Expert assessment
3 min

ANSES calls for the adoption of a more protective definition for nanomaterials

ANSES believes that the European Commission's new Recommendation on the definition of nanomaterial, published on 10 June 2022, is too restrictive and could lead to a regression in the protection of public health and the environment. The Agency is therefore urging the French authorities to take a more inclusive definition into account and work towards its integration in the revision of sectoral regulations at European level. With this in mind, the Agency has listed all the criteria needed to define nanoscale objects whose possible health effects warrant assessment.

A new European Commission definition that excludes too many nanoscale objects

In its new definition of the term “nanomaterial”, the amendments agreed by the European Commission tend to restrict the number and type of objects that will ultimately be considered as such. Applied as it stands, this definition will, for example, lead to some nanoscale objects being overlooked, such as micellar nanovectors (vesicles, liposomes, lipid particles, etc.) designed to carry substances of interest in medicine, nutrition or agriculture, which are currently stimulating a great deal of interest and development.

While the goal of this new definition was to clarify what nanomaterials are, it ultimately adds confusion with new concepts that pave the way for differences in interpretation. "Some of the changes proposed by the Commission are based on the use of terms on which there is no consensus, such as 'solid state' or the 'identifiable' nature of a nano-object. There are also concepts inherent to the subject that urgently require clarification, such as that of the 'constituent' particle," explains Anthony Cadene, coordinator of the expert appraisal report at ANSES.

The Agency points out that this new recommendation on the definition is less inclusive and flexible than the previous one. It would thus represent a regression in the prevention of health and environmental risks associated with nanomaterials.

Improve scientific knowledge of the potential hazards of nanomaterials

ANSES recommends providing the broadest possible definition of the term “nanomaterial” based solely on dimensional criteria. It also recommends establishing a uniform definition, regardless of the sector in which nanomaterials are used. The definition and regulations can only be refined in view of an assessment of the hazards they pose. Sectoral regulations – on cosmetics, biocides, food, etc. – could then specify which of these nanomaterials should be subject to specific measures such as product labelling, specific assessment, or authorisation before they are placed on the market.

"This definition should primarily make it possible to say whether or not an object is a nanomaterial, regardless of its sector of application or considerations related to measurement methods and instruments. Knowledge of the hazards and risks should come before adjustments to the regulations, not the other way around," continues Anthony Cadene.

Consider a broader definition from now on, in order to anticipate the risks

At the national level, ANSES is therefore calling for a broader definition of ”nanomaterial” than that recommended by the European Commission, in order to consider nanomaterials more comprehensively and not overlook any that could be a health concern.

For scientists, who have been waiting 10 years for it, this new definition is a decisive step because it will guide the production of new scientific knowledge that will enable the health and environmental risks of nanomaterials to be assessed.

With this in mind, the Agency has developed a guide detailing the various parameters of such a definition, pointing out those that may require choices to be made by the public authorities because they go beyond the strictly scientific field.

In practice, ANSES invites the public authorities to take advantage of the revision of the European regulations on chemicals (REACH and CLP) and cosmetics to propose a broader definition. They will be able to do so once the review of other sectoral regulations has begun.