Cosmetics and Siloxanes

In May 2019, D4 was added to Annex II of the EU Cosmetic Regulation N°1223/2009. This listing went into effect in June 2019. Materials on Annex II cannot be added intentionally to cosmetic formulations sold in the EU. However, the unintended presence of a small quantity of an Annex II substance is permissible in cosmetic formulations in the EU, provided:

  • such presence stems from an incidental source (such as impurities of ingredients, the manufacturing process, storage, or migration from packaging)
  • such presence is technically unavoidable in good manufacturing practice
  • the product remains safe for human health when used under normal or reasonably foreseeable conditions of use.

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. It further concluded in 2016 that D5 in cosmetic products is safe at the reported concentrations, except for use in hair styling aerosols and sun care spray products.

In 1991, the US Cosmetic Ingredient Review Committee studied the safety of cyclic methylsiloxanes (D3-D7) as cosmetic raw materials and reached the conclusion that these compounds are safe in cosmetic applications. In 2009, the safety evaluation of cyclic methylsiloxanes (D3-D7) as cosmetic raw materials was re-evaluated, but the same conclusion has been maintained: the application of these compounds in cosmetics is safe.


Learn about “Wash-Off” and “Leave-On” restrictions.

Substances of Very High Concern

The silicones industry believes that D4, D5, and D6 as SVHCs, ECHA do not meet the criteria of vPvB and PBT substances.

Draft Authorization Proposal

ECHA has identified D4, D5, and D6 in its draft recommendation as potential candidates for an authorization requirement.