Categorisation of biochemicals
Extra information to help you categorise the importation and manufacture (introduction) of biochemicals.
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):
You must read this page in conjunction with our categorisation guide.
What is a biochemical?
We define the term ‘biochemical’ in a way that might be different from usual definitions. Check our definitions carefully to make sure that your chemical is a biochemical according to our definition.
A biochemical is a biological chemical that:
- is directly produced by a microscopic organism, or
- is a protein or a nucleic acid.
A biological chemical is a chemical that is derived from, or produced by, a living or once-living organism.
An organism is a biological entity that is:
- viable or
- capable of reproduction or
- capable of transferring genetic material.
In other words, a biochemical is a chemical directly produced by microorganisms such as bacteria, algae, fungi, protozoa or viruses. An example of a biochemical is the enzyme subtilisin that is produced by Bacillus subtilis.
A biochemical can also be a protein or nucleic acid, such as keratin and collagen.
A biopolymer is a type of a biochemical – one that also meets our definition of a polymer. Read about categorisation of polymers.
Your Introduction is a ‘specified class of introduction’ if it is a biochemical.
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. Our increased level of concern for introductions of biochemicals is because of the organisms used to produce the biochemical. Small amounts of these production organisms might be present with the biochemical after it is produced and these organisms might remain viable. These could potentially cause adverse effects to humans or the environment. For this reason, there may be additional or different requirements when working out your category of introduction as well as additional record keeping obligations.
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 introduction does not meet the criteria for the listed or exempted or reported categories, it will be an assessed introduction (unless you meet the criteria for a commercial evaluation authorisation).
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 biochemical. 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 biochemical”.
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 biochemical”.
Additional record keeping obligations for exempted and reported introductions
If your introduction is of a biochemical and you worked out that your introduction category is 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, or
- your introduction is internationally assessed for the environment but not human health
then, you must keep the following records:
- the concentration of any remaining viable cell or cellular components of the organisms used to produce the biochemical
- information on any known adverse effects of any remaining viable cell or cellular components of the organisms used to produce the biochemical
If you do not know this information then you must keep a written undertaking from the person who has the information, that they will give us the records if we ask for them.
For all other record keeping requirements that apply to your chemical introduction see our guidance on reporting and record keeping obligations.