Guide to applying for an assessment certificate
Do not apply for an AICIS assessment certificate if you have not worked out your introduction category using our guide on categorising your importation and manufacture.
This is a guide is for Australian and foreign businesses who:
- must apply for an assessment certificate because their introduction is in the 'assessed' category
- have categorised their introduction as 'exempted' or 'reported' and choose to apply for a certificate to get a chemical added to the Australian Inventory of Industrial Chemicals (Inventory).
Timeframe
The statutory timeframe for completing an assessment is 70 working days.
Before you start this guide
Read our overview of certificate application types to understand:
- when you must (or can) apply
- how to apply
- application fee
Start this guide
Roles, permissions and data responsibilities in an assessment certificate application
1. Roles, permissions and data responsibilities in an assessment certificate application
This page explains who can be involved in an assessment certificate application, what each participant is responsible for, and what information they can access. in AICIS Business Services.
Understanding this upfront will help avoid application processing delays.
Participants
There are 3 types of participants who may be involved in an assessment certificate application. These are:
- the applicant(s)
- third party data provider (if applicable)
- agent (if applicable)
A participant only provides information they have been nominated to supply.
Applicants
Applicants must always provide exposure and use information, even if other participants supply other technical data.
The initial applicant starts the application in AICIS Business Services and may nominate other participants, including joint applicants.
More than one applicant may submit a joint application for the same chemical. Alternatively, individuals may submit separate applications for the same chemical.
Chemical data providers
If applicants don't have access to - or permission to use - required chemical data, they must nominate a chemical data provider.
A chemical data owner must be nominated at the start of the application in AICIS Business Services.
Chemical data providers supply required data, such as:
- toxicological studies
- environmental fate studies
- physico‑chemical data.
This role is essential when the applicant does not own or have permission to use the required information.
Agents
Both applicants and chemical data providers may appoint agents to act on their behalf.
Agents will only have access to the information of the participant they represent.
A participant nominates their agent in AICIS Business Services. The agent must acknowledge their role before they can take part in the application process - this is an automated process with the agent receiving an emailed request from AICIS Business Services.
If there is more than one participant
Before starting an assessment certificate application in AICIS Business Services, all participants should communicate with each other to confirm:
- who is responsible for each part of the application
- who owns the required chemical data
- whether permission is needed to use any data
- what information each participant must provide.
Responsibilities by role
Responsibilities depend on whether you are the initial applicant, another applicant, a data provider, or an agent.
Initial applicant
- Assigns roles (agents, data providers)
- Coordinates completion of all application sections
- Marks sections as final in AICIS Business Services
- Submits the completed application
Chemical data provider
- Supplies required technical data
- Completes the information they are nominated to provide in the application
Agent
- Acts on behalf of the applicant or chemical data provider
- Must confirm their nomination through AICIS Business Services
Access to information in an application
- Each participant can only access the sections they are responsible for.
- Applicants cannot view any technical data submitted by a chemical data provider.
For example: if a data provider enters technical study data, applicants and agents cannot view or access that information unless the data provider nominates them.
Acknowledging a role
- When participants are nominated, they receive a notification and must acknowledge their role in AICIS Business Services.
- A participant only provides information they have been nominated to supply.
Data ownership rules
If you do not own the chemical data required for the application, you must obtain permission from the data owner.
This includes study reports and any references used to support technical claims.
If you do not have permission to use the data, you cannot legally submit it. Instead, the data owner must be nominated as the chemical data provider.
Read more about your obligations on our copyright page.
Submitting data to support your application
You must either:
- submit the data yourself, if you own it or have permission to use it, or
- nominate the data owner as the chemical data provider, who will then submit the information directly to AICIS.
All information submitted by a data provider is not visible to other participants, except to an agent acting on behalf of the chemical data provider.
Examples of how participant roles work in practice
These scenarios illustrate how the roles apply. They are examples only.
Example 1
Who is involved
- Applicant – the business submitting the application
- Chemical data provider – the business that owns the technical chemical data
What happens
- The Applicant starts the application in AICIS Business Services.
- The Applicant does not own the technical chemical data, so they nominate a chemical data provider.
- The Chemical data provider enters the required data in their own instance of IUCLID and uploads the dossier file in AICIS Business Services.
- The Applicant cannot view or access any data uploaded by Chemical data provider.
Key point
The information is visible only to the chemical data provider.
Example 2
Shared responsibilities in a multi‑participant application
Who is involved
- An application involves multiple applicants and one or more chemical data providers.
- The applicant does not own chemical identity information or study data and only has information about intended use and exposure.
- The chemical data provider (or another applicant) owns identity and study data.
What happens
- The chemical data provider submits an IUCLID dossier containing the required technical data.
- The applicant submits a separate IUCLID dossier containing use and exposure information.
- AICIS reviews both dossiers together.
Key points
- Each participant provides only the data they are responsible for.
- Applicants do not need to submit technical data if a nominated data provider submits it.
2. Types of assessment applications and information required
Introduction
This page explains the types of assessments certificates you can apply for, and the information you must have to support the assessment certificate type you choose.
There are 4 types of assessment certificates based on your categorisation outcome which you must have established by using our Guide to categorising your chemical importation and manufacture.
- Health and environment focus
- Health focus
- Environment focus
- Very low to low risk
Health and environment focus applications and information required
Choose this application if:
- your introduction’s indicative human health risk is medium to high, and the indicative environment risk is medium to high, or
- you do not have necessary data to demonstrate that the highest indicative risk of the introduction to both human health and the environment is low or very low.
Note: The numbers in brackets represent the document numbers in IUCLID6 Version 4.18.0.
| IUCLID documentation | Medium to high risk for health and environment | |
|---|---|---|
| Sections | Subsections / Documents | Required / If available |
| 1. General information | Identification (1.1) | Required |
| Composition (1.2) | Required | |
| Analytical information (1.4) | Required | |
| 2. Classification, labelling | GHS (2.1) | Required |
| 3. Manufacture | Estimated quantities (3.2) | Required |
| Site (3.3) | Required for manufacture only | |
| Manufacture (3.5.1) | Required for manufacture only | |
| Formulation or re-packing (3.5.2) | If available – though at least one use must be provided in either 3.5.2, 3.5.3, 3.5.4 or 3.5.5. | |
| Uses at industrial sites (3.5.3) | ||
| Widespread uses by professional workers (3.5.4) | ||
| Consumer uses (3.5.5) | ||
| Article service life (3.5.6) | If available | |
| 4. Physical and chemical properties | Appearance / physical state / colour (4.1) | Required |
| Melting point / freezing point (4.2) | Required | |
| Boiling point (4.3) | Required | |
| Density (4.4) | Required | |
| Particle size distribution (Granulometry) (4.5) | Required | |
| Vapour pressure (4.6) | Required | |
| Partition coefficient (4.7) | Required | |
| Water solubility (4.8) | Required | |
| Solubility in organic solvents / fat solubility (4.9) | If available | |
| Surface tension (4.10) | If available | |
| Flash point (4.11) | Required | |
| Auto flammability (4.12) | Required | |
| Flammability (4.13) | Required | |
| Explosiveness (4.14) | Required | |
| Oxidising properties (4.15) | Required | |
| Oxidation reduction potential (4.16) | If available | |
| pH (4.20) | If available | |
| Dissociation constant (4.21) | Required | |
| Viscosity (4.22) | If available | |
| Self-reactive substances (4.23) | If available | |
| Additional physico-chemical information (4.27) | If available | |
| Nanomaterial agglomeration / aggregation (4.28.1) | If available | |
| Nanomaterial crystalline phase (4.28.2) | If available | |
| Nanomaterial crystallite and grain size (4.28.3) | If available | |
| Nanomaterial aspect ratio / shape (4.28.4) | If available | |
| Nanomaterial specific surface area (4.28.5) | If available | |
| Nanomaterial Zeta potential (4.28.6) | If available | |
| Nanomaterial surface chemistry (4.28.7) | If available | |
| Nanomaterial dustiness (4.28.8) | If available | |
| Nanomaterial porosity (4.28.9) | If available | |
| Nanomaterial pour density (4.28.10) | If available | |
| Nanomaterial photocatalytic activity (4.28.11) | If available | |
| Nanomaterial radical formation potential (4.28.12) | If available | |
| Nanomaterial catalytic activity (4.28.13) | If available | |
| Nanomaterial dispersion stability (4.28.14) | If available | |
| 5. Environmental fate and pathways | Phototransformation in air (5.1.1) | If available |
| Hydrolysis (5.1.2) | Required | |
| Phototransformation in water (5.1.3) | If available | |
| Biodegradation in water: screening tests (5.2.1) | Required | |
| Biodegradation in soil (5.2.3) | If available | |
| Bioaccumulation: aquatic / sediment (5.3.1) | Required (information on either 5.3.1 or 5.3.2) | |
| Bioaccumulation: terrestrial (5.3.2) | ||
| Adsorption / desorption (5.4.1) | Required | |
| Henry’s Law constant (5.4.2) | If available | |
| Other distribution data (5.4.4) | If available | |
| Additional information on environmental fate and behaviour (5.6) | If available | |
| 6. Ecotoxicological information | Short-term toxicity to fish (6.1.1) | Required |
| Long-term toxicity to fish (6.1.2) | If available | |
| Short-term toxicity to aquatic invertebrates (6.1.3) | Required | |
| Long-term toxicity to aquatic invertebrates (6.1.4) | If available | |
| Toxicity to aquatic algae and cyanobacteria (6.1.5) | Required | |
| Toxicity to aquatic plants other than algae (6.1.6) | If available | |
| Toxicity to microorganisms (6.1.7) | If available | |
| Endocrine disruptor testing in aquatic vertebrates – in vivo (6.1.8) | If available | |
| Toxicity to other aquatic vertebrates (6.1.9) | If available | |
| Sediment toxicity (6.2) | If available | |
| Toxicity to soil macroorganisms except arthropods (6.3.1) | If available | |
| Toxicity to terrestrial arthropods (6.3.2) | If available | |
| Toxicity to terrestrial plants (6.3.3) | If available | |
| Toxicity to soil microorganisms (6.3.4) | If available | |
| Additional ecotoxicological information (6.6) | If available | |
| 7. Toxicological information | Basic toxicokinetics (7.1.1) | If available |
| Dermal absorption (7.1.2) | If available | |
| Acute toxicity: oral (7.2.1) | Required (information on either 7.2.1, 7.2.2 or 7.2.3.) | |
| Acute toxicity: inhalation (7.2.2) | ||
| Acute toxicity: dermal (7.2.3) | ||
| Acute toxicity: other routes (7.2.4) | If available | |
| Skin irritation / corrosion (7.3.1) | Required | |
| Eye irritation (7.3.2) | Required | |
| Skin sensitisation (7.4.1) | Required | |
| Respiratory sensitisation (7.4.2) | If available | |
| Repeated dose toxicity: oral (7.5.1) | Required (information on either 7.5.1, 7.5.2 or 7.5.3) | |
| Repeated dose toxicity: inhalation (7.5.2) | ||
| Repeated dose toxicity: dermal (7.5.3) | ||
| Repeated dose toxicity: other routes (7.5.4) | If available | |
| Genetic toxicity in vitro (7.6.1) | Required. Information on point mutations (7.6.1 or 7.6.2) and chromosome damage (7.6.1 or 7.6.2) | |
| Genetic toxicity in vivo (7.6.2) | ||
| Carcinogenicity (7.7) | If available | |
| Toxicity to reproduction (7.8.1) | If available | |
| Developmental toxicity / teratogenicity (7.8.2) | If available | |
| Toxicity to reproduction: other studies (7.8.3) | If available | |
| Neurotoxicity (7.9.1) | If available | |
| Immunotoxicity (7.9.2) | If available | |
| Specific investigations: other studies (7.9.4) | If available | |
| Health surveillance data (7.10.1) | If available | |
| Epidemiological data (7.10.2) | If available | |
| Direct observations: clinical cases, poisoning incidents and other (7.10.3) | If available | |
| Sensitisation data (humans) (7.10.4) | If available | |
| Exposure related observations in humans: other data (7.10.5) | If available | |
| Additional toxicological information (7.12) | If available | |
| 9. Residues in food and feeding stuff | If available | |
| 11. Guidance on safe use | Required | |
| 13. Assessment report (attach SDS) | Required | |
Health focus applications and information required
Choose this application if your introduction’s indicative human health risk is medium to high, and the indicative environment risk is very low to low.
You will need to be able to demonstrate that the highest indicative risk of the introduction to the environment is very low or low risk. If you can’t do this, choose ‘Health and environment focus’.
Note: The numbers in brackets represent the document numbers in IUCLID6 Version 4.18.0.
| IUCLID documentation | Medium to high risk for health and low to very low risk for environment | |
|---|---|---|
| Sections | Subsections / Documents | Required / If available |
| 1. General information | Identification (1.1) | Required |
| Composition (1.2) | Required | |
| Analytical information (1.4) | Required | |
| 2. Classification, labelling | GHS (2.1) | Required |
| 3. Manufacture | Estimated quantities (3.2) | Required |
| Site (3.3) | Required for manufacture only | |
| Manufacture (3.5.1) | Required for manufacture only | |
| Formulation or re-packing (3.5.2) | If available – though at least one use (use name) must be provided in either 3.5.2, 3.5.3, 3.5.4 or 3.5.5. | |
| Uses at industrial sites (3.5.3) | ||
| Widespread uses by professional workers (3.5.4) | ||
| Consumer uses (3.5.5) | ||
| Article service life (3.5.6) | If available | |
| 4. Physical and chemical properties | Appearance / physical state / colour (4.1) | Required |
| Melting point / freezing point (4.2) | Required | |
| Boiling point (4.3) | Required | |
| Density (4.4) | Required | |
| Particle size distribution (Granulometry) (4.5) | Required | |
| Vapour pressure (4.6) | Required | |
| Partition coefficient (4.7) | Required | |
| Water solubility (4.8) | Required | |
| Solubility in organic solvents / fat solubility (4.9) | If available | |
| Surface tension (4.10) | If available | |
| Flash point (4.11) | Required | |
| Auto flammability (4.12) | Required | |
| Flammability (4.13) | Required | |
| Explosiveness (4.14) | Required | |
| Oxidising properties (4.15) | Required | |
| Oxidation reduction potential (4.16) | If available | |
| pH (4.20) | If available | |
| Dissociation constant (4.21) | Required | |
| Viscosity (4.22) | If available | |
| Self-reactive substances (4.23) | If available | |
| Additional physico-chemical information (4.27) | If available | |
| Nanomaterial agglomeration / aggregation (4.28.1) | If available | |
| Nanomaterial crystalline phase (4.28.2) | If available | |
| Nanomaterial crystallite and grain size (4.28.3) | If available | |
| Nanomaterial aspect ratio / shape (4.28.4) | If available | |
| Nanomaterial specific surface area (4.28.5) | If available | |
| Nanomaterial Zeta potential (4.28.6) | If available | |
| Nanomaterial surface chemistry (4.28.7) | If available | |
| Nanomaterial dustiness (4.28.8) | If available | |
| Nanomaterial porosity (4.28.9) | If available | |
| Nanomaterial pour density (4.28.10) | If available | |
| Nanomaterial photocatalytic activity (4.28.11) | If available | |
| Nanomaterial radical formation potential (4.28.12) | If available | |
| Nanomaterial catalytic activity (4.28.13) | If available | |
| Nanomaterial dispersion stability (4.28.14) | If available | |
| 5. Environmental fate and pathways | Phototransformation in air (5.1.1) | If available |
| Hydrolysis (5.1.2) | Required | |
| Phototransformation in water (5.1.3) | If available | |
| Biodegradation in water: screening tests (5.2.1) | If available | |
| Biodegradation in soil (5.2.3) | If available | |
| Bioaccumulation: aquatic / sediment (5.3.1) | If available | |
| Bioaccumulation: terrestrial (5.3.2) | If available | |
| Adsorption / desorption (5.4.1) | Required | |
| Henry’s Law constant (5.4.2) | If available | |
| Other distribution data (5.4.4) | If available | |
| Additional information on environmental fate and behaviour (5.6) | If available | |
| 6. Ecotoxicological information | Short-term toxicity to fish (6.1.1) | If available |
| Long-term toxicity to fish (6.1.2) | If available | |
| Short-term toxicity to aquatic invertebrates (6.1.3) | If available | |
| Long-term toxicity to aquatic invertebrates (6.1.4) | If available | |
| Toxicity to aquatic algae and cyanobacteria (6.1.5) | If available | |
| Toxicity to aquatic plants other than algae (6.1.6) | If available | |
| Toxicity to microorganisms (6.1.7) | If available | |
| Endocrine disruptor testing in aquatic vertebrates – in vivo (6.1.8) | If available | |
| Toxicity to other aquatic vertebrates (6.1.9) | If available | |
| Sediment toxicity (6.2) | If available | |
| Toxicity to soil macroorganisms except arthropods (6.3.1) | If available | |
| Toxicity to terrestrial arthropods (6.3.2) | If available | |
| Toxicity to terrestrial plants (6.3.3) | If available | |
| Toxicity to soil microorganisms (6.3.4) | If available | |
| Additional ecotoxicological information (6.6) | If available | |
| 7. Toxicological information | Basic toxicokinetics (7.1.1) | If available |
| Dermal absorption (7.1.2) | If available | |
| Acute toxicity: oral (7.2.1) | Required (information on either 7.2.1, 7.2.2 or 7.2.3) | |
| Acute toxicity: inhalation (7.2.2) | ||
| Acute toxicity: dermal (7.2.3) | ||
| Acute toxicity: other routes (7.2.4) | If available | |
| Skin irritation / corrosion (7.3.1) | Required | |
| Eye irritation (7.3.2) | Required | |
| Skin sensitisation (7.4.1) | Required | |
| Respiratory sensitisation (7.4.2) | If available | |
| Repeated dose toxicity: oral (7.5.1) | Required (information on either 7.5.1, 7.5.2 or 7.5.3) | |
| Repeated dose toxicity: inhalation (7.5.2) | ||
| Repeated dose toxicity: dermal (7.5.3) | ||
| Repeated dose toxicity: other routes (7.5.4) | If available | |
| Genetic toxicity in vitro (7.6.1) | Required. Information on point mutations (7.6.1 or 7.6.2) and chromosome damage (7.6.1 or 7.6.2) | |
| Genetic toxicity in vivo (7.6.2) | ||
| Carcinogenicity (7.7) | If available | |
| Toxicity to reproduction (7.8.1) | If available | |
| Developmental toxicity / teratogenicity (7.8.2) | If available | |
| Toxicity to reproduction: other studies (7.8.3) | If available | |
| Neurotoxicity (7.9.1) | If available | |
| Immunotoxicity (7.9.2) | If available | |
| Specific investigations: other studies (7.9.4) | If available | |
| Health surveillance data (7.10.1) | If available | |
| Epidemiological data (7.10.2) | If available | |
| Direct observations: clinical cases, poisoning incidents and other (7.10.3) | If available | |
| Sensitisation data (humans) (7.10.4) | If available | |
| Exposure related observations in humans: other data (7.10.5) | If available | |
| Additional toxicological information (7.12) | If available | |
| 9. Residues in food and feeding stuff | If available | |
| 11. Guidance on safe use | Required | |
| 13. Assessment report (attach SDS) | Required | |
Environment focus applications and information required
Choose this application if your introduction’s indicative human health risk is very low to low, and the indicative environment risk is medium to high
You will need to be able to demonstrate that the highest indicative human health risk of the introduction is very low or low risk. If you can’t do this, choose ‘Health and environment focus’.
Environment focus – information required
Note: The numbers in brackets represent the document numbers in IUCLID6 Version 4.18.0.
| IUCLID documentation | Medium to high risk for environment and low to very low risk for health | |
|---|---|---|
| Sections | Subsections / Documents | Required / If available |
| 1. General information | Identification (1.1) | Required |
| Composition (1.2) | Required | |
| Analytical information (1.4) | Required | |
| 2. Classification, labelling | GHS (2.1) | Required |
| 3. Manufacture | Estimated quantities (3.2) | Required |
| Site (3.3) | Required for manufacture only | |
| Manufacture (3.5.1) | Required for manufacture only | |
| Formulation or re-packing (3.5.2) | If available – though at least one use (use name) must be provided in either 3.5.2, 3.5.3, 3.5.4 or 3.5.5. | |
| Uses at industrial sites (3.5.3) | ||
| Widespread uses by professional workers (3.5.4) | ||
| Consumer uses (3.5.5) | ||
| Article service life (3.5.6) | If available | |
| 4. Physical and chemical properties | Appearance / physical state / colour (4.1) | Required |
| Melting point / freezing point (4.2) | Required | |
| Boiling point (4.3) | Required | |
| Density (4.4) | Required | |
| Particle size distribution (Granulometry) (4.5) | Required | |
| Vapour pressure (4.6) | Required | |
| Partition coefficient (4.7) | Required | |
| Water solubility (4.8) | Required | |
| Solubility in organic solvents / fat solubility (4.9) | If available | |
| Surface tension (4.10) | If available | |
| Flash point (4.11) | If available | |
| Auto flammability (4.12) | If available | |
| Flammability (4.13) | If available | |
| Explosiveness (4.14) | If available | |
| Oxidising properties (4.15) | If available | |
| Oxidation reduction potential (4.16) | If available | |
| pH (4.20) | If available | |
| Dissociation constant (4.21) | Required | |
| Viscosity (4.22) | If available | |
| Self-reactive substances (4.23) | If available | |
| Additional physico-chemical information (4.27) | If available | |
| Nanomaterial agglomeration / aggregation (4.28.1) | If available | |
| Nanomaterial crystalline phase (4.28.2) | If available | |
| Nanomaterial crystallite and grain size (4.28.3) | If available | |
| Nanomaterial aspect ratio / shape (4.28.4) | If available | |
| Nanomaterial specific surface area (4.28.5) | If available | |
| Nanomaterial Zeta potential (4.28.6) | If available | |
| Nanomaterial surface chemistry (4.28.7) | If available | |
| Nanomaterial dustiness (4.28.8) | If available | |
| Nanomaterial porosity (4.28.9) | If available | |
| Nanomaterial pour density (4.28.10) | If available | |
| Nanomaterial photocatalytic activity (4.28.11) | If available | |
| Nanomaterial radical formation potential (4.28.12) | If available | |
| Nanomaterial catalytic activity (4.28.13) | If available | |
| Nanomaterial dispersion stability (4.28.14) | If available | |
| 5. Environmental fate and pathways | Phototransformation in air (5.1.1) | If available |
| Hydrolysis (5.1.2) | Required | |
| Phototransformation in water (5.1.3) | If available | |
| Biodegradation in water: screening tests (5.2.1) | Required | |
| Biodegradation in soil (5.2.3) | If available | |
| Bioaccumulation: aquatic / sediment (5.3.1) | Required (information on either 5.3.1 or 5.3.2) | |
| Bioaccumulation: terrestrial (5.3.2) | ||
| Adsorption / desorption (5.4.1) | Required | |
| Henry’s Law constant (5.4.2) | If available | |
| Other distribution data (5.4.4) | If available | |
| Additional information on environmental fate and behaviour (5.6) | If available | |
| 6. Ecotoxicological information | Short-term toxicity to fish (6.1.1) | Required |
| Long-term toxicity to fish (6.1.2) | If available | |
| Short-term toxicity to aquatic invertebrates (6.1.3) | Required | |
| Long-term toxicity to aquatic invertebrates (6.1.4) | If available | |
| Toxicity to aquatic algae and cyanobacteria (6.1.5) | Required | |
| Toxicity to aquatic plants other than algae (6.1.6) | If available | |
| Toxicity to microorganisms (6.1.7) | If available | |
| Endocrine disruptor testing in aquatic vertebrates – in vivo (6.1.8) | If available | |
| Toxicity to other aquatic vertebrates (6.1.9) | If available | |
| Sediment toxicity (6.2) | If available | |
| Toxicity to soil macroorganisms except arthropods (6.3.1) | If available | |
| Toxicity to terrestrial arthropods (6.3.2) | If available | |
| Toxicity to terrestrial plants (6.3.3) | If available | |
| Toxicity to soil microorganisms (6.3.4) | If available | |
| Additional ecotoxicological information (6.6) | If available | |
| 7. Toxicological information | Basic toxicokinetics (7.1.1) | If available |
| Dermal absorption (7.1.2) | If available | |
| Acute toxicity: oral (7.2.1) | If available | |
| Acute toxicity: inhalation (7.2.2) | If available | |
| Acute toxicity: dermal (7.2.3) | If available | |
| Acute toxicity: other routes (7.2.4) | If available | |
| Skin irritation / corrosion (7.3.1) | If available | |
| Eye irritation (7.3.2) | If available | |
| Skin sensitisation (7.4.1) | If available | |
| Respiratory sensitisation (7.4.2) | If available | |
| Repeated dose toxicity: oral (7.5.1) | If available | |
| Repeated dose toxicity: inhalation (7.5.2) | If available | |
| Repeated dose toxicity: dermal (7.5.3) | If available | |
| Repeated dose toxicity: other routes (7.5.4) | If available | |
| Genetic toxicity in vitro (7.6.1) | If available | |
| Genetic toxicity in vivo (7.6.2) | If available | |
| Carcinogenicity (7.7) | If available | |
| Toxicity to reproduction (7.8.1) | If available | |
| Developmental toxicity / teratogenicity (7.8.2) | If available | |
| Toxicity to reproduction: other studies (7.8.3) | If available | |
| Neurotoxicity (7.9.1) | If available | |
| Immunotoxicity (7.9.2) | If available | |
| Specific investigations: other studies (7.9.4) | If available | |
| Health surveillance data (7.10.1) | If available | |
| Epidemiological data (7.10.2) | If available | |
| Direct observations: clinical cases, poisoning incidents and other (7.10.3) | If available | |
| Sensitisation data (humans) (7.10.4) | If available | |
| Exposure related observations in humans: other data (7.10.5) | If available | |
| Additional toxicological information (7.12) | If available | |
| 9. Residues in food and feeding stuff | If available | |
| 11. Guidance on safe use | Required | |
| 13. Assessment report (attach SDS) | Required | |
Very low to low risk applications and information required
You can select this if you have categorised your introduction as exempted or reported and you want your chemical to be added to the Inventory. If this is not the case, you do not need to apply for an assessment certificate for these categories.
Note: The numbers in brackets represent the document numbers in IUCLID6 Version 4.18.0.
| IUCLID documentation | Very low to low risk for health and environment risk | |
|---|---|---|
| Sections | Subsections / Documents | Required / If available |
| 1. General information | Identification (1.1) | Required |
| Composition (1.2) | Required | |
| Analytical information (1.4) | Required | |
| 2. Classification, labelling | GHS (2.1) | Required |
| 3. Manufacture | Estimated quantities (3.2) | Required |
| Site (3.3) | Required for manufacture only | |
| Manufacture (3.5.1) | Required for manufacture only | |
| Formulation or re-packing (3.5.2) | If available – though at least one use (use name) must be provided in either 3.5.2, 3.5.3, 3.5.4 or 3.5.5.
| |
| Uses at industrial sites (3.5.3) | ||
| Widespread uses by professional workers (3.5.4) | ||
| Consumer uses (3.5.5) | ||
| Article service life (3.5.6) | If available | |
| 4. Physical and chemical properties | Appearance / physical state / colour (4.1) | Required |
| Melting point / freezing point (4.2) | Required | |
| Boiling point (4.3) | Required | |
| Density (4.4) | Required | |
| Particle size distribution (Granulometry) (4.5) | Required | |
| Vapour pressure (4.6) | Required | |
| Partition coefficient (4.7) | Required | |
| Water solubility (4.8) | Required | |
| Solubility in organic solvents / fat solubility (4.9) | If available | |
| Surface tension (4.10) | If available | |
| Flash point (4.11) | If available | |
| Auto flammability (4.12) | If available | |
| Flammability (4.13) | If available | |
| Explosiveness (4.14) | If available | |
| Oxidising properties (4.15) | If available | |
| Oxidation reduction potential (4.16) | If available | |
| pH (4.20) | If available | |
| Dissociation constant (4.21) | Required | |
| Viscosity (4.22) | If available | |
| Self-reactive substances (4.23) | If available | |
| Additional physico-chemical information (4.27) | If available | |
| Nanomaterial agglomeration / aggregation (4.28.1) | If available | |
| Nanomaterial crystalline phase (4.28.2) | If available | |
| Nanomaterial crystallite and grain size (4.28.3) | If available | |
| Nanomaterial aspect ratio / shape (4.28.4) | If available | |
| Nanomaterial specific surface area (4.28.5) | If available | |
| Nanomaterial Zeta potential (4.28.6) | If available | |
| Nanomaterial surface chemistry (4.28.7) | If available | |
| Nanomaterial dustiness (4.28.8) | If available | |
| Nanomaterial porosity (4.28.9) | If available | |
| Nanomaterial pour density (4.28.10) | If available | |
| Nanomaterial photocatalytic activity (4.28.11) | If available | |
| Nanomaterial radical formation potential (4.28.12) | If available | |
| Nanomaterial catalytic activity (4.28.13) | If available | |
| Nanomaterial dispersion stability (4.28.14) | If available | |
| 5. Environmental fate and pathways | Phototransformation in air (5.1.1) | If available |
| Hydrolysis (5.1.2) | Required | |
| Phototransformation in water (5.1.3) | If available | |
| Biodegradation in water: screening tests (5.2.1) | If available | |
| Biodegradation in soil (5.2.3) | If available | |
| Bioaccumulation: aquatic / sediment (5.3.1) | If available | |
| Bioaccumulation: terrestrial (5.3.2) | If available | |
| Adsorption / desorption (5.4.1) | Required | |
| Henry’s Law constant (5.4.2) | If available | |
| Other distribution data (5.4.4) | If available | |
| Additional information on environmental fate and behaviour (5.6) | If available | |
| 6. Ecotoxicological information | Short-term toxicity to fish (6.1.1) | If available |
| Long-term toxicity to fish (6.1.2) | If available | |
| Short-term toxicity to aquatic invertebrates (6.1.3) | If available | |
| Long-term toxicity to aquatic invertebrates (6.1.4) | If available | |
| Toxicity to aquatic algae and cyanobacteria (6.1.5) | If available | |
| Toxicity to aquatic plants other than algae (6.1.6) | If available | |
| Toxicity to microorganisms (6.1.7) | If available | |
| Endocrine disruptor testing in aquatic vertebrates – in vivo (6.1.8) | If available | |
| Toxicity to other aquatic vertebrates (6.1.9) | If available | |
| Sediment toxicity (6.2) | If available | |
| Toxicity to soil macroorganisms except arthropods (6.3.1) | If available | |
| Toxicity to terrestrial arthropods (6.3.2) | If available | |
| Toxicity to terrestrial plants (6.3.3) | If available | |
| Toxicity to soil microorganisms (6.3.4) | If available | |
| Additional ecotoxicological information (6.6) | If available | |
| 7. Toxicological information | Basic toxicokinetics (7.1.1) | If available |
| Dermal absorption (7.1.2) | If available | |
| Acute toxicity: oral (7.2.1) | If available | |
| Acute toxicity: inhalation (7.2.2) | If available | |
| Acute toxicity: dermal (7.2.3) | If available | |
| Acute toxicity: other routes (7.2.4) | If available | |
| Skin irritation / corrosion (7.3.1) | If available | |
| Eye irritation (7.3.2) | If available | |
| Skin sensitisation (7.4.1) | If available | |
| Respiratory sensitisation (7.4.2) | If available | |
| Repeated dose toxicity: oral (7.5.1) | If available | |
| Repeated dose toxicity: inhalation (7.5.2) | If available | |
| Repeated dose toxicity: dermal (7.5.3) | If available | |
| Repeated dose toxicity: other routes (7.5.4) | If available | |
| Genetic toxicity in vitro (7.6.1) | If available | |
| Genetic toxicity in vivo (7.6.2) | If available | |
| Carcinogenicity (7.7) | If available | |
| Toxicity to reproduction (7.8.1) | If available | |
| Developmental toxicity / teratogenicity (7.8.2) | If available | |
| Toxicity to reproduction: other studies (7.8.3) | If available | |
| Neurotoxicity (7.9.1) | If available | |
| Immunotoxicity (7.9.2) | If available | |
| Specific investigations: other studies (7.9.4) | If available | |
| Health surveillance data (7.10.1) | If available | |
| Epidemiological data (7.10.2) | If available | |
| Direct observations: clinical cases, poisoning incidents and other (7.10.3) | If available | |
| Sensitisation data (humans) (7.10.4) | If available | |
| Exposure related observations in humans: other data (7.10.5) | If available | |
| Additional toxicological information (7.12) | If available | |
| 9. Residues in food and feeding stuff | If available | |
| 11. Guidance on safe use | Required | |
| 13. Assessment report (attach SDS) | Required | |
Reminder about the information you need to support the application type you've chosen
For all application types (except for health and environment focus), you must have sufficient supporting information to demonstrate the absence of hazard characteristics based on the acceptable test guidelines.
Additional application type - comparable hazard assessment
A comparable hazard assessment is a type of assessment certificate application. In AICIS Business Services, we'll ask you if you are using an acceptable comparable hazard assessment.
Choose this if your introduction has had a hazard assessment previously conducted by an acceptable overseas or Australian assessment body.
Assessment bodies we recognise
For assessment bodies, one of the following overseas or Australian assessment bodies must have already assessed your introduction.
- National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
- Australian Industrial Chemicals Introduction Scheme (AICIS)
- Environment and Climate Change Canada (ECCC) / Health Canada (HC) – (certain Schedules)
- United States Environmental Protection Agency (US EPA)
- European Commission (EC) Scientific Committee on Consumer Safety (SCCS) or its equivalent former committees — the Scientific Committee on Consumer Products (SCCP) and the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP)
- Therapeutic Goods Administration (TGA)
- Australian Pesticides and Veterinary Medicines Authority (APVMA)
- Food Standards Australia New Zealand (FSANZ)
- International parallel process assessments where Australia was involved as a secondary jurisdiction and Environment and Climate Change Canada (ECCC) / Health Canada (HC) or the United States Environmental Protection Agency (US EPA) performed the risk assessment
How to apply for a comparable hazard assessment
Information for publication purposes
We may use information on the purity, volume and/or concentration in a defined scope of assessment for an assessment certificate.
You need to agree with all participants the information that, for publication purposes, will be entered into AICIS Business Services about:
- Purity – it must be a number between 0 and 100 with no more than 2 decimal digits
- Volume – tonnes of the chemical to be introduced each year
- Concentration – introduction and end use concentration.
3. Using new animal test data for chemicals in cosmetics
Under the Industrial Chemicals Act 2019, new animal test data means any information from tests conducted on or after 1 July 2020, on a cephalopod or live vertebrate animal (other than a human being).
There are bans and/or restrictions on using new animal test data in certificate applications for chemicals with a cosmetic end use. These apply in your certificate application if:
1. the chemical will be used in cosmetics in Australia (either cosmetic only or multiple end use), and
2. the animal study was conducted on, or after, 1 July 2020.
There are exceptions to these bans and restrictions, including applying for pre-approval to use new animal test data for chemicals with multiple end-uses that include cosmetics.
Learn about the exception criteria and the use of animal test data.
4. Other information you may need to provide in an assessment certificate application
This page explains extra information you may need to provide in an assessment certificate application. Work through each question on this page to learn if any of these apply to your application.
Is your application a consolidated application?
You can apply for a consolidated application if you are seeking authorisation to import or manufacture (introduce) a group of similar chemicals or polymers with the same end use.
This type of application relies on the similarity of your chemicals to the primary chemical that you introduce.
If your application meets the similarity criteria, you pay a full fee for the primary chemical and reduced fees for the additional chemicals. Applications for the primary chemical and the additional chemicals must be made at the same time.
If we approve the application, you’ll get an assessment certificate for each chemical.
We use the term 'primary chemical' to describe the first chemical you intend to introduce with 2 or more new chemicals with similar properties and same end uses.
We use the term 'additional chemical' to describe every chemical you intend to introduce beyond the first when you introduce 2 or more new chemicals with similar properties and same end uses.
If you meet the criteria, you pay a full fee for the primary chemical and reduced fees for the additional chemicals. You’ll get an assessment certificate for each chemical.
What types of chemicals does the application cover?
This application can cover most types of chemicals, including polymers and inseparable mixtures of similar chemicals.
Are you introducing a group of polymers?
If you are introducing a group of polymers and wish to make a consolidated application, these polymers must meet our similar polymer criteria instead of similar chemical criteria.
What are the similarity criteria?
Depending on whether you are introducing chemicals or polymers, you must prove similarity in the relevant group of criteria, relating to either:
- similar chemical, including chemical properties and toxicity
- similar polymer, including chemical properties and toxicity
To be eligible for this application type, the end uses(s) of the additional chemicals must be the same as the primary chemical.
What’s a similar chemical?
The physico-chemical and toxicological properties must be similar to the primary chemical. This means:
- substructures that might play a critical functional role must be the same
- GHS classifications must be the same
- molecular properties must be the same or you must expect them to be the same
- molecular weight must be similar
- the octanol-water partition coefficient must be within 50-200% of the primary chemical
- the toxicity profile must be unaffected by differences in chemical identity
The following can be similar chemicals:
- salts of the primary chemical
- positional isomers
- stereoisomers.
What’s a similar polymer?
Similar polymers must be 1 of the following:
- contains 1 polymer constituent less than the primary polymer
- contains 1 polymer constituent different to the primary polymer
- the polymer constituent should be similar to the substituted constituent in the primary polymer
- structurally identical to the primary polymer, but have a different manufacturing method.
Similar polymers must also have:
- the same linkages and functional groups
- water solubility within the range of 50 to 200% of the primary polymer
- no changes in identity that changes toxicity profile.
What information do I need to provide and keep?
In addition to the information for an assessment certificate, you’ll need to provide and keep records of the following:
- introduction details about the chemicals or polymers
- information about anything affecting human health and the environment
- evidence that the chemicals or polymers have the same end uses
- evidence that the chemicals or polymers meet similar chemical criteria or similar polymer criteria.
After you submit your application
We’ll review your application and contact you if we need more information. You can also track and view the outcome of your application in AICIS Business Services.
Is it a multi-component introduction?
A multi‑component introduction applies when you are seeking an AICIS assessment certificate to introduce a mixture made up of 2 or more chemicals that are manufactured together. In these cases, there is no single CAS chemical name that adequately covers all the chemical components in the mixture.
A multi‑component introduction applies when you are seeking an AICIS assessment certificate to introduce a mixture made up of 2 or more chemicals that are manufactured together. In these cases, there is no single CAS chemical name that adequately covers all the chemical components in the mixture.
An introduction is a multi‑component introduction if all the following criteria are met:
- Manufactured together – The introduction is a chemical mixture where all component chemicals are manufactured simultaneously.
- Identifiable components – Each component chemical in the mixture can be uniquely identified.
- No separation during introduction or use – The component chemicals are not separated at any stage during introduction or use in Australia.
- No single CAS name – There is no single CAS chemical name available that specifically covers all component chemicals in the mixture.
You should consider the hazard profile and introduction volumes of the chemical mixture when you're working out if the assessment certificate will be health focused, environment focused or both.
Is your application for a 'specified class of introduction'?
A specified class of introduction refers to certain chemicals or introduction types that have greater potential to cause harm to human health or the environment. If your application relates to a specified class of introduction, you may need to provide additional or different information as part of your assessment certificate application. This information helps us identify and assess the risks associated with these higher-concern introductions.
Your chemical or introduction is a specified class of introduction if it is any of the following.
- Designated fluorinated chemicals - see details below.
- Chemicals at the nanoscale (1 - 100 nm) - see details below.
- Gas
- Biochemical
- For end use in an article with food contact
- For end use in tattoo ink
- For end use as a biocidal active
- Designated kind of release into the environment
- GM product
- Highly branched organic chemical
- Polyhalogenated organic chemical
- UV filter
Information requirements for designated fluorinated chemicals
If your introduction is of a designated fluorinated chemical, you should provide the following information:
| Information requirement | Acceptable test guidelines to use | Additional details | Circumstances in which this information may not be required |
|---|---|---|---|
| Fluorinated impurities | - | The identity and concentration of all fluorinated impurities that meet the definition of a designated fluorinated chemical must be provided if they are present in your introduction at greater than or equal to 1 mg/kg. The identity and concentration of all impurities of perfluorohexanesulfonic acid (PFHxS) and its salts, perfluorooctanoic acid (PFOA) and its salts, or perfluorooctane sulfonate (PFOS) and its salts must be provided if they are present in your introduction at greater than or equal to 0.025 mg/kg. | None. |
| Acute inhalation toxicity | OECD TG 403 | - | If inhalation is not expected to be a route of exposure during use. |
| Reproductive / developmental toxicity | OECD TG 422 or 433 | - | None. |
| Bioaccumulation | OECD TG 305, 315, or 317 | Bioaccumulation information based on log Kow is not acceptable. | If the molecular weight is greater than or equal to 1,000 g/mol. |
| Long-term toxicity to fish | OECD TG 240, 210, or 215 | - | None. |
| Long-term toxicity to aquatic invertebrates | OECD TG 211, or 202 Part II | - | None. |
| Chronic toxicity to algae | OECD TG 201 | A NOEC or EC10 value must be reported in the study. | None. |
| Toxicity to soil macroorganisms except arthropods | OECD TG 222 or 207 | - | If there is no expected release to soil. |
| Toxicity to terrestrial arthropods | OECD TG 213, 214, 232, 228, 237, 245, 246, 247, or 226 | - | If there is no expected release to soil. |
| Toxicity to terrestrial plants | OECD TG 208 or 227 | - | If there is no expected release to soil. |
| Toxicity to soil microorganisms | OECD TG 216 | - | If there is no expected release to soil. |
Information requirements for fluorinated degradation products
Test results or scientific justification indicating the identity of the fluorinated degradants and intermediates of the assessed designated fluorinated chemical.
A higher-tiered test such as an inherent biodegradability test report is required. The test should include characterisation of the degradation products and their rate of formation. An inherent biodegradability test is required as there is a greater possibility of degradation occurring in the presence of other nutrients than under the conditions of a ready biodegradability test, where only the test substance is present.
If it is claimed that no degradation of the assessed designated fluorinated chemical occurs, then a report on the analysis and characterisation of degradation products under relevant degradation conditions must be provided. An inherent biodegradability test does not by itself give information on other degradation modes such as hydrolysis, or on formation of stable degradation products by a mechanism which does not involve mineralisation of a substantial proportion of the chemical or polymer, such as side chain cleavage.
If literature sources relating to analogue data are provided, then scientific justification on the applicability of the studies to the assessed designated fluorinated chemical must also be included.
Circumstances in which this information may not be required
There are some default degradation assumptions contained within the reports on the PFAS chemicals that AICIS has previously assessed. These assumptions can be used to cover the requirements for the degradants for those chemicals that they are applicable to. See our page on previous PFAS chemical assessments.
For all persistent fluorinated degradants and intermediates of the assessed chemical, both 1 and 2:
The information required for a standard health and environment-focused certificate application set out above in this page.
Section 4. Physical and chemical properties – except: Flash point; Auto flammability; Flammability; Explosiveness; and Oxidising properties.
Section 5. Environmental fate and pathways
Section 6. Ecotoxicological information
Section 7. Toxicological information – except: Acute toxicity; Skin irritation / corrosion; Eye irritation; and Skin sensitisation.- Information requirements listed above for an assessed chemical that meets the designated fluorinated chemical definition
Circumstances in which this information may not be required
If the assessed designated fluorinated chemical is expected to degrade to a PFAS chemical that AICIS has previously assessed, then this chemical assessment can be used to cover the requirements for the degradants. See our page on previous PFAS chemical assessments.
Nanoscale means the particle size range of 1 to 100 nm. An introduction at the nanoscale is a ‘specified class of introduction’ if it:
- is introduced as a solid or is in a dispersion
- consists of 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
For details, see categorisation of chemicals at the nanoscale.
If your chemical is at the nanoscale and is categorised as an assessed introduction, you should give us the following information about the chemical’s identity and physicochemical properties.
Chemical details
- CAS name and/or IUPAC name
- CAS registry number, if available
- Common or trade name, if available
- Synonyms, if available (for example, chemical identifiers in study reports or test data reports)
- Molecular formula, if defined
- Structural formula, if defined
- Molecular weight or weight range, if defined
- Composition (for example, purity, identity of impurities, details of manufacturing method and batch-to-batch variation if applicable)
- Coated or not coated (if coated, the details of coating)
- Where relevant, information about crystallinity (crystal or amorphous structure). For example, if a chemical has different crystal structures because of the manufacturing technique; then you’ll need to provide the name/s of crystal structure/s and their proportions
Nanoscale-specific physicochemical properties
For nanoscale-specific physicochemical properties, multiple techniques may be needed to fully characterise a specific property. The choice of technique will depend on the individual characteristics of the chemical. When there are nano-specific methods available, you must provide justification for using a non-nano-specific method.
The details of testing methods and important issues of risk assessment are available for nanoscale materials in the Organisation for Economic Cooperation Development’s Publications in the Series on the Safety of Manufactured Nanomaterials.
Shape of the particle
- Description of the particle shape (for example, a qualitative or semi-quantitative geometrical description of the extremities of the particle, and/or particles, agglomerate or aggregate that make up the chemical).
- Image analysis (electron micrograph using transmission electron microscopes and/or scanning electron microscope).
- Morphology descriptors - see the International Organization for Standardization’s ISO 9276-6:2008: Representation of results of particle size analysis – Part 6: Descriptive and quantitative representation of particle shape and morphology.
For carbon nanotubes (CNT), you also need to provide the number of walls in the CNT.
For graphene, you also need to provide the number of plates in the particle.
Particle size and particle size distribution (PSD)
- Particle size and PSD with percentages of different particle sizes in a batch.
- Variation between batches, if applicable.
- Aspect ratio (length/diameter) is required for elongated and platelet shapes. For example, carbon nanotubes to indicate whether the aspect ratio is over 3.
For nano tubes and plates, you must provide all dimensions of the particle.
For details of the methods to be used, see the OECD’s test guideline publication TG 125 - Nanomaterial particle size and size distribution of nanomaterials.
Volume specific surface area
For details of the methods to be used, see OECD TG 124: Determination of the volume specific surface area of manufactured nanomaterials.
Another useful reference is ISO/TR 14187:2020: Surface chemical analysis – Characterization of nanostructured materials.
Surface chemistry – the chemical nature of the surface of a particle
The description must include whether the particles have been surface-treated.
If surface treated:
- the chemical identity of the surface treatment agents (CAS and/or IUPAC name of the chemicals) and the amount (% w/w) applied on the particle, if applicable
- the chemistry imparted to the surface, for example, an agent may be used to graft new functional groups to the surface, or to oxidize/reduce existing functional groups
- a schematic representation of the particle surface may be provided to illustrate the surface chemistry.
Surface charge
You need to provide measured data on the zeta potential of the chemical.
You may also submit isoelectric point and/or electrophoretic mobility as an indirect measurement of zeta potential.
Measured data describing dispersibility (if relevant and information is available)
- The degree of dispersion refers to the relative number or mass of particles in a suspending medium and relates to the stability, aggregation and agglomeration of the chemical in relevant media (for example, water).
- Measured data on particle concentration.
- Measurement methods include (but are not limited to) light-scattering methods, single particle ICP-MS, and scanning mobility particle sizer (OECD TG 318).
Measured data describing dustiness
This data is only required if inhalation exposure is likely to occur.
Measured data or suitable alternatives describing the Biological (re)activity
This includes oxidising properties, conditions causing instability, decomposition products.
Data on photoreactivity (if relevant)
This requirement applies where the chemical absorbs light between 200-750 nm wavelength (UV/visible light).
The following OECD test guidelines are available for testing the photoreactivity of chemicals (these are not specific to nanoscale chemicals or particles):
- OECD TG 432: In Vitro 3T3 NRU Phototoxicity Test, OECD TG 498: In vitro Phototoxicity: Reconstructed Human Epidermis Phototoxicity test method
- OECD TG 495: Reactive Oxygen Species (ROS) Assay for Photoreactivity.
Human health hazards
- Measured data or suitable alternative data/information describing the potential human health hazards consistent with the minimum data requirements for chemical assessments and any other hazard information available to the introducer. For details, see step 4 of our Categorisation Guide.
- If dermal and/or inhalation exposure is expected to occur, then you must submit information on dermal and/or inhalation toxicity (acute or repeated dose). If you can’t give us this information, you must provide a justification.
If other routes of exposure are expected, then you should provide toxicity data on those hazard end points.
All OECD TG available for testing human health toxicity end points are considered applicable in the absence of equivalent testing guidelines for nanoscale chemicals. For details, see OECD guidelines for the testing of chemicals: health effects.
Information to consider when providing toxicity data
- When experimental data for the nanoscale chemical are not available or limited, you may use the read-across approach using existing data from one or more analogous nanoscale chemicals. The read-across from a nanoscale material or a bulk substance requires strong evidence and justification for their suitability to the assessed chemical. You can follow grouping of chemicals when assessing the validity of an analogue. For details, see working out your hazards using read-across information.
- Information on genetic toxicity – the Ames test (OECD TG 471) is not considered to be a reliable test to confirm negative results for mutagenicity of nanoscale particles.
Contact us using our form and select 'Assessments/evaluations' as the topic.
5. How confidentiality works in assessment certificate applications
About confidentiality
You can protect certain information in your assessment certificate application in 2 ways:
- by making applying to protect the chemical name and/or end use as confidential business information (CBI), or
- by flagging other information as confidential.
This page explains the differences between these options and what to consider when applying.
Applying for protection of CBI
Use this option if you want to:
- protect the chemical name
- protect the end use of the chemical.
Learn more about applications for protection of CBI
Applying to protect the chemical name and/or end use
To protect commercial business interests related to the information published about an introduction, applicants may apply to protect the chemical name and/or end use as confidential business information (CBI). These protections are not automatic.
Key information
- This is the only way to request confidentiality for the chemical name and/or end use.
- You must submit a separate application at the same time as your assessment certificate application.
- A fee applies for each request.
- We assess applications against a statutory test.
When setting up your application, you’ll be asked whether you intend to apply for protection of the chemical name and/or end use. If you answer yes, a CBI tab displays for completion.
If we approve an application, the published assessment statement will include:
- a masked chemical name (AICIS‑approved chemical name) instead of the actual chemical name, and/or
- a generalised end use (instead of the specific end use).
More information: How to apply for protection of CBI as part of your assessment certificate application.
Important reminder
You must apply at the same time as your assessment certificate application. If you later decide that you want CBI protection but did not apply initially, you will need to withdraw your assessment certificate application and resubmit it together with the CBI application.
Flagging other information as confidential
You can flag certain information to indicate that it is commercially sensitive or confidential. There is no fee to do this.
Flagging information lets us know your concerns about publication. If we intend to publish flagged information, we will contact you and give you the opportunity to apply to protect the information as confidential business information (a fee applies).
To flag information as confidential, look for the prompts in the IUCLID dossier and apply the flags before you complete the form.
You cannot flag information in your application as confidential after you have submitted your application.
The following information cannot be flagged as confidential business information:
1. physical and chemical data that do not reveal the chemical’s composition
2. summaries of data relating to risks to human health or the environment.
You must flag information at the same time you submit the assessment certificate application.
6. Initial applicant checklist before setting up an application in AICIS Business Services
Use this checklist before you set up your assessment certificate application to confirm you have the required information and approvals you need.
Participants and access
A or B applies:
A. You are the only participant/applicant and have an AICIS Business Number ID (starts with 'NIC').
B. There are other participants (eg joint applicants, chemical data providers, agents).
- All participants are enrolled in AICIS Business Services.
- You have contact names for all participants.
- Everyone involved in the application has access to AICIS Business Services and has an AICIS Business Number ID (starting with 'NIC')
Chemical identity
A or B applies:
A. You can provide the chemical public name – either the CAS name or IUPAC name.
B. You are proposing a masked chemical name (AICIS approved chemical name).
Chemical data ownership
Important reminder: You must nominate any chemical data owner at the start of the application in AICIS Business Services.
- A or B applies:
A. You are submitting chemical data information yourself, and you have permission to use it.
B. You are nominating the data owner as the chemical data provider as you do not have the necessary permissions.
Information for publication purposes
- You have established and agreed among all participants information for publication purposes about the chemical's
- Purity (%)
- Volume (tonnes of the chemical to be introduced each year)
- Introduction concentration (%) and end use concentration (%)
Invoice payer
- You know who to nominate as the invoice payer. AICIS does not accept split payments.
Confidential business information applications
- A or B applies:
A. You or another participant is applying for protection of CBI (chemical name and/or end use) and understand any applications must be submitted at the same time as applying for the assessment certificate.
B. No participant is applying for protection of CBI.
Flagging information as confidential
- A or B applies
A. You or another participant will be flagging certain information as confidential and understand this must be done at the same time as applying for the certificate.
B. No participant is flagging information as confidential.
Application type
- You have established that your application is one of these types:
- Health and environment focus
- Health only focus
- Environment only focus
- Very low or low risk
- Comparable hazard assessment
Application scope - single or multiple chemical
A or B applies:
A. The application is for one chemical.
B. The application covers more than one chemical – that is, a ‘consolidated application’ or ‘multi-component application’.
Ready to start the application?
Once you've confirmed everything in this checklist, you can start your application. You also need to make sure you are ready to create and upload your chemical dataset in IUCLID.
7. Creating your chemical dossier in IUCLID
Once you’ve entered the initial information for your assessment certificate application, the next step is for the applicant and any chemical data provider(s) to upload chemical dossier information in IUCLID.
About IUCLID
IUCLID is free software developed by the European Chemicals Agency (ECHA) and the Organisation for Economic Cooperation and Development (OECD). It is used worldwide to record, store, maintain and exchange information on chemicals. IUCLID supports the reuse of chemical dossiers across Australian and international regulatory frameworks, reducing duplication and streamlining submissions for businesses operating in multiple jurisdictions (such as under the EU’s REACH legislation).
To complete a chemical dossier, both the applicant and chemical data provider(s) must have their own IUCLID instances. This involves downloading the IUCLID6 software and creating a substance dataset.
Tip: dataset terminology
If you see any reference in AICIS Business Services to chemical dataset, it has the same meaning as substance dataset.
Using IUCLID allows you to record, store and maintain data on the intrinsic and hazard properties of your chemical substances. This also helps you meet your AICIS record‑keeping obligations, as you will have a copy of the information you submit to us. You can reuse the information stored in IUCLID for submissions to other regulatory bodies or to share with businesses you work with.
Tip: IUCLID version compatibility
AICIS uses a specific version of IUCLID to process applications. These versions change over time. To avoid delays, select ‘export to previous major version’ when exporting your chemical dossier.
AICIS's IUCLID guide
Coming soon - new guide on creating a chemical dataset in IUCLID for an assessment certificate application
This separate guide will give participants step-by-step instructions on:
- setting up IUCLID
- creating chemical (substance) datasets
- validating dossiers against AICIS requirements
- exporting and submitting dossiers.
See more information about who submits information in IUCLID in Roles, permissions and data responsibilities.
8. Pay for and submit your assessment certificate application
This page explains how to pay for, check the status of required information and submit your application.
Pay the invoice
The Invoice tab displays once you’ve marked ‘Overview’, ‘Participants’ and ‘Application type’ as final.
You can continue to complete your certificate application before paying your invoice. You can come back to the ‘Invoice’ tab later.
Under the ‘Invoice’ tab, the system will generate an invoice based on the ‘Application type’.
You will be asked ‘Are you sure you wish to continue?’ This is to make sure that you have chosen the right certificate application type before paying the application invoice.
You can pay the invoice by credit card online. You can also download a PDF copy of the invoice. We also accept cheques or bank transfers.
If you need to cancel an application, select 'Cancel application'. If you have not paid the invoice, it will be automatically cancelled. If you have already paid the invoice, we will contact you and organise a refund.
Declaration
Open the Declaration tab to check the status of your application. The 'Declaration Checklist' shows which sections are complete.
Tabs marked in green with ‘no error detected’ are ready. You usually see the ‘Participants’ and ‘Application type’ tabs marked this way.
The Declaration tab is only visible to the initial applicant and to chemical data providers. Agents cannot see this tab.
Other tabs in the Declaration Checklist include:
- Application invoice
- CBI
- Chemical dossier(s)
- Declaration(s).
Any tab highlighted in red requires action. The declaration cannot be finalised until this occurs. For example, matters requiring your action could be:
- you haven’t marked the activity tab as final
- the invoice hasn’t been paid in full
- required data has not been submitted
- a participant has not completed their declaration.
Once all tabs are green, the initial applicant can submit the application after ticking the final declaration box.
9. After you submit your assessment certificate application
If we need more information
We will contact you if we need more information to assess your application. If the information you provide is commercially sensitive, you can flag it as confidential at the time you give us the information.
We may also need to consult with risk managers during the process.
If you wish to withdraw your application
The initial applicant can withdraw an application in AICIS Business Services. They can also withdraw if it’s already been submitted. If we have started our screening and risk assessment work, a partial refund will apply, and we will discuss this with you.
If we approve the application
We will issue you with an assessment certificate. Any introduction must comply with the terms of the assessment certificate.
If at any time, you can no longer introduce your chemical under the terms of the certificate, you should contact us to get our advice on your compliance obligations and next steps.
Assessment statement
We will publish an assessment statement on our website, including in cases where we decide not to issue an assessment certificate.
Inventory listings
We will add the chemical to the Inventory 5 years after we issue an assessment certificate. We can add it before 5 years if you successfully apply for an early listing.
Learn more about Inventory listings
If we do not approve your application
You may ask us to reconsider our decision not to approve your application. You must submit a written request to the Executive Director within 20 working days of receiving our decision.
Appendix: Apply for protection of confidential business information as part of your assessment certificate application
See our page on protecting confidential information, for broader guidance, including how confidentiality works and what happens after we receive an application.
Starting your CBI application in AICIS Business Services
Accessing the CBI tab
The CBI tab displays once the following sections are finalised:
- Overview
- Participants
- Application type
On the CBI tab, you will see 3 options:
- Create chemical name application
- Create end use application
- CBI validation
Two tables display:
- CBI application overview – lists all CBI applications created
- CBI other contacts overview – lists all participants with a CBI role and their business contact details
The CBI other contacts overview draws information from the Participants tab.
Each participant assigned a CBI role must submit their own CBI application. Once completed, their application appears in the CBI application overview.
Apply for protection of chemical name
- Only one participant may apply to protect the chemical name.
- Select the chemical name from the picklist (this is the public chemical name entered by the initial applicant).
- Under The chemical name you are applying for protection, enter the actual chemical name you do not want published.
- Under Suggest an AICIS Approved Chemical Name (AACN) for this chemical, provide a proposed AACN (masked chemical name).
If an AACN already exists for the chemical (issued to another introducer), we will assign the same AACN. Each chemical can only have one AACN.
Justification requirements
You must provide evidence and reasons:
- for the level of masking chosen
- to demonstrate that your request meets AICIS's statutory test.
You have the option to enter this information directly or upload a supporting file.
Your justification must address both the technical requirements, and the statutory test criteria.
See detailed guidance and examples for AACNs
See our statutory test guidance
If your proposed AACN is not acceptable, we will consult with you to determine a more suitable one.
Submit the application
Once you've entered the required information, follow these steps:
- Click 'Proceed to CBI invoice'
- Select the invoice payer from the picklist
- Save the application.
An invoice is then created for the invoice payer you've selected.
Apply to protect end use
- One or more participants may apply to protect the end use.
- Select the applicant from the picklist.
- Describe the specific end use you wish to protect.
For assistance, including examples, refer to the guidance on creating a generalised end use.
Justification requirements
You must provide evidence and reasons to show that your claim meets the statutory test. You can enter this directly or upload a supporting file.
See our statutory test guidance
Saving and invoicing
- Save the application as a draft once completed
- Click 'Proceed to CBI invoice'
- Select the invoice payer from the picklist
- Save the application.
If we approve the application, we will publish a generalised end use instead of the specific end use.
Returning to CBI overview
Click 'Return to CBI overview' to go to CBI validation.
CBI validation
To pass CBI validation, you must have completed your application in full and paid the CBI invoice. When CBI validation confirms this, the initial applicant can mark CBI validation as final.
Application fees
Go to our fees page for this information.
Help and commonly asked questions for assessment certificate applications
Translating information
If you have information in another language, check our guidance on translating foreign documents to English.
I’ve made an error
You can cancel the application and start again if this happens – for example, if you choose the wrong application type. You can do this before you reach the invoice step.
Who can cancel an application?
The initial applicant can cancel an application in AICIS Business Services. They can also withdraw if it’s already been submitted. If we have started our screening and risk assessment work, a partial refund will apply, and we will discuss this with you.
I need technical help
Contact us if you have any questions about the certificate application submission process and/or about supplying information in the IUCLID format to support this.
We can only give general advice before an application has been submitted to us.
In terms of information for the substance dataset, we can only help at the data validation step as we do not have access to your certificate application prior to this stage.
Contact us if you experience any technical problems when directly submitting chemical information in an IUCLID6 file.