Record keeping for reported introductions - internationally assessed

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.

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 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:
  1. 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:
     • the chemical does not have a CAS or IUPAC name
     • the chemical is a plant extract – examples are extract of flowers, seeds or leaves of trees, shrubs, herbs, grasses, ferns and mosses.
     • 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.
     • the plant extract cannot be chemically modified – for example, the chemical cannot be hydrolysed, acetylated or hydrogenated
  2. The names you use to refer to your chemical – written or electronic record of the names 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

You will need all 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 and they will provide the required 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 one of the following:
  • it’s not a polyhalogenated organic 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 100kg. We’ll accept shipping documents and any associated calculations.
  • your chemical and its known environmental degradation products is not persistent (see Guidelines). We’ll accept a study report.
• Nanoscale – records to prove 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%.
  • 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. We’ll accept a study report.
  • the introduction of the nanoscale portion of the chemical is incidental to the non-nanoscale portion. We’ll accept a justification for this.
• Gas – records to prove 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). 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 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 prove any known hazard classification for the chemical. We’ll accept an SDS.
• Records to prove 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 prove how you worked out that the risks to human health are no higher in Australia than in the overseas jurisdiction (see Guidelines).

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 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:
  1. 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:
     • the chemical does not have a CAS or IUPAC name
     • the chemical is a plant extract – examples are extract of flowers, seeds or leaves of trees, shrubs, herbs, grasses, ferns and mosses
     • 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
     • the plant extract cannot be chemically modified – for example, the chemical cannot be hydrolysed, acetylated or hydrogenated
  2. The names you use to refer to your chemical – written or electronic record of the names 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

You will need all 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 and that they will provide the required 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 one of the following:
  • it’s not a polyhalogenated organic 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 100kg. We’ll accept shipping documents and any associated calculations.
  • your chemical and its known environmental degradation products is not persistent (see Guidelines). We’ll accept a study report.
• Nanoscale – records to prove 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%.
  • 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. We’ll accept a study report.
  • the introduction of the nanoscale portion of the chemical is incidental to the non-nanoscale portion. We’ll accept a justification for this.
• Gas – records to prove 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). 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 10kg. 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 human health and environment hazard characteristics that would otherwise render the introduction medium to high risk. If you don’t have this information – a record of the outcomes of the information specified in the Guidelines, plus a written undertaking from the person who has the information that they’ll give it to us if we ask for it.

Other records

• Records to prove 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 prove how you worked out that the risks to human health are no higher in Australia than in the overseas jurisdiction (see Guidelines).

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 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.

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 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:
  1. 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:
     • the chemical does not have a CAS or IUPAC name
     • the chemical is a plant extract – examples are extract of flowers, seeds or leaves of trees, shrubs, herbs, grasses, ferns and mosses
     • 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
     • the plant extract cannot be chemically modified – for example, the chemical cannot be hydrolysed, acetylated or hydrogenated
  2. The names you use to refer to your chemical – written or electronic record of the names 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 prove 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 – 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

You will need all 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 and they will provide the required 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 one of the following:
  • it’s not a polyhalogenated organic 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 100kg. We’ll accept shipping documents and any associated calculations.
  • your chemical and its known environmental degradation products is not persistent (see Guidelines). We’ll accept a study report.
• Nanoscale – records to prove one of the following:
  1. It’s not introduced as a solid or in a dispersion (if applicable). We’ll accept an SDS or product information sheet that indicates the appearance.
  2. 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%.
  3. The introduction of the nanoscale portion of the chemical is incidental to the non-nanoscale portion. We’ll accept a justification for this.
  4. 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:
     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 prove 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). 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 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:
  • 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 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.

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 human health hazard characteristics that would otherwise render the introduction medium to high risk. If you don’t have this information – a record of the outcomes of the information specified in the Guidelines, plus a written undertaking from the person who has the information that they’ll give it to us if we ask for it.

Other records

• Records to prove 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 prove 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).

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 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 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.

• For UV filters (only required if the human health exposure band is 4) – a record of:
  • toxicokinetics information about the chemical*
  • photostability information about the chemical*

  * see Guidelines
  
  We’ll accept study reports. 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.