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Have your say: Information requirements for assessment certificate applications – specified classes of introduction

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We’re seeking feedback from businesses on the clarity of the targeted information requirements for assessment certificate applications involving specified classes of introduction.

Consultation closes

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Summary

  • Starting 1 July 2027, businesses that apply for an assessment of a ‘specified class of introduction’ will need to provide targeted information (or request a waiver) through IUCLID as part of their assessment certificate application form in AICIS Business Services. This change will help potential applicants understand what information they need to gather before applying, so they can make informed decisions about the cost and feasibility of an application. It will also ensure we receive the information upfront to complete a risk assessment.
  • We have detailed the information required for each specified class of introduction and we’re asking for your thoughts on whether the information requirements are clear and reasonable to support our risk assessment, and whether any requirements are missing.
  • This consultation is open for comments using our online form until 8 September 2026.

To note before you have your say

  1. This consultation only covers information requirements for assessment certificate applications involving a specified class of introduction, which is in addition to the standard information required for certificate applications.
  2. The additional information requirements for specified classes of introduction are not new regulatory requirements. We request this information from applicants during an assessment.
  3. This consultation does not relate to:
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Feedback we are seeking

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

Who this is for

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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.

What this is about

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:

Icon of an AICIS assessment certificate
  • incorporate the information requirements into IUCLID6 – applicants can then use the revised form to submit assessment certificate applications and provide the additional information for specified classes as part of their chemical dossier from 1 July 2027.
  • publish the information required for each specified class on our website, alongside the standard set of information requirements for certificate applications.

Before we add the information requirements to IUCLID, we’re seeking specific feedback about the clarity and suitability of the requirements.

Benefits for business and community

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.

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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:

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  • highly branched organic chemicals 
  • chemicals for end use as biocidal actives
  • chemicals that involve a designated kind of release into the environment, which includes
    • chemicals that are intentionally released to the environment during use
    • chemicals with an end use in firefighting
    • chemicals with an end use offshore
  • biochemicals
  • genetically modified products
  • chemicals at the nanoscale
  • polyhalogenated organic chemicals  
  • ultraviolet (UV) filters
  • chemicals for end use in articles with food contact
  • chemicals for end use in tattoo inks
  • chemicals for end use in articles that are children’s toys or children’s care products
  • chemicals that are a gas and are persistent.

Standard information required for assessment certificate applications

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

Information required for each specified class of introduction

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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:

  • acceptable test guidelines (where relevant)
  • additional details
  • circumstances where information may not be required (information waivers).

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:

  • we may also ask for more information on a case-by-case basis to make sure we can properly assess the risks of the chemical
  • the ban on new animal test data for cosmetics applies.
     

The legal definition of a highly branched organic chemical is an industrial chemical that:

  1. is carbon based; and
  2. 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

  3. is not a polymer.

Information requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances 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))

  • Ready biodegradability conducted in accordance with OECD TG 301 or OECD TG 310.
  • Read across and in silico information are not acceptable.
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)

  • Multi-generation fish toxicity tests conducted in accordance with OECD TG 210 or OECD TG 215 or OECD TG 240.
  • Read across and in silico information are not acceptable.
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))

  • Long-term toxicity to aquatic invertebrates conducted in accordance with OECD TG 211 or OECD TG 202 Part II.
  • Read across and in silico information are not acceptable.
If the chemical is not persistent.
Toxicity to aquatic algae and cyanobacteriaOECD TG 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test).
  • In vivo aquatic toxicity tests on algae and/or cyanobacteria conducted in accordance with OECD TG 201. A NOEC or EC10 value must be reported in the study.
  • Read across and in silico information are not acceptable.
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 requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances 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)

  • Ready biodegradability conducted in accordance with OECD TG 301 or OECD TG 310. 
  • Suitable read across information is acceptable.
  • In silico information is not acceptable.
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)

  • Bioaccumulation conducted in accordance with OECD TG 305 or OECD TG 310 or OECD TG 315 or OECD TG 317 or OECD TG 321.
  • Suitable read across information is acceptable. 
  • In silico information is not acceptable.
If the chemical has a Log Kow < 4.2.
Short-term toxicity to fishOECD TG 203 (Fish Acute Toxicity Test)
  • In vivo acute aquatic toxicity on fish conducted in accordance with OECD TG 203.
  • Suitable read across information is acceptable. 
  • In silico information is not acceptable.
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)

  • Multi-generation fish toxicity tests conducted in accordance with OECD TG 210 or OECD TG 215 or OECD TG 240.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
If the chemical is not persistent.
Short-term toxicity to aquatic invertebratesOECD TG 202 (Daphnia sp. Acute Immobilization Test)
  • In vivo test on Daphnia species conducted in accordance with OECD TG 202.
  • Suitable read across information is acceptable.
  • In silico information is not acceptable.
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))

  • Long-term toxicity to aquatic invertebrates conducted in accordance with OECD TG 211 or OECD TG 202 Part II.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
If the chemical is not persistent.
Toxicity to aquatic algae and cyanobacteriaOECD TG 201 (Freshwater Alga and Cyanobacteria Growth Inhibition Test)
  • In vivo aquatic toxicity tests on algae and/or cyanobacteria conducted in accordance with OECD TG 201. A NOEC or EC10 value must be reported in the study.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
None
Toxicity to microorganismsOECD TG 209 (Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation)
  • Toxicity to sludge microorganisms conducted in accordance with OECD TG 209. 
  • Suitable read across information is acceptable.
  • In silico information is not acceptable.
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 oral toxicity in accordance with OECD TG 420 or OECD TG 423 or OECD TG 425. 
  • Suitable read-across or in silico information is acceptable.
  • If acute toxicity data are available from other routes of exposure or
  • If the indicative risk of the introduction is very low to low risk for human health and the use concentration is <1%.
Acute toxicity: dermal

OECD TG 402 (Acute Dermal Toxicity: Fixed Dose Procedure) or 

Draft OECD TG 434 (Acute Dermal Toxicity: Fixed Dose Procedure)

  • Acute dermal toxicity in accordance with OECD TG 402 or Draft OECD TG 434. 
  • Suitable read-across or in silico information is acceptable.
  • If acute toxicity data are available from other routes of exposure or
  • If the indicative risk of the introduction is very low to low risk for human health and the use concentration is <1%.
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)

  • Acute inhalation toxicity conducted in accordance with OECD TG 403 or OECD TG 436 or OECD TG 433.
  • Suitable read-across or in silico information is acceptable.
  • If inhalation exposure is not expected during use or
  • If the indicative risk of the introduction is very low to low risk for human health and the use concentration is <1%.
Skin irritation

In vivo skin irritation and corrosion (OECD TG 404 (Acute Dermal Irritation/Corrosion)) or

In vitro skin corrosion:

  • OECD TG 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER)) or
  • OECD TG 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method) or
  • OECD TG 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion) or

In vitro skin irritation (OECD TG 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

  • In vivo skin irritation/corrosion conducted in accordance with OECD TG 404.
  • In vitro skin corrosion conducted in accordance with OECD TG 430, OECD TG 431 or OECD TG 435.
  • In vitro skin irritation conducted in accordance with OECD TG 439.
  • Suitable read-across or in silico information is acceptable.
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:

  • OECD TG 492B Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification or
  • OECD TG 494 Vitrigel Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage or 
  • OECD TG 496 In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage
  • Eye irritation conducted in accordance with OECD TG 405.
  • in vitro eye irritation studies conducted in accordance with:
    • OECD TG 437 or
    • OECD TG 438 or
    • OECD TG 491 or
    • OECD TG 492 or
    • OECD TG 460.
  • Eye irritation assessed using Defined Approaches (DAs) in accordance with OECD Guideline 467. The DAs should include data from one or more of the following methods: OECD TG 492B or OECD TG 494 or OECD TG 496. The results from these test methods should be combined and interpreted using a Defined Approach as described in OECD Guideline 467 to determine serious eye damage and eye irritation.
  • Suitable read-across or in silico information is acceptable.
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:

  • OECD TG 442C (In Chemico Skin Sensitisation) or
  • OECD TG 442D (In Vitro Skin Sensitisation) or
  • OECD TG 442E (In Vitro Skin Sensitisation)
  • Skin sensitisation conducted in accordance with OECD TG 406 or OECD TG 429 or OECD TG 442A or OECD TG 442B.
  • Defined Approaches (DAs):
    Skin sensitisation may also be assessed using Defined Approaches (DAs) under OECD Guideline 497. The DAs should include data from one or more of the following validated methods: OECD TG 442C or OECD TG 442D or OECD TG 442E. The results from these test methods should be combined and interpreted according to the decision frameworks described in OECD Guideline 497 to determine skin sensitisation and, where relevant, potency.
  • Suitable read across or in silico information is acceptable.
None
Respiratory sensitisation
  • Information indicating whether the chemical is known or presumed to cause hypersensitivity of the respiratory tract in humans. For more information, see Section 6.9.1 of the Categorisation Guidelines. 
  • Suitable read-across or in silico information is acceptable.
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 oral toxicity studies conducted in accordance with OECD TG 407 or OECD TG 408 or OECD TG 409.
  • Suitable read-across or in silico information is acceptable.
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)

  • Repeated dose dermal toxicity studies conducted in accordance with OECD TG 410 or OECD TG 411.
  • Suitable read-across or in silico information is acceptable.
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)

  • Repeated dose inhalation toxicity studies conducted in accordance with OECD TG 412 or OECD TG 413.
  • Suitable read-across or in silico information is acceptable.
If inhalation exposure is not expected during use.
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:
OECD TG 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays)

AND

Chromosome damage:

In vitro:
OECD TG 473 (In Vitro Mammalian Chromosomal Aberration Test) or

OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test)

In vivo:
OECD TG 475 (Mammalian Bone Marrow Chromosomal Aberration Test) or

OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or

OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay)

  • Genetic toxicity conducted in accordance with OECD test guidelines. 
  • At least one test on point mutation and at least one test on chromosome damage are required. 
  • Suitable read across or in silico information is acceptable.
None

The legal definition of ‘designated kind of release into the environment’ is an industrial chemical that is:

  1. intentionally released during use to land, biota, natural waterways or municipal water supplies;
  2. intentionally released to air during use (other than solely domestic or personal use, or end use in an air freshener);
  3. if the industrial chemical is introduced for an end use in firefighting - released (intentionally or otherwise) into the environment;
  4. if the industrial chemical is introduced for an end use offshore - released (intentionally or otherwise) into the ocean.

Information requirements

For all types of environmental compartments

Information requirementAcceptable test guidelines (TG) to use More detailsCircumstances 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)

  • Ready biodegradability measured in water conducted in accordance with OECD TG 301 or OECD TG 310.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
None
OECD TG 306 (Biodegradability in Seawater)
  • Biodegradability measured in marine water conducted in accordance with OECD TG 306.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
If the chemical is not expected to be released to marine waters.
OECD TG 307 (Aerobic and Anaerobic Transformation in Soil)
  • Persistence measured in soil conducted in accordance with OECD TG 307.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
If the chemical is not expected to be released to soil.
Details of release of the chemical to the environmentAll 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 requirementAcceptable test guidelines (TG) to useMore detailsCircumstances in which this information may not be required
Short-term toxicity to fishOECD TG 203 (Fish Acute Toxicity Test)
  • In vivo acute aquatic toxicity on fish conducted in accordance with OECD TG 203.
  • Suitable read across or in silico information is acceptable.
None
Short-term toxicity to aquatic invertebratesOECD TG 202 (Daphnia sp. Acute Immobilization Test)
  • In vivo acute aquatic toxicity on Daphnia species conducted in accordance with OECD TG 202.
  • Suitable read across or in silico information is acceptable.
None
Toxicity to aquatic algae and cyanobacteriaOECD TG 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
  • In vivo aquatic toxicity on algae and/or cyanobacteria conducted in accordance with OECD TG 201. A NOEC or EC10 value must be reported in the study.
  • Suitable read across or in silico information is acceptable.
None
Short-term toxicity to fish - MarineOECD TG 203 (Fish Acute Toxicity Test) or equivalent using saltwater species
  • If the chemical will be released to oceans, in vivo acute aquatic toxicity on fish conducted in accordance with test guidelines designed for or adapted to saltwater species.
  • Suitable read across information is acceptable. 
  • In silico information is not acceptable.
If the chemical is not expected to be released to marine waters.
Short-term toxicity to aquatic invertebrates - MarineOECD TG 202 (Daphnia sp. Acute Immobilization Test) or equivalent adapted to saltwater species
  • If the chemical will be released to oceans, in vivo acute aquatic toxicity on Daphnia species conducted in accordance with test guidelines designed for or adapted to saltwater species.
  • Suitable read across information is acceptable. 
  • In silico information is not acceptable.
If the chemical is not expected to be released to marine waters.
Toxicity to aquatic algae and cyanobacteria - MarineOECD TG 201 (Freshwater Alga and Cyanobacteria Growth Inhibition Test) or equivalent adapted to saltwater species
  • If the chemical will be released to oceans, in vivo aquatic toxicity on algae and/or cyanobacteria conducted in accordance with test guidelines designed for or adapted to saltwater species. A NOEC or EC10 value must be reported in the study.
  • Suitable read across information is acceptable. 
  • In silico information is not acceptable.
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)

  • Multi-generation fish toxicity tests conducted in accordance with OECD TG 210 or OECD TG 215 or OECD TG 240.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
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))

  • Long-term toxicity to aquatic invertebrates conducted in accordance with OECD TG 211 or OECD TG 202 Part II.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
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.

  • If the chemical will be released to oceans, in vivo chronic aquatic toxicity on fish conducted in accordance with test guidelines designed for or adapted to saltwater species. 
  • Suitable read across information is acceptable. 
  • In silico information is not acceptable.
  • If the chemical is not expected to be released to marine waters or
  • The chemical is not persistent.
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.

  • If the chemical will be released to oceans, aquatic toxicity chronic in vivo chronic aquatic toxicity on Daphnia conducted in accordance with test guidelines designed for or adapted to saltwater species.
  • Suitable read across information is acceptable.
  • If the chemical is not expected to be released to marine waters or
  • The chemical is not persistent.

Sediment

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances in which this information may not be required
Short-term toxicity to sediment dwelling life OECD TG 235 (Chironomus sp. Acute Immobilisation Test)
  • Acute toxicity to sediment dwelling life conducted in accordance with OECD TG 235. 
  • Suitable read across information is acceptable.
  • In silico information is not acceptable.
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)

  • Chronic toxicity to sediment dwelling life conducted in accordance with OECD TG 218 or OECD TG 219 or OECD TG 233.
  • Suitable read across information is acceptable.
  • In silico information is not acceptable.
  • If the chemical is not expected to be released to sediment or
  • The chemical is not persistent.

Soil

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances 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)

  • Toxicity to soil macroorganisms except arthropods conducted in accordance with OECD TG 222 or OECD TG 207. 
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
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)

  • Toxicity to soil microorganisms conducted in accordance with OECD TG 216 or OECD TG 217. Test must be extended beyond 28 days (up to 100 days).
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
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) 

  • Acute toxicity to terrestrial arthropods conducted in accordance with OECD TG 213 or OECD 214 or OECD TG 246 or OECD 247.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
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)

  • Chronic toxicity to terrestrial arthropods conducted in accordance with OECD TG 232 or OECD TG 228 or OECD TG 245 or OECD TG 226. 
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
  • If the chemical is not expected to be released to soil or
  • The chemical is not persistent.
Toxicity to terrestrial plants

OECD TG 208 (Terrestrial Plant Test Seedling Emergence and Seedling Growth Test) or

OECD TG 227 (Lumbriculus variegatus Reproduction Test)

  • Toxicity to terrestrial plants conducted in accordance with OECD TG 208 or OECD TG 227. A NOEC or EC10 value must be reported in the study.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
If the chemical is not expected to be released to soil.

The legal definition of a ‘biochemical’ is a biological chemical that:

  1. is directly produced by a microscopic organism; or
  2. is a protein or a nucleic acid.
  • biological chemical means an industrial chemical that:
  1. is derived from a living or once living organism, without further modification; or
  2. is produced by a living or once living organism, without further modification.

Information requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances in which this information may not be required
ConcentrationConcentration 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 biochemicalKnown adverse human health and environmental effects of the organisms used to produce the biochemical (production organism).None
Species/strain of the production organismThe 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 organismMethod(s) used to purify or extract the biochemical from the organisms used to produce the biochemical (production organism).None
By productsIdentifications 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 enzymeInformation whether the biochemical is an enzyme.None
Genetic toxicity

Point mutations:

In vitro:
OECD TG 471 (Bacterial Reverse Mutation Test) or

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:
OECD TG 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays)

AND

Chromosome damage:

In vitro:
OECD TG 473 (In Vitro Mammalian Chromosomal Aberration Test) or

OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test)

In vivo:
OECD TG 475 (Mammalian Bone Marrow Chromosomal Aberration Test) or

OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or 

OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay)

  • Genetic toxicity conducted in accordance with OECD test guidelines. 
  • At least one test on point mutation and at least one test on chromosome damage are required. 
  • Suitable read across or in silico information is acceptable.
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:

  1. an organism that has been modified by gene technology; or
  2. an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
  3. anything declared by the Gene Technology Regulations 2001 to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;

but does not include:

  1. a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
  2. an organism declared by the Gene Technology Regulations 2001 not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms.

Information requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances in which this information may not be required
IdentityDetails of the genetically modified organism (GMO) from which the genetically modified (GM) product was derived or produced, including species, strain and genetic modifications.None
ImpuritiesAny 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:

  • is a solid, or is in a dispersion, at the time of introduction; and
  • consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale

Nanoscale means the particle size range of 1 to 100 nm.

Information requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances in which this information may not be required
Manufacturing processDescription of the manufacturing process.None
CrystallinityDetails 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 stateOECD TG 125 (Nanomaterial particle size and size distribution of nanomaterials)
  • Information on:
    • particle size or particle size distribution
    • agglomeration/aggregation state
    • variation between batches (if applicable)
    • aspect ratio (e.g. length/diameter) for elongated or platelet shapes. For example, carbon nanotubes to indicate whether the aspect ratio is over 3.
  • Measurements conducted in accordance with the OECD TG 125 - Nanomaterial particle size and size distribution of nanomaterials.
If the chemical does not meet our definition of 'not soluble'.
Shape and morphologyA 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:

  • For nanotubes, provide the number of walls in the nanotubes.
  • For multilayer nanochemicals, provide the number of layers in the nano sheets or nanoplates or nanoribbons in the particle.
If the chemical does not meet our definition of 'not soluble'.
Dissolution rate and dispersionOECD 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 potentialOECD Guidance Document on Sample Preparation and Dosimetry for Manufactured Nanomaterials, 2025 Edition
  • Measured data on the zeta potential of the chemical conducted in accordance with OECD Guidance on Sample Preparation and Dosimetry for Manufactured Nanomaterials, 2025 Edition.
  • Isoelectric point and/or electrophoretic mobility are acceptable indirect measurements of zeta potential.
  • If dispersibility information is available or
  • If the chemical does not meet our definition of 'not soluble'.
HydrophobicityOECD 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:

  • details of particle surface modifications
  • chemID (CAS RN and name, and/or IUPAC name) of the surface treatment agents, and amount (%w/w) applied on the particles
  • the chemistry imparted to the surface (including schematic representation).
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'.
DustinessDustiness 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.
  • If there is no potential for inhalation exposure or
  • If the chemical does not meet our definition of 'not soluble'.
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).

  • Acute inhalation toxicity conducted in accordance with OECD TG 403 or OECD TG 436 or OECD TG 433.
  • Suitable read across or in silico information is acceptable.
  • If there is no potential for inhalation exposure or
  • If the chemical does not meet our definition of 'not soluble'. 
Repeated dose toxicity: inhalation

OECD TG 412 (Subacute Inhalation Toxicity: 28-day Study) or

OECD TG 413 (Subchronic Inhalation Toxicity: 90-day Study)

  • Repeated dose inhalation toxicity studies conducted in accordance with OECD TG 412 or OECD TG 413.
  • Suitable read across or in silico information is acceptable.
  • If there is no potential for inhalation exposure or
  • If the chemical does not meet our definition of 'not soluble'. 

The legal definition of ‘polyhalogenated organic chemical’ is an industrial chemical that:

  1. is carbon based; and
  2. contains more than one covalently bound bromine, chlorine, fluorine or iodine substituent.

Information requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances 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)

  • Ready biodegradability conducted in accordance with OECD TG 301 or OECD TG 310.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable. 
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)

  • Bioaccumulation conducted in accordance with OECD TG 305 or OECD TG 310 or OECD TG 315 or OECD TG 317 or OECD TG 321.
  • Suitable read across information is acceptable. 
  • In silico information is not acceptable.

If the chemical:

  • has a molecular weight greater than 1000g/mol or
  • is a high molecular weight polymer that has less than 5% by mass of molecules with molecular weight less than 1000g/mol, or less than 2% by mass of molecules with molecular weight less than 500 g/mol or
  • has a log Kow of <4.2 and does not contain fluorine.
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)

  • Multi-generation fish toxicity tests conducted in accordance with OECD TG 210 or OECD TG 215 or OECD TG 240.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
  • If the chemical meets the PLC criteria or
  • 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))

  • Long-term toxicity to aquatic invertebrates conducted in accordance with OECD TG 211 or OECD TG 202 Part II.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
  • If the chemical meets the PLC criteria or
  • If the chemical is not persistent.
Toxicity to aquatic algae and cyanobacteriaOECD TG 201 (Freshwater Alga and Cyanobacteria Growth Inhibition Test)
  • In vivo aquatic toxicity tests on algae and/or cyanobacteria conducted in accordance with OECD TG 201. A NOEC or EC10 value must be reported in the study.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
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 soil macroorganisms except arthropods conducted in accordance with OECD TG 222 or OECD TG 207. 
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable. 
  • If the chemical meets the PLC criteria or
  • If the chemical is not expected to be released to soil.
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 arthropods in accordance with OECD TG 213 or OECD TG  214 or OECD TG  226 or OECD TG  228 or OECDTG 232 or OECD TG 237 or OECD TG 245 or OECD TG 246 or OECD TG 247. 
  • Suitable read-across information is acceptable.
  • If the chemical meets the PLC criteria or
  • If the chemical is not expected to be released to soil.
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 terrestrial plants in accordance with OECD TG 208 or OECD TG 227.
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable. 
  • If the chemical meets the PLC criteria or
  • 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)

  • Toxicity to soil microorganisms conducted in accordance with OECD TG 216 or OECD TG 217. 
  • Suitable read-across information is acceptable.
  • In silico information is not acceptable.
  • If the chemical meets the PLC criteria or
  • If the chemical is not expected to be released to soil.
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 oral toxicity studies conducted in accordance with OECD TG 407 or OECD TG 408 or OECD TG 409.
  • Suitable read across or in silico information is acceptable.
  • If the chemical meets the PLC criteria or
  • 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)

  • Repeated dose dermal toxicity studies in accordance with OECD TG 410 or OECD TG 411.
  • Suitable read across or in silico information is acceptable.
  • If the chemical meets the PLC criteria or
  • 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)

  • Repeated dose inhalation toxicity studies in accordance with OECD TG 412 or OECD TG 413.
  • Suitable read across or in silico information is acceptable.
  • If the chemical meets the PLC criteria or
  • If inhalation exposure is not expected during use.
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)

  • An in vivo reproductive toxicity study conducted in accordance with OECD TG 415* or OECD TG 416 or OECD TG 421 or OECD 422 or OECD TG 443. 
    * Note that OECD TG 415 has been deleted and is no longer in use.
  • Suitable read across or in silico information is acceptable.
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)

  • An in vivo developmental study conducted in accordance with OECD TG 414 or OECD TG 421 or OECD TG 422 or OECD TG 426 or OECD TG 443. 
  • Suitable read across or in silico information is acceptable.
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 requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances in which this information may not be required
UV-vis absorption spectraOECD TG 101 (UV‑VIS Absorption Spectra)Analytical information on UV-vis absorption spectra conducted in accordance with OECD TG 101. None
Photostability information
  • Information on the chemical to demonstrate its stability in light, including the degree to which it degrades after exposure to UV light.
  • Suitable read across or in silico data is acceptable.

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
  • Phototransformation in air.
  • Suitable read across or in silico data is acceptable.
If the chemical does not partition in air.
OECD TG 316 (Phototransformation of Chemicals in Water - Direct Photolysis)
  • Phototransformation in water conducted in accordance with OECD TG 316.
  • Suitable read across or in silico data is acceptable.
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: 

  • OECD TG 432 (In Vitro 3T3 NRU Phototoxicity Test) or
  • OECD TG 495 (Reactive Oxygen Species(ROS) Assay for Photoreactivity) or
  • OECD TG 498 (In vitro Phototoxicity: Reconstructed Human Epidermis Phototoxicity test method).
  • Phototoxicity assessed in accordance with OECD Guideline 397 (Guidance Document on an Integrated Approach to Testing and Assessment (IATA) for Phototoxicity).
  • As part of the assessment, screening should be conducted using one or more of the following OECD Test methods:
    • OECD TG 432 (In Vitro 3T3 NRU Phototoxicity Test) or
    • OECD TG 495 (Reactive Oxygen Species(ROS) Assay for Photoreactivity) or
    • OECD TG 498 (In vitro Phototoxicity: Reconstructed Human Epidermis Phototoxicity test method).
      Data generated from these methods should be used as part of defined approaches and IATA frameworks to support the determination of the phototoxic potential of the chemical.
  • Suitable read across or in silico data is acceptable.
  • If the chemical has a molar extinction coefficient (MEC) of <1000 L mol-1cm-1 at wavelengths between 290-700 nm or
  • If the chemical exhibit absorption only at wavelengths below 313 nm, with insufficient absorption at longer wavelengths.
Dermal absorption 

OECD Test Guideline 427 (In Vivo Skin Absorption) or

OECD TG 428 (Skin Absorption: In Vitro Method)

  • Dermal absorption conducted in accordance with OECD TG 427 or OECD TG 428. 
  • Suitable read across or in silico data is acceptable.
None
Skin irritation

In vivo skin irritation and corrosion (OECD TG 404 (Acute Dermal Irritation/Corrosion)) or

In vitro skin corrosion:

  • OECD TG 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER)) or
  • OECD TG 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method) or
  • OECD TG 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion) or

In vitro skin irritation (OECD TG 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

  • In vivo skin irritation/corrosion conducted in accordance with OECD TG 404.
  • In vitro skin corrosion conducted in accordance with OECD TG 430 or OECD TG 431 or OECD TG 435.
  • In vitro skin irritation conducted in accordance with OECD TG 439.
  • Suitable read-across or in silico information is acceptable.
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:

  • OECD TG 492B Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification or
  • OECD TG 494 Vitrigel Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage or
  • OECD TG 496 In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage.
  • In vivo eye irritation conducted in accordance with OECD TG 405.
  • In vitro eye irritation studies: OECD TG 437 or OECD TG 438 or OECD TG 491 or OECD TG 492 or OECD TG 460.
  • Eye irritation assessed using Defined Approaches (DAs) in accordance with OECD Guideline 467. The DAs should include data from one or more of the following methods: OECD TG 492B or OECD TG 494 or OECD TG 496. The results from these test methods should be combined and interpreted using a Defined Approach as described in OECD Guideline 467 to determine serious eye damage and eye irritation.
  • Suitable read-across or in silico information is acceptable.
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:

  • OECD TG 442C (In Chemico Skin Sensitisation) or
  • OECD TG 442D (In Vitro Skin Sensitisation) or
  • OECD TG 442E (In Vitro Skin Sensitisation)
  • Skin sensitisation conducted in accordance with OECD TG 406 or OECD TG 429 or OECD TG 442A or OECD TG 442B.
  • Defined Approaches:
    Skin sensitisation may also be assessed using Defined Approaches (DAs) under OECD Guideline 497. The DAs should include data from one or more of the following validated methods:
    • OECD TG 442C or
    • OECD TG 442D or
    • OECD TG 442E. 
    • The results from these test methods should be combined and interpreted according to the decision frameworks described in OECD Guideline 497 to determine skin sensitisation and, where relevant, potency.
  • Suitable read across or in silico information is acceptable.
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 oral toxicity studies conducted in accordance with OECD TG 407 or OECD TG 408 or OECD TG 409.
  • Suitable read-across or in silico information is acceptable.
  • If repeat dose toxicity data are available from other routes of exposure or
  • 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.
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 dermal toxicity studies conducted in accordance with OECD TG 410 or OECD TG 411. 
  • Suitable read-across or in silico information is acceptable.
  • If repeat dose toxicity data are available from other routes of exposure or
  • 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.
Repeated dose toxicity: inhalation

OECD TG 412 (Subacute Inhalation Toxicity: 28-day Study) or 

OECD TG 413 (Subchronic Inhalation Toxicity: 90-day Study)

  • Repeated dose inhalation toxicity studies conducted in accordance with OECD TG 412 or OECD TG 413. 
  • Suitable read-across or in silico information is acceptable.
  • If repeat dose toxicity data are available from other routes of exposure or
  • 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.
Genetic toxicity

Point mutations:

In vitro:
OECD TG 471 (Bacterial Reverse Mutation Test) or

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:
OECD TG 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays) or

AND

Chromosome damage:

In vitro:
OECD TG 473 (In Vitro Mammalian Chromosomal Aberration Test) or

OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test)

In vivo:
OECD TG 475 (Mammalian Bone Marrow Chromosomal Aberration Test) or

OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or 

OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay)

  • Genetic toxicity conducted in accordance with OECD test guidelines.
  • At least one test on point mutation and at least one test on chromosome damage are required. 
  • Suitable read across or in silico information is acceptable.
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:

  1. where the end use of the industrial chemical is at the non food contact surface of a glass or metal article; or
  2. if the food that the article will come into contact with is rainwater—where the contact with the rainwater is transient.

Information requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances 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:

  • US FDA
  • FSANZ
  • EFSA
  • Health Canada
  • other overseas regulators.
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:

  • is a permitted flavouring substance as defined by Standard 1.1.2 of the Food Standards Australia New Zealand Act 1991, with the dietary concentration associated with the end use of the industrial chemical in an article with food contact less than that associated with end use as a flavouring substance, or
  • has an end use, concentration at the end use, and dietary concentration associated with the end use (where relevant), consistent with one or more of the following:
    • the listing of the industrial chemical under Annexes I or II to Regulation (EC) No 10/2011 or Annex I to Regulation (EC) No 1935/2004 and any applicable restrictions, or
    • an adopted opinion on the industrial chemical by the European Food Safety Authority that is in favour of authorising the evaluated substance, or
    • use of the industrial chemical authorised under the United States Food and Drug Administration (US FDA) regulations, 21 CFR.170-199, or
  • the No Observed Adverse Effect Level (NOAEL) in an in vivo study on the industrial chemical or from suitable read-across information of:
    • ≥ 1000 mg/kg bw/day for subacute oral toxicity or
    • ≥ 300 mg/kg bw/day for a subchronic oral toxicity.
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 oral toxicity in accordance with OECD TG 420 or OECD TG 423 or OECD TG 425.
  • Suitable read across or in silico information is acceptable.

If the chemical is:

  • included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical, or
  • a high molecular weight polymer that has <5% by mass of molecules with molecular weight <1000 g/mol, and <2% by mass of molecules with molecular weight <500 g/mol, or
  • If the indicative risk of the introduction is very low to low risk for human health and the use concentration is <1%.
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)

  • Repeated dose toxicity via the oral route conducted in accordance with OECD TGs 407 or OECD 408 or OECD TG 409.
  • Suitable read-across or in silico information is acceptable.

If the chemical is:

  • included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical, or
  • a high molecular weight polymer that has <5% by mass of molecules with molecular weight <1000 g/mol, and <2% by mass of molecules with molecular weight <500 g/mol.
Genetic toxicity

Point mutations:

In vitro:
OECD TG 471 (Bacterial Reverse Mutation Test) or

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:
OECD TG 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays)

AND

Chromosome damage:

In vitro:
OECD TG 473 (In Vitro Mammalian Chromosomal Aberration Test) or

OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test)

In vivo:
OECD TG 475 (Mammalian Bone Marrow Chromosomal Aberration Test) or

OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or 

OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay)

  • Genetic toxicity conducted in accordance with OECD test guidelines.
  • At least one test on point mutation and at least one test on chromosome damage are required.
  • Suitable read across or in silico information is acceptable.

If the chemical is:

  • included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical, or
  • is a high molecular weight polymer for which at least one of the following applies:
    • it contains only low concern reactive functional groups, or
    • it has a number average molecular weight that is greater than or equal to 10,000 g/mol and with both:
      • <2% by mass of molecules with molecular weight that is <500 g/mol, and
      • <5% by mass of molecules with molecular weight that is <1000 g/mol.

The legal definition of a ‘tattoo ink’ is a combination of industrial chemicals that:

  1. contains one or more colouring agents; and
  2. is applied to the dermal layer of the skin for the purpose of colouring the skin.

Information requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances in which this information may not be required
UV-vis absorption spectraOECD TG 101 (UV‑VIS Absorption Spectra)Analytical information on UV-vis absorption spectra conducted in accordance with OECD TG 101.None
Photostability information
  • Information on the chemical to demonstrate its stability in light, including the degree to which it degrades after exposure to UV light.
  • Suitable read across or in silico data is acceptable.

    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
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:

  • OECD TG 432 (In Vitro 3T3 NRU Phototoxicity Test) or
  • OECD TG 495 (Reactive Oxygen Species(ROS) Assay for Photoreactivity) or
  • OECD TG 498 (In vitro Phototoxicity: Reconstructed Human Epidermis Phototoxicity test method).
  • Phototoxicity assessed in accordance with OECD Guideline 397 (Guidance Document on an Integrated Approach to Testing and Assessment (IATA) for Phototoxicity).
  • As part of the assessment, screening should be conducted using one or more of the following OECD Test methods:

    • OECD TG 432 (In Vitro 3T3 NRU Phototoxicity Test) or
    • OECD TG 495 (Reactive Oxygen Species(ROS) Assay for Photoreactivity) or
    • OECD TG 498 (In vitro Phototoxicity: Reconstructed Human Epidermis Phototoxicity test method).

    Data generated from these methods should be used as part of defined approaches and IATA frameworks to support the determination of the phototoxic potential of the chemical.

  • Suitable read across or in silico information is acceptable.
  • If the chemical has a molar extinction coefficient (MEC) of <1000 L mol-1cm-1 at wavelengths between 290-700 nm, or
  • If the chemical exhibit absorption only at wavelengths below 313 nm, with insufficient absorption at longer wavelengths.
Skin irritation

In vivo skin irritation and corrosion (OECD TG 404 (Acute Dermal Irritation/Corrosion)) or

In vitro skin corrosion:

  • OECD TG 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER)) or
  • OECD TG 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method) or
  • OECD TG 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion) or
  • In vitro skin irritation (OECD TG 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
  • In vivo skin irritation/corrosion conducted in accordance with OECD TG 404.
  • In vitro skin corrosion conducted in accordance with OECD TG 430 or OECD TG 431 or OECD TG 435.
  • In vitro skin irritation conducted in accordance with OECD TG 439. 
  • Suitable read across or in silico information is acceptable.
None
Eye irritation
  • In vivo serious eye damage and eye irritation (OECD TG 405 (Acute Eye Irritation/Corrosion)) or
  • In vitro serious damage and eye irritation:
    • 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) 
    • 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 467 Defined Approaches for Serious Eye Damage and Eye Irritation using the following OECD TGs:
    • OECD TG 492B Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification or
    • OECD TG 494 Vitrigel Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage or
    • OECD TG 496 In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage.
  • In vivo eye irritation conducted in accordance with OECD TG 405.
  • In vitro eye irritation conducted in accordance with OECD TG 437 or OECD TG 438 or OECD TG 491 or OECD TG 492.
  • Eye irritation assessed using Defined Approaches (DAs) in accordance with OECD Guideline 467. The DAs should include data from one or more of the following methods: OECD TG 492B or OECD TG 494 or OECD TG 496. The results from these test methods should be combined and interpreted using a Defined Approach as described in OECD Guideline 467 to determine eye irritation, where relevant.
  • Suitable read-across or in silico information is acceptable.
None
Skin sensitisation

OECD TG 406 (Skin Sensitisation) or
OECD Guideline 497 (Defined Approaches on Skin Sensitisation) using the following OECD TGs:

  • OECD TG 442C (In Chemico Skin Sensitisation) or
  • OECD TG 442D (In Vitro Skin Sensitisation) or
  • OECD TG 442E (In Vitro Skin Sensitisation)
  • Skin sensitisation conducted in accordance with OECD TG 406. 
  • Defined Approaches:
    Skin sensitisation may also be assessed using Defined Approaches (DAs) under OECD Guideline 497. The DAs should include data from one or more of the following validated methods: OECD TG 442C or OECD TG 442D or OECD TG 442E. The results from these test methods should be combined and interpreted according to the decision frameworks described in OECD Guideline 497 to determine skin sensitisation and, where relevant, potency.
  • Suitable read across or in silico information is acceptable.
None 
Genetic toxicity

Point mutations:

In vitro:
OECD TG 471 (Bacterial Reverse Mutation Test) or

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:
OECD TG 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays) or

AND

Chromosome damage:

In vitro:
OECD TG 473 (In Vitro Mammalian Chromosomal Aberration Test) or

OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test)

In vivo:
OECD TG 475 (Mammalian Bone Marrow Chromosomal Aberration Test) or

OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or

OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay)

  • Genetic toxicity conducted in accordance with OECD test guidelines. At least one test on point mutation and at least one test on chromosome damage are required.
  • Suitable read across or in silico information is acceptable.
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:

  1. children’s sleep, relaxation or hygiene; or
  2. the feeding of children; or
  3. sucking by children.

Information requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances in which this information may not be required
Leaching studies in salivaIndoor 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) 

  • Acute oral toxicity conducted in accordance with OECD TG 420 or OECD TG 423 or OECD TG 425.
  • Suitable read across or in silico information is acceptable.
  • If acute toxicity data from other routes of exposure is available, or
  • If the chemical is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical, or
  • If the chemical is a high molecular weight polymer that has <5% by mass of molecules with molecular weight <1000 g/mol, and <2% by mass of molecules with molecular weight <500 g/mol, or
  • If the indicative risk of the introduction is very low to low risk for human health and the use concentration is <1%.
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 oral toxicity studies conducted in accordance with OECD TG 407 or OECD TG 408 or OECD TG 409.
  • Suitable read across or in silico information is acceptable.
  • If repeated dose toxicity data are available from other routes of exposure, or
  • If the chemical is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical, or
  • If the chemical is a high molecular weight polymer that has <5% by mass of molecules with molecular weight <1000 g/mol, and <2% by mass of molecules with molecular weight <500 g/mol.
Genetic toxicity

Point mutations:

In vitro:
OECD TG 471 (Bacterial Reverse Mutation Test) or

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:
OECD TG 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays)

AND

Chromosome damage:

In vitro:
OECD TG 473 (In Vitro Mammalian Chromosomal Aberration Test) or

OECD TG 487 (In Vitro Mammalian Cell Micronucleus Test)

In vivo:
OECD TG 475 (Mammalian Bone Marrow Chromosomal Aberration Test) or

OECD TG 474 (Mammalian Erythrocyte Micronucleus Test) or

OECD TG 489 (In Vivo Mammalian Alkaline Comet Assay)

  • Genetic toxicity conducted in accordance with OECD test guidelines.
  • At least one test on point mutation and at least one test on chromosome damage are required.
  • Suitable read across or in silico information is acceptable.
  • If the chemical is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical, or
  • If the chemical is a high molecular weight polymer for which at least one of the following applies:
    • it contains only low concern reactive functional groups, or
    • it has a number average molecular weight that is greater than or equal to 10,000 g/mol and with both:
      • <2% by mass of molecules with molecular weight that is <500 g/mol, and
      • <5% by mass of molecules with molecular weight that is <1000 g/mol.

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:

  • it has a degradation half-life (T½) in air of greater than or equal to 2 days, or
  • it has a degradation half-life (T½) in water of greater than or equal to 2 months, or
  • it has a degradation half-life (T½) in soil of greater than or equal to 6 months, or
  • it has a degradation half-life (T½) in sediment of greater than or equal to 6 months.

Information requirements

Information requirementAcceptable test guidelines (TG) to useMore detailsCircumstances in which this information may not be required
Physical chemical propertiesFlammability and explosivity.None
PersistenceEnvironment Monograph No 61, OECD/GD(92)172, Paris 1993 "The rate of photochemical transformation of gaseous organic compounds in air under tropospheric conditions."
  • Persistence of the gas:
    1. an in silico prediction of atmospheric photo transformation using a suitable model or
    2. experimental information on reactions with common atmospheric radicals (hydroxyl radicals, ozone) or
    3. other studies that use methods that are well established in published peer-reviewed scientific literature
  • Suitable read across or in silico information is acceptable.
None
100-year global warming potentialThe chemical's 100-year global warming potential (GWP100), using CO2 as the reference substance.None
Ozone depleting potentialOzone depleting potential using CFC-11 as the reference substance.If the chemical does not contain Chlorine, Bromine, or Iodine.

How to provide feedback

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Submit your feedback by 11:59 pm (AEST) on 8 September 2026.

Have your say using our online form

Next steps

We will:

  • announce the outcome after reviewing feedback 
  • publish a full set of information requirements and supporting guide as part of the assessment certificate guide. 
  • add the requirements to the approved form and IUCLID for assessment certificate applications.

Changes will come into effect on 1 July 2027.

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