JUDGMENT OF THE GENERAL COURT (Eighth Chamber)
9 June 2021(*)
(REACH – Establishment of a list of substances identified with a view to their eventual inclusion in Annex XIV of Regulation (EC) No 1907/2006 – Inclusion of phenanthrene on that list – Articles 57 and 59 of Regulation No 1907/2006 – Manifest error of assessment – Weight of evidence determination – Proportionality – Obligation to state reasons – Right to be heard)
In Case T‑177/19,
Exxonmobil Petroleum & Chemical BVBA, established in Antwerp (Belgium), represented by A. Kołtunowska and A. Bartl, lawyers,
applicant,
supported by
European Petroleum Refiners Association, established in Brussels (Belgium), represented by J.-P. Montfort and T. Delille, lawyers,
intervener,
v
European Chemicals Agency (ECHA), represented by W. Broere, C. Buchanan and M. Heikkilä, acting as Agents, and by S. Raes, lawyer,
defendant,
supported by
French Republic, represented by A.-L. Desjonquères, E. Leclerc, T. Stehelin and W. Zemamta, acting as Agents,
intervener,
APPLICATION under Article 263 TFEU seeking the annulment of ECHA Decision ED/88/2018 of 19 December 2018, in so far as it places phenanthrene on the list of substances identified as being of very high concern provided for in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, corrigendum OJ 2007 L 136, p. 3),
THE GENERAL COURT (Eighth Chamber),
composed of J. Svenningsen, President, T. Pynnä and J. Laitenberger (Rapporteur), Judges,
Registrar: B. Lefebvre, Administrator,
having regard to the written part of the procedure and further to the hearing on 10 November 2020,
gives the following
Judgment
Background to the dispute
1        Phenanthrene is a polycyclic aromatic hydrocarbon (PAH) composed of three fused aromatic rings. Phenanthrene is not produced intentionally but together with other PAHs as a constituent of substances of unknown or variable composition, complex reaction products or biological materials (called UVCB substances) derived from coal and petroleum.
2        On 2 December 2009, the Member State Committee of the Chemicals Agency (ECHA) (‘the MSC’) agreed to the identification of coal tar pitch, high temperature (‘CTPHT’) as a substance of very high concern, in particular due to its very persistent (‘vP’) and very bioaccumulative (‘vB’) properties (together, ‘vPvB properties’). That MSC agreement was based, inter alia, on the conclusion that phenanthrene met, in particular, the criterion for designation as a very persistent substance (‘vP substances’) in soil in accordance with Annex XIII (‘Annex XIII’) to 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) and 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, corrigendum OJ 2007 L 136, p. 3).
3        On the same day, the MSC also concluded, in the support document for the identification of CTPHT as a substance of very high concern due to its persistent ‘P properties’, bioaccumulative ‘B properties’ and toxic ‘T properties’ (together, ‘PBT properties’) and its carcinogenic, mutagenic or reprotoxic properties (‘the CTPHT Support Document’), that phenanthrene was a vP substance in soil.
4        In June 2017, the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA) (Federal Institute for Occupational Health and Safety, Germany) published a conclusion document on the analysis of the best risk management option for seven PAHs, including phenanthrene. That document recommended that phenanthrene be included on the list of substances identified for inclusion in Annex XIV (‘Annex XIV’), as referred to in Article 59(1) of Regulation No 1907/2006 (‘the Candidate List’). That recommendation was based on the vPvB properties of phenanthrene, in the context of the identification of CTPHT as a substance of very high concern. However, according to ECHA, that document was not part of the formal process that led to the identification of phenanthrene as a substance of very high concern.
5        On 29 August 2018, the French Republic submitted a dossier in accordance with Annex XV to Regulation No 1907/2006 (‘Annex XV’), proposing, pursuant to Article 59(3) of that regulation, to identify phenanthrene as a substance of very high concern (‘the dossier drawn up in accordance with Annex XV’). That dossier states, inter alia, that the assessment of the vPvB properties of this substance and the conclusion that it fulfils the vPvB criteria is ‘based mainly on the information in [the CTPHT Support Document] and supplemented with information from newer studies that are presented as further evidence as they do not trigger a need to modify the conclusions taken by authorities earlier on’.
6        The dossier drawn up in accordance with Annex XV concluded that phenanthrene met the criteria for persistent and vP substances in soil. However, it did not contain any specific conclusion that phenanthrene met the criteria for vP substances in sediments in Annex XIII or in Article 57(e) of Regulation No 1907/2006.
7        On 4 September 2018, in accordance with Article 59(4) of Regulation No 1907/2006, ECHA invited all interested parties to submit their comments on the dossier drawn up in accordance with Annex XV. That public consultation ended on 19 October 2018.
8        On 19 October 2018, the European Petroleum Refiners Association (‘Concawe’) submitted observations and information, including that which the applicant, Exxonmobil Petroleum & Chemical BVBA, had provided to it, demonstrating, according to that association and the applicant, that phenanthrene did not meet the criteria for vP substances, whether in water, soil or sediment.
9        In particular, Concawe and, through it, the applicant submitted the following elements to the public consultation:
–        a 2016 study by Junker et al. (‘the Junker et al. (2016) study’) which indicates that phenanthrene is readily biodegradable under strict conditions;
–        detailed summary of a water-sediment simulation study based on the Organisation for Economic Co-operation and Development (OECD) 308 Guideline by Meisterjahn et al. (‘the Meisterjahn et al. (2018a) OECD 308 study’), which demonstrates that phenanthrene is not very persistent in sediments according to the criteria of Annex XIII, under the conditions of the study, at a standard laboratory temperature of 20 °C;
–        a Concawe poster (‘the Concawe poster’) showing half-lives in surface waters measured at a temperature between 5 °C and 22 °C, which demonstrates that the half-life of phenanthrene is not temperature dependent. The poster includes full citations of nine scientific publications that confirm the absence of any influence of temperature on the half-life of phenanthrene.
10      Subsequently, the French Republic and ECHA prepared a document (‘the RCOM document’), dated 12 December 2018, containing responses to the comments received by ECHA during the public consultation, including those from Concawe.
11      Since comments were received concerning the identification of phenanthrene, ECHA forwarded the dossier to the MSC, in accordance with Article 59(7) of Regulation No 1907/2006. In line with its working procedures on the identification of substances of very high concern, the MSC received the dossier drawn up in accordance with Annex XV, a draft MSC agreement, and a working document (‘the Phenanthrene Support Document’) containing the assessment of the intrinsic properties of that substance in support of its identification under Article 57(e) of that regulation.
12      At its 62nd meeting, held from 10 to 14 December 2018, the MSC reached unanimous agreement on the identification of phenanthrene as a substance meeting the criteria in Article 57(e) of Regulation No 1907/2006. Like the Phenanthrene Support Document, the MSC concluded that phenanthrene is very persistent (‘vP’) in sediment. By contrast, contrary to the conclusion reached by ECHA in the process of identifying CTPHT as a substance of very high concern, the MSC considered that the information now available did not allow a definitive conclusion to be drawn on the persistence of this substance in soil.
13      That identification of phenanthrene is decisively based on the results, adjusted by ECHA, of the Meisterjahn et al. (2018a) OECD 308 study. That study concluded that, at a temperature of 20 °C, the degradation half-life of phenanthrene was between 114 and 130 days for the first sediment category and between 116 and 150 days for the second sediment category. Therefore, those results alone did not allow the conclusion that phenanthrene was very persistent in sediments. However, by applying the Arrhenius equation to that study and, consequently, extrapolating those results to a temperature of 12 °C, ECHA determined a much higher degradation half-life of phenanthrene, namely 216 to 247 days for the first sediment category and 220 to 285 days for the second sediment category. Those standardised results therefore indicated that the 180-day threshold for the very persistent criterion in sediment set out in Section 1.2.1(b) of Annex XIII was exceeded and therefore allowed ECHA to conclude that phenanthrene was vP in that environmental compartment.
14      On 19 December 2018, following the unanimous agreement in the MSC and pursuant to Article 59(8) of Regulation No 1907/2006, ECHA adopted Decision ED/88/2018 (‘the contested decision’), by which phenanthrene was included on the Candidate List for inclusion in Annex XIV, since that substance was identified, for the reasons set out in the Phenanthrene Support Document, as a very persistent and very bioaccumulative substance and, more particularly, as a vP substance in sediment, within the meaning of Article 57(e) of that regulation.
15      On 15 January 2019, the Candidate List published on ECHA’s website was updated in accordance with the contested decision.
Procedure and forms of order sought
16      By application lodged at the Registry of the General Court on 21 March 2019, the applicant brought the present action. By separate document of the same day, the applicant submitted a request for confidential treatment in relation to the public of certain data contained in the application and in the annexes.
17      On 17 June 2019, ECHA filed its statement of defence.
18      On 2 August 2019, the applicant lodged its reply.
19      By document lodged at the Registry of the Court on 16 July 2019, Concawe applied for leave to intervene in support of the form of order sought by the applicant.
20      By document lodged at the Registry of the Court on 19 July 2019, the French Republic applied for leave to intervene in support of the form of order sought by ECHA.
21      By document lodged at the Registry of the Court on 24 July 2019, Rain Carbon applied for leave to intervene in support of the form of order sought by the applicant.
22      By separate documents of 14 August 2019, ECHA indicated that it did not oppose the application for leave to intervene by Concawe and the French Republic. By contrast, by separate document filed on the same day, ECHA argued that Rain Carbon had not proved that it manufactured or supplied certain substances containing phenanthrene. ECHA therefore left it to the Court to determine whether Rain Carbon had a direct and present interest in the outcome of the case.
23      By separate documents of 19 August 2019, the applicant indicated that it did not oppose the applications for leave to intervene by Concawe, the French Republic and Rain Carbon.
24      On 19 August 2019 the applicant, by separate documents, submitted a request for confidential treatment, in respect of the French Republic, Concawe and Rain Carbon, of certain data contained in the application and in the annexes.
25      On 19 September 2019 ECHA lodged the rejoinder.
26      By orders of 24 September 2019, the President of the Fifth Chamber of the Court granted the applications for leave to intervene of the French Republic and Concawe. Furthermore, the President of the Fifth Chamber of the Court decided to send them a non-confidential version of the pleadings and annexes submitted by the main parties. By contrast, by order of 24 September 2019, Exxonmobil Petroleum & Chemical v ECHA (T‑177/19, not published, EU:T:2019:731), the President of the Fifth Chamber of the Court rejected Rain Carbon’s application for leave to intervene for failure to show a direct interest in the outcome of the case.
27      By separate document lodged at the Registry of the Court on 26 September 2019, the applicant requested, in addition to its initial request of 21 March 2019, confidential treatment in relation to the public of a further annex attached to the application.
28      By letter of 14 October 2019, Concawe stated that it had no objection to the confidential treatment of certain information in its regard. It nevertheless stated that it had become aware of the content of two of the annexes concerned by the applicant’s request in the context of its participation in the administrative procedure.
29      By decision of 18 October 2019 and following the change in the composition of the Chambers of the General Court, the case was reassigned to a new Judge-Rapporteur who was assigned to the Eighth Chamber.
30      On 12 November 2019, the French Republic and Concawe each submitted their statement in intervention. By separate document of the same date, Concawe also submitted a request for confidential treatment in relation to the public of certain data contained in that statement in intervention and in the annexes.
31      By documents lodged at the Registry of the Court on 24 January 2020, the applicant submitted its observations on the statements in intervention of the French Republic and Concawe.
32      By documents lodged at the Registry of the Court on 30 January 2020, ECHA submitted its comments on the statements in intervention of the French Republic and Concawe.
33      On 1 April 2020, the applicant requested a hearing pursuant to Article 106(1) of the Rules of Procedure of the General Court.
34      On 28 August 2020, the Court, by way of a measure of organisation of procedure, put questions to the parties on various aspects of the present case. The French Republic and Concawe replied on 7 October 2020. The applicant and ECHA replied on 8 October 2020. On that occasion, in response to one of the Court’s questions, the applicant stated that it would waive confidential treatment of two of the annexes at issue in relation to the French Republic and Concawe, since those two interveners were already aware of their content.
35      On 6 October 2020, the applicant sought authorisation to call three experts to speak at the hearing. By decision of 9 October 2020, the President of the Eighth Chamber authorised those three experts to speak at the hearing in the presence and under the supervision of the applicant’s representatives.
36      On 19 October 2020, the French Republic sought authorisation to participate in the hearing by videoconference. By decision of 4 November 2020, the President of the Eighth Chamber authorised the French Republic to plead at the hearing by videoconference.
37      On 20 October 2020, ECHA sought authorisation to have an expert speak at the hearing. By decision of 27 October 2020, the President of the Eighth Chamber authorised the expert to speak at the hearing in the presence and under the supervision of ECHA’s representatives.
38      On 29 October 2020, the applicant sought authorisation to have an expert intervene at the hearing by videoconference. The Court rejected that request, but informed the applicant that, if it considered it necessary, it could, at the hearing, ask to contact its expert by telephone and that, in that case, the hearing would be suspended for the time necessary for it to speak with him.
39      On 30 October 2020, ECHA sought authorisation to participate in the hearing by videoconference. By decision of 5 November 2020, the President of the Eighth Chamber authorised ECHA to plead at the hearing by videoconference.
40      On 5 November 2020, ECHA sought authorisation for the hearing to be broadcast via ‘Skype for business’ so that one of its experts could follow it. Since the Court does not, at this stage, allow live streaming of hearings to the public outside the Court of Justice of the European Union, that request by ECHA was rejected.
41      On 7 November 2020, the applicant submitted its observations regarding the report for the hearing.
42      The applicant claims that the Court should:
–        annul the contested decision in so far as it includes phenanthrene on the list of substances identified as being of very high concern;
–        order ECHA to pay the costs.
43      ECHA contends that the Court should:
–        dismiss the action;
–        order the applicant and Concawe to pay the costs.
44      The French Republic submits that the Court should dismiss the action.
45      Concawe claims that the Court should annul the contested decision in so far as it concerns phenanthrene.
Law
46      In support of its action, the applicant raises two pleas in law. The first plea alleges a manifest error of assessment concerning the vP character of phenanthrene, an ‘exceeding of competence’ and an infringement of Article 59 of Regulation No 1907/2006. The second plea alleges infringement of the principle of proportionality. Furthermore, Concawe raises two additional pleas in law, alleging, respectively, lack of an adequate legal basis and breach of the duty to state reasons, as well as breach of the right to be heard.
The first plea in law, alleging a manifest error of assessment, an ‘exceeding of competence’ and infringement of Article 59 of Regulation No 1907/2006
47      The first plea in law is divided into six parts. By the first part, the applicant, supported by Concawe, complains that ECHA committed a manifest error of assessment by relying on information on persistence provided in the CTPHT Support Document without carrying out its own assessment of the information in question and, consequently, by carrying over alleged errors contained in the CTPHT Support Document to the Phenanthrene Support Document. By the second part, the applicant, supported by Concawe, submits that ECHA committed a manifest error of assessment by drawing conclusions on the vP character of phenanthrene which the CTPHT Support Document does not support. By the third part, the applicant, supported by Concawe, claims that ECHA failed to examine the available data that raise questions about the reliability and extreme conservatism of the Meisterjahn et al. (2018a) OECD 308 study. By the fourth part, the applicant, supported by Concawe, claims that ECHA failed to take into account information that calls into question the use of a calculation model – the Arrhenius equation – to adjust the results of the Meisterjahn et al. (2018a) OECD 308 study for temperature. By the fifth part, the applicant, supported by Concawe, considers that ECHA committed a manifest error of assessment by not evaluating the new data on the persistence of phenanthrene which were allegedly provided to it during the public consultation. Finally, by the sixth part, the applicant, supported by Concawe, claims that ECHA failed to consider all the relevant information in determining the weight of evidence of the persistent properties of phenanthrene, in particular regarding photodegradation, dissolution and volatilisation.
48      ECHA, supported by the French Republic, contends that the first plea in law should be rejected.
49      Before examining each of those six parts, the Court considers it appropriate to clarify the scope of the first plea in law.
50      In that regard, it should be noted that the first plea in law is based, first, on a number of alleged manifest errors of assessment and, secondly, on an ‘exceeding of competence’ and an infringement of Article 59 of Regulation No 1907/2006. While there is no doubt that the six parts, referred to in paragraph 47 above, relate precisely to manifest errors of assessment allegedly committed by ECHA, it is equally clear that the applicant has not put forward, in its written pleadings, any argument relating to an alleged ‘exceeding of competence’, which should probably be understood as ultra vires, or to a possible infringement of Article 59 of Regulation No 1907/2006.
51      Furthermore, in response to an oral question from the Court, the applicant stated, during the hearing and in essence, that ECHA had exceeded its powers and infringed Article 59 of Regulation No 1907/2006 on two counts. First, the reasoning of the contested decision is equivocal in that it is not clear that ECHA relied mainly on the results of the Meisterjahn et al. (2018a) OECD 308 study, as adjusted by the application of the Arrhenius equation. Secondly, the applicant submits that ECHA should have reheard the interested parties, since the contested decision was mainly based on new elements, which were not in the Annex XV dossier, but which were derived from the public consultation, namely the results of the Meisterjahn et al. (2018a) OECD 308 study, as adjusted by the application of the Arrhenius equation. In doing so, interested parties did not have the opportunity to take a position on all available and relevant information before the adoption of the contested decision.
52      Even assuming that those complaints are admissible under Article 76(d) of the Rules of Procedure despite not being supported by any argument in the application, it must be observed, in any event, that they merge with the arguments developed by Concawe in the two additional pleas in law. Consequently, those complaints will be examined in the context of these two additional pleas in law.
53      Accordingly, consideration of the first plea in law is limited to the manifest errors of assessment referred to by the applicant in the six parts mentioned in paragraph 47 above. Furthermore, the Court considers it appropriate to examine the first and second parts of the first plea in law together.
The first and second parts of the first plea in law, alleging a manifest error of assessment in that ECHA wrongly relied on the CTPHT Support Document and, in particular, on the information from the Mackay et al. (1992) report, the Neff study (1979) and the Volkering and Breure study (2003) in the Phenanthrene Support Document
54      In the context of the first two parts, the applicant, supported by Concawe, claims that ECHA concluded that phenanthrene was vP by wrongly and without further assessment repeating the information on the persistence of that substance contained in the CTPHT Support Document and, in particular, that from the Mackay et al. (1992) report, the Neff study (1979) and the Volkering and Breure study (2003). In that regard, first, the conclusions of the Mackay et al. (1992) report regarding the half-lives of phenanthrene in sediments are derived from estimates based on the persistence of that substance, not in sediments, but in soils. Furthermore, the Mackay et al. (1992) report does not constitute ‘suitable and reliable’ information for assessing the vP properties of phenanthrene within the meaning of Section 3.2 of Annex XIII. Secondly, the applicant considers that little or no weight should also be given to the Neff (1979) and Volkering and Breure (2003) studies.
55      ECHA, supported by the French Republic, contends that the first two parts of the first plea in law should be rejected.
56      First of all, it should be noted that the applicant’s argument is based on the premiss that ECHA concluded that phenanthrene was vP in sediments by repeating, erroneously and without further assessment, certain information contained in the CTPHT Support Document and, in particular, that from the Mackay et al. (1992) report, the Neff study (1979) and the Volkering and Breure study (2003).
57      Before examining whether ECHA committed a manifest error of assessment in drawing its conclusions from that information, it must first be ascertained whether, as ECHA and the French Republic contend, the contested decision was, on the contrary, adopted decisively on the basis of the Meisterjahn et al. (2018a) OECD 308 study, provided by Concawe during the public consultation.
58      In that regard, the Court notes that all the five passages, with the exception of one (p. 20), in the Phenanthrene Support Document in which ECHA asserts that that substance is very persistent in sediments make express reference to the Meisterjahn et al. (2018a) OECD 308 study.
59      More specifically, four passages in the Phenanthrene Support Document (pp. 10 and 11, 14, 15 and 19) directly link that conclusion to the Meisterjahn et al. (2018a) OECD 308 study. That conclusion is always presented immediately after the description of that study. Furthermore, on pages 10 and 11 as well as 14 and 19 of that document, the link established by ECHA between that study and that conclusion is reinforced by the use of the conjunction ‘therefore’. Finally, on page 15 of that document, ECHA states unambiguously as a conclusion to Section 3.1 on phenanthrene degradation that ‘according to [the Meisterjahn et al. (2018a) OECD 308 study], provided during the public consultation, … phenanthrene meets the vP criteria for sediment’.
60      In contrast, only two passages in the Phenanthrene Support Document (pp. 14 and 19) make explicit reference to the Mackay et al. (1992) report. However, the conclusion on the persistence of phenanthrene in sediments never appears immediately following the mention of that report. Similarly, the Neff study (1979) and the Volkering and Breure study (2003) are only cited on page 9 of that document, when ECHA presents all the available information. However, no definitive conclusions are drawn from those two studies. At most, ECHA states, on the basis of those two studies and with caution, that low biodegradation of phenanthrene ‘is expected’ in sediments. Finally, when ECHA draws its conclusions under Section 3.1 on phenanthrene degradation (p. 15), it does not mention the Mackay et al. (1992) report, the Neff study (1979) or the Volkering and Breure study (2003).
61      It follows from those elements that ECHA established the vP character of phenanthrene in sediments decisively on the basis of the Meisterjahn et al. (2018a) OECD 308 study. Moreover, that conclusion is confirmed by the minutes of the MSC meeting of 12 December 2018, at which the vP character of phenanthrene in sediments was definitively established. Only the Meisterjahn et al. (2018a) OECD 308 study is mentioned there. By contrast, those minutes do not contain any references to the Mackay et al. (1992) report, the Neff study (1979) or the Volkering and Breure study (2003).
62      That conclusion is not called into question by the other arguments of the applicant and of Concawe.
63      In the first place, the applicant and Concawe argue that the supporting document on phenanthrene states that the assessment of the vPvB properties of phenanthrene is based ‘mainly’ on the information in the CTPHT Support Document.
64      That argument cannot succeed. Admittedly, the Phenanthrene Support Document states on two occasions that the assessment of the vPvB properties of this substance is ‘mainly’ based on the information contained in the CTPHT Support Document (pp. 3 and 20). However, first, it is clear that that statement is not repeated in the sections on the persistence of phenanthrene in sediments. It is only mentioned in the foreword (p. 3) and in the general conclusion (Section 6.2.2, p. 20) of that document. Furthermore, as can be seen in particular from paragraphs 58 to 61 above, there is no indication in the Phenanthrene Support Document that ECHA relied decisively on the CTPHT Support Document to conclude that phenanthrene is vP in sediments. Secondly, it is clear that the conclusion regarding the bioaccumulative and very bioaccumulative properties (‘B and vB properties’) of phenanthrene is based on the information available in the CTPHT Support Document. On that point, it should be noted that ECHA expressly states that that conclusion regarding the B and vB properties of phenanthrene was already included in the CTPHT Support Document and that the new data, reported in the Phenanthrene Support Document, do not call that conclusion into question (Section 6.2.1.2, p. 20). Consequently, the conclusion that the assessment of the vPvB properties of phenanthrene is based ‘mainly’ on the information contained in the CTPHT Support Document concerns, in fact, the B and vB properties and does not refer to the decisive factor for the identification of the vP character of that substance.
65      In the second place, the applicant considers that ECHA has always maintained that the issue of the vP character of phenanthrene was decided in the CTPHT Support Document. That is apparent both from the foreword to the Phenanthrene Support Document and from ECHA’s statements in the case giving rise to the judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA (T‑93/10, EU:T:2013:106).
66      That argument is also not convincing. In paragraphs 80 and 103 of the judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA (T‑93/10, EU:T:2013:106), the Court merely notes that, in the dossier relating to the identification of CTPHT, the MSC concluded that phenanthrene was to be regarded as having vPvB properties. In the same sense, the foreword to the Phenanthrene Support Document only mentions, as a historical reminder, that the vPvB properties of that substance had already been identified in the CTPHT Support Document. However, it is clear that those elements do not concern the vP character of phenanthrene in isolation, but refer to its vPvB properties in general. Furthermore, and most importantly, the main parties agree that, as indicated in paragraph 3 above, the CTPHT Support Document had concluded that phenanthrene is vP in soils and not, as in the present case, in sediments. Therefore, neither the judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA (T‑93/10, EU:T:2013:106), nor the reference in the foreword to the Phenanthrene Support Document at issue confirms that ECHA consistently considered that the question of the vP character of that substance in sediments had been decided in the CTPHT Support Document.
67      In the third place, the applicant claims, in essence, that the Kingdom of Belgium, the Federal Republic of Germany, the Kingdom of the Netherlands and the Kingdom of Norway also took for granted the fact that the CTPHT Support Document had concluded that phenanthrene was vP.
68      That argument must be rejected. Those States all submitted their comments on the basis of the dossier drawn up in accordance with Annex XV. In that regard and as recalled in paragraphs 5 and 6 above, the main parties agree that the dossier concluded, on the basis of the CTPHT Support Document, that phenanthrene met the P and vP criteria in soil, but that it did not contain any specific conclusion on the persistence of that substance in sediment. Therefore, the comments of those States were limited to the assumption that the previous conclusions of the MSC regarding the persistence of phenanthrene in soils were still valid. By contrast, it does not appear from those comments that those States had considered that the issue of persistence of phenanthrene in sediments had been resolved during the identification process of CTPHT and that, on that occasion, that substance had been considered to be of very high concern. Furthermore, it should be noted that those comments were submitted on 11 (Federal Republic of Germany), 16 (Kingdom of Belgium) and 19 October 2018 (Kingdom of the Netherlands and Kingdom of Norway) respectively. Therefore, logically, those comments could not have taken into account the Meisterjahn et al. (2018a) OECD 308 study that Concawe submitted on 19 October 2018.
69      In the fourth place, the applicant submits that the minutes of the MSC meeting of 12 December 2018 show that that body had also taken for granted the fact that the persistence of phenanthrene in sediments had already been established in the process of identifying CTPHT as a substance of very high concern.
70      That argument must also be rejected. The extract from those minutes, which the applicant set out in paragraph 35 of the reply, does not indicate that the MSC considered that the question of the persistence of phenanthrene had already been decided. That extract merely states that the representatives of the Belgian and French authorities considered that many of the points raised during the public consultation had already been taken into consideration and decided by the MSC in 2009. First, those statements are therefore not attributable to the MSC, as the applicant maintains, but to the Belgian and French authorities. Secondly, those statements do not indicate either that, as far as the Kingdom of Belgium and the French Republic are concerned, the question of the persistence of phenanthrene had already been settled. Their statements refer to ‘many of the points raised during the public consultation’, without further clarification. Thirdly, those minutes state that the Belgian and French authorities took into account the new information submitted during the public consultation, ‘in particular with regard to phenanthrene’, and assessed whether that information could modify the previous conclusions. Finally, those minutes also make it clear that, on the basis of the newly available information, the MSC could not adopt a definitive conclusion regarding the persistence of phenanthrene in soils. Those last elements thus show, once again, contrary to the applicant’s contention, that neither the Belgian and French authorities nor the MSC considered or proceeded on the assumption that the previous conclusions concerning the persistence of phenanthrene had already been definitively reached.
71      In the light of the foregoing, the applicant and Concawe are wrong to claim that ECHA committed a manifest error of assessment by relying on information on the persistence of phenanthrene contained in the CTPHT Support Document. ECHA decisively relied on the Meisterjahn et al. (2018a) OECD 308 study for the vP property of phenanthrene in sediments rather than on the CTPHT Support Document. The scientific validity of the conclusions drawn by ECHA from that study will be examined below in the context of the third and fourth parts of the first plea in law.
72      Consequently the first two parts of the first plea in law must be rejected.
The third part of the first plea in law, alleging a manifest error of assessment in that ECHA did not examine the available data which should have led it to question the reliability and extreme conservatism of the Meisterjahn et al. (2018a) OECD 308 study
73      In the context of the third part, the applicant, supported by Concawe, claims that ECHA failed to take into account certain information that could have called into question the reliability of the Meisterjahn et al. (2018a) OECD 308 study.
74      In the first place, the applicant submits that OECD Guideline 308 has already been criticised on the ground that it is not representative of environmental conditions because of its high sediment-to-water ratio and its lack of suitability for water bodies characteristic of receiving environments. Those criticisms were pointed out by Concawe during the public consultation. However, neither the French Republic nor the MSC addressed the question of the extreme conservatism of the Meisterjahn et al. (2018a) OECD 308 study, which overestimates the persistence of phenanthrene in sediments.
75      In the second place, the applicant and Concawe criticise the MSC for ignoring the second part of the Junker et al. (2016) study on a water-sediment screening tool (‘the WSST test’), which Concawe submitted during the public consultation. At most, the French Republic provided a response to Concawe’s comments, but the document including that response was not transmitted to the MSC. The results of that study, based on the WSST test, indicate that phenanthrene reached a mineralisation rate of 51.3% over 28 days in a water-sediment system, with a corresponding ultimate degradation half-life of 25.3 days. Thus, although the WSST test is not a test for ready biodegradability, it nevertheless allows for a faster degradation of phenanthrene than the results reached in the Meisterjahn et al. (2018a) OECD 308 study. According to the applicant, the MSC should therefore have included the results of that study, based on the WSST test, in its assessment of the evidence, which it did not do.
76      In the third place, the Meisterjahn et al. (2018a) OECD 308 study used a static and closed biometric method. Given that configuration, four factors affected the reliability of the results of that study. First, the water could not have been gently stirred at the surface, as required by OECD Guideline 308. Secondly, it was not possible to pass moist air over the surface of the water, as is also required by that guideline. Thirdly, at the reply stage, the applicant states that acetone was added because of the low solubility of phenanthrene in water. However, no account was taken of the oxygen consumed by the degradation of the acetone. Fourthly, still at the reply stage, the applicant states that, as a result of the first three factors (namely, the lack of stirring of the surface water, the absence of moist air being passed in and the addition of acetone), a biofilm had formed during the experiment. Those four factors, which the MSC did not identify or evaluate, led to increased oxygen depletion, which slowed down the biodegradation of phenanthrene and thus artificially induced an increase in the persistence of that substance.
77      Furthermore, Concawe believes that ECHA misunderstood the purpose of the Meisterjahn et al. (2018a) OECD 308 study. That study was not conducted with the primary aim of drawing conclusions on the biodegradation of phenanthrene in sediment. The objective of that study was to establish a test system that would allow volatile and hydrophobic chemicals, such as phenanthrene, to be appropriately tested.
78      ECHA, supported by the French Republic, contends that the third part of the first plea in law should be rejected.
79      As a preliminary point, and like ECHA and the French Republic, the Court points out the contradiction in the conduct of the applicant and Concawe, who are now attempting to disqualify in its entirety the scientific value of the Meisterjahn et al. (2018a) OECD 308 study, even though, as indicated in paragraph 9 above, it was they who submitted it for discussion during the public consultation. The Court considers that the applicant and Concawe cannot submit a scientific study to ECHA claiming that only their interpretation of the results of that study could be accepted and that any other assessment of those results would necessarily be irrelevant and scientifically invalid. In particular, they cannot claim a right to object to ECHA’s taking into account all the scientific findings that can be drawn from the publication thus brought to its attention by an interested party in the context of a public consultation. In that regard, while it remains true that the extent of the conclusions drawn by ECHA from that study must be examined, it is also true that the study presents precise and quantified data on the half-life of phenanthrene in sediments. Moreover, it was on the basis of those data that Concawe and, through it, the applicant relied during the public consultation to try to demonstrate that the persistence of phenanthrene in sediments was below the 120-day threshold.
80      Having made these initial observations, it is necessary to verify whether or not ECHA examined the available data which could have led it, as the applicant claims, to question the reliability and extreme conservatism of the Meisterjahn et al. (2018a) OECD 308 study, and whether those data should have led it to different conclusions from those it drew from that study.
81      In that regard, according to settled case-law, ECHA enjoys a broad discretion in the identification of substances of very high concern under Article 57(f) of Regulation No 1907/2006. The same applies to the application of Article 57(e) of that regulation. In that connection, it should be noted that that broad discretion of the authorities of the European Union, 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 European Union authorities which have adopted the act in question must be able to show before the European Union judicature that in adopting the act they actually exercised their discretion, which presupposes that they took into consideration all the relevant factors and circumstances of the situation the act was intended to regulate (see judgment of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 53 and the case-law cited; see also, by analogy, judgment of 21 June 2018, Poland v Parliament and Council, C‑5/16, EU:C:2018:483, paragraphs 150 to 152 and the case-law cited).
82      In the first place, the applicant claims that OECD Guideline 308 has already been criticised for not being representative of environmental conditions, due to a high sediment-to-water ratio and its lack of relevance to water bodies characteristic of receiving environments. In support of that claim, the applicant refers to a study by Shrestha et al. from 2016 (‘the Shrestha et al. (2016) study’). Those criticisms are also mentioned in the testimony of an expert witness submitted by the applicant as an annex to the application and in a 2019 article by Shrestha et al. (‘the Shrestha et al. (2019) article’) submitted by Concawe as an annex to its statement in intervention.
83      In that regard, it is clear that the Shrestha et al. (2016) study relates to the OECD Guideline 308 in general, and not the Meisterjahn et al. (2018a) OECD 308 study. That conclusion is valid given that that study was conducted in 2018, two years after the Shrestha et al. (2016) study.
84      Furthermore, even assuming that the criticisms made in the Shrestha et al. (2016) study are valid, the applicant has not provided any concrete evidence as to how and in what respects the alleged deficiencies in the methodology of OECD Guideline 308 affected the Meisterjahn et al. (2018a) OECD 308 study. Neither Concawe in the public consultation nor the applicant in its written submissions argued that the Meisterjahn et al. (2018a) OECD 308 study should be disqualified from the outset because it suffered from the same alleged flaws as those in OECD Guideline 308. On the contrary, both the applicant and Concawe relied on that study to the extent that they felt it could support their own conclusions.
85      Moreover, the impossibility of transposing the conclusions of the Shrestha et al. (2016) study as they stand to the Meisterjahn et al. (2018a) OECD 308 study is all the greater since, as Concawe pointed out in its written submissions, the latter study adjusted the mechanism created by OECD Guideline 308. That adjustment, which according to Concawe remained within the limits allowed by OECD Guideline 308, was precisely intended to address the alleged weaknesses of the standard OECD Guideline 308 mechanism for assessing hydrocarbons.
86      It follows from all those considerations that the Shrestha et al. (2016) study does not, in itself, call into question the reliability of the Meisterjahn et al. (2018a) OECD 308 study, so that ECHA’s choice not to disregard the latter study, despite the criticisms made in the Shrestha et al. (2016) study, does not constitute a manifest error of assessment.
87      Finally, neither the expert witness testimony referred to in paragraph 82 above nor the Shrestha et al. (2019) article can be taken into account, since both that testimony and that article post-date the adoption of the contested decision. ECHA could not therefore have taken them into consideration at the time of adoption of the contested act. Moreover, according to settled case-law, in the context of an action for annulment, the lawfulness of the contested act must be assessed in the light of the matters of fact and law existing on the date on which the act was adopted (see judgment of 10 September 2019, HTTS v Council, C‑123/18 P, EU:C:2019:694, paragraph 37 and the case-law cited).
88      In the second place, the applicant complains that the MSC ignored the second part of the Junker et al. (2016) study on the WSST test which Concawe had submitted during the public consultation. According to the applicant, the results of that study were not sent to the MSC.
89      In that regard, it should be noted that the French Republic expressly responded in the RCOM document to the observations made by Concawe on the basis of the second part of the Junker et al. (2016) study on the WSST test, which is not disputed by the applicant. Contrary to the latter’s assertion, it is clear that the RCOM document containing Concawe’s observations and the French Republic’s replies was sent to the MSC and that the MSC was therefore aware of it.
90      Admittedly, as the applicant submits, the Phenanthrene Support Document does not refer to the WSST test or to the response formulated by the French Republic in the RCOM document referred to in paragraph 10 above. However, the minutes of the MSC meeting of 12 December 2018 expressly state that the Belgian and French authorities presented, inter alia, an overview of the comments received during the public consultation and the responses formulated in the RCOM document during that meeting. Furthermore, those minutes also clearly mention that the new information provided during the public consultation was assessed against Chapter R.11, on the assessment of PBT and vPvB properties, of the ECHA Guidance on Information Requirements and Chemical Safety Assessment, dated June 2017 (‘the ECHA Guidance’). Finally, the minutes state that the MSC members endorsed the conclusions of the Belgian and French authorities and unanimously considered phenanthrene to have vPvB properties.
91      [confidential] (1)
92      It must therefore be noted that the second part of the Junker et al. (2016) study on the WSST test was not unknown to the members of the MSC. The applicant is therefore wrong to accuse the MSC of having ‘entirely ignored it’. As to the question whether ECHA correctly assessed the data from that study, that question is outside the scope of the present part of the plea and will be examined in the context of the fifth part of the first plea in law. The sole purpose of the present part is to assess the reliability of the Meisterjahn et al. (2018a) OECD 308 study. Apart from the finding of a divergent result in respect of the half-life of phenanthrene in sediments, the applicant has not put forward any argument, in the context of the present part, relating to the second part of the Junker et al. (2016) study on the WSST test to call into question the reliability of the Meisterjahn et al. (2018a) OECD 308 study.
93      In the third place, the applicant identifies four factors, namely the lack of stirring of the surface water, the absence of moist air passed in, the addition of acetone and the appearance of a biofilm, which allegedly negatively influenced the results of the Meisterjahn et al. (2018a) OECD 308 study. In the experiment, those four factors led to a higher oxygen depletion, which slowed down the biodegradation of phenanthrene and thus artificially induced an increase in the persistence of that substance. However, the MSC did not identify or assess those four factors, which are capable of calling into question the reliability of that study.
94      In that regard, first of all, it should be noted that it is not disputed between the parties that the device used in the Meisterjahn et al. (2018a) OECD 308 study was adapted from the standard device used under that guideline. It is also not disputed that, even with those adaptations, the level of oxygen flux in the device used may have been lower than that obtained in other tests on other substances. Finally, it is common ground that the question of a lower oxygen flux level was raised and addressed at the public consultation stage, as can be seen from page 13 of the RCOM document.
95      Next, it should nevertheless be noted that the purpose of the present part of the plea is to ascertain whether ECHA took into account, at the time of adoption of the contested decision, the available information which called into question the scientific reliability of the Meisterjahn et al. (2018a) OECD 308 study. It must therefore be verified that the four factors put forward by the applicant had been communicated to ECHA, or were known to that agency, or should have been known, before the adoption of the contested decision.
96      First, in response to a written question from the Court, the applicant and Concawe admitted that the summary of the Meisterjahn et al. (2018a) OECD 308 study provided during the public consultation did not contain any specific information as to the alleged lack of surface water stirring during that experiment. However, the applicant and Concawe indicated that the Concawe poster, as referred to in paragraph 9 above, shows that the half-lives of phenanthrene in sediment are longer in the Meisterjahn et al. (2018a) OECD 308 study than in the WSST test. The reason for that difference is that the WSST test was more oxygenated due to the stirring of the surface water. According to the applicant and Concawe, ECHA, as a specialised agency, could, or even should, have deduced those conclusions from the information contained in the Concawe poster. In any event, both parties consider that the fact that the summary of the Meisterjahn et al. (2018a) OECD 308 study did not contain any information on surface water stirring should have led ECHA to gather more information before drawing conclusions on the persistence of phenanthrene on the basis of that study.
97      In that regard, it follows from those elements that, when the summary of that study was submitted in the context of the public consultation, no clear and certain information had been communicated regarding, first, a possible absence of surface water stirring in the Meisterjahn et al. (2018a) OECD 308 study and, secondly, a certified or certifiable impact of such an absence on the conclusions of the study. That conclusion is not contradicted by the Concawe poster. Indeed, that poster merely states that it is ‘likely’ that there were different oxygen levels between the Meisterjahn et al. (2018a) OECD 308 study and the WSST test, in particular due to the fact that the surface water had been stirred in the latter test. However, that statement does not explicitly state that, in contrast to the WSST test, the surface water was not stirred during the Meisterjahn et al. (2018a) OECD 308 study. Moreover, that statement is made not as a certainty, but in a hypothetical form (‘likely’). Therefore, it is not clear from the parties’ responses whether the surface water was or was not stirred during the Meisterjahn et al. (2018a) OECD 308 study. The applicant’s argument that the surface water was not stirred therefore remains speculative.
98      Secondly, in response to a written question from the Court, the applicant and Concawe asserted that ECHA could have inferred the absence of moist air being passed in since the Meisterjahn et al. (2018a) OECD 308 study used a closed biometric system. Furthermore, the applicant and Concawe point out that Concawe had stated in its submissions to the public consultation that it was ‘likely that there was a reduction in oxygen due to no flow of air into the system’. A similar statement also appears in the Concawe poster.
99      In that regard, it is admittedly true that Concawe mentioned in its comments filed during the public consultation and in its poster that the Meisterjahn et al. (2018a) OECD 308 study suffered from a lack of airflow, which was also confirmed by ECHA at the hearing. However, the conclusion which the applicant and Concawe draw from that, namely a consequent fall in the level of oxygen, again appears speculative. It must be noted that, in that regard, Concawe’s assertions were made not as a matter of certainty, but in hypothetical form, both in its comments filed during the public consultation (‘[it was] likely that there was a reduction in oxygen due to the lack of airflow into the system’) or in its poster (‘[the Meisterjahn et al. (2018a) OECD 308 study] is likely to be particularly anoxic due to … no flow of air’).
100    Thirdly, in response to a written question from the Court, the applicant and Concawe indicated that the latter had mentioned in the summary of the Meisterjahn et al. (2018a) OECD 308 study that acetone had been added and that its potential effects on microbial activity had been monitored. However, the applicant acknowledges that the correct information on the monitoring of the effects of acetone on microbial activity had not been provided to ECHA. However, ECHA could, according to the applicant and Concawe, have inferred that acetone degradation influenced oxygen levels during the Meisterjahn et al. (2018a) OECD 308 study. Such an influence is well known in the scientific community. Furthermore, OECD Guideline 308 specifies that the use of acetone cannot lead to adverse effects on the microbial activity of the system. Finally, the applicant and Concawe point out that the Concawe poster stated that the Meisterjahn et al. (2018a) OECD 308 study was ‘likely to be particularly anoxic due to the use of solvent’. At the very least, ECHA should, according to the applicant and Concawe, have gathered more information before drawing conclusions on the persistence of phenanthrene based on that study.
101    In that regard, it is admittedly true that Concawe mentioned, in the summary of the Meisterjahn et al. (2018a) OECD 308 study submitted during the public consultation and in its poster, that acetone had been added, which the French Republic moreover acknowledged in response to a written question from the Court. However, the consequence which the applicant and Concawe draw from that, namely a correlative reduction in the level of oxygen, is also speculative. It must again be noted that, on that point, Concawe’s assertions were formulated, not as a matter of certainty, but in a hypothetical form, whether in the summary of the Meisterjahn et al. (2018a) OECD 308 study, which mentions ‘potential effects of the solvent on microbial activity’, or in its poster which states that ‘[the Meisterjahn et al. (2018a) OECD 308 study] is likely to be particularly anoxic due to the use of solvent’. In any event, once those potential effects had been tested, it was open to the applicant and Concawe to submit the result of those tests to the Court. However, they did not do so. Furthermore, no conclusion can be drawn from paragraphs 35 and 37 of OECD Guideline 308 to which the applicant and Concawe refer. Those paragraphs merely limit the amount of solvent that can be added during a test in order to avoid undesirable effects on the microbial activity of the system. However, neither the applicant nor Concawe has indicated whether or not that limit was respected and whether any adverse effects were observed in the present case. Finally, as to the very general assertion that it is well known in the scientific community that the degradation of acetone has an impact on oxygen levels, it is sufficient to note that no evidence, such as scientific papers, was submitted to the Court to support that assertion. Thus, neither the applicant nor Concawe demonstrated that a degradation of acetone that resulted in a decrease in oxygen levels during the Meisterjahn et al. (2018a) OECD 308 study should have been taken into account by ECHA in its assessment.
102    Fourthly, in response to a written question from the Court, the applicant and Concawe acknowledged that the formation of a biofilm had not been mentioned to ECHA before the adoption of the contested decision. However, the formation of such a biofilm would be the consequence of the existence of the first three factors discussed above.
103    In that regard, it is sufficient to note that the applicant and Concawe did not demonstrate the formation of a biofilm during the Meisterjahn et al. (2018a) OECD 308 study. Moreover, it cannot be assumed on the basis of the first three factors discussed above that such a biofilm was formed, since, as noted in paragraphs 97, 99 and 101 above, there is no evidence, first, that the surface water was not stirred, secondly, that the lack of flow of moist air implied a decrease in the oxygen level and, thirdly, that the degradation of acetone led to undesirable effects on microbial activity or a decrease in the oxygen level during the Meisterjahn et al. (2018a) OECD 308 study.
104    Fifthly, it is apparent from the written submissions of all the parties, as well as from their response to a written question from the Court, that no data relating to the level of oxygen measured during the Meisterjahn et al. (2018a) OECD 308 study were communicated to ECHA before the adoption of the contested decision. At most, Concawe indicated in the summary of the Meisterjahn et al. (2018a) OECD 308 study that pure oxygen was injected for 20 seconds whenever the oxygen concentration fell below 15%. Thus, ECHA was informed that the oxygen level was corrected in case of a drastic drop. However, there is no information submitted to ECHA during the public consultation or to the Court in the context of the present proceedings that specifies the extent of those oxygen drops or how many times pure oxygen had to be re-injected during that experiment. At the stage of the reply, the applicant admittedly stated that the oxygen measurements varied between 3.42 and 0.52 mg O2/L during the performance of that study, but that statement is not supported by any source or evidence. The applicant also did not indicate the stage to which those figures related during the experiment, although OECD Guideline 308 requires oxygen levels to be measured at the beginning, during and at the end of the experiment. Furthermore, the Court notes that, despite their written and oral submissions, the parties never indicated the oxygen levels measured at the beginning, during and at the end of the Meisterjahn et al. (2018a) OECD 308 study. By contrast, the Court must conclude that the detailed and provided summary of that study available at the time of ECHA’s assessment does not contain any explicit or specific reservation regarding the reliability of its results.
105    Consequently, contrary to the applicant’s contention, none of the four factors it highlighted was identified sufficiently to be taken into account in ECHA’s assessment, nor did they demonstrate a depletion of the oxygen level throughout the duration of the Meisterjahn et al. (2018a) OECD 308 study in such a way that its results would have been decisively altered. In view of all the above considerations, ECHA cannot therefore be criticised for failing to take into account those four factors and their possible impact on the oxygen level. The summary of the Meisterjahn et al. (2018) OECD 308 study does not mention them as such nor does it express any reservations about the reliability of the results presented, so that none of those four factors can be used to call into question the scientific value of that study.
106    In the fourth place, even if the main arguments of the applicant and Concawe were rejected, it is nevertheless necessary to verify whether, contrary to what they maintain, ECHA could, without committing a manifest error of assessment, rely solely on the summary of the Meisterjahn et al. (2018a) OECD 308 study, without waiting for the final and complete version of that study.
107    In that regard, first, it should be noted at the outset that no provision of Regulation No 1907/2006 requires that a decision to identify a vP substance be based on more than one study. At most, the existence or not of several studies must be taken into account in the assessment of the substance in question. That said, it would not be consistent with the regulatory objectives to consider that an identification decision could not be taken in the presence of concrete data of concern merely because those data are based on a single study, in the absence of indications at the time of the decision calling into question its reliability.
108    Secondly, Annex XIII requires only that ‘all relevant and available information’ be taken into account. It is clear from the foregoing considerations that the four factors referred to by the applicant and Concawe were neither ‘relevant’ nor ‘available’ when the persistence or otherwise of phenanthrene in sediment was considered. Those four factors had not been brought to the attention of ECHA in a way that allowed their consideration. Only the summary of the Meisterjahn et al. (2018a) OECD 308 study was ‘relevant and available’ at the time of the decision. However, that summary did not clearly and unequivocally indicate that there could be doubts about the validity of the results of that study.
109    Moreover, neither the applicant nor Concawe had expressed such doubts when they relied on that study to try to demonstrate the lack of persistence of phenanthrene. In addition, in paragraph 130 of the application, the applicant states that that study was ‘conducted according to OECD [Guideline] 308’. A similar statement also appears in the first sentence of the summary of that study provided by Concawe during the public consultation.
110    Thirdly, it remains to be determined whether, as the applicant and Concawe argue, ECHA was obliged under the provisions of Annex XIII to gather more information or to await the final results of the Meisterjahn et al. (2018a) OECD 308 study before adopting the contested decision.
111    In that regard, it should be noted, first of all, that all the provisions of Regulation No 1907/2006 are based on the precautionary principle (Article 1(3) of that regulation).
112    Regulation No 1907/2006 provides for a detailed and nuanced architecture for dealing with chemicals that may require increased monitoring or even use restrictions. In that regard, that regulation provides for a sequence of procedures ranging from the identification of a concern to the authorisation or non-authorisation of a use and the restriction of uses. Each procedural step is accompanied by appropriate conditions and obligations. It should be noted that the identification of a substance under Article 57 of Regulation No 1907/2006 entails certain obligations for its producers, suppliers and users. However, it is only a first step which must be followed, as necessary, by other steps to arrive at an authorisation or restrictions.
113    Next, it should be observed that, as the Court has already ruled (see, to that effect, judgment of 20 September, PlasticsEurope v ECHA, T‑636/17, under appeal, EU:T:2019:639, paragraph 170), bearing in mind the dynamic and exploratory nature of scientific research generally, there will probably always be, at the time of a decision by ECHA, a study on a substance examined under Article 57 of Regulation No 1907/2006 in the procedure referred to in Article 59 of that regulation, which is ongoing or about to be started. As a result, an obligation for ECHA to wait for the completion of all studies on a certain substance would make it impossible to identify it as a substance of very high concern, which would be contrary to the objective of a high level of protection of human health and the environment as enshrined in Article 1(1) of Regulation No 1907/2006. Furthermore, it should be noted that nothing in that regulation prohibits the consideration of summaries of studies or requires that identification decisions be based exclusively on definitive studies. By contrast, the reliability of a summary of a study and thus its evidential value must be assessed in the procedure leading to the adoption of an identification decision. In that regard, it is necessary to check whether the summary in question contains elements that raise doubts as to its probative value. Where the summary of a study presents – as is the case here, as noted in the preceding considerations – results which are concrete and of concern, without expressing a reservation as to their reliability, the mere fact that it is only a summary of a study cannot, in itself, create such a reservation.
114    Moreover, although Regulation No 1907/2006 does not contain express provisions concerning the possibility of re-examining the inclusion of a substance on the Candidate List under Article 59 of Regulation No 1907/2006, it should be recalled that any decision adopted on the basis of that provision can, as a general rule, be re-examined in the light of new information available without any express provision being required (see, to that effect, judgment of 20 September, PlasticsEurope v ECHA, T‑636/17, under appeal, EU:T:2019:639, paragraph 165).
115    In that regard, it should be observed that Article 58(8) of Regulation No 1907/2006 provides that substances included in Annex XIV to that regulation may be removed therefrom where, as a result of new information, they no longer meet the criteria of Article 57 of that regulation. That provision presupposes that ECHA can and, where necessary, must carry out a re-examination on the basis of new, relevant information. Given that the identification of a substance under Articles 57 and 59 of Regulation No 1907/2006 is carried out with a view to the eventual inclusion thereof in Annex XIV, the right and, where appropriate, the obligation to carry out a re-examination on the basis of new information applies a fortiori, inter alia also during the period between, first, the identification of a substance under Article 57 of Regulation No 1907/2006 and its inclusion on the Candidate List and, secondly, the subsequent inclusion in Annex XIV. Consequently, any new, sufficiently reliable, relevant and decisive information arising from a study that was still ongoing at the time of the identification of a substance as being of very high concern is therefore likely to be taken into account, where appropriate, even after the identification laid down in Articles 57 and 58 of Regulation No 1907/2006, and before the subsequent inclusion of that substance in Annex XIV.
116    In the light of the above, it must be considered that ECHA did not commit a manifest error of assessment by relying exclusively on the information submitted by Concawe during the public consultation, without waiting for the final outcome of the Meisterjahn et al. (2018a) OECD 308 study. The summary of the results of that study, presented by Concawe, as adjusted by the Arrhenius equation, appears sufficiently plausible and convincing from a scientific point of view to justify, under the precautionary principle, the identification of an extreme concern and therefore the adoption of the contested decision, knowing that that identification could possibly be adapted at a later stage if new elements were to demonstrate, sufficiently, the non-persistent character of phenanthrene.
117    Consequently the third part of the first plea in law must be rejected.
The fourth part of the first plea in law, alleging a manifest error of assessment in that ECHA did not take into consideration information which called into question the use of a calculation model to adjust the results of the Meisterjahn et al. (2018a) OECD 308 study to take account of the temperature
118    In the context of the fourth part, the applicant, supported by Concawe, argues that ECHA committed several manifest errors of assessment by having recourse to the Arrhenius equation to adjust the results of the Meisterjahn et al. (2018a) OECD 308 study.
119    In the first place, the use of the Arrhenius equation has not been validated for hydrocarbons. Section 1.3 of Annex XI to Regulation No 1907/2006 (‘Annex XI’) prohibits the use of a calculation method, more specifically a (Q)SAR model, if the substance in question does not fall within the scope of applicability of that (Q)SAR model.
120    In the second place, Chapter R.7b of the ECHA Guidance on Effects-Specific Information indicates that the use of the Arrhenius equation leads to potential uncertainties on the ground that it was designed for simple chemical reactions and that the specific activation energy of a substance is often unknown. The application of the Arrhenius equation to the Meisterjahn et al. (2018a) OECD 308 study therefore renders the temperature correction, performed by ECHA, uncertain.
121    In the third place, the ECHA Guidance specifies that the Arrhenius equation could only be used if the measured half-life, before temperature correction, is close to the persistence criterion. That was not the case here.
122    In the fourth place, according to the applicant and Concawe, the latter’s poster presented at the public consultation includes nine peer-reviewed studies which allegedly show that a temperature range of 5 °C to 22 °C does not affect the rate of degradation of phenanthrene. Therefore, the use of the Arrhenius equation to adjust the results of the Meisterjahn et al. (2018a) OECD 308 study is inappropriate and led to an overestimation of the half-life of phenanthrene at low temperatures. That conclusion is moreover confirmed by five studies, namely Ratkowski et al. (1982), Ratkowski et al. (1983), Rivkin et al. (1996), Kirchmann et al. (2005) and Lewis and Prince (2018), which demonstrate that the Arrhenius equation is not suitable for hydrocarbons.
123    ECHA, supported by the French Republic, contends that the fourth part of the first plea in law should be rejected.
124    As a preliminary point, it should be recalled that, as noted in paragraph 13 above, the Meisterjahn et al. (2018a) OECD 308 study had concluded, before its results were adjusted by ECHA, that, at a temperature of 20 °C, the degradation half-life of phenanthrene was between 114 and 130 days, for the first category of sediment, and between 116 and 150 days, for the second category of sediment. In other words, those results did not indicate that phenanthrene was very persistent in sediments. However, by applying the Arrhenius equation to that study and consequently extrapolating those results to a temperature of 12 °C, ECHA determined a much higher degradation half-life of phenanthrene, namely 216 to 247 days in the first sediment category and 220 to 285 days in the second sediment category. Those standardised results therefore indicated that the 180-day threshold for vP in sediments set out in Section 1.2.1(b) of Annex XIII was exceeded and thus allowed ECHA to conclude that phenanthrene was vP in that environmental compartment.
125    The present part therefore aims to determine whether ECHA could, without committing a manifest error of assessment, adjust the results of the Meisterjahn et al. (2018a) OECD 308 study by applying the Arrhenius equation to them.
126    In that regard, in the first place, the argument that the Arrhenius equation was developed and validated only for plant protection products and is inappropriate for hydrocarbons such as phenanthrene must be rejected.
127    First of all, it is clear that Chapter R.7b of the ECHA Guidance does not limit the use of the Arrhenius equation to one specific type of substance. Secondly, that chapter provides, without any limitation as to the type of substance involved, that if a study is carried out in accordance with OECD Guideline 308 at a temperature above 12 °C, which is the average temperature in Europe, that study ‘should be normalised’ using the Arrhenius equation. Finally, the chapter states that ‘in every case’, kinetic results such as degradation rates and degradation half-lives ‘should correspond’ to an environmentally relevant temperature, namely, by default 12 °C. There is therefore no indication that a study on the biodegradation of phenanthrene in sediment cannot be adjusted on the basis of the Arrhenius equation. On the contrary, Chapter R.7b of the ECHA Guidance specifically envisages the application of that equation to studies that have been conducted, as in the present case, in accordance with OECD Guideline 308 and at a temperature above 12 °C.
128    Consequently, the applicant’s argument based on Section 1.3 of Annex XI, which prohibits the use of a calculation method, more specifically a (Q)SAR model, if the substance in question does not fall within the scope of that (Q)SAR model, must be rejected. Even if the Arrhenius equation could be considered as a (Q)SAR model, which ECHA disputes, it is clear from the above considerations that phenanthrene falls within the scope of that equation, since Chapter R.7b of the ECHA Guidance does not restrict it to any specific substance.
129    It should also be noted that Chapter R.7b of the ECHA Guidance provides for the possibility of using the Arrhenius equation in the absence of class-specific structural equations or models reflecting the temperature dependence of biodegradation. Neither the applicant nor Concawe submitted such structural equations or models specific to phenanthrene, which could have precluded the application of the Arrhenius equation.
130    In the second place, the applicant notes that Chapter R.7b of the ECHA Guidance states that the use of the Arrhenius equation gives rise to potential uncertainties on the ground that it was designed for simple chemical reactions and that the specific activation energy of a substance, which is one of the parameters of that equation, is often not known. Phenanthrene has many possible degradation pathways and its specific activation energy is unknown. The application of the Arrhenius equation to a study based on OECD Guideline 308 therefore makes the temperature correction, performed by ECHA, uncertain.
131    That argument must be rejected. First, the fact that the specific activation energy for phenanthrene is unknown does not make the Arrhenius equation inapplicable or call into question the validity of its results. As explicitly stated in Chapter R.7b of the ECHA Guidance, it is rare that the specific activation energy for a substance is known. That chapter states that in such a situation a default value of 65.4 kJ/mol is used.
132    Secondly, it is admittedly true that Chapter R.7b of the ECHA Guidance states that the Arrhenius equation was designed more for simple chemical reactions than for biological processes. However, that clarification does not mean that the application of the Arrhenius equation is excluded with regard to biological processes, nor that the application of that equation to such processes necessarily results in invalid results. Furthermore, and as stated in paragraph 127 above, Chapter R.7b of the ECHA Guidance does not restrict the use of the Arrhenius equation to one specific type of substance.
133    In the third place, the applicant claims that the ECHA Guidance only requires the Arrhenius equation to be used if the measured half-life, before adjustment, is close to the persistence criterion. That is not the case here, since the Meisterjahn et al. (2018a) OECD 308 study concluded that the half-life of phenanthrene in sediment before adjustment was 116 days, which greatly diverges from the 180-day threshold. Furthermore, the ECHA Guidance only allows ‘small corrections’ to the measured half-lives in studies conducted at 20 °C. By applying the Arrhenius equation, ECHA almost doubled the half-life of phenanthrene measured in the Meisterjahn et al. (2018a) OECD 308 study.
134    That argument is based on a misreading of the ECHA Guidance. It is true that Chapter R.7b of the ECHA Guidance states that it is ‘particularly important’ to use the Arrhenius equation if the results of a study performed at 20 °C are close to the persistence criterion, namely a degradation half-life of more than 120 days. However, that guidance does not provide that the results must be close to the vP criterion, namely a degradation half-life of more than 180 days. The Court considers that a half-life of 116 days is not particularly far from a half-life of 120 days. Moreover, nowhere in that chapter does it state, and the applicant has not provided any specific reference in that regard, that only ‘small corrections’ are permissible.
135    In the fourth place, the applicant claims that the application of the Arrhenius equation in the present case led to an overestimation of the half-life of phenanthrene at low temperatures. That result deviates significantly from the results of the nine studies cited in the Concawe poster, as submitted during the public consultation. In the applicant’s view, that discrepancy between the results can only be explained by the inadequacy of the Arrhenius equation for phenanthrene.
136    As a preliminary point, the Court notes that the applicant’s position lacks clarity and consistency in that regard. In the application, the applicant dismisses any influence of temperature on the rate of degradation of phenanthrene. It states, on the basis of the nine studies of the Concawe poster, that ‘temperature ranging from 5 – 22 °C [does] not affect the rate of degradation of phenanthrene’, that ‘the half-life of phenanthrene is not dependent on temperature’ and that ‘no correlation of degradation half-life with temperature is evident from these data’. However, at the reply stage, the applicant contests having argued that ‘the degradation rate of phenanthrene [was] totally independent [from] temperature’. In any event, still at the reply stage, the applicant refocuses its argument on the question whether or not the Arrhenius equation allows the degradation of phenanthrene at different temperatures to be accurately defined.
137    In essence, therefore, the applicant submits that the discrepancy in results found at different temperatures between the nine studies listed in the Concawe poster and the ‘predictions’ of the Arrhenius equation can be explained solely by the inadequacy of that equation as regards phenanthrene.
138    In that regard, first of all, it should be noted that all the parties agree, in their replies to the Court’s written questions, that the rate of biodegradation of hydrocarbons is dependent on a multitude of factors. In that connection, Concawe mentions in particular the presence of light, oxygen and other nutrients. However, in those replies, the parties differed on the extent to which temperature was a factor.
139    Next, ECHA indicated in the Phenanthrene Support Document that it did not have sufficient information on the test conditions under which the nine studies mentioned in the Concawe poster were conducted. Furthermore, in its submissions to the Court, ECHA stated that it could not take those studies into account, as several parameters, not just temperature, had been changed. In other words, since the temperature was not the only parameter to have been changed, it was impossible for ECHA to compare the biodegradation rates obtained in those studies.
140    Those methodological reservations of ECHA were not contested by the applicant. At most, in paragraph 93 of the reply, the applicant merely states that the differences in the test parameters, the existence of which it does not deny, do not explain the discrepancy between the results.
141    In those circumstances, no conclusions can be drawn from the nine studies mentioned in the Concawe poster, since the temperature parameter cannot be isolated. That parameter is not the only variable that would have made it possible to compare the results. Other factors may have influenced the results. Consequently, contrary to what the applicant maintains, it cannot be inferred that the discrepancy between the results referred to above can be explained only by an alleged inadequacy of the Arrhenius equation for phenanthrene.
142    Finally, the five studies referred to in paragraph 122 above must be excluded. Neither the applicant nor Concawe demonstrated, in their replies to the Court’s written questions, that the Ratkowski et al. (1982), Ratkowski et al. (1983), Rivkin et al. (1996) and Kirchmann et al. (2005) studies specifically concerned hydrocarbons or phenanthrene. In contrast, the Lewis and Prince (2018) study, in particular Section 5 of that study, entitled ‘Oil and Dispersant Degradation under Arctic Conditions’, which is the only section referred to by the applicant and Concawe, deals with hydrocarbon degradation. However, first, that section mentions phenanthrene only once in order to specify its maximum solubility in sea water (p. 6103). Secondly, Section 5 does not analyse the degradation of hydrocarbons in sediments. In conclusion and after describing the degradation of these substances in the water column, the authors merely state that ‘further biodegradation can be expected in the sediment’ (p. 6104). That is not scientifically demonstrated and is only hypothetical. The Lewis and Prince (2018) study is therefore irrelevant to validate or invalidate the use of the Arrhenius equation in the present case.
143    Furthermore, in view of the case-law cited in paragraph 87 above, account also cannot be taken of the Sjøholm et al. (2019) and Sjøholm et al. (2020) studies, transmitted by the French Republic as an annex to its written replies, since those studies did not exist, and were therefore not available, when the contested decision was adopted.
144    In the light of all of these considerations, it must be concluded that the applicant has not demonstrated that ECHA committed a manifest error of assessment in adjusting, by the application of the Arrhenius equation, the results of the Meisterjahn et al. (2018a) OECD 308 study.
145    Consequently the fourth part of the first plea in law should be rejected.
The fifth part of the first plea in law, alleging a manifest error of assessment in that ECHA did not evaluate the new data on the persistence of phenanthrene which were communicated to it during the public consultation
146    In the context of the fifth part, in the first place, the applicant, supported by Concawe, claims that ECHA did not properly assess the positive result of the ready biodegradability test, carried out in accordance with OECD Guideline 301 C, as reported in the Junker et al. (2016) study. That result provides clear evidence that phenanthrene is readily biodegradable and therefore not persistent in sediments. Furthermore, Chapter R.7b of the ECHA Guidance states that such a positive result implies that the substance in question degrades rapidly and permanently under most environmental conditions. Moreover, according to Annexes VII and IX to Regulation No 1907/2006 and Chapters R.7b and R.11 of the ECHA Guidance, a simulation test in sediment is not required if the substance concerned is shown to be readily biodegradable. However, the MSC did not draw any conclusions from the positive result of the ready biodegradability test, reported in the Junker et al. (2016) study, and, in its assessment, merely confirmed that phenanthrene could biodegrade in water.
147    Likewise, it was wrong for ECHA to limit itself to noting the inconsistency between the results of the CITI (1992) and INERIS (2010) studies and those of the Junker et al. (2016) study. Chapter R.7b of the ECHA Guidance indeed requires that in such a case, the existence of possible differences in the design and conditions of the test be investigated. However, ECHA did not carry out that comparison. Furthermore, the INERIS (2010) study does not reveal any ready biodegradability, unlike the Junker et al. (2016) study. Finally, and even if all methodological parameters were not known, the CITI (1992) and INERIS (2010) studies could have led to false negative results. In any case, it is apparent from both Chapter R.7b of the ECHA Guidance and OECD Guideline 301 C that positive results of a ready biodegradability test substitute for negative results.
148    In the second place, the applicant complains that the MSC completely ignored the second part of the Junker et al. (2016) study describing the WSST test, which indicates that phenanthrene has a degradation half-life of 25.3 days. Furthermore, the French Republic and ECHA misunderstood the purpose of the study based on the WSST test and confused it with the other test, relating to ready biodegradability, cited in the Junker et al. (2016) study, conducted in accordance with OECD Guideline 301 C. Furthermore, the WSST test was specifically designed to assess the persistence of chemicals in sediments. Thus, the fact that it is not a recommended test does not justify disregarding it without any assessment. In any case, although the WSST test is not a ready biodegradability test, it nevertheless allows for a faster degradation of phenanthrene to be observed than that mentioned in the results of the Meisterjahn et al. (2018a) OECD 308 study.
149    ECHA contends that the fifth part of the first plea in law should be rejected. The French Republic does not develop any specific arguments regarding the fifth part, but it asserts that the choice of the MSC to give significant weight to the results of the Meisterjahn et al. (2018a) OECD 308 study is in line with both the objective pursued by Regulation No 1907/2006 and the recommendations of Chapter R.7b of the ECHA Guidance.
150    At the outset, it should be noted that the third paragraph of the preamble to Annex XIII provides as follows :
‘A weight-of-evidence determination means that all available information bearing on the identification of a [persistent, bioaccumulative and toxic (‘PBT substance’)] or a vPvB substance is considered together … The available results regardless of their individual conclusions shall be assembled together in a single weight-of-evidence determination.’
151    It should also be noted that the second paragraph of the preamble to Annex XIII provides as follows:
‘For the identification of PBT substances and vPvB substances a weight-of-evidence determination using expert judgement shall be applied, by comparing all relevant and available information listed in Section 3.2 with the criteria set out in Section 1. This shall be applied in particular where the criteria set out in Section 1 cannot be applied directly to the available information.’
152    Therefore, first, it is apparent from the preamble to Annex XIII that the Union legislature intended that all relevant and available information should be taken into account in the determination of probative value, while attaching specific importance to the information relating to the assessment of the P, vP, B, vB and T properties referred to in Section 3.2 of that annex.
153    In that regard, in particular with respect to the assessment of the vP character of substances in sediment, Section 3.2.1(c) of Annex XIII provides that the information to be taken into account is the ‘results from simulation testing on degradation in sediment’.
154    However, Section 3.2.1(d) of Annex XIII also allows ‘other information, such as information from field studies or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated’ to be taken into account for the same purpose.
155    Secondly, it is also clear from the preamble to Annex XIII that the relevant and available information referred to in Section 3.2 must be compared with the criteria set out in Section 1.
156    In that regard, Section 1.2.1(b) of Annex XIII provides that ‘a substance fulfils the “very persistent” criterion (vP) … where the degradation half-life in marine, freshwater or estuarine sediment is greater than 180 days’.
157    It is in the light of those elements that it must be verified whether, as the applicant and Concawe essentially maintain, ECHA committed a manifest error of assessment by giving a preponderant weight to the Meisterjahn et al. (2018a) OECD 308 study compared to the two tests cited in the Junker et al. (2016) study.
158    On that point, it is common ground between the parties that the Meisterjahn et al. (2018a) OECD 308 study is a water-sediment simulation test. At most, the applicant and Concawe question the scientific validity of that study, but they do not dispute its nature.
159    As pointed out in paragraphs 152 and 153 above, the Union legislature wished, with regard to the identification of very persistent substances in sediments, to attach specific importance to the results of the simulation tests.
160    Furthermore, information from the Meisterjahn et al. (2018a) OECD 308 study, as adjusted by application of the Arrhenius equation, indicates a persistence of phenanthrene in sediment that is well above the 180-day threshold set by Section 1.2.1 of Annex XIII, namely a half-life of between 216 and 319 days.
161    In those circumstances, ECHA did not commit a manifest error of assessment in giving significant weight to the results of the Meisterjahn et al. (2018a) OECD 308 study. That conclusion is all the more valid since the applicant and Concawe failed to demonstrate, in the context of the third and fourth parts of the first plea in law, that the results of that study were erroneous or that the Arrhenius equation was inappropriate for hydrocarbons.
162    That conclusion is not called into question by the other arguments of the applicant and Concawe.
163    In the first place, the Court notes that the applicant does not dispute that the ready biodegradability test, as cited in the first part of the Junker et al. (2016) study, was taken into account by ECHA. As to the applicant’s argument that the WSST test was totally ignored by the MSC, it should be recalled that it was rejected in paragraphs 88 to 92 above. That test was in fact examined by the French Republic in the RCOM document and discussed at the MSC meeting. In essence, ECHA therefore considered those two tests, but considered that the Meisterjahn et al. (2018a) OECD 308 study had a greater probative value.
164    For the sake of completeness, the Court does not grasp the scope of the argument developed by the applicant in relation to the WSST test. In essence, the applicant limits itself to criticising the French Republic for having confused the WSST test with the ready biodegradability test, as cited in the first part of the Junker et al. (2016) study. The French Republic was wrong to have considered the WSST test to be a ready biodegradability test. On that point, it is sufficient to note that, in its comments during the public consultation, Concawe specified that the WSST test had been developed ‘on the basis of [Guideline] 301 C’. However, OECD Guideline 301 states that it outlines six guidelines, including Guideline 301 C, which allow chemicals to be classified on the basis of their ‘ready biodegradability in an aerobic aqueous medium’. Furthermore, the applicant has not argued that the main result of the WSST test, as described by Concawe in its observations during the public consultation, namely the determination of a 51.3% mineralisation rate of phenanthrene over 28 days, was incorrectly reported by the French Republic in the RCOM document. In fact, that is not the case. In those circumstances, the Court does not understand in what way the applicant’s argument allows it to be held that ECHA incorrectly assessed the WSST test in the light of the criteria laid down by Annex XIII.
165    In the second place, ECHA did not fail to carry out an assessment under Annex XIII by disregarding the positive result of the ready biodegradability test, as reported in the first part of the Junker et al. (2016) study.
166    First, unlike the Meisterjahn et al. (2018a) OECD 308 study, the results of the ready biodegradability tests are, by nature, not ‘assessment information’ for vP character, within the meaning of Section 3.2 of Annex XIII, but ‘screening information’ for that property, within the meaning of Section 3.1 of that annex. The Court notes that Section 3.1.1 refers explicitly to ‘results from tests on ready biodegradation’. First, as indicated in paragraphs 152 and 153 above, the preamble to Annex XIII attaches specific importance to the information referred to in Section 3.2. Secondly, the wording itself of Section 3.1 specifies that screening information ‘may be considered’ in dossiers to identify the vP substances mentioned in Article 57(e) of Regulation No 1907/2006. In contrast, the second paragraph in the preamble to Annex XIII (‘by comparing all relevant and available information listed in Section 3.2 with the criteria set out in Section 1’) and Section 3.2 of that annex (‘the following information shall be considered’) require, by the use of the imperative mode, that information for assessment, such as the Meisterjahn et al. (2018a) OECD 308 study, be considered in a weight-of-evidence approach.
167    Secondly, it is admittedly true, as the applicant points out, that Figure R.11-3, included in the ECHA Guidance, appears to state, at first sight, that a positive result of a ready biodegradability test implies the absence of persistence of the substance concerned. However, in the commentary to that figure (Chapter R.11, p. 42), ECHA states that, in the presence of such a positive result, there is no reason to resort to further biodegradation tests, as that result ‘generally’ implies that the substance is neither persistent nor very persistent. The use of the adverb ‘generally’ means that there could be situations, even in rare cases, in which a positive result of a ready biodegradability test would not exclude the substance being persistent or even very persistent.
168    Similarly, Chapter R.7b of the ECHA Guidance states that no further investigation of the biodegradability of the substance is ‘normally’ required in case of a positive result. However, for the same reasons as explained in paragraph 167 above, the use of that adverb does not exclude that in some cases a positive result of a ready biodegradability test may still require further studies. Furthermore, and in any case, it must be noted that the causality between such a positive result and the absence of persistence is only ‘assumed’ on page 208 of Chapter R.7b of the ECHA Guidance.
169    Finally, even if it is considered that Figure R.11-3 and Chapter R.7b should be read in the sense that a positive result of a ready biodegradability test automatically implies the absence of persistence of the substance concerned, such an interpretation of the ECHA Guidance would be incompatible with the intention expressed by the Union legislature in the context of the assessment of probative value organised by Annex XIII. The interpretation advocated by the applicant amounts to a legal and irrefutable presumption of the absence of P or vP properties in the case of ready biodegradation. However, the combined reading of the applicable texts does not authorise such an interpretation, which would lead, as the case may be, to an obligation to ignore scientific evidence to the contrary. While it is true that the texts do not oblige ECHA to go further in the event of a finding of ready biodegradation, they must be interpreted, at the very least, in the sense of a rebuttable presumption, which is the only interpretation that can be reconciled with the objectives set out in Article 1(1) of Regulation No 1907/2006, and in particular the precautionary principle.
170    However, precisely, the results of the Meisterjahn et al. (2018a) OECD 308 study indicate that the degradation half-life of phenanthrene is well above the 180-day threshold set in Section 1.2.1 of Annex XIII.
171    In the third place, contrary to what is claimed by the applicant, supported by Concawe, ECHA did not commit a manifest error of assessment by failing to examine the reasons for the discrepancy in the results between, on the one hand, the Junker et al. (2016) study and, on the other hand, the CITI (1992) and INERIS (2010) studies. Similarly, the fact that ECHA did not give precedence to the positive results of the Junker et al. (2016) study over the negative results of the CITI (1992) and INERIS (2010) studies does not invalidate its conclusion either. It is sufficient to note that ECHA adopted the contested decision, in the exercise of its scientific discretion, not on the basis of the CITI (1992) and INERIS (2010) studies, but on the basis of the Meisterjahn et al. (2018a) OECD 308 study. As indicated above, ECHA, in accordance with Annex XIII and without committing a manifest error of assessment in that respect, gave more significant weight to the latter study in the assessment of vP of phenanthrene in sediment.
172    In the fourth place, the argument based on the alleged hierarchy of tests for the persistence of a substance organised by Annexes VII and IX to Regulation No 1907/2006 is not convincing either. In that regard, it is sufficient to note that those annexes simply do not derogate from Annex XIII. Those two annexes merely prescribe standard information requirements for substances manufactured or imported in quantities equal to or greater than one or 100 tonnes, respectively.
173    In the light of all those considerations, it must be held that the applicant has not demonstrated that ECHA committed a manifest error of assessment in giving preponderant weight to the results of the Meisterjahn et al. (2018a) OECD 308 study.
174    Consequently, the fifth part of the first plea in law must be rejected.
The sixth part of the first plea in law, alleging a manifest error of assessment in that ECHA did not examine all the relevant information in determining the probative value of the persistent properties of phenanthrene, in particular concerning photodegradation, dissolution and volatilisation
175    In the context of the sixth part, the applicant, supported by Concawe, submits, in essence, that ECHA did not properly consider, in its assessment of the persistence of phenanthrene based on the weight of evidence under Annex XIII, the information, submitted by Concawe during the public consultation, relating to photodegradation, dissolution and volatilisation of that substance. According to the applicant and Concawe, phenanthrene undergoes continuous exchange between sediments and the water column and air. Due to its solubility, phenanthrene is rapidly removed by biodegradation throughout the water column and by photodegradation in surface waters. In addition, due to its volatility, phenanthrene is removed from the water column to the atmosphere by evaporation from surface waters, where it is rapidly photodegraded. Therefore, the photodegradation rates of phenanthrene, as measured in the laboratory, correspond to half-lives of the order of a few minutes. Those processes result in the continuous transfer of phenanthrene from the sediment to the water column and then to the air in a dynamic system, so that it is not persistent in sediments. However, the MSC considered the role of photodegradation, dissolution and volatilisation of phenanthrene to be irrelevant, wrongly assuming that the presence of phenanthrene in sediment was a static process, when in fact it was a dynamic process.
176    ECHA contends that the sixth part of the first plea in law should be rejected. The French Republic does not present any specific arguments concerning the sixth part, but it asserts, in general, that ECHA complied with the requirements of Annex XIII by taking into consideration all the available information having a bearing on the identification of phenanthrene as a very persistent substance.
177    In that regard, it should be noted that, as mentioned in paragraph 154 above, Section 3.2.1(d) of Annex XIII allows for ‘other information, such as information from field studies or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated’, to be taken into account for the purpose of assessing the persistence or vP of a substance.
178    In order to assess the merits of the argument presented in the sixth part, it is necessary to verify, as a first step, whether or not the information on photodegradation, dissolution and volatilisation of phenanthrene constitutes reliable and suitable information within the meaning of Section 3.2.1(d) of Annex XIII. If the answer to that question is in the affirmative, the Court will consider, as a second step, whether ECHA took that information into account, together with the Meisterjahn et al. (2018a) OECD 308 study, in its weight-of-evidence assessment.
179    In that connection, ECHA considers that Section 3.2.1(d) of Annex XIII is only concerned with information on the ‘degradation’ of a substance. Therefore, the material scope of that provision excludes other information relating in particular to dissipation, partitioning or transfer from one environmental compartment to another of a substance.
180    In that regard, it is admittedly true that, unlike Section 3.2.1(a) to (c) of Annex XIII, Section 3.2.1(d) of that annex does not explicitly state that the information referred to therein must relate to the ‘degradation’ of a substance. That section merely refers to ‘other information … provided that its suitability and reliability can be reasonably demonstrated’.
181    However, the interpretation of Section 3.2.1(d) of Annex XIII must be based on a systemic approach and, therefore, cannot disregard Section 3.2.1(a) to (c) of Annex XIII or Section 1.2.1 of that annex.
182    First, Section 3.2.1(a) to (c) of Annex XIII expressly refers to the results of simulation tests on the ‘degradation’ of a substance in three environmental compartments, namely surface water, soil and sediment respectively. In those three cases, the assessment of the persistence or vP of a substance is therefore based exclusively on the ‘degradation’ of the substance concerned. Moreover, each of those cases associates that degradation process with a particular environmental compartment.
183    Secondly, the information referred to in Section 3.2.1(a) to (c) of Annex XIII must then be compared with the criteria set out in Section 1.2.1 of that annex. However, the latter section also makes explicit reference to the ‘degradation’ of the substance concerned, for each of the environmental compartments concerned. Therefore, in the present case, the vP character of phenanthrene is established under Section 1.2.1(b) of Annex XIII, as its ‘degradation’ half-life in sediments is greater than 180 days.
184    Both Section 1.2.1 and Section 3.2.1(a) to (c) of Annex XIII are therefore explicitly and exclusively based on information relating to the ‘degradation’ of the substance in question.
185    The Court therefore sees no prima facie reason to consider that Section 3.2.1(d) of Annex XIII has any other purpose than to provide information relating to the degradation process of a substance in a particular compartment.
186    The term ‘other information’ in Section 3.2.1(d) of Annex XIII is simply intended to capture information other than that mentioned in Section 3.2.1(a) to (c) of Annex XIII resulting from simulation tests. In that regard, Section 3.2.1(d) of Annex XIII gives as examples, without being exhaustive, ‘information from field studies or monitoring studies’.
187    In any event, it must be noted that the applicant has not explained in what way, in concrete terms, the processes of transfer of phenanthrene from sediments to the water column and then from the water column to the atmosphere, and of photodegradation and volatilisation of that substance, have a real impact on the speed and extent of the degradation of phenanthrene in sediments. In that connection, the Court notes that those processes only concern the water and air compartments and are not relevant to the degradation of phenanthrene in sediments. Therefore, at most, those processes only demonstrate that phenanthrene degrades in the water column and in air, but they do not provide any information as to the persistence of that substance in sediments.
188    In the present case, the only question of importance, in the light of the rules of Annex XIII, is whether or not the degradation half-life of phenanthrene is greater than 180 days in sediments before its transfer to the water column and to the air, and a fortiori in the absence of such transfer. In that regard, the results of the Meisterjahn et al. (2018a) OECD 308 study, as adjusted by the Arrhenius equation, show that phenanthrene is very persistent in sediments for the purposes of Section 1.2.1(b) of Annex XIII.
189    Therefore, the fact that, in assessing the persistence of phenanthrene in sediment, information concerning the photodegradation, dissolution and volatilisation of that substance in water and air was not taken into account in determining the weight of evidence does not constitute a manifest error of assessment.
190    For the sake of completeness, the Court concludes that, even if they could fall within the material scope of Section 3.2.1(d) of Annex XIII, none of the information mentioned by the applicant and Concawe is capable of demonstrating that phenanthrene is not very persistent in sediments.
191    In the first place, it should be noted that, although it mentions it in its written pleadings, the applicant has not put forward any concrete evidence to show that the process of biodegradation of phenanthrene in the water column has any impact on its persistence in sediments.
192    In the second place, as regards the photodegradation of phenanthrene in water, first of all, it should be noted that the parties agree that that process only takes place in surface water and not in the entire water column.
193    Next, the French Republic indicated, in the RCOM document, that, according to Chapter R.11 of the ECHA Guidance, data derived from abiotic studies, such as photodegradation, could not be used in isolation in the persistence assessment.
194    In addition to the responses of the French Republic, the Phenanthrene Support Document also referred to the photodegradation of that substance in water. While it acknowledged that the substance can be photodegraded, it added that that is only possible in the upper few centimetres of the water column, which could therefore not have a significant impact on the overall persistence of phenanthrene in the whole aquatic environment. Next, referring to Chapter R.7b of the ECHA Guidance and the Castro-Jiménez and de Meent (2011) study, the Phenanthrene Support Document states that, due to the multiplicity of factors affecting photodegradation rates, that process is generally not considered in the persistence assessment in the context of Regulation No 1907/2006. In conclusion, that document states that ‘aquatic photodegradation is not considered to have a significant impact on the overall persistence of phenanthrene in the environment’.
195    It follows from those elements, based in particular on Chapters R.7b and R.11 of the ECHA Guidance, that data on photodegradation of phenanthrene in surface water, assuming that they can be considered in another environmental compartment, do not constitute, in any case, ‘suitable’ and ‘reliable’ information within the meaning of Section 3.2.1(d) of Annex XIII, in order to demonstrate that that substance is not very persistent in sediments.
196    In the third place, for similar reasons, information on photodegradation of phenanthrene in air should not be considered ‘suitable’ or ‘reliable’ within the meaning of Section 3.2.1(d) of Annex XIII.
197    First of all, the photodegradation process takes place, in addition to surface waters, only in air. It is therefore alien to the sediment compartment. Next, as in the case of surface waters, Chapter R.11 of the ECHA Guidance states, on two occasions, that data from photodegradation are generally not taken into consideration for the assessment of persistence.
198    Furthermore, ECHA argued, in its written pleadings before the Court, that the results of the Mackay Level III fugacity model showed that phenanthrene only split at a very low percentage in air, namely 0.5%. ECHA concludes therefrom that photodegradation in air is not a relevant mechanism for the elimination of phenanthrene. The applicant does object to those statements, in particular because the Mackay Level III fugacity model does not give any indication of the fluxes taking place between the various environmental compartments. However, it does not refer to any scientific publication to support its objections. At most, it refers to the testimony of an expert, who allegedly used more accurate models than the Mackay Level III fugacity model. However, as that expert explains, and as the applicant also agrees, his analysis concerns only the photodegradation of phenanthrene in water, not in air. The testimony of that expert is therefore not such as to call into question ECHA’s assertions based on the Mackay Level III fugacity model.
199    In the fourth place, the arguments exchanged between the parties in response to the discussion initiated on that point by ECHA, on the volatilisation of phenanthrene from soil to air, are ineffective. Likewise, the Meisterjahn et al. (2018b) OECD 307 study, cited by Concawe and relating to the persistence of phenanthrene in soils, is not relevant. First, the volatilisation process of phenanthrene from soil to air is irrelevant for the assessment of the persistence of that substance in sediments. Secondly, and more importantly, the Phenanthrene Support Document noted that the information available at the time did not allow definitive conclusions to be drawn on the persistence of that substance in soils. In view of those scientific uncertainties, those data, assuming that they could be taken into account in another environmental compartment, do not in any case constitute ‘suitable’ and ‘reliable’ information within the meaning of Section 3.2.1(d) of Annex XIII in order to demonstrate that that substance is not very persistent in sediments.
200    In the fifth place, Concawe and, following it, the applicant argue that the Meisterjahn et al. (2018c) OECD 314 B study, which shows that phenanthrene is biodegradable in activated sludge and that its half-life is less than one day, was not taken into account either by the French Republic or by ECHA in the assessment of the persistence of that substance.
201    That argument must be rejected. First, the French Republic explicitly responded to Concawe on that point by stating in the RCOM document that the Meisterjahn et al. (2018c) OECD 314 B study was not suitable for a persistence assessment in accordance with Chapters R.7 and R.11 of the ECHA Guidance. Secondly, Concawe itself states in paragraph 112 of its statement in intervention that there are no persistence criteria directly applicable to that study. For those reasons, the data from the Meisterjahn et al. (2018c) OECD 314 B study, specific to active sludge and assuming that it could be considered in another environmental compartment, do not constitute, in any case, ‘suitable’ and ‘reliable’ information within the meaning of Section 3.2.1(d) of Annex XIII, in order to demonstrate that that substance is not persistent in sediments.
202    In the light of all the above considerations, it must be concluded that ECHA did not commit a manifest error of assessment by not including information on photodegradation, dissolution and volatilisation of phenanthrene in its weight-of-evidence review.
203    Consequently, the sixth part of the first plea in law and, consequently, the first plea in law in its entirety, must be rejected.
The second plea in law, alleging infringement of the principle of proportionality
204    In support of the second plea in law, the applicant, supported by Concawe, claims, in essence, that the contested decision infringes the principle of proportionality. According to the applicant, the contested decision exceeds the limits of what is appropriate and necessary to achieve the objectives pursued by Title VII of Regulation No 1907/2006 and does not constitute the least restrictive measure to which ECHA could have resorted.
205    ECHA contends that the second plea in law should be rejected. The French Republic did not submit any observations on the second plea in law.
206    In that regard, according to settled case-law, the principle of proportionality, which is part 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 achieve the objectives legitimately pursued by the legislation in question, it being understood that, 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 judgment of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 124 and the case-law cited; judgment of 1 February 2013, Polyelectrolyte Producers Group and Others v Commission, T‑368/11, not published, EU:T:2013:53, paragraph 75).
207    As regards judicial review of the conditions referred to in paragraph 206 above, ECHA must be allowed a broad discretion in a field 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 field 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, judgments of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 125 and the case-law cited, and of 1 February 2013, Polyelectrolyte Producers Group and Others v Commission, T‑368/11, not published, EU:T:2013:53, paragraph 76).
208    In the present case, it is apparent from the contested decision, and in particular from recital 10 thereof, but also from the Phenanthrene Support Document, that the MSC concluded that that substance was vP in sediments. In the light of that conclusion and the other conclusions relating to that substance, the contested decision provides, in paragraph 1 thereof, for the inclusion of phenanthrene on the list of substances identified for possible inclusion in Annex XIV and, in paragraph 3, for the updating of that list, on the ECHA website, in order to take account, inter alia, of the identification of phenanthrene as a substance of very high concern.
209    In that sense, the contested decision does not appear to be manifestly inappropriate for achieving the objectives pursued by Regulation No 1907/2006. According to Article 1(1) of that regulation, its purpose is to ensure a high level of protection of human health and the environment. In that regard, as stated in recital 76 of that regulation, international experience shows that substances with very persistent characteristics are of very high concern. However, as mentioned in recital 69 of that regulation and in accordance with the precautionary principle, special attention should be paid to substances of very high concern in order to ensure a sufficiently high level of protection of human health and the environment.
210    ECHA is therefore right, first, to maintain that the identification of phenanthrene as meeting the criteria set out in Article 57(e) of Regulation No 1907/2006 makes it possible to improve the information provided to the public and professionals on the risks associated with phenanthrene, which is, consequently, an instrument for improving the protection of human health and that of the environment (see, to that effect, judgments of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU: T:2015:254, paragraph 108 and the case-law cited, and of 11 July 2019, PlasticsEurope v ECHA, T‑185/17, not published, EU:T:2019:492, paragraph 52 and the case-law cited; see also, to that effect and by analogy, judgment of 7 July 2009, S.P.C.M. and Others, C‑558/07, EU:C:2009:430, paragraph 49).
211    Secondly, the identification of phenanthrene as a substance of very high concern also allows ECHA, the Member States and the European Commission, where appropriate, to consider that substance for possible inclusion in Annex XIV, in order to further protect human health and the environment. That conclusion is not invalidated by the fact, as argued by the applicant, that phenanthrene is currently only produced and used as a component of complex substances, and not as a substance as such. A substance may be identified as a substance of very high concern on the basis of the criteria laid down in Article 57 of Regulation No 1907/2006, even if it is only a constituent of another substance (see, to that effect and by analogy, judgments of 25 October 2017, PPG and SNF v ECHA, C‑650/15 P, EU:C:2017:802, paragraphs 63 and 65, and of 11 July 2019, PlasticsEurope v ECHA, T‑185/17, not published, EU:T:2019:492, paragraph 64).
212    In addition, the applicant claims that the contested decision is not appropriate to achieve the objective of increased protection of human health and the environment. However, as ECHA pointed out without being contradicted by the applicant, the latter has not in any way substantiated the reasons why, in its view, the contested decision is not such as to improve the protection of human health and the environment. At most, at the reply stage, the applicant states that the issue in this case is not the protection of human health or the environment, but the integrity of the process by which ECHA carried out the assessment of the persistence of phenanthrene. However, such an argument is irrelevant to the examination of the proportionality of the contested decision. In any event, that argument will be assessed in the context of the two additional pleas raised by Concawe.
213    Although the contested decision thus appears to be appropriate to ensure a high level of protection of human health and the environment, it is nevertheless necessary to ascertain whether there are, as the applicant claims, other measures which would make it possible to achieve that objective but which would be less restrictive.
214    In that regard, in the first place, the applicant considers that recourse to the substance evaluation procedure would have been less burdensome than the identification of phenanthrene as a substance of very high concern. The option chosen by ECHA, in fact, directly affected the applicant commercially, by bringing phenanthrene to significant adverse attention from non-governmental organisations (NGOs).
215    That argument must be rejected. First, the appropriateness of a measure must necessarily be analysed in the light of the objectives pursued by it. It is clear, as is explicitly stated in the applicant’s arguments, that the sole purpose of using the substance evaluation procedure instead of identifying phenanthrene as a substance of very high concern was to dispel the alleged uncertainties relating to the persistent nature of phenanthrene in sediments. The objective which the applicant assigns to the procedure for the assessment of the substance therefore does not sufficiently include the protection of public health and the environment. Moreover, as regards the alleged scientific uncertainties referred to by the applicant, the Court held, in the context of the first plea in law, that it was without committing a manifest error of assessment that ECHA had established that phenanthrene was very persistent in sediments.
216    Moreover, it has already been held that there is no indication in Regulation No 1907/2006 that the legislature intended to make the identification procedure carried out in accordance with Article 59 of that regulation, which is part of the authorisation procedure for a substance referred to in Title VII of that regulation, subject to the registration procedure provided for in Title II of that regulation, which includes the obligations referred to in Article 14 of that regulation, or to the evaluation procedure referred to in Articles 44 to 48 of that regulation. It is correct that the registration procedure and the evaluation procedure, which is designed as a follow-up to registration according to recital 20 of Regulation No 1907/2006, also serve to improve the information to the public and professionals on the hazards and risks of a substance, as set out in recitals 19 and 21 of that regulation. However, while registered substances should be allowed to circulate on the internal market, as set out in recital 19 of Regulation No 1907/2006, the objective of the authorisation procedure, which includes the identification procedure referred to in Article 59 of that regulation, is, inter alia, to progressively replace substances of very high concern by other suitable substances or technologies, where those are economically and technically viable. Furthermore, as is apparent from recital 69 of Regulation No 1907/2006 and as indicated in paragraph 209 above, the legislature intended to pay particular attention to substances of very high concern (judgment of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 114).
217    Consequently, the assessment of a substance provided for in Articles 44 to 48 of Regulation No 1907/2006 does not constitute an appropriate, necessary and sufficient measure to achieve the objectives pursued by that regulation regarding the treatment of substances of very high concern.
218    Secondly, it should be noted that the possible negative effects on trade which the applicant refers to are neither detailed in its written pleadings nor proven. It is therefore not possible to assess the extent of those alleged disadvantages and thus to conclude that the disadvantages are disproportionate to the objectives pursued. Moreover, even supposing that such negative effects exist, they are attributable to certain NGOs and not to the contested decision.
219    The applicant has therefore not demonstrated the existence of any disadvantages other than those resulting from the legal obligations, in particular the updating of the safety data sheet for the substance. On that last point, and in any event, it must be added that the objective of sharing information on substances of very high concern within the supply chain and with consumers, which, as stated in paragraph 210 above, contributes to improving the protection of human health and the environment, outweighs the disadvantages induced by the updating of the safety data sheet (see, to that effect, judgment of 11 July 2019, PlasticsEurope v ECHA, T‑185/17, not published, EU:T:2019:492, paragraph 64). Furthermore, the provisions of Articles 57 to 59 of Regulation No 1907/2006 would be rendered ineffective if their application were to be regarded as disproportionate solely on the ground that the public and professionals could take that information into account in their actions and decisions.
220    In the second place, Concawe argues that ECHA could have proposed an alternative dossier prepared in accordance with Annex XV, which could have allowed interested parties to demonstrate that phenanthrene did not meet the vP characteristic.
221    That argument must also be rejected. First, as ECHA points out, it is not competent to propose, on its own initiative, the submission of a dossier drawn up in accordance with Annex XV. According to Article 59(2) and (3) of Regulation No 1907/2006, the drawing up of a dossier in accordance with Annex XV is carried out either by a Member State or by ECHA ‘at the request of the Commission’. Secondly, even supposing that ECHA is competent to draw up, on its own initiative, a new dossier in accordance with Annex XV, it must be noted that the objective of such a dossier, as conceived by Concawe, namely to strengthen the scientific information available to demonstrate that phenanthrene is not persistent in sediments, is different from that pursued by the contested decision, namely to protect human health and the environment. Thus, the possible preparation of a new dossier in accordance with Annex XV also appears to be inappropriate for the protection of public health or the environment.
222    In the third place, the Court points out, as it has already noted in paragraphs 114 and 115 above, that the contested decision is capable of being re-examined if new relevant information becomes available. The inclusion of phenanthrene on the Candidate List under Article 57 of Regulation No 1907/2006 is therefore not, in itself, irreversible.
223    In the light of all the foregoing considerations, it must be concluded, first, that the contested decision is not manifestly inadequate to protect human health and the environment and, secondly, that neither the applicant nor Concawe has demonstrated the existence of other, less restrictive measures which would have made it possible to achieve that objective with the same degree of protection.
224    Consequently, the second plea in law must be rejected.
The first additional plea raised by Concawe, alleging lack of an adequate legal basis and an infringement of the obligation to state reasons
225    In support of the first additional plea in law, Concawe submits, in essence, that ECHA has not sufficiently identified the legal basis and reasons for the adoption of the contested decision. First, the contested decision does not provide any detailed justification for the identification of phenanthrene as a substance of very high concern. Secondly, the only document to which the contested decision refers is the Annex XV dossier submitted by the French Republic. Thirdly, ECHA did not, according to Concawe, specify the legal basis for not relying on the Annex XV dossier and for relying only on the MSC agreement referred to in paragraph 2 above and the Phenanthrene Support Document. Fourthly, the contested decision does not indicate that the latter two documents would serve as a basis for the decision. Consequently, the interested parties, including Concawe, were not clearly informed of the basis of the contested decision.
226    In its observations on Concawe’s statement in intervention and in its replies to a written question from the Court, the applicant recalls, first, that it had invoked, in the heading of the first plea in law, an infringement of Article 59 of Regulation No 1907/2006 and, secondly, that it had pointed out, in paragraph 42 of the reply, that ECHA had never made it clear that the contested decision was not based on the CTPHT Support Document. That constitutes a failure to comply with the duty to state reasons under Article 130 of Regulation No 1907/2006 and Article 296(2) TFEU, but also undermines the integrity of the process by which ECHA carried out the persistence assessment of phenanthrene.
227    In response to a written question from the Court, ECHA and the French Republic consider that that first additional plea is inadmissible, since it alters the subject matter of the dispute. The complaints and arguments put forward in support of the first additional plea do not appear in the application. Furthermore, in its observations on Concawe’s statement in intervention, ECHA contends that the first additional plea should be rejected as unfounded.
228    As a preliminary point, there is no need to rule on the admissibility of the first additional plea in law, since, in any event, according to settled case-law, a failure to state reasons or an inadequate statement of reasons is an infringement of essential procedural requirements within the meaning of Article 263 TFEU and constitutes a plea of public policy which may, or indeed must, be raised of its own motion by the EU judicature (see, to that effect, judgment of 3 May 2018, Malta v Commission, T‑653/16, EU: T:2018:241, paragraph 47 and the case-law cited).
229    Next, it should be recalled that the obligation to state reasons constitutes an essential formality which must be distinguished from the question of the merits of the statement of reasons, which is a matter of the substantive legality of the contested act (judgments of 22 March 2001, France v Commission, C‑17/99, EU:C:2001:178, paragraph 35, and of 20 September 2019, ICL-IP Terneuzen and ICL Europe Coöperatief v Commission, T‑610/17, EU:T:2019:637, paragraph 47).
230    Under the second paragraph of Article 296 TFEU, legal acts such as the contested decision must state the reasons on which they are based. As regards, more specifically, decisions taken under Regulation No 1907/2006, Article 130 of that regulation also provides that the reasons for them must be stated.
231    According to settled case-law, that statement of reasons must show clearly and unequivocally the reasoning of the institution which adopted the measure. It must, first, 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, secondly, enable the EU judicature to exercise its powers of review of legality. It is not, however, required to go into every relevant point of fact and law. 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 judgment of 12 December 2006, Germany v Parliament and Council, C‑380/03, EU:C:2006:772, paragraphs 107 and 108 and the case-law cited). Moreover, the participation of interested parties in the procedure for drawing up an act may reduce the requirement to state reasons, since it contributes to informing them (judgments of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 116, and of 1 February 2013, Polyelectrolyte Producers Group and Others v Commission, T‑368/11, not published, EU:T:2013:53, paragraph 101).
232    In the present case, it should be noted that the contested decision clearly and repeatedly states that it is based on Article 59 of Regulation No 1907/2006. Furthermore, the contested decision notes, in recitals 2 to 4 and 7, the holding of the public consultation and the fact that ECHA received comments on the identification of phenanthrene as a substance of very high concern. Finally, in recitals 8 and 10, the contested decision states that the dossier was forwarded to the MSC and that the members of the MSC unanimously concluded that phenanthrene fulfilled the vP criterion.
233    Admittedly, the contested decision merely summarises the main stages of the administrative phase. However, as is clear from the case-law referred to in paragraph 231 above, the statement of reasons need not specify all the relevant points of law or fact. Such a statement of reasons may also be derived from the context in which the contested decision is taken. Moreover, according to the same case-law, Concawe’s participation in the procedure leading to the adoption of the contested decision may reduce the requirement to state reasons, since it contributes to its information.
234    In that regard, it is common ground that Concawe and the applicant, which is a member of that association, were aware of the public consultation, since that association participated in it. Moreover, it was Concawe itself which, during that public consultation, forwarded to ECHA the Meisterjahn et al. (2018a) OECD 308 study. Concawe was also aware of the French Republic’s responses to its comments, as those responses were included in the RCOM document. Finally, Concawe was aware of the discussions at the MSC meeting of 12 December 2018 regarding both the Meisterjahn et al. (2018a) OECD 308 study and its adjustment by the Arrhenius equation. [confidential]
235    Moreover, as was noted when considering the first two parts of the first plea in law, in particular in paragraphs 57 to 61 above, it is explicitly apparent from the Phenanthrene Support Document and from the minutes of the MSC meeting of 12 December 2018 that the conclusion that that substance is highly persistent in sediments is decisively based on the Meisterjahn et al. (2018a) OECD 308 study.
236    In addition, Concawe’s claim that ECHA was not entitled to rely solely on an element which did not exist in the Annex XV dossier and which was only brought to its attention during the public consultation must be rejected. That complaint does not relate to the statement of reasons for the contested decision, but to its merits. In accordance with the case-law referred to in paragraph 229 above, that complaint is therefore irrelevant to the examination of the present plea. In addition, and in any event, the Court has already accepted that ECHA could rely, in order to identify a substance, on elements not mentioned in the dossier drawn up in accordance with Annex XV (see, to that effect, judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraphs 84 to 88; of 7 March 2013, Cindu Chemicals and Others v ECHA, T‑95/10, EU:T:2013:108, paragraphs 91 to 95; and of 7 March 2013, Rütgers Germany and Others v ECHA, T‑96/10, EU:T:2013:109, paragraphs 85 to 89). Moreover, to accept the opposite view would be to disregard the fact that the procedure laid down in Article 59 of Regulation No 1907/2006, consisting of the identification of the substances referred to in Article 57 of that regulation, takes place in several stages (judgments of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraph 29; of 7 March 2013, Cindu Chemicals and Others v ECHA, T‑95/10, EU:T:2013:108, paragraph 37; and of 7 March 2013, Rütgers Germany and Others v ECHA, T‑96/10, EU:T:2013:109, paragraph 31), but also to deprive the public consultation of any useful effect, since ECHA would then be legally prevented from taking into consideration the elements presented by the interested parties during that phase.
237    In the light of the foregoing, Concawe and the applicant are wrong to consider that ECHA has not sufficiently identified the legal basis and reasons for the adoption of the contested decision. The reasoning adopted, as it appears from the contested decision, but also from all of the abovementioned acts, enabled Concawe and the applicant to understand the scope and rationale of the contested decision and thus to defend their rights before the Court, as demonstrated in particular by the content of their arguments of fact and law set out in the present action. Similarly, that reasoning enabled the Court to review the legality of the contested decision.
238    Consequently, the first additional plea in law put forward by Concawe must be rejected.
The second additional plea in law put forward by Concawe, alleging an infringement of the right to be heard
239    In support of the second additional plea in law, Concawe claims, in essence, that the interested parties were not heard on all the factual and legal elements which led to the adoption of the contested decision. Both the dossier drawn up in accordance with Annex XV and the public consultation were concerned with the possible persistence of phenanthrene in soils. By contrast, the contested decision concludes that the substance is a vP substance in sediments. According to Concawe, the interested parties were never given the opportunity to comment on that new element, which formed the basis of the contested decision. In so doing, ECHA violated their right to be heard, as guaranteed by Article 59(4) of Regulation No 1907/2006.
240    In its observations on Concawe’s statement in intervention and in its replies to a written question from the Court, the applicant acknowledges that it did not explicitly raise such a complaint in its application, but that it is implicit in its written pleadings. In any event, it fully shares Concawe’s position. Apart from the fact that ECHA did not allow interested parties to comment on that new element, [confidential]
241    In response to a written question from the Court, ECHA and the French Republic consider that the second additional plea is inadmissible, since it alters the subject matter of the dispute. The complaints and arguments put forward in support of the second additional plea do not appear in the application. Furthermore, in its observations on Concawe’s statement in intervention, ECHA concludes that the second additional plea is unfounded.
242    As a preliminary point, the Court considers that, in the interests of the proper administration of justice, it is not necessary to rule on the admissibility of the second additional plea in law since, in any event, that plea must be rejected on the merits (see, to that effect, judgment of 26 February 2002, Council v Boehringer, C‑23/00 P, EU:C:2002:118, paragraph 52).
243    Contrary to what Concawe and the applicant maintain, Article 59(4) of Regulation No 1907/2006 does not guarantee a right to be heard to interested parties. At most, that provision provides that those parties are invited ‘to submit comments … to the Agency’ on the dossier prepared in accordance with Annex XV.
244    In that regard, it is settled case-law that, in the case of acts of general application, neither the process of drafting them nor those acts themselves require, by virtue of general principles of Union law, such as the right to be heard, consulted or informed, the participation of the persons affected. The situation is different if an express provision of the legal framework governing the adoption of that act confers such a procedural right on an affected person (see judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 87 and the case-law cited). It is common ground that the public consultation provided for in Article 59(4) of Regulation No 1907/2006 does not confer specific procedural rights on interested parties, other than the right to submit information. Even if that provision therefore provides for public consultation, that does not call into question the fact that ECHA is not required, under that article, to hear an individual who might be affected by the contested decision (see, to that effect and by analogy, judgment of 25 September 2015, VECCO and Others v Commission, T‑360/13, EU:T:2015:695, paragraphs 81 and 82 and the case-law cited).
245    Furthermore, for reasons similar to those set out in paragraph 236 above, the Court considers that the effectiveness of the provisions of Article 59 of Regulation No 1907/2006 would be undermined if ECHA were obliged to organise a new public consultation on the ground that it intended to rely on elements resulting from the first public consultation on which not all the interested parties had been able to comment. Such a requirement, which is not provided for in Regulation No 1907/2006, could encourage interested parties to submit new elements for each additional public consultation and thus permanently prevent the adoption of any decision by ECHA.
246    In the present case, neither Concawe nor the applicant disputes that a public consultation was held and that interested parties were able to submit observations. Indeed, Concawe did so.
247    Furthermore, even beyond the fact that it submitted observations during the public consultation, it appears from the file submitted to the Court and the parties’ written pleadings that Concawe was able to participate in the MSC meeting at which the Member States concluded that phenanthrene was highly persistent in sediments. [confidential].
248    In view of the foregoing, it must be concluded that Concawe and, through it, the applicant were able to submit their comments in accordance with the provisions of Article 59(4) of Regulation No 1907/2006.
249    Consequently, the second additional plea in law put forward by Concawe must be rejected and, therefore, the action in its entirety must be dismissed.
Costs
250    Under Article 134(1) 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 138(1) of the Rules of Procedure, the Member States which have intervened in the proceedings are to bear their own costs. Under Article 138(3) of the Rules of Procedure, the General Court may decide that an intervener other than those referred to in paragraphs 1 and 2 of that provision is to bear its own costs.
251    Since the applicant has been unsuccessful, it must be ordered to pay ECHA’s costs, in accordance with the form of order sought by the latter. The French Republic and Concawe shall each bear their own costs.
On those grounds,
THE GENERAL COURT (Eighth Chamber)
hereby:
1.      Dismisses the action;
2.      Orders Exxonmobil Petroleum & Chemical BVBA to bear its own costs and pay those incurred by the European Chemicals Agency (ECHA);
3.      Orders the French Republic and the European Petroleum Refiners Association to bear their own costs.
Svenningsen
Pynnä
Laitenberger
Delivered in open court in Luxembourg on 9 June 2021.
E. Coulon
S. Papasavvas
Registrar
President
Table of contents
Background to the dispute
Procedure and forms of order sought
Law
The first plea in law, alleging a manifest error of assessment, an ‘exceeding of competence’ and infringement of Article 59 of Regulation No 1907/2006
The first and second parts of the first plea in law, alleging a manifest error of assessment in that ECHA wrongly relied on the CTPHT Support Document and, in particular, on the information from the Mackay et al. (1992) report, the Neff study (1979) and the Volkering and Breure study (2003) in the Phenanthrene Support Document
The third part of the first plea in law, alleging a manifest error of assessment in that ECHA did not examine the available data which should have led it to question the reliability and extreme conservatism of the Meisterjahn et al. (2018a) OECD 308 study
The fourth part of the first plea in law, alleging a manifest error of assessment in that ECHA did not take into consideration information which called into question the use of a calculation model to adjust the results of the Meisterjahn et al. (2018a) OECD 308 study to take account of the temperature
The fifth part of the first plea in law, alleging a manifest error of assessment in that ECHA did not evaluate the new data on the persistence of phenanthrene which were communicated to it during the public consultation
The sixth part of the first plea in law, alleging a manifest error of assessment in that ECHA did not examine all the relevant information in determining the probative value of the persistent properties of phenanthrene, in particular concerning photodegradation, dissolution and volatilisation
The second plea in law, alleging infringement of the principle of proportionality
The first additional plea raised by Concawe, alleging lack of an adequate legal basis and an infringement of the obligation to state reasons
The second additional plea in law put forward by Concawe, alleging an infringement of the right to be heard
Costs
*      Language of the case: English.
1 Confidential information omitted.