Pre-introduction report - internationally-assessed
Information to help you submit your pre-introduction report for your internationally-assessed reported introduction. As we publish information about internationally-assessed introductions, you can apply for protection of your confidential business information.
Information and steps on this page apply to your pre-introduction report, if your reported introduction is for chemicals that are internationally assessed for:
- human health and the environment
- human health and are low or very low risk for the environment
- the environment and are low or very low risk for human health
When you go into AICIS Business Services to submit your report, you will be asked which one of the above applies to your introduction.
Information you will need to submit your pre-introduction report
Before you submit your report, 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.
Steps to follow if you don’t know the proper name for your chemical
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.
Other information you need
The information required differs depending on the report type. We need information such as:
- 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
- details of the body that assessed or evaluated the chemical, and when they did this
- the parameters of the international assessment or evaluation and any restrictions that are included
If you worked out that the indicative human health risk or indicative environment risk for your introduction is low or very low, using the human health or environment exposure bands, we need information on how you worked this out, such as:
- the human health or environment exposure band that applies to your introduction (as applicable)
- any human health or environment hazard characteristics of your chemical that you know about (as applicable)
- if your chemical will have an end use in cosmetics - whether new animal test data were used to categorise your introduction
Note that we will be publishing further details regarding the types of information you need to provide in your pre-introduction report for each of these reported introduction types soon. In the meantime, you should look at the following pages for additional help when submitting your pre-introduction report:
- pre-introduction report - highest indicative risk is low risk. We have detailed step-by-step guidance for this report type and some of the questions in it are the same as questions within the internationally-assessed chemical pre-introduction report types. You may find it helpful to look at but note that there are differences.
- Guide to categorising internationally assessed introductions
Applying for protection of your confidential business information
There is more public interest in these internationally-assessed reported introductions, due in part to the potential for them to be of higher hazard or exposure. Therefore we 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.
What happens after you submit your pre-introduction report
If you are not applying for CBI - once you’ve submitted your pre-introduction report, you can introduce your chemical.
If you are applying for CBI - you must submit your CBI application before you introduce your chemical.
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.