Food safety and quality
| share

OECD Unique Identifier details

Commodity: Cotton
Traits: Kanamycin resistance,Lepidoptera resistance
Name of product applicant: Monsanto Australia Ltd
Summary of application:
Monsanto Australia Ltd have made an application to ANZFA to vary Standard A18 to include food from insect resistant cotton lines in the Table to the standard. The insect resistant cotton lines described in the application are not intended to be used themselves in commercial production. Their insect resistant trait has been transferred into commercial cotton varieties by traditional breeding techniques.
Cotton lines 531, 757, 1076 and 1849 were generated by transformation of the parental cotton line (Gossypium hirsutum L. cv Coker C312) using Agrobacteriumûmediated transformation.
The cotton which is the subject of this application is known commercially in Australia as INGARD cotton or Bt cotton. The term Bt cotton denotes that the soil bacteria Bacillus thuringiensis is the source organism for the genes conferring resistance to the insect pests. The insect pests in question are larvae of the moths Helicoverpa punctigera and H. armigera otherwise known as native budworm and cotton bollworm, respectively.
Following advice from the Genetic Manipulation Advisory Committee, the National Registration Authority for Agricultural and Veterinary Chemicals registered the INGARD gene as a plant pesticide (Approval No. 48296/01, 48404) in Australia. Cotton varieties containing this gene were first grown commercially in Australia in 1996 and in 1997 comprised 15% of the Australian cotton acreage.
The only human food products obtained from the cotton are cottonseed oil and linters. Cotton seed oil is a premium quality oil that may be used in a variety of foods including frying oil, mayonnaise, salad dressing, shortening, margarine and packing oil. Linters are short fibres removed from the cottonseed during delinting. After extensive processing at alkaline pH and high temperatures, the linters can be used as high fibre dietary products, sausage casings and viscosity enhancers in ice cream and salad dressings. The linters consist primarily of cellulose (>99%).
Date of authorization: 07/12/2000
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Application A341 - Oil and Linters derived from Insect Resistant Cotton
Authorization expiration date (a blank field means there is no expiration date)
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:
Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
Useful links
Relevant documents
Stacked events:
FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food Standards Australia New Zealand (FSANZ) (