RIVM on Advanced Materials, March 2024

The safety of fullerenes in cosmetic products is uncertain, according to the EU European Union (European Union) Scientific Committee on Consumer Safety (SCCS). The information provided by the Notifier on the possible genotoxicity of fullerenes and other concerns was insufficient. The European Commission has recently proposed a new rule requiring the industry to provide additional data in the short term. If the industry fails to do so, fullerenes will be banned for use in cosmetic products, like other nanomaterials.

The use of fullerenes in cosmetics

Fullerenes are nanomaterials consisting of carbon-atoms that form a hollow football-like structure. They are used in cosmetic products because of their antioxidant, antimicrobial and skin-conditioning properties. Several manufacturers have reported using different forms of fullerenes in new cosmetic products in the Cosmetics Products Notification Portal (CPNP). Forms include fullerenes, hydroxylated fullerenes and hydrated forms of hydroxylated fullerenes. In the EU, fullerenes are currently not regulated under the Cosmetic Regulation ((EC) No. 1223/2009). 

Safety assessment by SCCS 

The European Commission (EC) is concerned about the use of different forms of fullerenes in cosmetic products. This is mainly because nanoparticles can get into the body and enter cells. Nanoparticles can absorb through the skin or cross a mucous membrane. Therefore, the EC asked the Scientific Committee on Consumer Safety (SCCS) to evaluate the safety of using fullerenes in cosmetic products. The SCCS assessed the information provided by the Notifiers and the available information from published literature. 

Various concerns on safety 

The committee could not determine if the different forms of fullerenes are safe for use in cosmetics. This is because there are several uncertainties and data gaps in the information. Specifically, the SCCS could not decide whether or not fullerenes in different forms are genotoxic. Thus, the SCCS does not consider fullerenes to be safe for use in cosmetic products. 

In addition to their possible genotoxic potential, the SCCS has other concerns about fullerenes. These include: 

  • Possible impurities and lack of data on the stability of hydroxylated fullerenes. 
  • The potential ability of fullerenes and derivatives to produce free oxyradicals and the phototoxicity and sensitising potential of hydroxylated fullerenes. 
  • The potential of fullerenes to be absorbed through the skin and distributed throughout the body. 

Before the SCCS can determine whether fullerenes are safe for cosmetic products, the Notifiers must address these uncertainties and data gaps. Only if SCCS deems the use of fullerenes safe can cosmetic products containing fullerenes enter the European market. 

Safety of other nanomaterials in cosmetic products

Previously, the SCCS evaluated other nanomaterials. For 12 nanomaterials, the safety could not be determined due to insufficient data provided by the Notifier. These 12 nanomaterials include nanoforms with styrene/strylene, copper, hydroxyapatite, gold, and platinum. 

In 2021, the SCCS published a Scientific Advice on the safety of nanomaterials used in cosmetics. The report includes a list of nanomaterials that are of concern and must undergo a safety assessment. If the data is insufficient, the EC must ban them. 

In October 2023, the EC adopted a draft Regulation called the ‘Omnibus Act on nanomaterials’. The Act will ban these 12 nanomaterials in cosmetics and add them to Annex II of the Cosmetics Regulation. The ban is based on the above-mentioned Scientific Advice and subsequent opinions

The inconclusive opinion of the fullerenes indicates that these may go a similar path. If the industry does not provide additional data in the short term, these materials will also be banned. 

Reflections by RIVM 

It is a good development that the European Commission is proposing a new rule to stop using specific nanomaterials in cosmetics. These nanomaterials are of concern for human health, either because people are exposed large amounts or because they are harmful. 

If a cosmetic company wants to use nanomaterials, it must demonstrate that it is safe. Sometimes, manufacturers do not provide complete information. The SCCS can now use other sources of information to conclude about possible health concerns. This forces the manufacturer to provide sufficient safety information if they want to market an application with nanomaterials. 

Currently, there are 12 nanomaterials in a new draft regulation to be placed on Annex II of the Cosmetics Regulation, meaning they will be banned in cosmetics. If sufficient data is provided that can fill the knowledge gaps, the product containing the nanomaterial can be reassessed, resulting in possible approval. If no additional data is provided for fullerenes, they will be banned in a subsequent 'Omnibus act nano'.

RIVM on Advanced Materials, March 2024