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Pre-introduction report - low-risk flavour or fragrance blend

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’. Note, you can flag certain information as confidential when you submit your report. 

Before you dive in further to this page, you need to have read Before you start with your pre-introduction report. It is also essential that you look at our page on categorisation of flavour and fragrance blend chemicals.

This guide is designed to help you complete the pre-introduction report type in AICIS Business Services called ‘low risk ingredient of a flavour blend or a fragrance blend’.

When you shouldn't submit a pre-introduction report

Do not submit if:

  • you did not categorise your introduction – use our categorisation guide to work out the introduction category and the next steps you must take

  • your introduction is categorised as listed – meaning that your chemical is already on our Inventory and your introduction meets the regulatory obligations specified in the chemical’s ‘Inventory terms of listing’ (if there are any)

When you must submit your pre-introduction report

You must submit a pre-introduction report if one of the following applies:

  1. The chemical you plan to introduce is not on the Inventory and you have worked out that your introduction is in the reported category.
  2. You're planning to introduce an Inventory-listed chemical outside the parameters of the defined scope of assessment and you have worked out that your introduction is in the reported category.

After you have submitted your pre-introduction report, you are legally required to keep certain records about your introduction.

 

Tips and important information you need to know

In your pre-introduction report, we ask you to enter the name of the flavour blend or fragrance blend that contains the industrial chemicals you are introducing in Australia.

For example, if you are introducing formulated shampoo, you would enter the name of the fragrance blend that you are introducing as part of that shampoo. Usually , this will be the name the fragrance manufacturer uses.  

The information you must then provide and how you provide it depends on whether or not you know the proper name (CAS or IUPAC) for the chemicals. From the instructions below, choose which is relevant to you.

How to complete your pre-introduction report

These instructions will help you complete your pre-introduction report in AICIS Business services.

To start, you'll see this question:

Do you know the proper name of the industrial chemical? (CAS or IUPAC name)?

If you don’t know this, you must nominate the person who has the proper name in your pre-introduction report. This could be the supplier, manufacturer or someone else. 

Select No, but my supplier, manufacturer or someone else knows.

Next select Business look up

Enter the AICIS business ID of the holder of this information (starting with NIC) followed by the contact person’s first and last name. If you don’t have their details, you must contact the holder as we cannot give you this information.


Pre-introduction report - related to introduction tab

How many industrial chemicals in the flavour blend or fragrance blend are to be introduced as ‘low-risk flavour or fragrance blend introductions’?

This can be 1 or more chemicals, depending on how you have categorised the introductions of the chemicals in your blend. Remember that you can submit a single-pre-introduction report for all the industrial chemicals in a flavour or fragrance blend that meet the criteria for ‘low-risk flavour or fragrance blend introductions’.  

Will the industrial chemical have an end use in cosmetics?

If you select Yes you must select 1 statement that applies to your introduction about the use of animal test data.

Option 1 - I did NOT use animal test data from tests conducted on or after 1 July 2020 to determine the highest indicative risk for the chemical. 

Select this option if either of these apply.

  • You did not use any animal test data to work out the highest indicative risk of your introduction.
  • You used animal test data to work out the highest indicative risk of your introduction, but the animal tests were all conducted before 1 July 2020.

Note: this is the option that we would generally expect to be selected for ‘low-risk flavour or fragrance blend introductions’

Option 2 - I will introduce the chemical for an end use solely in cosmetics and I used animal test data from tests conducted on or after 1 July 2020 to determine the highest indicative risk for the chemical in the circumstances mentioned in the General Rules Section 34.

Select this option if all of the following apply.

  1. Your chemical will only have an end use in cosmetics (and will not have any other end uses).
  2. You used animal test data from tests conducted on or after 1 July 2020 to work out the highest indicative risk of your introduction.
  3. You meet one of 3 exception criteria that allows cosmetics introducers to use animal test data under limited circumstances – exception 1, exception 2 or exception 3

Option 3: I will introduce the chemical for multiple end uses (including an end use in cosmetics) AND I used animal test data from tests conducted on or after 1 July 2020 to determine the highest indicative risk for the chemical. This animal test data is of a kind mentioned in the General Rules Section 31. 

Select this option if all of the following apply.

  1. Your chemical will have several end uses, which includes cosmetics.
  2. You used animal test data from tests conducted on or after 1 July 2020 to work out the highest indicative risk of your introduction.
  3. You meet one of 4 exception criteria that allows cosmetics introducers to use animal test data under limited circumstances – exception 1, exception 2, exception 3 or exception 4.

See: Animal test data - when it can and can’t be used and when you need pre-approval


Pre-introduction report – Declaration on CBI

Are you flagging any other information as confidential?

If you select Yes to this question, you need to tell us the information that you are flagging for protection.

By selecting 'yes', you are not applying for information to be treated as confidential business information (CBI). Rather, you are acknowledging that if we send you a notice that we intend to publish the flagged information (a section 113 notice under the Industrial Chemicals Act 2019), then you may apply for CBI. 

Learn more about flagging information as confidential and section 113 notices


Final declaration

The final item of the pre-introduction report is a declaration that the information you have given is true, correct and complete. Giving false or misleading information is a serious offence.


What happens after you submit your pre-introduction report

We may need additional information on your chemicals. 

If your chemicals are on the IFRA Transparency List - once you’ve submitted your pre-introduction report, you can introduce the blend containing your chemicals.

If your chemicals are not on the IFRA Transparency List -  you can introduce the blend containing your chemicals as soon as you’ve submitted your pre-introduction report and we have received certain information about those chemicals in the blend that are not on the IFRA Transparency List

Once you submit your pre-introduction report, we will contact the person you nominated as knowing the proper name of the chemicals in your flavour or fragrance blend. If they haven’t already done so, they can then give us certain information about those chemicals in the blend that are not on the IFRA Transparency List. They will need to tell you when they’ve done this (we will not contact you). 

Information we need about chemicals not on the IFRA Transparency List includes:

  • your chemical's proper name and its CAS number (if assigned)
  • any known hazard characteristics of your chemical 
  • the maximum concentration of your chemical in the blend
  • the name(s) you use to refer to the blend

How to submit information on chemicals that are not on the IFRA Transparency List

See our form to 'Provide information about chemicals in a flavour or fragrance blend'.

We've put together these instructions to help you complete your pre-introduction report in AICIS Business services.

To start, you'll see this question:

Do you know the proper name of the industrial chemical? (CAS or IUPAC name)? 

Select ‘Yes’.  You must provide a CAS name or IUPAC name for your chemical(s). How you provide this information to us depends on your response to the next question. 

Does your flavour or fragrance blend contain 2 or more chemicals that are of ‘low-risk flavour or fragrance blend introductions’?

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

If you are making 2 or more chemical introductions

Select Yes if your pre-introduction report is for 2 or more chemical introductions.

You need to submit information about chemical identity in the following form and then upload it in AICIS Business Services as indicated: 

Make sure you save it to your hard drive as a PDF. To view and use fillable forms, you need Adobe Reader version 5.0 or higher.

If you are making a single chemical introduction

Select No if your pre-introduction report is for a single chemical introduction. You provide chemical identity information in AICIS Business Services by answering these questions: 

What is the proper name of the industrial chemical?

You must provide a CAS name or IUPAC name for your chemical. 

Do not enter an INCI name, trade name or marketing name 

Is a Chemical Abstracts Service (CAS) registry number assigned for the industrial chemicals?

Select Yes if your chemical has been assigned a number by CAS. You must enter a valid CAS number, either with or without the hyphens, or the following error message will appear “CAS registry number must be a valid CAS Number. E.g. 12-34-0 or 12340”. 

Select No if your chemical has not been assigned a CAS registry number. 

What is the name (or synonym) you use to refer to the industrial chemical? 

Enter the names that you use to refer to the chemical, for example an INCI name. 


Pre-introduction report – related to introduction tab

How many industrial chemicals in the flavour blend or fragrance blend are to be introduced as ‘low-risk flavour or fragrance blend introductions’?

This could be 1 or more chemicals, depending on how you have categorised the introductions of the chemicals in your blend. The number you enter here should be consistent with your response to the earlier question “Does your flavour or fragrance blend contain 2 or more chemicals that are of ‘low-risk flavour or fragrance blend introductions’?”, i.e. if you selected: 

  • ‘no’ to this question, enter ‘1’ here
  • ‘yes’ to this question, enter the applicable number here (i.e. ‘2’ or higher) 

Will the industrial chemical have an end use in cosmetics?

If you select ‘Yes’ you must select 1 statement that applies to your introduction relating to the use of animal test data. 

Option 1 – I did NOT use animal test data from tests conducted on or after 1 July 2020 to determine the highest indicative risk for the chemical. 

Select this option if either of these apply.

  • You did not use any animal test data to work out the highest indicative risk of your introduction.
  • You used animal test data to work out the highest indicative risk of your introduction, but the animal tests were all conducted before 1 July 2020.

Note: this is the option that we would generally expect to be selected for ‘low-risk flavour or fragrance blend introductions’

Option 2 – I will introduce the chemical for an end use solely in cosmetics AND I used animal test data from tests conducted on or after 1 July 2020 to determine the highest indicative risk for the chemical in the circumstances mentioned in the General Rules Section 34.

Select this option if all of the following apply.

  • Your chemical will only have an end use in cosmetics (and will not have any other end uses).
  • You used animal test data from tests conducted on or after 1 July 2020 to work out the highest indicative risk of your introduction.
  • You meet one of 3 exception criteria that allows cosmetics introducers to use animal test data under limited circumstances – exception 1, exception 2 or exception 3.

Option 3: I will introduce the chemical for multiple end uses (including an end use in cosmetics) AND I used animal test data from tests conducted on or after 1 July 2020 to determine the highest indicative risk for the chemical. This animal test data is of a kind mentioned in the General Rules Section 31.

Select this option if all of the following apply. 

  • Your chemical will have several end uses, which includes cosmetics.
  • You used animal test data from tests conducted on or after 1 July 2020 to work out the highest indicative risk of your introduction.
  • You meet one of 4 exception criteria that allows cosmetics introducers to use animal test data under limited circumstances – exception 1, exception 2, exception 3 or exception 4.

See: Animal test data - when it can and can’t be used and when you need pre-approval

 


Pre-introduction report – Declaration

Are you flagging any other information as confidential? 

If you select Yes to this question, you then need to specify the information that you are flagging for protection.

In selecting Yes, you are not applying for information to be treated as confidential business information (CBI). Rather, you are acknowledging that if we send you a notice that we intend to publish the flagged information (a section 113 notice under the Industrial Chemicals Act 2019), then you may apply for CBI.

Learn more about flagging information as confidential and section 113 notices


Declaration

The final item of the pre-introduction report is a declaration that the information you have given is true, correct and complete. Giving false or misleading information is a serious offence.



What happens after you submit your pre-introduction report

We may need additional information on your chemicals

If your chemicals are on the IFRA Transparency List - once you’ve submitted your pre-introduction report, you can introduce the blend containing your chemicals.

If your chemicals are not on the IFRA Transparency List – you can introduce the blend containing your chemicals as soon as you’ve submitted your pre-introduction report and we have received certain information about those chemicals in the blend that are not on the IFRA Transparency List

The information that needs to be provided for chemicals that are not on the IFRA Transparency List includes:

  • the proper name of your chemical and its CAS number (if assigned)
  • any known hazard characteristics of your chemical 
  • the maximum concentration of your chemical in the blend
  • the name(s) you use to refer to the blend

You may have already given us this information if you uploaded a form to provide chemical identity information on 2 or more chemicals as part of your pre-introduction report. But if you didn’t, you need use our form to provide information about the chemicals in your flavour or fragrance blend.

How to submit information on chemicals that are not on the IFRA Transparency List

See our form to 'Provide information about chemicals in a flavour or fragrance blend'.

Ongoing obligations

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. 

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. 

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