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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:

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.

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