Linear siloxanes and EU regulatory procedures

On 19 March 2024, ECHA published an update to the Community Rolling Action Plan (CoRAP), according to which in 2024 Spain will evaluate tetradecamethylhexasiloxane (L6), as suspected persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB). If Spain’s assessment identifies risks from the substance, regulatory action may follow (harmonised classification, SVHC listing or restriction). 

The conclusions of the substance evaluation for L3 (octamethyltrisiloxane), L4 (decamethyltetrasiloxane) and L5 (dodecamethylpentasiloxane) were published. The Norwegian Environment Agency concluded that the substances meet the criteria as very persistent and very bioaccummulative (vPvB) in the environment. As potential next steps, the conclusion foresees a Regulatory Management Option Analysis (RMOA) for the group of linear siloxanes L2, L3, L4 and L5. For L2 (hexamethyldisiloxane) the evaluation is yet to be finalised. The conclusions also recommend that the substances might be identified as Substances of Very High Concern (SVHC), and might be added to the Candidate List. Having communicated its SVHC intentions, Norway is now expected to submit dossiers to ECHA by 2 August 2024 for L3, and by 3 February 2025 for L2, L4 and L5. Lastly, the conclusions propose a future REACH restriction. The decision on how and when potential next steps will be taken is at the discretion of the European Authorities. 

In 2015, the United Kingdom launched the evaluation of the linear siloxanes, L3, L4 and L5. Following Brexit, the procedures were also led by Norway.

In 2013, the Competent Authority of the United Kingdom initiated substance evaluation for hexamethyldisiloxane (L2) on initial grounds for concern relating to human health, exposure and aggregated tonnage. Since the United Kingdom’s departure from the EU, the procedures are led by Norway. The evaluation is yet to be finalised.