Skip to main content

Draft AICIS Cost Recovery Implementation Statement (CRIS) 2021-22 – read the CRIS and have your say. Comments close on 14 May 2021.

Work out your human health categorisation volume

This page accompanies Step 4.3 work out your human health exposure band. You might need to know the human health categorisation volume (HHCV) of your introduction to work out its human health exposure band. Information on this page tells you when you need to work out a HHCV and when you don't.

 

Explore our categorisation tool for help on this subject

Are you introducing a chemical with an end use in TATTOO INKS or PERSONAL VAPORISERS? If you are, your introduction is automatically in exposure band 4 for human health — go to Step 4.4: Work out your human health hazard characteristics.

Use this guidance to calculate your introduction's human health categorisation volume.

Instructions

  • We've included the equations to use and the options you have to choose from, dependent on the scenarios of your introduction.
  • You can adopt a simple method or a more detailed method (which can result in a lower introduction volume than the simpler method).
  • Once you have worked out your human health categorisation volume, you can complete step 4.3.

When you need to work out a HHCV for your chemical

You need to do this if you want to use an exposure band scenario in step 4.3 that includes HHCV as part of the criteria. This could be if you introduce and use the chemical at relatively high concentrations (> 1%).

When you do not need to work out a HHCV for your chemical

You don’t need to work out a HHCV if:

  • you want to use an exposure band scenario in step 4.3 that does not include HHCV as part of the criteria. This could be if the concentration of your chemical when it’s introduced and during its end use is low (concentrations ≤1% or concentrations <0.1%, depending on the exposure band scenario that applies)
  • it has an end use in tattoo inks or personal vaporisers

Methods you can use to work out a HHCV for your chemical

There are 2 ways to work out the human health categorisation volume.

Method 1: Simplest approach

Use this method if you want an easy way to work out your human health exposure band.

HHCV calculation for this approach

The HHCV is your chemical’s total introduction volume in a registration year for all end uses.

Method 2: More detailed approach

Use this method if you want a more refined human health categorisation volume. Using this method could result in an HHCV that is lower than the total introduction volume in a year. This could mean that your introduction ends up being in a lower human health exposure band than if the total introduction volume (method 1) had been used.

The calculation of the HHCV using method 2 is different depending on whether your chemical introduction has only 1 end use or more than 1 end use.

If your introduction has 1 end use

For a chemical with only 1 end use, calculate the HHCV by multiplying the introduction volume (IV) by the exposure reduction factor (ERF) for your chemical’s end use scenario:

Equation (1): HHCV = IV x ERF

The introduction volume you should use in your calculation is the total introduction volume in a registration year. Use the exposure reduction factor that applies to your end use scenario (see Table for ERFs for different end uses).

The ERF values range between 0 and 1. A low exposure reduction factor indicates that only a small portion of the introduction volume is likely to contribute to human exposure. A higher exposure reduction factor indicates that a higher proportion of the introduction volume could contribute to human exposure.

Exposure reduction factors (ERFs) for different end use scenarios

Your introduction's end use scenario ERF to use
Chemical imported into Australia; import containers remain closed; then exported for end use overseas 0
Chemical imported into Australia; limited handling of the chemical (such that import containers are opened); then exported for end use overseas 0.05
Chemical manufactured in Australia; exported for end use overseas 0.05
Specified consumer products with end use in Australia* 1
All other end uses in Australia 0.1

Note *Specified consumer products means any of the following products:

  • cosmetics
  • nasal sprays
  • ear sprays
  • intimate lubricants
  • massage oils and gels
  • products applied to the nails to harden, or deter the biting of, nails

Specified consumer products do not include tattoo inks and personal vaporisers. If your chemical has an end use in tattoo inks or personal vaporisers, its introduction will be in human health exposure band 4 and you do not need to calculate a HHCV for it.

If your introduction has more than 1 end use

You can choose from 2 options to calculate the HHCV where your chemical has more than one end use

Option 1: Simplest approach

Use this option if:

  • you do not know the annual introduction volume of your chemical for each end use
  • you want to simplify the process of working out your human health exposure band but still want a more refined human health categorisation volume

HHCV calculation for this approach

Allocate the total introduction volume to the end use scenario that has the highest exposure reduction factor (from the table), and use Equation (1) to calculate the HHCV. Note: do not just use the volume for one of the end uses.

Option 2: More detailed approach

Use option 2 if:

  • you know the annual introduction volume of your chemical for each end use
  • you are willing to keep track of any changes to your introduction volume for each end use. This is needed to make sure that the indicative human health risk of your introduction does not increase.

HHCV calculation for this approach

Calculate a separate human health categorisation volume for each of your end uses. Use the exposure reduction factor for the end use (from the table), and the volume that you will be introducing for that end use. Do this for all of your end uses and then add them up to get your total human health categorisation volume (use equation (2) below).

HHCV = (IV1 x ERF1) + (IV2 x ERF2) +… + (IVn x ERFn)

Note: IVn = the introduction volume for end use ‘n’

ERFn = the exposure reduction factor (ERF) for end use ‘n’.

Go back to step 4.3

Contents

Was this page helpful?
For broken links or technical issues, please provide as much detail as possible. Do not include your name, email address and other personal or commercially sensitive information.

Keep informed with updates