Categorisation of genetically modified products
Extra information to help you categorise the importation and manufacture (introduction) of genetically modified (GM) products.
Have you checked if your chemical is on our Inventory? If your chemical is on our Inventory and your introduction meets the terms of the Inventory listing, your introduction is categorised as a ‘listed’ introduction. Read about listed introductions.
Who should read this?
Importers and manufacturers of industrial chemicals (and products that are designed to release industrial chemicals) who are working out whether their importation/manufacture (introduction) will be an exempted, reported or assessed introduction. This information should be read before the chemical is introduced in Australia. You must read this in conjunction with our categorisation guide.
What is a GM product?
We define a GM product to have the same meaning as in the Gene Technology Act 2000. That is, a GM product is a thing derived or produced from a genetically modified organism (GMO), other than a GMO itself.
Introductions of an industrial chemical that is a GM product are referred to as a ‘specified class of introduction’. We have an increased level of concern for specified classes of introductions, due to a greater potential for particular hazards or high levels of human or environmental exposure. For this reason, there may be additional or different requirements when working out your category of introduction as well as additional record keeping obligations.
Our increased level of concern for introductions of chemicals that are a GM product, is because there is potential for adverse effects from exposure to GM products, depending on the nature of the genetic modification. The additional or different requirements arising from these concerns are outlined below.
Is this 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 (unless you meet the criteria for a commercial evaluation authorisation.
There are no additional or different requirements to be aware of when working out your category of introduction, due to your chemical being a GM product.
If your introduction is categorised as assessed, when submitting your application for an assessment certificate, you need to:
- identify that your introduction is a specified class of introduction
- provide any additional information that is required based on your chemical being a GM product.
If your introduction is categorised as reported, when submitting your pre-introduction report, you need to identify that your introduction is a specified class of introduction and select that “it is a genetically modified product”.
If your introduction is categorised as exempted, because you worked out that the highest indicative risk for your introduction is very low risk, you need to keep a record that your introduction is a specified class of introduction, i.e. that “it is a genetically modified product”.
Additional record keeping obligations for exempted and reported introductions
If your introduction is of a chemical that is a GM product, and:
- you worked out your introduction category as exempted or reported by following steps 4-6 of our categorisation steps, and
- your introduction is not internationally-assessed for human health and the environment,
then, you must keep the following records:
- the name of the GMO that the GM product is derived or produced from
- information on any GMO that remains in the GM product as an impurity.
For all other record keeping requirements that apply to your chemical introduction see our guidance on reporting and record keeping obligations.