Guide to categorising internationally assessed introductions
There is a streamlined way to categorise introductions of chemicals that have been assessed overseas.
Who should use this guide?
If you plan to use your chemical in a similar way to how it’s used overseas, your consideration of the criteria in this guide will most likely be straightforward and quick.
Using international assessments for categorisation
If a trusted overseas body has assessed your introduction and it meets the criteria described in this guide, you are eligible to use the internationally assessed pathway as a low-risk introduction for human health or the environment (or both).
For the full list of trusted overseas bodies that we accept, see Step 1 of Internationally assessed for human health only and Step 1 of Internationally assessed for the environment only.
The information in this guide will help you to work out whether your introduction could be one of the following:
- internationally assessed for human health
- internationally assessed for the environment
- internationally assessed for both human health and the environment
What is 'internationally assessed for human health only'
If a trusted overseas body has assessed your introduction for human health and you meet all other criteria in this guide related to human health, your indicative risk to human health is low.
You can also use our decision tool to work out if your introduction is low risk for human health.
If there is no assessment for the environment from a trusted overseas body, or there is one but it doesn’t meet all our criteria related to the environment, then you must go back to our categorisation guide and determine the risk to the environment.
If you work out that the indicative environment risk of your introduction is low or very low, you can categorise it as a reported introduction. You need to submit a pre-introduction report (PIR) in AICIS Business Services and select ‘internationally assessed for human health but not for the environment’.
What is 'internationally assessed for the environment only'
If a trusted overseas body has assessed your introduction for the environment and you meet all other criteria in this guide related to the environment, your indicative risk to the environment is low.
You can also use our decision tool to work out if your introduction is low risk for the environment.
If there is no assessment for human health from a trusted overseas body, or there is one but it doesn’t meet all our criteria related to human health, then you must go back to our categorisation guide and determine the risk to human health.
If you work out that the indicative human health risk of your introduction is low or very low, you can categorise it as a reported introduction. You need to submit a pre-introduction report in AICIS Business Services and select ‘internationally assessed for the environment but not for human health’.
What is 'internationally assessed for both human health and the environment'
If a trusted overseas body has assessed your introduction for both human health and environment and you meet all other criteria in this guide, the indicative risk to human health and environment is low and you can categorise it as a reported introduction.
You need to submit a pre-introduction report in AICIS Business Services and select ‘internationally assessed for both human health and the environment’.
What if my introduction meets the criteria for very low risk?
If you wish, you can choose to work through our categorisation guide to see if the indicative risk to human health or the environment is very low. If it meets the criteria for very low indicative risk to both human health and the environment, you can categorise it as an exempted introduction.
In this guide:
Internationally assessed for human health only
This section relates to introductions that are internationally assessed for human health only. You must meet all of the criteria described in each step to be considered a 'low risk' introduction under AICIS.
If you have not followed our main Categorisation Guide, do not go any further until you do so.
If a trusted overseas body has assessed your introduction for human health and it meets all the other criteria in this guide related to human health, its indicative risk to human health is low.
Your introduction must meet all of the criteria described in each step of this section.
You can also use our decision tool to work out if your introduction is low risk for human health.
Step 1: Is there an overseas assessment of your chemical?
This section relates to introductions that are internationally assessed for human health only. These must meet all of the criteria described in each step to be considered a 'low risk' introduction under AICIS.
If an overseas body has assessed your chemical, consider the following aspects of the assessment.
Step 1.1: Did a trusted overseas body perform the assessment?
A trusted overseas body listed in section 6 of the General Rules must have assessed or evaluated your introduction for its risks to human health, and published a report of the assessment or evaluation that describes the outcomes.
The trusted bodies are:
- Opinions from the 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). We’ll accept these opinions as long as they have been finalised and adopted by the committee; the terms of reference include a question about the safety of your chemical in a cosmetic product; and the opinion concludes that it’s safe.
- Opinions from the European Chemicals Agency (ECHA) Committee for Risk Assessment and the ECHA Committee for Socio-Economic Analysis. We’ll accept these opinions as long as they’ve formed the basis for the EC's decision to include or update a restriction in Annex XVII of the REACH regulation (REACH restrictions). REACH registration dossiers are not accepted.
- Opinions from the European Food Safety Authority (EFSA) on materials and articles intended to come into contact with food.
- European risk assessments that have formed the basis for the EC approving active biocidal substances. The ECHA or an authority of a member state of the European Union must have conducted these risk assessments, and the ECHA Biocidal Products Committee must have reviewed the risk assessment.
- Risk assessments from Health Canada. We'll accept risk assessments that used Schedule 5, 6, 9, 10 or 11 from the current Canadian regulations (31 October 2005 onwards). We'll also accept risk assessments that used Schedule II, III, VI, VII or VIII from the old Canadian regulations (before 31 October 2005).
- International parallel process assessments where Australia was involved as a secondary jurisdiction; and Health Canada OR the United States Environmental Protection Agency (US EPA) performed the risk assessment.
You may know that there is a report of the assessment or evaluation because:
- it is publicly available on the website of the trusted overseas body
- an alternative source is available – for example, you know that your overseas parent company has had the chemical assessed in Canada
If one of the trusted overseas bodies assessed or evaluated your chemical and completed a report for it, continue to Step 1.2 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
If one of the trusted overseas bodies has not assessed or evaluated your chemical, or there is no report for it, you do not meet our criteria for an introduction that has been internationally assessed for human health.
Step 1.2: Can I use the overseas assessment report?
The following factors determine whether you can use an overseas report.
1. The complete report must be available.
It’s important to note that:
- you must provide the complete report, not just a summary of it
- you must have permission to use the report and any information it contains for the purpose of introducing your chemical into Australia
- if the overseas report is publicly available and your company was not the applicant for the overseas assessment, you must ensure you have the applicant’s permission to use the assessment report
2. You must give us the report, if we ask for it.
This could mean:
- you give it to us directly, or tell us where we can find it (for example, if it’s publicly available on a website) or
- arrangements can be made for another party to give us the report
If the overseas report is available and you can provide it for these purposes, continue to Step 2 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
If the overseas report is not available or you can’t provide it for these purposes, you do not meet our criteria for an introduction that has been internationally assessed for human health.
If you are using a Canadian report
If you want to use a Canadian report in an application, it must have been completed by Environment and Climate Change Canada (ECCC) / Health Canada (HC). We do not accept other Canadian reports.
The Canadian notifier must authorise ECCC to share the reports about your chemical with us.
- The Canadian notifier must fill in the relevant sections of the authority to release assessment report to AICIS using their own letterhead.
- The Canadian notifier must send the completed letter to ECCC.
We recommend that you do this at least 60 calendar days before you submit your application to us.
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Step 2: Is the chemical prohibited overseas?
If the overseas report — or any other information from the overseas jurisdiction where the chemical was assessed — states that the chemical cannot be used or is prohibited, then you do not meet our criteria for an introduction that has been internationally assessed for human health.
If your chemical isn’t prohibited overseas, continue to Step 3 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
Step 3: Is there new human health hazard information about the chemical that was not available when it was assessed overseas?
If you have direct access to the complete overseas report, compare the hazard information available to you with the hazard studies described in the overseas report.
If you don’t have direct access to the complete overseas report, check the information submitted to the overseas body. This is the information that the overseas body based their assessment on.
If no new human health hazard information about the chemical has become available following the publication of the overseas report, continue to Step 4 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
If new hazard information about the chemical has become available following the publication of the overseas report, you must consider the following implications:
- If the new information shows that the chemical has a hazard to human health and it was not mentioned in the overseas report – you do not meet our criteria for an introduction that has been internationally assessed for human health.
- If the new information shows that the chemical has a hazard to human health that is more severe than the hazard characteristic described in the overseas report – you do not meet our criteria for an introduction that has been internationally assessed for human health.
- If the information shows that the chemical has a hazard to human health that is less severe, or of the same severity, as the hazard characteristic described in the overseas report – continue to Step 4 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
Example
An overseas assessment completed in 2011 shows that your chemical has the hazard characteristic ‘acute toxicity (harmful)’, based on an acute oral toxicity study. You also have an acute oral toxicity study that was not available in 2011. This study indicates that the chemical has the hazard characteristic ‘acute toxicity (fatal or toxic)’. This means that the severity of the acute oral toxicity hazard is higher than that published in the 2011 assessment – and you do not meet our criteria for an introduction that has been internationally assessed for human health.
Step 4: Is the end use of your chemical in Australia the same as its end use overseas?
Your chemical’s end use in Australia must be the same as the end use overseas. Otherwise, you will not meet our criteria for an introduction that has been internationally assessed for human health.
The end use overseas is the end use that the trusted overseas body assessed and described in the overseas report.
What do we mean by the ‘same end use’?
Most industrial chemical introductions into Australia will have at least one of the following end uses. See Part 2.1.2 of the Categorisation Guidelines for a definition of these end uses.
- adhesive and sealant products
- apparel and footwear care products
- arts, crafts and hobby products
- explosive products
- fuel, oil, fuel oil additives and related products
- lubricant and grease products
- personal care products - limited environmental release
- tattoo ink products
- paint and coating products
- plastic and polymer products
- construction products not covered by other end uses listed here
- fabric, textile and leather products not covered by other end uses listed here
- electronic products
- ink, toner and colourant products
- air care products
- anti-freeze and de-icing products
- automotive care products
- cleaning and furniture care products
- laundry and dishwashing products
- extractive products not covered by other end uses listed here
- paper products
- personal care products not covered by other end uses listed here
- photographic products
- water treatment products
For your chemical to have the ’same end use’, your end use in Australia and your end use overseas must both fit within the same entry from the above list.
If your chemical’s end use in Australia is the same as the end use described in the overseas report, continue to Step 5 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
If your chemical’s end use in Australia is different to the end use described in the overseas report, you do not meet our criteria for an introduction that has been internationally assessed for human health.
If you have direct access to the complete overseas report, check the above list to work out the correct end use description for your introduction.
If you do not have direct access to the complete overseas report, check the information that was submitted to the overseas body. This is the information that the overseas body based their assessment on.
Example
| End use in Australia | Hair care products |
| End use definition for the Australian end use | Personal care products not covered by other end uses |
| End use assessed overseas | Make-up products |
| End use definition for the overseas end use | Personal care products not covered by other end uses |
| Could you meet our criteria for an introduction that has been internationally assessed for human health? | Yes – the definition for the overseas end use and the Australian end use are the same |
Example
| End use in Australia | Cleaning products |
| End use definition for the Australian end use | Cleaning and furniture care products |
| End use assessed overseas | Lubricant |
| End use definition for the overseas end use | Lubricant and grease product |
| Could you meet our criteria for an introduction that has been internationally assessed for human health? | No – the definition for the overseas end use and the Australian end use are different |
Step 5: Is the end use concentration of your chemical in Australia the same or lower than overseas?
To meet our criteria for an introduction that has been internationally assessed for human health, the maximum end use concentration of the chemical in Australia must be the same or lower than the maximum concentration of the chemical during its end use overseas.
The maximum concentration of the chemical during its end use overseas is the maximum end use concentration that the accepted overseas jurisdiction assessed.
The maximum end use concentration in Australia could be:
- the upper limit of the end use concentration range
- the maximum concentration that you intend for the chemical to be present at end use in Australia
If the maximum end use concentration overseas is above the maximum end use concentration for your introduction into Australia, continue to Step 6 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
If the maximum end use concentration overseas is below the maximum end use concentration for your introduction into Australia, you do not meet criteria for an introduction that has been internationally assessed for human health.
If you have direct access to the complete overseas report, compare the maximum end use concentration for the chemical in the report with your proposed end use concentration in Australia.
If you do not have direct access to the complete overseas report, check the information that was submitted to the overseas body. This is the information that the overseas body based their assessment on.
Example
| Maximum end use concentration in Australia | Maximum end use concentration overseas | Criterion met? |
| 10% | 25% | Yes |
| 10% | 5% | No |
| 10% | 50% | Yes |
| range 10% – 25% | 10 – 20% (as stated in the overseas report) | No |
Step 6: Is the human health risk of your introduction in Australia the same or lower than overseas?
To meet our criteria for an introduction that has been internationally assessed for human health, the risks to human health from the introduction and use of your chemical in Australia must be no higher than the risks identified in the overseas report.
To work this out, you must look at each of the following parameters for your introduction in Australia and compare them with overseas:
- Step 6.1: Mode of introduction
- Step 6.2: Introduction concentration
- Step 6.3: Use of the chemical
- Step 6.4: Use concentration
- Step 6.5: Routes of human exposure
If your chemical is known to not have any human health hazards, any differences in these parameters are unlikely to increase the risk to human health in Australia.
If your chemical does have hazards to human health, you need to consider how the differences between these parameters increases human exposure to the chemical, and whether that increases the risk to human health in Australia.
If your chemical is a polymer, you also need to consider if there are any differences between the polymer that was assessed overseas and the polymer that you will be introducing into Australia.
These differences could include molecular weight details such as:
- number average molecular weight
- weight average molecular weight
- polydispersity index
- the percentage (by mass) of molecules with a molecular weight that is less than 1000g/mol
- the percentage (by mass) of molecules with a molecular weight that is less than 500g/mol
If there are differences in any of these parameters, consider if this increases the hazard of the polymer and whether that increases the risk to human health in Australia.
What happens if there are no differences in any of the parameters in Australia compared with overseas?
If there are no differences in any of the parameters, continue to Step 7 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
What happens if there are differences in some of the parameters in Australia compared with overseas?
If this is the case for any parameter, you need to consider if a difference you have identified will increase the risk to human health in Australia
You may also need to take into account of all of the parameters as a whole to conclude whether there’s an increased risk to human health.
If you conclude that any differences between these parameters mean the introduction’s human health risk is no higher in Australia than overseas, continue to Step 7 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
If you conclude that any differences between these parameters mean the introduction’s human health risk is higher in Australia than overseas, you do not meet our criteria for an introduction that has been internationally assessed for human health.
If you do not have direct access to the complete overseas report or the overseas report doesn’t discuss these parameters, you should consider whether this information is available elsewhere. For example, it could be:
- information that was submitted to the overseas body
- information that’s available to you through your contact with the overseas applicant
Step 6.1: Mode of introduction
Compare the chemical’s ‘mode of introduction’ (whether it is imported or manufactured) into Australia with the mode of introduction overseas.
Example
| Mode of introduction into Australia | Mode of introduction overseas | Criterion met? |
| Import | Import | Yes |
| Manufacture | Manufacture | Yes |
| Import | Manufacture | Yes |
| Manufacture | Import | Dependent on other factors |
Step 6.2: Introduction concentration
Compare the concentration of the chemical when introduced in Australia with its concentration when introduced overseas.
If the introduction concentrations are different, consider whether any increased concentration in Australia will lead to an equivalent increase in human exposure. This will depend on how the chemical is handled.
You may also need to consider whether any increased concentration will require additional processing steps in Australia - if yes, then you’ll need to consider any differences in the chemical’s use.
Step 6.3: Use of the chemical
Compare the chemical’s use in Australia with its use overseas.
Note that ‘use’ is different to ‘end use’. The term ‘use’ covers the life cycle of the chemical and includes activities such as processing, formulating, storing, transporting, handling and mixing.
Consider whether any of these processes or activities will be different in Australia — if yes, you’ll need to consider whether this leads to any increase in exposure to humans, or changes the way humans are exposed.
Step 6.4: Use concentration
Compare the concentration of the chemical when used in Australia with the concentration when used overseas — including the concentrations along the life cycle of the chemical and during any formulation activities.
If there are any differences, consider whether any increased concentration leads to an equivalent increase in human exposure.
Step 6.5: Routes of human exposure
Compare the routes of any expected human exposure to the chemical during introduction, use and end use in Australia with the routes of human exposure expected to occur during these processes overseas.
For example, whether human exposure is likely to occur via oral, dermal or inhalation routes, and any expected exposure through the environment.
If there are differences in the routes of exposure
For example, due to differences in the way the chemical is used, or differences in the specific end uses, then consider whether this has any impact on the risks to human health — including any particular hazards that are more likely to occur due to the different exposure route.
Example
| End use in Australia | Method of end use in Australia and route of human exposure | End use overseas | Method of end use overseas and route of human exposure | Criterion met? |
| Paints | Brush — mainly dermal exposure | Paints | Aerosol spray application — dermal and inhalation exposure | Yes — level of exposure to humans in Australia expected to be lower because of the methods of application |
| Paints | Aerosol spray application — dermal and inhalation exposure |
Paints | Brush and roller — mainly dermal exposure | Consider the level of human exposure and inhalation toxicity of the chemical |
Comparison example for consideration of the parameters in Step 6
| Australia | Canada | |
| Mode of introduction | Imported | Imported |
| End use | Paints and coatings | Paints and coatings |
| Method of end use / type and extent of exposure | Brush and roller application / Consumers | Brush and roller application / Consumers |
| Introduction volume | 1000kg - 1500kg per year | 2000kg per year |
| Concentration when introduced | 80% | 30% |
| Concentration in end-use products | 30% | 30% |
Human health risk considerations for this example:
- same end use and end use concentration
- same route of exposure during end use
- higher introduction concentration in Australia compared with Canada
- different use and higher use concentration of the chemical in Australia compared with Canada (due to the formulation processes occurring in Australia)
- possible different routes of human exposure during use (due to formulation processes)
If the chemical does not have any known human health hazards, continue to step 7 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.
If the chemical does have hazards to human health, consider the expected level and routes of human exposure during each step of the formulation process — and whether any differences will impact the risks to human health.
If your introduction’s human health risks are no higher in Australia than overseas, continue to step 7 to work out you meet our criteria for an introduction that has been internationally assessed for human health.
If your introduction’s human health risks are higher in Australia than overseas, you do not meet our criteria for an introduction that has been internationally assessed for human health.
Step 7: Can you comply with any conditions or restrictions placed on the chemical overseas?
The overseas assessment of the chemical might include conditions or restrictions on how it can be used so that any risks to human health are properly managed. If so, you must be able to follow these conditions or restrictions in Australia.
If there are no conditions or restrictions in the overseas assessment, you meet our criteria for an introduction that has been internationally assessed for human health.
If the overseas assessment includes conditions or restrictions, and you can comply with the conditions or restrictions, you meet our criteria for an introduction that has been internationally assessed for human health.
If the overseas assessment includes conditions or restrictions, but you are unable to comply with the conditions or restrictions, you do not meet our criteria for an introduction that has been internationally assessed for human health.
Example
| Conditions or restrictions overseas | Use/end use in Australia | Criterion met? |
| REACH restriction (according to Annex XVII of REACH Regulation) – shall not be placed on the market, or used, as substances or in mixtures in concentrations greater than 0.1% by weight | The chemical will be present in end use products at 0.05% concentration | Yes |
| SCCS condition – the SCCS considers the chemical safe when used in oxidative hair colouring products up to a maximum on-head concentration of 2% | The chemical will have end use in oxidative hair colouring products up to a maximum on-head concentration of 2% | Yes |
| SCCS condition – the use of the chemical as a preservative with a maximum concentration of 0.5% in rinse-off cosmetic products is considered safe | The end use of the chemical is as a preservative in rinse-off cosmetic products at a maximum concentration of 0.5% | Yes |
| Canadian Significant New Activity (SNAc) provision – any activity other than using it for the dyeing of polyester and modified polyester using batch dyeing techniques | The end use of the chemical is only for dyeing polyester or modified polyester and only uses batch dyeing techniques | Yes |
| Canadian Significant New Activity (SNAc) provision – a significant new activity is any activity involving the substance, in any quantity, other than for use in personal care products that are not applied as a spray or aerosol | The end use of the chemical is only for leave on cosmetics that are not applied by spray | Yes |
| Canadian Significant New Activity (SNAc) provision – any activity involving the use of the substance in a consumer product at a concentration of the substance in the product equal to or greater than 20% | The end use of the chemical is only in consumer products at concentrations of 15% | Yes |
Internationally assessed for the environment only
This section relates to introductions that are internationally assessed for the environment only. These must meet all of the criteria described in each step to be considered a 'low risk' introduction under AICIS.
If you have not followed our main Categorisation Guide, do not go any further until you do so.
If a trusted overseas body has assessed your introduction for the environment and it meets all the other criteria in this guide related to the environment, its indicative risk to the environment is low.
Your introduction must meet all of the criteria described in each step of this section.
You can also use our decision tool to work out if your introduction is low risk for the environment.
Step 1: Is there an overseas assessment of your chemical?
If an overseas body has assessed your chemical, consider the following aspects of the assessment.
Step 1.1: Did a trusted overseas body perform the assessment?
A trusted overseas body listed in section 6 of the General Rules must have assessed or evaluated your introduction for its risks to the environment, and published a report of the assessment or evaluation that describes the outcomes.
The trusted bodies are:
- Opinions from the European Chemicals Agency (ECHA) Committee for Risk Assessment and the ECHA Committee for Socio-Economic Analysis. We’ll accept these opinions as long as they’ve formed the basis for the European Commission’s (EC) decision to include or update a restriction in Annex XVII of the REACH regulation (REACH restrictions). We do not accept REACH registration dossiers.
- European risk assessments that have formed the basis for the European Commission (EC) approving active biocidal substances. ECHA or an authority of a member state of the European Union must have conducted these risk assessments, and the ECHA Biocidal Products Committee must have reviewed the risk assessment.
- Risk assessments from Environment and Climate Change Canada. We'll accept risk assessments that used Schedule 5, 6, 9, 10 or 11 from the current Canadian regulations (31 October 2005 onwards). We'll also accept risk assessments that used Schedule II, III, VI, VII or VIII from the old Canadian regulations (before 31 October 2005).
- International parallel process assessments where Australia was involved as a secondary jurisdiction; and Environment and Climate Change Canada OR the United States Environmental Protection Agency (US EPA) performed the risk assessment.
You may know that there is a report of the assessment or evaluation because:
- it is publicly available on the website of the trusted overseas body
- an alternative source is available, for example, you know that your overseas parent company has had the chemical assessed in Canada
If one of the trusted overseas bodies assessed or evaluated your chemical and completed a report for it, continue to Step 1.2 to work out if you meet our criteria for an introduction that has been internationally assessed for the environment.
If one of the trusted overseas bodies has not assessed or evaluated your chemical, or there is no report for it, you do not meet our criteria for an introduction that has been internationally assessed for the environment.
Step 1.2: Can I use the overseas assessment report?
The following factors determine whether you can use an overseas report.
1. The complete report must be available.
It’s important to note that:
- you must provide the complete report, not just a summary of it
- you must have permission to use the report and any information it contains for the purpose of introducing your chemical into Australia
- if the overseas report is publicly available and your company was not the applicant for the overseas assessment, you must ensure you have the applicant’s permission to use the assessment report
2. You must give us the report, if we ask for it.
This could mean:
- you give it to us directly, or tell us where we can find it (for example, if it’s publicly available on a website) or
- arrangements can be made for another party to give us the report
If the overseas report is available and you can provide it for these purposes, continue to Step 2 to work out if you meet our criteria for an introduction that has been internationally assessed for the environment.
If the overseas report is not available or you can’t provide it for these purposes, you do not meet our criteria for an introduction that has been internationally assessed for the environment.
If you are using a Canadian report
If you want to use a Canadian report in an application, it must have been completed by Environment and Climate Change Canada (ECCC) / Health Canada (HC). We do not accept other Canadian reports.
The Canadian notifier must authorise ECCC to share the reports about your chemical with us.
- The Canadian notifier must fill in the relevant sections of the authority to release assessment report to AICIS using their own letterhead.
- The Canadian notifier must send the completed letter to ECCC.
We recommend that you do this at least 60 calendar days before you submit your application to us.
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Step 2: Is the chemical prohibited overseas?
If the overseas report — or any other information from the overseas jurisdiction where the chemical was assessed — states that the chemical cannot be used overseas or is prohibited, then you do not meet our criteria for an introduction that has been internationally assessed for the environment.
If your chemical isn’t prohibited overseas, continue to Step 3 to work out if you meet our criteria for an introduction that has been internationally assessed for the environment.
Step 3: Is there new environment hazard information about the chemical that was not available when it was assessed overseas?
If you have direct access to the complete overseas report, compare the new hazard information available to you with the hazard studies described in the overseas report.
If you don’t have direct access to the complete overseas report, check the information that was submitted to the overseas body. This is the information that the overseas body based their assessment on.
If no new environment hazard information about the chemical has become available following the publication of the overseas report, continue to Step 4 to work out if you meet our criteria for an introduction that has been internationally assessed for the environment.
If new hazard information about the chemical has become available following the publication of the overseas report, you must consider the following implications:
- If the new information shows that the chemical has a hazard to the environment and it was not mentioned in the overseas report — you do not meet our criteria for an introduction that has been internationally assessed for the environment.
- If the new information shows that the chemical has a hazard to the environment that is more severe than the hazard characteristic described in the overseas report — you do not meet our criteria for an introduction that has been internationally assessed for the environment.
- If the information shows that the chemical has a hazard to the environment that is less severe, or of the same severity, as the hazard characteristic described in the overseas report — continue to Step 4 to work out if you meet our criteria for an introduction that has been internationally assessed for the environment.
Example
An overseas assessment completed in 2008 shows that the chemical has the hazard characteristic ‘harmful to aquatic life’, based on an acute aquatic toxicity study in fish. You also have an acute aquatic toxicity study in fish that was not available in 2008. This study indicates that the chemical has the hazard characteristic ‘toxic to aquatic life’. This means that the severity of the acute aquatic toxicity hazard is higher than that published in the 2008 assessment — and you do not meet our criteria for an introduction that has been internationally assessed for the environment.
Step 4: Is the end use of your chemical in Australia the same as its end use overseas?
Note: If you meet our equivalent criterion for an introduction that has been internationally assessed for human health, then you will also meet it for an introduction that has been internationally assessed for the environment.
Your chemical’s end use in Australia must be the same as the end use overseas. Otherwise, you will not meet our criteria for an introduction that has been internationally assessed for the environment.
The end use overseas is the end use that the trusted overseas body assessed and described in the overseas report.
What do we mean by the ‘same end use’?
Most industrial chemical introductions into Australia will meet at least one of the following end uses. See Part 2.1.2 of the Categorisation Guidelines for a definition of these end uses.
- adhesive and sealant products
- apparel and footwear care products
- arts, crafts and hobby products
- explosive products
- fuel, oil, fuel oil additives and related products
- lubricant and grease products
- personal care products - limited environmental release
- tattoo ink products
- paint and coating products
- plastic and polymer products
- construction products not covered by other end uses listed here
- fabric, textile and leather products not covered by other end uses listed here
- electronic products
- ink, toner and colourant products
- air care products
- anti-freeze and de-icing products
- automotive care products
- cleaning and furniture care products
- laundry and dishwashing products
- extractive products not covered by other end uses listed here
- paper products
- personal care products not covered by other end uses listed here
- photographic products
- water treatment products
For your chemical to have the ’same end use’, your end use in Australia and your end use overseas must both fit within the same entry from the above list.
If your chemical’s end use in Australia is the same as the end use described in the overseas report, continue to Step 5 to work out if you meet our criteria for an introduction that has been internationally assessed for the environment.
If your chemical’s end use in Australia is different to the end use described in the overseas report, you do not meet our criteria for an introduction that has been internationally assessed for the environment.
If you have direct access to the complete overseas report, check the above list to work out the correct end use description for your introduction.
If you do not have direct access to the complete overseas report, check the information that was submitted to the overseas body. This is the information that the overseas body based their assessment on.
Example
| End use in Australia | Hair care products |
| End use definition for the Australian end use | Personal care products not covered by other end uses |
| End use assessed overseas | Make-up products |
| End use definition for the overseas end use | Personal care products not covered by other end uses |
| Could you meet our criteria for an introduction that has been internationally assessed for the environment? | Yes – the definition for the overseas end use and the Australian end use are the same |
Example
| End use in Australia | Cleaning products |
| End use definition for the Australian end use | Cleaning and furniture care products |
| End use assessed overseas | Lubricant |
| End use definition for the overseas end use | Lubricant and grease product |
| Could you meet our criteria for an introduction that has been internationally assessed for the environment? | No – the definition for the overseas end use and the Australian end use are different |
Step 5: Is the introduction volume of the chemical into Australia the same or lower than overseas?
To meet our criteria for an introduction that has been internationally assessed for the environment, the maximum volume of the chemical to be introduced into Australia each year must be the same or lower than the maximum volume introduced overseas.
The maximum volume introduced overseas is the maximum volume that the accepted overseas jurisdiction assessed.
The maximum introduction volume in Australia could be:
- the upper limit of the volume range for your introduction into Australia
- the maximum volume that you intend to introduce into Australia
If the maximum volume introduced overseas is above the maximum volume for your introduction into Australia, continue to Step 6 to work out if you meet our criteria for an introduction that has been internationally assessed for the environment.
If the maximum volume introduced overseas is below the volume for your introduction into Australia, you do not our criteria for an introduction that has been internationally assessed for the environment.
If you have direct access to the complete overseas report, compare the maximum introduction volume for the chemical in the report with your proposed introduction volume in Australia.
If you don’t have direct access to the complete overseas report, check the information that was submitted to the overseas body. This is the information that the overseas body based their assessment on.
Example
| Maximum introduction volume in Australia (kg) | Maximum introduction volume overseas (kg) | Criterion met? |
| 100 | 250 | Yes |
| 10,000 | 5000 | No |
| 250 | 500 | Yes |
| range 100 – 300 | 100 – 200 (as stated in the overseas report) | No |
| range 100 – 300 | 100 – 1000 (as stated in the overseas report) | Yes |
Step 6: Is the environment risk of your introduction in Australia no higher than overseas?
To meet our criteria for an introduction that has been internationally assessed for the environment, the introduction and use of your chemical in Australia must not pose a greater risk to the environment than the risks identified in the overseas report.
To work this out, you must look at each of the following parameters for your introduction in Australia and risk assessment assumptions that would be used in Australia and compare them with the same parameters and risk assessment assumptions used to assess the risk in the overseas report:
If you don’t have access to the complete overseas report or the overseas report doesn’t discuss these parameters and risk assessment assumptions, consider whether this information is available elsewhere. For example, it could be:
- information that was submitted to the overseas body
- documents outlining risk assessment procedures used by overseas body
- information that’s available to you through your contact with the overseas applicant
If your chemical is a polymer, you also need to consider if there are any differences between the polymer that was assessed overseas and the polymer that you will be introducing into Australia.
These differences could include molecular weight details such as:
- number average molecular weight
- weight average molecular weight
- polydispersity index
- the percentage (by mass) of molecules with a molecular weight that is less than 1000g/mol
- the percentage (by mass) of molecules with a molecular weight that is less than 500g/mol
If there are differences in any of these parameters, consider if this increases the hazard of the polymer and whether that increases the risk to the environment in Australia.
What happens if there are no differences in any of the parameters or risk assessment assumptions in Australia compared with overseas?
If there are no differences in any of the parameters or risk assessment assumptions, continue to Step 7 to work out if you meet our criteria for an introduction that has been internationally assessed for the environment.
What happens if there are differences in some of the parameters and risk assessment assumptions in Australia compared with overseas?
If this is the case for any parameter or risk assessment assumption, refer to the instructions in the relevant sections below.
If you conclude that any differences between these parameters and risk assessment assumptions mean the introduction’s environment risk is no higher in Australia than overseas, continue to Step 7 to work out if you meet the criteria for an introduction that has been internationally assessed for the environment.
If you conclude that any differences between these parameters and risk assessment assumptions mean the introduction’s environment risk is higher in Australia than overseas, you do not meet our criteria for an introduction that has been internationally assessed for the environment.
Step 6.1: Environmental hazard parameters
International jurisdictions may have different criteria for chemical hazard characteristics in terms of persistence (P), bioaccumulation (B), and toxicity (T).
The assessment outcome for each of these 3 hazard characteristics in the overseas assessment should be higher or equal compared with the outcome under our Australian criteria.
For example, if your chemical is considered not persistent (not P) in the overseas assessment, but it is persistent (P) according to Australian criteria, then the indicative hazard of the chemical is higher in Australia.
If the overseas assessment uses the same P, B and T criteria as those used in Australia, continue to Step 6.2 to work out if you meet our criteria for an introduction that has been internationally assessed for the environment.
If the overseas assessment uses different P, B or T criteria to those used in Australia, you must use the Australian criteria to determine your chemical’s outcome for each criterion that is different.
If the outcome for each of the P, B and T hazard characteristics according to the Australian criteria is the same as in the overseas assessment, continue to Step 6.2 to work out if you meet our criteria for an introduction that is internationally assessed for the environment.
If the outcome for any of the P or B or T hazard characteristics according to the Australian criteria are different compared with the overseas assessment, consider if the difference increases the indicative hazard of the chemical.
If any of the P, B or T hazard characteristics are different according to the Australian criteria — and this increases the indicative hazard of your chemical — you do not meet our criteria for an introduction that has been internationally assessed for the environment.
If any of the P, B or T hazard characteristics are different according to the Australian criteria in a way that does not increase the indicative hazard of your chemical, continue to Step 6.2 to work out if you meet our criteria for an introduction that has been internationally assessed for the environment.
Note: Some jurisdictions use the descriptors ‘very persistent’ (vP) and ‘very bioaccumulative’ (vB). Consider these equivalent to persistent (P) and bioaccumulative (B) when comparing them with the Australian PBT criteria.
Step 6.2: Environmental exposure parameters
A chemical’s routes of exposure to the environment play a large role in assessing its overall risk. The higher the exposure of a chemical to the environment, the higher the indicative risk. You must consider each of the following exposure parameters when making this determination:
- Step 6.2.1: Mode of introduction
- Step 6.2.2: Use of the chemical
- Step 6.2.3: Release reduction factors
- Step 6.2.4: Efficiency of the removal of chemicals through sewage treatment plants
- Step 6.2.5: Receiving water dilution factors
If there are differences in any of these parameters in Australia compared with overseas, consider how these differences change the exposure of the chemical to the environment — and whether that increases the risk to the environment in Australia.
If the differences in these parameters mean that the environmental exposure of your chemical is higher in Australia than overseas, you do not meet our criteria for an introduction that has been internationally assessed for the environment.
If there are no differences in any of the parameters — or the differences in these parameters mean that the environmental exposure of your chemical in Australia is the same as, or lower than, overseas — continue to Step 7 to work out if you meet the criteria for an introduction that has been internationally assessed for the environment.
Step 6.2.1: Mode of introduction
Compare the chemical’s ‘mode of introduction’ (whether it is imported or manufactured) into Australia with the mode of introduction overseas.
Manufacturing a chemical in Australia carries a higher risk than importing it because the chemical may be released to the environment through various manufacturing processes.
If the mode of introduction into Australia is different than overseas (for example, it’s manufactured in Australia but imported overseas), consider if this difference changes the exposure of the chemical to the Australian environment.
Example
| Mode of introduction into Australia | Mode of introduction overseas | Criterion met? |
| Import | Import | Yes |
| Manufacture | Manufacture | Yes |
| Import | Manufacture | Yes |
| Manufacture | Import | Consider if this changes the exposure of the chemical to the environment. |
Step 6.2.2: Use of the chemical
Compare the chemical’s use throughout its lifecycle in Australia with its use lifecycle overseas. Note that ‘use’ is different to ‘end use’. The term ‘use’ covers the life cycle of the chemical and includes activities such as processing, formulating, storing, transporting, handling, and disposal.
Consider the chemical’s uses overseas — including formulating, storing, transporting, handling and disposal — and work out whether these are different to the uses you expect in Australia. For example:
- the overseas report mentions uses that are different to how you expect to use the chemical in Australia
- the disposal of the chemical overseas is different to the disposal in Australia. For example, incineration is a common disposal method in Europe but is rarely used in Australia.
If the chemical’s use throughout its lifecycle in Australia is likely to be different to the lifecycle covered in the overseas assessment, consider if this difference changes the exposure of the chemical to the Australian environment.
Step 6.2.3: Release reduction factors
The end use of a chemical influences its level of exposure to the environment. End use-specific release reduction factors are used to estimate the release volume of that chemical to the environment due to that end use. We list the end uses and their corresponding estimated release reduction factors in the categorisation guidelines. International jurisdictions may use different release reduction factors for specific end uses.
If the overseas assessment has used a release reduction factor (however named) that is different to the release reduction factor for the equivalent end use in Australia, consider if this changes the assumed exposure of the chemical to the Australian environment.
If the Australian release reduction factor is higher than the release reduction factor used overseas, this indicates that the overseas assessment is based on a lower level of exposure to the environment than the level of exposure estimated for the end use in Australia.
Example
Europe considers chemicals used in inks as ‘use at industrial site leading to inclusion into/onto article’ with a release factor of 0.5. In Australia, the use category is ‘ink, toner and colourant products’ and the estimated release factor is 0.8.
| End use and release reduction factor in Australia | End use release and reduction factor overseas | Criterion met? |
| 0.8 — ‘Ink, toner and colourant products’ | 0.5 — ‘Use at industrial site leading to inclusion into/onto article’ | No — the end uses are equivalent, but the release reduction factor is lower in the overseas jurisdiction |
Step 6.2.4: Efficiency of the removal of chemicals through sewage treatment plants
There are several factors that affect the removal efficiency of sewage treatment plants (STP). It’s important to consider these factors when modelling chemical emissions.
If the overseas risk assessment modelled the chemical’s removal from wastewater by processes in the STP, you will need to work out whether the model applied factors that are appropriate for Australian conditions.
Consider these factors when determining if the removal efficiency of the STP in the overseas assessment is comparable with Australia:
- Assumed country population size — some assessments use the number of people to estimate per capita release of the chemical and per capita water use for dilution of the chemical in the sewer.
- STP architecture assumptions — tertiary treatment plants have a higher removal efficiency than secondary treatment plants.
- Amount of suspended solids in effluent — lipophilic chemicals tend to adsorb to suspended solids in the effluent, resulting in the release of greater amounts of lipophilic contaminants. Australian STP effluent typically contains higher suspended solid concentrations than those in Europe and Canada.
If the overseas assessment modelled the chemical’s emission from STP using different factors to those used in Australia, consider if the differences change the exposure of the chemical to the Australian environment.
Step 6.2.5: Receiving water dilution factors
Assessments from international jurisdictions that have calculated a chemical’s predicted environmental concentration (PEC) based on the chemical’s concentration in STP effluent may use a dilution factor to account for the volume of the receiving water body. For example, in Canada it is typically assumed that sewage treatment plant effluent is diluted by a factor of between 1 and 10 (depending on the volume of the receiving waterway) in order to calculate the PEC.
Due to low rainfall in some parts of Australia, we assume that river flow may consist entirely of effluent release from STPs or other effluent sources. Therefore, our Australian chemical assessments assume that there is no dilution of STP effluent or other effluent sources when they are released to rivers and other surface waters in Australia; that is, the dilution factor used is 1.
If the overseas assessment has used a different dilution factor than the one used in Australia, consider if this difference changes the exposure of the chemical to the Australian environment.
Step 7: Can you comply with any conditions or restrictions placed on the chemical overseas?
The overseas assessment of the chemical might include conditions or restrictions on how it can be used so that any risks to the environment are reduced to an acceptable level. If so, you must be able to apply these conditions or restrictions in Australia.
Restrictions may be based on:
- a chemical’s intended use or end use
- chemical concentrations in certain types of products
If there are no conditions or restrictions in the overseas assessment, you meet our criteria for an introduction that has been internationally assessed for the environment.
If the overseas assessment includes conditions or restrictions, and you can comply with the conditions or restrictions, you meet our criteria for an introduction that has been internationally assessed for the environment.
If the overseas assessment includes conditions or restrictions, but you are unable to comply with the conditions or restrictions, you do not meet our criteria for an introduction that has been internationally assessed for the environment.
Internationally assessed for both human health and the environment
This section relates to chemicals that have been internationally assessed for human health and the environment.
If you have not followed our main Categorisation Guide, do not go any further until you do so.
For your introduction to meet the 'internationally assessed for human health' and 'internationally assessed for the environment' criteria, you must meet all of the criteria in the sections:
- internationally assessed for human health only; and
- internationally assessed for the environment only
Note: Your introduction can meet the 'internationally assessed for human health' and 'internationally assessed for environment' criteria by using:
- only one of the acceptable overseas assessments (because one assessment considered both human health and environment risks); or
- two separate acceptable overseas assessments
What information we may publish about your internationally assessed introduction?
If you're introducing a chemical in the reported category and your introduction is internationally assessed, you can apply for protection of the chemical's name and end use as confidential business information.
We consider internationally assessed reported introductions to potentially be of higher risk and therefore may decide to publish the following information on our website after you submit your pre-introduction report:
- chemical name
- end use
- name of international assessment body
If you do not want us to publish the chemical name and/or end use, you must apply to protect this information as confidential business information (CBI).
If we approve protection of your CBI, and if we decide we will publish information about the internationally-assessed introduction, we'll publish:
- an AICIS approved chemical name (AACN) instead of the chemical's proper name
- a generalised end use instead of a specific end use
- the name of the international assessment body
Note: you cannot apply for CBI protection of the international assessment body — if a decision is made to publish information about an internationally-assessed introduction - the name of the international assessment body will be published.
What do I need to do to introduce an internationally assessed chemical?
The following table summarises the information you must provide in your pre-introduction report.
We have separate guides to help you submit a PIR for each type of internationally-assessed introduction:
- internationally-assessed for both human health and the environment
- internationally-assessed for human health only
- internationally-assessed for the environment only
If you use the international pathway for human health or the environment only, you only need to submit the appropriate data items.
| Information requirement | Internationally assessed for human health and the environment | Internationally assessed for human health only | Internationally assessed for the environment only |
|---|---|---|---|
| Identity (few items) | ✓ | ✓ | ✓ |
| Sc 20 declaration | ✓ | ✓ | ✓ |
| Import or manufacture | ✓ | ✓ | ✓ |
| Introduction volume per year | ✓ | ✓ | |
| End use | ✓ | ✓ | ✓ (if not for research and development) |
| Maximum concentration at introduction and end use | ✓ | ✓ | ✓ |
| Known hazard classification | ✓ | ✓ | ✓ |
| International assessment body (health and/or environment) | ✓ | ✓ | ✓ |
| Parameters in international assessment (few items) | ✓ | ✓ | ✓ |
| Date (year) of international assessment | ✓ | ✓ | ✓ |
| Reference number and identity in international assessment | ✓ | ✓ | ✓ |
| Provide a declaration that the report of international assessment is available, at our request | ✓ | ✓ | ✓ |
| Conditions applied in international assessment, if any | ✓ | ✓ | ✓ |
| How you will meet those conditions in Australia | ✓ | ✓ | ✓ |
| Provide a declaration that the risk in Australia is no higher than the risk identified in the international assessment | ✓ (human health and environment) | ✓ (health) | ✓ (environment) |
| Provide a declaration regarding any hazard or increase in a hazard that was identified after the assessment | ✓ (human health and environment) | ✓ (health) | ✓ (environment) |
| Environment exposure band | ✓ | ||
| Whether there is designated release | ✓ | ||
| Environment categorisation volume (if not designated release) and how calculated | ✓ | ||
| Known environmental hazard characteristics | ✓ | ||
| Declaration regarding hazard information provision 31(a)(viii) | ✓ | ✓ | |
| Whether a specified class of introduction under 7(2) or 7(3) | ✓ | ||
| Human health exposure band, and criteria it is based on | ✓ | ||
| Polymer details (several) if high molecular weight and human health exposure band is 3 | ✓ | ||
| Known human health hazard characteristics | ✓ | ||
| If introduced under item 6 of Sc24 table, declaration that requirements have been met | ✓ | ||
| Whether a specified class of introduction under 7(3) or 7(4) | ✓ |
You will need to provide certain information in your pre-introduction report before you introduce a chemical using the international pathway.