Silicones are also known as siloxanes, and the substances D4 (octamethylcyclotetrasiloxane), D5 (decamethylcyclopentasiloxane) and D6 (dodecamethylcyclohexasiloxane) are all on the EU Candidate List of Substances of Very High Concern (SVHC).
After 6 June 2026, it will no longer be permitted to place any of these silicone substances on the market as a substance on its own, as a constituent of other substances or in mixtures in a concentration of 0.1% by weight.
In addition, there are deadlines by which the use of D4, D5 and D6 will no longer be allowed in a wide range of products, including:
- 6 June 2027: all cosmetic products (in wash-off products, D4 and D5 have already been regulated since 31 January 2021)
- 6 June 2031: medicinal products and veterinary medicinal products
- 6 June 2031: medical devices, including in vitro diagnostic medical devices
However, specific exemptions apply where D4, D5 and D6 occur as residues from silicone polymers in medical devices.
See all deadlines for D4, D5 and D6 in Commission Regulation 2024/1328 amending Annex XVII of REACH
For more information on the use of silicone substances in medical devices and cosmetics, please contact:
Poul Bo Larsen
pbl@dhigroup.com
Tel +45 4516 9478
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