PlasticsEurope v European Chemicals Agency.

• Jurisdiction: European Union
• ECLI: ECLI:EU:C:2021:1047
• Date: 21 December 2021
• Docket Number: C-876/19
• Celex Number: 62019CJ0876
• Court: Court of Justice (European Union)

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...