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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 5.1: Introductions that are always medium to high risk to the environment

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

 

You are at Step 5.1 because you've ruled out Steps 1, 2 and 3 and have completed step 4 of the categorisation process.

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

Step 5.1 instructions

  • You need to check each of the 5 types of chemical introductions we describe on this page.
  • If your introduction is any one of the types we describe, it means it is medium to high risk for the environment and in the assessed category and you need to apply for an assessment certificate.
  • If you establish your introduction is not any of the types we describe on this page (and you can prove that it is not), continue with all of step 5, then move on to step 6. Doing this will give you your final categorisation outcome: exempted, reported or assessed.

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

Get help with this step - explore our categorisation decision tool

The last 3 types of chemical introductions we describe on this page are exactly the same as the ones that we describe in step 4.1 for human health. This means that they are medium to high indicative risk to the environment and to human health. So if you are introducing one of these types of chemicals, you should have already worked out that your introduction category is assessed because of its indicative human health risk being medium to high. Also, you now know that it’s also assessed because of its indicative environment risk being medium to high.

Certain gases

Your chemical is a gas if it is in the gaseous phase at 20oC and 101.3kPa (ambient conditions).

I AM introducing this type of chemical

If you are introducing a gas, you must consider which of the below circumstances apply.

When your introduction of a gas IS in the assessed category

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

  • introduced at volumes greater than 100kg per year AND
  • persistent
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 gas 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 gas:

  • is 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 the environment. To continue to do this, first consider the next type of introduction we describe on this page (certain organotin chemicals), then follow the instructions at the end of that topic.

Scenario 2

If your gas is not persistent, it could be in the exempted or reported category.

You need to be able to prove that your gas is not persistent. We’ll accept information that shows your gas has a half-life in air of less than 2 days. This could be:

  • An in silico prediction using EPI Suite AOPWIN or
  • Studies that use methods that are well established in published peer-reviewed scientific literature
Next steps for scenario 2:

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

I am not introducing a gas

You must be able prove this. For example, you might have a SDS or product information sheet that indicates the appearance. You also need to be able to provide the information if we ask for it.

Next:

Continue to work out the indicative risk to the environment. To continue with this, first consider the next type of introduction we describe on this page (certain organotin chemicals), then follow the instructions at the end of that topic.

Certain organotin chemicals

Organotin chemicals are chemicals that contain at least 1 tin atom that is covalently bound to at least one carbon atom. They are widely used as polyvinyl chloride (PVC) stabilisers, biocides, and in antifouling paints.

I AM introducing an organotin chemical

If you are introducing an organotin chemical, you must consider which of the below circumstances apply.

When your introduction of an organotin chemical IS in the assessed category

Your introduction has a medium to high indicative risk to both the environment and human health and IS in the assessed category if it’s introduced at volumes greater than 10kg per year.

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 an organotin 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 it will be introduced at volumes equal to or less than 10kg per year.

Next steps:

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

I am not introducing an organotin 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:

Continue to work out the indicative risk to the environment. To continue with this, first consider the next type of introduction we describe on this page (chemicals that contain a sequence of 4 to 20 fully fluorinated carbon atoms), then follow the instructions at the end of that topic.

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 the environment and human health.

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.

Next:

Explore our information on how to apply for an assessment certificate.

or

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 the environment and human health and is in the assessed category if it’s:

  • introduced at volumes greater than 100kg each year AND
  • persistent, or has at least 1 known environmental degradation product that is persistent
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:

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 not 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 a solid or is in 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
      or
    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,
      or
    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:
        • temperature or
        • pressure 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.

Next:

Explore our information on how to apply for an assessment certificate

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 a solid or is not in a dispersion. You might have an SDS or product information sheet that indicates the appearance.
  • 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 (with reference to the items in subsection 28(2) and 29(2) of the General Rules)

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:

Go to step 5.2 Introductions that can be low risk to the environment

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