Regulators Conclude L2, L4, L5, and D3 Pose Low Risk to Environment and Human Health

WASHINGTON (August 6, 2019) – Members of the Global Silicones Council (GSC) welcome Canada’s draft risk assessment of a range of silicone materials, including L2, L4, L5, and D3[1]. The Canadian Minister of the Environment and the Minister of Health have concluded these siloxanes are not entering the environment in a quantity or concentration or under conditions that constitute a danger to the environment, nor a risk to human health. As such, Canada has not proposed any regulatory restrictions on the use of any of these materials.

“GSC supports Canada’s commitment to use a risk-based, weight-of-evidence approach when evaluating chemicals, and its conclusion that L2, L4, L5, and D3 do not pose risks to the environment nor to human health,” said Karluss Thomas, Executive Director, GSC. “The Canadian conclusion reaffirms what many independent scientists and experts have already confirmed – scientific research and testing demonstrate the safety of silicones in their diverse and important applications and no regulatory restrictions on these materials are warranted.”

In Canada, L2, L4, L5, and D3 are primarily used in a wide range of products such as cosmetics, electronics, medical devices, adhesives and sealants, as well as in industrial applications such as paints and coatings. Canadian authorities characterized the ecological and health risks of these materials using a risk-based approach, based on weighted consideration of multiple lines of evidence for determining the risk classification. None of the materials met any of the criteria pursuant to the Canadian Environmental Protection Act, and therefore, no further regulatory action is required.

Canadian regulators previously evaluated a number of other silicone materials, including D4, D5, D6, and L3. After a full review of all the relevant science, Canada did not impose any use restrictions or concentration-based restrictions on D4, D5, D6, or L3 for any product in Canada.

“Canada’s assessment of these siloxanes, coupled with Australia’s and Canada’s previous assessments of D4, D5, D6,[1] and L3, reiterates these substances can be used safely in appropriate applications without harming human health or the environment,” continued Thomas. “We continue to urge regulators around the world to adopt Australia’s and Canada’s risk-based approach to chemical evaluations. Because of the significant benefits these substances provide to consumers and society, it is important that any regulatory determinations be based on real-world exposure and all available relevant scientific data. Canada’s leadership on chemical management issues continues to demonstrate that regulators can simultaneously protect the environment and human health, while promoting product innovation.”

These silicone substances are critical building blocks used to produce a broad 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: transportationbuilding and construction, health carealternative energy technologies, and electronics. In these sectors, there are few, if any, satisfactory substitutes to silicone polymers.

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The Global Silicones Council (GSC) is a not-for-profit, international organization representing companies that produce and sell silicone products around the world. The GSC brings together all the major global manufactures via the three Regional Silicone Industry Associations in North America (Silicones Environmental, Health, and Safety Center – SEHSC), Europe (Silicones Europe – CES), and Japan (Silicones Industry Association of Japan – SIAJ) and encourages their cooperation and collaboration.

The GSC’s objective is to promote the safe use and stewardship of silicones globally. To accomplish its mission, the GSC undertakes the following activities:

  • Monitor the environmental, health, and safety activities of the three Regional Silicones Industry Associations (RSIAs) and coordinate such activities on a global basis.
  • Proactively promote industry communication with regulatory bodies around the world and with international environmental, health, and safety organizations, such as the World Health Organization, the Organization of Economic Cooperation and Development, and the United Nations.
  • Through the RSIAs, identify and anticipate opportunities to enhance environmental, health, and safety research relating to silicones and engage in global projects to communicate the industry’s product stewardship commitment.
  • Through the RSIAs, sponsor projects to improve the public’s understanding of the benefits and safety of silicones.
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