Companies and trade groups representing the global silicones industry have lost major appeal cases in the EU seeking to overturn decisions identifying siloxanes as substances of very high concern under REACH and banning them in wash-off cosmetics due to environmental hazards.
In two separate judgments delivered today, the European Court of Justice (ECJ) dismissed all pleas brought by the Global Silicones Council (GSC) and several of its member companies in their 2021 appeals against the European Commission and ECHA, drawing a line under a five-year court battle.
The groups, which include industry heavyweights Dow, Elkem and Evonik, had pleaded errors in law after the General Court rejected their initial lawsuit challenging the evidence the authorities relied on to support their 2018 decisions to control the risks posed by siloxanes D4, D5 and D6.
The companies argued that the court had misinterpreted REACH Annex XIII, which states criteria for persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances, and erred in law in the assessment of the evidence, and also distorted it.
Their central assertion was that PBT/vPvB criteria were intended only for carbon-based organic chemical substances, rather than silicone-based ones such as siloxanes, and their ‘hybrid nature’ should be taken into account in the assessment of bioaccumulation.
But the EU’s highest court upheld the earlier rulings, confirming both that ECHA was right to include the three siloxanes on the REACH candidate list, and the Commission was correct to restrict D4 and D5 in wash-off cosmetics.
In their submissions, the groups had flagged the Commission’s failure to state why the risks associated with D4/D5 were unacceptable. They had also questioned whether assessment of PBT/vPvB substances justifies an approach whereby emissions can be considered as a proxy for risk.
The EU restriction of D4 and D5 in wash-off cosmetics has applied since 1 February 2020.
ECHA said it welcomes the judgments, which are final with no further appeal available.
The rulings follow an opinion by the EU advocate general on 20 April that recommended a dismissal of the appeal action against ECHA.
Court battle
The cases were first brought to court in 2018, after the groups disagreed with ECHA's decision to include the siloxanes on the candidate list – a move that triggered new notification requirements and mandatory duties for industry to supply safe use information. Substances on the list are recommended for inclusion in the REACH authorisation list in stages.
ECHA proposed the siloxanes for inclusion on the REACH authorisation list (Annex XIV) in 2021. But the European Commission has yet to approve their addition.
The three cyclosiloxanes are used as raw materials in the production of silicone rubbers, gels and resins.
The GSC fought the case against ECHA together with six member companies – Dow, Elkem, Evonik, Momentive, Shin-Etsu and Wacker – while in the case against the Commission it was joined by four of them, minus Dow and Evonik.
The American Chemistry Council (ACC) intervened on the side of the industry groups while Germany backed both ECHA and the Commission.
The court ordered the GSC and its member companies to pay their costs and those of the main defendants, and intervening parties to bear their own costs.
Also today, the ECJ delivered a defeat for chemical giant Chemours in its appeal case over the GenX.