On 10 June 2022, the European Commission (EC) clarified 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 EC states that this new definition should be used in EU and national legislation, policy, or research programs.
This Recommendation updates Recommendation 2011/696/EU. 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.
Revised definition
The Recommendation states:
‘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 1 nm to 100 nm;
2. 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;
3. 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.
Implementation
Following the adoption of the new Recommendation, it is expected the different individual sectors will update their internal definition, replacing the old definition with the new one by copying the text of the definition or by referring directly to the Recommendation.
Each sector will proceed in accordance with its own timetable.
- For EU Cosmetics Regulation: The public consultation includes the question related to the definition of nanomaterial. The consultation closes on 21 June 2022.