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

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 at Step 4.1 because you've ruled out Steps 1, 2 and 3 of the categorisation process.

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

Step 4.1 instructions

See our page on record-keeping for the records you'll need to prove your introduction is not 1 of the types we describe here.

Get help with this step — explore our categorisation decision tools


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 of which are known as PFAS) are commonly used in products to add resistance to heat, other chemicals and abrasion, and also act as dispersion, wetting or surface treatment agents. They are medium to high indicative risk to both human health and the environment.

We have extra help on the categorisation of fluorinated chemicals.

I am introducing this type of chemical

If this applies to your introduction, it is in the assessed introduction category and you must apply for an assessment before you can introduce it.

I am not introducing this type of chemical

You must be able prove this. You (or the chemical identity holder) need information about the identity of the chemical as proof you are not introducing this type of chemical. You also need to be able to provide the information if we ask for it.

Next:

Consider the next type of chemical introduction we describe on this page (certain polyhalogenated organic chemicals).


Certain polyhalogenated organic chemicals

  • I am introducing this type of chemical
  • I am not introducing this type of chemical

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.

I am introducing a polyhalogenated organic chemical

If the chemical identity information you have about the chemical confirms this, you must consider which of the below circumstances apply.

When your introduction of a polyhalogenated organic chemical is in the assessed category

Your introduction has a medium to high indicative risk to both human health and the environment and is in the assessed category if it’s:

Next:

If this applies to your introduction, it is in the assessed introduction category and you must apply for an assessment certificate before you can introduce it.

When your introduction of a polyhalogenated organic chemical could be in the exempted or reported category

You may be able to introduce your chemical in another category (ie exempted or reported instead of assessed) if any of these scenarios apply to your introduction.

Scenario 1

If your polyhalogenated organic chemical:

is persistent, or has environmental degradation products that are persistent but will be introduced at volumes equal to or less than 100kg each year

it could be in the exempted or reported category.

Next steps for scenario 1:

Because your volumes are lower, you can continue to work out the indicative risk to human health and then the environment. To continue to do this, first consider the next type of introduction we describe on this page (certain chemicals at the nanoscale), then follow the instructions at the end of that topic.

Scenario 2

If your polyhalogenated organic chemical is not persistent and does not have any environmental degradation products that are persistent

it could be in the exempted or reported category.

You need to have test results that prove that your chemical and any of its known environmental degradation products are not persistent. We accept any of these studies and results on your chemical that show this:

  • a study conducted following OECD test guideline 301 (Ready Biodegradability) that results in 1 of the following pass levels being reached within the:
    • 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 OR
  • 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 steps for scenario 2:

If you have these test results to prove this scenario applies, you can continue to work out the indicative risk to human health and then the environment. To continue with this, first consider the next type of introduction we describe on this page (certain chemicals at the nanoscale), then follow the instructions at the end of that topic.

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.

I am no introducing a polyhalogenated organic chemical

You must be able prove this. You (or the chemical identity holder) need information about the identity of the chemical as proof you are not introducing this type of chemical. You also need to be able to provide the information if we ask for it.

Next:

Consider the next type of introduction we describe on this page (certain chemicals at the nanoscale).


Certain chemicals at the nanoscale

Introductions of chemicals that meet all of the following are in the assessed category because they are medium to high indicative risk to both human health and the environment. On this page we refer to these as ‘certain chemicals at the nanoscale’.

This is where all of the following apply to the chemical:

  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 must 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:
    1. the manufacture of the chemical (in Australia or overseas) at the nanoscale is the result of a deliberate manufacturing decision
    2. 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
    3. 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 or
      • chemicals reactions like electrochemical exfoliation, or catalysts or
      • other changes such as changes to pressure or temperature or pH or solvent

I am introducing a 'certain chemical at the nanoscale'

If the above applies to your introduction, it is in the assessed category because it has medium to high indicative risk for human health and the environment and you must apply for an assessment.

or

I am not introducing a ‘certain chemical at the nanoscale’

This means it could be in the exempted or reported category.

To be able to prove that your introduction is not a ‘certain chemical at the nanoscale’ that is in the assessed category, you'll need to be able to prove that any of points 1, 2, 3 or 4 (above) do not apply to your introduction.

Some examples of how you could do this are:

  • Point 1: to prove that your 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).
  • Point 2: to prove that your chemical is soluble. You might have a study report from a water solubility test
  • Point 3: to prove that your chemical does not consist of particles in an unbound state or as an aggregate or agglomerate, at least 50% of which (by number size distribution) have at least one external dimension in the nanoscale. You might have a study report about the particle size distribution of the chemical.
  • Point 4: to prove that the introduction of the nanoscale portion of your chemical is incidental to the non-nanoscale portion, you might be able to justify this by proving that a), b) and c) do notapply to the introduction of your chemical.

Learn more in our record-keeping guidance


Next:

My introduction is not any of the types on this page

To have reached this conclusion, you must have read the guidance for each type of chemical we've described on this page.

Complete the categorisation of your introduction

If your chemical is not any of the types on this page, to work out its introduction category (exempted, reported or assessed), complete:

  • the rest of step 4 to work out the human health risk of your introduction
  • step 5 to work out the environment risk of your introduction
  • step 6 for your categorisation outcome

Go to Step 4.2 Introductions that can be low risk for human health

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