Australia
October 14, 2025
The Regulator has issued licence DIR 216 to Bayer CropScience Pty Ltd, authorising the commercial release of cotton genetically modified (GM) for insect resistance and herbicide tolerance.
The release is authorised to take place throughout Australia. The GM cotton and products derived from the GM cotton may enter general commerce, including use in human food and animal feed.
The Risk Assessment and Risk Management Plan (RARMP) and the licence were finalised taking into account input received during consultation with, State and Territory governments, Australian Government agencies, the Minister for the Environment, the Gene Technology Technical Advisory Committee, local councils and the public. The Regulator thanks submitters for their contributions.
Submissions are summarised in Appendix C and Appendix D of the RARMP, together with information about how the issues raised relating to risks to human health and safety or the environment were considered in preparing and finalising the RARMP.
The finalised RARMP concludes that this commercial release poses negligible risks to people and the environment and does not require specific risk treatment measures. However, general licence conditions have been imposed to ensure ongoing oversight of the release.
The finalised RARMP, a summary of the RARMP, the licence and Questions and Answers about this decision can be obtained online from the DIR 216 page of the Office of the Gene Technology Regulator’s (OGTR) website or requested via the contacts detailed below.
Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 CANBERRA ACT 2601
Tel: 1800 181 030 E-mail: ogtr@health.gov.au
OGTR website
DIR 216
Commercial release of cotton genetically modified for insect resistance and herbicide tolerance (Bollgard® 3 ThryvOn™ cotton with XtendFlex® Technology)
Licence details
Licence number: DIR 216
Licence status: Current
Category: Agricultural
Release: Commercial
Organisation: Bayer CropScience Pty Ltd
Parent organism: Cotton (Gossypium hirsutum L.)
Modified trait: Insect resistance and herbicide tolerance
Licence issue date: 7 October 2025
Description:
The licence allows Bayer CropScience Pty Ltd to commercially cultivate cotton genetically modified (GM) for insect resistance and herbicide tolerance.
The GM cotton may be grown in all cotton growing areas in Australia, subject to restrictions in some Australian States and Territories for marketing reasons. Commercial cotton production occurs mainly in New South Wales and Queensland, and has recently expanded into northern Victoria, Western Australia and the Northern Territory.
The Regulator has not imposed any specific measures to manage risk, as the risk assessment concluded that this release of GM cotton poses negligible risk to the health and safety of people or the environment. General conditions have been imposed to ensure that there is ongoing oversight of the release.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.
Please see our factsheet for more information on GM cotton in Australia and GM crops in Australia. You can also find more information about cotton and how it is farmed in Australia in our Cotton Biology Document.
Date application received: 3 December 2024
RARMP open for public consultation: 15 July 2025
RARMP closed for public consultation: 9 September 2025
Documents
Licence decision - notification
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
Licence decision - Q&A
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
Risk assessment and risk management plan - summary
A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.
Risk assessment and risk management plan - full version
The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.
Licence conditions
Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.
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