EU Cosmetics Regulation 2024: New Ingredient Restrictions

On April 3, 2024, the European Commission adopted Regulation (EU) 2024/996, bringing further amendments to the Cosmetics Regulation (No. 1223/2009). The new regulation aims to improve safety standards, foster innovation, and reduce the environmental impact within the cosmetics industry. This update revises several key Annexes of the Cosmetics Regulation, informed by the latest scientific recommendations from the Scientific Committee on Consumer Safety (SCCS).

Key Updates in EU Cosmetics Regulation

Annex II: Prohibited Substances

A significant change comes with the addition of the UV-filter 4-Methylbenzylidene Camphor (4-MBC) to Annex II, which means it is now prohibited in cosmetic products. Previously listed in Annex VI, 4-MBC will no longer be allowed in products marketed in the EU after the following dates:

• • May 1, 2025: Products containing 4-MBC cannot be placed on the EU market.
  • May 1, 2026: Products containing 4-MBC cannot be made available for sale.

Annex III: Restricted Substances

Several new restrictions have been introduced under Annex III:

• • Vitamin A Derivatives: Retinol, Retinyl Acetate, and Retinyl Palmitate are now restricted. The new regulations limit the concentration of these substances in body lotions to 0.05% Retinol Equivalent (RE) and 0.3% in leave-on and rinse-off products. A new labeling requirement mandates that manufacturers include the text: “Contains Vitamin A. Consider your daily intake before use.”
  • Alpha-Arbutin and Arbutin: These skin-lightening agents are now restricted. Alpha-Arbutin is limited to 2% in face creams and 0.5% in body lotions. Arbutin has a concentration limit of 7% in face creams.
  • Genistein and Daidzein: The new regulation sets maximum concentrations for these compounds at 0.007% for Genistein and 0.02% for Daidzein in ready-to-use products.
  • Kojic Acid: Kojic Acid can now be used in face and hand products at a concentration of up to 1%.

Implementation Timelines:

• • Feb 1, 2025: Products containing Genistein, Daidzein, Kojic Acid, Alpha-Arbutin, and Arbutin that do not meet the new restrictions cannot be placed on the EU market.
  • Nov 1, 2025: These products will no longer be allowed to be made available for sale.
  • Nov 1, 2025: Retinol, Retinyl Acetate, and Retinyl Palmitate restrictions will take effect for placement on the market.
  • May 1, 2027: Products containing these Vitamin A derivatives will not be allowed to be made available on the market after this date.

Annex V: Preservatives – New Additions

Two preservatives, Triclocarbon and Triclosan, are now subject to new restrictions:

• • Triclocarbon: May be used in cosmetic products at a maximum concentration of 0.2%, excluding mouthwash. It must not be used in toothpaste intended for children under 6. A mandatory labeling requirement states: “Not to be used for children under 6 years of age.”
  • Triclosan: May be used at a maximum concentration of 0.3%, with a labeling warning: “Not to be used for children under 3 years of age.”

Implementation Timelines:

• • Dec 31, 2024: No new products containing Triclocarbon and Triclosan may be placed on the market.
  • Oct 31, 2025: Products containing these substances may no longer be made available on the market.

Compliance and Industry Action

These amendments reflect the cosmetics industry’s commitment to improving product safety, fostering innovation, and enhancing environmental stewardship. Manufacturers must ensure their products comply with the new restrictions by reviewing their ingredient lists, updating formulations, and including the necessary labeling. Consultation with regulatory experts and using advanced analytical methods will be essential to ensuring compliance.

For guidance on navigating evolving EU cosmetics regulations, contact us today.