Categorisation of chemicals introduced for research and development
Extra information to help categorise the importation and manufacture (introduction) of chemicals for use in research and development (R&D).
Have you checked if your chemical is on our Inventory? If your chemical is on our Inventory and your introduction meets any terms of the Inventory listing, your introduction is categorised as a ‘listed’ introduction. Read about listed introductions.
Who should read this?
Importers and manufacturers (introducers) of industrial chemicals (and products that release industrial chemicals) that are for use in research and development. This guidance will help you work out whether your introduction will be an exempted, reported or assessed introduction. You must read this information in conjunction with the categorisation guide.
What is research and development?
The introduction of an industrial chemical is for research and development if:
- the introduction is for the purposes of systematic investigation or research, by means of experimentation or analysis, including for the analysis of other chemicals; and
- the introduction is not for distribution of the industrial chemical, or a product containing the industrial chemical, to potential customers in order to explore market capability in a competitive situation.
Is your 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 your introduction does not meet the criteria for the exempted or reported categories, it will be an assessed introduction.
The following criteria apply:
Your chemical must only be used in research and development
Your introduction must only be for the chemical to be used by you (or those that you make it available to) in research and development.
Your chemical must not be made available to the general public
You cannot sell, supply or otherwise make your chemical available to the general public in any form, i.e.:
- on its own
- mixed with other chemicals, or
- as part of an article (including where it undergoes a physical or chemical change to produce that article)
Note: if your chemical will be introduced for research trials on people (for example, in consumer research of cosmetics), then your introduction doesn't meet our criteria.
You must ensure controls are in place
Appropriate procedures and safety controls must be in place to eliminate or minimise the risks from the introduction and use of your chemical to: those involved in the research and development and the environment.
Examples of procedures and controls include: engineering controls, personal protective equipment, safe collection and disposal of your chemical.
The volume you can introduce is limited unless additional criteria are met
No additional criteria apply to your introduction, if the total volume of your chemical that you will introduce in a registration year is:
- ≤ 10kg (exempted introductions – step 2 of the categorisation guide) or
- ≤ 100kg (reported introductions – step 3 of the categorisation guide)
Otherwise, to introduce larger volumes of your chemical, additional criteria apply for your introduction to be automatically categorised as exempted or reported.
Exempted introductions (10-250kg per registration year)
You can introduce ≤ 250kg of your chemical in a registration year, but your chemical must either: not be introduced as a solid or in a dispersion, or not consist of particles in an unbound state which (by number size distribution) have at least 1 external dimension in the nanoscale.
Reported introductions (> 250kg per registration year)
You can introduce > 250kg of your chemical in a registration year, but your chemical must either: not be introduced as a solid or in a dispersion, or not consist of particles in an unbound state which (by number size distribution) have at least 1 external dimension in the nanoscale.
Use of your chemical must be subject to your (the introducer’s) control. You can collaborate with other users, but use of your chemical must remain subject to the control of the person who introduces the chemical.
Reporting and record keeping obligations
You need to make sure you can meet your reporting and record keeping obligations. These requirements are less extensive for introductions automatically categorised as exempted or reported. For further details on your obligations, or to see the types of records you need to keep to prove that your introduction is in accordance with the above criteria, see our guidance on compliance, reporting and record keeping obligations.