In April 2021, the Canadian authorities removed several models of FFP2 protective masks containing graphene from the market, due to a potential risk of lung effects associated with the inhalation of graphene particles. As these same products had also been distributed in France, in particular to healthcare professionals, the French authorities suspended their distribution pending a risk assessment by ANSES, requested by the Directorate General for Health.
Following its expert appraisal, the Agency stresses that the available data did not reveal any exposure situations of concern. However, it was not possible to assess the health risks of exposure to graphene due to a lack of information on the graphene used by the manufacturers and on the toxicity of this substance, especially in the long term. Furthermore, the Agency points out that manufacturers have neither expressed nor demonstrated the purpose of graphene's addition to these masks. The Agency also notes that the Canadian authorities lifted the suspension of the products in summer 2021 after analysing additional data provided by the manufacturer.
As a result of this appraisal, ANSES now recommends that the public authorities give priority to the marketing or provision of graphene-free masks.
The Agency reminds manufacturers and marketers of their responsibility to ensure that their products are safe for use by consumers. This includes providing all the data necessary for determining the exact nature of the materials used, and demonstrating their utility in the product and their safety under normal conditions of use, both for consumers and for the environment.
How is graphene regulated?
Graphene is an innovative synthetic material consisting of one or more layers of carbon atoms arranged in a lattice structure. In Europe, it is not currently authorised for use as a biocidal substance in any type of product. When boxes of masks mention the inclusion of graphene for its biocidal activity, they are therefore withdrawn from the market by the DGCCRF for non-compliance with the regulations.
What are the different types of masks on the market?
- Respiratory protection masks (FFP) are personal protective equipment (PPE). They comply with European health and safety requirements verified by standard NF EN 149 or by recognised equivalent standards in other countries;
- Surgical masks are medical devices meeting European health and safety requirements verified by standard NF EN 14683;
- Textile masks, also referred to as "general public" masks, were developed during the COVID-19 pandemic. These textile masks have guaranteed filtration, and are generally washable and reusable. They are reserved for use outside the health system. The production of these masks is governed by a memo issued by the French authorities on 29 March 2020, updated on 26 April 2020;
- Textile masks manufactured by textile professionals or "home-made" in compliance with the AFNOR specification.