge hearing the application to rule on it, if necessary, without any supporting information, since the essential elements of fact and law on which the application is based must be found in the actual text of that application (see order of 6 September 2016, Inclusion Alliance for Europe v Commission, C‑378/16 P‑R, not published, EU:C:2016:668, paragraph 17 and the case-law cited).

28It is also settled case-law that, to determine whether all the conditions referred to in paragraphs 21 to 23 above are fulfilled, the judge hearing the application for interim measures must have specific and precise information, supported by detailed, certified documentary evidence, which shows the situation in which the party seeking the interim measures finds itself and enables the probable consequences, should the measures sought not be granted, to be assessed. It follows that that party, in particular when it relies on the occurrence of financial damage, must produce, with supporting documentation, an accurate overall picture of its financial situation (see order of 29 February 2016, ICA Laboratories and Others v Commission, T‑732/15 R, not published, EU:T:2016:129, paragraph 39 and the case-law cited).

29Last, although the application for interim measures can be supplemented, on specific points, by references to documents annexed thereto, those documents cannot compensate for the failure to set out the essential elements in that application. It is not the task of the judge hearing the application for interim measures to seek, in place of the party concerned, those matters contained in the annexes to the application for interim measures, in the main application or in the annexes to the latter which might support the application for interim measures. For such an obligation to be imposed on the judge hearing the application for those measures would, moreover, render ineffective Article 156(5) of the Rules of Procedure, which requires the application for interim measures to be made by a separate document (see order of 20 June 2014, Wilders v Parliament and Council, T‑410/14 R, not published, EU:T:2014:564, paragraph 16 and the case-law cited).

30In this case, it is necessary to examine, in the light of the factors relied on by the applicants, whether the contested decision is liable to cause them to incur serious and irreparable harm.

31As regards the first applicant, its first argument is that the contested decision will cause it to lose its market share and customers and will affect its reputation.

32With respect to, in the first place, the loss of market share and customers, it must be stated that the first applicant has failed to provide any information on the size of its undertaking, on its own turnover or on the turnover of the group to which it belongs. Further, it has also failed to provide any information on the significance of the substance at issue within its range of products. In addition, the first applicant also fails to indicate the extent of its sales of the substance at issue within the Union or worldwide. Last, it fails to state the turnover achieved in this substance within the Union or elsewhere.

33In the absence of any information with respect to the matters mentioned in paragraph 32 above, it cannot be concluded that the first applicant, in claiming the loss of its market in the substance at issue, has established urgency. It is clear from the case-law cited in paragraph 25 above that the significance of the loss of market share must be examined with regard to, inter alia, the size of the undertaking and its turnover and, where appropriate, the characteristics of the group to which it belongs. However, in the absence of such information, it must be concluded that the first applicant has failed to establish the importance to its undertaking and to the group to which it belongs of the loss of market share associated with the substance at issue.

34As regard, in the second place, the effect on its reputation, the first applicant maintains that, because of the contested decision, its reputation as a ‘solid and reliable supplier with a vested interest in supporting its active substances through scientific research and investment activities to ensure that these are safe for human health and the environment’ will be adversely affected.

35However, it must be observed that, if an adverse effect on the reputation of the first applicant was in fact a consequence of the contested decision, that effect would already have been caused when the contested decision was adopted and would last until such time as that decision is annulled by the judgment in the main proceedings (see, to that effect, order of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 42 and the case-law cited).

36Given that the contested decision was adopted following a complex administrative procedure, in which scientific experts and professionals working in the sector concerned participated, a suspension of the operation of that decision ordered by the judge hearing the application for interim measures, on a purely interim basis and in summary proceedings, would scarcely be such as to restore the reputation of the first applicant (see, to that effect, order of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 42 and the case-law cited).

37Second, the first applicant relies on its ‘inability to supply alternative active substances’.

38It is difficult, however to understand in what way its ‘inability to supply alternative active substances’, even if that were to be established, can constitute serious and irreparable harm.

In so far as the arguments of the first applicant seek to demonstrate the seriousness of the harm inherent in loss of market share, in that it would be impossible for the applicant, at least for a considerable period of time, to recover the lost market share, suffice it to state that the risk of losing market share cannot establish urgency in the absence of any information relevant to the assessment of the seriousness of the harm relied on, as is apparent from paragraphs 32 and 33 above. Accordingly, if it is the case that recovery of market share is impossible, which is a factor relevant to whether the harm is irreparable, that cannot compensate for the absence of the information that is required in order to assess the seriousness of the harm.

40Third, the first applicant claims that there is an adverse effect on its reputation and a loss of market share outside the European Union.

41Even if the domino effect suggested by the first applicant were to occur, the fact remains that, once again, it has failed to supply information to permit an assessment of the seriousness of the harm claimed.

42Fourth, the first applicant claims that the loss of ability to exercise data protection rights constitutes serious and irreparable harm, in that its expenditure in the course of the procedure for the authorisation of the substance at issue, in particular on scientific studies, would be frustrated.

43Irrespective of whether frustrated expenditure can constitute serious and irreparable harm, it is undisputed that such damage of a financial nature can be considered, in accordance with the case-law cited in paragraph 25 above, to be serious and irreparable only if the financial viability of the first applicant were imperilled. The first applicant fails to provide any information on that point.

44In the light of the foregoing, it must be concluded that the first applicant has failed to demonstrate urgency.

45With respect to the second applicant, its first claim is that the contested decision entails a risk to its financial viability.

46In that regard, it must be recalled that, in accordance with settled case-law, in a highly regulated market sector that often requires significant investment and in which the competent authorities may have to intervene rapidly when public health risks become apparent, for reasons which cannot always be foreseen by the undertakings concerned, it is for operators in that sector, if they are not to bear themselves the loss resulting from such intervention, to protect themselves against its consequences by adopting an appropriate policy (see order of 16 June 2016, ICA Laboratories and Others v Commission, C‑170/16 P(R), not published, EU:C:2016:462, paragraph 29 and the case-law cited).

47It must therefore be examined whether the second applicant, assuming that the contested decision is liable to cause it serious and irreparable harm, has successfully demonstrated that it adopted an appropriate policy to protect itself against the risk that the substance at issue not be approved.

48In that context, it must be observed, first, that the contested decision cannot be regarded as an unpredictable and unforeseeable event.

49Biocidal substances, including the substance at issue, have been the subject of review under Directive 98/8 since the year 2000. The procedure concerning the substance at issue began in 2006. As a general rule, the risk that a substance may not be approved in the course of review is inherent in such a procedure.

50The second applicant [

] (1) ought reasonably to have been aware of the fact that that substance was the subject of a review and of the risk that the outcome of that review might be non-approval.

51Second, the second applicant gives no information of any steps that it has undertaken in order to protect itself against the risks associated with a possible non-approval of the substance at issue.

52However, the second applicant submits that it should not be ‘penalised’ for not having invested significant resources in a contingency plan, since the non-approval of the substance at issue was not a certainty, let alone a likelihood.

53Such an argument is a misapprehension of the case-law cited in paragraph 46 above.

54That case-law is not concerned with ‘penalising’ economic operators, who have freedom in their business choices, but with giving effect to the settled case-law cited in paragraph 22 above, which states that the grant of the interim measure requested is justified only if the act concerned constitutes the decisive cause of the serious and irreparable harm claimed in the particular context of a highly regulated sector. It is accordingly necessary to examine whether the decisive cause of the harm claimed is in fact the action of the competent authority or whether the cause is to be found in the choice made by the economic operator not to protect itself against the risks associated with such action.

55Third, in that context, the arguments of the second applicant may be understood as intended to demonstrate that no real choice was open to it.

56In that regard, the assertion that the non-approval of the substance at issue was not a certainty, let alone a likelihood, cannot demonstrate that there was no choice that should be made by the second applicant.

57While the procedure was subject to changes in direction, at no time could the second applicant have been certain that the substance at issue would be approved, and it does not suggest otherwise. The risk of non-approval of the substance at issue accordingly existed throughout the procedure.

58In those circumstances [

], the second applicant cannot justifiably maintain that, in the face of that risk, it was not in a position to have to make, at least implicitly, a business choice as to whether it was appropriate and by what means to protect itself against the risks associated with possible non-approval of the substance at issue.

59Likewise, the arguments based on the fact that the second applicant had no real choice in that it was impossible for it to reduce its exposure to the risks associated with possible non-approval of the substance at issue cannot be upheld.

60As regards, in particular, the possibility of replacing the substance at issue with another substance, in this case the active substance transfluthrin, it is common ground that that substance has been approved as an active substance for use in biocidal products of product-type 18 and that it is aimed specifically at moths.

61Further, the second applicant, although stating that transfluthrin has not proved to be as effective as the substance at issue, mentions no technical reason which would make the replacement of the substance at issue by transfluthrin impossible.

62Nor can it be accepted that the second applicant was — for other reasons — in a position where it was impossible for it to replace the substance at issue with transfluthrin.

63While the procedure for making available on the market a biocidal product containing transfluthrin may require in practice up to 42 months, as submitted by the second applicant, the fact remains that risk of non-approval of the substance at issue has existed since 2006 and that transfluthrin was approved in 2014. It follows, a priori, that the second applicant would have had adequate time to complete such a procedure.

64Further, in paragraph 210 of the present application for interim measures, it is maintained, on the existence of irreparable harm as regards the first applicant, that it is likely that its customers will switch to alternative substances, such as transfluthrin.

65If the second applicant decided, notwithstanding the approval of transfluthrin, not to use that substance for economic reasons or because of its carcinogenic effects, the making of such a decision is fully within the ambit of its freedom to conduct business.

66It follows, accordingly, that the second applicant made the choice not to reduce its dependence on the substance at issue and, as a consequence, not to protect itself against the risk of non-approval of that substance.

67In the light of the foregoing and, in particular, the conduct of the re-examination procedure commenced in 2006, it must be concluded that the decisive cause of the harm relied on, namely the risk of insolvency, is not the contested decision, but the business policy adopted by the second applicant, in particular its decision not to protect itself against the risks associated with non-approval of the substance at issue.

68Second, [

].

69In that regard, suffice it to observe that those matters do not constitute claimed instances of harm that are distinct from the harm relating to the financial viability of the second applicant, examined above.

70Fifth, the second applicant argues that its reputation has been affected.

71However, in the light of the case-law cited in paragraphs 35 and 36 above, the second applicant has failed to explain in what way the suspension requested would be capable of providing a remedy for that alleged harm.

72In the light of the foregoing, it must be concluded that the second applicant has failed to demonstrate urgency.

73Last, the argument advanced both with respect to the first applicant and with respect to the second applicant that the harm suffered by them is not reparable, in that the harm cannot be quantified, cannot succeed either.

74Admittedly, financial damage may, for example, be considered to be irreparable if that damage, even when it occurs, cannot be quantified.

75However, in this case, the first applicant has been unable, by reason of the absence of any relevant information on the extent of the harm relied on, to demonstrate the seriousness of its pecuniary damage. Likewise, the contested decision is not the cause of the pecuniary damage relied on by the second applicant. In those circumstances, the possibility that damage of a pecuniary nature may be irreparable because it may be impossible to quantify that damage cannot remedy the failure to demonstrate urgency.

76It follows from all the foregoing that the application for interim measures must be dismissed on the ground that there is no urgency, there being no need to examine the objections of inadmissibility raised by the Commission with respect to the second applicant, or to examine whether there is a prima facie case, or to undertake a weighing of interests.

77Pursuant to Article 158(5) of the Rules of Procedure, the costs must be reserved.

On those grounds,

hereby orders:

1.The application for interim measures is dismissed.

2.The costs are reserved.

Luxembourg, 8 May 2019.

Registrar

Language of the case: English.

Confidential information omitted.