Draft Regulation: definition of ‘engineered nanomaterials
Disclaimer: This draft has not been adopted or endorsed by the European Commission. Any views expressed are the preliminary views of the Commission services and may not in any circumstances be regarded as stating an official position of the Commission
Article 1
Point (f) of Article 3(2) of Regulation (EU) 2015/2283 is replaced by the following:
‘(f)
(1) ‘Engineered nanomaterial’ means a 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 shall not be considered.
(2) For the purposes of point (1), the following apply:
(a) ‘manufactured material’ means a material produced, synthesised or generated
from physical/mechanical, and/or biological and/or chemical processing,
and/or formulation, and/or transformation, of raw and/or starting materials;
(b) ‘particle’ means a minute piece of matter with defined physical boundaries.
Single molecules are not considered ‘particles’;
(c) ‘aggregate’ means a particle comprising of strongly bound or fused particles;
(d) ‘agglomerate’ means 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.
(3) A material with a specific surface area by volume of < 6 m2/cm3 and/or with high solubility and/or dissolution/degradation rate values in water as determined using the thresholds, methodologies, and media identified by the Authority shall not be considered an engineered nanomaterial.’
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