Judgment — ECLI:EU:T:2013:107
Date: 2013-03-07
Language of the case: English
Court formation: Seventh Chamber, Extended Composition
Subject matter: Environment;Approximation of laws;Research and technological development;Public health;REACH
Procedure: Action for annulment - unfounded
Origin: Belgium;Czechia;Germany;Spain

summary parameters, as these tests measure the properties of the whole substance but do not provide information on its constituents. Accordingly, even if in such a test the whole substance might appear to be readily biodegradable, the presence of non-biodegradable constituents cannot be ruled out. According to the ECHA, similar difficulties are encountered in bioaccumulation and toxicity testing for certain UVCB substances. The physical form of such a substance may impede the release of its individual constituents to any significant extent if the substance is tested as such. Consequently, as regards bioaccumulation and toxicity testing, accumulation and toxicity might not be detected in testing but, in reality, after a certain time PAH constituents will be released into the environment. 114 The criticisms voiced by the applicants of those scientific considerations are not such as to demonstrate that the scientific reasons put forward by the ECHA are vitiated by a manifest error. 115 First, the applicants’ argument that the fact that a substance may break down into its constituents is addressed in the chemical safety assessment which must be carried out as part of the registration of the substance under Article 14 of Regulation No 1907/2006 does not contradict the assessment of the ECHA but merely indicates that decomposition must also, where appropriate, be taken into account in the course of another procedure under Regulation No 1907/2006 (in that regard, see also paragraph 106 above). 116 Second, the applicants’ argument that, contrary to what the ECHA alleges, most test methods can be performed with UVCBs, or where existing methods are not appropriate, the ‘weight of evidence’ approach can be used, is not substantiated by the scientific data at all and is thus not sufficient for the rejection of the approach followed by the ECHA as vitiated by a manifest error. 117 In the third place, as regards the application of the 0.1% threshold as a factor entailing the identification of the substance in question on the basis of its constituents, the applicants argue that, although they do not dispute the application of such a threshold in general, the criterion of a 0.1% threshold is not found in Annex XIII to Regulation No 1907/2006. Furthermore, they state that, while it is true that there are instruments which contain references to 0.1% as being in some instances a threshold over which a hazard classification will apply, that threshold may vary from 0.1% to 1%, depending on the hazard. 118 While it is true that no concentration threshold is provided for in Annex XIII to Regulation No 1907/2006, it must be observed that the application of such a threshold as a factor entailing identification of the substance in question on the basis of its constituents does not require that threshold to be specified in that annex. 119 Moreover, it appears from Regulation No 1907/2006 that the threshold of 0.1% has been applied by European Union legislation several times for the classification of a preparation on the basis of the substances contained in it. Article 31(3)(b) of Regulation No 1907/2006 imposes an information obligation on suppliers of a preparation if it contains a substance with PBT or vPvB properties in accordance with the criteria set out in Annex XIII in a concentration of 0.1% or more. Moreover, Article 14(2)(f) of that regulation requires an undertaking to make a chemical safety assessment of a preparation if the concentration of the substance in the preparation which meets the criteria in Annex XIII of the regulation is 0.1% or more. What is more, Article 56(6) of Regulation No 1907/2006 provides that the authorisation obligation is not applicable inter alia to the use of substances meeting the criteria set out in Article 57(d) and (e) of that regulation, where they are contained in preparations below a concentration limit of 0.1%. 120 Since the classification of a substance on the basis of the properties of its constituents appears comparable to the classification of a preparation on the basis of the properties of its substances (see paragraph 110 above) and the applicants do not dispute the application of the 0.1% threshold in general, it cannot be concluded that the contested decision is vitiated by a manifest error in that the 0.1% threshold was applied as a factor entailing the identification of the substance at issue on the basis of its constituents. 121 In the light of all the foregoing considerations, it must be concluded that anthracene oil was not identified as having PBT and vPvB properties solely because a constituent of that substance has a certain number of PBT and vPvB properties, but that the proportion in which such a constituent is present and the chemical effects of the presence of such a constituent were also taken into account (see paragraph 105 above). The applicants’ argument concerning the identification of anthracene oil as having PBT and vPvB properties on the basis of its constituents present in a concentration of at least 0.1% does not demonstrate that the contested decision is vitiated by a manifest error. 122 The first and second submissions must therefore be dismissed. – The third submission concerning the identification of the constituents of the substance at issue as having PBT or vPvB properties 123 The applicants observe, essentially, that the assessment of the constituents of the substance at issue is not a sufficient basis for its identification as having PBT or vPvB properties since those constituents have not been individually identified as having PBT or vPvB properties in a separate ECHA decision based on a thorough assessment for that purpose. 124 To recapitulate, anthracene oil was identified as having PBT and vPvB properties because it had two constituents which had to be considered to have PBT and vPvB properties, namely phenanthrene, which met the criteria to be considered to have vPvB properties and anthracene, which met the criteria to be considered to have PBT properties (see paragraph 102 above). 125 In the first place, the question arises whether the identification of the substance at issue as a substance of very high concern because of its PBT and vPvB properties, on the basis of the PBT and vPvB properties of its constituents, requires that those constituents must themselves have first been identified as having PBT and vPvB properties by a separate decision of the ECHA. In that regard, it must be observed that Article 57(d) and (e) and Article 59 of Regulation No 1907/2006 provide only that the criteria set out in Annex XIII to the regulation must be met. Moreover, the implementation of the procedure set out in Article 59 of Regulation No 1907/2006 for the independent identification of the relevant constituents of anthracene oil as having PBT and vPvB properties, does not bring any added value to the identification of the substance at issue as a substance of very high concern because of its PBT and vPvB properties on the basis of the PBT and vPvB properties of its constituents. In the context of the dossier prepared in accordance with Annex XV to that regulation concerning the substance at issue, a comparison should also have been made of the information available and the criteria under Annex XIII to the regulation. The applicants’ argument on that point must therefore be rejected. 126 Second, the applicants dispute the contention that the identification of the constituents at issue, other than anthracene, as constituents with PBT or vPvB properties is based on a thorough assessment. As regards anthracene, it is common ground that it was identified as a substance of very high concern on the basis of its PBT properties. According to the case‑law cited in paragraphs 98 and 99 above, it is therefore appropriate to examine whether the contested decision is vitiated by a manifest error in that respect. 127 The applicants refer, in support of their argument, to the comments made by the group of leading oil companies carrying out research on environmental issues relevant to the oil industry during the consultation period on the dossier prepared pursuant to Annex XV to Regulation No 1907/2006 for the substance at issue. A report analysing the bioaccumulation properties of 15 PAHs is attached to those comments. According to those comments, since the working group of the ECB responsible had not agreed on the PBT or vPvB properties of those constituents, it is premature and inappropriate to draw definitive conclusions for them in the dossier prepared in accordance with Annex XV to the regulation. According to that report, the available evidence does not support the broad, tentative conclusions included in that dossier that those constituents meet bioaccumulative or very bioaccumulative criteria, since reliable laboratory data demonstrate only a low bioaccumulation potential of those constituents. 128 In that regard, it must be observed that the applicants’ argument is essentially confined to a reference to the submission of comments and a report drawn up in the course of the procedure provided for by Article 59(4) of Regulation No 1907/2006. Anthracene oil was identified as a substance of very high concern on the basis of the analysis in the dossier prepared by the Federal Republic of Germany and approved by the Member State Committee on 2 December 2009, pursuant to Article 59(8) of that regulation, in the light of those comments and that report. Section 6 of that dossier assesses in detail the PBT and vPvB properties respectively of the relevant constituents of the substance at issue. In the light of the foregoing observations, the general reference to the fact that the working group of the ECB responsible, which, in any case, no longer exists under the regime of Regulation No 1907/2006, did not agree on the PBT and vPvB properties of the constituents at issue, on the one hand, and to the allegedly insufficient evidence, without disclosing which aspect of the analysis in that dossier is incorrect, on the other, is not sufficient to support a conclusion that the contested decision is vitiated by a manifest error. 129 It follows that the third submission must be rejected. 130 Consequently, the fourth plea must be rejected in its entirety. The fifth plea in law, alleging a breach of the principle of proportionality 131 The applicants submit that the contested decision does not respect the principle of proportionality. That decision is not suitable for the attainment of the objective of Regulation No 1907/2006, which is to ensure a high level of protection of human health and the environment. The applicants observe in that regard that the substances which can be used to replace anthracene oil also have PBT or vPvB properties. According to the applicants, the ECHA could have taken other appropriate and less onerous measures, namely the application of risk management measures on the basis of the chemical safety assessment in the registration dossier prepared by the applicants under Article 14 of Regulation No 1907/2006 or the presentation of a dossier concerning the substance at issue under Title VIII of that regulation. 132 According to settled case‑law, the principle of proportionality, which is one of the general principles of European Union law, requires that measures adopted by European Union institutions 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 98 above, paragraph 124 and the case‑law cited). 133 With regard to judicial review of the conditions referred to in the previous paragraph, it must be acknowledged that the ECHA has 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, to that effect, Etimine, paragraph 98 above, paragraph 125 and the case‑law cited). 134 In the present case, it is apparent from Article 1(1) of Regulation No 1907/2006 that the regulation seeks 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. Regard being had to recital 16 of the preamble to the regulation, it must be stated that the legislature established, as the main objective, the first of those three objectives, namely to ensure 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). As regards, more specifically, the aim of the authorisation procedure, Article 55 of the regulation provides that it seeks essentially to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. 135 In the first place, as regards the applicants’ argument that the contested decision is not appropriate for achieving the objectives pursued by Regulation No 1907/2006, it must be recalled that the contested decision identified anthracene oil as a substance of very high concern as a result of the procedure referred to in Article 59 of the regulation. Where a substance is identified as being of very high concern economic operators are subject to information obligations (see paragraph 33 above). 136 With regard to the objective of protecting human health and the environment, it must be stated from the outset that the identification of a substance as being of very high concern serves to improve information for the public and professionals as to the risks and dangers incurred and that, consequently, such identification must be regarded as a means of enhancing that protection (see, to that effect, S.P.C.M. and Others, paragraph 134 above, paragraph 49). 137 As regards, more specifically, the applicants’ argument that the contested decision is inappropriate in that regard since the substances capable of being used to replace the substance at issue also have PBT or vPvB properties, it must be observed that the contested decision does not entail a prohibition on placing anthracene oil on the market thereby obliging the operators concerned to use alternative substances. Such a consequence only follows, under Article 56 of Regulation No 1907/2006, for substances included in Annex XIV to that regulation, that is to say, the list of substances subject to authorisation. Moreover, although Article 59(1) of that regulation provides that the identification procedure applies for the purpose of eventual inclusion in Annex XIV to that regulation, it is apparent from the procedure set out in Article 58 of Regulation No 1907/2006 in that regard that the inclusion of a substance in the candidate list of substances does not automatically entail its inclusion in Annex XIV to that regulation. Under Article 58(1) and (3) of that regulation, the ECHA is to recommend priority substances to be included in that annex taking into account the opinion of the Member State Committee and specifying for each substance inter alia the uses or categories of uses exempted from the authorisation requirement. A substance may be subject to authorisation only as a result of a decision by the Commission to include that substance in Annex XIV. 138 Moreover, Regulation No 1907/2006 lays down, for the purpose of the identification of substances of very high concern, a procedure designed to subject those substances progressively to the authorisation procedure. In that regard, recital 77 of the preamble to the regulation states that, in view of workability and practicality considerations, both as regards natural or legal persons, who have to prepare application files and take appropriate risk management measures, and as regards the authorities, who have to process authorisation applications, only a limited number of substances should be subjected to the authorisation procedure at the same time. Accordingly, it is possible that, in the course of that progressive approach, the alternative substances referred to by the applicants might also be subject to the identification procedure set out in Article 59 of Regulation No 1907/2006. 139 The applicants’ argument that the identification of anthracene oil as a substance of very high concern is not appropriate for the achievement of the objectives pursued by Regulation No 1907/2006 since the risks of exposure to that substance are low because anthracene oil is principally used as an intermediate in the production of carbon black. Since anthracene oil constitutes an intermediate, the substance is exempted from Title VII of Regulation No 1907/2006, pursuant to Article 2(8) of that regulation and is thus not concerned by the information obligations entailed by the identification of a substance as being of very high concern under Article 59 of that regulation. Moreover, it must be held that the applicants’ argument is ineffective since it follows from it that the substance at issue is not used exclusively as an intermediate. 140 Consequently, the applicants’ argument concerning the allegedly inappropriate nature of the contested decision must be rejected. 141 In the second place, the applicants argue that the contested decision exceeds the limits of what is necessary to achieve the objectives pursued, given that the application of risk management measures or the presentation of a dossier pursuant to Annex XV to Regulation No 1907/2006 for restrictions concerning the substance at issue would also serve to provide a high level of protection of human health and of the environment, but would be less onerous. 142 First, as regards risk management measures, the applicants refer to the obligations set out in Article 14 of Regulation No 1907/2006. Under Article 14(1), they must carry out a chemical safety assessment and complete a chemical safety report for the substance at issue. According to Article 14(3)(d), the chemical safety assessment of a substance has to include a PBT and vPvB assessment. If that assessment leads to the conclusion that a substance has PBT or vPvB properties, the applicants have to carry out an exposure assessment and risk characterisation concerning the uses identified, pursuant to Article 14(4). Moreover, under Article 14(6) of Regulation No 1907/2006, the applicants must identify and apply the appropriate measures to adequately control the risks. As that assessment was not yet available at the time of the identification of the substance at issue as being of very high concern by the contested decision, the ECHA could have decided to wait for the presentation of the assessment in order to examine the chemical safety report and the proposed risk management measures, rather than identifying the substance at issue as being of very high concern. 143 There is no evidence in Regulation No 1907/2006 that the legislature intended to make the identification procedure carried out pursuant to Article 59 of that regulation, which is part of the authorisation procedure for a substance set out in Title VII of that regulation, subject to the registration procedure provided for in Title II of that regulation, which covers the obligations set out in Article 14 of that regulation. It is true that those obligations also serve to improve information for the public and professionals on the dangers and risks of a substance. However, since the substances registered should be allowed to circulate on the internal market, as is apparent from recital 19 of the preamble to Regulation No 1907/2006, the objective of the authorisation procedure, of which the identification procedure set out in Article 59 of that regulation is part, is, inter alia, progressively to replace substances of very high concern with other appropriate substances or technologies, where they are economically or technically viable (see paragraph 134 above). Moreover, as is apparent from recital 69 of the preamble to Regulation No 1907/2006, the legislature wished to pay careful attention to substances of very high concern. 144 Consequently, contrary to what the applicants allege, the risk management measures proposed under Article 14(6) of Regulation No 1907/2006 do not constitute appropriate measures for the achievement of the objectives pursued by that regulation as regards the treatment of substances of very high concern and are thus not less onerous measures in the present case. 145 Finally, as regards the applicants’ argument that the ECHA could have waited, before identifying anthracene oil as a substance of very high concern, for the presentation of the registration dossier on the substance at issue containing the chemical safety assessment, because such a dossier allegedly constitutes the best source of information, it is sufficient to note that the identification was made on the basis of information contained in the dossier concerning the substance at issue unanimously approved by the Member State Committee (see paragraph 101 above). That committee did not find that there was no information concerning the validity and relevance of the data. Furthermore, as registration of the substance at issue was required, under Article 23(1) of Regulation No 1907/2006, to take place only by 1 December 2010, thus two and a half years from the date from which the authorisation procedure was applicable pursuant to Article 141(2) of that regulation, that is to say, 1 June 2008, an alleged duty to wait for the presentation of the registration dossier at issue would damage the effectiveness of Regulation No 1907/2006. 146 Second, as regards the restriction measures, the applicants argue that a dossier concerning the proposal of such measures pursuant to Annex XV to Regulation No 1907/2006 must include available information about the existence of suitable alternatives, including information on the risks to human health and the environment related to the manufacture and use of these alternatives, availability and the technical and economical availability. Such a proposal, which would therefore have been based on similar parameters to a dossier for the purpose of identifying a substance as being of very high concern, would have avoided the negative consequences of such identification and led to the same result as regards the objectives of Regulation No 1907/2006. 147 In that regard, it must be observed that the mere fact that a substance appears in the candidate list of substances does not prevent that substance from being subject to restrictions rather than an authorisation. As is apparent from Article 58(5) and Article 69 of Regulation No 1907/2006, the Commission or a Member State may always propose that the manufacture, the placing on the market or the use of a substance be managed by restrictions rather than by an authorisation. 148 Furthermore, as is apparent from Annex XVII to Regulation No 1907/2006, restrictions, adopted in accordance with the procedure set out in Title VIII of that regulation, applicable to the manufacture, the placing on the market and the use of certain dangerous substances and certain preparations and dangerous articles, may range from specific conditions imposed on the manufacture or the placing on the market of a substance to a total ban on the use of a substance. Even if restriction measures are also appropriate for the achievement of the objectives pursued by that regulation, they thus do not constitute, as such, less onerous measures compared with the identification of a substance which does not entail information obligations. 149 Moreover, in so far as the applicants argue that the information contained in the dossier concerning a proposal for a restriction measure pursuant to Annex XV to Regulation No 1907/2006 demonstrates that the identification of the substance at issue was not necessary, it is sufficient to point out that such identification was carried out in accordance with the procedure set out in Article 59 of Regulation No 1907/2006, which constitutes a different procedure from that set out in Title VIII of the same regulation (see paragraph 147 above). 150 In the light of the foregoing considerations, it cannot be concluded that the contested decision breached the principle of proportionality. 151 Consequently, the fifth plea in law and, therefore, the action in its entirety must be dismissed. Costs 152 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. 153 As the applicants have been unsuccessful, they must be ordered to pay the costs in accordance with the form of order sought by the ECHA. On those grounds, THE GENERAL COURT (Seventh Chamber, Extended Composition) hereby: 1. Dismisses the action; 2. Orders Rütgers Germany GmbH, Rütgers Belgium NV, Deza, a.s., Industrial Química del Nalón, SA and Bilbaína de Alquitranes, SA to pay the costs. Dittrich Dehousse Wiszniewska-Białecka Prek Schwarcz Delivered in open court in Luxembourg on 7 March 2013. [Signatures] * Language of the case: English.