What happens after you submit your pre-introduction report
Once you’ve submitted your pre-introduction report, you can introduce your chemical – except for low-risk flavour or fragrance blend and internationally assessed types, which may require additional steps before you can introduce.
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.
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.
Exempted category introductions and pre-introduction reports
- Can I submit a pre-introduction report for my exempted introduction?
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. - 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?
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. - 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.
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).