Regulatory update, a big restriction on D4, D5, and D6

20/05/2024

Commission Regulation (EU) 2024/1328

Finally, last week was published the Commission Regulation (EU) 2024/1328, introducing further restrictions on the use of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6). This was announced in the summer of 2023.

ECHA identified cosmetic products as the main source of release of these substances in the environment, so this measure addresses the environmental risks associated with using these substances in consumer products that end up being released into the aquatic system and the atmosphere.

This is a big regulatory update, a big restriction on D4, D5 and D6.

What is REACH and why is relevant for cosmetics?

The new regulation amends REACH regarding the use of the mentioned substances. These restrictions are added to those already in place for D4 and D5 in rinse-off cosmetic products, in force since 2020.

REACH is Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation, and restriction of CHemicals in the European Union. REACH applies to substances, not finished products; hence, it affects raw materials that are the constituents of cosmetic products.

Previous amendments related to D4 and D5

The European Commission acted to restrict the use of silicones Octamethylcyclotetrasiloxane (D4) and Decamethylcyclopentasiloxane (D5) in rinse-off personal care products per Regulation (EU) 2018/35.

Later, on the 22nd of May 2019, an amendment to the cosmetics Regulation was published (Commission Regulation (EU) 2019/831), placing D4 (INCI Cyclotetrasiloxane) in Annex II of the Regulation.

As D4 was prohibited, the status of D5 was updated for rinse-off cosmetic products, that must not contain a concentration of Cyclopentasiloxane (D5) higher than 0.1%. At leave-on cosmetic products, Cyclopentasiloxane was not restricted. Cyclomethicone (mixture of D4, D5 and D6) cannot be used anymore, as contains D4.

The same existing restrictions for D4 and D5 apply in the United Kingdom. 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 restrict them under UK REACH further.

New restrictions for D5 and D6

The Commission Regulation (EU) 2024/1328 is complementary and provides a logical extension to the existing restriction on the placing on the market of D4 and D5 in rinse-off cosmetic products, contained in entry 70 of Annex XVII of REACH and D4 at entry 1388 of Annex II of the Cosmetics Regulation. We will be glad if the entire entry will be replaced in the future in the interest of legal certainty, and also for easy reading.

As D4 is already included in Annex II to the EU Cosmetics Regulation – the list of substances prohibited for use in cosmetics, the substance D4 maintains the prohibition of use, and D5 and D6 will change their status, used both in rinse-off and non-rinse cosmetic products at a concentration always less than 0.1% in the final product.

Specifically, the amendment states the following about D4, D5 and D6:

The mentioned substances shall not be placed on the market

  • as a substance on its own;
  • as a constituent of other substances; or
  • in mixtures;

in a concentration equal to or greater than 0,1 % by weight of the respective substance after the 6th of June 2026.

By way of derogation:

  • for D4 and D5 in rinse-off cosmetic products, paragraph 1, point (c), shall apply after the 31st of January 2020.
  • for all cosmetic products other than the ones mentioned in paragraph 3(a), paragraph 1 shall apply after the 6th of June 2027;

A 3-year transition period was established for the new restrictions, considered appropriate to balance two needs by the EU Commission to allow the industry enough time to comply with the new requirements.

Next steps

As a manufacturer or brand owner of cosmetic products, you need to verify if your products comply with Regulation 2024/1328 and, if your products contain D5 or D6, verify if they meet the concentration limit of 0.1%. Otherwise, a product reformulation will be needed.

After that, a new Safety Assessment must be done, retesting and updating the CPNP. Moreover, you must ensure that non-compliant products are out of the EU market by the end of the transition period.

To ensure compliance of your cosmetic products, contact us today to receive further information.

For detailed information click here.

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