Silicone manufacturers around the world voluntarily support health and environmental testing. This activity has been providing greater scientific understanding of the health and environmental safety of siloxanes used in consumer and industrial applications. The goal of the research is to investigate potential health or environmental concerns and communicate relevant research and safety information to regulatory agencies, employees and customers.

Enforceable Consent Agreement with EPA

To ensure that the U.S. Environmental Protection Agency’s environmental risk assessment of the siloxane octamethylcyclotetrasiloxane, more commonly known as D4, is based on real world monitoring data, rather than estimates based on computer models, five members of the Silicones Environmental, Health, and Safety Center have entered into an Enforceable Consent Agreement (ECA) with EPA for scientifically-robust environmental testing of D4. Learn more about D4.

“ECA Study Infographic Image” This extensive monitoring program confirms SEHSC’s commitment to generating the necessary data to support an environmental risk assessment for D4 that is consistent with sound science and comports with the industry's commitment to environmental stewardship. The agreement is an extension of the silicone industry's voluntary stewardship efforts to support greater scientific understanding of the health and environmental safety of siloxanes used in consumer and industrial applications.

Global Research and Assessments

Accordingly, the global silicone industry extensively studies the human health and environmental impacts of its products. These studies demonstrate that silicone materials are safe for human health and the environment when used as they are intended. Regulatory agencies in Canada, the United Kingdom (UK), and Europe have reviewed the scientific data available for specific silicone materials. These reviews have confirmed the safety of silicone materials for human health and the environment. In addition, an expert scientific panel (Cosmetic Ingredient Review (CIR)) has concluded that siloxanes do not pose a risk to human health from their use in cosmetics.

Other science advisory boards, which include nationally and internationally renowned scientists, are also used from time to time to provide independent reviews of the testing strategy, methodology and findings. Independent universities, qualified contract laboratories and Industry laboratories perform and review the tests and studies. Research results are regularly published in peer-reviewed journals.

Silicone manufacturers cooperate with global regulatory agencies to assess data and ensure that silicones continue to be safe for human health and the environment. Manufacturers are committed to making basic environmental, health, and safety data on silicone-based materials produced in high volumes available to all national governments through the Organization for Economic Cooperation and Development.

Thousands of studies have been completed during nearly four decades to support the safe use of siloxanes in their intended applications. A fundamental underpinning of the silicone industry’s commitment to product stewardship is the belief that comprehensive, robust, weight-of-evidence, risk-based assessment should be the primary driver for development of regulatory policy. A fundamental requirement for the development of scientific assessments is the availability of high-quality data. The silicone industry’s willingness to development those data is also an illustration of the industry’s commitment to generation of sound science to support regulatory decision-making.


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