Nanomaterials future ban: the draft EU Regulation related to the ban of some nanomaterial ingredients in cosmetics described in IL-093 has been updated.

The following changes have been included:

• Addition of COLLOIDAL SILVER (nano) (CAS: 7440-22-4) to the list of ingredients to be banned
• Correction of the restriction on HYDROXYAPATITE (nano): it will be allowed under the conditions below:
  • Max 10% in Toothpaste
  • Max 0.465% in Mouthwash
  • Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.
  • Only qualities of HYDROXYAPATITE (nano) having the following characteristics are allowed:
    [composed of] rod-shaped particles of which at least 95,8 % (in particle number) have an aspect ratio less than 3, and the remaining 4,2 % have an aspect ratio not exceeding 4,9. In addition, particles must not be coated or surface modified

We remind you that below ingredients are still into the draft EU regulation and remain into the list of ingredients to be banned:

• STYRENE/ACRYLATES COPOLYMER (nano) (CAS: 9010-92-8)
• SODIUM STYRENE/ACRYLATES COPOLYMER (nano) (CAS: 9010-92-8)
• COPPER (nano) (CAS: 7440-50-8)
• COLLOIDAL COPPER (nano) (CAS: 7440-50-8)
• GOLD (nano) (CAS: 7440-57-5)
• COLLOIDAL GOLD (nano) (CAS: 7440-57-5)
• GOLD THIOETHYLAMINO HYALURONIC ACID (nano) CAS: 1360157-34-1)
• ACETYL HEPTAPEPTIDE-9 COLLOIDAL GOLD (nano) (CAS: /)
• PLATINUM (nano) (CAS: 7440-06-4)
• COLLOIDAL PLATINUM (nano) (CAS: 7440-06-4)
• ACETYL TETRAPEPTIDE-17 COLLOIDAL PLATINUM (nano) (CAS: /)

The adoption of this regulation is expected to take place on the 3rd quarter of 2023.

Transition periods to allow the industry to comply with these bans will be granted. A tentative timeline would then be the following:

• 9 months after the entry into force only compliant product shall be placed in the Union market which brings us to Q2 2024.
• 18 months after the entry into force only compliant products shall be made available on the Union market which brings us to Q1 2025.

We recommend that you check whether your products contain the ingredients impacted by this ban and check if they are considered as nanomaterials according to the cosmetic Regulation definition. We strongly recommend that you start the phasing out of these ingredients as soon as possible.

We hope that this will be of help and stay at your disposal for any questions related to this topic. Should you have any question, please, feel free to contact your CRM (Customer Relationship Manager) or contact us directly: info@biorius.com.

Thanks to Stéphanie Annet for writing this article.

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