The legal framework for the regulation of the introduction (importation and manufacture) of industrial chemicals in Australia is the Industrial Chemicals Act 2019 (IC Act). It came into force on 12 March 2019 and establishes the Australian Industrial Chemicals Introduction Scheme (AICIS) and its Executive Director. The IC Act is supported by the Industrial Chemicals (General) Rules and the Industrial Chemicals Categorisation Guidelines, which set out technical and operational details of the AICIS and the requirements introducers need to meet to categorise their chemicals if they are not already listed on the AIIC. The IC Act regulates the importation and manufacture of industrial chemicals in Australia.
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Mar-18-2024
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.
Chemical Name |
CAS No |
Listing Date |
Cyclopentanol, 2-methyl-5-(1-methylethyl)-, 1-propanoate |
1245725-35-2 |
16 February 2024 |
L-Lysine, N-(3-carboxy-1-oxopropyl) derivs., calcium salts |
1917323-93-3 |
26 February 2024 |
L-Lysine, N-(3-carboxy-1-oxopropyl) derivs., sodium salts |
1917323-94-4 |
26 February 2024 |
2(3H)-Furanone, 5-(6-hepten-1-yl)dihydro-, (5S)- |
3017933-60-4 |
28 February 2024 |
AICIS Approved Chemical Name (AACN) |
Listing Date |
Glycine, N-methyl-N-[(9Z)-1-oxo-9-alkenyl]-, calcium salt (2:1) |
13 February 2024 |
2-Propenoic acid, 2-methyl-, Cx-y-alkyl esters, polymers with N-[(dialkylamino)alkyl]-2-methyl-2-propenamide, alkyl methacrylate, alkyl methacrylate and stearyl methacrylate |
26 February 2024 |
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.
Chemical Name |
CAS No |
Listing Date |
1-Octanamine, N,N′-(1,10-decanediyldi-1(4H)-pyridinyl-4-ylidene)bis-, hydrochloride (1:2) |
70775-75-6 |
20 February 2024 |
2-Propenoic acid, 2-methyl-, butyl ester, polymer with butyl 2-propenoate, ethenylbenzene, methyl 2-methyl-2-propenoate, 1,2-propanediol mono-2-propenoate and 2-propenoic acid |
64614-15-9 |
20 February 2024 |
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.
Chemical Name |
CAS No |
Listing Date |
2H-Pyran, 3,6-dihydro-4-methyl-2-[(2,2,3-trimethyl-3-cyclopenten-1-yl)methyl]- |
947237-75-4 |
17 January 2024 |
2H-Pyran, 5,6-dihydro-4-methyl-2-[(2,2,3-trimethyl-3-cyclopenten-1-yl)methyl]- |
947237-84-5 |
17 January 2024 |
2H-Pyran, tetrahydro-4-methylene-2-[(2,2,3-trimethyl-3-cyclopenten-1-yl)methyl]- |
947237-93-6 |
30 January 2024 |
Fatty acids, C12-14, reaction products with sulfur trioxide, sodium salts |
2215087-54-8 |
7 February 2024 |
AICIS Approved Chemical Name (AACN) |
Listing Date |
Amides, from alkanoic acid, ethylenediamine, hydrogenated plant-based oil fatty acids and octanoic acid |
2 February 2024 |
Amides, from alkanediamine, decanoic acid, hydrogenated plant-based oil fatty acids and octanoic acid |
2 February 2024 |
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.
Chemical Name |
CAS No |
Date Variation Will Take Effect |
2-Propenoic acid, 2-methyl-, 2-ethoxyethyl ester |
2370-63-0 |
29 February 2024 |
2-Propenoic acid, 2-methyl-, 2-methoxyethyl ester |
6976-93-8 |
29 February 2024 |
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 Name |
CAS No |
Listing Date |
Fatty acids, tall-oil, polymers with acrylic acid and styrene, tert-Bu peroxide-initiated, polymers with Bu acrylate, 2-ethylhexyl acrylate, Me methacrylate and styrene, ammonium salts |
1777808-07-7 |
15 January 2024 |
Poly(oxy-1,2-ethanediyl), .alpha.-[4-(dimethylamino)benzoyl]-.omega.-[[4-(dimethylamino)benzoyl]oxy]- |
71512-90-8 |
15 January 2024 |
Ethanesulfonic acid, 2-[(2-aminoethyl)amino]-, sodium salt (1:1), polymer with 1,6-diisocyanatohexane, dimethyl carbonate, 1,6-hexanediol and .alpha.-hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)], polyethylene-polypropylene glycol mono-Bu ether-blocked |
880105-45-3 |
15 January 2024 |
1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1,2-bis(2-ethylhexyl) ester |
26040-51-7 |
17 January 2024 |
Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with .alpha.-hydro-.omega.-hydroxypoly(oxy-1,4-butanediyl), 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and 1,2-propanediamine, compd. with N,N-diethylethanamine |
2016755-66-9 |
22 January 2024 |
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.
Chemical Name |
CAS No |
Listing Date |
2H-Pyran, 3-heptyltetrahydro- |
854737-09-0 |
2 January 2024 |
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.
Chemical Name |
CAS No |
Listing Date |
||
2-Propenoic acid, 2-methyl-, butyl ester, polymer with 2-hydroxyethyl 2-methyl-2-propenoate, 1,1′-methylenebis[4-isocyanatobenzene] and methyl 2-methyl-2-propenoate |
366806-19-1 |
22 November 2023 |
||
Fatty acids, C18-unsatd., dimers, polymers with .alpha.-hydro-.omega.-hydroxypoly(oxy-1,4-butanediyl) |
1431412-25-7 |
27 November 2023 |
||
Docosanoic acid, ester with 1,2,3-propanetriol |
77538-19-3 |
27 November 2023 |
||
|
96283-84-0 |
29 November 2023 |
||
Soybean oil, polymer with adipic acid and diethylene glycol-depolymd. poly(ethylene terephthalate) waste plastics |
2180951-94-2 |
8 December 2023 |
||
2-Propenoic acid, 2-methyl-, butyl ester, polymer with butyl 2-propenoate, ethenylbenzene, 2-hydroxyethyl 2-methyl-2-propenoate, methyl 2-methyl-2-propenoate and 2-propenoic acid, tert-Bu 3,5,5-trimethylhexaneperoxoate-initiated, compds. with 2-(dimethylamino)ethanol |
3008591-77-0 |
12 December 2023 |
||
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-C8-10 acyl derivs., inner salts |
638132-19-1 |
14 December 2023 |
||
1-Propanaminium, N-(carboxymethyl)-N,N-dimethyl-3-[(1-oxooctyl)amino]-, inner salt |
73772-46-0 |
14 December 2023 |
||
1-Propanaminium, N-(carboxymethyl)-N,N-dimethyl-3-[(1-oxodecyl)amino]-, inner salt |
73772-45-9 |
14 December 2023 |
||
Ferrocene, 1,1′′-octylidenebis- |
501410-94-2 |
14 December 2023 |
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.
Chemical Name |
CAS No |
Date of Variation |
6,10-Dodecadien-1-ol, 3,7,11-trimethyl-, (3S,6E)- |
27745-36-4 |
14 December 2023 |
6,10-Dodecadienal, 3,7,11-trimethyl-, (3S,6E)- |
194934-66-2 |
15 December 2023 |
Santalum austrocaledonicum, ext. |
91845-48-6 |
14 December 2023 |
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.
Chemical Name |
CAS No |
Listing Date |
2-Pentanol, 1-[[(2S,5R)-4,4,8-trimethyltricyclo[6.3.1.02,5]dodec-1-yl]oxy]-, (2R)- |
2411391-25-6 |
29 November 2023 |
2-Pentanol, 1-[[(2S,5R)-4,4,8-trimethyltricyclo[6.3.1.02,5]dodec-1-yl]oxy]-, (2S)- |
2411391-27-8 |
29 November 2023 |
2-Pentanol, 1-[[(2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-yl]oxy]-, (2R)- |
2952782-14-6 |
29 November 2023 |
2-Pentanol, 1-[[(2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-yl]oxy]-, (2S)- |
2952782-15-7 |
29 November 2023 |
Amines, polyethylenepoly-, reaction products with 2-[(carbopolycyclicoxy)methyl]heteromonocycle and succinic anhydride monopolyisobutenyl derivs. |
|
4 December 2023 |
Jan-30-2024
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.
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