JUDGMENT OF THE GENERAL COURT (Fifth Chamber)
7 October 2015 (*)
(Environment and protection of human health — Classification of pitch, coal tar, high-temperature, in the categories of acute aquatic toxicity and chronic aquatic toxicity — Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008 — Manifest error of assessment — Classification of a substance on the basis of its constituents)
In Case T‑689/13,
Bilbaína de Alquitranes, SA, established in Luchana-Baracaldo (Spain),
Deza, a.s., established in Valašské Meziříčí (Czech Republic),
Industrial Química del Nalón, SA, established in Oviedo (Spain),
Koppers Denmark A/S, established in Nyborg (Denmark),
Koppers UK Ltd, established in Scunthorpe (United Kingdom),
Koppers Netherlands BV, established in Uithoorn (Netherlands),
Rütgers basic aromatics GmbH, established in Castrop-Rauxel (Germany),
Rütgers Belgium NV, established in Zelzate (Belgium),
Rütgers Poland Sp. z o.o., established in Kędzierzyn-Koźle (Poland),
Bawtry Carbon International Ltd, established in Doncaster (United Kingdom),
Grupo Ferroatlántica, SA, established in Madrid (Spain),
SGL Carbon GmbH, established in Meitingen (Germany),
SGL Carbon GmbH, established in Bad Goisern am Hallstättersee (Austria),
SGL Carbon, established in Passy (France),
SGL Carbon, SA, established in La Coruña (Spain),
SGL Carbon Polska SA, established in Racibórz (Poland),
ThyssenKrupp Steel Europe AG, established in Duisburg (Germany),
Tokai erftcarbon GmbH, established in Grevenbroich (Germany),
represented by K. Van Maldegem, C. Mereu, P. Sellar and M. Grunchard, lawyers,
applicants,
supported by
GrafTech Iberica, SL, established in Navarre (Spain), represented by C. Mereu, K. Van Maldegem, P. Sellar and M. Grunchard,
intervener,
v
European Commission, represented by P.-J. Loewenthal and K. Talabér-Ritz, acting as Agents,
defendant,
supported by
European Chemicals Agency (ECHA), represented by M. Heikkilä, W. Broere and C. Jacquet, acting as Agents,
intervener,
APPLICATION for the partial annulment of Commission Regulation (EU) No 944/2013 of 2 October 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ 2013 L 261, p. 5), in so far as it classifies pitch, coal tar, high-temp. (EC No 266-028-2) as an Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) substance,
THE GENERAL COURT (Fifth Chamber),
composed of A. Dittrich (Rapporteur), President, J. Schwarcz and V. Tomljenović, Judges,
Registrar: S. Spyropoulos, Administrator,
having regard to the written procedure and further to the hearing on 10 June 2015,
gives the following
Judgment
Background to the dispute
1 The first nine applicants — Bilbaína de Alquitranes, SA, Deza, a.s., Industrial Química del Nalón, SA, Koppers Denmark A/S, Koppers UK Ltd, Koppers Netherlands BV, Rütgers basic aromatics GmbH, Rütgers Belgium NV and Rütgers Poland Sp. z o.o. (‘the first group of applicants’) — are suppliers of pitch, coal tar, high-temp. (EC No 266-028-2; ‘CTPHT’) in the European Union. The nine other applicants — Bawtry Carbon International Ltd, Grupo Ferroatlántica, SA, SGL Carbon GmbH (Germany), SGL Carbon GmbH (Austria), SGL Carbon, SGL Carbon, SA, SGL Carbon Polska SA, ThyssenKrupp Steel Europe AG and Tokai erftcarbon GmbH — are downstream users of CTPHT for the manufacture of aluminium, carbon, graphite, ferro-alloys or steel.
2 According to the description in Tables 3.1 and 3.2 in Annex VI to 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, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1), CTPHT is the residue from the distillation of high-temperature coal tar, a black solid with an approximate softening point from 30 ºC to 180 ºC, composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons. This substance is among the substances of unknown or variable composition, complex reaction products or biological materials, because it cannot be fully identified by its chemical composition. CTPHT is used mainly to produce electrode binders for the aluminium and steel industry. It is also used to produce refractories. Minor uses are clay targets, coating for corrosion protection, kerosene-resistant airfield applications, road construction, roofing and briquetting.
3 In September 2010, pursuant to Article 37 of Regulation No 1272/2008, the Kingdom of the Netherlands submitted a dossier to the European Chemicals Agency (ECHA) proposing that CTPHT should be classified as Carcinogenic 1A (H350), Mutagenic 1B (H340), Toxic for reproduction 1B (H360FD), Aquatic Acute 1 (H400), and Aquatic Chronic 1 (H410).
4 On 1 October 2010, the dossier submitted to ECHA by the Kingdom of the Netherlands was made publicly available on the ECHA website and the parties concerned were invited to submit their observations in that regard.
5 After having received observations on the dossier in question, in particular from the first group of applicants via the Coal Chemicals Sector Group to which they belong, ECHA referred the dossier to its Risk Assessment Committee (‘RAC’), referred to in Article 76(1)(c) 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).
6 On 21 November 2011, the RAC adopted its opinion on CTPHT, confirming the proposal submitted by the Kingdom of the Netherlands. That opinion was accompanied by a background document containing the RAC’s detailed analysis (‘the background document’) and a document containing the answers of the Kingdom of the Netherlands to the observations submitted on the dossier which it had drawn up.
7 With regard to the classification of CTPHT as a substance having aquatic toxicity, the RAC considered in its opinion, as the Kingdom of the Netherlands had proposed in its dossier submitted to ECHA, that this could not be based on data obtained in studies using the Water-Accommodated Fraction approach (‘the WAF approach’). The reasons stated by the RAC for that finding were, first, that the data had been obtained in the absence of ultraviolet (UV) irradiation, even though certain polycyclic aromatic hydrocarbon (‘PAH’) constituents of CTPHT are phototoxic and, secondly, that the studies concerned had been carried out with only a single loading. The RAC therefore took the view, as the Kingdom of the Netherlands had proposed in its dossier submitted to ECHA, that the classification of that substance was to be based on an alternative approach, namely to regard CTPHT as a mixture. According to that approach, the 16 PAH constituents of CTPHT, which have been defined as priority substances by the United States Environmental Protection Agency (EPA), and for which sufficient effect and exposure data were available (‘the 16 PAH constituents’), were analysed separately in accordance with their aquatic toxicity effects. By applying a method consisting in finding the sum of the results obtained by the attribution of multiplication factors to the different PAHs in order to attach more weight to the highly toxic constituents of CTPHT (the summation method), that analysis showed, according to the RAC’s opinion, that CTPHT had to be classified as Aquatic Acute 1(H400) and Aquatic Chronic 1 (H410).
8 On 2 October 2013, on the basis of the RAC’s opinion, the European Commission adopted Regulation (EU) No 944/2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 (OJ 2013 L 261, p. 5; ‘the contested regulation’). In accordance with Article 1(2)(a)(i) and 1(2)(b)(i) of the contested regulation, read together with Annexes II and IV thereto, CTPHT was classified as Carcinogenic 1A (H350), Mutagenic 1B (H340), Toxic for reproduction 1B (H360FD), Aquatic Acute 1 (H400), and Aquatic Chronic 1 (H410). Pursuant to Article 3(3) of the contested regulation, that classification is to apply from 1 April 2016. According to recital 5 in the preamble to the contested regulation, a longer transition time before the harmonised classification has to be applied should be foreseen as regards CTPHT, in order to allow operators to comply with the obligations resulting from the new harmonised classification for substances classified as very toxic to aquatic organisms which may cause long-term effects in the aquatic environment, in particular with those set out in Article 3 of Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ 2008 L 260, p. 13) and Annex III thereto.
Procedure and forms of order sought
9 By application lodged at the Court Registry on 20 December 2013, the applicants brought the present action.
10 By letter registered at the Court Registry on 30 April 2014, ECHA applied for leave to intervene in support of the form of order sought by the Commission. By letter lodged at the Court Registry on 5 May 2014, GrafTech Iberica, SL, applied for leave to intervene in support of the form of order sought by the applicants. Those applications were granted, after hearing the main parties, by orders of the President of the Fifth Chamber of the General Court of 11 July 2014.
11 The interveners lodged their statements in intervention on 10 October 2014. By documents lodged at the Court Registry on 9 and 10 December 2014 respectively, the applicants and the Commission submitted their observations on those statements in intervention.
12 On hearing the report of the Judge-Rapporteur, the Court (Fifth Chamber) decided to open the oral procedure.
13 By way of measures of organisation of procedure pursuant to Article 64 of its Rules of Procedure of 2 May 1991, the Court requested the parties to reply to a number of questions. The main parties and ECHA complied with that request within the period prescribed. GrafTech Iberica did not respond within the period prescribed.
14 The parties presented oral argument and answered the questions put to them by the Court at the hearing on 10 June 2015.
15 The applicants and GrafTech Iberica claim that the Court should:
– declare the action admissible and well founded;
– partially annul the contested regulation in so far as it classifies CTPHT as an Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) substance;
– order the Commission to pay the costs.
16 The Commission contends that the Court should:
– dismiss the action as unfounded;
– order the applicants to pay the costs.
17 ECHA contends that the Court should dismiss the application as unfounded.
Law
18 In support of their action, the applicants put forward three pleas in law alleging (i) breach of Regulation No 1907/2006 and Regulation No 1272/2008 and infringement of the principle of equal treatment; (ii) a manifest error of assessment; and (iii) failure to respect the principle of transparency and the rights of the defence.
19 It seems appropriate to examine first of all the second plea, alleging a manifest error of assessment.
20 The second plea comprises four parts. The applicants, supported by GrafTech Iberica, submit that the Commission committed a manifest error of assessment, first, by requiring UV irradiation testing, especially without having standardised test methods established and without taking into account the inert inherent properties of CTPHT, and, secondly, by applying the summation method to CTPHT. Thirdly, they submit that the Commission also committed a manifest error of assessment and breached Regulation No 1907/2006 and Regulation No 1272/2008 by directly including the classification and the multiplication factors for the PAHs in the dossier relating to CTPHT, in the absence of specific dossiers relating to the PAHs and a public consultation and without properly evaluating the studies which the applicants had invoked. Fourthly and lastly, according to the applicants, the Commission committed a manifest error of assessment by failing to take account of the information provided by the first group of applicants.
21 In this regard, the applicants, supported by GrafTech Iberica, have requested the Court to commission an expert’s report, pursuant to Article 65(d) and Article 70 of the Rules of Procedure of 2 May 1991, in order to assist the Court in verifying whether the Commission had committed a manifest error of assessment in the exercise of its discretion. However the Court considers that, in the present case, it has sufficient information available to it and is therefore able to understand all the relevant scientific issues in order to decide whether the Commission’s assessment was vitiated by a manifest error. Consequently, there is no need to grant that request for the commissioning of an expert’s report.
22 The Court considers it appropriate to examine, first of all, the second part of the second plea in law, alleging a manifest error of assessment as a result of the application of the summation method.
23 As a preliminary point, it should be pointed out that, in accordance with settled case-law, where 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, review by the EU Courts must be limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context, the EU Courts cannot substitute their assessment of scientific and technical facts for that of the authorities on which alone the FEU Treaty has conferred that task (judgment of 21 July 2011 in Etimine, C‑15/10, ECR, EU:C:2011:504, paragraph 60; order of 27 March 2014 in Polyelectrolyte Producers Group and Others v Commission, C‑199/13 P, EU:C:2014:205, paragraph 26; and judgment of 7 March 2013 in Bilbaína de Alquitranes and Others v ECHA, T‑93/10, ECR, EU:T:2013:106, paragraph 76).
24 Nevertheless, it must be stated that the broad discretion of the EU authorities, which implies limited judicial review of its exercise, applies not only to the nature and scope of the measures to be taken but also, 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 Courts 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 which the act was intended to regulate (judgments of 8 July 2010 in Afton Chemical, C‑343/09, ECR, EU:C:2010:419, paragraphs 33 and 34, and Bilbaína de Alquitranes and Others v ECHA, cited in paragraph 23 above, EU:T:2013:106, paragraph 77).
25 The applicants, supported by GrafTech Iberica, submit that the Commission committed a manifest error of assessment by classifying CTPHT as Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) in that it applied the summation method to that substance. In their view, the application of that method and the treatment of CTPHT as a multi-component mixture were based on the assumption that all of the PAHs present in CTPHT dissolved in water and were available to aquatic organisms, therefore becoming a potential source of emissions into the environment. However, according to the applicants, several studies have demonstrated the low water-solubility of the PAH constituents bound in CTPHT. Moreover, they submit that CTPHT is a substance with extremely low water solubility, which therefore has low bioavailability. Given the inert inherent properties of CTPHT, it cannot be assumed that the PAH constituents of that substance are freely available to aquatic organisms. The aquatic toxicity of CTPHT therefore could not be assessed on the basis of its various PAH constituents. According to the applicants, the classification should have been based on the WAF approach used by the first group of applicants to carry out studies on the water toxicity of CTPHT.
26 It should be noted that it is apparent from point 7.1.1, entitled ‘Toxicity test results’, in the background document annexed to the RAC’s opinion, on which the Commission based the classification of CTPHT, that the WAF approach was developed in order to determine the toxicity of that substance and that there were data in that respect based on different test solution preparation methods in the absence of UV irradiation. Moreover, that point contains a summary of the toxicity data for the individual PAHs in CTPHT, which were analysed. According to point 7.6 of that document, entitled ‘Conclusion on the environmental classification and labelling’, the WAF approach is considered to be the most appropriate for the purpose of classifying CTPHT. The data obtained using that approach concerned multi-component substances considered as a whole.
27 Furthermore, it can also be seen from point 7.6 of the background document that several PAHs in CTPHT are phototoxic and that it was therefore necessary, if the WAF approach were used, to test the aquatic species in the presence of UV irradiation. However, all the data relating to the toxicity of CTPHT from the studies performed using the WAF approach were obtained in the absence of UV irradiation. According to the RAC, it was therefore impossible to draw any definitive conclusions on the aquatic classification of CTPHT on the basis of the studies conducted using the WAF approach. In view of those difficulties, the RAC based the environmental classification of CTPHT on an alternative approach laid down in Part 1, entitled ‘General principles for classification and labelling’, of Annex I to Regulation No 1272/2008, and CTPHT was regarded as a mixture in that respect. According to the RAC, for the classification of mixtures, two approaches are described in Regulation No 1272/2008, one based on the summation of classified components and the other based on toxicity test data. As regards CTPHT, the classification based on summation was preferred because that method also takes into account the persistence and bioaccumulation potential of the mixture. For the purposes of that classification, each individual component is classified, if possible, and the weighted content of the components classified in the same category is then added together. If that sum exceeds 25%, the whole mixture is classified in that category, as stipulated in point 4.1.3.5 of Annex I to Regulation No 1272/2008. On that basis, the 16 PAH constituents of CTPHT were analysed in order to classify them individually.
28 It must be noted that the criteria for classification in the categories of environmental hazards are set out in Part 4, entitled ‘Environmental hazards’, of Annex I to Regulation No 1272/2008. Point 4.1.1.1 of that annex, entitled ‘Definitions’, states, in subparagraph (a), that ‘“acute aquatic toxicity” means the intrinsic property of a substance to be injurious to an aquatic organism in a short-term aquatic exposure to that substance’. According to point 4.1.1.1(g) of that annex, ‘“chronic aquatic toxicity” means the intrinsic property of a substance to cause adverse effects to aquatic organisms during aquatic exposures which are determined in relation to the life-cycle of the organism’. It follows that, in order to take the view that a substance falls within the categories of acute aquatic toxicity or chronic aquatic toxicity, that substance — and not merely its constituents — must satisfy the classification criteria.
29 However, as the constituents of a substance are an integral part of that substance, it cannot simply be held that the Commission committed a manifest error of assessment in taking the view that the substance at issue fell within the categories of acute aquatic toxicity or chronic aquatic toxicity because some of its constituents fell within those categories. Such a conclusion would fail to take adequate account of the objective pursued by Regulation No 1272/2008, set out in Article 1(1) thereof and recital 1 in the preamble thereto, which is to ensure a high level of protection of human health and the environment, as well as the free movement of chemical substances, mixtures and certain specific articles, while enhancing competitiveness and innovation. In addition, it is apparent from the first subparagraph of Article 10(1) of that regulation that the legislature recognised the principle that a substance with certain properties which is present in another substance may lead to the classification of the latter as having those properties. That provision provides that specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous. However, it cannot be held that, merely because a constituent of a substance has a certain number of properties, the substance itself also has them, but, rather, the proportion in which that constituent is present and the chemical effects of such presence must be considered (see, to that effect, judgment of 26 September 1985 in Caldana, 187/84, ECR, EU:C:1985:374, paragraph 17; order of 22 May 2014 in Bilbaína de Alquitranes and Others v ECHA, C‑287/13 P, EU:C:2014:599, paragraph 36; and judgment in Bilbaína de Alquitranes and Others v ECHA, cited in paragraph 23 above, EU:T:2013:106, paragraphs 83 and 87).
30 In the present case, it must be held that the Commission committed a manifest error of assessment in that, by classifying CTPHT as an Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) substance on the basis of its constituents, it failed to comply with its obligation to take into consideration all the relevant factors and circumstances so as to take due account of the proportion in which the 16 PAH constituents are present in CTPHT and their chemical effects.
31 According to point 7.6 of the background document, for the purpose of the classification of CTPHT on the basis of its constituents, it was assumed that all of the PAHs present in CTPHT dissolved in the water phase and were thus available to aquatic organisms. It is also mentioned that this assumption would likely give an overestimation of the toxicity of CTPHT and that, since the composition of the WAF was uncertain, that toxicity estimate could be regarded as the worst case scenario.
32 However, neither the Commission nor ECHA was able to establish before the Court that, in basing the classification of CTPHT as an Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) substance on the assumption that all of the PAHs present in that substance dissolved in the water phase and were thus available to aquatic organisms, the Commission took into consideration the fact that, according to point 1.3 of the background document, entitled ‘Physiochemical properties’, the constituents of CTPHT were released from CTPHT only to a limited extent and that that substance was very stable.
33 First, neither the RAC’s opinion on CTPHT nor the background document contains any reasoning which demonstrates that, in assuming that all of the PAHs present in that substance dissolve in the water phase and are available to aquatic organisms, account was taken of the low water solubility of CTPHT. Moreover, in response to a written question from the Court, the Commission and ECHA were able to demonstrate only that the water solubility of 16 PAH constituents, considered in isolation, had been taken into account during the classification procedure of CTPHT. In addition, in response to a question from the Court at the hearing, the Commission and ECHA merely indicated that it had been assumed that all of the PAHs in CTPHT dissolved in water inasmuch as the examination of the aquatic toxicity of that substance had been conducted on the basis of its constituents. Such reasoning does not, however, establish that the low solubility of that substance was taken into consideration.
34 Secondly, it must be noted that, according to point 1.3 of the background document, the highest rate of water solubility of CTPHT in relation to a loading was 0.0014% at maximum. Given the low water solubility of CTPHT, the Commission has in no way demonstrated that it could base the classification in question of that substance on the assumption that all of the PAHs present in CTPHT dissolved in the water phase and were available to aquatic organisms. It is apparent from Table 7.6.2 in the background document that the 16 PAH constituents of CTPHT constitute 9.2% of that substance. By assuming that all of those PAHs dissolve in water, the Commission therefore, in essence, based the classification in question on the assumption that 9.2% of CTPHT could dissolve in water. However, as can be seen from point 1.3 of the background document, such a value is not realistic, given that the maximum rate is 0.0014%.
35 Consequently, the second part of the present plea in law must be upheld.
36 Having regard to the foregoing, and without it being necessary to rule on the other parts of the present plea in law or on the other pleas in law put forward by the applicants, the action must be upheld and the contested regulation must be partially annulled in so far as it classifies CTPHT as an Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) substance.
Costs
37 Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. In accordance with Article 138(3) of those Rules, the Court may order an intervener other than the Member States, the institutions, the States other than the Member States which are parties to the EEA Agreement and the EFTA Surveillance Authority to bear its own costs. Since the Commission has been unsuccessful, it must be ordered to bear its own costs and to pay those of the applicants and GrafTech Iberica, in accordance with the forms of order sought by the latter. ECHA must be ordered to bear its own costs.
On those grounds,
THE GENERAL COURT (Fifth Chamber)
hereby:
1. Annuls Commission Regulation (EU) No 944/2013 of 2 October 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures in so far as it classifies pitch, coal tar, high-temp. (EC No 266-028-2) as an Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) substance;
2. Orders the European Commission to bear its own costs and to pay those of Bilbaína de Alquitranes, SA, Deza, a.s., Industrial Química del Nalón, SA, Koppers Denmark A/S, Koppers UK Ltd, Koppers Netherlands BV, Rütgers basic aromatics GmbH, Rütgers Belgium NV, Rütgers Poland Sp. z o.o., Bawtry Carbon International Ltd, Grupo Ferroatlántica, SA, SGL Carbon GmbH (Germany), SGL Carbon GmbH (Austria), SGL Carbon, SGL Carbon, SA, SGL Carbon Polska SA, ThyssenKrupp Steel Europe AG, Tokai erftcarbon GmbH and GrafTech Iberica, SL;
3. Orders the European Chemicals Agency (ECHA) to bear its own costs.
Dittrich | Schwarcz | Tomljenović |
Delivered in open court in Luxembourg on 7 October 2015.
[Signatures]