Global Silicones Council and Others v European Chemicals Agency.

• Jurisdiction: European Union
• ECLI: ECLI:EU:T:2021:404
• Docket Number: T-519/18
• Date: 30 June 2021
• Celex Number: 62018TJ0519
• Court: General Court (European Union)

JUDGMENT OF THE GENERAL COURT (Eighth Chamber, Extended Composition)

30 June 2021 (*)

(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)

In Case T‑519/18,

Global Silicones Council, established in Washington, DC (United States), and the other applicants whose names are listed in the annex, (1) represented by R. Cana and D. Abrahams, lawyers,

applicants,

supported by

American Chemistry Council, Inc. (ACC), established in Washington, represented by K. Nordlander and C. Grobecker, lawyers,

intervener,

v

European Chemicals Agency (ECHA), represented by M. Heikkilä, W. Broere and A. Hautamäki, acting as Agents,

defendant,

supported by

Federal Republic of Germany, represented by J. Möller, D. Klebs, S. Heimerl and S. Costanzo, acting as Agents,

and by

European Commission, represented by L. Haasbeek and R. Lindenthal, acting as Agents,

interveners,

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),

THE GENERAL COURT (Eighth Chamber, Extended Composition),

composed of S. Papasavvas, President, J. Svenningsen, R. Barents, T. Pynnä and J. Laitenberger (Rapporteur), Judges,

Registrar: B. Lefebvre, Administrator,

having regard to the written part of the procedure and further to the hearing on 30 September 2020,

gives the following

Judgment

Legal framework

1 On 1 June 2007, 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) entered into force.

2 Annex XIII to Regulation No 1907/2006 (‘Annex XIII’) lays down the criteria for the identification of persistent (‘P’), bioaccumulative (‘B’) and toxic (‘T’) substances (together, ‘PBT’), and very persistent (‘vP’) and very bioaccumulative (‘vB’) substances (together, ‘vPvB’).

3 On 15 March 2011, the European Commission adopted Regulation (EU) No 253/2011 amending Regulation No 1907/2006 as regards Annex XIII (OJ 2011 L 69, p. 7). That regulation amended the former Annex XIII taking into account experience acquired at international level.

4 The preamble to Annex XIII now states:

‘This Annex lays down the criteria for the identification of persistent, bioaccumulative and toxic substances (PBT substances), and very persistent and very bioaccumulative substances (vPvB substances) as well as the information that must be considered for the purpose of assessing the P, B, and T properties of a substance.

For the identification of PBT substances and vPvB substances a weight-of-evidence determination using expert judgement shall be applied, by comparing all relevant and available information listed in Section 3.2 with the criteria set out in Section 1. This shall be applied in particular where the criteria set out in Section 1 cannot be applied directly to the available information.

A weight-of-evidence determination means that all available information bearing on the identification of a PBT or a vPvB substance is considered together, such as the results of monitoring and modelling, suitable in vitro tests, relevant animal data, information from the application of the category approach (grouping, read-across), (Q)SAR results, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well documented case reports and observations. The quality and consistency of the data shall be given appropriate weight. The available results regardless of their individual conclusions shall be assembled together in a single weight-of-evidence determination.

The information used for the purposes of assessment of the PBT/vPvB properties shall be based on data obtained under relevant conditions.

The identification shall also take account of the PBT/vPvB-properties of relevant constituents of a substance and relevant transformation and/or degradation products.

This Annex shall apply to all organic substances, including organo-metals.’

5 Annex XIII provides, inter alia:

‘1.1.2. Bioaccumulation

A substance fulfils the bioaccumulation criterion (B) when the bioconcentration factor in aquatic species is higher than 2 000.

…

1.2.2. Bioaccumulation

A substance fulfils the “very bioaccumulative” criterion (vB) when the bioconcentration factor in aquatic species is higher than 5 000.’

6 Annex XIII also states as follows:

‘3.2. Assessment Information

The following information shall be considered for the assessment of P, vP, B, vB and T properties, using a weight-of-evidence approach.

…

3.2.2. Assessment of B or vB properties

(a) Results from a bioconcentration or bioaccumulation study in aquatic species;

(b) Other information on the bioaccumulation potential provided that its suitability and reliability can be reasonably demonstrated, such as:

– Results from a bioaccumulation study in terrestrial species;

…

(c) Information on the ability of the substance to biomagnify in the food chain, where possible expressed by biomagnification factors or trophic magnification factors.’

Background to the dispute

7 The first applicant, Global Silicones Council, is a non-stock corporation, established in the United States, representing companies which manufacture and sell silicone products throughout the world. The other applicants, whose names are listed in the annex, are companies which manufacture, sell and supply the chemical substances octamethylcyclotetrasiloxane (‘D4’), decamethylcyclopentasiloxane (‘D5’) and dodecamethylcyclohexsiloxane (‘D6’) on their own or in a mixture.

8 On 14 October 2014, the Executive Director of the European Chemicals Agency (ECHA) requested the ECHA Member State Committee (‘the MSC’) to deliver an opinion on the persistence and bioaccumulation of D4 and D5 in the light of the criteria laid down in Annex XIII.

9 On 17 April 2015, the United Kingdom of Great Britain and Northern Ireland submitted to ECHA a dossier based on Annex XV to Regulation No 1907/2006 (‘Annex XV’) proposing a restriction of the use of D4 and D5 in cosmetic products that were washed off in normal conditions of use. The restriction proposal was based on the purported PBT and vPvB properties of D4 and on the purported vPvB properties of D5.

10 On 22 April 2015, the MSC adopted an opinion according to which both D4 and D5 met the criteria set out in Annex XIII regarding the identification of vP and vB substances.

11 On 10 March 2016, the ECHA Committee for Risk Assessment (‘the RAC’) adopted an opinion on the basis of an examination of the United Kingdom’s restriction proposal and of the MSC’s opinion. The RAC, referring to the MSC’s opinion of 22 April 2015, stated that it had not reassessed the vP and vB properties of D4 and D5, but that it had examined the T properties of those substances. The RAC concluded that D4 fulfilled the identification criteria for PBT and vPvB substances set out in Annex XIII and that D5 fulfilled the identification criteria for vPvB substances, but that the latter, on the basis of the available evidence, did not meet the criteria set out in Annex XIII for toxicity.

12 A restriction on D4 and D5 was adopted by the Commission on 10 January 2018 (Regulation (EU) 2018/35 amending Annex XVII to Regulation No 1907/2006 as regards D4 and D5 (OJ 2018 L 6, p. 45)). By application received at the Court Registry on 2 April 2018, the majority of the applicants in the present case brought an action for annulment of that restriction. ECHA has intervened in support of the Commission in the case.

13 On 1 March 2017, the competent authority of the Federal Republic of Germany submitted dossiers under Article 59(3) of Regulation No 1907/2006 in accordance with Annex XV, proposing that D4 and D5 be identified as substances of very high concern on account of their PBT and vPvB properties. On 21 December 2017, the Commission, under Article 59(2) of that regulation, requested ECHA to prepare a dossier in accordance with Annex XV for the identification of D6 as a substance of very high concern. ECHA concluded in that dossier that D6 met the PBT and vPvB criteria.

14 On 8 March 2018, ECHA published the three dossiers prepared in accordance with Annex XV relating to D4, D5 and D6, respectively (‘the Annex XV dossiers’). On the same day, ECHA invited all interested parties to submit their comments on those dossiers, in accordance with Article 59(4) of Regulation No 1907/2006. ECHA received comments including, on 23 April 2018, those of the applicants.

15 Subsequently, the German competent authority and ECHA produced three documents (the ‘RCOM documents’), dated 12...