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July 6, 2021

EC Requests Scientific Opinion on Fullerenes and Hydroxylated Fullerenes

Lynn L. Bergeson Carla N. Hutton

The European Commission (EC) has requested a scientific opinion from the Scientific Committee for Consumer Safety (SCCS) on fullerenes and hydroxylated fullerenes. According to the request, the EC has received 19 notifications under Article 16 of the Cosmetics Regulation for cosmetic products containing fullerenes and hydroxylated fullerenes. The request states that these ingredients “are reported in CosIng database with the function of ‘antimicrobial’ and ‘skin conditioning-miscellaneous’ and in the open literature as ‘antioxidants’ (scavenging ability against free radicals).” Currently, fullerenes and hydroxylated fullerenes are not regulated under the Cosmetic Regulation (EC) No. 1223/2009. The EC is concerned “because of the potential for nanoparticles to be absorbed dermally or across a mucous membrane and to enter cells.” The EC asks whether SCCS considers fullerenes and hydroxylated fullerenes safe when used in cosmetic products according to the maximum concentrations and specifications as reported, taking into account reasonably foreseeable exposure conditions. The EC also asks SCCS to assess any further scientific concerns with regard to the use of fullerenes and hydroxylated fullerenes in cosmetic products and whether a potential risk to human health can be identified according to Article 16(6) Reg.1223/2009. The deadline for the opinion is six months.