JUDGMENT OF THE GENERAL COURT (Eighth Chamber)
23 February 2022 (*)
(REACH – Substances of very high concern – Establishment of a candidate list of substances for eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 – Decision identifying 2,3,3_3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides as a substance fulfilling the criteria laid down for inclusion in the list – Article 57 of Regulation No 1907/2006 – Manifest error of assessment – Proportionality)
In Case T‑636/19,
Chemours Netherlands BV, established in Dordrecht (Netherlands), represented by R. Cana and E. Mullier, lawyers,
applicant,
v
European Chemicals Agency (ECHA), represented by W. Broere, N. Herbatschek and M. Heikkilä, acting as Agents, and by S. Raes, lawyer,
defendant,
supported by
Kingdom of the Netherlands, represented by M. Bulterman, J. Langer and C. Schillemans, acting as Agents,
and by
ClientEarth AISBL, established in Brussels (Belgium),
ClientEarth, established in London (United Kingdom),
CHEM Trust Europe eV, established in Hamburg (Germany),
represented by N. Angelet, lawyer,
interveners,
APPLICATION under Article 263 TFEU seeking annulment of ECHA’s decision ED/71/2019 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),
THE GENERAL COURT (Eighth Chamber),
composed of J. Svenningsen, President, R. Barents and J. Laitenberger (Rapporteur), Judges,
Registrar: L. Ramette, Administrator,
having regard to the written part of the procedure and further to the hearing on 14 September 2021,
gives the following
Judgment
I.      Legal framework
1        Article 1 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), entitled ‘Aim and scope’, provides as follows:
‘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.’
2        Article 14(6) of Regulation No 1907/2006 reads as follows:
‘Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the safety data sheets which he supplies in accordance with Article 31.’
3        Article 31(9) of Regulation No 1907/2006 provides as follows:
‘Suppliers shall update the safety data sheet without delay on the following occasions:
(a)      as soon as new information which may affect the risk management measures, or new information on hazards becomes available;
…’
4        Article 33 of Regulation No 1907/2006, entitled ‘Duty to communicate information on substances in articles’, is worded as follows:
‘1.      Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0[.]1% weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.
2.      On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0[.]1% weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.
…’
5        Article 34 of Regulation No 1907/2006, entitled ‘Duty to communicate information on substances and mixtures up the supply chain’, provides as follows:
‘Any actor in the supply chain of a substance or a mixture shall communicate the following information to the next actor or distributor up the supply chain:
(a)      new information on hazardous properties, regardless of the uses concerned;
(b)      any other information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him, which shall be communicated only for identified uses.
…’
6        Article 55 of Regulation No 1907/2006, entitled ‘Aim of authorisation and considerations for substitution’, provides as follows:
‘The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.’
7        Article 56 of Regulation No 1907/2006, entitled ‘General provisions’, provides as follows:
‘1.      A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV, unless:
(a)      the use(s) of that substance on its own or in a mixture or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 60 to 64; …
…’
8        Article 57 of Regulation No 1907/2006, 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 [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 No 1907/2006 (OJ 2008 L 353, p. 1)];
(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 of this Regulation;
(e)      substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of 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.’
9        Article 58 of Regulation No 1907/2006, entitled ‘Inclusion of substances in Annex XIV’, provides in paragraph 2 thereof as follows:
‘Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community 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. In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form.’
10      Article 60 of Regulation No 1907/2006, entitled ‘Granting of authorisations’, provides as follows:
‘…
2.      Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with Section 6.4 of Annex I and as documented in the applicant’s chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the Commission shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision.
…
4.      If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. …
…’
II.    Background to the dispute
11      The applicant, Chemours Netherlands BV, 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 the European Chemicals Agency (ECHA).
12      In March 2019, the competent authority of the Kingdom of the Netherlands submitted a dossier under Annex XV to Regulation No 1907/2006, 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’ or ‘the substance at issue’) as a substance of very high concern, in that that group of substances allegedly met the criteria set out in Article 57(f) of Regulation No 1907/2006 (‘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 Regulation No 1907/2006, 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 Regulation No 1907/2006.
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 Regulation No 1907/2006, 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 Regulation No 1907/2006, 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 Regulation No 1907/2006 having probable serious effects to human health and the environment, within the meaning of Article 57(f) of Regulation No 1907/2006 (‘the contested decision’).
17      The contested decision came into force and was published on ECHA’s website on 16 July 2019. On the same date, under Article 59(10) of Regulation No 1907/2006, 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.
III. Procedure and forms of order sought
18      By application lodged at the Court Registry on 24 September 2019, the applicant brought the present action.
19      The applicant claims that the Court should:
–        annul the contested decision in so far as it includes HFPO-DA in the candidate list of substances of very high concern as a substance of equivalent concern for human health and/or in so far as it includes HFPO-DA in the candidate list as a substance of equivalent concern for the environment;
–        order ECHA to pay the costs of the proceedings and order any intervener to bear its own costs.
20      ECHA contends that the Court should:
–        dismiss the action;
–        order the applicant to pay the costs of both parties.
21      The Kingdom of the Netherlands supports the form of order sought by ECHA and contends that the action should be dismissed and the applicant should be ordered to pay the costs.
22      ClientEarth AISBL, ClientEarth and CHEM Trust Europe eV (‘ClientEarth and CHEM Trust Europe’) support the forms of order sought by ECHA and request the Court:
–        to dismiss the action in its entirety;
–        to order the applicant to pay the costs.
IV.    Law
23      In support of its action, the applicant relies on two pleas in law. By the first plea it alleges that ECHA breached Article 57(f) of Regulation No 1907/2006, exceeded its competence under that provision and manifestly erred in its assessment. By its second plea, the applicant alleges that ECHA breached the principle of proportionality.
A.      The first plea in law, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006, exceeded its competence and manifestly erred in its assessment
24      The first plea is divided into four parts.
1.      The first part of the first plea, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006 and manifestly erred in its assessment inasmuch as it failed to establish to the requisite legal standard that HFPO-DA causes probable serious effects on human health and the environment of an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of that regulation
25      The applicant claims that ECHA has not established to the requisite legal standard, in accordance with Article 57(f) of Regulation No 1907/2006, that HFPO-DA could cause probable serious effects on human health and the environment of an equivalent level of concern to the effects of the substances listed in points (a) to (e) of Article 57 of that regulation, that is to say, substances meeting the criteria for classification as substances that are carcinogenic, mutagenic or toxic for reproduction (‘CMR substances’), persistent, bioaccumulative and toxic substances (‘PBT substances’) and those which are very persistent and very bioaccumulative (‘vPvB substances’). In support of this part of the plea, the applicant puts forward two complaints. Those complaints turn on establishing serious effects on human health and the environment respectively of an equivalent level of concern to those of CMR, PBT and vPvB substances.
(a)    The first complaint of the first part of the first plea in law concerning serious effects on human health of an equivalent level of concern to those of CMR, PBT and vPvB substances
26      The applicant claims that ECHA has not established that there was scientific evidence of HFPO-DA’s probable serious effects on human health of an equivalent level of concern to those of CMR substances. The applicant puts forward three sets of arguments in that regard.
27      ECHA, supported by the Kingdom of the Netherlands and ClientEarth and CHEM Trust Europe, asserts that the first complaint of the first part of the first plea in law should be rejected.
(1)    Assessment of the scientific evidence
28      The applicant claims that ECHA committed a manifest error of assessment in considering that the scientific evidence on which it relied to identify HFPO-DA as a substance of very high concern corroborated its conclusions. In that regard, the applicant puts forward arguments relating to the considerations set out in the support document as regards, first, developmental toxicity, second, repeated dose toxicity, third, toxicokinetics and bioaccumulation, fourth, carcinogenicity and, fifth, reproductive toxicity.
(i)    Developmental toxicity
29      The applicant submits that ECHA found the information on developmental toxicity to be scarce. It should have considered those data to be inconclusive. However, ECHA stated that the developmental toxicity of HFPO-DA might be underestimated and that those ‘preliminary data already provide some indication that HFPO-DA may cause developmental effects’.
30      Thus, the applicant submits that the results of the studies by Edwards (Edwards, T.L., 2010a, ‘An Oral (Gavage) Reproduction/Developmental Toxicity Screening Study of H-28548 in Mice’; and Edwards, T.L., 2010b, ‘An oral gavage prenatal developmental toxicity study of H-28548 in rats’) do not support a concern for developmental toxicity, with the result that ECHA is wrong to challenge the relevance of its arguments.
31      Thus, first, the effects observed were limited to changes in foetal bodyweight. Those changes were observed in the ‘maternal animals’. Those effects are therefore secondary non-specific consequences of the observed maternal toxicity. Moreover, the substance at issue cannot be classified as toxic for reproduction in categories 1A, 1B or 2 under Section 3.7.2.1.1 of Annex I to Regulation No 1272/2008. It follows that the substance at issue does not entail serious effects giving rise to an equivalent level of concern to those of a substance meeting the criteria set out in Article 57(c) of Regulation No 1907/2006.
32      Second, according to the applicant, ECHA assessed the Edwards, 2010a study only with regard to the effects of the substance at issue on fertility, and not on developmental toxicity. In any event, that study cannot be used to justify the allegation that the effects of the substance at issue had been underestimated. ECHA failed to meet the criteria under Article 57(f) of Regulation No 1907/2006 when it based its conclusion on ‘preliminary data’ and found ‘some indication that HFPO-DA may cause effects’.
33      ECHA disputes those arguments.
34      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 classification 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, on the one hand, that it is probable that the substances concerned have serious effects on human health or the environment, and, on the other, that those effects ‘give rise to an equivalent level of concern to those of [CMR, PBT or 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).
35      Article 57(f) of Regulation No 1907/2006 therefore 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 2 of Annex XV to that regulation. It is therefore clear that 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).
36      In this connection, for example, the classification of a substance under Annex I to Regulation No 1272/2008 constitutes a relevant, but not decisive, element. Where a substance falls within one of the hazard classes in respect of human health or the environment provided for in that regulation, that circumstance may be sufficient to show the probability of ‘serious effects to human health or the environment’. Inclusion in a hazard class is nevertheless neither a necessary condition, nor a sufficient condition in this regard (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 28).
37      Consequently, it is necessary to reject the applicant’s argument that HFPO-DA does not entail serious effects giving rise to an equivalent level of concern to those of a substance meeting the criteria set out in Article 57(c) of Regulation No 1907/2006 in so far as it cannot be classified as a substance toxic for reproduction in category 1A, 1B or 2 in accordance with Section 3.7.2.1.1 of Annex I to Regulation No 1272/2008.
38      For the same reasons, it is necessary to reject the arguments put forward by the applicant at the hearing in response to ECHA’s arguments on developmental toxicity; according to the applicant’s arguments, ECHA committed a manifest error of assessment by failing to assess the effects observed in the light of the criteria laid down in Regulation No 1272/2008. According to the applicant, that regulation contains the only instruments of EU law establishing the relevance of the effects observed during animal testing for human health. The relevance of Regulation No 1272/2008 for the identification of a substance as being of very high concern follows from the case-law, in particular the judgment of 7 March 2013, Rütgers Germany and Others v ECHA (T‑96/10, EU:T:2013:109), and, as regards specifically developmental toxicity, from Article 57(a) to (c) of Regulation No 1907/2006.
39      The General Court finds that those arguments are not capable of calling into question the case-law of the Court of Justice cited in paragraph 36 above, according to which the classification of a substance under Annex I to Regulation No 1272/2008 constitutes a relevant, but not decisive, element in order to show the probability of ‘serious effects to human health or the environment’. Consequently, ECHA was not prevented in the present case 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.
40      As regards the scientific evidence relied on by ECHA, it should be noted that it is apparent from the support document that ECHA expressly based its conclusion regarding developmental toxicity on findings made on rats rather than on mice. Even if no developmental toxicity on mice had been found in the support document, that finding would not have called into question the available data on rats on which ECHA based its conclusion in relation to developmental toxicity. Consequently, the applicant’s arguments relating to the data on developmental toxicity on mice and the interpretation of the Edwards, 2010a study must be rejected as irrelevant.
41      In any event, the Court observes that the finding in the support document criticised by the applicant that the possibility of developmental toxicity could be underestimated is not only reasoned, in that document, by the fact that the data relating to developmental toxicity on mice are restricted to a study conducted in accordance with Guideline 421 of the Organisation for Economic Cooperation and Development (OECD) with insufficient dosing. In the support document, that finding is presented in a narrow context with the conclusions on developmental toxicity based on the effects observed in rats. Consequently, the finding at issue is credibly reasoned, on the one hand, by the lack of sufficient data on mice and, on the other hand, by the existence of relevant data on rats.
42      As regards the applicant’s argument that ECHA, by relying on ‘preliminary data’ and finding the existence of ‘some indication that HFPO-DA may cause developmental effects’, failed to comply with Regulation No 1272/2008 or Article 57(f) of Regulation No 1907/2006, which requires that there be scientific evidence of serious effects, it should be noted that the sentence referred to by the applicant in the support document refers to the data on mice rather than to the data on rats, as ECHA confirmed at the hearing in response to a question from the Court. Given that ECHA based its conclusion relating to developmental toxicity on the data on rats rather than on the data on mice, the applicant’s arguments must be rejected as ineffective.
43      As regards the applicant’s arguments relating to changes observed in foetal bodyweight which were raised at the stage of the reply, it should be noted that the contested decision was adopted on the basis of Article 59 of Regulation No 1907/2006. As is apparent from Article 1(1) of that regulation, its purpose 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.
44      According to the case-law, in an area of evolving and complex technology such as that in the present case, the competent EU authorities have a broad discretion, in particular as to the assessment of highly complex scientific and technical facts, in order to determine the nature and scope of the measures which they adopt, whereas review by the EU judicature has to be limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether the authorities have manifestly exceeded the limits of their discretion (see judgments of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 60 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 52 and the case-law cited).
45      In those circumstances, according to settled case-law, in order to establish that such an authority committed a manifest error in assessing complex facts such as to justify the annulment of the act in question, the evidence adduced by the applicant must be sufficient to make the factual assessments used in the act implausible (see judgment of 9 September 2011, France v Commission, T‑257/07, EU:T:2011:444, paragraph 86 and the case-law cited).
46      In such a context, the European Union judicature cannot substitute its assessment of scientific and technical facts for that of the institutions on which alone the FEU Treaty has placed that task (see judgments of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 60 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 52 and the case-law cited).
47      Also according to case-law, the EU authorities’ broad discretion, which implies limited judicial review of their exercise of that discretion, applies not only to the nature and scope of the measures to be taken but also applies, to some extent, to the finding of the basic facts. However, even though such judicial review is of limited scope, it requires that the European Union authorities which have adopted the act in question must be able to show before the European Union judicature that in adopting the act they actually exercised their discretion, which presupposes that they took into consideration all the relevant factors and circumstances of the situation the act was intended to regulate (see judgments of 8 July 2010, Afton Chemical, C‑343/09, EU:C:2010:419, paragraphs 33 and 34 and the case-law cited, and 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).
48      It is thus for the EU judicature to establish, in the light of the factors relied on by the applicant, 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 (judgments of 22 November 2007, Spain v Lenzing, C‑525/04 P, EU:C:2007:698, paragraph 57; of 6 November 2008, Netherlands v Commission, C‑405/07 P, EU:C:2008:613, paragraph 55; and of 9 September 2011, France v Commission, T‑257/07, EU:T:2011:444, paragraph 87).
49      The data on rats, on which ECHA based its conclusion on developmental toxicity in the present case, includes the Edwards, 2010b study conducted in accordance with OECD Guideline 414. The fact that ECHA considered the changes in foetal body weight observed by that study to be the manifestation of developmental toxicity is consistent with Section R.7.6 of the Guidance on information requirements and chemical safety assessment published by ECHA (‘the ECHA guidance’), according to which altered growth is a major manifestation of developmental toxicity.
50      As regards the applicant’s argument that those variations are a secondary non-specific consequence of maternal toxicity, it must be held that the mere fact that there are 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. In addition, it is apparent, inter alia, from the support document that the mean corrected body weight in the dams and the mean corrected body weight gain were not significantly reduced by comparison with the controls. Consequently, ECHA’s finding that a reduction in maternal weight was not the cause of the reduction in foetal body weight observed is credible.
51      Lastly, the Court notes that the applicant does not put forward any argument calling into question ECHA’s conclusions in the support document relating to the early deliveries observed in the Edwards, 2010b study, or the conclusions relating to the Conley et al., 2019 study, ‘Adverse Maternal, Fetal, and Postnatal Effects of Hexafluoropropylene Oxide Dimer Acid (GenX) from Oral Gestational Exposure in Sprague-Dawley Rats’, also carried out on rats, which, according to that document, are consistent with the weight reductions observed in mice.
52      Accordingly, it must be held that the applicant has not demonstrated that ECHA made a manifest error of assessment as regards the assessment and conclusion relating to HFPO-DA’s developmental toxicity.
(ii) Repeated dose toxicity
53      The applicant asserts that ECHA’s conclusion on repeated dose toxicity – that the main target organs of FRD-902 in rodents included the liver, the kidneys, the haematological system and the immune system – is relevant only to rodents and not to humans. According to the applicant, HFPO-DA may induce the peroxisome proliferator-activated receptor alpha (‘PPARα’), which is specific to rodents. At the hearing, the applicant stated that it did not dispute that PPARα exists in humans, but rather claimed that ECHA had neither evaluated nor established the relevance of the effects observed for humans.
54      ECHA disputes those arguments.
55      In that regard, the Court recalls that it stated, in its judgment of 20 September 2019, PlasticsEurope v ECHA (T‑636/17, EU:T:2019:639, paragraph 113), that the argument raised by the applicant in that case, according to which the finding of an equivalent level of concern required under Article 57(f) of Regulation No 1907/2006 ought to be based on human studies or on data from studies in animals establishing a strong presumption of the existence of effects was not, per se, an irrelevant argument in the case which gave rise to that judgment.
56      However, in the present case, it should be noted that it is apparent from the support document that ECHA took into account the fact that HFPO-DA could induce PPARα and described the function of that receptor and other receptors in the body. ECHA also stated in that document that there was a scientific debate, in particular as regards the induction of liver cancer in humans and the fact that there was less information on the differences between species as regards PPARα-related effects in other organs and during development. According to that document, ECHA also took into account information indicating that HFPO-DA could reinforce other modes of action relevant for humans. In addition, ECHA found in the support document that certain liver effects could be rodent-specific phenomena, but that those effects should be considered relevant to human health if they are accompanied by certain other effects. Liver necrosis indicates that another mode of action could be in place. Subsequently, ECHA found, inter alia, that the effects observed were repeatedly accompanied by necrosis.
57      In the light of the case-law cited in paragraph 45 above, it is therefore for the applicant to adduce sufficient evidence to make the assessment used in the contested decision implausible. In the present case, the applicant however merely asserted that the PPARα mode of action was specific to rodents and that ECHA had not established the relevance of the effects observed for humans. Nevertheless, it has not put forward any arguments calling into question the credibility of the findings set out in the support document in that regard.
58      Consequently, it must be held that the applicant has not demonstrated that ECHA made a manifest error of assessment as regards the conclusion relating to HFPO-DA’s repeated dose toxicity.
(iii) Toxicokinetics and bioaccumulation
59      The applicant asserts that in order to gauge the relevance of a substance’s properties it is necessary to determine whether it bioaccumulates.
60      Chapter R.11 of the ECHA guidance and the Commission’s legislative proposal in relation to Article 57 of Regulation No 1907/2006 confirm that bioaccumulative potential is relevant to assessing the seriousness of effects.
61      The available scientific data on bioaccumulation and toxicokinetics confirm that HFPO-DA is not bioaccumulative. According to the applicant, ECHA therefore manifestly erred in its assessment by finding HFPO-DA to be a substance of very high concern.
62      ECHA, supported by the Kingdom of the Netherlands and ClientEarth and CHEM Trust Europe, disputes that argument.
63      First of all, it should be recalled that, according to Article 57(f) of Regulation No 1907/2006, 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 Article 57(d) or (e) of that regulation, are to be identified as substances of very high concern if they meet the criteria laid down in Article 57(f) of that regulation. It must be stated that bioaccumulative or very bioaccumulative substances are listed in that provision only by way of example. Consequently, that provision does not require a substance to be bioaccumulative in order to be identified as a substance of very high concern.
64      The applicant’s arguments relating to Chapter R.11 of the ECHA guidance and to the Proposal for a Regulation COM(2003) 644 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) on Persistent Organic Pollutants (OJ 2004 C 96, p. 24) do not call that finding into question. The extracts from those documents cited by the applicant concern PBT and vPvB substances, and therefore bioaccumulative substances. That explains why the concerns arising from bioaccumulation are mentioned in those documents. However, that does not rule out the possibility that other substances may be identified as being of very high concern under Article 57(f) of Regulation No 1907/2006 irrespective of whether they are bioaccumulative.
65      Next, it should be noted that, according to the support document, the bioaccumulation potential of HFPO-DA in humans and the environment is uncertain. According to that document, although there is a concern related to possible bioaccumulation in humans, that concern is not presented as a factor taken into account in the assessment of the equivalent level of concern to those of CMR, PBT and vPvB substances. That is confirmed by the fact that HFPO-DA’s bioaccumulation is not among the intrinsic properties on the basis of which that substance was identified as a substance of very high concern in the support document, the contested decision and the relevant entry in the candidate list.
66      Consequently, even if it were scientifically established that HFPO-DA does not have any bioaccumulation potential, such a finding would not call into question ECHA’s conclusions relating to the serious effects on human health and to the equivalent level of concern to those of CMR, PBT and vPvB substances on which the contested decision is based.
67      Accordingly, the applicant’s arguments relating to the scientific evidence concerning toxicokinetics and bioaccumulation must be rejected as unfounded.
(iv) Carcinogenicity
68      The applicant asserts that ECHA erroneously concluded, on the basis of a single combined study on rats, that HFPO-DA was potentially carcinogenic. ECHA, it claims, failed to take into account the observation by the authors of that study that ‘the observed increase in tumours was induced via the non-genotoxic PPARα mode of action, which is specific for rodents’.
69      Moreover, the fact that ECHA adopted a decision in order to assess the carcinogenicity of the substance at issue confirms that the data assessed in the context of the procedure which led to the adoption of the contested decision do not support the conclusion that the substance is of equivalent concern to human carcinogens.
70      ECHA, supported by the Kingdom of the Netherlands and ClientEarth and CHEM Trust Europe, asserts that this argument is irrelevant and is contradicted by the facts of the case.
71      In that regard, it should be noted that the following remark appears in the ‘Remarks’ section of the candidate list:
‘The combined intrinsic properties justifying the inclusion for the [MSC] as a substance for which there is scientific evidence of probable serious effects to human health and the environment which give rise to an equivalent level of concern are the following:
Persistence, mobility, potential for long-range transport, observed adverse effects (at least the following probable effects for human health: effects on the liver, the kidneys, and the haematological and immune systems and effects on development; at least the following probable effects for the environment: population relevant effects on birds and mammals); as well as low adsorption potential and high water solubility rendering the substance fully bioavailable for uptake via (drinking) water. Together, these elements lead to a very high potential for irreversible effects.’
72      Furthermore, according to the support document, HFPO-DA may be a human carcinogen, but the data currently available are not sufficient to assess its carcinogenic potential. It is also stated therein that that concern is examined in the context of the evaluation of the substance. Consequently, according to that document, the information on the tumours observed in the chronic toxicity and carcinogenicity study in rodents were taken into account in the assessment of the equivalent level of concern to those of CMR, PBT and vPvB substances only as supporting information.
73      It is apparent from those factors that the contested decision was not based on a carcinogenicity potential of HFPO-DA. That finding is confirmed by the fact that HFPO-DA’s carcinogenicity is not among either the intrinsic properties or the adverse effects observed on human health which are listed in the contested decision and in the entry relating to HFPO-DA in the candidate list on the basis of which HFPO-DA was identified as a substance of very high concern.
74      Consequently, even the absence of any information relating to carcinogenicity or a finding that HFPO-DA cannot be considered to be carcinogenic on the basis of the available data would not call into question ECHA’s conclusions regarding the serious effects on human health and the equivalent level of concern to those of CMR, PBT and vPvB substances on which the contested decision is based.
75      As regards the applicant’s argument that such uncertain information cannot serve as a basis for identification as a substance of very high concern and cannot moreover be used as supporting information, it is sufficient to note that the current uncertainty concerning the carcinogenicity potential in humans is clearly apparent from the support document. ECHA did not commit a manifest error of assessment by mentioning as supporting information, in the support document, information which was insufficient at the time to support a conclusion on carcinogenicity in humans, but which was nevertheless available.
76      Accordingly, the applicant’s arguments relating to the carcinogenicity potential must be rejected as being, in part, irrelevant and, in part, unfounded.
(v)    Reproductive toxicity
77      In relation to reproductive toxicity, the applicant asserts that, in the support document, ECHA concluded in respect of fertility that in the ‘available reproduction/developmental screening study in mice, FRD-902 did not cause any reproductive effects’. The reproduction/developmental toxicity screening test in accordance with OECD Guideline 421 concluded that no effect was observed on mortality for the ‘parental animals’ or on reproductive performance.
78      According to the applicant, ECHA should therefore have concluded that HFPO-DA is not toxic for reproduction instead of concluding that ‘information is regarded [as] inconclusive with respect to potential effects on fertility and development’.
79      ECHA, supported by ClientEarth and CHEM Trust Europe, asserts that those arguments are irrelevant and, in any event, contradicted by the facts of the case.
80      In this respect, it should be noted that it is apparent from the support document that the information relating to reproductive toxicity is considered to be inconclusive. In accordance with that finding, reproductive toxicity is not among the effects observed listed in the contested decision and in the entry relating to HFPO-DA in the candidate list on the basis of which it was identified as a substance of very high concern. It is apparent from those factors that the contested decision is not based on a reproductive toxicity of HFPO-DA.
81      Consequently, even if it were established and acknowledged in the support document that HFPO-DA did not have any reproductive toxicity, such a finding would not call into question ECHA’s conclusions relating to the serious effects on human health and to the level of concern equivalent to those of CMR, PBT and vPvB substances on which the contested decision is based.
82      Accordingly, the applicant’s arguments relating to reproductive toxicity must be rejected as irrelevant.
83      It follows from the foregoing that the applicant has not demonstrated that ECHA made a manifest error in the assessment of the scientific evidence.
(2)    Whether serious effects on human health have been established
84      The applicant claims that ECHA has not demonstrated the existence of serious effects in accordance with Article 57(f) of Regulation No 1907/2006.
85      In the first place, ECHA did not consider the effects observed, individually, to be ‘serious’ on the basis, for instance, of the classification under Regulation No 1272/2008. Instead, ECHA combined various effects, none of which is ‘serious’ when considered individually, and concluded that those effects were ‘serious’ when considered together.
86      The applicant adds that ECHA neither assessed nor demonstrated to the requisite legal standard that the alleged effects were significant. There is no basis for asserting that the seriousness of the effects depends on which body organs they affect and that quality of life is only a function of which organ is affected.
87      The applicant submits that under Article 57(a) to (c) of Regulation No 1907/2006 it is not possible to identify merely any substance that is carcinogenic, mutagenic or toxic for reproduction as of very high concern, but only those fulfilling the criteria for classification as category 1A or category 1B substances. According to the applicant, if any substance not meeting the criteria for CMR substances of categories 1A or 1B according to that regulation could nevertheless be identified as a substance of very high concern in that the alleged irreversibility of its effects is sufficient to establish its toxicity, the classification system under Regulation No 1272/2008 would be flawed.
88      Lastly, the applicant asserts that HFPO-DA is not bioaccumulative and therefore cannot be identified under Article 57(d) of Regulation No 1907/2006. As regards substances other than those covered by Article 57(a) to (c) of that regulation, the legislature requires a substance to be both persistent and bioaccumulative, where its toxicity is proved, or very persistent and very bioaccumulative to be identified as a substance of very high concern. The legislature does not allow a substance to be identified on the grounds that it is persistent and mobile but not bioaccumulative. Mobility is not of the same level of concern as bioaccumulation. ECHA’s guidance states that the potential to contaminate remote areas can only occur if a substance is both persistent and bioaccumulative, besides being potentially toxic. Persistence – in conjunction with other effects that are insufficient in themselves – is not sufficient as such to identify a substance as of very high concern.
89      In the second place, ECHA allegedly relied on ‘yet unknown effects’, that is to say, ‘effects that may only become apparent after lifelong exposure’. In the applicant’s view, hypothetical effects cannot be considered to be serious.
90      ECHA, supported by ClientEarth and CHEM Trust Europe, disputes those arguments.
91      In the first place, and in the light of the case-law referred to in paragraph 36 above, the applicant’s arguments based on Regulation No 1272/2008 must be rejected. Those arguments are based on a misinterpretation of the relationship between Article 57(f) of Regulation No 1907/2006 and the classification criteria laid down in Annex I to Regulation No 1272/2008.
92      It is also necessary to reject the applicant’s arguments that the legislature allows a substance to be identified as a substance of very high concern only if it is very persistent and very bioaccumulative or persistent and bioaccumulative, where its toxicity is proved. Those arguments are also based on a misinterpretation of Article 57(f) of Regulation No 1907/2006. The fact that that provision refers, for the purposes of determining the equivalent level of concern, to the substances referred to in Article 57(a) to (e) of Regulation No 1907/2006, including to PBT and vPvB substances, does not mean that a substance must meet the identification criteria for those substances in order to be identified as a substance of very high concern under Article 57(f) of Regulation No 1907/2006. Similarly, that reference does not preclude properties such as persistence being taken into account in the context of such identification, irrespective of whether the substance at issue is also bioaccumulative.
93      First, nothing in the wording of Article 57(f) of Regulation No 1907/2006 supports the interpretation advocated by the applicant. On the contrary, the choice of the concept of ‘equivalent’ level of concern clearly indicates that the level of concern does not have to be ‘identical’.
94      Second, Article 57(f) of Regulation No 1907/2006 would be deprived of any useful effect if the applicant’s interpretation, according to which a substance can be identified as a substance of very high concern only if it displays the properties referred to in Article 57(d) and (e) of Regulation No 1907/2006, were to be followed. The objective of Article 57(f) of Regulation No 1907/2006 is to make it possible to identify as being of very high concern substances which do not meet the criteria set out in Article 57(d) and (e) of Regulation No 1907/2006, but which give rise to an equivalent level of concern. In that regard, Article 57(f) of Regulation No 1907/2006 expressly refers to substances ‘such as … 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)’.
95      Third, it does not follow from Article 57(f) of Regulation No 1907/2006 that those properties may be taken into account only when they appear in those precise combinations. In that regard, it is sufficient to note that those substances are mentioned only by way of illustration, which is unequivocally clear from the use of the words ‘such as … those’.
96      Fourth, the applicant’s interpretation is not consistent with the aim of Regulation No 1907/2006, as laid down in Article 1(1) of that regulation, which is to ensure a high level of protection of human health and the environment. Accordingly, that interpretation is also incompatible with the objective of Article 57(f) of Regulation No 1907/2006. 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. Persistence combined with other intrinsic properties of the substance in question may give rise to concerns of an equivalent level to those of CMR, PBT and vPvB substances. Consequently, the interpretation advocated by the applicant would preclude the identification as substances of very high concern of substances which are just as dangerous for human health and the environment as those referred to in Article 57(a) to (e) of Regulation No 1907/2006.
97      Fifth, as regards the establishment of serious effects on human health, it must be stated that, according to the support document, the available information on the adverse effects observed on the liver, kidneys, haematological system, immune system and development ‘together’ are considered probable and serious for human health.
98      Contrary to what the applicant claims, Article 57(f) of Regulation No 1907/2006 does not prohibit such a combination of several effects in order to establish their seriousness. The use of the plural in the expression ‘serious effects’ clearly indicates that several different effects may be taken into account and the interpretation advocated by the applicant is not compatible with the objectives of Regulation No 1907/2006; those objectives cannot allow only the identification of a substance on the basis of serious effects observed individually, and not on the basis of several effects taken together. The impact on human health is not necessarily less serious if it results only from several effects taken together.
99      Consequently, it is not necessary to examine the parties’ arguments as to whether or not the effects individually are serious. The applicant’s arguments in that regard are not relevant and must therefore be rejected.
100    Sixth, as regards the applicant’s assertion at the hearing that ECHA did not establish that the effects at issue were serious when taken together, it must be stated that, in the support document, under the heading ‘Weight of evidence approach to evaluate the concern for severe health effects and concern for yet unknown effects’, it carried out a detailed assessment of the seriousness of the effects on human health and the environment. In that context, and before concluding that there were serious effects on human health and the environment, ECHA assessed in detail several factors, in particular the type of effects observed, the dose at which those effects had been observed, the potential irreversibility of the effects observed on account of the very high persistence, mobility and bioavailability of HFPO-DA, leading, according to ECHA, to continuous exposure, and the internal toxic potency of HFPO-DA, which is, according to that document, higher than that of perfluorooctanoic acid (PFOA), a substance identified as being of very high concern.
101    As regards, more specifically, the potential irreversibility of the effects observed, according to the case-law of the Court of Justice referred to in paragraph 35 above, the effects of a substance on human health are capable of being regarded as ‘serious’ precisely, inter alia, on account of their irreversible nature.
102    Consequently, the fact that ECHA took into account the irreversible nature of the effects observed when determining their seriousness does not in itself constitute a manifest error of assessment on its part.
103    In the second place, as regards the ‘yet unknown’ effects, first of all, it must be noted that, in the support document, those effects were not classified as serious effects on human health. That document states merely, under the heading ‘Weight of evidence approach to evaluate the concern for severe health effects and concern for yet unknown effects’, that, ‘in addition to the observed adverse effects, there is potential for yet unknown effects’ and that that potential ‘contributes to the weight-of-evidence for probable serious effects on human health’.
104    Next, it is necessary to examine the applicant’s argument that the fact that those effects have not been identified as probable serious effects, as ECHA allegedly states, means that they are not to be considered as a basis for establishing that there are serious effects and for assessing the equivalent level of concern raised by the serious effects.
105    First, contrary to what the applicant suggests, ECHA did not refer to unknown effects which existed for any substance. The support document refers to as yet unknown effects resulting from the intrinsic properties of HFPO-DA which cannot be determined on the basis of standard tests.
106    Second, the intrinsic properties of HFPO-DA which serve as a basis for that conclusion, in particular its very high persistence, mobility and properties leading to its bioavailability (such as its high water solubility, low volatility and low adsorption potential), are based on scientific evidence or at least not disputed by the applicant in the context of this dispute.
107    In paragraph 9 of its observations on the statement in intervention submitted by ClientEarth and CHEM Trust Europe, it is true that the applicant claims that their assertion that HFPO-DA has a very low adsorption potential is incorrect and refers in that regard to its observations on the Annex XV dossier. However, the applicant has not substantiated that criticism or raised a separate complaint in that regard in the context of this dispute.
108    Third, the applicant does not put forward, in the context of the present complaint, any argument capable of calling into question the credibility of ECHA’s conclusion as such, on the basis of the properties referred to in paragraph 106 above.
109    On the one hand, contrary to what the applicant suggests, ECHA did not conclude that continuous exposure to HFPO-DA and the irreversibility of the effects were the consequence solely of that substance’s persistence. It is apparent from the support document that ECHA based that conclusion not only on HFPO-DA’s very high persistence, but also on its mobility and the properties leading to its bioavailability, such as its high water solubility, low volatility and low adsorption potential.
110    On the other hand, it is necessary to reject the applicant’s arguments relating to bioaccumulation. The applicant’s argument that mobility does not give rise to the same concerns as bioaccumulation is ineffective, given that there is nothing to indicate that ECHA made such a finding. The applicant’s argument that mobility is an element of the assessment of PBT and vPvB substances according to Annex XIII to Regulation No 1907/2006 is incorrect. Annex XIII makes no reference to mobility. In contrast to what the applicant claims, nor does the ECHA guidance state that the potential to contaminate remote areas only occurs if a substance is both persistent and bioaccumulative.
111    It follows from the foregoing that the applicant has not demonstrated that ECHA made a manifest error of assessment by mentioning as yet unknown effects as contributing to the weight of evidence of serious effects.
112    It must be concluded that all the applicant’s arguments relating to whether serious effects on human health have been established must be rejected.
(3)    Equivalent level of concern of the serious effects
113    The applicant claims that ECHA failed to establish that the alleged effects were of an equivalent level of concern to those of CMR substances as required by Article 57(f) of Regulation No 1907/2006 and therefore infringed that article and committed a manifest error of assessment.
114    The applicant submits that in the support document ECHA merely lists a number of alleged effects which are presented as contributing to the overall level of concern, without specifying the level of concern for human health resulting from those various effects in combination and without comparing that level to the level caused by the CMR substances listed in Article 57(a) to (c) of Regulation No 1907/2006.
115    In its observations on the statement in intervention filed by ClientEarth and CHEM Trust Europe, the applicant asserts that it is apparent from the case-law of the Court of Justice that when the level of concern for human health posed by a substance is assessed under Article 57(f) of Regulation No 1907/2006, that level of concern must be equivalent to the level of concern for human health posed by CMR substances under Article 57(a) to (c) of that regulation.
116    Whilst acknowledging that ECHA did compare the level in question with the level of concern posed by PBT and vPvB substances referred to in Article 57(d) and (e) of Regulation No 1907/2006, the applicant nevertheless submits that, in order to be identified as a substance of very high concern, a substance that does not meet a level of concern equivalent to CMR substances but does satisfy the toxicity criteria set out in Annex XIII to Regulation No 1907/2006 is required by the rules at least to be also persistent and bioaccumulative.
117    ECHA, supported by ClientEarth and CHEM Trust Europe, disputes those arguments.
118    In the first place, it should be noted that the support document, under the heading ‘Comparison of above concerns to concerns of PBT/vPvB substances’, makes a detailed comparison between the concerns raised by HFPO-DA and those raised by the use of PBT and vPvB substances referred to in Article 57(d) and (e) of Regulation No 1907/2006.
119    It is true, as the applicant states, that the support document does not carry out such a detailed comparison between the concern raised by HFPO-DA and that raised by the use of CMR substances referred to in Article 57(a) to (c) of Regulation No 1907/2006.
120    However, contrary to what is claimed by the applicant, Article 57(f) of Regulation No 1907/2006 does not require, in the case of serious effects on human health associated with the substance in question, that the level of concern to which those effects give rise must always be equivalent to those of CMR substances alone, irrespective of whether that level is equivalent to those of PBT and vPvB substances.
121    First, as the Court of Justice has confirmed, Article 57(f) of Regulation No 1907/2006 requires that there be scientific evidence that those effects give rise to an equivalent level of concern to those of CMR, PBT or vPvB substances (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 31).
122    Second, there is nothing in the wording of Article 57(f) of Regulation No 1907/2006 that indicates 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.
123    Third, as is apparent from the support document, the concerns stemming from PBT and vPvB substances with which ECHA compared the concerns associated with HFPO-DA relate to humans and other environmental organisms. In that regard, it is found in that document that emissions of HFPO-DA, which is a very persistent and mobile substance, lead to continuous and increasing exposure to HFPO-DA which will be fully bioavailable for wildlife and human beings via the environment. This may, according to that document, lead to internal exposure of those organisms similar to that resulting from properties with bioaccumulative and very bioaccumulative characteristics.
124    Fourth, in so far as the applicant refers to paragraphs 37 and 38 of the judgment of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207), it must be stated that those paragraphs do not indicate that Article 57(f) of Regulation No 1907/2006 precludes the level of concern raised by serious effects from a substance for human health from being compared with those of PBT and vPvB substances. Paragraph 37 states that, as regards hazards to human health, CMR substances are the only ones identified as being of very high concern, and therefore subject to the authorisation regime, solely on the basis of their classification under Annex I to Regulation No 1272/2008. Paragraph 38 states that the EU legislature therefore considered that, by their nature, the effects of those substances on human health give rise to concerns of such a level that differentiating them from all other substances, including those falling within other hazard classes that may result in death or other irreversible effects, is justified.
125    It is apparent from paragraphs 37 and 38 of the judgment of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207), (i) that CMR substances entail hazards to human health and (ii) that they are the only substances identified solely on the basis of their classification under Annex I to Regulation No 1272/2008, on account of the concerns raised by their effects on human health. Contrary to what is suggested by the applicant, it does not follow from this, however, that substances for which there is scientific evidence of probable serious effects on human health and which give rise to an equivalent level of concern to those of PBT and vPvB substances cannot be identified as substances of very high concern.
126    Consequently, the applicant’s argument based on misinterpretation of Article 57(f) of Regulation No 1907/2006 must be rejected.
127    In the second place, it is also necessary to reject the applicant’s argument that, if a substance could be identified for reproductive toxicity effects under Article 57(f) of Regulation No 1907/2006 based on any level of scientific evidence, this would bypass the legislature’s choice that, among all substances for which there is evidence of carcinogenic, mutagenic or toxic effects, only those fulfilling the criteria for category 1A or 1B under Regulation No 1272/2008 are capable of being identified as substances of very high concern. As was stated in paragraph 91 above in relation to the establishment of serious effects, that argument is based on a misinterpretation of the relationship between Article 57(f) of Regulation No 1907/2006 and the classification criteria laid down in Annex I to Regulation No 1272/2008. Although the applicant refers in that regard to the inadequacy of the scientific evidence, it does not in actual fact criticise the standard of proof, but repeats, in essence, its argument that HFPO-DA does not meet the criteria referred to in Article 57(a) to (c) of Regulation No 1907/2006, namely those of the classification criteria laid down in Annex I to Regulation No 1272/2008 which are mentioned in that article.
128    In the third place, it should be noted that the support document states, under the heading ‘Overall concern and assessment of the level of concern’, that ‘HFPO-DA is considered to be of equivalent level of concern to the very high concern for substances meeting the criteria laid down in [Article] 57(a) – (e) according to [Article] 57(f) of [Regulation No] 1907/2006 because of the overall concern arising from the concern elements described in section 6.3.2.’. A description of the qualitative components relevant for assessing the level of concern follows. Furthermore, as was stated in paragraph 116 above, the applicant expressly acknowledges that ECHA made a comparison between the concerns raised by HFPO-DA and those raised by the use of PBT and vPvB substances.
129    Consequently, it is necessary to reject the applicant’s argument that ECHA did not specify the level of concern raised by HFPO-DA on the ground that it is factually incorrect.
130    In the fourth place, it is necessary to examine the applicant’s arguments that ECHA should not have taken into consideration the ‘yet unknown’ effects in the assessment of the equivalent level of concern.
131    In that regard, it must be recalled that 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 (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 32).
132    Regulation No 1907/2006 seeks to reserve the authorisation procedure to certain substances, identified as being of very high concern, not only on account of the seriousness of their dangerous effects on health or on the environment, but also having regard to other factors. The latter may include, apart from the probability that the serious effects of a substance may occur under the normal conditions of use of that substance, the difficulty of adequately assessing the risks posed by those substances when it is impossible to determine, with the necessary certainty, a derived no-effect level or a predicted no-effect concentration, or indeed the level of concern that those substances engender in the public, the number of persons affected, and the impact of those effects on the lives, and in particular, the professional lives, of the persons affected (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 39).
133    In the present case, it is stated in the table in Section 6.3.3 of the support document entitled ‘Overview of the qualitative components relevant for assessing the level of concern’, in the line entitled ‘Potential for causing serious effects although those would not be observed in standard tests’, that HFPO-DA stays in the water phase and will be continuously bioavailable to organisms that are exposed to water. According to that document, in conjunction with HFPO-DA’s high potential to cause continuously increasing pollution stock, in particular on account of its low adsorption potential, its negligible degradation, its water solubility and its mobility, it has, according to that document, high potential to cause an increase in internal exposures and a high probability of achieving levels of exposure which would cause effects and, over time, serious effects which are not observed during standard tests. Moreover, in the line entitled ‘Uncertainties in deriving safe concentration limits’, the following is stated:
‘The irreversibility and high potential for increasing exposures increases the potential of HFPO-DA to cause yet unknown health effects. This uncertainty is of concern for both human health and the environment. With time, effects may be discovered that may lead to more stringent safety levels for HFPO-DA. The derivation of safe exposure levels may therefore be possible in principle but is considered not to be of sufficient reliability.’
134    It is true that the wording of Article 57(f) of Regulation No 1907/2006, according to which there must be scientific evidence of probable serious effects of the substances in question to human health or 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, indicates that there must be a link between the serious effects arising from a substance and the level of concern raised. However, as is demonstrated by the non-exhaustive list of factors set out in the case-law referred to in paragraph 132 above, including the impossibility of determining, at that stage, with the necessary certainty, a derived no-effect level or a predicted no-effect concentration, that link does not require a strict correspondence between the serious effects observed and the factors to be taken into consideration in the assessment of the level of concern.
135    Moreover, for PBT and vPvB substances referred to in Article 57(d) and (e) of Regulation No 1907/2006, the concern arises in particular from the fact, referred to in Section 4.0.1 of Annex I to Regulation No 1907/2006, that the hazard assessment addressing all the long-term effects and the estimation of the long-term exposure of humans and the environment cannot be carried out with sufficient reliability for those substances. Given that Article 57(f) of Regulation No 1907/2006 requires the level of concern in question to be equivalent to those of the substances listed in Article 57(a) to (e) of that regulation, including, therefore, those of PBT and vPvB substances referred to in Article 57(d) and (e), it is also necessary to permit account to be taken of the factors of concern comparable to those related to PBT and vPvB substances, such as, in the present case, the uncertainty which is apparent from the scientific evidence as to the long-term effects associated with the intrinsic properties of HFPO-DA.
136    As regards the applicant’s argument that a concern linked to possible, as yet unknown effects exists for any substance, it must be stated that ECHA did not take into consideration as yet unknown effects which existed for any substance and which are therefore purely hypothetical in the present case. As was stated in paragraph 105 above, it is apparent from the support document that ECHA based its finding as to the existence of a concern relating to the as yet unknown effects on the intrinsic properties of HFPO-DA, such as its persistence, its mobility, its low adsorption potential and its high water solubility resulting in increasing and continuous exposure. Moreover, the fact that that concern relating to yet unknown effects of HFPO-DA is additional to concerns linked to serious effects observed on human health, namely effects on the liver, kidneys and hematological and immune systems, as well as developmental effects, supports rather than relativises the concern.
137    Accordingly, the first complaint of the first part of the first plea must be rejected in its entirety.
(b)    The second complaint of the first part of the first plea in law concerning serious effects on the environment of an equivalent level of concern to those of PBT and vPvB substances
138    The applicant contends that ECHA breached Article 57(f) of Regulation No 1907/2006 and manifestly erred in its assessment by failing to establish that HFPO-DA could cause serious effects to the environment giving rise to an equivalent level of concern to those of PBT and vPvB substances. The applicant puts forward three sets of arguments in that regard.
139    ECHA, supported by the Kingdom of the Netherlands and ClientEarth and CHEM Trust Europe, asserts that the second complaint of the first part of the first plea in law should be rejected.
(1)    Whether serious effects on the environment have been established
140    The applicant contends that ECHA breached Article 57(f) of Regulation No 1907/2006 and manifestly erred in its assessment by failing to establish that HFPO-DA could cause serious effects on the environment.
141    In the first place, the only type of effects of HFPO-DA identified as affecting the environment are population-relevant effects on birds and mammals in the form of impacts on growth resulting from secondary poisoning. A small reduction in weight in a few species, such as that observed, does not in the applicant’s view necessarily amount to a serious effect on the environment.
142    The applicant asserts that several passages in the support document show that the evidence submitted by ECHA is unconvincing. ECHA itself considered that ‘direct toxicity of HFPO-DA to aquatic and terrestrial species [was] not considered to contribute significantly to the overall equivalent level of concern assessment for HFPO-DA’.
143    The applicant also emphasises that the ECHA guidance states that ‘the chemicals of concern with respect to secondary poisoning include lipophilic organic chemicals and some metal compounds’. HFPO-DA, which according to the applicant is neither a lipophilic organic chemical nor a metal compound, is therefore not a substance of concern in terms of secondary poisoning.
144    In the second place, the applicant asserts that it is impossible to determine whether or not hypothetical effects, that is to say, effects that are as yet unknown and may only become apparent after lifelong exposure – effects on which ECHA allegedly relied in the support document – would be serious. Moreover, effects that have not been demonstrated cannot be of equivalent concern within the meaning of Article 57(f) of Regulation No 1907/2006.
145    ECHA, supported by ClientEarth and CHEM Trust Europe, disputes those arguments.
146    In the first place, as regards the applicant’s arguments that several passages in the support document show that the evidence submitted by ECHA is unconvincing, it must be stated that all those passages concern findings relating to the direct toxicity of HFPO-DA for certain species, such as algae, daphnias, fish, earthworms and plants. It is apparent from the support document that ECHA considered birds and mammals to be more sensitive and that HFPO-DA’s toxicity for those species was relevant for secondary poisoning. ECHA concluded that there were probable serious effects on the environment on the basis of the effects observed on growth of the F1 generation of mice. The fact that ECHA expressly mentioned the lack of data concerning HFPO-DA’s direct toxicity to earthworms and plants and the existence of data indicating low direct toxicity for algae, daphnias and fish and the finding that, for those reasons, the environmental hazards associated with HFPO-DA had not been considered to be a priority in the support document does not call into question its conclusion on secondary poisoning in relation to birds and mammals. Accordingly, the applicant’s arguments must be rejected.
147    In the second place, it is necessary to reject the applicant’s argument that HFPO-DA cannot be regarded as a substance of very high concern because it is neither a lipophilic organic chemical nor a metallic compound. The passage from the ECHA guidance cited by the applicant mentions lipophilic chemical substances and certain metallic compounds as examples of substances of very high concern in relation to secondary poisoning without, however, excluding other substances or compounds.
148    In the third place, it is necessary to examine the applicant’s argument, raised at the stage of the reply, based on the alleged inconsistency of ECHA, which allegedly relied on the study carried out in line with OECD Guideline 421, in respect of its conclusions concerning the population effects of secondary poisoning, whereas, in the context of the assessment of reproductive toxicity and human development, the conclusions of that study were held to be inconclusive.
149    In that regard, it must be borne in mind that it is found in the support document that the study in question, namely the Edwards, 2010a study, reveals significantly lower weights for mouse pups, which is not disputed by the applicant. Those effects observed are not called into question by the finding in the support document relating to developmental toxicity in humans that it is not possible to draw from that study conclusions on fertility and development in the absence of data obtained with higher doses.
150    The applicant seems to suggest that that contradicts an argument of ECHA raised in the defence relating to population-relevant effects and states that ‘mortality, reproduction and development’ are the key factors in that regard. ECHA stated in the defence that ‘effects on mortality, reproduction or growth … are relevant effects for a population’. By that argument, ECHA therefore expressly argues that effects on growth are relevant for a population. Consequently, the fact that ECHA took into account effects observed on growth is entirely consistent with that argument. Nor has the applicant demonstrated that the taking into account of those effects was inconsistent with the finding relating to developmental toxicity in humans in the support document that it was not possible to draw conclusions on fertility and development from the study in question in the absence of data obtained with higher doses.
151    Next, in so far as the applicant claims that a small reduction in weight in a few species does not necessarily amount to a serious effect on the environment, the Court does not consider it necessary to rule on whether a small reduction in weight per se could be regarded as constituting serious effects on the environment. In the present case, it must be stated that it is clear from the support document that weight reductions of more than 20% were observed. Such reductions appear to be significant, not small. In addition, ECHA explained in the defence that such effects were relevant for the population and could lead to a reduction in the population size, for example through retarded overall development resulting in retarded sexual development and impaired ability to reproduce in time. By contrast, the applicant has not raised any argument capable of rendering implausible ECHA’s assessment that those effects were serious, but merely stated that ECHA had not stated the reasons why those effects were serious within the meaning of Article 57(f) of Regulation No 1907/2006.
152    Lastly, the applicant submits that it is unacceptable to find that the effects of a substance are serious in all mammals and wildlife on the basis of only one study on mice. According to the applicant, the data cannot be considered adequate as required by Section 10.8.2 of the ECHA guidance.
153    In that regard, the Court finds that, for the purposes of the assessment of secondary poisoning by HFPO-DA, the no-effect concentration observed was based on the effects observed in mice. Nevertheless, it should be noted that it is apparent from the support document that ECHA, in addition to the information on mice, also took into consideration the Rutgers et al., 2019 study. According to that document, that study contains a detailed description of an assessment of the concerns regarding secondary poisoning and includes, inter alia, data on birds, in this instance quails, and on mice and rats. According to those data, mice were, among those species, the most sensitive to possible effects of HFPO-DA, followed by rats and quails. At the hearing, it is true that the applicant claimed that the Rutgers et al., 2019 study, ‘Risicogrenzen GenX (HFPO-DA) voor grond en grondwater’, had not shown any toxic effect on quails. However, the applicant has not disputed that toxic effects were observed not only in mice but also in rats.
154    Consequently, the applicant’s arguments must be rejected as factually incorrect.
155    In any event, the applicant’s argument is ineffective. Neither Article 57(f) of Regulation No 1907/2006 nor any other applicable rule of law prohibits 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. That species forms part of the environment. Even the absence of evidence of toxicity of a substance for another species does not call into question the conclusion on the toxicity of that substance for mice.
156    In the fourth place, for the same reasons as those set out in the context of the first complaint, the applicant’s arguments relating to the as yet unknown effects (see paragraph 103 et seq.), to the combination of the alleged serious effects and the environmental fate properties (see paragraph 100 et seq.) and the alleged need for a substance to be bioaccumulative in order to exert its effects over the long term (see paragraph 63 et seq.) must also be rejected.
157    In the fifth place, in so far as the applicant states that ECHA has failed to identify what exposure levels would be sufficient to trigger the alleged serious effects or indeed the unknown effects, it is sufficient to note that it is apparent from the support document that ECHA took into account, in the context of the assessment of the level of concern equivalent to that of CMR, PBT and vPvB substances, uncertainties in deriving safe concentration limits. It is apparent from the case-law of the Court of Justice cited in paragraph 132 above that the impossibility of determining, with the necessary certainty, a derived no-effect level or a predicted no-effect concentration may be taken into account in the identification of a substance as a substance of very high concern in the light of the criterion referred to in Article 57(f) of Regulation No 1907/2006.
158    Consequently, the applicant’s arguments that such a scenario should not have been used as a basis for identifying a substance as a substance of very high concern in accordance with the criteria laid down in Article 57(f) of Regulation No 1907/2006 must be rejected.
159    Accordingly, the applicant has not shown that ECHA infringed Article 57(f) of Regulation No 1907/2006 or that it made a manifest error of assessment in relation to the establishment of serious effects on the environment.
(2)    The finding that persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties were relevant under Article 57(f) of Regulation No 1907/2006
160    The applicant asserts that properties relating to persistence, bioaccumulation and toxicity, in so far as they are covered by the criteria in Annex XIII to Regulation No 1907/2006, cannot be taken into consideration for the purposes of identifying a substance as of very high concern under Article 57(f) of Regulation No 1907/2006.
161    Consequently, since ECHA relied on those properties in order to identify HFPO-DA under Article 57(f) of Regulation No 1907/2006, it infringed that provision and exceeded its competence and it failed to establish that there is scientific evidence that HFPO-DA causes probable serious effects to the environment which give rise to an equivalent level of concern to those of PBT or vPvB substances.
162    ECHA, supported by ClientEarth and CHEM Trust Europe, disputes those arguments.
163    It should be borne in mind that, in the context of the identification of a substance as being of very high concern under Article 57(f) of Regulation No 1907/2006, ECHA may take into account certain properties for which Annex XIII to that regulation lays down criteria to which Article 57(d) and (e) of that regulation refers even if the other criteria referred to therein are not met.
164    Consequently, contrary to what the applicant claims, the fact that ECHA took into account such properties, and in particular the persistence of HFPO-DA, does not call into question ECHA’s conclusion that HFPO-DA has probable serious effects on the environment which give rise to an equivalent level of concern to those of the substances referred to in Article 57(a) to (e) of Regulation No 1907/2006. Nor does that fact constitute an infringement of Article 57(f) of Regulation No 1907/2006 or a misuse of powers by ECHA.
(3)    Assessment of certain scientific evidence
165    In the alternative, the applicant asserts that ECHA manifestly erred in its assessment of the data on HFPO-DA’s bioaccumulation potential, its occurrence in the environment, control of emissions into the environment and whether HFPO-DA can be removed from drinking water, or by failing to take into account certain data relating to those considerations.
(i)    Bioaccumulation potential
166    The applicant contends that ECHA manifestly erred in its assessment because it relied on information relating to different substances in order to assess HFPO-DA’s bioaccumulation potential and did not take into account the data on HFPO-DA itself.
167    The applicant argues that a recent study on the bioconcentration of HFPO-DA confirmed its very low bioaccumulation potential. In its view, ECHA failed to show any high risk associated with the fact that the bioconcentration factor allegedly increased as exposure concentrations decreased.
168    The applicant also states that, in relation to the assessment of enrichment in plants, ECHA indicated that ‘it should be noted that HFPO-DA is not strongly adsorbed to soil and therefore a [bioconcentration factor] from pore water would be more illustrative of the bioaccumulation’ and that ‘however, these data are not available’. ECHA nevertheless concluded that ‘due to the observed uptake in vegetables and fruits, consumption of these by plant-eating wildlife and humans can contribute significantly to the total exposure to HFPO-DA’. The applicant claims that, out of the seven calculated soil to plant bioaccumulation factors presented, only one value is higher than one.
169    ECHA, supported by ClientEarth and CHEM Trust Europe, asserts that the applicant’s arguments are irrelevant because bioaccumulation potential was not a relevant factor for assessing the potential serious effects or the level of concern of HFPO-DA.
170    First of all, the applicant’s arguments relating to HFPO-DA’s bioaccumulation potential must be rejected as irrelevant, given that the contested decision is not based on that potential, as was already noted in paragraphs 65 and 66 above.
171    Next, it is necessary to reject the applicant’s arguments raised at the stage of the reply that ECHA erred in its assessment of the intrinsic properties and serious effects giving rise to an equivalent level of concern by failing to assess bioaccumulation as part of the identification process, on the ground that they are factually incorrect. It is apparent from the support document, and in particular from Section 3.4 thereof, entitled ‘Bioaccumulation’, that ECHA carried out such an assessment.
172    If the applicant’s arguments are to be understood as meaning that it claims 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 Regulation No 1907/2006, it should be noted that the applicant does not explain how a low bioaccumulation potential, even if proved, would call into question ECHA’s conclusion in that regard.
173    Lastly, the applicant’s arguments in paragraph 168 above are based on selective quotation from the support document. The applicant has not explained how the finding in the support document that HFPO-DA is not strongly adsorbed to soil and the bioconcentration factor from pore water is therefore more illustrative of bioaccumulation would be capable of calling into question the finding 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, since the latter finding is based on monitoring data the reliability of which the applicant does not dispute.
174    Consequently, the applicant has not demonstrated that ECHA made a manifest error of assessment in the assessment of the data relating to HFPO-DA’s bioaccumulation potential.
(ii) Occurrence of HFPO-DA in the environment
175    The applicant submits that ECHA failed to mention certain information, that is to say, the results of the effluent water sampling set out in the Kärrman et al., 2019 study, ‘PFASs in the Nordic environment: Screening of Poly- and Perfluoroalkyl Substances (PFASs) and Extractable Organic Fluorine (EOF) in the Nordic Environment’, the air sampling results in the report by the Norwegian Institute for Air Research or the data on sediment, sludge and soil, for example in relation to samples from a river, the Elbe. Nor did ECHA assess the air sampling data from the Kärrman et al., 2019 study. HFPO-DA was not detected in any of those samples.
176    The applicant submits that in other instances ECHA failed to report the information correctly, for example, in relation to the two samples taken in the Norwegian Sea.
177    The applicant asserts that, since HFPO-DA was most often not detected and, when it was detected, the levels were low, it cannot be concluded that HFPO-DA is ‘widespread’ or ‘ubiquitous’.
178    ECHA, supported by ClientEarth and CHEM Trust Europe, contends that the applicant’s arguments are ineffective. ECHA asserts that it did in any event address the information mentioned by the applicant.
179    In the first place, it should be noted that, in the 11 pages included in Section 3.2.5 of the support document, under the heading ‘Field data’, there are extensive field data on the occurrence of HFPO-DA in the environment, including in a number European watercourses, in the marine environment, in Asia and in North America, in the air and rain water and in drinking water and biota. That section contains extensive data demonstrating the occurrence of HFPO-DA in the environment, for example in the Rhine-Meuse delta (Netherlands), the Ems delta (Germany), the Thames (United Kingdom), the Svartån (Sweden), Lake Hjälmaren (Sweden), the Dutch and German coast of the North Sea, the Wadden Sea, the German Bight, the German Baltic Sea, the Norwegian Sea, several watercourses in China, in South Korea and in North America, rainwater in the Netherlands and drinking water in the Netherlands and North America.
180    It was on the basis of those data that ECHA concluded in the support document that the monitoring data confirmed the concern that HFPO-DA, due to its intrinsic properties, had the potential to be widely spread by water far from its point of emission, without concluding that HFPO-DA is ubiquitous in the environment. The word ‘ubiquitous’ is used only once in the support document, when that document cites the Pan et al., 2018 study, ‘Worldwide Distribution of Novel Perfluoroether Carboxylic and Sulfonic Acids in Surface Water’, the authors of which state that there is ‘ubiquitous occurrence across the global environment’. Nor does the fact that ECHA mentioned that certain emissions played a role in the ‘widespread’ distribution of HFPO-DA or the fact that it found that HFPO-DA has the potential to cause ‘widespread’ exposures show the existence of a manifest error of assessment in the light of the intrinsic properties of that substance and of the available monitoring data.
181    The fact that HFPO-DA was not detected in several samples at certain locations does not call into question ECHA’s conclusion based on extensive data demonstrating the presence of HFPO-DA at other locations, the reliability of which the applicant did not moreover dispute.
182    In any event, contrary to what the applicant suggests, the support document mentions a number of samples in which HFPO-DA was not detected, including samples from the River Elbe, the Swedish Lakes Vättern and Vänern, certain samples from, for example, Greenland (Denmark), Iceland, the Faroe Islands (Denmark), Norway and Finland, and in rainwater in North Carolina (United States). More specifically, the support document expressly mentions two samples taken in the Norwegian Sea in which HFPO-DA was not detected and the explanations provided by the authors of the Heydebreck, F., 2017 study, ‘Per- and Polyfluoroalkyl Substances in the Environment – Shifting toward Fluorinated Alternatives?’, in that regard. In addition, that document cites the Kärrman et al., 2019 study on several occasions, in particular under the headings ‘Other European rivers’ and ‘Biota’. That document also mentions, admittedly under the heading ‘Biota’ rather than under the heading ‘Air and rain water’, the air sampling of the Heimstad et al., 2018 study, ‘Environmental pollutants in the terrestrial and urban environment 2017’, and states that HFPO-DA was not detected in any of the samples. The support document analyses the results of samples taken from a number of European rivers, including the Elbe, in which HFPO-DA was not detected.
183    It is true, as ECHA expressly acknowledges, that the Kärmann et al., 2019 study is not mentioned under the heading ‘Air and rain water’. However, the support document states that HFPO-DA was not detected in all samples. Consequently, even if the Kärmann et al., 2019 study provided further data concerning air samples in which HFPO-DA had not been detected, that would not call into question ECHA’s conclusion in that regard.
184    In the second place, it is necessary to reject the applicant’s assertion in the reply that the finding that the available data were sufficient to establish a concern has no legal basis and that that finding is general and unsubstantiated. That assertion by the applicant is unsubstantiated and is contradicted by the facts of the present case. As has already been noted, the support document contains a detailed presentation of the extensive data relating to the presence of HFPO-DA in the environment.
185    In the third place, it is necessary to reject the applicant’s argument raised in the reply that the mere presence of a substance is not sufficient to establish a concern. That argument is irrelevant given that the concerns relating to HFPO-DA are not established in the support document solely on the basis of data relating to its occurrence in the environment. As ECHA correctly states, the information on the occurrence of HFPO-DA is presented, in that document, as an element confirming the concern resulting from its intrinsic properties.
186    In its observations on the statement in intervention of the Kingdom of the Netherlands, the applicant asserts that examination of the information in the Heydebreck, 2017 study – on samples taken downstream of a chemical park in Leverkusen (Germany) – would only have enabled ECHA to conclude that the detection of HFPO-DA in the water was due to a low and irregular discharge.
187    In that regard, first, it must be noted that, as ECHA and the Kingdom of the Netherlands stated at the hearing in response to a question put by the Court by way of a measure of organisation of procedure, information relating to samples taken at a single very specific location is not capable of calling into question ECHA’s conclusion based on extensive data demonstrating the presence of HFPO-DA at other locations the reliability of which the applicant has not disputed. That is all the more true given that the very fact that HFPO-DA was not detected in several samples at certain locations did not call that conclusion into question. Second, as ECHA and the Kingdom of the Netherlands stated at the hearing in reply to a question put by the Court by way of a measure of organisation of procedure, the support document refers to those samples. The support document mentions the fact that, in 2013, a concentration of 108 ng/l was detected and that, in the following study of 2015, HFPO-DA was not detected in the samples taken of effluents from three sewage treatment plants. The applicant has not given any indication of how those data were presented incorrectly. The mere fact that ECHA did not expressly set out, word by word, a potential explanation in the study relating to the different results of the samples taken at a location does not constitute a manifest error of assessment or a breach of the principle of proportionality.
188    Consequently, the applicant has not demonstrated that ECHA made a manifest error in the assessment of the data relating to the presence of HFPO-DA in the environment.
(iii) Control of HFPO-DA emissions into the environment
189    The applicant submits that ECHA manifestly erred in its assessment by concluding that the concern was that as long as HFPO-DA continued to be released its presence in the environment would continue to increase and that slowly increasing environmental concentrations therefore appeared unavoidable, without taking into account the fact that emissions of the substance can be controlled.
190    ECHA, supported by the Kingdom of the Netherlands and ClientEarth and CHEM Trust Europe, asserts that the applicant’s argument is ineffective. Moreover, ECHA, supported by the Kingdom of the Netherlands, disputes that HFPO-DA is only used in one place.
191    First of all, it must be noted that ECHA’s conclusion in the support document on the potential of HFPO-DA to cause an increasing pollution stock is based exclusively on HFPO-DA’s intrinsic properties, such as its very high persistence, its mobility, its low adsorption and its high water solubility. ECHA did not base that conclusion on actual future and current emissions of the substance. Consequently, the applicant’s argument that emissions could be controlled is not capable of calling that conclusion into question.
192    In that regard, the General Court also notes that the Court of Justice has held that Article 57(f) of Regulation No 1907/2006 does not prohibit the taking into consideration of data other than those relating to the hazards arising from the intrinsic properties of the substances concerned in the context of the examination of the second condition laid down in that article, namely the establishment of an equivalent level of concern to those of CMR, PBT and vPvB substances (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 40 to 44). Thus, ECHA has a discretion but is not obliged to take into account information other than that concerning intrinsic properties (judgment of 11 July 2019, PlasticsEurope v ECHA, T‑185/17, not published, EU:T:2019:492, paragraph 79).
193    Consequently, the fact that ECHA did not take into consideration data relating to the potential control of HFPO-DA emissions does not constitute a manifest error of assessment.
194    Next, the applicant’s argument that (i) the substance at issue is registered in the European Union for a single industrial application and (ii) emissions can be controlled, as it claims is apparent from data relating to emissions from its own factory, must be rejected, as that argument is ineffective and contradicted by the documents before the Court. As ECHA, supported by the Kingdom of the Netherlands, contends, it is found in the support document that the data on the presence of HFPO-DA in the environment suggest the presence of diffuse sources of emissions, which indicates that emissions are not under proper control. Furthermore, it is apparent from the support document that FRD-902 has been notified by more than 30 undertakings and that 2,3,3_3-tetrafluoro-2-(heptafluoropropoxy)propanoic acid (FRD-903) has been notified by 99 undertakings.
195    Lastly, the applicant’s argument raised at the stage of the reply that ECHA established its conclusion of a continuous and increasing presence in the environment of HFPO-DA exclusively on the persistence of that substance, which is not sufficient to identify a substance as being of very high concern within the meaning of Article 57 of Regulation No 1907/2006, was already rejected in the context of the first complaint in paragraph 109 above on the ground that it was factually incorrect.
196    In so far as the applicant claims, in that context, that mobility and long-range transport have no impact on the continuous and increasing environmental presence of a substance, but rather on the way it spreads, it should be noted that the support document explains how HFPO-DA’s mobility contributes, according to ECHA, to the potential of that substance to cause an increasing pollution stock. In that regard, it is stated in that document, for example, that, as a mobile substance, there are no local or intermittent sinks for the pollution stock and therefore the substance has high potential to cause continuous increase of exposure of wildlife to that substance. In addition, the support document contains concerns relating to the rapid and uncontrollable spread of HFPO-DA in the environment as a result of its high mobility. The applicant’s argument is not capable of making those findings implausible.
(iv) Whether HFPO-DA can be removed from drinking water
197    The applicant submits that ECHA erred in its assessment of the information available on the fact that granular activated carbon had been shown to be effective in removing HFPO-DA from water. When it found that ‘removal of the substance using current purification techniques [could] be regarded as negligible’, ECHA failed to take into account the information submitted or manifestly erred in its assessment. The applicant contends that ECHA also failed to take into account the fact that the technologies mentioned for removing HFPO-DA from water were available and efficiently implemented.
198    ECHA, supported by ClientEarth and CHEM Trust Europe, disputes that argument.
199    In that regard, it should be noted that the extract from the support document mentioned by the applicant, according to which the ‘removal of the substance using current purification techniques can be regarded as negligible’, is not a conclusion of ECHA but an extract from a publication of Roelandse, A. and Timmer, H. of 2017, ‘Het effect van de industriële lozing van Chemours op de aanwezigheid van FRD-903 in oevergrondwater’, cited in the support document.
200    In addition, it is apparent from the support document that, contrary to what the applicant claims, ECHA took into account data relating to granular activated carbon filtration in Section 3.2.2 under the heading ‘Water treatment techniques’ and in Section 6.3.1.7 under the heading ‘Decontamination and release reduction for removal of HFPO-DA from the environment and from drinking water’. The applicant has not indicated how the assessment of those data in the support document is vitiated by a manifest error of assessment. It merely asserted that ECHA had failed to take into account the available information or had committed a manifest error of assessment.
201    Lastly, the applicant has also failed to state how ECHA’s findings that there was a societal concern, in particular in the light of the detection of HFPO-DA in certain drinking water sources and the high societal costs required for decontamination, as indicated by EurEau, the European Federation of National Associations of Water Services, and several drinking water distribution companies, are vitiated by a manifest error of assessment.
202    It follows from the foregoing that all of the applicant’s arguments relating to the alleged possibility of removing HFPO-DA from drinking water must be rejected.
203    Accordingly, the first part of the first plea must be rejected in its entirety.
2.      The second part of the first plea in law, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006, exceeded its competence and manifestly erred in its assessment inasmuch as it considered exposure to HFPO-DA to be a relevant factor for establishing probable serious effects and inasmuch as it failed to take into account the potential control of exposure to the substance, and concluded in consequence that HFPO-DA was of an equivalent level of concern
204    The applicant argues that ECHA breached Article 57(f) of Regulation No 1907/2006, exceeded its competence under that provision and manifestly erred in its assessment, first by considering exposure to HFPO-DA to be a relevant factor for establishing probable serious effects and, second, by failing to take into account the potential control of exposure to the substance; this led it to conclude wrongly that HFPO-DA was of an equivalent level of concern to those of CMR, PBT and vPvB substances.
205    In the first place, the applicant, providing two extracts from the support document, asserts that exposure considerations were key to justifying the serious nature of the effects on human health and the environment. In its view, exposure is not in itself a property of the substance on the basis of which an effect becomes serious.
206    In the second place, the applicant states that the exposure factor was fundamental for ECHA in reaching its conclusions on both the seriousness of the effects and the equivalent level of concern. The applicant submits that, when it determined the equivalent level of concern, ECHA should have taken into account and assessed the fact that exposure to the substance at issue could be controlled, which the applicant indicated in its comments on the Annex XV dossier, referring to survey data published by the United States Center for Disease Control in the National Health and Nutrition Examination Survey. According to the applicant, had ECHA taken that fact into account, it could not have concluded that reversible effects of the substance were made irreversible or that exposure contributed to the combination of effects giving rise to an equivalent level of concern.
207    ECHA, supported by ClientEarth and CHEM Trust Europe, disputes those arguments.
208    In the first place, it should be recalled, as a preliminary point, that it is apparent from the case-law cited in paragraph 35 above that the first condition of Article 57(f) of Regulation No 1907/2006, namely the establishment of serious effects on health or the environment, requires an examination of the hazards arising from the intrinsic properties of the substance under consideration.
209    In that regard, it must be stated that, according to the first extract provided by the applicant from the support document, ECHA took into account continuous exposure resulting from certain intrinsic properties of HFPO-DA. Those properties result, according to that document, in a continuous and increasing presence of the substance in the environment and thus strengthen the concern in respect of the effects observed on human health. Again according to the support document, if continuous exposure reaches certain levels, the effects could be considered irreversible. Those findings could be made by ECHA without taking account of actual exposure, that is to say by examining only the intrinsic properties of HFPO-DA, which already enabled it to conclude that the potential for an increasing pollution stock in the environment was high. The continuous exposure considerations set out in the support document in the context of the assessment of serious effects are therefore part of an examination of the hazards arising from the intrinsic properties of HFPO-DA.
210    As regards the second extract from the support document cited by the applicant relating to the potential for as yet unknown effects, it must be stated that ECHA indicates in that extract that such effects might only become apparent after human exposure over decades or an entire lifetime. Those findings of ECHA also refer to exposure such as might result from HFPO-DA’s intrinsic properties and are therefore part of an examination of the hazards arising from HFPO-DA’s intrinsic properties. Those findings are not moreover based on an assessment of actual and specific exposure.
211    It follows from the above that the applicant’s argument that ECHA justified the seriousness of the effects on human health and the environment by relying on exposure considerations, whereas exposure is not a relevant factor in establishing the seriousness of the effects under Article 57(f) of Regulation No 1907/2006, must be rejected.
212    In the second place, as regards the alleged potential for controlling exposure to HFPO-DA, first of all, it must be held that, even if ECHA did not take into consideration data relating to the potential control of exposure to HFPO-DA, that does not constitute a manifest error of assessment, since ECHA is not required to take into account information other than that relating to intrinsic properties (see, to that effect, judgment of 11 July 2019, PlasticsEurope v ECHA, T‑185/17, not published, EU:T:2019:492, paragraph 79).
213    Next, it is apparent from the support document that ECHA took into account (i) data available on the presence of HFPO-DA in the blood of employees in the Netherlands and of residents living close to an HFPO-DA processing factory in China and (ii) inter alia the fact that HFPO-DA had not been detected in United States citizens who had had prolonged historical exposure to the substance. ECHA concludes in that document that the exposure route is largely unknown.
214    As regards the fact that ECHA did not take into account, in that context, monitoring data published by the United States Center for Disease Control in the National Health and Nutrition Examination Survey, first, it should be noted that, at the hearing and in response to a question put by the Court, the applicant and ECHA confirmed that that study did not relate to HFPO-DA, but to other substances. The applicant has not explained why that study relating to other substances could be relevant in the present case. Second, the extract from the study provided by the applicant refers to the fact that the ‘reduction [observed] in body burden indicates that exposure to [the] substances [concerned] can be controlled’. However, neither that extract nor the applicant indicates how exposure to the substances concerned by that study could be controlled.
215    Consequently, and in the light of the case-law cited in paragraphs 47 and 48 above, ECHA was entitled to find, without committing a manifest error of assessment, that that study was not relevant in the present case.
216    In the third place, as regards the applicant’s argument that ECHA’s claims in the defence and the contested decision are based on assumptions and uncertainties in terms of the prediction of exposure and long-term effects, it should be pointed out that the phrase ‘scientific evidence’ refers to the standard of proof which ECHA must meet in order to be able to conclude that a substance has serious effects on human health or the environment and that it is dependent on a scientific approach (judgment of 20 September 2019, PlasticsEurope v ECHA, T‑636/17, EU:T:2019:639, paragraph 92).
217    It is apparent from the support document that all ECHA’s conclusions disputed by the applicant are based on scientific evidence. In particular, the intrinsic properties (and notably persistence), which could, according to that document, lead to an increasing concentration of HFPO-DA in the environment, are scientifically proven or, at the very least, not disputed by the applicant in the present dispute. In so far as the applicant claims that ECHA’s argument that exposure levels ‘will remain high’ is based on an unproven assumption of an exposure level that is already high, it should be noted that the statement of ECHA in question is set out in the defence and not in the contested decision. In any event, it is formulated in the future tense and follows the conclusion that the intrinsic properties lead to a continuous and increasing environmental presence of HFPO-DA. Thus, that finding does not presuppose that exposure levels are already high.
218    As regards the uncertainties in terms of the prediction of exposure and long-term effects which are acknowledged in the support document, it is sufficient to note that the mere existence of uncertainties, which is, moreover, usual in the context of a scientific assessment, does not demonstrate that ECHA committed a manifest error of assessment. That applies a fortiori in the light of the precautionary principle, on which the provisions of Regulation No 1907/2006 are underpinned pursuant to Article 1(3) thereof.
219    In addition, Section 4.0.1 of Annex I to Regulation No 1907/2006 states that a ‘hazard assessment … addressing all the long-term effects and the estimation of the long-term exposure of humans and the environment … cannot be carried out with sufficient reliability for substances satisfying the PBT and vPvB criteria in Annex XIII’. As ECHA credibly explains in the support document, that consideration relating to long-term effects and the estimation of long-term exposure with respect to PBT and vPvB substances also applies to HFPO-DA, taking into account the very high persistence of that substance, the adverse effects observed and the uncertainty of the long-term effects. Thus, the uncertainties disputed by the applicant result, according to that document, from the intrinsic properties of HFPO-DA and are not due to a lack of data that can be remedied by carrying out relevant tests, as ClientEarth and CHEM Trust Europe correctly observe.
220    Consequently, the applicant has not demonstrated that ECHA’s findings did not meet the standard of proof required by Article 57(f) of Regulation No 1907/2006.
221    Lastly, it must be held that those findings are also not called into question by the applicant’s argument that it is apparent from Section 1.2.1 of Annex XIII to Regulation No 1907/2006 that a substance could very well satisfy the criterion for being considered very persistent (vP), but could not be much more persistent and go beyond that criterion. The applicant does not state how that assertion could lead to a finding that an error had been made by ECHA. Moreover, ECHA used the expression ‘much more persistent’ with the sole aim of illustrating the very high level of persistence of the substance at issue by applying the criteria laid down in Annex XIII to Regulation No 1907/2006 and by stating in the support document that the substance at issue ‘meets the P and vP-criteria of … Annex XIII by far’. ECHA did therefore not assign HFPO-DA to a persistence category not provided for in Annex XIII to that regulation, but considered that the criteria for identifying a substance as very persistent were far exceeded and thus fulfilled. Consequently, this argument of the applicant must be rejected.
222    It follows from the foregoing that the second part of the first plea must be rejected in its entirety.
3.      The third part of the first plea, alleging breach of Article 57(f) of Regulation No 1907/2006 and a manifest error of assessment committed by ECHA inasmuch as it did not examine the available scientific evidence in accordance with the principles of scientific excellence
223    The applicant submits that ECHA breached Article 57(f) of Regulation No 1907/2006 and manifestly erred in its assessment by not examining the available scientific evidence in accordance with the principles of scientific excellence. The applicant asserts that ECHA erroneously concluded that effects which are reversible must be considered irreversible merely because of continuous exposure.
224    According to the applicant, that conclusion runs counter to the meaning of the term ‘reversibility’ and amounts to considering exposure to be a hazard in itself. It also runs counter to the accepted interpretation of repeated dose toxicology studies. The OECD Guidelines on repeated dose oral toxicity for 28-day and 90-day tests require inter alia reporting of whether or not the effects are reversible.
225    Furthermore, ECHA did not reach its conclusions on continuous exposure to HFPO-DA on the basis of existing, reliable and measurable data. The applicant contends that it is clear from the support document that exposure to the substance could not be determined with full certainty.
226    ECHA, supported by ClientEarth and CHEM Trust Europe, disputes those arguments.
227    In the first place, it should be noted that it is apparent from the case-law that compliance with the principle of scientific excellence means that ECHA must comply with the best current scientific standards (judgment of 20 September 2019, PlasticsEurope v ECHA, T‑636/17, EU:T:2019:639, paragraph 94).
228    In that regard, it must be stated that it is apparent from the support document that ECHA did indeed take into account the fact that, according to the standard toxicity tests, the effects observed are reversible. As the applicant itself observed, ECHA found that ‘these effects would be reversible in standard toxicity tests upon removal of exposure’ and referred to ‘the irreversibility of adverse effects that are normally considered as reversible’. ECHA therefore did indeed take into account the results of the standard toxicity tests and thus complied with the OECD Guidelines, relied on by the applicant, relating to repeated-dose toxicity studies, according to which it is necessary to mention whether or not the effects, according to the parameters of those studies, are reversible. In particular, ECHA did not state that the effects observed were irreversible according to the standard toxicity tests for the purpose of the OECD Guidelines.
229    Contrary to the applicant’s submission, the fact that ECHA nevertheless concluded that, in the light of continuous exposure resulting from the intrinsic properties of HFPO-DA, those effects could be regarded as irreversible does not vitiate that assessment by a manifest error.
230    First, ECHA’s conclusion relating to irreversible effects refers to a period of exposure which exceeds the exposure periods examined in the repeated-dose toxicity studies. Those studies deal, as the applicant itself observes, with a trial period of 28 or 90 days or a maximum of one year. The relevance of the standard toxicity tests is therefore limited to effects arising from time-limited exposure. However, 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. The assessment of the irreversibility of the effects may differ depending on the exposure period examined, namely, on the one hand, time-limited exposure or, on the other, continuous exposure with no limit in time, without that running counter to the concept of reversibility, or being contradictory in itself. Moreover, 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.
231    Second, contrary to what the applicant claims, nor does it follow from ECHA’s conclusion that exposure was considered to be a hazard. As was already held in the context of the second part of the first plea, ECHA considered, without committing a manifest error of assessment, that that continuous exposure resulted from HFPO-DA’s intrinsic properties and that, consequently, HFPO-DA’s hazards stemmed from its intrinsic properties rather than from actual exposure. In addition, it must be borne in mind that it is apparent from the support document that those intrinsic properties are based on scientific data and lead to continuous exposure, which, again according to the support document, could beyond a certain level result in the effects being irreversible. The applicant has not shown how those conclusions were not in line with the best current scientific standards.
232    Third, contrary to what the applicant submits in the reply, such an approach does not mean that any substance which meets the persistence criterion and which has any effect whatsoever could be identified under Article 57(f) of Regulation No 1907/2006. As was already stated in the context of the first complaint of the first part of the first plea, ECHA did not reach its conclusions on continuous exposure to HFPO-DA and the irreversibility of the effects on account solely of HFPO-DA’s persistence (see paragraph 109 above). Moreover, the mere fact that other substances may also be identified does not call into question ECHA’s assessment regarding HFPO-DA, in particular if it is considered that those other substances must in turn fulfil the conditions laid down in Article 57(f) of Regulation No 1907/2006.
233    In the second place, as regards the applicant’s argument that ECHA’s conclusions on continuous exposure are not based on reliable, existing and measurable data, it must be stated that it is not apparent from the applicant’s arguments how that argument has a scope independent of the argument, put forward in the context of the second part of the first plea, that ECHA’s claims are based on assumptions and uncertainties in terms of the prediction of exposure and long-term effects. Thus, for the reasons referred to in paragraph 216 et seq. above, it must be held that ECHA did not commit a manifest error of assessment in reaching its conclusions on continuous exposure to HFPO-DA despite existing uncertainties.
234    It follows from the foregoing that the third part of the first plea must be rejected in its entirety.
4.      Fourth part of the first plea in law, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006 and manifestly erred in its assessment inasmuch as it concluded that HFPO-DA was a substance of very high concern on the basis of information related to a different substance
235    In the fourth part, the applicant alleges that ECHA breached Article 57(f) of Regulation No 1907/2006 and manifestly erred in its assessment in so far as ECHA concluded that HFPO-DA was a substance of very high concern on the basis of information related to a different substance.
236    The applicant asserts that ECHA manifestly erred in its assessment by considering HFPO-DA to be toxicologically and kinetically the same as PFOA whilst not examining the differences between the two substances, and by transposing concerns about PFOA to HFPO-DA. Specifically, building on the evidence available on PFOA, ECHA concluded that FRD-902 and ammonium pentadecafluorooctanoate (APFO) behaved in a similar way, on the basis, inter alia, of the alleged fact that those substances are used similarly in the production of fluoropolymers.
237    However, FRD-902 and APFO are two very different substances, which according to the applicant do not behave in the same way when used in a fluoropolymer polymerisation process.
238    HFPO-DA is significantly different from PFOA. PFOA is a good substrate for organic anion transporters (‘OATs’). HFPO-DA, in contrast, is less good as an OAT substrate.
239    According to the applicant, instead of presuming the substances to be similar, ECHA should have assessed the relevance of the significant differences between them and established that those differences did not affect their behaviour.
240    ECHA disputes those arguments.
241    First of all, it must be stated that the applicant does not specify either what conclusions regarding HFPO-DA ECHA allegedly drew on the basis of data relating to PFOA, without examining the differences between the two substances, or what conclusion ECHA allegedly drew regarding FRD-902 on the basis of data relating to PFOA; the applicant explicitly acknowledged this at the oral hearing and in response to a question put by the Court.
242    In addition, as regards the applicant’s assertion that ECHA incorrectly concluded that FRD-902 and APFO behaved in a similar way, in particular because those substances were used similarly in the production of fluoropolymers, it must be stated that the word ‘fluoropolymers’ is used only three times in the support document, in order to describe the use of two substances, named HFPO and FRD-903. That word is therefore not used in the support document in the context suggested by the applicant.
243    Similarly, it is apparent from the support document, contrary to what the applicant suggests, that the OAT potential of HFPO-DA and PFOA and their differences were indeed assessed. It is concluded in that regard in that document that, in the absence of any data relating to HFPO-DA, any effects of that substance on the functioning of OATs were not known.
244    At the hearing and in response to a question put by the Court, the applicant stated that its arguments raised in the context of that fourth part referred to Section 4.7.3 of the Annex XV dossier, provided in Annex A.3 to the application. That section is entitled ‘Summary and discussion of carcinogenicity’. However, it has already been established that the contested decision was not based on a carcinogenicity potential of HFPO-DA (see paragraphs 71 to 76 above). Consequently, and in the absence of any indication as to how the applicant’s arguments could nevertheless call into question the conclusions on which the contested decision is based, those arguments are, in any event, ineffective.
245    Lastly, in so far as the applicant adapted in the reply the arguments raised in the context of this part of the plea so that it now claims that all the information on PFOA and APFO should have been rejected as irrelevant to the conclusions relating to HFPO-DA and that the information’s mere presence and the fact that it was taken into consideration, either in the weight of evidence or as a means of interpretation of the information on HFPO-DA, constitutes a manifest error of assessment, it is sufficient to state the following. Those arguments are too vague and the applicant still does not explain what specific conclusion or what specific interpretation of ECHA is vitiated by a manifest error of assessment. Moreover, the mere fact that, in the support document, information relating to other substances, such as PFOA, was mentioned, for example in order to make comparisons between bioconcentration factors or the persistence of those two substances, does not in itself mean that conclusions concerning HFPO-DA were drawn on the basis of the data relating to PFOA, let alone demonstrates the existence of a manifest error of assessment.
246    The fourth part of the first plea must therefore be rejected on the ground that the arguments are in part unfounded, and in particular have no factual basis, and are in part irrelevant.
247    The first plea must therefore be rejected in its entirety.
B.      The second plea, alleging breach of the principle of proportionality
248    The applicant submits that the contested decision breaches the principle of proportionality because that decision is neither necessary nor appropriate to attaining the objective legitimately pursued by the authorisation procedure set out in Title VII of Regulation No 1907/2006, for two main reasons.
249    First, since HFPO-DA is used only by one declarant for a single registered use, authorisation is not appropriate, in particular since there are already stringent risk-management measures in place for that registered use and emissions are minimised.
250    Second, the absence of any commercially viable alternatives to HFPO-DA hinders the authorisation process aimed at replacing substances subject to authorisation with ‘less dangerous substances or technologies’.
251    ECHA, supported by the Kingdom of the Netherlands and ClientEarth and CHEM Trust Europe, disputes that line of argument.
252    According to settled case-law, the principle of proportionality, which is part of the general principles of EU law, requires that EU measures do not exceed the limits of what is appropriate and necessary in order to attain the objectives legitimately pursued by the legislation in question; when there is a choice between several appropriate measures recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (judgments of 8 July 2010, Afton Chemical, C‑343/09, EU:C:2010:419, paragraph 45; of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 124; and of 1 February 2013, Polyelectrolyte Producers Group and Others v
Commission, T‑368/11, not published, EU:T:2013:53, paragraph 75).
253    As regards judicial review of the conditions referred to in paragraph 252 above, ECHA must be allowed a broad discretion in a field which entails political, economic and social choices on its part, and in which it is called upon to undertake complex assessments. The legality of a measure adopted in that area can be affected only if the measure is manifestly inappropriate having regard to the objective which the legislature is seeking to pursue (judgments of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 125, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 105).
254    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. Having regard to recital 16 of that regulation, the legislature established the first of those three objectives as the main objective, namely to ensure a high level of protection of human health and the environment (see judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraph 134 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 106 and the case-law cited).
255    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 (see judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraph 134 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 106 and the case-law cited). 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 (judgments of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraph 124; of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraph 120; and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 114).
256    As regards the objective of protecting human health and the environment, it must be stated that the identification of a substance as being of very high concern serves to improve information for the public and professionals as to the risks and hazards incurred and that, consequently, such identification must be regarded as a means of enhancing that protection (judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraph 136, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 108 and the case-law cited; see also, by analogy, judgment of 7 July 2009, S.P.C.M. and Others, C‑558/07, EU:C:2009:430, paragraph 49).
257    In that regard, it should be noted, as a preliminary point, that the applicant’s line of argument in the context of the second plea appears to be based on an incorrect premiss, since, contrary to what the applicant presupposes, the contested decision does not pursue the objective of ‘address[ing] the perceived ubiquitous nature of [HFPO-DA] in the environment’. The contested decision has no immediate bearing on the use of HFPO-DA and its presence in the environment.
258    In any event, the arguments put forward by the applicant in the context of this plea cannot succeed.
259    First, as regards the applicant’s argument that the contested decision is inappropriate because there are at present no commercially viable alternatives to HFPO-DA, with the exception of other fluorinated substances, it must be observed that the contested decision does not entail a prohibition on placing HFPO-DA on the market, thereby obliging the operators concerned to use alternative substances. Such a consequence only follows, under Article 56 of Regulation No 1907/2006, for substances included in Annex XIV to that regulation, that is to say, the list of substances subject to authorisation. It is apparent from the procedure set out in Article 58 of Regulation No 1907/2006 that the inclusion of a substance in the candidate list does not automatically entail its inclusion in Annex XIV to that regulation. The question whether or not alternative substances exist is therefore irrelevant as regards whether or not the identification of a substance as a substance of very high concern is appropriate (see, to that effect, judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraph 119).
260    Second, as regards the applicant’s line of argument relating to the single registered use of HFPO-DA, it must be pointed out that a substance is identified as a substance of very high concern solely on account of the hazards arising from the intrinsic properties of the substance and not because of its uses (see, to that effect, judgments of 11 July 2019, PlasticsEurope v ECHA, T‑185/17, not published, EU:T:2019:492, paragraph 75, and of 20 September 2019, PlasticsEurope v ECHA, T‑636/17, EU:T:2019:639, paragraph 67). Uses may be taken into account at the stage of the inclusion in Annex XIV to Regulation No 1907/2006, or at the stage of the granting of an authorisation pursuant to Article 60(2) or (4) of that regulation (judgment of 20 September 2019, PlasticsEurope v ECHA, T‑636/17, EU:T:2019:639, paragraph 207).
261    Consequently, contrary to what is claimed by the applicant, even if it were established that HFPO-DA is used only by one declarant for a single registered use, this would not make the inclusion of that substance in the candidate list inappropriate.
262    That finding is supported by the fact that, according to the Court of Justice’s case-law, a substance may be identified as a substance of very high concern even if none of the known uses of the substance falls within the scope of the authorisation procedure laid down in Chapters 2 and 3 of Title VII of Regulation No 1907/2006 (see, to that effect, judgment of 25 October 2017, PPG and SNF v ECHA, C‑650/15 P, EU:C:2017:802, paragraphs 62, 63 and 71). It is therefore necessary to reject a fortiori the applicant’s line of argument that the contested decision is inappropriate because the substance in question is registered only for a single use which, following potential inclusion in Annex XIV to Regulation No 1907/2006, would be subject to an authorisation requirement.
263    Third, it must be stated that even if the applicant’s assertion that there were already stringent risk-management measures in place and that emissions were minimised were established, this would also not permit the inference that the contested decision is inappropriate. 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 by risk-management measures does not preclude its identification as a substance of very high concern (judgment of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraph 61). This is also 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).
264    In any event, even if the existence of risk-management measures put in place by the applicant were established, this would not imply either that those measures are sufficient to manage the risks, which the applicant has not established, or that other undertakings would adopt the same solutions.
265    Moreover, according to the case-law, risk-management measures proposed under Article 14(6) of Regulation No 1907/2006 are not less onerous measures than the identification of a substance as being of very high concern. Such measures do not constitute appropriate measures for the achievement of the objective of progressively replacing substances of very high concern by suitable alternative substances or technologies where these are economically and technically viable, or of the objective that particular attention be paid to substances of very high concern (see paragraph 255 above) (see, to that effect, judgments of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraphs 124 and 125; of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraphs 120 and 122; and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraphs 114 and 116).
266    Similarly, the risk-management measures to which the applicant refers do not constitute such less onerous measures.
267    Consequently, the applicant’s arguments relating to the existence of risk-management measures must be rejected.
268    Fourth, as regards the applicant’s line of argument raised at the stage of the reply, according to which ECHA’s weighing up of interests is flawed because it failed to acknowledge all the consequences of the contested decision, namely inter alia the information obligations under Article 33 of Regulation No 1907/2006, it must be stated that, according to the case-law, the objective of the candidate list of substances concerning the sharing of information on substances of very high concern within the supply chain and with consumers prevails over the difficulties resulting, inter alia, from 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). That objective also prevails over the difficulties resulting from an application of Article 33 of that regulation. The mere fact that, in its defence, ECHA mentioned only the information obligations under Article 31(9) of Regulation No 1907/2006 and not those under Article 33 of that regulation has no bearing on that finding.
269    Consequently, the applicant’s arguments relating to the weighing up of interests must also be rejected.
270    The second plea in law, alleging breach of the principle of proportionality, must therefore be rejected and, accordingly, the action must be dismissed in its entirety.
V.      Costs
271    Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by ECHA and ClientEarth and CHEM Trust Europe, in accordance with the forms of order sought by them.
272    In accordance with Article 138(1) of the Rules of Procedure, Member States which have intervened in the proceedings are to bear their own costs. The Kingdom of the Netherlands must therefore bear its own costs.
On those grounds,
THE GENERAL COURT (Eighth Chamber)
hereby:
1.      Dismisses the action;
2.      Orders Chemours Netherlands BV to bear its own costs and to pay the costs incurred by the European Chemicals Agency (ECHA) and ClientEarth AISBL, ClientEarth and CHEM Trust Europe Ev;
3.      Orders the Kingdom of the Netherlands to bear its own costs.
Svenningsen
Barents
Laitenberger
Delivered in open court in Luxembourg on 23 February 2022.
E. Coulon
S. Papasavvas
Registrar
President
Table of contents
I. Legal framework
II. Background to the dispute
III. Procedure and forms of order sought
IV. Law
A. The first plea in law, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006, exceeded its competence and manifestly erred in its assessment
1. The first part of the first plea, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006 and manifestly erred in its assessment inasmuch as it failed to establish to the requisite legal standard that HFPO-DA causes probable serious effects on human health and the environment of an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of that regulation
(a) The first complaint of the first part of the first plea in law concerning serious effects on human health of an equivalent level of concern to those of CMR, PBT and vPvB substances
(1) Assessment of the scientific evidence
(i) Developmental toxicity
(ii) Repeated dose toxicity
(iii) Toxicokinetics and bioaccumulation
(iv) Carcinogenicity
(v) Reproductive toxicity
(2) Whether serious effects on human health have been established
(3) Equivalent level of concern of the serious effects
(b) The second complaint of the first part of the first plea in law concerning serious effects on the environment of an equivalent level of concern to those of PBT and vPvB substances
(1) Whether serious effects on the environment have been established
(2) The finding that persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties were relevant under Article 57(f) of Regulation No 1907/2006
(3) Assessment of certain scientific evidence
(i) Bioaccumulation potential
(ii) Occurrence of HFPO-DA in the environment
(iii) Control of HFPO-DA emissions into the environment
(iv) Whether HFPO-DA can be removed from drinking water
2. The second part of the first plea in law, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006, exceeded its competence and manifestly erred in its assessment inasmuch as it considered exposure to HFPO-DA to be a relevant factor for establishing probable serious effects and inasmuch as it failed to take into account the potential control of exposure to the substance, and concluded in consequence that HFPO-DA was of an equivalent level of concern
3. The third part of the first plea, alleging breach of Article 57(f) of Regulation No 1907/2006 and a manifest error of assessment committed by ECHA inasmuch as it did not examine the available scientific evidence in accordance with the principles of scientific excellence
4. Fourth part of the first plea in law, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006 and manifestly erred in its assessment inasmuch as it concluded that HFPO-DA was a substance of very high concern on the basis of information related to a different substance
B. The second plea, alleging breach of the principle of proportionality
V. Costs
*      Language of the case: English.