New Regulation on D4, D5, and D6

On May 17, 2024, the Official Journal of the European Union published Commission Regulation (EU) 2024/1328, amending REACH regulations regarding the use of specific siloxanes: octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6). These new restrictions build upon existing regulations for D4 and D5 in rinse-off cosmetic products.

Environmental Concerns Prompt Regulation

The updated measures aim to mitigate environmental risks associated with these substances, which are often released into aquatic systems and the atmosphere through consumer products. The Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) identified cosmetic products as a significant source of environmental contamination by these siloxanes.

D4 Prohibition and New Restrictions on D5 and D6

D4 is already listed in Annex II of the EU Cosmetics Regulation, which bans its use in cosmetic products. Therefore, the new REACH restrictions for D4 will not impact cosmetics.

For D5 and D6, the new REACH restrictions specify the following conditions:

• Decamethylcyclopentasiloxane (D5):
  • Maximum concentration of 0.1% in rinse-off cosmetic products, effective since January 31, 2020.
  • Maximum concentration of 0.1% in leave-on cosmetic products, effective from June 6, 2027.
• Dodecamethylcyclohexasiloxane (D6):
  • Maximum concentration of 0.1% in both rinse-off and leave-on cosmetic products, effective from June 6, 2027.

Transition Period for Compliance

The European Commission has deemed a three-year transition period appropriate for these new restrictions. This period balances the need to reduce emissions promptly with the necessity for the industry to adapt to the new requirements.

Highlights

• New EU regulation (EU 2024/1328) amends REACH for D4, D5, and D6.
• D4 remains banned in cosmetic products under Annex II of the EU Cosmetics Regulation.
• New limits for D5: 0.1% in leave-on products from June 6, 2027.
• New limits for D6: 0.1% in both rinse-off and leave-on products from June 6, 2027.
• A three-year transition period is provided for industry compliance.

The complete regulation can be accessed through the Official Journal of the European Union.