Categorisation of chemicals in flavour and fragrance blends
Extra information to help categorise the importation and manufacture (introduction) of chemicals in flavour and fragrance blends.
Have you checked if your chemical is on our Inventory? If your chemical is on our Inventory and your introduction meets the terms of the Inventory listing, your introduction is categorised as a ‘listed’ introduction. Read about listed introductions.
Who should read this?
Introducers of chemicals in flavour and fragrance blends who are working out if their importation or manufacture (introduction) will be categorised as exempted, reported or assessed should read this information before introducing the chemical in Australia. You must read this in conjunction with our categorisation guide.
What are flavour and fragrance blends?
- A fragrance blend is a mixture of chemicals that is formulated to impart a scent or to cover a malodour.
- A flavour blend is a mixture of industrial chemicals that is formulated to impart a taste.
Is this introduction exempted, reported or assessed?
You must work out if your introduction meets the criteria for the exempted or reported categories by going through steps 1-6 of the categorisation guide. If you are introducing chemicals in a flavour or fragrance blend, your introduction is categorised as reported if it meets our criteria (step 3 of the categorisation guide). Otherwise, you need to work out if your introduction category as exempted, reported or assessed by going through steps 4-6 of categorisation guide.
Criteria for reported introduction – low-risk flavour or fragrance blend
If your introduction meets the following criteria, it is categorised as reported (step 3 of the categorisation guide):
1. Your chemical must be introduced as part of a flavour or a fragrance blend.
Your flavour or fragrance blend could be introduced:
- on its own for formulation into end use products in Australia; or
- in combination with other chemicals (for example, import of formulated products for end use)
2. Your chemical must have a concentration at introduction and at end use of 1% or less.
3. Your chemical must not have an end use in a personal vaporiser, such as e-cigarettes.
4. Your chemical must not have any of the hazard characteristics in human health hazard band C or environment hazard band D.
Your chemical must not have any of the hazard characteristics in human health hazard band C:
- carcinogenicity
- reproductive toxicity
- developmental toxicity
- adverse effects mediated by an endocrine mode of action
- genetic toxicity
Your chemical must not have any of the hazard characteristics in environment hazard band D:
- contains arsenic, cadmium, lead or mercury
- ozone-depleting chemical
- synthetic greenhouse gas
- adverse effects mediated by an endocrine mode of action
- persistent, bioaccumulative and toxic
If you know that your chemical has any of these hazard characteristics (for example, based on information from your supplier), then your chemical cannot be categorised as reported. Otherwise, you need to confirm that it doesn’t have any of these hazard characteristics by checking that your chemical (and the chemical of which it is an ester or salt) is not on the ‘list of chemicals with high hazard for categorisation’. You do not need to have data to demonstrate that your introduction meets the hazard characteristics criteria.
5. Your chemical must either be on the IFRA Transparency List at the time that your pre-introduction report is submitted, or certain information about its introduction must be given to us before you introduce the chemical.
If your chemical is not on the IFRA Transparency List at the time that your pre-introduction report is submitted, then we need to have certain information before you can introduce the blend containing your chemicals. The information we need is:
- the proper name of your chemical and its CAS number (if assigned)
- the known hazard characteristics of your chemical (for example, you might tell us that your chemical is a known sensitiser, but you don’t need to give us actual study reports)
- the maximum concentration of your chemical in the blend
- the name(s) you use to refer to the blend
Either you or your supplier can give us this information, and it only needs to be provided once for each blend. Multiple introducers of the same blend do not need to submit the information each time. Reporting and record-keeping obligations
To meet your reporting and record-keeping obligations, you will need to:
- submit a pre-introduction report. You can submit a single report for all chemicals in your blend that meet the criteria for ‘low-risk flavour or fragrance blend introductions’.
- give us information about your chemicals before they’re introduced, if they’re not on the IFRA Transparency List and this information hasn’t already been given to us
- keep records about your introduction
- submit an annual declaration
- vary your pre-introduction report, if necessary
Frequently asked questions
Q. Can I categorise the chemicals I’m introducing as ‘low-risk flavour or fragrance blend introductions’ if I’m introducing the fragrance blend on its own for reformulation in Australia?
A. Yes, if the chemicals in your blend meet all of the criteria for ‘low-risk flavour or fragrance blend introductions’. The criteria apply to the introductions of chemicals in flavour or fragrance blends, where those blends are introduced:
- on their own, for formulation into end use products in Australia; or
- in combination with other chemicals (for example, import of formulated products for end use)
Q. Do I still need to submit a pre-introduction report if my chemicals are on the IFRA Transparency List?
A. Yes. If the chemicals that you are introducing as ‘low-risk flavour or fragrance blend introductions’ are on the IFRA Transparency List, you don’t need to give us certain information about those chemicals before you introduce them, but you still need to submit a pre-introduction report and keep records about your introduction.
Q. When can I start introducing the blend containing my chemicals?
A. If your introduction is a ‘low-risk flavour or fragrance blend introduction’, you can start introducing 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
Q. What if I don’t know the proper names of the chemicals in the blend that I’m introducing?
A. You will be relying on information that is held by another person to categorise your chemical introduction. In your pre-introduction report, you need to give us the name of the person who knows the proper name of your chemicals. Once you have submitted your report, we will email that person to remind them to provide us with certain information on your chemicals before they are introduced, if required. You will also need to keep a written undertaking from the person who knows the proper name of your chemicals. Learn more about your record-keeping requirements for low-risk flavour or fragrance blends.
Q. Do I need to track the volume of each chemical in the blend that I’m introducing?
A. There are no volume criteria for ‘low-risk flavour or fragrance blend introductions’, so you don’t need to track the volume of the individual chemicals in the blends. You do need to keep records to prove the total volume that you have introduced in the registration year of either the:
- blend; or
- products containing the blend
It should be easier for you to keep a record of the volume of the blend or of the products containing that blend, particularly if you introduce the same blend in several different products. Learn more about your record-keeping requirements for low-risk flavour or fragrance blends.
Q. What if my introduction doesn’t meet all of the criteria for a low-risk flavour or fragrance blend introduction?
A. If your introduction does not meet all of the above criteria, then you need to categorise it as you would for any other chemical introduction. You must work out if your introduction meets the criteria for the exempted or reported categories by going through steps 4-6 of the categorisation guide. If your introduction does NOT meet the criteria for the exempted or reported categories, it will be an assessed introduction.
Q. Can I categorise my introduction as exempted?
A. If your introduction meets the criteria for a ‘low-risk flavour or fragrance blend’, it is in the reported category. However, you can choose to work out if your introduction is categorised as exempted using steps 4-6 of the categorisation guide. You must ensure you can meet your reporting and record-keeping obligations - which are more extensive if you categorise your introduction as exempted using the exposure and hazard band criteria.
Q. Will my chemical be added to the Inventory?
A. If your chemical introduction is authorised under the reported category as a ‘low-risk flavour or fragrance blend introduction’, we will NOT add it to the Inventory. If you want to add your chemical to the Inventory, you will need to apply for - and be issued with - an assessment certificate.
Q. I’ve submitted a pre-introduction report for the introductions of chemicals in a fragrance blend (Blend A) that are ‘low-risk flavour or fragrance blend introductions’. What do I need to do if the name of the blend that I’m introducing has changed (Blend B)?
A. Before introducing Blend B, you need to vary the pre-introduction report for Blend A to identify the additional fragrance blend name (i.e. the varied pre-introduction report would then contain the names of both blends, Blend A and Blend B). You can do this if Blend A and Blend B are very similar or the same. There may be minor differences between the formulations, but all of the following apply:
1. Either
- you know the proper names of the chemicals in Blend A and Blend B Or
- the person who knows the proper name of the chemicals in Blend A and Blend B is the same
2. Blend A and Blend B contain the same number of chemicals that would be introduced as ‘low-risk flavour or fragrance blend introductions’
3.The identities of all the chemicals that would be introduced as ‘low-risk flavour or fragrance blend introductions’ in Blend B are the same as those in Blend A
4.The information given to us about the chemicals in Blend A that are not on the IFRA Transparency List (including the maximum concentration of the chemicals in Blend A at introduction and at end-use) is the same as for Blend B.
You then need to keep records about the introductions of the chemicals in Blend B, as you are required to do for the chemicals in Blend A.
If any of points 1-4 do not apply, then you need to submit a separate pre-introduction report for the introductions of the chemicals in Blend B. You will also need to give us information about the chemicals in Blend B before they’re introduced, if they’re not on the IFRA Transparency List and this information hasn’t already been given to us (for Blend B). You then need to keep records about your introductions.
Q. I’ve submitted a pre-introduction report for the introductions of chemicals in a fragrance blend (Blend A) that are ‘low-risk flavour or fragrance blend introductions’. What do I need to do to introduce those same chemicals in a different fragrance blend (Blend B)?
A. You need to submit a separate pre-introduction report for the introductions of the chemicals in Blend B. You will also need to give us information about the chemicals in Blend B before they’re introduced, if they’re not on the IFRA Transparency List and this information hasn’t already been given to us (for Blend B). You then need to keep records about your introductions.