Video series on categorising your introduction
An overview of categorisation and step-by-step categorisation instructions.
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These videos are current to AICIS, but were prepared under our former scheme, NICNAS.
An overview of categorisation
Hello! This video will provide a general overview about the concept of categorisation and how it will work under the new regulatory framework for industrial chemicals. This, together with a number of other videos that will accompany it, aim to show you how to work out your introduction category. We are going to guide you through the process of categorisation.
There will be several videos on the topic of categorisation.
The first is this one, which is the overview. This will introduce the process used to work out your introduction category, which can be up to 6 steps.
The second video will provide further details about the initial steps in the categorisation process – steps 1, 2 and 3.
The third video will then give details about steps 4, 5 and 6. These are the steps that require you to work out your introduction category based on the highest indicative risk for your introduction. These steps are only needed if you couldn’t get to your introduction category from steps 1-3.
There will also be a number of videos that will work through some examples of introduction scenarios and the process you would go through to get to your introduction category, based on the information that’s available about your introduction. These videos with examples will be released soon.
Now to move onto the content of this particular presentation.
In our video presentation, called ‘NICNAS to AICIS’, we summarised the obligations of an introducer under the new scheme using this diagram. The requirement to categorise all of your chemical introductions relates to obligations 2 and 3: that you know what you’re introducing, are able to place all of your chemical introductions into the correct introduction category, and understand the categories that apply to you and their associated obligations.
So let’s take a look at the different chemical introduction categories. There are 5 main categories, each with its own criteria and regulatory obligations.
Listed introductions are where your chemical is on the Inventory, and your introduction and use are within any and all terms of the Inventory listing, including any conditions.
If your introduction is not Listed, then there are 4 Categories it could fall into. 3 of them are based on the indicative risk profile of your introduction, with associated obligations that are proportionate to that risk.
Very low risk introductions fall into the Exempted category, which requires a once-off post-introduction declaration.
Low risk introductions fall into the Reported category, which means you need to submit a Report before you start introducing.
Medium to high risk introductions fall into the Assessed category. These require risk assessment by us before you get a certificate authorising you to start introducing. This is also the only category that leads to your chemical introduction being listed on the Inventory.
There is also a separate category for introductions that are for the sole purpose of commercial evaluation. These are known as Commercial Evaluation Authorisations and they involve a pre-introduction risk assessment by us, in a shorter time frame, for a more limited authorisation to introduce.
Three of the introduction categories are distinguished from each other based on their level of risk. Risk is a function of the hazard of the chemical, which is the effect on humans or the environment; and the exposure to the chemical, that is, how much of it humans or the environment come into contact with it during introduction and use. This can mean that a hazardous chemical with minimal exposure during its use could have the same introduction category as another chemical with a lower level of hazard but a far greater level of exposure to humans or the environment. This is because they present a similar level of risk. This is also the reason why individual chemicals are not categorised, but the introduction of individual chemicals is categorised.
The risk for exempted introductions is very low; the risk for reported introductions is low; and the risk for assessed introductions is medium to high. The regulatory obligations for each introduction category vary with the level of risk of the category. Consider, for example, the level of information that an introducer needs to provide to us about their introduction and when they need to provide it. First, we have the very low risk exempted introduction category, that just requires a simple declaration to be made to AICIS and this only to occur after the chemical has been introduced into Australia. This is appropriate because of the very low risk of the introduction. By comparison, for the low risk reported introduction category, an introducer needs to provide us more information, and this has to be before the chemical is introduced into the country. Finally, for the medium to high risk assessed introduction category, detailed information needs to be provided to us so that we can do an assessment and issue a certificate before a chemical can be introduced. This is the appropriate treatment for an introduction that is of medium to high risk.
The scheme, under the ICNA Act, the Industrial Chemicals Notification and Assessment Act, had a lot of different options for introducing chemicals that were not listed on the Inventory. The options are summarised on this slide. I just wanted to highlight here that under the ICNA Act, many of the introduction options required an assessment to be done by us, and a permit or a certificate to be issued before you’re authorised to introduce your chemical. This involved time, which could cause delays in getting the chemicals onto the Australian market; and it also involved money. And this pre-introduction assessment had to be done even for introductions that are of low or very low risk. Bear in mind that this scheme was set up about 30 years ago and that there were good reasons why it was done like this at the time. Things have moved on since then though and we have learnt a lot.
So in contrast, the new scheme, under the Industrial Chemicals Act, is more risk proportionate. A smaller subset of introductions will need to be assessed by the regulator and paid for. And these are only the ones that are of medium to high risk, in the assessed category, or those that could be of medium to high risk in the commercial evaluation authorisation category.
Before I explain how to categorise your introduction, I’ll first mention the type of information that you might need to be able to do this. It’s important to note that it is not always necessary for the Australian introducer to know all of this information. If you don’t know all the information you will most likely need to contact your supplier to help you categorise. I should also note that this is the information needed for categorisation, and that different information may be needed if you apply for an assessment certificate.
The most important piece of information that you must know about your introduction is the chemical identity – you have to know what you’re introducing. Among other things, this will allow you to figure out if your introduction is on our Inventory or not, that is, if it’s a listed introduction.
There’s also some information that you might need to be able to categorise. In some cases you will need this information; in other cases, you won’t. Your annual introduction volume will be needed for things like working out your exposure band for human health and environment. You might need to know the concentration that your chemical is introduced at and the concentration that it’s present at during its end use to figure out your human health exposure band. You may need to know the end use of your chemical because this will help you to work out things like your exposure band for human health and the environment. Hazard information about your chemical might be needed to work out the hazard bands that apply to your chemical or do not apply to your chemical. If you already have hazard information available for your chemical, you should consider this when you categorise. You may need to know whether your chemical is a specified class of introduction because these classes have some different or additional requirements.
Then there’s information that it would be useful for you to have or to know about. It will be helpful for you to know if your chemical is a polymer and if it’s a high molecular weight polymer. This is because high molecular weight polymers will usually have less hazard information requirements than other chemicals. It will also be useful to know if your chemical has been assessed overseas because this could mean that there is a streamlined pathway to determine its introduction category and that the introduction category could be lower than it might have otherwise been.
The very first thing that you need to do to categorise your introduction is to check our Inventory to find out if it’s a listed introduction. Search for your chemical on the Inventory. If you don’t find it there, continue on with the steps that I’ll describe on the next slide. If you do find it there, you then need to check whether your introduction meets the terms and conditions that are on the Inventory, if there are any. If you meet the terms and conditions of the listing, it’s a listed introduction, and this is the end of your categorisation journey. If you don’t meet the terms and conditions of the Inventory listing, you might need to apply to vary the Inventory listing, or there could be other options available for you. There are more details about this in the video about the Inventory.
This slide gives a summary of the process you need to go through to get to your introduction category, assuming that you have already worked out that your introduction is not listed. There are up to 6 steps in this process, and the final outcome you will get to at the end is either exempted, reported or assessed. You could get to this outcome after just 1 or 2 steps, or you might need to go all the way to step 6 to get to your outcome. This depends on the details of your introduction.
For step 1, check if your introduction is one that cannot be exempted or reported. For example, chemicals that are listed on the Rotterdam Convention cannot be exempted or reported. If your introduction is one of the types covered by step 1, it could mean that your category is assessed. If it is not one of these, move on to step 2.
For step 2, check if your introduction is one that can automatically be in the exempted category. These are ones that are very low risk to human health and the environment, like a polymer of low concern. If it’s one of these, your introduction is in the exempted category and your categorisation journey ends here. If it’s not one of these, go to step 3.
In step 3, check if your introduction is one that can automatically be in the reported category. These are ones that are low risk to human health and the environment, like a low risk fragrance blend introduction. If it’s one of these, your introduction is in the reported category, and your categorisation is complete. If it’s not one of these, move on to step 4.
Step 4 has many smaller steps within it that lead you to work out the indicative human health risk of your introduction. This involves working out your human health exposure band, and considering the human health hazard characteristics of your chemical. At the end of step 4, you will have worked out whether the indicative human health risk of your introduction is medium to high, low or very low.
Next, move to step 5. This is where you work out the indicative environment risk of your introduction. Your work out your environment exposure band, and consider the hazards that your chemical has to the environment. You will then end up with the indicative environment risk of your introduction being medium to high, low or very low.
Finally, step 6 involves taking the outcomes from steps 4 and 5 and working out what this means for your overall introduction category. This is determined by the highest indicative risk for your introduction out of the human health risk that you determined and the environment risk that you determined. Your introduction will be in the exempted, reported or assessed category and your categorisation is complete.
Thank you for joining us for this overview of categorisation. Subsequent videos will go into more details on each of the steps involved in categorisation. You can also find further information on our website, including guidance material and links to our legislation.
Categorisation: Steps 1 to 3
Categorisation: steps 4-6