ORDER OF THE VICE-PRESIDENT OF THE COURT

28 May 2018 ( )

(Appeal — Order for interim measures — Decision of the Board of Appeal of the European Chemicals Agency (ECHA) relating to the substance evaluation of triclosan — Suspension of operation — Urgency — Intervention — No direct, existing interest)

In Case C‑565/17 P(R),

APPEAL pursuant to the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 25 September 2017,

BASF Grenzach GmbH, established in Grenzach-Wyhlen (Germany), represented by K. Nordlander, advokat, and K. Le Croy, Solicitor,

appellant,

the other party to the proceedings being:

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

defendant at first instance,

THE VICE-PRESIDENT OF THE COURT,

after hearing the Advocate General, M. Wathelet,

makes the following

Order

1 This appeal has been brought against the order of the President of the General Court of the European Union of 13 July 2017, BASF Grenzach v ECHA (T‑125/17 R, not published, ‘the order under appeal’, EU:T:2017:496), by which the President dismissed the application brought by BASF Grenzach GmbH (‘the appellant’) under Articles 278 and 279 TFEU for the grant of interim measures to (i) suspend the implementation of Decision A-018-2014 of the Board of Appeal of the European Chemicals Agency (ECHA) of 19 December 2016, relating to the substance evaluation of triclosan (‘the decision at issue’), and (ii) order the extension of the prescribed period to communicate the results of the tests for the duration of the suspension.

Background to the dispute, procedure before the General Court and the order under appeal

2 The appellant manufactures triclosan, for which it is the sole registrant 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, ‘the REACH Regulation’).

3 Triclosan is a broad-spectrum antibacterial that is approved for use as a preservative in certain types of cosmetic products. Triclosan is registered only for cosmetic use under the REACH Regulation.

4 In 2012, triclosan was included in the Community Rolling Action Plan, taking account of concerns relating to its persistent, bioaccumulative and toxic properties as well as its potential for endocrine disruption.

5 The competent Dutch authority was appointed to carry out the evaluation of triclosan in cooperation with the competent Danish authority.

6 On 20 March 2013, the ECHA informed the appellant of the draft decision.

7 On 23 April 2013, the appellant provided its comments on the draft decision.

8 The draft decision was then revised by the competent Dutch authority. On 6 March 2014, the draft decision was notified to the competent authorities of the other Member States, which made proposals for amendment.

9 Subsequently, the draft decision was amended by the competent Dutch authority. The appellant provided comments on the proposals for amendment which were taken into account.

10 On 22 April 2014, the draft decision was referred to the Member States’ Committee referred to in Article 76(1)(e) of the REACH Regulation. That Committee also received the appellant’s comments. On 12 June 2014, the Member States’ Committee reached unanimous agreement on the draft decision and, on 19 September 2014, ECHA adopted its decision (‘the decision of 19 September 2014’).

11 In accordance with that decision, the appellant had to provide information for the substance evaluation of triclosan in the context of the Community Rolling Action Plan.

12 To that end, the appellant had to perform three studies:

– first, simulation testing on ultimate degradation in fresh surface water and sea water (‘the persistency test’);

– second, in view of concerns as to effects on the endocrine system, a neurotoxicity study of development and reproduction on rats (‘the rat test’), and

– third, a study on the sexual development of fish with zebrafish or Japanese medaka (‘the fish test’).

13 In accordance with the decision of 19 September 2014, the appellant also had to submit available information on the effects of triclosan on the cardiovascular system and some exposure information.

14 The decision of 19 September 2014 set the deadline to provide the requested information as 26 September 2016.

15 On 17 December 2014, the appellant brought an administrative appeal against the ECHA decision, which had the effect, in accordance with Article 91(2) of the REACH Regulation, of suspending the decision of 19 September 2014.

16 On 19 December 2016, the Board of Appeal of ECHA adopted the decision at issue, by which it annulled the decision of 19 September 2014 in so far as that decision had required the appellant to provide information as to the effects of triclosan on the cardiovascular system and dismissed the action as to the remainder. That decision also set 26 December 2018 as the deadline to submit the required information resulting, inter alia, from the persistency test, the rat test and the fish test.

17 By application lodged at the Court Registry on 28 February 2017, the appellant brought an action, in essence, for annulment of the decision at issue in so far as it dismissed its administrative appeal.

18 By a separate document lodged at the Court Registry on 28 February 2017, the appellant brought an application for interim measures, by which it asked the President of the General Court to (i) order the immediate suspension of the implementation of the decision at issue, pending a decision on the application for interim measures, (ii) suspend the implementation of the decision at issue in so far as it concerns the rat test, the fish test and the persistence test, (iii) order, consequently, the extension of the prescribed period to provide the test results for the duration of the suspension, and (iv) order ECHA to pay the costs.

19 On 13 July 2017, the President of the General Court adopted the order under appeal, by which he dismissed the application for interim measures.

20 To that end, the President of the General Court first of all examined whether the condition relating to urgency was satisfied.

21 He first observed, in paragraph 37 of the order under appeal, that the appellant had put forward, in essence, two arguments, namely the risk of incurring liability for infringement of Article 18 of 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’), which prohibits, as a general rule, animal testing, and the alleged risk of losing ‘the entire European market for triclosan’.

22 As regards the first argument — more specifically, the risk raised by the appellant of incurring liability for infringement of the Cosmetics Regulation if it implements the decision at issue — the President of the General Court observed, in paragraph 45 of the order under appeal, that the appellant was required, on account of that decision, to conduct animal testing.

23 After recalling, in paragraph 46 of the order under appeal, the Court’s case-law according to which 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, to that effect, judgment of 6 October 2015, Schrems, C‑362/14, EU:C:2015:650, paragraph 52 and the case-law cited), the President of the General Court observed, in paragraph 47 of that order, that, in so far as the appellant was required by the decision at issue to conduct animal testing, the fact of complying with that requirement cannot result in it incurring liability because of another EU measure of general scope, in the present case the Cosmetics Regulation.

24 In those circumstances, the President of the General Court considered, in paragraph 48 of the order under appeal, that the risk claimed by the appellant of facing legal action for possible infringement of the Cosmetics Regulation appeared to be purely hypothetical as based on the occurrence of future and uncertain events and could not therefore establish the imminent risk of the occurrence of serious and irreparable harm.

25 As regards the second argument, the President of the General Court stated, in paragraph 53 of the order under appeal, that the harm claimed in that respect, namely the effect on market share or the loss of ‘the entire European market for triclosan’, was financial.

26 Thus, after recalling, in paragraph 55 of that order, the conditions under which the adoption of interim measures would be justified, in accordance with the relevant case-law, in respect of such harm, the President of the General Court then pointed out, in paragraphs 56 and 57 of the order, that the appellant had not provided any information, inter alia in respect of the size of its undertaking, its turnover and whether it belonged to the BASF group. Therefore, the appellant had not established the importance that the alleged loss of the entire European market for triclosan would represent for its undertaking and, where appropriate, for the group to which it belongs.

27 In paragraph 60 of the order under appeal, the President of the General Court accordingly dismissed the application for interim measures, as the appellant had failed to establish urgency, considering that it was not necessary to rule on the prima facie case or weigh up the interests.

Forms of order sought by the parties before the Court of Justice

28 The appellant claims that the Court should:

– set aside the order under appeal;

– grant the application for interim measures, namely the suspension of the operation of the decision at issue or, in the alternative, refer the application for interim measures back to the General Court and suspend the decision until the General Court has ruled on the application for interim measures, and

– order ECHA to pay the costs.

29 ECHA contends that the Court should:

– dismiss the appeal as unfounded;

– in the alternative, reject the application for interim measures, and

– order the appellant to pay the costs.

The application to intervene

30 By application lodged at the Court Registry on 23 October 2017, PETA International Science Consortium Ltd (‘PISC’) applied to intervene in support of the form of order sought by the appellant in the present case.

31 By documents of 8 November 2017, the appellant and ECHA submitted their observations on that request.

32 In order to rule on that request, it must be noted that, under the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, the right of an individual to intervene is subject to the condition that that person is able to establish an interest in the result of the case.

33 According to settled case-law, the concept of an ‘interest in the result of a case’, within the meaning of that provision, must be defined in the light of the precise subject matter of the case and be understood as meaning a direct, existing interest in the ruling on the form of order sought, and not as an interest in relation to the pleas in law or arguments put forward. The words ‘result of a case’ refer to the final decision sought, as set out in the operative part of the future judgment or order (orders of the Vice-President of the Court of Justice of 6 October 2015, Metalleftiki kai Metallourgiki Etairia Larymnis Larko v Commission, C‑385/15 P(I), not published, EU:C:2015:681, paragraph 6, and of 1 March 2016, Cousins Material House v Commission, C‑635/15 P(I), not published, EU:C:2016:166, paragraph 5).

34 As regards the applications to intervene lodged by associations of undertakings, such applications are granted, inter alia, if the purpose of those associations is to protect their members and if they apply to intervene in cases raising questions of principle liable to affect those members (see, to that effect, orders of the President of the Court of Justice of 17 June 1997, National Power and PowerGen v Commission, C‑151/97 P(I) and C‑157/97 P(I), EU:C:1997:307, paragraph 66, and of 28 September 1998, Pharos v Commission, C‑151/98 P, EU:C:1998:440, paragraph 6).

35 The application to intervene itself must, in accordance with Article 130 of the Rules of Procedure of the Court of Justice, contain a summary of the circumstances establishing the right to intervene.

36 As regards PISC’s application, it must be noted that, in order to establish its interest in these appeal proceedings and, more specifically, to show that the result of the proceedings is such as to affect the interests of its members, PISC claims that it represents a significant number of non-profit organisations and a large number of individuals sharing a common interest, namely the reduction and ultimate elimination of animal testing. PISC therefore submits that it has a direct, existing interest in the result of the proceedings, as they would be likely to affect appreciably its legal situation.

37 In that regard, it suffices to note that the fact that PISC protects the interests of animals is not sufficient alone to show how its legal situation, or that of its members, would be affected by the Court’s decision on the appellant’s appeal concerning interim measures.

38 Moreover, the alleged harm to animals, if such harm were to be established, would be an indirect consequence only of the decision at issue and not likely in itself to establish a direct interest pursuant to the case-law referred to in paragraph 33 of this order.

39 It follows that PISC has not been able to establish the direct and specific impact of the result of these appeal proceedings on the activity of its members, with the result that its application to intervene must be dismissed.

The appeal

40 The appellant relies on three grounds of appeal.

The first ground of appeal

41 By its first ground of appeal, the appellant claims that the President of the General Court erred in law when he found that the decision at issue did not present a risk, both imminent and foreseeable with a sufficient degree of probability, that it would incur liability under the Cosmetics Regulation.

42 First of all, according to the appellant, the President of the General Court was wrong to find that the presumption applicable to measures of the EU institutions extends to decisions of the ECHA as an EU agency in such a way that, by complying with the decision at issue, the appellant did not run the risk that it would incur liability under another EU act such as the Cosmetics Regulation.

43 Next, according to the appellant, even if ECHA’s measures under the REACH Regulation were presumed to be lawful, that presumption would not rule out the appellant incurring liability under the Cosmetics Regulation, notwithstanding the decision at issue.

44 Lastly, the appellant alleges that the order under appeal is vitiated by a failure to state reasons, as the President of the General Court summarily dismissed the application for interim measures for lack of urgency without examining the arguments relating to the irreparable loss of its market share on account of the considerable legal and structural obstacles that it would come up against if the marketing ban provided for under the Cosmetics Regulation were implemented.

45 ECHA disputes the appellant’s arguments.

46 It should be borne in mind, first of all, that, in accordance with Article 156(4) of the Rules of Procedure of the General Court, 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.

47 Accordingly, the judge hearing an application for interim measures may order interim relief only 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. The judge hearing the application for interim measures must, where appropriate, also weigh up the interests involved (orders of the President of the Court of 24 April 2008, Commission v Malta, C‑76/08 R, not published, EU:C:2008:252, paragraph 21, and of 10 December 2009, Commission v Italy, C‑573/08 R, not published, EU:C:2009:775, paragraph 11, and order of the Vice-President of the Court of 3 December 2014, Greece v Commission, C‑431/14 P-R, EU:C:2014:2418, paragraph 19).

48 As regards, more specifically, the examination of the condition relating to urgency, the Court emphasises that urgency must be assessed in the light of the need of an order for interim measures to avoid serious and irreparable harm to the party requesting the interim measure (order of the Vice-President of the Court 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).

49 It is for that party to prove that it cannot wait for the outcome of the main proceedings without suffering serious and irreparable harm (see, to that effect, order of the Vice-President of the Court of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P-R, EU:C:2014:1749, paragraph 37 and the case-law cited). While it is not necessary, in that regard, for it to be absolutely certain that the damage will occur, a sufficient degree of probability being enough, the applicant is nonetheless required to prove the facts which are considered to found the prospect of such damage (order of the President of the Court of Justice of 20 June 2003, Commission v Laboratoires Servier, C‑156/03 P-R, EU:C:2003:368, paragraph 36).

50 In the present case, as regards, in the first place, the appellant’s claims, recalled in paragraphs 42 and 43 of this order — alleging an error committed by the President of the General Court in finding, in paragraphs 46 and 47 of the order under appeal, that ECHA decisions are presumed to be lawful with the result that, in complying with those decisions, the appellant could not incur liability under the Cosmetics Regulation — it is relevant to note that, irrespective of whether such a presumption also applies to those decisions, the President of the General Court correctly found in paragraph 48 of the order under appeal that the risk alleged by the appellant was based on the occurrence of future and uncertain events.

51 It must be observed that, even in its appeal, the appellant has confined itself to stating that the Member States could merely potentially take legal action against it under the Cosmetics Regulation, without however providing specific evidence in support of its argument. Therefore, the appellant has not proved that there is a sufficient degree of probability that it would suffer the alleged harm.

52 In those circumstances, in accordance with the case-law recalled in paragraph 49 of this order, the President of the General Court did not err in law when he found, in paragraph 48 of the order under appeal, that such — purely hypothetical — harm was not such as to justify the grant of the interim measures applied for.

53 As regards, in the second place, the argument concerning the loss of market share, referred to in paragraph 44 of this order, it suffices to note that that question, as observed by ECHA in its response, had been broadly dealt with by the President of the General Court in paragraphs 49 to 59 of the order under appeal.

54 Consequently, the first ground of appeal must be rejected as unfounded.

The second ground of appeal

55 By its second ground of appeal, the appellant criticises the President of the General Court for having committed an error of law in classifying the whole of the harm it would suffer through the loss of market share as purely financial in such a way that, in order to obtain a suspension of the operation of the decision at issue, it was required to prove that it would find itself in a situation likely to endanger its very existence.

56 On the contrary, according to the appellant, it could have obtained the suspension of that decision merely by arguing that it would find itself in a situation likely to irreparably affect its market share. To that end, it would suffice to demonstrate that structural or legal obstacles would prevent it from regaining an appreciable proportion of its market share, which it had moreover proved in its application for interim measures.

57 ECHA disputes that reasoning.

58 In that regard, it must be noted that, contrary to the appellant’s claim, after identifying the harm in question as being of a financial nature, the President of the General Court correctly observed, in paragraph 55 of the order under appeal, that the interim measures sought are justified if, in the absence of those measures, the appellant would be in a position that would jeopardise its financial viability, or if its market share would be affected substantially in the light, inter alia, of the size and turnover of its undertaking and, where appropriate, the characteristics of the group to which it belongs (see order of the Vice-President of the Court of Justice of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P-R, EU:C:2014:1749, paragraph 46 and the case-law cited).

59 Thus, having stated, in paragraph 56 of the order under appeal, that the appellant had not provided any information on, inter alia, the size of its undertaking, its turnover, whether it belongs to the BASF group, or the characteristics of that group, the President of the General Court concluded that the appellant had not established the importance that loss of the entire European market for triclosan would represent for its undertaking.

60 In those circumstances, it is clear that the President of the General Court did not err in law when he found that the appellant had not established urgency.

61 Consequently, the second ground of appeal must be rejected.

The third ground of appeal

62 By its third ground of appeal, the appellant claims that the President of the General Court failed to give due consideration to the risk of the harm the appellant would be required to inflict on animals in its care in order to comply with the decision at issue. The appellant will personally suffer irreparable harm in that the tests conducted pursuant to that decision are to be carried out on those animals and would lead to their suffering or even death.

63 ECHA disputes that reasoning.

64 In that regard, it must be noted that the appellant’s reasoning is based on a misinterpretation of the duties of the judge hearing an application for interim measures when examining the condition relating to urgency and weighing up the interests involved.

65 It is settled case-law that the conditions in paragraph 47 of this order are cumulative, so that applications for interim measures must be dismissed if any one of them is not satisfied (order of the Vice-President of the Court of Justice of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P-R, EU:C:2016:21, paragraph 21 and the case-law cited).

66 The Court has also consistently held that, in the context of his 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 EU law imposing a pre-established scheme of analysis within which the need to order interim measures must be analysed (order of the Vice-President of the Court of Justice of 22 March 2018, Wall Street Systems UK v ECB, C‑576/17 P(R), not published, EU:C:2018:208, paragraph 31 and the case-law cited).

67 It must be noted that the appellant’s arguments concerning the death and suffering inflicted on animals are set out in paragraphs 77 to 79 of its application for interim measures, in the part concerning the weighing up of interests.

68 As the President of the General Court rejected that application on the ground that the appellant had not shown to the requisite legal standard that the condition relating to urgency had been met, he was not required to weigh up the interests involved and therefore examine the arguments raised in that respect by the appellant.

69 Consequently, the third ground of appeal must be rejected.

70 It follows from all the foregoing that the appeal must be dismissed in its entirety.

Costs

71 Under Article 138(1) of the Rules of Procedure, which applies to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since ECHA has applied for costs and BASF Grenzach GmbH has been unsuccessful, the latter must be ordered to pay the costs. Since none of the parties has applied for PISC to pay the costs and PISC has been unsuccessful, it must be ordered to bear its own costs.

On those grounds, the Vice-President of the Court hereby orders:

1. The appeal is dismissed.

2. BASF Grenzach GmbH shall pay the costs.

3. The application to intervene of PETA International Science Consortium Ltd is dismissed.

4. PETA International Science Consortium Ltd shall bear its own costs.

Luxembourg, 28 May 2018.





A. Calot Escobar A. Tizzano