Australia upgrades PFAS regulations! New data requirements for ‘designated fluorinated chemicals’, see response strategies→
On February 24, 2025, the Australian Industrial Chemicals Introduction Scheme (AICIS) officially released additional data requirements for applying for assessment certificates for ‘designated fluorinated chemicals’ on its official website and solicited public comments to understand whether applicants and other relevant parties can clearly understand these data requirements.
Designated fluorinated chemical
Designated fluorinated chemicals are a subset of per- and polyfluoroalkyl substances (PFAS) that capture the PFAS chemicals of highest concern to human health and the environment. This includes longer chain PFAS chemicals that are similar to PFOS, PFOA and PFHxS.
The legal definition of a designated fluorinated chemical is a chemical that contains a sequence of atoms (whether linear, branched or cyclic) to which all of the following paragraphs apply:
(a) subject to paragraph (b), the sequence consists only of at least 4, but no more than 20, fluorinated carbon atoms, none of which are fluorinated carbon atoms that are part of conjugated double bonds;
(b) if the sequence is broken in any place, the break consists only of a single atom or single substituted atom;
(c) the sequence includes at least one perfluorinated methyl group (CF3) or perfluorinated methylene group (CF2).
Fluorinated carbon atom means a carbon atom attached to at least one fluorine atom.
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Examples of chemicals that meet the definition of a ‘designated fluorinated chemical’ |
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Chemical Name |
CAS Number |
Structure |
| Cyclohexanesulfonic acid,
1,2,2,3,3,4,4,5,5,6,6-undecafluoro- |
2106-55-0 |
 |
| Propane, 1,1,2,2,3,3-hexafluoro-1,3-bis[(1,2,2-trifluoroethenyl)oxy]- |
13846-22-5 |
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| 3-Pentanone, 1,1,1,2,2,4,4,5,5,5-decafluoro- |
684-32-2 |
 |
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Examples of chemicals that DO NOT meet the definition of a ‘designated fluorinated chemical’ |
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Chemical Name |
CAS Number |
Structure |
| Benzene, 1,2,3,4,5-pentafluoro-6-(1,1,2,2,3,3,3-heptafluoropropyl)- |
54326-26-0 |
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| 3,5-Octadiene, 1,1,1,2,2,3,4,5,6,7,7,8,8,8-tetradecafluoro-, (E,E)- |
105311-63-5 |
 |
| Butanoic acid, 2,2,3,3,4,4,4-heptafluoro-, 2-chloro-1,1,2,3,3,3-hexafluoropropyl ester |
67135-90-4 |
 |
Assessment process
According to AICIS’s regulatory requirements, ‘designated fluorinated chemicals’ not listed in the Australian Inventory of Industrial Chemicals (AIIC) must go through the following assessment procedures before entering the market. The specific process is as follows:
1、Assessment application：
Applicants need to submit an application for an assessment certificate through the AICIS Business Services platform. For such special substances, since the environmental risks of PFAS attracted global attention in 2004, AICIS has significantly strengthened the assessment standards, requiring applicants to provide additional data such as substance structural characteristics and environmental behavior characteristics in addition to basic materials to support comprehensive risk assessment.
2、Risk assessment
AICIS will systematically assess the potential risks that the chemical may pose to human health (e.g., bioaccumulation, toxic effects) and the ecological environment (e.g., persistence, mobility) throughout its life cycle, including production, import, use, and disposal, based on the materials submitted by the applicant. The assessment process focuses on:
- The inherent hazard properties of the chemical
- Risk exposure scenarios and routes of exposure
- The feasibility of risk management measures
3、Assessment result
The assessment results are usually divided into the following two situations:
- issue a certificate that allows the introducer to manufacture or import the chemical into Australia within strict terms
- reject the application if the risks to people or the environment cannot be safely managed
Action purpose
The full set of information requirements for assessment certificate applications for designated fluorinated chemicals are not currently in the application form in AICIS Business Services. They are also not available on the AICIS website. Causing applicants to be unable to prepare the data required for the assessment as required before submitting the assessment certificate application.
This has led to requirements being communicated to an applicant as an information request after a certificate application has been submitted.
In addition, with the progress and development of international understanding and management requirements for PFAS substances, in order to more scientifically assess the introduction risks of ‘designated fluorinated chemicals’ and to optimize the relevant application process and improve transparency, AICIS has officially proposed additional data requirements for the assessment certificate application of ‘designated fluorinated chemicals’ and intends to incorporate them into the assessment certificate application form. The information requirements are based on the latest scientific knowledge about PFAS chemicals. It includes requirements for toxicological studies on the chemical and information about impurities and degradation products.
Specific requirement
Below are the current information requirements that AICIS needs to assess ‘designated fluorinated chemicals’. Information requirements apply for both the assessed chemical and its fluorinated degradation products.
When applying for a ‘health and environment focus’ application type for ‘designated fluorinated chemicals’, in addition to the information required for the assessment of general substances, the following required information must also be provided.
AICIS do not accept in silico information to meet the information requirements for designated fluorinated chemicals, but may accept information from suitable read-across sources to meet the information requirements.
1、Information requirements for the assessed chemical
PFAS substances pose a threat to ecosystems and human health due to their environmental persistence, bioaccumulation, and potential toxicity, and have therefore become a globally concerned pollutant. Therefore, for the assessment of ‘designated fluorinated chemicals’, AICIS requires applicants to provide additional bioaccumulation and toxicity data on the substance itself, as follows:
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Information requirements for the assessed chemical |
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Information requirement |
Acceptable test guidelines to use |
Additional details |
Circumstances in which this information may not be required |
| Fluorinated impurities | – | The identity and concentration of all fluorinated impurities that meet the definition of a designated fluorinated chemical must be provided if they are present in your introduction at greater than or equal to 1 mg/kg.
The identity and concentration of all any impurities of perfluoro hexane sulfonic acid (PFHxS) and its salts, perfluorooctanoic acid (PFOA) and its salts, or perfluoro octane sulfonate (PFOS) and its salts must be provided if they are present in your introduction at greater than or equal to 0.025 mg/kg. |
None. |
| Acute inhalation toxicity | OECD TG 403 | If inhalation is not expected to be a route of exposure during use. | |
| Reproductive / developmental toxicity | OECD TG 422 or 443 | None. | |
| Bioaccumulation | OECD TG 305, 315, or 317 | Bioaccumulation information based on log Kow is not acceptable. | If the molecular weight is greater than or equal to 1,000 g/mol. |
| Long-term toxicity to fish | OECD TG 240, 210, or 215 | None. | |
| Long-term toxicity to aquatic invertebrates | OECD TG 211, or 202 Part II | None. | |
| Chronic toxicity to algae | OECD TG 201 | A NOEC or EC10 value must be reported in the study. | None. |
| Toxicity to soil macroorganisms except arthropods | OECD TG 222 or 207 | If there is no expected release to soil. | |
| Toxicity to terrestrial arthropods | OECD TG 213,214, 232, 228, 237, 245, 246, 247, or 226 | If there is no expected release to soil. | |
| Toxicity to terrestrial plants | OECD TG 208 or 227 | If there is no expected release to soil. | |
| Toxicity to soil microorganisms | OECD TG 216 | If there is no expected release to soil. | |
2、Information requirements for fluorinated degradation products
The degradation of PFAS in the environment is mainly achieved through microbial action, photocatalysis, or plasma treatment, but it is usually limited to partial degradation, and the final products are still other forms of PFAS. Common degradation products include short-chain perfluorocarboxylic acids (such as PFBA, PFPeA) and short-chain perfluorosulfonic acids (such as PFBS, PFHxS). Therefore, AICIS also requires additional information on the fluorinated degradation products and intermediates of ‘designated fluorinated chemicals’.
In order to fully study the degradation behavior of fluorinated degradation products in the environment, AICIS requires higher-level degradation testing compared to rapid biodegradation, such as inherent biodegradation.
In cases where conventional degradation testing cannot assess degradation characteristics, other degradation mode-related tests, such as hydrolysis and photolysis, should also be considered. The specific requirements are as follows:
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Information requirements for fluorinated degradation products |
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Information requirement |
Circumstances in which this information may not be required |
| Test results or scientific justification indicating the identity of the fluorinated degradants and intermediates of the assessed designated fluorinated chemical.
A higher-tiered test such as an inherent biodegradability test report is required. The test should include characterisation of the degradation products and their rate of formation. An inherent biodegradability test is required as there is a greater possibility of degradation occurring in the presence of other nutrients than under the conditions of a ready biodegradability test, where only the test substance is present. If it is claimed that no degradation of the assessed designated fluorinated chemical occurs then a report on the analysis and characterisation of degradation products under relevant degradation conditions must be provided. An inherent biodegradability test does not by itself give information on other degradation modes such as hydrolysis, or on formation of stable degradation products by a mechanism which does not involve mineralisation of a substantial proportion of the chemical or polymer, such as side chain cleavage. If literature sources relating to analogue data are provided, then scientific justification on the applicability of the studies to the assessed designated fluorinated chemical must also be included. |
There are some default degradation assumptions contained within the reports on the PFAS chemicals that AICIS has previously assessed. These assumptions can be used to cover the requirements for the degradants for those chemicals that they are applicable to. |
For all persistent fluorinated degradants and intermediates of the assessed chemical, both:
Section 4. Physical and chemical properties – except: Flash point; Auto flammability; Flammability; Explosiveness; and Oxidising properties. Section 5. Environmental fate and pathways Section 6. Ecotoxicological information Section 7. Toxicological information – except: Acute toxicity; Skin irritation / corrosion; Eye irritation; and Skin sensitization.
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If the assessed designated fluorinated chemical is expected to degrade to a PFAS chemical that AICIS has previously assessed, then this chemical assessment can be used to cover the requirements for the degradants. |
Follow-up actions
The public comment window period ends on April 8, 2025. It is recommended that PFAS-related companies keep abreast of possible future changes in data requirements and provide timely feedback on relevant opinions and suggestions. After the end of the window period, AICIS will:
- announce the outcome after reviewing the feedback
- add the requirements to the form for an assessment certificate application in AICIS Business Services
- publish the full set of information requirements and supporting guidance as part of the assessment certificate guide.
This adjustment not only aligns the assessment requirements with international PFAS management standards, but also helps companies establish a more systematic data management system and reduce compliance risks through pre-information disclosure.
How REACH24H Can Help
REACH24H recommends that applicants keep abreast of AICIS platform updates and prepare key materials in advance in accordance with the new requirements. We will also continue to monitor the regulatory developments of industrial chemicals in Australia, and welcome your continued attention.
If you have any questions regarding chemical compliance in Australia, please feel free to contact us.
Tel: (+86) 571 8700 7555
Email: customer@reach24h.com
