Australia Regulatory News

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.

In a significant step to improve public health and safety, the Therapeutic Goods Administration (TGA) has announced the adoption of the new Australian/New Zealand Sunscreen Standard: AS/NZS 2604:2021 ...

In a significant step to improve public health and safety, the Therapeutic Goods Administration (TGA) has announced the adoption of the new Australian/New Zealand Sunscreen Standard: AS/NZS 2604:2021 on 11 April 2024. This update aims to align sunscreen regulations in both countries, ensuring higher standards of safety and efficacy for consumers.

Key Highlights of the Proposed Sunscreen Standard AS/NZS 2604:2021

The proposed standard introduces several key changes:

1. Improved UV Protection: The new standard emphasizes improved protection against both UVA and UVB radiation. This change is designed to provide better protection against skin cancer and premature ageing caused by sun exposure.

2. Stricter Testing Requirements: Sunscreen products will undergo more rigorous testing to verify their efficacy and safety. This includes mandatory broad spectrum testing to ensure comprehensive UV protection.

3. Updated Labelling Guidelines: The new standard requires  clearer and more informative labelling. Consumers will benefit from easy-to-understand information on the level of protection offered, water resistance and proper use instructions.

4. Regulatory Harmonization: By adopting AS/NZS 2604:2021, Australia and New Zealand aim to streamline sunscreen regulations to facilitate smoother cross-border trade and reduce confusion for manufacturers and consumers.

Public Health Benefits

The adoption of this updated standard is expected to bring significant public health benefits. The stricter regulations will ensure that only high quality sunscreen products are available on the market, increasing consumer trust and promoting better skin health. Improved UV protection and clearer labelling will help consumers make more informed choices, ultimately reducing the incidence of skin cancer and other UV-related health problems.

Industry Implications

For manufacturers, the new standard presents both a challenge and an opportunity. While the increased requirements may require adjustments to formulation and testing processes, they also offer a chance to demonstrate a commitment to quality and safety. Compliance with AS/NZS 2604:2021 is likely to become a mark of excellence in the sunscreen industry, distinguishing high quality products in a competitive market.

Transitional Arrangements

The following transitional arrangements will apply:

• From 1 July 2024, all new sunscreen products registered on the Australian Register of Therapeutic Goods (ARTG) must comply with the 2021 Sunscreen Standard.

• Existing aerosols and spray pump packs listed on the ARTG before 1 July 2024 will be given a 1-year transition period to comply with the updated labelling requirements of the 2021 Sunscreen Standard.

• All sunscreen products (both aerosols and non-aerosols) already listed in the ARTG before 1 July 2024 will have a 5-year transition period during which they may comply with the testing requirements of either the 2021 Sunscreen Standard or the previous standard (2604:2012).

After the transition period, all existing sunscreen products listed on the ARTG, and all new products released for supply must comply with the 2021 Sunscreen Standard.

Conclusion

The adoption of the new Australian/New Zealand Sunscreen Standard: AS/NZS 2604:2021 is a significant step forward for public health and safety. By setting higher standards for sunscreen efficacy and safety, Australia and New Zealand are leading the way in protecting their populations from the harmful effects of sun exposure.

The Australian Department of Climate Change, Energy, Environment and Water (DCCEEW) is seeking public input on proposed Industrial Chemicals Environmental Management Standard (IChEMS) decisions on int...

The Australian Department of Climate Change, Energy, Environment and Water (DCCEEW) is seeking public input on proposed Industrial Chemicals Environmental Management Standard (IChEMS) decisions on internationally recognized chemicals of concern and lower-concern chemicals. The newly proposed standards aim to optimize the management of the use, storage, handling and disposal of chemicals within industrial sectors. IChEMS is dedicated to providing a consistent national framework that ensures environmentally sound practices and promotes the adoption of safer chemical alternatives across Australia.

The IChEMS Register classifies chemicals into one of seven categories based on their environmental risks, increasing transparency and guiding industry towards effective risk management. These classifications, along with specific risk management measures aim to protect natural ecosystems and promote sustainable industrial practices.

Public feedback is essential to refine the proposed standards and will directly influence the scheduling of chemicals on the IChEMS Register. Supporting documents for the consultation include indicative lists of chemicals with their respective Chemical Abstracts Service (CAS) Registry Numbers, providing essential data for stakeholders to identify and manage chemicals more efficiently.

Key Proposals for Feedback:

Internationally Recognized Chemicals of Concern:

- Dechlorane Plus® and UV-328: These chemicals are part of the Stockholm Convention on Persistent Organic Pollutants (POPs), indicating a high level of environmental threat requiring stringent controls.

The consultation is on inclusion in Schedule 6 of the IChEMS Register. Inclusion in Schedule 6 will prohibit their import, manufacture, use and export in Australia, with limited exceptions for unintentional trace contamination, research, environmentally sound disposal and articles in use before the date the decision takes effect. The proposed effective date is 1 July 2026.

Chemicals with Lower Environmental Risks:

- Melamine, boric acid and its precursors, and β-alanine: These are considered to pose a lower risk, but still require careful management to prevent environmental damage. The consultation is for inclusion in Schedule 2 (melamine and boric acid) and Schedule 3 (β-alanine) of the IChEMS Register.

Participation and Submission Process

Stakeholders are encouraged to review the detailed proposal and accompanying Q&A document to fully understand the scope and implications of the standards. To submit feedback:

- Access the online survey here (scroll down). The survey allows for comprehensive feedback and the option to attach relevant documents.

- Deadline for Submissions: Feedback must be submitted by 5pm (AEST) on Monday 13 May 2024.

In April 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) released a comprehensive proposal detailing adjustments to fees and charges for the 2024-25 fiscal year. As part of its r...

In April 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) released a comprehensive proposal detailing adjustments to fees and charges for the 2024-25 fiscal year. As part of its regulatory mandate, AICIS aims to manage the introduction and manufacture of industrial chemicals in Australia, ensuring the safety and environmental sustainability of these processes. The proposed fees are based on the principles of full cost recovery in accordance with the Australian Government’s Cost Recovery Policy.

Key Proposals for 2024-25

The AICIS fees and charges document outlines significant updates, including adjustments to registration level thresholds and the indexation of fees to more closely reflect inflation and the actual cost of services provided. The changes are expected to streamline operations, improve the fairness of the distribution of the costs among stakeholders, and ensure that the fees collected match the regulatory efforts. The proposed changes to fees and charges are made up of two components:

- Adjustment of Registration Level Thresholds: The proposed changes aim to realign registration charges according to the scale of introductions, thereby facilitating a more equitable distribution of regulatory costs.

- Indexation of Fees: AICIS plans to increase existing service fees by 3.1% to reflect inflationary pressures, particularly in employee wages and supplier costs.

Stakeholder Engagement and Feedback

AICIS has actively engaged with key industry stakeholders including Accord Australasia, the Australian Chamber of Commerce and Industry, and Chemistry Australia. While there is broad support for the initiative to adjust introduction value thresholds, concerns remain about potential fee increases for top-tier registrants.

The AICIS is seeking broader industry feedback through its consultation hub, which runs from 2 April 2024 to 1 May 2024. This feedback will be crucial in shaping the final proposal to be submitted to the government.

Implications for Industry

Companies involved in the industrial chemicals sector will need to closely review the proposed changes, which could impact the cost structure of chemical introductions in Australia. The adjustment of fees and the method of their application reflect AICIS's commitment to maintaining a balanced approach to regulatory cost recovery while promoting a competitive market environment.

Conclusion

The AICIS's proposed fees and charges for 2024-25 reflect its ongoing efforts to align regulatory costs with the services provided. Stakeholders are encouraged to participate in the consultation process to ensure that their views are considered in the final decision. With these changes, AICIS continues to support the safe and responsible introduction of industrial chemicals in Australia, promoting both public health and environmental protection.

For detailed information on the proposed fees and to participate in the consultation, stakeholders can visit the AICIS consultation hub here or contact AICIS directly through its website.

The Australian Industrial Chemicals Introduction Scheme (AICIS) will implement significant changes to the Industrial Chemicals (General) Rules 2019, from 24 April 2024. These modifications are the res...

The Australian Industrial Chemicals Introduction Scheme (AICIS) will implement significant changes to the Industrial Chemicals (General) Rules 2019, from 24 April 2024. These modifications are the result of extensive consultation and feedback from stakeholders and reflect a concerted effort to streamline processes and improve environmental and health protection in the chemical industry. 

Key Updates to the General Rules: 

- Transition from Written Undertakings to Simplified Records: In an effort to simplify compliance, AICIS will replace written undertakings with simpler recordkeeping practices. 

- Wider Acceptance of INCI Names: The reporting and record-keeping framework will now broader accept International Nomenclature of Cosmetic Ingredients (INCI) names, facilitating a more standardized global approach. 

- Refined Categorisation Criteria: Adjustments to the categorisation criteria will benefit several sectors, including: 

  - Local soap manufacturers 

  - Introducers of chemicals in flavour and fragrance mixtures 

  - Introducers of hazardous chemicals, with controlled introduction and use 

Further, the rules will introduce stricter criteria and/or reporting requirements specifically designed to prevent persistent organic pollutants (POPs) from being categorized as exempted or reported introductions. 

Feedback and Adjustments: 

The initial proposals received broad support from stakeholders. However, based on valuable feedback, some adjustments were made in order to: 

- Simplify record keeping for listed introductions 

- Expand the circumstances where INCI names can be used for both reporting and record keeping 

- Broaden the eligibility criteria for chemicals used in flavour and fragrance mixtures 

These adjustments aim to reduce regulatory burden while ensuring that the necessary protection remains in place. 

Upcoming Guideline Changes: 

Further changes to the Industrial Chemicals Categorisation Guidelines are on the horizon with announcements expected soon. These adjustments, set to take effect on 24 April 2024, will align with the commencement of the amended rules. Additional changes, expected in September 2024, will address the need for companies to have more time to prepare, as indicated by industry feedback. 

Transitional Provisions for NICNAS Introducers: 

Temporary recordkeeping provisions will be available until 23 April 2024, for chemical introducers transitioning from the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to AICIS. This accommodation is specifically for eligible introducers who continue to import or manufacture chemicals previously listed on the NICNAS Inventory. 

The upcoming changes reflect the AICIS’s commitment to regulatory excellence, which aims to promote innovation and safety in the chemical industry while minimizing administrative burdens. Stay tuned for detailed updates on these important changes, which promise to shape the future of chemical management and safety standards in Australia. 

During the months of December 2023 and January, February, and March 2024, the Australian Industrial Chemistry Introductory Scheme (AICIS) has made several updates to the Australian Inventory of Indust...

During the months of December 2023 and January, February, and March 2024, the Australian Industrial Chemistry Introductory Scheme (AICIS) has made several updates to the Australian Inventory of Industrial Chemicals (AIIC). The updates include the addition of new chemicals to the inventory and variations to inventory listings following evaluation. Details of the updates are summarised below.

Latest snapshot of AIIC available

On 2 January 2024 the AICIS that the latest AIIC snapshot is available and can be downloaded as a spreadsheet in Excel format here. The AICIS aims to publish a downloadable version of the inventory twice a year.

Chemicals added to the Inventory following issue of assessment certificate (early listing) (I)

On 5 March 2024, the AICIS issued a notice adding six chemical substances to the AIIC following the issuance of early listing assessment certificates. This is in accordance with Section 83 of the Industrial Chemicals Act 2019. Details of the substances are shown in the two tables below.

Chemicals added to the Inventory (I)

On 27 February 2024, the AICIS announced that two substances had been added to the AIIC because 5 years have passed since the assessment certificates for the chemicals were issued. This is in accordance with Section 82 of the Industrial Chemicals Act 2019. Information requirements apply to the new substances. The AICIS must be informed within 28 days if the circumstances of introduction (import or manufacture) differ from their assessment. The two substances are listed in the table below.

Chemicals added to the Inventory following issue of assessment certificate (early listing) (II)

On 13 February 2024, the AICIS issued a notice adding six chemical substances to the AIIC following the issuance of early listing assessment certificates. The same specific information requirements as described above for early listings apply. The six substances are listed in the two tables below.

Variation to inventory listing after evaluation

The AICIS has completed an evaluation under Part 4 of the Industrial Chemicals Act 2019, resulting in an obligation to provide information for the two substances listed in the table below. If the substance is being introduced for consumer end-use (other than in articles) the volume of introduction, use and end-use of the substance must be reported to the Executive Director within 20 working days.

Chemicals added to the Inventory (II)

On 24 January 2024, the AICIS announced that five substances had been added to the AIIC because 5 years have passed since the chemical’s assessment certificates were issued. The same specific information requirements apply as described above. The five substances are listed in the table below.

Chemical added to the Inventory following issuance of assessment certificate  

On 4 January 2024, the AICIS published a notice adding a chemical substance to the AIIC following the issue of an assessment certificate. This is in accordance with Section 83 of the Industrial Chemicals Act 2019. Details of the substance are given in the table below.

Chemicals added to the Inventory (III)

On 18 December 2023 the AICIS announced that five substances had been added to the AIIC because 5 years have passed since the assessment certificates for the chemicals were issued. The same specific information requirements as described above apply. The five substances are listed in the table below.

Variation of inventory listings following approval of applications

On three occasions in December the Executive Director of AICIs varied the terms of the Inventory listings of chemicals following the approval of an application under Section 93 of the Industrial Chemicals Act 2019. The details can be found here, here and here.

Chemicals added to the Inventory following issue of assessment certificate (early listing) (III)

On 7 December 2023, the AICIS published a notice adding five chemical substances to the AIIC following the issuance of early listing assessment certificates. The same specific information requirements as described above for early listings apply. The five substances are listed in the table below.

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...

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.