Last reviewed 1 August 2022

The European Commission has updated the nanomaterial definition.

The definition is now as follows.

1. “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.

  1. One or more external dimensions of the particle are in the size range 1nm to 100nm.

  2. The particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1nm and the other dimension is larger than 100nm.

  3. The particle has a plate-like shape, where one external dimension is smaller than 1nm and the other dimensions are larger than 100nm.

    In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100μm need not be considered.

    However, a material with a specific surface area by volume of < 6m2/cm3 shall not be considered a nanomaterial.

    2. For the purposes of point one, the following definitions apply.

    1. “Particle” means a minute piece of matter with defined physical boundaries; single molecules are not considered “particles”.

    2. “Aggregate” means a particle comprising of strongly bound or fused particles.

    3. “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. It is recommended that the definition of the term “nanomaterial” set out in the latest recommendation or other act providing a definition of nanomaterial for horizontal policy and legislative use adopted by the Commission or Union legislator is used

    When addressing materials or issues concerning products of nanotechnologies.

    1. By the Commission, when preparing legislation, policy programmes or research programmes and when implementing such legislation or programmes also with other Union institutions and agencies.

    2. By Member States, when preparing legislation, policy programmes or research programmes and when implementing such legislation or programmes.

    3. By economic operators, when preparing and conducting their own policies and research.

    4. This Recommendation updates Recommendation 2011/696/EU.