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What we heard about information requirements for designated fluorinated chemicals
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Overview
From February to April 2025, we asked for feedback on information that AICIS requires from assessment certificate applicants to assess introductions of designated fluorinated chemicals. We wanted your thoughts on whether the requirements for this type of introduction were clear before we formally added them to the assessment certificate online application form in AICIS Business Services.
We received a total of 8 submissions, which are summarised on this page along with our responses.
Outcome
We will implement the proposed information requirements without change. Below is the required information for certificate applications of designated fluorinated chemicals that we originally published earlier this year. An applicant will also need to provide the required information for a 'health and environment focus' application type.
Our information requirements are based on what we currently know about the potential hazards of designated fluorinated chemicals and the risks they pose if manufactured or imported into Australia. We may update these requirements as more information becomes available to us. We will seek feedback when appropriate and announce any changes before they take effect.
Information requirements for the assessed chemical
| 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 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 433 | – | 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. |
Information requirements for fluorinated degradation products
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.
Circumstances in which this information may not be required
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 1 and 2:
The information required for a standard health and environment-focused certificate application set out in the apply for an assessment certificate page.
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 sensitisation.- Information requirements listed above for an assessed chemical that meets the designated fluorinated chemical definition
Circumstances in which this information may not be required
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.
Feedback and responses
The submissions focused on questions about how the information requirements would work. We have answered them here and will also clarify these in future supporting guidance.
Response
We aim to keep our assessments proportionate to the level of risk. This means we only request data that is directly relevant to the assessment and the exposure scenario provided by the applicant. But additional data may be required if there is an indication during the assessment that the designated fluorinated chemical is likely to be released to soil from the proposed use, and the applicant has not supplied the necessary information.
We also place a ‘defined scope of assessment’ as a term of the certificate that is issued at the end of an assessment. Any intended use outside of the defined scope means that the applicant must apply for a reassessment and receive our approval before they can import or manufacture the chemical.
If the applicant anticipates release to soil in a reassessed use, then we would require information on terrestrial toxicity.
Response
The information requirements only apply to chemicals that require a certificate application before they can be introduced. They also only apply to chemicals that meet the definition of a designated fluorinated chemical.
They do not apply if the chemical is on the Inventory and the introduction meets the criteria for the listed introduction category.
Response
The threshold for providing the identity and concentration of fluorinated impurities that meet the definition of a designated fluorinated chemical is greater than or equal to 1 mg/kg except for impurities of perfluorohexanesulfonic acid (PFHxS) and its salts, perfluorooctanoic acid (PFOA) and its salts, or perfluorooctane sulfonate (PFOS) and its salts where the threshold is greater than or equal to 0.025 mg/kg.
These thresholds are consistent with the Industrial Chemicals Environmental Management Standard.
Response
We are not identifying test guidelines within the information requirements for determining the level of fluorinated impurities. We will consider adding content on what factors should be considered when selecting appropriate methods as part of the assessment certificate guidance.
Response
The information requirements for designated fluorinated chemicals apply to the assessed chemical that is the subject of the certificate application and all persistent fluorinated degradants and intermediates of the assessed chemical.
The information requirements for designated fluorinated chemicals do not apply to fluorinated impurities that may be present alongside the designated fluorinated chemical that is being assessed.
There is no need to purify the assessed designated fluorinated chemical before testing. Applicants should identify any fluorinated impurities above the levels specified in the information requirements.
Response
We do not accept in silico data to meet the information requirements for designated fluorinated chemicals. Currently, there are no validated in vitro methods available to fulfil these requirements. However, we can accept data from appropriate read-across sources.
For potential fluorinated degradants and intermediates, if there is an existing relevant AICIS assessment, the applicant can refer to this assessment to meet the information requirements for the fluorinated degradants and intermediates.
Response
We are not identifying test guidelines within the information requirements for quantifying the degradation products. We will consider adding content on what factors should be considered when selecting appropriate methods and thresholds as part of the assessment certificate guidance.
Response
Only degradants resulting from normal conditions of use and relevant exposure scenarios need to be identified.
Next steps
We have published these existing information requirements on the ‘Apply for an assessment certificate’ page to assist any applicant planning to apply for an assessment certificate for the introduction of a designated fluorinated chemical.
We are working to add the information requirements to the online application form in AICIS Business Services and are preparing guidance to further explain the information requirements. In the meantime, applicants are advised to include this information as part of their applications. If it is not included, we will ask for it as an additional information request, and the assessment will be paused until it is submitted.
We will announce the release of the updated form and supporting guidance in our news hub and monthly newsletter – sign up to the Industrial Chemicals Regulatory News.
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