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Information requirements for assessment certificate applications of ‘designated fluorinated chemicals’
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What’s this about?
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.
AICIS assesses the health and environmental risks of designated fluorinated chemicals that are not on the Australian Inventory of Industrial Chemicals (the Inventory), after an application for an assessment certificate is submitted through the form in AICIS Business Services. The chemical can only be manufactured or imported into Australia if AICIS issues an assessment certificate.
Our information requirements for these certificate applications 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.
We are seeking your feedback on the clarity of the information requirements that will be added to the form for an AICIS assessment certificate application for a chemical that is a ‘designated fluorinated chemical’ – will an applicant be able to clearly understand these requirements?
Why are we consulting?
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. Instead, the website directs potential applicants to contact us for guidance about the information needed for their application. This has led to requirements being communicated to an applicant as an information request after a certificate application has been submitted.
Before improving transparency by adding the requirements to the application form and publishing them, we would like your feedback about whether an applicant will be able to clearly understand them.
View the information requirements
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. An applicant must also provide the required information for a 'health and environment focus' application type.
We do not accept in silico information to meet the information requirements for designated fluorinated chemicals. We may accept information from suitable read-across sources to meet the information requirements.
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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 perfluorohexanesulfonic acid (PFHxS) and its salts, perfluorooctanoic acid (PFOA) and its salts, or perfluorooctane 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. |
| Details | 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. See our page on previous PFAS chemical assessments. |
For all persistent fluorinated degradants and intermediates of the assessed chemical, both:
| 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. See our page on previous PFAS chemical assessments. |
What will happen after the consultation closes?
We 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.
As with all assessments, we may still ask certificate applicants for more information on a case-by-case basis to make sure we can properly assess the risks of the chemical.
How would this affect introducers?
Updating the application form is only expected to affect a very small number of applicants. There have only been 2 applicants for assessment certificates for designated fluorinated chemicals since AICIS began in July 2020.
The current requirements will be clearer because they will be part of an amended application form and supporting guidance. This will allow future applicants to make more informed business decisions, such as helping them to estimate the costs of submitting an application. This should also reduce the number of requests from AICIS for more information after an applicant submits their certificate application.
How would this affect the community?
Clearer upfront information requirements mean that applicants are more likely to provide us with all the information necessary to assess the risks to human health and the environment. This will help to maintain and enhance the current levels of protection from the risks of these chemicals.
Background
Applicants must provide information in their certificate application for designated fluorinated chemicals that is unique to the assessment of these chemicals. This is because we need more information to assess designated fluorinated chemicals than for most other types of chemicals. This has been the case since 2004, shortly after concerns with certain PFAS chemicals first became known. We use this information to assess the risks to Australians’ health and the environment from manufacturing, importing and using these chemicals. After we assess the chemical, we either:
- 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.
What’s a ‘designated fluorinated chemical’?
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.
Related content:
Glossary description of designated fluorinated chemicals
Past evaluations on PFAS chemicals on the Inventory
Categorisation of fluorinated chemicals
Have your say by 8 April 2025
Use our online form to submit comments about the clarity of the information requirements.