The Scientific Committee on Consumer Safety (SCCS) Issues Final Opinion on Fullerenes, Hydroxylated Fullerenes, and Their Hydrated Forms

The Scientific Committee on Consumer Safety (SCCS) has released its conclusive opinion on the safety of Fullerenes, Hydroxylated Fullerenes, and hydrated forms of Hydroxylated Fullerenes in cosmetic products. The key findings and conclusions are outlined below:

1. Safety Assessment:

- After thorough evaluation of scientific data, the SCCS cannot determine the safety of Fullerenes, Hydroxylated Fullerenes, and their hydrated forms in cosmetic products due to significant uncertainties and data gaps.

- Physicochemical, toxicokinetic, and toxicological aspects lack sufficient information, and these gaps must be addressed by the Notifiers to establish the safety of these materials for cosmetic use.

- Genotoxicity potential of fullerenes (C60 and C70) cannot be excluded. Hydrated forms of hydroxylated fullerenes are considered genotoxic and, accordingly, are deemed unsafe for cosmetic use. Similar concerns apply to hydroxylated fullerenes.

2. Additional Concerns and Request for Further Assessment:

- The SCCS has identified potential risks associated with the use of these materials in cosmetic products, as follows:

- Presence of impurities (e.g., epoxide forms), heavy metals, contaminants, or organic solvents in the notified nanomaterials.

- Lack of data on the stability of hydroxylated fullerenes and their hydrated forms.

- Potential induction of free oxyradicals by fullerenes and derivatives in cosmetic products.

- Phototoxicity of hydroxylated fullerenes, with similar concerns for their hydrated forms.

- Sensitizing potential of hydroxylated fullerenes.

- Potential dermal absorption and systemic availability of nanoparticles via cosmetic product use.

- Potential distribution of systemically available fullerenes to various organs, with potential accumulation in organs like lungs and liver.

- Insufficient evidence to exclude the genotoxic/carcinogenic potential of the assessed materials.

3. Further Assessment Request:

- Based on the current scientific literature and expert judgment, the SCCS is tasked with evaluating any additional scientific concerns related to the use of these materials in cosmetic products. The aim is to identify potential risks to human health as per Article 16(6) Reg.1223/2009.

4. Concerns Noted in Annex-1:

- The SCCS has documented concerns in Annex-1 regarding the risks associated with the use of fullerenes, hydroxylated fullerenes, and hydrated forms of hydroxylated fullerenes in cosmetic products.

This SCCS opinion urges a comprehensive investigation into the safety of these materials, emphasizing the need to address identified uncertainties and potential risks before considering their use in cosmetic formulations.

Source: European Commission