EU Updates Definition of Nanomaterial

On 14 June 2022 the EU Official Journal published Commission Recommendation 2022/914 of 10 June 2022 on the Definition of Nanomaterial. The revision is part of the EU Chemicals Strategy for Sustainability.

3E Review

Commission Recommendation 2011/696/EU contains a definition of nanomaterial. The text also requires the European Commission to review the existing definition by 2014.

Following a series of reports published by the commission's Joint Research Centre (JRC), a new recommendation is now published. According to the text, 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:

• 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 particular, the revised definition highlights the requirement that the nanomaterial be in a solid form (i.e., not liquid or gaseous form). It also keeps the default threshold of 50% of particles with external dimensions at the nanoscale but removes the previous flexibility of the default threshold value provided in Recommendation 2011/696/EU. The definition also provides clarifications on the external dimensions, allowing thus more materials to fall under the scope of the definition.

The new nanomaterial definition is not binding. However, it may be used to address regulatory requirements in the absence of an official definition in a particular EU legislation, as well as to serve different EU and national policies and legislative and research purposes.

The update of the nanomaterial definition is based on the following JRC reports:

• Towards a review of the EC Recommendation for a definition of the term “nanomaterial”; Part 1: Compilation of information concerning the experience with the definition
• Towards a review of the EC Recommendation for a definition of the term “nanomaterial”; Part 2, Assessment of collected information concerning the experience with the definition
• Towards a review of the EC Recommendation for a definition of the term “nanomaterial”: Part 3: Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation
• An overview of concepts and terms used in the European Commission’s definition of nanomaterial
• Identification of nanomaterials through measurements

3E Analysis

The new nanomaterial definition is not legally binding. However, it may be used to address regulatory requirements in the absence of another official definition in a particular EU legislation, as well as to serve different EU and national policies and legislative and research purposes.