BACKGROUND

The European Chemicals Agency (ECHA) identified Octamethylcyclotetrasiloxane (D4), CAS No. 556-67-2 / 293-51-6; Decamethylcyclopentasiloxane (D5), 541-02-6; and Dodecamethylcyclohexasiloxane (D6), CAS No. 540-97-6, as having very persistent and very bioaccumulative (vPvB) properties. Furthermore, ECHA identified D4 as having persistent, bioaccumulative and toxic (PBT) properties, and D5 and D6 as having PBT properties when they contain 0.1% or more by weight of D4.

D4 and D5 are already restricted under Regulation (EC) No 1907/2006, known as REACH Regulation (entry 70 of Annex XVII), and shall not be placed on the market in rinse-off cosmetic products in a concentration equal to or greater than 0,1 % by weight of either substance, since 31 January 2020.

D4 is included in Annex II to Regulation (EC) No. 1223/2009 (list of substances prohibited in cosmetic products).

WHAT’S NEW?

On 22 June 2023, the European Commission notified the World Trade Organization (WTO) of a draft amendment to REACH Regulation. The notification concerns the amendment of Annex XVII as regards to D4, D5 and D6, with applicable restrictions in leave-on and rinse-off cosmetic products.

This draft regulation aims to restrict the placing on the market of D4, D5, and D6 on their own, as a constituent of other substances (but excluding polymers), and in mixtures in consumer and professional products.

WHAT NOW?

Cosmetic brands must ensure that cosmetic products containing D4, D5 or D6 comply with the aplicable restrictions within the established timelines, as follows:

Cyclotetrasiloxane (D4), 556-67-2 / 293-51-6

Already listed in Annex II – Prohibited in cosmetic products. Only technically unavoidable traces are tolerated as follows:

– In rinse-off products: already restricted at max 0.1%
– In leave-on products: max 0.1% from Q4 2026

Cyclopentasiloxane (D5), 541-02-6

– In rinse-off products: already restricted at max 0.1%
– In leave-on products: max 0.1% from Q4 2026

Cyclohexasiloxane (D6), 540-97-6

– In wash-off products: max 0.1% from Q4 2025
– In leave-on products: max 0.1% from Q4 2026

References:

WTO Notification G/TBT/N/EU/989 – Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6)