The EU Commission has revised the definition of nanomaterial
On 10 June 2022, the EU Commission published a recommendation on the definition of nanomaterial. This recommendation clarifies the definition adopted by the European Commission in 2011 (Recommendation on the definition of a nanomaterial 2011/696/EU).
In the 2011 EU Recommendation, the definition of a nanomaterial is as following:
‘Nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.
The review of the Recommendation 2011/696/EU concluded by the adoption of the revised definition on 10 June 2022. The new Recommendation supports a coherent EU regulatory framework for nanomaterials, helping to align legislation across all sectors. It should be used in EU and national legislation, policy or research programmes.
The new definition of “nanomaterial” (see the revised definition below) states that only solid particles should be considered. It includes an added condition that particles larger than 100 micrometers (µm) “need not be counted.” The revised definition is as following:
‘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. In addition, the commission’s revised definition also clarifies that single molecules are not nanomaterials.
The new definition replaces the initial definition of 2011.
If you want to know more on the review of the definition of nanomaterial.
In addition, the EFSA has published 2 guidances on the technical requirements to establish the presence of small particles. See the information published by Orchidali.
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