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Record keeping for reported introductions - internationally assessed

For these types of introductions, you’ll need to keep certain records  and provide them within 20 working days if we ask for them.

Before you read this page, make sure you've read and understood the information on our record-keeping overview page.
 
We may ask for your records. The type of records you must keep depends on whether you know the CAS number, CAS name, IUPAC name or eligible INCI plant extract name for your chemical.

Records to keep – chemical is internationally assessed for human health and the environment

Chemical identity

  • If you know the CAS number – written or electronic record of the CAS number for your chemical and one of the following:
    • CAS name
    • IUPAC name
    • INCI name.
  • If you don’t know the CAS number or it is not assigned – written or electronic records of one of the following:
    • CAS name, 
    • IUPAC name or 
    • eligible INCI plant extract name
    • The names you use to refer to your chemical – including the names given in your pre-introduction report.
  • The names of any products containing your chemical that you have imported into Australia.

The introduction isn’t medium to high risk

If you know your chemical’s identity

You must have records to demonstrate that your introduction does not meet the criteria for a medium to high risk introduction – see checkboxes below.

If someone else holds information about your chemical’s identity

You must have records showing all 3 below:

  1. Why you believe your introduction does not meet the criteria for medium to high risk. These criteria are detailed in the checkboxes below. 
  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. Why you believe the information holder will supply 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.

  • 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.

Introduction, use and exposure

  • Records to prove the total volume of your chemical introduced in a registration year doesn’t exceed that specified in your pre-introduction report and does not exceed the volume of the chemical assessed in the international assessment or evaluation. We’ll accept shipping documents and any associated calculations.

Other records

  • Records to demonstrate any known hazard classification for the chemical. We’ll accept an SDS.
  • Records to demonstrate how you’re meeting any restrictions or conditions associated with the introduction or use of your chemical in the overseas jurisdiction. For example, use restriction – we’ll accept copies of correspondence between you and your downstream users detailing the restrictions on use and their acknowledgement of the restrictions.
  • Records to demonstrate how you worked out that the risks to human health are no higher in Australia than in the overseas jurisdiction (see Guidelines and our Guide to categorising internationally assessed introductions for the human health and environment parameters that need to be considered).

Records to keep – chemical is internationally assessed for human health only

Chemical identity

  • If you know the CAS number – written or electronic record of the CAS number for your chemical and one of the following:
    • CAS name
    • IUPAC name
    • INCI name.
  • If you don’t know the CAS number or it is not assigned – written or electronic records of one of the following:
    • CAS name, 
    • IUPAC name or 
    • eligible INCI plant extract name
    • The names you use to refer to your chemical – including the names given in your pre-introduction report.
  • The names of any products containing your chemical that you have imported into Australia.

The introduction isn’t medium to high risk

If you know your chemical’s identity

You must have records to demonstrate that your introduction does not meet the criteria for a medium to high risk introduction – see checkboxes below.

If someone else holds information about your chemical’s identity

You must have records showing all 3 below:

  1. Why you believe your introduction does not meet the criteria for medium to high risk. These criteria are detailed in the checkboxes below. 
  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. Why you believe the information holder will supply 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.

  • 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 prove one of the following:
    • it’s not an organotin chemical. We’ll accept a signed and dated declaration that this check took place.
    • the total volume introduced in a registration year is less than or equal to 10 kg. We’ll accept shipping documents and any associated calculations.

Introduction, use and exposure

  • 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.
  • Which type of designated kind of release into the environment occurs* (if any). We’ll accept information included as part of a spreadsheet on the chemical.

Hazard characteristics

  • Records to prove any known hazard classification for the chemical. We’ll accept an SDS.
  • Detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of certain environment hazard characteristics that would otherwise make the introduction medium to high risk. This may include confirmation that it’s 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 5.4 Work out your environment hazard characteristics (Environment hazard bands D, C, B & A) of the online Categorisation Guide
    If you don’t hold this information – records showing:
    • outcomes of the information specified in the Guidelines to demonstrate the absence of the hazard characteristics/ Step 5.4 of the Categorisation Guide, 
    • 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 will 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. 

Other records

  • Records to demonstrate how you’re meeting any restrictions or conditions associated with the introduction or use of your chemical in the overseas jurisdiction. For example, use restriction – we’ll accept copies of correspondence between you and your downstream users detailing the restrictions on use and their acknowledgement of the restrictions.
  • Records to demonstrate how you worked out that the risks to human health are no higher in Australia than in the overseas jurisdiction (see Guidelines and our Guide to categorising internationally assessed introductions for human health parameters that need to be considered).

Specified class of introduction

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 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. 


Records to keep – chemical is internationally assessed for the environment only 

Chemical identity

  • If you know the CAS number – written or electronic record of the CAS number for your chemical and one of the following:
    • CAS name
    • IUPAC name
    • INCI name.
  • If you don’t know the CAS number or it is not assigned – written or electronic records of one of the following:
    • CAS name, 
    • IUPAC name or 
    • eligible INCI plant extract name
    • The names you use to refer to your chemical – including the names given in your pre-introduction report.
  • The names of any products containing your chemical that you have imported into Australia.
  • 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 1000 g/mol 
    • percentage by mass of molecules with molecular weight that is less than 500 g/mol

    We’ll accept a GPC analysis report.

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

    • why you believe your introduction is a high molecular weight polymer
    • who you believe can provide the required polymer molecular weight details if we ask for them and
    • why you believe the information holder will give the required information if we ask for it. 

    This may include an email from your supplier. 

The introduction isn’t medium to high risk

If you know your chemical’s identity

You must have records to demonstrate that your introduction does not meet the criteria for a medium to high risk introduction – see checkboxes below.

If someone else holds information about your chemical’s identity

You must have records showing all 3 below:

  1. Why you believe your introduction does not meet the criteria for medium to high risk. These criteria are detailed in the checkboxes below. 
  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. Why you believe the information holder will supply 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.

  • 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 prove one of the following:
    • it’s not an organotin chemical. We’ll accept a signed and dated declaration that this check took place.
    • the total volume introduced in a registration year is less than or equal to 10 kg. We’ll accept shipping documents and any associated calculations.

Introduction, use and exposure

  • Records to prove the total volume of your chemical introduced in a registration year doesn’t exceed:

    • the volume specified in your pre-introduction report and
    • the volume assessed in the international assessment or evaluation.

    We’ll accept shipping documents and any associated calculations

  • If the applicable human health exposure band criteria included 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

Hazard characteristics

  • Records to prove any known hazard classification for the chemical. We’ll accept an SDS.
  • Detailed information, including full study reports, of the kind specified in the Guidelines to demonstrate the absence of certain environment hazard characteristics that would otherwise make the introduction medium to high risk. This may include confirmation that it’s 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 (Human health hazard bands C, B & A) of the online Categorisation Guide
    If you don’t hold this information – records showing:
    • outcomes of the information specified in the Guidelines to demonstrate the absence of the hazard characteristics/ Step 4.4 of the Categorisation Guide, 
    • 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 will 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. 

Other records

  • Records to demonstrate how you’re meeting any restrictions or conditions associated with the introduction or use of your chemical in the overseas jurisdiction. For example, use restriction – we’ll accept copies of correspondence between you and your downstream users detailing the restrictions on use and their acknowledgement of the restrictions.
  • Records to demonstrate how you worked out that the risks to the environment from the introduction and use of the chemical are no higher in Australia than in the overseas jurisdiction (see Guidelines and our guide to categorising internationally assessed introductions for the environment parameters that need to be considered).

Specified class of introduction

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 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. 
  • why you believe the information holder would give the required information to AICIS. 
  • 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. 

  • 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. 
  • 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. *

*Guidelines refers to the Industrial Chemicals Categorisation Guidelines

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