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Australia Finalizes General Rules and Transitional Rules for AICIS

Australia announced that the General Rules and Transitional Rules for AICIS are final, and the final draft of the Categorization Guidelines is now available.

To inform and facilitate the upcoming implementation of its new chemical regulatory framework, namely Australian Industrial Chemicals Introduction Scheme (AICIS), the Australian government has been fleshing out relevant supporting rules and legislations. In early December, 2019, it issued a notice, announcing that the Industrial Chemicals (General) Rules [1] and the Transitional Rules [2] have been finalized, and the final draft of the Industrial Chemicals Categorization Guidelines [3] is available as well.

Each of the three rules focuses on different aspects. The General Rules involves details as to how to regulate manufacture or import of chemicals in the country under the AICIS, such as how to categorize industrial chemical introductions, criteria for Commercial Evaluation Authorizations, reporting and recordkeeping requirements, etc.; the Categorization Guidelines majorly lays out instructions concerning introduction categorization and relevant requirements; and the Transitional Rules offers provisions for managing the transition from the existing National Industrial Chemicals Notification and Assessment Scheme to the AICIS.

The NICNAS website offers a summary of key changes [4] which detail categorization, use of new animal test data, certain types of introductions, information waivers and requirements, etc. Notably, businesses should be aware of two transitional highlights: the NICNAS exemption categories will remain available until August 31, 2022 for introduction of chemicals not listed on the AICIS Inventory, and the NICNAS low volume and controlled use permits will remain in force until at least June 30, 2022.

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