New definition of the term ’nanomaterial’ out for stakeholder consultation


The European Commission has completed it's long-awaited review of it's recommendation on the definition of the term nanomaterial from 2011.

This has resulted in a new proposed defintion of nanomaterials that is now subject to stakeholder consultation. The new definition to be reviewed is:

1. 'Nanomaterial' means a natural, incidental or manufactured material [E1] consisting of [E2] solid particles that are either [E2] present on their own or as identifiable constituent particles in ag g reg ates or ag g lomerates and where [E3] 50 % or more of the particles in the number size distribution fulfil one of the following conditions: 

a) one or more external dimensions of the particle are in the size rang e 1 nm to 100 nm; or 

b) [E2] the particle has an elong ated shape, such as a rod, fibre or tube, the external dimensions of which do not satisfy point a), but where at least one external dimension is smaller than 1 nm; or 

c) [E2] the particle is in a plate-like shape, the external dimensions of which do not satisfy point a), but where one external dimension is smaller than 1 nm. 

[E2] Particles with at least two orthog onal external dimensions larg er than 100 micrometres shall not be counted for the purpose of the number size distribution.  

[E4] A material with a specific surface area by volume of 5 m2 /cm3 or less shall not be considered a nanomaterial.

A targeted stakeholder consultation relating to the new definition is now underway and will end June 30th, 2021.

The adoption of a new definition could have widespread implications of future regulation of these novel materials as the new definition can serve as the technical and scientific basis for EU legislation and policies that set provisions to specific nanomaterials. 

The previous proposed defintion was adopted in 2011) and the Commission has committed itself to review the definition again by December 2026, with a view to amend it if new scientific evidence is provided.