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

ORDER OF THE PRESIDENT OF THE GENERAL COURT

22 June 2021 (*)

(Application for interim measures – REACH – Hexahydro-4-methylphthalic anhydride substance – Obligation to register – Evaluation of dossiers – Examination of testing proposals – Obligation to provide certain information requiring animal testing – Application for interim measures – No urgency)

In Case T‑207/21 R,

Polynt SpA, established in Scanzorosciate (Italy), represented by C. Mereu, P. Sellar and S. Abdel-Qader, lawyers,

applicant,

v

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

defendant,

APPLICATION under Articles 278 and 279 TFEU for the suspension of the operation of Decision A‑015‑2019 of the Board of Appeal of ECHA of 9 February 2021, which requests the applicant to carry out an Extended One-Generation Reproductive Toxicity Study (EOGRTS) of the substance hexahydro-4-methylphthalic anhydride or for the grant of any other interim measures deemed appropriate,

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

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

1        The applicant, Polynt SpA, a company active in the market for chemical substances, such as composites, coating resins and intermediate and specialty chemical polymers, submitted to the European Chemicals Agency (ECHA) a registration dossier for the substance hexahydro-4-methylphalic anhydride (‘the substance’) pursuant to 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, corrigendum OJ 2007 L 136, p. 3; ‘the REACH Regulation’).

2        The substances manufactured by the applicant are used exclusively in industrial processes and incorporated by professional companies resulting in articles utilised in very diverse markets, such as construction, electricity and electronics, transportation and, to a lesser extent, household appliances, paints and sporting goods.

3        The substance is used as an intermediate for the production of formulations and in polymerisation processes.

4        On 4 September 2019, ECHA adopted Decision TPE-D-2114483466-38-01/F, in accordance with Article 40 of the REACH Regulation, by which it requested the applicant to conduct an Extended One-Generation Reproductive Toxicity Study (EOGRTS) and to send it the results of that study by 13 September 2021.

5        On 4 December 2019, the applicant filed an appeal against that decision with the Board of Appeal of ECHA.

6        On 9 February 2021, the Board of Appeal of ECHA confirmed the ECHA decision and set the deadline for providing the requested information at 20 February 2023 (‘the contested decision’).

7        By application lodged at the Court Registry on 16 April 2021, the applicant brought an action for annulment of the contested decision.

8        By separate document lodged at the Court Registry on 22 April 2021, 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;

–        grant any other interim measures deemed appropriate;

–        order ECHA to pay the costs of the proceedings.

9        In its observations on the application for interim measures, which were lodged at the Registry of the General Court on 6 May 2021, ECHA contends that the President of the General Court should:

–        dismiss the application for interim measures;

–        order the applicant to pay the costs.

 Law

10      It is apparent from Articles 278 and 279 TFEU, read in conjunction 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, 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 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).

11      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 applied for’.

12      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. Where appropriate, the judge hearing such an application must also weigh up the interests involved (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).

13      In the context of that overall examination, the judge hearing the application for interim measures 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 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).

14      Having regard to the material in the case file, the President of the General 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.

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

16      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).

17      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).

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

19      In the present case, in the first place, the applicant submits in order to demonstrate the serious nature of the injury that the contested decision obliged it to infringe the requirements of Article 13 TFEU and Article 25(1) of the REACH Regulation and therefore to bear the consequences inherent in the infringement of the principles relating to animal welfare and to the avoidance of unnecessary animal testing. The carrying out of the study requested by ECHA, which will lead to the sacrifice of approximately 600 animals, will thus cause the applicant to breach its own policies on animal welfare and lose the benefits of selling a substance that can be considered by the market as cruelty free. It cannot therefore be ruled out that the applicant will not be able to sell the substance to companies which are required by their own clients to resort to cruelty-free products and components.

20      In the second place, in order to demonstrate the irreparable nature of the damage, the applicant claims that the death of approximately 600 animals will directly harm its commercial interests and its reputation. That damage will endure beyond a judgment of the Court annulling the contested decision in the main application, since the test will have had to be conducted in the meantime. However successful the outcome of the main application is, the animals will be dead and the reputation of being a company that conducted an unlawful animal test in spite of its policies and pleas from its customers cannot be restored. The applicant will thus suffer non-material damage, linked to the negative effects on its reputation, which cannot be quantified, in that it is impossible to assess a priori how the applicant’s clients will react.

21      In that regard, in the first place, it should be noted that, by the argument that it is obliged to bear the consequences inherent in the infringement of the principles relating to animal welfare and to the avoidance of unnecessary animal testing, the applicant seeks to argue that it risks legal proceedings for failing to comply with animal-welfare and animal-testing-prevention objectives enshrined in the FEU Treaty and the REACH Regulation. That risk arises, however, from the contested decision, which requires it to carry out animal testing. Until such time as a decision from an EU institution is declared invalid by the EU Courts, the Member States and their organs cannot adopt measures contrary to that decision (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).

22      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).

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

24      As the 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 required by an individual decision from an EU agency which is addressed to it, in the present case the contested decision, to carry out animal testing, the fact of complying with that requirement cannot result in it incurring liability because of another EU measure of general scope. Even if the contested decision were annulled, in any event, the applicant, when it conducted animal testing, was complying with that decision.

25      In those circumstances, it must be concluded that the risk of facing legal action for possible infringement of the FEU Treaty and of the REACH Regulation is hypothetical as it is based on the occurrence of a future and uncertain event and cannot therefore establish the imminent risk of the occurrence of serious harm.

26      In the second place, as regards the applicant’s argument that it will not be able to sell the substance to companies which are required by their own clients to resort to cruelty-free products and components, it must be held that the harm alleged in that respect is of a financial nature.

27      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. In that regard, it is settled case-law that the assessment of the serious nature of such damage is carried out in the light of, inter alia, the size and turnover of the undertaking and the characteristics of the group to which it belongs (see order of 21 January 2019, Agrochem Maks v Commission, T‑574/18 R, EU:T:2019:25, paragraphs 33 and 34 and the case-law cited).

28      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, the second sentence of 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.

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

30      However, the applicant confines itself to assertions which are not substantiated by evidence.

31      As regards, in particular, the alleged risk of losing important contracts with some of its clients which are required to resort to cruelty-free products and components, ECHA rightly argues that the information provided by the applicant does not state in clear and unequivocal terms that the clients in question will stop doing business with the applicant on the ground that it has performed testing on animals mandated by ECHA, which happens to be a standard information requirement imposed by the REACH Regulation. The applicant not only fails to specify the imminence and extent of that risk, but also fails to specify the impact which that risk’s materialising might have on its turnover.

32      In those circumstances, it must be held that the applicant has failed to demonstrate urgency based on a risk to its financial viability.

33      In the third place, as regards the applicant’s argument that the death of approximately 600 animals will directly harm its commercial interests and its reputation, it should be noted, as a preliminary point, that the EU legislature established, as the main purpose of the obligation to register laid down in Article 6(3) of the REACH Regulation, the objective of ensuring a high level of protection of human health and the environment. The means by which to achieve that objective is, as recital 19 of the REACH Regulation states, the registration obligation imposed on manufacturers and importers, which includes the obligation to generate data on the substances which they manufacture or import, to use those data to assess the risks related to those substances and to develop and recommend appropriate risk-management measures (see, to that effect, judgment of 7 July 2009, S.P.C.M. and Others, C‑558/07, EU:C:2009:430, paragraphs 45 and 46).

34      It is true that the objective of ensuring animal protection is also pursued by the REACH Regulation, in particular by Article 13(1) and Article 25(1) thereof. According to that latter provision, testing on vertebrate animals for the purposes of that regulation is to be undertaken only as a last resort.

35      However, the information requirements set out in Annexes VII to X to the REACH Regulation confirm that animal testing cannot be avoided in every case. In some cases, only testing on vertebrate animals will provide sufficient scientific information to enable measures to be taken to protect human health and the environment.

36      In particular, as regards the argument relating to the allegedly irreparable damage to the applicant’s reputation, first, it must be held that, since the applicant sells the substance only to professional clients, who are very familiar with the relevant regulatory framework, 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 (see, to that effect, order of 23 February 2021, Symrise v ECHA, T‑655/20 R, not published, under appeal, EU:T:2021:98, paragraph 30).

37      It is apparent from the applicant’s own written pleadings that [confidential]. (1)

38      Secondly, it follows from 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).

39      In the fourth and last place, 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 or herself to draw up the form of order which he or she is subsequently supposed to assess (see order of 15 July 2019, 3V Sigma v ECHA, T‑176/19 R, not published, EU:T:2019:547, paragraph 37 and the case-law cited).

40      It follows from all of the foregoing that the application for interim measures 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.

41      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 shall be reserved.

Luxembourg, 22 June 2021.

*      Language of the case: English.

1 Confidential data omitted.

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