14The background to the dispute is set out in paragraphs 7 to 21 of the judgment under appeal in the following terms: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 … 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 [ECHA] requested the ECHA Member State Committee (“the MSC”) to prepare an opinion on the persistence and bioaccumulation of D4 and D5 against the criteria 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 [the REACH Regulation] (“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 vP [and] vB 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 [properties].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 concerning D4 and D5 was adopted by the Commission on 10 January 2018 (Regulation (EU) 2018/35 amending Annex XVII to Regulation No 1907/2006 [of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)] as regards [octamethylcyclotetrasiloxane (“D4”) and decamethylcyclopentasiloxane (“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 [P, B, T, vP and vB] 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 [P, B, T, vP and vB] criteria.14 On 8 March 2018, ECHA published the three dossiers prepared in accordance with Annex XV relating to D4, D5 and D6, respectively … . On the same day, ECHA invited all interested parties to submit their comments on those dossiers, in accordance with Article 59(4) of [the REACH Regulation]. ECHA received comments including, on 23 April 2018, those of the applicants.15 Subsequently, the German competent authority and ECHA produced three documents …, dated 12 June 2018, containing those authorities’ responses to all the comments received by ECHA in the course of the public consultation.16 Having received comments concerning the identification of the three substances at issue, ECHA, in accordance with Article 59(7) of Regulation No 1907/2006, referred the dossiers to the MSC. In accordance with the MSC’s working procedures for the identification of substances of very high concern, the MSC was provided with an Annex XV dossier, a draft MSC agreement and a draft support document for each of the three substances.17 At its 60th meeting, held from 12 to 14 June 2018, the MSC reached unanimous agreements on the identification of D4, D5 and D6 as substances of very high concern, on the ground that those substances met the criteria for identification as PBT and vPvB substances under Article 57(d) and (e) of [the REACH Regulation]. The grounds for those agreements are set out in the respective support documents.18 The support documents for D4 and D5 refer several times, including in the summaries concerning the persistence and bioaccumulation of the two substances, to the MSC’s opinion of 22 April 2015 on D4 and D5 and, concerning the toxicity of D4, to the RAC’s opinion of 10 March 2016. The data are supplemented in the support documents for D4 and D5 by references to new studies published after those opinions. The support document for D4 concludes that D4 has [P, B, T, vP and vB] properties in accordance with Annex XIII. The support document for D5 does not evaluate data on the toxicity of that substance for human health or the environment. That document concludes that D5 is a vPvB substance and that, when it contains D4 in a concentration greater than or equal to 0.1% (weight by weight), it is also PBT.19 The support document for D6 presents, inter alia, assessments on the degradation and distribution of that substance and refers to data provided in the support documents for D4 and D5. The support document for D6 does not assess the environmental and human-health toxicity of D6. It concludes that D6 is a vPvB substance and states that it also meets the criteria for PBT substances when it contains D4 in a concentration greater than or equal to 0.1% (weight by weight). In addition, given that D4 and D5 were identified as impurities in D6, it concluded, with reference to the MSC’s opinion of 22 April 2015 and the RAC’s opinion of 10 March 2016, that D6 also fulfils the criteria for vPvB substances when it contains D4 or D5 in a concentration greater than or equal to 0.1% (weight by weight).20 On 27 June 2018, pursuant to Article 59(8) of [the REACH Regulation], ECHA adopted Decision ED/61/2018 regarding the inclusion of D4, D5 and D6 in the Candidate List for eventual inclusion in Annex XIV to Regulation No 1907/2006, as referred to in Article 59(1) of that regulation (“the Candidate List”), on the ground that they had been identified as PBT and vPvB substances within the meaning of Article 57(d) and (e) of Regulation No 1907/2006 [(“the decision at issue”)], published the same day on ECHA’s website.21 On the same day, the Candidate List published on ECHA’s website in accordance with Article 59(10) of that regulation was updated to include entries for D4, D5 and D6. The remarks on the respective Candidate List entries provide that D5 fulfils the criteria laid down in Article 57(d) of [the REACH Regulation] for a PBT substance when it contains a quantity of D4 greater than or equal to 0.1% (weight by weight). For D6, the remark states that that substance fulfils the criteria laid down in Article 57(d) of [the REACH Regulation] for a PBT substance when it contains a quantity of D4 greater than or equal to 0.1% (weight by weight). As regards D6, the remark also states that, in addition to its intrinsic properties, that substance also meets the criteria set out in Article 57(e) of [the REACH Regulation] for a vPvB substance when it contains a quantity of D4 or D 5 greater than or equal to 0.1% (weight by weight).’
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