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August 7, 2020

Australia Releases Extra Guidance on Categorizing Chemicals at the Nanoscale under AICIS

Lynn L. Bergeson Carla N. Hutton

The Australian Industrial Chemicals Introduction Scheme (AICIS) took effect on July 1, 2020.  Under AICIS, companies that import or manufacture (including introduce) industrial chemicals, or products that release industrial chemicals, into Australia for commercial purposes should first check whether the industrial chemical is listed on the Inventory.  If the chemical is on the Inventory and the introduction meets the terms of Inventory listing, the introduction is automatically categorized as a “listed” introduction.  If the chemical is not listed, it must be categorized into one of five categories.  On August 3, 2020, Australia published additional guidance for the introduction of industrial chemicals (and products that release industrial chemicals) with at least one external dimension in the nanoscale.  Australia notes that if the chemical is a nano form of a chemical that is listed on the Inventory, “then it is only considered to be on our Inventory[] if the nano form has the same [Chemical Abstracts Service (CAS)] number as the bulk form of the chemical.”  The guidance addresses what is a chemical at the nanoscale; whether the introduction is exempted, reported, or assessed; introductions of chemicals for use in research and development; introductions categorized using steps four through six of the categorization guide; and categorization outcomes.

The guidance states that nanoscale means the particle size range of one to 100 nanometers (nm).  The introduction is a “specified class of introduction” if it is of a chemical that:

  • Is introduced as a solid or is in a dispersion; and
  • Consists of particles in an unbound state or as an aggregate or agglomerate, at least 50 percent (by number size distribution) of which have at least one external dimension in the nanoscale.

The guidance states that Australia has “an increased level of concern” for specified classes of introductions due to a greater potential for particular hazards or high levels of human or environmental exposure.  According to the guidance, Australia’s increased level of concern for chemicals at the nanoscale “is because of uncertainty about the risks of some of these chemicals due to their potentially different properties, such as chemical reactivity, relative to the non-nanoscale forms of the chemicals.”  This uncertainty requires either assessment by Australia or increased reporting or recordkeeping requirements.  The guidance outlines the additional or different requirements arising from these concerns.