Silicone materials have been subject to hundreds of scientific studies showing that they are safe for human health, when used for their intended purposes. Risk evaluations have been conducted by several regulatory agencies such as 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. All of these risk assessments concluded that there is no risk to human health from silicone materials when used as intended.

Canadian Studies

In Canada, government health officials used a risk-based approach to evaluate specific siloxanes and determined there was no indication of any risk to children or adults.

“Siloxanes were evaluated for risks to human and environmental health under the Chemicals Management Plan. An analysis of exposure through cosmetic products showed that the substances do not present a risk to human health as currently used.”
–Health Canada

Australian Studies

Australia also conducted a human health assessment for the siloxanes D4, D5, and D6. The Australia Department of Health “found that D4 posed no risk to human health and that current risk management measures are considered adequate to protect public and workers’ health and safety. Australia’s regulatory officials noted that “no further assessment of D4 is currently required.”

Australia’s human health assessment of D5 stated, “There are no critical health effects for the chemical.” Australia concluded that “Overall, the MoS/MoE [Margin of Safety/Margin of Exposure] estimates indicate that the chemical, when used in consumer products, does not pose a human health risk.” As a result, no further assessment is currently required for D5.

Similarly, the Australian assessment concluded that there are no critical health effects for D6. They stated that “…given the low bioavailability and low toxicity of the chemical, significant public risk is not expected.” The assessment also reported, “Based on the available data, the chemical is not likely to be hazardous to human health.” Australia found that no further assessment of D6 is required.

In addition, the United States Cosmetic Ingredient Review concluded that D4, D5, and D6 are safe as cosmetic ingredients under current practices of use.

Also, some regulatory authorities and non-governmental organizations recently have raised concerns that D4 might cause estrogenic effects in humans and, consequently, the substance has appeared on some so-called “endocrine disruptor” lists. As part of its ongoing efforts to improve scientific understanding of the safety of silicone materials, the global Silicones Industry has conducted a comprehensive literature review evaluating the potential for endocrine activity of D4.

All available scientific evidence illustrates that D4 does not behave like an endocrine disruptor. Tests conclude that the material does not exhibit sufficient activity via the estrogen system to produce adverse effects in humans or the environment. Any so-called “endocrine disruptor” lists that have included D4 were developed based solely on the inaccurate supposition that it exhibits endocrine activity, and without evidence of a link between that purported activity and any adverse health effects. The substance is safe for adults and children in its intended uses.

The Silicones Industry will continue to be at the forefront of research to provide even greater scientific understanding of the health and environmental safety of silicone materials used in consumer and industrial applications.