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

ORDER OF THE PRESIDENT OF THE GENERAL COURT

7 November 2019 (*)

(Application for interim measures — Plant protection products — Regulation (EC) No 1107/2009 — Active substance ethoprophos — Conditions for approval for placing the substance on the market — Application for suspension of operation — Lack of urgency)

In Case T‑317/19 R,

AMVAC Netherlands BV, established in Amsterdam (Netherlands), represented by C. Mereu, M. Grunchard and S. Englebert, lawyers,

applicant,

v

European Commission, represented by F. Castilla‑Contreras and I. Naglis, acting as Agents,

defendant,

APPLICATION pursuant to Articles 278 and 279 TFEU seeking suspension of the operation of Commission Implementing Regulation (EU) 2019/344 of 28 February 2019 concerning the non-renewal of approval of the active substance ethoprophos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2019 L 62, p. 7),

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

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

1        The applicant, AMVAC Netherlands BV (‘AMVAC’), is a company established under Dutch law belonging to the American Vanguard Corporation, a U.S. holding company and producer of chemical products. AMVAC was established in 2012 as a marketing, distribution and registration subsidiary of the AMVAC Chemical Corporation, a subsidiary of the American Vanguard Corporation that manufactures, formulates and distributes substances for the protection of crops, turf, ornamental plants, and human and animal health. As such, the applicant markets, inter alia, the active substance ethoprophos.

2        In 2010, the American Vanguard Corporation invested in the acquisition of two product lines from Bayer CropScience AG, one of which was an ethoprophos-based product line marketed as MOCAP®, a broad-spectrum soil nematicide and insecticide registered to counteract damage to flora caused by nematode worms and other soil insects.

3        In accordance with the procedure for listing the active substances of plant protection products established by Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1), ethoprophos was added to Annex I to Directive 91/414 by Commission Directive 2007/52/EC of 16 August 2007 amending Directive 91/414/EEC to include ethoprophos, pirimiphos-methyl and fipronil as active substances (OJ 2007 L 214, p. 3).

4        Active substances included in Annex I to Directive 91/414 are deemed to have been approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1) and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ 2011 L 153, p. 1).

5        The approval of ethoprophos is subject to the standard regulatory renewal of approval procedure under Article 14 et seq. of Regulation No 1107/2009.

6        An application for the renewal of the approval of ethoprophos was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation No 1107/2009 (OJ 2012 L 252, p. 26).

7        On 28 February 2019, the Commission adopted Implementing Regulation (EU) 2019/344 concerning the non-renewal of approval of the active substance ethoprophos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2019 L 67, p. 7; ‘the contested regulation’).

8        The Commission concluded that it had not been established with respect to one or more representative uses of at least one plant protection product containing ethoprophos that the approval criteria provided for in Article 4 of Regulation No 1107/2009 were satisfied. It was therefore appropriate not to renew the approval of the active substance ethoprophos, in accordance with Article 20(1)(b) of that regulation.

9        The contested regulation thus establishes that approval of the active substance ethoprophos is not to be renewed.

10      In accordance with Article 3 thereof, the contested regulation requires Member States to withdraw authorisations for plant protection products containing ethoprophos as an active substance by 21 September 2019 at the latest. Article 4 provides for a possible ‘grace period’ that will expire by 21 March 2020 at the latest.

11      By application lodged at the Registry of the General Court on 24 May 2019, the applicant seeks the annulment of the contested regulation.

12      By separate document lodged at the Court Registry on the same day, the applicant lodged an application for interim measures, in which it claims, in essence, that the President of the General Court should:

–        suspend with immediate effect the contested regulation in accordance with Article 157(2) of the Rules of Procedure of the General Court until the Court has given judgment in the main proceedings;

–        grant any other interim measures as appropriate and hold an oral hearing if necessary;

–        order the Commission to pay the costs.

13      In its observations on the application for interim measures, which were lodged at the Court Registry on 11 June 2019, the Commission contends that the President of the General Court should:

–        dismiss the application for interim measures;

–        reserve the costs until judgment in the main proceedings.

 Law

 General considerations

14      It is apparent from a combined reading of Articles 278 and 279 TFEU, on the one hand, and Article 256(1) TFEU, on the other, that the judge hearing the application for interim measures may, if he considers that the circumstances so require, order that application of an act contested 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 brought before the Court do not have suspensory effect, since acts adopted by the institutions of the European Union are presumed to be lawful. It is therefore only in exceptional circumstances that a judge hearing an application for interim measures may order suspension of the application of an act contested before the General Court or prescribe interim measures (order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 17 and the case-law cited).

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

16      Accordingly, the judge hearing an application for interim relief may order suspension of operation of an act, or 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, so that an application for interim measures must be dismissed if any one of them is not satisfied. Where appropriate, the judge hearing such an application must also weigh up 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).

17      In carrying out that overall examination, the judge considering the application has a wide discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis for assessing the need for an interim decision (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).

18      Having regard to the material in the case file, the judge hearing the application considers that he has all the information needed to rule on the present application for interim measures without there being any need first to hear oral argument from the parties.

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

 Urgency

20      For the purpose of determining 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 avoid a lacuna in the legal protection afforded by the EU Courts. For the purpose of attaining that objective, urgency must generally be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable damage to the party seeking the interim relief. 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).

21      In addition, according to well-established case-law, there is urgency only if the serious and irreparable damage 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 is nonetheless required, in any event, to prove the facts that form the basis of its claim that such damage is likely, it being clear that purely hypothetical damage, based on future and uncertain events, cannot justify the granting of interim measures (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 24 and the case-law cited).

22      Moreover, 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’.

23      Thus, an application for interim measures must be sufficiently clear and specific in itself to enable the defendant to prepare its observations and the judge hearing the application to rule on it, where necessary, without other supporting information, the essential elements of fact and law on which it is founded being set out in a coherent and comprehensible fashion in the actual text of the application for interim relief (see orders of 23 May 2019, Trifolio-M and Others v EFSA, C‑163/19 P(R) and C‑163/19 P(R)‑R, not published, EU:C:2019:453, paragraph 38 and the case-law cited, and 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).

24      It is in the light of those criteria that it should be examined whether the applicant has managed to demonstrate urgency.

25      The applicant alleges, in essence, serious and irreparable damage due to (i) the effects on its turnover and market share in the European Union, (ii) a loss which would be irreversible due to the presence of strong competitors and obstacles of a structural or legal nature, (iii) the knock-on effects in third countries and (iv) the damage to its reputation.

Effects on the applicant’s EU sales and market share

26      In the first place, so far as concerns the alleged damage due to the loss of income relating to the sale of ethoprophos and ethoprophos-based products, the applicant considers that it will suffer a significant loss of turnover and profits.

27      It is well-established case-law that damage of a pecuniary nature cannot, save in exceptional circumstances, be regarded as irreparable or even hardly reparable since, as a general rule, pecuniary compensation is capable of restoring the aggrieved person to the situation that obtained before he suffered the damage. Any such damage could, in particular, be recouped by the applicant’s bringing an action for compensation on the basis of Articles 268 and 340 TFEU (see orders of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 80 and the case-law cited, and of 28 November 2013, EMA v Intermune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 48 and the case-law cited).

28      Regarding the seriousness of the financial damage alleged, it is settled case-law that the interim measure sought will be justified only if it is apparent that, without such a measure, the party seeking it would be in a position that could imperil its existence before final judgment is given in the main action (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 32 and the case-law cited).

29      As indicated in settled case-law, the assessment of the serious nature of such damage is carried out in the light of, inter alia, the size and turnover of the undertaking and the characteristics of the group to which it belongs (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 33 and the case-law cited; see also, to that effect, order of 15 April 1998, Camar v Commission and Council, C‑43/98 P(R), EU:C:1998:166, paragraph 36 and the case-law cited).

30      In addition, it is settled case-law that, with regard to a loss corresponding to less than 10% of the turnover of undertakings operating on highly regulated markets, the financial difficulties which those undertakings risk suffering do not appear to be such as to threaten their very existence (order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 34 and the case-law cited; see also, to that effect, order of 11 April 2001, Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraph 106).

31      In the case at hand, the applicant does not claim that its existence is under threat. It does, nevertheless, provide percentages of sales and profits that allegedly would be affected by the contested regulation, leading to a loss of profits that, in its view, could be regarded as sufficiently serious for the purposes of interim relief.

32      It is apparent from these figures that the applicant’s EU sales of ethoprophos-based products amounted to 1.9% of the group’s turnover in 2017 and to 2% in 2018.

33      In the light of those data, and in accordance with the case-law cited in paragraph 28 above, it may be concluded that the turnover relating to the sales of the substance at issue thus represents a small part of the turnover assessed, as regards the group to which the applicant belongs (see, to that effect and by analogy, order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 37 and the case-law cited).

34      Therefore, the loss of turnover or profit generated by sales of ethoprophos and ethoprophos-based products cannot, in itself, suffice for the alleged damage to be regarded as serious within the meaning of the case-law cited above.

35      However, the applicant also submitted that the Court has previously held that a turnover loss of less than 0.2% of the group’s total annual turnover can be viewed as being sufficiently serious when seen in the broader context of the factual and legal circumstances to be taken into account.

36      It is indeed accepted by case-law that, when evaluating the seriousness of the damage, the judge hearing the application for interim measures cannot confine himself to having recourse, in a mechanical and rigid manner, solely to the relevant turnover, but must also examine the circumstances of each case and, when taking his decision, view them in the context of the damage occasioned in terms of turnover (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 39 and the case-law cited).

37      Nevertheless, it is for the party concerned, not the judge hearing the application for interim measures, to seek the evidence supporting the applicant’s allegations. As indicated in paragraph 23 above, an application for interim measures must be sufficiently clear and specific in itself to enable the judge hearing the application to rule on it. Therefore, it is for the applicant to demonstrate the existence of such circumstances, which it has failed to do in the present case.

38      In the second place, the applicant states that it meets in its own right the threshold of seriousness for the purposes of interim relief as established by the Court. It is apparent from the figures provided by the applicant that its EU sales of ethoprophos-based products accounted for 12.3% of its turnover in 2018 and 9.7% in 2017.

39      This argument cannot be accepted. The figures put forward by the applicant must be compared to the group’s turnover, since the judge hearing the application for interim relief has to assess the risk of disappearance from the market in light of the characteristics of the group to which the applicant belongs.

40      In the third place, relying on the order of 19 July 2007, Du Pont de Nemours (France) and Others v Commission (T‑31/07 R, EU:T:2007:236), the applicant submits that the Court has previously held that a turnover loss of less than 0.2% will not preclude a company from meeting the threshold of seriousness for the purposes of interim relief where a loss of market share is claimed.

41      In that respect, the applicant claims that it would suffer irreparable harm if the operation of the contested regulation were not suspended as its market share in the EU would be diminished and it would face significant structural and legal obstacles preventing it from recovering that market share.

42      First, it must be stated that the alleged damage due to loss of market share is purely financial.

43      It is settled case-law that the market share held by a company indicates only the percentage of all the products present on the market in question which were sold by that company to customers over the course of a specified reference period. Consequently, the loss of that market share consists in the loss of the profits that may be realised in the future on sales of the product in question. A market share can thus be represented in financial terms, as the holder of that market share can benefit from it only in so far as it generates profit for him (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 54 and the case-law cited).

44      While, according to case-law, account has also been taken of the fact that, if the measure sought were not granted, the applicant’s market share would be irremediably affected, this situation corresponds to that of the risk of disappearance from the market. Hence, adoption of the interim measure sought is justified only if the irremediable effect on the market share is also of a serious nature. It is therefore not sufficient that a market share may be irremediably lost by an undertaking. Rather, it is necessary for that market share to be sufficiently large in the light of, in particular, the size of that undertaking, regard being had to the characteristics of the group to which it belongs through its shareholders (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 58 and the case-law cited).

45      In the case at hand, the applicant argues that the impending losses of market share meet the threshold of seriousness for the purposes of interim relief, since MOCAP® covers a total acreage of 87 000 hectares in central and southern Europe. Moreover, the market share held by MOCAP® varies between 91.3% and 59.5% of the total area treated for wireworm dosed with the product across the various zones and jurisdictions.

46      However, in giving such isolated items of information, the applicant does not place the judge hearing the application for interim relief in a position to assess the situation in accordance with the requisite legal standard, as indicated in paragraph 44 above. Moreover, this information does not render devoid of relevance the fact, as previously stated, that, in the light of the analysis of the figures provided and the evidence set out in the application, the level of turnover allegedly affected does not appear to be of a sufficient magnitude for the alleged damage to be considered serious (see paragraphs 29 and 37 above).

47      Second, an applicant invoking the loss of market share as constituting irreparable harm must demonstrate, furthermore, that regaining a significant proportion of that share is impossible by reason of obstacles of a structural or legal nature (see order of 12 October 2018, Taminco v EFSA, T‑621/17 R, EU:T:2018:763, paragraph 98 and the case-law cited).

48      In the case at hand, the applicant has not demonstrated to the requisite legal standard that there are obstacles of a structural or legal nature making it impossible to regain a significant portion of that share.

49      First, the applicant seems to put forward arguments related to the need to submit a new application for approval of the active substance concerned, which would be a cumbersome and lengthy process.

50      However, it is sufficient to note that such a situation would arise only in the event that the applicant lost its case. As is rightly pointed out by the Commission in its observations of 11 June 2019, the purpose of interim measures is to prevent irreparable damage while the case on the merits is pending and not to defer in time the potential consequences for the applicant if the main application is rejected on the merits.

51      Second, the applicant claims that it does not have any other product registered for the same use as MOCAP® that it could offer to its customers once the active substance concerned is no longer available on the market. In addition, the production of a new nematicide/insecticide would face clear and obvious structural and regulatory obstacles, which would prevent such product development in time to recapture lost MOCAP® sales.

52      Having regard to the average duration of proceedings before the General Court, a decision on the legality of the contested regulation will be handed down long before the approval of any replacement substance capable of recapturing lost MOCAP® sales. Consequently, the lack of a replacement product in the applicant’s substance portfolio does not appear to be a factor relevant to whether the damage alleged is irreparable (see, to that effect, order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 90).

53      Third, the applicant considers that the loss of its market share will be irreversible in so far as its competitors have other products that will enable them to recoup that market share and its customers within the EU, whereas it does not have substitute products.

54      In that regard, the applicant’s submissions appear to be inconsistent and contradictory. On the one hand, the applicant claims that competitors have alternative products that will allow them to take over its market share, thus causing irreparable damage. On the other hand, the applicant claims that the contested regulation will leave the EU’s producers with no guaranteed protection against wireworm infestation in the very short term at a time of hardship for the industry.

55      Therefore, the applicant fails to comply with the criteria set out in paragraphs 26 to 29 above and its arguments must be dismissed.

Knock-on effects on sales outside the EU

56      The applicant alleges that the knock-on effects on its sales in countries outside the EU constitute serious harm.

57      First, the reduction in sales in countries not belonging to the EU as a consequence of the adoption of a regulation banning or restricting the use of a substance, due to the fact that some non-member countries are likely to follow the EU rules, cannot be taken into account when assessing the seriousness of the damage alleged, since such measures would be the direct consequence not of the contested regulation, but of a decision taken by the authorities of each non-member country in the exercise of their absolute discretion (see, to that effect, order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 45 and the case-law cited).

58      Second, the applicant refers to certain EU free trade agreements in an attempt to show that the EU exerts its regulatory influence through these instruments and that the third countries involved will mirror the EU’s ethoprophos ban. However, as pointed out by the Commission, the provisions mentioned by the applicant do not state that the EU ban of an active substance is binding on other parties.

59      Third, the simple reference to the Rotterdam Convention does not show by itself that the notification system set up by that convention may cause the applicant foreseeable and quantifiable damage in a given non-member state while the main proceedings are ongoing. In particular, the applicant has not shown that the mechanism under the Rotterdam Convention would result directly and inevitably in losses of sales of ethoprophos-based products on the markets of countries outside the EU (see, to that effect, order of 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:T:2009:124, paragraph 57 and the case-law cited).

60      Fourth, it must be stated that the applicant has not established that the interim measures sought, assuming they were granted, would prevent third country authorities from ordering the withdrawal of its products from their territory. Consequently, the applicant has not demonstrated that suspension of operation of the contested regulation would be liable to prevent the alleged damage materialising (see, to that effect, order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 46 and the case-law cited).

Reputational damage

61      The applicant argues that the contested regulation will damage its reputation, the reputation of its ethoprophos-based line of products marketed as MOCAP®, as well as the reputation of other products produced by the applicant.

62      First, the withdrawal of a plant protection product from the market is not necessarily detrimental to the reputation of the undertaking concerned as a whole. Indeed, it is common knowledge that many undertakings active in the market at issue have had their products withdrawn from the market, without such withdrawal having a stigmatizing effect on those undertakings or their products. The regulatory authorities and the operators in the sector concerned, which are familiar with the regulatory framework, tend to view a decision not to authorise a plant protection product as a normal part of a regulatory procedure. Such a decision may be regarded as being simply the result of scientific developments and improvement in research methods (see, to that effect, order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 72 and the case-law cited).

63      Second, if damage to the applicant’s reputation and its products actually followed from the adoption of the contested regulation, it is likely that it would have already been caused the day the contested regulation was published and will last until that that regulation is annulled by the decision on the main action. Given that the contested regulation was adopted following a complex administrative procedure lasting a number of years and involving scientific experts and specialist professionals, suspension of the operation of that regulation ordered by the judge on a purely interim basis in summary proceedings would scarcely be such as to dispel doubts which may exist as to the merits of the claim that the active substance ethoprophos is harmless (see, to that effect, order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 74 and the case-law cited).

64      In that regard, the applicant does not indicate how suspension of operation of the contested regulation would put an end to the fears that have already been caused by the publication of EFSA’s assessment of ethoprophos, which is not subject to suspension since the adoption of the order of 15 July 2018 in Case T‑720/18 R has the force of res judicata. In fact, by letter lodged at the Court Registry on 3 June 2019, the applicant informed the Court, in accordance with Article 125 of the Rules of Procedure, that it wished to discontinue proceedings in Case T‑720/18. Accordingly, this case was removed from the register by order of 23 July 2019.

65      Moreover, the applicant itself recognises that suspension of the operation of the contested regulation on an interim basis may not be enough to restore lost reputation.

66      Finally, it is not possible on the basis of the evidence in the case file to reach a conclusion as to whether there is likely to be damage to the applicant’s reputation since the applicant received letters of support from its customers requesting special authorisation to use its products despite EFSA’s and the Commission’s negative decisions.

67      Moreover, the applicant does not put forward any argument to demonstrate that the alleged loss of reputation would be irreversible. On the contrary, the letters from the applicant’s customers, annexed to the application for interim relief, seem to show the opposite, as customer support remains strong for the use of ethoprophos-based products, despite the risks identified by EFSA and the Commission. Similarly, in omitting to address possible means of recovering any potential loss of customers (such as, for instance, marketing events or publicity campaigns), the applicant has failed to substantiate its claims regarding the irreparable harm its reputation would suffer as a result of the adoption of the contested regulation, at odds with the case-law mentioned in paragraphs 26 to 29 above.

68      In the light of the foregoing, it must be concluded that the applicant has not established that the alleged damage is serious and irreparable.

69      In the fifth and last place, the applicant considers that financial compensation alone, obtained by bringing an action for damages, will not suffice to constitute restitutio in integrum, as, in the applicant’s view, no amount of damages can compensate it for the loss of revenue, reputation and market share it will suffer during the period preceding the delivery of a judgment annulling the contested regulation.

70      However, in formulating such an assumption, the applicant does no more than make assertions, without adducing any evidence enabling the President of the Court to assess the relevance of such a claim, at odds with the criteria indicated in paragraph 23 above.

71      In the light of the foregoing, the applicant has not demonstrated that the condition relating to urgency is satisfied.

72      In those circumstances, as the conditions for granting suspension of operation and interim measures are cumulative, the application for interim measures must be rejected for lack of urgency, without it being necessary to examine in greater detail the condition relating to the establishment of a prima facie case, or to weigh up the interests involved.

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

On those grounds,

THE PRESIDENT OF THE GENERAL COURT

hereby orders:

1.      The application for interim measures is dismissed.

2.      The costs are reserved.

Luxembourg, 7 November 2019.

*      Language of the case: English

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