In the framework of the assessment of nanomaterials notified under Article 16 of the Cosmetics Regulation 1223/2009, the European Commission had mandated the SCCS to assess the safety of Fullerenes and Hydroxylated Fullerenes in June 2021. The Scientific Committee has just published its preliminary Opinion, adopted at its plenary meeting on 21-22 March 2023. It is open for comment until 12 June 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 has 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.
For an exhaustive background information, see the article
• Fullerenes, α- and β-arbutin: Requests for Opinions of the SCCS, CosmeticOBS, 5 July 2021
Opinion
1. In view of the above, and taking into account the scientific data provided, does the SCCS consider Fullerenes and Hydroxylated Fullerenes safe when used in cosmetic products according to the maximum concentrations and specifications as reported via CPNP, taking into account reasonably foreseeable exposure conditions?
Having assessed the information provided by the Notifiers, and the information available from published literature, the SCCS has not been able to conclude on the safety of fullerenes and (hydrated) hydroxylated forms of fullerenes due to a number of uncertainties and data gaps in regard to physicochemical, toxicokinetic and toxicological …
