Ingredients in the spotlight: silicones D4, D5, and D6

November 21, 2023. Silicones in cosmetic products have several functions, such as hair and skin conditioning. Furthermore, they make products feel light on the skin as they evaporate rapidly and have water-biding properties that help keep the skin hydrated.

In the summer of 2023, the European Commission notified the WTO of a draft Regulation establishing new restrictions under REACH on the following silicones (cyclosiloxanes):

• Octamethylcyclotetrasiloxane, (Cyclotetrasiloxane, commonly known as D4)
• Decamethylcyclopentasiloxane (Cyclopentasiloxane, commonly known as D5)
• Dodecamethylcyclohexasiloxane, (Clohexasiloxane, commonly known as D6)

These substances are in the spotlight of authorities due to their environmental hazards. They have bioaccumulative and persistent properties and pose a risk to the environment when released in the water and atmosphere. Considering this, EU authorities decided to restrict their use under REACH to mitigate their environmental risks.

The European Commission will likely adopt the draft Regulation by the end of this year. The new restrictions concerning cosmetic products will start applying after a 3-year transition period.

          What is REACH and why it is relevant for cosmetics

REACH is Regulation (EC) No 1907/2006 on the registration, evaluation, authorization, and restriction of chemicals in the European Union. Regulation (EC) No 1907/2006 applies to substances, not finished products; hence, it affects raw materials that are constituents of goods e.g., cosmetics. REACH is a horizontal Regulation and, therefore, it impacts vertical (sectorial) Regulations, such as the EU Cosmetics Regulation.

Additionally, D4 has been classified as a CMR substance, and consequently, it has been prohibited for use in cosmetic products since June 2019. Thus, D4 is listed in Annex II of the EU Cosmetics Regulation, the main purpose of which is to ensure consumer safety.

Check the restrictions

The table below shows the EU restrictions on D4, D5, and D6 in cosmetic products. However, it is important to highlight that the upcoming REACH restrictions concern the use of these substances in several products, such as medical devices, medicines, and dry-cleaning products.

* Wash off = rinse off products, products that, under normal conditions of use, are washed off with water after application (e.g., shampoo, hand soap)

In the United Kingdom, the same existing restrictions for D4 and D5 apply. As for the upcoming limits, they will not directly apply in the UK. However, in March 2023, the Health and Safety Executive opened a call to gather information on cyclosiloxanes to evaluate whether to further restrict them also under UK REACH.

What to do now?

In light of the upcoming REACH restrictions on cyclosiloxanes, as a brand selling cosmetic products in the , you should draft an action plan including the following activities:

• Spread the news within your company and ensure your suppliers are aware of the restrictions;
• Verify with your producers whether this draft Regulation impacts your products;
• Reformulate your products if needed;
• If you need any help in fulfilling regulatory requirements, seek the support of a professional company.

Contact us to receive further guidance on how to comply with the EU requirements on cosmetic products.

 

 

References:

• European Commission. (2023). Commission Regulation (EU) xxx/xxx amending Annex XVII to REACH as regards octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6). Retrieved on 15/11/2023
• European Commission. (2023). Annex. Retrieved on 15/11/2023