Symrise v ECHA (Appeal Interim order - Registration, evaluation, authorisation and restriction of chemicals - 2-ethylhexyl salicylate - Order) [2021] EUECJ C-281/21P(R)

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(Appeal – Interim order – Regulation (EC) No 1907/2006 – Registration, evaluation, authorisation and restriction of chemicals (REACH) – Substance 2-ethylhexyl salicylate – Substance used exclusively in the manufacture of cosmetic products – Decision of the European Chemicals Agency (ECHA) requesting that the applicant submit additional toxicity studies and tests – Application for interim measures – No urgency – Dismissal)

APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 30 April 2021,

Symrise AG, established in Holzminden (Germany), represented by R. Cana, avocat, E. Mullier and H. Widemann, avocates, and L. Gorywoda, adwokat,

European Chemicals Agency (ECHA), represented by W. Broere, L. Bolzonello and A. Deloff-Bialek, acting as Agents,

1 By its appeal, Symrise AG seeks to have set aside the order of the President of the General Court of the European Union of 23 February 2021, Symrise v ECHA (T‑655/20 R, not published, EU:T:2021:98; ‘the order under appeal’), by which the President of the General Court dismissed its application for suspension of operation of the decision of the Board of Appeal of the European Chemicals Agency (ECHA) of 18 August 2020, in Case A‑010‑2018, concerning the appellant’s registration dossier for salicylate 2‑ethylhexyl (‘the decision at issue’).

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

2 Symrise AG manufactures the substance 2‑ethylhexyl salicylate, of which it is the main declarant 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, and corrigendum OJ 2007 L 136, p. 3).

3 2‑Ethylhexyl salicylate is an organic single-component chemical substance which is used exclusively in cosmetic and personal care products as an ultraviolet filter.

4 That substance is included in Annex VI to 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) as an ultraviolet filter authorised in cosmetic products with a maximum concentration of 5% in ready-for-use preparations.

5 On 13 March 2018, in the context of a compliance check of the registration of that substance, ECHA adopted a decision requesting that the appellant submit, by 21 September 2021 at the latest, certain toxicological and ecotoxicological information for the evaluation of the substance 2‑ethylhexyl salicylate.

6 To that end, Symrise was to carry out the following four studies and tests (‘the studies and tests at issue’):

– first, a prenatal developmental toxicity study carried out on rats or rabbits;

– second, an extensive toxicity study for reproduction in one generation carried out on rats;

7 On 12 June 2018, the appellant filed an appeal against that decision with the Board of Appeal of ECHA. By the decision at issue, the Board of Appeal of ECHA confirmed the decision of 13 March 2018 and set the deadline for providing the information requested – namely, the results of the studies and tests at issue – at 25 February 2024.

8 By application lodged at the Registry of the General Court on 27 October 2020, the appellant brought an action for annulment of the decision at issue.

9 By separate document lodged at the Registry of the General Court on 27 November 2020, the appellant brought an application for interim measures, in which it claimed that the President of the General Court should (i) suspend the operation of the decision at issue with immediate effect, in accordance with Article 157(2) of the Rules of Procedure of the General Court, (ii) order that suspension of operation pending the decision of the General Court in the main proceedings, (iii) consequently, order the extension, for the duration of that suspension, of the prescribed period within which it is to submit the results of the studies and tests at issue, in the event that the action in the main proceedings is not upheld, (iv) grant any other interim measures deemed appropriate and hold an oral hearing as needed, and (v) order ECHA to pay the costs.

10 By the order under appeal, the President of the General Court dismissed that application for interim measures.

11 In that connection, the President of the General Court examined at the outset whether the condition of urgency was satisfied.

12 In the first place, in paragraphs 21 to 24 of the order under appeal, the President of the General Court rejected the appellant’s argument that the sacrifice of a large number of vertebrate animals, required by the studies and tests at issue, had to be taken into consideration in order to ascertain whether the condition relating to the urgency of the interim measures sought was satisfied. According to the President of the General Court, first, the condition relating to urgency required that the appellant demonstrate that those measures were necessary for the protection of its own interests and, second, harm caused to a general interest, such as that invoked by Symrise, could have been taken into account only at the stage of weighing up the interests involved.

13 In the second place, in paragraphs 25 to 29 of the order under appeal, the President of the General Court rejected the appellant’s argument that, in order to comply with the decision at issue, it risked legal proceedings for failure to comply with animal welfare and animal testing prevention objectives enshrined in the national legislation concerned and in EU law. In that regard, he held that the risk alleged by Symrise was purely hypothetical, in that it was based on the occurrence of future and uncertain events and could not, therefore, establish an imminent risk of the occurrence of serious and irreparable damage.

14 In the third place, in paragraphs 30 and 31 of the order under appeal, the President of the General Court rejected the appellant’s argument that it would suffer irreparable damage to its reputation if the studies and tests in question were to be carried out, by finding that, in so far as Symrise sells the substance 2‑ethylhexyl salicylate only to professional clients, it was unlikely that such customers would interpret the applicable legal framework incorrectly, which made it unlikely that damage would be caused to the appellant’s reputation.

15 In the fourth place, in paragraphs 32 to 37 of the order under appeal, the President of the General Court rejected the appellant’s argument that the decision at issue affected its position on the 2‑ethylhexyl salicylate market. In that connection, he found, first, that the damage alleged in that respect was of a financial nature and that, save in exceptional circumstances, that damage could not be regarded as irreparable. Second, the President of the General Court noted that Symrise had confined itself to making mere assertions, unsupported by any evidence capable of demonstrating urgency based on a risk to its financial viability.

16 In those circumstances, the President of the General Court held that the application for interim measures had to be dismissed on the ground that the appellant had failed to establish urgency, without it being necessary to rule on whether there was a prima facie case or weigh up the interests involved.

– set aside the order under appeal and grant the suspension of operation of the decision at issue;

– order the extension, for the duration of that suspension of operation, of the prescribed period within which it is to submit the results of the studies and tests at issue, in the event that the action in the main proceedings is not upheld;

– in the alternative, refer the application for suspension of operation back to the General Court for consideration; and

20 By its first ground of appeal, the appellant submits that the President of the General Court erred in law, in particular in paragraphs 21 to 23 of the order under appeal, in that he did not regard the sacrifice of a large number of animal lives as a relevant factor for assessing the urgency of the interim measures sought.

21 In that regard, first, the appellant submits that account should already have been taken of that factor in the assessment of urgency and not only as a factor to be taken into consideration at the stage of weighing up the interests involved, having regard to the broad discretion enjoyed by the court hearing the application for interim relief in the application of interim measures. Second, the appellant recalls that carrying out the studies and tests at issue would entail sacrificing the lives of thousands of vertebrate animals. That sacrifice may prove unnecessary if the action for annulment of the decision at issue were to be upheld by the General Court.

22 Third, according to the appellant, the question of the protection of animal welfare cannot be regarded as a mere factor to be taken into consideration at the stage of weighing up the interests involved, as that question is the main subject matter of the decision at issue and forms the basis of the urgency justifying the suspension of operation of that decision.

23 Furthermore, the importance attached to animal welfare in EU law justifies urgency being assessed not only in the light of the appellant’s own interests but also in the light of the protection of the interests of the European Union. Were the suspension of operation sought not to be granted, such interests would be prejudiced if sacrificing the lives of thousands of vertebrate animals were to prove unnecessary, in the event that the action for annulment of the decision at issue is upheld by the General Court.

24 Lastly, according to the appellant, granting the suspension of operation of the decision at issue would also ensure the effectiveness of its right to bring judicial proceedings, thereby ensuring protection of the appellant’s right to an effective remedy.

26 As a preliminary point, it should be recalled that Article 156(4) of the Rules of Procedure of the General Court 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. Thus, according to the settled case-law of the Court, the court hearing an application for interim relief may order the suspension of operation of an act, or 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 damage to the interests of the party making the application, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, so that applications for interim measures must be dismissed if any one of them is not satisfied. The court hearing an application for interim relief must also, where appropriate, weigh up the interests involved (order of the Vice-President of the Court of 20 December 2019, Puigdemont i Casamajó and Comín i Oliveres v Parliament, C‑646/19 P(R), not published, EU:C:2019:1149, paragraph 51).

27 In particular, 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 Court. 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 (order of the Vice-President of the Court of 7 July 2016, Commission v Bilbaína de Alquitranes and Others, C‑691/15 P-R, not published, EU:C:2016:597, paragraph 41).

28 Furthermore, in the context of its examination of those conditions, the court hearing the 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 EU law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (order of the Vice-President of the Court of 17 December 2020, Anglo Austrian AAB and Belegging-Maatschappij “Far-East” v ECB, C‑207/20 P(R), not published, EU:C:2020:1057, paragraph 102).

29 In the present case, it should be observed that, by its first ground of appeal, the appellant does not rely on serious and irreparable damage to its own interests, in accordance with the conditions laid down in the case-law set out in paragraphs 26 and 27 above, in order to show that, in the order under appeal, the President of the General Court erred in law as regards the assessment of the urgency of the interim measures sought.

30 To that end, the appellant in fact merely claims, in essence, that a general interest – namely, the protection of animal welfare – should be taken into account as a relevant factor in assessing urgency, having regard to the sensitive nature of that interest and to the large number of animal lives which could be sacrificed unnecessarily.

31 In those circumstances, it cannot be accepted that the President of the General Court erred in law by holding, in paragraphs 22 and 23 of the order under appeal, that the appellant had not claimed any direct damage that it would suffer on account of the studies and tests at issue and that, consequently, the argument relating to the protection of animal welfare, while having an ethical dimension, cannot establish the urgency of the suspension sought by the appellant.

32 Similarly, having regard to the broad discretion enjoyed by the court hearing the application for interim relief, in accordance with the case-law referred to in paragraph 28 of the present order, the President of the General Court did not err in law when he essentially held, in paragraph 24 of the order under appeal, that the question of the possible harm to the general interest, in relation to the protection of animal welfare, could have been taken into account at the stage of weighing up the interests involved and that the court hearing the application for interim relief is not required to carry out such a weighing up if it finds beforehand that one of the conditions for granting interim measures has not been satisfied.

34 By the second ground of appeal, the appellant claims that the President of the General Court erred in law, in paragraphs 30, 31, 37 and 39 of the order under appeal, in that he failed to take into account the seriousness of the risk of damage to its reputation.

35 If sacrificing the lives of more than 3 200 vertebrate animals were to prove unnecessary, in the event that the decision at issue is annulled by the General Court, the appellant’s reputation vis-à-vis its customers would be damaged. The appellant submits that such damage would occur, contrary to what is stated in the order under appeal, irrespective of the knowledge that those customers may have of the relevant legal framework. Thus, the appellant would lose part of its clientele, since those customers would no longer buy the substance concerned if incorporating it into their cosmetic products ran the risk of calling their cruelty-free commitments into question.

36 The appellant submits, furthermore, that the order under appeal fails to take account of the damage to the appellant’s reputation which would be caused vis-à-vis all consumers as a result of the public ‘name-and-shame’ campaigns elicited by the studies and tests at issue. Furthermore, that risk would not only adversely affect the appellant as an undertaking but would also have negative consequences for its employees.

37 The appellant adds that the risk of stigmatisation of its conduct is not at all hypothetical, since non-governmental organisations and manufacturers of cosmetic products have already publicly criticised the sacrifice of a large number of vertebrate animals required by the operation of the decision at issue.

38 The appellant submits that, consequently, it cannot be accepted that the annulment of the decision at issue would constitute sufficient compensation for the damage suffered by the appellant to its reputation, as the President of the General Court held in paragraph 31 of the order under appeal. Even if that decision were to be annulled, the damage to the appellant’s reputation suffered as a result of the experimentation unnecessarily carried out on vertebrate animals would not be mitigated, in the eyes of the public, by the fact that the studies and tests at issue should not have been required in the decision at issue in the first place.

39 Lastly, the appellant also observes that, in the order under appeal, the President of the General Court did not address its arguments relating to the consequences for human health and the world cosmetics industry if the suspension of operation were not to be granted. For the same reasons, which are additional to the failure to take account of the risk of serious damage to the appellant’s reputation, the order under appeal also infringes the appellant’s right to be heard.

40 It must be recalled that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the definitive future decision, in order to ensure that there is no lacuna in the legal protection provided by the Court. It is for the purpose of attaining that objective that urgency must be assessed in the light of the need for an interlocutory order to avoid serious and irreparable damage to the party seeking the interim relief. It is for that party to prove that it cannot await for the outcome of the main proceedings without suffering such damage. While it is true that, in order to establish the existence of serious and irreparable damage, it is not necessary for the occurrence and imminence of the damage to be demonstrated with absolute certainty, it being sufficient to show that damage is foreseeable with a sufficient degree of probability, the party seeking interim measures is nevertheless required to prove the facts forming the basis of its claim that serious and irreparable damage is likely (order of the Vice-President of the Court of 17 December 2020, Anglo Austrian AAB and Belegging-Maatschappij “Far-East” v ECB, C‑114/20 P(R), not published, EU:C:2020:1059, paragraph 45).

41 In that regard, the court hearing the application for interim relief must have concrete and precise indications, supported by detailed documents which demonstrate the situation of the party seeking the interim measures and enable the precise effects which would probably follow if the measures sought were not granted to be examined. That party is therefore required to provide, with supporting documentation, evidence and information allowing an accurate overall picture of its financial situation to be established (order of the Vice-President of the Court of 17 December 2020, Anglo Austrian AAB and Belegging-Maatschappij “Far-East” v ECB, C‑114/20 P(R), not published, EU:C:2020:1059, paragraph 50).

42 Those requirements apply in particular where the damage alleged is damage of a pecuniary nature which cannot, other 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 or she suffered the damage. Any such damage could be remedied by the applicant’s bringing an action for compensation on the basis of Articles 268 and 340 TFEU (order of the Vice-President of the Court of 17 December 2020, Anglo Austrian AAB and Belegging-Maatschappij “Far-East” v ECB, C‑114/20 P(R), not published, EU:C:2020:1059, paragraph 51).

43 In the present case, it must be found that, in so far as its arguments concern the risk of losing customers as well as the risk of negative publicity to consumers, the appellant is claiming damage of a pecuniary nature.

44 Contrary to the requirements arising from the case-law set out in paragraphs 40 to 42 of the present order, the appellant has failed to produce concrete and precise indications to establish that the risk of pecuniary damage pleaded would be serious and irreparable, and confines itself to setting out general considerations, according to which the conduct of the studies and tests at issue would damage its reputation.

45 Similarly, it cannot be accepted that the President of the General Court erred in law, in paragraph 31 of the order under appeal, by holding that, assuming that the appellant’s reputation is actually compromised by the decision at issue, the annulment of that decision at the end of the main proceedings would constitute sufficient compensation for the non-material damage alleged.

46 It should be noted that the appellant has failed to produce any sufficiently concrete evidence to enable the precise effects which would probably follow if the measures sought were not granted to be examined, by confining itself to stating, in that connection, that (i) press releases issued by non-governmental organisations and by manufacturers of cosmetic products made public the fact that the decision at issue required the appellant to carry out the studies and tests at issue, and (ii) those organisations and manufacturers had sought leave to intervene in the main proceedings before the General Court.

47 Moreover, in so far as concerns the submissions relating to the risk which would be borne by the appellant’s employees and the alleged harm to human health and the world cosmetics industry, it should be observed that the appellant has not invoked an interest of its own, but rather general or third-party interests. Consequently, for the reasons set out in the examination of the first ground of appeal, those arguments cannot succeed.

48 Lastly, in the light of the considerations set out above concerning the risk of damage to the appellant’s reputation, it cannot be held that the President of the General Court infringed the appellant’s right to be heard.

50 In the light of all the foregoing considerations, the appeal must be dismissed.

51 Under Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is unfounded, the Court is to make a decision as to the costs.

52 Under Article 138(1) of the Rules of Procedure, which are applicable to the procedure on appeal 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.

53 Since the appellant has been unsuccessful, it must be ordered to pay the costs, in accordance with the form of order sought by ECHA.

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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Symrise v ECHA (Appeal Interim order - Registration, evaluation, authorisation and restriction of chemicals - 2-ethylhexyl salicylate - Order) [2021] EUECJ C-281/21P(R)_CO (16 July 2021) URL: http://www.bailii.org/eu/cases/EUECJ/2021/C28121P(R)_CO.html Cite as: EU:C:2021:632, ECLI:EU:C:2021:632, [2021] EUECJ C-281/21P(R)_CO

Court of Justice of the European Communities (including Court of First Instance Decisions)