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

ORDER OF THE PRESIDENT OF THE GENERAL COURT

23 February 2021 (*)

(Application for interim relief – REACH – Substance homosalate – Compliance check of registrations – Obligation to provide certain information requiring animal testing – Application for interim measures – No urgency)

In Case T‑656/20 R,

Symrise AG, established in Holzminden (Germany), represented by R. Cana, E. Mullier and H. Widemann, lawyers,

applicant,

v

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

defendant,

APPLICATION pursuant to Articles 278 TFEU and 279 TFEU for the grant of interim measures, first, to suspend implementation of Decision A‑009‑2018 of the Board of Appeal of ECHA of 18 August 2020, relating to the applicant’s registration dossier for homosalate and, second, to order the extension of the prescribed period to communicate the results of the tests for the duration of the suspension,

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, Symrise AG, imports the substance homosalate, of which it is the main declarant 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, and corrigendum OJ 2007 L 136, p. 3; ‘the REACH Regulation’).

2        Homosalate is an organic single-component chemical substance which is used exclusively in cosmetic and personal care products as an ultraviolet filter.

3        That substance is included in Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ 2009 L 342, p. 59; ‘the Cosmetics Regulation’) as an ultraviolet filter authorised in cosmetic products with a maximum concentration of 10% in ready-for-use preparations.

4        On 13 March 2018, in the context of a compliance check of the registration of that substance, the European Chemicals Agency (ECHA) adopted a decision requesting the applicant to submit, by 21 September 2021 at the latest, certain information for the evaluation of the substance homosalate.

5        To that end, the appellant had to carry out four studies:

–        first, a subchronic toxicity study carried out on rats;

–        second, a prenatal developmental toxicity study carried out on a first species (rats or rabbits);

–        third, an extensive toxicity study for reproduction in one generation carried out on rats;

–        fourth, identification of degradation products.

6        On 12 June 2018, the applicant filed an appeal against that decision with the Board of Appeal of ECHA.

7        On 18 August 2020, the Board of Appeal of ECHA confirmed the ECHA decision and set the deadline for providing the requested information at 25 February 2024 (‘the contested decision’).

8        By application lodged at the Court Registry on 27 October 2020, the applicant brought an action seeking the annulment of the contested decision.

9        By separate document lodged at the Court Registry on 27 November 2020, the applicant brought the present application for interim measures, in which it claims, in essence, that the President of the Court should:

–        suspend the operation of the contested decision with immediate effect, in accordance with Article 157(2) of the Rules of Procedure of the General Court;

–        order the suspension of operation of the contested decision pending the decision of the General Court in the main proceedings;

–        consequently, order the extension, for the duration of that suspension, of the prescribed period within which it is to submit the results of its tests, in the event that the action in the main proceedings is not upheld;

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

–        order ECHA to pay the costs of the proceedings.

10      In its observations on the application for interim measures, lodged at the Court Registry on 14 December 2020, ECHA contends that the President of the Court should:

–        reject the application for interim measures;

–        reserve the costs.

 Law

11      It is apparent from a combined reading of Articles 278 and 279 TFEU, together with Article 256(1) TFEU, that the judge hearing an application for interim measures may, if he or she 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, under 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).

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

13      The judge hearing an application for interim measures 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 measures 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).

14      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).

15      Having regard to the documents in the case file, the President of the Court 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.

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

17      In order to determine whether the interim measures sought are urgent, it should be noted that the purpose of the procedure for interim measures 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 (order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P‑R, EU:C:2016:21, paragraph 27).

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

19      It is in the light of those criteria that it is necessary to examine whether the applicant has succeeded in demonstrating urgency.

20      In the present case, to demonstrate the serious and irreparable nature of the damage, the applicant claims, first, that the studies requested by ECHA will require it to sacrifice a large number of vertebrate animals in order to comply with the contested decision and that any annulment of that decision will have no effect on the tests already carried out. Second, the applicant submits that, to comply with the contested decision, it also risks being prosecuted, penalised or sued for failure to comply with animal welfare and animal testing prevention objectives, enshrined, in particular, in national legislation, the REACH Regulation and the Cosmetics Regulation. Those regulations provide, in particular, that tests on vertebrate animals are to be carried out only if there is no other solution (Article 25(1) of the REACH Regulation) and that animal testing on cosmetic ingredients is, as a general rule, prohibited (Article 18(1)(d) of the Cosmetics Regulation). The applicant submits, third, that those animal tests will damage its reputation and, fourth, that they will affect its position on the homosalate market.

21      In the first place, with regard to the applicant’s argument that the studies required will lead to the sacrifice of many vertebrate animals, it should be noted that, in accordance with settled case-law, to prove that the condition relating to urgency is satisfied, the party seeking interim measures must show that those measures are necessary for the protection of its own interests, whereas it cannot rely, in order to establish urgency, on an adverse effect on an interest which is not personal to it, such as an adverse effect on a public interest or on third parties’ rights. Thus, that party must demonstrate that the alleged harm is liable, in itself, to cause serious and irreparable personal harm (see order of 30 April 2020, Nouryon Industrial Chemicals and Others v Commission, T‑868/19 R, not published, EU:T:2020:171, paragraph 24 and the case-law cited).

22      In the present case, the applicant does not claim any direct damage that the carrying out of those studies on vertebrate animals would entail for itself.

23      Accordingly, and in so far as the applicant has not put forward sufficiently precise and specific evidence to call into question the case-law of the Court, it follows that, as the Court has previously held in paragraph 25 of the order of 30 April 2020, Nouryon Industrial Chemicals and Others v Commission (T‑868/19 R, not published, EU:T:2020:171), while the argument that the implementation of the contested decision would harm animal welfare is indeed ethical, it cannot establish the urgency to the applicant of the suspension requested.

24      It is true that, in accordance with settled case-law, harm caused to the general interest or to the rights of third parties is not entirely irrelevant in the context of the examination of an application for interim measures, since it may, where appropriate, be taken into account when weighing up the interests involved (see order of 19 August 2019, BASF v Commission, T‑472/19 R, not published, EU:T:2019:555, paragraph 32 and the case-law cited). However, in accordance with the case-law cited in paragraph 14 above, 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. Consequently, it follows that the judge hearing an application for interim measures is not required to undertake such a balancing of interests if he or she first finds that one of the conditions for the grant of interim relief is not satisfied (see order of 30 April 2020, Nouryon Industrial Chemicals and Others v Commission, T‑868/19 R, not published, EU:T:2020:171, paragraph 26 and the case-law cited).

25      In the second place, with regard to the argument that the applicant, to comply with the contested decision, risks legal proceedings for failing to comply with animal welfare and animal testing prevention objectives enshrined, in particular, in national legislation, the REACH Regulation and the Cosmetics Regulation, it must be pointed out from the outset that it is not for the Judge hearing applications for interim measures to give a final ruling on questions concerning the relationship between the prohibition of animal testing, laid down in the REACH Regulation, and the Cosmetics Regulation. However, it is for that Judge to determine whether the risk alleged by the applicant is foreseeable with a sufficient degree of probability or whether it is purely hypothetical, in that it is based on the occurrence of future, uncertain events (order of 13 July 2017, BASF Grenzach v ECHA, T‑125/17 R, not published, EU:T:2017:496, paragraph 43).

26      In that regard, it must be borne in mind, first, that the applicant is obliged by the contested decision to carry out animal testing and, second, that, as long as a decision emanating from an EU institution has not been declared invalid by the Courts of the European Union, the Member States and their organs cannot adopt measures contrary to that decision. Measures of the EU institutions are, in principle, presumed to be lawful and accordingly produce legal effects until such time as they are withdrawn, annulled in an action for annulment or declared invalid following a reference for a preliminary ruling or a plea of illegality (see order of 13 July 2017, BASF Grenzach v ECHA, T‑125/17 R, not published, EU:T:2017:496, paragraph 46 and the case-law cited).

27      The same is true of the contested decision, which emanates from an agency of the European Union.

28      As the General Court held in paragraph 47 of the order of 13 July 2017, BASF Grenzach v ECHA (T‑125/17 R, not published, EU:T:2017:496), in so far as the applicant is bound by an individual decision of an EU agency addressed to it, in this case the contested decision, to carry out animal testing, the fact of complying with that requirement cannot give rise to liability on account of another EU act of general application. That would also be the case, in principle, if the contested decision were subsequently annulled. The fact remains that the applicant, at the time at which it carried out animal testing, had complied with that decision.

29      In those circumstances, it must be held that the risk alleged by the appellant that legal proceedings will be brought against it, on account of a possible infringement of the REACH Regulation, the Cosmetics Regulation and national legislation, is purely hypothetical, in that it is based on the occurrence of future and uncertain events and cannot, therefore, establish an imminent risk of the occurrence of serious and irreparable harm.

30      In the third place, as regards the argument relating to the allegedly irreparable damage to the applicant’s reputation, it must be held, as ECHA observes, that, since the applicant sells the substance homosalate only to professional clients, that is to say, manufacturers of cosmetic products, it is unlikely that such customers would interpret the applicable legal framework incorrectly, which makes it unlikely that harm would be caused to the applicant’s reputation in that regard.

31      Furthermore, it must be held, in accordance with settled case-law, that, assuming that the applicant’s reputation is actually compromised by the contested decision, the annulment of that decision at the end of the main proceedings would constitute sufficient compensation for the non-material damage alleged (see, to that effect, order of 6 April 2016, GABO:mi v Commission, T‑10/16 R, not published, EU:T:2016:197, paragraph 49 and the case-law cited).

32      In the fourth place, with regard to the argument that the contested decision will affect the applicant’s position on the homosalate market, it must be noted at the outset that the damage alleged in that respect is financial.

33      In accordance with settled case-law, damage of a pecuniary nature cannot, other than in exceptional circumstances, be regarded as irreparable since, as a general rule, pecuniary compensation is capable of restoring the aggrieved person to the situation that prevailed before the damage was suffered (see order of 11 September 2020, Datax v REA, T‑381/20 R, not published, EU:C:2020:414, paragraph 37 and the case-law cited). Any such damage could be remedied by the applicant’s bringing an action for compensation on the basis of Articles 268 TFEU and 340 TFEU (see order of 23 April 2015, Commission v Vanbreda Risks & Benefits, C‑35/15 P(R), EU:C:2015:275, paragraph 24 and the case-law cited).

34      However, where the harm referred to is of a financial nature, the interim measures sought are justified where, in the absence of those measures, the applicant would be in a position that would imperil its financial viability before final judgment is given in the main action, or where its market share would be affected substantially in the light, inter alia, of the size and turnover of its undertaking and, as the case may be, the characteristics of the group to which it belongs (see order of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P‑R, EU:C:2014:1749, paragraph 46 and the case-law cited).

35      In order to determine whether these conditions are fulfilled, the judge hearing the application for interim measures must, according to well-established case-law, 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 must produce, with supporting documentation, an accurate overall picture of its financial situation (see order of 10 July 2018, Synergy Hellas v Commission, T‑244/18 R, not published, EU:T:2018:422, paragraph 27 and the case-law cited). Furthermore, Article 156(4) of the Rules of Procedure expressly provides that an application for interim measures must contain all the evidence and offers of evidence available to justify the grant of the interim measures requested.

36      In that regard, it should be noted that, in accordance with the case-law referred to in paragraph 35 above, in order to demonstrate a risk to its financial viability, the applicant should have produced, with supporting documents, an accurate overall picture of its financial situation.

37      However, in so far as the applicant confines itself to mere assertions, unsupported by any evidence, it must be concluded that it has failed to demonstrate urgency based on a risk to its financial viability.

38      It follows from all the foregoing that the application for interim relief must be dismissed, as the applicant has failed to establish urgency, without it being necessary to rule on the prima facie case or to weigh up the interests.

39      Under 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 are reserved.

Luxembourg, 23 February 2021.

*      Language of the case: English.

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