On 23 May 2023, the European Union transmitted to the WTO a draft Regulation aiming to ban 12 cosmetic ingredients in the form of nanomaterials, and to introduce restrictions on the use of a 13th. A first text had already been transmitted in February 2022: it has been corrected to take into account the latest SCCS Opiniosn.
The key points of the draft Regulation
• Addition of 12 new entries in Annex II (prohibited substances) to Cosmetics Regulation 1223/2009:
-> Styrene/Acrylates Copolymer (nano)
-> Sodium Styrene/Acrylates Copolymer (nano)
-> Copper (nano)
-> Colloidal Copper (nano)
-> Colloidal Silver (nano)
-> Gold (nano)
-> Colloidal Gold (nano)
-> Gold Thioethylamino Hyaluronic Acid (nano)
-> Acetyl Heptapeptide-9 Colloidal Gold (nano)
-> Platinum (nano)
-> Colloidal Platinum (nano)
-> Acetyl Tetrapeptide-17 Colloidal Platinum (nano) • Addition of Hydroxyapatite (nano) in Annex III (restricted substances), with the following conditions: -> authorised only in toothpastes (maximum 10%) and mouthwashes (maximum 0.465%) -> authorised only in the form 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, not coated or surface modified -> prohibited in applications that may lead to exposure of the end-user’s lungs by inhalation
Notification Date
23 May 2023
Products covered
Cosmetics
Title of the notified document
Draft Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of the nanomaterials Styrene/Acrylates copolymer, Sodium Styrene/Acrylates copolymer, Copper, Colloidal Copper, Hydroxyapatite, Gold, …
