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Pre-introduction reports - reported category

You must submit a pre-introduction report for all introductions that are authorised under our reported category before you can import or manufacture them in Australia. There is no fee to submit this report.

Required

for reported introductions. Do not submit for listed introductions

Nil fee

There is no fee to submit a pre-introduction report. But you must submit before you import or manufacture the chemical.

This only applies to introductions that are in the reported category. If you're not sure, read our categorisation guide.

What is a pre-introduction report and who submits it

This is a once-off report that all industrial chemical importers or manufacturers must submit for chemical introductions that are authorised under our reported category.

You only need to submit the report the first time you introduce the chemical. It is separate to your annual declaration obligations.

Once you have submitted your pre-introduction report you can introduce your chemical immediately – except for low-risk flavour or fragrance blend and internationally assessed types with confidential business information which require additional steps before you can introduce.

When you must submit a pre-introduction report

If you have categorised your chemical introduction as reported, you must give us certain details about the introduction before importing or manufacturing it in Australia. Once you have completed the report, you can introduce the chemical.

You must at all times ensure that any introduction is in line with the information given in your pre-introduction report. If any circumstance of your introduction changes, you must check that it can still be categorised as a reported introduction and, if so, whether you need to vary your pre-introduction report.

How to submit a pre-introduction report

The online form for a pre-introduction report is available on the AICIS Business Services portal. There is no fee to submit or vary your report.

There are 6 types:

  • The highest indicative risk is low risk
  • Low-risk flavour or fragrance blend
  • Chemicals that are only for use in research and development and meet the criteria for reported introductions
  • Chemicals that are internationally assessed for human health and the environment
  • Chemicals that are internationally assessed for human health and are low or very low risk for the environment
  • Chemicals that are internationally assessed for the environment and are low or very low risk for human health
For chemicals with international assessments: You must be able to provide the complete overseas report to us and obtain permission to use it. We do not accept REACH registration dossiers for the 3 types of internationally assessed pre-introduction reports. See the categorisation guide for a list of accepted international assessments for human health and the environment. Read our guide to categorising internationally assessed introductions.

When we do publish information about a reported introduction

We only publish information about a reported introduction, if you have used an accepted international risk assessment to categorise. We consider these internationally assessed reported introductions to potentially be of higher risk and therefore publish the following information on our website after you submit your pre-introduction report:

  • chemical name
  • end use
  • name of international assessment body

If you do not want us to publish the chemical name and/or end use, you must apply to protect them as confidential business information (CBI). Note, we always publish the name of the international assessment body.

Learn more about applying for protection of your CBI 

For other types of reported introductions, you can flag certain information in your PIR as confidential.

Chemical identity information you need

Before you start, check that you have the following information:

  • If you know the proper name for your chemical, you’ll need to provide the CAS (Chemical Abstracts Service) or IUPAC (International Union of Pure and Applied Chemistry) name and the CAS number (if assigned).
  • If you don’t know the proper name for your chemical, you’ll need the name you use to refer to your chemical and the name of the person who has the proper chemical name. This could be the supplier, manufacturer or someone else. We will contact them before you submit your pre-introduction report. (Unless it’s for low-risk flavour or fragrance blends, in which case we will contact them after you submit your pre-introduction report. We provide more details on this below.)

Steps to follow if you don’t know the proper name for your chemical (except low-risk flavour or fragrance blends)

Step 1: Enter the required information into your pre-introduction report. You must nominate the person who knows the proper chemical name.

Step 2: We will email the person you nominate.

Step 3: They enter the chemical identity information into your pre-introduction report (this information will not be visible to you). They need to let you know when they have completed this task.

Step 4: Submit your completed pre-introduction report and introduce your chemical.

Steps to follow for low-risk flavour or fragrance blends

You can submit a single-pre-introduction report for the industrial chemicals in a flavour or fragrance blend that meet the criteria for ‘low-risk flavour or fragrance blends’.

For each of these chemicals, you will need to either:

  • check and confirm that it’s on the IFRA Transparency List; or
  • give us certain information (if you haven’t already done so), including CAS names and CAS numbers (if assigned); any known hazard characteristics; the maximum concentration of these chemicals in the blend at introduction and end use; and the name you use to refer to the blend

If you need to give us this information and you know the proper name for your chemicals, you can do this by:

  • downloading our fillable PDF form
  • either filling out the form and uploading it when submitting your pre-introduction report; or
  • emailing the form to us (you must send us the completed form before you introduce your chemicals)

If you don’t know the proper name for your chemicals, you must nominate the person who has the proper name in your pre-introduction report. This could be the supplier, manufacturer or someone else. We will contact them after you submit your pre-introduction report and, if needed, they can give us information about the chemicals in the blend by:

Use this form to provide information about the chemicals in your flavour or fragrance blend. Make sure you save it to your hard drive as a PDF.

Download form

Provide information about chemicals in a flavour or fragrance blend

Send your completed form to reportedintroductions@industrialchemicals.gov.au

To view and use fillable forms, you need: 


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. 

Learn more about categorisation of chemicals in a flavour or flavour blend
 

Other information you need

If you worked out that the highest indicative risk for your introduction is low, we need information on how you worked this out, such as:

  • the human health and environment exposure bands that apply to your introduction
  • the total volume you will introduce during the registration year
  • the end use for your chemical
  • any human health and environment hazard characteristics of your chemical that you know about
  • if your chemical will have an end use in cosmetics - whether new animal test data were used to categorise your introduction

If your introduction is internationally assessed for human health or the environment, we need information about the international assessment or evaluation, such as:

  • details of the body that assessed or evaluated the chemical, and when they did this
  • the parameters of the assessment or evaluation and any restrictions that are included

If you’re introducing a low-risk ingredient in a flavour or fragrance blend, we need information about the blend, such as:

  • the name of the blend that contains your chemical
  • the number of chemicals in the blend that meet the criteria for ‘low-risk flavour or fragrance blend introductions’

How to vary your pre-introduction report

You must vary your pre-introduction report if:

  • you will no longer introduce or use your chemical in line with the terms of your pre-introduction report, AND
  • your introduction will remain categorised as reported

It’s important to note that some changes in circumstances will mean that your introduction is no longer authorised under our reported category.

To vary your pre-introduction report, send the details of how your report must be varied to reportedintroductions@industrialchemicals.gov.au and we will vary it for you.

When you must vary your pre-introduction report

If the circumstances of your introduction or use of your chemical change, you may need to vary your pre-introduction report.

A variation would apply in the following example scenarios:

  • You want to manufacture a chemical in Australia that you were previously importing.
  • The applicable human health exposure band criterion for your chemical means you can introduce and use it at ≤1% concentration. You want to introduce the chemical at 10% concentration and reformulate to ≤1% concentration for end use. You categorise your introduction under the changed circumstances and it remains a reported introduction.
  • You want your chemical to have a new end use, such as using it in inks when a term of your pre-introduction report was that your chemical had an end use in paints. You categorise your introduction under the changed circumstances and it remains a reported introduction.
  • The applicable environment categorisation volume for your introduction is ≤1000kg. You intend to change the use pattern of your chemical, such that it will be increasing to 1500kg. You categorise your introduction under the changed circumstances and it remains a reported introduction.
  • You become aware of a hazard characteristic that is associated with your chemical, and a term of your pre-introduction report was that there were no known hazard characteristics. You categorise your introduction and it remains a reported introduction.

When you don’t need to vary your pre-introduction report

If the circumstances of your introduction change, but you will continue to introduce and use your chemical in line with the terms of your pre-introduction report, then you don’t need to vary your pre-introduction report.

A variation would not apply in the following example scenarios:

  • The terms of your pre-introduction report allow you to introduce ≤100kg of your chemical in a registration year. Due to a decline in sales, you project that the maximum volume of your chemical that you will introduce in each of the coming registration years is 15kg, rather than the 50kg you had been introducing previously. You don’t need to vary the terms of your pre-introduction report because you’ll still be introducing within the terms.
  • You become aware of an in vitro study indicating that your chemical is a skin irritant, but you have already indicated in your pre-introduction report that skin irritation is a known hazard characteristic (based on the safety data sheet for your chemical). You don’t need to vary the terms of your pre-introduction report because you’ll still be introducing within the terms.

What happens after you submit your pre-introduction report

Once you’ve submitted your pre-introduction report, you can introduce your chemical.

Note that our compliance team monitors introductions to make sure they’re authorised under our laws. You must keep records about your introductions and give them to us if we ask for them.

Submit a pre-introduction report in AICIS Business Services 

Frequently asked questions

Q. Can I submit a pre-introduction report for my exempted introduction?

A. If your introduction is authorised under the exempted category, you can still choose to categorise it as either exempted, reported or assessed. If you choose the reported introduction category, you must meet all regulatory obligations associated with this category — including submitting a pre-introduction report and keeping records about your introduction.

Q. Based on the information provided by my supplier, I think I can categorise my introduction as exempted. However, I’m not confident that I can provide all the hazard information to support my categorisation, if requested. Can I categorise my introduction as reported and submit a pre-introduction report?

A. Yes. If you are not confident that you can meet your obligations for the exempted introduction category, but you can meet the reporting and record-keeping requirements associated with the reported introduction category, then you can categorise your introduction as reported.

Example:
Company XYZ want to introduce a chemical for use in household cleaning products. They have worked out that the human health exposure band for their introduction is 3 and the environment exposure band for their introduction is 2. They work out that they could categorise their introduction as exempted, based on the outcomes of studies provided by their supplier for the relevant human health and environment hazard characteristics. However, they are not confident that they would be able to provide the full study reports, if requested. They are confident that they could meet the obligations associated with the reported introduction category and therefore choose to categorise their introduction as reported, based on the fact that the highest indicative risk for their introduction is low. They submit a pre-introduction report and keep the required records for their reported introduction. 

Q. Can I categorise my introduction as reported (instead of exempted) and submit a pre-introduction report based on volume forecasts? Our business predicts it will introduce higher volumes in future registration years compared with the current registration year.

A. Yes, it is up to introducers to categorise their introductions depending on their own circumstances and business model. You can choose to categorise your introduction as reported — instead of exempted — as long as you meet all the regulatory obligations associated with the reported introduction category.

Example:
Company JKL wants to introduce a chemical for use in cosmetics. They expect to introduce up to 25kg of the chemical in the current registration year. They work out that they can categorise their introduction as exempted, based on the fact that the highest indicative risk for their introduction is very low (human health exposure band is 2 and the environment exposure band is 1). However, they predict that they could introduce up to 50kg of their chemical in future registration years. They have 2 options:

Option 1: Categorise the introduction as exempted based on an introduction volume of up to 25kg. They then need to monitor the volume of the chemical introduced and, if they can see that the 25kg threshold will be exceeded, they must re-categorise the introduction based on the changed introduction circumstances.

Option 2: Categorise the introduction based on an introduction volume of up to 50kg. If they do this, they work out that their introduction category is reported, based on the fact that the highest indicative risk for their introduction is low (human health exposure band is 3 and the environment exposure band is 2).

The company chooses option 2. They categorise their introduction as reported, submit a pre-introduction report and keep the required records for their reported introduction. In their pre-introduction report they indicate that the ‘maximum total volume of the chemical introduced in Australia during a registration year’ is ‘>25kg to ≤100kg’. They can introduce up to 100kg in any registration year and do not need to vary their pre-introduction report (provided that the introduction is in accordance with all other terms of their pre-introduction report). 

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