31 July 2024 (*)

(Interim relief – Environment and protection of human health – Regulation (EC) No 1272/2008 – Classification, labelling and packaging of certain substances and mixtures – Classification of 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs. – Application for suspension of operation of a measure – Lack of any urgency)

In Case T‑174/24 R,

represented by C. Mereu and S. Englebert, lawyers,

applicant,

European Commission,

represented by B. Cullen and J. Jokubauskaitė, acting as Agents,

defendant,

makes the following

1By its application under Articles 278 and 279 TFEU, the applicant, Djchem Chemicals Poland S.A., seeks partial suspension of the operation of Commission Delegated Regulation (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances (OJ L 2024/197; ‘the contested regulation’) in so far as it classifies the substance 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs.; Reaction mass of N-phenyl,N’-o-tolyl-phenylene diamine, N,N’-diphenyl-p-phenylene diamine and N,N’-di-o-tolyl-phenylene diamine (‘DAPD’) as toxic for reproduction category 1B.

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

2The applicant is an undertaking which manufactures DAPD and sells it to tyre manufacturers who use it as a compound in the mixture of substances used for the manufacture of tyres for consumers. The applicant has mainly dedicated its plant in Wołomin (Poland) to the production of that substance.

3On 19 October 2023, the European Commission adopted the contested regulation. By that regulation, DAPD was added to Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1) with harmonised classification and labelling in the hazard class for ‘reproductive toxicity’ category 1B (substances presumed to be toxic for human reproduction).

4By application lodged at the Registry of the General Court on 27 March 2024, the applicant brought an action for annulment of the contested regulation in so far as it classifies DAPD in the hazard class ‘Toxic for reproduction’ category 1B.

5By separate document, lodged at the Registry of the General Court on 16 May 2024, the applicant submitted the present application for interim measures, in which it claims that the President of the General Court should:

–order, even before the other party to the proceedings has submitted its observations, under Article 157(2) of the Rules of Procedure of the General Court, the suspension of operation of the contested regulation in so far as it classifies DAPD in the hazard class ‘Toxic for reproduction’ category 1B;

–order the suspension of operation of the contested regulation in so far as it classifies DAPD in the hazard class ‘Toxic for reproduction’ category 1B pending the Court’s ruling on the main action;

–order the Commission to pay the costs.

6In its observations on the application for interim measures, which were lodged at the Court Registry on 17 June 2024, the Commission contends that the President of the General Court should:

–dismiss the application for interim measures;

–order the applicant to pay the costs.

Law

General Considerations

7It 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 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 relief 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).

8The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim relief 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’.

9The judge hearing an application for interim relief may order the 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).

10In the context of that overall examination, the judge hearing the application for interim measures enjoys a broad 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).

11Having 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.

12In the circumstances of the present case, it is appropriate to examine first whether the condition relating to urgency is satisfied.

The condition relating to urgency

13In 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 generally be assessed in the light of the need of an interlocutory order to avoid serious and irreparable damage to the party requesting the interim protection. 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).

14In addition, in accordance with the second sentence of Article 156(4) of the Rules of Procedure, applications for interim relief are to ‘contain all the evidence and offers of evidence available to justify the grant of interim measures’.

15It is in the light of those criteria that it is necessary to examine whether the applicant has succeeded in demonstrating urgency.

16In the present case, in order to demonstrate the serious and irreparable nature of the harm alleged, the applicant claims that the classification of DAPD as toxic for reproduction category 1B will prevent tyre manufacturers from using that substance, given that substances classified in that category cannot be used in products for the ‘general public’. As a result, sales of DAPD for use in tyres will be effectively prohibited following the entry into force of the contested regulation. The applicant claims that that prohibition will cause it the following harm.

17In the first place, the applicant states that it will lose approximately 70% of its turnover and market share.

18In the second place, the applicant maintains that it will not be able to cover the operating costs of its Wołomin plant or to repay the outstanding amount of its loans and that it might be obliged to dismiss several employees.

19In the third place, the applicant claims non-pecuniary harm resulting from the loss of an intangible asset consisting of a customer base, the value of that customer base and the value brought to the goodwill of the business.

20In the fourth place, the applicant asserts that it could not recoup its losses on account of insurmountable structural and legal obstacles.

21First, the applicant maintains that the Wołomin plant could not simply be repurposed for the production of different substances, since synthesis of chemical substances is a highly technical process that requires skilled workers.

22Second, the applicant claims that even if the Wołomin plant could be repurposed for the production of a different substance, the process of identifying an alternative substance would take several years and the likelihood of success would be highly uncertain.

23Third, the applicant claims that the production of a substance requires administrative authorisation from local authorities as well as registration 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 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’).

24Fourth, the applicant asserts that the loss of revenue from sales of DAPD would prevent it from bearing the high costs associated with the repurposing of the Wołomin plant and/or the payment of the costs associated with the registration of a new substance under the REACH Regulation.

25Fifth, the applicant observes that its losses could not be compensated through an action for damages in the event of a positive outcome in the main action.

26Lastly, the applicant claims that its pecuniary damage is so serious and irreparable that the contested regulation would result in the cessation of its activities.

27The Commission disputes the applicant’s arguments.

28As a preliminary point, it should be noted that the materialisation of the harm alleged by the applicant is based on the premiss that the classification of DAPD made in the contested regulation would make it impossible for the applicant to sell DAPD to tyre manufacturers. In reaching that conclusion, the applicant submits, in essence, that it follows from a combined application of Regulation (EC) No 1272/2008 and the REACH Regulation that substances classified as toxic for reproduction category 1B cannot be used in products intended for the general public above certain concentrations.

29Referring to Appendix 6 to Annex XVII to the REACH Regulation, the applicant asserts, in essence, that a substance classified as toxic for reproduction category 1B and included in Appendix 6 to that regulation cannot be used in products intended for the general public. According to the applicant, the inclusion of substances in Appendix 6 to Annex XVII to the REACH Regulation is a mere formality which the Commission carries out on an ongoing basis.

30In that regard, it should be noted, in the first place, that it is apparent from the provisions of Annex XVII to the REACH Regulation that the substances listed in Appendix 6 may not be placed on the market, or used for supply to the general public, as substances, as constituents of other substances, or in mixtures, when the individual concentration in the substance or mixture is equal to or greater than a certain limit. Those provisions do not mention a restriction in respect of articles containing those substances. That interpretation is confirmed by the answer to question 1523 in the questions and answers database available on the website of the European Chemicals Agency (ECHA). It follows from that answer that substances present in articles do not come within the scope of the restriction imposed by entries 28 to 30 (namely Appendices 1 to 6) of Annex XVII to the REACH Regulation.

31In the present case, it is apparent from the case file that the applicant does not provide DAPD directly to the general public as a substance or in mixtures, but sells that substance to tyre manufacturers. Tyres constitute an article within the meaning of the REACH Regulation. The concept of ‘article’ is defined in Article 3(3) of that regulation as an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.

32Accordingly, since the applicant’s premiss set out in paragraph 28 above is incorrect, it must be held that the applicant has not demonstrated that serious and irreparable harm may occur should the Commission include DAPD in Appendix 6 to Annex XVII to the REACH Regulation.

33In the second place, it should be noted that it is apparent from the case-law that suspension of the operation of an EU act is justified only where that act constitutes the decisive cause of the alleged serious and irreparable harm (see, to that effect, order of 7 March 2013, EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraph 41 and the case-law cited). Moreover, while it does not have to be established with absolute certainty that the alleged harm is imminent, its occurrence must nevertheless be foreseeable with a sufficient degree of probability (see order of 11 November 2013, CSF v Commission, T‑337/13 R, not published, EU:T:2013:599, paragraph 31 and the case-law cited), since purely hypothetical harm, based on the occurrence of future and uncertain events, does not justify the granting of interim measures (see, to that effect, order of 27 February 2015, Spain v Commission, T‑826/14 R, EU:T:2015:126, paragraph 33 and the case-law cited).

34In the present case, it is apparent from the applicant’s arguments that the alleged harm is not likely to occur as a result of the adoption of the contested regulation, but rather as a result of a future and uncertain event, namely the adoption by the Commission of a regulation including DAPD in Appendix 6 to Annex XVII to the REACH Regulation. Indeed, the mere harmonised classification of a substance as toxic for reproduction in category 1B does not automatically mean that that substance is subject to the restriction laid down in Appendix 6 to Annex XVII to the REACH Regulation.

35In the light of the foregoing, it must be concluded that the harm alleged by the applicant is purely hypothetical in that it is based on the occurrence of future and uncertain events and cannot justify the granting of interim measures.

36Moreover, it should also be noted that it is apparent from Article 2(2) of the contested regulation that that regulation is to apply only from 1 September 2025. Therefore, even if the mere classification of DAPD made in the contested regulation were liable to cause harm to the applicant, which is not apparent from the arguments put forward in the application for interim measures, it should be noted that the applicant benefits from a transition period enabling it to reduce the extent of any such harm. Indeed, it is explicitly stated in recital 8 of the contested regulation that compliance with the new or updated harmonised classifications should not be required immediately as a certain period of time is necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new or updated classifications and to sell existing stocks subject to the previous regulatory requirements. That period of time is also necessary to allow suppliers sufficient time to take the actions required to ensure continuing compliance with other legal requirements following the changes made under that regulation.

37It follows from all of the foregoing that the application for interim measures must be dismissed as the applicant has failed to establish that the condition relating to urgency is satisfied, without it being necessary to rule on whether there is a prima facie case or to weigh up the interests involved.

38Under Article 158(5) of the Rules of Procedure, the costs are to be reserved.

39On those grounds,

hereby orders:

1.The application for interim measures is dismissed.

2.The costs are reserved.

Luxembourg, 31 July 2024.

Registrar

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Language of the case: English.