On 17 May 2024, the Official Journal of the European Union published Commission Regulation (EU) 2024/1328, 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). To this end, the use of these substances in leave-on and wash-off cosmetic products as well as other consumer and professional products is subject to restrictions.

Background

The European Chemicals Agency identified D4, D5 and D6 as having very persistent and very bioaccumulative (vPvB) properties. Moreover, the Agency 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. The hazard properties of D4, D5 and D6 give rise to specific concerns for the environment when present in consumer and professional products that end up released into both the aquatic and the atmospheric compartments. The restriction aims to minimise the emissions of D4, D5, and D6 caused by leave-on cosmetic products and other consumer and professional products, as well as the emissions of D6 from wash-off cosmetic products.

D4 and D5 are already restricted under REACH Regulation (entry 70 of Annex XVII), and thus they shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0,1 % by weight of either substance, after 31 January 2020.

Note that according to the Cosmetics Regulation (EC) No 1223/2009, D4 is included in the Annex II-List of substances prohibited in cosmetic products. Only technically unavoidable traces are tolerated (max 0.1%).

Νew restrictions on cosmetic products

According to the updated REACH restrictions, decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) can be used in cosmetics according to the following conditions.

• D6 shall not be placed on the market and made available on the market in wash-off cosmetic products in a concentration equal to or greater than 0,1 % by weight of either substance.

• Also, D5, and D6 shall not be placed on the market and made available on the market in leave-on cosmetic products in a concentration equal to or greater than 0,1 % by weight of either substance.

Timeline

• The D6 restriction in wash-off cosmetic products shall apply after 6 June 2027;
• The D5 and D6 restrictions in leave-on cosmetic products shall apply after 6 June 2027.
• D4, D5, and D6 as substances on their own, as constituents of other substances, or generally in mixtures shall not be placed on the market after 6 June 2026 in a concentration equal to or greater than 0,1 % by weight of the respective substance. However, note the exemption until 2027 for cosmetic products.

1. Make sure that by 6 June 2026, non-compliant substances and non-compliant mixtures (e.g., chemical products, (except for cosmetics)) are out of the EU market.
2. Make sure that by 6 June 2027, non-compliant cosmetic products are out of the EU market.

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