Provisional text
ORDER OF THE PRESIDENT OF THE GENERAL COURT
13 July 2017 (*)
(Interim measures — REACH — Substance triclosan — Evaluation procedure — Decision of the Board of Appeal of the ECHA — Obligation to provide certain information requiring animal testing — Application for interim measures — No urgency)
In Case T‑125/17 R,
BASF Grenzach GmbH, established in Grenzach-Wyhlen (Germany), represented by K. Nordlander and M. Abenhaïm, lawyers,
applicant,
v
European Chemicals Agency (ECHA), represented by W. Broere, T. Röcke and M. Heikkilä, acting as Agents,
defendant,
APPLICATION pursuant to Articles 278 TFEU and 279 TFEU for the grant of interim measures to (i) suspend implementation of Decision A-018-2014 of the Board of Appeal of ECHA of 19 December 2016, relating to the substance evaluation of triclosan, and (ii) order the extension of the prescribed period to communicate the results of the tests for the duration of the suspension,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Background to the dispute, procedure and forms of order sought
1 The applicant, BASF Grenzach GmbH, 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’).
2 Triclosan is a broad-spectrum antibacterial that is approved for use as a preservative in certain types of cosmetic products. Triclosan is only registered for cosmetic use under REACH.
3 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.
4 The competent authority of the Netherlands was appointed to carry out the evaluation of triclosan in cooperation with the competent authority of Denmark.
5 On 20 March 2013, the European Chemicals Agency (ECHA) informed the applicant of the draft decision.
6 On 23 April 2013, the applicant provided its comments on the draft decision.
7 The draft decision was, next, revised by the competent authority of the Netherlands. On 6 March 2014, the draft decision was notified to the competent authorities of the other Member States, which made proposals for amendment.
8 Subsequently, the draft decision was amended by the competent authority of the Netherlands. The applicant provided comments on the proposals for amendment which were taken into account.
9 On 22 April 2014, the draft decision was referred to the Member States’ Committee. That Committee also received the applicant’s comments. On 12 June 2014, the Member States’ Committee reached unanimous agreement on the draft decision and, on 19 September 2014, the ECHA adopted its decision (‘the decision of 19 September 2014’).
10 In accordance with that decision, the applicant had to provide information for the substance evaluation of triclosan in the context of the Community Rolling Action Plan.
11 To that end, the applicant 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’);
– third, a study on the sexual development of fish with zebrafish or Japanese medaka (‘the fish test’).
12 In accordance with the decision of 19 September 2014, the applicant also had to submit available information on the effects of triclosan on the cardiovascular system and some exposure information.
13 The decision of 19 September 2014 set the deadline to provide the requested information as 26 September 2016.
14 On 17 December 2014, the applicant 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.
15 On 19 December 2016, ECHA’s Board of Appeal adopted Decision A-018-2014, relating to the substance evalulation of triclosan, by which it annulled the decision of 19 September 2014 in so far as that had required the applicant to provide information as to the effects of triclosan on the cardiovascular system and dismissed the action as to the remainder (‘the contested decision’). In addition, the contested decision 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.
16 By application lodged at the Court Registry on 28 February 2017, the applicant brought an action, in essence, for annulment of the contested decision in so far as it dismissed its administrative appeal.
17 By a separate document lodged at the Court Registry on 28 February 2017, the applicant brought the present application for interim measures, in which it claims, in essence, that the President of the General Court should:
– order the immediate suspension of the implementation of the contested decision, pending a decision on the present application for interim measures;
– suspend the implementation of the contested decision in so far as it concerns the rat test, the fish test and the persistence test;
– order, consequently, the extension of the prescribed period to provide the test results for the duration of the suspension;
– order the ECHA to pay the costs.
18 In its observations on the application for interim measures, lodged at the Court Registry on 17 March 2017, the ECHA contends that the President of the General Court should:
– dismiss the application for interim measures;
– order the applicant to pay the costs.
19 By written application lodged at the Court Registry on 18 April 2017, PETA International Science Consortium Ltd (PISC) sought leave to intervene in support of the form of order sought by the applicant. It follows from that application that PISC seeks to demonstrate that the contested decision involves the unnecessary death and suffering of thousands of vertebrate animals, which should be taken into account ‘if not in the assessment of the urgency requirement, then at least in the balancing the interests for and against interim measures’.
20 The ECHA opposed this, while the applicant expressed its support for PISC to be granted leave to intervene. In that context, the applicant stated that the tests on rats and fish were to begin in June 2017.
21 Since it followed from the schedule of 24 February 2017 for the implementation of tests on rats and fish, submitted as Annex R1 to the application for interim measures, that those tests were to begin in the fourth quarter of 2017, the President of the General Court asked questions on 29 May 2017 to clarify the timetable for those tests.
22 It follows from the applicant’s replies of 6 June 2017 that the schedule produced as Annex R1 to the application for interim measures was no longer up to date. In fact, the preparatory phase of the rat test, aimed at determining the dosage, began in June 2017. The main phase of the study will start in the fourth quarter of 2017. Similarly, with regard to the test on fish, fish eggs were ordered in March 2017 and the resulting hatchlings, are used to constitute a breeding stock population. In June 2017, growing and rearing the population forming the fish breeding stock occurred. In addition, the preparatory phase of the fish test to determine the dosage will begin in July 2017. The main phase of the study is expected to start in the fourth quarter of 2017.
Law
23 It is apparent from reading Articles 278 TFEU 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).
24 The first sentence of Article 156(4) of the Rules of Procedure requires applications for interim measures 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’.
25 Accordingly, the judge hearing an application for interim relief 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 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).
26 In the context of that overall examination, the judge hearing the application 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, Case C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).
27 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.
28 In the circumstances of the present case, it is appropriate to examine first whether the condition relating to urgency is satisfied.
29 In order to determine whether the interim measures sought are urgent, it should be borne in mind 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 for an interlocutory order to avoid serious and irreparable damage 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).
30 Furthermore, following settled case-law, there is urgency only if the serious and irreparable harm feared by the party requesting 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 23 March 2017, Gollnisch v Parliament, T‑624/16, not published, EU:T:2017:243, paragraph 25 and the case-law cited).
31 Furthermore, under the second sentence of Article 156(4) of the Rules of Procedure, an application for interim measures must ‘contain all the evidence and offers of evidence available to justify the grant of interim measures’.
32 Thus, an application for interim measures must, of itself, enable the defendant to prepare its observations and the judge hearing the application to rule on it, if necessary without any other supporting information, since the essential elements of fact and law on which the application is based must be found in the actual text of that application (see order of 6 September 2016, Inclusion Alliance for Europe v Commission, C‑378/16 P-R, not published, EU:C:2016:668, paragraph 17 and the case-law cited).
33 It is also established case-law that, in order to determine whether all the conditions set out in paragraphs 29 and 30 above are met, the judge hearing the application for interim measures must have hard and precise information, supported by detailed and certified documents showing the situation of the party seeking interim relief and making it possible to examine the actual consequences which would be likely to result if the measures sought were not granted. It follows that that party, especially where it alleges harm of a financial nature, must provide, with supporting documentation, an accurate and comprehensive picture of its financial situation (see, to that effect, order of 29 February 2016, ICA Laboratories and Others I Commission, T‑732/15 R, not published, EU:T:2016:129, paragraph 39 and the case-law cited).
34 Lastly, while the application for interim measures may be supplemented on specific points by references to documents annexed to the application, those documents cannot compensate for the failure to set out the essential elements of that application. It is not the task of the judge hearing the application for interim measures to seek, in place of the party concerned, the information that may be found in the annexes to the application for interim measure, in the main application or in the annexes to that application, which is liable to substantiate the application for interim measures. To impose such an obligation on the judge hearing the application for interim measures would also be likely to deprive of any effect Article 156(5) of the Rules of Procedure, under which the application for interim measures must be made by separate document (see, to that effect, order of 20 June 2014, Wilders v Parliament and Others, T‑410/14 R, not published, EU:T:2014:564, paragraph 16 and the case-law cited).
35 It is in the light of those criteria that it is necessary to examine whether the applicant has succeeded in demonstrating the imminence of serious and irreparable harm.
36 In the present case, the applicant maintains that, having regard to the deadline prescribed by the contested decision, it would have to immediately carry out the studies before a judgment is delivered on the merits, thereby, to a large extent, depriving the main action of its purpose and effect.
37 As regards, more specifically, the risk of serious and irreparable harm to the applicant, it puts 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’) and the risk of losing ‘its entire European market for triclosan’.
38 As regards the first argument, the applicant states that triclosan is registered only for cosmetic use under the REACH Regulation. It claims that it follows from Article 18(1) of the Cosmetics Regulation that animal testing of cosmetic ingredients ‘in order to meet the requirements of this Regulation’ is, as a general rule, prohibited.
39 Moreover, an infringement of the prohibition to carry out animal testing could give rise to penalties under Article 37 of the Cosmetics Regulation, including those of a criminal nature, as is the case in the United Kingdom.
40 That risk is all the more relevant since there is considerable legal uncertainty as to the relationship between the REACH Regulation and the Cosmetics Regulation as regards animal testing.
41 In that regard, the applicant refers, inter alia, to various communications from the Commission and ECHA and to the judgment of 21 September 2016, European Federation for Cosmetic Ingredients (C‑592/14, EU:C:2016:703).
42 The applicant states that it would find itself in the untenable situation where it would have to choose between compliance with the contested decision and the risk of incurring liability for infringement of the Cosmetics Regulation.
43 In order to examine that argument it should be stated at the outset that it is not for the President of the General Court to definitively rule on the questions on the relationship between the prohibition on animal testing provided for in the Cosmetics Regulation and the REACH Regulation. In contrast, it is for him to determine whether the risk claimed by the applicant is foreseeable with a sufficient degree of probability or is purely hypothetical in that it is based on the occurrence of future and uncertain events.
44 In any event, it is not necessary, in the present case, to examine the relationship between the prohibition on animal testing provided for in the Cosmetics Regulation and the REACH Regulation.
45 It is sufficient to bear in mind that the contested decision obliges the applicant to conduct animal testing.
46 It is settled case-law that, 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. 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 same is true of the contested decision which is a decision of an EU agency. Furthermore, the Court’s settled case-law should be recalled according to which the European Union is a union based on the rule of law (see, to that effect, judgment of 6 October 2015, Schrems, C‑362/14, EU:C:2015:650, paragraph 60 and the case-law cited).
47 Accordingly, 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, in the present case the Cosmetics Regulation. In principle, the same would be true of the subsequent annulment of the contested decision. In any event, the applicant, when it conducted animal testing, was complying with that decision.
48 In those circumstances, the risk claimed by the applicant of facing legal action for possible infringement of the Cosmetics Regulation appears to be purely hypothetical as based on the occurrence of future and uncertain events and cannot, in accordance with the case-law cited in paragraph 30 above, establish the imminent risk of the occurrence of serious and irreparable harm.
49 As regards the second argument, namely the risk of losing ‘its entire European market for triclosan’, the applicant claims, in essence, that its customers using triclosan in cosmetic products will, pursuant to the contested decision, be led to replace triclosan with other ingredients.
50 In that regard, the applicant puts forward two scenarios. In the first scenario, under Article 18(1)(a) of the Cosmetics Regulation, animal testing carried out in compliance with the contested decision could result in the prohibition to place on the market cosmetic products containing triclosan as an ingredient.
51 In the second scenario, the legal uncertainty as to the scope of Article 18(1)(a) of the Cosmetics Regulation could lead cosmetics producers to look for products replacing triclosan in order to avoid any risk of a prohibition to place on the market cosmetic products containing triclosan as an ingredient. Similarly, in view of the ‘reputational issues usually associated with animal testing in the cosmetics sector’, cosmetics producers may have to look for products replacing triclosan by the mere fact of animal testing which the applicant would conduct in implementing the contested decision.
52 According to the applicant, the effects of implementing the contested decisions in both scenarios would be irreversible. Changing an ingredient would require significant investment in product development, product testing, regulatory registrations and other resources. Once the applicant’s customers have made those investments and consumers have accepted products containing another ingredient, it is highly unlikely, in the applicant’s view, that they would return to triclosan. Accordingly, the mere implementation of the contested decision would significantly and irreversibly affect the applicant’s share of the triclosan market and could even lead to the loss of ‘its entire European market for triclosan’.
53 For the purposes of examining those arguments, it must be stated at the outset that the harm claimed in this respect, namely the effect on market share or the loss of ‘its entire European market for triclosan’, is financial.
54 Following settled case-law, damage of a pecuniary nature cannot, otherwise than in exceptional circumstances, be regarded as irreparable since, as a general rule, pecuniary compensation is capable of restoring the aggrieved person to the situation that prevailed before he suffered the damage. Any such damage could be recouped by the applicant’s bringing an action for compensation on the basis of Articles 268 TFEU and 340 TFEU (see order of 23 April 2015, Commission v Vanbreda Risks & Benefits, C‑35/15 P(R), EU:C:2015:275, paragraph 24 and the case-law cited).
55 Where the harm alleged is of a financial nature, the interim measures sought are justified if, in the absence of those measures, the applicant would be in a position that would imperil its financial viability before final judgment is given in the main action, 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 12 June 2014, Commission v Rusal Armenal, C‑21/14 P-R, EU:C:2014:1749, paragraph 46 and the case-law cited).
56 In that regard, it should be stated that the applicant has not provided any information on the size of its undertaking, its turnover or possibly belonging to the BASF group, and, where appropriate, the characteristics of the BASF group. Furthermore, it has not provided any information on the importance of triclosan in its product range. In addition, it also does not indicate the importance of sales of triclosan in the European Union or on a global level. Finally, it does not show the turnover that it generates with triclosan in the European Union or elsewhere.
57 In the absence of any information as to the factors referred to in the preceding paragraph, it cannot be concluded that the applicant, in claiming the loss of the entire European market for triclosan, has established urgency. It follows from the case-law referred to in paragraph 55 above that the size of the loss of market share must be examined having regard, in particular, to the size and turnover of its undertaking, and, where appropriate, the characteristics of the group to which it belongs. However, in the absence of that information, it must be concluded that the applicant has not established the importance which the loss of the entire European market for triclosan would represent for its undertaking and, where appropriate, for the group to which it belongs.
58 Moreover, for the same reason, namely the lack of any information as to the factors referred to in paragraph 56 above, it cannot either be concluded that the alleged loss of its entire European market for triclosan can be categorised as ‘financial harm which is objectively significant’ within the meaning of paragraph 33 of the order of the Vice-President of the Court of 7 March 2013, EDF v Commission (C‑551/12 P(R), EU:C:2013:157).
59 In that regard, it must be added that, if the applicant, despite the requirements arising from the case-law referred to in paragraphs 31 to 34 above, does not provide such information in its application for interim measures, it is not for the judge hearing the application for interim measures to seek them, instead of and in the place of the party concerned.
60 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 even to weigh up the interests. In those circumstances and in the light of the case-law following which the interest invoked by the intervener is, if appropriate, taken into account in the balancing of interests (order of 26 July 2004, Microsoft v Commission, T‑201/04 R, EU:T:2004:246, paragraph 34), it is not necessary to rule on PISC’s application to intervene.
61 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, 13 July 2017.