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Product Regulation

All sensitive applications that silicones are used in are thoroughly regulated by specific sectoral legislation to ensure their safety. This includes food contact materials, medical applications and cosmetics.

Cosmetics and personal care

Cosmetic products are regulated in the EU by the Cosmetics Regulation (EC 1223/2009), which places strong safety requirements on cosmetic products and require the preparation of a special product safety report prior to placing a cosmetic product on the market.

The regulatory authorities in the EU are supported by scientific committees, which provide advice on specific substances used in cosmetic products. In 2010, the Scientific Committee for Consumer Safety (SCCS) concluded that cyclomethicone, the silicone mixture used in personal care products, does not pose a risk to human health when used in cosmetics. The European Chemicals Agency (ECHA) is currently assessing the use of certain silicones in rinse-off personal care products. ECHA’s conclusions are expected at the end of 2015.

Food contact materials

In Europe, all food contact materials are regulated by the Food Contact Framework Regulation (EC 1935/2004). This regulation provides the basis for securing a high level of protection of human health for all articles and materials intended to come into contact with food (directly or indirectly). Article 3 of this regulation provides general but essential requirements for such food contact materials: they may not transfer substances to food which change the composition, endanger human health and/or change the taste and smell of food. Specific migration limits have been set for certain substances.

Silicone rubbers are also subject to national provisions, such as the French Arrêté of 25 November 1992 and the Recommendation XV. Silicone of the German Institute for Risk Assessment.

Medical applications

Silicone materials can be manufactured and used for a wide range of different applications and must meet high quality standards. The manufacturing of materials for medical applications is particularly strictly regulated, in Europe as well as in other regions of the world.

The EU is currently in the process of updating its legal framework on Medical Devices, which currently consists of three directives. The purpose, among other things, is to further improve the traceability of products intended for medical use.

CES member companies communicate to their customers documentation such as data sheets and safety data sheets to ensure that they are informed about the properties of the raw material they purchase and help them to comply with the applicable regulations.