The EU Commission clarify the definition of nanomaterials in the new Commission Recommendation of 10.06.2022 to support a “coherent EU regulatory framework for nanomaterials”.

And the fact is that, although their peculiar physicochemical properties make them a powerful source of innovation, their use can increase the toxicity of the products, or even require a more complex protocol to guarantee their safe use. Because of this, various EU laws (REACH, CLP, BPR) include additional provisions on nanomaterials to ensure proper data collection, risk assessment or product labeling to inform consumers about the presence of nanomaterials.

Until now, several definitions have been used individually that differ according to the legal text that collects them, the sector or even the country in which they have been defined.

Therefore, after this new definition, which we explain below, the Commission is going to focus its efforts on using it in all its regulatory texts and on aligning the legislation on nanomaterials of all sectors and member countries, including the obligation to use it in legislation, national and European research policies or programmes.


'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 fulfill 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.

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