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May 9, 2023

JRC Publishes Guidance Document on Implementation of the EC’s Revised Definition of Nanomaterials, Launches Free Course on Nanomaterials in EU Legislation

Lynn L. Bergeson Carla N. Hutton

On May 2, 2023, the European Commission’s (EC) Joint Research Center (JRC) announced that it published a guidance document entitled Guidance on the implementation of the Commission Recommendation 2022/C 229/01 on the definition of nanomaterial. As reported in our June 10, 2022, blog item, in June 2022, the EC published a new Recommendation aimed at harmonizing the interpretation of the term “nanomaterial” in regulatory contexts. The updated definition of nanomaterials replaced the previous one released in October 2011 and presently used in several legislations, including the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. According to JRC, the new definition makes it easier to identify nanomaterials. These materials consist of solid natural, incidental, or man-made particles and most of the particles are in the 1-100 nanometer (nm) range. It serves different policy, legislative, and research purposes when addressing nanomaterials or issues concerning products of nanotechnologies. JRC states that the new definition will facilitate the formulation of a single nanomaterial definition in European Union (EU) legislation in the future, including on chemicals, novel food, cosmetics, biocides, or medical devices; “preparat[i]ons for updates have already begun in several sectors.” The new JRC guidance is intended to help stakeholders to understand the new definition and will support regulatory implementation of the new definition. The guidance gives an overview of the key terminology and concepts, provides a decision tree to identify nanomaterials, and addresses identification of nanomaterials through measurements.

Along with the new guidance document, JRC announced that it has launched a free course on nanomaterials in EU legislation available on the EU Academy. More specifically, according to JRC, participants will learn about:

  • What a nanomaterial is and what makes it special in a legal context;
  • The EC’s definition of nanomaterial and the challenges to implement it;
  • The EU legislative framework for chemicals and how it is implemented; and
  • Why different pieces of EU legislation address chemicals and nanomaterials differently.