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

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 0, 1, 2 and 3 and have completed step 4 of the categorisation process.

Instructions

Start from the top and check whether you are introducing any of the 5 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. 

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).

No I am not introducing this type of chemical

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 step: Go to 'Certain organotin chemicals'

Yes I am introducing this type of chemical

If you are introducing a gas, you must consider which of the following circumstances apply to your introduction.

1. Introduced at volumes less than 100kg 

Next step: Go to 'Certain organotin chemicals'.

2. Introduced at volumes higher than 100kg each year

You need to have information about the persistence of your gas. 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 step: If you do have the in silico predictions or studies to prove that your gas is not persistent, go to 'Certain organotin chemicals'. 

If you do not have the required in silico predictions or studies described above, then you cannot prove that your gas is not persistent. Your introduction is medium to high indicative risk to 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 'Environment focus' as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).


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.

No 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 step: Go to 'Chemicals that contain a sequence of 4 to 20 fully fluorinated carbon atoms (including per- and poly-fluorinated alkyl substances, known as PFAS).

Yes I am introducing this type of chemical

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

1. Introduced at volumes less than or equal to 10kg per year

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

2. Introduced at volumes greater than 10kg per year

Outcome and next step: If this applies to your introduction, it is in the assessed introduction category and is called an 'assessed introduction'. Before you can introduce the chemical, you must apply for an assessment certificate and select 'Environment' focus as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).


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 categorising 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).


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.

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).


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, continue to step 5.2.

Next - Step 5.2 Introductions that can be low risk to the environment

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