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October 31, 2018

JRC Posts Report on Workshop on Regulatory Preparedness for Innovation in Nanotechnology

Lynn L. Bergeson Carla N. Hutton

The European Commission (EC) Joint Research Center (JRC) posted a report on the October 5-6, 2017, “NanoReg2 Regulatory Preparedness for Innovation in Nanotechnology Workshop.”  Regulatory preparedness was defined at the workshop as the regulators’ timely awareness of innovations and the regulators’ actions to check whether present legislation covers all safety aspects of each innovation, including initiating revision of the legislation as appropriate.  Achieving regulatory preparedness for innovations based on nanotechnology requires a continuous proactive combination of interconnected activities:  awareness of innovations; dialogue; knowledge building; methodology enhancement and optimization; reflection; and consideration.  To implement regulatory preparedness for nanotechnology innovations as a part of the Safe Innovation Approach (SIA) pursued by NanoReg2, the following “road map” of actions of different time scales and levels of formal acceptance was outlined:

  • Near-term:
    • Acceptance of Safe-by-Design (SbD) by regulators:
      • Early engagement of regulators in product design process; and
      • Industry addresses hazard and exposure concerns early in the product design process;
    • Establishment of databases for valid (reliable) data;
    • Establishment of registries;
    • Pre-consultations with the industry (individual products);
    • Prioritization of the development of the most needed experimental protocols and guidance; and
    • Broader stakeholder meetings.
  • Mid-term:
    • Development of Organization for Economic Cooperation and Development (OECD) Test Guidelines for nanomaterials;
    • Development of other general guidance specific to nanomaterials;
    • Exploit the European Union (EU) Nanomedicine Characterization Laboratory (NCL) as a model for a (nano)innovation network:
      • Cooperation between regulators and industry;
      • Protocol development;
      • Early screening for the industry (not only medical); and
      • Open to industry use; and
    • Identification of the most promising protocols and methods in development.
  • Formal regulatory developments:
    • Moving from guidance to legislation;
    • Where required, shifts in definitions and regulatory requirements for data;
    • Finalization of protocols;
    • Validation and acceptance of alternative methods; and
    • Development of a more effective data generation process that benefits all:
      • Nanospecific tiered testing or intelligent testing strategies; and
      • Valid protocols for these strategies.

According to the report, the ideas presented at the workshop and the outcomes will feed back into the NanoReg2 project.