Video — ban on animal test data: meeting your obligations
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Hello, this video will provide a general overview on the use of data obtained from animal tests when meeting your regulatory obligations under AICIS, the Australian Industrial Chemicals Introduction Scheme.
From 1 July 2020, the use of new animal test data will be restricted for introductions of chemicals that will have an end use in cosmetics. This includes:
- chemicals that will have an end use solely in cosmetics, and
- chemicals that will have multiple end uses (one of which is in cosmetics).
This video has been prepared to help introducers of chemicals with an end use in cosmetics, to understand what the restrictions are and how they will apply. Note that the restrictions do not apply to listed introductions.
In this video, I will:
- outline when you can use animal test data
- provide details of other information that you can use instead of animal test data, and
- outline how we will know if you're using new animal test data.
The first topic today, is “When you can use animal test data”.
Before I proceed, I want to clarify what we mean when we refer to “new animal test data”. New animal test data are any data that were obtained from tests conducted on animals on or after 1 July 2020. If your chemical will have an end use in cosmetics, even if it will also have other end uses, you cannot use new animal test data:
- to categorise your introduction or
- in an assessment certificate application,
unless an exception applies (and these exceptions apply in very limited circumstances). You can continue to use existing animal test data, and by that we mean animal test data that were obtained from tests conducted prior to 1 July 2020.
I would now like to provide details of the exceptions, which permit use of new animal test data. There are 4 exceptions and in the coming slides, I will go through each of these in more detail. The key message from this slide is that the first 3 exceptions, that is:
- exception 1: the data show a hazard
- exception 2: there is no alternative for environmental hazards, and
- exception 3: there is read across information from non-cosmetic chemicals
apply regardless of whether the chemical has an end use in cosmetics only or the chemical has multiple end uses, including in cosmetics. Exception 4, which is where pre-approval has been given to use new animal test data, only applies if your chemical has end uses in addition to cosmetics.
Exception 1 allows the use of new animal test data, if the results show that your chemical has a hazard characteristic.
For the purposes of categorisation, you can use the data if those data result in a higher risk introduction category determination. For example, imagine you have new animal test data indicating that your chemical has the potential to cause skin sensitisation. Without the data being considered, you work out that your introduction category is ‘exempted’; however, when you have regard to this information then your category of introduction is ‘reported’. This means you cannot ignore adverse data on human health and environment effects, where it would change the categorisation outcome to a higher risk category.
For the purposes of an application for an assessment certificate, you can use new animal test data showing your chemical has a hazard characteristic if the results conflict with other information in your application. Using the same example, as in the previous slide, you can use new animal test data showing that your chemical has the potential to cause skin sensitisation, if this information was not shown in other information in your application. Note that the information requirements that are set out in the approved form for certificate applications, must be met using other information (and not the new animal test data). This means you cannot ignore adverse data on human health and environmental effects, but it also creates no incentive for you to generate new animal test data to fulfill your regulatory requirements under AICIS.
Exception 2 allows the use of new animal test data, if it is the only information that can demonstrate whether or not your chemical has a particular environment hazard characteristic. In this case, there must be no validated alternative tests that you can use for that hazard characteristic. For example, computer modelling is a validated alternative for many chemicals to predict aquatic toxicity. However, it is not accurate for some chemicals, such as surfactants and UVCB's.
Exception 3 allows the use of new animal test data, if the test was conducted on another chemical that is not introduced by you for an end use in cosmetics. Essentially, it allows for use of read across information such as animal test data on an analogue chemical. For example, if you have access to suitable read across information demonstrating that your chemical doesn't have the skin sensitisation hazard characteristic, you can use this new animal test data if the chemical that was tested:
- is not introduced into Australia by you, or
- if it is introduced into Australia by you, it does not have an end use in cosmetics.
Exception 4 allows the use of new animal test data, if we have approved an application from you to use those data to work out your category of introduction or in an assessment certificate application. However, this exception only applies if your chemical will have multiple end uses, one of which is in cosmetics. It does not apply if your chemical will only have an end use in cosmetics. Later in the video, I will discuss this application further.
The second topic today is “Other information that you can use” instead of new animal test data.
There are a number of alternatives available to animal testing. These include:
- in vitro testing methods - which use reconstructed tissues, whole cells or parts of cells;
- in silico methods - which involve computer simulations of effects based on chemical structure and physical properties; and
- read across methods - where the effects for one chemical are predicted using data for the same effect from another chemical, which is considered to be similar in terms of chemical structure, physico-chemical properties or bioactivity.
Not all of these methods are available for use for every hazard characteristic.
Under AICIS, there is a reduced reliance on animal test data.
- We have graduated information requirements for categorization, so test data are not necessarily needed at lower exposures
- There are options for non-animal data provided where the validated alternatives exist
- We have information waivers where reasonable so that unnecessary testing is not conducted, and
- The requirements for categorisation and certificate applications are set out in the Categorisation Guidelines and approved forms. The benefit of this, is that changes require approval of the Executive Director only, which means we can quickly respond to the availability of new non-animal methods.
In this slide we show the alternate options to new animal test data that are available in the Categorisation Guidelines for each of these hazard characteristics. It is important to note that detailed information is not always required for these hazard characteristics. As previously indicated:
- the information requirements are graduated, so may not be needed at lower exposures, and
- information waivers may apply.
What this does show, is that there are some hazard characteristics where validated alternative options are readily available (such as skin irritation) and other hazard characteristics where the only alternative option is read across methods. In some cases, in silico methods can only be used in combination with other methods, such as in vitro methods, and these options may only be available for use at lower exposures.
If you do not have suitable alternate information available for you to use, and none of the 4 exceptions allowing use of new animal test data apply:
- you should check to see if you can introduce your chemical under a higher risk introduction category, which may require less hazard information. For example, you might have been hoping to use the exempted introduction category but instead you are able to introduce under the reported category;
- you should also check to see if you can introduce under a lower exposure scenario, such as lower volume or concentration. This may result in a lower exposure band and may require less hazard information for you to categorise your introduction.
If you can't do this, you can't introduce your chemical for an end use in cosmetics.
For example, imagine you wish to introduce 300kg of your chemical for use in cosmetics. The applicable human health exposure band is 4. You can't demonstrate that your chemical doesn't have the acute toxicity (fatal or toxic) hazard characteristic, which is in human health hazard band B, based on the information that you have available. You can’t use a new animal test (as no exception applies) and the non-animal testing options in the Categorisation Guidelines don't apply to your introduction. To enable you to introduce this chemical, you reduce the annual introduction quantity of the chemical to 100kg, which means that the applicable human health exposure band is now band 3. In this exposure band, you don’t need to demonstrate that your chemical doesn’t have the acute toxicity (fatal or toxic) hazard characteristic for the indicative human health risk to be low.
The final topic today is “How we’ll know if you're using new animal test data”.
The first way that we will know, is if you apply to use new animal test data. This is exception 4 that I spoke about earlier. Just to reiterate, if your chemical will have multiple end uses including an end use in cosmetics, you can apply to use new animal test data:
- to work out your introduction category and/or
- to include new animal test data in your assessment certificate application.
You can submit an application to use new animal test data in the AICIS Business Services. The timeframe for us to decide on your application is 10 working days (unless we need further information from you) and there is no fee to submit this application. In making a decision on your application, the Executive Director must have regard to whether the non-cosmetic end use involves exposure of humans or the environment to the chemical, where the use of animal test data is for the purpose of identifying a human health or environment hazard characteristic, respectively.
Where you are applying to use new animal test data in an assessment certificate application, you will need to get approval to use the animal test data before submitting your application for an assessment certificate.
The other way that we will know if you are using new animal test data, is because you need to tell us if you are using those data to work out the highest indicative risk. For exempted introductions, you'll do this in your declaration and for reported introductions, you need to do it in your pre-introduction report. Through our post-introduction monitoring program, we will be confirming compliance with the restrictions on use of animal test data. If we ask for it, you need to provide us with the information that you used to demonstrate the absence of hazard characteristics for exempted and reported introductions.
I hope that this video has helped you to understand what the restrictions on use of animal test data are and how they apply. Thank you for your attention. For further information including guidance materials and links to our legislation, please visit our website.