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

ORDER OF THE PRESIDENT OF THE GENERAL COURT

21 January 2019 (*)(1)

(Application for interim measures — Plant-protection products — Active substance oxasulfuron — Non-renewal of approval for placing on the market — Application for suspension of operation — Lack of urgency — Balancing of interests)

In Case T‑574/18 R,

Agrochem-Maks d.o.o., established in Zagreb (Croatia), represented by S. Pappas, lawyer,

applicant,

v

European Commission, represented by A. Lewis, I. Naglis and G. Koleva, acting as Agents,

defendant,

APPLICATION based on Articles 278 and 279 TFEU, seeking suspension of the operation of Commission Implementing Regulation (EU) 2018/1019 of 18 July 2018 concerning the non-renewal of approval of the active substance oxasulfuron, 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 Commission Implementing Regulation (EU) No 540/2011 (OJ 2018 L 183, p. 14),

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,Agrochem-Maks d.o.o., is a family-owned private company incorporated under Croatian law. It currently operates only on the Croatian market for plant protection products. The applicant holds authorisations for certain plant protection products in Croatia and sells others in Croatia on behalf of holders of authorisations. It sells those products to wholesalers and retailers, which in turn sell them to farmers.

2        The applicant holds inter alia an authorisation in Croatia for the product Laguna 75 WG (‘Laguna’), which is a post-emergence broadleaf herbicide (used after the plant is removed from the ground), whose active substance is oxasulfuron and which is intended for use on soya beans. That product is manufactured in Europe by Syngenta, an undertaking established in Switzerland. Through the product Laguna, in 2017 and 2018, the applicant controlled the majority of the Croatian market herbicides for soya beans, with an estimated market share of 54.7% for 2017.

3        Post-emergence herbicides are, however, used in a minority of cases in the European Union, with the current trend being more in favour of pre-emergence products (used before the plant is removed from the ground). Thus, only the Republic of Croatia and the Italian Republic authorise the use of products containing oxasulfuron.

4        Laguna is imported into the European Union by a company owned by the applicant’s shareholders, Kavran-Maks d.o.o. (‘Kavran’), which carries out import activities solely on the applicant’s behalf. Furthermore, the applicant belongs to the same group of companies as Bioplin-Maks d.o.o. (Bioplin), which manages a biogas facility for electricity production and whose raw material requirements are financed by the applicant.

5        In accordance with the procedure for the inclusion of active substances of plant protection products implemented by Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1), oxasulfuron was added to Annex I to Directive 91/414 by Commission Directive 2003/23/EC of 25 March 2003 amending Directive 91/414 to include imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid as active substances (OJ 2003 L 81, p. 39), for a period of 10 years expiring on 30 June 2013.

6        After the entry into force 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 (OJ 2009 L 309, p. 1), oxasulfuron was included in the list provided for by Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation No 1107/2009 as regards the list of approved active substances (OJ 2011 L 153, p. 1).

7        In accordance with Article 14 of Regulation No 1107/2009, the applicant submitted a request to renew the approval of the active substance oxasulfuron to the competent authorities of the Italian Republic, acting as the designated rapporteur Member State.

8        On 29 January 2016, the Italian Republic and the Republic of Austria (acting as the designated co-rapporteur Member State) sent their assessment report in respect of the renewal of the approval to the European Food Safety Authority (EFSA) and the European Commission. That report concluded that the renewal dossiers were sufficiently complete to allow a full assessment of the substance and that the information provided warranted acceptance of the renewal of oxasulfuron. That report was sent to the applicant and to the Member States for comments and a public consultation was launched.

9        In the second half of 2016, the rapporteur Member State submitted a revised approval assessment report. In January 2017, EFSA issued the peer review report on oxasulfuron. On 30 January 2017, EFSA adopted its conclusions in accordance with Article 13(1) of Regulation No 1107/2009, in which it referred to the Italian Republic’s revised assessment report. In its findings, EFSA drew up a list of gaps in the data submitted by the applicant. Seven issues were accordingly regarded by EFSA as ‘could not be finalised’ (meaning that the information available was deemed insufficient to conclude that the active substance can be expected to fulfil the approval criteria) and two issues as containing ‘areas of critical concern’.

10      Taking account of the above, on 14 June 2018, the Standing Committee on Plants, Animals, Food and Feed of the Commission finalised the renewal report for the substance in question.

11      On 18 July 2018, the Commission adopted Implementing Regulation (EU) 2018/1019 concerning the non-renewal of approval of the active substance oxasulfuron, in accordance with Regulation No 1107/2009, and amending Implementing Regulation No 540/2011 (OJ 2018 L 183, p. 14, ‘the contested regulation’).

12      Article 1 of the contested regulation states that the approval of the active substance oxasulfuron is not renewed.

13      In accordance with Article 3 thereof, the contested regulation requires Member States to withdraw authorisations for plant protection products containing oxasulfuron by 8 November 2018 at the latest. Article 4 of that regulation provides for a ‘grace period’ of up to one year, expiring on 8 November 2019 at the latest.

14      By application lodged at the Court Registry on 28 September 2018, the applicant claimed that the Court should annul the contested regulation.

15      By separate document lodged at the Court Registry on the same day, the applicant made an application for the case to be decided under an expedited procedure, in accordance with Article 152(1) of the Rules of Procedure of the General Court.

16      By a separate document, lodged at the Court Registry on the same date, the applicant brought the present application for interim measures, in which it claims that the President of the General Court should:

–        suspend the operation of the contested regulation until the Court has ruled on the application for annulment of that regulation;

–        suspend the operation of the contested regulation pursuant to Article 157(2) of the Rules of Procedure pending the adoption of an order bringing the present proceedings for interim relief to an end;

–        order the Commission to pay the costs.

17      In its observations on the application for interim measures, lodged at the Registry of the General Court on 10 October 2018, the Commission contends that the President of the General Court should:

–        reject the application for interim measures; and

–        reserve the costs.

 Law

 General considerations

18      It is apparent from Articles 278 and 279 TFEU, read in conjunction with Article 256(1) TFEU, that the judge hearing the application for interim measures may, if he considers that circumstances so require, order that an act challenged before the General Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure of the General Court. Nevertheless, Article 278 TFEU states that in principle actions are not to have suspensory effect, in so far as acts adopted by the EU institutions enjoy a presumption of legality. It is therefore only exceptionally that a judge hearing an application for interim measures may order suspension of the operation of an act contested before the General Court or prescribe interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).

19      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 measures applied for’.

20      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 proceedings. Those conditions are cumulative, so that an application for interim measures must be dismissed if either of them is absent. Where appropriate, the judge hearing such an application must also weigh 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).

21      In the context of that overall examination, the judge hearing the application for interim measures enjoys a broad discretion and is free to determine, having regard to the particular 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).

22      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.

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

 Urgency

24      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 Court. To attain that objective, urgency must 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 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).

25      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 remains, in any event, required 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).

26      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’.

27      Thus, 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).

28      It is also settled case-law that, to determine whether all the conditions referred to in paragraphs 24, 25 and 27 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).

29      Lastly, 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 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 28 and the case-law cited).

30      It is in the light of those criteria that it must be examined whether the applicant has succeeded in demonstrating urgency.

31      The applicant invokes, in essence, serious and irreparable damage due to the risk of adverse effects on its turnover, loss of market share, of impact on one of its manufacturing plants, and reduction of the total value of the undertaking.

 The serious nature of the harm

32      In the first place, so far as concerns the seriousness of the alleged damage due to the risk of adverse effects on its turnover and profits, and the risk of a reduction in its total enterprise value, which must be examined together, the applicant considers that, as a result of the contested regulation, it will suffer a significant loss of turnover and profits, as well as of its ‘implied enterprise value’. In that regard, it is thus appropriate to point out that the damage alleged is purely financial.

33      Regarding the seriousness of the financial damage alleged, it is settled case-law that the interim measure sought will be justified only if it appears that, without such a measure, the party seeking it would be in a position that could imperil its existence before the final decision in the main action (see order of 30 April 2010, Xeda International and Pace International v Commission, T‑71/10 R, not published, EU:T:2010:173, paragraph 42 and the case-law cited).

34      In that regard, it is settled case-law that 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 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 20 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).

35      In addition, it must be recalled that, also according to settled case-law, it has been found, that, on the one hand, with regard to a loss corresponding to less than 10% of turnover of undertakings active in highly regulated markets, the financial difficulties which those undertakings risked suffering do not appear to be such as to threaten their very existence (order of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 21; 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) and, on the other, regarding a loss representing almost two thirds of the turnover of those undertakings, while acknowledging that the financial difficulties they underwent could have been such as to threaten their very existence, it has nevertheless been underlined that, in a highly regulated sector where major investment is often required and the competent authorities may be led to intervene when public health risks become apparent, for reasons which cannot always be foreseen by the undertakings concerned, it was for those undertakings, if they were 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).

36      In the present case, the applicant maintains, for 2017, that it has a total income of EUR 114 751 316, including EUR 15 216 941.17 from sales of the product Laguna, that is to say approximately 13.26% of its total turnover. In addition, sales of three products ancillary to Laguna, for the same year, reported a total of EUR 5 079 535.60, namely 4.43% of its total turnover. It submits, next, that the import on its behalf of those four products represents, for Kavran, EUR 15 716 330.04 for a total turnover of EUR 56 996 563, that is to say approximately 27.57% of Kavran’s total turnover. It submits, finally that Laguna and its ancillary products together represent more than 50% of its ‘implicit enterprise value’ with Kavran.

37      At the outset, the necessarily personal nature of the harm alleged in the analysis relating to urgency, as referred to in settled case-law, should be noted (order of 4 December 2007, Cheminova and Others v Commission, T‑326/07 R, EU:T:2007:364, paragraph 50 and the case-law cited). The applicant cannot thus, in the context of the present application for interim measures, rely on harm caused to other undertakings, which are not parties to the case, in order to demonstrate the seriousness of the alleged harm.

38      In that regard, it must be noted that, although the applicant states that the three ancillary products are generally purchased at the same time as Laguna, it does not adduce any evidence to show that they cannot be used without Laguna, for example in combination with another herbicide. The turnover relating to the three ancillary products cannot therefore be taken into account in analysing the seriousness of the harm.

39      In any event, it must be pointed out that it was accepted –– in the order of 28 April 2009, United Phosphorus v Commission (T‑95/09 R, not published, EU:T:2009:124, paragraph 69) –– that, in the evaluation of the seriousness of the harm, the judge hearing the application for interim relief could not confine himself to having recourse, in a mechanical and rigid manner, solely to the relevant turnover, but was required also to examine the circumstances particular to each case and relate them, when taking his decision, to the harm occasioned in terms of turnover.

40      While it is true that that case-law has, up to now, principally been invoked in order to allow the court to assess whether the seriousness of the alleged harm could be established despite the fact that the turnover did not exceed the indicative threshold of 10% referred to in paragraph 35 above, that prohibition of a mechanical and rigid analysis cannot be limited to that interpretation alone, but must also be understood as requiring the courts to confirm whether, given the specific circumstances of the case, the seriousness ought not to be established despite that threshold being exceeded.

41      In these circumstances, it appears that it must be noted, first, that it is apparent from the documents in the file that the applicant is, effectively, a distributor in Croatia of oxasulfuron manufactured by a Chinese subcontractor according to a formula provided by Syngenta and imported into Croatia by Kavran. Accordingly, it did not have to bear the significant investments, general costs and fixed costs that developing the activity of a manufacturer involved.

42      In that regard, it must be pointed out, at the outset, that, contrary to the view of the Commission, the status of distributor does not automatically mean that it is easy to replace a banned product with a similar one. Indeed, there are many obstacles which can, in that context, hinder or prevent the development of new substances, especially in a highly regulated market such as the one in question.

43      Moreover, it follows from the applicant’s observations, and from the marginal market share of pre-emergence herbicides, that those herbicides, which appear to be recommended for use in humid climates, accordingly seem not correspond to the Croatian market and therefore do not constitute, in principle, a viable alternative solution to oxasulfuron.

44      However, it must be noted, first, that, although the applicant claims that the only other post-emergence herbicide on the Croatian market is imazamox, sold by the competitor undertaking BASF, it puts forward no information concerning any alternative post-emergence products already present in the European Union which could be distributed on the Croatian market. In accordance with the principles referred to in paragraphs 26 to 28 above, it is for the party seeking interim measures to provide evidence enabling the court to rule.

45      Next, the applicant’s argument that it could not find any alternative herbicide to distribute on the Croatian market since the developers and manufacturers of active substances are generally responsible themselves for distribution cannot, as it stands, convince the judge hearing the application for interim measures. First, up to now, the applicant has been distributing a product developed by another undertaking, which accordingly contradicts its claim, and, second, the applicant’s facility and the distribution network it has developed on the Croatian market, together with the business opportunity that the disappearance of oxasulfuron would represent, appear to constitute evidence that the applicant could use in the process of finding new manufacturers.

46      Second, it must be noted that the applicant is operating in a highly regulated market. However, as noted in paragraph 35 above, it was therefore incumbent on the applicant to behave in such a way as to take into account the increased risk of a ban on the marketing of its product, in terms of having to bear the loss arising from such a ban. Consequently and contrary to what the applicant maintains, the Court should, in its analysis of the seriousness of the alleged harm, take into account the applicant’s business strategy.

47      In the present case, the share of turnover represented by sales of its product Laguna must be assessed as the result of a deliberate policy in a highly regulated market. Nevertheless, without any further evidence relating to measures that the applicant may have taken to avoid a potentially risky situation in the light of the nature of the market in question, exceeding the indicative threshold of 10% cannot, in itself, convince the judge hearing the application for interim measures of the seriousness of the alleged harm.

48      In this context, it should be pointed out that the applicant cannot rely on any legitimate expectations arising from the outcome arrived at by the rapporteur Member State. As the Commission rightly points out, this report is only an intermediate stage of a well-known procedure and does not in any way predict the final outcome to be determined by the Commission. Moreover, as the settled case-law points out, the principle of the protection of legitimate expectations can only be invoked in relation to a situation that could give rise to it caused by the institution empowered to take the final decision (see judgment of 30 January 2018, Przedsiębiorstwo Energetyki Cieplnej v ECHA, T‑625/16, not published, EU:T:2018:44, paragraphs 75 and 76 and the case-law cited). The principle of legitimate expectations cannot therefore arise, in the context of a procedure for the renewal of the approval of a plant protection substance such as in the present case, with regard to the results of the interim report submitted by the rapporteur Member State.

49      It must therefore be held that the facts of the case must lead the judge to place the significance of the relevant turnover in context and to conclude that the alleged loss is not serious on account of the likelihood of a negative effect on its turnover and profits or a reduction in its total business value.

50      In the second place, as regards the seriousness of the alleged harm on account of the risk of loss of its market share, the applicant maintains that its market share, which it puts at 54.7% of the Croatian market for herbicides for soya beans, will be lost to competitors. It claims, moreover, that the potential grace period provided for in Article 4 of the contested regulation would have no effect in the present case, in so far as it concerns only the use of stock already placed on the market and thus would not permit a new placing on the market in 2019.

51      In that regard, it must be pointed out that the alleged harm is purely financial. 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 liable to be realised in the future on sales of the product in question. A market share can thus clearly 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 30 April 2010, Xeda International v Commission, T‑71/10 R, not published, EU:T:2010:173, paragraph 41 and the case-law cited).

52      As regards the seriousness of the alleged financial harm, it must be recalled, first, that the interim measure sought will be justified only if it appears that, without such a measure, the party seeking it would be in a position that could imperil its existence before final decision in the main action (see paragraph 33 above).

53      In the present case, it does not appear from the pleadings or the analysis of the figures provided by the applicant and referred to in paragraph 36 above that the applicant’s existence would be under threat.

54      Second, the applicant appears to be of the view that, without a suspension of operation, its market share would be damaged irreparably in so far as it would face significant legal and regulatory obstacles under the applicable rules.

55      While, in the 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, it must be pointed out that this situation can be placed on an equal footing with that of the risk of disappearance from the market and justify adoption of the interim measure sought only if the irremediable effect on 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 30 April 2010, Xeda International v Commission, T‑71/10 R, not published, EU:T:2010:173, paragraph 43 and the case-law cited).

56      In that regard, it has been stated, first, that, in the light of the specific circumstances of the case, the level of turnover allegedly affected does not appear to be of a sufficient magnitude to consider the alleged harm serious (see paragraph 49 above).

57      Second, the option for the Croatian authorities to grant a grace period as provided for in Article 4 of the contested regulation enables the applicant in the present case to benefit from an additional year to distribute its oxasulfuron-based products.

58      As the applicant maintains, since the period for sowing soya beans in Croatia lasts from April to May each year, wholesalers and retailers place their orders with it between February and May of the year in question.

59      As is apparent from Article 20 of Regulation No 1107/2009, and contrary to what the applicant claims, the grace period allows, during the first six months, not only use of stocks already placed on the market but also the placing on the market of new quantities of the product in question. The competent authorities may, therefore, up to 8 May 2019, authorise the applicant to place oxasulfuron on the national market. Given that, as stated in paragraph 58 above, orders for 2019 will be placed by its customers between February and May 2019, it will in principle be able to respond to all requests for the 2019 season.

60      It must, therefore, be held that the contested regulation does not appear immediately to endanger the applicant’s market share on the Croatian market for herbicides for soya beans. Since the applicant is, moreover, as stated in paragraph 46 above, not a producer, but the distributor of the product in question, the one-year period does not appear, in principle, unreasonable for the purposes of planning, or developing, the distribution of replacement active substances. In that regard, the possibilities raised in paragraph 44 above, concerning possible replacement post-emergence herbicides in the territory of the European Union, and in paragraph 45 above, as regards the well-established distribution network that the applicant has built up on the Croatian market, does not seem, at first sight, to be irrelevant.

61      Therefore, the mere loss of its market share relating to its activities concerning oxasulfuron, as claimed by the applicant, cannot suffice for the alleged harm to be regarded as serious within the meaning of the case-law cited in paragraph 55 above.

62      In the light of the foregoing, it must be concluded that the applicant has not established the seriousness of the harm alleged.

 Irreparable nature of the harm

63      Neither does it appear, moreover, that the harm alleged in the present case can be categorised as irreparable.

64      In the first place, it is well-established case-law that damage of a pecuniary nature cannot, save in exceptional circumstances, be regarded as irreparable or even as reparable with difficulty 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 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, and of 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:T:2009:124, paragraph 33 and the case-law cited).

65      In the event of such damage, the interim measure sought is justified if it appears that, without that measure, the party seeking the interim measures would be in a position that could imperil its existence before the final decision in the main action. Since imminent disappearance from the market does constitute damage that is both irremediable and serious, adoption of the interim measure sought appears justified in such a situation (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 81 and the case-law cited).

66      In the present case, it is apparent from the analysis carried out by the judge hearing the application for interim measures in paragraphs 32 to 49 above, concerning the alleged damage due to the risk of adverse effects on its turnover and profits, that the applicant is not in such a situation.

67      In the second place, as has been recalled in paragraph 55 above, although account has also been taken of the fact that, if the interim measure sought was not granted, the market share of the applicant would be irremediably affected, it must be pointed out that this situation can be placed on an equal footing with that of the risk of disappearance from the market and justify the adoption of the interim measure sought only if the irremediable effect on 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. A party seeking interim measures which invokes the loss of such a market share 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 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:T:2009:124, paragraph 35 and the case-law cited).

68      In the case at hand, it has been concluded that the market share, the loss of which is feared by the applicant is not large (see paragraph 61 above). In any event, the applicant has not demonstrated, to the requisite legal standard, the existence of obstacles of a structural or legal nature making a significant portion of that share impossible to regain.

69      In that regard, the applicant claims that its lost market share will go to the competitor company BASF, whose imazamox-based products are the only other post emergence herbicides for soya beans authorised on the Croatian market with a comparable spectrum of effectiveness. The applicant will then hold, according to its estimates, an 85% market share for soya-bean herbicides (and a 100% market share for post-emergence soya-bean herbicides); the remaining 15% will be held by undertakings developing pre-emergence herbicides. This monopoly situation would, according to the applicant, allow BASF to build brand loyalty to its products with farmers. The applicant maintains that brand loyalty is of crucial importance to the conduct of farmers and retailers who look to the previous year when placing their orders. The applicant submits that it will therefore be virtually impossible for it to regain its lost market share if the post-emergence herbicides market for soya beans were to be monopolised by imazamox-based products for at least two years.

70      First, it must be pointed out that those claims regarding brand loyalty are based on assumptions which are not supported by any evidence provided by the applicant. According to the settled case-law referred to in paragraph 27 above, the basic matters of law and fact on which the application for interim measures is based must clearly be found in that application and must, in themselves, allow the judge hearing the application for interim measures to rule on it. It is not for the judge hearing the application for interim measures to seek, in place of the party concerned, evidence in support of its claims.

71      Moreover, and contrary to the settled case-law referred to in paragraph 67 above, the arguments raised by the applicant in support of the demonstration of the irreparable nature of the harm in no way constitute structural or legal obstacles, but are of a purely commercial nature. The difficulty invoked, as is apparent from the pleadings, in regaining market share lost as a result of the loyalty of end consumers to the product they use cannot, therefore, in itself, convince the judge hearing the application for interim measures of the irreparable nature of the alleged harm.

72      Second, as stated in paragraph 59 above, the grace period provided for in Article 4 of the contested regulation enables the applicant to continue to place its oxasulfuron-based product on the Croatian market until 8 May 2019, that is to say, it appears, until the end of the order period for the wholesalers and retailers which buy from it, enabling it accordingly to meet demand for 2019 in full.

73      In that regard, it should be noted that, having regard to the average duration of proceedings before the General Court, (see, to that effect, order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 90 and the case-law cited), the decision on the substance in the present case is likely to be delivered within two years, that is to say in autumn 2020. Consequently, it is highly likely that a complete ban on the use of Laguna will therefore be seen only in 2020, before the Court delivers its ruling on the lawfulness of the contested regulation.

74      Users of oxasulfuron-based products who must therefore turn to alternative products — whether imazamox, pre-emergence herbicides or new products — only for the duration of a single soya-bean growth period, the hypothetical loyalty to this new substance in such a short period does not seem, in the light of the evidence adduced by the applicant, to be a relevant factor with regard to the irreparable nature of the alleged harm.

75      In the third place, it must nevertheless be pointed out that harm of a financial nature may be considered to be serious and irreparable if the harm, even when it occurs, cannot be quantified (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 92 and the case-law cited).

76      It is true that the 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. 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 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 93 and the case-law cited).

77      However, 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 (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 94 and the case-law cited).

78      However, in the case at hand, even though the applicant considers the alleged damage unlikely to be recoverable, it does not appear from its submissions that that is the case, and 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. On the contrary, the applicant puts forward, as referred to in paragraphs 36, 50 and 69 above, a certain amount of accounting information enabling, at first sight, that damage not only to be identified, but also to be quantified in an adequate manner.

79      In that regard, the reasoning set out in paragraphs 59 and 73 above shows that, given the average duration of proceedings before the Court and in view of the grace period enabling the applicant to place its product on the market for 2019, the only period during which the applicant would be prevented from distributing oxasulfuron before a decision on the merits is likely to be the year 2020. It is apparent from the file that both the market share held by the applicant and its volume of orders and related profits have remained stable. The harm which would arise from a ban on marketing the active substance on the Croatian market in 2020 cannot therefore be regarded as quantifiable.

80      It follows that the applicant has failed to establish either the seriousness or the irreparable nature of the alleged harm.

81      In the light of the foregoing, it follows that the applicant has failed to show that the condition relating to urgency, as defined in paragraph 24 above, was satisfied.

 Balancing of interests

82      Next, it must be emphasised that the balancing of interests does not tip in favour of suspension of the contested regulation.

83      According to the case-law, the risks associated with each of the possible disposals of the case must be weighed in the proceedings for interim measures. In practical terms, that means examining whether or not the interest of the party seeking interim measures in obtaining suspension of the operation of the contested act outweighs the interest in its immediate implementation. In that examination, it must be determined whether the possible annulment of that act by the judgment on the substance would make it possible to reverse the situation that would have been brought about by its immediate implementation and, conversely, whether suspension of its operation would be such as to impede the objectives pursued by the contested act in the event of the main action being dismissed (order of 1 March 2017, EMA v MSD Animal Health Innovation and Intervet international, C‑512/16 P(R), not published, EU:C:2017:149, paragraph 127).

84      In the present case, the applicant considers that the balance weighs in its favour in so far as, first, the substance in question does not present a known and demonstrated danger to public health and, second, the immediate application of the contested regulation would have the consequence of switching users of oxasulfuron to imazamox, which, being described by the Commission as a ‘candidate for substitution’, itself constitutes a danger to public health.

85      As a preliminary point, it must be pointed out that the non-renewal of the product concerned is based, first, on the existence of two factors raising serious concerns and, second, on the existence of seven issues that could not be finalised. Although the first two factors concern established risks to earthworms and aquatic organisms, it cannot be inferred that a lack of information, such as the gaps arising from the seven issues that could not be finalised in the present case, can be interpreted as meaning that it follows that there is no risk to public health.

86      In the first place, so far as concerns the argument based on the lack of danger to public health, the applicant states that the substance at issue and the substance-based products have been on the market for over 20 years and that no public health incidents have taken place to date following their commercialisation. In addition, it claims that, otherwise, the extension of the initial approval for a period of six years from 2013 to 2019, pending the examination of the substance, would not have been granted by the Commission.

87      It is apparent from the material in the case file that risks to human health cannot be ruled out. In that regard, it must, first, be noted that the applicant can draw no convincing argument in the case at hand from the fact that the substance has been safely used in the European Union for more than 20 years without any harmful effects on human health ever having been reported. In the sector concerned by the present case, scientific developments are not uncommon and thus provide the opportunity to assess once again substances in the light of new knowledge and scientific discoveries. That is the basis of renewal procedures and the rationale for applying time limits to marketing authorisations. Consequently, the examination by the judge hearing the application for interim measures in the context of the balancing of interests must extend to the risks now identified (see, to that effect, order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 105), on the one hand, and which cannot be ruled out, on the other hand.

88      Next, the applicant’s position that there is no public health risk is based primarily on the arguments it raises in the context of its demonstration of the existence of a prima facie case, namely, first, that the decision to adopt the contested regulation stems from an infringement, first, of the obligation to state reasons of the administration with regard to its assessment that the shortcomings identified justify the non-renewal of the approval of oxasulfuron and, second, of the obligation to state reasons of the administration concerning the existence of a high risk for aquatic organisms and earthworms.

89      Those aspects fall within the review of the legality of the procedure and cannot lead, without other elements and with the exception of a possible acknowledgement of a manifest error of assessment, the judge hearing the application for interim measures, in the context of the balancing of interests, to consider that the conclusions presented in those documents must prevail over the preceding assessments which are in principle the result of a meticulous and exhaustive examination. It is not for him to conduct a technical assessment of scientific data that would exceed his powers (see, to that effect, order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 108).

90      This is especially true in the present case, where the alleged harm does not result, with regard to public health, from scientific data collected, but specifically from the lack of such data, constituting the shortcomings identified in the contested regulation. As noted in paragraph 85 above, those shortcomings do not make it possible to rule out risks to public health which, as identified in the contested regulation, must therefore be taken into consideration in the light of the other interests at stake.

91      In that regard, the applicant does not refer to any interest other than preventing the harm that the contested regulation would cause it, harm which, it has moreover been established, was neither serious nor irreparable. It is settled case-law that, in principle, the requirements of the protection of public health must unquestionably be given precedence over economic considerations (see order of 11 April 2001, Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraph 112 and the case-law cited, and judgment of 19 April 2012, Artegodan v Commission, C‑221/10 P, EU:C:2012:216, paragraph 99 and the case-law cited).

92      The alleged harm does not suffice to tip the balance of interests in favour of the applicant in so far as the public health risks identified in respect of oxasulfuron must be regarded as recognised (see paragraph 87 above).

93      In any event, even if the applicant had succeeded in proving the urgency relating to the characteristics of its damage, it would still have been necessary to assess it in the light of the principle laid down by well-established case-law according to which the precedence of the imperative requirements of the protection of public health may justify restrictions which have adverse consequences, and even substantial adverse consequences, for certain operators (see, to that effect, judgment of 1 June 2010, Blanco Pérez and Chao Gómez, C‑570/07 and C‑571/07, EU:C:2010:300, paragraph 90 and the case-law cited). In that context, the importance of recognising the precautionary principle has been highlighted; according to that principle, where there is uncertainty as to the existence or extent of risks to human health, the EU institutions may take protective measures without having to wait until the reality and seriousness of those risks have been demonstrated (see, to that effect, order of 19 December 2013, Commission v Germany, C‑426/13 P(R), EU:C:2013:848, paragraph 54 and the case-law cited).

94      Consequently, the arguments advanced by the applicant concerning the safety of the substance at issue purporting to demonstrate that public health considerations cannot have greater weight than those relating to its damage must be rejected.

95      In the second place, as regards the argument that oxasulfuron is a better solution for the processing of soya beans than imazamox, the applicant claims, first, that, since imazamox has been designated a ‘candidate for substitution’, it is a greater threat to public health than Laguna and, second, that the ban on oxasulfuron would necessarily entail, on account of the lack an alternative post-emergence herbicide for soya beans on the Croatian market, the use of imazamox.

96      First, it must be pointed out that, although imazamox was designated a candidate for substitution, its approval was renewed by Commission Implementing Regulation (EU) 2017/1531 of 7 September 2017 renewing the approval of the active substance imazamox, as a candidate for substitution, in accordance with Regulation No 1107/2009, and amending the Annex to Implementing Regulation No 540/2011 (OJ 2017 L 232, p. 6), unlike the applicant’s active substance. As referred to in paragraph 20 above, the reasoning of the judge hearing the application for interim measures is confined to a prima facie analysis of the matters of fact and of law underlying the application. It cannot therefore be concluded, on the basis of the evidence in the file, that a substance which remains authorised on the market is more damaging to the environment and to public health than a substance whose approval has not been renewed.

97      Second, since the applicant, as explained in paragraphs 46 and 59 above, is not a producer but a distributor of the product in question and, furthermore, has been granted a grace period allowing it to sell that product until 8 November 2019, nor can its argument that failure to suspend the contested regulation would amount to a definitive transfer of its entire market share to the competitor undertaking, BASF, convince the judge hearing the application for interim measures.

98      Although it is apparent from the evidence in the file that the use of a pre-emergence herbicide seems not to be a viable alternative in a climate such as that of Croatia, that fact alone is not, however, sufficient to prove irretrievable transfer of its market share to imazamox-based products. The applicant has not provided any information concerning replacement post-emergence herbicides (both for oxasulfuron and imazamox) potentially available on the EU market that its status as a well-established distributor on the Croatian market and the grace period would enable it to develop, as established in paragraph 60 above.

99      Consequently, the arguments adduced by the applicant concerning the danger to public health presented by failure to suspend the contested regulation until a final decision has been made in the main proceedings must be rejected.

100    In the light of the foregoing, it must be concluded that, in accordance with the case-law cited in paragraph 83 above, the balance of interests does not tip in favour of granting the interim measures sought.

101    Without it being necessary to examine whether the condition relating to the existence of a prima facie case is satisfied in the case at hand, it is necessary to conclude that the application for interim measures must be dismissed in so far as the applicant has not succeeded in demonstrating that, first, the condition of urgency was satisfied, the serious and irreparable nature of the alleged damage having being absent, and, second, the balance of interests tipped in its favour.

102    By virtue of 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 shall be reserved.

Luxembourg, 21 January 2019.

*      Language of the case: English.

1 This order is published in extract form.

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