Cyclosiloxanes - Information Center

Statement - Silicones industry says scientific evidence points to the safety of D4 and D5

News published on 16 July 2014 Download document Read more


Brussels (16th July 2014) – The following statement can be attributed to the Global Silicones Council (GSC) following the United Kingdom’s (UK) recent registration of its intent to submit a restrictions proposal under the European Union’s chemicals management program (REACH) that would call for limiting D4 and D5 in rinse-off personal care products.

The silicones industry does not believe there is a need to restrict the use of D4 or D5 in any application, since the concentrations of these materials that have been measured in the environment are substantially below the levels that might pose a risk to the environment. Imposing restrictions will unnecessarily hamper international trade, stifle innovation, and deprive people of the products they rely on every day.

The existing criteria for assessing whether a substance is PBT1 or vPvB1 under REACH do not allow for accurate evaluation of silicon-based substances. Current criteria over-predict the potential bioaccumulation and concentration of these substances in the environment. In our view and the view of many leading scientific experts, D4 and D5 are not PBT or vPvB. The weight-of-evidence indicates that these substances are safe for human health and the environment when used as intended. Environmental monitoring data collected by the global silicones industry and governmental regulatory agencies demonstrate that D4 and D5 are not found at, nor will be found at, levels that pose a risk to the environment.

A comprehensive, risk-based assessment of the data conducted by an independent, group of leading scientific experts selected by the Canadian Government concluded that D5 does not pose a risk to the environment now, or in the future. In addition, Environment Canada, having reviewed the environmental data available for D4, has not imposed any product concentration restrictions on the use of D4 in any application.

The safety of D4 and D5 in personal care products has also been confirmed by independent expert panels, including the European Scientific Committee for Consumer Safety, the United States Cosmetics Review Panel, and Health Canada. The silicones industry will continue to work with U.K. regulatory authorities on the development of regulatory assessments and associated management measures that minimize environmental impacts, and that facilitate innovation, job-creation, and economic growth.

1 Persistent, Bioaccumulative, Toxic (PBT); Very Persistent, Very Bioaccumulative (vPvB)

About the Global Silicones Council:

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 manufacturers 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 role is to promote the safe use and stewardship of silicones globally.

For more information, please contact:

Dr. Pierre Germain
Secretary General
CES – Silicones Europe
Telephone: +32 (0)2 676 73 77

North America
Karluss Thomas
Executive Director
Telephone: + 1 (703) 788 6535

Hideshi Kurihara
Secretary General
Telephone: +81 (3) 3592 1671