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We've updated our guidance on NICNAS to AICIS transitional arrangements.

Step 4.1 Introductions that are always medium to high risk for human health

Some introductions are always medium to high risk to human health. This means they will be in the assessed introduction category and you need to apply for an assessment certificate.

 

You are here because you have already gone through Steps 0, 1, 2 and 3 of the categorisation process.

Instructions

Start from the top and check whether you are introducing any of the 3 types of chemical introductions we describe on this page.

For each one work out if you are, or are not introducing that type of chemical and follow the instructions to find out your outcome or next steps.

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Chemicals that contain a sequence of 4 to 20 fully fluorinated carbon atoms (including per- and poly-fluorinated alkyl substances, known as PFAS)

These chemicals (some known as PFAS) are commonly used in products to add resistance to heat, other chemicals and abrasion. They can also act as dispersion, wetting or surface treatment agents.

We have extra guidance on categorisation of fluorinated chemicals

No I am not introducing this type of chemical

You must have information about your chemical's identity as proof that you're not introducing this type of chemical. You (or the chemical identity holder) need to provide the information if we ask for it.

Next step: Go to 'Certain polyhalogenated organic chemicals' below.

Yes I am introducing this type of chemical

Outcome and next step: Your introduction has a medium to high indicative risk to both human health and the environment. This means your introduction is in the assessed category and called an 'assessed introduction'. Before you can introduce the chemical, you must apply for an assessment certificate and select 'Health and environment focus' as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).

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Certain polyhalogenated organic chemicals

Polyhalogenated organic chemicals are carbon-based chemicals that contain more than 1 covalently bonded halogen atom, such as bromine, chlorine, fluorine or iodine. They may have long-term effects on human health and the environment. They’re commonly used as flame retardants in plastics, textiles and electronic circuitry.

We have extra guidance on the categorisation of polyhalogenated organic chemicals 

No I am not introducing this type of chemical

You must have information about your chemical's identity as proof that you're not introducing this type of chemical. You (or the chemical identity holder) need to provide the information if we ask for it.

Next step: Go to 'Certain chemicals at the nanoscale' below.

Yes I am introducing this type of chemical

If the chemical identity information that you (or the chemical identity holder) have confirms you are introducing this type of chemical, you must consider which of the following circumstances apply to your introduction.

1. Introduced at volumes less than or equal to 100 kg each year

Next step: Go to 'Certain chemicals at the nanoscale' below.

2. Introduced at volumes higher than 100 kg each year

You need to have test results about the persistence of your chemical and any of its known environmental degradation products. To prove that your chemical and any of its known environmental degradation products are not persistent, we accept study results in option 1 or 2.

Option 1

A study conducted following OECD test guideline 301 (Ready Biodegradability) that results in the pass levels being reached within one of the following time periods:

  • specified time period – such that the chemical is considered to be readily biodegradable or
  • duration of the test – but not within the specified time period for the chemical to be considered readily biodegradable, provided biodegradation has started within the specified time period

Option 2

A study conducted following OECD test guideline 308 (Aerobic and Anaerobic Transformation in Aquatic Sediment Systems) that results in both a degradation half-life of less than 2 months in water and 6 months in sediment.

Next step: If you have study results described in option 1 or 2, go to 'Certain chemicals at the nanoscale' below.

If you do not have any study result described in option 1 or 2, then you cannot prove that your chemical (and any of its known environmental degradation products) are not persistent. Your introduction is medium to high indicative risk to human health and the environment. This means your introduction is in the assessed category and called an 'assessed introduction'. Before you can introduce the chemical, you must apply for an assessment certificate and select 'Health and environment focus' as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).

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Certain chemicals at the nanoscale

We have extra guidance on categorising chemicals at the nanoscale

Introductions of chemicals that meet all of the following criteria are medium to high indicative risk to both human health and the environment. We refer to these introductions as 'certain chemicals at the nanoscale'.

Criteria

  1. It is introduced as a solid or is in a dispersion.
  2. It consists of particles in an unbound state or as an aggregate or agglomerate. At least 50% (by number size distribution) of the particles have at least 1 external dimension in the particle size range of 1nm to 100nm (ie. the nanoscale).
  3. It is not soluble. This means the solubility of the chemical in water is less than 33.3 g/L measured following OECD test guideline 105 or 120 for water solubility; or the dissolution rate of the chemical is not more than 70%.
  4. The introduction of the nanoscale portion of the chemical (the part that has a particle size range of 1nm to 100nm) is not incidental to the introduction of the non-nanoscale portion. This is the case if any of the following apply: 
  • the manufacture of the chemical (in Australia or overseas) at the nanoscale is the result of a deliberate manufacturing decision
  • the manufacture of the chemical (in Australia or overseas) at the nanoscale is necessary for the manufacture of the non-nanoscale portion of the chemical. This means that to make the non-nanoscale chemical, part of the chemical has to be at the nanoscale
  • the chemical at the nanoscale has specific technical characteristics that are the intended result of changes in the manufacturing process. For example, if the process of manufacturing the chemical changes in order to change the particle size of the chemical, or its properties at the nanoscale. This could happen by:
    • mechanical actions like milling, grinding, shearing, sieving or sonication
    • chemicals reactions like electrochemical exfoliation, or catalysts
    • other changes such as changes to pressure or temperature or pH or solvent

No I am not introducing this type of chemical

This means that you have information or studies to prove that your chemical does not meet any of the 4 criteria, or it only meets some of the 4 criteria. Below are examples of how you might prove that each criterion are not met.

Criterion 1: How to prove the chemical is not introduced as a solid or in a dispersion.

You might have an SDS or product information sheet that indicates the appearance (for example, in liquid form).

Criterion 2: How to prove that your chemical does not consist of particles in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale.

You might have a study report about the particle size distribution of the chemical.

Criterion 3: How to prove the chemical is soluble.

You might have a study report from a water solubility test.

Criterion 4: How to prove that the introduction of the nanoscale portion of your chemical is incidental to the non-nanoscale portion.

You might have information about the manufacturing process which explains that although a portion of your chemical is present at the nanoscale:

  • this was not the result of a deliberate manufacturing decision
  • this was not required to manufacture the non-nanoscale portion of your chemical
  • you did not change your manufacturing process in order to manufacture chemicals at the nanoscale with specific technical characteristics

Next step: If you can prove that at least one of the 4 criterion is not met, then continue to step 4.2.

If you can't prove this, then your introduction is considered medium to high indicative risk to both human health and the environment. This means your introduction is in the assessed category and called an ‘assessed introduction’. Before you can introduce the chemical, you must apply for an assessment certificate and select 'Health and environment focus' as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).

Yes I am introducing this type of chemical

This means that your introduction meets all 4 criteria above and is a 'certain chemical at the nanoscale'.

Outcome and next step: Your introduction has a medium to high indicative risk to both human health and the environment. This means your introduction is in the assessed category and called an ‘assessed introduction’. Before you can introduce the chemical, you must apply for an assessment certificate and select 'Health and environment focus' as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).

If you've followed the guidance on this page and can prove that your introduction is not any of these, then continue to step 4.2.

Next – Step 4.2 Introductions that can be low risk for human health

Definitions

Known environmental degradation products are the expected breakdown products of the chemical under environmentally relevant conditions. These breakdown products are ones that have been found in scientific literature or studies.

A persistent chemical remains intact in the environment for long periods of time. A chemical is persistent if its degradation half-life (T1/2) is greater than or equal to:

  • 2 days in air or
  • 2 months in water or 6 months in soil or
  • 6 months in sediment.
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