Today, May 17, 2024, the Official Journal of the European Union published Commission Regulation (EU) 2024/1328. As anticipated, the new Regulation amends REACH regarding the use of octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6). These restrictions are added to those already in place under REACH for D4 and D5 in rinse-off cosmetic products.
This measure is necessary to address the environmental risks associated with the use of these substances in consumer products that end up being released into the aquatic system and into the atmosphere. Furthermore, the Risk Assessment Committee (RAC) of ECHA identified cosmetic products as the main source of release of these substances in the environment.
It is important to remind that D4 is included in Annex II to the EU Cosmetics Regulation – the list of substances prohibited for use in cosmetics. Hence, the new REACH restrictions for this substance will not affect cosmetic products since its use is already banned.
New restrictions for D5 and D6
According to the updated REACH restrictions, decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) can be used in cosmetics according to the following conditions.
Decamethylcyclopentasiloxane (D5):
- Up to a maximum concentration of 0,1% in rinse-off cosmetic products since January 31, 2020 (already applicable);
- Up to a maximum concentration of 0,1% in leave-on cosmetic products as of June 6, 2027.
Dodecamethylcyclohexasiloxane (D6):
- Up to a maximum concentration of 0.1% in rinse-off and leave-on cosmetic products as of June 6, 2027.
In the opinion of the European Commission, a 3-year transition period for the new restrictions is appropriate to balance two needs. On one side, the need limit the emissions in a timely manner. On the other side, the necessity to allow the industry enough time to comply with the new requirements.
What to do now
As a manufacturer or brand owner of cosmetic products, you need to verify whether your products contain D5 or D6. If so, you have to verify whether they meet the concentration limit of 0.1% or otherwise proceed with the reformulation, retesting, and renotification to the CPNP. Moreover, you must ensure that by June 6, 2027, non-compliant products are out of the EU market. To this end, a good management of the supply chain is essential.
Do you need help to ensure compliance of your cosmetic products? Contact us today to receive further information on how we can assist you.
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