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September 27, 2017

OECD Tour de Table Highlights International Developments on the Safety of Manufactured Nanomaterials

Lynn L. Bergeson Carla N. Hutton

On September 27, 2017, the Organization for Economic Cooperation and Development (OECD) published a corrected version of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour De Table, which covers developments on the safety of manufactured nanomaterials that were provided by OECD delegations from March to August 2017.  It summarizes relevant information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level.  The reported activities include:

  • The French National Institute for Industrial Environment and Risks (INERIS) “has developed some preliminary guidance values on human toxicity (inhalation, ingestion) as well as for ecotoxicity for the case of [titanium dioxide] at the nanoform.”
  • Germany’s Federal Institute for Occupational Safety and Health (BAuA) and Federal Institute for Risk Assessment (BfR) have “decided on including investigations on nanofibers with special emphasis on fiber rigidity in their research program. The focus shall be on characterization, exposure assessment and inhalation toxicology.”
  • Korea’s Ministry of Environment (MOE) has added nanomaterials to the list for hazard evaluation prescribed in the Act on Registration and Evaluation, etc. of Chemical Substances (K-REACH):
    • Risk assessment decisions, including the type of: (a) nanomaterials assessed; (b) testing recommended; and (c) outcomes of the assessment;
    • Development related to exposure measurement and exposure mitigation;
    • Risk management approaches;
    • Any updates, including proposals or modifications to previous regulatory decisions; and/or
    • New regulatory challenge(s) with respect to any action for nanomaterials.

Based on the policy and research infrastructures developed from the first National Nano-Safety Master Plan (2012-2016) at interministerial levels (including MOE and the Ministries of Trade, Industry, and Energy, and Food and Drug Safety), the Korean government will establish the goal, vision, and implementation plan of the second Master Plan (2017-2021), and intended to make an official announcement by the first half of 2017.  MOE plans to introduce an effective safety management system of nanomaterials and nanoproducts distributed during the second period.  The secondary plan will include assessing the hazards of nanomaterials, and evaluating and managing safety assessments of nanomaterials in nanoproducts.

  • The European Commission (EC) intends to propose the adoption of possible revised Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation addressing nanomaterials in the beginning of 2018, “with further transition arrangement regarding full application.”