JUDGMENT OF THE GENERAL COURT (Seventh Chamber)
1 February 2013 (*)
(REACH – Transitional measures concerning the restrictions on the placing on the market and use of acrylamide for grouting applications – Annex XVII to Regulation (EC) No 1907/2006 – Proportionality – Obligation to state reasons)
In Case T‑368/11,
Polyelectrolyte Producers Group, established in Brussels (Belgium),
SNF SAS, established in Andrézieux-Bouthéon (France),
Travetanche Injection SPRL, established in Brussels,
represented by K. Van Maldegem and R. Cana, lawyers,
applicants,
v
European Commission, represented by P. Oliver and E. Manhaeve, acting as Agents, assisted by K. Sawyer, Barrister,
defendant,
supported by
Kingdom of the Netherlands, represented by C. Wissels, M. Noort and B. Koopman, acting as Agents,
intervener,
APPLICATION for annulment of Commission Regulation (EU) No 366/2011 of 14 April 2011 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Acrylamide) (OJ 2011 L 101, p. 12),
THE GENERAL COURT (Seventh Chamber),
composed of A. Dittrich (Rapporteur), President, I. Wiszniewska-Białecka and M. Prek, Judges,
Registrar: S. Spyropoulos, Administrator,
having regard to the written procedure and further to the hearing on 22 November 2012,
gives the following
Judgment
Background to the dispute
1 The first applicant, Polyelectrolyte Producers Group is a European Economic Interest Grouping which is established in Belgium. It represents the interests of companies which are producers and/or importers of acrylamide, polyelectrolytes, polyacrylamide and/or other polymers containing acrylamide. All EU manufacturers of acrylamide are members of that group. The second applicant, SNF SAS, is a member company of the first applicant. It is principally active in the manufacture of acrylamide, intended in particular for grouts, and acrylamide-based polymers which it sells directly to customers throughout the European Union (EU). The third applicant, Travetanche Injection SPRL, is a Belgian-based company whose main activity is the provision of acrylamide grouting services on construction sites.
2 The substance at issue, acrylamide (CAS No 79-06-1), is used in the production of polyacrylamide, which is used in the construction and public works sector to repair masonry and concrete to prevent water infiltration. It is used, inter alia, for grouting applications, namely water shut-off, concrete repair and salt damp remediation.
3 On 23 March 1993, the Council adopted Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances (OJ 1993 L 84, p. 1). Under Article 1(1) thereof, that regulation applied to, firstly, the collection, circulation and accessibility of information on existing substances and, secondly, the evaluation of the risks of existing substances to man, including workers and consumers, and to the environment, in order to ensure better management of those risks within the framework of Community provisions. Articles 3 and 4 of that regulation required manufacturers and importers of those substances to report certain relevant information, depending on the quantity of the substance produced or imported. On the basis of that information, the Commission of the European Communities, in consultation with the Member States, had regularly to draw up lists of priority substances or groups of substances (‘priority lists’) requiring immediate attention because of their potential effects on man or the environment, in accordance with Article 8 of Regulation No 793/93. Under Article 10 of that regulation, for each substance on the priority lists, a Member State had to be given responsibility for the evaluation of the risk of that substance to man and the environment and had, where appropriate, to suggest a strategy for limiting those risks, including control measures and/or surveillance programmes. The principles for the assessment of risks to man and the environment of existing substances in accordance with Regulation No 793/93 were laid down by Commission Regulation (EC) No 1488/94 of 28 June 1994 (OJ 1994 L 161, p. 3).
4 On 25 May 1994, acrylamide was included in the first priority list and the United Kingdom of Great Britain and Northern Ireland was given responsibility for the evaluation of that substance by Commission Regulation (EC) No 1179/94 concerning that list as foreseen under Regulation No 793/93 (OJ 1994 L 131, p. 3).
5 Subsequently, the United Kingdom prepared a European Union (EU) risk assessment report on acrylamide. That report was discussed by a group of Member States’ experts within the Technical Committee on New and Existing Substances (TCNES). In 2001, TCNES reached agreement on that report and the Scientific Committee on Toxicity, Ecotoxicity and the Environment, established under Commission Decision 97/579/EC of 23 July 1997 setting up scientific committees in the field of consumer health and food safety (OJ 1997 L 237, p. 18), achieved a consensus on that report. The European Union Risk Assessment Report on Acrylamide was published in 2002. That report concluded, inter alia, that it was necessary to reduce the following risks:
– the risk to the aquatic compartment from use of acrylamide-based grouts in construction applications, and the risk to other organisms from indirect exposure through contaminated water from the same applications (point 5.2);
– the risk to workers as a consequence of exposure arising from small and large-scale use of acrylamide-based grouts (point 5.3.1.1), and
– the risk to humans exposed via their environment to acrylamide as a consequence of exposure arising from large-scale use of acrylamide-based grouts (point 5.3.1.3).
6 The results of the risk assessment and the risk reduction strategy for acrylamide were adopted by the Commission in Recommendation 2004/394/EC of 29 April 2004 (OJ 2004 L 144, p. 75), pursuant to Article 11(2) of Regulation No 793/93. In order to reduce the risk to human health and the environment, it was recommended, inter alia, to consider at Community level marketing and use restrictions in Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (OJ 1976 L 262, p. 201), for the use of acrylamide in grouts for small and large-scale applications. For workers, the legislation concerning their protection in force at that time at Community level was generally considered to give an adequate framework to limit the risks of acrylamide to the extent necessary.
7 On that basis, the Commission, in June 2007, envisaged proposing Community measures concerning applicable restrictions for acrylamide in the framework of Directive 76/769, pursuant to Article 11(3) of Regulation No 793/93.
8 On 4 February 2008, the Commission produced an impact assessment accompanying a draft decision amending Directive 76/769 as regards acrylamide.
9 From 1 June 2008 and 1 June 2009 respectively, Regulation No 793/93 and Directive 76/769 were repealed pursuant to Article 139 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Regulation No 793/93 and Regulation No 1488/94 as well as Directive 76/769 and Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1).
10 Article 137(1)(a) of Regulation No 1907/2006 contains transitional measures. It provides that, by 1 June 2010, the Commission is, if necessary, to prepare a draft amendment to Annex XVII to that regulation in accordance with any risk assessment and recommended strategy for limiting risks that has been adopted at Community level in accordance with Article 11 of Regulation No 793/93, as far as it includes proposals for restrictions in accordance with Title VIII of Regulation No 1907/2006 but for which a decision under Directive 76/769 has not yet been taken. Thus, the Commission prepared a draft amendment to Annex XVII to Regulation No 1907/2006 which contains the restrictions applicable to the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles.
11 On 14 April 2011, the Commission adopted Regulation (EU) No 366/2011 amending Regulation No 1907/2006 as regards Annex XVII (Acrylamide) (OJ 2011 L 101, p. 12, ‘the contested regulation’). Article 1 of the contested regulation amended Annex XVII to Regulation No 1907/2006 and the following text concerning acrylamide was inserted into that annex:
‘Shall not be placed on the market or used as a substance or constituent of mixtures in a concentration, equal to or greater than 0.1% by weight for grouting applications after 5 November 2012.’
Procedure and forms of order sought by the parties
12 By application lodged at the Registry of the General Court on 8 July 2011, the applicants brought the present action.
13 By letter registered at the Court Registry on 18 October 2011, the Kingdom of the Netherlands sought leave to intervene in support of the form of order sought by the Commission. After hearing the principal parties, leave to intervene was granted by order of 22 November 2011 of the President of the Seventh Chamber of the Court.
14 By letter lodged at the Court Registry on 12 December 2011, the Kingdom of the Netherlands waived its right to lodge a statement in intervention.
15 Upon hearing the report of the Judge-Rapporteur, the Court (Seventh Chamber) decided to open the oral procedure.
16 By way of measures of organisation of procedure as provided for in Article 64 of the Rules of Procedure, the Court requested the Commission to produce the minutes of the meeting of TCNES held on 6 and 7 March 2008. The Commission complied with that request within the prescribed period.
17 By letter lodged at the Court Registry on 12 October 2012, the Kingdom of the Netherlands waived its right to participate in the oral procedure.
18 By document lodged at the Court Registry on 30 October 2012, the third applicant made an application for interim relief, requesting, in essence, that the President of the Court suspend operation of the contested regulation.
19 By order of the President of the Court of 5 November 2012 in Case T‑368/11 R Travetanche Injection v Commission, not published in the ECR, operation of the contested regulation was suspended in so far as it concerns the third applicant until the order terminating the proceedings for interim relief was made; costs were reserved.
20 By letter lodged at the Court Registry on 7 November 2012, the applicants lodged observations on the report for the hearing.
21 The applicants and the Commission presented oral argument and replied to the questions asked by the Court at the hearing on 22 November 2012. At the hearing the applicants stated that the reference, in the reply, to violation of the principle of equal treatment by the contested regulation was a clerical error.
22 The applicants claim that the Court should:
– declare the action admissible and well founded;
– annul the contested regulation;
– order the Commission to pay the costs.
23 The Commission contends that the Court should:
– declare the action unfounded;
– order the applicants to pay the costs of both parties.
Law
24 The applicants put forward three pleas in law in support of their action. The first alleges a manifest error of assessment in relation to the risk evaluation. The second plea concerns an alleged breach of the principle of proportionality. The third plea alleges breach of the obligation to state reasons.
First plea: manifest error of assessment in the evaluation of risks
25 The applicants maintain that the Commission committed a manifest error of assessment, since the risk assessment, on the basis of which the contested regulation was adopted, is incorrect. More specifically, the applicants submit that the Commission, in evaluating the risks relating to acrylamide, failed to take account of all the relevant factors and circumstances. In addition, the applicants maintain, first, that the information on which the contested regulation is based related neither to exposure arising from uses of acrylamide that are known or reasonably foreseeable in the EU, nor to uses to which humans or the environment are exposed or likely to be exposed. Second, they argue that the information on which the restrictions on the use of acrylamide in large-scale grouting applications were based related to a product which contains N-methylolacrylamide (NMA), a grouting agent distinct from acrylamide.
Preliminary observations
26 It should be observed that the contested regulation was adopted under Article 137(1)(a) of Regulation No 1907/2006, which provides that, by 1 June 2010, the Commission had, if necessary, to prepare a draft amendment to Annex XVII to that regulation in accordance with any risk assessment and recommended strategy for limiting risks that had been adopted at Community level in accordance with Article 11 of Regulation No 793/93, as far as it included proposals for restrictions in accordance with Title VIII of Regulation No 1907/2006 but for which a decision under Directive 76/769 had not yet been taken.
27 Since the risk assessment and the strategy for limiting risks for acrylamide had been adopted by the Commission in Recommendation 2004/394 (see paragraph 6 above), the introduction of new restrictions relating to acrylamide by the contested regulation had to comply with Title VIII of Regulation No 1907/2006. When such requirements were introduced, the requirements mentioned in Article 68(1) of Regulation No 1907/2006 thus had to be observed. Article 68(1) states that when there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on an EU-wide basis, Annex XVII to Regulation No 1907/2006 is to be amended by adopting new restrictions for the manufacture, use or placing on the market of substances on their own, in preparations or in articles, pursuant to the procedure set out in Articles 69 to 73 of the regulation. Any such decision had to take into account the socio-economic impact of the restriction, including the availability of alternatives.
28 Consequently, in order to be able to adopt the contested regulation, the Commission had to consider that there was an unacceptable risk to human health or the environment arising from the manufacture, use or placing on the market of acrylamide, which needed to be addressed on an EU-wide basis.
29 In that regard, it must be pointed out that, in an area of evolving and complex technology such as that in the present case, the EU authorities have a broad discretion, in particular as to the assessment of highly complex scientific and technical facts in order to determine the nature and scope of the measures which they adopt, whereas review by the EU judicature has to be limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether the authorities have manifestly exceeded the limits of their discretion. In such a context, the EU judicature cannot substitute its assessment of scientific and technical facts for that of the EU authorities on which alone the FEU Treaty has placed that task (see, by analogy, Case C‑343/09 Afton Chemical [2010] ECR I‑7027, paragraph 28, and Case C‑15/10 Etimine [2011] ECR I‑0000, paragraphs 59 and 60).
30 Contrary to the contention of the applicants, that case-law is applicable to the present case. Even if acrylamide grouts have been used in the same way for decades, the determination of the nature and the extent of the restrictions in issue required an assessment of highly complex scientific and technical facts.
31 Nevertheless, it must be stated that the EU authorities’ broad discretion, which implies limited judicial review of their exercise of that discretion, applies not only to the nature and scope of the measures to be taken but also applies, to some extent, to the finding of the basic facts. However, even though such judicial review is of limited scope, it requires that the EU authorities which have adopted the act in question must be able to show before the EU judicature that in adopting the act they actually exercised their discretion, which presupposes the taking into consideration of all the relevant factors and circumstances of the situation the act was intended to regulate (see, by analogy, Afton Chemical, paragraph 29 above, paragraphs 33 and 34).
The complaint alleging failure to take into account all the relevant factors and circumstances
32 The applicants maintain that the Commission made a manifest error of assessment because it did not, when evaluating the risks relating to acrylamide, take into account all the relevant factors and circumstances.
33 In the first place, the applicants submit that the Commission did not take account of a report of 14 March 2000 entitled ‘Risk Reduction Strategy and Analysis of Advantages and Drawbacks for Acrylamide’, prepared by a consultancy for the UK Department of the Environment, Transport and the Regions (‘the consultancy report’). That report did not recommend any marketing and use restrictions for acrylamide-based grouts on the ground that such a measure would be disproportionate.
34 That argument cannot be accepted. The consultancy report was in fact taken into account by the Commission in the course of the administrative procedure leading up to adoption of the contested regulation, as can be seen from the Commission’s impact assessment of 4 February 2008 accompanying the Commission’s draft decision amending Directive 76/769 as regards acrylamide. The aim of the consultancy report was, according to point 1.3 thereof, to evaluate the appropriateness of a range of risk reduction measures based on their likely effectiveness, practicality, economic impact and monitorability. The Commission’s impact assessment dealt with the possible policy options that could be adopted to control the risks to human health and the environment arising from the use of acrylamide for specific applications that were concerned by the draft decision in question, as well as with the comparative advantages and drawbacks of those options. Section 6 of the impact assessment contained a description of the various policy options in respect of which an impact analysis had been conducted taking into account the efficiency and proportionality of the options envisaged to reduce the risks identified. Section 6 stated that advantages and disadvantages had been examined for each option. The Commission referred to the consultancy report in the part of the impact assessment relating to a total ban on acrylamide-based grouts. That reference was made in the framework of the assessment of alternative substances, which was also one of the central points of the consultancy report (see point 2.4 of that report). The report was also mentioned in the references listed at the end of the impact assessment.
35 The conclusion that the Commission took the consultancy report into account is confirmed by point 5 of the draft minutes of the meeting on 15 February 2006 of the working group responsible for implementing Directive 76/769, according to which the report was discussed in the presence of the Commission. That conclusion is also corroborated by the fact that, in a letter of 22 September 2010 sent to the Commission by the first applicant, the latter stated that the Commission acknowledged the relevance of the consultancy report but failed to acknowledge the conclusions related to the lack of alternatives.
36 In the second place, the applicants argue that the Commission did not take into account the information provided to it by the first applicant in its letter of 17 January 2006, concerning the use of acrylamide in small-scale grouting applications in the Netherlands and Belgium.
37 It is the case (i) that the EU risk assessment report states, in points 4.1.1.1.7 and 5.3.1.1, that no information on exposure relating to small-scale applications in the EU is available but that data from the United States of America exist in that regard, and (ii) that, on the basis of the appraisal of those data, the contested regulation was adopted by the Commission.
38 However, it does not appear from the documents before the Court that relevant exposure data for small-scale acrylamide applications in the EU were available. The Commission points out in that regard that it was not possible during the procedures under Regulation No 793/93 and Directive 76/769 to obtain such data.
39 That finding is not called in question by the contents of the letter of 17 January 2006. In that letter, the first applicant merely referred, in general terms, to the use of acrylamide to treat certain damage caused to houses by the destructive action of moisture and salt in the Netherlands and Belgium. In that letter, the first applicant described how such damage develops, pointed out the advantages of using acrylamide and gave its estimate of the amount of acrylamide used for treating that damage in the Netherlands and Belgium. The applicants do not specify in any way how that very general information relating to the use of acrylamide could have been relevant for the assessment of the risks relating to exposure to that substance.
40 Consequently, this complaint must be rejected.
The complaint alleging a manifest error of assessment in relation to the evaluation of the exposure data taken into account by the Commission
41 The applicants maintain that the Commission based the contested regulation on exposure data from the United States and on information relating to instances of exposure in Norway and Sweden. Contrary to what is provided for by Article 3(3) of Regulation No 1488/94, such exposure is neither known nor reasonably foreseeable in the EU. Human populations and the environment are therefore not exposed or likely to be exposed to acrylamide as a result of grouting applications as described in the risk assessment, contrary to what is required under Articles 4 and 5 of Regulation No 1488/94. Thus the Commission made a manifest error of assessment.
42 Under Article 3(1) of Regulation No 1488/94, ‘the risk assessment shall entail hazard identification and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterisation’. It must be based on ‘the information on the substance submitted in accordance with Articles 3, 4, 7(1) and (2), 9(1) and (2) and 10(2) of Regulation … No 793/93 and on other available information and shall normally be conducted in accordance with the procedures set out in Articles 4 and 5 of [Regulation No 1488/94]’. Under Article 3(3) of Regulation No 1488/94, ‘in conducting an exposure assessment, the rapporteur shall take into account those human populations or environmental spheres for which exposure to the substance is known or reasonably foreseeable in the light of available information on the substance, with particular regard to manufacture, transport, storage, formulation into a preparation or other processing, use and disposal or recovery’.
43 Articles 4 and 5 of Regulation No 1488/94 concern risk assessments for human health and the environment respectively. Article 4(a)(ii) and Article 5(a)(ii) of that regulation specify that the exposure assessments are for whichever human population-group (i.e. workers, consumers or man exposed indirectly via the environment) is exposed or likely to be exposed to the substance and for the environmental spheres exposed or likely to be exposed to the substance.
44 In the first place, the applicants submit that the Commission made a manifest error of assessment in taking account, for the purpose of its risk assessment, exclusively of data from the United States so far as small-scale grouting applications are concerned. Those data are not known or reasonably foreseeable in the EU. Humans and the environment are thus not exposed or likely to be exposed to acrylamide as a result of those grouting applications.
45 Firstly, the Court notes that the Commission does not dispute that the data in question – which are included in the EU risk assessment report and on which the Commission based its assessment of the risks relating to small-scale grouting applications and, thereafter, the contested regulation – come exclusively from the United States. However, the fact that the Commission’s assessment of the risks relating to small-scale grouting applications is founded exclusively on data from a State outside the EU does not establish that the Commission took account, in evaluating the risks, of an exposure to acrylamide that was not known or reasonably foreseeable in the EU and that its assessment was therefore vitiated by a manifest error.
46 Under the third subparagraph of Article 10(1) of Regulation No 793/93, the United Kingdom, having been given responsibility for the EU risk assessment report relating to acrylamide, was responsible for evaluating not only the information submitted by the manufacturers or importers in conformity with the requirements of Articles 3, 4, 7 and 9 of that regulation, but also any other available information. Moreover, by virtue of Article 3(1), second sentence, of Regulation No 1488/94, the risk assessment had to be based on the information on the substance submitted in accordance with Articles 3, 4, 7(1) and (2), 9(1) and (2) and 10(2) of Regulation No 793/93 and on other available information. Furthermore, Annexes I B and III B to Regulation No 1488/94, which contain the guidelines for the risk assessment for human health and the environment, state that ‘where adequately measured, representative exposure data are available, special consideration shall be given to them when conducting the exposure assessment’. It follows from those provisions that the risk assessment could, in principle, also be founded on data other than those submitted pursuant to Regulation No 793/93 and that there was no requirement for those data to come from the EU.
47 In that regard, the Court rejects the applicants’ argument that both Article 10(1) of Regulation No 793/93 and Article 3(1) of Regulation No 1488/94 refer to ‘any other available information’ as an additional source of information, not as an alternative source of information. Those provisions make no reference to exposure data from the EU and there is thus no requirement that such data should be available in order for a risk assessment to be undertaken.
48 Secondly, as regards the applicants’ argument that the uses of acrylamide in the United States relied on as small-scale grouting applications did not exist in the EU, it can be seen from the EU risk assessment report that its scope was a comprehensive risk assessment, on the basis of the available information, of all exposures to the substance that were known or reasonably foreseeable from all uses of acrylamide. It is also apparent from point 5.3.1.1 of that report that it could be assumed that there would be similarities between the uses of acrylamide-based grouts in the United States and the EU and that, consequently, exposures in the United States and the EU could reasonably be regarded as similar. In that regard, the Court observes that TCNES reached agreement on the EU risk assessment report and that the Scientific Committee on Toxicity, Ecotoxicity and the Environment achieved a consensus on that report (see paragraph 5 above). In view of the experts’ approval of the data in question, the applicants’ argument does not call in question the Commission’s view that the data from the United States relating to small-scale grouting applications were representative of uses of acrylamide and exposure to that substance that were reasonably foreseeable in the EU. Moreover, the applicants give no explanation as to why they consider the Commission’s view in that regard to be clearly incorrect.
49 Consequently, in basing its assessment of the risks relating to small-scale grouting applications on the data from the United States that were included in the EU risk assessment report, the Commission took into account data relating to an exposure to acrylamide that was reasonably foreseeable, in accordance with Article 3(3) of Regulation No 1488/94, and thus did not make a manifest error of assessment.
50 In the second place, the applicants argue that the Commission made a manifest error of assessment in basing the contested regulation on information relating to two exposure scenarios in Sweden and Norway that were not known or reasonably foreseeable in the EU so far as large-scale grouting applications are concerned. They argue that the data resulting from the use of acrylamide in two tunnels in Sweden and Norway are not representative of conditions of known exposure to acrylamide, because the use of the grouting products did not comply with the manufacturer’s instructions and is thus not representative of the correct use of those products. With regard to the tunnel in Sweden, a finding to that effect was made in a judgment of the Helsingborg tingsrätt (District Court) (Sweden) of 25 September 2007. The difficulties experienced were also caused by the fact that the products were used incorrectly.
51 The Court notes that, with regard to the use of acrylamide-based grouts in large-scale grouting applications, the EU risk assessment report, on which the Commission based its evaluation of the risks, refers, on a number of occasions, to the application of those products in the construction of two tunnels, one in Hallandsås (Sweden) and the other in Romeriksporten (Norway) (see inter alia point 3.1.4.2.1 relating to environmental exposure and point 4.1.1.1.7 relating to occupational exposure of human health).
52 It is therefore appropriate to consider whether, in relying on the data relating to the construction of those tunnels, the Commission made a manifest error of assessment in concluding that exposure to acrylamide during those grouting applications was representative of exposure which was known or reasonably foreseeable, in accordance with Article 3(3) of Regulation No 1488/94.
53 Firstly, it should be pointed out that, as the Commission maintains, the EU risk assessment report, on which the Commission based its evaluation of the risks relating to acrylamide exposure, was based, so far as large-scale grouting applications were concerned, on the worst-case scenario under normal conditions of use of the grouting products employed.
54 The fact that the EU risk assessment report is, in general, based on the worst-case scenario as regards large-scale grouting applications is apparent from a number of the findings made therein. Thus, point 3.1.2.3 of the report, which concerns releases of acrylamide from the use of acrylamide and NMA-based grouts, and point 5.3.1.3 of the report, which deals with the conclusions relating to human health in the case of persons exposed via their environment, expressly refer to the fact that the worst-case scenario is taken into account. Furthermore, the scenario taken into account in relation to the conclusions on the health of workers (point 5.3.1.1 of the report) shows that the risk assessment was based, as regards large-scale grouting applications of the grouts used, on the worst-case scenario. According to point 5.3.1.1 of the report, part of the risk to be considered was the probability of unpredictable and excessive exposure occurring during large-scale applications and of there being adverse effects to human health. Point 5.3.1.1 also stated that the risk was considered to be very high for a substance such as acrylamide because of its hazardous properties and because workers are usually applying the product in enclosed or poorly ventilated areas.
55 Concerning the question whether, in the EU risk assessment report, account was taken in evaluating the risks connected to large-scale grouting applications of the normal conditions of use of the grouting products used, the Court observes that those products were used in both tunnels in order to seal them and stop water infiltration, as also appears from points 2.2.2 and 2.2.3 of the consultancy report. Such an application is among the normal uses of those products. Moreover the use of those grouts in the tunnel-construction sector is one of the uses which the applicants list as being among the applications of those grouts.
56 The view that the Commission, in relying on the EU risk assessment report, took account of the normal conditions of use of the grouting products used is not called in question by the applicants’ argument that that report incorrectly considered the use of the products in question in the two tunnels to be representative of correct usage.
57 It is true that point 4.1.1.1.7 of the EU risk assessment report, which analyses occupational exposure during use of acrylamide grouts, states that the grouting product was applied by the correct means and that the exposure data were thus interpreted as representative for correct usage. Following the incidents that occurred in the two tunnels in question during the application of the grouting products, the use of the products in those tunnels cannot, however, be regarded as representative of correct usage. Indeed, in the case of the Hallandsås tunnel, the Commission does not dispute that, as is apparent from the judgment of the Helsingborg tingsrätt of 25 September 2007, the grouting product used was handled completely incorrectly and with a shocking carelessness of the risks involved and that the product was used by unskilled staff with no regard to possible effects on the environment. So far as the Romeriksporten tunnel is concerned, it is clear from point 2.2.3 of the consultancy report that the problems that arose in that tunnel were similar.
58 However, point 4.1.1.1.8 of the EU risk assessment report, which concerns inhalation exposure, concludes that the data relating to this type of exposure were interpreted as representative for normal use. Furthermore, point 5.3.1.1 of that report states that ‘it is understood that the use pattern was normal in the sense of how the product was applied although what happened afterwards may not always occur with the use of these products’. It should also be noted that, in the analysis of occupational exposure of human health during the use of the grouts in the Hallandsås tunnel, the report took account of the fact that the safety instructions laid down for those products had not been followed. The report states that the safety data sheet was inaccurate and that the product information sheet contained incorrect data concerning the authorised concentration limit in air for acrylamide (point 4.1.1.1.7 of the report).
59 It can be seen from the foregoing that, although the EU risk assessment report took account, for the purpose of examining the worst-case scenario, of the fact that incidents had occurred in the two tunnels when the grouts were used, it also took into account the normal conditions of use of the grouts employed, as has been stated in paragraph 55 above.
60 Secondly, it must be stated that the Commission did not make a manifest error of assessment when it held, on the basis of the worst-case scenario under normal conditions of use, that the acrylamide exposure during the grouting applications in Sweden and Norway was representative of an exposure that was known or reasonably foreseeable in the light of the information available.
61 Indeed, the Commission must take into account all handling and uses occurring in normal circumstances, which encompasses, in particular, the need to take account of realistic and foreseeable accidents (see, to that effect, Etimine, paragraph 29 above, paragraph 71). Even assuming that the incidents that occurred in the two tunnels in Sweden and Norway could have been avoided if the risks had been evaluated in advance, as seems to be the case so far as the Swedish tunnel is concerned according to the final report of the Tunnel Commission, referred to in the consultancy report, the data resulting from the use of the grout in those tunnels show that such a scenario was neither unrealistic nor unforeseeable. That is particularly true given that the incidents that occurred in the two tunnels when acrylamide was applied were similar, as is clear from point 2.2.3 of the consultancy report (see paragraph 57 above).
62 That conclusion is borne out by the objectives of Regulation No 1907/2006, as they are stated in recital 1 to the regulation and Article 1(1) thereof; they are 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. According to recitals 87, 89 and 91 to Regulation No 1907/2006, the legislature set as the main purpose of the introduction of new restrictions and the amendment of existing restrictions, as provided for in Title VIII of that regulation, the first of those three objectives, namely ensuring a high level of protection of human health and the environment (see, to that effect, Case C‑558/07 S.P.C.M. and Others [2009] ECR I‑5783, paragraph 45). That objective is consistent with the first subparagraph of Article 168(1) TFEU, which provides that a high level of human health protection is to be ensured in the definition and implementation of all EU policies and activities, and with the first subparagraph of Article 191(2) TFEU, which provides that EU policy on the environment is to aim at a high level of protection and is to be based on the precautionary principle and the principle that preventive action should be taken (see, by analogy, Joined Cases C‑14/06 and C‑295/06 Parliament and Denmark v Commission [2008] ECR I‑1649, paragraph 75).
63 In the light of the foregoing the first plea must be rejected.
The complaint alleging that a product containing a grouting agent distinct from acrylamide was taken into account
64 The applicants submit that the Commission made a manifest error of assessment because it based the restrictions on the placing on the market and use of acrylamide in large-scale grouting applications on information related to the use, in the Hallandsås and Romeriksporten tunnels, of grouting products containing a substance other than acrylamide, namely NMA. Acrylamide and NMA are distinct substances under Regulation No 1907/2006. Acrylamide is merely an impurity in grouting products containing NMA as a grouting agent. The applicants also submit that the Commission failed to consider whether data related to grouts containing NMA were a suitable basis for the assessment of grouts containing acrylamide.
65 The Commission does not dispute that acrylamide and NMA are distinct substances pursuant to the definition contained in point 1 of Article 3 of Regulation No 1907/2006. However, it asserts that the risk assessment covered all known exposures to acrylamide and in particular exposures of humans and the environment resulting from both the use of the substance as such in grouting applications and from the application of NMA-based grouts. The latter also contain acrylamide and, when they are applied, NMA may be partially transformed into acrylamide.
66 Point 3.1.2.3 of the EU risk assessment report does indeed indicate that the grouting product used until that time in the EU contained NMA as well as acrylamide and formaldehyde as impurities. However, even though acrylamide and formaldehyde are present as impurities in NMA, as the applicants point out, acrylamide cannot be considered to be present solely as an impurity in the grouts used in the grouting applications in the two tunnels in question, in view of the precise information about concentrations of substances included in other points of the EU risk assessment report.
67 It is apparent from point 2.2.1.2 of that report that those grouting products were NMA based. According to point 2.2.1.2, NMA is a derivative of acrylamide and is also used in grouting applications. The product ‘Siprogel’ used in the Hallandsås tunnel is prepared by the mechanical mixing of two solutions designed to be diluted with water and mixed on site. The first solution, namely ‘Rhoca Gil’, contains, according to points 2.2.1.2 and 4.1.1.1.7 of that report, approximately 37% NMA and approximately 1% formaldehyde. ‘Rhoca Gil’ contained, according to point 2.2.1.2 of the EU risk assessment report, a maximum of 1.5% acrylamide, whilst according to point 4.1.1.1.7 of that report, the manufacturer, after carrying out analyses, stated that the acrylamide content was about 4%. According to those two points, the second solution contains sodium silicate and sodium persulphate.
68 Furthermore, according to point 2.2.1.2 of the EU risk assessment report, NMA may regenerate acrylamide, although the extent to which such regeneration happens in practice is not known and is dependent on the environmental conditions. It is also stated in point 2.2.1.2 that NMA may be partially transformed into acrylamide when sodium silicate is added. In two-solution grouting systems sodium silicate is often used in one solution and acrylamide or NMA in the other. It is possible that when the two components are mixed to set off polymerisation, the potential hydrogen (pH) of the mixture changes to levels that allow transformation of NMA into acrylamide. Exposure to mixed, but not yet polymerised, product may thus lead to exposure to higher concentrations of acrylamide than expected. According to points 2.2.1.2 and 3.1.2.3 of the EU risk assessment report, once the two solutions are mixed with water and once polymerisation has begun, the residual acrylamide monomer should, according to the manufacturers of the NMA-based grouting product, be consumed. In laboratory experiments the manufacturers found that the acrylamide content in the final resin was 1% after three hours and 0.04% after seven days.
69 In view of those considerations, there are no grounds for concluding that the Commission made a manifest error of assessment in basing its evaluation of the risks concerning exposure to acrylamide in large-scale grouting applications on data relating to NMA-based grouts. Indeed, given that NMA-based grouts also contain acrylamide and given that NMA in those products may be transformed into acrylamide, with the result that the acrylamide content in the final resin is still 1% three hours after the solutions concerned have been mixed with water and polymerisation has begun, humans and the environment are exposed to acrylamide during large-scale grouting applications.
70 With regard, more particularly, to the applicants’ argument that Articles 68 and 69 of Regulation No 1907/2006 refer to restrictions adopted as a result of circumstances related to the manufacture, use or placing on the market of a substance on its own, in a preparation or in an article, it should be noted that the EU risk assessment report does indeed concern risks arising from the use of acrylamide, as has been stated in paragraphs 66 to 69 above.
71 Finally, as regards the applicants’ argument that neither the EU risk assessment report nor the Commission addressed the question of whether data related to grouts containing NMA was a suitable basis for the assessment of grouts containing acrylamide, it is sufficient to observe that it is clear from point 2.2.1.2 of that report that that question was examined in the course of the procedure that culminated in adoption of the contested regulation (see paragraph 68 above). Moreover, in points 3.1.2.3 and 3.1.4.2.1 of the EU risk assessment report, the composition and use of NMA-based grouts were examined in relation to environmental exposure to acrylamide. Furthermore, consideration was given, in point 4.1.1.1.7 of that report, to human exposure to acrylamide during use of NMA-based grouts in large-scale grouting applications.
72 Consequently, the EU risk assessment report examined the extent to which and the way in which NMA-based grouts may have an effect on human and environmental exposure to acrylamide. Furthermore, since, in NMA and sodium silicate-based grouting systems, NMA grouts also contain acrylamide and since NMA may be transformed into acrylamide, the Commission did not make a manifest error of assessment in considering the relevance of data resulting from the use of NMA-based grouts to justify the restrictions introduced for acrylamide.
73 In view of the foregoing, this complaint and thus the first plea in its entirety must be rejected.
Second plea: infringement of the principle of proportionality
74 The applicants maintain that the contested regulation infringes the principle of proportionality. The regulation is not appropriate to achieve its objective, namely protecting human health and the environment, because it is based on information that does not relate to the placing on the market of acrylamide and because it does not affect either the placing on the market or the use of NMA-based grouts. The applicants further submit that the substances that may be used as substitutes for acrylamide may pose higher risks than acrylamide. They also maintain that the Commission could have taken other appropriate and less restrictive measures.
75 It is settled case-law that the principle of proportionality, which is one of the general principles of EU law, requires that EU measures do not exceed the limits of what is appropriate and necessary in order to attain the objectives legitimately pursued by the legislation in question; when there is a choice between several appropriate measures recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (see Etimine, paragraph 29 above, paragraph 124 and the case-law cited).
76 With regard to judicial review of the conditions referred to in the previous paragraph, the Commission must be allowed a broad discretion in a sphere which entails political, economic and social choices on its part and in which it is called upon to undertake complex assessments. The legality of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate having regard to the objective which the legislature is seeking to pursue (see Etimine, paragraph 29 above, paragraph 125 and the case-law cited).
77 In the present case, it is apparent from recital 5 in the preamble to the contested regulation that the objective of the regulation is to protect human health and the environment. That objective is consistent with the objectives pursued by Regulation No 1907/2006. Indeed, the purpose of Regulation No 1907/2006 is, pursuant to Article 1(1) thereof, to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. Having regard to recitals 87, 89 and 91 to Regulation No 1907/2006, the Court finds that the legislature set as the main purpose of the introduction of new restrictions and the amendment of existing restrictions, as provided for in Title VIII of that regulation, the first of those three objectives, namely ensuring a high level of protection of human health and the environment (see paragraph 62 above).
78 According to recital 86 to the regulation, it should be the responsibility of the manufacturer, importer and downstream user to identify the appropriate risk management measures needed to ensure a high level of protection for human health and the environment from the manufacturing, placing on the market or use of a substance on its own, in a preparation or in an article. However, where this is considered to be insufficient and where EU legislation is justified, appropriate restrictions should be laid down.
79 In the first place, as regards the applicants’ argument that the contested regulation is not appropriate to achieve the objective sought, it should be observed that the purpose of the regulation is to introduce marketing and use restrictions on acrylamide as a substance or as a constituent of mixtures.
80 In that context, as regards the applicants’ argument that the contested regulation is based on information that does not relate to the placing on the market of acrylamide and that it does not affect either the placing on the market or the use of NMA-based grouts, the Court observes, first, that that argument is not relevant to the question as to whether the contested regulation complies with the principle of proportionality. Second, the restrictions imposed by the contested regulation concern the placing on the market and use of acrylamide not only as a substance but also as a constituent of mixtures. As follows from the reasoning in paragraphs 66 to 72 above, those restrictions may also concern NMA-based grouts which contain acrylamide and in which NMA may be transformed into acrylamide.
81 Turning to the applicants’ argument that the contested regulation is not appropriate because the substances that can be used as substitutes for acrylamide pose higher risks than acrylamide, the Court observes that, in accordance with Article 8 of Regulation No 793/93, acrylamide was included on the priority list (see paragraphs 3 and 4 above). The substances that may be substitutes for acrylamide have not been included on that list. They are covered by Regulation No 1907/2006 and could, depending on their characteristics, be subject to an authorisation or a restriction under Title VII or VIII thereof. In that regard, recital 80 to Regulation No 1907/2006 states that the proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. In view of the foregoing, the fact that the substances used as substitutes are not subject to a restriction does not mean that the contested regulation is inappropriate to achieve the objective sought.
82 Consequently, the applicants’ argument relating to the allegedly inappropriate nature of the contested regulation must be rejected.
83 In the second place, the applicants submit that the contested regulation goes beyond the limits of what is necessary to achieve its objective, as is shown, in their submission, by the Commission’s impact assessment of 4 February 2008. In addition, they maintain that the Commission could have adopted less restrictive measures to address the alleged risks identified that are linked to use of acrylamide-based grouts.
84 Firstly, regarding the Commission’s impact assessment, it is true that, as the applicants point out, that assessment acknowledges that, for particular groups of the population, the necessary risk reduction measures are already in place. Thus, EU legislation lays down minimum requirements for the protection of workers and these requirements are considered appropriate and sufficient legislative instruments to eliminate and reduce risks for workers due to acrylamide exposure. It is also true that the impact assessment states that the existing legislative framework is considered sufficient to address the risks identified for consumers.
85 However, it is to be noted that those statements are found in section 2 of the impact assessment, which concerns the identification of risks for human health and for the environment. In that section, the Commission refers, on the one hand, to the EU risk assessment report and, on the other, to Recommendation 2004/394, which takes account of that report and of the opinion issued by the Scientific Committee on Toxicity, Ecotoxicity and the Environment and which contains, on that basis, the risk evaluation and the risk reduction strategy for acrylamide adopted by the Commission. Before making the statements mentioned in paragraph 84 above, the Commission describes, on the basis of the abovementioned documents, the risks identified for human health and for the environment. After those statements, the Commission specifies that those risks are not limited to the risks identified for workers and consumers, for whom the necessary risk reduction measures are already in place or for whom the existing legislative framework is considered sufficient. The Commission again states that Recommendation 2004/394 defines a strategy in order to limit the remaining risks, that is to say, risks for humans exposed via the environment resulting from the use of acrylamide-based grouts and risks for the aquatic environment as a consequence of exposure arising from the use of acrylamide-based grouts in construction applications. As is clear from recitals 2 and 3 to the contested regulation, the latter was intended precisely to limit the remaining risks to which reference was made in the Commission’s impact assessment. Furthermore, it should be noted that according to point 5.3.1.1 of the EU risk assessment report it was also necessary to limit the risks for workers (see paragraph 5 above).
86 In view of the foregoing, the applicants’ arguments relating to the impact assessment must be rejected.
87 Secondly, the applicants maintain that the Commission could have taken other appropriate, less restrictive, measures, such as improved hazard and labelling communication, the adoption of specific conditions for the use of acrylamide, improved personal protective equipment or the introduction of specific derogations from the ban on acrylamide grouts given the absence of substitutes on the market, at least in relation to essential uses for water shut-off and rising damp.
88 In that regard, the Court observes that the contested regulation is the result of a lengthy administrative procedure during which the various policy options for limiting the risks for humans exposed via the environment as a result of the use of acrylamide-based grouts and the risks for the aquatic environment as a consequence of exposure arising from the use of acrylamide-based grouts in construction applications were examined by the Commission in its impact assessment. It is clear from section 5 of that assessment that the various policy options considered were maintenance of the status quo, voluntary action by the industry concerned to substitute other substances for acrylamide, establishment of specific conditions for the use of acrylamide in grouts and a total ban on acrylamide in grouts. After comparing the various policy options for limiting the risks, the Commission concluded, in section 7 of its impact assessment, that the most effective and proportionate option would be a total ban on the placing on the market and use of acrylamide-based grouts.
89 The arguments put forward by the applicants do not establish that the contested regulation goes beyond the limits of what is necessary to achieve the objective sought.
90 As regards, first, measures to improve hazard and labelling communication and the adoption of specified conditions for the use of acrylamide, the applicants refer to the consultancy report. Section 6.2 of that report concluded that, for the purpose of risk reduction, restrictions were considered the least preferred form of risk reduction and that the improvement of data safety sheets and labelling systems as well as the adoption of specific conditions for the use of acrylamide were recommended.
91 However, the consultancy report dates from March 2000. As can be seen from page ii thereof, the conclusion that restrictive measures did not appear justified was based on the view that the desired reduction in risk could be achieved through specifying conditions of use for acrylamide at a lower cost than that which restrictions would entail. On the very same page, however, that conclusion was considered to be subject to uncertainty. The Commission took account of the consultancy report in its impact assessment (see paragraphs 33 and 34 above). In section 6 of the impact assessment, it indicated that the EU market had changed since 2000, since the majority of undertakings had moved to substitutes and no longer sold acrylamide-based products in the EU. According to the impact assessment, the introduction of a total ban on the marketing and use of acrylamide grouts could thus not be expected to cause significant additional costs in relation to the benefits that could be expected from that ban.
92 In that regard, it is also important to point out that, contrary to what the applicants contend when they refer to the first applicant’s letter to the Commission of 22 September 2010, the consultancy report does not show that the conclusions in the impact assessment that are mentioned in paragraph 91 above were incorrect because substitutes did not exist.
93 When they analysed possible substitutes in point 2.4 of the consultancy report, the authors of that report did not conclude that no substitutes existed for small and large-scale grouting applications. On the contrary, in point 2.4.3, the report stated that the most popular grouts for construction in the United Kingdom and Europe are sodium silicates and sodium aluminates and that those grouts also form the main substitutes for acrylamide and NMA-based grouts. Furthermore, it is stated that cement, microcement and bentonite grouts are also widely used because of their relatively low costs. It is also stated in point 2.4.3 that acrylamide and NMA grouts are used in only 1% of cases and that in most situations there are already substitutes for those products. According to point 2.4.4 of the report, which concerns comparative risk implications, the main substitutes for acrylamide and NMA grouts are (i) polyurethanes for use in sewer and manhole repairs and (ii) cements, microcements and silicates for use in construction applications. In addition, the impact assessment takes account of the fact that substitutes might be less effective. As regards, more particularly, the use of acrylamide for sealing micro-cracks or salt damp, the Commission’s letter of 30 July 2010 to the first applicant shows that, in its view, siloxanes and epoxy resins may be used as substitutes.
94 Furthermore, in point 1.1 of the consultancy report, which concerns the background to the study, and in footnote 18 to that report, it was stated that the report did not attempt to address comprehensively risks to human health, since those risks were to be examined separately by a United Kingdom authority.
95 The applicants’ argument relating to the consultancy report must therefore be rejected.
96 Concerning, second, the applicants’ argument concerning less restrictive measures involving improved personal protective equipment, they refer to a report from the United States Environmental Protection Agency (the EPA), adopted in 2002, in which the EPA concluded that it was not necessary to prohibit the use of acrylamide-based grouts in order to protect the health of grouters. In that connection, the Court observes that the applicants have not argued that the EPA’s scientific and technical evaluation of acrylamide was different from that of the Commission. Risk management is not, however, subject to the same principles and rules in the United States as it is in the EU since the legal and political frameworks are different. The fact that the EPA did not conclude that it was necessary to ban the use of acrylamide grouts thus does not establish that the Commission made a manifest error in its assessment, which was founded on the conclusions of TCNES and the Scientific Committee on Toxicity, Ecotoxicity and the Environment. Moreover, it is apparent from the EPA report that it abandoned in 2001 its initial proposal, dating from 1991, for a ban on the manufacture, import, distribution and use of acrylamide and NMA grouts solely because effective and affordable personal protective equipment was allegedly available and it was expected that workers who used that equipment correctly would be adequately protected when using those products. However, the risks that needed to be reduced according to the EU risk assessment report and Recommendation 2004/394 concerned not only risks for workers but also risks for the aquatic environment and for humans exposed to acrylamide via their environment. The improvement of personal protective equipment would thus not have been appropriate in relation to the objective pursued by the contested regulation. In that connection, it should also be noted that, so far as risks to workers were concerned, the strategy for limiting risks provided for in Recommendation 2004/394 no longer envisaged adopting restrictions (see paragraph 6 above). The applicants’ argument must therefore be rejected.
97 Finally, the applicants refer to the first applicant’s letter of 11 June 2010 with regard to the introduction of specific derogations from the ban on acrylamide-based grouts in view of the absence of substitutes on the market, at least in relation to essential uses for water shut-off and rising damp. That letter does indeed state that the first applicant submitted information to the Commission on 2 February 2010 and that the Commission considered that information insufficient to justify a derogation from the restrictions proposed for grouting applications. However, it is not possible to ascertain from that letter either the content or the extent of that information. The Commission’s letter of 30 July 2010 to the first applicant does indeed show that the first applicant requested specific derogations. However, the Commission’s response to that request was that siloxanes and epoxy resins could be used as substitutes. On that basis it cannot be concluded that the contested regulation exceeds the limits of what is necessary to achieve the objective sought.
98 In view of the foregoing, it is not established that the principle of proportionality was infringed when restrictions on acrylamide were introduced in the contested regulation.
99 Consequently, the second plea must be rejected.
Third plea: infringement of the obligation to state reasons
100 The applicants submit that the Commission was in breach of its duty to state reasons since it did not explain why it referred, in the contested regulation, to a concentration of 0.1% by weight of acrylamide.
101 Under the second subparagraph of Article 296 TFEU, legal acts such as the contested regulation must state the reasons on which they are based. It is settled case-law that the statement of reasons must show clearly and unequivocally the reasoning of the institution which adopted the measure. It must, on the one hand, enable the persons concerned to understand the full significance of and the reasons for the measure at issue in order to enable them to safeguard their rights and, on the other hand, enable the EU judicature to exercise its powers of review of legality. Furthermore, the question whether a statement of reasons satisfies the requirements must be assessed with reference not only to the wording of the measure but also to its context and to the whole body of legal rules governing the matter in question (see, by analogy, Case C‑380/03 Germany v Parliament and Council [2006] ECR I‑11573, paragraphs 107 and 108 and the case-law cited). In addition, where the persons concerned are involved in the process by which a measure comes about, the requirement to state reasons may be circumscribed, since they acquire information through their involvement (Etimine, paragraph 29 above, paragraph 116).
102 In the present case, the Commission explained the reference to a concentration of 0.1% by weight of acrylamide in recital 4 to the contested regulation, according to which the limit value of 0.1% of acrylamide is included to cover other sources of free acrylamide in the grouting process such as from NMA, as indicated in Recommendation 2004/394.
103 In the part of Recommendation 2004/394 that relates to the strategy for limiting risks for human health and the environment – in which it is recommended to consider at Community level marketing and use restrictions in Directive 76/769 for the use of acrylamide in grouts for small and large-scale applications – it is stated that NMA-based grouts are also a potential source of free acrylamide in the grouting process and consideration should be given to examining the risks from this chemical.
104 Having regard to those considerations and to the procedural context in which the contested regulation was prepared, with which the applicants were familiar as is apparent from the application and the annexes thereto, the Commission did not infringe its obligation to state reasons.
105 Indeed, point 2.2.1.2 of the EU risk assessment report indicates that NMA may be partially transformed into acrylamide in two-solution grouting systems, which might lead to exposure to higher concentrations of acrylamide than expected (see paragraph 68 above). Next, it can be seen from the part of section 6 of the Commission’s impact assessment that deals with the ban on acrylamide in grouting applications that a limit value of 0.1% for acrylamide should be established since below that limit substances are usually considered to be impurities or trace contaminants that have not been deliberately added. Consequently, it is sufficiently clear from the reasons set out in the contested regulation that the concentration of 0.1% by weight of acrylamide was introduced in order to cover NMA-based grouts as well. In any event it is also apparent from the first applicant’s letter of 18 June 2010 that it had, in its capacity as the representative of the sector concerned, been involved in the process of preparing the measure for many years.
106 As regards the question whether NMA-based grouts actually fall within the scope of the restrictions covered by the contested regulation, that question concerns the merits of the reasons, which goes to the substantive legality of the act in question and which must be distinguished from the obligation to state reasons laid down in the second subparagraph of Article 296 TFEU (see, to that effect, Case C‑521/09 P Elf Aquitaine v Commission [2011] ECR I‑0000, paragraph 146 and the case-law cited). Moreover, that question has already been considered in paragraph 80 above.
107 Consequently, the third plea and thus the action in its entirety must be dismissed.
Costs
108 Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Under Article 87(4) of those Rules, the Member States which have intervened in the proceedings are to bear their own costs.
109 Since the applicants have been unsuccessful, they must be ordered to bear the costs they have incurred in the main proceedings and to pay those incurred by the Commission, in accordance with the form of order sought by the latter. The costs relating to the proceedings for interim measures shall be paid by the third applicant, in accordance with the form of order sought by the Commission. The Kingdom of the Netherlands shall bear its own costs.
On those grounds,
THE GENERAL COURT (Seventh Chamber)
hereby:
1. Dismisses the action;
2. Orders Polyelectrolyte Producers Group, SNF SAS and Travetanche Injection SPRL to bear the costs they have incurred in the main proceedings and to pay those incurred by the European Commission;
3. Orders Travetanche Injection to pay the costs relating to the proceedings for interim measures;
4. Orders the Kingdom of the Netherlands to bear its own costs.
Dittrich | Wiszniewska-Białecka | Prek |
Delivered in open court in Luxembourg on 1 February 2013.
[Signatures]