JUDGMENT OF THE COURT (Ninth Chamber)

21 December 2021 ( )

(Appeal – Establishment of a list of substances subject to authorisation – List of substances identified with a view to their eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 – Updating of the entry of the substance bisphenol A as a substance of very high concern)

In Case C‑876/19 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 29 November 2019,

PlasticsEurope AISBL, established in Brussels (Belgium), represented initially by R. Cana, E. Mullier and F. Mattioli, and subsequently by R. Cana and E. Mullier, avocats,

appellant,

the other parties to the proceedings being:

European Chemicals Agency (ECHA), represented by W. Broere, A.K. Hautamäki and M. Heikkilä, acting as Agents, and by S. Raes, advocaat,

defendant at first instance,

French Republic, represented by T. Stehelin and E. Leclerc, acting as Agents,

ClientEarth, established in London (United Kingdom), represented by P. Kirch, avocat,

interveners at first instance,

supported by:

Federal Republic of Germany, represented by D. Klebs, acting as Agent,

intervener in the appeal,

THE COURT (Ninth Chamber),

composed of K. Jürimäe, President of the Third Chamber, acting as President of the Ninth Chamber, S. Rodin (Rapporteur) and N. Piçarra, Judges,

Advocate General: M. Szpunar,

Registrar: A. Calot Escobar,

having regard to the written procedure,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

Judgment

1 By its appeal, PlasticsEurope AISBL asks the Court of Justice to set aside the judgment of the General Court of the European Union of 20 September 2019, PlasticsEurope v ECHA (T‑636/17, ‘the judgment under appeal’, EU:T:2019:639), by which the General Court dismissed its action for annulment of Decision ED/30/2017 of the Executive Director of the European Chemicals Agency (ECHA) of 6 July 2017 (‘the contested decision’), by which the existing entry relating to bisphenol A on the list of substances identified with a view to their 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, and corrigendum OJ 2007 L 136, p. 3), as amended by Commission Regulation (EU) No 253/2011 of 15 March 2011 (OJ 2011 L 69, p. 7) (‘the REACH Regulation’) was supplemented to the effect that bisphenol A was also identified as a substance within the meaning of Article 57(f) of the REACH Regulation.

Legal context

2 Recitals 12, 16, 69 and 70 of the REACH Regulation state:

‘(12) An important objective of the new system to be established by this Regulation is to encourage and in certain cases to ensure that substances of high concern are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available. This Regulation does not affect the application of Directives on worker protection and the environment, especially Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) [(OJ 2004 L 158, p. 50 and corrigendum OJ 2004 L 229, p. 23)] and Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) [(OJ 1998 L 131, p. 11)], under which employers are required to eliminate dangerous substances, wherever technically possible, or to substitute dangerous substances with less dangerous substances.

…

(16) This Regulation lays down specific duties and obligations on manufacturers, importers and downstream users of substances on their own, in preparations and in articles. This Regulation is based on the principle that industry should manufacture, import or use substances or place them on the market with such responsibility and care as may be required to ensure that, under reasonably foreseeable conditions, human health and the environment are not adversely affected.

…

(69) To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable. Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority.

(70) Adverse effects on human health and the environment from substances of very high concern should be prevented through the application of appropriate risk management measures to ensure that any risks from the uses of a substance are adequately controlled, and with a view to progressively substituting these substances with a suitable safer substance. Risk management measures should be applied to ensure, when substances are manufactured, placed on the market and used, that exposure to these substances including discharges, emissions and losses, throughout the whole life-cycle is below the threshold level beyond which adverse effects may occur. For any substance for which authorisation has been granted, and for any other substance for which it is not possible to establish a safe level of exposure, measures should always be taken to minimise, as far as technically and practically possible, exposure and emissions with a view to minimising the likelihood of adverse effects. Measures to ensure adequate control should be identified in any Chemical Safety Report. These measures should be applied and, where appropriate, recommended to other actors down the supply chain.’

3 Article 1 of that regulation, entitled ‘Aim and scope’, provides:

‘1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.

2. This Regulation lays down provisions on substances and mixtures within the meaning of Article 3. These provisions shall apply to the manufacture, placing on the market or use of such substances on their own, in mixtures or in articles and to the placing on the market of mixtures.

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.’

4 Article 2(8) of that regulation states:

‘On-site isolated intermediates and transported isolated intermediates shall be exempted from:

(a) Chapter 1 of Title II, with the exception of Articles 8 and 9; and

(b) Title VII.’

5 Article 3(15) of that regulation reads as follows:

‘For the purposes of this Regulation:

…

(15) intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis):

(a) non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;

(b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities;

(c) transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites’.

6 Under Article 7(2) of the REACH Regulation:

‘Any producer or importer of articles shall notify [ECHA], in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

(b) the substance is present in those articles above a concentration of 0,1% weight by weight (w/w).’

7 Article 10(a)(iii) of that regulation provides:

‘A registration required by Article 6 or by Article 7(1) or (5) shall include all the following information:

(a) a technical dossier including:

…

(iii) information on the manufacture and use(s) of the substance as specified in section 3 of Annex VI; this information shall represent all the registrant’s identified use(s). This information may include, if the registrant deems appropriate, the relevant use and exposure categories’.

8 Article 17(3) of that regulation states:

‘Paragraph 2 shall apply only to on-site isolated intermediates if the manufacturer confirms that the substance is only manufactured and used under strictly controlled conditions in that it is rigorously contained by technical means during its whole lifecycle. Control and procedural technologies shall be used to minimise emission and any resulting exposure.

If these conditions are not fulfilled, the registration shall include the information specified in Article 10.’

9 Article 18(4) of that regulation states:

‘Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions: …’

10 Article 31(1) to (3) of the REACH Regulation reads as follows:

‘1. The supplier of a substance or a mixture shall provide the recipient of the substance or mixture with a safety data sheet compiled in accordance with Annex II:

(a) where a substance or mixture meets the criteria for classification as hazardous in accordance with 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 the REACH Regulation (OJ 2008 L 353, p. 1)], or

(b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or

(c) where a substance is included in the list established in accordance with Article 59(1) for reasons other than those referred to in points (a) and (b).

2. Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment. If the safety data sheet is developed for a mixture and the actor in the supply chain has prepared a chemical safety assessment for that mixture, it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the mixture instead of with the chemical safety report for each substance in the mixture.

3. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:

(a) in an individual concentration of ≥ 1% by weight for non-gaseous mixtures and ≥ 0,2% by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or

(b) in an individual concentration of ≥ 0,1% by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or

(c) a substance for which there are Community workplace exposure limits.’

11 Under Article 33 of the REACH Regulation:

‘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.

The relevant information shall be provided, free of charge, within 45 days of receipt of the request.’

12 Article 55, of that regulation, entitled ‘Aim of authorisation and considerations for substitution’, which forms part of Title VII thereof, entitled, ‘Authorisation’, provides:

‘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.’

13 Article 57 of that regulation, entitled ‘Substances to be included in Annex XIV’, is worded as follows:

‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:

(a) substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008;

(b) substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008;

(c) substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation(EC) No 1272/2008;

(d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII 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.’

14 Under point 0.3 of Annex I to the REACH Regulation:

‘The chemical safety assessment of a manufacturer shall address the manufacture of a substance and all the identified uses. The chemical safety assessment of an importer shall address all identified uses. The chemical safety assessment shall consider the use of the substance on its own (including any major impurities and additives), in a mixture and in an article, as defined by the identified uses. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses. The chemical safety assessment shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance taking into account implemented and recommended risk management measures and operational conditions.’

15 The preamble to Annex XIII to that regulation states:

‘…

For the identification of PBT substances and vPvB substances a weight-of-evidence determination using expert judgement shall be applied, by comparing all relevant and available information listed in Section 3.2 with the criteria set out in Section 1. This shall be applied in particular where the criteria set out in Section 1 cannot be applied directly to the available information.

A weight-of-evidence determination means that all available information bearing on the identification of a PBT or a vPvB substance is considered together, such as the results of monitoring and modelling, suitable in vitro tests, relevant animal data, information from the application of the category approach (grouping, read-across), (Q)SAR results, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well documented case reports and observations. The quality and consistency of the data shall be given appropriate weight. The available results regardless of their individual conclusions shall be assembled together in a single weight-of-evidence determination.

…’

16 Section 1.1.3(b) of Annex XIII to that regulation provides:

‘A substance fulfils the toxicity criterion (T) in any of the following situations:

…

(b) the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Regulation EC No 1272/2008’.

17 Section 1.1.1.4 of Annex I to Regulation No 1272/2008 provides:

‘For the purpose of classification for health hazards (Part 3) established hazardous effects seen in appropriate animal studies or from human experience that are consistent with the criteria for classification shall normally justify classification. Where evidence is available from both humans and animals and there is a conflict between the findings, the quality and reliability of the evidence from both sources shall be evaluated in order to resolve the question of classification. Generally, adequate, reliable and representative data on humans (including epidemiological studies, scientifically valid case studies as specified in this Annex or statistically backed experience) shall have precedence over other data. However, even well-designed and conducted epidemiological studies may lack a sufficient number of subjects to detect relatively rare but still significant effects, to assess potentially confounding factors. Therefore, positive results from well-conducted animal studies are not necessarily negated by the lack of positive human experience but require an assessment of the robustness, quality and statistical power of both the human and animal data.’

18 Section 3.6.2.1 of Annex I to that regulation states:

‘For the purpose of classification for carcinogenicity, substances are allocated to one of two categories based on strength of evidence and additional considerations (weight of evidence). In certain instances, route-specific classification may be warranted, if it can be conclusively proved that no other route of exposure exhibits the hazard.’

19 Section 3.7.2.1.1 of Annex I to that regulation provides:

‘For the purpose of classification for reproductive toxicity, substances are allocated to one of two categories. Within each category, effects on sexual function and fertility, and on development, are considered separately. In addition, effects on lactation are allocated to a separate hazard category.’

Background to the proceedings

20 Bisphenol A (BPA, 2,2-bis(4-hydroxyphenyl)propane or 4,4’-isopropylidenediphenol, EC 201-245-8, CAS 0000080-05-7) is an organic compound of the aromatic family, used mainly in the manufacture of plastics and resins. Achieved by reaction between two equivalents of phenol and an acetone equivalent, its molecule comprises two phenol functional groups.

21 On 4 January 2017, ECHA adopted Decision ED/01/2017 whereby bisphenol A must be included in the candidate list of substances, that is, the list of substances identified with a view to their eventual inclusion in Annex XIV to the REACH Regulation, on the ground that that substance had been identified as a substance toxic for reproduction within the meaning of Article 57(c) of that regulation.

22 On 2 March 2017, the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (National Agency for Food, Environmental and Occupational Health and Safety, France) (‘the French competent authority’) submitted, pursuant to Article 59(3) of the REACH Regulation, a dossier prepared in accordance with Annex XV to that regulation (‘the dossier prepared in accordance with Annex XV’), in which it proposed that bisphenol A be identified as an endocrine disrupting substance for which there was scientific evidence of probable serious effects on human health. That dossier was intended to supplement the entry relating to bisphenol A on the candidate list, which had been included in that list since 12 January 2017, with a view to that substance also being identified as a substance of very high concern under Article 57(f) of that regulation.

23 On 9 March 2017, ECHA published the dossier prepared in accordance with Annex XV, as submitted by the French competent authority.

24 On the same day, in accordance with Article 59(4) of the REACH Regulation, ECHA invited all interested parties to submit their comments on that dossier.

25 On 21 March 2017, the appellant brought an action before the General Court for annulment of ECHA Decision ED/01/2017, registered as Case T‑185/17.

26 On 21 April 2017, the appellant submitted comments, on behalf of its members, on the dossier prepared in accordance with Annex XV.

27 The French competent authority subsequently produced a document (‘the RCOM Document’), dated 14 June 2017 and containing that authority’s responses to all the comments received by ECHA in the course of the public consultation.

28 On 14 June 2017, ECHA’s Member State Committee unanimously agreed on the identification of bisphenol A as a substance which fulfils the criteria laid down in Article 57(f) of the REACH Regulation ‘because it [was] a substance with endocrine disrupting properties for which there [was] scientific evidence of probable serious effects to human health … which [gave] rise to an equivalent level of concern to those of other substances listed in paragraphs (a) to (e) of Article 57 of the [REACH] Regulation’. The dossier prepared in accordance with Annex XV served as the basis for the creation of the document upon which the Member State Committee relied before reaching unanimous agreement (‘the Support Document’).

29 On 6 July 2017, the Executive Director of ECHA adopted the contested decision, whereby the existing entry relating to the substance bisphenol A on the list of substances identified with a view to their eventual inclusion in Annex XIV to the REACH Regulation, in accordance with Article 59 thereof, was supplemented to the effect that that substance was also identified as a substance with endocrine disrupting properties that may have serious effects on human health which give rise to a level of concern equivalent to those of other substances listed in Article 57(a) to (e) of that regulation, within the meaning of Article 57(f) thereof.

30 By judgment of 11 July 2019, PlasticsEurope v ECHA (T‑185/17, not published, EU:T:2019:492), the General Court dismissed the action brought against ECHA Decision ED/01/2017.

The procedure before the General Court and the judgment under appeal

31 By application lodged at the Court Registry on 15 September 2017, the appellant brought an action for annulment of the contested decision.

32 In support of the action, the appellant relied on six pleas in law. By its first and third pleas, the appellant alleged infringement of the principle of legal certainty and the principle of protection of legitimate expectations. The second plea alleged that ECHA had committed manifest errors of assessment and breached its duty of care. The fourth plea referred to an alleged infringement of Article 57(f) and Article 59 of the REACH Regulation. By the fifth and sixth pleas, the appellant alleged infringement of Article 2(8)(b) of that regulation and of the principle of proportionality.

33 By the judgment under appeal, the General Court dismissed that action and ordered the appellant to pay the costs.

The procedure before the Court of Justice and the forms of order sought

34 By order of the President of the Court of Justice of 2 September 2020, PlasticsEurope v ECHA (C‑876/19 P, not published, EU:C:2020:667), the Federal Republic of Germany was granted leave to intervene in support of the form of order sought by ECHA, the French Republic and ClientEarth.

35 The appellant claims that the Court should:

– set aside the judgment under appeal;

– annul the contested decision and, in the alternative, refer the case back to the General Court for a ruling on its action for annulment; and

– order ECHA to pay the costs of these proceedings, including the costs of the proceedings before the General Court, including those of the interveners.

36 ECHA contends that the Court should:

– dismiss the appeal and

– order the appellant to pay the costs.

37 The French Republic contends that the Court should dismiss the appeal.

38 ClientEarth contends that the Court should:

– dismiss the appeal and

– order the appellant to bear its own costs and to pay the costs incurred by ECHA, the French Republic and ClientEarth, including the costs at first instance.

39 The Federal Republic of Germany contends that the Court should dismiss the appeal.

The appeal

40 The appellant relies on four grounds in support of its appeal. The first ground of appeal alleges misinterpretation of Article 57(f) of the REACH Regulation. The second ground of appeal, divided into six branches, alleges a failure to state reasons in the judgment under appeal and errors of law in the assessment of the evidence available to the General Court, or a distortion of some of that evidence. The third ground of appeal alleges infringement of the principle of equal treatment and the fourth ground of appeal alleges misinterpretation of Article 2(8)(b) of the REACH Regulation and infringement of the obligation to state reasons in that regard.

41 Since the assessment of the first ground of appeal depends on the assessment of the second ground of appeal, the second ground of appeal will be assessed first, the first ground of appeal second and the other grounds of appeal in the order in which they have been raised.

The second ground of appeal

42 The second ground of appeal is divided into six branches.

The first branch of the second ground of appeal, alleging failure to state reasons in the judgment under appeal

– Arguments of the parties

43 By the first branch of the second ground of appeal, the appellant claims that the General Court erred, in paragraphs 100 and 101 of the judgment under appeal, in the assessment of its arguments that ECHA had not established the existence of ‘probable’ serious effects of bisphenol A. The appellant claimed, in paragraphs 49 to 97 of its application, not that ECHA failed to declare that the serious effects of bisphenol A were probable, but that ECHA’s assertion relating to those effects was unfounded since it did not demonstrate that such effects were probable. In its assessment of that substance, ECHA concluded that it has endocrine disrupting properties, without establishing that the effects caused are serious and probable.

44 Since the reasoning in the judgment under appeal does not address the appellant’s observations in paragraphs 49 to 97 of its application, it must, according to the appellant, be regarded as insufficient.

45 The general finding made by the General Court, in paragraph 100 of the judgment under appeal, that the probable nature of the effects of bisphenol A could be inferred ‘inter alia and similarly’ from two sentences in the replies to ECHA’s comments on the estradiol levels set out in the RCOM Document, does not address the appellant’s arguments, does not make it possible to understand the reasoning of the judgment under appeal and does not show that ECHA established that the effects of that substance were probable and serious.

46 The General Court also relied on short-term in vitro studies which are inadequate in order to conclude that the effects attributable to the substance at issue are probable, since they were conducted at unrealistic concentrations that were not physiologically relevant for animals or humans, which ECHA also confirmed, in its Comment 64 in the RCOM Document. Moreover, ECHA failed to take into consideration the potential alternative non-endocrine mediated mechanisms such as cytotoxicity, which could also be a reasonable explanation for the effects described.

47 According to the appellant, the alleged effects identified by ECHA as being possible as regards oestrous cycles were, moreover, in reality neither possible nor probable. ECHA based its analysis on the Lee (2013a) study, whereas various high-quality studies, such as Goodman (2009, 2006), Gray (2004), Center for the Evaluation of Risks to Human Reproduction (2008), EFSA (2015) and SCOEL (2014), show no effect on oestrous cyclicity by reference to a relevant level of human exposure. In addition, ECHA also stated, as is apparent from Comment No 81 of the RCOM Document, that there are ‘contradictory results which the [competent French authority] was unable to explain’.

48 The appellant submits, moreover, that the Clarity-BPA core study, according to which no treatment-related effect on the duration of the oestrous cycle has been found, is clearly superior in scientific reliability to the Lee (2013a) study due, in particular, to the robust design of the tests, consistent with good laboratory practice, the wide range of dose groups, including two dosing arms, the sensitive window of exposure covered and individual animal data publicly available.

49 ECHA, the French Republic, ClientEarth and the Federal Republic of Germany submit that the first branch of the second ground of appeal is inadmissible and, in any event, unfounded.

– Findings of the Court

50 By the first branch of the second ground of appeal, the appellant submits that the General Court infringed its obligation to state reasons since it did not respond to its observations in paragraphs 49 to 97 of its application relating to ECHA’s obligation to demonstrate the existence of ‘probable’ serious effects of bisphenol A, but merely reproduced, in paragraphs 100 and 101 of the judgment under appeal, ECHA’s findings in that regard.

51 It must be borne in mind that the obligation to state reasons constitutes an essential procedural requirement which must be distinguished from the question whether the reasoning is well founded, which goes to the substantive legality of the measure at issue (see, to that effect, judgment of 14 September 2016, Trafilerie Meridionali v Commission, C‑519/15 P, EU:C:2016:682, paragraph 40).

52 That obligation is intended to enable the persons concerned to know the reasons which led it to adopt the judgment in question and provide the Court of Justice with sufficient material for it to exercise its power of review (judgment of 7 June 2018, Equipolymers and Others v Council, C‑363/17 P, not published, EU:C:2018:402, paragraph 45).

53 However, the obligation to state reasons does not require the General Court to provide an account which follows exhaustively and one by one all the arguments put forward by the parties to the case, since the reasoning may be implicit on condition that it enables the persons concerned to know why the General Court has not upheld their arguments and provides the Court of Justice with sufficient material for it to exercise its power of review (judgment of 7 June 2018, Equipolymers and Others v Council, C‑363/17 P, not published, EU:C:2018:402, paragraph 46). Similarly, the General Court is not required to provide reasons for each of its choices where it relies on one item of evidence as opposed to another in support of its decision (judgment of 7 June 2018, Equipolymers and Others v Council, C‑363/17 P, not published, EU:C:2018:402, paragraph 44).

54 In the first place, it should be noted that, in paragraphs 47 to 63 of the application the appellant’s arguments are set out relating to the legal requirements imposed on ECHA when assessing whether a substance falls within the scope of Article 57(f) of the REACH Regulation and not the appellant’s arguments relating to the fact that ECHA has not established the probable serious effects on human health.

55 In the second place, paragraphs 41 to 43 of the judgment under appeal contain the statement of reasons by which the General Court responded to the arguments relied on in support of the first complaint in the first branch of the second plea set out in paragraphs 64 to 68 of the application by which the appellant claimed that ECHA, in relying on the fact that bisphenol A is classified as an endocrine disruptor, failed to establish the level of concern referred to in Article 57(f) of the REACH Regulation for that substance specifically.

56 In the third place, paragraphs 58 to 114 of the judgment under appeal contain the reasoning by which the General Court addressed the arguments put forward by the appellant in support of the second complaint in the first branch of the second plea set out in paragraphs 69 to 84 of the application.

57 In the context of that statement of reasons, paragraphs 100 and 101 of the judgment under appeal are intended specifically to address the appellant’s argument that ECHA relied on a criterion of ‘plausibility’ of adverse effects rather than on that of ‘probability’ required under Article 57(f) of the REACH Regulation.

58 However, on the basis of findings made by ECHA in the contested decision, but also on the basis of evidence contained in the Support Document and in the RCOM Document, the General Court came to the conclusion that ECHA had made a finding of probable and not just possible serious effects on health or the environment.

59 Moreover, it is apparent from paragraphs 61 to 85 and 103 to 114 of the judgment under appeal that the General Court also addressed the appellant’s arguments relied on in support of the second complaint in the first branch of the second plea by which it challenged the assessments of the evidence carried out by ECHA, namely, first, the arguments relating to the fact that ECHA had relied on a series of studies which did not comply with the principle of excellence and, in part, reached different conclusions from those of the European Food Safety Authority (EFSA) and, secondly, the fact that ECHA had not demonstrated that the alleged adverse effects of bisphenol A gave rise to an ‘equivalent level of concern’ to that arising from the effects of substances meeting the criteria of Article 57(a) to (e) of the REACH Regulation.

60 It should be noted in particular that it is in paragraphs 103 to 112 of the judgment under appeal, which are not disputed by the appellant, that the General Court addressed the appellant’s arguments relating to ECHA’s assessment of the evidence concerning the mode of action of bisphenol A and the effects of that substance on human health.

61 First, in paragraph 106 of the judgment under appeal, the General Court addressed the appellant’s argument relating to the second paragraph of Section 4.6 of the Support Document, noting that that section is cited only in part by the appellant, since it did not refer to the conclusion of the overall assessment from which it is apparent that ‘the disruption of estrogenic pathways is a common [mode of action] consistently involved in each of the four effects’.

62 Secondly, in paragraph 107 of the judgment under appeal, the General Court found that ‘the [appellant] has failed to support in any way its claims that, in essence, ECHA has failed conclusively to demonstrate that there was “a respective [mode of action] or mechanism of action that [was] relevant for an observed adverse effect”’. The reasoning set out by the General Court is based both on several parts of the Support Document which it cited, in part, in paragraph 108 of the judgment under appeal and summarised, in part, in paragraph 109 of that judgment, and on the fact, noted in paragraph 110 of that judgment and set out in paragraph 111 thereof, that the appellant’s complaints are general in nature, although they do not deprive ECHA’s assessments of plausibility.

63 In the fourth place, the General Court responded, in paragraphs 118 to 125 of the judgment under appeal, to the arguments submitted in support of the third complaint in the first branch of the second plea, set out in paragraphs 85 and 86 of the application, which concerned the manifest error of assessment on the part of ECHA in that it had not taken into account the safe level for the use of bisphenol A required in other provisions of EU law.

64 In the fifth place, the General Court addressed, in paragraphs 128 to 131 of the judgment under appeal, the arguments put forward in the second branch of the second plea, set out in paragraphs 87 to 97 of the application, which concerned a breach by ECHA of its duty of care.

65 It follows that the General Court examined and addressed, in paragraphs 39 to 131 of the judgment under appeal, all the arguments set out in paragraphs 64 to 97 of the application. In particular, in paragraphs 103 to 112 of that judgment, it responded to the appellant’s arguments concerning the application by ECHA of the standard of proof referred to in Article 57(f) of the REACH Regulation.

66 Since the General Court did not fail to comply with its duty to state reasons, the first branch of the second ground of appeal must be rejected as unfounded.

The second branch of the second ground of appeal, alleging that the General Court erred in law in its assessment of the equivalent level of concern

– Arguments of the parties

67 By the second branch of the second ground of appeal, the appellant submits that the General Court, in paragraphs 41 to 44 of the judgment under appeal, erred in law by confining itself to finding that ECHA’s relevant obligations were fulfilled because ECHA made a declaration to that effect when the General Court should have determined whether ECHA had in fact reached the conclusion that the substance at issue gives rise to an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of the REACH Regulation on the basis of the evidence available to it. Thus, the General Court did not address its complaint in that regard.

68 ECHA, ClientEarth and the Federal Republic of Germany dispute the appellant’s arguments and contend that the second branch of the second ground of appeal is unfounded.

– Findings of the Court

69 It should be noted, first, that under Article 256(1) TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union, an appeal lies on points of law only. The General Court has exclusive jurisdiction to find and appraise the relevant facts and assess the evidence. It follows that, in the context of an appeal, the Court of Justice has no jurisdiction to establish the facts or, in principle, to examine the evidence which the General Court accepted in support of those facts (order of 20 January 2021, ZU v EEAS, C‑266/20 P, not published, EU:C:2021:42, paragraph 7).

70 The jurisdiction of the Court of Justice to review the findings of fact by the General Court therefore extends, inter alia, to the substantive inaccuracy of those findings as apparent from the documents in the file, distortion of the evidence, the legal characterisation of the evidence and whether the rules relating to the burden of proof and the taking of evidence have been observed (order of 20 January 2021, ZU v EEAS, C‑266/20 P, not published, EU:C:2021:42, paragraph 8).

71 Secondly, according to the Court of Justice’s settled case-law, an appeal must indicate precisely the contested elements of the judgment which the appellant seeks to have set aside and also the legal arguments specifically advanced in support of the appeal and must not amount in reality to no more than a request for a re-examination of the application brought before the General Court (judgment of 31 October 2019, Repower v EUIPO, C‑281/18 P, EU:C:2019:916, paragraph 44).

72 Thus, where an appellant claims that the General Court erred in law, it must indicate what error of law it made (see, to that effect, judgment of 10 July 2014, Telefónica and Telefónica de España v Commission, C‑295/12 P, EU:C:2014:2062, paragraph 72; orders of 20 June 2019, FCA US v EUIPO, C‑795/18 P, not published, EU:C:2019:525, paragraph 6; of 19 November 2019, Nonnemacher v EUIPO, C‑659/19 P, not published, EU:C:2019:995, paragraph 16; and of 30 April 2020, Hochmann Marketing v Parliament, C‑557/19 P, not published, EU:C:2020:315, paragraph 21).

73 As regards the appellant’s argument that the General Court, in paragraphs 41 to 44 of the judgment under appeal, erred in law in that it did not determine whether ECHA had in fact complied with the obligation to examine the information available to it in order to reach the conclusion that there was an equivalent level of concern, it must be noted that the appellant does not specify what error of law the General Court is said to have made in those paragraphs.

74 As regards the appellant’s argument that the General Court did not address, in paragraphs 41 to 44 of the judgment under appeal, its complaint at first instance, it should be noted that the appellant does not specify the part of its application in which it set out that complaint.

75 Accordingly, the second branch of the second ground of appeal must be rejected as inadmissible.

The third branch of the second ground of appeal, alleging that the General Court erred in law in its assessment of the relevance of EFSA’s conclusions

– Arguments of the parties

76 By the third branch of the second ground of appeal, the appellant complains that the General Court erred in not holding that ECHA had a duty, at the very least, to assess the relevance of EFSA’s conclusions on the quality of the studies that were relied on by the agency, in particular where such studies were considered to be key studies by ECHA but had been dismissed by EFSA on the ground of inadequate or insufficient quality or reliability. The General Court, in paragraphs 62 to 70 and 83 of the judgment under appeal, rejected that argument on the sole ground that EFSA and ECHA have different roles and act within different legal frameworks.

77 EFSA assessed the same studies and information as that examined by ECHA and reached patently opposite conclusions as regards their intrinsic reliability and value. A study that an EU body finds unacceptable for regulatory purposes cannot be accepted, according to the appellant, as valid evidence by another EU body or, at least, as the appellant submitted, the differences in the conclusions of the body that assessed the study at issue in the first place must be acknowledged and addressed.

78 The French Republic and ClientEarth maintain that the third branch of the second ground of appeal is inadmissible and, like ECHA, that it is unfounded.

– Findings of the Court

79 By the third branch of the second ground of appeal, the appellant complains that the General Court did not find that ECHA had a duty, at the very least, to assess the relevance of EFSA’s conclusions on the quality of the studies on which ECHA relied. The General Court, in paragraphs 62 to 70 and 83 of the judgment under appeal, rejected the appellant’s argument that the studies which ECHA regarded as key studies had been rejected by EFSA.

80 Suffice it to note, in that regard, that the appellant is in fact seeking, by that line of argument, a re-examination of the findings of fact made by the General Court, in respect of which the Court of Justice does not have jurisdiction in an appeal, as follows from the case-law referred to in paragraphs 71 and 72 of the present judgment.

81 Accordingly, the third branch of the second ground of appeal must be rejected as inadmissible.

The fourth branch of the second ground of appeal, alleging that the General Court erred in law in its assessment of EFSA’s opinion of 25 March 2015

– Arguments of the parties

82 By the fourth branch of the second ground of appeal, the appellant submits that the General Court, in paragraph 68 of the judgment under appeal, erred in law in finding that EFSA’s opinion of 25 March 2015 indirectly confirms ECHA’s conclusion that bisphenol A has an effect on the human endocrine system. It arrived at that finding without having evidence and by distorting the overall meaning of the evidence cited by the appellant.

83 The General Court failed to demonstrate, in paragraph 69 of the judgment under appeal, that the studies referred to in that paragraph could lead to the conclusion that any of the observed effects meet the criteria laid down in Article 57(f) of the REACH Regulation, and in particular, give rise to a level of concern equivalent to that arising from substances which are carcinogenic, mutagenic, or toxic for reproduction, categories 1A or IB.

84 According to the appellant, EFSA reached the opposite conclusion by stating, in its opinion of 25 March 2015, that bisphenol A is ‘as likely as not’ to have effects on the functions relevant to that assessment and summarised its analysis by stating on its website that ‘therefore, based on [the World Health Organisation (WHO)] criteria, it was not considered possible to conclude that [bisphenol A] is an endocrine disruptor’.

85 ECHA, the French Republic and ClientEarth dispute the merits of the fourth branch of the second ground of appeal.

– Findings of the Court

86 By the fourth branch of the second ground of appeal, the appellant submits that the General Court, in paragraphs 68 and 69 of the judgment under appeal, erred in law in finding that EFSA’s opinion of 25 March 2015 indirectly confirms ECHA’s conclusion that bisphenol A has an effect on the human endocrine system. It arrived at that conclusion without evidence and by distorting the overall meaning of the evidence cited by the appellant.

87 Where an appellant alleges distortion of the evidence by the General Court, he or she must, under Article 256 TFEU, the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union and Article 168(1)(d) of the Rules of Procedure of the Court of Justice, indicate precisely the evidence alleged to have been distorted by the General Court and show the errors of appraisal which, in his or her view, led to such distortion. In addition, according to the Court of Justice’s settled case-law, that distortion must be obvious from the documents in the Court’s file, without there being any need to carry out a new assessment of the facts and the evidence (judgment of 29 April 2021, Fortischem v Commission, C‑890/19 P, not published, EU:C:2021:345, paragraph 70).

88 It should be noted, in that regard, that the part of the reasoning set out in paragraphs 68 and 69 of the judgment under appeal, which is based on several studies cited by EFSA, forms part of the reasoning set out in paragraphs 63 to 69 of that judgment seeking to justify the finding made in paragraph 62 of that judgment that EFSA’s opinion does not contain any specific conclusion as to whether bisphenol A possesses endocrine disrupting properties that give rise to the level of concern referred to in Article 57(f) of the REACH Regulation.

89 As is apparent from paragraphs 63 to 67 of the judgment under appeal, the General Court relied on the fact that EFSA’s failure to reach a specific conclusion as to whether bisphenol A is an endocrine disruptor is, in general, based on a risk assessment linked to a particular use of the substance concerned and not on an analysis of the hazards arising from its intrinsic properties as carried out by ECHA.

90 Accordingly, EFSA’s conclusion is not manifestly inconsistent with the General Court’s finding, in paragraph 68 of the judgment under appeal, that EFSA’s opinion of 25 March 2015 indirectly confirms ECHA’s conclusion that bisphenol A has an effect on the human endocrine system.

91 It follows that the fourth branch of the second ground of appeal must be rejected as unfounded.

The fifth branch of the second ground of appeal, alleging distortion by the General Court of the evidence and the appellant’s submissions

– Arguments of the parties

92 By the fifth branch of the second ground of appeal, which is divided into five complaints, the appellant claims that the General Court distorted the evidence submitted to it and the appellant’s submissions.

93 By the first complaint of the fifth branch of the second ground of appeal, the appellant submits, in its first argument, that the General Court, in paragraph 75 of the judgment under appeal, distorted the evidence by finding that the study by the Organisation for Economic Cooperation and Development (OECD) Task Force on Endocrine Disruptors Testing and Assessment of the Test Guidelines Programme (‘the OECD Working Group study’) was not evidence in support of its arguments challenging the Lee (2013a) study relied on by ECHA. According to the OECD Working Group study, increase in body weight is an observable effect in all aromatase inhibitors, whereas the Lee (2013a) study does not mention bisphenol A having such an effect, even though the latter is an aromatase inhibitor. By its second argument, the appellant asserts that the General Court’s finding in paragraph 75 that it did not refer to any study other than the OECD Working Group study distorted the fact that it relied, in paragraph 20 of its reply, on the Yamasaki (2002) study.

94 By the second complaint in the fifth branch of the second ground of appeal, the appellant claims that the General Court distorted the evidence in so far as it found, in paragraph 76 of the judgment under appeal, that the Yamasaki (2002), Hengstler (2011), EFSA (2015) and ECHA (2014) studies were not added to the case file or summarised in a comprehensible and conclusive manner in the pleadings submitted by the appellant, whereas the appellant summarised, in paragraph 70 of its application, the conclusions of those studies and cited and referenced them in Annex 10 to its application. In addition, the General Court cited the EFSA (2015) study in several parts of the judgment under appeal.

95 By the third complaint in the fifth branch of the second ground of appeal, the appellant states that, in paragraph 79 of the judgment under appeal, the General Court distorted the evidence in so far as it found that there was nothing to indicate which level 4 and 5 studies it was referring to, even though they were cited in paragraph 50 of the Support Document.

96 By the fourth complaint in the fifth branch of the second ground of appeal, the appellant claims that the General Court, in paragraph 82 of the judgment under appeal, distorted the evidence and facts in so far as it did not respond to its argument that the results of the neurotoxicity studies, summarised in paragraph 70 of the application, do not confirm ECHA’s conclusions, but merely noted that ‘the [appellant] has failed to clarify the link between neurotoxicity and the nature of endocrine disruptors of very high concern’. The link between the neurotoxicity of bisphenol A and its nature as an endocrine disruptor was implicitly established by ECHA, at page 161 of the Support Document, in so far as ECHA relied on that link in order to establish the endocrine disrupting properties of bisphenol A.

97 By the fifth complaint in the fifth branch of the second ground of appeal, the appellant submits that, in paragraph 85 of the judgment under appeal, the General Court distorted the evidence in finding that the ToxRTool was used solely to supplement the results of the weight-of-evidence approach, although there is no doubt, as is apparent from page 21 of the Support Document cited in Annex A.13 to the application, that it was in fact that tool that was used for the purposes of assessing the weight of the evidence. According to the Support Document, ‘the ToxRTool was used to assess the reliability of the experimental studies that were considered as the most informative to reach the conclusions’ and ‘in its submissions, the newer studies … have been incorporated into a weight of evidence approach and the ToxRTool was used to evaluate the studies considered as key studies by them, to confirm in a transparent way that they were reliable’. Had the General Court not erred in this way, it would have had to assess the appellant’s arguments on the lack of transparency, and the lack of protocol, in the application of the ToxRTool and how those deficiencies resulted in a flawed assessment of the evidence.

98 ECHA and ClientEarth dispute the merits of the five complaints in the fifth branch of the second ground of appeal.

– Findings of the Court

99 As regards the first argument of the first complaint in the fifth branch of the second ground of appeal, alleging distortion, in paragraph 75 of the judgment under appeal, of the evidence relating to the OECD Working Group study, suffice it to note that that study was irrelevant to the criticism of the Lee (2013a) study. The General Court found, in that paragraph, that it was impossible to know whether the Lee (2013a) study mentions the body weight of animals after exposure to bisphenol A and whether in the context of that study, body weight had in fact increased since the appellant did not provide that study, which the appellant does not dispute in its appeal.

100 As regards the second argument of the first complaint in the fifth branch of the second ground of appeal, alleging distortion, in paragraph 75 of the judgment under appeal, of the evidence relating to the Yamasaki (2002) study and concerning the second complaint in that branch, alleging distortion, in paragraph 76 of that judgment, of the evidence relating to that study and the Hengstler (2011), EFSA (2015) and ECHA (2014) studies, it should be noted that, in that paragraph, the General Court found, in the context of its analysis of the appellant’s arguments that ECHA’s conclusions are not supported by the studies which that agency had found to be persuasive, that it was not in a position to verify the data that those studies contain, since they were not added to the case file, or summarised in a comprehensible and conclusive manner in the pleadings submitted by the appellant.

101 The reference to Annex 10 to its application, by which the appellant submits that it demonstrates the distortion of evidence by the General Court, refers only to page 7 of the appellant’s observations on the file in accordance with Annex XIV to the REACH Regulation, that page containing only the same contentions as those set out in paragraph 70 of the application and not the studies at issue themselves. Thus, the General Court was not in a position to verify the appellant’s contentions in paragraph 70 of its application, even if they summarised in a comprehensible and conclusive manner the Yamasaki (2002), Hengstler (2011), EFSA (2015) and ECHA (2014) studies.

102 The first and second complaints of the fifth branch of the second ground of appeal must therefore be rejected as unfounded.

103 As regards the third complaint in the fifth branch of the second ground of appeal, alleging distortion, in paragraph 79 of the judgment under appeal, of the evidence relating to the level 4 and 5 studies, it must be noted that the appellant does not specify the paragraph of its application from which it is apparent that it referred to paragraph 50 of the Support Document included in Annex A.13 to the application in connection with its claims relating to those studies.

104 Accordingly, the third complaint must be rejected as inadmissible.

105 As regards the fourth complaint in the fifth branch of the second ground of appeal, alleging distortion, in paragraph 82 of the judgment under appeal, of the evidence and facts relating to the neurotoxicity of bisphenol A, it should be noted that the appellant did not specify, in paragraph 70 of its application, contrary to what it claims in that complaint, either the link between the neurotoxicity of bisphenol A and its nature as an endocrine disruptor, or the fact that it is ECHA that established that link.

106 Therefore, the fourth complaint in the fifth branch of the second ground of appeal must be rejected as unfounded.

107 As regards the fifth complaint in the fifth branch of the second ground of appeal, alleging distortion, in paragraph 85 of the judgment under appeal, of the evidence relating to the ToxRTool, it is not obvious from page 21 of the Support Document, contrary to what is claimed by the appellant, that the ToxRTool was used by ECHA for purposes other than to supplement the results deriving from the weight-of-evidence approach. It is apparent from that page that the experimental studies were considered ‘the most informative to reach the conclusions’ and ‘key’.

108 It follows from the foregoing that the fifth complaint in the fifth branch of the second ground of appeal must be rejected as unfounded.

109 It follows that the fifth branch of the second ground of appeal must be rejected as in part inadmissible and in part unfounded.

The sixth branch of the second ground of appeal, alleging errors of law made by the General Court in the assessment of the evidence

– Arguments of the parties

110 The sixth branch of the second ground of appeal is divided into six complaints.

111 By the first complaint of the sixth branch of the second ground of appeal, the appellant claims that the General Court erred in law by not itself determining whether or not ECHA made an error, but relied, in paragraph 82 of the judgment under appeal, solely on ECHA’s reasoning.

112 By the second complaint in the sixth branch of the second ground of appeal, the appellant submits that the General Court, in paragraph 73 of the judgment under appeal, distorted the evidence by considering that the Tyl (2008) and Delclos (2014) studies show that bisphenol A has adverse effects on oestrous cyclicity, without taking into account the fact that the Tyl (2008) study does not show any effect on oestrous cyclicity and without taking account of other studies cited in paragraph 19 of its reply and to which, inter alia, EFSA had given different weight. Moreover, the General Court did not give reasons for its decision not to take that other evidence into consideration.

113 By the third complaint in the sixth branch of the second ground of appeal, the appellant submits that, in paragraph 75 of the judgment under appeal, the General Court erred in its assessment of the evidence by excluding the OECD Working Group study specifically cited by the appellant to confirm that increase in body weight is an observable effect in all aromatase inhibitors. The General Court’s statement in that paragraph is contradictory, in so far as it held that the appellant’s allegation could not be verified on the basis of the very evidence which gave rise to that allegation instead of verifying whether that study was capable of supporting the appellant’s submission.

114 In addition, the appellant states that the last sentence of paragraph 75 of the judgment under appeal is void of purpose or sense since it submitted, in paragraph 70 of its application, the conclusions drawn from the results of the Lee (2013a) study, which ECHA does not dispute. Moreover, the General Court did not provide sufficient reasoning to explain what study was missing and did not enable the appellant to understand the rationale for its conclusions.

115 By the fourth complaint in the sixth branch of the second ground of appeal, the appellant claims that, in paragraph 85 of the judgment under appeal, the General Court not only distorted the sense of the evidence, as it claims in the fifth complaint of the fifth branch of the second ground of appeal, but also erred in law in rejecting its arguments as ineffective, whereas it should have assessed ECHA’s error in failing to explain how it had used the ToxRTool, even though it had relied on the results of the application of that tool to reach and substantiate its conclusions.

116 By the fifth complaint in the sixth branch of the second ground of appeal, the appellant submits that the General Court failed to provide a basis for its reference to a ‘common approach in science’ in paragraph 77 of the judgment under appeal.

117 By the sixth complaint of the sixth branch of the second ground of appeal, the appellant claims that the General Court erred in law by observing, in paragraph 130 of the judgment under appeal, that it was not for ECHA to postpone the adoption of the contested decision pending publication of the results of the Clarity-BPA Programme. The General Court should have responded to its argument, set out in paragraph 91 of its application, that ‘[ECHA] should have, at a minimum, indicated why it considers that it can decide on the application of self-selected criteria for endocrine disrupters to [bisphenol A] when other scientific bodies of the [European Union] have decided that they cannot do so’.

118 ECHA contends that the sixth complaint in the sixth branch of the second ground of appeal is inadmissible and, in any event, unfounded, whereas the other complaints in that branch are unfounded. ClientEarth maintains that the first, second and sixth complaints in that branch are inadmissible and, in any event, unfounded, while the other complaints are inadmissible.

– Findings of the Court

119 As regards the first complaint in the sixth branch of the second ground of appeal, the appellant submits that the General Court erred in law by not itself determining whether ECHA had made an error in its response to the arguments the appellant had put forward in relation to the neurotoxicity studies and the link between that neurotoxicity and the nature of an endocrine disruptor of very high concern. It should be noted, in that regard, that the appellant therefore merely suggests a failure to state reasons in the judgment under appeal without further specifying the error of law made by the General Court or in which part of its application it challenged ECHA’s reasoning.

120 Furthermore, it is clear that that complaint is, in reality, merely a repetition of the allegation of a failure to state reasons raised by the appellant in the first branch of the second ground of appeal. It is apparent, in particular, from paragraphs 55 to 64 of the present judgment, that that allegation is unfounded.

121 Accordingly, the first complaint must be rejected as inadmissible and, in any event, unfounded.

122 As regards the second complaint in the sixth branch of the second ground of appeal, alleging distortion, in paragraph 73 of the judgment under appeal, of the evidence relating to the Tyl (2008) study and the other studies cited by the appellant in paragraph 19 of its reply, it must be borne in mind that the General Court, in paragraphs 72 and 73 of that judgment, gave reasons for rejecting the appellant’s argument that ECHA failed to take account of certain data which had been recognised as scientifically valid and reliable by other regulatory bodies of the European Union or gave insufficient weight to those studies.

123 In paragraph 72 of the judgment under appeal, it found that ‘regulatory bodies and scientific committees other than ECHA, including EFSA and [the Scientific Committee on Occupational Exposure Limits (SCOEL)], do not have the same duties as ECHA and draw up their scientific opinions for purposes other than those envisaged by ECHA’.

124 In paragraph 73 of the judgment under appeal the General Court added that ‘it is true that it follows from the observations set out on page 24 of the Support Document that the Tyl (2002) and Ema (2001) studies did not identify any significant differences in the oestrous cyclicity diagram. However, contrary to what the [appellant] appears to submit – and as observed by ECHA, which was not challenged in that regard – there are numerous other studies, including the Tyl (2008) and Delclos (2014) studies relied upon by the [appellant], which, conversely, demonstrate that bisphenol A has adverse effects on oestrous cyclicity. The [appellant] makes no reference to the results of the other studies and does not explain what specific conclusions, different to ECHA’s own findings, the regulatory bodies and scientific committees allegedly drew from those other studies’.

125 It is apparent from those two paragraphs of the judgment under appeal that the General Court rejected the appellant’s argument that ECHA did not take into account certain data which had been recognised as scientifically valid and reliable by regulatory bodies and scientific committees or gave insufficient weight to those studies on the ground that the appellant did not explain which conclusions those bodies and committees drew from the studies which demonstrate that bisphenol A has adverse effects on oestrous cyclicity including the Tyl (2008) and Delclos (2014) studies.

126 First, the appellant does not specify, in the second complaint in the sixth branch of the second ground of appeal, in which part of its application it cited the part of the Tyl (2008) study from which it is clear that the General Court distorted the conclusions of that study.

127 Secondly, the appellant proceeds from the incorrect premiss that the General Court itself established, in paragraph 73 of the judgment under appeal, that bisphenol A has adverse effects on oestrous cyclicity, whereas it merely reproduced the conclusions of the Tyl (2008) and Delclos (2014) studies in order to highlight their findings contrary to the appellant’s claims, which did not, however, explain which specific conclusions, different from those of ECHA, the regulatory bodies and the scientific committees drew from those studies. Moreover, as paragraph 19 of the reply in the proceedings before the General Court does not contain any reference to the content of the studies referred to therein, the General Court was not in a position to verify the appellant’s claims with regard to those studies.

128 Accordingly, the second complaint in the sixth branch of the second ground of appeal must be rejected as in part inadmissible and in part unfounded.

129 As regards the third complaint in the sixth branch of the second ground of appeal, alleging that the General Court erred in law, in paragraph 75 of the judgment under appeal, in the assessment of the OECD Working Group study, as stated in paragraph 99 above, that study was irrelevant to the criticism of the Lee (2013a) study.

130 Accordingly, the third complaint must be rejected as ineffective.

131 As regards the fourth complaint in the sixth branch of the second ground of appeal, alleging that the General Court erred in law, in paragraph 85 of the judgment under appeal, in its assessment of the use of the ToxRTool, suffice it to note that the appellant does not specify how the General Court is alleged to have erred in law in that paragraph, nor does it explain why its arguments at first instance could not be regarded as ineffective by the General Court.

132 Accordingly, the fourth complaint must be rejected as inadmissible.

133 As regards the fifth complaint in the sixth branch of the second ground of appeal, alleging that the General Court erred in law, in paragraph 77 of the judgment under appeal, in so far as it did not justify the reference to a ‘common approach in science’, it should be noted that the General Court considered, in that paragraph, that negative or merely inconclusive epidemiological studies, such as those at issue before the General Court, cannot invalidate positive studies in animals and not that they are irrelevant, which the competent French authority noted in Comment No 89 of the RCOM Document. The appellant has not challenged the approach of that authority either at first instance or in the appeal.

134 It follows that the appellant’s argument analysed by the General Court in paragraph 77 of the judgment under appeal cannot succeed regardless of whether that authority’s approach is common in science.

135 Accordingly, the fifth complaint in the sixth branch of the second ground of appeal is ineffective.

136 As regards the sixth complaint in the sixth branch of the second ground of appeal, alleging that the General Court erred in law, in paragraph 130 of the judgment under appeal, in the application of the principles of sound administration and legal certainty, it must be borne in mind that, according to the settled case-law of the Court of Justice, the principle of legal certainty requires that any measure adopted by the EU institutions should be clear and precise, so as to enable the persons concerned to ascertain precisely what their rights and obligations are under the measure and to take steps accordingly (see, by analogy, judgment of 10 April 2014, Areva and Others v Commission, C‑247/11 P and C‑253/11 P, EU:C:2014:257, paragraph 128).

137 The General Court was therefore right to find, in paragraph 163 of the judgment under appeal, to which paragraph 130 thereof refers, that the principle of legal certainty does not require that an EU institution await the preparation of a specific scientific study before taking a decision, since such a delay is not capable of influencing the accuracy with which the persons concerned are in a position to ascertain their rights and obligations arising from that decision or to take steps accordingly.

138 Accordingly, the sixth complaint in the sixth branch of the second ground of appeal must be rejected as unfounded and, consequently, the sixth branch must be rejected in its entirety.

139 It follows that the second ground of appeal must be rejected as in part inadmissible and in part unfounded.

The first ground of appeal, alleging misinterpretation of Article 57(f) of the REACH Regulation

140 The first ground of appeal is divided into two branches.

The first branch of the first ground of appeal, alleging an error of law in the application of the plausibility test

– Arguments of the parties

141 By the first branch of the first ground of appeal, the appellant submits that the word ‘plausibility’ is taken from the recommendations of the Commission’s Joint Research Centre (‘the JRC’). According to the JRC, the adverse effects on human health should have a biologically plausible link to an endocrine mode of action. However, the General Court wrongly extended, in paragraphs 92 to 94 and 99 of the judgment under appeal, the plausibility test to all the scientific evidence required under Article 57(f) of the REACH Regulation, when that test is relevant only in order to determine whether there is a link between a mode of action and the adverse effects attributed to a substance.

142 Such an application of the plausibility test is not supported, first of all, by the express wording of Article 57(f) of the REACH Regulation, which requires that the adverse effects of the substance concerned be scientifically proven, without limiting that obligation to mere plausibility. Next, such an application is also not supported by the judgment of 11 May 2017, Deza v ECHA (T‑115/15, EU:T:2017:329), referred to by the General Court in paragraph 92 of the judgment under appeal, since it does not concern the standard of proof implied by the expression ‘for which there is scientific evidence of probable serious effects’, but rather the existence of probable serious effects. Lastly, according to the appellant, the expression ‘biologically plausible’ in the JRC recommendations cannot lead to an extension of the plausibility test to the requirement imposed in Article 57(f), since it applies to a different standard of proof. The question whether there is a plausible biological link between the adverse effects of a substance and its mode of action is relevant for the purposes of determining whether that substance can be classified as an endocrine disruptor within the meaning of the JRC recommendations, but that classification does not exempt ECHA from demonstrating that all the conditions set out in that provision are fulfilled in cases where it wishes to identify the substance concerned as a substance of very high concern. In addition, all the scientific evidence should be assessed and considered in the light of its reliability, relevance and adequacy, as is apparent from the OECD Guidelines for hazard assessment, ECHA guidance on chemical safety assessment and law, and not merely on the basis of a plausibility test taken out of context.

143 ECHA, the French Republic, ClientEarth and the Federal Republic of Germany submit that the first branch of the first ground of appeal must be rejected as unfounded.

– Findings of the Court

144 By the first branch of the first ground of appeal, the appellant submits that the General Court held, in paragraphs 91 to 94 and 99 of the judgment under appeal, that, contrary to Article 57(f) of the REACH Regulation, the plausibility test was a test which had to be satisfied by all the evidence gathered by ECHA, whereas that test is relevant only in determining whether there is a link between a mode of action and the adverse effects attributed to a substance.

145 It should be noted at the outset that the first branch of the first ground of appeal is based on a misreading of paragraphs 92 to 94 and 99 of the judgment under appeal.

146 First of all, in paragraph 99 of the judgment under appeal, the General Court found that ‘in the light of the foregoing, the [appellant’s] complaint that ECHA added a “plausibility” criterion to the “probability” criterion referred to in Article 57(f) of [the REACH Regulation] cannot succeed. ECHA did not in fact add any additional threshold to that provision. The [appellant’s] argument referred to in paragraph 88 above is actually based on confusion between (i) the question of “plausibility” as a criterion to be satisfied by all of the evidence gathered by ECHA (see paragraphs 91 to 94 above) and (ii) the question of the possible or probable nature of the effects of a substance (see paragraphs 95 to 98 above)’.

147 Next, contrary to what is claimed by the appellant, it is apparent from paragraph 94 of the judgment under appeal, which is summarised in paragraph 99 of that judgment in conjunction with paragraphs 91 to 93 thereof, that the General Court noted that, according to the recommendations in the JRC’s report, the causal link between the endocrine-related mode of action of a substance and undesirable effects on human health must be plausible in order for that substance to be regarded as an endocrine disruptor.

148 Lastly, paragraphs 92 to 94 and 99 of the judgment under appeal are included, as is apparent from paragraph 86 thereof, in the part of that judgment in which the General Court responded to the appellant’s arguments calling into question ECHA’s finding relating to the mode of action of bisphenol A.

149 It follows that the General Court referred to the plausibility criterion only in the context of verifying the existence of a causal link between a mode of action and the adverse effects attributed to a substance, which the appellant does not dispute, and therefore the General Court did not extend that criterion to all the evidence gathered by ECHA.

150 Accordingly, the first branch of the first ground of appeal must be rejected as unfounded.

The second branch of the first ground of appeal, alleging an error of law resulting from the substitution of the concept of possible effects for that of the probable effects of a substance on human health

– Arguments of the parties

151 By the second branch of the first ground of appeal, the appellant submits that the General Court, in paragraphs 98 and 101 of the judgment under appeal, erred in law in its interpretation of Article 57(f) of the REACH Regulation by holding that that provision requires only that ECHA demonstrate that the substance concerned has possible effects, and not that it has probable effects, on human health.

152 The appellant states that the literal meaning of Article 57(f) of the REACH Regulation was clear to the parties involved. The language used by the parties throughout the entire proceedings leading to the adoption of the contested decision was English and all the stakeholders had in mind the English version of that regulation. The contextual and purposive interpretation of Article 57(f) of that regulation leads to the same conclusion.

153 According to the appellant, Article 57 of the REACH Regulation constitutes an exception which must be interpreted restrictively. The exceptional nature of the procedure laid down in that article is expressed by the fact that, in each of the points of that article, the substances concerned must meet certain conditions corresponding to the level of concern deemed to be the highest. The appellant submits that the EU legislature chose to classify substances according to the level of certainty, in the light of the available scientific evidence, that those substances may actually have serious effects on human health. Thus, the EU legislature decided that only carcinogenic substances classified in Categories 1A or 1B, in accordance with Section 3.6 of Annex I to Regulation No 1272/2008, could be identified as substances of very high concern under Article 57(a) of the REACH Regulation. Substances which are merely suspected carcinogens, namely category 2, and for which there is therefore not a high degree of certainty that they will actually have carcinogenic effects, are excluded from the identification process, pursuant to that provision. In addition, in Article 57(d) and (e) of that regulation, the EU legislature considered that the level of concern applies to substances which satisfy all the cumulative criteria set out in Annex XIII to that regulation, and not to those which meet only one of those criteria and which, consequently, are not considered to be substances of very high concern for the purposes of identification under Article 57(d) or (e).

154 Moreover, the EU legislature expressly intended that Article 57(f) of the REACH Regulation should set a level as high and restrictive as in the other points of Article 57, by requiring that the substances identified on the basis of Article 57(f) of that regulation give rise to an equivalent level of concern to those of other substances meeting the criteria listed in Article 57(a) to (e) of that regulation.

155 In addition, limiting the identification of substances as substances of very high concern to those for which it is not only hypothetically possible that they may cause serious effects to human health, but also actually probable that they could have such effects, is in line with the objectives of the authorisation process under the REACH Regulation, under Article 55 of that regulation, and with the purpose and scope referred to in Article 1 thereof.

156 According to the appellant, the case-law on the concepts of risk and hazard cited by the General Court, in paragraphs 97 and 98 of the judgment under appeal, in support of its interpretation of Article 57(f) of the REACH Regulation, is not applicable to the interpretation of that provision. The appellant observes that it is settled case-law, in particular in the light of the judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208, paragraphs 34 to 36), that the identification of a substance under that provision is not limited to a mere categorisation of its intrinsic properties. The distinction between risk and hazard is therefore not appropriate to exclude the possibility that that provision requires the demonstration of probable serious effects on human health. It is apparent from the points of Article 57 of the REACH Regulation, other than point (f) of that article, that the available scientific evidence must demonstrate the probable presence of certain intrinsic properties of a substance. Otherwise, the classification of a substance as a category 1A, 1B or 2 carcinogen would depend on exposure to that substance, which would lead indirectly to reclassification of the classification process provided for by Regulation No 1272/2008 as a risk assessment, contrary to what follows from the judgment of 21 July 2011, Nickel Institute (C‑14/10, EU:C:2011:503, paragraphs 81 to 83).

157 The appellant acknowledges that Article 57(d) and (e) of the REACH Regulation does not refer to Regulation No 1272/2008, but explains this by the fact that that regulation does not contain criteria for identifying the persistence or bioaccumulation of a substance and points out that the specific criteria for the identification of substances as substances of very high concern are defined in accordance with Annex XIII to the REACH Regulation, which provides for a weight-of-evidence determination, to which Article 57(d) and (e) of that regulation refers. The level of certainty that the evidence must present in the light of the latter provisions should be the same as that laid down in Article 57(a) to (c) of the REACH Regulation, but it requires specific provisions, detailed in Annex XIII to that regulation, since the criteria of persistence and bioaccumulation are not laid down under Regulation No 1272/2008.

158 Furthermore, the General Court’s statement, in paragraph 98 of the judgment under appeal, that the approach adopted by the EU legislature is in line with the precautionary principle, cannot pre-empt the meaning of Article 57(f) of the REACH Regulation. Further, the contested decision is not a preventive measure adopted by ECHA on the basis of the precautionary principle as such, rather it is a legal act adopted pursuant to the legal framework established by that regulation for the identification of substances of very high concern. Moreover, the entire authorisation procedure under Title VII of that regulation is itself a direct expression of the precautionary principle which does not preclude the probability test, according to the judgment of 11 May 2017, Deza v ECHA (T‑115/15, EU:T:2017:329).

159 Lastly, the appellant submits that that judgment, referred to by the General Court in paragraph 96 of the judgment under appeal, supports its position because of the reference to the existence of a probability test under Article 57(f) of the REACH Regulation.

160 ECHA submits that the second branch of the first ground of appeal is unfounded and ineffective, whereas the French Republic, ClientEarth and the Federal Republic of Germany submit that it is unfounded.

– Findings of the Court

161 By the second branch of the first ground of appeal, the appellant submits that the General Court erred in law, in paragraphs 98 and 101 of the judgment under appeal, by finding that Article 57(f) of the REACH Regulation requires ECHA to demonstrate that a substance has possible serious effects, and not that it has probable serious effects, on human health.

162 It should be recalled, first, that the General Court considered, in paragraph 101 of the judgment under appeal, that ECHA, in accordance with what the appellant claims in the second branch of the first ground of appeal, established the probable nature of the serious effects on human health of bisphenol A, even though ECHA was required to establish only that it is possible that bisphenol A may produce such effects.

163 Secondly, in that same paragraph, the General Court rejected, without that rejection being challenged by the appellant, the claim that ECHA had not correctly applied the standard of proof referred to in Article 57(f) of the REACH Regulation in the present case in the light of the mode of action of bisphenol A and the effects of that substance on human health.

164 It follows that even if the General Court had misinterpreted Article 57(f) of the REACH Regulation, the appellant’s line of argument is not capable of calling into question ECHA’s conclusion that it is scientifically proven that bisphenol A presents a mode of action which permits the inference that that substance is an endocrine disruptor of very high concern within the meaning of Article 57(f) of that regulation.

165 Therefore, the second branch of the first ground of appeal must be rejected as ineffective.

166 It follows that the first ground of appeal must be rejected as in part ineffective and in part unfounded.

The third ground of appeal, alleging infringement of the principle of equal treatment

Arguments of the parties

167 By its third ground of appeal, the appellant submits that the General Court infringed the principle of equal treatment in so far as, concerning the merit accorded to the submissions of each of the parties, the General Court treated it less favourably than ECHA, in particular in paragraphs 100 and 75 of the judgment under appeal.

168 In the first place, the General Court relied, in paragraph 100 of the judgment under appeal, on ECHA’s own statements relating to the probable nature of the identified effects of bisphenol A on human health in order to find that ECHA had in fact demonstrated that those effects were probable. In the second place, it presumed, in paragraph 75 of that judgment, that the studies which ECHA relied on, without having provided them, substantiated the propositions advanced by ECHA in the contested decision, whereas it considered that the fact that the appellant had not provided such studies deprived it of the possibility to substantiate a claim. In the third place, the General Court did not grant the appellant’s claims the same benefit of the doubt, nor did it use the means at its disposal to verify those claims. That unequal treatment cannot be justified by the principle that it is for the applicant to prove its claims or that a party’s arguments are more credible solely because that party is a defendant.

169 In addition, the appellant states that, under Article 57(f) of the REACH Regulation, it is for ECHA to demonstrate that all the conditions in that provision are met.

170 ECHA, the French Republic, ClientEarth and the Federal Republic of Germany contend that the third ground of appeal is unfounded.

Findings of the Court

171 In so far as, by its third ground of appeal, the appellant alleges infringement of the principle of equal treatment, it should be recalled that the General Court found, in paragraph 75 of the judgment under appeal, that, ‘on account of the [appellant’s] failure to provide [the Lee (2013a) study], it is impossible to know whether it mentions the body weight of animals after exposure to bisphenol A and whether, in the context of that study, body weight had in fact increased’.

172 According to the case-law of the Court of Justice, the General Court does not infringe either the principle of equality of arms or the right to a fair hearing where it requires that, in order to establish that an EU body has committed an error in assessing the facts such as to justify the annulment of the decision which it has taken, the evidence adduced by the applicant must be sufficient to make the assessment of the facts in that decision implausible (see, by analogy, judgment of 7 May 2020, BTB Holding Investments and Duferco Participations Holding v Commission, C‑148/19 P, EU:C:2020:354, paragraph 76).

173 Therefore, in so far as the General Court rejected, in paragraph 75 of the judgment under appeal, the appellant’s contentions that the assessment of the facts in the contested decision was implausible because the appellant had not provided evidence enabling the General Court to verify those contentions, it did not infringe the principle of equality of arms.

174 In addition, in paragraph 100 of the judgment under appeal, the General Court noted ECHA’s final conclusions, which were not disputed as such by the appellant either at first instance or on appeal.

175 Therefore, by making the findings in paragraphs 75 and 100 of the judgment under appeal, the General Court did not infringe the principle of equality of arms.

176 It follows that the third ground of appeal must be rejected as unfounded.

The fourth ground of appeal, alleging misinterpretation of Article 2(8)(b) of the REACH Regulation and infringement of the duty to state reasons in that regard

Arguments of the parties

177 By its fourth ground of appeal, the appellant submits that the General Court erred in law in finding, in paragraphs 186 to 213 of the judgment under appeal, that intermediates are not exempt from the identification procedure laid down in Articles 57 and 59 of the REACH Regulation on the ground that those provisions relate only to the intrinsic properties of a substance and not to its uses and that it was not disproportionate for ECHA to carry out such identification. The General Court, instead of assessing all the relevant arguments raised in the application, relied on judgments in previous and similar cases. That amounted to a serious infringement of the General Court’s duty to state reasons.

178 In that regard, the appellant submits, first of all, citing the judgment of 25 October 2017, PPG and SNF v ECHA (C‑650/15 P, EU:C:2017:802, paragraph 59), that the General Court’s interpretation of Article 2(8)(b) of the REACH Regulation is contrary to the literal interpretation of that provision, which exempts, without exception, intermediates from Title VII of that regulation, since their existence is temporary as they are intended, as is apparent from the definition in Article 3(15) of that regulation, to be transformed into other substances.

179 Next, the appellant disputes the findings made by the General Court in paragraphs 196 and 197 of the judgment under appeal that intermediates, as substances of very high concern, do not escape the identification procedure and the information obligations. The requirements of Article 7(2) and Article 33 of the REACH Regulation were not designed to cover intermediates, but are triggered by the presence, in articles manufactured from chemical substances, of substances meeting the criteria set out in Article 57 of that regulation.

180 Lastly, the appellant submits, first, that the General Court erred in law in concluding that the concept of intermediate refers to the uses of a substance and, secondly, that the uses of a substance are not relevant for identification as a substance of very high concern. It is necessary to draw a distinction between the words ‘intermediate use’, as used correctly in the application, and the words ‘intermediate as a use’, as used by ECHA and also interpreted and systematically employed by the General Court in paragraphs 191, 193 and 206 of the judgment under appeal and its earlier judgments. The General Court and ECHA gave those words a meaning contrary to the definition in Article 3(15) of the REACH Regulation, in so far as they regarded them as a specific use of a substance. By contrast, because of their temporary existence, intermediates constitute a special class of substances that benefit from specific exemptions.

181 In addition, the appellant claims that the General Court infringed its obligation to state reasons by failing to address a number of arguments set out in its application, which differed from the arguments put forward in the case that gave rise to the judgment of 25 October 2017, PPG and SNF v ECHA (C‑650/15 P, EU:C:2017:802), relied on by the General Court in the judgment under appeal.

182 First, the appellant states that it highlighted, in paragraph 122 of its application, the fact that substances that are intermediates are subject to specific registration requirements laid down in Articles 17 to 19 of the REACH Regulation, applicable to intermediates understood not in the sense of intermediate uses, but as substances. The use of a substance is determined by its downstream users in the course of their industrial or professional activities. By contrast, the registration status of a substance is decided by the manufacturer or importer, at the time of registration. It is therefore the manufacturer who decides to register a substance as an intermediate, on the basis of information from its supply chain. Various uses may be covered by the registration dossier for a substance, whilst intermediate substances have their own registration rules.

183 Secondly, the appellant submits that it put forward additional arguments detailed in paragraph 122 of its application, relating to the fact that Article 17(3) and Article 18(4) of the REACH Regulation lay down specific conditions under which the registration dossiers for intermediate substances may contain less information than the registration dossiers for non-intermediate substances. The legal status of an intermediate should not be affected by the fortuitous circumstance that the limited information requirements laid down in Articles 17 and 18 of that regulation are not applicable to monomers, such as bisphenol A as an intermediate, and that, consequently, the information provided for registration could potentially enable them to be identified as substances of very high concern thus altering their legal status as compared with that of other intermediates. The exemption of monomer intermediates from the derogation provided for in Articles 17 and 18 of that regulation should be interpreted and used restrictively and solely for the purpose for which that exemption was provided.

184 Thirdly, the appellant submits that it put forward, in paragraph 125 of its application, the argument that ‘for intermediates under strictly controlled conditions, only available, existing information must be submitted for their registration’. If the intention of the EU legislature had been to subject intermediates to identification as substances of very high concern, it would have phrased the exemption in Article 2(8)(b) of the REACH Regulation accordingly and would have foreseen that the lack of necessary data could hinder the identification of an intermediate as a substance of very high concern and its listing on the candidate list.

185 Fourthly, the appellant states that the General Court should have addressed the argument, raised in paragraph 126 of its application, that not only are intermediates under strictly controlled conditions allowed to be registered with limited information, as compared to the registration of substances, but on-site isolated intermediates that are used under strictly controlled conditions are also specifically exempt from substance evaluation under Article 49 of the REACH Regulation. Were intermediates simply uses of substances, as claimed by ECHA, those specific exemptions could be attached to their regulatory obligations, without it being possible to explain them.

186 Fifthly, the appellant submits that it put forward an argument, in paragraph 127 of its application, in which it explained that, for the registration of monomers, which are by definition intermediates, the exemptions laid down in Articles 17 and 18 of the REACH Regulation are not applicable and data relating to all relevant endpoints are required for their registration even if they are manufactured under strictly controlled conditions. Those conditions in no way alter the specific nature of intermediates in the context of that regulation.

187 Lastly, the appellant challenges the General Court’s rejection of its sixth plea in law alleging infringement of the principle of proportionality by ECHA. Although in very minor applications, bisphenol A is not intended to be transformed into another substance, those uses represent small volumes and are very topical. Bisphenol A has already been restricted in its main application as a non-intermediate and is listed in Annex XVII of the REACH Regulation.

188 ECHA, the French Republic and the Federal Republic of Germany contend that the fourth ground of appeal is unfounded, whereas ClientEarth considers it to be in part inadmissible and in part unfounded.

Findings of the Court

189 As regards the complaint alleging misinterpretation of Article 2(8)(b) of the REACH Regulation and infringement of the obligation to state reasons in that regard, it must be noted that, in paragraphs 196 to 198 of the judgment under appeal, the General Court referred to paragraphs 59, 62 and 63 of the judgment of 25 October 2017, PPG and SNF v ECHA (C‑650/15 P, EU:C:2017:802).

190 It should be borne in mind that, in paragraph 63 of the judgment of 25 October 2017, PPG and SNF v ECHA (C‑650/15 P, EU:C:2017:802), the Court of Justice held that the exemption provided for in Article 2(8)(b) of the REACH Regulation is not applicable to the provisions of Title VII of that regulation which govern substances in accordance with their intrinsic properties and that that provision does not therefore preclude a substance from being identified as being of very high concern on the basis of the criteria laid down in Article 57 of that regulation, even though it is used merely as an on-site isolated intermediate or as a transported isolated intermediate.

191 Since the General Court based its interpretation of Article 2(8)(b) of the REACH Regulation on the relevant case-law of th