On 15 March 2024, the Official Journal of the European Union published Commission Regulation (EU) 2024/858 on the use of several nanomaterials, amending the EU Cosmetics Regulation.
Amendments to Annex II and III
In the Annex II-List of substances prohibited in cosmetic products, the following entries are added.
- Styrene / Acrylates copolymer (nano), CAS no 9010-92-8
- Sodium Strylene / Acylates copolymer (nano), CAS no 9010-92-8
- Copper (nano), CAS no 7440-50-8
- Colloidal Copper (nano), CAS no 7440-50-8
- Colloidal Silver (nano), CAS no 7440-22-4
- Gold (nano), CAS no 7440-57-5
- Colloidal Gold (nano), CAS no 7440-57-5
- Gold Thioethylamino Hyaluronic Acid (nano), CAS no 1360157-34-1
- Acetyl heptapeptide-9 Colloidal gold (nano)
- Platinum (nano), CAS no 7440-06-4
- Colloidal Platinum (nano), CAS no 7440-06-4
- Acetyl tetrapeptide-17 Colloidal Platinum (nano)
In the Annex III-List of substances that cosmetic products must not contain except subject to the restrictions laid down, the following entry is added.
| INCI name | CAS no | Product type, body parts | Maximum concentration in ready use preparation | Other |
| Hydroxyapatite (nano) | 1306-06-5 | (a) Toothpaste (b) Mouthwash | (a) 10 % (b) 0,465 % | For (a) and (b): Not to be used in applications that may lead to exposure of the end-users lungs by inhalation. Only nanomaterials having the following characteristics are allowed: 1) [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; 2) the particles are not coated or surface-modified |
Timeline
This Regulation will enter into force on 4 April 2024.
Regarding the new entries in Annex II; From 1 February 2025 cosmetic products containing that substances shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance shall not be made available on the Union market.
Regarding the new entry in Annex III; From 1 February 2025 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance shall not be made available on the Union market.