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Welcome to the website of the Australian Industrial Chemicals Introduction Scheme (AICIS). We started on 1 July 2020. Read about us.

Step 4.2 Introductions that can be low risk for human health

If you've established your introduction is NOT medium to high risk for human health (Step 4.1), now see if your introduction CAN be low risk for human health. 

 

This step relates to international assessments and how to work out if your introduction is of low risk for human health based on its international assessment.

Skip this step if you are not using an internationally assessed chemical. Note, your introduction might still be low indicative risk to human health but you will need to complete steps 4.3, 4.4 and 4.5 to work this out.

Step 4.2 instructions (international assessments)

  • Check if your chemical has been assessed or evaluated by a trusted overseas body that we accept.
  • Follow guidance on this page to see if you meet the other criteria for international assessments.
  • Follow the final part of this step on what to do next.

Get help with this step — explore our categorisation decision tools

Have you read our information on getting started with your chemical categorisation?

Trusted overseas bodies

We will accept international assessments or evaluations from these trusted bodies (See section 6 of the Rules for full details):

  • Opinions from the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) or its equivalent former committees (Scientific Committee on Consumer Products – SCCP; and Scientific Committee on Cosmetic Products and Non-Food Products – SCCNFP). We’ll accept these opinions as long as they have:
    • been finalised and adopted by the Committee
    • terms of reference that include a question about the safety of your chemical in a cosmetic product and conclude that its safe
  • Opinions from the European Chemicals Agency (ECHA) Committee for Risk Assessment and the ECHA Committee for Socio-Economic Analysis. We’ll accept these opinions as long as they have been the basis for the European Commission (EC) deciding to include or update a restriction in Annex XVII of the REACH regulation (i.e. REACH restrictions). REACH registration dossiers are not accepted. 
  • Opinions from the European Food Safety Authority (EFSA) on materials and articles intended to come into contact with food
  • European risk assessments that have been the basis for the European Commission (EC) approving active biocidal substances. These risk assessments must have been conducted by ECHA or by an authority of a member state of the European Union. The risk assessment must have been reviewed by the ECHA Biocidal Products Committee
  • Risk assessments from Environment and Climate Change Canada OR Health Canada. We’ll accept certain Schedules from their current regulations and their old regulations. See table items 1 and 2 of subsection 6(3) of the General Rules for details of the schedules and regulations:
  • International parallel process assessments where:
    • Australia was involved as a secondary jurisdiction and
    • The risk assessment was done by Environment and Climate Change Canada OR Health Canada OR by the United States Environmental Protection Agency (US EPA)

Next:

Go to the following section on this page to check if the international assessment or evaluation meets all the required criteria for you to be able to use it to categorise your introduction.

Explore our categorisation decision tool on international assessments

Criteria for internationally assessed introductions

Your introduction CAN BE low risk for human health if it meets ALL the following criteria:

  • a trusted overseas assessment body assessed or evaluated your chemical for its risks to human health
  • a report by the assessment body is available and you can provide it to us if we ask for it
  • the chemical's international assessment or evaluation was for:
    • the same end use as your introduction
    • a maximum concentration at end use equal to or higher than the maximum concentration of your introduction at end use
  • the risks to human health from the introduction and use are no higher in Australia than the overseas jurisdiction (determined in accordance with part 4.1.2 of the Guidelines)
  • the international assessment or evaluation:
    • has conditions or restrictions that must be followed to manage risks to human health and you can follow these conditions in Australia or
    • has no restrictions or conditions to manage risks to human health that you need to follow
  • no more information has become available since completion of the international assessment or evaluation about:
    • any hazards to human health the international assessment or evaluation didn't identify or
    • an increase in severity of any hazards to human health the international assessment or evaluation did identify

and

  • the introduction isn't prohibited in the country that conducted the assessment or evaluation

Outcomes for this step and what to do next

My introduction MEETS the criteria for international assessments


This means your introduction CAN be low risk for human health. You can either decide to continue with your categorisation to check if it can be very low risk for human health OR go to Step 5 and start categorising your introduction's risk to the environment.

Next:

Choose 1 of the following options:

Once you’ve done this, go to step 4.5 for your final answer (to see if your introduction can be low indicative risk for human health).

OR

  • Don't continue with human health categorisation and keep the outcome you already have – your introduction is low risk for human health
  • Go to step 5 to start categorising the indicative risk to the environment of your introduction.

My introduction DOES NOT meet the criteria for international assessments

Continue with step 4 to work your introduction's risk to human health.

Next:

Once you’ve done this, go to step 4.5 for your final answer (to see if your introduction can be low indicative risk for human health).

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