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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).
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Who should read this?
Importers and manufacturers of industrial chemicals (and products that are designed to release industrial chemicals) who are working out which category applies to their chemical importation/manufacture (introduction):
- listed
- exempted
- reported
- assessed
You must read this page in conjunction with our categorisation guide.
What is research and development?
The introduction of an industrial chemical is for research and development if is it both of the following:
- the introduction is for the purposes of systematic investigation or research, by means of experimentation or analysis, including for the analysis of other chemicals
- 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 listed, exempted, reported or assessed?
There are different criteria for each category and you must work out which one applies to your introduction by going through our categorisation guide, starting at 'Step 0: introductions that are in the listed category'.
If your chemical is not in the listed category and will only be used in research and development, its introduction may be categorised as exempted (step 2) or reported (step 3), if it meets our criteria.
Common criteria for the exempted and reported categories
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 such as consumer research of cosmetics, then your introduction does not 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 or less (exempted introductions – step 2 of the categorisation guide) or
- 100kg or less (reported introductions – step 3 of the categorisation guide)
Otherwise, to introduce larger volumes of your chemical, additional criteria apply for your introduction to be categorised as exempted or reported.
Exempted introductions (10-250 kg per registration year)
You can introduce 250 kg (or less) of your chemical in a registration year, but all quantities of your chemical must be either 1 or 2:
- not be introduced as a solid or in a dispersion
- not consist of solid particles in an unbound state, or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least 1 external dimension in the nanoscale (see our categorisation guide for information on how you can demonstrate this)
Reported introductions (greater than 250 kg per registration year)
You can introduce greater than 250 kg of your chemical in a registration year, if use of your chemical is 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.
Also, all quantities of your chemical must be either 1 or 2:
- not be introduced as a solid or in a dispersion
- not consist of solid particles in an unbound state, or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least 1 external dimension in the nanoscale (see our categorisation guide for information on how you can demonstrate this)
Related content: categorisation of chemicals at the nanoscale
Reporting and record keeping obligations
There are different reporting and record keeping obligations for each introduction category. You must check these and make sure that you can meet them.
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