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.

Guidance on this page must be read in conjunction with Step 5.2: Introductions that can be low risk for the environment in our main Categorisation Guide. Step 5.2 relates to internationally-assessed introductions for the environment.

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?

This section relates to chemicals that have been 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 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.
Note: The only REACH assessments that we will accept are opinions about REACH restrictions. We do not accept REACH registration dossiers.

 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

Note: If you want to use a Canadian assessment report, you must be able to authorise the release of the Canadian assessment reports about this chemical to us from Canada (Environment and Climate Change Canada). Contact us for more information on how to do this.

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.

Step 2: Is the chemical prohibited overseas?

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 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?

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 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?

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.

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
  • personal vaporiser 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?

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.

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?

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.

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: 

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?

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.

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.