EU Procedures & Regulations
Linear siloxanes and EU regulatory procedures
L2, L3, L4, L5
and EU regulatory procedures
On 31st March 2022, 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. 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.
L3, L4, L5 substance evaluation
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.
L2 substance evaluation
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.
Silicones Europe takes note of the conclusions and will continue to engage with the authorities in potential future regulatory processes to ensure a viable pathway for these substances. Regarding the underlying science, Silicones Europe would like to highlight that the substance evaluation was based primarily on laboratory screening studies that do not take into account the physiochemical properties of the substances and how they behave in the environment. Silicones Europe will continue to work with European authorities to incorporate the latest scientific findings into their regulatory assessment of siloxanes to ensure balanced regulation.