GSC Welcomes Australia’s Use of a Risk-Based Assessment of Siloxanes

Regulators have not proposed product restrictions based on evaluation of silicone science

WASHINGTON (July 9, 2018) – Members of the Global Silicones Council (GSC) welcome a new Australian risk assessment for a range of silicone materials, including D4, D5, and D6. The assessment from Australia’s Department of the Environment and Energy concludes, “[t]he direct risks to aquatic life from exposure to these chemicals at expected surface water concentrations are not likely to be significant.” As such, Australia has not proposed any regulatory restrictions on the use of any of the materials.

“The Global Silicones Council supports the Australian government’s commitment to using a risk-based assessment of chemicals, and its conclusion that these silicone materials don’t pose risks to the environment, said Karluss Thomas, Executive Director of the GSC. “The Australian conclusion is further validation that siloxanes are not found in the environment at concentrations that would merit regulatory restrictions.”

Australia’s assessment focused on a series of siloxanes, including D3, D4, D5, D6, D7, and cyclomethicone. Australia’s assessment for D4, D5, and D6 is consistent with Canada’s assessment and risk management decisions for these three materials and is in stark contrast with recent decisions by EU regulators to pursue product restrictions that don’t fully consider the whole body of scientific evidence. The Silicones Industry maintains that regulatory safety evaluations should be conducted in a manner that is consistent with the consensus in the scientific community, which has long maintained that consideration of environmental exposure and use of weight-of-evidence (WoE) is required to fully assess the behavior of siloxanes in the environment.

“Australia’s assessment, coupled with the completed regulatory evaluations for D4, D5, and D6 in Canada, demonstrates that the substances can be used safely and that product restrictions are unnecessary,” said Thomas. “We urge regulators around the world to look to Australia and Canada as models for the use of risk-based chemical evaluations that consider weight of evidence, particularly for chemistries whose unique properties mean that traditional criteria are inadequate to predict real-life behavior.

D4, D5, and D6 are critical building blocks used to produce a wide range of silicone polymers which provide unique product performance characteristics that engender innovation in thousands of products that benefit key segments of the global economy, including: transportation, building and construction, health care, alternative energy technologies, and electronics. In these sectors, there are few, if any, satisfactory substitutes to silicone polymers.