In the framework of the assessment of nanomaterials notified under Article 16 of the Cosmetics Regulation 1223/2009, the SCCS assessed the safety of Fullerenes and Hydroxylated Fullereness. The Scientific Committee has just published its preliminary Opinion, adopted at its plenary meeting on 26 October 2023.
Background
The Commission services received 19 notifications under Article 16 of the Cosmetics Regulation via the Cosmetic Product Notification Portal (CPNP) for cosmetic products containing Fullerenes and Hydroxylated Fullerenes (CAS/EC No.: 99685-96-8/628-630-7, 11538-22-7/-, 182024-42-6/-).
Currently, Fullerenes and Hydroxylated Fullerenes are not regulated under the Cosmetic Regulation (EC) No.1223/2009.
The Commission had concerns on the use of Fullerenes and Hydroxylated Fullerenes because of the potential for nanoparticles to be absorbed dermally or across a mucous membrane and to enter cells and mandated the SCCS to assess their safety.
The Scientific Committee published its preliminary Opinion in May 2023.
For an exhaustive background information, see the articles
• Fullerenes, α- and β-arbutin: Requests for Opinions of the SCCS, CosmeticOBS, 5 July 2021
• Fullerenes: preliminary Opinion of the SCCS, CosmeticOBS, 2 May 2023
This Opinion has been subject to a commenting period (from 24 April to 12 June 2023) after its initial publication. Comments received during this period were considered by the SCCS.
For this Opinion, main changes occurred in the sections on physicochemical part and in toxicokinetic part, based on the newly submitted information.
The final Opinion
1. In view of the above, and taking into account the scientific …
