Record keeping for exempted introductions - highest indicative risk is very low

You must keep certain records for introductions where the highest indicative risk is very low risk, which you’ve categorised as exempted. You must provide these records within 20 working days if we ask for them.

On this page

Before you read this page’s content, make sure you’ve already read and understood:

why you must keep records
written undertakings as records (if you’ve relied on information held by another person — such as a supplier or manufacturer — to categorise your introduction)

Go to our record-keeping overview page for this information.

Records you must keep

The type of records you must keep depends on whether you know the CAS number or the proper name (CAS, IUPAC or INCI for plant extracts under certain criteria) for your chemical. Work through the information on this page to understand your record-keeping obligations for this type of introduction.

Use our glossary if you need to check on any terminology.

These items are to prove your introduction is not covered by any provisions of section 25, items 1-3, 7-8 in subsection 28(1) and items 1-5, 10-11 of the table in subsection 29(1) of the General Rules.

Chemical identity

If you know the CAS number – written or electronic record of the CAS number and either the CAS name or INCI name for the chemical.
If you don’t know the CAS number – you must have either A or B.

A. Written or electronic record of the CAS name or IUPAC name. An INCI name can only be used if the chemical and its name meet all 4 criteria:

i. the chemical does not have a CAS or IUPAC name

ii. the chemical is a plant extract – examples are extracts of flowers, seeds, or leaves of trees, shrubs, herbs, grasses, ferns, and mosses

iii. the name of the plant extract is an INCI name based on a proper botanical name – for example, 'Helianthus Annus Leaf/Stem Extract' is acceptable but 'Sunflower extract' is not acceptable.

iv. the plant extract cannot be chemically modified – for example, the chemical cannot be hydrolysed, acetylated, or hydrogenated.

B. Written or electronic record of the names you use to refer to your chemical and a written undertaking from the supplier or manufacturer that they will give us the proper name (CAS or IUPAC) and CAS number (if assigned) if we ask for them.
The names of any products containing your chemical that you have imported into Australia.
If it’s a UVCB substance and the human health exposure band is 4 or the environment exposure band is 3 or 4 – a record of the UVCB substance description.

If you don’t have this information – a written undertaking from the supplier or manufacturer that they will give us the UVCB substance description, if we ask for it.
If it’s a high molecular weight polymer and its human health exposure band is 4 – records to prove the following.
- number-average molecular weight
- weight-average molecular weight
- polydispersity index
- percentage by mass of molecules with molecular weight that is less than 1000g/mol
- percentage by mass of molecules with molecular weight that is less than 500g/mol
We’ll accept a GPC analysis report. If you don’t have this information – a written undertaking from the supplier or manufacturer confirming it’s a high molecular weight polymer. (They must provide information to prove the polymer molecular weight details if we ask for it.)

The introduction isn't medium to high risk or low risk

A record of the indicative human health risk and indicative environment risk for your introduction.

You will also need all of the following records or a written undertaking from the supplier or manufacturer confirming your introduction doesn’t meet the criteria for medium to high risk or low risk. They must provide the following information if we ask for it.

Records to prove your chemical:
- isn’t listed in Annex III of the Rotterdam Convention or Part 1 of Annex A, B or C of the Stockholm Convention on POPs (unless it is introduced solely for use in research or analysis and the amount that you introduce in a registration year does not exceed 100kg).
- isn’t listed on the Inventory with conditions of introduction or use that will be contravened
  
  We’ll accept a signed and dated declaration that these checks took place.
Fully fluorinated – records to prove it doesn’t contain a sequence of greater than or equal to 4 and less than or equal to 20 fully fluorinated carbon atoms. We’ll accept a signed and dated declaration that this check took place.
Polyhalogenated – records to prove it’s not a polyhalogenated organic chemical. We’ll accept a signed and dated declaration that this check took place.
Nanoscale – records to prove the following:
- it’s not introduced as a solid or in dispersion (if applicable). We’ll accept an SDS or product information sheet that indicates the appearance.
- it doesn’t meet the definition of ‘not soluble’ (see Guidelines). We’ll accept a study report (OECD test guideline 105 or 120) showing the solubility of the chemical in water is greater than or equal to 33.3 g/L; or the dissolution rate is greater than 70%.
- it doesn’t consist of particles in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale. The information we'll accept depends on the particle size range of the solid or dispersion.
  - If it’s greater than 1µm in all dimensions, we’ll accept:
    - an SDS or technical data sheet for the chemical or the product that it’s introduced in that indicates it will be introduced as granules, pellets or a wax; or
    - a study result from a particle size distribution study on your chemical or the product that you will introduce into Australia (conducted according to OECD TG 110)
  - If it’s greater than 200nm and less than or equal to 1µm in all dimensions, we’ll accept:
    - a study result from a particle size distribution study on your chemical or the product that you will introduce into Australia (conducted according to OECD TG 110). This can be used to measure particle size and distribution to support that a chemical is not at the nanoscale for particles and fibres with sizes above 250 nm.
    - draft OECD TG on particle size and particle size distribution on nanomaterials. This is currently in development and is expected to be finalised in 2022.
    - If the chemical is in a dispersion, the spectroscopy- and microscopy-based methods such as scanning electron microscopy (SEM) and transmission electron microscopy (TEM) are more appropriate.
      
      Note: For particle size distributions in this range, information only from an SDS/technical data sheet or similar is not enough.
  - If it’s less than or equal to 200nm, we’ll accept
    - A study result from a particle size distribution study on your chemical or the product that you will introduce into Australia.
    - A draft OECD TG on particle size and particle size distribution on nanomaterials. is currently under progress and expected to be finalised in 2022.
    - If the chemical is in a dispersion, the spectroscopy- and microscopy-based methods such as scanning electron microscopy (SEM) and transmission electron microscopy (TEM) are more appropriate.
      
      Note: For particle size distributions in this range, information only from an SDS/technical data sheet or similar is not enough.
Gas – records to prove the following:
- it’s not a gas. We’ll accept an SDS or product information sheet that indicates the appearance.
- the total volume introduced in a registration year is less than or equal to 100kg. We’ll accept shipping documents and any associated calculations.
- it’s not persistent (see Guidelines). We’ll accept a study report.
Organotin – records to prove it’s not an organotin chemical. We’ll accept a signed and dated declaration that this check took place.
UV filter – records to prove it’s not a UV filter. For most introductions, we’ll accept a signed and dated declaration that this check took place, but it will depend on your chemical and its end uses.
Biocidal active – records to prove it doesn’t have an end use as a biocidal active. For most introductions, we’ll accept a signed and dated declaration that this check took place, but it will depend on your chemical and its end uses.

Introduction, use and exposure

Whether your chemical is imported and/or manufactured in Australia.
The maximum total volume of your chemical that you intend to introduce in a registration year.
Records to prove the end use for your chemical. We'll accept product labels, a list of product names and uses, or technical information sheets.
The human health exposure band for your introduction and the applicable human health exposure band criteria.
If the applicable human health exposure band criteria include a concentration upper limit – a record of the maximum concentration at introduction and at each end use. We’ll accept an SDS, product labels, technical information sheets or documents from your supplier.
If the applicable human health exposure band criteria include a human health categorisation volume (HHCV) upper limit – a record of the HHCV for your chemical and records to prove the HHCV doesn’t exceed that specified in the exposure band criteria. We’ll accept shipping documents and any associated calculations.
Whether your introduction involves a designated kind of release into the environment, and if so, which kind. We’ll accept information included as part of a spreadsheet on the chemical.
The environment exposure band for your introduction and the applicable environment exposure band criteria.
If the applicable environment exposure band criteria include an environment categorisation volume (ECV) upper limit – a record of the ECV for your chemical and records to prove the ECV doesn’t exceed that specified in the exposure band criteria. We’ll accept shipping documents and any associated calculations.

Hazard characteristics

Records to prove any known hazard classification for the chemical. We’ll accept an SDS.
A record of any human health hazard characteristics and environment hazard characteristics of your chemical that are known to you.
Detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of certain human health and environment hazard characteristics that would otherwise render the introduction medium to high risk or low risk.

If you don’t have this information – a record of the outcomes of the information specified in the Guidelines, including full study reports, plus a written undertaking from the person who has the information that they’ll give it to us if we ask for it.

Specified class of introduction

Whether your introduction is a specified class of introduction and, if so, which class.

If your introduction is a specified class of introduction, you’ll also need the following records. If you don’t hold the information, there are circumstances when you can hold a written undertaking from the person who does have the information as set out below. They must provide the information to us if we ask for it

For introductions that involve a designated kind of release into the environment – if practicable, a record of the:
- location of the release into the environment (including all receiving water bodies)
- frequency of the release into the environment
- the quantity of the chemical released to the environment
  
  We‘ll accept information included as part of a spreadsheet on the chemical.
For biochemicals – a record of:
- the concentration of any remaining viable cell or cellular components of the organisms used to produce the biochemical
- any known adverse effects of any remaining viable cell or cellular components of the organisms used to produce the biochemical
  
  We'll accept a document from your supplier. If you don’t have this information, you must have a written undertaking.
For GM products – a record of:
- the name of the genetically modified organism from which the GM product was derived or produced
- details of any genetically modified organism that remains in the GM product as an impurity
  
  We’ll accept a document from your supplier. If you don’t have this information, you must have a written undertaking.
Where the end use is in an article with food contact – a record of:
- any approval (if known) for the chemical for an end use in an article with food contact in another country by an agency or authority of that country
- the potential for the chemical to migrate to food (see Guidelines).
  
  We’ll accept study reports or other information. If you don’t have this information, you must have a written undertaking.
Where the end use is in an article that’s a children’s toy or children’s care product – a record of:
- whether the article can be placed in the mouth
- if so, the potential for the chemical to be released into the mouth during end use or mouthing (see Guidelines).
  
  We’ll accept quantitative information on the extent of the chemical’s transfer to the mouth. If you don’t have this information, you must have a written undertaking.

How to print the checklist

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clicking the print button at the top-right this page / or pressing Ctrl P
selecting your printer or choosing the 'Save as PDF' option.

Examples of information you can provide on request

The following 2 examples show how you can satisfy our request to provide records.

Example 1 — If you don't know the proper name for your chemical

Chemical X introduced in formulated cosmetic products at less than 0.1% concentration — up to 200kg in a registration year

You don’t know the proper name for the chemical you’re introducing, so you rely on information from your supplier to categorise your introduction:

The human health exposure band is 2 (its indicative human health risk is very low based on the absence of human health hazard band C hazard characteristics).
The environment exposure band is 2 (its indicative environment risk is very low based on the absence of environment hazard band B, C and D hazard characteristics).

Therefore, the highest indicative risk for the introduction is very low (‘exempted introduction’). Your written undertaking from the supplier includes the following information:

The supplier will provide the proper name and CAS number for Chemical X, if we ask for them.
The introduction of Chemical X isn’t covered by any of the provisions of section 25, items 1 - 3, 7 or 8 of the table in subsection 28(1), or items 1-5, 10 or 11 of the table in subsection 29(1) of the Industrial Chemicals (General Rules) 2019. The supplier will provide the records to prove this, if we ask for them.
Chemical X is not a UVCB substance or high molecular weight polymer.
The introduction of Chemical X is not a specified class of introduction.
Chemical X isn’t known to have any of the hazard characteristics in human health band C or environment hazard bands B, C or D.
It is a skin and eye irritant.
It’s not on the list of chemicals with high hazards for categorisation.
The following information is available to demonstrate the absence of hazard characteristics: 1) a suitable in-silico prediction for partition coefficient (log Kow) of less than 4.2, and 2) suitable in-silico predictions on the chemical for aquatic toxicity to fish (LC50), invertebrates (EC50) and algae (ErC50) of greater than 10 mg/L.

Chemical X introduced in formulated cosmetic products at less than 0.1% concentration — up to 200kg in a registration year

The supplier will provide detailed information, including study reports, of the kind specified in the Guidelines to prove the absence of the hazard characteristics for Chemical X, if we ask for this information.

We then ask for your records to ensure the introduction of Chemical X is authorised as an exempted introduction.

You provide:

spreadsheet containing 1) the name of the imported chemical (Chemical X), 2) that ChemicalX is imported, 3) the names of the products containing Chemical X that are imported into Australia, 4) that less than or equal to 200 kg of Chemical X is intended to be introduced in a registration year, 5) that the indicative human health risk and indicative environment risk for the introduction of Chemical X are very low, 6) the human health and environment exposure bands an applicable exposure band criteria, 7) that the introduction of Chemical X doesn’t involve a designated kind of release into the environment, and 8) the Environment Categorisation Volume (ECV, 200 kg)
written correspondence from the supplier indicating that Chemical X is present in each of the products at less than 0.1% concentration.
technical information sheets provided by the supplier.
shipping documents to support the ECV.
a copy of your written undertaking.

The supplier provides:

the CAS name and number for Chemical X.
a signed declaration dated prior to the introduction that the appropriate checks took place to ensure Chemical X isn’t in Annex III to the Rotterdam Convention; isn’t in part I of Annex A, B or C to the Stockholm Convention on POPs; isn’t listed on the Inventory with conditions of introduction or use that will be contravened; and isn’t on the list of chemicals with high hazards for categorisation.
a signed declaration dated prior to the introduction that the appropriate checks took place to ensure Chemical X doesn’t contain greater than or equal to 4 and less than or equal to 20 fully fluorinated carbon atoms; it’s not a polyhalogenated organic chemical; it’s not a UV filter and it’s not an organotin chemical.
the SDS and technical information sheets for Chemical X indicating its appearance and solubility.
detailed information to support that the partition coefficient (log Kow) of less than 4.2 was derived from a suitable in-silico prediction for the chemical, as per the Guidelines.
detailed information to support that the aquatic toxicity predictions of greater than 10 mg/L were derived from suitable in-silico predictions for the chemical, as per the Guidelines.

Example 2 — If you do know the proper name for your chemical

Chemical T introduced as a powder and formulated into coatings - up to 150kg in a registration year

You know the proper name for the chemical you’re introducing and have all the information you need to categorise your introduction and keep records:

The human health exposure band is 2 (its indicative human health risk is very low based on the absence of human health hazard band C hazard characteristics).
The environment exposure band is 1 (its indicative environment risk is very low based on the absence of environment hazard band C and D hazard characteristics).

Therefore, the highest indicative risk for the introduction is very low (‘exempted introduction’).

We then ask for your records to ensure the introduction of Chemical T is authorised as an exempted introduction.