On 15 March 2024, Regulation 2024/858 was published, amending Annexes II and III of Regulation 1223/2009 with regard to certain nanomaterials.
The following have been added to Annex II (and are therefore prohibited in cosmetic products):
– Styrene/Acrylates copolymer (nano) – CAS 9010-92-8
– Sodium Styrene/Acrylates copolymer (nano) – CAS 9010-92-8
– Copper (nano), Colloidal Copper (nano) – CAS 7440-50-8
– Colloidal silver (nano) – CAS 7440-22-4
– Gold (nano), Colloidal Gold (nano) – CAS 7440-57-5
– Gold Thioethylamino Hyaluronic Acid (nano) – CAS 1360157-34-1
– Acetyl heptapeptide-9 Colloidal gold (nano) –
– Colloidal Platinum (nano) – CAS 7440-06-4
– Acetyl tetrapeptide-17 Colloidal Platinum (nano) –
Annex III was instead amended as follows:
Hydroxyapatite (nano) (CAS – 1306-06-5), to be used
– In toothpastes – maximum 10%
– In mouthwashes – maximum 0.465%.
Not to be used in applications that may lead to exposure of the end-user’s lungs through inhalation.
Only nanomaterials with the following characteristics are permitted:
– consisting of rod-shaped particles, of which at least 95.8 % (in particle number) have a size ratio of less than 3 and the remaining 4.2 % have a size ratio of no more than 4.9
– the particles are not coated or surface modified.
These provisions apply:
– From 1 February 2025 for products newly placed on the market
– From 1 November 2025 for products already on the market
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