ORDER OF THE PRESIDENT OF THE GENERAL COURT
30 April 2020 (*)
(Interim measures — REACH — Dimethyl ether substance — Compliance check — Commission decision — Obligation to provide certain information requiring testing on animals — Application for suspension of operation of a measure — No urgency)
In Case T‑868/19 R,
Nouryon Industrial Chemicals BV, established in Amsterdam (Netherlands),
Knoell NL BV, established in Maarssen (Netherlands),
Grillo-Werke AG, established in Duisburg (Germany),
PCC Trade & Services GmbH, established in Duisburg,
represented by R. Cana and G. David, lawyers, and Z. Romata, Solicitor,
applicants,
v
European Commission, represented by R. Lindenthal and K. Mifsud-Bonnici, acting as Agents,
defendant,
APPLICATION pursuant to Articles 278 and 279 TFEU seeking, first, the suspension of operation of Commission Implementing Decision C(2019) 7336 final of 16 October 2019 on the compliance check of a registration of dimethyl ether referred by the European Chemicals Agency to the Commission pursuant to Article 51(7) 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, corrigendum OJ 2007 L 136, p. 3), and, secondly, the grant of any other interim measures which the Court considers appropriate,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Facts, procedure and forms of order sought
1        The applicants, Nouryon Industrial Chemicals BV, Knoell NL BV, Grillo-Werke AG and PCC Trade Services GmbH, are manufacturers or importers of the substance dimethyl ether, established in the European Union, or exclusive representatives acting for non-EU manufacturers of that substance. The first applicant acts as the lead registrant for the joint registration dossier, pursuant to Article 11 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, corrigendum OJ 2007 L 136, p. 3, ‘the REACH Regulation’).
2        Dimethyl ether is an aerosol propellant and a solvent, used mainly in industrial and consumer aerosol products, including in pharmaceutical applications. Other industrial applications include its use as a chemical building block for another substance (dimethyl sulfate), and uses in oil extraction and engine fuel.
3        In accordance with 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 the REACH Regulation (OJ 2008 L 353, p. 1), that substance is classified as ‘extremely flammable gas (H220)’ and is labelled as: ‘contains gas under pressure; may explode if heated (H280)’. It is not included in the category of hazards for human health or the environment in Annex VI to that regulation.
4        Article 10 of the REACH Regulation defines the information that must be contained in the registration dossier for a substance. In addition, Article 12 of that regulation specifies the information to be submitted by registrants depending on the tonnage of the substances manufactured or imported. As regards substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer, Article 12(1)(e) of the REACH Regulation states that the registrant must provide as a minimum the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X to that regulation.
5        In the present case, the applicants jointly registered the substance dimethyl ether for quantities exceeding 1 000 tonnes per year. In the context of the compliance check of the dimethyl ether registration dossier, pursuant to Article 41(1) of the REACH Regulation, the Member State Committee did not reach unanimous agreement on the draft decision prepared by the European Chemicals Agency (ECHA). Consequently, Implementing Decision C(2019) 7336 final of 16 October 2019 on the compliance check of a registration of dimethyl ether (‘the contested decision’) was adopted by the European Commission, in accordance with Article 51(7) of the REACH Regulation.
6        In the contested decision, the Commission concluded that the registration of the substance did not comply with the standard information requirements as regards two different endpoints within reproductive toxicity. The missing information concerns the fertility of adults and hazards related to the prenatal or postnatal development of the child.
7        The contested decision requires the applicants and two other registrants, in the context of the joint submission, to submit information on the substance, first, from a prenatal development toxicity study to be conducted in a second species, rabbits, by the inhalation route and, secondly, from an extended one-generation reproductive toxicity study in rats, to be conducted via the inhalation route. Before carrying out that second study, the applicants must conduct a preliminary dose-range finding study. The contested decision requires the applicants to submit an update of the registration to the ECHA, together with the results of the requested studies, within 36 months of the date of notification of that decision.
8        By application lodged at the Court Registry on 20 December 2019, the applicants brought an action for annulment of the contested decision.
9        By separate document, lodged at the Court Registry on the same date, the applicants lodged the present application for interim measures, in which they claim that the President of the General Court should:
–        order the suspension of operation of the contested decision with immediate effect, pursuant to Article 157(2) of the Rules of Procedure of the General Court, until he has adjudicated on this application for interim measures;
–        order the suspension of operation of the contested decision until the Court has ruled on the main action;
–        consequently, order the extension, for the duration of the suspension, of the time limit set by the contested decision for providing the test results;
–        grant any other interim measures as appropriate and hold a hearing if he considers it necessary;
–        order the Commission to pay the costs.
10      By separate document, lodged at the Court Registry on the same date, the applicants submitted an application for the omission of certain data vis-à-vis the public.
11      In its observations on the application for interim measures, lodged at the Court Registry on 14 February 2020, the Commission contends that the President of the General Court should:
–        dismiss the application for interim relief as manifestly bound to fail or, in any event, as manifestly unfounded;
–        reserve the costs.
Law
General
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      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’.
14      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).
15      In the context of that overall examination, the judge hearing an 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 to examine first whether the condition relating to urgency is satisfied.
Urgency
18      In order to determine whether the interim measures sought are urgent, it must 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 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      In order to demonstrate the urgency of the suspension sought, the applicants put forward, in essence, two points. First, they submit that the tests required by the Commission will cause irreparable harm in that this will result in the sacrifice of many animals, that is to say of some 1 050 rabbits and over 2 000 rats. Any annulment of the contested decision will have no effect on the tests already carried out or on the lives of those animals killed pursuant to that decision. Furthermore, no compensation can compensate for loss of animal life.
20      In that regard, the applicants submit that the Court of Justice has already acknowledged the possible relevance of the arguments relating to animal welfare without, however, ruling on whether the loss of animal life following testing such as that required by the contested decision met the condition of irreparable harm in the context of an application for interim measures.
21      Secondly, the applicants submit that they would face risks if, following annulment of the contested decision by the General Court, it became apparent that the tests concerned ought not have been conducted. In that case, the applicants could be prosecuted, penalised or sued on the ground that they had not complied with the objectives enshrined in the REACH Regulation, Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ 2010 L 276, p. 33) and national animal-welfare legislation. According to the applicants, those legal actions could be initiated by Member States or by private parties, including non-governmental organisations active in the protection of animal welfare and activists fighting against all animal experiments. It is common knowledge that activists in that field have already had resort to potentially violent actions in similar contexts.
22      The Commission contends that the present application for interim measures is manifestly bound to fail and without merit, in so far as the applicants refer to the harm resulting in the loss of animal life. According to settled case-law, the applicants cannot rely on damage which they have not sustained personally. As regards the damage resulting from the actions initiated against the applicants on account of the testing concerned, the Commission contends that the applicants do not even seek to argue that the occurrence of such damage may be foreseeable with a sufficient degree of probability required by the case-law.
23      First, it must be found that the applicants’ argument that the tests required will result in the sacrifice of many animals is irrelevant as regards proof of urgency in the present case.
24      According to settled case-law, in order to prove that the condition of urgency is met the party seeking interim measures must show that they are necessary in order to protect its own interests, whereas that party cannot, in order to establish urgency, plead damage to an interest which is not personal to it, such as for example to an aspect of public interest or to the rights of third parties (see, to that effect, order of 10 November 2004, Wam v Commission, T‑316/04 R, EU:T:2004:333, paragraph 28 and the case-law cited). Thus, that party must show that the damage alleged is likely to entail — for itself — serious and irreparable personal damage (see order of 25 October 2018, Antonakopoulos v Parliament, T‑590/18 R, not published, EU:T:2018:727, paragraph 17 and the case-law cited).
25      Although the applicants in the present case refer to a large number of animals which have to be sacrificed on account of the tests concerned, they do not claim, apart from the risk of actions being initiated against themselves in the event that the contested decision is annulled, any direct damage, such as non-material or financial damage, which the carrying out of those animal tests would entail for the applicants. Consequently, while their argument that the implementation of the contested decision would harm animal welfare does indeed have an ethical dimension, it cannot establish the urgency of the suspension sought for the applicants.
26      In that regard, it must also be borne in mind that, according to settled case-law, harm to a general interest or the rights of third parties is not entirely devoid of relevance in the context of the examination of an application for interim measures, since it can be taken into account, where appropriate, 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, as the Vice-President of the Court of Justice noted in paragraph 68 of the order of 28 May 2018, BASF Grenzach v ECHA (C‑565/17 P(R), not published, EU:C:2018:340), to which the applicants also refer (see paragraph 20 above), the judge hearing an application for interim measures is not required to weigh up the interests involved if he first finds that one of the conditions for the grant of interim measures is not met (see also the case-law cited in paragraph 14 above).
27      Secondly, the applicants submit that, in the event that the contested decision is annulled, various actions could be initiated against them by Member States or private parties, in particular non-governmental organisations and activists striving to protect animal welfare.
28      However, it must be pointed out that the applicants mention in that regard possibilities, or even assumptions, without, however, submitting any specific matters of law or of fact capable of substantiating their line of argument. In particular, their argument is based on a possible annulment of the contested decision. In addition, the applicants do not specify at all which States or organisations, in which context and on the basis of which specific provision, such actions could be initiated, or whether the threat of such action has already been addressed to them.
29      According to well-established case-law, there is urgency only if the serious and irreparable harm feared by the party seeking 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 (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 24 and the case-law cited).
30      In the present case, it must be concluded that the risk thus alleged by the applicants is purely hypothetical in that it is based on future and uncertain events and cannot, therefore, establish the imminent risk of serious and irreparable harm.
31      Thirdly, as regards the head of claim seeking the adoption of ‘any other interim measures as appropriate’, it must be noted that it is vague and imprecise, so that it must be declared inadmissible (see, to that effect, orders of 2 July 2004, Enviro Tech Europe and Enviro Tech International v Commission, T‑422/03 R II, EU:T:2004:202, paragraph 59 and the case-law cited, and of 6 April 2016, GABO:mi v Commission, T‑10/16 R, not published, EU:T:2016:197, paragraph 33 and the case-law cited).
32      Fourthly, the applicants submit that, if the compliance check procedure had led to an ECHA decision, they would have had the possibility of challenging that decision before the Board of Appeal of the ECHA and that such an appeal would have had suspensive effect. In the present case, only a suspension of operation of the contested decision would ensure that the applicants have the right to effective judicial protection, as protected by Article 47 of the Charter of Fundamental Rights of the European Union.
33      That argument must be rejected. Admittedly, the judge hearing an application for interim measures has accepted a certain easing of the conditions applicable to assessing whether there is urgency, in particular, taking into account the requirements which follow from the effective provisional judicial protection, guaranteed by Article 47 of the Charter of Fundamental Rights (see, to that effect, order of 23 April 2015, Commission v Vanbreda Risk & Benefits, C‑35/15 P(R), EU:C:2015:275, paragraphs 30 and 57). However, without its being necessary to consider whether such an easing could be applied in the context of proceedings other than in public procurement matters (see, to that effect, order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraphs 37 to 42 and the case-law cited), it must be stated that it cannot, in any event, be interpreted as allowing the judge hearing an application for interim measures to set aside all the conditions establishing the urgency of an interim measure (see, to that effect, order of 22 March 2018, Wall Street Systems UK v ECB, C‑576/17 P(R), not published, EU:C:2018:208, paragraphs 24 to 27).
34      Yet, it follows from all the foregoing that, in the present case, the applicants have not established, to the requisite legal standard, that the granting of the interim measures sought was necessary in order to avoid any personal and imminent harm to their interests.
35      It follows from the foregoing that the application for interim measures must be dismissed for lack of urgency, and there is no need to examine whether the condition relating to the existence of a prima facie case is met or to weigh up the interests at stake.
Costs
36      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, 30 April 2020.
E. Coulon
M. van der Woude
Registrar
President
*      Language of the case: English.