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Animal test data - when it can and can’t be used and when you need pre-approval

There is a prohibition on using new animal test data for chemicals with an end use only in cosmetics and restrictions on using new animal test data for chemicals with multiple end uses in Australia, including an end use in cosmetics. There are exceptions to this - if you meet the criteria for these exceptions, you can use new animal test data without getting approval first.

Under our laws, new animal test data are any data obtained from tests conducted on a cephalopod or any live vertebrate animal (other than a human being) on or after 1 July 2020. For example, this includes data obtained from tests conducted on fish, but does not include data obtained from tests on daphnia. You can continue to use data obtained from tests conducted on animals prior to 1 July 2020.

Key points about using new animal test data 

  • We have set limited exception criteria about when you can use new animal test data for chemicals with an end use in cosmetics. 
  • Where your introduction
    • is only for use in cosmetics and you don't meet the exception criteria and you don't have alternative data to animal test data, you can't introduce the chemical
    • has multiple end uses (including in cosmetics) and you don't meet the exception criteria and you don't have alternative data to animal test data, you can ask for permission to use it because it has non-cosmetic uses.

Scroll down to check the exception criteria.

or...

if you have a multiple end use introduction and you need pre-approval 

When prohibitions and restrictions on animal test data don't apply

The following applies to both cosmetic only introductions and multi end use introductions.

There are limited circumstances in which these prohibitions or restrictions do not apply. This is necessary to continue to protect human health and the environment, and to align as far as possible with comparable international bans on animal test data. These circumstances are where the new animal test data you have:

  • shows that your chemical has a hazard characteristic and this conflicts with your non-animal test data 
  • is the only information that can demonstrate whether or not your chemical has a particular environment hazard characteristic
  • is from tests conducted on a different industrial chemical to the one you are categorising or submitting an application for, and you are not introducing that different chemical for an end use in cosmetics.

We explain the specifics of these exceptions below.

What you must do if your introduction is for an end use in cosmetics

We DO NOT require you to have data to demonstrate the absence of hazard characteristics for many introductions, including listed introductions and some exempted and reported introductions – for example, PLCs and those that fall into lower human health and environment exposure bands.

We've outlined the circumstances where we do require information to demonstrate the absence of hazard characteristics to categorise your introduction in the Industrial Chemical Categorisation Guidelines. For each hazard characteristic we provide details of all acceptable alternatives that you can use instead of animal test data.


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For assessed introductions we do require you to have hazard information to support your assessment certificate application. The information we require, including the acceptable alternatives to animal test data that you can use in your application, are set out in the application form.

If you don't have alternatives to animal test data and if you don't meet our exception criteria you cannot introduce the chemical for an end use in cosmetics

Exception criteria 1-3 (cosmetic only and multi end use introductions)

You don't need to apply for pre-approval to use new animal test data, if you meet exception criteria 1-3.  This applies to both cosmetic only and multi end use introductions.

Exception 4 criteria is for multi end use introductions, not cosmetic only introductions. 

This exception applies if the animal test data that you have:

  • are from tests conducted on or after 1 July 2020, and
  • show that your chemical has a hazard characteristic.

When categorising your introduction, you can only have regard to the animal test data if doing so results in a higher risk introduction category determination.

Example: you have new animal test data indicating your chemical has the potential to cause skin sensitisation  

Without the data being considered, you work out that your introduction category is exempted.

When you have regard to the data, your category of introduction is reported.

You cannot ignore adverse data on human health and environmental effects where it would change the categorisation outcome to a higher risk category. You categorise your introduction as reported. You indicate in your pre-introduction report that you used new animal test data to categorise your introduction.

When applying for an assessment certificate, you can only submit the animal test data if the results conflict with other information in your application. The information requirements set out in the approved form must be met using other information (not the new animal test data).

Example: you have new animal test data indicating your chemical has the potential to cause skin sensitisation  

The new animal test data (from an LLNA test) that you have on your chemical conflict with other information in your application (an existing GPMT undertaken before 1 July 2020).

You cannot ignore adverse data on human health and environmental effects that conflict with other information in the application. You submit the new animal test data with your assessment certificate application.

This exception applies if the animal test data that you have:

  • are from tests conducted on or after 1 July 2020, and
  • are the only information that can demonstrate whether or not your chemical has a particular environment hazard characteristic.

This means that there must be no validated alternative tests that you can use to determine whether or not your chemical has a particular environment hazard characteristic.

Example: Computer modelling cannot be used to predict aquatic toxicity for your chemical

The chemical you are introducing is a UVCB and the computer modelling predictions are not accurate. 

There are no other validated alternative tests that you can use to predict the acute aquatic toxicity that is associated with your chemical. 

You have data from an animal test conducted after 1 July 2020 indicating that it is not harmful to fish.


You use the new animal test data to categorise your introduction.

If your chemical only has an end use in cosmetics, this exception applies if the animal test data that you have:

  • are from tests conducted on or after 1 July 2020, and
  • were conducted on a chemical that is not introduced by you for an end use only in cosmetics.

This allows for use of read across information, but the chemical that the tests were conducted on:

  • must not be introduced into Australia by you, or
  • is introduced into Australia by you, but it does not have an end use only in cosmetics.

Example: Your chemical will only have an end use in cosmetics

You have suitable read across information demonstrating your chemical doesn’t have the skin sensitisation hazard characteristic.

You have new animal test data on a suitable analogue chemical.

The analogue chemical is introduced by you, but it does not have an end use only in cosmetics (it is also used in household products).

You use the new animal test data to categorise your introduction.

If your chemical has multiple end uses (including cosmetics), this exception applies if the animal test data that you have: 

  • are from tests conducted on or after 1 July 2020, and
  • were conducted on a chemical that is not introduced by you for an end use in cosmetics 

This allows for use of read across information, but the chemical that the tests were conducted on: 

  • must not be introduced into Australia by you, or 
  • is introduced into Australia by you, but it does not have an end use in cosmetics. 

Note: if the chemical that the tests were conducted on does have an end use in cosmetics, then you can apply to use the data to work out your introduction category and in assessment certificate applications (see Exception 4 below for further information).
 

Example: Your chemical will have multiple end uses (including cosmetics)
 
You have suitable read across information demonstrating your chemical doesn’t have the skin sensitisation hazard characteristic.

You have new animal test data on a suitable analogue chemical.

The analogue chemical is introduced by you, but it does not have an end use in cosmetics.

You use the new animal test data to categorise your introduction.

 

Exception 4 criteria (multi end use introductions only)

This exception applies if we give you pre-approval to use new animal test data for chemicals with multiple end uses (including cosmetics).

For more information and to apply, go to the page relevant to your circumstances

Pre-approval to use new animal test data to work out your introduction category

or

Pre-approval to include new animal test in your assessment certificate application 

 

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