Silicone materials have been subject to hundreds of scientific studies showing that they are safe for human health and the environment, when used for their intended purposes. Risk-based evaluations have been conducted by several regulatory agencies such as Environment and Health Canada, Australia Departments of Environment and Health, UK regulatory bodies, as well as expert scientific panels such as the Cosmetic Ingredient Review and the EU Scientific Committee on Consumer Safety.
Regulatory Information
Global Silicones Council/Silicones Environmental Health and Safety Center Approach
Regulatory authorities should use a risk-based weight-of-evidence (WoE) approach which considers exposure to evaluate the safety of silicone materials. Regulatory authorities should avoid adopting assessment conclusions or risk-management approaches from countries or regions that do not utilize risk-based WoE approaches. A fundamental underpinning of the silicones industry’s commitment to product stewardship is the belief that comprehensive, robust, risk-based assessments utilizing a WoE approach should be the primary driver for development of chemical regulatory policy. A core requirement for the development of scientific assessments is the availability of high-quality data. The silicones industry’s willingness to develop those data is an illustration of the industry’s commitment to the generation of sound science to support chemical regulatory decision-making.
United States and D4 Risk Assessment
In the US, the silicones industry worked with the US Environmental Protection Agency (EPA) to design a monitoring program to assess levels of D4 in the environment and produce exposure data the agency needed to conduct a thorough and scientifically sound risk assessment. The final results of the D4 environmental monitoring program were submitted to EPA in September 2017.
An independent peer-reviewed study of the monitoring program data concluded that D4 poses negligible risk to the environment and that no regulatory restrictions for D4 are warranted.
In February 2020, the industry submitted its request to EPA to conduct a risk evaluation of D4 under the Toxic Substances Control Act (TSCA). In October 2020, the industry received official notification that EPA had granted the industry request for a D4 risk evaluation, which is expected to be finalized by the end of 2025. The industry has been steadfast in its support for risk-based assessments of silicone substances, including D4, and is confident of the safety of D4 for human health and the environment.