Varying your pre-introduction report

You may need to change (vary) your submitted pre-introduction report (PIR) if the circumstances of your introduction change.

When you must vary your pre-introduction report

If you have already submitted a pre-introduction report and both 1 and 2 applies:

1. You can no longer introduce the chemical under the terms of your pre-introduction report because of a change in circumstances (see examples below).
2. Although your introduction circumstance has changed, it remains in the ‘reported’ category.

The ‘terms’ of your pre-introduction report refers to the details of your chemical importation or manufacture that you provided in your pre-introduction report form.

These are example scenarios of when you must vary your pre-introduction report.

• Change from import to manufacturing: You stated in your pre-introduction report that you were importing the chemical, but you will now manufacture the chemical in Australia.
• Change to concentration of chemical at introduction: Based on the human health exposure band criterion that applies for your chemical introduction, you were able to introduce and use your chemical at less than or equal to 1% concentration. You want to introduce the chemical at 10% concentration and reformulate to less than or equal to 1% concentration for end use. You categorise your introduction under the changed circumstances and it remains a reported introduction.
• New end use: In your pre-introduction report you indicated that the chemical will be used in paints. You now plan to sell a range of printing inks that include this chemical as an ingredient. You categorise your introduction to account for use in printing inks and it remains a reported introduction.
• Change to environment categorisation volume: The environment categorisation volume for your introduction is less than or equal to 1000kg. You intend to increase this to 1500kg. You categorise your introduction based on an environment categorisation volume of 1500kg and it remains a reported introduction.
• Hazard characteristic: In your pre-introduction report, you stated that there were no known hazard characteristics. You become aware of a hazard characteristic that is associated with your chemical. You categorise your introduction using the new hazard information and it remains a reported introduction.

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

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

You're not required to vary your report if the circumstances of your introduction change, but you will continue to introduce and use your chemical within the terms of your pre-introduction report.

Example 1: Your introduction volume decreases

You submitted in your pre-introduction report that you will introduce less than or equal to 100kg of your chemical in a registration year. This means that the terms of your pre-introduction report allow you to introduce maximum of 100kg of your chemical in an AICIS registration year.

Due to a sales decline, you project that you will introduce a maximum of 15kg in each of the coming registration years. You don’t need to vary your pre-introduction report because you’ll still be introducing within the terms.

Example 2: You have test data showing a hazard, but you already told us about this hazard characteristic

You stated in your pre-introduction report that skin irritation is a hazard characteristic for your chemical (taken from the safety data sheet). You get an in vitro study confirming that your chemical is a skin irritant. You don’t need to vary your pre-introduction report because you already told us about this hazard characteristic and so will still be introducing within the terms.

How to vary your pre-introduction report (other than chemical name or CAS number)

Log in to AICIS Business Services and click “Vary report” on your pre-introduction report (PIR) dashboard. You will be asked if you want to change the pre-introduction report type.

Select no if the report type remains the same and you just want to vary the circumstances of your introduction.

Select yes if you need to switch to a different report type. For example, you originally submitted a report type ‘internationally-assessed for human health’ and you wish to change to ‘highest indicative risk is low risk and the other types do not apply’. After you click yes, a new report will be created with a new PIR ID. Complete the PIR and submit.

How to vary your chemical’s name or CAS number

Use the form below to change any of the following details that you provided in your original PIR. An introducer or their agent can submit this form.

• Provide a new or different name for the industrial chemical – the name you use to refer to the chemical or the name of the flavour or fragrance blend that contains the chemical (as applicable)
• Change the ‘proper name’ of the chemical – this may be because you submitted an incorrect proper name or because the CAS name has been updated by CAS.
• Change the CAS Registry Number – this may be because you submitted an incorrect CAS number or because the number has been updated by CAS.