Australia Regulatory News

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.

The Australian Department of Climate Change, Energy, the Environment and Water (DCCEEW) has recently published scheduling decisions under the Industrial Chemicals Environmental Management Standard (IC...

The Australian Department of Climate Change, Energy, the Environment and Water (DCCEEW) has recently published scheduling decisions under the Industrial Chemicals Environmental Management Standard (IChEMS) for a number of persistent organic pollutants (POPs).

The Industrial Chemicals Environmental Management Standard                                                                                                                                       

IChEMS is a national approach in Australia designed to efficiently manage the use, storage, handling and disposal of chemicals. It not only facilitates industry compliance by standardising environmental protocols for industrial chemicals but also encourages the adoption of less hazardous alternatives. Under IChEMS, chemicals are listed on the IChEMS Register, which categorises chemicals into seven schedules based on their environmental risk and provides essential information on appropriate risk-based controls to protect the environment. More hazardous chemicals, particularly those that pose a threat to human health, are subject to more stringent controls.

 IChEMS Register Schedules

In the IChEMS Register, Schedules 6 and 7 list the industrial chemicals of greatest environmental concern, e.g. chemicals that are persistent, bioaccumulative and toxic, such as POPs. All uses of chemicals in Schedules 6 and 7 are being phased out, except for essential uses. Schedules 2 to 5 list industrial chemicals of medium environmental concern. They are subject to controls that are proportionate to the nature and level of risk. Schedule 1 lists the industrial chemicals of lowest concern.

Scheduling decisions

 In the second half of 2023 the DCCEEW held three consultations on the proposed scheduling decisions for perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorohexane sulfonate (PFHxS), pentachlorobenzene (PeCB), brominated flame retardants (BFRs) and short-chained chlorinated paraffins.

These consultations, which received 100 submissions, have resulted in the following substances being added to the IChEMS Register. From 1 July 2024 (1 July 2025 for PFOA, PFOS and PFHxS), the import, manufacture, use, and export of these substances will be prohibited in Australia.

Substances added to Schedule 6:

• Decabromodiphenyl ether and nonabromodiphenyl ether (decaBDE and nonaBDE)

Substances added to Schedule 7:

• Perfluorooctanoic acid (PFOA) and related substances

• Perfluorooctanesulfonic acid (PFOS) and related substances

• Perfluorohexanesulfonic acid (PFHxS) and related substances

• Pentachlorobenzene (PeCB)

• Octabromodiphenyl ether (octaBDE), heptabromodiphenyl ether (heptaBDE) and hexabromodiphenyl (hexaBDE)

• Pentabromodiphenyl ether (pentaBDE) and tetrabromodiphenyl ether (tetraBDE)

• Hexabromocyclododecane (HBCDD)

• Short chain chlorinated paraffins (SCCPs)

These chemicals are globally recognised as persistent organic pollutants (POPs) that pose a significant environmental risk and require effective management to protect the environment. Inclusion of these chemicals in the IChEMS Register will establish a consistent standard for their management across Australia, contributing to a safer circular economy.

During the months of September, October, and November 2023, the Australian Industrial Chemistry Introductory Scheme (AICIS) has made several updates to the Australian Inventory of Industrial Chemicals...

During the months of September, October, and November 2023, the Australian Industrial Chemistry Introductory Scheme (AICIS) has made several updates to the Australian Inventory of Industrial Chemicals (AIIC). The updates include adding new chemicals to the inventory, correcting chemical names and correction of chemical names in the inventory. Details of the updates are summarised below.

Correction of chemical names

On 23 November 2023, the AICIS announced that the names of 27 chemicals in the AIIC have been updated to the Chemical Abstracts Service (CAS) name or the CAS name has been updated. The updates do not change the identity of the chemical substances themselves. These amendments were made in accordance with section 85 of the Industrial Chemicals Act 2019. The details of the substances are listed in the table below.

Chemicals added to the Inventory

On 10 November 2023 the AICIS announced that seven 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. Obligations to provide information about the new substances apply. The AICIS must be informed within 28 days if the circumstances of the introduction (importation or manufacture) differ from their assessment. The seven substances are listed in the table below.

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

On 2 November 2023, the AICIS issued a notice adding two chemical substances to the AIIC following the issuance of an early listing assessment certificates. This is in accordance with section 83 of the Industrial Chemical Act 2019. The details of the substances are listed in the table below.

Chemicals added to the Inventory (II)

On 24 October 2023 the AICIS announced that seven 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 seven substances are listed in the table below.

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

On 17 October 2023, the AICIS issued a notice adding seven chemical substances (fragrances) to the AIIC following the issuance of an early listing assessment certificates. The same specific information requirements as described above for early listings apply. The seven substances are listed in the table below.

Chemicals added to the Inventory (III)

On 10 October 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.

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

On 19 September 2023, the AICIS issued a notice adding two chemical substances to the AIIC following the issuance of an early listing assessment certificates. The same specific information requirements as described above for early listings apply. The two substances are listed in the table below.

Food Standards Australia New Zealand (FSANZ) proposes to amend its Food Standards Code to align residue limits (MRLs) for agricultural and veterinary chemicals with other national regulations.  Re...

Food Standards Australia New Zealand (FSANZ) proposes to amend its Food Standards Code to align residue limits (MRLs) for agricultural and veterinary chemicals with other national regulations. 

Regulatory Authority involved:

• Food Standards Australia New Zealand (FSANZ)

• Australian Pesticides and Veterinary Medicines Authority (APVMA)

APVMA sets maximum residue levels that are not likely to be exceeded if agricultural or veterinary chemicals are used in accordance with approved label instruction. In considering maximum residue levels (MRLs) and variations to MRLs, the APVMA considered studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice, and dietary exposure.

The following substances in particular plant and animal commodities are the subject of the proposed amendments:

Plant commodities: Fenpropidin, florylpicoxamid, abamectin, acibenzolar-S-methyl, benzovindiflupyr, chlorantraniliprole, cyanamide, cyantraniliprole, difenoconazole, dimethoate, fenpropidin, fluxapyroxad, isocycloseram, isopyrazam, omethoate, pyraclostrobin, spirotetramat, tebuconazole, tetraniliprole, trifloxystrobin, and trifludimoxazi Australian Pesticides and Veterinary Medicines Authorityroln.

Animal commodities: Fenpropidin, halauxifen-methyl, and trifluralin

Key highlights of amended version of MRL standard:

• New MRLs have been established for a variety of pesticides and veterinary compounds, including those used on new crops or to combat novel pests and diseases.

• MRLs for various pesticides and veterinary chemicals have been increased to reflect the latest scientific research on their safety.

• MRLs for various pesticides and veterinary compounds have been reduced to ensure that dietary exposure remains safe.

FSANZ has assessed the scientific data on chemicals and concluded that the proposed MRLs are safe for consumers.

Public is invited to comment on proposed amendments until 14 November 2023.

Proposed date of adoption and publication anticipated in January 2024.

On 29 September 2023, the Australian Industrial Chemicals Introduction Scheme (AICIS) opened consultation on 20 draft evaluation statements covering 1996 industrial chemicals. The deadline for comment...

On 29 September 2023, the Australian Industrial Chemicals Introduction Scheme (AICIS) opened consultation on 20 draft evaluation statements covering 1996 industrial chemicals. The deadline for comments is 27 November 2023.

This type of consultation has been conducted by the AICIS on four previous occasions, first in October 2021 (1387 substances), in May 2022 (157 substances), in October 2022 (187 substances) and in May 2023 (1768 substances).

Evaluation roadmap

The evaluations are a part of Australia’s Evaluation Roadmap for 2024 and beyond, published in September 2021 and the accompanying rolling action plan for prioritising chemicals for evaluation. Both have been implemented to accelerate the risk assessment process for industrial chemicals that can be used in the country. The evaluation roadmap aims to evaluate at least 20 % of the chemicals on the Australian Inventory of Industrial Chemicals (AIIC) that do not have an up-to-date risk assessment by 30 June 2024 and the remaining unassed industrial chemicals of higher concern by the end of 2030.

Under the Australian Industrial Chemicals Act 2019, any chemical that meets the definition of an industrial chemical (or class of industrial chemicals) may be subject to evaluation. Evaluations may cover a single chemical, a class or group of chemicals, a specific use, a specific hazard, a specific exposure, or specific circumstances of a chemical introduction.

Draft Evaluation statements

The list of draft evaluation statements provides an overview of the evaluations including the proposed outcomes for each chemical. Some examples are:

• Acetoin, cinnamaldehyde, diethylene glycol, and ethylene glycol are evaluated in order to provide information on human health risks, focusing on the risk to public health from the use of the chemical in e-cigarettes (vaping products).

• 2-Methoxyethyl methacrylate and 2-ethoxyethyl methacrylate where the evaluation selection analysis has indicated a potential risk to human health and the AICIS proposes to vary the terms of the Inventory for this substance. The substances are used in nail enhancement products (such as artificial nails)

The majority of the substances (approximately 1800 of the 1996 substances) are not considered for in-depth evaluation because they are no longer commercially active in Australia.

The full list of Draft Evaluation Statements can be found here.