Internationally assessed for human health only

This section relates to introductions that are internationally assessed for human health only. You must meet all of the criteria described in each step to be considered a 'low risk' introduction under AICIS.

Guidance on this page must be read in conjunction with Step 4.2: Introductions that can be low risk for human health in our main Categorisation Guide. Step 4.2 relates to internationally-assessed introductions for human health.

If you have not followed our main Categorisation Guide, do not go any further until you do so. 

If a trusted overseas body has assessed your introduction for human health and it meets all the other criteria in this guide related to human health, its indicative risk to human health is low. 

Your introduction must meet all of the criteria described in each step of this section.

You can also use our decision tool to work out if your introduction is low risk for human health.

Step 1: Is there an overseas assessment of your chemical?

This section relates to introductions that are internationally assessed for human health only. These must meet all of the criteria described in each step to be considered a 'low risk' introduction under AICIS.

If an overseas body has assessed your chemical, consider the following aspects of the assessment.

Step 1.1: Did a trusted overseas body perform the assessment? 

A trusted overseas body listed in section 6 of the General Rules must have assessed or evaluated your introduction for its risks to human health, and published a report of the assessment or evaluation that describes the outcomes.

The trusted bodies are:

  • Opinions from the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) or its equivalent former committees — the Scientific Committee on Consumer Products (SCCP) and the 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; the terms of reference include a question about the safety of your chemical in a cosmetic product; and the opinion concludes that it’s 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’ve formed the basis for the EC's decision to include or update a restriction in Annex XVII of the REACH regulation (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 formed the basis for the EC approving active biocidal substances. The ECHA or an authority of a member state of the European Union must have conducted these risk assessments, and the ECHA Biocidal Products Committee must have reviewed the risk assessment.
  • Risk assessments from Health Canada. We'll accept risk assessments that used Schedule 5, 6, 9, 10 or 11 from the current Canadian regulations (31 October 2005 onwards). We'll also accept risk assessments that used Schedule II, III, VI, VII or VIII from the old Canadian regulations (before 31 October 2005).
  • International parallel process assessments where Australia was involved as a secondary jurisdiction; and Health Canada OR the United States Environmental Protection Agency (US EPA) performed the risk assessment.
Note: The only REACH assessments that we will accept are opinions about REACH restrictions. We do not accept REACH registration dossiers.

You may know that there is a report of the assessment or evaluation because:

  • it is publicly available on the website of the trusted overseas body
  • an alternative source is available – for example, you know that your overseas parent company has had the chemical assessed in Canada

If one of the trusted overseas bodies assessed or evaluated your chemical and completed a report for it, continue to Step 1.2 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.

If one of the trusted overseas bodies has not assessed or evaluated your chemical, or there is no report for it, you do not meet our criteria for an introduction that has been internationally assessed for human health.

Step 1.2: Can I use the overseas assessment report?

The following factors determine whether you can use an overseas report.

1. The complete report must be available. 

It’s important to note that:

  • you must provide the complete report, not just a summary of it
  • you must have permission to use the report and any information it contains for the purpose of introducing your chemical into Australia
  • if the overseas report is publicly available and your company was not the applicant for the overseas assessment, you must ensure you have the applicant’s permission to use the assessment report

2. You must give us the report, if we ask for it. 

This could mean:

  • you give it to us directly, or tell us where we can find it (for example, if it’s publicly available on a website) or  
  • arrangements can be made for another party to give us the report 

If the overseas report is available and you can provide it for these purposes, continue to Step 2 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.

If the overseas report is not available or you can’t provide it for these purposes, you do not meet our criteria for an introduction that has been internationally assessed for human health.

If you are using a Canadian report

If you want to use a Canadian report in an application, it must have been completed by Environment and Climate Change Canada (ECCC) / Health Canada (HC). We do not accept other Canadian reports.

The Canadian notifier must authorise ECCC to share the reports about your chemical with us.

  1. The Canadian notifier must fill in the relevant sections of the authority to release assessment report to AICIS using their own letterhead.
  2. The Canadian notifier must send the completed letter to ECCC. 

We recommend that you do this at least 60 calendar days before you submit your application to us.

Download the authority

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Step 2: Is the chemical prohibited overseas?

If the overseas report — or any other information from the overseas jurisdiction where the chemical was assessed — states that the chemical cannot be used or is prohibited, then you do not meet our criteria for an introduction that has been internationally assessed for human health.

If your chemical isn’t prohibited overseas, continue to Step 3 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.

Step 3: Is there new human health hazard information about the chemical that was not available when it was assessed overseas?

If you have direct access to the complete overseas report, compare the hazard information available to you with the hazard studies described in the overseas report. 

If you don’t have direct access to the complete overseas report, check the information submitted to the overseas body. This is the information that the overseas body based their assessment on. 

If no new human health hazard information about the chemical has become available following the publication of the overseas report, continue to Step 4 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.

If new hazard information about the chemical has become available following the publication of the overseas report, you must consider the following implications:

  • If the new information shows that the chemical has a hazard to human health and it was not mentioned in the overseas report – you do not meet our criteria for an introduction that has been internationally assessed for human health.
  • If the new information shows that the chemical has a hazard to human health that is more severe than the hazard characteristic described in the overseas report – you do not meet our criteria for an introduction that has been internationally assessed for human health.
  • If the information shows that the chemical has a hazard to human health that is less severe, or of the same severity, as the hazard characteristic described in the overseas report – continue to Step 4 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.

Example

An overseas assessment completed in 2011 shows that your chemical has the hazard characteristic ‘acute toxicity (harmful)’, based on an acute oral toxicity study. You also have an acute oral toxicity study that was not available in 2011. This study indicates that the chemical has the hazard characteristic ‘acute toxicity (fatal or toxic)’. This means that the severity of the acute oral toxicity hazard is higher than that published in the 2011 assessment – and you do not meet our criteria for an introduction that has been internationally assessed for human health.

Step 4: Is the end use of your chemical in Australia the same as its end use overseas?

Your chemical’s end use in Australia must be the same as the end use overseas. Otherwise, you will not meet our criteria for an introduction that has been internationally assessed for human health. 

The end use overseas is the end use that the trusted overseas body assessed and described in the overseas report.

What do we mean by the ‘same end use’?

Most industrial chemical introductions into Australia will have at least one of the following  end uses. See Part 2.1.2 of the Categorisation Guidelines for a definition of these end uses. 

  • adhesive and sealant products
  • apparel and footwear care products
  • arts, crafts and hobby products
  • explosive products
  • fuel, oil, fuel oil additives and related products
  • lubricant and grease products
  • personal care products - limited environmental release
  • tattoo ink products
  • paint and coating products
  • plastic and polymer products
  • construction products not covered by other end uses listed here
  • fabric, textile and leather products not covered by other end uses listed here
  • electronic products
  • ink, toner and colourant products
  • air care products
  • anti-freeze and de-icing products
  • automotive care products
  • cleaning and furniture care products
  • laundry and dishwashing products
  • extractive products not covered by other end uses listed here
  • paper products
  • personal care products not covered by other end uses listed here
  • photographic products
  • water treatment products
  • personal vaporiser products

For your chemical to have the ’same end use’, your end use in Australia and your end use overseas must both fit within the same entry from the above list.

If your chemical’s end use in Australia is the same as the end use described in the overseas report, continue to Step 5 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.

If your chemical’s end use in Australia is different to the end use described in the overseas report, you do not meet our criteria for an introduction that has been internationally assessed for human health.

If you have direct access to the complete overseas report, check the above list to work out the correct end use description for your introduction.

If you do not have direct access to the complete overseas report, check the information that was submitted to the overseas body. This is the information that the overseas body based their assessment on.

Example

End use in Australia Hair care products
End use definition for the Australian end use Personal care products not covered by other end uses
End use assessed overseas Make-up products
End use definition for the overseas end use Personal care products not covered by other end uses
Could you meet our criteria for an introduction that has been internationally assessed for human health? Yes – the definition for the overseas end use and the Australian end use are the same 

Example

End use in Australia Cleaning products
End use definition for the Australian end use Cleaning and furniture care products
End use assessed overseas Lubricant
End use definition for the overseas end use Lubricant and grease product 
Could you meet our criteria for an introduction that has been internationally assessed for human health? No – the definition for the overseas end use and the Australian end use are different

Step 5: Is the end use concentration of your chemical in Australia the same or lower than overseas?

To meet our criteria for an introduction that has been internationally assessed for human health, the maximum end use concentration of the chemical in Australia must be the same or lower than the maximum concentration of the chemical during its end use overseas.

The maximum concentration of the chemical during its end use overseas is the maximum end use concentration that the accepted overseas jurisdiction assessed. 

The maximum end use concentration in Australia could be:

  • the upper limit of the end use concentration range
  • the maximum concentration that you intend for the chemical to be present at end use in Australia

If the maximum end use concentration overseas is above the maximum end use concentration for your introduction into Australia, continue to Step 6 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.

If the maximum end use concentration overseas is below the maximum end use concentration for your introduction into Australia, you do not meet criteria for an introduction that has been internationally assessed for human health.

If you have direct access to the complete overseas report, compare the maximum end use concentration for the chemical in the report with your proposed end use concentration in Australia. 

If you do not have direct access to the complete overseas report, check the information that was submitted to the overseas body. This is the information that the overseas body based their assessment on. 

Example

Maximum end use concentration in Australia Maximum end use concentration overseas Criterion met?
10% 25% Yes
10% 5% No 
10% 50% Yes 
range 10% – 25% 10 – 20% (as stated in the overseas report)  No

Step 6: Is the human health risk of your introduction in Australia the same or lower than overseas?

To meet our criteria for an introduction that has been internationally assessed for human health, the risks to human health from the introduction and use of your chemical in Australia must be no higher than the risks identified in the overseas report.

To work this out, you must look at each of the following parameters for your introduction in Australia and compare them with overseas:

If your chemical is known to not have any human health hazards, any differences in these parameters are unlikely to increase the risk to human health in Australia.

If your chemical does have hazards to human health, you need to consider how the differences between these parameters increases human exposure to the chemical, and whether that increases the risk to human health in Australia.

If your chemical is a polymer, you also need to consider if there are any differences between the polymer that was assessed overseas and the polymer that you will be introducing into Australia.

These differences could include molecular weight details such as:

  • number average molecular weight
  • weight average molecular weight
  • polydispersity index
  • the percentage (by mass) of molecules with a molecular weight that is less than 1000g/mol
  • the percentage (by mass) of molecules with a molecular weight that is less than 500g/mol

If there are differences in any of these parameters, consider if this increases the hazard of the polymer and whether that increases the risk to human health in Australia.

What happens if there are no differences in any of the parameters in Australia compared with overseas?

If there are no differences in any of the parameters, continue to Step 7 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.

What happens if there are differences in some of the parameters in Australia compared with overseas?

If this is the case for any parameter, you need to consider if a difference you have identified will increase the risk to human health in Australia

You may also need to take into account of all of the parameters as a whole to conclude whether there’s an increased risk to human health.

If you conclude that any differences between these parameters mean the introduction’s human health risk is no higher in Australia than overseas, continue to Step 7 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.

If you conclude that any differences between these parameters mean the introduction’s human health risk is higher in Australia than overseas, you do not meet our criteria for an introduction that has been internationally assessed for human health.

If you do not have direct access to the complete overseas report or the overseas report doesn’t discuss these parameters, you should consider whether this information is available elsewhere. For example, it could be:

  • information that was submitted to the overseas body
  • information that’s available to you through your contact with the overseas applicant

Step 6.1: Mode of introduction

Compare the chemical’s ‘mode of introduction’ (whether it is imported or manufactured) into Australia with the mode of introduction overseas.

Example

Mode of introduction into Australia Mode of introduction overseas Criterion met?
Import Import Yes
Manufacture Manufacture Yes
Import Manufacture Yes
Manufacture Import Dependent on other factors

Step 6.2: Introduction concentration

Compare the concentration of the chemical when introduced in Australia with its concentration when introduced overseas.

If the introduction concentrations are different, consider whether any increased concentration in Australia will lead to an equivalent increase in human exposure. This will depend on how the chemical is handled.

You may also need to consider whether any increased concentration will require additional processing steps in Australia - if yes, then you’ll need to consider any differences in the chemical’s use.

Step 6.3: Use of the chemical

Compare the chemical’s use in Australia with its use overseas.

Note that ‘use’ is different to ‘end use’. The term ‘use’ covers the life cycle of the chemical and includes activities such as processing, formulating, storing, transporting, handling and mixing.

Consider whether any of these processes or activities will be different in Australia — if yes, you’ll need to consider whether this leads to any increase in exposure to humans, or changes the way humans are exposed.

Step 6.4: Use concentration

Compare the concentration of the chemical when used in Australia with the concentration when used overseas — including the concentrations along the life cycle of the chemical and during any formulation activities.

If there are any differences, consider whether any increased concentration leads to an equivalent increase in human exposure.

Step 6.5: Routes of human exposure

Compare the routes of any expected human exposure to the chemical during introduction, use and end use in Australia with the routes of human exposure expected to occur during these processes overseas.

For example, whether human exposure is likely to occur via oral, dermal or inhalation routes, and any expected exposure through the environment.

If there are differences in the routes of exposure

For example, due to differences in the way the chemical is used, or differences in the specific end uses, then consider whether this has any impact on the risks to human health — including any particular hazards that are more likely to occur due to the different exposure route.

Example

End use in Australia Method of end use in Australia and route of human exposure End use overseas Method of end use overseas and route of human exposure Criterion met?
Paints Brush — mainly dermal exposure Paints Aerosol spray application — dermal and inhalation exposure Yes — level of exposure to humans in Australia expected to be lower because of the methods of application
Paints Aerosol spray application —
dermal and inhalation exposure
Paints Brush and roller — mainly dermal exposure Consider the level of human exposure and inhalation toxicity of the chemical 

Comparison example for consideration of the parameters in Step 6

  Australia Canada
Mode of introduction Imported Imported 
End use Paints and coatings Paints and coatings
Method of end use / type and extent of exposure Brush and roller application / Consumers Brush and roller application / Consumers
Introduction volume 1000kg - 1500kg per year 2000kg per year
Concentration when introduced 80% 30%
Concentration in end-use products 30% 30%

 Human health risk considerations for this example: 

  • same end use and end use concentration
  • same route of exposure during end use
  • higher introduction concentration in Australia compared with Canada
  • different use and higher use concentration of the chemical in Australia compared with Canada (due to the formulation processes occurring in Australia)
  • possible different routes of human exposure during use (due to formulation processes)

If the chemical does not have any known human health hazards, continue to step 7 to work out if you meet our criteria for an introduction that has been internationally assessed for human health.

If the chemical does have hazards to human health, consider the expected level and routes of human exposure during each step of the formulation process — and whether any differences will impact the risks to human health. 

If your introduction’s human health risks are no higher in Australia than overseas, continue to step 7 to work out you meet our criteria for an introduction that has been internationally assessed for human health. 

If your introduction’s human health risks are higher in Australia than overseas, you do not meet our criteria for an introduction that has been internationally assessed for human health.

Step 7: Can you comply with any conditions or restrictions placed on the chemical overseas?

The overseas assessment of the chemical might include conditions or restrictions on how it can be used so that any risks to human health are properly managed. If so, you must be able to follow these conditions or restrictions in Australia.

If there are no conditions or restrictions in the overseas assessment, you meet our criteria for an introduction that has been internationally assessed for human health.

If the overseas assessment includes conditions or restrictions, and you can comply with the conditions or restrictions, you meet our criteria for an introduction that has been internationally assessed for human health.

If the overseas assessment includes conditions or restrictions, but you are unable to comply with the conditions or restrictions, you do not meet our criteria for an introduction that has been internationally assessed for human health.

Example 

Conditions or restrictions overseas Use/end use in Australia Criterion met?
REACH restriction (according to Annex XVII of REACH Regulation) – shall not be placed on the market, or used, as substances or in mixtures in concentrations greater than 0.1% by weight The chemical will be present in end use products at 0.05% concentration Yes
SCCS condition – the SCCS considers the chemical safe when used in oxidative hair colouring products up to a maximum on-head concentration of 2% The chemical will have end use in oxidative hair colouring products up to a maximum on-head concentration of 2% Yes
SCCS condition – the use of the chemical as a preservative with a maximum concentration of 0.5% in rinse-off cosmetic products is considered safe The end use of the chemical is as a preservative in rinse-off cosmetic products at a maximum concentration of 0.5% Yes
Canadian Significant New Activity (SNAc) provision – any activity other than using it for the dyeing of polyester and modified polyester using batch dyeing techniques The end use of the chemical is only for dyeing polyester or modified polyester and only uses batch dyeing techniques Yes
Canadian Significant New Activity (SNAc) provision – a significant new activity is any activity involving the substance, in any quantity, other than for use in personal care products that are not applied as a spray or aerosol The end use of the chemical is only for leave on cosmetics that are not applied by spray Yes
Canadian Significant New Activity (SNAc) provision – any activity involving the use of the substance in a consumer product at a concentration of the substance in the product equal to or greater than 20% The end use of the chemical is only in consumer products at concentrations of 15% Yes