Seeking a more protective European definition for nanomaterials

In the European Union, the definition of nanomaterial varies according to the industry sector. The European Commission launched a public consultation to revise the definition of nanomaterial with a view to possible harmonisation. In its response, ANSES urged the Commission not to exclude from this definition certain nanomaterials that could still be problematic for human health and the environment.

Used in a wide variety of everyday products (such as food, cosmetics, drugs, etc.), nanomaterials raise many questions about the risks to human health and the environment generated by their presence.

The European Union currently defines "nanomaterial" as a material whose size or structure in one or more of its three dimensions is between about 1 and 100 nanometres. In practice, this definition can vary according to the industry sector. For example, the same material will not be considered as nano in foodstuffs but will be identified as such in cosmetics.

In anticipation of a possible revision, the European Commission launched a public consultation from 6 May to 30 June 2021 on whether to revise the terms of the definition and consider adaptations or even harmonisation in the various industry sectors.

In its response to the consultation, ANSES maintained that the changes suggested by the Commission tend to restrict the number and type of objects that will ultimately be considered as nanomaterials. For example, nanoplastics, as well as certain emulsions and lipid nanoparticles, might not be considered to fall under this definition. Such objects are increasingly being developed for industrial purposes.

For ANSES, the definition needs to be as comprehensive as possible and define nanomaterials in a unique way based on physico-chemical criteria. Sectoral regulations – for cosmetics, biocides, food, etc. – could then clarify which of these nanomaterials should be subject to specific measures: product labelling, specific assessment, authorisation before they are placed on the market, etc.

The Agency also finds it unfortunate that the size thresholds (1-100 nm) used in the current definition were not open to discussion as part of this consultation, as they have no scientific basis.

The Agency will publish an opinion by 2022, with the support of a multidisciplinary group of experts, providing more information and perspective on its response to the European consultation.