26 September 2019 (*)

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

In Case T‑518/19 R,

Sipcam Oxon SpA,

established in Milan (Italy), represented by C. Mereu and P. Sellar, lawyers,

applicant,

European Commission,

represented by I. Naglis and A. Dawes, acting as Agents,

defendant,

APPLICATION based on Articles 278 and 279 TFEU, seeking suspension of the operation of Commission Implementing Regulation (EU) 2019/677 of 29 April 2019 concerning the non-renewal of the approval of the active substance chlorothalonil, 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 2019 L 114, p. 15),

makes the following

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

The applicant, Sipcam Oxon SpA, is a company established under Italian law that produces and distributes chemical and plant protection products via its subsidiaries. Its products include herbicides, acaricides, fungicides and biological products. The applicant markets, inter alia, the active substance chlorothalonil, a fungicide used to control diseases in cereals, as well as other vegetable crops.

Pursuant to Annex I 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), chlorothalonil was included among substances 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). As such, the approval of chlorothalonil was subject to the standard regulatory renewal of approval process under Article 14 of Regulation No 1107/2009.

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 (EC) No 1107/2009 (OJ 2012 L 252, p. 26), the renewal of approval was subject to an initial evaluation by the rapporteur Member State, the Kingdom of the Netherlands, and the co-rapporteur Member State, the Kingdom of Belgium.

On 2 September 2016, the rapporteur Member State, in consultation with the co-rapporteur Member State, submitted a draft renewal assessment report (‘RAR’) to the European Food Safety Authority (‘EFSA’) and the Commission, proposing the classification of chlorothalonil as carcinogen category 2 (‘suspected human carcinogens’ under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1)).

On 24 October 2016, EFSA distributed the draft RAR to the Member States and to the applicant for comments.

By letter of 28 February 2017, following consideration of the comments submitted to it about the draft RAR, EFSA sent to the applicant a request for additional information.

In November 2017, in consideration of the comments and additional information provided by the applicant, the Commission issued a revised RAR, proposing the classification of chlorothalonil as carcinogen category 1B (‘substances presumed to have carcinogenic potential for humans’ under Regulation No 1272/2008).

On 4 December 2017, EFSA issued its Conclusion on the Peer Review of the Pesticide Risk Assessment of the active substance chlorothalonil (‘EFSA Conclusion’) about whether chlorothalonil could be expected to meet the approval criteria provided for in Article 4 of Regulation No 1107/2009 and sent it to the applicant and to the Commission.

In this document, EFSA identified a critical concern in relation to the contamination of groundwater by metabolites of chlorothalonil, stated that it cannot currently be established that the presence of metabolites of chlorothalonil in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health and that the genotoxicity concern for residues to which consumers will be exposed cannot be excluded, and identified a high risk to amphibians and fish for all the uses evaluated. Furthermore, EFSA observed that several areas of the risk assessment could not be finalised due to insufficient data in the dossier.

By email of 29 January 2018, the Commission invited the applicant to submit its comments on the EFSA Conclusion by 19 February 2018 at the latest.

By email of 16 February 2018, the applicant submitted its comments on the EFSA Conclusion.

On 22 March 2019, the Commission issued its final renewal report for the active substance chlorothalonil, which was finalised in the Standing Committee on Plants, Animals, Food and Feed at its meeting on 22 March 2019 in view of the non-renewal of the approval of chlorothalonil as active substance in accordance with Regulation No 1107/2009.

On 29 April 2019, the Commission adopted Implementing Regulation (EU) 2019/677 concerning the non-renewal of the approval of the active substance chlorothalonil, in accordance with Regulation No 1107/2009, and amending Commission Implementing Regulation No 540/2011 (OJ 2019 L 114, p. 15; ‘the contested regulation’).

The contested regulation establishes the non-renewal of the approval of the active substance chlorothalonil.

In accordance with Article 3 thereof, the contested regulation requires Member States to withdraw authorisations for plant protection products containing chlorothalonil as active substance by 20 November 2019 at the latest. Article 4 provides for a ‘grace period’ that is to expire by 20 May 2020 at the latest.

By application lodged at the Registry of the General Court on 22 July 2019, the applicant seeks the annulment of the contested regulation.

By separate document lodged at the Court Registry on 30 July 2019, the applicant lodged an application for interim measures, in which it claims that the President of the General Court should:

–suspend the contested regulation with immediate effect, pursuant to Article 157(2) of the Rules of Procedure of the General Court, pending the Court’s ruling in the main application;

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

–order the Commission to pay the costs.

In its observations on the application for interim measures, which were lodged at the Court Registry on 26 August 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

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 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 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 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).

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 interim measure applied for’.

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 damage 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 either of them is absent. Where appropriate, the judge hearing such an application must also weigh the competing interests (see, to that effect, 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).

In the context of that overall examination, the judge hearing 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 within which the need to order interim measures must be assessed (see, to that effect, 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).

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.

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

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. 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, to that effect, order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P‑R, EU:C:2016:21, paragraph 27 and the case-law cited).

In 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).

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’.

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 (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).

Furthermore, in view of the rapidity which, by its nature, characterises the interim relief procedure, it is reasonable to require the party seeking interim relief to submit, save in exceptional circumstances, all the evidence available in support of the application when that application is made, so that the judge hearing the application for interim relief may assess, on that basis, the merits of the application (see order 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 56 and the case-law cited).

A request for interim relief which fails to set out the facts and evidence which should be included as essential elements of the conditions for the grant of the interim relief sought and which could be set out in that application does not meet those requirements, since the applicant was not unable to rely on them when that application was made (see order 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 57 and the case-law cited).

It is also settled case-law that, in order to determine whether all the conditions referred to in paragraphs 25, 26 and 28 above are fulfilled, the judge hearing the application for interim measures must have concrete and precise indications, 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 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 27 and the case-law cited).

While the application for interim measures may be supplemented on specific points by references to documents annexed to it, those documents cannot compensate for the lack of essential information in that application. It is not for the judge hearing the application for interim measures to seek, in the stead 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 that might support the application for interim measures. Such an obligation being 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, to that effect, 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).

It must be recalled that the President of the General Court alone is the judge of the possible need to supplement the information which he has available to him in the cases before him (see order 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 60 and the case-law cited).

If the fact that the President of the General Court attaches particular importance to the lack of evidence necessary for the examination of an application for interim relief were to suffice, as such, for the applicant to be able to insist that it be allowed to supplement its application, the President of the General Court would in practice be bound, whenever he had doubts as to the probative value or sufficiency of the evidence submitted in support of the urgency of an application for interim relief, to invite the applicant to respond to those doubts, which would be manifestly incompatible with both the nature of proceedings for interim relief and the discretion enjoyed by the judge hearing the application for such relief within such proceedings (see order 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 62 and the case-law cited).

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

The applicant invokes, in essence, serious and irreparable damage due to the effects on its sales in the European Union, the loss of which would be irreversible due to the following elements: the withdrawal of the United Kingdom from the European Union without the ratification of a withdrawal agreement, the adverse effects on its sales in third countries, the review of the existing maximum residue limit (‘MRL’) for chlorothalonil by EFSA, the regulatory obstacles preventing it from submitting new dossiers to seek approval of chlorothalonil, the fact that it is impossible to purchase and distribute competing products, and the fact that it is impossible for the applicant to diversify into appropriate neighbouring sectors.

Seriousness of the damage

With regard to the seriousness of the alleged damage due to the loss of all the applicant’s income from sales of chlorothalonil and chlorothalonil-based products in the European Union, the applicant considers that it represents a loss of 3.5% of the group’s total global sales of the substance and roughly 7% of its own total global sales of the substance (according to figures from 2018). In that regard and as rightly noted by the Commission in its observations submitted on 26 August 2019, the damage alleged is purely financial.

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 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 32 and the case-law cited).

However, in the present case, the applicant does not claim that its existence is under threat. It does, nevertheless, provide data concerning the percentages of sales that would allegedly be affected by the contested regulation.

As indicated in settled case-law, the assessment of the serious nature of financial 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).

In addition, it must be recalled that, also according to settled case-law, it has been found, on the one hand, that, 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 22 June 2018, Arysta LifeScienceNetherlands 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) 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, to that effect, 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).

In the case at hand, the applicant provides, inter alia, the figures reproduced in the table below:

% EU sales related to the total global substance sales of the group of companies to which the applicant belongs

% EU sales related to the total substance sales of the applicant

2018

3.5%

2017

3.6%

2016

4.3%

In the light of this data, it is sufficient to recall that, in accordance with the case-law cited in paragraph 41 above, a loss corresponding to less than 10% of turnover does not appear to be such as to threaten the very existence of the company or of the group in question.

The turnover relating to the sale of the substance at issue thus represents a small part of the turnover assessed both as regards the applicant and as regards the group to which it belongs (see, to that effect and by analogy, order of 22 June 2018, Arysta LifeScienceNetherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 37 and the case-law cited).

Therefore, the loss of turnover generated from those sales of chlorothalonil and chlorothalonil-based products cannot, in itself, suffice for the alleged damage to be regarded as serious within the meaning of the case-law cited above.

However, 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, 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 bring them into relation, when taking his decision, with the damage occasioned in terms of turnover.

In the analysis of the seriousness of the damage in that case, therefore, account was taken of the serious economic and financial crises, which afflicted the world economy for several months and impacted the value of the group to which the applicant belonged. The judge hearing the application for interim measures thereby concluded that, in view of those ‘special circumstances’, the applicant in that case had established the gravity of the damage it would suffer if the interim measures sought were not granted.

It should be pointed out that the applicant does not invoke such an exceptional situation.

Nevertheless, in the case at hand, the applicant puts forward a number of elements, which could be regarded as being an attempt to establish those specific circumstances, as the alleged financial damage would be serious and irreparable once taken into account and put into perspective with the above figures.

In the first place, the applicant claims that a withdrawal of the United Kingdom from the European Union without the ratification of a withdrawal agreement will adversely affect the turnover of the group of companies to which the applicant belongs and of the applicant as a result, first, of uncertainties as to the recognition by the United Kingdom of marketing authorisations in force in the European Union and, second, of the possible introduction of custom duties on products imported from the European Union.

In that regard, the applicant refers to the order of 28 April 2009, United Phosphorus v Commission (T‑95/09 R, not published, EU:T:2009:124), referred to in paragraph 46 above.

However, while, in that case, the applicant invoked an acknowledged fact, in the present case the applicant bases its argument on an uncertain and, at this stage, hypothetical situation. In addition, and as pointed out by the Commission in its observations, the decision and process by which the United Kingdom leaves the European Union is entirely exogenous to the adoption of the contested regulation.

In the second place, the applicant claims that the implementation of the contested regulation will have adverse effects on its sales outside the European Union.

On the one hand, it should be noted that, in general, the reduction of sales in countries not belonging to the European Union as a consequence of the adoption of a regulation banning or restricting the use of a substance, by reason of the fact that some non-member countries are likely to follow the EU rules cannot be taken into account in the assessment of the seriousness of the alleged damage, 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, orders of 12 October 2018, Taminco v EFSA, T‑621/17 R, EU:T:2018:763, paragraph 65, and of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 45 and the case-law cited).

On the other hand, the applicant has not established that the interim measures sought, assuming they are 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 from materialising (see, to that effect, orders of 12 October 2018, Taminco v EFSA, T‑621/17 R, EU:T:2018:763, paragraph 66, and of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 46 and the case-law cited).

Therefore, none of the authorities are legally bound by the contested regulation and the applicant puts forward nothing regarding the effects of the requested measures on the decision-making process of those authorities (see, to that effect, order of 12 October 2018, Taminco v EFSA, T‑621/17 R, EU:T:2018:763, paragraph 70).

Accordingly, the alleged impact on the applicant’s sales in the United Kingdom and in third countries does not constitute a special circumstance enabling a conclusion to be reached as to the seriousness of the damage.

In the third place, the applicant claims that, pursuant to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ 2005 L 70, p. 1), the decision not to renew the approval of chlorothalonil will lead to a decrease to a MRL below the limit of quantification of 0.01 mg/Kg. In the fourth place, as a consequence of the foregoing, products which are treated with chlorothalonil outside the European Union and are imported into the European Union will have to comply with that level set by EFSA in order to be placed on the European market. The applicant considers that, as a result, sales of chlorothalonil by the group to which it belongs will drop outside the European Union.

In that regard, it is sufficient to note that the damage allegedly suffered as a result of that new MRL is not a direct consequence of the contested regulation. The EU procedure for setting MRLs is independent of the restriction of the use of chlorothalonil. It follows that the applicant’s assertions as to the problems posed by a MRL are irrelevant in the present context (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 50 and the case-law cited).

Accordingly, the consequences expected by the applicant as a result of the setting of a new MRL do not constitute a special circumstance enabling a conclusion as to the seriousness of the damage to be reached.

It must therefore be held that the case at hand does not exhibit any special circumstance which, assessed in the light of the relevant turnover, leads the judge hearing the application for interim measures to conclude as to the seriousness of the alleged damage due to the loss of all the applicant’s income relating to the sales of chlorothalonil and chlorothalonil-based products in the European Union.

Finally, it should be pointed out that, while it is apparent from the case-law that it cannot be excluded that financial damage which is objectively significant and which allegedly results from the obligation to make a final commercial choice of some magnitude within a disadvantageous timescale could be considered as ‘serious’, or even that the seriousness of such damage could be considered as obvious, even in the absence of information concerning the size of the undertaking concerned (see, to that effect, order of 7 March 2013, EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraph 33), the applicant does not put forward any specific material in that regard. It is not for the judge hearing the application for interim measures to seek, in the stead of the party concerned, that material, especially in highly regulated sectors where commercial choices and timescale are elements to be taken seriously by companies involved in these activities when considering their developments.

Consequently, the alleged damage due to the withdrawal of the United Kingdom from the European Union without the ratification of a withdrawal agreement, the adverse effects on its sales in third countries and the setting of a new MRL by EFSA cannot be categorised as financial damage which is objectively significant within the meaning of that case-law.

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

Irreparability of the damage

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

It is well-established case-law that damage of a pecuniary nature cannot, save in exceptional circumstances, be regarded as irreparable or even difficult to repair 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 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 80 and the case-law cited).

67In 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).

68In the present case, as is already stated in paragraph 39 above, not only does the applicant not claim that its existence is under threat, but it is apparent from the analysis carried out in paragraphs 37 to 64 above, which concerns the alleged damage due to the risk of adverse effects on its sales, that the applicant is not in such a situation.

69Nevertheless, the judge dealing with the application for interim measures must not apply mechanically and rigidly the condition relating to the irreparable nature of the financial damage pleaded, but must take account of the factual and legal circumstances specific to each case and determine, in the light of those specific circumstances, the manner in which those conditions of urgency are to be examined (order of 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:T:2009:124, paragraph 74 and the case-law cited).

70In that regard, the applicant advances four elements, which could be regarded as being an attempt to establish those specific circumstances.

71In the first place, the applicant claims that it takes a significant amount of time to complete new approval procedures for chlorothalonil and maintains that it would face regulatory obstacles preventing it from submitting new dossiers to seek approval of that substance.

72First, the applicant submits — without, however, providing any precise estimate as to timing — that new scientific data should be generated in order to prepare a dossier in accordance with Regulation No 1107/2009; second, that the timeline for dossier approval under that regulation is at least 30 months; third, that re-establishing national authorisation for chlorothalonil will take ‘from a minimum of 15 months to a more realistic 18-24 months once the active substance has been approved at EU level, leading to an overall time to be back on the market of minimum 4 years’; fourth — without providing any precise estimate as to timing — that the authorisation process is subject to local requirements and is lengthy because of a lack of harmonisation in relation to data and risk assessment requirements; fifth, that the Draft guidance on the renewal of approval of active substances published in March 2019 (SANCO/2012/11251 rev. 5) is the source of a rise in the risk of approval not being granted at EU level, the new guidelines being more demanding and less comprehensible.

73As concerns the arguments put forward by the applicant, it should be noted that, having regard to the average duration of proceedings before the Court, and as the applicant rightly notes, the decision on the substance in the present case will probably be delivered within 2 years (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). Therefore, the applicant will be informed of the legality of the contested regulation well before the period required for the approval of chlorothalonil expires. In that context, it must be pointed out that the applicant has not requested application of the expedited procedure provided for in Article 151 et seq. of the Rules of Procedure. Furthermore, by virtue of Article 4 of the contested regulation, it can potentially enjoy a ‘grace period’ until 20 May 2020 during which the Member States may maintain authorisations for plant protection products containing chlorothalonil (see paragraph 15 above).

74In the second and third place, the applicant considers that, on the one hand, its competitors will take its customers and supply them with competing active substances and, on the other, that it cannot reasonably be expected to agree with competitors to purchase and distribute substances of other producers in order not to lose market share.

75Even if it is doubtful that these arguments would qualify as being an obstacle of a structural or legal nature, but seem to be purely commercial in nature, it can be noted that the submissions of the applicant appear contradictory because, on the one hand, it claims that the competitors will take its customers and, on the other hand, it claims that neither of its powerful competitors has chlorothalonil-based products in their portfolios.

76In addition, it should be pointed out that, as the applicant acknowledges in its application, it already has in its portfolio an active alternative for chlorothalonil, tebuconazole, which is sold as a straight product due to chlorothalonil’s withdrawal.

77Furthermore, the applicant claims that it holds 0.6% of the market share in the cereal fungicides market in the European Union. As underlined by the Commission in its observations, the damage alleged 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 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 54 and the case-law cited).

78In 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. However, 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 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 58 and the case-law cited).

79In any case, the applicant has not demonstrated to the requisite legal standard the existence of obstacles of a structural or legal nature making it impossible to regain of a significant portion of that share.

80In the fourth place, the applicant claims that regulatory obstacles exist preventing its diversification into appropriate neighbouring sectors due to the proposed classification of chlorothalonil as carcinogen category 1B.

81The applicant claims that it ‘cannot look to diversify into other obvious neighbouring markets using chlorothalonil to compensate for losses made. In particular, it cannot consider whether use of chlorothalonil as a biocidal product is commercially viable because its proposed classification as carcinogen category 1B means it cannot be lawfully approved except if specific, limited and narrowly interpreted exceptions apply (Article 5 of Regulation [No] 528/2012)’.

82It should be noted that, in accordance with Article 5(1) of Regulation No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p.1), the active substances which meet the criteria to be classified as carcinogen category 1A or 1B shall not be approved. However, pursuant to Article 5(2) of that regulation active substances referred to in Article 5(1) may be approved if it is shown that at least one of the conditions listed in that paragraph is met.

83In the case at hand, it must be pointed out that, contrary to what is required by the case-law cited in paragraphs 28 to 32 above, the applicant does not put forward any arguments to demonstrate its difficulties in meeting one of the conditions listed in Article 5(2) of Regulation No 528/2012.

84Consequently, without any further elements, the application is not self-explanatory as to why the applicant could not diversify into appropriate neighbouring sectors.

85Therefore, it must be held that the case at hand does not exhibit any specific circumstances, within the meaning of the case-law recalled in paragraphs 61 to 69 above, that would lead the judge hearing the application for interim measures to find the alleged financial damage to be of an irreparable nature.

86Admittedly, damage of a financial nature may be considered to be serious and irreparable if the damage, even when it occurs, cannot be quantified (see orders of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 49 and the case-law cited, and of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 92).

87The 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 orders of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 50 and the case-law cited, and of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 93).

88However, 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 damage 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 damage by bringing an action for damages (see orders of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 51 and the case-law cited, and of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 94).

89In the case at hand, it does not appear from the applicant’s submissions that that is the case, and that, in view of its nature and the manner in which it might foreseeably occur, the damage 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 damage by bringing an action for damages. On the contrary, the applicant puts forward 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.

90Moreover, the applicant considers that compensation alone, obtained by bringing an action for damages, will not suffice to restore the applicant to the position it was in previously. In its view, restitutio in integrum is not possible in so far as no amount of damages can compensate it for the loss of revenue and market share it will suffer during the period preceding the delivery of any judgment annulling the contested regulation.

91However, first, in formulating such assumption, the applicant confines itself to making mere assertions, without adducing any evidence enabling the President of the Court to assess whether the alleged damage exists and its relevance, contrary to the criteria indicated at paragraphs 25, 26, 28 and 31 above, and, second, all arguments put forward in the application as regards the alleged irreparable nature of the alleged damage have been rejected.

92In the light of the foregoing, it is apparent that the applicant has not demonstrated that the condition relating to urgency, within the meaning of the case-law set out in paragraph 25 above, is satisfied.

93In 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 detail the condition relating to the establishment of a prima facie case, or weigh up the interests involved.

94By virtue of Article 158(5) of the Rules of Procedure, it is appropriate to reserve the costs.

On those grounds,

hereby orders:

1.The application for interim measures is dismissed.

2.The costs are reserved.

Luxembourg, 26 September 2019.

Registrar

Language of the case: English.