T-448/25

ORDER OF THE PRESIDENT OF THE GENERAL COURT 21 November 2025 (*) ( Interim relief – REACH – Substance 4,4’‑Isopropylidenediphenol, oligomeric reaction products with 1‑chloro‑2,3‑epoxypropane, esters with acrylic acid – Compliance check of registrations – Obligation to provide a study requiring animal testing – Application for interim measures – No urgency ) In Case T‑448/25 R, Arkema France, established in Puteaux (France), Miwon Europe GmbH, established in Mainz (Germany), represented by R. Cana and E. Mullier, lawyers, applicants, v European Chemicals Agency (ECHA), represented by M. Heikkilä and T. Basmatzi, acting as Agents, defendant, THE PRESIDENT OF THE GENERAL COURT makes the following Order 1        By their application pursuant to Articles 278 and 279 TFEU, the applicants, Arkema France and Miwon Europe GmbH, seek, first, the suspension of the operation of Decision A-003-2024 of the Board of Appeal of the European Chemicals Agency (ECHA) of 29 April 2025 concerning a compliance check of the registration for the substance 4,4’‑Isopropylidenediphenol, oligomeric reaction products with 1‑chloro‑2,3‑epoxypropane, esters with acrylic acid (EC 500-130-2, CAS 55818-57-0) (‘the substance’), issued following an appeal brought against Decision CCH-D-2114664303-53-01/F adopted by ECHA pursuant to Article 42(1) of 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 contested decision’), and, second, the grant of such other interim measures as the President of the General Court may deem appropriate.  Background to the dispute and forms of order sought 2        The applicants produce the substance in, or import it into, the territory of the European Union. 3        The substance is used as a monomer in industrial coatings and ink formulations which are cured under ultraviolet light or electro-beam radiation. 4        On 24 October 2017, ECHA notified Arkema France of a compliance check decision in respect of the registration of the substance under Article 41 of Regulation No 1907/2006, by which it requested that Arkema France provide, by 31 October 2019 at the latest, a basic design of the Extended One Generation Reproductive Toxicity Study (‘EOGRTS’), together with additional specificities including Cohort 3. 5        The EOGRTS is a technically complex design study, the aim of which is to assess the presumed effects of chemical products on fertility and development, in particular on developing nervous and immune systems. 6        In October 2019, Arkema France provided ECHA with the EOGRTS. 7        On 9 March 2022, ECHA notified Arkema France of an initial follow-up decision concerning a compliance check of the registration for the substance pursuant to Article 42(1) of Regulation No 1907/2006, as well as Articles 50 and 51 thereof, by which it concluded that the study provided by Arkema France did not meet the requirements of point 8.7.3. of Annex X to that regulation. 8        On 7 June 2022, Arkema France brought an appeal before the Board of Appeal of ECHA against the decision of 9 March 2022. 9        On 5 July 2022, the Interim Executive Director of ECHA decided to rectify the decision of 9 March 2022 pursuant to Article 93(1) of Regulation No 1907/2006 by withdrawing that decision in its entirety, as a result of which those appeal proceedings were closed. 10      On 5 January 2024, ECHA adopted a second follow-up decision, by which it concluded that the study provided by Arkema France did not meet the requirements of point 8.7.3. of Annex X to Regulation No 1907/2006 and declared that Arkema France was still required to provide an EOGRTS. 11      On 4 April 2024, Arkema France, in its capacity as lead registrant and representative of the registrants of the substance under Annex X to Regulation No 1907/2006, brought an appeal before the Board of Appeal of ECHA against the decision of 5 January 2024. 12      On 29 April 2025, the Board of Appeal of ECHA adopted the contested decision, whereby it dismissed the appeal in its entirety. 13      By application lodged at the Registry of the General Court on 8 July 2025, the applicants brought an action seeking, inter alia, the annulment of the contested decision. 14      By separate document lodged at the Court Registry on 8 August 2025, the applicants have brought the present application for interim relief, in which they claim, in essence, that the President of the General Court should: –        suspend the operation of the contested decision and the effects thereof which confirm the decision of 5 January 2024, pending a definitive ruling on the main action; –        grant such other interim measures as he may deem appropriate; –        order ECHA to pay the costs. 15      In its observations regarding the application for interim relief, lodged at the Court Registry on 22 August 2025, ECHA contends that the President of the General Court should: –        refuse the application for interim relief as inadmissible in so far as it concerns Miwon Europe and, in the alternative, as unfounded; –        refuse the application for interim relief as unfounded in so far as it concerns Arkema France; –        reject as inadmissible the applicants’ head of claim concerning other unspecified interim measures, as well as that concerning the suspension of the effects of ECHA’s decision of 5 January 2024; –        order the applicants to pay all the costs and expenses incurred for the purposes of the present proceedings.  Law  General considerations 16      It is apparent from reading Articles 278 and 279 TFEU together with Article 256(1) TFEU that the judge hearing an application for interim relief may, if he or she considers that the circumstances so require, order that the operation of an act contested before the General Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure of the General Court. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, as 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 relief may order the suspension of the operation of an act contested 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). 17      The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim relief are to 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’. 18      The judge hearing an application for interim relief may thus order the suspension of the 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 interests of the person seeking interim relief, 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). 19      In the context of that overall examination, the judge hearing an application for interim relief 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). 20      Having regard to the documents in the case file, the President of the General Court considers that he has all the necessary information to rule on the present application for interim relief, without there being any need to hear oral argument from the parties beforehand. 21      In the circumstances of the present case, and without there being any need to rule on the admissibility of (i) the present application for interim relief in so far as it was brought by Miwon Europe and (ii) the applicants’ head of claim seeking the suspension, by the President of the General Court, of the operation of the effects of the contested decision which confirm the decision of 5 January 2024, it is necessary to begin by examining whether the condition relating to urgency is satisfied.  The condition relating to urgency 22      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 judicature. To attain that objective, urgency must, generally, be assessed in the light of the need for an interlocutory order so as to avoid serious and irreparable harm to the person seeking the adoption of interim measures. That person must prove 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). 23      It is in the light of those criteria that it is necessary to examine whether the applicants have succeeded in demonstrating urgency. 24      In the present case, in the first place, the applicants argue that the seriousness of the harm is connected with the fact that the conducting of a second EOGRTS requires that 1 400 vertebrate animals be killed, which must be avoided pending the outcome of the main proceedings in order to comply with the objective of protecting animal welfare enshrined in Article 25 of Regulation No 1907/2006 and Article 13 TFEU. 25      In the second place, in order to demonstrate the irreparable nature of the harm relied on, the applicants allege that subsequent annulment of the contested decision will have no effect on the studies already conducted and that the lives of many vertebrate animals will be sacrificed in order to comply with the contested decision. 26      In that connection, the applicants explain that the loss of animal life is prejudicial to their interests. The fact that they do not themselves directly suffer serious and irreparable harm does not necessarily preclude the grant of interim measures for reasons of animal welfare protection. 27      According to the applicants, it is for the judge hearing the application for interim relief to give a ruling on the question whether the loss of animal life following a request to conduct a study that has already validly been submitted, as is required by the contested decision, satisfies the condition that there be ‘irreparable harm’ in the context of an application such as that submitted in connection with the present case. 28      In order to substantiate that argument, the applicants put forward the following elements. 29      First of all, the applicants recall that, in the order of 11 April 2024, Vivendi v Commission (C‑90/24 P(R), EU:C:2024:318, paragraph 75), the Vice-President of the Court of Justice held that the condition relating to urgency could be satisfied where the person applying for interim relief was acting personally, in order to protect its own interests by avoiding being forced itself to cause serious and irreparable harm to third parties. That being so, in the present case, the subjects directly suffering the serious and irreparable harm which consists in loss of life cannot request the suspension of the operation of the contested decision. It is therefore for the applicants, also in order to protect their own interests, to submit the present application for interim relief and to demonstrate that the condition relating to urgency is satisfied. 30      Next, the applicants refer to the public commitments of Arkema France with regard to animal welfare. 31      Lastly, the applicants consider that the criterion identified by the Court of Justice for assessing whether irreparable harm has been caused to the protection of the environment should also be applicable to the protection of animal welfare. Accordingly, they request the President of the General Court to transpose to the present case the case-law relating to breaches of EU environmental law, according to which damage to the environment and human health is generally irreversible since, more often than not, damage to such interests cannot, by reason of its nature, be eliminated retroactively. 32      In the third place, the applicants claim that compensation alone cannot constitute restitutio ad integrum. Unlike the financial costs of conducting the EOGRTS, the loss of animal life cannot be remedied by compensation. 33      In that regard, in the first place, with regard to the applicants’ argument that the EOGRTS required by ECHA will lead to many vertebrate animals being killed, it should be borne in mind that, in accordance with recital 1 of Regulation No 1907/2006, that regulation should ensure a high level of protection of human health and the environment as well as the free movement of substances. 34      In addition, it should be pointed out that, in accordance with settled case-law, in order to prove that the condition relating to urgency is satisfied, the person 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 general interest or on third parties’ rights. Thus, that person must demonstrate that the alleged harm is liable to cause it serious and irreparable personal harm (see orders of 23 February 2021, Symrise v ECHA, T‑655/20 R, not published, EU:T:2021:98, paragraph 21 and the case-law cited, and of 23 February 2021, Symrise v ECHA, T‑656/20 R, not published, EU:T:2021:99, paragraph 21 and the case-law cited). 35      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 relief, as it may, where appropriate, be taken into account when weighing up the interests involved. However, in accordance with the case-law cited in paragraph 19 above, the judge hearing an application for interim relief 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. Consequently, it follows that the judge hearing an application for interim relief 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 measures is not satisfied (see orders of 23 February 2021, Symrise v ECHA, T‑655/20 R, not published, EU:T:2021:98, paragraph 24 and the case-law cited, and of 23 February 2021, Symrise v ECHA, T‑656/20 R, not published, EU:T:2021:99, paragraph 24 and the case-law cited). 36      In the present case, while acknowledging that they do not themselves directly suffer serious and irreparable harm, the applicants claim that the loss of animal life is prejudicial to their interests. 37      In that context, the applicants argue that the conditions laid down by the case-law of the Court of Justice for assessing urgency are dynamic and that urgency is to be assessed taking into account the circumstances of the case. 38      First of all, regarding the case-law derived from the order of 11 April 2024, Vivendi v Commission (C‑90/24 P(R), EU:C:2024:318), it should be pointed out that, in paragraph 75 of that order, the Vice-President of the Court of Justice acknowledged that, by its application for interim relief, the applicant in that case was seeking to act not in place of third parties who were independently concerned by the effects of the decision at issue, but rather personally, in order to protect its own interests. 39      Thus, it is apparent from that case-law, as from the case-law cited in paragraph 34 above, that a person applying for interim relief must rely on an interest which is personal to it. 40      In that context, it is admittedly not inconceivable that the personal interests of the person applying for interim relief may merge with the interests of third parties. 41      However, in the present case, the applicants only argue that, given that animals cannot request the suspension of the operation of the contested decision, it is for them to do so, also in order to protect their own interests. 42      The applicants do not identify the nature of their own interests. They do not claim any direct harm that would result for them from the EOGRTS being carried out on vertebrate animals. 43      Next, it must be pointed out that the reference made by the applicants to the public commitments of Arkema France with regard to animal welfare is not such as to demonstrate that the loss of animal life is prejudicial to the applicants’ interests. It must be acknowledged, as has been noted by ECHA, that accepting such a position would mean that a private company’s public commitments to general interests could be grounds for a finding of serious and irreparable harm in the context of an application for interim measures. Moreover, in the absence of numerical data concerning the economic significance of the applicants’ commercial activities relating to the substance, it is not possible to verify whether they may themselves avoid the loss of animal life by suspending those activities for the duration of the main proceedings. 44      Lastly, regarding the applicants’ argument that the criterion identified by the Court of Justice for assessing whether irreparable harm has been caused to the protection of the environment should also be applicable to the protection of animal welfare, it must be pointed out, as has been noted by ECHA, that private companies, such as the applicants, cannot rely on the existence of a risk that harm will be caused to a general interest as proof that the condition relating to urgency is satisfied. Indeed, the situation of those companies is different to that of a Member State which seeks to prevent serious and irreparable harm to its national interests, which may include protecting the environment in its territory. It is also different from actions taken by the European Commission against Member States in the context of infringement proceedings. The Commission is entitled, as the guardian of the general interests of the Union, to adduce evidence of harm caused to the Union. 45      Consequently, and in so far as none of the applicants’ arguments is capable of justifying calling in question the case-law of the General Court, it follows that, while the argument that the operation of the contested decision would be prejudicial to animal welfare does indeed have an ethical dimension, it cannot establish the urgency of the suspension sought for the applicants (see, to that effect, order of 30 April 2020, Nouryon Industrial Chemicals and Others v Commission, T‑868/19 R, not published, EU:T:2020:171, paragraph 25). 46      In the second place, regarding the applicants’ argument that, unlike the financial costs of conducting the EOGRTS, the loss of animal life cannot be remedied by means of compensation, it should be noted that, in the light of the considerations set out in paragraphs 33 to 45 above, the applicants cannot in any event confine themselves to relying on the possible harm that might be suffered by third parties in order to demonstrate the existence of harm that would affect them personally. 47      It follows from all of the foregoing that the application for interim relief must be refused on the grounds that the applicants have failed to establish urgency, without it being necessary to give a ruling on the prima facie case or to weigh up the interests involved. 48      In addition, it is necessary to reject as inadmissible the head of claim by which the applicants request the grant of such other interim measures as may be deemed appropriate, in accordance with the settled case-law to the effect that asking the judge hearing an application for interim relief to adopt any other interim measures, without specifying in what those measures might consist, amounts to asking the judge him- 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). 49      Under Article 158(5) of the Rules of Procedure, the costs are to be reserved. On those grounds, THE PRESIDENT OF THE GENERAL COURT hereby orders: 1.      The application for interim relief is refused. 2.      The costs are reserved. Luxembourg, 21 November 2025. V. Di Bucci   M. van der Woude Registrar   President *      Language of the case: English.