Judgments nº T-636/17 of Tribunal General de la Unión Europea, September 20, 2019

• Resolution Date: September 20, 2019
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-636/17

(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,

v

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

Judgment

1. Background to the dispute

   1 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.

   2 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.

   3 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 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.’

   5 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.

   6 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.

   7 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 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.

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

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

   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 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...