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

For introductions where the highest indicative risk is very low risk, which you’ve categorised as exempted, you’ll need to keep certain records – and provide them within 20 working days if we ask for them.  

On this page

Before you read this page’s content, make sure you’ve read and understood the information on our record-keeping overview page. We may ask for your records. If you’ve relied on information held by another person — such as a supplier or manufacturer — to categorise your introduction, then you must keep records on who can give certain information about the chemical to AICIS.

Records you must keep

The type of records you must keep for introductions where the highest indicative risk is very low risk can depend on:

  • whether you know the CAS number, CAS name, IUPAC name, INCI name or eligible INCI plant extract name for your chemical  
  • your introduction’s human health and environment exposure band  

An introducer is taken to know the CAS number, CAS name, IUPAC name, or INCI name/eligible INCI plant extract name if it would be reasonably practicable for them to find out that number/name.  

This means introducers must proactively try to find this information, including checking for it with their chemical supplier.   

Chemical identity

Human health exposure band is 1 or 2 and environment exposure band is 1 

  • If you know the CAS number for your chemical – written or electronic record of the CAS number for the chemical and one of the following:

    • CAS name
    • IUPAC name 
    • INCI name

    If you know the CAS name or IUPAC name for your chemical (but not CAS number) - written or electronic record of one of the following:

    • CAS name
    • IUPAC name

    If you know the INCI name for your chemical (but not the CAS number, CAS name or IUPAC name) – written or electronic record of:

    • INCI name

    If you don’t know the CAS number or it is not assigned, and you don’t know the CAS name, IUPAC name or INCI name for your chemical - written or electronic record of:

    • names you use to refer to the chemical
    • name of the person or business who you believe (on reasonable grounds) would give the CAS number (if assigned), and the CAS name, IUPAC name or INCI name of the chemical, if requested by the introducer, following a request from the Executive Director. 
    • why you believe the information holder will give the required to AICIS. For example, this could be information in an email from the chemical identity holder or minutes of a meeting.
  • The names of any products containing your chemical that you have imported into Australia.

General chemical identity requirements (apply to all introductions unless the above requirements for lower exposure band introductions apply).

  • If you know the CAS number for your chemical – written or electronic record of the CAS number for the chemical and one of the following:

    • CAS name
    • IUPAC name 
    • INCI name

    If you know the CAS name or IUPAC name for your chemical (but not CAS number) - written or electronic record of one of the following:

    • CAS name
    • IUPAC name

    If you know the eligible INCI plant extract name for your chemical (but not the CAS number, CAS name or IUPAC name) – written or electronic record of:

    • Eligible INCI plant extract name

    If you don’t know the CAS number or it is not assigned, and you don’t know the CAS name, IUPAC name or eligible INCI plant extract name for your chemical - written or electronic record of:

    • names you use to refer to the chemical
    • name of the person or business who you believe (on reasonable grounds) would give the CAS number (if assigned), and the CAS name, IUPAC name or eligible INCI plant extract name of the chemical, if requested by the introducer, following a request from the Executive Director. 
    • why you believe the information holder will give the required to AICIS. For example, this could be information in an email from the chemical identity holder or minutes of a meeting.

  • Important! Eligible INCI plant extract name
    The INCI name for an industrial chemical is an eligible INCI plant extract name if:

    • the industrial chemical is a plant extract that has not intentionally undergone any chemical processes, or treatments, to change its chemical structure and
    • the INCI name is based on a botanical name for the relevant plant.

    Examples of plant extracts
    Extracts of flowers, seeds or leaves of trees, shrubs, herbs, grasses, ferns and mosses.

    Examples of changes to the chemical structure: definition not met
    Where the chemical has been intentionally:

    • hydrolysed
    • acetylated 
    • hydrogenated.
  • 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 (except where you know the eligible INCI plant extract name for your chemical and keep a record of this). 

    If you don’t have this information – records showing:
    • the name of the person or business who you believe (on reasonable grounds) would give AICIS the UVCB substance description if requested by you, following a request from the Executive Director and 
    • why you believe the information holder will give us the UVCB substance description if we ask for it. For example, this could be information in an email from the holder of the information or minutes of a meeting.

  • If it’s a high molecular weight polymer and its human health exposure band is 4 – records to demonstrate the:

    • 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 – records showing:

    • why you believe your introduction is of a high molecular weight polymer
    • the name of the person or business who you believe (on reasonable grounds) would give AICIS records to demonstrate the polymer molecular weight details, if requested by you, following a request from the Executive Director and
    • why you believe the information holder will give the required information if we ask for it.

    For example, this could be information in an email from the holder of the information or minutes of a meeting.

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

  • A record of the indicative human health risk and indicative environment risk for your introduction.
  • If you know your chemical’s identity

    You must have records to prove your chemical does not meet the criteria for low risk, or medium to high risk – see checkboxes below.
          
    If someone else holds information about your chemical’s identity

    You must have records showing all 3 below:
    1. 1. Why you believe your introduction does not meet the criteria for low risk, or medium to high risk. These criteria are detailed in the checkboxes below.
    2. 2. The name of the person or business who you believe (on reasonable grounds) would give AICIS the required information, if requested by you, following a request from the Executive Director.
    3. 3. Why you believe the information holder will give the required information, if we ask for it. For example, this could be information in an email from the holder of the information or minutes of a meeting
  • Records to prove your chemical is not one that cannot be exempted or reported at step 1 of the categorisation process. That is:
    • isn’t listed in Annex III of the Rotterdam Convention* or 
    • isn't listed in Part 1 of Annex A, B or C of the Stockholm Convention* 
    • the Persistent Organic Pollutants Review Committee has not decided that your chemical meets the POPs screening criteria set out in Annex D of the Stockholm Convention*
    • the AICIS Executive Director has not decided that your chemical meets the Annex D screening criteria for POPs while making the decision about issuing an assessment certificate for that chemical*
    • the AICIS Executive Director has not decided that your chemical meets the Annex D screening criteria for POPs based on an AICIS evaluation done on that chemical*

    • your chemical 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. 

      *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.

  • Designated fluorinated chemicals – records to demonstrate your chemical does not contain a sequence of atoms (whether linear, branched, or cyclic) to which all of the following apply:

    1. subject to paragraph (b), the sequence consists only of at least 4, but no more than 20, fluorinated carbon atoms*, none of which are fluorinated carbon atoms* that are part of conjugated double bonds
    2. if the sequence is broken in any place, the break consists only of a single atom or a single substituted atom
    3. the sequence includes at least one perfluorinated methyl group (CF3) or perfluorinated methylene group (CF2)

    This may include a signed and dated declaration that these checks took place.

    *fluorinated carbon atom means a carbon atom attached to at least one fluorine atom.

  • Polyhalogenated – records to demonstrate one of the following:
    • it’s not a polyhalogenated organic chemical. This may include a signed and dated declaration that this check took place.
    • the total volume introduced in a registration year is less than or equal to 100kg. We’ll accept shipping documents and any associated calculations.
    • your chemical and its known environmental degradation products is not persistent (see Guidelines and definition of persistent). We’ll accept a study report.

  • Nanoscale – records to demonstrate one of 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’. 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%.
    • the introduction of the nanoscale portion of the chemical is incidental to the non-nanoscale portion. We’ll accept a justification for this.
    • it doesn’t consist of solid 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:
      • Greater than 1000 nm 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)
      • Greater than 200 nm and less than or equal to 1000 nm 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 or 125). 
        • 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. 
      • Less than or equal to 200 nm in at least one dimension – 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 125).
        • 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.

    You can use OECD TG 110 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.

    OECD TG 125 on Nanomaterial Particle Size and Size Distribution of Nanomaterials measures particles and fibres with a diameter of 1 to 1000 nm and fibres with a length up to 20 µm.

  • You can use OECD TG 110 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. 

    OECD TG 125 on Nanomaterial Particle Size and Size Distribution of Nanomaterials measures particles and fibres with a diameter of 1 to 1000 nm and fibres with a length up to 20 µm.
  • Gas – records to demonstrate one of 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 and our definition of persistent). We’ll accept a study report.
  • Organotin – records to demonstrate one of the following:
    • it’s not an organotin chemical. We’ll accept records, such as an email from your supplier, or a signed and dated declaration, indicating this check took place.
    • the total volume introduced in a registration year is less than or equal to 10kg. We’ll accept shipping documents and any associated calculations.
  • the total volume introduced in a registration year is less than or equal to 10kg. We’ll accept shipping documents and any associated calculations.
  • For UV filters (only required if the human health exposure band is 4)* – a record of:
    • toxicokinetics information about the chemical for both of the following:
      • the bioavailability of the chemical by the dermal route which may be determined using any of the following:
        • an in vitro study of the chemical conducted following OECD test guideline 428
        • an in vivo study on the chemical or suitable read-across information conducted following OECD test guideline 417
        • an in vivo study on the chemical or suitable read-across information conducted following OECD test guideline 427 (to predict skin absorption)
        • an in vivo study on the chemical or suitable read-across information that tests for specific target organ toxicity following repeated dermal exposure in which toxicokinetic parameters are also measured and
      • any available information on the toxicokinetics of the chemical, which may include information on:
        • the absorption of the chemical into the body 
        • the distribution of the chemical within the body 
        • the metabolism of the chemical within the body
        • the excretion of the chemical from the body 
    • photostability information about the chemical
      •  information on the chemical to demonstrate its stability in light, including the degree to which it degrades after exposure to UV light. 
      • We’ll accept study reports. 
  • Biocidal active – records to demonstrate 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 demonstrate 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 demonstrate 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.

    Note: this is not a requirement if your introduction is in human health exposure band 1 or 2 and environment exposure band 1
  • 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 demonstrate 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 demonstrate 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.

  • General requirements
    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. This includes confirmation, as appropriate, that the chemical is not on the list of chemicals with high hazards for categorisation and that it is not a salt or ester of specified chemicals.

    We also detail these requirements in Step 4.4 Work out your human health hazard characteristics and Step 5.4 Work out your environment hazard characteristics of the online categorisation guide. 

    If you don’t have this information – records showing:

    • the outcomes of the information specified in the Guidelines to demonstrate the absence of the hazard characteristics and
    • name of the person or business who you believe (on reasonable grounds) would give the detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of these hazard characteristics to AICIS, if requested by you, following a request from the Executive Director and
    • why you believe the information holder has detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of the hazard characteristics and why you believe they would give this information to AICIS. For example, you have an email from your supplier which specifies this information or you have minutes from a meeting with the chemical supplier indicating this information.

    This may include an email from your supplier.

    If your introduction is in human health exposure band 1 or 2 and environment exposure band 1
    Information to demonstrate the absence of human health hazard band C and environment hazard band D and hazard band C characteristics. This may include confirmation that it’s not on the list of chemicals with high hazards for categorisation.

Specified class of introduction

If you know that your introduction is a specified class, you’ll also need the following records. If you don’t hold the information, there are circumstances (*) when you need to hold records of:

  • the name of the person or business who you believe (on reasonable grounds) would give the required information to AICIS, if requested by you, following a request from the Executive Director. if we ask for it and 
  • why you believe the information holder would give the required information to AICIS.

  • 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.

  • 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. 

  • 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. 
  • 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. *

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