SCCS OPINION ON Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes (nano) - SCCS/1649/23 - Preliminary Opinion U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, M. Stepnik, S. Wijnhoven, W.H. de Jong, N. von Goetz The SCCS adopted this document at its plenary meeting on 21-22 Mach 2023 Mise en ligne : 24 Avril 2023 (87 pages) https://health.ec.europa.eu/system/files/2023-04/sccs_o_271_0.pdf https://health.ec.europa.eu/publications/fullerenes-hydroxylated-fullerenes-and-hydrated-forms-hydroxylated-fullerenes-nano_en Publication date : 24 April 2023 Author : Scientific Committee on Consumer Safety (SCCS) Description : SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri (Rapporteur), M. Stepnik, S. Wijnhoven SCHEER members: W.H. de Jong SCCS external experts: N. von Goetz Contact: SANTE-SCCS@ec.europa.eu On request from: European Commission SCCS Number: SCCS/1649/23 Adopted on: 21-22 March 2023 Conclusion of the opinion: (1) In view of the above, and taking into account the scientific data provided, does the SCCS consider Fullerenes, Hydroxylated Fullerenes and hydrated forms of 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 aspects. These uncertainties and data gaps have been indicated in relevant sections of the Opinion and must be addressed by the Notifiers to enable a conclusion on the safety of the materials for use in cosmetic products. In particular, the SCCS has not been able to conclude on the genotoxicity potential of fullerenes (C60 and C70). The available evidence indicates that hydrated forms of hydroxylated fullerenes are genotoxic and hence SCCS considers them as not safe for use in cosmetic products. In view of equivalence as discussed before (see section 3.1.1.5), the same concerns over genotoxicity potential also apply to hydroxylated fullerenes. (2) Based on the currently available scientific literature and SCCS’ expert judgement, the SCCS is requested to assess any further scientific concerns with regard to the use of Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes in cosmetic products and whether a potential risk to human health can be identified according to Article 16(6) Reg.1223/2009. In Annex-1 of this Opinion, the SCCS has noted the basis for concerns over risks that the use of fullerenes, hydroxylated fullerenes and hydrated forms of hydroxylated fullerenes in cosmetic products may pose to the consumer. In brief, the SCCS has a concern in regard to: − the potential presence of impurities, heavy metals, accompanying contaminants and/or organic solvents in the notified nanomaterials. Lack of data on stability of hydroxylated fullerenes and their hydrated forms. − the potential ability of fullerenes and derivatives to induce production of free oxyradicals when used in cosmetic products. − phototoxicity of hydroxylated fullerenes – with similar concerns for the hydrated forms of hydroxylated fullerenes. − sensitising potential of hydroxylated fullerenes. − dermal absorption and systemic availability of the nanoparticles after use in cosmetic products. − distribution of systemically available fullerenes to various organs in the body and potential accumulation of the nanoparticles in certain organs – such as lungs and liver. − the available information does not allow the SCCS to exclude genotoxic/carcinogenic potential of any of the materials assessed in this Opinion. Keywords: SCCS, scientific opinion, Fullerenes, Hydroxylated Fullerenes, hydrated forms of Hydroxylated Fullerenes, nano, CAS/EC No. 99685-96-8/628-630-7, 11538-22-7/-, 182024-42-6/-, Regulation 1223/2009 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes (nano), preliminary version of 21-22 March 2023, SCCS/1649/23.