ORDER OF THE PRESIDENT OF THE GENERAL COURT
17 December 2015(*)
(Application for interim measures — REACH — Making available on the market and use of biocidal products — Inclusion of a company as a supplier of an active substance on the list referred to in Article 95 of Regulation (EU) No 528/2012 — Application for suspension of operation — Lack of urgency)
In Case T‑543/15 R,
Lysoform Dr. Hans Rosemann GmbH, established in Berlin (Germany),
Ecolab Deutschland GmbH, established in Monheim am Rhein (Germany),
Schülke & Mayr GmbH, established in Norderstedt (Germany),
Diversey Europe Operations BV, established in Utrecht (Netherlands),
represented by K. Van Maldegem, M. Grunchard, lawyers, and P. Sellar, Advocate,
applicants,
v
European Chemicals Agency (ECHA), represented by C. Buchanan and W. Broere, acting as Agents,
defendant,
APPLICATION for suspension of operation of the decision of ECHA of 17 June 2015 to include company O. as a supplier of an active substance on the list referred to in Article 95(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1),
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Background to the dispute, procedure and forms of order sought by the parties
1 On 18 December 2006 the European Parliament and the Council of the European Union adopted Regulation (EC) No 1907/2006 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), a corrected version of which was published in the Official Journal of the European Union (OJ 2007 L 136, p. 3), and which was later amended several times. By so doing the legislature established a system for the registration, evaluation, authorisation and restriction of chemicals intended in particular to ensure a high level of protection of human health and the environment and the free movement of chemicals within the internal market.
2 In the present dispute, the applicants Lysoform Dr. Hans Rosemann GmbH, Ecolab Deutschland GmbH, Schülke & Mayr GmbH and Diversey Europe Operations BV, which are chemical and pharmaceutical undertakings operating inter alia in the fields of hygiene, disinfection, antiseptics and cleansing, challenge a measure adopted by the European Chemicals Agency (ECHA) which, in their view, deprived them of their right to obtain financial compensation from company O. for the costs they had to incur in connection with the review programme conducted by ECHA in respect of a particular biocidal active substance.
3 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ 1998 L 123, p. 1) provided a framework for the authorisation and placing on the market of biocidal products within the Member States of the European Union. To that end it laid down common rules for the evaluation and inclusion of active substances contained in biocidal products on positive lists of authorised active substances, and for the re-registration of biocidal products containing such substances at Member State level.
4 The biocidal active substance propan-1-ol (‘propyl alcohol’) forms part of a review programme at EU level established under Article 16 of Directive 98/8. It was notified to the European Commission for review, by the applicants as members of the Alcohol Task Force working group, which was set up in 2001 in order to collaborate and share in the costs of and efforts for the submission of a dossier for the review inter alia of propyl alcohol at EU level. Company O. is not a member of that working group.
5 Participation in the review of propyl alcohol meant that the applicants, as makers of a notification, incurred expenditure, since they had to produce scientific data and pay fees to the Commission and the Member States for the review programme. The applicants, as the notifying companies, thus submitted the requisite dossier for propyl alcohol for review by the Member State designated as rapporteur.
6 Pending the review, all persons or entities producing propyl alcohol or formulating biocidal products containing propyl alcohol were authorised to start or continue to sell propyl alcohol or biocidal products containing propyl alcohol, even if they had made no notification themselves. The applicants consider that company O. is one of those persons or entities. They conclude that company O., as a non-participating company, benefits from free riding on the efforts made by the applicants in the review procedure for propyl alcohol.
7 Directive 98/8 was replaced by Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1), as amended, which entered into force on 1 September 2013. Under Article 95(1) of Regulation No 528/2012, ECHA was required as of 1 September 2013 to publish a list of all active substances for which a dossier complying with that regulation or the repealed directive had been submitted and accepted or validated as part of a review programme (‘the relevant list’). That list included propyl alcohol, and gave the names of the notifying companies, in their capacity as manufacturers or importers into the European Union of propyl alcohol, or in their capacity as formulators of biocidal products based on propyl alcohol.
8 Article 95(2) and (3) of Regulation No 528/2012 provides that from 1 September 2015 no biocidal product consisting of, containing or generating a substance which is included in the relevant list is to be made available on the EU market unless the supplier of the substance or the supplier of the product appears on that list. Consequently, companies which are not on the relevant list but wish to market after 1 September 2015 biocidal products containing a substance included in the relevant list must submit to ECHA, in accordance with the second subparagraph of Article 95(1) of Regulation No 528/2012, either a complete dossier on the substance or a letter of access to a complete dossier on the substance or a reference to a complete dossier on the substance.
9 Where a company draws up a complete dossier for submission to ECHA with a view to being included in the relevant list, it is required to comply with the mandatory rules on data sharing laid down in Articles 62 and 63 of Regulation No 528/2012. Thus where data on vertebrate animals, toxicological and ecotoxicological studies, and environmental fate and behaviour studies have already been produced by another company and those data are the data required by a particular company to complete its dossier, that company must approach the owner of the data in question and make efforts to negotiate a right of access to the data. If the negotiations are successful, the agreement will provide, first, for payment of a fair contribution by the requesting company to the data owner’s costs of generating the data and, secondly, for that company to have access to the data for the purpose of being included in the relevant list. If the negotiations fail, ECHA is entitled to authorise the requesting company to refer to the data notwithstanding the lack of agreement between the parties, subject, however, to a fair and proportionate contribution by that company to the costs.
10 For existing active substances such as propyl alcohol, the protection period for data submitted for the first time to the Commission or ECHA is 10 years from the first day of the month following the date of adoption of a decision on approval for the product type concerned (first subparagraph of Article 60(2) of Regulation No 528/2012), or until 31 December 2025 for product types which are included in the review programme but have not yet been approved on 1 September 2013 (Article 95(5) of that regulation, as amended).
11 As regards the data needed during the review of propyl alcohol, the rapporteur Member State in 2008 required the applicants to generate a vertebrate study carried out in vivo on rat liver, stomach and blood cells (‘the comet assay’). That requirement was the subject of discussions before being confirmed by the national authorities of another Member State at a technical meeting held in June 2009. It was indicated to the applicants that failure to present the study would lead to a decision that the dossier was incomplete. The applicants proposed a waiver for certain data, but that was refused by the rapporteur Member State. The applicants thereupon carried out the study and submitted it to complete their dossier.
12 As for company O., it approached ECHA in October 2013 in order to be included on the relevant list as a supplier of propyl alcohol. Company O. also contacted the applicants with a view to possible data sharing within the meaning of Article 62 of Regulation No 528/2012, but made no attempt to negotiate access to the comet assay, even though the applicants had informed it of the rapporteur Member State’s requirement in this respect.
13 Despite the fact that company O. had not gained access to the comet assay, ECHA decided on 17 June 2015 that the company had on 29 January 2015 submitted a complete dossier to it on propyl alcohol in accordance with the second subparagraph of Article 95(1) of Regulation No 528/2012, and that it should therefore be entered in the relevant list (‘the contested decision’). According to the applicants, the effect of the contested decision is, first, that company O. is authorised to continue to supply propyl alcohol to its customers from 1 September 2015 and, secondly, that in accordance with Article 95(4) of Regulation No 528/2012 its customers can continue to market products containing propyl alcohol in the EU market without having themselves to be included in the relevant list.
14 On 28 July 2015 the applicants asked ECHA to inform them whether it considered that the comet assay was not necessary for the inclusion of company O. in the relevant list. By letter of 18 August 2015, ECHA confirmed that that was indeed its view.
15 On 28 August 2015 the applicants first challenged the contested decision before the Board of Appeal of ECHA in accordance with Article 92(1) of Regulation No 1907/2006.
16 By application lodged at the Registry of the General Court on 18 September 2015, they then brought an action for the annulment of the contested decision.
17 Following the rejection of their complaint by the Board of Appeal of ECHA on 25 September 2015, the applicants, by separate document lodged at the Registry of the Court on 20 November 2015, brought the present application for interim measures, in which they claim that the President of the Court should:
– suspend the operation of the contested decision with effect from the date of its entry into force;
– order any other interim measures that he may find appropriate and hold a hearing if he considers it necessary;
– order ECHA to pay the costs of these proceedings.
18 In its observations on the application for interim measures, lodged at the Court Registry on 30 November 2015, ECHA contends that the President of the Court should dismiss the application for interim measures and order the applicants to pay the costs. ECHA submits principally that the main action on which the application is founded is manifestly inadmissible, since the applicants are not directly or individually concerned by the contested decision within the meaning of the fourth paragraph of Article 263 TFEU, and the individual decision can also not be classified as a regulatory act which does not entail implementing measures within the meaning of that article.
Law
19 In accordance with Articles 278 TFEU and 279 TFEU read in conjunction with Article 256(1) TFEU, 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. 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 interim measures (see order of 11 November 2013 in CSF v Commission, T‑337/13 R, EU:T:2013:599, paragraph 21 and the case-law cited).
20 In addition, Article 156(3) of the Court’s 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 measures applied for. The judge hearing an application for interim measures may thus order 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 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, so that an application for interim measures must be dismissed if either of them is not satisfied (see order in CSF v Commission, cited in paragraph 19 above, EU:T:2013:599, paragraph 22 and the case-law cited).
21 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. Where appropriate, the judge must also weigh up the interests involved (see order in CSF v Commission, cited in paragraph 19 above, EU:T:2013:599, paragraph 23 and the case-law cited).
22 Having regard to the material in the case file, the judge hearing the present application for interim measures considers that he has all the information needed to rule on the application without there being any need first to hear oral argument from the parties.
23 In the circumstances of the present case, it is appropriate first of all to determine whether the condition relating to urgency is satisfied.
24 The applicants submit that the contested decision exposes them to serious and irreparable harm, namely the loss of their right to receive fair compensation. The contested decision has the effect of including company O., a supplier of propyl alcohol on the EU market, in the relevant list. Its inclusion followed the submission of a dossier which ECHA found to be sufficiently complete, although, as appears from the main application, there was no legal justification for that finding of completeness. It was therefore in breach of Regulation No 528/2012 that ECHA included company O. in the relevant list.
25 The applicants point out that one of the aims of Regulation No 528/2012 is to ensure a level playing field for competing companies, with fairness to be brought about by the mechanism of mandatory data sharing which obliges undertakings such as company O. to contact undertakings such as the applicants which own data that company O. lacks in order to complete its dossier. An agreement is thus to be reached which is beneficial for both parties. On the one hand, company O. obtains access to the data in question which will allow it to complete its dossier and be included in the relevant list. In that way, it can continue to sell its propyl alcohol and products based on propyl alcohol on the EU market, while its customers can continue to market their products containing propyl alcohol on the EU market without having to be included on the list themselves. On the other hand, the applicants receive as counterpart a fair and proportionate contribution to the costs they have incurred for the review of propyl alcohol.
26 The contested decision perpetuates the imbalance in the relationship between the applicants and company O., in so far as company O. ought, in accordance with Regulation No 528/2012, to have negotiated its access to the comet assay owned by the applicants. ECHA’s failure to apply that regulation correctly deprived the applicants of their right to receive fair compensation from company O. for that access. Furthermore, since company O. is on the relevant list, the companies which bought propyl alcohol from it in order then to resell it on the EU market can continue to do so, as they are being supplied by a company which appears on that list. If company O. had not been included on the relevant list, those customers would have had to apply to be included on the list themselves. To succeed in their application, they would have been obliged to submit a complete dossier or a letter of access to such a dossier. For that purpose they would have had to approach the applicants in order to negotiate access to their complete dossier, in return for fair compensation for any access granted. The contested decision therefore had the effect of removing the need for those customers to seek to negotiate access to the applicants’ complete dossier, since they can instead approach company O., which will be unjustly enriched as a result. Moreover, other companies wishing to appear on the relevant list can also contact company O. in order to negotiate access to its complete dossier. If company O. were not included on the list, those companies would have to contact the applicants for that purpose, and they could then receive fair compensation for access to the data sought.
27 According to the applicants, the contested decision has a further, probably irreversible consequence. They have every reason to believe that propyl alcohol will be approved in 2017, before judgment is given in the main action. Once propyl alcohol is approved under Regulation No 528/2012, the actual approval will normally enter into force 18 months after the approval decision. However, the rules on the authorisation of the product in question will apply from the entry into force of the approval regulation, that is, 20 days after publication, and applications for product authorisation can be submitted from that date. By virtue of those rules, any company wishing to remain in the EU market must have submitted a complete dossier or a letter of access to the complete dossier relating to propyl alcohol to the competent national authority or to ECHA. On approval, the only dossier which will be deemed to be complete will be that owned by the applicants. However, should the approval of propyl alcohol enter into force before judgment is given in the main action, company O. together with its customers will be able to obtain product authorisations on the basis of that company’s dossier, those product authorisations being valid for 10 years. Regardless of any judgment given in the main action, those product authorisations will remain valid even if a customer’s letter of access is withdrawn. In addition, the data would only be protected until 2025, which means that, by that time, the data would no longer be protected and could be used freely without any compensation.
28 ECHA takes the view, by contrast, that the applicants have not succeeded in showing the urgency of the suspension of operation sought.
29 In this connection, it must be recalled that, according to settled case-law, the urgency of an application for interim measures must be assessed in relation to the necessity for an interim order to prevent serious and irreparable damage to the party applying for interim measures. It is for that party to adduce solid evidence that it cannot wait for the outcome of the main proceedings without having personally to suffer harm of that kind. While the imminence of the alleged harm does not have to be proved with absolute certainly, its occurrence must nevertheless be foreseeable with a sufficient degree of probability (see orders in CSF v Commission, cited in paragraph 19 above, EU:T:2013:599, paragraph 31 and the case-law cited, and of 27 November 2014 in SEA v Commission, T‑674/14 R, EU:T:2014:1009, paragraph 54 and the case-law cited), and purely hypothetical harm, based on the occurrence of future and uncertain events, does not justify the grant of interim measures (see, to that effect, order of 27 February 2015 in Spain v Commission, T‑826/14 R, ECR, EU:T:2015:126, paragraph 33 and the case-law cited).
30 In the present case, the applicants claim essentially that the contested decision deprives them of their rights to receive fair compensation in return for the efforts they have made and the costs they have incurred in participating in the review of propyl alcohol, and continues the lack of a level playing field since, first, it means that they have to bear a disproportionate burden of the costs of producing a complete dossier which would have been compensated if ECHA had complied with Regulation No 528/2012 and, secondly, company O. does not have to incur the cost of a fair contribution to those costs.
31 As regards the interference with the right to receive compensation, it has repeatedly been held that it is not sufficient to allege infringement of fundamental rights in the abstract for the purpose of establishing that the harm which could result would necessarily be irreparable (see, to that effect, orders of 10 October 2013 in Commission v Pilkington Group, C‑278/13 P(R), ECR, EU:C:2013:558, paragraph 40; 28 November 2013 EMA v InterMune UK and Others, C‑390/13 P(R), ECR, EU:C:2013:795, paragraph 42; and 25 February 2015 BPC Lux 2 and Others v Commission, T‑812/14 R, EU:T:2015:119, paragraph 28). It is true that a breach of certain fundamental rights, such as the prohibition of torture and inhuman or degrading treatment or punishment enshrined in Article 4 of the Charter of Fundamental Rights of the European Union, may, on account of the very nature of the right violated, in itself give rise to serious and irreparable harm. However, the fact remains that it is always for the party seeking interim measures to set out and establish the likelihood of such harm occurring in his particular case (orders in Commission v Pilkington Group, EU:C:2013:558, paragraph 41, and EMA v InterMune UK and Others, EU:C:2013:795, paragraph 43).
32 A fortiori, a breach of a purely regulatory right, such as that deriving in the present case from Regulation No 528/2012, even if proven, is insufficient to establish serious and irreparable harm. The applicants have not shown how the fact of being deprived of the financial compensation conferred by that right would in itself cause them serious and irreparable harm. The argument based on an interference with their right to receive such compensation therefore cannot establish urgency.
33 It is indeed correct that, in a dispute specifically concerning the protection of an undertaking against the publication of allegedly confidential commercial information, the President of the General Court was able to find that, if such information were published before the Court gave judgment in the main action, there was a risk that the fundamental right of the undertaking concerned to the protection of its business secrets, enshrined in Article 339 TFEU and Article 7 of the Charter of Fundamental Rights, would irreversibly lose all meaning in relation to that information, and that it was at the same time likely that the undertaking’s fundamental right to an effective remedy, enshrined in Article 47 of the Charter of Fundamental Rights, would be jeopardised, so that its fundamental rights could be seriously and irreparably harmed, and it was thus clearly urgent to grant the interim measures sought (see, to that effect, order of 11 March 2013 in Pilkington Group v Commission, T‑462/12 R, ECR, EU:T:2013:119, paragraph 45). However, that approach disregarding all financial considerations in its specific context was overruled in the order in Commission v Pilkington Group, cited in paragraph 31 above (EU:C:2013:558, paragraphs 39 to 44).
34 It necessarily follows that, in order to establish urgency, the applicants are required to show that a loss of the fair compensation they seek would be liable to cause them serious and irreparable harm, with it being apparent that that harm must be categorised as purely financial.
35 However, according to settled case-law, purely financial harm is normally not irreparable, since financial compensation for that harm can be obtained subsequently, unless it appears that the party seeking the interim measures would find itself, without those measures, in a position that could imperil its very existence before final judgment is given in the main proceedings or that its market share would be substantially affected, having regard to the size and turnover of its business and the characteristics of the group to which it belongs, directly or indirectly, through its shareholders (see, to that effect, orders of 13 July 2006 in Romana Tabacchi v Commission, T‑11/06 R, ECR, EU:T:2006:217, paragraph 111, and SEA v Commission, cited in paragraph 29 above, EU:T:2014:1009, paragraph 54 and the case-law cited).
36 It should be added that serious and irreparable harm must be proved by each of the applicants personally and individually. The question of urgency is a specific question that must be examined separately for each applicant (see, to that effect, orders of 24 March 2009 in Cheminova and Others v Commission, C‑60/08 P(R), EU:C:2009:181, paragraphs 35 and 36; 15 December 2009 Dow AgroSciences and Others v Commission, C‑391/08 P(R), EU:C:2009:785, paragraph 44; and 12 June 2014 Commission v Rusal Armenal, C‑21/14 P-R, ECR, EU:C:2014:1749, paragraph 51).
37 In any event, in order to determine whether the harm alleged is serious and irreparable, the judge hearing the application for interim measures must have specific and precise information, supported by detailed, certified documentary evidence, which shows the situation in which the party seeking the interim measures finds itself and enables the probable consequences, should the measures sought not be granted, to be assessed. It follows that that party, in particular where it relies on the occurrence of financial damage, must produce, with supporting documentation, an accurate overall picture of its financial situation (see, to that effect, order in SEA v Commission, cited in paragraph 29 above, EU:T:2014:1009, paragraph 55 and the case-law cited).
38 In the present case, the applicants have clearly not submitted any specific information, supported by evidence, from which it could be concluded that each of them would in fact be exposed to the risk, in the event that the application for interim measures is dismissed, of finding itself in a position that could imperil its very existence or of its market share being substantially affected. The applicants have not provided, with respect to each of them individually, any information whatsoever on their size, characteristics of production or total turnover in respect of all products.
39 In particular, the applicants have remained silent both as to the total amount of costs they incurred for the review of propyl alcohol and as to the division among them of those costs, and have not claimed that those costs and how they were divided up could for some reason or other not be quantified. The judge hearing the application for interim measures is therefore unable to assess the seriousness, whether absolute or relative, of any definitive loss of the compensation the applicants claim in order to cover those costs.
40 In the absence of relevant information providing an accurate overall picture of their financial situation, the assertions made by the applicants to illustrate the harm they fear they will suffer describe only the most disastrous potential consequences of the immediate operation of the contested decision, in the form of the least favourable scenarios that might arise (see, to that effect, orders of 23 December 2008 in AES-Tisza v Commission, T‑468/08 R, EU:T:2008:621, paragraph 49, and 10 July 2009 TerreStar Europe v Commission, T‑196/09 R, EU:T:2009:270, paragraph 55), those assertions not being supported by figures to show that the alleged serious and irreparable harm is certain or, at the very least, likely to occur.
41 That is true in particular of the applicants’ speculative proposition that ‘it is more than probable that by including [company O.] onto the [relevant] List and where [propyl alcohol] is approved within the next 18 or so months (i.e. before the conclusion of the Main Application), the Applicants will have irreparably lost their right to compensation for the full costs they have incurred during the review of [propyl alcohol] because of the laws in application’. Even if such a scenario were to become reality, however harmful it might be for the applicants, they have failed to establish the extent of the maximum financial harm they might suffer in this respect, by relating it to their overall financial strength.
42 Consequently, the applicants have not succeeded in establishing that the condition of urgency of the suspension of operation sought is satisfied.
43 It follows from all the foregoing that the application for interim measures must be dismissed for lack of urgency, there being no need to examine the condition relating to a prima facie case, or to weigh up the interests involved (see, to that effect, order of 14 December 1999 in DSR-Senator Lines v Commission, C‑364/99 P(R), ECR, EU:C:1999:609, paragraph 61). In those circumstances, there is also no need to rule on the question raised by ECHA of the admissibility of the main action.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1. The application for interim measures is dismissed.
2. Costs are reserved.
Luxembourg, 17 December 2015.