OPINION OF ADVOCATE GENERAL

SZPUNAR

delivered on 8 September 2022 ( )

Case C‑119/21 P

PlasticsEurope

v

European Chemicals Agency (ECHA)

(Appeal – Establishment of a list of substances subject to authorisation – List of substances identified for eventual inclusion in Annex XIV – Updating of the entry of the substance bisphenol A as a substance of very high concern)





Introduction

1. By its appeal, PlasticsEurope asks the Court of Justice to set aside the judgment of the General Court of the European Union of 16 December 2020, PlasticsEurope v ECHA, ( ) by which the General Court dismissed its action seeking annulment of Decision ED/01/2018 of 3 January 2018 of the European Chemicals Agency (ECHA) (‘the decision at issue’). The decision at issue updated and supplemented the existing entry for the chemical substance bisphenol A in the list of substances identified for eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006, ( ) pursuant to Article 59 of that regulation, in so far as that substance was identified as a substance having endocrine disrupting properties that may have serious effects on the environment which give rise to an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of that regulation, within the meaning of Article 57(f) thereof.

2. As requested by the Court of Justice, I will confine this Opinion to an analysis of the first part of the first ground of appeal. That ground alleges that the General Court misinterpreted and misapplied the REACH Regulation when it found the appellant’s plea in law in its action challenging ECHA’s decision, claiming, inter alia, that ECHA committed several manifest errors of assessment in the light of Article 57(f) of that regulation, under which the identification of a substance as an endocrine disruptor of very high concern must be based on ‘scientific evidence of probable serious effects to … the environment’ which give rise to ‘an equivalent level of concern’ to the effects covered by Article 57(a) to (e) of that regulation, to be unfounded.

3. The first part of the first ground of appeal relates to the alleged errors committed by the General Court in its review of the decision at issue and will give the Court of Justice the opportunity to clarify the scope of such review so far as concerns decisions relating to the identification of a substance of very high concern under Article 57(f) of the REACH Regulation.

Legal context

4. Article 57 of the REACH Regulation, entitled ‘Substances to be included in Annex XIV’, lists the substances that may be included in Annex XIV in accordance with the procedure laid down in Article 58 of that regulation and mentions, in particular, under (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’.

The background to the dispute and the decision at issue

5. Bisphenol A (2,2-bis(4-hydroxyphenyl)propane or 4,4’-isopropylidenediphenol, EC 201-245-8, CAS 0000080-05-7) is a substance which is mainly used as a monomer for the manufacture of polymers such as polycarbonate and epoxy resins.

6. The appellant is an international professional association, established in Belgium and governed by Belgian law, which represents and defends the interests of member undertakings, made up of manufacturers and importers of plastic products. Some of the member undertakings are active in placing bisphenol A on the market in the European Union.

7. On 4 January 2017, ECHA adopted Decision ED/01/2017 pursuant to which bisphenol A must be included in the list of candidate substances, that is 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 toxic for reproduction within the meaning of Article 57(c) of that regulation. The action for annulment against that decision was dismissed by the General Court. ( )

8. On 6 July 2017, the Executive Director of ECHA adopted Decision ED/30/2017, whereby the existing entry relating to the substance bisphenol A on the candidate list 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 an equivalent level of concern to that raised by other substances listed in Article 57(a) to (e) of that regulation, within the meaning of Article 57(f) thereof. That decision was also the subject of an action for annulment brought by the appellant, dismissed by judgment of General Court. ( ) The appeal brought against that judgment was subsequently dismissed by the Court of Justice. ( )

9. On 29 August 2017, the Umweltbundesamt (Federal Environment Agency, Germany) submitted, pursuant to Article 59(3) of the REACH Regulation, a dossier in accordance with Annex XV thereto (‘the dossier prepared in accordance with Annex XV’) in which it proposed that bisphenol A also be identified as an endocrine disruptor for which there is scientific evidence of probable serious effects to the environment, within the meaning of Article 57(f) of that regulation.

10. On 5 September 2017, ECHA published the dossier prepared in accordance with Annex XV to the REACH Regulation.

11. 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.

12. On 20 October 2017, the appellant submitted comments, on behalf of its members, on the dossier prepared in accordance with that annex.

13. The Federal Environment Agency subsequently produced a document dated 14 December 2017 containing its responses to all the comments received by ECHA in the course of the public consultation.

14. Once comments had been received concerning the identification of bisphenol A, ECHA forwarded the dossier to the Member State Committee (‘the MSC’), in accordance with Article 59(7) of the REACH Regulation. In line with its working procedures on the identification of substances of very high concern, the MSC received the dossier prepared in accordance with Annex XV to that regulation, a draft agreement of the MSC, and a working document (‘the Support Document’) containing the assessment of the intrinsic properties of bisphenol A in support of its identification under Article 57(f) of that regulation.

15. At its 57th meeting, which took place from 11 to 15 December 2017, the MSC unanimously decided to identify bisphenol A as a substance of very high concern that meets the criteria set out in Article 57(f) of the REACH Regulation, even though four Member States abstained from the vote, including the United Kingdom of Great Britain and Northern Ireland which set out the reasons for its abstention in a statement annexed to the minutes of the meeting. The grounds for the identification of bisphenol A were set out in an amended version of the Support Document, as adopted on 14 December 2017.

16. The final version of the Support Document concluded, on the basis of an analysis of multiple studies, that bisphenol A meets the definition of endocrine disruptor as established by the World Health Organisation (WHO) and interpreted by the European Commission’s Endocrine Disrupters Expert Advisory Group. More specifically, the Support Document found that the in vitro and in vivo data analysed indicate that bisphenol A acts as an oestrogen agonist in certain species of fish, and as a thyroid antagonist in certain species of amphibian. Moreover, that document takes the view, in further support of its conclusions, that the analyses of various taxa of invertebrates show that it is possible that the serious effects of bisphenol A are the result of the endocrine mode of action. Lastly, it is stated in the Support Document that the effects of bisphenol A on fish and amphibians are regarded as giving rise to a level of concern equivalent to that of substances listed in Article 57(a) to (e) of the REACH Regulation, namely substances that are carcinogenic, mutagenic or toxic to reproduction, or persistent, bioaccumulative and toxic substances and very persistent and very bioaccumulative substances. To those ends, the Support Document relies, inter alia, on the severity and irreversible nature of the effects on organisms and populations, as well as the difficulties encountered in determining a safe level of exposure to bisphenol A.

17. On 3 January 2018, following the unanimous agreement of the MSC and in accordance with Article 59(8) of the REACH Regulation, ECHA adopted the decision at issue, whereby the existing entry relating to the substance bisphenol A on the candidate list was supplemented to the effect that that substance was also identified, for reasons set out in the Support Document, as a substance with endocrine disrupting properties that may have serious effects on the environment which give rise to an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of that regulation, within the meaning of Article 57(f) thereof.

The proceedings before the General Court and the judgment under appeal

18. By its action lodged at the Court Registry on 23 March 2018, the appellant brought an action for annulment of the decision at issue.

19. In support of its action, the appellant put forward four pleas in law alleging, first, the existence of several manifest errors of assessment in the identification of bisphenol A as a substance of very high concern within the meaning of Article 57(f) of the REACH Regulation, second, infringement of Article 59, read in conjunction with Article 57(f), of that regulation, third, infringement of Article 2(8)(b) of that regulation and, lastly, fourth, infringement of the principle of proportionality.

20. The Federal Republic of Germany, the French Republic and ClientEarth sought leave to intervene in the proceedings in support of the forms of order sought by ECHA. The General Court granted those applications for leave to intervene.

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

The proceedings before the Court of Justice and the forms of order sought by the parties

22. The appellant asks the Court to set aside the judgment under appeal and the decision at issue or, in the alternative, to refer the case back to the General Court for a ruling on its action for annulment, and to order ECHA to pay the costs of these proceedings, including the costs of the proceedings before the General Court, including those of the interveners.

23. ECHA contends that the Court should dismiss the appeal and order the appellant to pay the costs.

24. The Federal Republic of Germany contends that the Court should dismiss the appeal and order the appellant to bear the costs.

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

26. 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 Federal Republic of Germany, the French Republic and its own costs, including the costs at first instance.

The decision at issue and its effects

27. The decision at issue had the effect of amending the existing entry relating to a chemical substance on the candidate list. In order to place the decision at issue and its effects within the system established by the REACH Regulation, I shall make a few introductory remarks on the rules laid down by that regulation in relation to so-called substances ‘of very high concern’.

28. Such substances are subject to the authorisation regime laid down in Title VII of the REACH Regulation. It is apparent from Article 55 of that regulation that the aim of that authorisation regime 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’.

29. The first stage of that authorisation regime is the procedure for identifying substances of very high concern on the basis of the criteria set out in Article 57 of the REACH Regulation, and the inclusion of those substances on the candidate list. The second stage is the inclusion of those substances on the list of substances subject to authorisation set out in Annex XIV to that regulation. The third and final stage concerns the procedure that leads, if appropriate, to the authorisation of a substance of very high concern. ( )

30. Under the first stage of that authorisation regime, the identification of substances of very high concern has essentially been entrusted to ECHA, which carries out that task in accordance with the procedure set out in Article 59 of the REACH Regulation.

31. A substance identified by ECHA as being a substance of very high concern for (one of) the reasons set out in Article 57 of the REACH Regulation, and which is consequently included in the candidate list cannot (immediately and automatically) be included in Annex XIV to that regulation. ( ) However, the identification of such a substance and its inclusion in the candidate list tends in principle to be the preliminary step to its inclusion in Annex XIV to the REACH Regulation. Inclusion of a substance in the candidate list therefore tends to precede its becoming subject to the obligation to apply for authorisation for the placing on the market or use of that substance.

32. In addition, three main legal obligations arise in principle from the fact that a substance has been identified as being of very high concern but has not yet been included in that annex. In essence, economic operators involved in the marketing of the substance in question must fulfil certain information requirements with regard to ECHA, the recipients of the substance or a preparation for that substance and the recipients of articles containing that substance. ( )

33. The decision at issue is situated in the first stage of the authorisation regime. The difference is that the decision at issue does not lead to the inclusion, for the first time, of an entry for bisphenol A in the candidate list. The decision at issue has the effect of updating and supplementing the existing entry in the sense that, in addition to its identification as a substance that is toxic for reproduction within the meaning of Article 57(c) of the REACH Regulation and as a substance with endocrine disrupting properties that may have serious effects on human health which give rise to an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of that regulation, within the meaning of Article 57(f) thereof, bisphenol A has also been identified as an endocrine disruptor that may have serious effects on the environment giving rise to an equivalent level of concern. From the point of view of economic operators involved in the marketing of that substance, the decision at issue has, in practice, the potential to widen the scope of their obligations resulting from the inclusion of bisphenol A in the candidate list.

Summary of the arguments put forward in support of the first part of the first ground of appeal and the position of the parties

34. The first ground of appeal consists of four parts. According to the title of the first ground of appeal, by that ground the appellant criticises the General Court for having erred in law and for infringing the principle of scientific excellence. Such criticism is common to all four parts of the first ground of appeal, while being the main thrust of the appellant’s argument in support of the first part of that ground.

35. In support of the first part of the first ground of appeal, the appellant submits that, by considering, in paragraph 64 of the judgment under appeal, that there can be a finding of a manifest error of assessment only if ECHA completely and wrongly disregarded a reliable study, the inclusion of which would have altered the overall assessment of the evidence in such a way that the contested decision would have been implausible, the General Court, contrary to the principle of scientific excellence, established an unreasonable threshold and allowed ECHA to exclude reliable scientific studies, while escaping judicial review as to the existence of manifest errors of assessment. If a study is reliable and relevant, its results should be included in the application of the weight of evidence approach, in accordance with the obligation incumbent on ECHA to take account of all relevant information.

36. Furthermore, according to the appellant, the judgment under appeal sets the burden of proof incumbent on EU citizens challenging a weight of evidence determination under Article 57(f) of the REACH Regulation, at an unacceptable and unachievable level that is contrary to the ratio legis behind the weight of evidence concept referred to in point 1.2 of Annex XI to that regulation. The judgment under appeal requires that the study disregarded by ECHA must be of such a nature that, by disregarding it, the overall assessment contained in ECHA’s final decision would have been implausible. According to the appellant, a weight-of-evidence determination applies, by definition, when there is more than one study justifying the conclusion, since a single study is not sufficient to justify the conclusion drawn by ECHA. Any failure to take into account, in a weight-of-evidence determination, the results of a reliable scientific study relating to bisphenol A which are relevant to the property assessed constitutes a manifest error of assessment, a failure to fulfil the obligation incumbent on ECHA to take account of all relevant information, and an infringement of the principle of scientific excellence.

37. According to ECHA, the Federal Republic of Germany, the French Republic and ClientEarth, the General Court never stated that the results of a reliable scientific study which are relevant to the property assessed could be disregarded by ECHA in the application of the weight of evidence approach.

Assessment

38. The first part of the first ground of appeal concerns paragraph 64 of the judgment under appeal and seems to relate, primarily, to the General Court’s finding that ‘there can be a finding of a manifest error of assessment only if ECHA completely and wrongly disregarded a reliable study, the inclusion of which would have altered the overall assessment of the evidence in such a way that the final decision would have been implausible’.

39. The first part of the first ground of appeal is divided into two arguments.

40. According to the appellant, the General Court, first, authorised, in practice, ECHA to exclude reliable and relevant studies and, second, set, in paragraph 64 of the judgment under appeal, the burden of proof incumbent on EU citizens challenging a weight of evidence determination under Article 57(f) of the REACH Regulation, at an unacceptable and unachievable level that is contrary to the ratio legis behind the weight of evidence concept referred to in point 1.2 of Annex XI to that regulation.

41. Those two arguments, taken together, lead the appellant to conclude that the General Court misinterpreted and misapplied the principle of scientific excellence, the weight of evidence concept and the obligation incumbent on ECHA to take account of all relevant information, by accepting that the latter may exclude a reliable and relevant study, unless ECHA ‘completely and wrongly’ disregarded that study and its inclusion would have altered the overall assessment of the evidence in such a way that the final decision would have been implausible.

42. In essence, by its arguments, the appellant seeks to call into question the consideration – set out in the last sentence of paragraph 64 of the judgment under appeal – relating to the scope of the review by the EU judicature with regard to a decision identifying a substance as being of very high concern within the meaning of Article 57(f) of the REACH Regulation.

43. As a preliminary point, in order to be able to rule on the arguments put forward by the appellant, it is necessary to put the consideration at issue into context.

44. It follows from the first sentence of paragraph 64 of the judgment under appeal, according to which ‘the approach taken by ECHA – that is, the weight of evidence approach – together with the discretion which it enjoys’ and paragraphs 62 and 63 of that judgment that that consideration is based on two premisses. First, ECHA enjoys a broad discretion in the identification of substances as being of very high concern under Article 57(f) of the REACH Regulation ( ) and, second, the identification of bisphenol A as being of very high concern was made, in the present case, using the weight of evidence approach. ( )

45. As I will demonstrate below, those two premisses affect the scope of the review of the EU judicature before which an action concerning the identification of a substance as being of very high concern under Article 57(f) of the REACH Regulation is brought.

The case-law on the scope of judicial review in areas in which the EU authority enjoys a broad discretion

46. It is settled case-law that, where an EU authority is called upon, in the performance of its duties, to make complex assessments, it enjoys a broad discretion, the exercise of which is subject to a limited judicial review. ( ) Where the EU authorities have a broad discretion, in particular as to the assessment of highly complex scientific and technical facts in order to determine the nature and scope of the measures which they adopt, review by the EU judicature is limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context, the EU judicature cannot substitute its assessment of scientific and technical facts for that of the institutions on which alone the Treaty has placed that task. ( )

47. In the light of the purpose and effects of the decision at issue, ( ) that case-law is unquestionably applicable to the present case.

48. The identification of candidate substances to be included in Annex XIV to the REACH Regulation requires the assessment of highly complex scientific and technical facts. Such identification is carried out in the context of ensuring effective management of the technical, scientific and administrative aspects that the EU legislature has entrusted to ECHA. ( ) ECHA fulfils that role as an independent central entity, in accordance with the rules laid down in Title X of that regulation, in particular with regard to transparency, combating fraud and liability. ECHA is therefore neither a competitor, nor an adversary, of economic operators involved in the marketing of chemical substances.

49. In addition, in the order in Polyelectrolyte Producers Group and Others v Commission, ( ) the Court of Justice examined the appeal brought against a judgment of the General Court wherein it dismissed the action for annulment of a Commission regulation, adopted under Title VIII of the REACH Regulation, amending Annex XVII thereto. Annex XVII contains the restrictions applicable to the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles. The amendment to Annex XVII, covered by the action brought before the General Court, amounted to amending the text relating to a substance already subject to restrictions.

50. In the appeal examined by the Court of Justice, the appellants claimed that the General Court had erred in law in confining itself to finding that the EU institutions had not committed a manifest error or a misuse of power or that they had not clearly exceeded the bounds of their discretion.

51. In that regard, first, the Court of Justice held that the case-law cited in point 46 of this Opinion, ( ) was applicable, on the basis of the General Court’s finding that ‘the [EU institutions’] broad discretion, which implies limited judicial review of their exercise of discretion, … also applies, to some extent, to the finding of the basis facts’. ( ) Second, the Court found that the General Court did not manifestly infringe the appellants’ right to access to justice, since they were clearly able to challenge the contested regulation in order to ensure the defence of their interests.

52. Furthermore, following the same line of reasoning as that adopted in the order in Polyelectrolyte Producers Group and Others v Commission, ( ) the Court has also dismissed appeals in the context of decisions on the inclusion of a substance in the candidate list. ( )

53. In adopting the decision at issue, ECHA had a broad discretion which, in accordance with the case-law cited in point 46 of this Opinion, affects the scope of the review carried out by the General Court. That review concerns both the burden of proof incumbent on a party seeking to set aside a decision and the nature of the errors subject to review by the EU judicature.

54. In that regard, in so far as, by the first part of the first ground of appeal, the appellant criticises the General Court for having incorrectly determined the burden of proof incumbent on EU citizens challenging a weight-of-evidence determination under Article 57(f) of the REACH Regulation, I will examine, in the first place, the implications of the case-law cited in point 46 of this Opinion on the burden of proof incumbent on a party seeking to challenge a decision of ECHA. In the second place, I will analyse the implications of that case-law on the nature of the errors subject to review by the EU judicature.

The burden of proof with regard to manifest errors committed in the exercise of discretion

55. In a field such as that of the present case, in the context of which the EU authority enjoys a broad discretion, a review must be carried out by the General Court in line with the case-law cited in point 46 of this Opinion.

56. Thus, in the first place, if, in accordance with the case-law applicable to the present case, the EU judicature cannot substitute its assessment of scientific and technical facts for that of ECHA, an applicant cannot request the General Court to conduct a second assessment of such facts, in so far as ECHA is the authority to which the EU legislature has entrusted the task of identifying substances of very high concern. An applicant cannot therefore, by making general assertions, request the EU judicature to investigate errors committed by ECHA.

57. Moreover, even in the fields where the review of legality is supplemented by unlimited jurisdiction and where the EU judicature is empowered to substitute its own appraisal for that of an EU authority, with the exception of pleas involving matters of public policy which the Courts are required to raise of their own motion, it is for the applicant to raise pleas in law against a decision of that authority and to adduce evidence in support of those pleas. ( ) A fortiori, in particular with regard to the principle of the right to a hearing, the same must apply to the identification of substances as being of very high concern, in which the scope of judicial review is limited.

58. In the second place, the consideration that, having regard to the scope of the review which the EU judicature is to carry out in the field of chemicals, the arguments of an applicant must permit the view to be taken by the Court that an EU authority manifestly exceeded the limits of its discretion is also supported by the Court’s case-law in the field of chemicals in preliminary rulings on questions concerning the assessment of validity. ( ) If the EU Judicature answers the question as to whether an act should be declared invalid on the ground that limits of discretion have been manifestly exceeded only in the light of the arguments put forward, the same must apply in the context of actions for annulment.

59. In the third place, the consideration that only the arguments of an applicant permit the view to be taken by the EU judicature that an EU authority manifestly exceeded the limits of its discretion seems to echo the Court’s case-law in fields other than that of chemicals, such as the common agricultural and fisheries policies, ( ) in which the EU authorities also enjoy a broad discretion with regard to highly complex facts. Furthermore, according to that case-law, in such fields, the EU authorities must, in turn, at the very least be able to produce and set out clearly and unequivocally the basic facts which had to be taken into account as the basis of the contested measures of the act and on which the exercise of their discretion depended. ( )

60. In conclusion, having regard to the case-law cited in point 46 of this Opinion, in order to challenge the decision at issue, it was for the appellant to put forward arguments before the General Court enabling it to conduct a review and to conclude that ECHA committed a manifest error of assessment or manifestly exceeded the limits of its discretion.

Manifest errors committed in the exercise of discretion

61. In accordance with the case-law cited in point 46 of this Opinion, only manifest errors relating to the exercise of discretion can be reviewed by the EU judicature.

62. The first part of the first ground of appeal raises the question as to whether ECHA commits such a manifest error relating to the exercise of its discretion by disregarding a study which, even though it was included in the basic facts, would not alter the overall assessment of the evidence in such a way that the final decision would be implausible.

63. In the present case, the overall assessment of highly complex scientific and technical facts led ECHA, in the exercise of the task entrusted to it by the EU legislature, to consider it necessary to supplement and update the existing entry relating to bisphenol A on the candidate list, under Article 57(f) of the REACH Regulation.

64. To reach that conclusion, it was for ECHA to examine, first, whether it is ‘probable’ that the substance concerned has serious effects on human health or the environment and, second, whether those effects ‘give rise to an equivalent level of concern’ to those of other substances listed in points (a) to (e) of Article 57 of the REACH Regulation. ( )

65. In the present case, that conclusion resulted from the overall assessment of the evidence carried out using the weight of evidence approach. The appellant does not dispute the choice of approach adopted by ECHA, but rather the scope of the judicial review of its application.

66. Under the weight of evidence approach, the identification of a substance as being of very high concern is not based on the results of a single scientific study or on a single piece of scientific evidence. It is therefore possible to adopt that approach when a single study is not sufficient in itself to determine whether or not to identify a substance as being of very high concern under Article 57(f) of the REACH Regulation.

67. To refute the General Court’s finding, set out in the last sentence of paragraph 64 of the judgment under appeal, the appellant asks how a study can refute the overall conclusion drawn from all the evidence, even though, according to the weight of evidence approach, and in the light of point 1.2 of Annex XI to the REACH Regulation, the conclusion itself cannot be drawn from a single study.

68. However, it does not follow from the judgment under appeal that, according to the General Court, there is a manifest error leading to the annulment of an ECHA decision only where the inclusion of a study in the basic facts would alter the overall conclusion as to whether or not a substance must be included on the candidate list.

69. Having regard to the case-law developed in fields in which the EU authorities carry out complex assessments, it should rather be considered that, according to the judgment under appeal, in order to demonstrate a manifest error on the basis of evidence which renders ‘implausible’ the assessment of the facts carried out by an EU authority, an appellant is not required to refute the assessment carried out by that authority in its entirety, or the conclusion drawn from that assessment. By contrast, it must demonstrate that there was an error sufficiently serious as to ‘undermine’ the complex assessment carried out by that authority. ( )

70. That reading of the last sentence of paragraph 64 of the judgment under appeal becomes even clearer when read in the light of all the considerations set out in that judgment.

71. The General Court did not reject the pleas in law and arguments put forward by the appellant, but merely examined whether taking account of a study allegedly disregarded by ECHA would alter the overall conclusion that bisphenol A is a substance of very high concern under Article 57(f) of the REACH Regulation.

72. To illustrate this, I will show that, as ECHA and the interveners maintain ( ) and contrary to what the appellant claims, the General Court did not ‘authorise’ ECHA to disregard evidence that is both reliable and relevant. ( ) A fortiori, the General Court did not, moreover, ‘authorise’ ECHA to disregard any study the consideration of which would not have altered the overall conclusion that bisphenol A must be identified as being a substance of very high concern.

‘Authorisation’ to disregard a reliable and relevant study

73. According to the argument put forward by the appellant, the General Court ‘authorised’ ECHA to disregard studies that were both reliable and relevant, virtually exempting it from any judicial review as to the existence of manifest errors of assessment.

74. However, in the first place, the General Court considered, in the last sentence of paragraph 64 of the judgment under appeal, that, subject to certain circumstances, ( ) ECHA cannot actually be criticised, in the context of an action for annulment, for having disregarded a reliable study. It does not therefore follow from that paragraph of the judgment under appeal that ECHA may, without risking the annulment of its decision, disregard any study that is both reliable and relevant.

75. In the second place, according to the first sentence of paragraph 64 of the judgment under appeal, ‘[ECHA] may exclude studies that it does not deem relevant for plausible reasons connected to the internal consistency of the assessment carried out’. ( ) A priori, the General Court did not therefore find that ECHA may also ‘exclude’ studies that it does deem relevant. In that regard, more generally, any finding that evidence is relevant is the result of consideration by the authority called upon to make a decision in the case in point, although that consideration may be vitiated by error and, at least in principle and/or under certain conditions, subject to judicial review. ( )

76. In the third place, the first sentence of paragraph 64 of the judgment under appeal, according to which ‘[ECHA] may exclude studies that it does not deem relevant for plausible reasons connected to the internal consistency of the assessment carried out’ is followed by an observation which falls within the context established by that first sentence (‘in that regard’). According to that observation, ‘bisphenol A is one of the most studied substances in the world’. In the General Court’s view, it follows (‘consequently’) that ‘the obligation incumbent on the institutions of the European Union to take all relevant evidence into consideration cannot mean that all the studies conducted, irrespective of the reliability or relevance thereof, must necessarily and without exception be included in ECHA’s assessment’. ( )

77. It is true that the passage ‘irrespective of the reliability or relevance thereof’, taken in isolation, can be viewed as a suggestion that, in the General Court’s view, ECHA does not necessarily have to include all the studies in its assessment, even those that are highly reliable and/or relevant. To paraphrase, ECHA is not required to take account of those studies, irrespective of whether they are reliable and/or relevant.

78. However, it may also be considered that, in the third sentence of paragraph 64 of the judgment under appeal, the General Court sought to indicate that ECHA does not necessarily have to include any study in its assessment, disregarding the fact that a study is not particularly reliable and/or relevant (‘irrespective of the reliability or relevance thereof’).

79. The express references to paragraph 64 of the judgment under appeal in paragraphs 125 and 174 of that judgment support such an interpretation of paragraph 64 of that judgment. They support the General Court’s findings that the low reliability of a study or data contained therein does not necessarily preclude ECHA from using that study in its assessment of a substance. ( )

80. Furthermore, independently of the reading given to paragraph 64 of the judgment under appeal, it is necessary to determine whether, and if so, to what extent, the observations of a general nature appearing in that paragraph of the judgment under appeal have been used by the General Court to reject the pleas in law and arguments raised by the appellant. If such observations of a general nature do not result in a finding adopted by the General Court with regard to such pleas and arguments, the error in law invoked in respect of that paragraph of the judgment under appeal, if established, is not, in any event, capable of leading to the annulment of that judgment.

81. Consequently, for the reasons set out in points 78 to 80 of this Opinion, and in order to be able to establish what constitutes, in the General Court’s view, according to its observations set out in paragraph 64 of the judgment under appeal, a manifest error relating to the exercise of discretion that could lead to the annulment of the decision at issue, I will examine how that court carried out its review of the pleas and arguments put forward by the appellant relating to the studies allegedly disregarded by ECHA.

82. A fortiori, in doing so, I will examine the argument put forward by the appellant in the introductory part of its first ground of appeal, according to which the General Court ‘has endorsed [ECHA’s] approach of cherry-picking scientific data to support its targeted hypothesis that [bisphenol A] meets the criteria of Article 57(f) [of the REACH Regulation], including by choosing to selectively disregard reliable scientific studies whose results did not fit that hypothesis on the one hand and relying on unreliable scientific studies whose results seemed to support the hypothesis, on the other hand’. ( )

The ‘relevance’ of evidence in the light of ECHA’s hypothesis

83. As a preliminary point, contrary to what the terminology used in the appeal may suggest, there was no ‘ECHA hypothesis’ that that agency sought to confirm by any means possible which, in the present case, took the form of the cherry-picking of studies. As recital 15 of the REACH Regulation makes clear ECHA was created ‘to ensure effective management of the technical, scientific and administrative aspects of this Regulation at [Union] level’. As I have already stated in point 48 of this Opinion, it fulfils that role as an independent central entity. The hypothesis in question in circumstances such as those of the present case is that initially put forward by ECHA, that that agency carries out an examination which, as the case may be, will confirm or contradict that hypothesis.

84. When it comes to identifying a substance as being of very high concern, under Article 57(f) of the REACH Regulation, the hypothesis is that, first, it is ‘probable’ that the substance concerned has serious effects on human health or the environment and, second, that those effects ‘give rise to an equivalent level of concern’ to those of other substances listed in points (a) to (e) of Article 57 of the REACH Regulation. ( )

85. From a methodological point of view, a hypothesis under examination does not take the form of a question or an alternative (‘or not’) proposal. The hypothesis is not biased. It may be confirmed or contradicted, both results being, however, equally satisfactory from a scientific point of view.

86. As to the substance, the General Court did not determine the relevance of a study from the point of view of its compatibility with the hypothesis examined by ECHA, by authorising the latter to exclude from the outset any study which, in terms of its result, does not correspond to that hypothesis.

87. By contrast, I understand the passage set out in the first sentence of paragraph 64 of the judgment under appeal, according to which ‘[ECHA] may exclude studies that it does not deem relevant for plausible reasons connected to the internal consistency of the assessment carried out’, as meaning that, in the General Court’s view, that agency may regard as not being particularly relevant studies that are not capable of contradicting – and, even if this is not part of the argument of the appellant in the present case, confirming – a hypothesis. The finding that a study is not capable of doing so, constitutes, in itself, the outcome of the examination of a study. That finding is the result of a careful examination of a study from the point of view of its ability to confirm or contradict the hypothesis in question.

88. Such a reading of the aforementioned passage set out in the first sentence of paragraph 64 of the judgment under appeal is supported by the examination of other paragraphs in that judgment.

89. It can be inferred from paragraph 65 of the judgment under appeal that the General Court examined, in the light of the ‘preliminary observations’ set out in paragraphs 62 to 64, whether ECHA had committed a manifest error of assessment on the ground that it failed to take into consideration four studies relied on by the appellant. ( )

90. In that regard, as is apparent from paragraphs 67 and 69 of the judgment under appeal, the General Court took the view, that ECHA took into consideration, albeit indirectly, two of those four studies. In order to examine the application of the observations set out in paragraph 64 of that judgment when it comes to studies ‘disregarded’ by ECHA, it is therefore necessary to focus on the two studies referred to in paragraphs 66 and 68 of that judgment.

91. As the General Court stated in paragraph 66 of the judgment under appeal, ECHA failed to regard the Bjerregaard et al. (2008) study as particularly relevant. According to the General Court, it could be considered that the results of that study were not conclusive with regard to the effect of bisphenol A in the gonad development of fish, since, as the authors of that study themselves acknowledged, the study’s exposure period covered too short a part of the sex differentiation period. In other words, the Bjerregaard et al. (2008) study was not capable of calling into question ECHA’s hypothesis, in so far as it was possible to consider that the conclusion drawn from the results of that study were premature given the study’s exposure period of fish to bisphenol A. The General Court found, ECHA was therefore able, without committing a manifest error of assessment, to consider that the Bjerregaard et al. (2008) study did not constitute relevant evidence.

92. In that vein, the General Court stated, in paragraph 68 of the judgment under appeal, that ECHA did not commit a manifest error by not relying on the Lee (2010) study, on the ground that, first, the endocrine disruption in the organisms examined in the study was not sufficiently understood at the scientific level. Second, the General Court noted that the appellant had failed either to explain or demonstrate the extent to which the results of that study – which does not set out any endocrine mediated effects – contradict the identification of bisphenol A as being a substance of very high concern on the basis of evidence other than that relating to invertebrates, with the result that those results invalidate the weight of evidence in the assessment carried out. Accordingly, the General Court took the view that ECHA could, without committing a manifest error of assessment, consider that the Lee (2010) study did not constitute relevant evidence on the ground that the appellant failed either to explain or demonstrate the extent to which that study could contradict the hypothesis examined by ECHA.

93. Thus, in the General Court’s view, the ‘relevance’ of a study depends on its capacity to confirm or contradict the hypothesis examined by ECHA using the weight of evidence approach, in accordance with the procedure provided for in Article 59 of the REACH Regulation.

94. Moreover, the last sentence of paragraph 64 of the judgment under appeal must be understood as meaning that, according to the General Court’s reasoning, ECHA can be criticised for committing a manifest error in the exercise of its discretion only if it ‘completely’ disregarded a reliable study which could have contradicted, or even confirmed, the hypothesis examined by ECHA. In addition, as is apparent from point 60 of this Opinion, it is for the appellant to put forward arguments before the General Court enabling it to conduct a review and to conclude that ECHA committed such a manifest error.

95. In that regard, the weight of evidence approach presupposes that the competent authority examines all the relevant information to conclude that a substance must be identified as being of very high concern. The application of that approach implies that the identification of a substance is made on the basis of complete data which allow the competent authority to exercise the discretion it enjoys under Articles 57 and 59 of the REACH Regulation while taking into account all relevant evidence available at the time when the authority adopts its decision.

96. From a technical and/or methodological point of view, a finding that a study is not relevant due to its inability to contradict or confirm the hypothesis examined by ECHA may be made prior to the weighting of the evidence. There is no need to address the weighting of evidence that, in the context under consideration, is irrelevant. In any event, if a finding that evidence is irrelevant is preceded by the careful examination of that evidence – in terms of its ability to confirm or contradict the hypothesis examined – the finding that evidence is irrelevant amounts to finding, in the context in question, that it has no evidential value.

97. Furthermore, the approach according to which the relevance of the studies is determined prior to the weighting of the evidence is consistent with point 1.2 of Annex XI to the REACH Regulation, to which the appellant refers in its appeal.

98. According to the first paragraph of point 1.2, ‘there may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or has not a particular dangerous property, while the information from each single source alone is regarded insufficient to support this notion’.

99. Contrary to what the appellant maintains, it does not follow that all evidence must be taken into account where a decision is not based on the results of a single scientific study or on a single piece of scientific evidence. By contrast, it is always a question of ‘independent sources of information’ that are appropriate to ‘validly [confirm]’ – and therefore ‘relevant’ within the meaning of paragraph 64 of the judgment under appeal – that a substance has or has not a particular dangerous property.

100. Consequently, the appellant’s argument that the determination of the burden of proof is unacceptable, unachievable and contrary to the ratio legis behind the weight of evidence concept referred to in point 1.2 of Annex XI to the REACH Regulation must be rejected.

101. In that vein, the General Court cannot be criticised for having misinterpreted or misapplied the obligation incumbent on EU institutions to take all relevant information into account.

102. The same applies to the criticism that the General Court misinterpreted and misapplied the principle of scientific excellence.

103. According to the General Court’s case-law, ( ) compliance with that principle implies that ECHA must comply with the best current scientific standards. By contrast, it does not follow from that principle that ECHA must follow a methodological approach according to which it must take into account any study, regardless of its capacity to confirm or contradict the hypothesis examined by ECHA.

104. Accordingly, the General Court considered, without committing an error that could lead to the judgment under appeal being set aside, in paragraph 64 of that judgment, that ‘there can be a finding [by the General Court] of a manifest error of assessment only if ECHA completely and wrongly disregarded a reliable study, the inclusion of which would have altered the overall assessment of the evidence in such a way that the final decision would have been implausible’.

105. In that regard, I must observe that ‘completely’ disregarding a reliable study, which could have altered the overall assessment of the evidence, is not tantamount to ‘partially’ disregarding that study.

106. If ECHA partially took a study into account, it cannot be considered that it manifestly erred in considering that that study was irrelevant. On the contrary, it follows that ECHA had to identify reasons for considering that study to be partially relevant. Accordingly, to consider that ECHA’s decision can be called into question because it ‘partially’ disregarded a relevant study would amount to the substitution, by the EU judicature, of its assessment for that of ECHA.

107. Moreover, it must be observed that the General Court’s reference, in paragraph 64 of the judgment under appeal, to the situation in which ECHA ‘completely … disregarded’ a reliable study, seems to refer to cases where a study is not, even indirectly, taken into account by ECHA. By contrast, it cannot be considered that a study is ‘completely’ disregarded if it is integrated into another study on which ECHA formally relied for the adoption of its decision. ( )

108. It follows from the foregoing that the first part of the first ground of appeal is unfounded and should be rejected in its entirety.

Conclusion

109. In the light of the foregoing considerations, I propose that the Court should reject the first part of the first ground of appeal put forward by the appellant in its entirety as unfounded.