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June 17, 2024

ECHA Updates Report on Key Areas of Regulatory Challenge, Addresses Micro- and Nano-Sized Materials

Lynn L. Bergeson Carla N. Hutton

On June 12, 2024, the European Chemicals Agency (ECHA) announced that it updated its report on key areas of regulatory challenge, providing more detailed information on areas where scientific research is needed to protect human health and the environment from hazardous chemicals. The report addresses micro- and nano-size materials, stating:

  • Why further research is needed: Critical test methods to address the human and environmental hazard and risk assessment of nanomaterials are still missing. Furthermore, for most new approach methodologies (NAM), validation is missing to allow regulatory acceptance and uptake;
  • Regulatory needs: These include test method development for nanomaterials, as well as suitable NAMs covering relevant regulatory endpoints. These should consider the analytical characterization of the materials to shed light on toxico-kinetics and -dynamics under different exposure scenarios. Further research should focus on the (bio)degradation potential, long-term effects in, e.g., sediments and soils, and their bioaccumulation potential; and
        • Impact: Includes:

          • Standard test methods for the hazard and risk assessment of nanomaterials;

          • A framework for accepted regulatory NAMs to help the assessment of single nanoforms or sets of nanoforms; and

          • Moving away from animal testing.

        The report’s section on analytical methods of enforcement uses characterization of nanomaterials, including advanced nanomaterials, as an example of an area of application. The report states that specific research needs include:

        • Developing and validating measurement techniques that can cover the entire nano range (1-100 nanometers (nm)) effectively. The microplastic restriction is already confronted with this problem;
        • Enhancing the comparability and interoperability of different nanomaterial measurement techniques to reduce variability and uncertainty;
        • Innovating sample preparation methods that are adaptable to a variety of nanomaterials and measurement techniques; and
        • Establishing standardized methodologies that can be widely adopted for the characterization of nanomaterials.