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.
You must be able to provide a complete report from an accepted international assessment body and have permission to use it. Read our guide to categorising internationally assessed introductions for a list of accepted international assessments.
What is the type of your pre-introduction report?
There are 3 types for internationally assessed reported introductions. You must read our guide to categorising internationally assessed introductions to work out which one applies:
internationally assessed for both human health and the environment
internationally assessed for human health and are low or very low risk for the environment
internationally assessed for the environment and are low or very low risk for human health
Do you know the proper name of the industrial chemical?
You, or someone else, must provide the chemical's CAS name or IUPAC name. If you do not have a CAS or IUPAC name for the chemical, we accept an INCI name under very limited circumstances as described below.
Select Yes if you can provide the chemical's CAS name or IUPAC name, or an INCI name if it meets all 4 criteria for the chemical and its name. You will then need to enter the CAS name, IUPAC name or INCI name and the CAS registry number (if assigned). You will also need to enter any other names you use to refer to your chemical.
Select No if someone else – such as your supplier or manufacturer – is going to provide the CAS name or IUPAC name, or an INCI name that meets all 4 criteria for the chemical and its name. Click Business look up and enter the AICIS business ID of your chemical data provider (starting with NIC) followed by the first and last name of your chemical data provider’s contact person. We will then email the contact person and ask them to provide this information directly to us. They need to let you know when they have provided us with this information.
If you don’t know the contact person’s name or AICIS business ID details, you must contact your chemical data provider as we cannot give you this information.
You will then need to enter the names that you use to refer to your chemical.
If you wish to use an International Nomenclature of Cosmetic Ingredients (INCI) name as the 'proper name' for an industrial chemical, you must meet all 4 criteria below for the chemical and its name:
1. The chemical does not have a CAS or IUPAC name.
2. The chemical is a plant extract – for example, extract of flowers, seeds or leaves of trees, shrubs, herbs, grasses, ferns and mosses.
3. The name for the plant extract is an INCI name based on a proper botanical name.
✔ Helianthus Annuus Leaf/Stem Extract
❌ Sunflower extract
4. The plant extract cannot be chemically modified. For example, the chemical cannot be hydrolysed, acetylated or hydrogenated.
❌ We would not accept 'Hydrogenated sweet almond oil'.
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.