Australia Proposes Changes to Industrial Chemicals Categorization Guidelines

In a significant development for the industrial chemicals sector, the Australian Department of Health and Aging has launched a consultation process in September 2023 to consider significant amendments to the Industrial Chemicals (General) Rules 2019 and the Industrial Chemicals Categorization Guidelines, commonly referred to as the Guidelines. The main objective of these proposed amendments is to improve the efficiency and effectiveness of the industrial chemicals categorization process.

The List of High-Hazard Chemicals

At the core of these proposed changes is the 'List of Chemicals with High Hazards for Categorization,' hereafter referred to as the ‘List’. This carefully compiled list serves as a comprehensive compilation of chemicals that are recognized by trusted national and international sources as posing significant risks to human health and the environment. These chemicals are identified by their placement within the highest hazard bands, specifically categorized as human health hazard band C and environment hazard band C or D.

Streamlining Categorization

The List plays a key role in the categorization process, serving as a critical screening tool during steps 4 to 6 of the process. It assists introducers in determining whether their chemical introduction (import) should be categorized as exempted or reported. It is important to note that esters and salts of chemicals listed on the List are currently considered to have the same high hazard characteristics as their parent chemicals. Depending on the circumstances of the introduction, chemicals listed on the List with high hazard characteristics, such as carcinogenicity, may be categorized as assessed, indicating a medium to high level of risk.

Addressing Data Gaps

In the area of industrial chemicals, obtaining comprehensive hazard data within the highest hazard bands can be challenging. In many cases, the necessary data may not be available, and carrying out the necessary studies may be costly and time-consuming. In this context, the List serves a dual purpose:

1. To assist introducers by enabling them to categorize their chemical introductions based on the available information.

2. To prevent chemicals of high concern from being incorrectly classified as very low risk (exempted introductions) or low risk (reported introductions), depending on the particular circumstances of the introduction.

Defining High-Hazard Chemicals

The List contains chemicals with hazard characteristics aligning with human health hazard band C or environment hazard bands D or C. These classifications are based on information sources identified in Appendix 8.1 of the Guidelines. The List is an integral component of the Guidelines, and it is publicly available in the form of an Excel spreadsheet on the Australian Industrial Chemicals Introduction Scheme (AICIS) website. It is an essential tool to facilitate the categorization process.

Simplifying Ester and Salt Verification

Esters and salts of listed chemicals have attracted attention due to the complexity of identifying these chemical derivatives. Recognizing the challenges faced by introducers, consultations were conducted last year to address these concerns. The goal was to reduce the regulatory burden by simplifying the process for introducers to check whether their chemicals are esters or salts of those chemicals on the List. The proposed changes include:

- Removing of the existing requirement for individual testing on esters and salts of most chemicals on the List.

- The explicit specification of chemicals that require verification for ester and salt status.

- The definition of excemptions for esters and salts, potentially exempting certain chemicals from the high hazard characteristic classification.

Seeking Stakeholder Input

Having carefully considered the feedback received on this overarching proposal, the Department is now actively seeking input on the specific chemicals designated for ester and salt verification, and any associated exemptions. Importantly, these proposed changes are not intended to introduce any additional regulatory burdens on introducers. They aim to streamline steps 4 and 5 of the categorization process for those dealing with salts and esters. Introducers would only need to:

1. Confirm whether their chemical is on the List.

2. Check whether their chemical qualifies as an ester or salt of the chemicals listed in a designated table, and assess whether any exemptions, if defined (currently, there are none), apply.

The consultation is open till 22 February 2024, and comments can be submitted here.

Conclusion

These proposed amendments have the potential to improve the efficiency and clarity of the industrial chemicals categorization process, while simultaneously ensuring strict adherence to safety and regulatory compliance standards. Public engagement and feedback is actively encouraged to ensure that the final revisions meet the collective interests and needs of all stakeholders within the industrial chemicals sector.