June 10th 2022 - The European Commission is clarifying the definition of nanomaterials in a new Recommendation. The new Recommendation 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.
So far the European Commission Recommendation 2011/696/EU1 determined whether a material should be considered a 'nanomaterial' for legislative and policy purposes in the Union. Between 2013 and 2021, the Commission carried out a review of the 2011 Recommendation (2011/696/EU), addressing the objective, scope, clarity and use of its definition of nanomaterial. The review in particular focused on whether the particle number-based size distribution threshold of 50 % should be increased or decreased and whether to include materials with internal structure or surface structure in the nanoscale such as complex nanocomponent materials including nanoporous and nanocomposite materials that may be used in specific sectors.
Now, the nanomaterial definition in Recommendation 2011/696/EU is updated as follows:
'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:
- one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
- 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;
- 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.
Commission Recommendation: https://ec.europa.eu/environment/chemicals/nanotech/pdf/C_2022_3689_1_EN_ACT_part1_v6.pdf