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OECD Unique Identifier details

MON-87769-7
Commodity: Soyabean / Soybeans
Traits: High stearidonic acid
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:
Soybean line MON87769 has been genetically modified (GM) to produce seeds containing stearidonic acid (SDA), an omega-3 fatty acid. In humans and other mammals, SDA is an intermediate in the metabolic pathway leading to the production of the long chain omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), normally found in fish and marine oil products derived from fish, krill or marine algae. SDA soybean therefore represents a plant-based source of dietary omega-3 polyunsaturated fatty acids(PUFA).
MON87769 was created from conventional soybean by introducing two genes: a delta-6 (Δ6) desaturase gene from Primula juliae and a delta-15 (Δ15) desaturase gene from Neurospora crassa. The seed-specific expression of these two desaturase enzymes results in the production of SDA and other more minor changes to fatty acids in soybean seeds.
Refined soybean oil from MON87769 contains 20-30% SDA (% total fatty acids), and 5-8% gamma-linolenic acid (GLA), neither of which is present in conventional soybean oil. SDA soybean oil also contains slightly higher levels of alpha-linolenic acid (ALA) and palmitic acid as well as lower levels of oleic acid and linoleic acid (LA), compared with conventional soybean oil. The variability in the SDA concentration is attributed to natural variation in growing conditions for the soybean.
Stearidonic acid is a fatty acid with 18 carbons and four double bonds (18:4). As SDA has fewer double bonds than EPA (20:5) and DHA (22:6), the Applicant claims that
SDA soybean oil is more stable to oxidation compared with fish oils. This property may
expand the potential formulation options for food manufacturers seeking to use oils rich in omega-3 fatty acids.
It is anticipated that SDA soybean oil could partially replace regular soybean oil or other vegetable oils in a variety of packaged foods such as baked goods, breakfast cereals, grain products and pastas, sauces, milk products and soups. SDA soybean oil may also be used in aquaculture and feed applications as an alternative to fish oil and other omega-3 rich feed components. The seed meal from MON87769 soybean is compositionally similar to other commodity soybean meal and can be used in any conventional food and feed applications.
When commercialised, the SDA soybean crop is intended for cultivation and processing in soybean growing regions of northern USA under an identity-preserved (IP) system. Due to its targeted applications, the Applicant anticipates that SDA soybean will be a low acreage crop (<5% of total US soybean acreage) compared with other commercialised soybean lines. This would amount to an area of cultivation of approximately 3-3.5 million acres. There are currently no plans to produce SDA soybean in Australia and/or New Zealand.
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Date of authorization: 17/11/2011
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:
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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 A1041 - Food derived from SDA Soybean Line MON 87769
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Authorization expiration date:
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
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) (http://www.foodstandards.gov.au)
United States of America
Name of product applicant: Monsanto Company
Summary of application:
Soybean
Trait 1 Added Protein: Delta-6 desaturase (PjΔ 6D)
Source: Primula juliae (primrose)
Intended Effect: Conversion of alpha-linolenic acid to stearidonic acid
Trait 2 Added Protein: Delta-15 desaturase (NcΔ 15D)
Source: Neurospora crassa (fungus)
Intended Effect: Conversion of linoleic acid to alpha-linolenic acid
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Date of authorization: 30/07/2012
Scope of authorization: Food and feed
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.):
Summary of the safety assessment:
Please consult the FDA website links below.
Upload:
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: FDA's webpage regarding this variety
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Authorization expiration date:
E-mail:
jason.dietz@fda.hhs.gov
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:
The United States is currently in the process of populating this database.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food and Drug Administration (premarkt@fda.hhs.gov); Environmental Protection Agency