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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > Amendments to Australia's Industrial Chemicals General And Transitional Rules Include Provisions Concerning Nanoscale Chemicals

Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
The Australian Industrial Chemicals Introduction Scheme (AICIS) announced on November 22, 2021, rules amendments and regulatory changes beginning on November 23, 2021, and December 10, 2021, following amendments to the Industrial Chemicals (General Rules) 2019 and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019.

November 24th, 2021

Amendments to Australia's Industrial Chemicals General And Transitional Rules Include Provisions Concerning Nanoscale Chemicals

The Australian Industrial Chemicals Introduction Scheme (AICIS) announced on November 22, 2021, rules amendments and regulatory changes beginning on November 23, 2021, and December 10, 2021, following amendments to the Industrial Chemicals (General Rules) 2019 and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019. See https://www.industrialchemicals.gov.au/news-and-notices/rules-amendments-and-regulatory-changes-23-november-2021 After considering stakeholder feedback, the Minister for Regional Health signed the Industrial Chemicals (General) Legislation Amendment (2021 Measures No. 1) Rules 2021 on October 30, 2021. See https://www.legislation.gov.au/Details/F2021L01584 AICIS states that it has revised the "Guide to categorising your chemical importation and manufacture" and other pages on its website to reflect amendments that were made to the General and Transitional Rules. Changes that began on November 23, 2021, that concern nanoscale chemicals include:

- Requirements for chemicals introduced at the nanoscale (items 1-19 in Schedule 1 of the amending rules): Internet content changes to clarify:
-- The criteria for introductions of chemicals at the nanoscale;
-- How the nanoscale criteria apply in practice; and
-- The associated recordkeeping obligations.

Changes that will begin on December 10, 2021, that concern nanoscale chemicals include:

- Pre-introduction report requirement relating to nanoscale chemicals for research and development (R&D) (item 20 in Schedule 1 of the amending rules): An extra requirement will be added for pre-introduction reports that requires introducers to report whether the chemical is at the nanoscale. This applies to introductions of chemicals used only for R&D.

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