December 8, 2021

Volume XI, Number 342

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December 07, 2021

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December 06, 2021

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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. 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. 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.

©2021 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 328
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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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