Choose from 5 options:
We’re seeking feedback from businesses on the clarity of the targeted information requirements for assessment certificate applications involving specified classes of introduction.
We want to hear your feedback about the information required for each specified class:
Are the requirements clear?
Do you think any of the requirements are unreasonable and if so, why?
Do you think any requirements are missing?
View the information requirements for each specified class of introduction and have your say
The audience is businesses, industry representatives, consultants and agents for businesses that supply or introduce (manufacture or import) industrial chemicals into Australia.
We’d particularly like to hear from you if you have previously applied for an AICIS assessment of a ‘specified class of introduction’, are planning to, or could apply for an assessment certificate for one of the specified classes.
Anyone applying for an assessment certificate for a specified class of introduction must provide additional targeted information, beyond the standard application requirements. AICIS needs this information to assess risks to human health and the environment because these specified classes can involve higher hazards or greater exposure to people and the environment.
Currently, AICIS assessors request this information from applicants after they have submitted an assessment certificate application. However, we will improve transparency so that applicants know what information they need to provide upfront in their submission. We plan to:
Before we add the information requirements to IUCLID, we’re seeking specific feedback about the clarity and suitability of the requirements.
We expect that updating the application form will only affect a very small number of applicants – this is because a very low proportion of assessment certificate applications are for a specified class of introduction.
By making information requirements for specified classes of introduction upfront and visible on the website and application form, we aim to make the assessment certificate process more predictable, transparent and efficient.
Businesses will have greater clarity about the information and studies they need to give to support their application. This allows potential applicants to make informed decisions about the time, cost and feasibility of applying for an assessment certificate. We also expect this change to reduce delays caused by requests for additional information after submission, while helping AICIS assess applications more efficiently and consistently.
Clearer upfront information requirements mean that applicants are more likely to give us 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 for workers, consumers and the public from the risks of these chemicals.
This consultation relates to assessment certificate applications for:
All certificate applications must include a standard set of physico-chemical, human health and environmental information. For any specified class of introduction application, the applicant must submit both the standard set of information and targeted information for that class.
The current standard information requirements are described in our online guide to applying for an assessment certificate.
From 1 July 2027, we will create a new fee structure for certificate applications to better align application fees with the resources that we need to assess them. The existing information requirements for health focus, environment focus and health/environment focus application types will be restructured to fit the new application types, though the requirements themselves will remain unchanged.
See the new certificate types and standard information requirements from 1 July 2027
In the tables below, we describe the extra information required to support a certificate application of a specified class of introduction. This information is needed for all types of certificate applications. The tables outline:
An applicant must also provide the standard information for the type of assessment certificate they are applying for.
The information will be mandatory, unless one of the ‘circumstances in which this information may not be required’ as shown in the tables below for each specified class applies, or the applicant requests an information waiver. Requests for waivers will still be subject to AICIS’s approval.
As with all our assessments:
The legal definition of a highly branched organic chemical is an industrial chemical that:
is branched at:
i. more than one tertiary carbon; or
ii. more than one quaternary carbon; or
iii. a combination of tertiary and quaternary carbons; and
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Persistence | OECD TG 301 (Ready Biodegradability) or OECD TG 310 (Ready Biodegradability ‑ CO2 in sealed vessels (Headspace Test)) |
| None |
| Long-term toxicity to fish | OECD TG 210 (Fish, Early Life Stage Toxicity Test) or OECD TG 215 (Fish, Juvenile Growth Test) or OECD TG 240 (Medaka Extended One Generation Reproduction Test) |
| If the chemical is not persistent. |
| Long-term toxicity to aquatic invertebrates | OECD TG 211 (Daphnia magna Reproduction Test) or OECD TG 202 Part II (Daphnia sp. Acute Immobilisation Test (Part II)) |
| If the chemical is not persistent. |
| Toxicity to aquatic algae and cyanobacteria | OECD TG 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test). |
| None |
The legal definition of ‘biocidal active’ is an industrial chemical that is intended to act by chemical means on or against a harmful organism by destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, the harmful organism.
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Persistence | OECD TG 301 (Ready Biodegradability) or OECD TG 310 (Ready Biodegradability CO2 in Sealed Vessels Headspace Test) |
| None |
| Bioaccumulation | OECD TG 305 (Bioaccumulation in Fish Aqueous and Dietary Exposure) or OECD TG 310 (Ready Biodegradability CO2 in Sealed Vessels Headspace Test) or OECD TG 315 (Bioaccumulation in Sediment-dwelling Benthic Oligochaetes) or OECD TG 317 (Bioaccumulation in Terrestrial Oligochaetes) or OECD TG 321 (Hyalella azteca Bioconcentration Test) |
| If the chemical has a Log Kow < 4.2. |
| Short-term toxicity to fish | OECD TG 203 (Fish Acute Toxicity Test) |
| None |
| Long-term toxicity to fish | OECD TG 210 (Fish, Early Life Stage Toxicity Test) or OECD TG 215 (Fish, Juvenile Growth Test) or OECD TG 240 (Medaka Extended One Generation Reproduction Test) |
| If the chemical is not persistent. |
| Short-term toxicity to aquatic invertebrates | OECD TG 202 (Daphnia sp. Acute Immobilization Test) |
| None |
| Long-term toxicity to aquatic invertebrates | OECD TG 211 (Daphnia magna Reproduction Test) or OECD TG 202 Part II (Daphnia sp. Acute Immobilisation Test (Part II)) |
| If the chemical is not persistent. |
| Toxicity to aquatic algae and cyanobacteria | OECD TG 201 (Freshwater Alga and Cyanobacteria Growth Inhibition Test) |
| None |
| Toxicity to microorganisms | OECD TG 209 (Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation) |
| If the chemical is not released to sewage treatment plant. |
| Acute toxicity: oral | OECD TG 420 (Acute Oral Toxicity – Fixed Dose Procedure) or OECD TG 423 (Acute Oral Toxicity – Acute Toxic Class Method) or OECD TG 425 (Acute Oral Toxicity – Up and Down Procedure) |
|
|
| Acute toxicity: dermal | OECD TG 402 (Acute Dermal Toxicity: Fixed Dose Procedure) or Draft OECD TG 434 (Acute Dermal Toxicity: Fixed Dose Procedure) |
|
|
| Acute toxicity: inhalation | OECD TG 403 (Acute Inhalation Toxicity) or OECD TG 436 (Acute Inhalation Toxicity – Acute Toxic Class Method) or OECD TG 433 (Acute Inhalation Toxicity: Fixed Concentration Procedure) |
|
|
| Skin irritation | In vivo skin irritation and corrosion (OECD TG 404 (Acute Dermal Irritation/Corrosion)) or In vitro skin corrosion:
In vitro skin irritation (OECD TG 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method) |
| If the indicative risk of the introduction is very low to low risk for human health and the use concentration is <1%. |
| Eye irritation | OECD TG 405 (Acute Eye Irritation/Corrosion)) or OECD TG 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage) or OECD TG 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants) or OECD TG 491 (Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage) or OECD TG 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage) or OECD TG 460 Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants or OECD TG 467 Defined Approaches for Serious Eye Damage and Eye Irritation using the following OECD TGs:
|
| If the indicative risk of the introduction is very low to low risk for human health and the use concentration is <1%. |
| Skin sensitisation | OECD TG 406 (Skin Sensitisation) or OECD TG 429 (Skin Sensitisation: Local Lymph Node Assay) or OECD TG 442A (Skin Sensitisation: Local Lymph Node Assay: DA) or OECD TG 442B (Skin Sensitisation: Local Lymph Node Assay: BrdU-ELISA) or OECD Guideline 497 (Defined Approaches on Skin Sensitisation) using the following OECD TGs:
|
| None |
| Respiratory sensitisation | – |
| None |
| Repeated dose toxicity: oral | OECD TG 407 (Repeated Dose 28-day Oral Toxicity Study in Rodents) or OECD TG 408 (Repeated Dose 90-day Oral Toxicity Study in Rodents) or OECD TG 409 (Repeated Dose 90-day Oral Toxicity Study in Non-Rodents |
| If repeat dose toxicity data are available from other routes of exposure. |
| Repeated dose toxicity: dermal | OECD TG 410 (Repeated Dose Dermal Toxicity: 21/28-day Study) or OECD TG 411 (Subchronic Dermal Toxicity: 90-day Study) |
| If repeat dose toxicity data are available from other routes of exposure. |
| Repeated dose toxicity: inhalation | OECD TG 412 (Subacute Inhalation Toxicity: 28-day Study) or OECD TG 413 (Subchronic Inhalation Toxicity: 90-day Study) |
| If inhalation exposure is not expected during use. |
| Genetic toxicity | Point mutations: In vitro: OECD TG 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene) or In vivo: AND Chromosome damage: In vitro: OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test) In vivo: OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay) |
| None |
The legal definition of ‘designated kind of release into the environment’ is an industrial chemical that is:
For all types of environmental compartments
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Persistence | OECD TG 301 (Ready Biodegradability) or OECD TG 310 (Ready Biodegradability CO2 in Sealed Vessels Headspace Test) |
| None |
| OECD TG 306 (Biodegradability in Seawater) |
| If the chemical is not expected to be released to marine waters. | |
| OECD TG 307 (Aerobic and Anaerobic Transformation in Soil) |
| If the chemical is not expected to be released to soil. | |
| Details of release of the chemical to the environment | – | All applicable environmental compartment(s) - information of receiving environmental compartments, including geographic location, existing endangered species in the environmental compartments, population and human activities of the environmental compartments. | None |
| – | Frequency of the chemical released, and quantity of the chemical released e.g. report a volume of chemical released per interval of time. For example, for water 2000kg per month or 10,000 kg per year or for soil the relevant application rate 1000 kg/ hectare. | None | |
| – | Concentration of the chemical at release. | None |
Water
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Short-term toxicity to fish | OECD TG 203 (Fish Acute Toxicity Test) |
| None |
| Short-term toxicity to aquatic invertebrates | OECD TG 202 (Daphnia sp. Acute Immobilization Test) |
| None |
| Toxicity to aquatic algae and cyanobacteria | OECD TG 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test) |
| None |
| Short-term toxicity to fish - Marine | OECD TG 203 (Fish Acute Toxicity Test) or equivalent using saltwater species |
| If the chemical is not expected to be released to marine waters. |
| Short-term toxicity to aquatic invertebrates - Marine | OECD TG 202 (Daphnia sp. Acute Immobilization Test) or equivalent adapted to saltwater species |
| If the chemical is not expected to be released to marine waters. |
| Toxicity to aquatic algae and cyanobacteria - Marine | OECD TG 201 (Freshwater Alga and Cyanobacteria Growth Inhibition Test) or equivalent adapted to saltwater species |
| If the chemical is not expected to be released to marine waters. |
| Long-term toxicity to fish | OECD TG 210 (Fish, Early Life Stage Toxicity Test) or OECD TG 215 (Fish, Juvenile Growth Test) or OECD TG 240 (Medaka Extended One Generation Reproduction Test) |
| If the chemical is not persistent. |
| Long-term toxicity to aquatic invertebrates | OECD TG 211 (Daphnia magna Reproduction Test) or OECD TG 202 Part II (Daphnia sp. Acute Immobilisation Test (Part II)) |
| If the chemical is not persistent. |
| Long-term toxicity to fish - Marine | OECD TG 210 (Fish, Early Life Stage Toxicity Test) or OECD TG 215 (Fish, Juvenile Growth Test) or OECD TG 240 (Medaka Extended One Generation Reproduction Test) or equivalent adapted to saltwater species. |
|
|
| Long-term toxicity to aquatic invertebrates - Marine | OECD TG 211 (Daphnia magna Reproduction Test) or OECD TG 202 Part II (Daphnia sp. Acute Immobilisation Test (Part II)) or equivalent adapted to saltwater species. |
|
|
Sediment
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Short-term toxicity to sediment dwelling life | OECD TG 235 (Chironomus sp. Acute Immobilisation Test) |
| If the chemical is not expected to be released to sediment. |
| Long-term toxicity to sediment dwelling life | OECD TG 218 (Sediment‑Water Chironomid Toxicity Using Spiked Sediment) or OECD TG 219 (Sediment‑Water Chironomid Toxicity Using Spiked Water) or OECD TG 233 (Sediment‑Water Chironomid Life‑Cycle Toxicity Test Using Spiked Water or Spiked Sediment) |
|
|
Soil
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Toxicity to soil macroorganisms except arthropods | OECD TG 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)) or OECD TG 207 (Earthworm, Acute Toxicity Tests) |
| If the chemical is not expected to be released to soil. |
| Toxicity to soil microorganisms | OECD TG 216 (Soil Microorganisms: Nitrogen Transformation Test) or OECD TG 217 (Soil Microorganisms: Carbon Transformation Test) |
| If the chemical is not expected to be released to soil. |
| Short-term toxicity to terrestrial arthropods | OECD TG 213 (Honeybees Acute Oral Toxicity Test) or OECD TG 214 (Honeybees Acute Contact Toxicity Test) or OECD TG 237 (Honey Bee Larval Toxicity Test Single Exposure) or OECD TG 246 (Bumblebee, Acute Contact Toxicity Test) or OECD TG 247 (Bumblebee, Acute Oral Toxicity Test) |
| If the chemical is not expected to be released to soil. |
| Long-term toxicity to terrestrial arthropods | OECD TG 232 (Collembolan Reproduction Test in Soil) or OECD TG 228 (Determination of Developmental Toxicity to Dipteran Dung Flies(Scathophaga stercoraria L. (Scathophagidae), Musca autumnalis De Geer (Muscidae))) or OECD TG 245 Honey Bee (Apis Mellifera L.), Chronic Oral Toxicity Test (10‑Day Feeding) or OECD TG 226 (Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil) |
|
|
| Toxicity to terrestrial plants | OECD TG 208 (Terrestrial Plant Test Seedling Emergence and Seedling Growth Test) or OECD TG 227 (Lumbriculus variegatus Reproduction Test) |
| If the chemical is not expected to be released to soil. |
The legal definition of a ‘biochemical’ is a biological chemical that:
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Concentration | – | Concentration or cell count of any remaining viable cell or cellular components of the organisms used to produce the biochemical (production organism). | None |
| Known adverse effects of any remaining viable cell or cellular components of the organisms used to produce the biochemical | – | Known adverse human health and environmental effects of the organisms used to produce the biochemical (production organism). | None |
| Species/strain of the production organism | – | The species and strain of the organisms used to produce the biochemical (production organism). | None |
| The methods used to purify or extract the biochemical from the production organism | – | Method(s) used to purify or extract the biochemical from the organisms used to produce the biochemical (production organism). | None |
| By products | – | Identifications of all products or by-products that are present in the biochemical. Known hazard of all products or by-products that are present in the biochemical. | None |
| Whether the biochemical is an enzyme | – | Information whether the biochemical is an enzyme. | None |
| Genetic toxicity | Point mutations: In vitro: OECD TG 476 (In Vitro Mammalian Cell Gene Mutation Tests Using the Hprt and xprt Genes) or OECD TG 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene) In vivo: AND Chromosome damage: In vitro: OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test) In vivo: OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay) |
| None |
The legal definition of a ‘GM product’ has the same meaning as in the Gene Technology Act 2000.
A GM product means something (other than a GMO – genetically modified organism) derived or produced from a GMO.
Genetically modified organism means:
but does not include:
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Identity | – | Details of the genetically modified organism (GMO) from which the genetically modified (GM) product was derived or produced, including species, strain and genetic modifications. | None |
| Impurities | – | Any GMO remaining in the GM product, including concentration or cell count, known adverse human health and environmental effects. | None |
The legal definition of a ‘chemical at the nanoscale’ is an industrial chemical that:
Nanoscale means the particle size range of 1 to 100 nm.
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Manufacturing process | – | Description of the manufacturing process. | None |
| Crystallinity | – | Details of crystallinity (for example, crystallite size). For further information, refer to the Guidance on Sample Preparation and Dosimetry for Manufactured Nanomaterials, 2025 Edition. | If the chemical does not have a crystalline structure. |
| Particle size, particle size distribution and agglomeration/aggregation state | OECD TG 125 (Nanomaterial particle size and size distribution of nanomaterials) |
| If the chemical does not meet our definition of 'not soluble'. |
| Shape and morphology | – | A description of the geometric shape (qualitative or quantitative geometrical description of the extremities of the particles, including agglomerate or aggregate). | If the chemical does not meet our definition of 'not soluble'. |
| – | Image analysis (including transmission or scanning electron microscopy). | If the chemical does not meet our definition of 'not soluble'. | |
| ISO 9276-6:2008 (Representation of results of particle size analysis – Part 6: Descriptive and quantitative representation of particle shape and morphology) | Morphology descriptors (see ISO 9276-6:2008: Representation of results of particle size analysis – Part 6: Descriptive and quantitative representation of particle shape and morphology). | If the chemical does not meet our definition of 'not soluble'. | |
| – | For nanotubes and multilayer chemicals, information on all physical dimensions of the chemical to be introduced. This includes information about nanotubes and multilayer nanochemicals as detailed below:
| If the chemical does not meet our definition of 'not soluble'. | |
| Dissolution rate and dispersion | OECD Guidance Document No. 318 (Guidance Document for the Testing of Dissolution and Dispersion Stability of Nanomaterials, and the Use of the Data for Further Environmental Testing and Assessment) | Measured data on the dissolution rate and dispersibility. For more information, refer to the OECD Guidance Document No. 318 (Guidance Document for the Testing of Dissolution and Dispersion Stability of Nanomaterials, and the Use of the Data for Further Environmental Testing and Assessment). | None |
| Surface charge/Zeta potential | OECD Guidance Document on Sample Preparation and Dosimetry for Manufactured Nanomaterials, 2025 Edition |
|
|
| Hydrophobicity | OECD TG 126 (Determination of the Hydrophobicity Index of Nanomaterials Through an Affinity Measurement) | Measured data on the hydrophobicity index of the chemical conducted in accordance with OECD TG 126 (Determination of the Hydrophobicity Index of Nanomaterials Through an Affinity Measurement). | If the chemical does not meet our definition of 'not soluble'. |
| Surface chemistry, coating and surface area | – | Information on the chemical nature of the surface of a particle in the nanoscale. The description must include:
| If the chemical has not been surface treated. |
| – | Coated or not coated (if coated, the details of coating). | If the chemical is not intentionally coated. | |
OECD TG 124 (Determination of Volume Specific Surface Area of Manufactured Nanomaterials) or ISO/TR 14187:2020 (ISO/TR 14187:2020 - Surface chemical analysis — Characterization of nanostructured materials) | Measurements on volume specific surface area for your chemical in the nanoscale conducted in accordance with OECD TG 124 or surface chemical analysis for characterisation of nano structured materials in accordance with ISO/TR 14187:2020. | If the chemical does not meet our definition of 'not soluble'. | |
| Dustiness | – | Dustiness study. For further information, refer to the OECD Guidance on Sample Preparation and Dosimetry for Manufactured Nanomaterials, 2025 Edition, where inhalation exposure may be relevant for workers or the public. |
|
| Acute toxicity: inhalation | OECD TG 403 (Acute Inhalation Toxicity) or OECD TG 436 (Acute Inhalation Toxicity – Acute Toxic Class Method) or OECD TG 433 (Acute Inhalation Toxicity: Fixed Concentration Procedure). |
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| Repeated dose toxicity: inhalation | OECD TG 412 (Subacute Inhalation Toxicity: 28-day Study) or OECD TG 413 (Subchronic Inhalation Toxicity: 90-day Study) |
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|
The legal definition of ‘polyhalogenated organic chemical’ is an industrial chemical that:
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Persistence | OECD TG 301 (Ready Biodegradability) or OECD TG 310 (Ready Biodegradability CO2 in Sealed Vessels Headspace Test) |
| If the chemical meets the polymer of low concern (PLC) criteria. |
| Bioaccumulation | OECD TG 305 (Bioaccumulation in Fish Aqueous and Dietary Exposure) or OECD TG 310 (Ready Biodegradability CO2 in Sealed Vessels Headspace Test) or OECD TG 315 (Bioaccumulation in Sediment-dwelling Benthic Oligochaetes) or OECD TG 317 (Bioaccumulation in Terrestrial Oligochaetes) or OECD TG 321 (Hyalella azteca Bioconcentration Test) |
| If the chemical:
|
| Long-term toxicity to fish | OECD TG 210 (Fish, Early Life Stage Toxicity Test) or OECD TG 215 (Fish, Juvenile Growth Test) or OECD TG 240 (Medaka Extended One Generation Reproduction Test) |
|
|
| Long-term toxicity to aquatic invertebrates | OECD TG 211 (Daphnia magna Reproduction Test) or OECD TG 202 Part II (Daphnia sp. Acute Immobilisation Test (Part II)) |
|
|
| Toxicity to aquatic algae and cyanobacteria | OECD TG 201 (Freshwater Alga and Cyanobacteria Growth Inhibition Test) |
| If the chemical meets the PLC criteria. |
| Toxicity to soil macroorganisms except arthropods | OECD TG 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)) or OECD TG 207 (Earthworm, Acute Toxicity Tests) |
|
|
| Toxicity to terrestrial arthropods | OECD TG 213 (Honeybees, Acute Oral Toxicity Test) or OECD TG 214 (Honeybees, Acute Contact Toxicity Test) or OECD TG 226 (Predatory mite (Hypoaspis (Geolaelaps) aculeifer), reproduction test in soil) or OECD TG 228 (Determination of Developmental Toxicity to Dipteran Dung Flies(Scathophaga stercoraria L. (Scathophagidae)), Musca autumnalis De Geer (Muscidae))) or OECD TG 232 (Collembolan, Reproduction Test in Soil) or OECD TG 237 (Honey Bee (Apis Mellifera) Larval Toxicity Test, Single Exposure) or OECD TG 245 (Honey Bee (Apis Mellifera L.), Chronic Oral Toxicity Test (10‑Day Feeding)) or OECD TG 246 (Bumblebee, Acute Contact Toxicity Test) or OECD TG 247 (Bumblebee, Acute Oral Toxicity Test) |
|
|
| Toxicity to terrestrial plants | OECD TG 208 (Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test) or OECD TG 227 (Terrestrial Plant Test: Vegetative Vigour Test) |
|
|
| Toxicity to soil microorganisms | OECD TG 216 (Soil Microorganisms: Nitrogen Transformation Test) or OECD TG 217 (Soil Microorganisms: Carbon Transformation Test) |
|
|
| Repeated dose toxicity: Oral | OECD TG 407 (Repeated Dose 28-day Oral Toxicity Study in Rodents) or OECD TG 408 (Repeated Dose 90-day Oral Toxicity Study in Rodents) or OECD TG 409 (Repeated Dose 90-day Oral Toxicity Study in Non-Rodents) |
|
|
| Repeated dose toxicity: Dermal | OECD TG 410 (Repeated Dose Dermal Toxicity: 21/28-day Study) or OECD TG 411 (Subchronic Dermal Toxicity: 90-day Study) |
|
|
| Repeated dose toxicity: Inhalation | OECD TG 412 (Subacute Inhalation Toxicity: 28-day Study) or OECD TG 413 (Subchronic Inhalation Toxicity: 90-day Study) |
|
|
| Reproductive toxicity | OECD TG 415 (One Generation Reproduction Toxicity Study)* or OECD TG 416 (Two Generation Reproduction Toxicity Study) or OECD TG 421 (Reproduction Developmental Toxicity Screening Test) or OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction Developmental Toxicity Screening Test) or OECD TG 443 (Extended One Generation Reproductive Toxicity Study) |
| If the chemical meets the PLC criteria. |
| Developmental toxicity | OECD TG 414 (Prenatal Developmental Toxicity Study) or OECD TG 421 (Reproduction Developmental Toxicity Screening Test) or OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction Developmental Toxicity Screening Test) or OECD TG 426 (Developmental Neurotoxicity Study) or OECD TG 443 (Extended One Generation Reproductive Toxicity Study) |
| If the chemical meets the PLC criteria. |
The legal definition of ‘UV filter’ is an industrial chemical that is intended to protect the skin against ultraviolet radiation in the range of 290 to 400 nm by absorption, reflection or scattering of ultraviolet radiation.
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| UV-vis absorption spectra | OECD TG 101 (UV‑VIS Absorption Spectra) | Analytical information on UV-vis absorption spectra conducted in accordance with OECD TG 101. | None |
| Photostability information | – |
For more information on study design when conducting stability studies, follow the general principles outlined in ICH Q1B Photostability Testing of New Drug substances and Medicinal Products (CPMP/ICH/279/95). | None |
| – |
| If the chemical does not partition in air. | |
| OECD TG 316 (Phototransformation of Chemicals in Water - Direct Photolysis) |
| If the chemical is readily biodegradable. | |
| Phototoxicity | OECD Guideline 397 (Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Phototoxicity) using one or more of the following testing strategies:
|
|
|
| Dermal absorption | OECD Test Guideline 427 (In Vivo Skin Absorption) or OECD TG 428 (Skin Absorption: In Vitro Method) |
| None |
| Skin irritation | In vivo skin irritation and corrosion (OECD TG 404 (Acute Dermal Irritation/Corrosion)) or In vitro skin corrosion:
In vitro skin irritation (OECD TG 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method) |
| None |
| Eye irritation | OECD TG 405 (Acute Eye Irritation/Corrosion)) or OECD TG 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage) or OECD TG 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants) or OECD TG 491 (Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage) or OECD TG 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage) or OECD TG 460 Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants or OECD TG 467 Defined Approaches for Serious Eye Damage and Eye Irritation using the following OECD TGs:
|
| None |
| Skin sensitisation | OECD TG 406 (Skin Sensitisation) or OECD TG 429 (Skin Sensitisation: Local Lymph Node Assay) or OECD TG 442A (Skin Sensitisation: Local Lymph Node Assay: DA) or OECD TG 442B (Skin Sensitisation: Local Lymph Node Assay: BrdU-ELISA) or OECD Guideline 497 (Defined Approaches on Skin Sensitisation) using the following OECD TGs:
|
| None |
| Repeated dose toxicity: oral | OECD TG 407 (Repeated Dose 28-day Oral Toxicity Study in Rodents) or OECD TG 408 (Repeated Dose 90-day Oral Toxicity Study in Rodents) or OECD TG 409 (Repeated Dose 90-day Oral Toxicity Study in Non-Rodents) |
|
|
| Repeated dose toxicity: dermal | OECD TG 410 (Repeated Dose Dermal Toxicity: 21/28-day Study) or OECD TG 411 (Subchronic Dermal Toxicity: 90-day Study) |
|
|
| Repeated dose toxicity: inhalation | OECD TG 412 (Subacute Inhalation Toxicity: 28-day Study) or OECD TG 413 (Subchronic Inhalation Toxicity: 90-day Study) |
|
|
| Genetic toxicity | Point mutations: In vitro: OECD TG 476 (In Vitro Mammalian Cell Gene Mutation Tests Using the Hprt and xprt Genes) or OECD TG 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene) or In vivo: AND Chromosome damage: In vitro: OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test) In vivo: OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay) |
| If oral and inhalation exposure is not expected during use and dermal absorption data demonstrates that the chemical does not penetrate beyond the stratum corneum. |
The legal definition of a chemical for end use in an article with food contact is an industrial chemical that has an end use in an article with food contact where the industrial chemical becomes part of an article that will come into contact with food, other than:
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Approvals or prohibitions | – | Whether your chemical has been approved or refused elsewhere for an end use in an article with food contact, and if so provide information on the approval or prohibition. For example, provide information from:
| None |
| Quantitative information on migration of the chemical from the article to food | Commission Regulation (EU) No 10/2011 or US FDA 21 CFR parts 170–189 (indirect additives) or other relevant guidelines | Provide quantitative data describing the extent to which the chemical migrates from the article/material into food. | If the chemical:
|
| Acute toxicity: oral | OECD TG 420 (Acute Oral Toxicity – Fixed Dose Procedure) or OECD TG 423 (Acute Oral Toxicity – Acute Toxic Class Method) or OECD TG 425 (Acute Oral Toxicity – Up-and-Down Procedure) |
| If the chemical is:
|
| Repeated dose toxicity: oral | OECD TG 407 (Repeated Dose 28 day Oral Toxicity Study in Rodents) or OECD TG No. 408 (Repeated Dose 90 day Oral Toxicity Study in Rodents) or OECD TG 409 (Repeated Dose 90 day Oral Toxicity Study in Non Rodents) |
| If the chemical is:
|
| Genetic toxicity | Point mutations: In vitro: OECD TG 476 (In Vitro Mammalian Cell Gene Mutation Tests Using the Hprt and xprt Genes) or OECD TG 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene) or In vivo: In vitro: OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test) OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay) |
| If the chemical is:
|
The legal definition of a ‘tattoo ink’ is a combination of industrial chemicals that:
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| UV-vis absorption spectra | OECD TG 101 (UV‑VIS Absorption Spectra) | Analytical information on UV-vis absorption spectra conducted in accordance with OECD TG 101. | None |
| Photostability information | – |
| None |
| Phototoxicity | OECD Guideline 397 (Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Phototoxicity) using one or more of the following testing strategies:
|
|
|
| Skin irritation | In vivo skin irritation and corrosion (OECD TG 404 (Acute Dermal Irritation/Corrosion)) or In vitro skin corrosion:
|
| None |
| Eye irritation |
|
| None |
| Skin sensitisation | OECD TG 406 (Skin Sensitisation) or
|
| None |
| Genetic toxicity | Point mutations: In vitro: OECD TG 476 (In Vitro Mammalian Cell Gene Mutation Tests Using the Hprt and xprt Genes) or OECD TG 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene) or In vivo: AND Chromosome damage: In vitro: OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test) In vivo: OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay) |
| None |
A children’s toy is an object for children to play with.
The legal definition of a children’s care product is a product that is intended to facilitate:
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Leaching studies in saliva | Indoor Exposure Product Testing Protocols Version 2.0 (US EPA, 2017) | If products containing the chemical can be placed in the mouth, quantitative information on release of the chemical from the products to the mouth (including study results where migration of the chemical into saliva is measured). This should include study results where migration of the chemical into saliva is measured. For more information, refer to the Indoor Exposure Product Testing Protocols Version 2.0 (US EPA, 2017). | If products containing the chemical are not likely to be placed in the mouth. |
| Acute toxicity: oral | OECD TG 420 (Acute Oral Toxicity – Fixed Dose Procedure) or OECD TG 423 (Acute Oral Toxicity – Acute Toxic Class Method) or OECD TG 425 (Acute Oral Toxicity – Up-and-Down Procedure) |
|
|
| Repeated dose toxicity: oral | OECD TG 407 (Repeated Dose 28-day Oral Toxicity Study in Rodents) or OECD TG 408 (Repeated Dose 90-day Oral Toxicity Study in Rodents) or OECD TG 409 (Repeated Dose 90-day Oral Toxicity Study in Non-Rodents) |
|
|
| Genetic toxicity | Point mutations: In vitro: OECD TG 476 (In Vitro Mammalian Cell Gene Mutation Tests Using the Hprt and xprt Genes) or OECD TG 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene) or AND Chromosome damage: In vitro: OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test) OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay) |
|
|
A chemical is a gas if it is in the gaseous phase at 20°C and 101.3kPa (ambient conditions).
The legal definition of ‘persistent’ is that any of the following applies to the industrial chemical:
| Information requirement | Acceptable test guidelines (TG) to use | More details | Circumstances in which this information may not be required |
|---|---|---|---|
| Physical chemical properties | – | Flammability and explosivity. | None |
| Persistence | Environment Monograph No 61, OECD/GD(92)172, Paris 1993 "The rate of photochemical transformation of gaseous organic compounds in air under tropospheric conditions." |
| None |
| 100-year global warming potential | – | The chemical's 100-year global warming potential (GWP100), using CO2 as the reference substance. | None |
| Ozone depleting potential | – | Ozone depleting potential using CFC-11 as the reference substance. | If the chemical does not contain Chlorine, Bromine, or Iodine. |
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