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

ORDER OF THE PRESIDENT OF THE GENERAL COURT

15 July 2019 (*)

(Application for interim measures — REACH — UVASORB HEB — Evaluation procedure — Decision of the Board of Appeal of ECHA — Application for interim measures — No urgency)

In Case T‑176/19 R,

3V Sigma SpA, established in Milan (Italy), represented initially by C. Bryant, S. Hainsworth, Solicitors, and C. Krampitz, lawyer, and subsequently by C. Bryant, S. Hainsworth and D. Anderson, Solicitors,

applicant,

v

European Chemicals Agency (ECHA), represented initially by M. Heikkilä and W. Broere, and subsequently by W. Broere, acting as Agents,

defendant,

APPLICATION under Articles 278 and 279 TFEU seeking suspension of the application of Decision A-004-2017 of the Board of Appeal of ECHA of 15 January 2019 regarding the substance evaluation of the chemical substance UVASORB HEB and, consequently, the extension of the prescribed period for submission of the results of the tests for the duration of the suspension or an order for any other or additional measure which the President of the Court may consider necessary or appropriate,

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

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

1        The applicant, 3V Sigma SpA, manufactures the chemical substance UVASORB HEB, for which it is one of the four registrants under Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1) (‘the REACH Regulation’).

2        The chemical substance UVASORB HEB is used as an ultra-violet (UV) filter in cosmetic products.

3        In 2015 UVASORB HEB was included in the Community rolling action plan pursuant to Articles 44 to 48 of the REACH Regulation due to grounds for concern relating to its potential, persistent, bioaccumulative and toxic or very persistent and very bioaccumulative properties.

4        The German Member State Competent Authority (‘the eMSCA’) was appointed to conduct the substance evaluation for UVASORB HEB. 

5        Following that evaluation, the European Chemicals Agency (ECHA) notified the applicant of its draft decision on 26 April 2016.

6        Following comments from the applicant, which were taken into account, ECHA adopted a decision (‘the original decision’) on 20 December 2016, according to which the applicant was to submit by 27 September 2018 further information on UVASORB HEB, namely:

–        first, sediment simulation testing (aerobic and anaerobic transformation in aquatic sediment systems, EU C.24/OECD 308) with UVASORB HEB at 20 °C according to the specification of the test conditions listed in Appendix 1 Section 1.1.3 to the original decision (‘the OECD TG 308 study’);

–        second, further information on uses and environmental emissions, as specified further in Appendix 1 to the original decision.

7        On 20 March 2017 the applicant filed an administrative appeal with the Board of Appeal of ECHA against the original decision, which had the effect of suspending that decision pursuant to Article 91(2) of the REACH Regulation.

8        On 15 January 2019 the Board of Appeal of ECHA adopted decision A-004-2017 regarding the substance evaluation of UVASORB HEB (‘the contested decision’), in which it annulled in part the original decision to the extent that it requested further information but dismissed the appeal as to the remainder. In addition, the contested decision set the deadline for the submission of the OECD TG 308 study as 22 October 2020.

9        By application lodged at the Court Registry on 25 March 2019, the applicant brought an action seeking, in essence, annulment of the contested decision.

10      By separate document lodged at the Court Registry on 29 March 2019, the applicant brought the present application for interim measures, in which it claims, in essence, that the President of the Court should:

–        order the immediate suspension of the application of the contested decision;

–        order, consequently, the extension of the prescribed period for submission of the results of the OECD TG 308 study for the duration of the suspension;

–        order any other form of interim measure necessary; and

–        order ECHA to pay the costs.

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

–        dismiss the application for interim measures;

–        order the applicant to pay the costs.

 Law

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

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

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

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

16      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.

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

18      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 Courts. To attain that objective, urgency must be assessed in the light of the need of an interlocutory order to avoid serious and irreparable harm to the party requesting the interim measure. That party must demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable harm (see order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P‑R, EU:C:2016:21, paragraph 27 and the case-law cited).

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

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

21      Those criteria can guide the examination of whether the applicant has managed to establish urgency, by showing that serious and irreparable harm is imminent.

22      In this instance, with regard to the likelihood of serious and irreparable harm, the applicant relies on four arguments.

23      In its first argument, the applicant submits, in essence, that, given the period prescribed in the contested decision for the performance of the OECD TG 308 study, since 12 to 18 months are necessary to perform that study, it would be obliged to start the study while the main proceedings are pending, thus depriving that action of its purpose and effect.

24      In its second argument, the applicant submits, in essence, that, if it has to perform the OECD TG 308 study in the conditions required by the contested decision, and in particular using the temperature specified, the effect of using that unrealistically high temperature will be that transformation and/or degradation products will be formed. According to the applicant, there is a risk that this would cause the eMSCA to adopt inappropriate follow-up measures concerning the substance evaluation. In addition, the applicant claims that the eMSCA and ECHA are already prejudiced in favour of the adoption of risk management measures, despite the fact that, in the substance evaluation process for UVASORB HEB performed as part of the Community rolling action plan, it was determined that it did not have persistent, bioaccumulative and toxic or very persistent and very bioaccumulative properties. Consequently, the applicant claims that any performance of the OECD TG 308 study in conditions that it considers to be unrealistic will most likely be used against it. Accordingly, the applicant asserts that only suspension of the effects of the relevant parts of the contested decision prior to the outcome in the main proceedings will allow it to avert those negative consequences.

25      In its third argument, the applicant submits that, if the OECD TG 308 study had to be performed under the conditions prescribed in the contested decision, the impact on its reputation could not be reversed or quantified, as the harm would go beyond mere financial damage. In that respect, the applicant confirms that it has already received queries from customers in relation to the properties of UVASORB HEB and that, if the OECD TG 308 study had to be performed under the conditions specified, those concerns would only be compounded.

26      In its fourth argument, the applicant submits, in essence, that the expenditure incurred in performing the OECD TG 308 study would be such that it would be unable to recover the costs. In this regard, while the applicant recognises that harm of a pecuniary nature cannot, other than in exceptional circumstances, be regarded as irreparable, it submits that such exceptional circumstances exist in the present case.

27      According to the applicant, it is for the President of the General Court to find within these proceedings that the contested decision constitutes a sufficiently serious breach that causes the European Union to incur non-contractual liability. If he fails to do so, the applicant argues that it will be impossible to compensate that party for the financial damage that it claims to have suffered. Accordingly, the applicant asserts that any financial damage would be irreversible.

28      In addition, the applicant submits that UVASORB HEB constitutes 12% of its turnover and that, if it were to lose that market, its financial viability would be threatened.

29      With respect to the applicant’s first argument, it should be noted that, according to the case-law, even if certain circumstances are likely to have an immediate and irreversible impact on an applicant’s situation, it is still necessary that those circumstances be likely to cause serious and irreparable harm to that applicant in order to satisfy the conditions for granting interim measures and, in particular, the condition relating to urgency (see, to that effect, order of 23 November 2017, Nexans France and Nexans v Commission, T‑423/17 R, not published, EU:T:2017:835, paragraph 51). Accordingly, the mere fact that, according to the applicant’s claims, it would be obliged to perform the OECD TG 308 study while the main proceedings are pending is not, in itself, sufficient to establish urgency.

30      In any event, it should be noted that, contrary to what is claimed by the applicant, the action in the main proceedings would not be devoid of purpose, as it would allow the applicant to obtain a finding, by the EU judicature, that an unlawful act has been committed against it, so that that finding can then be the basis for any action for damages aimed at properly restoring the harm caused by the contested decision (see, to that effect, judgment of 17 July 2014, Westfälisch-Lippischer Sparkassen- und Giroverband v Commission, T‑457/09, EU:T:2014:683, paragraph 137).

31      With regard to the second argument, in which the applicant submits that, if it had to perform the OECD TG 308 study in the conditions prescribed by the contested decision, there is a risk that this would cause the eMSCA to adopt inappropriate follow-up measures concerning the substance evaluation, it need only be noted that the applicant’s claim is based on the occurrence of uncertain and hypothetical events and therefore cannot, in itself, establish the imminent risk of serious and irreparable harm (see, to that effect, order of 13 July 2017, BASF Grenzach v ECHA, T‑125/17 R, not published, EU:T:2017:496, paragraph 48).

32      Further, the applicant’s argument that the eMSCA and ECHA are prejudiced in favour of the adoption of risk management measures must also be rejected, as it constitutes only an unsubstantiated assertion unsupported by any evidence and, therefore, remains merely an allegation.

33      With regard to the third argument concerning the allegedly irreparable nature of the harm caused to the applicant’s reputation, it must be stated that, in accordance with settled case-law, if it were to be established, the harm would already have been caused by the contested decision, so that the harm has already occurred. The purpose of interim proceedings is not to secure reparation for harm already suffered (see, to that effect, order of 10 December 2015, GGP Italy v Commission, T‑474/15 R, not published, EU:T:2015:958, paragraph 35 and the case-law cited). In addition, the applicant cannot reasonably claim, in order to establish that it has suffered serious and irreparable harm, that only suspension of the application of the contested decision would make it possible to avoid harm to its reputation. Annulment of the contested decision on conclusion of the main proceedings would provide sufficient reparation for the alleged non-material harm (see, to that effect, orders of 22 July 2010, H v Council and Others, T‑271/10 R, not published, EU:T:2010:315, paragraph 37, and of 18 November 2011, EMA v Commission, T‑116/11 R, not published, EU:T:2011:681, paragraph 21).

34      Last, with regard to the fourth argument, in which the applicant claims, in essence, that it is for the President of the General Court to find that there exists a prerequisite for the European Union to incur non-contractual liability — namely that there has been a sufficiently serious breach — in order to avoid irreparable harm being caused, it need only be pointed out that, in the context of the examination of urgency, it is not for the President of the General Court to find that there exists a prerequisite for the European Union to incur non-contractual liability. It has consistently been held that the urgency of an application for an interim measure must be assessed in the light of the extent to which an interim order is necessary in order to avoid serious and irreparable harm to the party requesting the interim measure (see order of 26 June 2006, Olympiakes Aerogrammes v Commission, T‑416/05 R, not published, EU:T:2006:173, paragraph 51 and the case-law cited).

35      With regard to the submission concerning the threat to the applicant’s financial viability due to the fact that UVASORB HEB constitutes 12% of its turnover, it need only be pointed out that, given that, at this stage, no decision on the marketing of UVASORB HEB has been taken, the harm to which the applicant refers is uncertain and hypothetical. This submission must therefore be rejected.

36      As the applicant has not shown that serious and irreparable harm is imminent, it is therefore also necessary to refuse its application for interim relief in the form of an order from the President of the General Court extending the prescribed period for submission of the results of the OECD TG 308 study for the duration of the suspension.

37      Finally, it is necessary to reject as inadmissible the head of claim in which the applicant requests an order for any other or additional measure considered necessary or appropriate, in accordance with settled case-law to the effect that asking the judge hearing the application for interim measures to adopt any other interim relief measures, without specifying in what those measures might consist, amounts to asking the judge himself to draw up the form of order which he is subsequently supposed to assess (order of 4 May 2018, Czarnecki v Parliament, T‑230/18 R, not published, EU:T:2018:262, paragraph 23; see also, to that effect, order of 13 December 2004, Sumitomo Chemical v Commission, C‑381/04 P(R), not published, EU:C:2004:796, paragraph 20).

38      As urgency has not been established by the applicant, the present application for interim measures must be dismissed, and there is no need to examine the requirement that there be a prima facie case or to weigh the competing interests.

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

On those grounds,

THE PRESIDENT OF THE GENERAL COURT

Hereby orders:

1.      The application for interim measures is dismissed.

2.      The costs shall be reserved.

Luxembourg, 15 July 2019.

*      Language of the case: English.

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