The European Commission is clarifying the definition of nanomaterials in a new Recommendation which supports a coherent EU regulatory framework for nanomaterials, helping to align legislation across all sectors. The new definition should be used in EU and national legislation, policy or research programmes and it replaces the initial definition of 2011. The changes were developed following a comprehensive review, and should allow easier and more efficient implementation, but will not significantly affect the scope of identified nanomaterials.
According to the new recommendation ’Nanomaterial’ means 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.
The following parts of the definition are similar to the previous recommendation:
• particle size, 1 nm – 100 nm,
• 50% number based threshold
The changes implemented in the new recommendation refer to:
• no flexibility of the 50 % threshold
• generalised derogation: elongated and flat particles < 1 nm count as nanomaterials
• upper threshold for counting: 100 μm
• removal of specific surface area by volume > 60 m2/cm3 as a proxy indicator when identifying a nanomaterial
• introduction of criterion to identify “non-nanomaterials” specific surface area by volume < 6 m2/cm3
You can read more here.