Language of document : ECLI:EU:T:2018:407

ORDER OF THE PRESIDENT OF THE GENERAL COURT

22 June 2018(*)

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

In Case T‑476/17 R,

Arysta LifeScience Netherlands BV, established in Amsterdam (Netherlands), represented by C. Mereu and M. Grunchard, lawyers,

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) 2017/855 of 18 May 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance diflubenzuron (OJ 2017 L 128, p. 10),

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order (1)

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 Law

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 Urgency

23      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 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).

24      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 23 March 2017, Gollnisch v Parliament, T‑624/16, not published, EU:T:2017:243, paragraph 25 and the case-law cited).

25      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’.

26      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).

27      It is also settled case-law that, in order to determine whether all the conditions referred to in paragraphs 23, 24 and 26 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 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).

28      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 or in the main application lodged in the main proceedings which could 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, to that effect, order of 20 June 2014, Wilders v Parliament and Others, T‑410/14 R, not published, EU:T:2014:564, paragraph 16 and the case-law cited).

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

30      The applicant invokes, in essence, serious and irreparable damage due to the risk of adverse effects on its turnover and profits, the risk of loss of market share, of impact on one of its manufacturing plants and of damage to its reputation.

 Seriousness of the damage

31      In the first place, so far as concerns the alleged damage due to the risk of adverse effects on its turnover and profits, the applicant considers that, as a result of the contested regulation, it will suffer a significant loss of turnover and profits. In that regard, it is thus appropriate to point out that the damage alleged is purely financial.

32      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 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).

33      First, 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).

34      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).

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37      The turnover, like the profit generated by the sale of the substance at issue for the use prohibited by the contested regulation, thus represents a small part of the turnover or of the gross profit of the applicant or that of the group to which it belongs (see, to that effect and by analogy, order of 11 April 2001, Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraph 105).

38      Therefore, the loss of turnover or profit generated from those sales cannot alone suffice for the alleged damage to be regarded as serious within the meaning of the case-law cited in paragraph 36 above.

39      Second, as has been highlighted by the applicant, 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 harm occasioned in terms of turnover.

40      In the analysis of the seriousness of the damage in that case, therefore, account was taken of the serious economic and financial crisis 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 had established the gravity of the harm it would suffer if the interim measures sought were not granted.

41      It has to be pointed out that the applicant does not invoke such an exceptional situation.

42      Nevertheless, even though the applicant does not clearly identify the circumstances which, in the case at hand, would be relevant in the examination of the seriousness of its damage, it seems that, amid its submissions relating to that aspect of the damage, it advances a certain number of elements which could be regarded as falling within those specific circumstances of the case at hand.

43      It is therefore appropriate to examine its claims relating to the envisaged consequences of its diflubenzuron-related business on account of, first, the application of the Brazilian legislation 7.802/89 and, second, the setting of a new maximum residue limit (‘MRL’).

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45      In that regard, first of all, 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, order of 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:T:2009:124, paragraph 56 and the case-law cited).

46      Next, it must be stated that the applicant has not established that the interim measures sought, assuming they are granted, would prevent the Brazilian authorities from banning the sale of diflubenzuron for edible purposes in their territory. Consequently, it 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, order of 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:T:2009:124, paragraph 56 and the case-law cited).

47      Last, it appears that the materialisation of that fear is hypothetical to the extent that the applicant has in its possession a study of 28 February 2017, carried out in conformity with the latest recommendations, confirming PCA’s lack of potential genotoxicity (‘In Vivo Mutation Assay at the cII Locus in Big 10 Blue® Transgenic F344 Rats and Micronuclei Analysis in Peripheral Blood’). In consequence, there could be reasonable doubts as to the final assessment of the Brazilian authorities regarding the genotoxicity of diflubenzuron in so far as it is conceivable that, in the light of that study, those authorities will consider the updated results of the scientific community not to lean in favour of a ban. The aspect of the damage alleged in that regard can only be uncertain in nature, within the meaning of the case-law cited in paragraph 24 above.

48      Accordingly, the consequences expected by the applicant for its diflubenzuron-related business as a result of the application of the Brazilian legislation 7.802/89 do not constitute a special circumstance enabling a conclusion as to the seriousness of the damage.

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52      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 risk of adverse effects on its turnover and profits.

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61      In the third place, so far as concerns the seriousness of the alleged damage due to the risk of impact on one of its manufacturing plants, the applicant states that it exclusively manufactures the substance at issue at a manufacturing plant in Ankerweg (Netherlands), which is largely dedicated to the production of the substance at issue for use within and outside the European Union. The loss of diflubenzuron ‘edible crops’ labels in the European Union means a loss of EUR 618 859 production cost absorption, which represents 89.7% of total cost absorption and volume loss of 36 735 kg, which represents 95% of the EU volume. Therefore, the impact of losing the diflubenzuron edible-use volumes would mean that all remaining products would have to absorb that EUR 618 859 cost, thereby increasing costs and reducing competitiveness in the EU market and in other global markets for all other products.

62      In addition, in the context of its arguments on the irreparable nature of the alleged damage due to the risk of impact on one of its manufacturing plants, the applicant invokes a certain number of elements which actually fall within the assessment of the seriousness of the damage. It states that approximately 25 employees of the manufacturing plant are associated with the substance at issue and with diflubenzuron-based products and that the viability of that plant is at risk considering that EU edible-use products absorb EUR 618 859 (or 16.7%) of the total EUR 3 699 373 diflubenzuron production costs at the Ankerweg plant, even though their volume represents 8.4% of the total volume. Moreover, it recalls inter alia that the review of the MRL for edible commodities would have a significant impact on products sold into the key markets globally and that, considering that the total production of diflubenzuron represents approximately 30% of the volume and absorbs approximately 30% of the costs of the Ankerweg plant, a reduction or loss of product sold on the global market would have a significant impact on the viability of that plant.

63      It is thus apparent from the foregoing that the alleged damage due to the expected impact of the contested regulation on the Ankerweg manufacturing plant is pecuniary in nature.

64      In that regard, it should be recalled that, in accordance with the case-law cited in paragraph 32 above, regarding the seriousness of such damage, 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.

65      First, however, the applicant’s fear is not about the imperilling of its existence, but about the viability of a manufacturing plant. In that regard, contrary to the case-law cited in paragraphs 24 to 27 above, the applicant provides no element indicating that there is any threat to its survival due to the alleged risks related to the plant’s viability.

66      Second, the plant concerned produces the substance at issue not exclusively for use within the European Union, but also for use outside the Union. To the extent that the applicant indicates the potential effects of setting a new MRL for edible products on its global sales, it is sufficient to refer to the reasoning set out in paragraph 50 above to render that argument irrelevant.

67      Third, contrary to the case-law cited in paragraphs 24 to 27 above, the applicant does not provide the judge hearing the application for interim measures with the essential material enabling him to examine the seriousness of the alleged impact, such as information regarding the possibilities of redeploying the staff concerned or of reconverting the manufacturing processes of its production chain within that plant. In the same way, the Commission notes, rightly, that the applicant has not demonstrated that that manufacturing plant cannot be used to produce one of the many other plant production products made by the applicant’s group.

68      Therefore, the impact on one of its manufacturing plants cannot alone suffice for the alleged damage to be regarded as serious within the meaning of the case-law cited in paragraph 64 above.

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71      In the fourth place, so far as concerns the seriousness of the alleged damage due to the risk of adverse effects on its reputation, the applicant argues that the contested regulation will damage the applicant’s reputation generally, the reputation of its diflubenzuron-based products and the reputation of its main brand Dimilin and the formulation types relating to those products.

72      First, to the extent that the applicant fears that the contested regulation, on the one hand, undermines its reputation generally, the reputation of its diflubenzuron-based products and the reputation of its main brand Dimilin and the formulation type related to those products by stigmatising diflubenzuron and, on the other, calls into question more generally its expertise in the field of plant protection products, its ability to provide safe products of high quality and have a knock-on negative effect on the reputation of other products produced by it, in particular in the plant protection area, it should be noted that the withdrawal of a plant protection product from the market — and, a fortiori, the imposition of a restriction in its scope of use — is not necessarily detrimental to the undertaking concerned as a whole. In that regard, it is common knowledge that many undertakings active in the market at issue have had their products withdrawn from the market, and those undertakings or products cannot be deemed to be stigmatised. The regulatory authorities and the operators in the sector concerned, which are familiar with the regulatory framework, tend to view a decision not to authorise a plant protection product as a normal part of a regulatory procedure. Such a decision may be regarded as being simply the result of scientific developments and improvement in research methods (see, to that effect, order of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 43 and the case-law cited).

73      Second, it should be noted that, if damage to the applicant’s reputation actuallyfollowed from the adoption of the contested regulation, it would already have been caused the day that regulation was adopted and would last so long that that regulation would not be annulled by the decision on the main action (see, to that effect, order of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 42 and the case-law cited).

74      Third, the applicant invokes the particular sensitivity of the health sector. However, given that the contested regulation was adopted following a complex administrative procedure lasting a number of years, in which scientific experts and professionals working in the sector concerned participated, a suspension of the operation of that regulation ordered by the judge hearing the application for interim measures on a purely interim basis and in summary proceedings would scarcely be such as to dispel doubts which may exist as to the merits of the lack of danger of diflubenzuron on the edible crops market (see, to that effect, order of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 42 and the case-law cited). In that regard, it must be noted that, contrary to the case-law mentioned in paragraphs 24 to 27 above, the applicant does not explain how the situation at hand would make those findings irrelevant and, in particular, does not indicate how a suspension of operation of the contested regulation would put an end to the fears that have already been caused by the publication of the assessment of diflubenzuron by the designated Rapporteur Member State and by EFSA and the conclusion inter alia as regards the genotoxicity of PCA, documents which have been available for many years.

75      Similarly, so far as concerns the applicant’s claim that the contested regulation is highly likely to impact seriously on the confidence of consumers in diflubenzuron-based products and to raise significant concerns in the minds of consumers as to its safety, it is not apparent from the material in the case file that a suspension as an interim measure ordered by the judge hearing the application for those measures would be a measure that would prevent such a loss of confidence. In that regard, the applicant merely claims that, if the contested regulation is allowed to stand, the stigma attached to the substance at issue as a result of the restriction imposed by that regulation is likely to grow with time. As has been highlighted in paragraph 73 above, however, the identification of the danger of diflubenzuron on the edible crops market and the communication of that information to the public pre-dates the adoption of the contested regulation.

76      In the fifth and last place, it should be pointed out that, as has been indicated in paragraph 34 above, in the context of a highly regulated market, such as that in the case at hand, in which the competent authorities may intervene rapidly when public health risks become apparent, for reasons which cannot always be foreseen, it is for the undertakings concerned, if they are not to bear themselves the loss resulting from such intervention, to protect themselves against its consequences by adopting an appropriate policy (see order of 16 June 2016, ICA Laboratories and Others v Commission, C‑170/16 P(R), not published, EU:C:2016:462, paragraph 29 and the case-law cited).

77      In the present case, at 7 September 2012 at the earliest, during the delivery of EFSA’s conclusion identifying a new concern, relating to the potential exposure to PCA as a residue (see paragraph 5 above), or, at the latest, 18 July 2013, when the Commission informed the applicant of the decision to review the approval of the substance at issue pursuant to Article 21 of Regulation No 1107/2009 (see paragraph 7 above), the applicant had information on the basis of which it was within its diligence to take the appropriate measures to meet any risks faced in relation to restrictions on the use of diflubenzuron, in accordance with the case-law recalled in paragraph 76 above. Furthermore, it must be pointed out that the present application for interim measures does not contain any indication in that regard. Besides, those considerations are all relevant even if it were accepted, as the applicant claims in its application, that it was only from July 2015 that it might have had reason to address the concerns regarding the genotoxicity of the metabolite.

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

 Irreparability of the damage

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

80      First, it is well-established case-law that damage of a pecuniary nature cannot, save in exceptional circumstances, be regarded as irreparable or even hardly reparable since, as a general rule, pecuniary compensation is capable of restoring the aggrieved person to the situation that obtained before he suffered the damage. Any such damage could, in particular, be recouped by the applicant’s bringing an action for compensation on the basis of Articles 268 and 340 TFEU (see orders of 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).

81      In the event of such damage, the interim measure sought is justified if it appears that, without that measure, the applicant would be in a position that could imperil its existence before final decision in the main action (order of 3 December 2002, Neue Erba Lautex v Commission, T‑181/02 R, EU:T:2002:294, paragraph 84). 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 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:T:2009:124, paragraph 34 and the case-law cited).

82      In the present case, it is apparent from the analysis carried out by the judge hearing the application for interim measures in paragraphs 31 to 52 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.

83      In the same way, so far as concerns the arguments raised in relation to the viability of the Ankerweg manufacturing plant, it has already been concluded that the present application for interim measures did not contain essential information regarding the possibilities of redeploying the staff concerned or of reconverting the manufacturing processes of its production chain within that plant. Such information is necessary for the examination by the judge hearing the application for interim measures of the irreparable nature of the damage alleged. In any event, only the applicant’s survival is relevant in the context of the assessment of the irreparable nature of the damage, in accordance with the case-law cited in paragraph 81 above. As has been noted in paragraph 65 above, however, the applicant’s fear is not about the imperilling of its existence, but about the viability of a manufacturing plant.

84      Second, as has been recalled in paragraph 58 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. An applicant 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).

85      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 60 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 impossible the regaining of a significant portion of that share.

86      In that regard, the applicant asserts, first of all, that, if the main action is upheld, it cannot reasonably be expected that an advertising campaign would be successful in reinstating the market share currently held by the applicant, which would have to ‘overcome the negative publicity’ engendered by the contested regulation. It considers itself not to be in a position to mount a deep pocket publicity campaign (or equivalent) to overcome any negative perceptions since neither it nor the group to which it belongs as a whole has sufficient funds to sponsor such activity.

87      However, in accordance with the case-law cited in paragraphs 24 to 27 above, it is for the party seeking the interim measures to provide the judge hearing the application for those measures the information necessary for him to carry out the assessment inter alia of the irreparable nature of the damage alleged. Thus, mere assertions cannot suffice to satisfy those criteria established by case-law. In the present case, none of the documents made available to the judge hearing the application for interim measures enable, at first sight, the assertions of the applicant relating to its impossibility of recovering that market share to be confirmed. The applicant merely pleads difficulties in recovering market share because there may be a loss of confidence in its products yet does not, however, establish the existence of obstacles of a structural or legal nature that would prevent it from recovering that confidence from both its customers and its consumers and thus from regaining a significant proportion of that market share from them following the putting into place, in particular, of appropriate publicity measures (see, to that effect, order of 11 April 2001, Commission v Gerot Pharmazeutika, C‑479/00 P(R), EU:C:2001:224, paragraph 92). Thus, the applicant is limited merely to asserting that neither it nor the group to which it belongs has sufficient funds to sponsor such activity.

88      In addition, to prove customers’ necessarily negative reaction, the applicant invokes the presumed consequences of the sending of an email to the company Audax, further to the publication of the contested regulation, which will entail the substance at issue being placed on a negative list for supermarkets that Audax supports. It does not envisage, however, the consequences that sending a similar email informing those customers of the contested regulation’s annulment will have, should its action in the main proceedings succeed. While the mere sending of such an email may have the negative consequences mentioned by the applicant, it appears that sending an email informing that the applicant’s action is well founded could have consequences capable of countering the said consequences.

89      Next, the applicant considers that, even if it could invent a new replacement substance, it would face significant legal and regulatory obstacles under the applicable rules, such as the requirement to produce a comprehensive scientific dossier of data demonstrating the safety of the replacement substance, the review of that dossier and the regulatory approval procedure, the total duration of the procedure being approximately 10 years. Moreover, product registration would cost approximately between 1.5 and 2 million euros on average, depending on the diversity of crops desired for the product label and the stage in the cycle of the renewal of approval of the active substance(s) in the product.

90      In that regard, it should be noted that, having regard to the average duration of proceedings before the General Court, the decision on the substance in the present case will probably be delivered within two years (see, to that effect, order of 21 July 2017, Polskie Górnictwo Naftowe i Gazownictwo v Commission, T‑130/17 R, EU:T:2017:541, paragraph 47). Therefore, the applicant will be informed of the legality of the contested regulation well before the period required for the approval of any replacement substance. In that context, it must be pointed out that the applicant has not requested the application of the expedited procedure provided for in Article 151 et seq. of the Rules of Procedure. Furthermore, by virtue of Article 3 of the contested regulation, it can potentially enjoy a ‘grace period’ until 8 September 2018 during which the Member States may maintain authorisations for plant protection products containing diflubenzuron. In addition, as it highlights in its application, a renewal procedure, subject to a strict deadline, is underway and could result, from 2018, in the conclusion that there is no genotoxic potential for the metabolite. In the Commission’s opinion, the date of closure of that procedure should be not long before 30 June 2019. Consequently, the lack of replacement product in the applicant’s substance portfolio does not appear to be an element relevant to the irreparable nature of the damage alleged.

91      Last, the applicant merely claims that damage to its reputation is impossible to overcome since, first, its parent company, Platform Specialty Products, can do nothing to restore its reputation pending final decision in the present case and, second, that loss of reputation cannot be compensated for purely on a financial basis by its parent company, nor can it be temporarily restored. Not only, as has been indicated in paragraph 74 above, does the applicant not specify how the suspension of operation sought would enable that presumed damage to be adequately responded to, but such assertions cannot convince the judge hearing the application for interim measures without other elements supporting them, in accordance with the case-law cited in paragraphs 24 to 27 above.

92      Third, 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 (order 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).

93      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 of the Court of Justice. At the interlocutory stage, the possibility of subsequently obtaining compensation for pecuniary damage if an action for damages is brought following annulment of the contested measure is necessarily uncertain. Interlocutory proceedings are not intended to act as a substitute for an action for damages in order to remove that uncertainty, since their purpose is only to guarantee the full effectiveness of the final future decision that will be made in the main action (in this case an action for annulment), to which the interlocutory proceedings are an adjunct (see order of 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).

94      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 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).

95      However, in the case at hand, even though the applicant considers the alleged damage unlikely tobe 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 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.

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 Balancing of interests

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

102    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).

103    In the case at hand, the applicant considers that the balance of interests tips in its favour in so far as, first, the substance at issue does not present a known danger to public health and, second, any approach other than that consisting in the suspension of the contested regulation until a definitive decision concerning the renewal procedure of the substance at issue has been issued would be disproportionate and unnecessarily penalising for the applicant in so far as maintaining that regulation would render it impossible to reverse, in the event that the contested regulation is annulled on the merits, the effects brought about by its immediate implementation.

104    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 40 years and that no public health incidents have taken place to date following their commercialisation. In addition, it specifies that diflubenzuron is authorised outside the European Union. Last, it considers that the issues raised by the Commission are more speculative than real and that, consequently, public health considerations cannot be accorded greater weight than the harm caused to the applicant as a result of the contested regulation.

105    It is apparent from the material in the case file that risks to human health have been identified. In that regard, 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 40 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.

106    In that regard, the Commission recalls that diflubenzuron is a carcinogen category 1B and that its genotoxic properties were demonstrated following a full assessment by the Rapporteur Member State, EFSA and Member States’ experts.

107    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 is a manifest error of assessment in so far as the Commission failed to examine carefully and impartially certain items of information demonstrating the lack of a ground for concern regarding the genotoxicity of the substance at issue and, second, that it was deprived of the right to defend itself by not being given opportunities to submit observations on certain documents concluding that diflubenzuron caused health risks.

108    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 acknowledgment 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. In the circumstances of the case, the risks to public health, as identified in the contested regulation, must therefore be taken into consideration in the light of the other interests at stake.

109    In that regard, the applicant does not mention any interests other than that of avoiding the occurrence of the damage caused to it by the contested regulation. 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).

110    In the case at hand, it must be noted that, in the absence of any other interest to be taken into account, the alleged damage — which, it has moreover been established, had neither the requisite seriousness nor irreparable nature — 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 diflubenzuron must be regarded as recognised (see paragraph 105 above).

111    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).

112    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.

113    In the second place, concerning the argument based on the disproportionality of the adoption of any approach other than that consisting in suspending the contested regulation until a definitive decision concerning the renewal procedure of the substance at issue has been issued, the applicant recalls that the substance at issue is currently being assessed in the Union for the purposes of a renewal of approval in accordance with Regulation No 1107/2009 (see paragraph 8 above), which was subject to a regulatory time limit expiring in December 2018. It states that, in that context, the data on the genotoxicity of PCA and, thus, the risk to consumers, would be under assessment by the Hellenic Republic, as Rapporteur Member State, and indicates that the result of that assessment was to be known in October 2017. It adds that the study of 28 February 2017 addressed the PCA concern (see paragraph 47 above).

[omissis]

116    First of all, it should be pointed out that the present case does not involve a situation requiring an immediate withdrawal of diflubenzuron-based products. On the one hand, the contested regulation merely restricts the use of diflubenzuron by excluding it only from the edible crops market and therefore does not fully prohibit the use of diflubenzuron in insecticides, thus allowing the applicant to continue to produce and market plant protection products containing that substance for use on non-edible crops. On the other hand, the contested regulation provides for a grace period lasting until 8 September 2018.

117    In that regard, it is necessary to point out that granting a grace period does not rule out the existence of public health risks. While Member States are not under the obligation to act before the expiry of that period, they may nevertheless already take the necessary measures. Therefore, imposing such a period allows a degree of protection against the risks identified, which would actually prevent the issue of a suspension of operation. The relevance of the existence of a grace period in respect of the balancing of interests performed by the judge hearing the application for interim measures occurs in the taking into account by that judge of the intensity of the risks identified as against the significance of other interests whose safeguarding is sought. In the present case, however, it is apparent from the analysis of the interests put forward by the applicant, namely the damage it fears that it will suffer due to the application of the contested regulation, that those interests are of a lesser intensity than those involving human health (see paragraphs 109 to 112 above), especially as that grace period simply lessens the feared repercussions of the effects of the contested regulation on the applicant’s situation.

118    Next, as the Commission notes in its observations, the pending renewal procedure allows the applicant’s interests to be safeguarded in so far as it may thereby argue as to the alleged absence of danger of the substance at issue to public health. According to the applicant, however, the effects of that pending procedure could already be observed in the course of 2018.

119    Last, although the applicant invokes the existence of a regulatory time limit expiring in December 2018 the authorisation of which diflubenzuron enjoyed before the adoption of the contested regulation, it seems inappropriate to order the suspension of the effects of the contested regulation merely by restricting it to that date, in so far as public health risks, which the judge hearing the application for interim measures must take into consideration (see paragraphs 105 to 108 above), have been identified and considered to prevail over the other interests advanced by the applicant (see paragraphs 109 to 112 above). A fortiori, making such an interim measure conditional upon a time limit set at the end of the renewal procedure, as has been requested by the applicant, is similarly objectionable in so far as that procedure could, according to the Commission, last until 30 June 2019.

120    Therefore, on the one hand, the situation in which the applicant finds itself allows it to continue to market to some extent its diflubenzuron-based products (see paragraph 116 above) and the prospect of a decision on the renewal of authorisation previously obtained seems close (see paragraph 118 above) and, on the other hand, maintaining the effects of the contested regulation ensures, already now, a degree protection of public health against newly identified risks (see paragraph 119 above).

121    Accordingly, the arguments put forward by the applicant regarding the disproportionality of the adoption of any approach other than that consisting in suspending the contested regulation until a definitive decision concerning the renewal procedure of the substance at issue has been issued must be rejected.

122    In the light of the foregoing, it must be concluded that, in accordance with the case-law cited in paragraph 102 above, the balance of interests does not tip in favour of granting the interim measures sought.

123    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.

124    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 are reserved.

Luxembourg, 22 June 2018.


E. Coulon

 

M. Jaeger

Registrar

 

President


*      Language of the case: English.


1      Only the paragraphs of the present Order which the Court considers it appropriate to publish are reproduced here.