Editor's Note: This article was originally published on April 3, 2024, and was updated on April 25, 2024, as per the latest developments.
On April 24, 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) started to implement the amendements to the Industrial Chemicals (General) Rules 2019 and the Industrial Chemical Categorization Guidelines. The amendements are expected to make compliance easier for introducers and enhance protection against hazardous chemicals.
On March 21 and 27, 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) announced the amendments to the Industrial Chemical (General) Rules 2019 (hereafter referred to as the Rules)1 and the Industrial Chemicals Categorization Guidelines (hereafter referred to as the Guidelines)2, respectively.
In Australia, chemical introductions must be completed before the chemicals are manufactured in or imported to Australia. They are divided into five categories3:
Category | Application scope |
Listed introductions | Chemicals listed on the Australia Inventory of Industrial Chemicals (AIIC) and whose introduction is within the terms of the listing (if any) |
Exempted introductions | Chemical with very low risk |
Reported introductions | Chemicals with low risk |
Assessed introductions | Chemicals with medium-to-high risk |
Commercial evaluation authorizations | Chemicals whose commercial potential must be determined before introduction, and the commercial evaluation authorization is needed |
The amendments to the Rules are mainly on the introduction categorization, reporting, and record-keeping. They include:
1. Records replace some written undertakings, making compliance easier for introducers (manufacturers or importers) who find it difficult to obtain undertakings from chemical identity holders.
2. International Nomenclature of Cosmetic Ingredients (INCI) names are accepted for the following three types of exempted/reported introductions, if the introducer does not know the CAS or IUPAC (International Union of Pure and Applied Chemistry) name.4
Chemicals imported and subsequently exported (please refer to step 2 of the categorization process)
Research and development (please refer to step 2 and 3 of the categorization process)
The highest indicative risk is at a low level, which means reported introductions apply to this type (human health exposure band 1-4 and environment exposure band 1-4)
3. The chemical introduction categorization criteria are expanded for:
Domestic soap makers
Introducers of chemicals in flavor and fragrance blends
Introducers of hazardous chemicals where introduction and use are controlled.
4. Criteria and/or reporting requirements are enhanced for health and environmental protection, as an effort to prevent persistent organic pollutants (POPs) from being categorized as exempted or reported introductions.
Key changes to the Guidelines include:
1. Requirements are more detailed for checking hazardous esters and salts of chemicals on the “List of Chemicals with High Hazards for Categorization (hereafter referred to as the List)”
2. Highly hazardous chemicals are added to the List based on an AICIS assessment or evaluation
3. Options are expanded for introducers to demonstrate the absence of skin irritation and skin sensitization.
4. More models are provided for in silico predictions; a test guideline is added for ready biodegradability.
The amendments are expected to reduce the challenges for chemical introducers in meeting their regulatory obligations, and strengthen the protection of human health and the environment from hazardous chemicals. The scheduled effective date of the amendments is April 24, 2024.
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