EU Procedures & Regulations

Product-specific Regulations

All sensitive applications of silicones are thoroughly regulated by sector-specific legislation to ensure their safety. This includes cosmetics, food contact materials, and medical applications.

Silicone in 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 updated its Medical Device Regulation in 2017, replacing all existing directives.

Silicones in Personal Care Products

In the EU, cosmetic products are regulated by the Cosmetic Products Regulation. The EU regulatory authorities are assisted with scientific advice by the Scientific Committee for Consumer Safety (SCCS). In 2010, SCCS concluded that cyclomethicone, the silicone mixture used in personal care products, does not pose a risk to human health when used in cosmetics. It further concluded in 2016 that D5 in cosmetic products is safe at the reported concentrations, except for use in hairstyling aerosols and sun care spray products.

In line with the Chemicals Strategy for Sustainability, the European Commission is in the process of revising the Cosmetic Products Regulation. The Commission is expected to publish its revised proposal in 2023. The revision of the Regulation will not have an immediate impact on silicone products.

Silicone in Food Contact Materials

In the EU, all food contact materials (FCMs) are regulated by the Food Contact Materials Regulation (EC 1935/2004). This regulation establishes safety requirements for articles and materials intended to come in contact with food, including that 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.

The FCMs Regulation is currently under revision, which is expected to address the perceived lack of prioritisation of the most hazardous substances, among other aspects. The Commission is expected to publish the revised Regulation in 2023. The revision of the Regulation will not have an immediate impact on silicone products.