Today marks a significant development in the cosmetics industry as the Official Journal of the European Union publishes Commission Regulation (EU) 2024/858. This crucial amendment to EU Cosmetics Regulation (EC) No. 1223/2009 sets strict guidelines on using specific nanomaterials in cosmetic products, driven by the latest scientific assessments by the Scientific Committee on Consumer Safety (SCCS).
What changes?
The updated regulation explicitly lists nanomaterials that are now banned in cosmetics, including various forms of copper, gold, and platinum, along with specific copolymers. In addition, hydroxyapatite (nano) use in toothpastes and mouthwashes is restricted to ensure consumer safety.
The amended annexes and their respective new entries are set out below.
The updated Annex II now includes the following nanomaterials banned in cosmetics:
– Nano Styrene/Acrylates copolymer and Sodium Styrene/Acrylates copolymer.
– Nano Copper and Colloidal Copper (nano)
– Colloidal Silver (nano)
– Gold (nano) and Colloidal Gold (nano)
– Gold Thioethylamino Hyaluronic Acid (nano)
– Acetyl heptapeptide-9 Colloidal Gold (nano)
– Platinum (nano) and Colloidal Platinum (nano)
– Acetyl tetrapeptide-17 Colloidal Platinum (nano)
Annex III has been updated to restrict hydroxyapatite (nano) use: It is limited to 10% in toothpaste and 0.465% in mouthwash. Its application is discouraged when inhalation by the end user is possible.
Key deadlines:
- February 1, 2025: Deadline for manufacturers to stop placing products containing these substances on the EU market.
- November 1, 2025: Products containing these substances must be withdrawn from the EU market.
This regulatory update is crucial for medicine manufacturers, as it signals the urgent need to review and adapt product formulations to meet enhanced safety standards. Meeting the set deadlines is essential to ensure uninterrupted market access and maintain consumer safety standards across the EU.
Next steps:
As a valued partner, we urge you to examine your product portfolio for compliance closely. Our team is available to assist you with any formulation adjustments or regulatory queries you may have. Let’s work together towards a safer and more sustainable future for cosmetics.
Please get in touch with our regulatory affairs team for detailed information on the regulation and its implications.
Stay informed. Comply with the regulation.
