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Record keeping for reported introductions - highest indicative risk is low

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.

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 for introductions where the highest indicative risk is 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. Records to prove your introduction is NOT 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 General Rules.

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. Records to prove the end use for your chemical.

6. 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.

7. 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.

8. 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.

9. Which type of designated kind of release into the environment occurs (if any)

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

11. 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, 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.

11. 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

UV filters in human health exposure band 4, a record of:

a. toxicokinetics information about the chemical (see Guidelines); and

b. photostability information about the chemical (see Guidelines)

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 Guidelines)

1. The names you use to refer to your chemical (including the names given in your pre-introduction report)

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

3. 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 of the table in subsection 28(1) or items 1 – 5 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.

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. Records to prove the end use for your chemical.

6. 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.

7. 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.

8. 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.

9. Which type of designated kind of release into the environment occurs (if any)

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

11. 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, 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.

12. 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 impurit 

UV filters in human health exposure band 4, a record of:

a. toxicokinetics information about the chemical (see Guidelines); and

b. photostability information about the chemical (see Guidelines)

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 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 3 in the table above - records to prove your introduction is NOT 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 General Rules.

For example: item 3 of the tables in subsection 28(1) and 29(1) is 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.
  • that the introduction of the nanoscale portion of the chemical is incidental to the non-nanoscale portion. We’ll accept a justification for this (with reference to the items in subsection 28(2) and 29(2) of the General Rules).

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. 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

 

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