AICIS Industrial Chemicals Categorisation Guidelines
We now have a final draft of the AICIS Industrial Chemicals Categorisation Guidelines. They set out technical details and requirements for the importation and manufacture of industrial chemicals in Australia and will help you to categorise your introduction. The Categorisation Guidelines need to be read with the Industrial Chemicals (General) Rules 2019 (General Rules).
A snapshot of what's changed since the consultation
We’ve streamlined the Categorisation Guidelines. There’s now:
on this page:
Information about some key changes we've made.
Animal test data
We’ve added a new section to explain how you should consider animal test data when you categorise your introduction. The generation of new animal test data should only be a last resort.
We’ve added more information waivers so now there's more reasons why you might not need to have information about certain hazards.
For example now you won't need to prove that your chemical does not have:
- specific target organ toxicity following repeated exposure if it is also a food additive permitted by certain parts of the FSANZ Code. This applies as long as other criteria are also met
You also will not need to prove that your chemical does not have:
- toxicity to aquatic life
- genetic toxicity
- acute toxicity or
- specific target organ toxicity
following repeated exposure if it is:
- a vegetable fat
- vegetable wax
- vegetable oil
- animal fat
- animal oil, or
- animal wax
There are now waivers for these types of chemicals and others that are covered by Entry 9 of Annex V of the REACH Regulation
Certain high molecular weight polymers waivers
There are still waivers for certain high molecular weight polymers. This means that you might not need to prove that your high molecular weight polymer is
- corrosive to the skin
- sensitising to the skin
- damaging to the eyes
- PBT (persistent, bioaccumulative and toxic)
- toxic to aquatic life
See the Categorisation Guidelines for more details.
We've simplified information requirements.
The Categorisation Guidelines explain how information requirements for certain hazard characteristics differ for each exposure band.
We’ve moved information about what test methods you can use to work out hazard characteristics, or the absence of hazard characteristics, to appendices in the Categorisation Guidelines. This means that we can update these easily in the future.
We've replaced specified lists with a single consolidated list
- We now have a consolidated list of chemicals with high hazards. This has changed since our last consultation. Now you'll be able to check a single list instead of multiple lists when you're categorising your introduction. You'll use the list to check if your chemical has hazards in the:
- highest human health hazard band or the
- 2 highest environment hazard bands
- We’ve made some changes to the sources of this list*. For example:
- our consolidated list will only include chemicals in the ‘International Agency for Research on Cancer (IARC) Monographs’ that are classified in Groups 1, 2A and 2B
- our consolidated list will only include chemicals in the ‘European Commission Endocrine Disruptors Strategy’ list if they have endocrine activity in at least one animal study
- we’ve also added the ‘United Nations Environment Programme scientific knowledge on endocrine disrupting chemicals’ as a list source. From this, our consolidated list includes those with known or potential endocrine activity.
- We’ve added more in silico models that can be used when you categorise your chemical introduction.
We’ve changed the parts of the Categorisation Guidelines that explain the criteria for internationally-assessed chemical introductions that can be low indicative risk for human health or the environment. We’ve made it clearer what you need to consider to work out that the risks of your chemical in Australia are no higher than the risks overseas.
Last update 3 December 2019