Draft Authorization Proposal

ECHA has identified D4, D5, and D6 in its draft recommendation as potential candidates for an authorization requirement. The reason why D4, D5 and D6 are considered is due to their PBT and vPvB classification, high volumes and wide-dispersive uses.

According to standard REACH procedure, ECHA compiles, at least every second year, a list with substances it recommends prioritizing for authorization. In addition to D4, D5, and D6 the draft list contains four substances. If a substance is subject to an authorization requirement, all uses in scope of the authorization requirement are banned in the EU unless the EU Commission grants specific permissions The ECHA draft recommendation includes exemptions for D4, D5 and D6 when used as monomers and intermediates. An exemption also applies to polymers with unintentional residues of D4, D5 or D6, both as substances and as part of mixtures.

The silicones industry contends that an authorization requirement for D4, D5, and D6 by the EU would be inconsistent with sound science and out of step with regulatory outcomes for these substances in other regions of the world, including Australia and North America. The EU proposal for authorizing D4, D5, and D6 is an unfortunate consequence of the EU’s precautionary approach for these silicone materials. The EU’s assessment of D4, D5, and D6 did not consider all available evidence, did not consider the unique properties of these substances, and ignored technical input from leading academic experts.

GSC provided extensive comments during the public consultation on this proposal, which ended in June, 2020. The next step in the process is that the ECHA Member State Committee will prepare an opinion on ECHA’s draft recommendation. Based on the Member State Committee’s opinion and the consultation, ECHA will provide its final recommendation on all seven proposed substances to the European Commission in the Spring of 2021. The Commission then will decide which of the substances to include in the Authorization List.


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.

Cosmetics and Siloxanes

Learn about Annex II of the EU Cosmetics Regulation.