Guide to categorising your chemical importation and manufacture

From 1 July 2020, all industrial chemical importers and manufacturers must categorise their chemical importation or manufacture (introduction). This step by step guide takes you through the process of categorising your introduction.

Click the printer-friendly version button at the bottom of this page to print the whole guide or save as a PDF using your browser.

Drawing on information in the IC Act, General Rules and the Industrial Chemicals Categorisation Guidelines we've put together this practical step-by-step guide with supporting self-guided decision tools to help you categorise your chemical introduction as exempted or reported or assessed.

Before you start categorising your introduction

Before you start the steps in this guide, you must search our industrial chemicals database (Inventory). Chemicals listed on the Inventory are available for industrial use in Australia. If your chemical is on the Inventory and your introduction meets any terms specified in the Inventory listing, your introduction is categorised as 'listed'.

Another category of introduction, not discussed in this guidance, but which will be available from 1 July are commercial evaluation authorisations. Under this category, you can apply for a time-limited commercial evaluation authorisation for the purpose of testing a chemical's commercial viability in Australia. We'll have more guidance on this soon.

Introduction categories

Listed introductions

A chemical introduction that is categorised as ‘listed’ means it is on our Inventory and already available for industrial use in Australia. You must be registered and meet any terms of the listing for that chemical.

Exempted introductions

A chemical introduction that is categorised as ‘exempted’ means we consider it to be very low risk to human health and the environment. You can introduce the chemical without telling us beforehand, as long as you’re registered with us.

Reported introductions

A chemical introduction that is categorised as ‘reported’ means we consider it to be low risk to human health and the environment. You must submit a once-off report before you start introducing it.

Assessed introductions

A chemical introduction that is categorised as ‘assessed’ means we consider it to be medium to high risk to human health and the environment. It cannot be exempted or reported. We must assess your introduction and issue an assessment certificate before you can import or manufacture it.

General information about introduction categories

There is no fee for listed, exempted or reported introductions. There is an application fee for assessed introductions. For each introduction category, you have reporting and record-keeping obligations. A registration fee applies to all introduction categories.

Learn more on our basics of importing and manufacturing page

This image summarises the above information about introduction categories, including whether an application fee is payable in a particular category.

A diagram of categorisation of industrial chemicals in Australia.

You must check that each industrial chemical (including ingredients in products) is on our Inventory.  To search the Inventory, use the chemical's Chemical Abstracts Service (CAS) number or name.

Get started with using the Inventory


If your chemical is on the Inventory without obligations under the terms of listing

Your introduction is categorised as 'listed'. You are authorised to introduce the chemical without telling us beforehand, if you're registered with us. You must make sure you understand your annual declaration and record-keeping obligations for listed introductions.


If your chemical is on the Inventory and it does have obligations

An Inventory listing for a chemical may include these regulatory obligations and restrictions:

  • Defined scope of assessment
  • Conditions of introduction or use
  • Specific information requirement

If any of these are on your chemical's listing, you must check each term to see if your introduction does or does not meet requirements. If you meet all obligations or restrictions we have set, your introduction is categorised as 'listed'. You can introduce your chemical without telling us beforehand, if you're registered with us. You must make sure you understand your annual declaration and record-keeping obligations for listed introductions.

If you don't meet the requirements, you need to follow our detailed information on what to do next.

Follow our guidance on what each Inventory listing term means and your options


Reasons why you can't find your chemical on the Inventory and what to do next

If you have the correct CAS number or chemical name and still get no result when you search the Inventory, the reasons are 1 of the following:

 

 

Information you need to work out your introduction category

Before you dive into the details of how to work out the category of your chemical introduction, we want to give you an idea of the information you'll need to do this.

Make sure you've checked out our page Before you start categorising your introduction before reading further.

Getting started

On this page you can read about:

  • Information you must know
  • Information you might need - if your introduction is not in the listed category
  • Information it might be useful to have - if your introduction is not in the listed category

If you don't have some of this information you may need to contact your supplier for it, or you might need to ask them to help you with categorisation.

We refer to categorisation steps on this page. These are steps you need to follow to work out what category your introduction can be authorised under: exempted, reported or assessed.

Information you must know, might need to know and is useful to have

Chemical identity - do you have the proper name of your chemical?

You must know this. If you don’t, you must have a relationship with someone who does know it and can provide it to you or directly to us. Usually, it will be your supplier.

Related information on this topic

Record keeping - outlines requirements for suppliers to be able to provide information to us, such as the proper name of the chemical.

Confidential business information - we have measures to protect a supplier's CBI. For example, your supplier can add chemical identity information into a pre-introduction report (these are required for reported introductions). We will see this information, not you.

Inventory (part 1) — is your chemical on the Inventory? You must check this.

The Inventory is our chemical database of chemicals available for industrial use in Australia. If you don’t know your chemical's identity, you might need to ask your supplier to check the Inventory for you and to let you know if the chemical is there or not.

If you are searching the Inventory yourself, you need to understand what your search results mean. You also need to understand what to do next if you can't find the chemical. Sometimes, a chemical is listed on the Inventory but won't come up in search results because of CBI. We can help in this regard by confirming whether the chemical is listed or not.

Related information on this topic

What your Inventory search results will show — explanations of listing terms and steps to follow.

I can't find my chemical on the Inventory — the reasons you might be having trouble getting a search result on the Inventory and steps to follow.

Inventory (part 2) — if the chemical is on the Inventory

Does your introduction comply with any terms or conditions in the Inventory listing? This includes any requirements to provide AICIS with specific information about your introduction.

If you don’t know the chemical identity of the chemical you are introducing, you’ll need to ask your supplier to help you confirm that your introduction meets the terms or conditions of the Inventory listing. We suggest that your supplier tell you what the terms or conditions of the Inventory listing of your chemical are, so that you can ensure that your introduction of the chemical meets these.

Related information on this topic

If your introduction does not comply, read this guidance — what to do if you don't meet any Inventory terms of listing

If your introduction does comply, it is a 'listed introduction'. 

Introduction volume

Do you know the total quantity of chemical in kilograms that you will manufacture or import into Australia within a registration year (September- August)?

You might need this to work out your exposure band for human health and the environment.

Steps 2, 3, 4.1, 4.3, 5.1, 5.2 and 5.3

Introduction concentration

Do you know what the concentration (%) of your chemical will be when it’s introduced into Australia?

You might need this to work out the human health exposure band.

Steps 3 and 4.3

End use concentration

Do you know the final concentration (%) of the chemical in end use products?

You might need this to work out the human health exposure band.

 Steps 3, 4.2 and 4.3

End use 

Do you know what the chemical will ultimately  be used for?

You might need this to help you work out your exposure band for human health and the environment.

Steps 1, 2, 3, 4.2, 5.2 

Hazard information 

Do you have any existing hazard information available on the chemical or from suitable read-across information?

Note that the higher your introduction's exposure band, the more hazard information you will need to work out your chemical's hazard characteristics and then it's introduction category.

Steps 4.2, 4.4, 5.2, 5.4 

Specified classes of introduction

Do you know if your introduction a ‘specified class of introduction? Are you introducing any of these specified classes of introduction?

Specified classes of introduction might have different requirements for categorisation. You might need to know if your introduction is one when following our categorisation steps.

To find out more about specified classes of introduction, refer to section 7 of the General Rules.

Steps 2, 3, 4.1, 4.3, 4.4, 4.5, 5.1, 5.3, 5.4, 5.5

It's useful to have this information as it will help you get to your introduction category more easily.

Is your chemical a polymer?

Some requirements only apply to polymers such as some of the environment exposure band criteria.

Steps 2, 4.4, 5.5

If your chemical is a polymer, do you know its molecular weight? Is it a high molecular weight polymer?

High molecular weight polymers usually have less information requirements for categorisation.

Steps 2, 4.4, 5.3, 5.4

International assessments

Has there been an international assessment of your chemical?

Was it assessed by a trusted / accepted overseas assessment body for risks to human health or the environment?

Does your introduction meet the criteria for international assessments? Some (but not all) of the criteria for international assessments includes:

  • the chemical must have been internationally assessed for the same end use as your planned use in Australia 
  • the risks to human health or the environment in Australia must not be any higher than the risks overseas 
  • the risks must be able to be managed in Australia

You must follow our detailed guidance on criteria for international assessments in steps 4.2 (human health) and 5.2 (environment)

If you can answer yes all the criteria for international assessments, it could mean there is a streamlined pathway to work out your introduction category, and that the introduction category could be lower than it might have otherwise been.

Steps 4.2, 5.2

Step 1: Introductions that cannot be exempted or reported

Some introductions are not eligible for the exempted or reported categories.

Chemicals listed in the Rotterdam Convention or Stockholm Convention

Industrial chemicals that are listed in Annex III to the Rotterdam Convention or Part 1 of Annex A, B or C to the Stockholm Convention can not be categorised as an exempted or reported introduction.

If you wish to trade (import or export) a chemical that is listed in Annex III to the Rotterdam Convention and in Section 71 or 73 of the Industrial Chemicals (General) Rules, you must apply in writing using our application forms and pay a fee. This application process is known as the prior informed consent (PIC) procedure.

If you wish to introduce a chemical that is listed in Annex III to the Rotterdam Convention or Part 1 of Annex A, B or C to the Stockholm Convention but it is not listed in Section 71 of the Industrial Chemicals (General) Rules, your introduction is in the assessed category. You must apply for an assessment before you can introduce this chemical.

Introductions of tetraethyl lead for aviation gasoline

Tetraethyl lead is a highly toxic fuel additive that is subject to special conditions under section 72 of the Industrial Chemicals (General) Rules 2019.

Tetraethyl lead is listed on the Inventory, but you can only introduce it in aviation gasoline, or use it to produce aviation gasoline.

If you wish to introduce tetraethyl lead into Australia you must:

  • First seek approval from [insert government authority] under subsection 13(1) of the Fuel Quality Standards Act 2000

Chemicals listed on the Inventory but you don’t meet the conditions of introduction or use

If your chemical is listed on the Inventory with a condition of introduction or use, you must ensure you can meet the conditions when you introduce the chemical.

An Inventory listing can include a condition about:

  • the total annual volume of the chemical that you can introduce
  • the location where you can introduce or use the chemical

If your introduction does not meet our conditions of introduction or use, it is not authorised under our exempted or reported categories. You will need to apply to vary the terms of the Inventory listing.

We must approve your application before you can start introducing the chemical.

If your introduction is not described on this page, go to step 2.

Step 2: Introductions that are automatically categorised as exempted

Certain chemical introductions are considered to be ‘very low risk’ to human health and the environment and are therefore automatically categorised as exempted.

Our categorisation decision tool can also help you with step 2


Chemicals that are imported and subsequently exported

Your introduction is automatically categorised as exempted if all of the following apply:

  • the entire volume is imported and subsequently exported out of Australia
  • the packaging in which your chemical is immediately contained is never opened
  • whilst your chemical is in Australia, it remains under the control of either customs (for longer than 25 working days) or the introducer.

Note: if your chemical is under customs controls whilst in Australia and leaves Australia within 25 days, then your introduction is an excluded introduction.

Chemicals that are only used for research and development

Your introduction is automatically categorised as exempted if all of the following apply (note that the volume of chemical that you can introduce in a registration year is lower, unless you can demonstrate that the nanoscale criteria do not apply to your introduction):

  • you only use your chemical for research and development, or you make it available to another person who only uses it for research and development
  • you don’t make your chemical available to the public on its own, in combination with other industrial chemicals or as part of an article
  • you use control measures to eliminate or minimise any risks to the environment and any risks to the people involved in using the chemical for research and development

and, either 1 or 2 applies:

  1. you will introduce up to 250kg of your chemical in a registration year and you can demonstrate that your chemical is either:
    • not introduced as a solid or in a dispersion or
    • does not consist of particles in an unbound state or as an aggregate or agglomerate, at least 50% (by number size distribution) of which have at least one external dimension in the particle size range of 1 to 100 nm, or otherwise
  2. you will introduce up to 10 kg of your chemical in a registration year

Notes:

  • 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).
  • 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 your chemical.
     

Learn more about categorising chemicals introduced for research and development

Polymers of low concern (plc)

Your introduction is automatically categorised as exempted if it meets the criteria for a polymer of low concern and it’s not a high molecular weight polymer that has lung overloading potential.

Learn about plc criteria

If you are introducing polymers of low concern, you must submit a once-off exempted introduction declaration by 30 November (following the end of our registration year). Your first AICIS exempted introduction declaration is due by 30 November 2021.

Low-concern biological polymers

Your introduction is automatically categorised as exempted if it’s a low-concern biological polymer that meets all of the following criteria:

  • the chemical is a biological chemical (that is, it’s derived from, or produced by, a living or once-living organism)
  • the chemical is a polymer
  • the polymer meets most of the polymer of low concern criteria, except that it’s not stable, meaning that it substantially degrades, decomposes or depolymerises during use into simpler, smaller weight chemicals

If you are introducing low-concern biological polymers, you must submit a once-off exempted introduction declaration by 30 November (following the end of our registration year). Your first AICIS exempted introduction declaration is due by 30 November 2021.

Polymers that are comparable to listed polymers

Your introduction is automatically categorised as exempted if ALL of the following apply:

  • your chemical is a polymer
  • your polymer contains exactly the same reactants (must have each of the reactants) as another polymer that is already listed on the Inventory
  • your polymer contains one or more other reactants (the additional reactants) that the listed polymer does not
  • each additional reactant is present at no more than 2% by weight of the polymer

You must also comply with any regulatory requirements associated with the listed polymer.

Chemicals that are comparable to listed chemicals

If you’re introducing any of the 16 chemicals in the comparable chemicals table below, your introduction is automatically categorised as exempted - as long as you meet any terms and conditions for the listed chemical. This is because these chemicals are comparable to chemicals that are already listed on the Inventory. Check column 2 and 3 of the comparable chemicals table below to see if your chemical is there.

If your chemical is not in the comparable chemicals table

If your chemical is not in the table below and none of the other introductions described on this page apply to you, move on to step 3: Introductions that are automatically categorised as reported.

If your chemical is in the comparable chemicals table

If your chemical is in columns 4/5 of the table, then search the Inventory using the CAS number in column 5. If your chemical is in columns 2/3 of the table, read across the row to get the CAS number of the comparable listed chemical in column 5. Search the Inventory using the CAS number to check the regulatory requirements and obligations for the listed chemical.

If your search results show:

  • there are no regulatory requirements for the chemical, your introduction is automatically categorised as exempted 
  • there are regulatory requirements for the chemical and you can meet these requirements, your introduction is categorised as exempted 
  • there are regulatory requirements for the chemical, but you cannot meet these requirements and none of the other introductions described on this page apply to you, move onto step 3: Introductions that are automatically categorised as reported.

Item

Industrial chemical to be introduced

CAS no. of industrial chemical to be introduced

Industrial chemicals listed on the Inventory

CAS no. of listed industrial chemical

1

Aloe barbadensis, extract

94349-62-9

Aloe vera, extract

85507-69-3
2

Brassica oleracea botrytis, extract

223749-36-8

Cabbage, extract

89958-13-4

3

Brassica oleracea, extract

91771-39-0

Cabbage, extract

89958-13-4

4

Brassica oleracea gemmifera, extract

1174275-27-4

Cabbage, extract

89958-13-4

5

Fatty acids, palm-oil, sodium salts

61790-79-2

Fatty acids, C14-18 and C16-18-unsaturated, sodium salts

67701-11-5

6

Jojoba, extract

90045-98-0

Jojoba oil

61789-91-1

7

3,6,9,12,15,18,21,21,24,27-Nonaoxanonatriacontan-1-ol

3055-99-0

Poly(oxy 1,2-ethanediyl), α-dodecyl-ω-hydroxy

9002-92-0

8

Matricaria recutita, extract

84082-60-0

Oils, Chamomile, German

8002-66-2

9

Orange, extract

84012-28-2

Orange, sweet, extract

8028-48-6
10

Pelargonium roseum, extract

90082-55-6

Pelargonium graveolens, extract

90082-51-2

11

Soya lecithins

8030-76-0

Lecithins

8002-43-5

12

Soya phospholipids

308069-41-2

Phospholipids

123465-35-0

13

Spiro[isobenzofuran- 1(3H),9’[9H]xanthen]-3-one, 2’,4’,5’,7’-tetrabromo -4,5,6,7-tetrachloro-3’,6’-dihydroxy-, aluminum salt (3:2)

15876-58-1

Spiro[isobenzofuran-1(3H),9’-[9H]xanthen]-3-one, 2’,4’,5’,7’-tetrabromo-4,5,6,7-tetrachloro-3’,6’-dihydroxy-, aluminum salt (3:1)

27532-17-8

14

Tridymite

15468-32-3

Silica

7631-86-9

15

Tylosin, (2R,3R)-2,3-dihydroxybutanedioate (1:1)

74610-55-2

Tylosin, (2R,3R)-2,3-dihydroxybutanedioate (salt)

1405-54-5

16

Wheat germ oil

313258-61-6

Oils, wheat

68917-73-7

Contact us if you’d like to suggest chemicals to add to this table.

Examples

Your proposed introduction: 
Your (unlisted) chemical is (CAS No.61790‑79‑2) ‘fatty acids, palm-oil, sodium salts’ and it's on the comparable chemicals table

The comparable chemical ‘is (CAS No. 67701‑11‑5) ‘fatty acids, C14‑18 and C16‑18‑unsaturated, sodium salts’. Your search of the Inventory reveals there are no regulatory requirements listed for this chemical. This means you can introduce your chemical as an exempted introduction.

Your proposed introduction:
Your (unlisted) chemical is (CAS No.308069‑41‑2) soya phospholipids. You wish to introduce soya phospholipids at a concentration level of 30%.

The comparable chemical is (CAS No. 123465‑35‑0) phospholipids. Your search of the Inventory reveals there are regulatory obligations under the term ‘defined scope of assessment’: This chemical has been assessed as a component of dermal cosmetic products at concentrations no more than 20%. This chemical is not to be used in topical products intended for the eye. You don't meet our conditions of use because the concentration of soya phospholipids in your end use products will be 30%. If none of the other introductions described on this page apply to you, go to step 3: Introductions that are categorised as reported.

Chemicals resulting from non-functionalised surface treatment of listed chemicals

Your chemical introduction is automatically categorised as exempted if the chemical is a non-functionalised surface-treated chemical resulting from a reaction of chemicals that are all listed on the Inventory. To be an exempted introduction, your chemical must meet all of the following criteria:

  • it is the result of a reaction between 2 or more chemicals, all of which are listed on the Inventory
  • the reaction to produce the chemical occurs at the surface of one of the chemicals (the substrate chemical)
  • it does not have any reactive functional groups that were not already on the substrate chemical before the reaction occurred
  • it is not a chemical that is a solid or is in a dispersion that consist of particles in an unbound state or as an aggregate or agglomerate, at least 50% (by number size distribution) of which have at least one external dimension in the particle size range of 1 to 100 nm.

What are your obligations for this category?

You can introduce an industrial chemical that’s automatically categorised as exempted into Australia without telling us, as long as you:

You may also need to submit an exempted introduction declaration. This is a once-off post-introduction declaration due after the end of our registration year and only applies if you are introducing:

  • polymers of low concern
  • low-concern biopolymers

Your first AICIS exempted introduction declaration is due by 30 November 2021.

Even if your introduction is not covered on this page, there is another way that you could categorise your introduction as exempted. To do this, you need to work out your introduction’s indicative risk to human health and the environment. If the indicative risk is very low for both health and the environment, your introduction is categorised as exempted. To work out your introduction’s indicative risk, go to step 4 then step 5.

Check out Step 3 Introductions that are automatically categorised as reported

Step 3: Introductions that are automatically categorised as reported

Certain chemical introductions are considered to be ‘low risk’ to human health and the environment and are therefore automatically categorised as reported introductions.

Chemicals that are only used for research and development

Your introduction is automatically categorised as reported if all of the following apply (note that the volume of chemical that you can introduce in a registration year is limited, unless use of the chemical will be subject to the introducer’s control and you can demonstrate that the nanoscale criteria do not apply to your introduction):

  • you only use your chemical for research and development, or make it available to another person who only uses it in research and development
  • you don’t make your chemical available to the public in any form (whether on its own, in combination with other industrial chemicals or as part of an article)
  • you use control measures to eliminate or minimise any risks to the environment and any risks to the people involved in using the chemical for research and development

and, either 1 or 2 applies:

  1. you will introduce more than 250 kg of your chemical in a registration year, use of your chemical will be subject to your (the introducer’s) control and you can demonstrate that your chemical is either:
    • not introduced as a solid or in a dispersion or
    • does not consist of particles in an unbound state or as an aggregate or agglomerate, at least 50% (by number size distribution) of which have at least one external dimension in the particle size range of 1 to 100 nm, or otherwise
  2. you will introduce more than 10 kg, but not more than 100 kg of your chemical in a registration year

Notes:

  • 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).
  • 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 your chemical.

Learn more about categorisation of chemicals introduced for research and development

Low-risk flavour or fragrance blend introductions

Flavour blends are mixtures of chemicals that are formulated to impart a taste. Fragrance blends are mixtures of chemicals that are formulated to impart a scent or cover a malodour. Your introduction is automatically categorised as reported if it meets the following requirements:

  • your chemical is part of a flavour or a fragrance blend and the blend is introduced either on its own, or with other chemicals
  • the concentration of your chemical when it is introduced is 1% or less
  • the concentration of your chemical in end-use products is 1% or less
  • your chemical must not have an end use in a personal vaporiser, such as e-cigarettes
  • your chemical does not have any of the hazard characteristics in the highest human health and the environment hazard bands
  • your chemical must either be on the IFRA Transparency List at the time that your pre-introduction report is submitted, or certain information about its introduction must be given to us before you introduce the chemical, including:
    • the proper name of your chemical and its CAS number (if assigned)
    • information on known hazard characteristics
    • the maximum concentration of the chemical in the blend at introduction and end use
    • the name you use to refer to the blend

Learn more about categorisation in flavour or fragrance blend introductions

What are your obligations for this category?

You can go ahead and introduce a chemical that’s automatically categorised as reported into Australia, as long as you:

Even if your introduction is not covered on this page, there is another way that you can categorise your introduction as reported. To do this, you need work out your introduction’s indicative risk to human health and the environment. If the highest indicative risk is low, your introduction is categorised as reported. To work out your introduction’s indicative risk, go to step 4 and then step 5.

Step 4: Work out your introduction's risk to human health risk

To be able to finish your categorisation you need to work out the risks of your introduction to human health and the environment.

In Step 4, you need to work out the human health risk of your introduction - is it medium to high, low or very low? To work this out start at 4.1 and continue as far as you need to through each step.

Once you have your answer for human health, move to step 5 to work out the risk to the environment of your introduction.

At Step 6, you'll combine the human health risk and environment risk for the final category of your introduction.

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

Start at this step to see if your introduction is of a type that is always medium to high risk for human health.

Step 4.2 Introductions that can be low risk for human health

This step relates to international assessments and how to work out if your introduction can be low risk for human health based on its international assessment.

Step 4.3 Work out your human health exposure band

Part of the process to work out the human health risk of your introduction is to work out its exposure band. There are 4 human health exposure bands - exposure band 1 has the lowest level of human exposure and exposure band 4 the highest level. 

Step 4.4 Work out your human health hazard characteristics

A chemical has a human health hazard characteristic if the chemical can cause damage, harm or adverse effects to humans. Find out what you need to do to establish the human health hazard characteristics of your chemical, including when you can refer to our list of chemicals with high hazards for categorisation.

Step 4.5 Outcome - your human health risk for categorisation

Use the table on this page to confirm the human health risk of your introduction: medium to high, low or very low. After you do this go to step 5 to work out the risk to the environment of your introduction.

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

  • You need to check each of the 3 types of chemical introductions we describe on this page:
    • chemicals that contain a sequence of 4 to 20 fully fluorinated carbon atoms (including per- and poly-fluorinated alkyl substances, known as PFAS)
    • certain polyhalogenated organic chemicals
    • certain chemicals at the nanoscale
  • If your introduction is any one of the types we describe, it means it is medium to high risk for human health 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 4, then go to steps 5 and 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 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.

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 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 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:
  • 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 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 (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:

  • 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

Step 4.2 Introductions that can be low risk for human health

If you've established your introduction is NOT medium to high risk for human health (Step 4.1), now see if your introduction CAN be low risk for human health. 

 

This step relates to international assessments and how to work out if your introduction is of low risk for human health based on its international assessment.

Skip this step if you are not using an internationally assessed chemical. Note, your introduction might still be low indicative risk to human health but you will need to complete steps 4.3, 4.4 and 4.5 to work this out.

Step 4.2 instructions (international assessments)

  • Check if your chemical has been assessed or evaluated by a trusted overseas body that we accept.
  • Follow guidance on this page to see if you meet the other criteria for international assessments.
  • Follow the final part of this step on what to do next.

Get help with this step — explore our categorisation decision tools

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

Trusted overseas bodies

We will accept international assessments or evaluations from these trusted bodies (See section 6 of the Rules for full details):

  • Opinions from the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) or its equivalent former committees (Scientific Committee on Consumer Products – SCCP; and Scientific Committee on Cosmetic Products and Non-Food Products – SCCNFP). We’ll accept these opinions as long as they have:
    • been finalised and adopted by the Committee
    • terms of reference that include a question about the safety of your chemical in a cosmetic product and conclude that its safe
  • Opinions from the European Chemicals Agency (ECHA) Committee for Risk Assessment and the ECHA Committee for Socio-Economic Analysis. We’ll accept these opinions as long as they have been the basis for the European Commission (EC) deciding to include or update a restriction in Annex XVII of the REACH regulation (i.e. REACH restrictions). REACH registration dossiers are not accepted. 
  • Opinions from the European Food Safety Authority (EFSA) on materials and articles intended to come into contact with food
  • European risk assessments that have been the basis for the European Commission (EC) approving active biocidal substances. These risk assessments must have been conducted by ECHA or by an authority of a member state of the European Union. The risk assessment must have been reviewed by the ECHA Biocidal Products Committee
  • Risk assessments from Environment and Climate Change Canada OR Health Canada. We’ll accept certain Schedules from their current regulations and their old regulations. See table items 1 and 2 of subsection 6(3) of the General Rules for details of the schedules and regulations:
  • International parallel process assessments where:
    • Australia was involved as a secondary jurisdiction and
    • The risk assessment was done by Environment and Climate Change Canada OR Health Canada OR by the United States Environmental Protection Agency (US EPA)

Next:

Go to the following section on this page to check if the international assessment or evaluation meets all the required criteria for you to be able to use it to categorise your introduction.

Explore our categorisation decision tool on international assessments

Criteria for internationally assessed introductions

Your introduction CAN BE low risk for human health if it meets ALL the following criteria:

  • a trusted overseas assessment body assessed or evaluated your chemical for its risks to human health
  • a report by the assessment body is available and you can provide it to us if we ask for it
  • the chemical's international assessment or evaluation was for:
    • the same end use as your introduction
    • a maximum concentration at end use equal to or higher than the maximum concentration of your introduction at end use
  • the risks to human health from the introduction and use are no higher in Australia than the overseas jurisdiction (determined in accordance with part 4.1.2 of the Guidelines)
  • the international assessment or evaluation:
    • has conditions or restrictions that must be followed to manage risks to human health and you can follow these conditions in Australia or
    • has no restrictions or conditions to manage risks to human health that you need to follow
  • no more information has become available since completion of the international assessment or evaluation about:
    • any hazards to human health the international assessment or evaluation didn't identify or
    • an increase in severity of any hazards to human health the international assessment or evaluation did identify

and

  • the introduction isn't prohibited in the country that conducted the assessment or evaluation

Outcomes for this step and what to do next

My introduction MEETS the criteria for international assessments


This means your introduction CAN be low risk for human health. You can either decide to continue with your categorisation to check if it can be very low risk for human health OR go to Step 5 and start categorising your introduction's risk to the environment.

Next:

Choose 1 of the following options:

Once you’ve done this, go to step 4.5 for your final answer (to see if your introduction can be low indicative risk for human health).

OR

  • Don't continue with human health categorisation and keep the outcome you already have – your introduction is low risk for human health
  • Go to step 5 to start categorising the indicative risk to the environment of your introduction.

My introduction DOES NOT meet the criteria for international assessments

Continue with step 4 to work your introduction's risk to human health.

Next:

Once you’ve done this, go to step 4.5 for your final answer (to see if your introduction can be low indicative risk for human health).

Step 4.3 Work out your human health exposure band

Are you introducing a chemical with an end use in TATTOO INKS or PERSONAL VAPORISERS? If you are, your introduction is automatically in exposure band 4 for human health — go to Step 4.4 Work out your human health hazard characteristics.

Look at the questions / scenarios we pose under each exposure band to work out your exposure band.

For some scenarios, you need to know your human health categorisation volume — follow our guidance on how to work this out

  • You need to know certain information about your introduction to be able to work out your human health exposure band. For example, you might need to know the volume you are introducing.
  • There are 4 exposure bands — start at exposure band 1 and work down the page.
  • Each exposure band directs you to your next step depending on your answer.
  • When you know your exposure band, you then need to work out the human health hazard characteristics of your introduction (step 4.4)

Why you need to work out your introduction's exposure band?

It is part of the process to identify the indicative human health risk of your introduction. In step 5, you also have to work out your introduction's environment exposure band.

What does a human health exposure band identify about your introduction?

It identifies the likelihood and extent of human exposure to the chemical.  This likelihood and extent of exposure increases with each band. Exposure band 4 is the highest exposure band. Introductions in human health exposure band 4 will have the highest level of human exposure.

Information that's used to assign a chemical to its correct exposure band

Need to know your human health categorisation volume?

Follow our guidance on how to work this out

You can also get help to work this out using our online decision tool

The information you need to be able to work out your exposure band can be different depending on the exposure band criteria you will be using. Some of the exposure band criteria mainly depend on human health categorisation volume, while others mainly depend on the concentration of your chemical when it's introduced into Australia and during its end use. This is a full list of the information you might need to be able to work out your human health exposure band:

  • Human health categorisation volume (needed for scenario 1 of Exposure Band 2, scenario 1 of Exposure Band 3 and Exposure Band 4)
  • Concentration of your chemical at introduction (needed for Exposure Band 1, scenario 2 of Exposure Band 2 and scenario 2 of Exposure Band 3).
  • Concentration of your chemical across all end uses (needed for Exposure Band 1, scenario 2 of Exposure Band 2 and scenario 2 of Exposure Band 3).
  • If it has an end use in tattoo inks or personal vaporisers (which are always in human health exposure band 4)
  • If there are any consumer end uses for the chemical introduction (needed for Exposure Band 1 and scenario 2 of Exposure Band 2 and).

We define 'consumer end use' (which we refer to throughout this page) to be where the chemical is made available to the general public, either on its own, with other chemicals or as part of an article.

What's your human health exposure band?

Start with Exposure Band 1 and work down the page.

Note, if your introduction has an end use in tattoo inks or personal vaporisers, it will be in exposure band 4.

Exposure band 1 criteria

To be in exposure band 1, your introduction must meet all of the criteria:

  • The concentration of your chemical at introduction IS LESS than 0.1 % 
  • The concentration IS LESS than 0.1 % across all your introduction’s end uses 
  • The introduction is NOT for any consumer end use

If your introduction meets all criteria, go to Step 4.4 to work out the human health hazard characteristics of your introduction

If your introduction does not meet all criteria, go to Exposure band 2.

Exposure band 2 criteria

To be in exposure band 2, your introduction must be at least 1 of these scenarios:

Scenario 1

  • The human health categorisation volume for your chemical does not exceed 25kg.

Scenario 2

  • The concentration of your chemical at introduction is less than 0.1 % and
  • The concentration is less than 0.1 % across all your introduction’s end uses and
  • The introduction has at least 1 consumer end use

If your introduction meets the criteria, go to Step 4.4 to work out the human health hazard characteristics of your introduction.

If your introduction does not meet the criteria, go to Exposure Band 3.

Exposure band 3 criteria

To be in exposure band 3, your introduction must be at least 1 of these scenarios:

Scenario 1

  • The human health categorisation volume for your chemical does not exceed 100kg.

Scenario 2

  • The concentration of your chemical at introduction is less than or equal to 1% and
  • The concentration is less than or equal to 0.1% across all your introduction’s end uses

If your introduction meets the criteria, go to Step 4.4 to work out the human health hazard characteristics of your introduction.

If your introduction does not meet the criteria, go to Exposure Band 4.

Exposure band 4 criteria

Reminder about tattoo inks or personal vaporisers: If you're introducing a chemical with an end use in tattoo inks or personal vaporisers you are automatically in Exposure Band 4 for human health. If this is your introduction type, go to Step 4.4: Work out your human health hazard characteristics.

If the human health categorisation volume of your introduction is greater than 100kg, your introduction is in exposure band 4.

Next: Step 4.4 Work out your human health hazard characteristics

 

 

 

 

Work out your human health categorisation volume

This page accompanies Step 4.3 work out your human health exposure band. You might need to know the human health categorisation volume (HHCV) of your introduction to work out its human health exposure band. Information on this page tells you when you need to work out a HHCV and when you don't.

 

Explore our categorisation tool for help on this subject

Are you introducing a chemical with an end use in TATTOO INKS or PERSONAL VAPORISERS? If you are, your introduction is automatically in exposure band 4 for human health — go to Step 4.4: Work out your human health hazard characteristics.

Use this guidance to calculate your introduction's human health categorisation volume.

Instructions

  • We've included the equations to use and the options you have to choose from, dependent on the scenarios of your introduction.
  • You can adopt a simple method or a more detailed method (which can result in a lower introduction volume than the simpler method).
  • Once you have worked out your human health categorisation volume, you can complete step 4.3.

When you need to work out a HHCV for your chemical

You need to do this if you want to use an exposure band scenario in step 4.3 that includes HHCV as part of the criteria. This could be if you introduce and use the chemical at relatively high concentrations (> 1%).

When you do not need to work out a HHCV for your chemical

You don’t need to work out a HHCV if:

  • you want to use an exposure band scenario in step 4.3 that does not include HHCV as part of the criteria. This could be if the concentration of your chemical when it’s introduced and during its end use is low (concentrations ≤1% or concentrations <0.1%, depending on the exposure band scenario that applies)
  • it has an end use in tattoo inks or personal vaporisers

Methods you can use to work out a HHCV for your chemical

There are 2 ways to work out the human health categorisation volume.

Method 1: Simplest approach

Use this method if you want an easy way to work out your human health exposure band.

HHCV calculation for this approach

The HHCV is your chemical’s total introduction volume in a registration year for all end uses.

Method 2: More detailed approach

Use this method if you want a more refined human health categorisation volume. Using this method could result in an HHCV that is lower than the total introduction volume in a year. This could mean that your introduction ends up being in a lower human health exposure band than if the total introduction volume (method 1) had been used.

The calculation of the HHCV using method 2 is different depending on whether your chemical introduction has only 1 end use or more than 1 end use.

If your introduction has 1 end use

For a chemical with only 1 end use, calculate the HHCV by multiplying the introduction volume (IV) by the exposure reduction factor (ERF) for your chemical’s end use scenario:

Equation (1): HHCV = IV x ERF

The introduction volume you should use in your calculation is the total introduction volume in a registration year. Use the exposure reduction factor that applies to your end use scenario (see Table for ERFs for different end uses).

The ERF values range between 0 and 1. A low exposure reduction factor indicates that only a small portion of the introduction volume is likely to contribute to human exposure. A higher exposure reduction factor indicates that a higher proportion of the introduction volume could contribute to human exposure.

Exposure reduction factors (ERFs) for different end use scenarios

Your introduction's end use scenario ERF to use
Chemical imported into Australia; import containers remain closed; then exported for end use overseas 0
Chemical imported into Australia; limited handling of the chemical (such that import containers are opened); then exported for end use overseas 0.05
Chemical manufactured in Australia; exported for end use overseas 0.05
Specified consumer products with end use in Australia* 1
All other end uses in Australia 0.1

Note *Specified consumer products means any of the following products:

  • cosmetics
  • nasal sprays
  • ear sprays
  • intimate lubricants
  • massage oils and gels
  • products applied to the nails to harden, or deter the biting of, nails

Specified consumer products do not include tattoo inks and personal vaporisers. If your chemical has an end use in tattoo inks or personal vaporisers, its introduction will be in human health exposure band 4 and you do not need to calculate a HHCV for it.

If your introduction has more than 1 end use

You can choose from 2 options to calculate the HHCV where your chemical has more than one end use

Option 1: Simplest approach

Use this option if:

  • you do not know the annual introduction volume of your chemical for each end use
  • you want to simplify the process of working out your human health exposure band but still want a more refined human health categorisation volume

HHCV calculation for this approach

Allocate the total introduction volume to the end use scenario that has the highest exposure reduction factor (from the table), and use Equation (1) to calculate the HHCV. Note: do not just use the volume for one of the end uses.

Option 2: More detailed approach

Use option 2 if:

  • you know the annual introduction volume of your chemical for each end use
  • you are willing to keep track of any changes to your introduction volume for each end use. This is needed to make sure that the indicative human health risk of your introduction does not increase.

HHCV calculation for this approach

Calculate a separate human health categorisation volume for each of your end uses. Use the exposure reduction factor for the end use (from the table), and the volume that you will be introducing for that end use. Do this for all of your end uses and then add them up to get your total human health categorisation volume (use equation (2) below).

HHCV = (IV1 x ERF1) + (IV2 x ERF2) +… + (IVn x ERFn)

Note: IVn = the introduction volume for end use ‘n’

ERFn = the exposure reduction factor (ERF) for end use ‘n’.

Go back to step 4.3

Step 4.4 Work out your human health hazard characteristics

To work out the human health hazard characteristics your chemical DOES and DOES NOT have, you must know your human health exposure band (Step 4.3). The information you need to consider hazard characteristics varies depending on your introduction’s exposure band.

Important! Your starting point is always hazard band C (the highest hazard band)
Then work your way down the hazard bands as far as you need to get to your outcome (that is, C then B then A). Our guidance on this page steps you through this. Tables on this page list the hazard characteristics for each hazard band.

Information on this page is an overview only. Please download the Categorisation Guidelines so you can check how we define a particular hazard characteristic and for guidance on how you can prove your chemical does not have that characteristic.


Download the Categorisation Guide to help you with this step


On this page:

  • Hazard characteristics in human health hazard bands
  • Information you need and hazard characteristics you need to consider
  • Information you need for lower indicative risk
  • Where to start and stop when considering your chemical's hazard characteristics
  • When you might not need to consider all of the hazard bands
  • When you can STOP working through your chemical's human health hazard characteristics
  • How to consider each hazard characteristic
  • How to prove that your chemical does not have a hazard characteristic 
  • Hazard band tables
  • Using our list of chemicals with high hazards for categorisation

Hazard characteristics in human health hazard bands

A chemical has a human health hazard characteristic if the chemical can cause damage, harm or adverse effects to humans. For example, a chemical that has the 'skin corrosion hazard' characteristic can cause irreversible damage to the skin of humans.

Human health hazard characteristics are split up into hazard bands. Hazard characteristics of most concern are in hazard band C, while those of lower concern are in hazard band A.

These tables list hazard characteristics for each hazard band. Where you need to, refer to the relevant part of our Categorisation Guidelines for a complete description of a particular hazard characteristic (eg carcinogenicity and so on).

Information you need and hazard characteristics you need to consider

This varies depending on your introduction’s human health exposure band.

The following information is a summary — for complete details, you need to refer to the Categorisation Guidelines.

If your introduction is in a LOWER exposure band

Generally, in the lower exposure bands, where the level of exposure to humans is relatively low, as a minimum you have to consider only a few hazard characteristics and you don’t need much information on them (we explain this further in the Categorisation Guidelines).

If your introduction is in a HIGHER exposure band

In comparison, in higher exposure bands, where the level of exposure to humans is higher, generally you’ll need to consider more hazard characteristics and need more information on them (we explain this further in the Categorisation Guidelines).

Information you need for lower indicative risk

You will need more hazard information to be able to get to lower indicative risk outcomes. Generally, within any given human health exposure band you need:

  • less hazard information to get to medium to high risk
  • more hazard information to get to low risk
  • the most hazard information to get to very low risk

See Step 4.5 for more information about indicative human health risk outcomes

Where to start and when you can stop considering your chemical's hazard characteristics

Starting point — is always hazard band C

Always start in the highest hazard band (hazard band C) and work your way down the hazard bands as far as you need to get to your outcome (that is, C then B then A).

You must consider each hazard characteristic in the hazard band you are in (unless there is a reason for you to stop sooner) — does your chemical have that hazard characteristic or not?

  • Hazard band C (has 5 hazard characteristics you need to consider)
  • Hazard band B (has 9 hazard characteristics you need to consider)
  • Hazard band A (has 6 hazard characteristics you need to consider)

When you might not need to consider all of the hazard bands

  • Because your introduction’s human health exposure band (which you worked out in step 4.3) doesn’t require it. For example, if your introduction’s human health exposure band is 1, you only need to consider the hazards in hazard band C to get to an indicative human health risk of either low or very low.
  • Because the outcome for indicative human health risk that you are trying to get to doesn’t require it. For example, if your introduction’s human health exposure band is 3 and you want to get to an indicative human health risk of low, you only need to consider the hazard characteristics in human health hazard band C.

In many cases, you’ll only need to consider hazard band C. But in other cases you might need to consider C, B and A because your introduction is in exposure band 3 or 4 and you are trying to get to very low indicative human health risk.

See step 4.5 for more about indicative human health risk outcomes

When you can STOP working through your chemical’s human health hazard characteristics

STOP if you:

  • determine that your chemical has a hazard characteristic in the hazard band (eg carcinogenicity — you are in hazard band C) OR
  • cannot demonstrate that your chemical does NOT have a certain hazard characteristic in that hazard band. This means that we consider your chemical to have this hazard characteristic OR
  • get to an indicative human health risk outcome and don’t want to go any further — see step 4.5 for more information about human health risk outcomes OR
  • have demonstrated that your chemical does not have any hazard characteristics in hazard bands C, B and A. This would only be needed for human health exposure bands 3 and 4. It means that the indicative human health risk of your introduction is very low.

After you stop, you don’t need to consider the remaining hazard characteristics in the hazard band where you stopped, or any of the hazard characteristics in lower hazard bands. Take note of where and why you stopped.

Example: Anna's introduction is in human health exposure band 4. She considers all of the hazard characteristics in human health hazard band C and can demonstrate that her chemical does not have any of these hazards. Anna then moves on to hazard band B. She works through the hazard characteristics in this hazard band in the order that they are shown in the table. When Anna comes to eye damage, she finds that her chemical has the 'eye damage' hazard characteristic. This means Anna can stop there. The indicative human health risk of Anna's introduction is medium to high. She does not need to continue further to see if her chemical has any of the other hazard characteristics in hazard band B, like skin sensitisation, or specific target organ toxicity after repeated exposure. Also Anna doesn't need to consider if her chemical has any of the hazard characteristics in hazard band A, such as skin irritation.

How to consider each hazard characteristic

Look at whether your chemical meets the hazard characteristic definition based on the information that you have.

If it DOES MEET the hazard characteristic definition, stop there.

If it DOES NOT MEET the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic.

Part 6 of the Categorisation Guidelines has hazard characteristic definitions, and the ways to prove that your chemical does not have each hazard characteristic. For example, part 6.3.1 of the Categorisation Guidelines defines carcinogenicity in human health hazard band C, and part 6.3.2 tells you ways that you could prove that your chemical does not have the carcinogenicity hazard characteristic.

How to prove that your chemical does not have a hazard characteristic

Options in the Categorisation Guidelines for proving that your chemical doesn't have a particular hazard characteristic include:

  • checking if your chemical is on the list of chemicals with high hazards for categorisation
  • in silico predictions
  • in vitro test results
  • in vivo test results
  • other information about your chemical that means that testing and in silico predictions are not necessary (that is, information waivers)

In most cases, you can use suitable read-across information in place of information on the chemical itself. Refer to Appendix 8.3 of the Categorisation Guidelines for more details about what we consider to be suitable read across information. You can also read our guidance about working out your hazards using read-across information.

If you can prove that your chemical does not have the hazard characteristic, move on to the next hazard characteristic in that hazard band, or from the next hazard band down.

If you cannot prove that your chemical does not have the hazard characteristic, stop there – your chemical is considered to have this hazard characteristic.

Take note of the hazard band that this hazard characteristic is in.

If your chemical is one of these:

  • polyhalogenated organic chemical
  • UV filter
  • is introduced for an end use in a tattoo ink
  • is introduced for an end use in a personal vaporiser
  • is introduced for an end use in an article that is a children’s toy or a children’s care product
  • is introduced for an end use in an article with food contact

there may be different requirements for you to prove that your chemical does not have certain hazard characteristics. See Part 6 of the Categorisation Guidelines for details.

Human health hazard band C hazard characteristics – using our list of chemicals with high hazards for categorisation

In most cases we do not expect that you will have information about the high level hazard characteristics in human health hazard band C, such as carcinogenicity. Instead, to demonstrate that your chemical does not have these hazard characteristics you can search the list of chemicals with high hazards for categorisation. This is a list that we have compiled directly from trusted international sources, and provides you with a single place to search for your chemical to check if it might be known to have these hazards. The Categorisation Guidelines tells you when you might need to search this list.

Learn more about our list of chemicals with high hazards for categorisation and how to use it 

Hazard band tables

Hazard band C hazard characteristics

Hazard band C hazard characteristic Categorisation Guidelines
(relevant part)
Carcinogenicity 6.3
Reproductive toxicity 6.4
Development toxicity 6.5
Adverse effects mediated by an endocrine mode of action 6.6
Genetic toxicity 6.7

Hazard band B hazard characteristics

Hazard band B hazard characteristics Categorisation Guidelines
(relevant part)
High molecular weight polymer that is water absorbing 6.8
Respiratory sensitisation 6.9
Corrosive 6.10
Specific target organ toxicity after a single exposure (significant toxicity) 6.11
Skin corrosion 6.12
Eye damage 6.13
Skin sensitisation 6.14
Acute toxicity (fatal or toxic) 6.15
Specific target organ toxicity after repeated exposure 6.16

Hazard band A hazard characteristics

Hazard band A hazard characteristics Categorisation Guidelines
(relevant part)
High molecular weight polymer that has lung overloading potential 6.17
Aspiration hazard 6.18
Specific target organ toxicity after a single exposure (harmful or transient effects) 6.19
Skin irritation 6.20
Eye irritation 6.21
Acute toxicity (harmful) 6.22

 

Next: Go to step 4.5 Your human health risk for categorisation

Step 4.5 Outcome - your human health risk for categorisation

The table on this page shows how you can work out your indicative human health risk by using your human health exposure band and the human health hazard characteristics that your chemical does or does not have.

Get help with this step — explore our categorisation decision tools

We explain the table in detail for each human health exposure band that your introduction could be in. This includes what your indicative human health risk outcome will be, depending on which hazard characteristics your chemical does or does not have. Your outcome will be that your introduction has an indicative human health risk of:

  • medium to high
  • low OR
  • very low

Refer back to step 4.4 for information about how to consider the hazard characteristics and where to start and stop when considering hazard characteristics.

Human health risk table

Work out your indicative human health risk Human health exposure band
    1 2 3 4
Human health hazard band C Low risk Medium to high risk Medium to high risk Medium to high risk
B Very low risk Very low risk Low risk Medium to high risk
A Very low risk Very low risk Low risk Low risk
Not C, B, A Very low risk Very low risk Very low risk Very low risk

If your introduction is in human health exposure band 1

If your introduction is in human health exposure band 1, you will need to consider if your chemical has any of the hazard characteristics in human health hazard band C. It’s not necessary to consider the hazard characteristics in band B or A.

The indicative human health risk of your introduction will be:

  • low if your chemical has 1 or more of the hazard characteristics in human health hazard band C OR
  • very low if your chemical does not have any of the hazard characteristics in human health hazard band C

If your introduction is in human health exposure band 2

If your introduction is in human health exposure band 2, you will need to consider if your chemical has any of the hazard characteristics in human health hazard band C. It’s not necessary to consider the hazard characteristics in band B or A.

The indicative human health risk of your introduction will be:

  • medium to high if your chemical has 1 or more of the hazard characteristics in human health hazard band C OR
  • very low if your chemical does not have any of the hazard characteristics in human health hazard band C

If your introduction is in human health exposure band 3

If your introduction is in human health exposure band 3, at a minimum, you will need to consider if your chemical has any of the hazard characteristics in human health hazard band C.

The indicative human health risk of your introduction will be:

  • medium to high if your chemical has 1 or more of the hazard characteristics in human health hazard band C OR
  • low if your chemical does not have any of the hazard characteristics in human health hazard band C

You can choose to stop if you get to low indicative human health risk.

If you want to see if your introduction could have a very low indicative human health risk, you will also need to consider if it has any of the hazard characteristics in human health hazard bands B and A.

The indicative human health risk of your introduction will be:

  • low if your chemical has 1 or more of the hazard characteristics in human health hazard band B or A OR
  • very low if your chemical does not have any of the hazard characteristics in human health hazard band B or A

If your introduction is in human health exposure band 4

If your introduction is in human health exposure band 4, you will first need to consider if your chemical has any of the hazard characteristics in human health hazard band C. If it does not, then continue on to consider the hazard characteristics in human health hazard band B.

The indicative human health risk of your introduction will be:

  • medium to high if your chemical has 1 or more of the hazard characteristics in human health hazard band C or B OR
  • low if your chemical does not have any of the hazard characteristics in human health hazard band C or B

You can choose to stop if you get to low indicative human health risk.

If you want to see if your introduction could have a very low indicative human health risk, you will also need to consider if it has any of the hazard characteristics in human health hazard band A.

The indicative human health risk of your introduction will be:

  • low if your chemical has 1 or more of the hazard characteristics in human health hazard band A OR
  • very low if your chemical does not have any of the hazard characteristics in human health hazard band A

'Special cases' — introductions that CANNOT have a very low indicative human health risk

Your introduction CANNOT have a very low indicative human health risk if it is a:

  • UV filter OR
  • chemical that is introduced as a solid or a dispersion that is not soluble, that meets the nanoscale particle size criteria, and the introduction of the nanoscale portion of the chemical (the part that has a particle size range of 1nm to 100nm) is incidental to the introduction of the non-nanoscale portion

If your introduction is 1 of these, and you got a very low risk outcome in this step, you need to CHANGE that outcome to LOW RISK.

This means if your consideration of step 4.5 got you to an outcome of very low risk, your final outcome needs to be changed to low risk.

Definitions of these 'special cases'

UV filter is a chemical that is intended to protect the skin against ultraviolet radiation in the range of 290nm to 400nm by absorption, reflection, or scattering of ultraviolet radiation.

Nanoscale particle size criteria means that the chemical 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 (i.e. the nanoscale).

Not soluble means the solubility of the chemical in water is less than 33.3 g/L measured following OECD test guidelines 105 or 120 for water solubility; or the dissolution rate of the chemical is not more than 70%.

Next

Go to step 5 to work out the risk to the environment of your introduction

 

Step 5: Work out your introduction's risk to the environment

By now you know the human health risk of your introduction  - medium to high, low or very low - which you completed in step 4.

To be able to finish your categorisation you need to work out the risks of your introduction to the environment. To work this out start at 5.1 and continue as far as you need to through each step.

Once you have your answer for the risk of your introduction to the environment - medium to high, low or very low - go to Step 6. In Step 6 you'll combine the human health risk and the environment risk for the final category of your introduction.

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

Start at this step if your chemical introduction is a type that is always medium to high risk to the environment.

Step 5.2 Introductions that can be low risk to the environment

This step relates to international assessments and how to work out if your introduction can be low risk to the environment based on its international assessment.

Step 5.3 Work out your environment exposure band

Part of the process to work out the risk to the environment of your introduction is to work out its exposure band. There 4 environment exposure bands - Exposure band 1 has the lowest level of environment exposure and exposure band 4 the highest level

Step 5.4 Work out your environment hazard characteristics

A chemical has an environmental hazard characteristic if it can  cause damage, harm or adverse effects to the environment. Find out what you need to do to establish the environment hazard characteristics of your chemical.

Step 5.5 Outcome - your environment risk for your categorisation

Use the table on this page to confirm the risk of your introduction: medium to high, low or very low. After you this, go to step 6 to complete your categorisation.

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 tools

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.

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

Step 5.2 Introductions that can be low risk to the environment

If you've established your introduction is not medium to high risk to the environment (Step 5.1), now see if your introduction can be low risk to the environment. 

This step relates to international assessments and how work out if your introduction is of low risk to the environment based on its international assessment.

Skip this step if you are not using an internationally assessed chemical. Note, your introduction might still be low indicative risk to the environment but you will need to complete steps 5.3, 5.4 and 5.5 to work this out.

Step 5.2 instructions (international assessments)

  • Check if your chemical has been assessed or evaluated by a trusted overseas body that we accept.
  • Follow guidance on this page to see if you meet the other criteria for international assessments.
  • Follow the final part of this step to see what to do next.

Get help with this step — explore our categorisation decision tools

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


Trusted overseas bodies

We will accept international assessments or evaluations from these trusted bodies (See section 6 of the Rules for full details):

  • Opinions from the European Chemicals Agency (ECHA) Committee for Risk Assessment and the ECHA Committee for Socio-Economic Analysis. We’ll accept these opinions as long as they have been the basis for the European Commission (EC) deciding to include or update a restriction in Annex XVII of the REACH regulation (i.e. REACH restrictions). REACH registration dossiers are not accepted. 
  • European risk assessments that have been the basis for the European Commission (EC) approving active biocidal substances. These risk assessments must have been conducted by ECHA or by an authority of a member state of the European Union. The risk assessment must have been reviewed by the ECHA Biocidal Products Committee
  • Risk assessments from Environment and Climate Change Canada OR Health Canada. We’ll accept certain Schedules from their current regulations and their old regulations. See table items 1 and 2 of subsection 6(3) of the General Rules for details of the schedules and regulations:
  • International parallel process assessments where:
    • Australia was involved as a secondary jurisdiction and
    • The risk assessment was done by Environment and Climate Change Canada OR Health Canada OR by the United States Environmental Protection Agency (US EPA)

Next:

Go to the following section on this page to check if the international assessment or evaluation meets all the required criteria for you to be able to use it for categorisation purposes.


Criteria for internationally assessed introductions

Your introduction CAN BE low risk to the environment if it meets ALL the following:

  • A trusted overseas assessment body assessed or evaluated your chemical for its risks to the environment
  • A report by the assessment body is available and you can provide it to us if we ask for it
  • The chemical's international assessment or evaluation was for:
    • the same end use as your introduction
    • a volume equal to or higher than the introduction volume of your chemical in Australia
  • The risks to the environment from the introduction and use are no higher in Australia than the overseas jurisdiction (determined in accordance with part 4.2.2 of the Guidelines)
  • The international assessment or evaluation has:
    • conditions or restrictions that must be followed to manage risks to environment and you can follow these conditions in Australia or
    • has no restrictions or conditions
  • No more information has become available since completion of the international assessment or evaluation about: 
    • any hazards to environment the international assessment or evaluation didn't identify or
    • an increase in severity of any hazards to environment the international assessment or evaluation did identify

and

  • the introduction isn't prohibited in the country that conducted the assessment or evaluation

Outcomes for this step and what to do next

My introduction meets the criteria for international assessments

This means your introduction CAN be low risk to the environment. You can either decide to continue with your categorisation to check if it can be very low risk to the environment or go to Step 6 to complete your categorisation.

Next (if continuing with step 5):

To work out if it can be very low risk to the environment, you need to complete the rest of step 5:

Once you've done this, go to step 5.5 for your final answer (is your introduction still low risk to the environment or is it very low risk).

Go to step 5.3 Work out your introduction's exposure band

My introduction does not meet the international assessment criteria on this page

Your introduction might still be low risk to the environment but you'll need to complete further steps to work this out.

Next:

To work out if your introduction can be low risk to the environment, complete the rest of step 5:

Once you’ve done this, go to step 5.5 for your final answer (to see if your introduction can be low indicative risk to the environment).

Go to step 5.3 Work out your introduction's exposure band

Step 5.3 Work out your environment exposure band

There are 4 environment exposure bands - exposure band 1 has the lowest level of environmental exposure and exposure band 4 the highest level. Follow steps on this page to work out your environment exposure band.

Are you introducing a chemical that will have a designated kind of release to the environment? If you are, your introduction is automatically in exposure band 4 for environment — go to Step 5.4: Work out your environment hazard characteristics.

Getting started

  • Look at the questions / scenarios we pose under each exposure band to work out your exposure band.
  • You need to know your environment categorisation volume — follow our guidance on how to work this out.
  • You must know the volume of the chemical you are introducing. This will mean that you can work out the environment categorisation volume of your chemical.
  • There are 4 exposure bands, start at exposure band 1 and work down the page.
  • Each exposure band directs you to your next step depending on your answer.
  • When you know your exposure band, you then need to work out the environment hazard characteristics of your introduction (step 5.4)

Need to know your environment categorisation volume?

Get help with working out your environment categorisation volume

Explore our online decision tool on categorisation volumes


Why you need to work out your introduction's exposure band?

It is part of the process to identify the indicative environment risk of your introduction. In step 4, you also had to work out your introduction's human health exposure band.

What does an environment exposure band identify about your introduction?

It identifies the likelihood and extent of environmental exposure to the chemical.  This likelihood and extent of exposure increases with each band. Exposure band 1 is the lowest exposure band, and exposure band 4 the highest. Introductions in environment exposure band 1 will have the lowest level of environmental exposure, and exposure band 4, the highest.

Information that's used to assign a chemical to its correct exposure band

  • Environment categorisation volume. 
  • If your chemical has a designated kind of release into the environment.

We define 'designated kind of release into the environment' (which we refer to throughout this page) to be where the chemical is intentionally released during use to land, biota, natural waterways, municipal water supplies or air (unless its only for domestic or personal use). It also includes any releases to the environment from firefighting end uses and releases into the ocean.


What's your environment exposure band?

Start with Exposure Band 1 and work down the page.

Note, if your introduction has a designated kind of release into the environment, it will be in exposure band 4.

Exposure band 1 criteria

To be in exposure band 1, your introduction must meet the criteria:

  • The environment categorisation volume for your chemical does not exceed 25kg

Next...Work out the environment hazard characteristics of your introduction (Step 5.4)

If your introduction does not meet criteria for band 1; Next...check exposure band 2.

Exposure band 2 criteria

To be in exposure band 2, your introduction must meet the criteria:

  • The environment categorisation volume for your chemical is greater than 25kg, but no more than 1,000kg

Next...Work out the environment hazard characteristics of your introduction (Step 5.4)

If your introduction does not meet criteria, go to Exposure band 2; Next...check exposure band 3.

Exposure band 3 criteria

To be in exposure band 3, your introduction must meet the criteria:

  • The environment categorisation volume for your chemical is greater than 1,000kg, but no more than 10,000kg

Next...Work out the environment hazard characteristics of your introduction (Step 5.4).

If you are not in exposure bands 1-3 for the environment, you are in exposure band 4.

Exposure band 4 criteria

Reminder about introductions with a designated kind of release into the environment: if you're introducing one of these you are automatically in exposure band 4 for the environment. If this is your introduction type, go to Step 5.4: Work out your environment hazard characteristics.

To be in exposure band 4, your introduction must meet the criteria — the environment categorisation volume of your introduction is greater than 10,000kg.

Next:

Step 5.4 Work out your environment hazard characteristics

 

 

 

 

Work out your environment categorisation volume

This page accompanies Step 5.3 work out your environment exposure band.

You need to know the environment categorisation volume (ECV) of your introduction to work out its environment exposure band.

Explore our categorisation tool for help on this subject

Are you introducing a chemical that will have a DESIGNATED KIND OF RELEASE INTO THE ENVIRONMENT? If you are, your introduction is automatically in exposure band 4 for environment — go to Step 5.4: Work out your environment hazard characteristics.

Instructions

  • Use this guidance to calculate your introduction's environment categorisation volume.
  • We've included the equations to use and the options you have to choose from, dependent on the scenarios of your introduction.
  • You can adopt a simple method or a more detailed method (which can result in a lower introduction volume than the simpler method).
  • Once you have worked out your environment categorisation volume, you can complete step 5.3.

Methods you can use to work out an ECV for your chemical

There are 2 ways to work out the environment categorisation volume.

Method 1: Simplest approach

Use this method if you want an easy way to work out your environment exposure band.

ECV calculation for this approach

The ECV is your chemical’s total introduction volume in a registration year for all end uses.

Method 2: More detailed approach

Use this method if you want a more refined environment categorisation volume. Using this method could result in an ECV that is lower than the total introduction volume in a year. This could mean that your introduction ends up being in a lower environment exposure band than if the total introduction volume (method 1) had been used.

The calculation of the ECV using method 2 is different depending on whether your chemical introduction has 1 end use or more than 1 end use.

If your introduction has 1 end use

For a chemical with only 1 end use, calculate the ECV by multiplying the introduction volume (IV) by the release reduction factor (RRF) for your chemical’s end use scenario:

Equation (1): ECV = IV x RRF

The introduction volume you should use in your calculation is the total introduction volume in a registration year. Use the RRF that applies to your end use scenario (see table for RRFs for different end uses in Categorisation Guidelines part 2.1.2).

The RRF values range between 0 and 1. A low RRF indicates that only a small portion of the introduction volume is likely to contribute to environmental exposure. A higher RRF indicates that a higher proportion of the introduction volume could contribute to environmental exposure.

If your introduction has more than 1 end use

You can choose from 2 options to calculate the ECV where your chemical has more than 1 end use.

Option 1: Simplest approach

Use this option if:

  • you do not know the annual introduction volume of your chemical for each end use
  • you want to simplify the process of working out your environment exposure band but still want a more refined environment categorisation volume

ECV calculation for this approach

Allocate the total introduction volume to the end use scenario that has the highest RRF (Categorisation Guidelines part 2.1.2), and use Equation (1) to calculate the ECV. Note: do not just use the volume for one of the end uses.

Option 2: More detailed approach

Use option 2 if:

  • you know the annual introduction volume of your chemical for each end use
  • you are willing to keep track of any changes to your introduction volume for each end use. This is needed to make sure that the indicative environment risk of your introduction does not increase

Calculate a separate environment categorisation volume for each of your end uses. Use the RRF for the end use (Categorisation Guidelines part 2.1.2), and the volume that you will be introducing for that end use. Do this for all of your end uses and then add them up to get your total environment categorisation volume (use equation (2) below).

ECV = (IV1 x RRF1) + (IV2 x RRF2) +… + (IVn x RRFn)

Note: IVn = the introduction volume for end use ‘n’

RRFn = the release reduction factor (RRF) for end use ‘n’.

Go back to step 5.3

Step 5.4 Work out your environment hazard characteristics

To work out the environment characteristics your chemical DOES and DOES NOT have, you must know your environment exposure band (Step 5.3). The information you need to consider hazard characteristics varies depending on your introduction’s exposure band.

Important! Your starting point is always hazard band D (the highest hazard band)    
Then work your way down the hazard bands as far as you need to get to your outcome (that is, D, then C, then B, then A). Our guidance on this page steps you through this. Tables on this page list the hazard characteristics for each hazard band.

Information on this page is an overview only. Make sure you have our Categorisation Guidelines available to refer to. You’ll need these to see how we define a particular hazard characteristic and for guidance on how you can prove your chemical does not have that characteristic.


Download the Categorisation Guidelines to help you with this step


On this page:

  • Hazard characteristics in environment hazard bands
  • Information you need and hazard characteristics you need to consider
  • Information you need for lower indicative risk
  • Where to start and stop when considering your chemical's hazard characteristics
  • When you might not need to consider all of the hazard bands
  • When you can STOP working through your chemical's environment hazard characteristics
  • How to consider each hazard characteristic
  • How to prove that your chemical does not have a hazard characteristic 
  • Hazard band tables

Hazard characteristics in environment hazard bands

A chemical has an environment hazard characteristic if the chemical can cause damage, harm or adverse effects to the environment. For example, a chemical that has the 'toxic to any aquatic life' hazard characteristic can cause toxic injury to an organism following short term aquatic exposure.

Environment hazard characteristics are split up into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A.

These tables list hazard characteristics for each hazard band. Where you need to, refer to the relevant part of our Categorisation Guidelines for a complete description of a particular hazard characteristic (e.g. synthetic greenhouse gas and so on).

Information you need and hazard characteristics you need to consider

This varies depending on your introduction’s environment exposure band.

The following information is a summary - for complete details, you need to refer to the Categorisation Guidelines.

If your introduction is in a LOWER exposure band

Generally, in the lower exposure bands, where the level of exposure to the environment is relatively low, as a minimum you have to consider only a few hazard characteristics and you don’t need much information on them (we explain this further in the Categorisation Guidelines).

If your introduction is in a HIGHER exposure band

In comparison, in higher exposure bands, where the level of exposure to the environment is higher, generally you’ll need to consider more hazard characteristics and need more information on them (we explain this further in the Categorisation Guidelines).

Information you need for lower indicative risk

You will need more hazard information to be able to get to lower indicative risk outcomes. Generally, within any given environment exposure band you need:

  • Less hazard information to get to medium to high risk
  • More hazard information to get to low risk
  • The most hazard information to get to very low risk

See Step 5.5 for more information about indicative environment risk outcomes

Where to start and when you can stop considering your chemical's hazard characteristics

Starting point — is always hazard band D

Always start in the highest hazard band (hazard band D) and work your way down the hazard bands as far as you need to get to your outcome (that is, D, C then B then A).

You must consider each hazard characteristic in the hazard band you are in (unless there is a reason for you to stop sooner) - does your chemical have that hazard characteristic or not?

  • Hazard band D (has 5 hazard characteristics you need to consider)
  • Hazard band C (has 2 hazard characteristics you need to consider)
  • Hazard band B (has 1 hazard characteristics you need to consider)
  • Hazard band A (has 6 hazard characteristics you need to consider)

When you might not need to consider all of the hazard bands

  • Because your introduction’s environment exposure band (which you worked out in step 5.3) doesn’t require it. For example, if your introduction’s environment exposure band is 2, you only need to consider the hazards in hazard band D to get to an indicative environment risk of either medium to high or low.
  • Because the outcome for indicative environment risk that you are trying to get to doesn’t require it. For example, if your introduction’s environment exposure band is 3 and you want to get to an indicative environment risk of low, you only need to consider the hazard characteristics in environment hazard bands D and C.

In many cases, you’ll only need to consider hazard band D. But in other cases you might need to consider D, C, B and A because your introduction is in exposure band 3 or 4 and you are trying to get to very low indicative environment health risk.

See step 5.5 for more about indicative environment health risk outcomes

When you can STOP working through your chemical’s environment hazard characteristics

STOP if you:

  • Determine that your chemical has a hazard characteristic in the hazard band (e.g. persistent, bioaccumulative and toxic - you are in hazard band D) OR
  • Cannot demonstrate that your chemical does NOT have a certain hazard characteristic in that hazard band . This means that we consider your chemical to have this hazard characteristic OR
  • Get to an indicative environment risk outcome and don’t want to go any further - see step 5.5 for more information about environment risk outcomes OR
  • Have demonstrated that your chemical does not have any hazard characteristics in hazard bands D, C, B and A . This would only be needed for environment exposure bands 3 and 4. It means that the indicative environment risk of your introduction is very low

After you stop, you don’t need to consider the remaining hazard characteristics in the hazard band where you stopped, or any of the hazard characteristics in lower hazard bands. Take note of where and why you stopped.

Example: Rosemary's introduction is in environment exposure band 4. She considers all of the hazard characteristics in environment hazard band D and can demonstrate that her chemical does not have any of these hazards. Rosemary then moves on to hazard band C. She works through the hazard characteristics in this hazard band in the order that they are shown in the table. When Rosemary comes to 'very toxic to any aquatic life', she finds that her chemical has this hazard characteristic. This means Rosemary can stop there. The indicative environment risk of Rosemary's introduction is medium to high. She does not need to continue further to see if her chemical has the other hazard characteristic in hazard band C (persistent and bio-accumulative). Also Rosemary doesn't need to consider if her chemical has any of the hazard characteristics in hazard bands B or A.

How to consider each hazard characteristic

Look at whether your chemical meets the hazard characteristic definition based on the information that you have.

If it DOES MEET the hazard characteristic definition, stop there.

If it DOES NOT MEET the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic.

Part 6 of the Categorisation Guidelines has hazard characteristic definitions, and the ways to prove that your chemical does not have each hazard characteristic. For example, part 6.26.1 of the Categorisation Guidelines defines persistent, bio-accumulative and toxic (PBT) in environment hazard band D and part 6.26.2 tells you ways that you could prove that your chemical does not have the PBT hazard characteristic.

How to prove that your chemical does not have a hazard characteristic

Options in the Categorisation Guidelines for proving that your chemical doesn't have a particular hazard characteristic include:

  • Checking if your chemical is on the list of chemicals with high hazards for categorisation
  • In silico predictions
  • In vitro test results
  • In vivo test results
  • Other information about your chemical that means that testing and in silico predictions are not necessary (that is, information waivers)

In most cases, you can use suitable read-across information in place of information on the chemical itself. Refer to Appendix 8.3 of the Categorisation Guidelines for more details about what we consider to be suitable read-across information. You can also read our guidance about working out your hazards using read-across information.

If you can prove that your chemical does not have the hazard characteristic, move on to the next hazard characteristic in that hazard band, or from the next hazard band down.

If you cannot prove that your chemical does not have the hazard characteristic, stop there – your chemical is considered to have this hazard characteristic.

Take note of the hazard band that this hazard characteristic is in.

If your chemical is one of these:

  • highly branched organic chemical
  • introduced for an end use as a biocidal active

there may be different requirements for you to prove that your chemical does not have certain hazard characteristics. See Part 6 of the Categorisation Guidelines for details.

Hazard band tables

Hazard band D hazard characteristics

Hazard characteristic Hazard characteristic
Contains arsenic, cadmium, lead or mercury -
Ozone depleting chemical 6.23
Synthetic greenhouse gas 6.24
Adverse effects mediated by an endocrine mode of action 6.25
Persistent, bioaccumulative and toxic 6.26

Hazard band C hazard characteristics

Hazard characteristic Hazard characteristic
Very toxic to any aquatic life 6.27
Persistent and bioaccumulative 6.28

Hazard band B hazard characteristics

Hazard characteristic Hazard characteristic
Toxic to any aquatic life 6.29

Hazard band A characteristics

Hazard characteristic Hazard characteristic
Contains aluminium, chromium, copper, nickel, selenium, silver or zinc -
Polymer that does not have a low cationic density -
Polymer that is not stable 6.30
Bioaccumulation potential 6.31
Industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability 6.32
Harmful to any aquatic life 6.33

Next go to step 5.5 Your risk to the environment for categorisation

Step 5.5 Your environment risk for categorisation

The table on this page shows how you can work out your indicative environment risk by using your environment exposure band (step 5.3) and the environment hazard characteristics (step 5.4) that your chemical does or does not have. 

Get help with this step — explore our categorisation decision tools

We explain the table in detail for each environment exposure band that your introduction could be in. This includes what your indicative environment risk outcome will be, depending on which hazard characteristics your chemical does or does not have. Your outcome will be that your introduction has an indicative environment risk of:

  • Medium to high
  • Low OR
  • Very low

Refer back to step 5.4 for information about how to consider the hazard characteristics and where to start and stop when considering hazard characteristics.

Environment risk table

Work out your indicative environment risk Environment exposure band
1 2 3 4
Environment hazard band D Medium to high risk Medium to high risk Medium to high risk Medium to high risk
C Low risk Low risk Medium to high risk Medium to high risk
B Very low risk Low risk Low risk Medium to high risk
A Very low risk Very low risk Low risk Low risk
Not A, B, C or D Very low risk Very low risk Very low risk Very low risk

If your introduction is environment exposure band 1

If your introduction is in environment exposure band 1, at a minimum, you will need to consider if your chemical has any of the hazard characteristics in environment hazard band D.

The indicative environment risk of your introduction will be:

  • Medium to high if your chemical has 1 or more of the hazard characteristics in environment hazard bands D OR
  • Low if your chemical does not have any of the hazard characteristics in environment hazard band D

You can choose to stop if you get to low indicative environment risk.

If you want to see if your introduction could have a very low indicative environment risk, you will also need to consider if it has any of the hazard characteristics in environment hazard band C.

The indicative environment risk of your introduction will be:

  • Low if your chemical has 1 or more of the hazard characteristics in environment hazard band C OR
  • Very low if your chemical does not have any of the hazard characteristics in environment hazard band C

If your introduction is environment exposure band 2

If your introduction is in environment exposure band 2, you will need to consider if your chemical has any of the hazard characteristics in environment hazard band D.

The indicative environment risk of your introduction will be:

  • Medium to high if your chemical has 1 or more of the hazard characteristics in environment hazard band D OR
  • Low if your chemical does not have any of the hazard characteristics in environment hazard band D

You can choose to stop if you get to low indicative environment risk.

If you want to see if your introduction could have a very low indicative environment risk, you will also need to consider if it has any of the hazard characteristics in environment hazard bands C and B.

The indicative environment risk of your introduction will be:

  • Low if your chemical has 1 or more of the hazard characteristics in environment hazard bands C or B OR
  • Very low if your chemical does not have any of the hazard characteristics in environment hazard bands C or B

If your introduction is environment exposure band 3

If your introduction is in environment exposure band 3, you will first need to consider if your chemical has any of the hazard characteristics in environment hazard band D. If it does not, then continue on to consider the hazard characteristics in environment hazard band C.

The indicative environment risk of your introduction will be:

  • Medium to high if your chemical has 1 or more of the hazard characteristics in environment hazard bands D or C OR
  • Low if your chemical does not have any of the hazard characteristics in environment hazard bands D or C

You can choose to stop if you get to low indicative environment risk.

If you want to see if your introduction could have a very low indicative environment risk, you will also need to consider if it has any of the hazard characteristics in environment hazard bands B and A.

The indicative environment risk of your introduction will be:

  • Low if your chemical has 1 or more of the hazard characteristics in environment hazard bands B or A OR
  • Very low if your chemical does not have any of the hazard characteristics in environment hazard bands B or A

If your introduction is environment exposure band 4

If your introduction is in environment exposure band 4, you will first need to consider if your chemical has any of the hazard characteristics in environment hazard band D. If it does not, then continue on to consider the hazard characteristics in environment hazard band C. If it does not, then continue on to consider the hazard characteristics in environment hazard band B.

The indicative environment risk of your introduction will be:

  • Medium to high if your chemical has 1 or more of the hazard characteristics in environment hazard bands D, C or B OR
  • Low if your chemical does not have any of the hazard characteristics in environment hazard bands D, C or B

You can choose to stop if you get to low indicative environment risk.

If you want to see if your introduction could have a very low indicative environment risk, you will also need to consider if it has any of the hazard characteristics in environment hazard band A.

The indicative environment risk of your introduction will be:

  • Low if your chemical has 1 or more of the hazard characteristics in environment hazard band A OR
  • Very low if your chemical does not have any of the hazard characteristics in environment hazard band A

'Special cases' - introductions that CANNOT have a very low indicative environment risk

Your introduction CANNOT have a very low indicative environment risk if it is a:

  • Organotin chemical OR
  • Polyhalogenated organic chemical OR
  • A chemical that has an end use as a biocidal active OR
  • A chemical that is introduced as a solid or a dispersion that is not soluble, that meets the nanoscale particle size criteria, and the introduction of the nanoscale portion of the chemical (the part that has a particle size range of 1nm to 100nm) is incidental to the introduction of the non-nanoscale portion

If your introduction is 1 of these, and you got a very low risk outcome in this step, you need to CHANGE that outcome to LOW RISK.

This means if your consideration of step 5.5 got you to an outcome of very low risk, your final outcome needs to be changed to low risk.

Definitions of these 'special cases'

Organotin chemicals are chemicals that contain at least 1 tin atom that is covalently bound to at least one carbon atom.

Polyhalogenated organic chemicals are carbon-based chemicals that contain more than 1 covalently bonded halogen atom, such as bromine, chlorine, fluorine or iodine.

Biocidal active is a chemical that is intended to act by chemical means on or against a harmful organism by destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, the harmful organism.

Nanoscale particle size criteria means that the chemical 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 (i.e. the nanoscale).

Not soluble means the solubility of the chemical in water is less than 33.3 g/L measured following OECD test guidelines 105 or 120 for water solubility; or the dissolution rate of the chemical is not more than 70%.

Next – go to step 6 to complete your categorisation 

Step 6: Complete your categorisation

In this step, it's time to work out your introduction’s category using your introduction's indicative human health risk from step 4.5 and indicative environment risk from step 5.5.

What's my introduction's category?

Your introduction is 1 of the following.

Exempted

The indicative risk of your introduction to both human health and the environment is 'very low'.

Reported

The highest indicative risk of your introduction to human health or the environment is 'low'. This means either low risk to both human health and the environment, or, low risk for one and very low risk for the other.

Assessed

The highest indicative risk of your introduction to human health or the environment is 'medium to high'. This means either medium to high risk to both human health and environment, or, medium to high risk for one and low or very low risk for the other.

Example: David has worked through step 4.5 and found that his introduction's indicative human health risk is low. He then worked through step 5.5 and found that the indicative risk to the environment is medium to high. The highest indicative risk for David's introduction is medium to high, therefore his introduction is categorised as assessed.

We have summarised this in our image below.

  1. First, find the column that corresponds with your introduction's indicative human health risk, which is either 'very low', 'low' or 'medium to high'.
  2. Next, move down the rows until you find your introduction's indicative environment risk, which is either 'very low', 'low' or 'medium to high'.
  3. Where these intersect, you have your introduction category
A diagram of the risk to human health and the environment of an industrial chemical introduction. This is explained in full on the content of the page.

All risk combinations and outcomes:

  • Indicative human health risk very low, indicative environment risk very low = exempted introduction
  • Indicative human health risk very low, indicative environment risk low = reported introduction
  • Indicative human health risk very low, indicative environment risk medium to high = assessed introduction
  • Indicative human health risk low, indicative environment risk very low = reported introduction
  • Indicative human health risk low, indicative environment risk low = reported introduction
  • Indicative human health risk low, indicative environment risk medium to high = assessed introduction
  • Indicative human health risk medium to high, indicative environment risk very low = assessed introduction
  • Indicative human health risk medium to high, indicative environment risk low = assessed introduction
  • Indicative human health risk medium to high, indicative environment risk medium to high = assessed introduction

If your introduction is categorised as exempted, you can introduce your chemical without telling us first, if you are already registered with us.

If your introduction is categorised as reported, you must be registered with us and submit a pre-introduction report before you can introduce the chemical.

If your introduction is categorised as assessed, you must be registered with us and apply for an assessment certificate before you can introduce the chemical.

See your reporting and record-keeping obligations for each introduction category