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Australian Export Controls and the Life Sciences

A guide to understanding export control laws regarding the physical export, intangible supply, publication or brokering of life sciences related goods, software or technology

8: Understanding the “required” threshold

When combined, the control listing for a DSGL technology item and the General Technology Note limit the technology that is subject to export control to only that specific information that is peculiarly responsible for achieving or extending the controlled performance levels, characteristics or functions of a controlled item that is necessary for the “development”, “production” or “use” of the controlled goods or software. Each control item text will identify whether it is the technology for the “development”, “production” or “use” of the controlled item that is subject to control. The fact that the technology is intended for civilian use does not remove the requirement to seek a permit, though it would be relevant to whether a permit would be granted.

When assessing if technology is subject to control, it is important to determine if the technology is “required” for the “development”, “production” or “use” of a DSGL listed good. If the technology is not specific or detailed enough to be directly used to develop or produce a listed chemical, pathogen, toxin, genetic element or genetically modified organism, that technology is not controlled because it has not met the “required” threshold.

A similar distinction can be made between experimental research activities and commercial-scale production. The experimental or theoretical pursuit of new knowledge or observable facts or phenomena is generally insufficient to meet the “required” threshold (as opposed to technology for proprietary research and industrial development, design, and production technology). The latter will generally require a permit, unless an exemption applies.

EXAMPLE: Control Item 1C351.d.1 lists botulinum toxin. All forms of botulinum toxins are controlled except pharmaceutical formulations that are pre-packaged and authorised for distribution as medical products. A botulinum vaccine would also be exempt from control.

The related technology control, 1E001, only applies to the technology that can be considered “required” for the “development” or “production” of botulinum. Instructions on how to extract and purify botulinum toxins will only meet the “required” threshold if they are unique to botulinum toxins. If the instructions are generic with other non-controlled toxins then the threshold is not met and will not be controlled.

Controlled “technology” may take the form of blueprints, plans, diagrams, models, formulae, tables, designs and specifications, or manuals and instructions, either written or recorded on other media or devices such as disks, tapes or read-only memories. It can also include instruction, skills, training, working knowledge or consulting services that involve the transfer of “technology”.

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