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We've updated our guidance on NICNAS to AICIS transitional arrangements.

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.

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