20 September 2019 (*1)

(REACH — Establishment of a list of substances identified with a view to their eventual inclusion in Annex XIV of Regulation (EC) No 1907/2006 — Supplement to the entry relating to the substance bisphenol A on that list — Articles 57 and 59 of Regulation No 1907/2006 — Manifest error of assessment — Legal certainty — Legitimate expectations — Proportionality)

In Case T‑636/17,

PlasticsEurope, established in Brussels (Belgium), represented by R. Cana, E. Mullier and F. Mattioli, lawyers,

applicant,

European Chemicals Agency (ECHA), represented by M. Heikkilä, W. Broere, C. Buchanan and A. Hautamäki, acting as Agents, and initially by S. Raes, lawyer,

defendant,

supported by

French Republic, represented initially by D. Colas, E. de Moustier and J. Traband, and subsequently by D. Colas, J. Traband and A.‑L. Desjonquères, acting as Agents,

and by

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

interveners,

APPLICATION pursuant to Article 263 TFEU seeking the annulment of Decision ED/30/2017 by the Executive Director of ECHA of 6 July 2017, by which the existing entry relating to bisphenol A on the list of identified substances 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, corrigendum OJ 2007 L 136, p. 3), in accordance with Article 59 of that regulation, was supplemented to the effect that that substance is 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 that raised by the use of other substances listed in Article 57(a) to (e) of that regulation, within the meaning of Article 57(f) thereof,

THE GENERAL COURT (Fifth Chamber),

composed of D. Gratsias, President, I. Labucka and A. Dittrich (Rapporteur), Judges,

Registrar: F. Oller, Administrator,

having regard to the written part of the procedure and further to the hearing on 11 April 2019,

gives the following

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. It is thus used as an intermediate. In addition, bisphenol A can be used for non-intermediate purposes. This is the case, for example, where it is used in the manufacture of thermal paper.

In 2012, a research programme called ‘Consortium Linking Academic and Regulatory Insights on Bisphenol A Toxicity’ (‘the Clarity-BPA programme’) was launched under the auspices of the National Toxicology Programme (United States; ‘the NTP’), the National Center for Toxicological Research (United States; ‘the NCTR’), the United States Food and Drug Administration (‘the FDA’) and the National Institute of Environmental Health Sciences (United States; ‘the NIEHS’). That programme was launched to examine the divergent findings reached, up until that point, by a series of toxicological studies concerning bisphenol A. It was designed to examine, inter alia, the potential human health effects of exposure to low levels of endocrine active agents, and take into account a wide range of doses and new relevant ‘parameters’ (‘endpoints’) which have never been used before. More specifically, the programme combines, in particular, a core perinatal 2-year chronic toxicity study, which is compliant with guidelines or recommendations and with good laboratory practices and is performed at FDA premises, on the one hand, with additional mechanistic endpoints and studies conducted by academic researchers, on the other. In the latter regard, 13 university-based research projects were selected by the NIEHS.

Also in 2012, in accordance with Article 44 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council 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 at OJ 2007 L 136, p. 3), bisphenol A was included in the Community Rolling Action Plan for the evaluation of that substance.

4.4

On 23 December 2013, the European Chemicals Agency (ECHA) adopted a decision on the evaluation of bisphenol A (‘the evaluation decision’) pursuant to Article 46(1) of Regulation No 1907/2006. The section of that decision devoted to ‘Procedure’ reads as follows: ‘The [competent evaluating authority] did not evaluate [endocrine disrupting] properties related to human health in the Substance Evaluation in detail, yet acknowledged the information currently available with respect to [that] endpoint. The [competent evaluating authority] took note of other ongoing studies [the NIEHS, NTP and FDA rodent study (the Clarity-BPA programme; see Schug et al. 2013)], which are currently performed by American laboratories. Therefore, the need for further data requirements was not assessed at this stage. Any need for further testing may depend on the results from these studies and on other relevant new information which might become available. Hence, endocrine disruption for human health may be considered at a later stage. The registrants are reminded that they have the obligation to include the results of any new relevant information in the considerations for the risk characterisation and to update the [Chemical Safety Report] accordingly once such results become available.’

The conclusions of the evaluation and the evaluation report produced by the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Federal Institute for Occupational Health and Safety, Germany), as the competent authority within the meaning of Article 45 of Regulation No 1907/2006, dated May 2017, were published on 31 August 2017.

On 12 January 2017, ECHA published on its website its decision ED/01/2017 of 4 January 2017 on the inclusion of bisphenol A in the ‘Candidate List’, that is, the list of substances identified with a view to their eventual inclusion in Annex XIV to Regulation No 1907/2006 on the ground that that substance had been identified as a substance toxic for reproduction within the meaning of Article 57(c) of Regulation No 1907/2006.

On 21 March 2017, the applicant, PlasticsEurope, brought an action for annulment in respect of that decision, registered by the Registry of the General Court under Case T‑185/17. By judgment of 11 July 2019, the Court dismissed that action (PlasticsEurope v ECHA, T‑185/17, EU:T:2019:492). The applicant is an international professional association, established in Belgium and governed by Belgian law, which represents and defends the interests of over 100 member undertakings, made up of manufacturers and importers of plastic products. It has legal personality and capacity. Four of the applicant’s member undertakings, which are part of the applicant’s ‘Polycarbonate/Bisphenol A’ group, are active in placing bisphenol A on the market in the European Union. The members of that group market bisphenol A for both intermediate and non-intermediate uses.

8.8

On 2 March 2017 the relevant French competent authority, that is to say, 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, Anses, France; ‘the French competent authority’), submitted, pursuant to Article 59(3) of Regulation No 1907/2006, a dossier consistent 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. More specifically, 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 (see paragraph 6 above), with a view to that substance also being identified as a substance of very high concern under Article 57(f) of Regulation No 1907/2006.

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

10.10

On the same day, in accordance with Article 59(4) of Regulation No 1907/2006, ECHA invited all interested parties to submit their comments on that dossier.

11.11

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

12.12

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.

13.13

On 14 June 2017, at its 54th meeting, 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 Regulation No 1907/2006 ‘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 [Regulation No 1907/2006]’. 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’).

14.14

On 6 July 2017, the Executive Director of ECHA adopted Decision ED/30/2017 (‘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 Regulation No 1907/2006, 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 that raised by the use of other substances listed in Article 57(a) to (e) of that regulation, within the meaning of Article 57(f) thereof.

15.15

On 7 July 2017 the Candidate List published on ECHA’s website was updated in accordance with the contested decision.

II. Procedure and forms of order sought

16.16

By application lodged at the Court Registry on 15 September 2017, the applicant brought the present action.

By documents lodged at the Court Registry on 21 and 27 December 2017, respectively, the French Republic and ClientEarth applied for leave to intervene in support of the form of order sought by ECHA.

18.18

The defence was lodged at the Court Registry on 5 December 2017.

By separate documents, lodged at the Court Registry on 29 January 2018, the applicant submitted two requests for confidential treatment of certain information communicated in the application vis-à-vis the French Republic and ClientEarth, respectively.

The reply was lodged at the Court Registry on 29 January 2018.

21.21

By two orders of 5 March 2018, the President of the Fifth Chamber of the Court granted the French Republic and ClientEarth leave to intervene.

22.22

Since the French Republic did not oppose, within the prescribed time limit, the confidential treatment of certain information communicated in the application, as requested by the applicant on 29 January 2018, that request was granted in relation to that Member State in accordance with the Rules of Procedure of the Court.

23.23

On 12 March 2018 the rejoinder was lodged at the Court Registry.

24.24

By written submission lodged at the Court Registry on 23 March 2018, ClientEarth opposed the request for confidential treatment, lodged by the applicant on 29 January 2018 vis-à-vis ClientEarth.

25.25

By document lodged at the Court Registry on 29 March 2018, the applicant asked the Court, pursuant to Article 85(3) of the Rules of Procedure, to accept new evidence in the form of a document, dated February 2018, entitled ‘Draft [United States] NTP Research Report on the Clarity-BPA Core Study: A Perinatal and Chronic Extended-Dose-Range Study of Bisphenol A in Rats’. The applicant attached that document as an annex to the document lodged on 29 March 2018.

26.26

On 19 April 2018, the French Republic and ClientEarth lodged their respective statements in intervention, drafted on the basis of a confidential version of the application, at the Court Registry.

27.27

By written submission of 25 April 2018, ECHA stated that, in its view, the evidence produced by the applicant on 29 March 2018 was inadmissible. ECHA added that, in any case, that evidence did not add anything new to the arguments already put forward in that case. ECHA therefore claimed that it should be rejected.

28.28

By order of 18 May 2018, the President of the Fifth Chamber of the Court granted the request for confidential treatment vis-à-vis ClientEarth.

29.29

On 4 June 2018 ClientEarth lodged a supplementary statement in intervention at the Court Registry.

By documents lodged at the Court Registry on 19 and 20 July 2018, respectively, ECHA and the applicant each submitted their observations on the statements in intervention.

The applicant claims that the Court should:

–annul the contested decision;

–order ECHA to pay the costs;

–take such other or further measure as justice may require.

ECHA contends that the Court should:

–dismiss the action;

–order the applicant to pay the costs.

ClientEarth contends that the Court should:

–dismiss the action in its entirety;

–order the applicant to bear the costs.

The French Republic contends, for its part, that the Court should dismiss the action.

III. Law

In support of the action, the applicant relies on six pleas in law. By its first and third pleas, the applicant alleges infringement of the principles of legal certainty and protection of legitimate expectations. The second plea alleges that ECHA committed manifest errors of assessment and breached its duty of care. The fourth plea refers to an alleged infringement of Article 57(f) and Article 59 of Regulation No 1907/2006. By the fifth and sixth pleas, the applicant alleges infringement of Article 2(8)(b) of that regulation and of the principle of proportionality.

The Court considers it appropriate to begin by examining the second plea.

The second plea alleges that ECHA committed manifest errors of assessment and breached its duty of care. This plea is divided into two branches, the first of which is subdivided into several complaints.

(a) First branch of the second plea in law: error of law and manifest errors of assessment

The first branch of the second plea alleges, in essence, that the identification by ECHA of bisphenol A as an endocrine disruptor of very high concern which fulfils the criteria laid down in Article 57(f) of Regulation No 1907/2006 is vitiated by an error of law and manifest errors of assessment.

(1) The first complaint in the first branch of the second plea: error of law on the ground that ECHA failed to establish the ‘level of concern’ referred to in Article 57(f) of Regulation No 1907/2006

In the context of the first complaint of the first branch of the second plea, the applicant submits that ECHA infringed Article 57(f) of Regulation No 1907/2006 by failing to establish that, in addition to the alleged endocrine disrupting properties of the substance, there was scientific evidence of its probable serious effects on human health which gave rise to the level of concern referred to in that provision. It is claimed that, in the Support Document, ECHA concluded that ‘[bisphenol A was] identified as a [substance of very high concern] according to Article 57(f) [of Regulation No 1907/2006] for probable serious effects on human health, due to its endocrine disrupting properties, which are of [an equivalent level of concern]’. According to the applicant, it is apparent from that statement that ECHA considered the alleged endocrine disrupting properties to be, per se, of an equivalent level of concern.

ECHA, supported by the French Republic and ClientEarth, contests those arguments.

It should be observed that the first complaint in the first branch of the second plea proceeds on the assumption that the fact that a substance is an endocrine disruptor does not suffice per se to demonstrate that it is of an equivalent level of concern. In that connection, it should be borne in mind that Article 57(f) of Regulation No 1907/2006 requires, as regards the identification of substances other than those meeting the classification criteria referred to in Article 57(a) to (e) of that regulation, that it be established, on a case-by-case basis, on the basis of scientific evidence, that (i) the substances concerned can have serious effects on human health or the environment, and (ii) those effects give rise to an equivalent level of concern to those of other substances referred to in Article 57(a) to (e) of Regulation No 1907/2006. As regards the condition related to establishing serious effects on human health or the environment, this requires an analysis of the hazards linked to the intrinsic properties of the substance under consideration. As regards the condition related to the existence of a certain level of concern, it requires that the demonstration that the serious effects on human health or the environment of the substance under consideration give rise to an equivalent level of concern to the substances referred to in Article 57(a) to (e) of the same regulation, be based on the analysis of the hazards arising from the intrinsic properties of the substances concerned, without prohibiting the taking into consideration of other data (see, to that effect, judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraphs 26, 27 and 40). In particular, in order for a substance to be identified as an endocrine disruptor of very high concern, it is necessary that it be established, on a case-by-case basis, on the basis of scientific evidence, that (i) a substance with endocrine disrupting properties can have serious effects on human health or the environment, and (ii) those effects give rise to an equivalent level of concern to the substances referred to in Article 57(a) to (e) of Regulation No 1907/2006.

There is no factual basis for the applicant’s statement — in the context of the first complaint in the first branch of the second plea in law — that ECHA confined itself to finding that bisphenol A was merely an endocrine disruptor and failed to establish that that endocrine disruptor gave rise to an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006.

That statement is in fact contradicted by the Support Document (Annex A.13 to the application, page 160 et seq.). More specifically, as is apparent from Section 6.3.2 of that document, following on from the French competent authority’s assessments, ECHA distinguished very clearly between (i) the nature of bisphenol A as an endocrine disruptor as such and (ii) the question whether that endocrine disruptor gave rise to the level of concern referred to in Article 57(f) of Regulation No 1907/2006. In the wake of that distinction, ECHA, again following on from the French competent authority’s assessments, also stated the specific criteria used in examining the question of which level of concern was to be attributed to bisphenol A. Those criteria were the effects on health, impact on quality of life, societal concern and the question whether a safe concentration could be established. More specifically, with regard to effects on health, the following were taken into account: the type of possible effects on health, the irreversibility of effects on health, and the delay in the manifestation of effects on health.

Having regard to those factors, the first complaint in the first part of the second plea in law must be rejected.

(2) The second complaint in the first branch of the second plea in law: manifest error of assessment in that ECHA failed to meet the criteria laid down in Article 57(f) of Regulation No 1907/2006 and comply with certain general principles of EU law

In the context of the second complaint in the first branch of the second plea, the applicant calls into question, in essence, the scientific assessment conducted by ECHA to demonstrate that bisphenol A is a substance which may have adverse effects giving rise to a level of concern equivalent to that raised by the use of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006.

In the first place, according to the applicant, ECHA relied on a series of studies in a manner inconsistent with the principle of excellence.

It is claimed, first, that some of the studies relied on by ECHA in support of the contested decision and identified in the dossier prepared in accordance with Annex XV as the most informative studies have been recognised, by other expert committees, as having obvious limitations and as being unreliable. For example, concerning mammary gland development, all the studies highlighted as the most informative in the dossier prepared in accordance with Annex XV had already been included in a review conducted by the European Food Safety Authority (EFSA) in 2015, which had reported notable limitations for those studies. This is the case with the Jenkins (2009), Tharp et al. (2012) and Ayyanan (2011) studies. ECHA considered that those studies permitted the conclusion that there was a serious effect on health. By contrast, in a document entitled ‘Scientific Opinion on the risks to public health related to the presence of Bisphenol A (BPA) in foodstuffs’ of 25 March 2015 (Executive Summary: EFSA Journal 2015;13(1):3978. DOI: 10.2903/j.efsa.2015.3978; ‘the EFSA Opinion of 25 March 2015’), the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (‘the EFSA CEF Panel’) considered the three studies mentioned above ‘supportive’ only in order to take them into account in its safety assessment. Concerning cognitive function, it is argued that EFSA took the view that, according to some of the studies referred to as the most informative in the dossier prepared in accordance with Annex XV, exposure of mice to bisphenol A had showed, in those animals, an ‘inconsistent change’ in the hippocampal NMDA receptors and that, therefore, no conclusion could be drawn from those results. This is the case with the Xu (2010b) study. With regard to another study, namely the Inagaki (2012) study, EFSA concluded, inter alia, that its design, the doses and the number of animals used in the various tests appeared unclear. Moreover, concerning that study, ECHA itself identified the following limitations: ‘Weaknesses: — Single dose acute administration — Test performed in one sex only; Insufficient study report; Inappropriate statistics.’

Secondly, it is claimed that ECHA did not give appropriate weight in its assessment to data recognised as scientifically valid and reliable by other regulatory bodies of the European Union. For example, concerning reproductive function, the Tyl (2002), Tyl (2008), Ema (2001) and Delclos (2014) studies, which are acknowledged as key studies by other regulatory bodies such as ECHA’s Risk Assessment Committee, EFSA and the Scientific Committee on Occupational Exposure Limits (‘SCOEL’), are not mentioned in the dossier prepared in accordance with Annex XV amongst the ‘most informative’ studies. With particular regard to the oestrous cyclicity endpoint, the applicant observes that several studies are not cited in the Annex XV dossier even though they contain research carried out regarding oestrous cyclicity at different life stages. The majority of those studies show no effect on oestrous cyclicity using a human relevant exposure level (Goodman (2009, 2006), Gray (2004), C[enter for the] E[valuation of] R[isks to] H[uman] R[eproduction] (2008), EFSA (2015), SCOEL (2014)). The applicant takes the view that if all the relevant data had been taken into account as part of an assessment based on the weight of evidence approach, bisphenol A could not have been considered an endocrine disruptor in relation to oestrous cyclicity. Concerning mammary gland development, the comprehensive study by Delclos (2014) was not considered by ECHA as ‘most relevant’ even though EFSA considered that it was relevant. Concerning cognitive function, studies conducted by the FDA and the NCTR were available and evaluated by EFSA, but not considered by ECHA.

Thirdly, it is argued that the studies relied upon by ECHA do not support the conclusions reached by that body. For example, concerning reproductive function, it is true that the dossier prepared in accordance with Annex XV did indeed state, in essence, that, according to the Lee (2013a) study, tests on adult female Sprague-Dawley rats showed that ‘one clear cut primary target of [bisphenol A] [was] the reduction of the expression of aromatase’. According to the applicant, in other words, bisphenol A is an aromatase inhibitor. However, the applicant claims that, according to the Organisation for Economic Cooperation and Development (OECD) Task Force on Endocrine Disruptors Testing and Assessment of the Test Guidelines Programme, one of the several severe effects of the aromatase inhibitor is the dramatic increase in body weight in female rats. However, in the applicant’s view, the Lee (2013a) study did not report body weight increase in the results and does not therefore confirm the hypothesis proposed by ECHA. Furthermore, the Yamasaki (2002) study, a comprehensive study performed in accordance with the OECD Guidelines for the Testing of Chemicals No 407 called ‘OECD TG 407’ was available concerning bisphenol A. According to the applicant, no increase in body weight had been reported at any dose tested in that study. Since no consistent effect on fertility is reported at a dose of between 1 and 100 μg/kg (that is to say, the dose level investigated by the Lee (2013a) study) in in-depth multi-generation studies dosing adult animals (generation F0), experts concluded in their evaluations that there was no consistent or reproducible effect at those dose levels (Hengstler (2011), EFSA (2015), ECHA (2014)). Concerning mammary gland development, the studies by one research group mentioned in the dossier to support this conclusion used an inappropriate study design. Concerning metabolism, the author of the dossier prepared in accordance with Annex XV stated that, ‘even if available epidemiological studies [were] inconclusive, these effects [were] [nevertheless] considered relevant for humans because similarities [existed] … between animals and humans’. According to the applicant, it is not comprehensible that inconclusive human data was considered relevant because similarities exist between animals and humans.

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