Commission Recommendation on the definition of nanomaterial
The Commission Recommendation of 10 June 2022 on the definition of nanomaterials refines the definitions in Regulation (EU) 2017/745, new features compared to the MDR are
Nanomaterial: a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50 % or more of these particles in the number-based size distribution fulfil at least one of the following conditions:
(a)one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
(b)the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;
(c)the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.
In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 μm need not be considered.
However, a material with a specific surface area by volume of < 6 m2/cm3 shall not be considered a nanomaterial.
Particle: a minute piece of matter with defined physical boundaries; single molecules are not considered ‘particles’;
Aggregate: a particle comprising of strongly bound or fused particles;
Agglomerate: a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components.