EU Procedures & Regulations

EU regulatory framework for silicones

The European Union (EU) has one of the most comprehensive regulatory frameworks for chemicals in the world, complemented by sector-specific legislation. This page will give you an insight into the relevant EU procedures and latest policy updates

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Siloxanes are amongst the most studied substances and have a rich data set of toxicological and ecotoxicological data. Some siloxanes like volatile cyclic methylsiloxanes D4 (Octamethylcyclotetrasiloxane), D5 (Decamethylcyclopentasiloxane) and D6 (Dodecamethylcyclohexasiloxane) have been under regulatory evaluation in the EU for many years. For wash-off cosmetic uses, an EU restriction entered into force in 2022 to restrict formulations containing D4 or D5 in quantities of more or equal to 0.1 % w/w .

European regulators have adopted a consumer and professional use restriction proposal for the placing of D4, D5 and D6 on both consumer and professional markets.

In parallel an authorisation proposal by ECHA for D4, D5 and D6 is under evaluation by the European Commission. It is also important to mention that other regulatory authorities outside the EU conducted risk evaluations of some volatile siloxanes including D4, D5 and D6. As of today there are no use restrictions in place outside the EU.

In view of the European Green Deal’s objective to achieve a toxic-free environment, the European Commission is in the process of revising both REACH and CLP. While considerable progress has been made on CLP, whose revised text has been agreed on by the co-legislators, the European Commission is yet to present the REACH revision. The process was initiated by the Chemicals Strategy for Sustainability, which set the EU’s ambition to put in place stricter requirements for the management of chemicals and to ensure the improved harmonisation and efficiency of the chemical regulatory framework.

Cyclosiloxanes and the EU

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Linear siloxanes and the EU

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Product Specific-Regulations

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Core to the EU’s chemicals policy are the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the Regulation on Classification, Labelling and Packaging (CLP), which work in synchrony to ensure a high level of human health and environmental protection. Silanes and non-polymeric siloxanes are registered under REACH.

In view of the European Green Deal’s objective to achieve a toxic-free environment, the European Commission is in the process of revising both REACH and CLP. The process was initiated by the Chemicals Strategy for Sustainability, which set the EU’s ambition to put in place stricter requirements for the management of chemicals and to ensure the improved harmonisation and efficiency of the chemical regulatory framework.

In addition, sector-specific legislation addresses the use of chemicals in key products and product groups, among which cosmetics, food contact materials, and medical devices. Some of the sector-specific legislation is also subject to revision to contribute to the EU’s environmental objectives and ensure regulatory consistency.

For more information on the international framework, please visit the Global Silicones Council’s website.

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Silicones and Registration, Evaluation, Authorisation and Restriction of Chemicals

The purpose of REACH is to ensure the safe use of manufactured and imported chemicals, throughout their whole life cycle. REACH is based on the key principle of “no data, no market”, which obliges manufacturers and importers to manage the risks of chemical substances and to collect information on their properties. Companies have to register their chemical substances with the European Chemicals Agency (ECHA), which evaluates the compliance of the registrations. In addition, the EU Member States can evaluate chemical substances in the case of presence of human and environmental concerns. To ensure the highest level of safety, substances could be subject to prior authorisation or restriction, if risks are proven to be unmanageable.

Silicones and Classification, Labelling and Packaging Regulation

CLP obliges companies to classify, label and package chemicals identified as hazardous in an appropriate manner. If the CLP classification criteria are met, the hazardous properties of substances and mixtures are assigned hazard classes and categories. In line with the established hazard classification, CLP provides provisions for the labelling and packaging of the substances. In addition, the Regulation is the basis of key risk management provisions.