On 24 September 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) introduced Version 3 of the Industrial Chemicals Categorisation Guidelines. This major update introduces specific revisions to guide chemical importers and manufacturers in Australia, ensuring compliance with current hazard assessment standards and aligning with recent regulatory changes.

Resources and Support for Chemical Introducers

The AICIS has refined its guidance resources, particularly in steps 4.4 (Human Health Hazard Characteristics) and 5.4 (Environmental Hazard Characteristics) of the Categorisation Guidelines, reflecting updates first outlined in March and August 2024. These adaptations clarify test methods, predictive tools and hazard identification criteria, particularly for bioaccumulation and organ toxicity assessments. The updated resources aim to streamline the categorisation process for companies and ensure compliance with current regulatory expectations.

List of Chemicals with High Hazard: Comprehensive Update

The revised AICIS Guidelines includes a significantly expanded list of high-hazard chemicals, adding nearly 600 unique entries for introducers to refer to when categorising chemicals as exempted, reported, or assessed. This list consolidates chemicals recognised as highly hazardous by trusted national and international bodies (e.g. European Chemicals Agency (ECHA), Chemical Substances Control Law of Japan (CSCL)). In addition, the European Commission’s Endocrine Disruptor List (List I) has been added as a source. It is expected that the list will be updated annually. The current version of the list is available here.

Detailed Focus on Hazard Characteristics

To streamline the safety and hazard identification processes, the AICIS has updated its guidance on key hazard characteristics:

• Organ Toxicity (Repeated Exposure): Revised requirements provide companies with clearer pathways to demonstrate the absence of target organ toxicity. This change appears under the category "Human Health Hazard Band B".

• Bioaccumulation Potential: The updated guidance requires more rigorous evidence for chemicals to demonstrate the absence of bioaccumulation, especially in environmental contexts, as detailed under "Environment Hazard Band A".

These refinements will help standardize the data required to establish safer chemical profiles, thereby reducing risks to both human health and the environment.

Vaping Chemicals Reclassified as Therapeutic Goods

From 1 July 2024, the AICIS no longer classifies chemicals used in vaping goods as “industrial chemicals.” Due to recent legislation, these chemicals are now regulated as therapeutic goods under the Therapeutic Goods Act 1989. As a result, the AICIS removed references to personal vaporisers from Version 3 of the Guidelines, and importers or manufacturers of vaping-related chemicals must now comply with Therapeutic Goods Administration (TGA) regulations. The AICIS will only regulate these chemicals if they have other industrial uses beyond vaping.

Version 3  of the Industrial Chemicals Categorisation Guidelines can be found here.

The Australian Industrial Chemicals Introduction Scheme (AICIS) is reminding businesses to submit their Post-Introduction Declarations (PIDs) for the 2023-2024 period by 30 November 2024. This applies to those who have first introduced an exempted category chemical between 1 September 2023 and 31 August 2024.

Who Needs to Submit?

A PID is required for those who have introduced chemicals from the following exempted categories:

• Polymers of low concern

• Low-concern biological polymers

• Chemicals classified as very low risk to human health and the environment

A separate PID must be submitted for each chemical introduced for the first time during the period.

How to Submit

To submit a PID, businesses must:

1. Log in to AICIS Business Services.

2. Access the PID Dashboard and select the type of introduction.

3. Submit the form by the 30 November 2024 deadline.

For more details, visit the Exempted Introduction Declaration page on the AICIS website's here.