JUDGMENT OF THE GENERAL COURT (Eighth Chamber)
10 November 2021 (*)
(REACH – Substances of very high concern – Establishment of a list of identified substances with a view to their eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 – Decision identifying the substance 4-tert-butylphenol as a substance meeting the criteria for inclusion in the list – Article 57 of Regulation (EC) No 1907/2006 – Weight of evidence approach – Manifest error of assessment – Proportionality)
In Case T‑661/19,
Sasol Germany GmbH, established in Hamburg (Germany),
SI Group – Béthune, established in Béthune (France),
BASF SE, established in Ludwigshafen am Rhein (Germany),
represented by C. Mereu and P. Sellar, lawyers,
applicants,
v
European Commission, represented by R. Lindenthal and K. Mifsud-Bonnici, acting as Agents,
defendant,
supported by
Federal Republic of Germany, represented by D. Klebs, J. Möller, S. Heimerl and S. Costanzo, acting as Agents,
and by
European Chemicals Agency (ECHA), represented by M. Heikkilä, W. Broere, S. Mahoney and A. Hautamäki, acting as Agents,
interveners,
APPLICATION under Article 263 TFEU seeking the annulment of Commission Implementing Decision (EU) 2019/1194 of 5 July 2019 on the identification of 4‑tert-butylphenol (PTBP) as a substance of very high concern pursuant to Article 57(f) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (OJ 2019 L 187, p. 41),
THE GENERAL COURT (Eighth Chamber),
composed of J. Svenningsen, President, R. Barents and J. Laitenberger (Rapporteur), Judges,
Registrar: E. Artemiou, Administrator,
having regard to the written part of the procedure and further to the hearing on 20 April 2021,
gives the following
Judgment
Background to the dispute
1        The applicants, Sasol Germany GmbH, SI Group – Béthune and BASF SE are manufacturers, suppliers and users of 4-tert-butylphenol (‘PTBP’). PTBP is a chemical substance primarily used as a monomer in chemical synthesis, for example, for the production of polycarbonate, phenolic resins and epoxy resins. PTBP has a harmonised classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1). PTBP has been classified as a category 2 toxic substance for reproduction, causing category 2 skin irritation and category 1 eye damage. PTBP has also been classified as toxic aquatic chronic 1 since 1 May 2020.
2        On 15 June 2016, the Federal Republic of Germany prepared a Risk Management Option Analysis and recommended the identification of PTBP as a substance of very high concern in accordance with Article 57(f) 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).
3        On 30 August 2016, in accordance with Article 59(3) of Regulation No 1907/2006, the Federal Republic of Germany submitted a dossier prepared in accordance with Annex XV to that regulation (‘the Annex XV dossier’) proposing that PTBP be identified as a substance of very high concern pursuant to Article 57(f) of Regulation No 1907/2006, that is to say, as a substance with endocrine disrupting properties for which there is scientific evidence of probable serious effects on the environment which give rise to a level of concern equivalent to that resulting from the use of other substances listed in Article 57(a) to (e) of that regulation.
4        Having received comments concerning the identification of PTBP from certain Member States and a number of interested parties, including the applicants, in the context of the public consultation organised pursuant to Article 59(4) of Regulation No 1907/2006, the European Chemicals Agency (ECHA) referred the dossier to the ECHA’s Member State Committee (‘MSC’), in accordance with Article 59(7) of that regulation.
5        On 15 December 2016, the MSC gave its opinion on the Annex XV dossier. Whilst the majority of the MSC members took the view that PTBP had to be identified as a substance of very high concern pursuant to Article 57(f) of Regulation No 1907/2006, the MSC was unable to reach unanimous agreement. Two members of that committee, namely the United Kingdom of Great Britain and Northern Ireland and the Czech Republic, expressed doubts as to the reliability of the key scientific study and were of the opinion that the available evidence did not give rise to a level of concern equivalent to that resulting from the use of other substances listed in Article 57(a) to (e) of that regulation. The assessment of PTBP on which the majority opinion is based is set out in a document entitled ‘Support Document’ (‘the support document’).
6        On 17 January 2017, pursuant to Article 59(9) of Regulation No 1907/2006, the ECHA forwarded the opinion of the MSC to the European Commission in order for the latter to take a decision on the identification of PTBP on the basis of Article 57(f) of that regulation.
7        On 5 July 2019, the Commission adopted, in accordance with the procedure referred to in Article 133(3) of Regulation No 1907/2006, Implementing Decision (EU) 2019/1194 on the identification of PTBP as a substance of very high concern pursuant to Article 57(f) of Regulation No 1907/2006 (OJ 2019 L 187, p. 41; ‘the contested decision’).
8        The recitals to the contested decision state:
‘…
(4)      The Commission concurs with the MSC opinion expressing its unanimous agreement …
that there is scientific evidence of adverse effects in fish linked to an oestrogen mode of action of PTBP, which demonstrates that the substance meets the World Health Organisation/International Programme on Chemical Safety (WHO/IPCS) definition of an endocrine disruptor. Exposure to PTBP leads to serious and irreversible adverse effects on sexual development of fish, namely a complete and irreversible sex reversal of affected fish populations resulting in all-female populations. The conclusion that PTBP exerts endocrine disruptive properties is further supported by read-across from other substances belonging to the same chemical class of alkylphenols as PTBP. For these reasons, the Commission concludes that for PTBP there is scientific evidence of probable serious effects [on] the environment.
(5)      The Commission considers that the adverse effects are of a severity similar to those of other substances which have been identified as substances of very high concern pursuant to Article 57(f) of Regulation (EC) No 1907/2006 due to their endocrine disrupting properties with probable serious effects to the environment. Effects observed in fish are irreversible and may be relevant for wildlife populations. The majority of the MSC was of the opinion that, on the basis of the available information, it appears difficult to derive a safe level of exposure to adequately assess the risks although it may exist. The Commission concurs with that assessment. The Commission therefore considers that the level of concern of the adverse effects is equivalent to those of substances referred to in points (a) to (e) of Article 57 of Regulation (EC) No 1907/2006. The fact that the adverse effects on the sexual development of fish were observed in the key study at low concentration levels (lowest observed effect concentration: 1 μg/l) further strengthens the concern.
…’
9        According to
paragraph 1 of Article 1 of the contested decision, PTBP ‘is identified as a substance of very high concern pursuant to Article 57(f) of Regulation (EC) No 1907/2006 due to its endocrine disrupting properties with probable serious effects [on] the environment which give rise to an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of that Regulation’. In addition, paragraph 2 of Article 1 of the contested decision provides that PTBP ‘shall be included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006’.
Article 2 of the decision provides that that decision is addressed to the ECHA.
10      Following the contested decision, the ECHA adopted Decision ED/71/2019, by which that agency updated the list of substances identified with a view to their eventual inclusion in Annex XIV to Regulation No 1907/2006 (‘the candidate list’), including, inter alia, PTBP in that list. That decision is dated 4 July 2019 and was published on the ECHA website on 16 July 2019.
11      By application lodged at the Registry of the General Court on 25 September 2019, the applicants brought an action under Article 263 TFEU for annulment of Decision ED/71/2019, which the Court dismissed as inadmissible by order of 14 July 2020, Sasol Germany and Others v ECHA (T‑640/19, not published, EU:T:2020:336).
Procedure and forms of order sought
12      By application lodged at the Court Registry on 27 September 2019, the applicants brought the present action.
13      On 20 December 2019, the Commission lodged its defence at the Court Registry.
14      By documents lodged at the Court Registry on 3 January and 22 January 2020 respectively, the Federal Republic of Germany and the ECHA sought leave to intervene in the present case in support of the form of order sought by the Commission.
15      By documents lodged at the Court Registry on 3 February and 14 February 2020, the applicants submitted their observations on the applications of the Federal Republic of Germany and the ECHA
for leave to intervene.
16      By decision of the President of the Eighth Chamber of the General Court of 11 February 2020, the Federal Republic of Germany was granted leave to intervene in the present case in support of the form of order sought by the Commission.
17      On 25 March 2020, the applicants lodged their reply at the Court Registry.
18      By order of 3 April 2020, the President of the Eighth Chamber of the General Court granted the ECHA leave to intervene in support of the form of order sought by the Commission.
19      On 18 May and 17 June 2020 respectively, the Federal Republic of Germany and the ECHA lodged their statements in intervention at the Court Registry.
20      On 9 June 2020, the Commission lodged the rejoinder at the Court Registry.
21      On 11 September and 14 September 2020 respectively, the main parties submitted their observations on the statements in intervention of the Federal Republic of Germany and of the ECHA.
22      The parties presented oral argument and answered the questions put by the Court at the hearing on 20 April 2021.
23      The applicants claim that the Court should:
–        declare the action admissible and well founded;
–        annul the contested decision;
–        order the Commission to pay the costs of the proceedings.
24      The Commission, supported by the Federal Republic of Germany and the ECHA, contends that the Court should:
–        dismiss the action as being unfounded;
–        order the applicants to pay the costs.
Law
25      The applicants put forward five pleas in law in support of their action. The first plea in law alleges ‘violation of criteria for endocrine disruption and the weight of evidence approach’. In the second plea in law, the applicants claim that the Commission infringed Article 57(f) of Regulation No 1907/2006 in considering the level of concern to be equivalent to that raised by the substances listed in Article 57(a) to (e) of Regulation No 1907/2006. The third plea in law alleges a manifest error of assessment owing to the ‘failure to consider carefully all relevant information and in particular exposure data’. The fourth plea in law alleges infringement of the principle of proportionality owing to the failure to choose the least onerous options. The fifth plea in law alleges infringement of the principle of proportionality owing to the failure to conduct a proper Risk Management Option Analysis, taking into account the risk-management measures already in place.
The first plea in law: ‘violation of criteria for endocrine disruption and the weight of evidence approach’
26      By the first plea, which comprises three parts, the applicants allege ‘violation of criteria for endocrine disruption and the weight of evidence approach’.
The first part of the first plea: failure to apply the ‘weight of evidence approach’
27      In the first part of the first plea, the applicants claim that identification as a substance of very high concern under Article 57(f) of Regulation No 1907/2006 must be based on consideration of all the available data obtained following the ‘weight of evidence approach’ (the ‘weight of evidence approach’). Despite the lack of criteria relating to endocrine disrupting properties in Regulation No 1907/2006, the weight of evidence approach provides indications on how to assess the intrinsic properties of a substance with endocrine disrupting properties and is therefore an essential component of the procedure for deciding on a substance’s properties. That approach, they submit, is a widely applied method for hazard assessment under Regulation No 1907/2006.
28      First, the applicants rely in that regard on the third paragraph of Annex XIII to Regulation No 1907/2006, which states that, for the purpose of identifying the substances referred to in Article 57(d) and (e) of that regulation, namely (i) persistent, bioaccumulative and toxic substances and (ii) very persistent and very bioaccumulative substances (together, ‘PBT and vPvB substances’), all available information is to be considered in the weight of evidence determination. Therefore, that approach requires that ‘all available information’ on the substance be assembled together and assessed.
29      Second, the applicants refer to Regulation No 1272/2008, which provides in section 1.1.1 of Annex I that the weight of evidence approach should be applied to identify the properties of a substance. Similarly, Article 9(3) of that regulation provides that it may be necessary, for the purposes of classifying a substance on the basis of its hazards, to weigh all available information.
30      Third, they submit, the ECHA’s Guidance on alternatives to animal testing (version 2.0 of July 2016) states that the weight of evidence approach is an essential component of the procedure for deciding on a substance’s properties and that that approach involves gathering all available information. Similarly, the previous version of the ‘Guidance for the preparation of an Annex XV dossier on the identification of SVHCs from June 2007’ reflected that approach, since it stated that assessment of endocrine disruptors required a weight of evidence approach taking into account, inter alia, responses observed in both in vitro and in vivo assays, potency and environmental exposure.
31      In addition, relying on the judgment of 20 September 2019, PlasticsEurope v ECHA (T‑636/17, under appeal, EU:T:2019:639), the applicants maintain that the ECHA is bound by the principle of scientific excellence when analysing the intrinsic properties of a substance.
32      According to the applicants, the Commission has, however, provided no evidence to show that it applied the weight of evidence approach. It failed to take into account all available information as part of that approach. The Commission, they argue, did not therefore adequately demonstrate that there was scientific evidence of probable effects on the environment, as required by Article 57(f) of Regulation No 1907/2006.
33      The Commission, supported by the Federal Republic of Germany and the ECHA, disputes those arguments.
34      In that regard, it should be recalled that Article 57(f) of Regulation No 1907/2006 requires, as regards the identification of substances other than those meeting the identification criteria referred to in Article 57(a) to (e) of that regulation, that it be established, on a case-by-case basis, on the basis of scientific evidence, first, that the substances concerned can have serious effects on human health or the environment, and, second, that those effects give rise to a level of concern equivalent to that of the substances referred to in Article 57(a) to (e) of Regulation No 1907/2006. As regards the condition concerning serious effects on human health or the environment, this requires an analysis of the hazards arising from the intrinsic properties of the substance under consideration. As regards the condition concerning the existence of a certain level of concern, this requires that the demonstration that the serious effects on human health or the environment of the substance under consideration give rise to a level of concern equivalent
to that of the substances referred to in Article 57(a) to (e) of that regulation should be based on the analysis of the hazards arising from the intrinsic properties of the substances concerned, without prohibiting other data from being taken into account (see, to that effect, judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraphs 26, 27 and 40). In particular, in order for a substance to be identified as an endocrine disruptor of very high concern, it is necessary that it be established, on a case-by-case basis, on the basis of scientific evidence, first, that a substance with endocrine disrupting properties can have serious effects on human health or the environment, and, second, that those effects give rise to a level of concern equivalent to that of the substances referred to in Article 57(a) to (e) of Regulation No 1907/2006.
35      It follows that the case-law requires that the intrinsic properties of a substance be analysed on the basis of scientific evidence and in compliance with the principle of scientific excellence. Consequently, when the ECHA and the Commission analyse the intrinsic properties of a substance, they are bound by the principle of scientific excellence, which means that they must comply with the best current scientific standards. By contrast, it is not apparent from the case-law that every assessment is required to follow a specific and uniform methodological approach. In particular, it is not apparent from the case-law that the formal weight of evidence approach must be applied to all assessments.
36      The existence of an obligation on the ECHA and the Commission to follow that approach for the purpose of identifying a substance such as PTBP under Article 57(f) of Regulation No 1907/2006, namely as an endocrine disruptor, is also not apparent from the provisions or documents relied on by the applicants.
37      First, as regards Annex XIII on which the applicants rely, it must be stated that that annex concerns the criteria for identification of PBT and vPvB substances, as referred to in Article 57(d) and (e) of Regulation No 1907/2006. Therefore, those criteria cannot, as such, guide the ECHA or the Commission in the identification of the substances referred to in Article 57(f) of that regulation.
38      Second, as regards Regulation No 1272/2008, the purpose of that regulation, according to Article 1(1) thereof, is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles referred to in Article 4(8) of that regulation by harmonising, in particular, the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures. Accordingly, that regulation does not concern the identification of substances of very high concern with a view to their eventual inclusion in Annex XIV to Regulation No 1907/2006, with the result that the provisions found in Regulation No 1272/2008 also cannot oblige the ECHA or the Commission to follow a specific methodological approach for the purposes of such identification.
39      Third, it must be stated that the ECHA’s Guidance on alternatives to animal testing is aimed, according to point 1.1 of that guidance, at manufacturers and importers of substances subject to the obligation to provide information in the context of the registration procedure for substances and is intended to avoid unnecessary testing on vertebrate animals. Accordingly, that guidance cannot bind the ECHA or the Commission in the identification of substances of very high concern. Even if that guidance were binding on the ECHA and/or the Commission, it must be stated that that guidance does indeed regard the weight of evidence approach as an important element of the chemical safety assessment, but it is considered to be only one possible approach among others, depending on the specific features of the instant case.
40      Therefore, contrary to what the applicants appear to claim, neither the ECHA nor the Commission was obliged to follow the formal weight of evidence approach, with the result that that argument of the applicants must be rejected. The only methodological obligation imposed on the ECHA and the Commission is to carry out an analysis on the basis of scientific evidence in compliance with the principle of scientific excellence.
41      However, the applicants have been unable to demonstrate that the ECHA or the Commission failed to comply with that obligation.
42      In that regard, it must be stated that, as is apparent from the support document, for the purposes of the identification of PTBP, the ECHA and the Commission relied on a number of scientific studies, the results of which they assessed in the light of the Organisation for Economic Cooperation and Development (OECD) guidelines for the testing of chemicals while also taking account of their scientific reliability, assessed using the Klimisch scoring system (as described in an article by Klimisch, H.J.,
Andreae, M. and Tillmann, U., ‘A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data’, Regulatory Toxicology and Pharmacology, Elsevier, 1997, vol. 25, pp. 1-5) (‘the Klimisch scoring system’), in order to decide whether PTBP met the World Health Organisation (WHO) definition of an endocrine disruptor, which definition is accepted by the Commission’s Joint Research Centre (JRC) Expert Advisory Group on Endocrine Disruptors.
43      Therefore, the ECHA and the Commission relied on scientific evidence while respecting the principle of scientific excellence in their basic methodological approach.
44      Moreover, although neither the support document nor the contested decision expressly mentions the weight of evidence approach, the approach followed for the purposes of assessing PTBP as described in paragraph 42 above is, from a methodological point of view, equivalent to an approach based on the weight of evidence, as, moreover, the Federal Republic of Germany explained in its statement in intervention and as the ECHA confirmed at the hearing. According to section 1.2 of Annex XI to Regulation No 1907/2006, that approach is characterised by the fact that the assumption that a substance has or has not a particular dangerous property may legitimately be confirmed by evidence from a number of independent sources of information. In the present case, the assumption that PTBP acts as an endocrine disruptor with serious effects on the environment has been confirmed by multiple data in vitro and in vivo respectively, which are capable of providing information on the endocrine disrupting properties of PTBP and its effects on the environment, which were assessed in an overall examination, taking into account their respective strengths and weaknesses.
45      In those circumstances, it must be found that the assessment of the intrinsic properties of PTBP and of its effects on the environment was consistent with the principle of scientific excellence, with the result that the first part of the first plea, alleging failure to apply the weight of evidence approach, must be rejected as being unfounded.
The second part of the first plea: failure to take into account all available data
46      By the second part of the first plea, the applicants claim, more specifically, that the Commission failed to take into consideration, for the purposes of assessing the intrinsic properties of PTBP, all the available data.
47      First of all, the applicants argue that neither the Federal Republic of Germany, which submitted the Risk Management Option Analysis and the identification proposal in the Annex XV dossier, nor the MSC took into consideration the potency, persistence and bioaccumulation in the ‘Annex XV dossier’, despite the fact that the United Kingdom and the Republic of Finland had taken the view that those elements were considered to be relevant for assessment of the endocrine disrupting properties of PTBP. Moreover, neither the Federal Republic of Germany nor the MSC took account of exposure to PTBP through the environment, for which degradability and environmental monitoring indicate a very low actual exposure. According to the applicants, all the available data, including exposure, must be taken into account for the identification of the properties of a substance under Article 57(f) of Regulation No 1907/2006.
48      In addition, the applicants maintain that the assertion in the dossier drawn up in accordance with Annex XV
to Regulation No 1907/2006 that PTBP ‘might still enter the environment due to residue concentrations’ was not explained further. The Federal Republic of Germany did not present a qualitative or quantitative assessment of residue concentrations or explain to what extent those alleged residue concentrations might have adverse effects on the environment.
49      Furthermore, they submit, the Federal Republic of Germany failed to take into account the risk-mitigation measures and operational conditions recommended in the exposure scenarios of the Chemical Safety Report on PTBP prepared by the applicants in accordance with Article 14(6) of Regulation No 1907/2006.
50      Lastly, the applicants refer to Annex XV to Regulation No 1907/2006, which provides in section II, entitled ‘Content of dossiers’, under the heading ‘Information on exposures, alternative substances and risks’, that ‘the available use and exposure information and information on alternative substances and techniques shall be provided’. Consequently, the Commission failed to take into account all available and relevant information for the identification of PTBP.
51      The Commission, supported by the Federal Republic of Germany and the ECHA, disputes those arguments.
52      As a preliminary point, it should be observed that the institutions, bodies, offices or agencies of the European Union have a broad discretion in the identification of substances of very high concern under Article 57(f) of Regulation No 1907/2006. In that connection, it should be noted that that broad discretion of the EU authorities, which implies limited judicial review of their 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, judicial review, even though it is of limited scope, requires that the EU authorities which have adopted the act in question must be able to show before the EU Courts that, in adopting the act, they actually exercised their discretion, which presupposes that they took into consideration all the relevant factors and circumstances of the situation which that act was intended to regulate (see, to that effect, 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).
53      Article 57(f) of Regulation No 1907/2006 requires, for the identification of substances other than those meeting the identification criteria laid down in Article 57(a) to (e), that it be established, on a case-by-case basis, on the basis of scientific evidence, first, that it is probable that the substances concerned have serious effects on human health or the environment, and, second, that those effects ‘give rise to an equivalent level of concern to those of other substances listed [in Article 57(a) to (e)]’. As regards the first condition, that condition requires that the effects of the substance on human health or the environment be capable of being regarded as ‘serious’, on account of, for example, their significance or their irreversible nature. The examination of that condition is based on an assessment of the hazards to human health or to the environment, on the basis of the information in the relevant parts of sections 1 to 4 of Annex I to Regulation No 1907/2006, as stated in section II of Annex XV to that regulation. It is therefore clear that that first condition laid down in Article 57(f) of that regulation requires an analysis of the hazards arising from the intrinsic properties of the substance under consideration (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 27).
54      It follows from the foregoing that, in the context of the first condition laid down in Article 57(f) of Regulation No 1907/2006, only information which makes possible an analysis of the hazards linked to the intrinsic properties of a substance on account of which it is subject to an identification procedure is relevant for the purposes of the identification of an endocrine disruptor with serious effects on the environment and must therefore necessarily and compulsorily be taken into consideration by the authority carrying out that identification.
55      In that regard, it must also be observed that, in the present case, the Commission identified PTBP under Article 57(f) of Regulation No 1907/2006 due to its endocrine disrupting properties. It is apparent from the very wording of Article 57 of that regulation that such substances with endocrine disrupting properties are to be distinguished, for the purposes of their identification with a view to their eventual inclusion in the candidate list, from substances with persistent and bioaccumulative properties. First, PBT substances and vPvB substances are referred to in Article 57(d) and (e) of that regulation respectively. Second, Article 57(f) of that regulation distinguishes, by way of illustration, between substances with endocrine disrupting properties and ‘those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) [of Article 57 of that regulation]’. It follows that persistence and bioaccumulation are properties of a substance which allow an independent identification which is distinct from an identification on account of endocrine disrupting properties. Therefore, information on persistence and bioaccumulation cannot be considered to be relevant for the purposes of the identification of a substance as an endocrine disruptor under Article 57(f) of that regulation and, consequently, did not compulsorily have to be taken into consideration by the Commission for the purposes of the identification of PTBP.
56      Any other interpretation of Article 57(f) of Regulation No 1907/2006 would make Article 57(f) a mere duplication of the provisions of Article 57(d) and (e) of that regulation, which would render the provisions of Article 57(f) of that regulation ineffective in so far as it refers to substances with endocrine disrupting properties. In particular, such an interpretation would thus run counter to the purpose of Regulation No 1907/2006, set out in Article 1(1) of that regulation, namely that of ensuring a high level of protection of human health and the environment, in so far as that interpretation would give rise to a situation in which substances found to be of a very high level of concern owing to their endocrine disrupting properties, but which do not possess the properties referred to in Article 57(a) to (e) of Regulation No 1907/2006, could not be identified as such. According to the very wording of Article 57(f) of that regulation, that provision covers, in particular, substances ‘which do not fulfil the criteria of [Article 57(d) and (e) of the regulation]’
(see, to that effect, judgment of 16 December 2020, PlasticsEurope v ECHA, T‑207/18, under appeal, EU:T:2020:623, paragraph 225).
57      As regards the applicants’ argument that the Commission ought to have taken into consideration environmental exposure and, furthermore, ought to have analysed further the residue concentrations in the environment, it must be observed that those considerations do not relate to an intrinsic property of PTBP. As is apparent in particular from section 5 of Annex I to Regulation No 1907/2006, exposure refers to the concentration of a substance to which the environment is or may be exposed depending on, inter alia, its use. Accordingly, exposure may have an impact on the subsequent decision to exempt, under Article 58(1) of that regulation, certain uses from the authorisation procedure. However, considerations relating to environmental exposure cannot affect the analysis of the hazards linked to the intrinsic properties of PTBP underlying its identification under Article 57(f) of that regulation as a substance with endocrine disrupting properties. Environmental exposure cannot therefore constitute relevant data which the Commission ought to have taken into consideration for those purposes.
58      Annex XV to Regulation No 1907/2006, relied on in this regard by the applicants, cannot call that analysis into question. It is true that that annex, which lays down the general principles for preparing dossiers to propose and justify the identification of a substance of very high concern, provides in section II, under the heading ‘Content of dossiers’, in
point 2, that ‘the available use and exposure information … shall be provided’ in the document proposing the identification of a substance of very high concern. Nevertheless, it is apparent from the same point that that information is not part of the justification for the identification proposal. According to the information in the second paragraph, headed ‘Justification’, in section II, under the heading ‘Content of dossiers’, in Annex XV, such a justification must relate to an assessment of the hazards of a substance and not to the risks linked with its use. In those circumstances, taking exposure data into consideration does admittedly make it possible to refine the material on the basis of which recourse to the authorisation procedure appears to be the most appropriate course (see, to that effect, judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 41). Nevertheless, those data cannot be regarded as relevant for the purposes of identifying a substance under Article 57(f) of that regulation, with the result that they must compulsorily and necessarily be taken into consideration in that regard.
59      As regards the applicants’ argument that the Commission did not take into consideration the potency of PTBP, it must be stated, as the Federal Republic of Germany did, that the potency of an endocrine disrupting substance is represented by the concentration of that substance in a specific organism or in a test system which is necessary for it to be possible to observe a specific effect. As such, potency does not provide information on intrinsic endocrine disrupting properties, but rather on the risks that those properties may have for the environment depending on the concentration of a substance in organisms. Therefore, potency also did not constitute information which necessarily and compulsorily had to be taken into consideration for the purposes of the identification of PTBP due to its intrinsic endocrine disrupting properties.
60      That said, there was nothing to prevent the Commission from relying, in addition, on considerations linked to potency in order to demonstrate that the effects of PTBP give rise to a level of concern equivalent to that of the other substances referred to in Article 57(a) to (e) of Regulation No 1907/2006. In that regard, it is apparent in the present case from recital 5 of the contested decision that the Commission considered that the fact that effects on the sexual development of fish had been observed in the Demska-Zakęś (2005) study at the low concentration of 1 μg/l strengthened the concern raised by PTBP. Therefore, PTBP’s potency was indeed taken into consideration in determining the level of concern, and the applicants have not demonstrated the extent to which PTBP’s potency precluded PTBP from being identified as a substance of very high concern.
61      Lastly, as regards the applicants’ argument that the Commission ought to have taken into consideration the risk-mitigation measures and operational conditions as recommended in the exposure scenarios contained in the Chemical Safety Report on PTBP which they had prepared, it must be stated that, given that the identification of substances of very high concern is carried out on the basis of the hazards linked to the intrinsic properties of the substance, Article 57 of Regulation No 1907/2006 does not require, in respect of the substances concerned, a risk assessment to be carried out analogous to that required, in the context of the evaluation procedure, under section 6 of Annex I to that regulation, or, in the context of the authorisation procedure, under Article 64(4) thereof, or, as regards the restriction procedure, under Article 70 of that regulation (see, to that effect, judgment of 15 March 2017,
Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 25).
62      In that regard, it should also be stated that a distinction must be made between hazards and risks. Hazard assessment constitutes the first stage of the process of risk assessment, which is a more specific concept. Thus, an assessment of the hazards linked to the intrinsic properties of a substance must not be limited in light of specific circumstances of use, as in the case of a risk assessment, and may be properly carried out regardless of the place where the substance is used, the route by which contact with the substance might arise and the possible levels of exposure to the substance (judgment of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraphs 74 and 75).
63      Therefore, the risk-mitigation measures and the operational conditions as set out in the Chemical Safety Report on PTBP prepared by the applicants did not constitute relevant information for the purposes of the analysis of the hazards linked to the intrinsic properties of PTBP. That analysis could be undertaken without reference to the considerations relating to the actual use of PTBP.
64      It is apparent from Article 60(2) of Regulation No 1907/2006 that the fact that the negative effects associated with the use of a substance can be controlled adequately does not preclude its identification as a substance of very high concern. This is confirmed by Article 58(2) of Regulation No 1907/2006, under which uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific EU legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled (judgment of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraph 68).
65      In those circumstances, the second part of the first plea must be rejected as being unfounded.
The third part of the first plea: the Demska-Zakęś (2005) key study concerning the alleged adverse effects on the environment is unreliable
66      By the third part of the first plea, the applicants submit that the Demska-Zakęś (2005) study is vitiated by a number of serious flaws which call into question the reliability of that study and therefore preclude its use as a key study in the identification of PTBP. In that regard, the applicants maintain that the Demska-Zakęś (2005) study should have been given a reliability score of 3 according to the Klimisch scoring system (namely, not a reliable study) or a reliability score of
4 according to the Klimisch scoring system
(namely, not assignable) instead of a reliability score of 2 according to the Klimisch scoring system (namely, a study which is reliable with restrictions), which was the score given by the Federal Republic of Germany to that study.
67      The applicants’ criticisms of the Demska-Zakęś (2005) study are structured around nine points which make it apparent that that study did not follow OECD Guideline 234 and did not comply with Good Laboratory Practice (‘GLP’). In that regard, they refer in particular to the failure to analyse actual concentrations during testing, high stocking density, the limited number of replicates and the fact that the results of the study have never been repeated. In addition, they submit that the sex ratio is biased because a cannibalism episode, which is also referred to in the Colchen et al. (2019) study, occurred during the trial.
68      Given the questionable reliability of the Demska-Zakęś (2005) study, the Federal Republic of Germany and the Commission ought, according to the applicants, to have taken account of other sources of information, in particular the Krueger et al.
(2008) study, which, they claim, is more reliable since it complies with OECD Guideline 210 and because the observed results of that study have been confirmed.
69      The Commission, supported by the Federal Republic of Germany and the ECHA, disputes those arguments.
70      As a preliminary point, it should be recalled that the limits to the review by the EU Courts in an area such as that of identifying substances of very high concern, in which the Commission has a broad discretion, do not affect their duty to establish whether the evidence relied on is factually accurate, reliable and consistent, whether that evidence contains all the information which must be taken into account in order to assess a complex situation, and whether it is capable of substantiating the conclusions drawn from it (see judgment of 9 September 2011, France v Commission, T‑257/07, EU:T:2011:444, paragraph 87 and the case-law cited).
71      In the present case, the applicants rely on a number of alleged deficiencies vitiating the reliability of the Demska-Zakęś (2005) study which, in their view, precluded its use as a key study for the purpose of the identification of PTBP.
72      In that regard, it must be observed that it is apparent from recitals 2 and 5 of the contested decision that the Commission regarded the Demska-Zakęś (2005) study as a key study for the purpose of the identification of PTBP. Furthermore, the support document awards a reliability score of 2 according to the Klimisch scoring system to that study. According to the applicants, however, that study ought to have been awarded a reliability score of 3 or even 4.
73      According to the Klimisch scoring system, the score ‘1 = reliable without restriction’ is awarded, inter alia, to studies or data conducted or obtained in accordance with validated and/or internationally recognised guidelines, preferably in accordance with GLP, but also to studies in which all parameters are highly comparable to a guideline. The score ‘2 = reliable with restrictions’ is awarded to studies or data generally not performed in accordance with GLP, in which the test parameters documented do not comply fully with the specific testing guideline, but are sufficient to accept the data or in which the investigations are described which cannot be subsumed under a testing guideline, but which are well documented and scientifically acceptable. By contrast, the score ‘3 = not reliable’ is awarded to studies or data in which there are interferences between the measuring system and the test substance or in which organisms or test systems were used which are not relevant in relation to the exposure (for example, unphysiological pathways of application) or which were carried out or generated according to a method which is not acceptable, the documentation of which is not sufficient for assessment and which is not convincing for an expert judgment. Lastly, the score ‘4 = not assignable’ is awarded to studies or data which do not provide sufficient experimental details.
74      In the present case, it is common ground that the Demska-Zakęś (2005) study does not comply in full with OECD Guideline 234. The fact that a study does not follow validated methods does not necessarily mean that it is vitiated by shortcomings which preclude its use for regulatory purposes (see, to that effect, judgment of 16 December 2020, PlasticsEurope v ECHA, T‑207/18, under appeal, EU:T:2020:623, paragraph 86). For the same reasons, there is nothing, as a matter of principle, to preclude such a study from being awarded a reliability score of 2, with the result that it may be regarded as reliable with restrictions.
75      It is therefore necessary to analyse the arguments put forward specifically in relation to the Demska-Zakęś (2005) study in order to ascertain whether they are such as to call into question that study’s reliability for the purposes of the identification of PTBP.
76      First, as regards the argument that the Demska-Zakęś (2005) study presents a number of flaws in relation to the requirements of OECD Guideline 234 and does not comply with GLP, reference should be made to the findings set out in paragraph 74 above. It is apparent from those findings that the fact that a study does not fully comply with an internationally validated method does not preclude that study from nevertheless being regarded as reliable and from being used for regulatory purposes. In the present case, it must be stated that the deviations from the abovementioned guideline explain, in particular, the award of a reliability score of 2 according to the Klimisch scoring system, given the study’s failure to comply with GLP in the performance of the study, which is not disputed by the Commission. In that regard, it must also be stated that there is no absolute rule that only studies which comply with GLP are to be considered to be reliable. That is apparent, in particular, from point 1.1.2 of Annex XI to Regulation No 1907/2006, which provides that data on environmental properties from experiments not carried out according to GLP are considered to be equivalent to data generated by validated testing methods if certain conditions relating, in particular, to the parameters used, the exposure duration and the description of the study are met.
77      In the present case, a detailed analysis of the Demska-Zakęś (2005) study is provided in Annex II to the support document. It is apparent from this that the award of the reliability score of 2 according to the Klimisch scoring system, despite the deviations from the abovementioned guideline, is explained by the fact that that long-term study was well conducted, in so far as the number of fish was high, the results were consistent, all the physico-chemical parameters were measured and the fish were the subject of a histological inspection. Therefore, the award of the Klimisch reliability score of 2 to that study cannot be regarded as being vitiated by a manifest error of assessment which would call into question its use for the purposes of the identification of PTBP. In any event, the applicants have not indicated the deviation from OECD Guideline 234 or GLP which is capable of vitiating that assessment by such an error.
78      Second, as regards the argument that the Demska-Zakęś (2005) study contains no analysis of actual concentrations, but merely indicates nominal concentrations, it must be stated that Annex II to the support document does indeed state that the failure to measure concentrations during the study is capable of creating particular uncertainties as to actual concentrations. Nevertheless, that annex explains at the same time that nominal concentrations may be considered, in semi-static conditions such as those in the Demska-Zakęś (2005) study, to be worst-case assumptions, given that degradation and absorption contribute to a reduction in the actual concentration. In the light of that explanation, which, moreover, is not called into question by the applicants, the presumption that actual concentrations were necessarily lower than nominal concentrations does not therefore appear to be vitiated by a manifest error, with the result that those concentrations are presented as the maximum possible concentration. In any event, the Demska-Zakęś (2005) study described the effects of PTBP on the sex ratio as from a nominal concentration of 1 μg/l. Accordingly, it is apparent from the Demska-Zakęś (2005) study that PTBP acts as an endocrine disruptor and therefore has endocrine disrupting properties. The question of the concentration at which the effects of a substance can be observed concerns the criterion of a substance’s potency. As has been pointed out in paragraph 59 above, potency does not necessarily and compulsorily have to be taken into consideration at the stage of a substance’s identification. Consequently, the absence of any indication of actual concentrations in the Demska-Zakęś (2005) study does not preclude conclusions from being drawn from that study on the endocrine disrupting properties of PTBP.
79      Third, as regards the argument that the sex ratio in the Demska-Zakęś (2005) study was biased because (i) fish were inserted into the aquaria at the start of the study and (ii) a cannibalism episode occurred during the trial, it is apparent from Annex II to the support document that a change in the sex ratio was observed solely in the four treatments at concentrations of 1 μg/l, 10 μg/l, 100 μg/l and 200 μg/l respectively, and not in the controls, namely in fish which had not been exposed to PTBP in control tests. In the controls, the sex ratio remained at 1:1 during the trial. In those circumstances, it is reasonable to take the view, as the Commission did, that the sex ratio shift is an effect caused by PTBP. Therefore, it seems implausible (i) that the sex ratio was biased by the insertion of a larger number of female fish than male into aquaria at the beginning of the study, and (ii) that a cannibalism episode occurred only in the four treatments and not in the controls. Furthermore, as the Commission has pointed out, it is apparent from Annex II to the support document that the sex ratio shift observed in the Demska-Zakęś (2005) study increased progressively as the concentration increased. That observed dependence of the effect in relation to the concentration militates against the argument that cannibalism played a role in that study. Finally, it can be considered, as the Commission did, that a cannibalism episode ought to have contributed to an increase in mortality. However, such an increase was not observed in the Demska-Zakęś (2005) study.
80      In those circumstances, the argument relating to the alleged cannibalism episode in the pike perch must be rejected.
81      Fourth, as regards the argument that the stocking density of 38 kg of biomass/m³ was too high in comparison with the recommended values and, therefore, inadequate for the health of the fish, it should be recalled that the Demska-Zakęś (2005) study did not fully comply with OECD Guideline 234, which explains in particular the award of the reliability score of 2 according to the Klimisch scoring system. Furthermore, it is apparent from Annex II to the support document that the fact that the recommended value of 30 kg of biomass/m³ was exceeded was found to be neither significant nor crucial, given that the water quality parameters were complied with. Accordingly, it must be found that the fact that the recommended value was exceeded was taken into account by the Commission when it assessed the reliability of that study.
82      Fifth, as regards the alleged uncertainty as to the level of the statistics on account of the limited number of replicates, it must be observed that, in the Demska-Zakęś (2005) study, the treatments with four concentrations were tested at least in duplicate. Moreover, the Commission explained that the results had shown consistency between the duplicates, which is not called into question by the applicants. Indeed, the Commission was not bound to cast doubt on the reliability of the results on account of the limited number of replicates. In that regard, it should also be noted that no effect on the sex ratio was observed in the controls in solvent and diluted water, that is to say, without exposure to PTBP. That observation is, in any event, capable of strengthening the reliability of the observed results regarding the effects on the sex ratio in the treatments with four concentrations of PTBP.
83      Sixth, the argument that no concentration control analysis was carried out and that, therefore, the minimum exposure concentration could not be determined is equivalent, in essence, to the argument set out in paragraph 78 above, with the result that reference should be made to the grounds set out in that paragraph in order to reject that argument. Furthermore, it must be stated that the fish were exposed to four concentrations, the lowest of which was 1 μg/l. Consequently, the Commission did not make a manifest error of assessment in taking as a starting point the premiss that, as is also apparent from recital 5 of the contested decision, the lowest observed effect concentration, that is to say the lowest test concentration on which the substance has an observed effect, was 1 μg/l.
84      Seventh, the argument that the monitoring of the trial did not comply with GLP is equivalent to that set out in paragraph 76 above, with the result that it is appropriate to refer to the grounds set out in paragraphs 76 and 77 above in order to reject that argument.
85      Eighth, as regards the argument that the results of the Demska-Zakęś (2005) study have never been repeated, it must be stated that the absence of other studies which have as their purpose to repeat the results of a study cannot affect either the reliability of that study per se or the internal coherence of the observed effects. It is true that the existence of studies which set out results capable of calling into question the results of a particular study could lead the ECHA or the Commission to review the conclusions which they draw from that study for the purposes of identifying a substance of very high concern. However, the applicants have not put forward any study capable of calling into question the conclusions which the Commission drew from the Demska-Zakęś (2005) study. The applicants appear to argue that the Krueger et al. (2008) study calls into question the conclusions drawn from the Demska-Zakęś (2005) study in so far as that study did not show effects on the sex ratio at the same concentrations as those used in the Demska-Zakęś (2005) study. Nevertheless, the Krueger et al. (2008) study, which involved a different species of fish, namely the fathead minnow (pimephales promelas), was not deemed to reproduce the results of the Demska-Zakęś (2005) study and is therefore not capable of invalidating the conclusions drawn from that study.
86      Ninth, as regards the argument that the Demska-Zakęś (2005) study did not use a species of fish recommended by OECD Guideline 234, it should be recalled that, in awarding a Klimisch reliability score of 2 to that study, the support document and thereafter the Commission took due account of the fact that it did not fully comply with that validated method. In any event, that argument does not call into question the fact that that study found endocrine disrupting effects in another species of fish.
87      Lastly, as regards the applicants’ argument that the Commission ought to have taken account of the Krueger et al. (2008) study, since that study is more reliable than the Demska-Zakęś (2005) study on account, inter alia, of the fact that it allegedly complies with OECD Guideline 210, the following should be noted.
88      First of all, the support document sets out, at pages 30 to 34, how the data from the Krueger et al. (2008) study indicate that PTBP has an endocrine mode of action with serious effects on the environment and, consequently, takes account of results contained in that study. In the light of its compliance with OECD Guideline 234 alleged in the support document and its compliance with GLP, the support document awarded it a Klimisch reliability score of 1. Accordingly, the applicants’ argument that that study was not taken into consideration is wholly unfounded. In addition, it is apparent from the support document that that study reveals a number of indicators of an endocrine mode of action and its effects on the environment, inter alia, inducing vittelogenin in female fish, feminisation of the gonadal ducts and effects on secondary sex characteristics. Consequently, that study does not contradict the Demska-Zakęś (2005) study, but supports the conclusions on the identification of PTBP as an endocrine disruptor with adverse effects on the environment. It is true that the concentration at which the Krueger et al. (2008) study indicated effects on the sex ratio, namely a concentration of 500 μg/l, is appreciably higher than in the Demska-Zakęś (2005) study, which demonstrated such effects at a concentration of 1 μg/l. Nevertheless, that cannot be regarded as a contradiction given that the studies were carried out on two different species of fish.
89      In the light of the foregoing, the third part of the first plea must be rejected as being unfounded, as must that first plea in its entirety.
The second plea in law: infringement of Article 57(f) of Regulation No 1907/2006 relating to the level of concern equivalent to thatof the substances listed in Article 57(a) to (e) of Regulation No 1907/2006
90      In the context of the second plea, the applicants claim that the Federal Republic of Germany, the ECHA and the Commission made three errors vitiating the assessment of the level of concern raised by PTBP. First, it is submitted, they collectively failed to take into account other relevant factors. Second, they improperly took into account an irrelevant factor, namely a read-across to other substances. Third, they relied on a misplaced comparison between PTBP and other substances already on the candidate list.
The first part of the second plea: failure to take into account other relevant factors
91      By the first part of the second plea, the applicants allege failure to take into account all the relevant factors for the purposes of determining the level of concern raised by PTBP. The contested decision, they argue, concludes incorrectly that the alleged serious effects of PTBP on the environment are of an equivalent level of concern to those of the substances listed in Article 57(a) to (e) of Regulation No 1907/2006, since that conclusion disregards, according to the applicants, the fact that PTBP degrades rapidly. Relying on the minority opinion of the MSC, the applicants submit that, if a substance does not meet the persistency criterion, it is not of equivalent concern to a PBT or a vPvB substance and must therefore be considered to be of lower concern, with the result that it cannot be identified as a substance of very high concern.
92      In that regard, relying on the judgments of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207), and of 20 September 2019, PlasticsEurope v ECHA (T‑636/17, under appeal, EU:T:2019:639), the applicants claim that the determination of the level of concern cannot be restricted solely to hazards arising from the intrinsic properties of a substance but must take into account other factors, such as exposure reflecting the risk-management measures in force. Those additional factors, they argue, are essential in order to ensure that the authorisation process, which may follow the inclusion of a substance in the candidate list, is necessary to control the risks arising from the use of that substance. In that regard, the applicants maintain that identification of a substance of very high concern cannot be based on a purely hypothetical risk or on a risk which is not sufficiently backed up by scientific data. Relying also on the judgment of 11 September 2002, Pfizer Animal Health v Council (T‑13/99, EU:T:2002:209), the applicants consider that an approach which seeks to exclude all risk (‘zero risk’ approach) would be contrary to the principle of proportionality. In support of those arguments, first, the applicants refer to an ECHA guidance document on the identification of substances of very high concern, which states that it is necessary to consider data other than those relating to the intrinsic properties in order to show that the substance gives rise to an equivalent level of concern. Second, they refer, by way of example, to the identification of Bisphenol A due to its effects on human health.
93      The Commission, supported by the Federal Republic of Germany and the ECHA, disputes those arguments.
94      In response to that first part of the second plea raised by the applicants, it should be recalled from the outset that Article 57(f) of Regulation No 1907/2006 requires, as regards the identification of substances other than those meeting the criteria referred to in Article 57(a) to (e) of that regulation, that it be established, on a case-by-case basis, on the basis of scientific evidence, first, that it is probable that the substances concerned have serious effects on human health or the environment, and, second, that those effects give rise to a level of concern equivalent to that of other substances referred to in Article 57(a) to (e) of Regulation No 1907/2006, namely substances which are carcinogenic, mutagenic or toxic for reproduction (‘CMR substances’), as well as PBT and vPvB substances. Those conditions are cumulative, with the result that the identification of a substance as being of very high concern must be rejected if either of those conditions is not met (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 26).
95      As regards the second condition laid down in Article 57(f) of Regulation No 1907/2006, it must be demonstrated that those effects ‘give rise to an equivalent level of concern’ to those of CMR, PBT or vPvB substances. As the Court of Justice noted in paragraph 32 of the judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208), Article 57(f) of Regulation No 1907/2006 does not lay down any criterion and does not provide any clarification as regards the nature of the concerns that may be taken into consideration for the purposes of identifying a substance other than CMR, PBT or vPvB substances.
96      In those circumstances, it is necessary to determine, solely in the light of the factors taken into consideration by the Commission, whether the Commission made a manifest error of assessment in determining the level of concern.
97      First of all, it should be noted that it is apparent from recital 5 of the contested decision that the Commission considered that the adverse effects of PTBP were of a severity similar to those of other substances which have been identified under Article 57(f) of Regulation No 1907/2006. In that regard, in that decision, the Commission refers in particular to the fact that the effects observed in fish are irreversible and may be relevant for wildlife populations. In addition, the Commission shares the view expressed by the majority of the MSC that it appears difficult to derive a safe level of exposure to assess adequately the risks, although such a level may exist. The Commission concludes that the level of concern of the adverse effects and those raised by the substances referred to in Article 57(a) to (e) of that regulation are of an equivalent level. To that, the Commission adds the considerations, linked to PTBP’s potency, that the adverse effects on the sexual development of fish were observed in the Demska-Zakęś (2005) key study even from a lowest concentration of 1 μg/l further strengthens the concern.
98      As regards the applicants’ argument that the determination of a level of concern equivalent to those of the substances listed in Article 57(a) to (e) of Regulation No 1907/2006 is precluded by the fact that PTBP degrades rapidly, it is necessary to refer to paragraph 56 above, according to which the alternative interpretation referring to endocrine disruptors put forward by the applicants of Article 57(f) of Regulation No 1907/2006 would, in essence, make Article 57(f) a mere duplication of the provisions of Article 57(d) and (e) of that regulation, which would render the provisions of Article 57(f) of that regulation ineffective in so far as it refers to substances with endocrine disrupting properties.
99      Next, as regards the argument that the determination of the level of concern must necessarily take account of factors other than those linked to the hazards arising from intrinsic properties, such as the impact of the risk-management measures in force on environmental exposure, it must be pointed out that it is apparent from the case-law that the scope of Article 57(f) of that regulation encompasses the possibility, but not the obligation, of taking into consideration, for the purposes of comparison, material going beyond merely the hazards arising from the intrinsic properties of the substance concerned, in order to ensure that, amongst the different regimes established by that regulation, authorisation is necessary in order to succeed in controlling the risks arising from the use of that substance (judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraphs 34, 36, 40, 43 and 44). Those other factors which may be taken into consideration by the ECHA and the Commission for the purpose of determining the level of concern may in fact include, in particular, the difficulty of adequately assessing the risks posed by a substance when it is impossible to determine, with the required certainty, a derived no-effect level or data linked to environmental exposure reflecting the risk-management measures in force (see, to that effect, judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraphs 39 and 41).
100    In the present case, the Commission did not in fact, for the purposes of determining an equivalent level of concern, simply analyse the hazards arising from the intrinsic properties of PTBP. On the contrary, as is apparent from recital 5 of the contested decision, the Commission took into consideration, in particular, the difficulties in adequately assessing the risks due to the difficulties in deriving a safe level of exposure while also noting (i) that the effects were irreversible, (ii) that the effects may be relevant for wildlife populations and (iii) the potency of PTBP expressed by a lowest observed effect concentration of 1 μg/l.
101    In those circumstances, the mere reference made by the applicants to risk-management measures in force and their possible impact on environmental exposure is not such as to remedy the difficulties identified in deriving a safe level of exposure. Therefore, even if the Commission had taken into consideration environmental exposure and the risk-management measures in force, those data would not have enabled the Commission to draw different conclusions on the level of concern provoked by PTBP given the difficulties surrounding a proper risk assessment. In other words, if a correct assessment of the risks is not possible due to the difficulties in determining a safe level of exposure, environmental exposure data are of limited relevance since they cannot provide information on risks and, consequently, on the level of concern raised by PTBP.
102    The first part of the second plea must therefore be rejected.
The second part of the second plea: taking into account read-across
103    By the second part of the second plea, the applicants contend that the conclusion that PTBP is of an equivalent
level of concern relies, without valid justification or context, on an exclusive benchmark of read-across from other substances in the group of alkylphenols (for example, 4-nonylphenol and 4-tert-octylphenol). However, as in the minority opinion of the MSC, it should be noted that PTBP differs from the other alkylphenols and, in particular, from 4-tert-pentylphenol, in that it is rapidly degradable. Consequently, it can be inferred that PTBP has less of an endocrine disrupting effect than other alkylphenols. The applicants argue that the Commission failed to carry out a critical assessment of PTBP’s biodegradability before taking into consideration the read-across.
104    In that regard, the applicants also submit that, given that its persistence is lower, PTBP ought to have been given a lower classification for its aquatic chronic effects, that is to say, PTBP ought to have been classified as Aquatic Chronic 2 and not as Aquatic Chronic 1. Therefore, relying on the minority opinion of the MSC and on Regulation No 1272/2008, the applicants take the view that PTBP does not give rise to the highest level of concern or to a level of concern that would trigger identification as a substance of very high concern.
105    The Commission, supported by the Federal Republic of Germany and the ECHA, disputes those arguments.
106    As a preliminary point, it should be noted that it is apparent from recitals 4 and 5 of the contested decision that the Commission considered that ‘the conclusion that PTBP exerts endocrine disruptive properties is further supported by read-across from other substances belonging to the same chemical class of alkylphenols as PTBP’. It was on that basis that the Commission concluded that there was scientific evidence of probable serious effects on the environment which it considered to be ‘of a severity similar to those of other substances which have been identified as substances of very high concern pursuant to Article 57(f) of [Regulation No 1907/2006]’. According to the support document, use of the read-across method is explained, in the present case, in particular by the lack of data on the long-term and intergenerational effects of exposure to PTBP. That document explains that, for 4-nonylphenol and 4-tert-octylphenol, such data are available and that, because of the similarity between the properties of PTBP, 4-nonylphenol and 4-tert-octylphenol, it is highly likely that such effects will also occur following exposure to PTBP.
107    It has been established that Regulation No 1907/2006 acknowledges recourse to the read-across method in order to assess chemicals (see, to that effect, judgment of 21 July 2011, Nickel Institute, C‑14/10, EU:C:2011:503, paragraph 77).
108    According to Article 13 of Regulation No 1907/2006, the information supplied for the purpose of assessing chemicals for human toxicity in particular is to be obtained whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across).
109    In addition, section 1.5 of Annex XI to Regulation No 1907/2006 expressly provides for use of the read-across approach in assessing chemicals. In that regard, it is laid down in particular that substances whose physico-chemical, toxicological and eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group or ‘category’ of substances. Application of the group concept requires that physico-chemical properties, human health effects and environmental effects may be predicted from data for one or more reference substances within the group by interpolation to other substances in the group (read-across approach).
110    It follows that use of the read-across method is justified, first, by the objective of avoiding testing on vertebrate animals and, second, by the similarity between the physico-chemical, toxicological and eco-toxicological properties of substances belonging to the same group.
111    In the present case, the applicants do not call into question the fact that PTBP is part of the alkylphenol group and is structurally similar to other alkylphenols already identified. Nevertheless, the applicants take the view, as did the minority opinion of the MSC, that the lower persistence of PTBP precluded use of the read-across method.
112    As the ECHA, among others, explained at the hearing, PTBP’s rapid biodegradability in itself cannot call into question the conclusion that PTBP is structurally similar to other alkylphenols already identified as regards physico-chemical properties and endocrine disrupting effects. Also, as the Federal Republic of Germany pointed out at the hearing, since biodegradability is merely a criterion capable of providing information as to the time period during which a substance remains in the environment, it is not a relevant factor in relation to the question of whether the substance has serious effects on the environment and the resulting level of concern. Even if a substance degrades rapidly, it can nevertheless have serious effects on the environment, in particular if that substance is introduced into the environment on a continuous basis. In those circumstances, the finding that PTBP is readily biodegradable could not preclude the Commission from having recourse to read-across to other structurally similar substances at the level of physico-chemical properties in relation to its identification by reason of the endocrine disrupting effects.
113    Moreover, it should be noted that the Commission relied, in the determination of the level of concern, in particular on the fact that the effects on the environment throughout the life cycle of organisms exposed to other alkylphenols were irreversible. Those considerations are borne out by the support document, which states that exposure to 4-nonylphenol and 4-tert-octylphenol during sensitive life stages of fish may result in effects which continue to be irreversible not only in organisms exposed during the life cycle but also in the following generations, with the result that those effects persist even post-exposure. It follows that the serious effects of PTBP on the environment are not dependent on PTBP remaining in the environment, but, on the contrary, persist even after exposure. Consequently, the rapid biodegradability of PTBP in the environment cannot remedy the concerns linked to the irreversibility of the effects which persist even after PTBP has degraded.
114    In those circumstances, the fact that PTBP differs from other alkylphenols in so far as it is rapidly degradable in the environment did not, in itself, preclude the Commission from relying, by means of the read-across approach, on the conclusions drawn from the other identified alkylphenols as to the irreversibility of the effects in fish exposed for the purposes of determining the level of concern.
115    Furthermore, it must be stated that it is apparent from the contested decision that the Commission used the read-across solely in order to support the conclusion that PTBP acts as an endocrine disruptor with serious effects on the environment giving rise to an equivalent level of concern. That conclusion was drawn in the first place from the various data in vitro and in vivo, in particular the Demska-Zakęś (2005) key study. As regards, more particularly, the level of concern, the contested decision refers to, inter alia, the difficulties in deriving a safe level of exposure to assess adequately the risks. Also, it is apparent from the contested decision that the fact that the adverse effects on the sexual development of fish were observed in the key study at low concentration levels further strengthens the concern raised by PTBP. In those circumstances, it is necessary to reject, in particular, the applicants’ argument that the Commission relied exclusively and decisively on read-across to other alkylphenols in order to identify PTBP as a substance of very high concern.
116    Finally, it should be pointed out that the applicants cannot call into question, in the present action, the classification of PTBP under Regulation No 1272/2008 owing to its chronic aquatic toxicity given that that classification was not harmonised by the contested decision. Even if the classification of PTBP were to prove to be incorrect and even if that substance ought rather to have been classified as a substance with chronic aquatic toxicity 2 instead of 1, such a classification would not preclude, as such, a finding of an equivalent level of concern under Article 57(f) of Regulation No 1907/2006, which is not dependent upon such classification.
117    In those circumstances, the second part of the second plea must be rejected as being unfounded.
The third part of the second plea: comparison with other substances already included in the candidate list
118    In support of the third part of the second plea, the applicants observe that it is apparent from the contested decision that PTBP is a substance of very high concern because it gives rise to a level of concern equivalent ‘to those of other substances listed in Article 57(a) to (e) of that Regulation’. Accordingly, the generic nature of the wording of Article 1 of the contested decision suggests, in the applicants’ view, that PTBP was also identified as a substance giving rise to an equivalent level of concern to that of CMR substances as referred to in Article 57(a) to (c) of Regulation No 1907/2006. Whilst the Annex XV dossier and the opinion of the MSC concentrated their assessment on the PBT and vPvB properties of the substance, the Commission, they submit, provided no scientific assessment in support of its assertion in Article 1 of the contested decision that PTBP gives rise to a level of concern equivalent to those raised by CMR substances. The objective of the identification of substances of very high concern to establish obligations to share information on substances of very high concern within the supply chain and with consumers would have been better achieved, according to the applicants, if the contested decision had accurately indicated the reasons behind the inclusion.
119    The Commission, supported by the Federal Republic of Germany and the ECHA, disputes those arguments.
120    As a preliminary point, it should be observed that, by the third part of the second plea, the applicants are, in essence, calling into question the form of wording used by the Commission in the contested decision, according to which ‘the level of concern of the adverse effects is equivalent to those of substances referred to in [Article 57(a) to (e)] of Regulation [No 1907/2006]’. The applicants take the view that the Commission ought to have explained how the effects of PTBP gave rise to a level of concern which could be regarded as equivalent to the levels of concern raised specifically by the substances referred to in Article 57(a) to (c) of that regulation, namely CMR substances.
121    The applicants’ argument, however, is based on a misinterpretation of the wording of Article 57(f) of Regulation No 1907/2006.
122    Article 57(f) of Regulation No 1907/2006 requires, as regards the identification of substances other than those meeting the criteria referred to in Article 57(a) to (e) of that regulation, that it be established, on a case-by-case basis, on the basis of scientific evidence, first, that it is probable that the substances concerned have serious effects on human health or the environment, and, second, that those effects give rise to a level of concern equivalent to those of other substances referred to in Article 57(a) to (e) of Regulation No 1907/2006, namely CMR, PBT and vPvB substances. Those conditions are cumulative, with the result that the identification of a substance as being of very high concern must be rejected if either of those conditions is not met (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 26).
123    According to the second condition laid down in Article 57(f) of Regulation No 1907/2006, it must be shown that those effects ‘give rise to an equivalent level of concern’ to those of CMR, PBT or vPvB substances. As the Court of Justice stated in paragraph 32 of the judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208), Article 57(f) of Regulation No 1907/2006 does not lay down any criterion and does not provide any clarification as regards the nature of the concerns that may be taken into consideration for the purposes of identifying a substance other than CMR, PBT or vPvB substances.
124    The second condition requires neither that the substance at issue to be identified under Article 57(f) of Regulation No 1907/2006 share the same intrinsic properties as the substances referred to in Article 57(a) to (e), nor that the concerns raised by that substance be identical to the concerns raised by each category of substances referred to in Article 57(a) to (e). Any other interpretation would make Article 57(f) a mere duplication of the provisions of Article 57(a) to (e) and, in particular, would run counter to the purpose of Regulation No 1907/2006, set out in Article 1(1) of that regulation, namely that of ensuring a high level of protection of human health and the environment (see, to that effect, judgment of 16 December 2020, PlasticsEurope v ECHA, T‑207/18, under appeal, EU:T:2020:623, paragraph 225).
125    In the present case, the Commission followed the majority opinion of the MSC as set out in the support document. It is apparent from the support document that that opinion considered that PTBP raised a level of concern that was equivalent to the level of concern raised by the PBT and vPvB substances referred to in Article 57(d) and (e) of Regulation No 1907/2006. It is true that, according to recital 5 of the contested decision, the Commission ‘therefore considers that the level of concern of the adverse effects is equivalent to those of substances referred to in points (a) to (e) of Article 57 of Regulation (EC) No 1907/2006’. Nevertheless, it must be stated that that general wording, which replicates the wording of Article 57(f) of that regulation, is also to be found in the ‘Conclusions’ section of the support document and its use corresponds to a common practice in drafting decisions identifying substances of very high concern. From that it cannot be inferred that the Commission also took the view that the concerns raised by PTBP were equivalent to those raised by the CMR substances referred to in points (a) to (c) of that article.
126    In any event, the Commission, in recital 5 of the contested decision, referred to the considerations which led it to take the view that the condition of equivalent level of concern was met. In that regard, when it relies on cross-references to other substances belonging to the group of alkylphenols, that decision is referring in particular to the severity of the effects, the fact that those effects are irreversible and the fact that the adverse effects on the sexual development of fish were observed in the key study even from a lowest observed effective concentration of 1 μg/l.
127    In addition, contrary to what the applicants appear to claim, the contested decision is worded in such a way as to enable suppliers and users of PBTP to comply with the information obligations laid down in Regulation No 1907/2006. Obligations to provide information throughout the supply chain as triggered by the identification of a substance and its inclusion in the candidate list relate to its hazardous properties. Accordingly, the safety data sheets must contain, in accordance with Article 31(6) of Regulation No 1907/2006, information on the identification of the substance, its hazards and its physical and chemical properties. In the present case, the contested decision provides the necessary information in that regard in so far as it states clearly that PTBP is identified under Article 57(f) of that regulation, due to its endocrine disrupting properties having adverse effects on the environment linked to an oestrogen mode of action of PTBP.
128    In the light of the foregoing, the third part of the second plea must be rejected, as must that plea in its entirety.
The third plea in law: manifest error of assessment owing to the ‘failure to consider carefully all relevant information and in particular exposure data’
129    In the context of a third plea, the applicants, relying on the judgment of 9 September 2008, Bayer CropScience and Others v Commission (T‑75/06, EU:T:2008:317), allege a manifest error of assessment on the ground that the Commission failed to examine carefully and impartially all the allegedly relevant factors for the purposes of identifying PTBP, in particular, the potency, degradability, bioaccumulation and environmental exposure of PTBP.
130    The Commission, supported by the Federal Republic of Germany and by the ECHA, disputes those arguments. The Commission considers that this third plea in law is, in essence, a repetition of (i) the second part of the first plea, in so far as it concerns a failure to take into account all available data for the fulfilment of the first condition laid down in Article 57(f) of Regulation No 1907/2006 and (ii) the first part of the second plea, in so far as it concerns a failure to take other factors into account for the purpose of determining an equivalent level of concern.
131    When questioned at the hearing on whether the wording of the third plea is self-contained, the applicants explained that the third plea differs from the second part of the first plea and from the first part of the second plea in so far as the third plea relates in particular to the failure to examine carefully and impartially the factors referred to in paragraph 129 above.
132    In response to that argument, it must be pointed out that it is apparent from paragraph 84 of the judgment of 9 September 2008, Bayer CropScience and Others v Commission (T‑75/06, EU:T:2008:317), relied on by the applicants in support of the third plea, that the EU Courts must examine whether the institution in question has examined, carefully and impartially, all the relevant facts of the individual case.
133    As has been noted in paragraphs 54 to 59 and 112 above, in the present case, in the context of the identification of a substance under Article 57(f) of Regulation No 1907/2006 due to its endocrine disrupting properties, the factors in respect of which the applicants allege a failure to conduct a careful and impartial examination, namely degradability, bioaccumulation, potency and environmental exposure, do not constitute information which must be regarded as relevant for the purposes of such identification. Accordingly, the Commission was not obliged to take them into consideration when identifying PTBP, with the result that the Commission cannot be criticised for failing to examine those factors carefully and impartially.
134    Consequently, the third plea must be rejected as being unfounded.
The fourth plea in law: infringement of the principle of proportionality owing to the failure to choose the least onerous options
135    By the fourth plea, the applicants submit that the identification of PTBP as a substance of very high concern is disproportionate, since identification is the most onerous of the measures and causes disadvantages which are excessive in relation to the objective of Regulation No 1907/2006, namely to ensure a high level of protection of the environment.
136    In that regard, the applicants explain that they performed a chemical safety assessment of PTBP as part of the registration process, in accordance with Article 14 of Regulation No 1907/2006. That assessment included assessment of the environmental hazards, exposure scenarios and risk characterisation. On the basis of that assessment, the applicants applied appropriate measures to control adequately the risks identified in the chemical safety report.
137    In those circumstances, the Commission should, in the applicants’ view, have carefully analysed the chemical safety report and the risk-management measures proposed by the applicants before deciding whether it was appropriate to identify PTBP as a substance of very high concern. Furthermore, in the applicants’ view, it would have been more appropriate to assess PTBP in the context of the evaluation process under Title VI of Regulation No 1907/2006.
138    In the light of the measures mentioned above, the identification of PTBP and its inclusion in the candidate list is, in the applicants’ view, the most onerous measure. The objective of ensuring a high level of environmental protection could, they submit, have been achieved through the application of risk-management measures which, according to the applicants, constituted an approach which was less onerous but nevertheless adequate for controlling the risks posed by PTBP.
139    The Commission, supported by the Federal Republic of Germany and by the ECHA, disputes those arguments.
140    In that regard, it should be recalled, as a preliminary point, that the principle of proportionality, which is laid down in Article 5(4) TEU and which is one of the general principles of EU law, requires, according to settled case-law, that the measures adopted by the institutions do not exceed the limits of what is appropriate and necessary in order to attain the objective pursued; when there is a choice between several appropriate measures, recourse must be had to the least onerous. With regard to judicial review of those conditions, it must be acknowledged that the Commission has a broad discretion in areas in which it is called upon to undertake complex assessments. The legality of a measure adopted in that area 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, judgment of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraphs 124 and 125 and the case-law cited).
141    It is apparent from Article 1(1) of Regulation No 1907/2006 that the purpose of that regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. Regard being had to recital 16 of that regulation, it must be stated that the legislature established, as the main objective, the first of those three objectives, namely to ensure a high level of protection of human health and the environment (judgment of 7 July 2009, S.P.C.M. and Others, C‑558/07, EU:C:2009:430, paragraph 45). As regards, more specifically, the aim of the authorisation procedure, of which the identification procedure referred to in Article 59 of Regulation No 1907/2006 forms part, Article 55 of that regulation provides that it seeks essentially to ensure the good functioning of the internal market while ensuring that the risks from substances of very high concern are properly controlled and that those substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable (judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraph 116).
142    The applicants claim that the contested decision exceeds the limits of what is necessary to achieve the objectives pursued, since the assessment of PTBP and the application of the risk-management measures identified in the chemical safety report drawn up in accordance with Article 14 of Regulation No 1907/2006 constitute less onerous measures.
143    In that regard, it must be stated that it is not in any way apparent from Regulation No 1907/2006 that the legislature intended to make the identification procedure carried out pursuant to Article 59 of that regulation, which forms part of the authorisation procedure for a substance set out in Title VII of that regulation, subject to the registration procedure laid down in Title II of that regulation and of which the obligations set out in Article 14 of that regulation form part, or to the evaluation procedure set out in Articles 44 to 48 of that regulation. It is true that the registration procedure and the evaluation procedure, which is intended as a follow-up to registration according to recital 20 of Regulation No 1907/2006, also serve to improve information for the public and professionals as to the hazards and risks of a substance, as is apparent from recitals 19 and 21 of that regulation. However, whereas the substances registered should be allowed to circulate on the internal market, as is apparent from recital 19 of Regulation No 1907/2006, the objective of the authorisation procedure, of which the identification procedure set out in Article 59 of that regulation forms part, is, inter alia, progressively to replace substances of very high concern by suitable alternative substances or technologies where these are economically and technically viable. Furthermore, as is apparent from recital 69 of Regulation No 1907/2006, the legislature wanted particular attention to be paid 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).
144    Therefore, contrary to the applicants’ assertions, neither the evaluation of a substance provided for in Articles 44 to 48 of Regulation No 1907/2006 nor the risk-management measures proposed under Article 14(6) of that regulation
constitute appropriate measures for the achievement of the objectives pursued by that regulation as regards the treatment of substances of very high concern and are thus not less onerous measures in the present case (see, to that effect, judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraphs 123 to 126).
145    Furthermore, it should be noted that the Court has held that the objective of the candidate list concerning the sharing of information on substances of very high concern within the supply chain and with consumers prevails over the difficulties resulting from, inter alia, an application of Article 31(9) and Article 34 of Regulation No 1907/2006 (judgment of 11 July 2019, PlasticsEurope v ECHA, T‑185/17, not published, EU:T:2019:492, paragraph 64). The applicants cannot, therefore, claim that the identification of PTBP gives rise to disadvantages which are excessive in relation to the objectives pursued by Regulation No 1907/2006.
146    In those circumstances, the fourth plea must be rejected as being unfounded.
The fifth plea in law: infringement of the principle of proportionality owing to the failure to conduct a proper Risk Management Option Analysis, taking into account the risk-management measures already in place
147    By the fifth plea, the applicants claim that the principle of proportionality was infringed since, before PTBP was identified as a substance of very high concern, the most appropriate instrument was not considered as part of the Risk Management Option Analysis conducted by the Federal Republic of Germany.
148    In that regard, the applicants refer to the Commission’s Roadmap to 2020 on substances of very high concern (‘the Roadmap’) and to the Roadmap implementation plan. According to the latter, a Risk Management Option Analysis should facilitate the conclusion on whether a substance fulfilling the criteria set out in Article 57 of Regulation No 1907/2006 is relevant under the Roadmap and, therefore, whether the authorisation process, of which identification as a substance of very high concern is the first stage, should be initiated or whether a different risk-management route should be pursued, such as recommendation of a restriction under Article 69 of that regulation. The Roadmap gives priority to, inter alia, substances which are not registered exclusively for intermediate uses, the available information on which does not, prima facie, demonstrate that there is a risk which is not adequately controlled, whilst for those uses that have a demonstrated risk linked to use a restriction process should be initiated in accordance with Article 69 of that regulation.
149    In the reply, the applicants claim that, in adopting the Roadmap, the Commission ‘limited its discretion to take different views’. Relying on the judgment of 17 May 2018, BASF Agro and Others v Commission (T‑584/13, EU:T:2018:279), in which the Court held that the Commission had infringed the precautionary principle because it had failed to carry out an assessment as to the impact of the proposed measures, although such analysis is provided for in the Communication on the precautionary principle, the applicants submit that the Commission ought not to have departed from the provisions of the Roadmap without giving adequate reasons.
150    In that context, the applicants submit that PTBP ought not to have been identified as a substance of very high concern since the criteria laid down in the Roadmap are not met. First, PTBP is principally used as an intermediate and, second, the risks that PTBP poses could, in the applicants’ view, have been addressed via the risk-management measures which they have already put in place, as they appear in the Chemical Safety Report on PTBP. In addition, they claim that the Federal Republic of Germany should have assessed whether it was appropriate to initiate a restriction process before recommending the initiation of the process for identification of the substance as a substance of very high concern. However, that Member State, in its Risk Management Option Analysis for PTBP, did not assess the least onerous option, namely the restriction process, and, consequently, incorrectly recommended the initiation of a process for the inclusion of PTBP in the candidate list. When questioned on that argument at the hearing, the applicants explained that they took the view that identification of a substance of very high concern inevitably resulted in it being subject to the authorisation scheme, which was equivalent, in essence, to a prohibition on the placing of that substance on the market, except in the case of authorisation granted in accordance with Article 60 of Regulation No 1907/2006. Furthermore, even if such authorisation is granted, a substance included in Annex XIV ought progressively to be replaced by other substances. By contrast, a restriction does not necessarily mean an absolute prohibition on using a substance. Accordingly, a restriction could be determined dependent on the concentration levels of PTBP posing a risk to the environment, with the result that the substance could be used within the framework defined by such a restriction.
151    According to the applicants, the Federal Republic of Germany simply concluded that further considerations were needed to analyse the most appropriate risk-management measures without, however, stating what those other considerations were. The Risk Management Option Analysis failed, in particular, properly to consider existing exposure data, risk-mitigation measures and operational conditions included in the Chemical Safety Report on PTBP which show safe exposure levels. The contested decision is therefore, according to the applicants, based on truncated information and is also disproportionate in relation to the objectives pursued. In that regard, the applicants also claim that a ‘zero risk’ approach is not recognised by case-law and that such an approach would be contrary to the principle of proportionality.
152    The Commission, supported by the Federal Republic of Germany and by the ECHA, disputes those arguments.
153    By the fifth plea, the applicants claim, in essence, that PTBP ought not to have been identified as a substance of very high concern in accordance with the recommendations of the Risk Management Option Analysis, given that that analysis failed to assess, inter alia, the most appropriate risk-management measures by taking into consideration, inter alia, existing exposure data, risk-mitigation measures and operational conditions included in the Chemical Safety Report on PTBP which show safe exposure levels. In those circumstances, the applicants argue, the Risk Management Option Analysis could not have recommended that PTBP be identified. That, moreover, would be contrary to the criteria established by the Roadmap.
154    As a preliminary point, it should be noted that the Roadmap on substances of very high concern was drafted by the Commission in collaboration with the ECHA and sought to define a procedure for identifying and including in the candidate list all substances found to be of very high concern (‘relevant’) by 2020. The Roadmap is expressed to be without prejudice to the legal provisions of Regulation No 1907/2006. Although the Risk Management Option Analysis is intended to be a critical step in establishing the relevance of a substance of very high concern, it nonetheless remains a voluntary exercise. Moreover, in the present case, a Member State, namely the Federal Republic of Germany, carried out the Risk Management Option Analysis. It follows that the Commission was in no way bound by that analysis in its own identification of PTBP.
155    Furthermore, it should be noted that, for the reasons set out below and contrary to the applicants’ assertions, the identification of PTBP is not contrary to the guidance provided by the Roadmap on substances of very high concern.
156    First, it is apparent from the Roadmap that the Commission takes the view that, in the specific case of endocrine disruptors, formal identification as a substance of very high concern can be foreseen, irrespective of the recommendations from the Risk Management Option Analysis.
157    Second, although the Roadmap finds that a substance of very high concern which is held to be relevant for the purposes of a formal identification ought to be a substance which has not been registered only for intermediate uses, it is common ground that PTBP is used not only for intermediate purposes but also for non-intermediate purposes. Furthermore, the Roadmap expressly recognises that, even if a substance is registered exclusively for intermediate uses, that does not prevent the substance from nevertheless being considered relevant for identification as a substance of very high concern.
158    Third, as regards the argument that the analysis of the risk-management options ought to have assessed the option to use the restriction process, it should be noted that that argument is based on a misinterpretation of the Roadmap and of the provisions of Regulation No 1907/2006, in so far as the applicants appear to be of the view that identification and the restriction process are mutually exclusive. That is, however, not the case. Accordingly, it is apparent from the Roadmap itself, particularly in the specific case of endocrine disruptors, that such a substance may be included in the candidate list even if a restriction is foreseen because formal identification as a substance of very high concern may avoid further discussion of hazardous properties during the restriction procedure. In addition, case-law has already confirmed that the mere fact that a substance appears on the candidate list of substances does not prevent that substance from being subject to restrictions (see, to that effect, judgment of 25 September 2015, PPG and SNF v ECHA, T‑268/10 RENV, EU:T:2015:698, paragraphs 90 and 91).
159    Lastly, it must be observed that the applicants rely on the incorrect assumption that restriction is a less onerous measure than the identification of a substance. However, the identification of a substance, under Article 59 of Regulation No 1907/2006, essentially triggers information obligations such as those laid down in, inter alia, Article 7(2), Article 31(1)(c), Article 31(3)(b) and Article 33(1) and (2) of that regulation. By contrast, the restriction procedure initiated in accordance with Article 69(1) or Article 69(4) of that regulation may lead to a restriction on the manufacture, placing on the market or use of a substance. In so far as the applicants appear to claim that the identification of a substance of very high concern inevitably leads to the inclusion of that substance in Annex XIV and to the subjection of that substance to the authorisation scheme, it must be stated that the inclusion of a substance identified as a substance of very high concern in Annex XIV, under Article 58 of Regulation No 1907/2006, constitutes a decision which is independent of the identification decision taken in accordance with Article 59 of that regulation. Accordingly, it is apparent from Article 58(2) of that regulation that the decision on the inclusion of the substance in Annex XIV may, inter alia, provide that certain uses or categories of use will be exempt from the authorisation requirement. In those circumstances, the applicants cannot claim that the decision to identify a substance as being of very high concern necessarily entails an absolute prohibition on placing on the market and using the substance at issue and that, consequently, a restriction would constitute a less onerous measure than the identification of PTBP as a substance of very high concern under Article 57(f) of Regulation No 1907/2006.
160    Therefore, it cannot be asserted, in support of an alleged infringement of the principle of proportionality, that restriction constitutes a less onerous measure than the identification of a substance under Article 59 of Regulation No 1907/2006.
161    In the light of the foregoing, the fifth plea must be rejected as being unfounded.
162    Consequently, the action must be dismissed in its entirety.
Costs
163    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. Since the applicants have been unsuccessful, they must be ordered to pay their own costs as well as the costs incurred by the Commission, in accordance with the form of order sought by the Commission.
164    Article 138(1) of the Rules of Procedure provides that Member States and institutions which have intervened in the proceedings are to bear their own costs. Under Article 1(2)(f) of the Rules of Procedure, the term ‘institutions’ means the institutions of the European Union referred to in Article 13(1) TEU and the bodies, offices or agencies established by the Treaties, or by an act adopted in implementation thereof, which may be parties before the General Court. Under Article 100 of Regulation No 1907/2006, the ECHA is a body of the European Union. It follows that the Federal Republic of Germany and the ECHA must bear their own costs.
On those grounds,
THE GENERAL COURT (Eighth Chamber)
hereby:
1.      Dismisses the action;
2.      Orders Sasol Germany GmbH, SI Group – Béthune and BASF SE to bear their own costs and to pay those incurred by the European Commission;
3.      Orders the Federal Republic of Germany and the European Chemicals Agency (ECHA) to bear their own costs.
Svenningsen
Barents
Laitenberger
Delivered in open court in Luxembourg on 10 November 2021.
E. Coulon
S. Gervasoni
Registrar
President
*      Language of the case: English.