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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

Go through A, B and C to work out if you are, or are not, introducing any of these types of chemicals. You must keep records of study reports and other information that you used to answer each question.

A. Does your chemical contain a sequence of 4 to 20 fully fluorinated carbon atoms (including per- and poly-fluorinated alkyl substances, known as PFAS).

B. Is your chemical a certain polyhalogenated organic chemical?.

C. Is your chemical a certain chemical at the nanoscale?.

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A. Does your chemical contain a sequence of 4 to 20 fully fluorinated carbon atoms (including per- and poly-fluorinated alkyl substances, known as PFAS)?

Fluorinated chemicals contain fluorine atoms and include per- and polyfluorinated chemicals (PFAS). These are commonly used in products to add resistance to heat, other chemicals, and abrasion. They also act as dispersion, wetting or surface treatment agents. We have an increased level of concern for introductions of chemicals that contain a sequence of 4 to 20 fully fluorinated carbon atoms (including PFAS) because these chemicals, or their degradation products, may be persistent in the environment, bioaccumulate and be highly toxic. 

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 'B. Is your chemical a certain polyhalogenated organic chemical?'.

Yes I am introducing this type of chemical

We have extra guidance on categorisation of fluorinated chemicals

Outcome: 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'.

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B. Is your chemical a certain polyhalogenated organic chemical?

Polyhalogenated organic chemicals are carbon-based chemicals that contain more than 1 covalently bonded halogen atom, such as bromine, chlorine, fluorine, or iodine. Polyhalogenated organic chemicals are commonly used as flame retardants in plastics, textiles, and electronic circuitry. They may have long-term effects on human health and the environment. We have an increased level of concern for introductions of chemicals that are polyhalogenated organic chemicals because these chemicals, or their degradation products, may be persistent in the environment, bioaccumulate and be highly toxic. 

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 'C. Is your chemical a certain chemical at the nanoscale?' below.

Yes I am introducing this type of chemical

We have extra guidance on the categorisation of polyhalogenated organic chemicals 

All introductions of polyhalogenated chemicals are specified class of introduction.

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 'C. Is your chemical a certain chemical 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.

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

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

If you have this study showing these results, then move on to 'C. Is your chemical a certain chemical at the nanoscale?' below.

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.

If you have this study showing these results, then move on to 'C. Is your chemical a certain chemical at the nanoscale?' below.

If you do not have either of the study results described in option 1 or 2

Outcome: Your introduction is medium to high indicative risk to human health and the environment because you cannot prove that your chemical (and any of its known environmental degradation products) are not persistent. This means your introduction is in the assessed category and called an 'assessed introduction'.

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C. Is your chemical a certain chemical at the nanoscale?

Introductions of chemicals that meet all 4 criteria below are medium to high indicative risk to both human health and the environment. We refer to these introductions as 'certain chemicals at the nanoscale'. We have an increased level of concern for chemicals at the nanoscale, because of uncertainty about the risks of some of these chemicals due to their potentially different properties, such as chemical reactivity, relative to the non-nanoscale forms of the chemicals. 

  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). Note that if you meet criteria 1 and 2, and regardless of whether you meet criteria 3 and 4, your introduction is a specified class of introduction
  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
      • chemicals reactions like electrochemical exfoliation, or catalysts
      • other changes such as changes to pressure or temperature or pH or solvent

Yes I am introducing this type of chemical

We have extra guidance on categorising chemicals at the nanoscale

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

Outcome: 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’. 

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. Answering the questions below will help you prove this. As you go through the questions, we'll tell you the next steps you should take.

Extra questions about certain chemicals at the nanoscale

For example, information on appearance could be recorded on an SDS or technical data sheet of the chemical or product that will be introduced into Australia.

Note: 

  • If your information indicates that it’s a powder, flakes, granules, pellets or wax, select ‘yes’.
  • If your information indicates that it’s a liquid, select ‘no’.

Yes 

Go to question 2. 

I don't know

Go to question 2. Alternatively, contact your chemical supplier and return to this page when you have further information.

No 

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

The criteria for ‘certain chemicals at the nanoscale’ are not met for your introduction. 

Next step: Go to 'Step 4.2 Introductions that can be low risk for human health' and continue to categorise your introduction.

For example, there is information on the chemical or product’s appearance on an SDS or technical data sheet.

No - the chemical will not be introduced as granules, pellets, or a wax.

Go to question 3.

Yes - the chemical will be introduced as granules, pellets, or a wax.

Note: you must keep a record of this information.

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

Next step: Go to 'Step 4.2 Introductions that can be low risk for human health' and continue to categorise your introduction.

Examples of when you should answer 'yes'

  • Your chemical is imported in an end use product such as laundry or dishwashing powder and it is not known to be an insoluble component of the product. For the product to work the way it should, the chemical must be soluble in water.
  • You have a study result from a water solubility study on your chemical that was carried out following the test guideline OECD TG 105.
  • You will introduce a polymer and have information on solution/extraction behaviour of the polymer in water (OECD TG 120).
  • You have information on the dissolution rate (OECD WPMN Guidance document for the testing of dissolution and dispersion stability of nanomaterials and the use of the data for further environmental testing and assessment strategies; July 2021).

No or don't know - my information does not indicate that the chemical is soluble in water or has a high dissolution rate or I don't have access to information about this

Go to question 4.

Yes - I have access to information that indicates that the chemical is soluble in water or has a high dissolution rate

This means that your introduction is not a 'certain chemical at the nanoscale'. You must keep a record of information you have available. If the information includes a study result and another person holds the study, you must be able to provide the study to us, if we ask for it.

Learn more about your record keeping obligations 

If you have information that shows the chemical consists 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 (1-100 nm), the introduction will be a specified class of introduction. Extra reporting obligations apply.

Next step: Go to 'Step 4.2 Introductions that can be low risk for human health' and continue to categorise your introduction.

For example: 

  • Information on appearance and mean particle size could be recorded on an SDS or technical data sheet of the chemical or product that will be introduced into Australia.
  • You have a study result from a particle size distribution study on your chemical or the product that you will introduce into Australia (conducted according to OECD TG 110).

I don't have access to any information about the mean particle size (all dimensions) / I don't know 

Go to question 7.

The information I have access to indicates the mean particle size is less than or equal to 1µm in one or more dimensions 

Go to question 5.

Yes - information I have access to indicates the mean particle size is greater than 1µm in all dimensions

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

Next step: Go to 'Step 4.2 Introductions that can be low risk for human health' and continue to categorise your introduction.

Note: you must keep a record of the information you have available. 

For example: you have a study result from a particle size distribution study on your chemical or the product that you will introduce into Australia (conducted according to OECD TG 110).

Note the following:

  1. For particle size distributions in this range, information only from an SDS/technical data sheet or similar is not enough.
  2. OECD TG 110 on Particle Size Distribution/ Fibre Length and Diameter Distributions for insoluble chemicals can be used to measure particle size and distribution to support that a chemical is not at the nanoscale for particles and fibres with sizes above 250 nm. 
  3. A draft OECD TG on particle size and particle size distribution on nanomaterials is currently under development. It is expected to be finalised in 2022.
  4. If the chemical is in a dispersion, the spectroscopy- and microscopy-based methods such as scanning electron microscopy (SEM) and transmission electron microscopy (TEM) are more appropriate.

No - I don't have access to any study results that indicate this / I don't know

Go to question 6.

Yes - I do have access to study results that indicate the mean particle size is greater than 200 nm in all dimensions

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

Next step: Go to 'Step 4.2 Introductions that can be low risk for human health' and continue to categorise your introduction. 

Note: you must keep a record of the information you have available. If another person holds the study, you must be able to give it to us, if we ask for it.

Learn more about your record keeping obligations 

For example - you have a study result from a particle size distribution study on your chemical or the product that you will introduce into Australia. A draft OECD TG on particle size and particle size distribution on nanomaterials is currently under progress and expected to be finalised in 2022. 

Note the following:

  1.  For particle size distributions in this range, information only from an SDS/technical data sheet or similar is not enough.
  2. If the chemical is in a dispersion, the spectroscopy- and microscopy-based methods are more appropriate.

No - I don't have access to study results that indicate this / I don't know

Go to question 7.

Yes - I have access to study results that indicate the mean particle size is less than or equal to 200 nm in one or more dimensions and the chemical consists 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 (1-100 nm)

Go to question 7 - note the introduction will be a specified class of introduction and extra reporting obligations will apply.

Yes - I have access to study results that indicate the mean particle size is less than or equal to 200 nm in one or more dimensions and the 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 (1-100 nm):

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

Next step: Go to 'Step 4.2 Introductions that can be low risk for human health' and continue to categorise your introduction.  

Note: you must keep a record of the information you have available. If the study is held by another person, you must be able to provide it to us, if we ask for it. 

Learn more about your record keeping obligations 

For example, you could have a combination of 1 and 2:

  1. A declaration from the chemical manufacturer indicating all of the below:
    1. the manufacture of any chemical at the nanoscale is not the result of a deliberate manufacturing decision; and
    2. the manufacture of any chemical at the nanoscale is not necessary for the manufacture of the non-nanoscale portion of the chemical; and
    3. any chemical at the nanoscale does not have specific technical characteristics that are the intended result of changes in the manufacturing process.
  2. Information to show that the presence of any nanoscale particles in the chemical is not providing a commercial advantage to the non-nanoscale chemical, such as the absence of claims related to the presence of the nanoscale particles in technical data sheets and commercial product labels on the chemical/introduced product. 

Note: in general, the declaration must be from the manufacturer of the chemical in its solid/dispersion form. The declaration must also be held in conjunction with other supporting information.

No - I do not have access to this information / I don't know

You do not have enough information to demonstrate that your introduction is not a ‘certain chemical at the nanoscale’. In the absence of more information from the manufacturer or supplier of your chemical, 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'. We must assess it before you can introduce. This means your introduction is in the assessed category and called an 'assessed introduction'.

Yes - I do have access to this information that indicates this

This means that your introduction is not of a ‘certain chemical at the nanoscale’.

Next step: Go to 'Step 4.2 Introductions that can be low risk for human health' and continue to categorise your introduction. 

Note: you must keep a record of the information you have available. 

Definition - specified class of introduction

A ‘specified class of introduction’ are introductions that have an increased level of concern to human health or the environment. The reason is due to greater potential for certain hazards or high level of human or environmental exposure. Additional, or different, requirements relating to hazard information, reporting or record keeping apply to specified classes of introductions. These vary depending on whether you have categorised your introduction as exempted, reported or assessed. 

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

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