Silicones are some of the most widely-studied chemicals used in consumer products and industrial applications. The industry supports the safe and responsible use of silicone materials and endorses the U.S.’ risk-based weight-of-evidence assessments for effective human health decision-making.
More than 1,000 studies have been conducted by silicone manufacturers to assess the safety of silicones relative to workers, consumers, the environment and manufacturing processes. The results of this continuous research and testing demonstrate the safety of silicones in their diverse and important applications.
Independent scientists have confirmed conclusions that silicones – and siloxanes, specifically – pose no risk to human health.
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. According to Health Canada, “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.”
In addition, the United States Cosmetic Ingredient Review and European Scientific Committee for Consumer Safety concluded there is no risk to human health in cosmetic applications.
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. The goal of the research is to investigate potential health concerns and communicate relevant research and safety information to regulatory agencies, employees, and customers.
The silicone industry is committed to the responsible use of silicones and international environmental stewardship. The industry continues to evaluate the science behind its materials through robust environmental monitoring programs.
To provide the U.S. Environmental Protection Agency (EPA) with environmental monitoring data on one of the basic substances used to make silicones, the siloxane D4, in March 2016 members of the SEHSC began an environmental monitoring program, designed in partnership with EPA, to assess levels of D4 in the environment. Data generated in the program will facilitate EPA's environmental risk assessment for D4, using actual environmental concentrations, rather than predicting concentrations based on computer models.
Generating real-world data from multiple locations throughout the U.S. will help regulators better understand the fate and distribution of D4 in the environment, which is consistent with the silicones industry's international environmental stewardship efforts.
Global governments are using real-world data to drive the chemical assessments. For example, Environment Canada reviewed the scientific data and environmental monitoring results available for D4, and determined that no restrictions needed to be imposed on product use or product concentration limits on the use of D4 in any application. Canada’s Minister of the Environment also ruled that no regulatory restrictions on the siloxane known as D5 need to be imposed after it was found by an independent panel of expert toxicologists to pose no risk to the environment now, or in the future.
As part of the industry’s commitment to product stewardship, the silicones industry set up a Monitoring Program for D4 and D5 in 2010. The Silicones Monitoring Program takes place in four different locations around the world to provide a representative picture of the silicone materials’ fate and distribution, i.e. Lake Pepin in the United States; Lake Ontario in Canada; Osloforjd in Norway; and Tokyo Bay in Japan.
The Silicones Monitoring Program consists of three main parts:
- Evaluating emissions from wastewater treatment plants (WWTP) by determining the effectiveness of WWTP and the representative concentrations of D4 and D5 releases;
- Long-term monitoring program for D4 and D5 in surface sediment and aquatic biota to determine if concentrations are stable or changing over time; and,
- State-of-the-art modelling techniques for accurate predictions of a large number of similar locations.
When completed, the results of the Silicones Monitoring Program will be published as a series of scientific papers in peer-reviewed journals.
The initial five-year program is almost complete. The industry however, has committed to continue to monitor the sites, taking into account what has been learned to date.