Commission releases revised nanomaterial definition

NIA Staff
2 min read

Summary

  • The EU has published its updated nanomaterial definition, replacing the original 2011 text after a multi-year review process involving three JRC studies and a formal stakeholder consultation.

  • Key changes address longstanding ambiguities around particle size boundaries, the particle number concentration threshold, and the treatment of materials like graphene and carbon nanotubes.

  • A guidance document to support implementation is due before year end, and NIA members can access a dedicated factsheet breaking down what has changed and what it means in practice.

The revision process for the definition of a nanomaterial has concluded with the publication of the updated definition.
First adopted in 2011, the definition provides a reference for EU legislation containing specific nanomaterial provisions; over the last several years, the Commission has been assessing the fitness for purpose of the definition, and its Joint Research Centre (JRC) performed three studies covering i) the collected practical experiences of application of the definition; ii) an assessment of those experiences; and iii) a scientific and technical evaluation of the potential options to clarify the definition and facilitate its implementation.

Based on the interim JRC findings, the Commission launched a stakeholder consultation in June 2021 (see the NIA contribution here), focusing in particular on particle aspects (consideration of particles with dimensions outside 1-100 nm, generalization from the derogation of fullerenes, single-wall carbon nanotubes, and graphene flakes); the flexibility of the particle number concentration threshold; and the reference to Volume Specific Surface Area (VSSA).

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