Video — Categorisation example: low concentration cosmetic ingredient, no available hazard information

Slide 1

Hello! This video works through an example of a common introduction scenario and how to determine its introduction category. The example is of a cosmetic ingredient that is imported into Australia at low concentrations and there is no hazard information available for it. This video complements the other videos on the topic of categorisation, and assumes that you are familiar with their content. The first video was called ‘Overview of Categorisation’, and gave an overview of the whole categorisation process. The second video was called ‘Step-by-Step Categorisation: Steps 1 – 3’, and worked through the initial categorisation steps: steps 1, 2 and 3. The third video was called ‘Step-by-Step Categorisation: Steps 4 – 6’ and worked through the final 3 steps of the categorisation process. This video shows you how the categorisation process works in practice.

Slide 2

Under the new scheme, AICIS, all chemical introductions must be categorised. The 5 main introduction categories are shown here. They are listed – for introductions of chemicals that are listed on the Inventory and whose introduction is within the terms of the Inventory listing. Exempted – for introductions that are very low risk. Reported – for introductions that are low risk. Assessed – for introductions that are medium to high risk. Commercial evaluation authorisations – to determine the commercial potential of a chemical (without retail exposure). The first categorisation video, which was called ‘Overview of Categorisation’, went into more detail about each of these categories. 

Slide 3

Once the listed category has been ruled out by checking our Inventory, the process of working out the introduction category is summarised by this slide. There are up to 6 steps in this process, and the final outcome at the end will be that the introduction is either exempted, reported or assessed. We could get to this outcome after just 1 or 2 steps, or we might need to go all the way to step 6 to get to the outcome. This depends on the details of the introduction. 

Slide 4

The example that we will run through in this video is where 300kg of a cosmetic ingredient is being imported in a registration year. The concentration when it’s imported and during its end use is 0.05%. There is no hazard information available on the chemical. And it’s not one of the types of introductions that are covered by steps 1, 2 or 3 of the step-by-step categorisation process. So here we will focus on how to work through steps 4, 5 and 6 of the categorisation process. 

Slide 5

Step 4 is where we work out the indicative human health risk. There are several different sub-steps within step 4. These need to be followed in the order they are described here to be able to get to the final step 4 outcome for the indicative human health risk of very low, low, or medium to high.

For step 4.1, first check if the chemical introduction is one that is considered to be of medium to high indicative risk for human health. In our example here, the chemical is none of these – it doesn’t contain a sequence of 4 to 20 fully fluorinated carbon atoms; it’s not a polyhalogenated organic chemical introduced at volumes more than 100kg per year that is persistent or has known environmental degradation products that are persistent; and it’s not a chemical at the nanoscale so we don’t have to consider the nanoscale criteria further. 

Because the chemical is not any of the types covered by step 4.1, and we haven’t got to an outcome for the indicative human health risk yet, we continue on to step 4.2. The chemical in this example has not been assessed overseas, so it’s not covered by step 4.2. We don’t know yet if it can have an indicative human health risk of low. We need to move on to step 4.3.

Slide 6

Step 4.3 is where we work out the human health exposure band of the introduction. Refer to Part 1 of Schedule 1 of the Industrial Chemicals General Rules for details about the exposure band scenarios. The concentration of the chemical when it’s introduced is low, so we can consider the concentration-based exposure band scenarios. This means that there is no need to work out the human health categorisation volume. The chemical has a consumer end use, but not one that involves a designated kind of human exposure, which would be if it had an end use in tattoo inks. Its concentration at introduction and at end use is less than 0.1%. This places it in human health exposure band 2, because it fits the scenario shown on this slide.

Slide 7

Next, move onto step 4.4. This is where we need to consider the human health hazard characteristics of the chemical. To do this, we always start with the hazards in human health hazard band C. These are carcinogenicity, reproductive toxicity, developmental toxicity, adverse effects mediated by an endocrine mode of action, and genetic toxicity. Even though there is no hazard information about this chemical, this is not a problem for an introduction in exposure band 2. According to the Categorisation Guidelines, you would just need to check if the chemical is on our ‘list of chemicals with high hazards for categorisation’, and whether it’s there because it is known to have one of the hazard characteristics in human health hazard band C. This list is available on our website, together with instructions on how to search it. For our example, the chemical is not found on the list.

Slide 8

The final part of step 4 is 4.5, where we combine what we found out about the human health exposure band in step 4.3, and the human health hazard band in step 4.4. Using the diagram shown here, this will give the indicative human health risk of the introduction. Our example here is in exposure band 2, and we were able to show that it doesn’t have any hazard characteristics in human health hazard band C. This means it will have an indicative human health risk of very low. Note that it was possible for us to get to this very low indicative risk outcome without needing to check if the chemical has any of the hazard characteristics in human health hazard bands B or A. It was sufficient just to check the hazards in band C. So we have our indicative human health risk outcome, and that brings us to the end of step 4. 

Slide 9

Now we’re ready to move onto step 5. In step 5, we’ll do the equivalent steps to what we did in step 4 and we’ll end up with an outcome for the indicative environment risk. Step 5 involves a lot of similar considerations to what we did in step 4. 

There are several different sub-steps within step 5. These need to be followed in the order they are described here to be able to get to the final step 5 outcome for the indicative environment risk of very low, low, or medium to high.

For step 5.1, first check if the chemical introduction is one that is considered to be of medium to high indicative risk to the environment. In our example here, the chemical is none of these – it doesn’t contain a sequence of 4 to 20 fully fluorinated carbon atoms; it’s not a polyhalogenated organic chemical introduced at volumes more than 100kg per year that is persistent or has known environmental degradation products that are persistent; it’s not a chemical at the nanoscale so we don’t have to consider the nanoscale criteria further; it’s not a persistent gas introduced at volumes more than 100kg each year; and it’s not an organotin chemical introduced at volumes more than 10kg per year.

Because the chemical is not any of the types covered by step 5.1, and we haven’t got to an outcome for the indicative environment risk yet, we continue on to step 5.2. The chemical in this example has not been assessed overseas, so it’s not covered by step 5.2. We don’t know yet if it can have an indicative environment risk of low. We need to move on to step 5.3.

Slide 10

Step 5.3 is where we work out the environment exposure band of the introduction. Refer to Part 2 of Schedule 1 of the Industrial Chemicals General Rules for details about the exposure band scenarios. We first need to figure out the environment categorisation volume. We know that the introduction of the chemical does not involve a designated kind of release into the environment. We know the introduction volume, which is 300kg. And by looking at Table 1 of Part 2.1.2 of the Categorisation Guidelines, we find that the release reduction factor for the end use of this chemical is 1 because its end use is in personal care products. This means that the environment categorisation volume is the same as the introduction volume, that is, 300 kg. This places the introduction in environment exposure band 2, because it fits the scenario that is shown at the bottom of this slide. 

Slide 11

Next, move onto step 5.4. This is where we need to consider the environment hazard characteristics of the chemical. To do this, we always start with the hazards in environment hazard band D. The first of these is whether the chemical contains arsenic, cadmium, lead or mercury. We know the chemical doesn’t contain any of these elements so we can rule out this hazard. Next, we consider if the chemical is an ozone depleting chemical or a synthetic greenhouse gas. We do this by looking at the Categorisation Guidelines. By doing this, we find that we can also easily rule out these hazards based on our knowledge of the chemical. The remaining hazard characteristics in environment hazard band D are adverse effects mediated by an endocrine mode of action, and persistent, bioaccumulative and toxic (commonly referred to as PBT). Even though we don’t have any hazard information about these hazards, this is not a problem for an introduction in environment exposure band 2. According to the Categorisation Guidelines, we would just need to check if the chemical is on our ‘list of chemicals with high hazards for categorisation’, and if it’s there because it’s known to have one of the hazard characteristics in environment hazard band D. This list is available on our website, together with instructions on how to search it. For this example, the chemical is not found on the list.

Slide 12

The final part of step 5 is 5.5, where we combine what we found out about the environment exposure band in step 5.3, and the environment hazard band in step 5.4. Using the diagram shown here, this will give the indicative environment risk of the introduction. Our example here is in exposure band 2, and we were able to show that it doesn’t have any hazard characteristics in environment hazard band D. This means it will have an indicative environment risk of low. This is our indicative environment risk outcome, bringing us to the end of step 5. 
If the chemical in this example had hazard information available for it, we might like to see if we could get to very low indicative environment risk. This would involve checking the hazard characteristics in hazard bands C and B. If the chemical had none of these hazard characteristics it could be very low indicative environment risk. For the purposes of our example, however, we are stopping with the indicative environment risk outcome of low.

Slide 13

Now for the very last step, step 6. This involves working out the introduction category of exempted, reported or assessed. To do this, we consider our indicative risk outcomes from step 4 for human health, and step 5 for the environment. The highest of these 2 dictates what the introduction category will be. We can use the diagram here to help. The indicative human health risk for this example was very low so we go across the top to the very low column. The indicative environment risk for this example was low, so we go down the side to the low row. Where these intersect is shown circled here, giving us the introduction category of reported. And we’ve now completed our categorisation example.

Slide 14

Thank you for joining us for this video taking you through an example introduction scenario. We’ve stepped through the process to get to the introduction category, based on the information that’s available about the introduction. 

You can also find further information on our website, including guidance material and links to our legislation.