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Editor's note: This article was originally published on June 27, 2023, and was updated on May 17, 2024, as per the latest developments. The updated contents are marked in red below.
On June 22, 2023, EU introduced new amendments to the Annex XVII to Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) through a draft regulation notified to WTO. This draft proposed to further restrict the use of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6) in cosmetics as well as other consumer and professional products.1 On May 17, 2024, EU published the finalized regulation titled Commission Regulation (EU) 2024/1328 in its Official Journal, which will come into effect on June 6, 2024.2
Reason for Amendments
D4, D5, and D6 are listed as substances of very high concern (SVHC) under REACH due to their very persistent and very bioaccumulative (vPvB) properties. On January 10, 2018, the European Commission adopted the Commission Regulation 2018/35 to restrict rinse-off cosmetics containing D4 and/or D5 to be placed on the market. This restriction has come into effect since January 31, 2020.
When the Committee for Risk Assessment (RAC) assessed the proposal that was ultimately adopted in Commission Regulation 2018/35, it did not exclude a potential risk of using D4 and D5 in leave-on cosmetics. For this reason, the Commission mandated the European Chemicals Agency (ECHA) to prepare a dossier to assess the risks associated with D4 and D5 in leave-on cosmetics, as well as in other consumer and professional products. Later in February 2018, the Commission requested ECHA to also include D6 in the dossier, given its similarities to D4 and D5 in terms of properties and potential risks. Based on ECHA's submitted dossier, together with the supporting opinions from RAC and the Committee for Socio-economic Analysis (SEAC), the Commission proposed the new amendments.
Amendments Related to Cosmetics
The Commission Regulation imposes a stricter restriction on D4, D5, and D6 in rinse-off and leave-on cosmetics. As per it, the respective concentration of these substances shall be less than 0.1% in both types of cosmetics. In terms of the transitional period,
For rinse-off cosmetics containing D6, this restriction will come into effect on June 6, 2027;
For leave-on cosmetics containing D4, D5 and D6, this restriction will come into effect on June 6, 2027.
Exceptionally, the transitional period does not apply to rinse-off cosmetics containing D4 and D5, as the corresponding restriction has already taken effect from January 31, 2020, in accordance with the Commission Regulation 2018/35.
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