Industry Update

Industry position on REACH restriction proposal

EU regulators are currently considering a REACH restriction proposal for the placing on the Consumer and Professional markets of D4, D5 and D6 as substances, as constituents of other substances, or in mixtures in a concentration equal to or greater than 0.1% w/w of each substance, as well as a solvent for the dry cleaning of textiles, leather and fur. The restriction would only apply to products on the European market.

Given the lack of clarity in some of the restricted uses and the lack of benefit the restriction would have for the environment, the silicone industry actively engaged in the restriction process to ensure that essential consumer applications are not harmed.

The industry, in its contribution to the public consultation, sought further clarity to the derogation for industrial uses and proposed to extend derogations to essential consumer and professional applications such as dental impression and dental reproduction materials or personalised prosthetic devices e.g. limbs and hands, as well as applications which are important to industrial innovation such as materials used for prototyping, including 3D printing.

In response to stakeholder input, ECHA subsequently proposed derogations for uses or for increased allowable concentrations for some uses including dental impression materials and medical devices for scar and wound management and stoma care.

The industry would also like to highlight that other regions like Australia and Canada have taken different regulatory approaches and reached conclusions of no significant risk and no necessary restrictions for these substances. Currently, there are no restrictions on any uses for any silicone substances anywhere in the world outside of Europe.

This is demonstrated by the legal action undertaken by the industry with regards to other regulatory restrictions and nominations found to be unjustified.

CES believes that in designating D4, D5, and D6 as SVHCs, ECHA did not consider the full range of relevant evidence that demonstrates these materials do not behave as vPvB and PBT substances. The PBT/vPvB SVHC criteria were intended only for carbon-based organic chemical substances. However, siloxanes and silicones are Si-based substances with an inorganic backbone. The criteria were not intended for inorganic or hybrid organic-inorganic substances and do not appropriately predict their environmental behaviour.

ECHA relied primarily on laboratory models and the strict regulatory screening criterial and failed to consider newer, more accurate real-world data that shows that siloxanes do not pose a risk to the environment. Consequently, there is no underlying scientific justification for the SVHC listing. Relevant studies and real-world data can be found in our science section.