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Open for public comment: proposed amendments to the General Rules – closes 17 September 2021.

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

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

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

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

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

Records you must keep

The following table provides information about the records you must keep where the highest indicative risk for your introduction is very low risk.

The type of records you must keep depends on whether you know the Chemical Abstracts Service Registry Number (CAS number) or the proper name (CAS or IUPAC) for your chemical.

Records to keep if you know the CAS number and/or proper name for your chemical

Records to keep if you DO NOT know the proper name for your chemical

1a. If you know the CAS number – a record of it, plus the CAS name or INCI name OR

1b. If you know the proper name (CAS or IUPAC) but no CAS number is assigned – a record of the proper name

2. The names of any products containing your chemical that you have imported into Australia

3. The UVCB substance description of your chemical (if your introduction is of a UVCB substance and the human health exposure band is 4 or the environment exposure band is 3 or 4)

4. Records to prove the polymer molecular weight details for your chemical (if your introduction is of a high molecular weight polymer and its human health exposure band is 4)

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

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

7. Whether your chemical is imported and/or manufactured in Australia

8. The maximum total volume of your chemical you intend to introduce in a registration year

9. Records to prove the end use for your chemical

10. The human health exposure band for your introduction and the applicable human health exposure band criteria

11. If the applicable human health exposure band criteria for your introduction include a concentration upper limit – a record of the maximum concentration of your chemical at introduction and at each end use

12. If the applicable human health exposure band criteria for your introduction 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

13. Whether your introduction involves a designated kind of release into the environment, and if so, which kind

14. The environment exposure band for your introduction and the applicable environment exposure band criteria

15. If the applicable environment exposure band criteria for your introduction include an 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

16. Records to prove any known hazard classification for your chemical

17. A record of any human health hazard characteristics and environment hazard characteristics of your chemical that are known to you

18. Detailed information, including full study reports, of the kind specified in the Categorisation Guidelines to demonstrate the absence of certain human health and environment hazard characteristics that would otherwise render the introduction low or medium to high risk. If you don’t have this information, keep 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 will give us the records if we ask for them

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

20. Records needed if your introduction is one of the following specified classes of introduction:

— Introductions that involve a designated kind of release into the environment a record of the:

a. location of the release into the environment (including all receiving water bodies); and

b. frequency of the release into the environment

Biochemicals – a record of:

a. the concentration of any remaining viable cell or cellular components of the organisms used to produce the biochemical; and

b. information on any known adverse effects ofany remaining viable cell or cellular components of the organisms used to produce the biochemical

GM products – a record of:

a. the name of the genetically modified organism from which the GM product was derived or produced; and

b. information on any genetically modified organism that remains in the GM product as an impurity

Where the end use is in an article with food contact, a record of:

a) any approval (if known) for your chemical for an end use in an article with food contact in another country by an agency or authority of that country; and

b. the potential for your chemical to migrate to food (see Guidelines)

Where the end use is in an article that is a children’s toy or children’s care product – a record of:

a. whether the article can be placed in the mouth;

and

b. if so, the potential for the chemical to be released into the mouth during end use or mouthing (see Categorisation Guidelines)

1. The names you use to refer to your chemical and a written undertaking from the supplier or manufacturer that they will give us the proper name (CAS or IUPAC) and CAS number (if assigned), if we ask for them

2. The names of any products containing your chemical that you have imported into Australia

3. If your introduction is of a UVCB substance and the human health exposure band is 4 or the environment exposure band is 3 or 4 – a written undertaking from the supplier or manufacturer that they will give us the UVCB substance description of your chemical, if we ask for it

4. A written undertaking from the supplier or manufacturer that the introduction is of a high molecular weight polymer (if applicable, and the human health exposure band is 4) and the person who holds the information will give us the records to prove this, if we ask for them

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

6. A written undertaking from the supplier or manufacturer that the introduction of your chemical isn’t covered by any of the provisions of section 25, items 1 - 3, 7 or 8 of the table in subsection 28 (1) or items 1 - 5, 10 or 11 of the table in subsection 29(1) of the General Rules, and that the person who holds the information will give us the records to prove this, if we ask for them

7. Whether your chemical is imported and/or manufactured in Australia

8. The maximum total volume of your chemical you intend to introduce in a registration year

9. Records to prove the end use for your chemical

10. The human health exposure band for your introduction and the applicable human health exposure band criteria

11. If the applicable human health exposure band criteria for your introduction include a concentration upper limit, a record of the maximum concentration of your chemical at introduction and at end use

12. If the applicable human health exposure band criteria for your introduction 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

13. Whether your introduction involves a designated kind of release into the environment, and if so, which kind

14. The environment exposure band for your introduction and the applicable environment exposure band criteria

15. If the applicable environment exposure band criteria for your introduction 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

16. Records to prove any known hazard classification for your chemical

17. A record of any human health hazard characteristics and environment hazard characteristics of your chemical that are known to you

18. Detailed information, including full study reports, of the kind specified in the Categorisation 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, keep 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 will give us the records if we ask for them

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

20. Records needed if your introduction is one of the following specified classes of introduction:

— Introductions that involve a designated kind of release into the environment – a record of the:

a. location of the release into the environment (including all receiving water bodies); and

b. frequency of the release into the environment

Biochemicals – a record of:

a. the concentration of any remaining viable cell or cellular components of the organisms used to produce the biochemical; and

b. information on any known adverse effects of any remaining viable cell or cellular components of the organisms used to produce the biochemical

GM products – a record of:

a. the name of the genetically modified organism from which the GM product was derived or produced; and

b. information on any genetically modified organism that remains in the GM product as an impurity

Where the end use is in an article with food contact – a record of:

a. any approval (if known) for your chemical for an end use in an article with food contact in another country by an agency or authority of that country; and

b. the potential for your chemical to migrate to food (see Guidelines)

Where the end use is in an article that is a children’s toy or children’s care product – a record of:

a. whether the article can be placed in the mouth; and

b. if so, the potential for the chemical to be released into the mouth during end use or mouthing (see Categorisation Guidelines)

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 table above, but it’s not meant to be an exhaustive list.

It also expands on the requirements for item 6 in the table above – records to prove your introduction is not covered by any of the provisions of section 25, items 1 - 3, 7 or 8 of the table in subsection 28(1) or items 1 - 5, 10 or 11 of the table in subsection 29(1) of the General Rules.

For example: item 7 of the table in subsection 28(1) and item 10 of the table in subsection 29(1) are related to chemicals at the nanoscale. Our checklist indicates that you need records to prove one of the following:

  • your chemical isn’t introduced as a solid or in dispersion (if applicable). We’ll accept an SDS or product information sheet that indicates the appearance.
  • the definition of “not soluble” (see Guidelines) is not met for your chemical. We’ll accept a study report.
  • your chemical doesn’t consist of particles in an unbound state or as an aggregate or agglomerate, at least 50% of which (by number size distribution) have at least one external dimension in the nanoscale. We’ll accept a study report.

Download the checklist:

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Examples of information you can provide on request

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

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

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

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

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

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

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

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

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

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

You provide:

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

The supplier provides:

  • the CAS name and number for Chemical X.
  • a signed declaration dated prior to the introduction that the appropriate checks took place to ensure Chemical X isn’t in Annex III to the Rotterdam Convention; isn’t in part I of Annex A, B or C to the Stockholm Convention on POPs; isn’t 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; it’s not a UV filter and it’s not an organotin chemical.
  • the SDS and technical information sheets for Chemical X indicating its appearance and solubility.
  • detailed information to support that the partition coefficient (log Kow) of < 4.2 was derived from a suitable in-silico prediction for the chemical, as per the Guidelines.
  • detailed information to support that the aquatic toxicity predictions of >10 mg/L were derived from suitable in-silico predictions for the chemical, as per the Guidelines.

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

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

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

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

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

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

You provide:

  • a spreadsheet containing 1) the CAS number and CAS name for Chemical T (it’s imported into Australia under this name), 2) that Chemical T is imported, 3) that ≤150 kg of Chemical T is intended to be introduced in a registration year, 4) that the indicative human health risk and indicative environment risk for the introduction of Chemical T are very low, 5) the human health and environment exposure bands and applicable exposure band criteria, 7) that the introduction of Chemical T doesn’t involve a designated kind of release into the environment, 8) the Environment Categorisation Volume, 9) that Chemical T is known to have the skin sensitisation hazard characteristic, and 10) that the introduction of Chemical T is not a specified class of introduction.
  • a signed declaration dated prior to the introduction that the appropriate checks took place to ensure Chemical T 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 T doesn’t contain ≥ 4 and ≤ 20 fully fluorinated carbon atoms; it’s not a polyhalogenated organic chemical; it’s not an organotin chemical; and it’s not a biocidal active.
  • a water solubility study to prove that the definition of ‘not soluble’ is not met for Chemical T.
  • 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 T.
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