1 By its appeal, Chemours Netherlands BV seeks to have set aside the judgment of the General Court of the European Union of 23 February 2022, Chemours Netherlands v ECHA (T‑636/19, ‘the judgment under appeal, EU:T:2022:86), by which the General Court dismissed its action for annulment of Decision ED/71/2019 of the European Chemicals Agency (ECHA) of 4 July 2019, which came into force on 16 July 2019, in so far as it includes 2,3,3,3‑tetrafluoro‑2‑(heptafluoropropoxy)propionic acid, its salts and its acyl halides (and their isomers and combinations thereof) in the list of substances identified for eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 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), as amended by, inter alia, Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 (OJ 2008 L 353, p. 1) (‘the REACH Regulation’). Legal context
2 Article 1 of the REACH Regulation, entitled ‘Aim and scope’, provides: ‘1. The purpose of this 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. … 3. This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle.’
3 Article 57 of that regulation, entitled ‘Substances to be included in Annex XIV’, is worded as follows: ‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58: (a) substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with Section 3.6 of Annex I to Regulation (EC) No 1272/2008; (b) substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with Section 3.5 of Annex I to Regulation (EC) No 1272/2008; (c) substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with Section 3.7 of Annex I to Regulation (EC) No 1272/2008; (d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII [to] this Regulation; (e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII [to] this Regulation; (f) substances - such as those having endocrine disrupting properties or 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) - for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.’ Background to the dispute
4 The background to the dispute was set out by the General Court in paragraphs 11 to 17 of the judgment under appeal as follows: ‘11 [Chemours Netherlands], a company established in the Netherlands, is an importer and supplier in the European Union of ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate (“FRD‑902”), a substance that it has registered with [ECHA]. 12 In March 2019, the competent authority of the Kingdom of the Netherlands submitted a dossier under Annex XV to [the REACH Regulation], supporting identification of 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (and their isomers and combinations of isomers) (“HFPO-DA” …) as a substance of very high concern, in that that group of substances allegedly met the criteria set out in Article 57(f) of [the REACH Regulation] (“the Annex XV dossier”). When released into the environment, substances belonging to that group, which includes FRD-902, dissociate to form the substance 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate, also known as HFPO-DA. 13 On 13 March 2019, in accordance with Article 59(4) of [the REACH Regulation], ECHA invited all the interested parties to submit their observations on the Annex XV dossier by 29 April 2019. The applicant submitted its observations on 29 April 2019. 14 As it had received observations on the identification of HFPO-DA, ECHA forwarded the dossier to the Member State Committee (“MSC”) in accordance with Article 59(7) of [the REACH Regulation]. 15 At its 65th meeting, held between 24 and 27 June 2019, the MSC unanimously agreed to identify HFPO-DA as a substance of very high concern. The grounds of the agreement were set out in the support document relating to HFPO-DA (“the support document”). 16 On 4 July 2019, in accordance with Article 59(8) of [the REACH Regulation], the executive director of ECHA adopted decision ED/71/2019, which provides for the inclusion of HFPO-DA in the candidate list for eventual inclusion in Annex XIV to [the REACH Regulation], as envisaged in Article 59(1) of that regulation (“the candidate list”), on the grounds that it is of an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of [the REACH Regulation] having probable serious effects to human health and the environment, within the meaning of Article 57(f) of [the REACH Regulation] [“the decision at issue”]. 17 The [decision at issue] came into force and was published on ECHA’s website on 16 July 2019. On the same date, under Article 59(10) of [the REACH Regulation], ECHA updated the candidate list published on its website in order to include HFPO-DA in that list as a substance of very high concern.’ The action before the General Court and the judgment under appeal
5 By application lodged at the Registry of the General Court on 24 September 2019, Chemours Netherlands brought an action for annulment of the decision at issue.
6 In the proceedings before the General Court, the Kingdom of the Netherlands, as well as ClientEarth AISBL, ClientEarth and CHEM Trust Europe eV (together ‘ClientEarth and CHEM Trust Europe’) intervened in support of the form of order sought by ECHA.
7 In support of its action, the appellant relied on two pleas in law. By the first plea it alleged that ECHA breached Article 57(f) of the REACH Regulation, exceeded its competence under that provision and manifestly erred in its assessment. By its second plea, the appellant alleged that ECHA breached the principle of proportionality.
8 By the judgment under appeal, the General Court dismissed that action. Forms of order sought by the parties to the appeal
9 By its appeal, the appellant claims that the Court of Justice should: - set aside the judgment under appeal; - annul the decision at issue; - in the alternative, refer the case back to the General Court to rule on its application for annulment; and - order ECHA to pay the costs of these proceedings, including the costs of the proceedings before the General Court, and those of the interveners.
10 ECHA contends that the Court should: - dismiss the appeal as inadmissible in part and unfounded in its entirety; and - order the appellant to pay all the costs and expenses of these proceedings.
11 The Kingdom of the Netherlands contends that the Court should: - dismiss the appeal; and - order the appellant to pay the costs of the proceedings.
12 ClientEarth and CHEM Trust Europe contend that the Court should: - dismiss the appeal as a whole; and - order the appellant to bear its own costs and to pay the costs incurred by ECHA, the Kingdom of the Netherlands, ClientEarth and CHEM Trust Europe, including the costs incurred at first instance. The appeal
13 The appellant puts forward three grounds of appeal in support of its appeal. The first ground of appeal alleges an error of law, an error of assessment and an infringement and a misinterpretation of Article 57(f) of the REACH Regulation, in that the General Court held that ECHA had not manifestly erred in considering that serious effects on human health of an equivalent level of concern had been established. The second ground of appeal alleges an error of law, an error of assessment and an infringement and a misinterpretation of Article 57(f) of the REACH Regulation, in that the General Court held that ECHA had not manifestly erred in considering that serious effects on the environment of an equivalent level of concern had been established. The third ground of appeal alleges infringement by the General Court of the principle of scientific excellence and of the limits of its review. The first ground of appeal
14 The first ground of appeal is divided into three parts. By the first part of that ground of appeal, the appellant disputes the possibility that effects which do not form the basis of the decision at issue may contribute to establishing an ‘equivalent level of concern’ within the meaning of Article 57(f) of the REACH Regulation. The second part concerns developmental toxicity, as observed on rats, and repeated dose toxicity and the extent to which those effects give rise to an equivalent level of concern within the meaning of that provision. The third part concerns the joint examination of the effects on human health and the environment. The first part of the first ground of appeal, alleging an error of law, an error of assessment and an infringement and a misinterpretation of Article 57(f) of the REACH Regulation, in that the General Court held that ECHA could conclude that effects which did not form the ‘basis’ of the decision at issue could contribute to establishing ‘an equivalent level of concern’ within the meaning of that provision - Arguments of the parties
15 The first part of the first ground of appeal comprises, in essence, two arguments.
16 The first argument concerns the grounds set out in paragraphs 109 and 110 of the judgment under appeal, which analyse the as yet unknown effects of HFPO-DA.
17 In that regard, the appellant submits that the General Court’s reasoning is contradictory and therefore incorrect, in so far as, after stating that ECHA’s conclusions on continuous exposure to HFPO-DA and irreversibility were not only based on relevance, but also on mobility, the General Court held, in paragraph 110 of that judgment, that ECHA had not found that the mobility of that substance gave rise to the same concerns as bioaccumulation. However, by basing its conclusions on mobility, ECHA did in fact make the finding that there was the same concern as for bioaccumulation, which, as is apparent from paragraph 65 of that judgment, is not among the intrinsic properties on the basis of which that substance was identified as a substance of very high concern.
18 The second argument relates to the grounds set out in paragraphs 75 and 128 of the judgment under appeal. The appellant submits that the General Court erred in its interpretation of Article 57(f) of the REACH Regulation in finding that ECHA could adopt the decision at issue on the basis of that provision and conclude that the ‘equivalent level of concern’ criterion was satisfied on the basis of information which does not form the ‘basis’ of that decision.
19 According to the appellant, as is apparent from the decision at issue, the probable effects for human health on which that decision is based are (i) the effects observed during the repeated dose studies, namely the effects on the liver, the kidneys and the haematological and immune systems, and (ii) the effects on development. No other supporting information could be considered relevant to the question whether HFPO-DA fulfils the conditions laid down in Article 57(f) of the REACH Regulation.
20 In that regard, the appellant observes that it was held in the judgment under appeal that bioaccumulation (paragraph 65 of that judgment), carcinogenicity (paragraph 73 of that judgment) and reproductive toxicity (paragraph 80 of that judgment) are not among the intrinsic properties on the basis of which HFPO-DA was identified in the decision at issue as being of very high concern. As regards the as yet unknown effects of that substance, it is apparent from paragraphs 103, 104, 111 and 136 of the judgment under appeal that they were not relied on as the basis of the decision at issue, but were mentioned as considerations additional to the assessment of the potential effects of that substance.
21 However, despite the insufficient nature of certain information on which to base the decision at issue, the General Court held, in paragraph 75 of the judgment under appeal, that the indication by ECHA, as supporting information, in the support document, of information which was insufficient to support a conclusion on carcinogenicity in humans, but which was nevertheless available, did not constitute a manifest error of assessment.
22 In so doing, the General Court erred in law in that ECHA did not merely refer to that information as ‘supporting information’, but used it to justify its conclusion on the ‘equivalent level of concern’ within the meaning of Article 57(f) of the REACH Regulation. That is apparent from paragraph 128 of that judgment, according to which HFPO-DA was considered to be ‘of [an] equivalent level of concern … because of the overall concern arising from the concern elements described in Section 6.3.2’ of the support document. That section groups together all the alleged effects of that substance, including those which were acknowledged by the General Court and ECHA as not forming ‘the basis’ of the decision at issue.
23 ECHA, supported by the Kingdom of the Netherlands, contends that the first part of the first ground of appeal should be rejected as unfounded and asserts that the decision at issue draws a distinction, used in ecotoxicology, between the ‘key’ considerations which form the basis of a decision and the ‘supporting’ or ‘complementary’ considerations which merely support a key consideration.
24 ClientEarth and CHEM Trust Europe contend that the first part of the first ground of appeal should be rejected as inadmissible, since the appellant has not identified any error of law or distortion of the evidence allegedly vitiating the judgment under appeal. In any event, the arguments put forward in support of this part of the ground of appeal should be rejected as unfounded. - Findings of the Court
25 It is apparent from the file submitted to the Court that, by the decision at issue, as based on the support document, ECHA found, in essence, that HFPO-DA fulfilled the two conditions set out in Article 57(f) of the REACH Regulation, since HFPO-DA is liable to have probable serious effects on both human health and the environment, and those effects are such as to give rise to an equivalent level of concern to those of other substances which are carcinogenic, mutagenic or toxic for reproduction (‘CMR substances’), persistent, bioaccumulative and toxic (‘PBT substances’) or very persistent and very bioaccumulative (‘vPvB substances’).
26 ECHA based the decision at issue, in essence, as regards human health, on the finding that there were significant effects on development and on several essential organs, namely the liver, the kidneys, blood and the immune system, and, as regards the environment, on the finding that there was a significant reduction in the weight of mice, a conclusion which was found to be relevant also for other mammals and for birds. It also found that those effects give rise to an equivalent level of concern to those of CMR, PBT or vPvB substances within the meaning of Article 57(f) of the REACH Regulation. By contrast, ECHA took the view that carcinogenicity, bioaccumulation, fertility, early parturition and as yet unknown effects could not be used as a basis for the finding of serious effects on human health or the environment.
27 By its first argument, the appellant claims that the General Court based paragraphs 109 and 110 of the judgment under appeal on contradictory reasoning. The question whether the grounds of a judgment of the General Court are contradictory or inadequate is a question of law which is amenable, as such, to judicial review on appeal (judgment of 8 February 2007, Groupe Danone v Commission , C‑3/06 P, EU:C:2007:88, paragraph 45 and the case-law cited).
28 As regards the content of the statement of reasons in the judgment under appeal in relation to the as yet unknown effects of HFPO-DA, it must be observed that, in paragraph 109 of that judgment, the General Court set out ECHA’s conclusion that continuous exposure to HFPO-DA and the irreversibility of the effects were the consequence of the persistence, mobility and properties leading to that substance’s bioavailability.
29 In paragraph 110 of that judgment, the General Court specified, in response to the appellant’s arguments on bioaccumulation, that ECHA did not make the finding that mobility gives rise to the same concerns as bioaccumulation. It cannot be inferred from the fact that ECHA based the conclusion set out in paragraph 109 of the judgment under appeal on several factors, including mobility, that it stated or suggested that the same concern existed in relation to bioaccumulation.
30 By the second argument, the appellant disputes, in essence, the grounds set out in paragraphs 75 and 128 of the judgment under appeal and submits that the General Court misinterpreted Article 57(f) of the REACH Regulation by validating ECHA’s approach of finding that the ‘equivalent level of concern’ condition was satisfied on the basis of information which did not form the ‘basis’ of that decision.
31 The appellant thus complains that the General Court erred in law in its interpretation of that provision, which, contrary to what is claimed by ClientEarth and CHEM Trust Europe, renders its argument admissible.
32 In order to assess whether that argument is well founded, it should be recalled at the outset that the substances of very high concern are those listed in either Article 57(a) to (e) of the REACH Regulation due to their carcinogenic, mutagenic or reproductive toxic properties (CMR substances), or because they are persistent, bioaccumulative and toxic (PBT substances) or very persistent and very bioaccumulative (vPvB substances), or in Article 57(f), which includes all other substances ‘for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e)’ (judgment of 10 September 2015, FCD and FMB , C‑106/14, EU:C:2015:576, paragraph 35).
33 It is thus apparent from Article 57(f) of that regulation that, for a substance, other than CMR, PBT or vPvB substances, to be identified as being of very high concern, it must be established, on the basis of scientific evidence (i) that that substance has probable serious effects on human health or the environment and (ii) that those effects give rise to an equivalent level of concern to those of CMR, PBT or vPvB substances. Those conditions are cumulative, so that the identification of a substance as being of very high concern must be rejected if either of those conditions is not met.
34 The first of those conditions, which concerns the serious nature of the effects of the substance on human health or the environment, requires an analysis of the hazards arising from the intrinsic properties of that substance. The second condition, which concerns the determination of an equivalent level of concern to those of CMR, PBT or vPvB substances, requires a range of factors to be taken into consideration, wider than those relevant to the categorisation of the effects and intrinsic properties of a substance (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 27 and 36).
35 It is apparent from that case-law that, when assessing whether the level of concern to which the substance in question gives rise is equivalent to that of CMR, PBT or vPvB substances, ECHA may take into consideration information which goes beyond the data relating to the intrinsic properties of the substance concerned.
36 As is apparent from paragraph 71 of the judgment under appeal, which is not disputed by the appellant, it was considered in the present case that the intrinsic properties of the candidate substances, including HFPO-DA, are as follows: persistence, mobility, potential for long-range transport, probable adverse effects on human health (in terms of the liver, the kidneys, the haematological and immune systems, and development), probable effects on the environment (in terms of birds and mammals), low adsorption potential and high water solubility rendering the substance fully bioavailable for uptake via drinking water.
37 By contrast, according to paragraphs 65, 73 and 80 of the judgment under appeal, bioaccumulation, carcinogenicity potential and reproductive toxicity are not among the intrinsic properties of HFPO-DA. It is also apparent from paragraph 103 of that judgment that, in the support document, the ‘[as] yet unknown’ effects were not classified as ‘serious effects on human health’.
38 In paragraph 128 of the judgment under appeal, the General Court found that that support document states, under the heading ‘Overall concern and assessment of the level of concern’, that ‘HFPO-DA is considered to be of [an] equivalent level of concern to the very high concern for substances meeting the criteria laid down in [Article 57(a) to (e) of the REACH Regulation] according to [Article] 57(f) of [that regulation] because of the overall concern arising from the concern elements described in Section 6.3.2’ of that document.
39 Some of the considerations in that section concern aspects which were not relied on as the basis of the decision at issue, in particular those relating to HFPO-DA’s carcinogenicity potential, which, it is stated, in paragraph 75 of the judgment under appeal, constitutes supporting information, and the considerations relating to the ‘as yet unknown effects on the intrinsic properties of HFPO-DA’ which, as is apparent from paragraph 136 of the judgment under appeal, ‘[are] additional to concerns linked to serious effects observed on human health’.
40 However, as is apparent from paragraph 34 of the present judgment, the determination of the level of concern under Article 57(f) of the REACH Regulation may be based on information other than that arising from the intrinsic properties of the substances concerned used to determine the risk of serious effects on health or the environment. There is therefore nothing to prevent ECHA from finding that there is an equivalent level of concern within the meaning of that provision following an overall assessment of the various information available to it.
41 Consequently, the General Court was entitled, without erring in law, to validate, first of all, in paragraph 75 of the judgment under appeal, the taking into account by ECHA, as supporting information, of HFPO-DA’s carcinogenicity potential and, second, in paragraph 128 of that judgment, the overall assessment of the factors described in Section 6.3.2 of the support document which was carried out by that agency when determining the level of concern raised by HFPO-DA.
42 It follows from the foregoing that the first part of the first ground of appeal must be rejected as unfounded. The second part of the first ground of appeal, alleging an error of law, an error of assessment and an infringement and a misinterpretation of Article 57(f) of the REACH Regulation, in that the General Court held that ECHA had established that developmental toxicity and the effects of repeated dose toxicity gave rise to an ‘equivalent level of concern’ within the meaning of that provision - Arguments of the parties
43 According to the appellant, the General Court misinterpreted the relationship between Article 57(f) of the REACH Regulation and Regulation No 1272/2008, by upholding ECHA’s conclusion that the effects on human health which were not sufficient for the classification of HFPO-DA under Article 57(c) of the REACH Regulation could nevertheless be taken into account in order to consider that that substance gave rise to an ‘equivalent level of concern’ within the meaning of Article 57(f) of that regulation.
44 The second part of the first ground of appeal comprises, in essence, three arguments.
45 As regards, in the first place, the assessment of HFPO-DA’s developmental toxicity, the appellant submits that this falls within the scope of reproductive toxicity, within the meaning of Article 57(c) of the REACH Regulation. According to that provision, in order for a substance to be identified as toxic for reproduction, it must meet the criteria laid down in Annex I to Regulation No 1272/2008.
46 On the other hand, in order for a substance to be identified under Article 57(f) of the REACH Regulation, it is necessary for it to have serious effects of an equivalent level of concern to the substances falling inter alia within the scope of Article 57(c) of that regulation. It follows from those provisions that the criteria for classification of a substance as toxic for reproduction laid down by Regulation No 1272/2008 must also be taken into account in the evaluation of a substance under Article 57(f) of the REACH Regulation. Moreover, the effects on human health under the latter provision must be compared with the concerns raised by CMR substances falling within the scope of Article 57(a) to (c) of that regulation.
47 The General Court’s interpretation in paragraph 39 of the judgment under appeal renders Article 57 of the REACH Regulation redundant and constitutes an error of law in so far as the General Court held that ‘ECHA was not prevented … from taking into account, in the context of establishing serious effects on human health, of developmental effects observed during tests on mice and rats, without establishing that HFPO-DA fulfils the criteria of Regulation No 1272/2008 as regards developmental toxicity’.
48 As regards the General Court’s assessment, in paragraph 93 of the judgment under appeal, that the requirement of equivalence does not require the level of concern to be ‘identical’, the appellant contends, first, that the effects associated with the same hazard class must be assessed within the framework of that class in accordance with Regulation No 1272/2008 and, second, that even if it were considered that those effects do not need to be identical, ECHA should have established their actual equivalence, by comparison with the effects set out in Article 57(c) of the REACH Regulation.
49 The appellant claims that the General Court also misapplied the case-law, inter alia the judgment of 7 March 2013, Rütgers Germany and Others v ECHA (T‑96/10, EU:T:2013:109), and the judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208), in particular when it relied on the latter judgment in order to find, in paragraph 36 of the judgment under appeal, that the classification of a substance under Annex I to Regulation No 1272/2008 constitutes a relevant, but not decisive, element for the purposes of the application of Article 57(f) of the REACH Regulation.
50 Consequently, the General Court erred in law in its interpretation of the relationship between Article 57(f) of the REACH Regulation and Regulation No 1272/2008 as regards developmental effects related to reproductive toxicity, in particular in paragraphs 35, 36, 39, 91, 93 and 125 to 127 of the judgment under appeal.
51 As regards, in the second place, the effects related to repeated dose toxicity, the appellant observes that, in the context of Regulation No 1272/2008, the endpoint of repeated dose toxicity is only relevant for the potential classification under hazard classes other than CMR substances. Those effects cannot therefore lead to the classification of a substance as a CMR substance under Article 57(a) to (c) of the REACH Regulation.
52 ECHA completely failed (i) to establish the existence of an equivalent level of concern for developmental effects and those related to repeated dose toxicity and (ii) to compare the observed effects of HFPO-DA with those referred to in Article 57(a) to (c) of the REACH Regulation for CMR substances. Having correctly found, in paragraph 119 of the judgment under appeal, that such a comparison was lacking, the General Court did not draw the appropriate conclusions from that finding. In so doing, it erred in law.
53 As regards, in the third place, the irreversibility of the effects, the appellant submits that, in paragraphs 100 to 102 of the judgment under appeal, the General Court upheld ECHA’s interpretation that continuous exposure to HFPO-DA could have irreversible effects. However, irreversibility of effects in toxicology refers to the situation in which the affected organs do not recover after they cease being exposed to a substance. According to the appellant, that toxicological principle is recognised by Regulation No 1272/2008, in which there are numerous references to ‘reversible’ or ‘irreversible’ effects. The specific criteria laid down in Regulation No 1272/2008 must be taken into consideration in order to classify the effects of a substance as ‘irreversible’.
54 Consequently, the General Court made an error of assessment and misinterpreted Article 57(f) of the REACH Regulation in holding that ECHA had demonstrated that developmental toxicity and the effects of repeated dose toxicity gave rise to an ‘equivalent level of concern’ within the meaning of that provision.
55 ECHA, supported by the Kingdom of the Netherlands, contends that the second part of the first ground of appeal must be rejected as unfounded. It maintains that, in a situation such as that in the present case, it is possible to compare the concern for human health raised by HFPO-DA with the concern raised by PBT and vPvB substances, since the effects of the latter substances are also relevant for humans.
56 According to ClientEarth and CHEM Trust Europe, the second part of the first ground of appeal must be rejected as inadmissible in part and, in any event, unfounded. - Findings of the Court
57 By the second part of the first ground of appeal, the appellant disputes, in essence, the General Court’s interpretation of the relationship between Article 57(f) of the REACH Regulation and Regulation No 1272/2008 and the consequences of that interpretation. The appellant claims that the criteria laid down in the latter regulation should have guided ECHA’s conclusion when determining the serious effects on human health and that the level of concern raised by the developmental effects of repeated dose toxicity should, as regards its ‘equivalence’, have been compared with that of CMR substances.
58 In that regard, it must first of all be observed that, in the judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208), the Court of Justice interpreted Article 57(f) of the REACH Regulation by examining in an abstract manner the scope of that provision. It is not apparent from the grounds of that judgment that such an interpretation is limited to the factual situation at issue in the case which gave rise to that judgment. Therefore, the General Court correctly applied, in paragraphs 35, 36, 39 and 91 of the judgment under appeal, the case-law arising from that case in order to conclude that the classification of a substance under Annex I to Regulation No 1272/2008 constitutes a relevant, although not decisive, element in order to demonstrate the risk of serious effects on human health or the environment.
59 It follows that the General Court did not err in law in validating ECHA’s approach not to refer to the criteria established by Regulation No 1272/2008 when assessing HFPO-DA’s developmental toxicity and repeated dose toxicity, as well as ECHA’s assessment that there was no need to always compare the level of concern raised by the effects on human health of a substance with those of CMR substances alone.
60 As the General Court held, in paragraph 123 of the judgment under appeal, which, moreover, is not disputed by the appellant, and as has been argued by ECHA, ClientEarth and CHEM Trust Europe, the concerns raised by the use of PBT and vPvB substances relate not only to the environment but also humans. First, that conclusion is supported by Section 6.5 of Annex I to the REACH Regulation, from which it is apparent that the risk management measures recommended to users by the manufacturer or importer of substances satisfying the PBT or vPvB criteria are intended to minimise exposure and emissions for both humans and the environment. Second, such a conclusion also meets the objective pursued by the REACH Regulation, as established in Article 1(1) thereof, which is to ensure a high level of protection of human health and the environment, and satisfies the precautionary principle by which the provisions of that regulation are underpinned pursuant to Article 1(3) thereof.
61 Consequently, the General Court was right to take the view, after finding, in paragraph 119 of the judgment under appeal, that the support document does not carry out such a detailed comparison between the concern raised by HFPO-DA and that raised by CMR substances, that ECHA had not committed a manifest error of assessment by proceeding in this manner.
62 As regards, next, the equivalent nature of the level of concern, the appellant is wrong to challenge the grounds set out in paragraph 93 of the judgment under appeal, according to which the use of the word ‘equivalent’ clearly indicates that the level of concern does not have to be ‘identical’. Its line of argument is mistaken on two counts. First, the appellant claims that ECHA should have established the effects of HFPO-DA in relation to the criteria laid down in Regulation No 1272/2008, which is incorrect for the reasons set out in paragraphs 58 to 61 of the present judgment. Second, it confuses the equivalence of the level of concern, required for the application of Article 57(f) of the REACH Regulation, with the equivalence of the effects, a condition which goes beyond the scope of that provision.
63 As regards, lastly, the argument relating to the irreversibility of the observed effects of HFPO-DA, in so far as that argument relates to the manner in which that irreversibility was taken into account as a factor characterising the seriousness of those effects, the objection of inadmissibility raised by Client Earth and CHEM Trust Europe must be rejected and that argument must be examined on its merits. In that regard, it must be observed that, as is apparent from the case-law and as was recalled by the General Court, in paragraph 101 of the judgment under appeal, effects are capable of being regarded as serious on account, for example, of their significance and their irreversible nature (judgment of 15 March 2017, Polynt v ECHA , C‑323/15 P, EU:C:2017:207, paragraph 27). In those circumstances, the General Court was right to hold, in paragraph 102 of the judgment under appeal, that the fact that ECHA took into account the irreversible nature of the effects observed does not constitute a manifest error of assessment on its part.
64 It should also be noted that Article 57(f) of the REACH Regulation does not lay down any criterion and therefore does not provide any clarification as regards the determination of the serious nature of the effects of a substance. In that regard, that provision requires only that there be scientific evidence of that serious nature. Therefore, the appellant’s argument relating to the need to apply, to that end, the concept of ‘irreversibility’ established by Regulation No 1272/2008 is unfounded.
65 Accordingly, it must be observed that paragraphs 100 to 102 of the judgment under appeal are not vitiated by any error of law.
66 The second part of the first ground of appeal must therefore be rejected as unfounded. The third part of the first ground of appeal, alleging misinterpretation of Article 57(f) of the REACH Regulation, in that the General Court validated ECHA’s approach to assessing the individual effects on human health and the possibility of considering the effects on human health and the environment jointly - Arguments of the parties
67 According to the appellant, the General Court erred in law by validating ECHA’s position of applying a weight-of-evidence approach to the individual effects for human health and considering the effects for health and the environment jointly for the purposes of the application of Article 57(f) of the REACH Regulation.
68 As regards, in the first place, the application of the weight-of-evidence approach to the individual effects for human health, the appellant submits that the General Court erred in law in holding, in paragraph 97 of the judgment under appeal, that the combined effects for human health ‘“together” are considered probable and serious’. In the appellant’s view, the only effects on human health which form the basis of the decision at issue are those relating to developmental toxicity and repeated dose toxicity which, it is disputed, meet the criteria of seriousness and equivalent level of concern.
69 In the appellant’s submission, even if it were possible, as the General Court held in paragraph 98 of the judgment under appeal, that ‘several effects taken together’ which, individually, do not give rise to an equivalent level of concern may be considered jointly to give rise to such a level of concern, ECHA should have examined whether, taken together, the combined effects are serious and of an equivalent level of concern to those set out in Article 57(a) to (c) of the REACH Regulation for CMR substances, an assessment which was not carried out in the present case.
70 As regards, in the second place, the joint consideration of the effects on human health and the environment, the appellant submits that the General Court erred in law in finding, in paragraph 122 of the judgment under appeal, that ‘there is nothing in the wording of Article 57(f) of [the REACH Regulation] that indicates an obligation to distinguish between the equivalent level of concern’ raised by the substance in question for human health and the environment respectively. In the appellant’s view, since the identification of HFPO-DA as a substance of very high concern is expressly divided into two entries in the candidate list of substances, one for human health and the other for the environment, it was for ECHA to assess and establish the existence of serious effects of an equivalent level of concern for each of those two entries.
71 In paragraphs 120 and 122 of the judgment under appeal, the General Court suggests that ECHA could be exempted from establishing the serious effects giving rise to an equivalent level of concern on each of those two aspects. The General Court therefore erred in law, in paragraph 125 of that judgment, in finding that it was sufficient for ECHA to establish (i) serious effects for human health and (ii) an equivalent level of concern for the environment, in order to identify HFPO-DA under Article 57(f) of the REACH Regulation.
72 According to ECHA, supported by the Kingdom of the Netherlands, ClientEarth and CHEM Trust Europe, the third part of the first ground of appeal must be rejected as inadmissible in part, unfounded in part and ineffective in part.
73 In its reply, the appellant disputes the arguments relating to the inadmissibility in part of the third part of the first ground of appeal and asserts that the arguments raised in support of that third part meet the requirements laid down in Article 168(1)(d) of the Rules of Procedure of the Court of Justice. - Findings of the Court
74 By the third part of the first ground of appeal, the appellant disputes the grounds set out in paragraphs 96 to 99, 120, 122 and 125 of the judgment under appeal and asserts that the General Court misapplied (i) the weight-of-evidence approach to the individual effects on human health and (ii) the need to distinguish and justify separately the level of concern raised by HFPO-DA for human health and the environment where, as in the present case, those two concerns justify the identification of that substance as being of very high concern.
75 As regards, in the first place, the argument relating to the possibility of identifying serious effects for human health by the corroborated assessment of the individual effects of that substance, the appellant disputes the grounds set out in paragraphs 97 to 99 of the judgment under appeal.
76 In that regard, it should be noted that, in paragraph 97 of the judgment under appeal, the General Court found that the adverse effects observed on the liver, kidneys, haematological system, immune system and development, taken together, are considered probable and serious for human health. In paragraph 98 of that judgment, the General Court observed, relying on the use of the plural in the expression ‘serious effects’, that a combination of several effects in order to establish their seriousness is not contrary to Article 57(f) of the REACH Regulation. In paragraph 99 of that judgment, the General Court rejected the appellant’s arguments as to whether or not the effects individually are serious as irrelevant.
77 The arguments put forward by the appellant in support of the third part of the first ground of appeal are not sufficient to show that paragraphs 97 to 99 of the judgment under appeal are vitiated by an error of law. The appellant merely reproduces the arguments already put forward before the General Court which were summarised, inter alia, in paragraphs 85 to 87 of the judgment under appeal.
78 An appeal which confines itself to reproducing the pleas in law and arguments previously submitted to the General Court does not satisfy the requirements arising from Article 256 TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union and from Article 168(1)(d) and Article 169(2) of the Rules of Procedure. Such an appeal amounts in reality to no more than a request for re-examination of the application submitted to the General Court, which the Court of Justice does not have jurisdiction to undertake (judgment of 27 April 2023, Casa Regina Apostolorum della Pia Società delle Figlie di San Paolo v Commission , C‑492/21 P, EU:C:2023:354, paragraph 53 and the case-law cited).
79 The first argument in the third part of the first ground of appeal must therefore be rejected as inadmissible.
80 As regards, in the second place, the possibility of taking into consideration jointly the effects on health and those on the environment, the appellant disputes the grounds set out in paragraphs 120, 122 and 125 of the judgment under appeal, claiming that they are vitiated by errors of law, in so far as the General Court suggests that ECHA may be exempted from establishing serious effects giving rise to an equivalent level of concern for human health on the basis of the effects on the environment.
81 In that regard, it should be observed that, in order for a substance to be identified as being of very high concern, Article 57(f) of the REACH Regulation requires that there be scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of CMR, PBT or vPvB substances. It is apparent from the very wording of that provision that the equivalence of the level of concern raised by the effects of a substance on human health need not necessarily be established in relation to the concerns raised by CMR substances, since the EU legislature lists for that purpose, in an alternative manner, all the substances provided for in Article 57(a) to (e) of the REACH Regulation, namely CMR, PBT and vPvB substances.
82 Consequently, as the General Court correctly stated in paragraph 120 of the judgment under appeal, Article 57(f) of the REACH Regulation does not require that the level of concern raised by the serious effects of a substance on human health must always be equivalent to those of CMR substances, irrespective of whether that level is equivalent to those of PBT and vPvB substances. The General Court was therefore right to conclude, in paragraph 125 of that judgment, that a substance for which there is scientific evidence of probable serious effects on human health and which gives rise to an equivalent level of concern to those of PBT and vPvB substances can be identified as being of very high concern.
83 Moreover, in the present case, the concerns stemming from PBT and vPvB substances with which ECHA compared the concerns associated with HFPO-DA relate, as noted in paragraph 123 of the judgment under appeal, to humans and other environmental organisms.
84 It is in that context that the General Court was right to hold, in paragraph 122 of the judgment under appeal, that Article 57(f) of the REACH Regulation does not imply an obligation to distinguish between the equivalent level of concern raised by serious effects, on the one hand, on human health and, on the other, on the environment.
85 The third part of the first ground of appeal must therefore be rejected as inadmissible in part and unfounded in part. The second ground of appeal
86 The second ground of appeal is divided into two parts. The first part concerns the possibility of establishing serious effects for the environment on the basis of human health toxicity data. The second part concerns the consequences to be drawn from HFPO-DA’s lack of bioaccumulation. The first part of the second ground of appeal, alleging misinterpretation of Article 57(f) of the REACH Regulation in so far as the General Court validated ECHA’s approach of establishing serious effects on the environment on the basis of human health toxicity data - Arguments of the parties
87 The appellant challenges the grounds set out by the General Court in paragraphs 146 to 159 of the judgment under appeal. It complains of a misinterpretation of Article 57(f) of the REACH Regulation in so far as the General Court concluded that the existence of serious effects on the environment had been established by ECHA based on secondary poisoning assumed from data relating to a single species, which were taken from a single study, namely the Edwards, T.L. study, 2010a, entitled ‘ An Oral (Gavage) Reproduction/Developmental Toxicity Screening Study of H-28548 in Mice ’, by which the toxicity of the substance in question to mice was studied in order to assess whether that substance poses a risk to human health (‘the Edwards study’).
88 In support of this part of the ground of appeal, the appellant puts forward, in essence, two arguments.
89 By the first argument, the appellant claims that the General Court erred in law in validating ECHA’s approach of using human health data from the Edwards study in order to establish the existence of a risk to the environment. If that were the intention of the EU legislature, the REACH Regulation would not have drawn any distinction between the risks to human health and the environment and between toxicological data and ecotoxicological data.
90 The appellant states that the Edwards study is a reproductive and developmental toxicity screening study carried out in accordance with Guideline No 421 of the Organisation for Economic Cooperation and Development (OECD). It is a test method used not to obtain ecotoxicological information relevant for assessing the potential risks to the environment, but to obtain toxicological information relevant to the assessment of the potential risks of a substance to human health.
91 By the second argument, the appellant disputes the relevance of the Edwards study, claiming that, during that study, HFPO-DA had been administered orally, by gavage, in one go, instead of allowing the animals, namely mice, to uptake the selected dose through a dietary administration, in this case feeding or drinking, which was a more representative route of exposure in the environment.
92 The appellant also claims that the Edwards study does not establish the existence of probable serious effects on the environment. The support document acknowledges that environmental hazards were not considered to be a priority and the General Court confirmed, in paragraph 146 of the judgment under appeal, that that study does not establish direct toxicity, but that it was used to demonstrate secondary poisoning in birds and mammals.
93 In paragraph 153 of that judgment, the General Court confirmed that there are no toxic effects in quails, namely the only bird species referred to by ECHA. Although, in paragraph 151 of that judgment, the General Court found that a 20% reduction in weight of the F1 generation of mice is significant and not small, it did not rule on whether that reduction had a serious effect on the environment.
94 In paragraph 153 of that judgment, the General Court also found that ECHA had taken into consideration the Rutgers et al., 2019 study, without, however, confirming that that study established serious effects on the environment. Similarly, although, in paragraph 155 of the judgment under appeal, the General Court held that it was possible to conclude that there were serious effects on the basis of data relating to a single species, it did not establish that ECHA had demonstrated that HFPO-DA could actually have such effects as required by Article 57(f) of the REACH Regulation.
95 According to ECHA, supported by the Kingdom of the Netherlands, ClientEarth and CHEM Trust Europe, the first part of the second ground of appeal should be rejected as inadmissible in part, ineffective in part and, for the rest, unfounded.
96 Those parties contend, in essence, that the appellant’s arguments concerning the prohibition on basing environmental concerns on the toxicology studies were not relied on before the General Court and that the arguments concerning the design settings of the Edwards study and some of its findings relate to findings of fact which cannot be challenged, in the absence of distortion, in the context of an appeal. In any event, they contend that the appellant’s arguments in support of the first part of the second ground of appeal are unfounded.
97 In its reply, the appellant states that it does not challenge the General Court’s conclusion that serious effects for the environment can be established based on data relating to a single species, but that it challenges the relevance of the Edwards study to establish serious effects on the environment. The appellant disputes that the argument relating to the use of toxicological studies is inadmissible and claims that it is not a new plea in law within the meaning of Article 127 of the Rules of Procedure.
98 In its rejoinder, ECHA notes that the toxic effects that were shown for mice and rats give rise to a very high concern for the environment. Although ECHA disputes the appellant’s interpretation of paragraph 153 of the judgment under appeal, it agrees with the appellant that the Rutgers et al., 2019 study did not show any toxic effect on quails. However, ECHA observes that whether or not HFPO-DA is of very high concern to birds is immaterial for this case since it has already been established that the presence of that substance in the environment is of very high concern to mammals. - Findings of the Court
99 By the first part of the second ground of appeal, the appellant challenges the grounds set out by the General Court, in paragraphs 146 to 159 of the judgment under appeal, and the General Court’s examination of the serious effects of HFPO-DA on the environment.
100 As a preliminary point, it should be noted that, in its appeal, the appellant expressly challenged the conclusion reached by the General Court in paragraph 155 of the judgment under appeal, according to which nothing in the REACH Regulation precludes ECHA from concluding that there are serious effects on the environment on the basis of data relating to a single species, in this instance mice. However, in its reply, the appellant states that it does not dispute the General Court’s finding that serious effects for the environment may be established on the basis of data relating to a single species.
101 Consequently, the examination of the first part of the second ground of appeal is limited to the arguments concerning, first, the possibility of establishing the risk of serious effects on the environment within the meaning of Article 57(f) of the REACH Regulation, on the basis of human health toxicity data, and, second, the appropriateness of the Edwards study to establish that risk.
102 As regards the first argument, concerning the possibility of assessing the effects on the environment on the basis of the toxicological data, as ECHA, ClientEarth and CHEM Trust Europe contend, the distinction between toxicological information and ecotoxicological information and the consequences thereof were not debated at first instance.
103 According to settled case-law of the Court of Justice, to allow a party to put forward for the first time before the Court of Justice a plea in law which it has not raised before the General Court would in effect allow that party to bring before the Court of Justice a wider case than that heard by the General Court. In an appeal, the jurisdiction of the Court of Justice is confined to review of the findings of law on the pleas argued before the General Court (judgment of 27 April 2023, Casa Regina Apostolorum della Pia Società delle Figlie di San Paolo v Commission , C‑492/21 P, EU:C:2023:354, paragraph 100 and the case-law cited).
104 The first argument must therefore be rejected as inadmissible.
105 As regards the second argument, relating to the relevance of the Edwards study, in that it is not representative of exposure to HFPO-DA and therefore does not enable the effects of that substance on the environment to be assessed, it should be recalled that, in the context of an appeal, the Court of Justice has no jurisdiction to establish the facts or, in principle, to examine the evidence which the General Court accepted in support of those facts. Provided that the evidence has been properly obtained and the general principles of law and the rules of procedure in relation to the burden of proof and the taking of evidence have been observed, it is for the General Court alone to assess the value which should be attached to the evidence that has been submitted to it, save where that evidence has been distorted (see, to that effect, judgments of 9 March 2023, PlasticsEurope v ECHA , C‑119/21 P, EU:C:2023:180, paragraphs 84 and 85 and the case-law cited, and of 22 June 2023, DI v ECB , C‑513/21 P, EU:C:2023:500, paragraph 53 and the case-law cited).
106 As is apparent, in particular, from the elements of the appellant’s arguments summarised in paragraph 91 of the present judgment, the appellant is, in reality, seeking to obtain a re-examination by the Court of Justice of an item of evidence produced before the General Court and analysed in the judgment under appeal, without alleging any distortion of that evidence, which, for the reasons set out above, falls outside the jurisdiction of the Court of Justice.
107 The second argument must therefore also be rejected as inadmissible.
108 It follows from the foregoing that the first part of the second ground of appeal must be rejected as inadmissible. The second part of the second ground of appeal, alleging misinterpretation of Article 57(f) of the REACH Regulation, in that the General Court did not consider the lack of bioaccumulation to be a relevant element to be taken into consideration by ECHA in the specific circumstances of this case - Arguments of the parties
109 In the appellant’s submission, in paragraph 96 of the judgment under appeal, the General Court wrongly held that ‘persistence combined with other intrinsic properties [of HFPO-DA]’ met the criteria set out in Article 57(f) of the REACH Regulation. It also erred in law in finding that that provision ‘allows account to be taken of the intrinsic property of persistence for identification as a substance of very high concern, irrespective of whether that property is combined with very specific and limited properties, namely with bioaccumulation and toxicity’.
110 In that regard, the appellant submits that it is common ground that HFPO-DA has persistent properties. However, its bioaccumulation potential is uncertain and is not the basis for the decision at issue. In the appellant’s submission, other intrinsic properties of that substance, namely mobility and long-range transport, high water solubility, low volatility, and low adsorption potential, constitute not independent properties but manifestations of the persistence of that substance in water, and are characteristic of any substance that is persistent, or very persistent in water.
111 However, persistence in itself, without bioaccumulation, is not sufficient for the identification of a substance as being of very high concern within the meaning of Article 57(f) of the REACH Regulation, which, according to the appellant, requires an equivalent level of concern to those of substances that are persistent, bioaccumulative and toxic or those which are very persistent and very bioaccumulative. The General Court therefore misrepresented and failed to address the appellant’s arguments and also erred in law when it found, in paragraph 63 of the judgment under appeal, that Article 57(f) of the REACH Regulation ‘does not require a substance to be bioaccumulative in order to be identified as a substance of very high concern’ for the purposes of that provision.
112 The appellant also claims that the General Court made an error of assessment, in paragraph 172 of the judgment under appeal, when it found that the appellant had not explained ‘how a low bioaccumulation potential, even if proved, would call into question ECHA’s conclusion’ relating to the serious effects of HFPO-DA on the environment. However, the appellant did explain, in its application for annulment, the manifest errors committed by ECHA.
113 Similarly, in paragraph 173 of that judgment, the General Court wrongly held that it had not explained why the finding of no strong adsorption to soil and of a bioconcentration factor from pore water would call in question information on uptake by vegetables and fruits and ultimately by plant-eating wildlife. The appellant states that it set out, in its application for annulment, the manifest errors made by ECHA in the assessment of the bioaccumulation potential of HFPO-DA, with the result that it was for ECHA to establish that it had reached its conclusions ‘carefully and impartially’, within the meaning of the case-law (judgment of 22 November 2017, Commission v Bilbaína de Alquitranes and Others , C‑691/15 P, EU:C:2017:882, paragraph 35 and the case-law cited) and for the General Court to exercise its power of review in that regard.
114 It follows that the General Court erred in law and in its interpretation of Article 57(f) of the REACH Regulation in ruling that ECHA had not committed a manifest error of assessment in considering that HFPO-DA could have serious effects on the environment which give rise to an equivalent level of concern to those of PBT or vPvB substances.
115 According to ECHA, supported by the Kingdom of the Netherlands, the second part of the second ground of appeal must be rejected, in essence, as unfounded, since the General Court correctly analysed the relationship between the persistence and bioaccumulation of a substance in the light of Article 57(f) of the REACH Regulation. In particular, as regards the argument relating to the environmental fate and the non-independent nature of the physico-chemical properties on which the decision at issue is based and which are allegedly merely a manifestation of HFPO-DA’s persistence in water, ECHA observes that, since that argument was not put forward before the General Court, it is inadmissible. In any event, the argument is unfounded.
116 ClientEarth and CHEM Trust Europe contend that the complaints relied on by the appellant in support of the second part of the second ground of appeal are inadmissible because they contain factual arguments which cannot succeed on appeal. - Findings of the Court
117 In the second part of the second ground of appeal, the appellant disputes the grounds set out in paragraphs 63, 96, 172 and 173 of the judgment under appeal, and claims that, by holding that a substance can be identified as being of very high concern under Article 57(f) of the REACH Regulation on the basis of its persistence, irrespective of its bioaccumulation, the General Court erred in law.
118 In that regard, it must be observed, in the first place, that, in paragraph 63 of the judgment under appeal, the General Court concluded that bioaccumulative or very bioaccumulative substances are listed in that provision only by way of example, so that that provision does not require a substance to be bioaccumulative in order to be identified as being of very high concern. In paragraph 96 of that judgment, the General Court explained, in essence, that the interpretation advocated by the appellant, according to which the legislature did not allow a substance to be identified as being of very high concern on the ground that it is persistent and mobile, but not bioaccumulative, would exclude from such identification substances which are just as dangerous for human health and the environment as those referred to in Article 57(a) to (e) of the REACH Regulation.
119 That assessment of the General Court is not vitiated by any error of law. In that regard, it must be observed that the conclusion reached by the General Court in paragraph 63 of the judgment under appeal is supported by the findings which it set out in paragraphs 94 and 95 of that judgment, which are not disputed by the appellant, according to which it is not apparent from the wording of Article 57(f) of the REACH Regulation, in particular from the words ‘such as … those’, that persistence, bioaccumulation and toxicity can be taken into account only when they appear in a specific combination. That textual interpretation reflects the objective pursued by that regulation, which is to ensure a high level of protection of human health and the environment.
120 In the second place, the argument relating to the fact that HFPO-DA’s intrinsic properties other than persistence, which are identified in the decision at issue are, in reality, merely manifestations of persistence in water, is, as ECHA contends, an argument relied on for the first time at the appeal stage.
121 Consequently, as is apparent from the case-law referred to in paragraph 103 of the present judgment, that argument is inadmissible.
122 As regards, in the third place, the arguments relating to the grounds set out in paragraphs 172 and 173 of the judgment under appeal, it should be noted that those paragraphs form part of the General Court’s examination of ECHA’s assessment of certain scientific data during its assessment of the effects of HFPO-DA on the environment, namely data relating to the bioaccumulation potential of that substance.
123 In that regard, in paragraph 170 of that judgment, the General Court found that the appellant’s arguments concerning HFPO-DA’s bioaccumulation must be rejected, since the decision at issue is not based on the bioaccumulation potential of that substance. In paragraph 172 of that judgment, the General Court examined the situation in which those arguments were to be understood as meaning that ECHA should have taken bioaccumulation into account when establishing serious effects on the environment giving rise to an equivalent level of concern to those of the substances referred to in Article 57(a) to (e) of the REACH Regulation and found that the appellant had not explained how a low bioaccumulation potential, even if proved, would call into question ECHA’s conclusion in that regard.
124 In paragraph 173 of the judgment under appeal, the General Court also considered that the appellant had not explained how the line of argument based on the adsorption of HFPO-DA to soil and on the relevance of the bioconcentration factor from pore water for bioaccumulation was capable of calling into question the assertion that, due to the observed uptake in vegetables and fruits, consumption of these by plant-eating wildlife and humans could contribute significantly to total exposure to HFPO-DA.
125 Although the appellant challenges those two paragraphs of the judgment under appeal, it should be noted that it merely reiterates the arguments which it raised before the General Court by referring to the respective paragraphs of its application for annulment and its reply without alleging any distortion in relation to those arguments.
126 In so doing, by its arguments, the appellant seeks, in reality, to obtain a re-examination by the Court of Justice of the evidence produced before the General Court and analysed in the judgment under appeal. However, as is apparent from the case-law referred to in paragraphs 78 and 105 of the present judgment, such a line of argument is inadmissible.
127 Consequently, the second part of the second ground of appeal must be rejected as unfounded in part and inadmissible in part. The third ground of appeal Arguments of the parties
128 The third ground of appeal is divided into three parts.
129 By the first part of the third ground of appeal, the appellant challenges the grounds set out in paragraphs 49 to 51 and 230 of the judgment under appeal and asserts that the General Court manifestly exceeded the limits of its review. Thus, first, in paragraphs 49 to 51 of that judgment, the General Court not only assessed whether certain studies had been considered by ECHA but actually undertook an assessment of the available data itself and assigned significance to the effects allegedly observed, independently of the criteria established by Regulation No 1272/2008. Second, in paragraph 230 of that judgment, the General Court itself reached scientific conclusions and thus infringed the limits of its review by holding that ‘if it is found that the effects observed are reversible when exposure has been discontinued, the conclusion that the effects are irreversible if exposure is not discontinued, in other words if exposure is continuous or even irreversible, is credible’.
130 By the second part of the third ground of appeal, the appellant submits that, in paragraph 230 of the judgment under appeal, the General Court infringed the principle of scientific excellence by holding that ECHA ‘expressed its view, referring to irreversible effects, on the effects liable to arise if exposure did not cease after a certain period of time and continued’, which does not satisfy the requirement to comply with the best current scientific standards.
131 By the third part of the third ground of appeal, the appellant reiterates the complaint made in the second part of the first ground of appeal and alleges that the General Court erred in its interpretation of the concept of ‘irreversibility’.
132 According to ECHA, supported by the Kingdom of the Netherlands and ClientEarth and CHEM Trust Europe, since the three parts of the third ground of appeal are based on a misreading of the judgment under appeal, that ground of appeal must be rejected as unfounded. Findings of the Court
133 By the third ground of appeal, the appellant challenges the grounds set out in paragraphs 38 to 40, 49 to 51 and 230 of the judgment under appeal and asserts that the General Court exceeded the limits of its review, infringed the principle of scientific excellence and misinterpreted the concept of ‘irreversibility’.
134 As regards the first part of the third ground of appeal, concerning the limits of the review carried out by the General Court in an area such as that of identifying substances of very high concern under Article 57(f) of the REACH Regulation, it should be recalled that, where the EU authorities have a broad discretion, in particular in so far as concerns the assessment of highly complex scientific and technical facts in order to determine the nature and scope of the measures which they adopt in that context, review by the Courts of the European Union is limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context, the Courts of the European Union cannot substitute their assessment of scientific and technical facts for that of the institutions on which alone the FEU Treaty has entrusted that task (see, to that effect, judgment of 9 March 2023, PlasticsEurope v ECHA , C‑119/21 P, EU:C:2023:180, paragraph 46 and the case-law cited).
135 The broad discretion of the EU authorities, which implies limited judicial review of its exercise, applies not only to the nature and scope of the measures to be taken but also, to some extent, to the finding of the basic facts. However, even though such judicial review is of limited scope, it requires that the EU authorities which have adopted the act in question must be able to show before the Courts of the European Union that in adopting the act they actually exercised their discretion, which presupposes that they took into consideration all the relevant factors and circumstances of the situation the act was intended to regulate (judgment of 9 March 2023, PlasticsEurope v ECHA , C‑119/21 P, EU:C:2023:180, paragraph 47 and the case-law cited).
136 In paragraphs 49 to 51 of the judgment under appeal, the General Court found that ECHA had based its conclusion on toxicity on the finding of impaired growth in foetal body weight in rats as a major manifestation of that toxicity. It held that the mere fact that there are also maternal toxicity effects at the same time as developmental effects does not establish that those latter effects are a secondary non-specific consequence of maternal toxicity. It was in that context that it described as ‘credible’ ECHA’s finding that a reduction in maternal weight was not the cause of the reduction in foetal body weight. In so doing, the General Court did not disregard the limits of the review which it was required to carry out.
137 The same conclusion applies to the reasons why the General Court found, in paragraph 230 of the judgment under appeal, that ECHA’s conclusion on the irreversibility of the observed effects of HFPO-DA in the event that exposure to that substance did not cease after a certain period of time and continued, in other words in the event of continuous exposure, was credible.
138 As regards the second part of the third ground of appeal, relating to the infringement of the principle of scientific excellence, in so far as the General Court validated, in paragraph 230 of the judgment under appeal, a mere ‘view’ expressed by ECHA concerning the irreversible effects of HFPO-DA, it must be observed that the arguments put forward in support of such a complaint are not capable of demonstrating an infringement of that principle.
139 The English version of that paragraph, according to which ECHA ‘expressed its view, referring to irreversibility effects’, and on which it appears that the appellant bases its claims, must be read in the context of the judgment under appeal, with the result that it cannot support the assertion that ECHA confined itself to expressing a ‘view’ in breach of its obligation to comply with the best current scientific standards.
140 In that regard, it should be noted that the General Court’s reasoning in paragraph 230 of the judgment under appeal began in paragraph 228 of that judgment and was developed in the light of the principle of scientific excellence set out in paragraph 227 of that judgment. The General Court thus found that the standard toxicity tests were taken into account by ECHA in order to conclude that the effects observed were reversible. In paragraph 230 of that judgment, the General Court found that the standard tests are however limited to a trial period of 28 or 90 days and therefore involve time limited exposure. It was in that context that the General Court found that ‘ECHA expressed its view … on the effects liable to arise if exposure … continued’.
141 The third part of the third ground of appeal concerning the interpretation given in the judgment under appeal to the concept of ‘irreversibility’ must be rejected for the same reasons as those set out in the second part of the first ground of appeal.
142 Accordingly, the third ground of appeal must be rejected as unfounded.
143 It follows from the foregoing considerations that the appeal must be dismissed in its entirety. Costs
144 Under Article 184(2) of the Rules of Procedure, where the appeal is unfounded, the Court is to make a decision as to the costs. Under Article 138(1) of those rules, applicable to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
145 Under Article 184(4) of the Rules of Procedure, where the appeal has not been brought by an intervener at first instance, he or she may not be ordered to pay costs in the appeal proceedings unless he or she participated in the written or oral part of the proceedings before the Court. Where an intervener at first instance takes part in the proceedings, the Court may decide that he or she is to bear his or her own costs.
146 Under Article 140(1) of those rules, Member States and institutions which have intervened in the proceedings are to bear their own costs.
147 Since ECHA, ClientEarth and CHEM Trust Europe have applied for costs and the appellant has been unsuccessful, the appellant must be ordered to pay the costs.
148 The Kingdom of the Netherlands, intervener at first instance, is to bear its own costs. On those grounds, the Court (Fourth Chamber) hereby: 1. Dismisses the appeal; 2. Orders Chemours Netherlands BV to bear its own costs and to pay the costs incurred by the European Chemicals Agency (ECHA), ClientEarth, ClientEarth AISBL and CHEM Trust Europe eV; 3. Orders the Kingdom of the Netherlands to bear its own costs. Lycourgos Spineanu-Matei Bonichot Rodin Rossi Delivered in open court in Luxembourg on 9 November 2023. A. Calot Escobar C. Lycourgos Registrar President of the Chamber * Language of the case: English.