Australia Regulatory News

The Australian Industrial Chemicals Introduction Scheme (AICIS) is seeking feedback on proposed updates to the list of chemicals with high hazards for categorisation and categorization guidelines for ...

The Australian Industrial Chemicals Introduction Scheme (AICIS) is seeking feedback on proposed updates to the list of chemicals with high hazards for categorisation and categorization guidelines for 2025. Key changes include the addition of 116 new chemicals and four AICIS-assessed substances, streamlined guidelines and an annual update schedule. Stakeholders are encouraged to share their input by 5 December 2024.

Key Updates to the High Hazard Chemical List

• New Additions

The AICIS will add 116 new chemicals to the list of chemicals with high hazards for categorisation, reflecting updates from external sources since the last revision. These chemicals exhibit hazard characteristics classified as human health hazard band C or environment hazard band C or D. As a result, their introduction may not qualify as exempted or reported under Steps 4 and 5 of the categorisation process.

While these changes will only affect a small number of importers or manufacturers based on current pre-introduction reports and post-introduction declarations, the AICIS will proactively contact affected companies prior to before implementing these updates.

• Adding AICIS-Assessed Chemicals to the List

Four chemicals that have been directly assessed by AICIS under the Industrial Chemicals Act 2019 are also proposed for inclusion. These substances meet the criteria for inclusion based on their human health hazard band C or environment hazard band C or D classifications. The AICIS will reach out to affected stakeholders before these chemicals are officially added.

How Chemicals Are Added to the List

AICIS has streamlined the process for adding chemicals to the list of chemicals with high hazards for categorisation. As outlined in the April 2024 Guidelines update, the executive director has discretionary authority to include chemicals identified as hazardous through assessments conducted under the Industrial Chemicals Act 2019 or the Industrial Chemicals (Notification and Assessment) Act 1989.

Proposed Revisions to the Categorization Guidelines

AICIS is seeking feedback on proposed revisions to the Industrial Chemicals Categorisation Guidelines, including editorial and structural updates. Key revisions include:

• Annual Updates: The AICIS plans to update the Guidelines and list of chemicals with high hazards for categorisation annually, beginning in September 2025, coinciding with the registration year.

• Clarified Information: Simplified descriptions in Appendix 8.1 will remove unnecessary text and ensure clear identification of listed chemicals.

• Text and Formatting Enhancements: Formatting changes will improve document accessibility and remove outdated references, including redundant footnotes.

Additional Highlights

• Text Corrections: Updates to source descriptions in Appendix 8.1 will clarify the basis for inclusion of chemicals without changing their categorisation status.

• Removed References: Sources removed in previous updates, such as the "Government of Canada Toxic Substances List," will no longer appear in the downloadable spreadsheet, streamlining the list.

• Editorial Adjustments: Non-substantive changes, such as naming conventions and link updates, are intended to improve the user experience without altering the content.

Opportunities for Stakeholder Feedback

The AICIS welcomes stakeholder perspectives on the following:

• Annual update schedule and fixed consultation timelines.

• Inclusion of AICIS-Assessed Chemicals on list of chemicals with high hazards for categorisation.

• Whether additional salts or esters of high hazard chemicals should be included in the guidelines.

The consultation will close on 5 December 2024. Feedback can be submitted through the AICIS consultation page here.

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 ...

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...

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.

The Australian Department of Climate Change, Energy, Environment and Water (DCCEEW) is seeking feedback on the proposed standards for the management of industrial chemicals under the Industrial Chemi...

The Australian Department of Climate Change, Energy, Environment and Water (DCCEEW) is seeking feedback on the proposed standards for the management of industrial chemicals under the Industrial Chemicals Environmental Management Standard (IChEMS). This consultation covers chemicals identified as being of high or low concern, as well as updates to existing standards.

IChEMS aims to harmonize the management of industrial chemicals across Australia to ensure environmental protection through responsible use, storage and disposal. The standards focus on classifying chemicals based on their environmental impact and helping businesses make informed, safer choices.

Chemicals Subject to Public Consultation

The chemicals subject to public consultation are:

• Hexachlorobenzene (HCB)

• Polychlorinated biphenyls (PCBs)

• Polychlorinated terphenyls (PCTs)

• Lauryl (dodecyl) sulfates

• Linear alkylbenzene sulfonates

In addition, the consultation also covers updates to the standards for the following substances:

• Pentachlorobenzene (PeCB)

• Perfluorooctanesulfonic acid (PFOS) and related substances

• Perfluorooctanoic acid (PFOA) and related substances

• Short-chain chlorinated paraffins (SCCPs)

The IChEMS standards apply only to industrial use of chemicals and do not cover medical, veterinary or agricultural uses, which are regulated under separate frameworks.

New Proposed Decisions

Proposed Decision for Hexachlorobenzene: Under the proposed standards, hexachlorobenzene (HCB) (CAS number: 118-74-1) will be placed under Schedule 7 of chemicals likely to cause serious environmental harm. The HCB standard aligns with the Stockholm Convention on Persistent Organic Pollutants and will enter into force on 1 July 2025. Key measures include:

• Prohibition of Manufacture: The manufacture of HCB will be prohibited except for research purposes or unintentional trace contamination (≤ 5 mg/kg).

• Import and Export Restrictions: Import and export of HCB is prohibited except for research or environmentally sound disposal under a hazardous waste permit.

• Use Restrictions: Industrial use of HCB is prohibited except for trace contamination, research or disposal purposes.

• Waste Management: Waste containing HCB must be treated to destroy or irreversibly transform the chemical and concentrations above 50 mg/kg must be managed in accordance with Basel Convention guidelines.

Proposed Decision for Polychlorinated Biphenyls: Under the proposed standards, polychlorinated biphenyls (PCBs) (CAS number: 1336-36-3) will be classified under Schedule 7 for chemicals likely to cause serious environmental harm. The measures are based on the Stockholm Convention, the Australian PCB Management Plan and international standards. Key elements of the proposed decision include:

• Effective Date: The standards for PCBs will come into force on 1 July 2025, giving entities time to comply.

• Manufacture Prohibition: The manufacture of PCBs will be prohibited, except for research purposes or when present as unintentional trace contamination (≤ 2 mg/kg). Australia has never manufactured PCBs commercially, so this standard is consistent with current regulations.

• Import and Export Restrictions: The import and export of PCBs will be prohibited except for research or environmentally sound disposal, in line with the requirements of the Stockholm and Basel Conventions.

• Restrictions on Use: Industrial use of PCBs is prohibited except for articles already in use before 1 July 2025, or if the contamination level is ≤ 2 mg/kg. Articles containing PCBs in concentrations above 50 mg/kg must be disposed of in an environmentally sound manner.

• Waste Management: Waste with PCB concentrations ≥ 50 mg/kg must be treated to destroy or irreversibly transform the chemical or disposed of in accordance with the Basel Convention. Waste with concentrations below 50 mg/kg must still be managed according to environmentally sound practices.

Key Definitions and Standards for HCB and PCBs

• Unintentional Trace Contamination (UTC): HCB and PCBs may be present as unintentional contaminants in products, with limits set at ≤ 5 mg/kg for HCB and ≤ 2 mg/kg for PCBs.

• Environmentally Responsible Waste Management: Waste containing HCB or PCBs must be managed in accordance with national and international regulations, with emphasis on preventing contamination and ensuring safe disposal.

• Information and Awareness: Manufacturers and importers must provide information on the environmental risks posed by these chemicals throughout the supply chain to help ensure safe practices at all stages.

Proposed Decision for Polychlorinated Terphenyls (PCTs): Polychlorinated terphenyls (PCTs) (CAS number: 61788-33-8) are to be classified under Schedule 7, as they are identified as chemicals likely to cause serious environmental damage and have no essential industrial uses. The measures are based on control strategies for polychlorinated biphenyls (PCBs) due to their comparable risk profiles, with reference to the Stockholm Convention, the Basel Convention and other international guidelines. Key elements of the proposed decision for PCTs  include:

• Effective Date: The standards for PCTs will come into force on 1 July 2025, giving businesses time to comply.

• Manufacturing Prohibition: The manufacture of PCTs will be prohibited, except for research purposes or when present as unintentional trace contamination (≤ 2 mg/kg). PCTs are not manufactured commercially in Australia.

• Import and Export Restrictions: The import and export of PCTs will be prohibited except for research, environmentally sound disposal, or trace contamination (≤ 2 mg/kg).

• Restrictions on Use: The use of PCTs, including in products or articles, will be prohibited except for research or disposal purposes or if the article was already in use before 1 July 2025.

• Waste Management: Waste containing PCTs in concentrations ≥ 50 mg/kg must be treated to destroy or irreversibly transform the chemical. Waste with lower concentrations must be managed in accordance with Basel Convention guidelines.

These standards align with both national and international protocols for the management of hazardous chemicals and persistent organic pollutants.

Key Definitions and Standards for PCTs

• Unintentional Trace Contamination (UTC): PCTs may be present as unintentional contaminants in products, with limits set at ≤ 2 mg/kg.

• Environmentally Responsible Waste Management: Waste containing PCTs must be managed in accordance with local and international regulations to ensure environmentally safe disposal.

• Information and Awareness: Manufacturers and reformulators must provide relevant environmental risk information throughout the supply chain to ensure safe handling and use of PCTs.

Proposed Decision for Lauryl (Dodecyl) Sulfates: Lauryl (dodecyl) sulfates (CAS numbers: 151-41-7, 151-21-3, 2235-54-3, 3097-08-3, 4706-78-9), including sodium lauryl sulfate and its derivatives, are classified in Schedule 3 for chemicals with the potential to cause environmental damage. The measures are based on the Australian Industrial Chemical Introduction Scheme (AICIS) Evaluation Statement and focus on managing the use of these chemicals in various industrial products. Key elements of the proposed decision for lauryl (dodecyl) sulfates  include:

• Effective Date: The standards for lauryl (dodecyl) sulfates will enter into force on 1 July 2025, allowing sufficient time for businesses to adapt.

• Chemical Management: The chemicals must be managed in compliance with the IChEMS Minimum Standards, which outline best practices for safe handling, storage and environmental risk reduction.

• End Uses: These chemicals are commonly used in personal care, cleaning, paints, plastics, automotive care and laundry products. Given their wide use as surfactants, the proposed standards aim to reduce potential environmental damage through responsible use and disposal.

Proposed Decision for Linear Alkylbenzene Sulfonates: Linear alkylbenzene sulfonates (LASs), including salts of alkylbenzene sulfonic acid with linear alkyl chains between 10 and 16 carbon atoms, are to be included in Schedule 3 for chemicals that have the potential to cause environmental harm. The measures are based on the Australian Industrial Chemical Introduction Scheme (AICIS) Evaluation Statement. Key elements of the proposed decision for linear alkylbenzene sulfonates (CAS numbers: 27176-87-0; 121-65-3; and others) include:

• Effective Date: The standards will come into force on 1 July 2025, allowing sufficient time for industry to comply.

• Chemical Management: Linear alkylbenzene sulfonates must be managed in accordance with the IChEMS Minimum Standards to ensure safe handling, storage, and disposal.

• End Uses: LASs are widely used in products such as laundry detergents, dishwashing liquids, cleaning agents, automotive care products, and plastic and polymer care products. These chemicals act as surfactants in various domestic and industrial applications.

IChEMS Minimum Standards Agreed by Commonwealth, State, and Territory regulators, the standards provide guidance on the safe management of chemicals to ensure environmental risks are minimized throughout the supply chain.

Have Your Say

To provide feedback, please review the proposed standards and associated documents. Contributions can be made via the survey here. The deadline for responses is 25 October 2024.

It is time for registered importers or manufacturers who introduced industrial chemicals into Australia for commercial purposes between 1 September 2023 and 31 August 2024 to submit their Annual Decla...

It is time for registered importers or manufacturers who introduced industrial chemicals into Australia for commercial purposes between 1 September 2023 and 31 August 2024 to submit their Annual Declaration to the Australian Industrial Chemicals Introduction Scheme (AICIS). This online declaration confirms that chemical introductions were authorized under the Industrial Chemicals Act 2019.

How to Submit                                                                                   

The Annual Declaration form is available on AICIS Business Services and must be submitted by 30 November 2024. The form requires the selection of the categories that apply to the introductions, ensuring that the chemicals meet the criteria for the selected category.

New for 2023-24: Exempted Categories

This year, if introductions fall under the exempted category, all exempted introduction types that applied must be selected on the form:

• Introductions where the highest indicative risk was very low risk

• Polymers of low concern

• Low-concern biological polymers

• Industrial chemicals solely for research and development

• Manufactured soap

• Chemicals imported and subsequently exported

• Chemicals comparable to listed chemicals

• Polymers comparable to listed polymers

• Chemicals resulting from non-functionalized surface treatment of listed chemicals

For more information on submitting the declaration, please visit the annual declaration page.

The Australian Industrial Chemicals Introduction Scheme (AICIS) has announced changes to fees and charges for the 2024-25 registration year, effective from September 1, 2024. These changes will impact...

The Australian Industrial Chemicals Introduction Scheme (AICIS) has announced changes to fees and charges for the 2024-25 registration year, effective from September 1, 2024. These changes will impact industrial chemical introducers, with adjustments to the introduction value thresholds for most registration levels.

Key Changes to Fees and Charges

• Fee Increase: All AICIS service fees will increase by 3.1% to reflect inflationary costs. Details can be found in the 2024-25 AICIS Cost Recovery Implementation Statement (CRIS).

• Registration Charges: Charges and introduction value thresholds will be adjusted. If a company imports or manufactures less than $15 million worth of industrial chemicals, the charges will either remain the same or decrease.

Important Dates

• The next AICIS registration year begins on September 1, 2024.

• Interested parties can view the updated fees and charges for the 2024-25 registration year here.

Updated Registration Level Thresholds

The introduction value thresholds for registration levels have been updated as follows:

Financial Forecasts and Compliance

The adjustments are made following approval by the Assistant Minister for Health and Aged Care. The CRIS transparently outlines how AICIS fees and charges align with the Government’s cost recovery framework, provides financial forecasts and ensures that fees reflect the resources required for various business processes and activities.

The Australian Industrial Chemicals Introduction Scheme (AICIS) has released its updated Rolling Action Plan (RAP), which lists ongoing and recently completed chemical evaluations. This initiative is ...

The Australian Industrial Chemicals Introduction Scheme (AICIS) has released its updated Rolling Action Plan (RAP), which lists ongoing and recently completed chemical evaluations. This initiative is essential to protect human health and the environment.

What is the Rolling Action Plan?

The Rolling Action Plan (RAP) is a strategic work plan used to prioritize chemicals for evaluation based on the results of the Evaluation Selection Analysis (ESA) process. It lists proposed, ongoing and recently completed evaluations, but excludes those with a current assessment certificate.

Update Schedule

The RAP is generally updated as evaluations are completed, with notices published on the AICIS website. Updates may also occur as a result of new information, stakeholder requests, or adverse events requiring evaluation.

Key Details Included in the RAP

• Subject of the evaluation: Chemical name or group name

• Reason for the evaluation

• Estimated date of completion of the evaluation

• Evaluation focus: Human health, environment or both

• Amendments to the evaluation list

Evaluation Process

During the ESA process, chemicals that pose potential risks to human health and/or the environment are identified. Evaluations are prioritized on the basis on these risks, and Evaluation Statements are published for chemicals that do not require further regulation.

Ongoing and Recent Evaluations

The RAP includes lists of ongoing, open for public consultation and recently completed evaluations. A downloadable spreadsheet provides detailed information on chemicals under evaluation.

Chemicals under Evaluation

Chemicals currently under evaluation include:

• 1H-Benzotriazole and its derivatives: Potential risk to human health

• Phenolic benzotriazoles: Potential risk to human health

• Tellurium and its compounds: Potential risk to human health

• Acrylic acid and its salts: Potential environmental risk

• Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester (homosalate): Potential health and environmental risk

Recently completed evaluations cover a range of chemicals, including water-soluble zinc salts and acetoin, with results indicating both environmental and human health risks.

Staying Informed

To stay informed on the latest chemical evaluations and RAP updates, stakeholders can subscribe to notifications via email through the AICIS website. For detailed information or to provide input on specific chemicals listed in the RAP, stakeholders are encouraged to contact AICIS directly.

Conclusion

The Rolling Action Plan is a critical component of AICIS' efforts to effectively manage industrial chemical risks. By staying informed and involved, stakeholders can contribute to the continuous improvement of chemical safety and environmental protection.