Judgment of the General Court (Eighth Chamber, Extended Composition) of 30 June 2021 – Global Silicones Council and Others v ECHA
(Case T‑519/18)
(REACH – Establishment of a list of substances identified for eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 – Entry of octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexsiloxane (D6) in that list – Articles 57 and 59 of Regulation No 1907/2006 – Annex XIII to Regulation No 1907/2006 – Weight-of-evidence determination – Manifest error of assessment – Proportionality)
1.      Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Discretion of the EU authorities – Scope – Judicial review – Limits – Manifest error, misuse of powers or manifest exceeding of the limits of the discretion
(European Parliament and Council Regulation No 1907/2006, Arts 1(1), 57(d) and (e), 59 and Annex XIII)
(see paras 51, 52, 53, 54, 294)
2.      Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Assessment of hazards linked to the intrinsic properties of a substance – Criteria for assessment
(European Parliament and Council Regulation No 1907/2006, Arts 57 and 59 and Annexes XIII and XV)
(see paras 116, 133)
3.      Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Classification on the basis of the properties of constituents – Whether permissible – Condition – Account taken of the level of the presence of the constituents concerned and their chemical effects – Substances having persistent, bioaccumulable and toxic or very persistent and very bioaccumulable properties – Classification on the basis of the properties of the constituents – Whether permissible – Application of a concentration threshold for the purposes of classification – Whether permissible
(European Parliament and Council Regulation No 1907/2006, Arts 14(2)(f), 31(3)(b), 56(6) and 57(d) and (e), and Annex XIII)
(see paras 265, 266, 273)
4.      Action for annulment – Actionable measures – Concept – Measures producing binding legal effects – Preparatory measures – Not included – Decision of the European Chemicals Agency (ECHA) identifying D4, D5 and D6 as substances of very high concern – Act intended to produce legal effects – Included
(Art. 263, first para., TFEU; European Parliament and Council Regulation No 1907/2006, Arts 57(d) and (e) and 59)
(see paras 277, 278)
5.      Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Decision of the European Chemicals Agency (ECHA) identifying D4, D5 and D6 as substances of very high concern – Breach of principle of proportionality – None
(European Parliament and Council Regulation No 1907/2006, Art. 59)
(see paras 293, 295, 296)
6.      Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Distinct from and independent of the evaluation procedure – Weight-of-evidence determination
(European Parliament and Council Regulation No 1907/2006, Recitals 19 to 21 and 69 and Arts 57 and 59)
(see paras 297, 298, 301, 303, 307, 308)
Re:
Application under Article 263 TFEU for the annulment in whole or in part of the decision of ECHA of 27 June 2018 including octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexsiloxane (D6) in the Candidate List for 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).
Operative part
The Court:
1.
Dismisses the action;
2.
Orders Global Silicones Council and the other parties listed in the annex to bear their own costs and to pay those incurred by the European Chemicals Agency (ECHA);
3.
Orders the Federal Republic of Germany, the European Commission and American Chemistry Council, Inc. (ACC) each to bear their own costs.