NON-CONFIDENTIAL VERSION
ORDER OF THE PRESIDENT OF THE GENERAL COURT
26 March 2010 (*)
(Proceedings for interim measures – REACH – Identification of acrylamide as a substance of very high concern – Application for suspension of operation of the measure and for interim relief – No urgency)
In Case T‑1/10 R,
SNF SAS, established in Andrézieux-Bouthéon (France), represented by K. Van Maldegem and R. Cana, lawyers, and P. Sellar, Solicitor,
applicant,
v
European Chemicals Agency (ECHA), represented by M. Heikkila and W. Broere, acting as Agents,
defendant,
APPLICATION for suspension of operation of the decision identifying acrylamide as a substance of very high concern which is stated to have been adopted by the European Chemicals Agency (ECHA) on 7 December 2009 pursuant to Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1),
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Legal context
1 On 18 December 2006, the European Parliament and the Council 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), subsequently amended, in particular, by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC (OJ 2008 L 353, p. 1) (‘Regulation No 1907/2006’).
2 The legislature thereby established a regime concerning the registration, evaluation, authorisation and restriction of chemicals (‘REACH’), the purpose of which is, in particular, to ensure a high level of protection of human health and the environment as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. Article 3(1) of Regulation No 1907/2006 defines ‘substance’ as ‘a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition’.
3 More specifically, one of the fundamental objectives of REACH is to ensure that ‘substances of very high concern’ are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available.
4 Regulation No 1907/2006 thus lays down, in Title VII, an authorisation procedure the aim of which is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern will be properly controlled and that these substances will progressively be replaced by suitable alternative substances or technologies where these are economically and technically viable (Article 55 of Regulation No 1907/2006). The authorisation procedure applies to all substances fulfilling the criteria referred to in Article 57 of the regulation. Under that provision, among the substances that may be included in Annex XIV to the regulation are substances meeting the criteria for classification as carcinogenic or mutagenic in accordance with Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ, English Special Edition 1967, p. 234), as amended in particular by Commission Directive 2004/73/EC (OJ 2004 L 152, p. 1) and by Regulation No 1272/2008.
5 The first stage of the authorisation procedure consists in identifying the substances that meet the criteria referred to in Article 57 of Regulation No 1907/2006 and establishing a list of substances identified for eventual inclusion in Annex XIV to the regulation (‘the candidate list of substances’). Article 59 lays down a multi-step procedure for this purpose.
6 The identification procedure can be begun on the initiative of a Member State, which may prepare a dossier for substances which in its opinion are of very high concern and forward the dossier to ECHA (Article 59(3) of Regulation No 1907/2006). Next, ECHA makes the dossier available to all the Member States and publishes on its website a notice inviting all interested parties to submit comments to it (Article 59(2) to (4) of the regulation). If ECHA receives such comments, it refers the dossier to the Member State Committee and, if that committee reaches a unanimous agreement on the identification of a substance, ECHA includes the substance in the candidate list of substances (Article 59(7) and (8) of the regulation). Finally, ECHA is to publish and update the candidate list of substances without delay after a decision on inclusion of a substance has been taken (Article 59(10) of the regulation).
7 Following the inclusion of a substance in the candidate list of substances, the economic operators concerned, in particular producers, importers and suppliers of the substance, are subject to information obligations, in accordance with Article 7(2) and (4), Article 31(1)(c), Article 31(3)(b) and Articles 33 and 34 of Regulation No 1907/2006.
8 The second stage of the authorisation procedure consists in the inclusion, in order of priority, of candidate substances in Annex XIV to Regulation No 1907/2006, that is to say, in the list of substances subject to authorisation. For this purpose, as is apparent from Article 58 of the regulation, the Commission takes its decision in accordance with the procedure referred to in Article 133(4) of the regulation, upon a recommendation from ECHA, the latter taking into account the opinion of the Member State Committee and comments submitted by interested parties. Inclusion of a substance in Annex XIV triggers a prohibition on placing it on the market after a date set for that purpose, unless an authorisation is granted; however, certain uses or categories of uses may be exempted from the authorisation requirement.
9 The third stage of the authorisation procedure consists in examination of the applications for authorisation that have been made by manufacturers, importers or users for one or several uses of a substance included in Annex XIV to Regulation No 1907/2006 (Articles 60 to 64 of the regulation). Article 64 lays down a multi-step procedure for this purpose. The procedure provides, in particular, for an opinion to be obtained from ECHA’s Committee for Risk Assessment and from its Committee for Socio-economic Analysis. Ultimately, a final decision granting or refusing the authorisation is taken in accordance with the procedure referred to in Article 133(3) of the regulation.
10 Article 2(8)(b) of Regulation No 1907/2006 provides, however, for a derogation regarding the field of application of the authorisation procedure envisaged in Title VII of the regulation. It expressly states that ‘on-site isolated intermediates and transported isolated intermediates’ are exempted from Title VII. According to Article 3(15) of the regulation, ‘intermediate’ means ‘a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance’, while Article 3(15)(a), (b) and (c) define the terms ‘non-isolated intermediate’, ‘on-site isolated intermediate’ and ‘transported isolated intermediate’.
11 With a view to ensuring effective management of the technical, scientific and administrative aspects of Regulation No 1907/2006 at European Union level, an independent central entity was created, namely the European Chemicals Agency (ECHA) (Articles 75 to 111 of the regulation and recital 15 in its preamble).
Background to the dispute
12 The applicant, SNF SAS, has as its principal activity the manufacture of acrylamide and of acrylamide-based polymers (‘polyacrylamides’). It is part of the SPCM SA group of companies which has more than 30 subsidiaries and operations in more than 140 countries around the world. The group has manufacturing sites in France, the United States, China and South Korea. It has, with 40% of world capacity, the largest capacity for the manufacture of polyacrylamides, which are mainly used in water treatment (both for drinking water and wastewater), paper manufacturing, textile printing and mineral extraction and processing.
13 On 25 August 2009, a Member State, namely the Netherlands, forwarded to ECHA a dossier which it had prepared for identification of acrylamide as a substance meeting the criteria mentioned in Article 57(a) and (b) of Regulation No 1907/2006; it referred to the classification of acrylamide as carcinogenic and mutagenic in Annex I to Directive 67/548 and Part 3 of Annex VI to Regulation No 1272/2008. On 31 August 2009, ECHA published on its website a notice inviting interested parties to submit comments on the dossier prepared for acrylamide. On the same day it also invited the competent authorities of the other Member States to submit comments in this regard.
14 After receiving comments on the dossier in question and the responses of the Member State concerned to those comments, ECHA referred the dossier to the Member State Committee, which, on 27 November 1999, reached unanimous agreement on the identification of acrylamide as a substance of very high concern, on the ground that it met the criteria referred to in Article 57(a) and (b) of Regulation No 1907/2006.
15 On 7 December 2009, ECHA issued a press release announcing, first, that the Member State Committee had reached unanimous agreement on the identification of acrylamide and 14 other substances as substances of very high concern since they met the criteria referred to in Article 57 of Regulation No 1907/2006 and, second, that the candidate list of substances would be formally updated in January 2010. On 22 December 2009, the Executive Director of ECHA issued an internal instruction for the candidate list of substances to be published and updated on 13 January 2010, as regards those 15 substances.
Procedure and forms of order sought
16 By application lodged at the Court Registry on 4 January 2010, the applicant and the Polyelectrolyte Producers Group EIEG (PPG), a European federation in the economic sector concerned of which the applicant is a member, brought an action for annulment of the decision identifying acrylamide as a substance of very high concern, a decision stated to have been adopted by ECHA on 7 December 2009 pursuant to Article 59 of Regulation No 1907/2006 (‘the contested decision’).
17 By separate document, lodged at the Court Registry on 5 January 2010, the applicant brought the present application for interim measures, in which it essentially requested the President of the Court to:
– suspend the operation of the contested decision pursuant to Article 105(2) of the Rules of Procedure of the Court, pending the ruling on the application for interim measures;
– in any event, suspend the operation of the contested decision with effect from the date on which it was adopted;
– grant any other interim measures as appropriate;
– order ECHA to pay the costs of the proceedings for interim measures;
– order a hearing.
18 By order of 11 January 2010, made pursuant to Article 105(2) of the Rules of Procedure, operation of the contested decision was suspended until the order terminating the present proceedings for interim measures has been made. Following that order, the Executive Director of ECHA suspended the inclusion of acrylamide in the candidate list of substances. In its press release of 13 January 2010, ECHA referred to the inclusion of 14 substances in the candidate list of substances and inserted a footnote in which it stated that acrylamide had also been identified as a substance of very high concern, but that the inclusion of that substance in the candidate list of substances had been suspended, by the abovementioned order of 11 January 2010, until the order terminating the proceedings for interim measures in Case T-1/10 R was made.
19 In its written observations lodged at the Court Registry on 21 January 2010, ECHA contends that the President of the Court should:
– dismiss the application for interim measures;
– order the applicant to pay the costs.
20 After ECHA lodged its observations, the applicant was permitted to respond to certain points in those observations, which it did by a pleading of 1 February 2010. ECHA then responded by a pleading of 12 February 2010.
Law
21 Under Articles 278 TFEU and 279 TFEU, in conjunction with Article 256(1) TFEU, the judge hearing the application for interim measures may, if he considers that circumstances so require, order that application of the act contested before the General Court be suspended or prescribe any necessary interim measures.
22 Article 104(2) of the Rules of Procedure provides that an application 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. Thus, the judge hearing the application may order suspension of operation of an act and 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 (order in Case C‑268/96 P(R) SCK and FNK v Commission [1996] ECR I-4971, paragraph 30).
23 In addition, 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 analysed and assessed (order in Case C-149/95 P(R) Commission v Atlantic Container Line and Others [1995] ECR I‑2165, paragraph 23, and order of the President of 3 April 2007 in Case C‑459/06 P(R) Vischim v Commission, not published in the ECR, paragraph 25). Where appropriate, the judge hearing the application must also weigh up the interests involved (order in Case C‑445/00 R Austria v Council [2001] ECR I‑1461, paragraph 73).
24 Finally, it is to be noted that Article 278 TFEU establishes the principle that actions are not to have suspensory effect, since acts adopted by the institutions, bodies, offices and agencies of the European Union are presumed to be lawful. It is therefore only by way of exception that the judge hearing the application can order that operation of the act contested before the General Court be suspended or prescribe interim measures (see, to this effect, the order of the President of 17 December 2009 in Case T-396/09 R Vereniging Milieudefensie and Stichting Stop Luchtverontreiniging Utrecht v Commission, not published in the ECR, paragraph 31 and the case-law cited).
25 Having regard to the documents in the case, the President of the Court considers that he has all the material needed in order to rule on the present application for interim measures and that it is not expedient first to hear oral argument from the parties. Consequently, the applicant’s request that a hearing be arranged must be rejected.
Arguments of the parties
Admissibility
26 ECHA contends that the application for interim measures must be declared inadmissible since the main application is manifestly inadmissible. In its submission, the contested decision is a preparatory act which does not bring about a distinct change in the applicant’s legal position. In any event, the contested decision is not of direct concern to the applicant as neither the identification of acrylamide as a substance of very high concern nor its inclusion in the candidate list of substances produces legal obligations for the applicant.
27 ECHA explains that, while Articles 7 and 33 of Regulation No 1907/2006 set out information obligations, those obligations bind not the applicant as a manufacturer of acrylamide but its customers. As to the information obligation laid down in Article 34(a) of the regulation, this does not extend to requiring communication of the ‘new’ information on hazardous properties of acrylamide. The identification of acrylamide as a substance of very high concern is merely a consequence of acrylamide’s classification from 1993 as carcinogenic and mutagenic for the purposes of Directive 67/548. The hazardous properties of acrylamide have therefore already been known to the applicant and its customers for more than 15 years.
28 The applicant contends that the contested decision is a challengeable act in that it definitively lays down ECHA’s position on the conclusion of the procedure. In its submission, there is no scope for any change in the contested decision between the time the decision was taken and the updating of the candidate list of substances, since the subsequent publication of that list is merely a confirmation of the decision already taken. Furthermore, Article 7(2), Article 31(1)(c) and Articles 33 and 34 of Regulation No 1907/2006 show that the identification of acrylamide as a substance of very high concern produces direct legal effects on the applicant.
29 As regards Article 34 of Regulation No 1907/2006, the applicant explains that, far from merely confirming a pre-existing classification, inclusion in the candidate list of substances constitutes a new regulatory development which brings with it a clear sign that acrylamide will have to be replaced by an alternative, less hazardous, substance. The applicant contends that it is therefore obliged, as a precaution, to communicate this development to the next actor in the supply chain. It adds that, as a result of the contested decision, Article 31(1)(c) of Regulation No 1907/2006 henceforth requires it to provide its customers with a safety data sheet when it sells them ‘acrylamide in polyacrylamide’. Finally, it acknowledges that Articles 7 and 33 of the regulation are addressed principally to its customers who use polyacrylamide to make an article, but asserts that they do not know the ‘precise levels of acrylamide in the polyacrylamide’. If they are not to infringe the information obligations imposed upon them, the customers must find out that level, and the only way of obtaining the information is to request it from the applicant. The contested decision therefore imposes upon the applicant an information obligation vis-à-vis its customers.
Prima facie case
30 In the applicant’s submission, since acrylamide is used in the European Union only as an intermediate within the meaning of Regulation No 1907/2006, the contested decision is contrary to Article 2(8) of the regulation, which exempts intermediates from Title VII thereof, relating to the authorisation procedure. It is therefore not possible to identify acrylamide as a substance of very high concern. The Member State which forwarded the dossier relating to acrylamide to ECHA and the Member State Committee conceded that, in more than 99.9% of cases, acrylamide was used as an ‘intermediate’. Moreover, in the remaining 0.1% of cases, it was used for either grouting or electrophoresis. Acrylamide must also be classified as an ‘intermediate’ in the context of such uses. In any event, the dossier forwarded by the Member State concerned does not contain any information on acrylamide as a ‘non-intermediate substance’ or any evidence to establish that grouting and electrophoresis are not uses of acrylamide as an ‘intermediate’, so that the contested decision is vitiated by a manifest error of appraisal.
31 Furthermore, the contested decision infringes the principle of proportionality, in that identification of acrylamide as a substance of very high concern has the objective of eliminating that substance from the market although the authorisation procedure does not concern intermediates, which are deemed not to pose a risk since they are ‘consumed’ within another substance. Identification of acrylamide as a substance of very high concern is also contrary to the principle of non-discrimination in that other substances having the same properties and presenting the same risks have not been identified as substances of very high concern.
32 In ECHA’s submission, it is apparent from the wording of Article 59(1) of Regulation No 1907/2006 that the purpose of the first stage of the authorisation procedure is to determine whether the substance in question meets the criteria set out in Article 57 of the regulation. This stage in the authorisation procedure therefore involves only an assessment of the intrinsic properties of the substance, without consideration of its actual uses. Also, the use of a substance as an ‘isolated intermediate’ is not relevant in relation to determination of its intrinsic properties.
33 ECHA explains that the use of acrylamide becomes relevant only in the second stage of the authorisation procedure, ‘in order to determine whether or not a substance should be included in Annex XIV [to Regulation No 1907/2006] and what uses should be exempt from authorisation pursuant to Article 58(2) [of that regulation]’. The mere fact that a substance is used as an ‘isolated intermediate’ does not therefore render it unlawful to identify that substance as one of very high concern in accordance with Article 59(1) of the regulation. Should acrylamide be used exclusively as an ‘isolated intermediate’, this circumstance could be a reason for subsequently not including it in Annex XIV to the regulation.
34 Nor does the contested decision constitute a disproportionate measure. The inclusion of acrylamide in the candidate list of substances merely identifies the substance as meeting the criteria set out in Article 57 of Regulation No 1907/2006, without entailing any legal consequence. Finally, the line of argument relating to breach of the principle of non-discrimination is unfounded, since ECHA has no margin of discretion as to whether and when the identification procedure concerning a chemical should be started. The forwarding of the dossier relating to acrylamide by the Member State concerned automatically triggered the identification procedure for that substance under Article 59 of the regulation.
Urgency and the balance of interests
35 The applicant submits that, if the application for the suspension of operation of the contested decision were not granted, it would suffer serious and irreparable damage, as the contested decision would have effects of this kind on its market share, its turnover and its production facility in [confidential] (1).
36 In order to demonstrate the gravity of the damage pleaded, the applicant submits that as a result of the contested decision its customers will stop using acrylamide, causing it to lose its market shares in the European Union. It observes that it has already received letters from three of its key customers in which they state that, due to concerns arising from the identification of acrylamide as a substance of very high concern, they will cancel their orders if the situation is not swiftly resolved. This is in line with the policy of major retailers of products containing polymerised acrylamide and other customers might follow suit. The applicant asserts that its ability to manufacture acrylamide and polyacrylamides would thus be endangered. The applicant states that, given the importance of acrylamide in its industrial activity, its insurer expressed serious concerns about the identification of acrylamide as a substance of very high concern and drew its attention to the consequences of identification for its insurance policies, even envisaging the possibility that it might cease to be insurable. The applicant fears that its banks and investors may raise similar concerns.
37 The applicant states that its sales of acrylamide and acrylamide-based products in the European Union from January to November 2009 amounted to EUR [confidential]. It maintains that it will no longer be able to make such sales in the future as a result of the identification of acrylamide as a substance of very high concern and that, consequently, the global turnover of the group to which it belongs will decrease by [confidential]%, as global group turnover amounted to EUR [confidential] in the 2008 financial year. It states that sales to the three customers mentioned in paragraph 36 above amounted in 2009 to EUR [confidential], which is approximately [confidential]% of its turnover from sales of acrylamide and acrylamide-based products in the European Union. It fears that the financial damage suffered will lead to closure of its factory in [confidential], which would have a destabilising effect on its parent company. Accordingly, the fact that it belongs to a larger group of companies will not serve to lessen the damage it will suffer.
38 Nor can that damage be reduced by the sale of substitute products. There are only very few substitutes for polymerised acrylamide and none of them is equivalent to or as effective as that substance. The applicant maintains that it does not have any effective alternative products which it can offer to customers. Moreover, its sales outside the European Union are not sufficient to offset the adverse effects suffered in the European Union. On the other hand, it can be envisaged that less efficient products or processes may be used for some applications.
39 In order to demonstrate the irreparability of the damage pleaded, the applicant submits that there are obstacles making it impossible for the lost market shares to be regained immediately upon annulment of the contested decision, namely the impossibility for the applicant to offer substitute products and the fact that its production site in [confidential] would probably close as it is totally dependent on the manufacture of acrylamide. Consequently, even annulment of the contested decision upon conclusion of the main proceedings would not enable the applicant to recommence production and sales of acrylamide, at least in the short to medium term, thereby preventing the applicant from regaining its market shares.
40 Even in the unlikely event of it being possible for the applicant to recommence the production and sale of acrylamide immediately following the annulment of the contested decision, the applicant is unlikely to be able to regain its customers which will have moved to substitute products, manufactured by its competitors. The latter are very powerful companies which have considerable financial resources that would enable them to conduct an aggressive business policy in order to retain any customers they might have gained as a result of the contested decision. Moreover, once customers have started to deal with another supplier or product, it is often very difficult to persuade them to change supplier or product, and the longer acrylamide is on the candidate list of substances the more difficult that is likely to be.
41 So far as concerns the balance of interests, the applicant acknowledges that the protection of public health must normally take precedence over economic considerations, but submits that, in the circumstances of the case in point, suspension of operation of the contested decision would not involve any serious risk to public health or to the environment. At least 99.9% of acrylamide placed on the market in the European Union is sold as an ‘intermediate’ which cannot be a substance of very high concern. Furthermore, acrylamide-based products have been sold in the European Union for more than 50 years without having ever given rise to serious health or environmental problems. The applicant adds that it would have to rationalise its businesses, laying off [confidential] employees at its production site in [confidential], with a possible further [confidential] job losses in the European Union related to distribution and resale.
42 In ECHA’s submission, the application for interim measures is characterised by a lack of evidence proving the serious and irreparable nature of the harm alleged. Indeed, the applicant's case for urgency is hinged upon the hypothetical market behaviour of its customers as a result of the inclusion of acrylamide in the candidate list of substances and not on any legal effects produced by the contested decision itself.
43 In so far as the applicant states that three of its customers were threatening to cancel their orders of acrylamide, ECHA observes that that loss amounts to less than [confidential]% of the total turnover of the group to which the applicant belongs. Such a loss cannot be classified as serious harm.
44 The applicant’s assertion that its customers will stop using acrylamide is purely speculative. The commercial policy of all of the applicant’s customers, around [confidential] in number cannot be deduced from that of three of them. Nor, in any event, should the hazardous properties of acrylamide come as a surprise to those customers, since the identification of acrylamide as a substance of very high concern simply confirms what the applicant’s customers already knew, namely that acrylamide is a carcinogenic and mutagenic substance, classified as a dangerous substance in Annex I to Directive 67/548, which is now incorporated in Table 3.2 in Annex VI to Regulation No 1272/2008.
45 ECHA maintains that the inclusion of acrylamide in the candidate list of substances does not prohibit the manufacture, marketing or use of acrylamide or acrylamide-based products in any way, as its inclusion has the effect only of imposing certain information obligations. ECHA observes that if, as the applicant appears to indicate in its arguments, it uses acrylamide as an ‘intermediate’ within the meaning of Article 3(15) of Regulation No 1907/2006 or places that substance on the market for such use, any Commission decision including acrylamide in Annex XIV to the regulation will, pursuant to Article 2(8) of the regulation, not result in the prohibition of that use.
Findings of the President of the Court
46 In the circumstances of the present case, it should first be examined whether the condition as to urgency is satisfied.
47 In that regard, it should be borne in mind that the urgency of an application for interim measures must be assessed in relation to the need for an interlocutory order in order to prevent serious and irreparable damage to the party requesting the interim measures. That party must prove that it cannot wait for the outcome of the main proceedings without having to suffer damage of that kind (see the order in Case T‑151/01 R Duales System Deutschland v Commission [2001] ECR II‑3295, paragraph 187, and the order of the President of 25 April 2008 in Case T‑41/08 R Vakakis v Commission, not published in the ECR, paragraph 52 and the case-law cited).
48 It does not have to be established with absolute certainty that the damage pleaded is imminent. It is sufficient that the damage, particularly when it depends on the occurrence of a number of factors, should be foreseeable with a sufficient degree of probability, whilst the party invoking damage is required to prove the facts forming the basis of its claim that serious and irreparable damage is likely (see the order of the President of 28 April 2009 in Case T-95/09 R United Phosphorus v Commission, not published in the ECR, paragraph 32 and the case-law cited). However, purely hypothetical damage, based on future and uncertain events, cannot justify the granting of interim measures (see, to that effect, the orders in Case C‑335/99 P(R) HFB and Others v Commission [1999] ECR I‑8705, paragraph 67, in Case T‑241/00 R Le Canne v Commission [2001] ECR II‑37, paragraph 37, and in Joined Cases T‑195/01 R and T‑207/01 R Government of Gibraltar v Commission [2001] ECR II‑3915, paragraph 101).
49 In the present case, it should be examined whether the applicant has proved to a sufficient degree of probability that, if its application for interim measures were dismissed, it would suffer the serious and irreparable damage that it pleads, namely the loss of its market shares in the European Union so far as concerns acrylamide and polyacrylamides and the closure of its production plant in [confidential].
50 The applicant expressly concedes, in paragraph 60 of its observations of 1 February 2010, that the inclusion of a substance in the candidate list of substances does not entail an immediate ban on that substance. Also, in those observations it does not contest ECHA’s line of argument that the inclusion of a substance in the candidate list of substances does not entail a ban on, or limitation of, the marketing and use of that substance, as Title VII of Regulation No 1907/2006, relating to authorisation, does not impose legal obligations concerning the use of a substance stemming from its identification as a substance of very high concern and its inclusion in the candidate list of substances.
51 Nor does Regulation No 1907/2006 contain any provision that would have the legal effect of prohibiting or restricting the manufacture, marketing or use of a chemical merely because, in the first stage of the authorisation procedure laid down in Title VII of the regulation, it has been identified as a substance of very high concern and included in the candidate list of substances, in accordance with Article 59 of the regulation. It cannot therefore be profitably claimed that the damage pleaded would result from the fact that, by adopting the contested decision, ECHA prohibited or imposed restrictions on the manufacture, marketing or use of acrylamide.
52 Furthermore, in so far as Articles 7, 31 33 and 34 of Regulation No 1907/2006 impose upon the economic operators concerned certain information obligations resulting from the inclusion of a substance in the candidate list of substances, suffice it to state that the applicant has not asserted, and all the less established, that those information obligations concerning acrylamide would be such as to cause it serious and irreparable damage, because of their cost or their content. Suspension of operation of the contested decision as requested or grant of the interim measures applied for cannot therefore be justified on the basis of the information obligations resulting from the inclusion of acrylamide in the candidate list of substances, and there is no need to specify the extent of those obligations.
53 With regard to Article 55 of Regulation No 1907/2006, from which it is apparent that Title VII of the regulation has the aim that substances of very high concern be ‘progressively replaced by suitable alternative substances or technologies’, the applicant maintains that inclusion of acrylamide in the candidate list of substances necessarily leads to its inclusion in Annex XIV to the regulation and to its phasing out. The applicant also submits that its customers, faced with the uncertainty of the authorisation procedure and refusal by their downstream customers to purchase products containing substances of very high concern, will inevitably switch to other products. Thus, industry will move away from the use of acrylamide, even before its inclusion in Annex XIV to the regulation and any requirement for authorisation. The applicant submits that such a consequence is recognised by ECHA, one of the conclusions of which at the workshop of 21 and 22 January 2009 on the candidate list of substances and authorisation as risk management instruments (Annex 1 to the applicant’s observations of 1 February 2010) was that ‘the listing of substances in the [candidate list of substances] is a way to promote their replacement by alternative substances/technologies (industry/[downstream users]) or articles (consumers)’.
54 It must, however, be stated that the applicant’s view, according to which, in essence, the inclusion of acrylamide in the candidate list of substances is the first step in a procedure leading irremediably to the loss of its market shares, is based on a skewed reading of the relevant provisions.
55 It is true that Article 55 of Regulation No 1907/2006 defines the aim of Title VII as seeking, inter alia, to ensure that substances of very high concern are progressively replaced by suitable alternative substances or technologies. However, far from thereby establishing an absolute and unconditional objective of replacement, that provision expressly makes the replacement envisaged dependent upon the economic and technical viability of those alternative substances and technologies, that is to say, upon the technical and economic feasibility of any substitution (recital 72 in the preamble to the regulation). Furthermore, Article 60(4) of the regulation and recital 69 in its preamble make it clear that, even if it is not proved that the risks to human health and the environment arising from the use of a substance of very high concern are adequately controlled, that use may still be authorised ‘if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable’.
56 So far as concerns the eventuality that acrylamide will, as a substance of very high concern on the candidate list of substances, be included in Annex XIV to Regulation No 1907/2006, it is apparent from Article 58 of the regulation that such inclusion requires a decision by the Commission and that that decision would be adopted at the conclusion of a procedure which requires inter alia that ECHA forward to the Commission a recommendation to that effect, taking into account the opinion of the Member State Committee and of the comments of interested parties ‘in particular on uses which should be exempt from the authorisation requirement’. In addition, while it is true that the inclusion of acrylamide in Annex XIV to the regulation results in a prohibition on placing that substance of very high concern on the market unless an authorisation is granted, Article 58(2) provides that certain uses of the substance may be exempted from the authorisation requirement.
57 In this connection, ECHA stated in paragraphs 87 and 88 of its observations of 21 January 2010 and paragraphs 22 and 59 of its observations of 12 February 2010 that if the applicant ‘uses acrylamide as an intermediate or places it on the market for use as an intermediate within the meaning of Article 3(15) of [Regulation No 1907/2006], such use will pursuant to Article 2(8) of [that regulation] not be prohibited following a possible Commission decision including acrylamide in Annex XIV [to the regulation]’. ECHA concluded therefrom that, ‘on the basis of the information provided by the applicant, there is no risk that its use of acrylamide can be prohibited under Title VII of [Regulation No 1907/2006]’.
58 It follows that the progressive replacement of acrylamide by suitable alternative substances or technologies cannot be regarded as proven. Accordingly, this fact cannot form the basis for concluding that serious and irreparable damage linked thereto is likely (see paragraph 48 above).
59 It follows from the foregoing that the applicant has not proved to a sufficient degree of probability that, if its application for interim measures were dismissed, it would lose its market shares in the European Union so far as concerns acrylamide and polyacrylamides and would have to close its production plant in [confidential].
60 This conclusion is not contradicted by the reference made by the applicant to ECHA’s conclusions at its workshop of 21 and 22 January 2009 on the candidate list of substances and authorisation as risk management instruments. First, the legal value to be attributed to those conclusions is questionable, given that, as stated in the workshop proceedings, ‘the opinions expressed in this document may not reflect an official position of [ECHA] or the organisations that participated in the workshop’ (see the note on page 2 of the workshop proceedings). Second, it need merely be pointed out that the passage invoked, according to which the inclusion of a substance in the candidate list of substances is a way to promote its replacement, does no more than partially cite Article 55 of Regulation No 1907/2006. As has already been explained above, that provision, placed in its regulatory context, does not prevent the damage pleaded from being classified as purely hypothetical.
61 In any event, the passage relied upon by the applicant is only an extract from Conclusion 3(b) of the abovementioned workshop. The full text of that conclusion confirms that the inclusion of a substance in the candidate list of substances does not lead automatically to its progressive replacement by suitable alternative substances or technologies, inasmuch as the full text sets out, apart from the objective of replacement, other aims pursued by the establishment of that list, such as the aim of gathering and providing information on uses of substances of very high concern.
62 Finally, the applicant contends that the candidate list of substances is viewed by industry and consumers as a ‘black list’ of substances to be avoided, since those substances will be included in Annex XIV to Regulation No 1907/2006 and hence prohibited unless authorisations are obtained, company by company and use by use. It submits that the inclusion of acrylamide in this ‘black list’ amounts to the ‘regulatory stigmatising’ of acrylamide as a substance of very high concern. It considers its fear to be entirely realistic, as it has already received letters from three customers which state that the suspicion engendered by the identification of acrylamide as a substance of very high concern will lead to cancellation of their orders.
63 As to those submissions, it is necessary to reject first of all the argument alleging that the candidate list of substances is to be regarded as a ‘black list’. Since the inclusion of substances in the candidate list of substances does not lead automatically to their progressive replacement by suitable alternative substances or technologies, that argument cannot succeed. It is not founded on any objective factor capable of establishing its validity. In any event, the applicant refers too generally to the candidate list of substances as a whole, when the inclusion of acrylamide in that list, with which alone the present proceedings are concerned, does not appear to prevent the applicant from continuing to engage in its economic activities relating to acrylamide and polyacrylamides, at least 99.9% of which seem to comprise intermediate uses, so that the progressive replacement of acrylamide by suitable alternative substances or technologies cannot be regarded as proven (see paragraphs 56 to 58 above).
64 Next, as regards the conduct of certain economic operators, such as the applicant’s customers, banks, investors and insurers and major retailers of products containing polymerised acrylamide, who are stated to have already announced that they will stop using acrylamide or to have expressed, or to be liable to express, their disquiet with regard to that substance being one of very high concern, it is undisputed that ECHA identified acrylamide as a substance of very high concern, for the purposes of Article 57 of Regulation No 1907/2006, for the sole reason that acrylamide had already been classified as carcinogenic and mutagenic in the list of hazardous substances, as set out in Annex I to Directive 67/548 and Part 3 of Annex VI to Regulation No 1272/2008.
65 Given that, first, the inclusion of acrylamide in the candidate list of substances will not lead automatically to its progressive replacement by suitable alternative substances or technologies and, second, there is nothing to prevent the economic sector in question from continuing the use of acrylamide as an ‘intermediate’, that is to say almost all of its uses, the identification of acrylamide as a ‘substance of very high concern’, simply by reference to its carcinogenic and mutagenic nature, essentially does no more than confirm that it is potentially ‘hazardous’.
66 It follows that the negative reactions of the customers of the applicant, banks, investors, insurers or other economic operators cannot be regarded as conclusions that an economic operator could reasonably have drawn from the mere identification of acrylamide as a substance of very high concern, since its identification does not provide any new information regarding the intrinsically hazardous properties of that substance. Assuming that those negative reactions are explained by a policy change on the part of the economic operators in question, based on increased awareness in relation to carcinogenic and mutagenic substances (see the eco-labels mentioned by the applicant) or on a misunderstanding of the objectives pursued by ECHA in identifying acrylamide as a substance of very high concern, that would be an independent choice made by those economic operators, which would constitute the decisive cause of the damage pleaded.
67 It follows from all the foregoing that the application for interim measures must be dismissed for lack of urgency, without it being necessary to examine, first, whether the application is admissible as incidental to an action for annulment brought against a challengeable act and, second, whether the other conditions for suspending the operation of a measure or granting interim relief are met in the present case.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1. The application for interim measures is dismissed.
2. Costs are reserved.
Luxembourg, 26 March 2010.