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EU Enhances Restriction on the Use of Silicone D4, D5 and D6

By June 6, 2027, D4, D5 and D6 shall not be used in all cosemtic products with concentration of more than 0.1%.

On May 16, 2024, the European Commission adopted Regulation (EU) 2024/1328 to amend REACH Regulation (Regulation (EC) 1907/2006), which introduces more restrictions on the use of D4, D5, and D6.

Octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) are basic members of the broad family of silicone materials. They are primarily used as emollients, which help to moisturize and soften the skin, as well as improve the texture and spreadability of cosmetic products. 

The use of these silicones in cosmetics has been a topic of regulatory scrutiny in some regions, notable in EU. On January 10, 2018, the Commission adopted Commission Regulation (EU) 2018/35 restricting the placing on the market of D4 and D5 in wash-off cosmetic products.

On June 13, 2018, D4, D5 and D6 were identified by the Member State Committee of the European Chemicals Agency (ECHA) as substances of very high concern (SVHC) with very persistent and very bioaccumulative (vPvB) properties. D4 was identified as having persistent, bioaccumulative and toxic (PBT) properties. D5 and D6 were also identified as having PBT properties when they contain 0.1 % or more by weight of D4.

To address the risks to the environment posed by the use of D4, D5 and D6 when discharged into environmental compartments, the following restrictive measures are supplemented: 

  • By June 6, 2026, D4, D5 and D6 shall not be placed on the market as a substance on its own or in mixtures in a concentration equal to or greater than 0.1%;

  • By June 6, 2025, D4 and D6 shall not be used as a solvent for the dry cleaning of textiles, leather and fur;

  • By June 6, 2027, D4, D5 and D6 shall not be used in leave-on cosmetics with concentration equal to or greater than 0.1%;

  • By June 6, 2031, D4, D5 and D6 shall not be used in devices, medicinal products, and veterinary medicinal products;

  • By June 6, 2034, D5 shall not be used as a solvent in the dry cleaning of textiles, leather and fur.

The new Regulation can be accessed here

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