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Record keeping for reported introductions - highest indicative risk is low risk

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

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 written undertakings as records (read more in our record-keeping overview page)

Records you must keep

The type of records you must keep for introductions where the highest indicative risk is low risk 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.

You can also download and print this information in the checklist below.

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

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 extracts – 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, and they will 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:
    • 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 not 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 end use for your chemical. We’ll accept product labels, a list of product names and uses, or technical information sheets.
  • If the applicable human health exposure band criteria include a concentration upper limit – a record of the maximum concentration at introduction and 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.
  • 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.

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.

  • 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.

Download the record-keeping checklist

Our record-keeping checklist indicates the type and level of information we expect to receive for each of the requirements in the list above, but it’s not meant to be an exhaustive list.

Download the checklist

We aim to provide documents in an accessible format. If you're having problems using a document with your accessibility tools, please contact us for help. 

Examples of information you can provide on request

The following 2 examples show how you can satisfy our request to provide records. The first example applies if you don't know the proper name for your chemical. The second example applies if you do know the proper name for your chemical.

Chemical X introduced in formulated rinse-off cosmetic products at < 1% concentration — up to 800kg 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 3 (its indicative human health risk is low based on the absence of human health hazard band C hazard characteristics).
  • The environment exposure band is 2 (its indicative environment risk is low based on the absence of environment hazard band D hazard characteristics).

Therefore, the highest indicative risk for the introduction is low (‘reported introduction’). You submit a pre-introduction report. Your written undertaking from the supplier includes the following information:

  • The introduction of Chemical X isn’t covered by any of the provisions of section 25, items 1-3 of the table in subsection 28(1), or items 1-5 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 isn’t known to have any of the hazard characteristics in human health b and C or environment hazard band D.
  • It’s not on the list of chemicals with high hazards for categorisation.
  • It’s not PBT based on a suitable in-silico prediction for partition coefficient (log Kow) of < 4.2.
  • The supplier will provide detailed information, including study reports, of the kind 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 a reported introduction.

You provide:

  • a spreadsheet containing the name of the imported chemical (Chemical X) and the names of the products containing Chemical X that are imported into Australia
  • written correspondence from the supplier indicating that Chemical X is present in each of the products at < 1% concentration.
  • the SDS for the imported products
  • shipping documents to support the Environment Categorisation Volume (ECV)
  • a copy of your written undertaking

The supplier provides:

  • 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 in section 71, 72 or 73 of the Industrial Chemicals (General) Rules 2019; 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 ≥ 4 and ≤ 20 fully fluorinated carbon atoms; it’s not a polyhalogenated organic chemical; 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 < 4.2 was derived from a suitable in-silico prediction for the chemical, as per the Guidelines

 

Chemical Z introduced as a powder and formulated into coatings — up to 200kg 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 low based on the absence of environment hazard band D hazard characteristics, but known hazard band C hazard characteristics).

Therefore, the highest indicative risk for the introduction is low (‘reported introduction’). You submit a pre-introduction report.

We then ask for your records to ensure the introduction of Chemical Z is authorised as a reported introduction.

You provide:

  • The CAS number and CAS name for Chemical Z (it’s imported into Australia under this name).
  • A signed declaration dated prior to the introduction that the appropriate checks took place to ensure Chemical Z 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 in section 71, 72 or 73 of the Industrial Chemicals (General) Rules 2019; isn’t listed on the Inventory with conditions of introduction or use that will be contravened; and is not 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 Z doesn’t contain ≥ 4 and ≤ 20 fully fluorinated carbon atoms; it’s not a polyhalogenated organic chemical; and it’s not an organotin chemical.
  • A water solubility study to prove that  the definition of ‘not soluble’ is not met for Chemical Z.
  • Product information sheets containing information on end use.
  • Shipping documents to support the Human Health Categorisation Volume (HHCV) and the Environment Categorisation Volume (ECV).
  • The SDS for Chemical Z, which indicates that it’s very toxic to fish.
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