Food safety and quality
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OECD Unique Identifier details

Commodity: Soyabean / Soybeans
Traits: Herbicide tolerance,Insect resistance
Name of product applicant: INDEAR S.A.
Summary of application:

The DBN-Ø8ØØ2-3 soybean has been obtained by transformation mediated by A. tumefasciens and gives the plant resistance to lepidoptera and tolerance to the herbicide glufosinate ammonium.

Date of authorization: 30/06/2021
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 (food safety):
Organism subject to control: Soy has a history of safe consumption and according to the intended use its allergenic and toxicological characteristics do not represent a concern for human or animal health. Donor organisms: The introduced genes come from: - Streptomyces viridochromogenes (pat) - Bacillus thuringiensis (cmVip3Aa) Donor organisms have a history of food use and their allergenic and toxicological characteristics do not represent a concern for human or animal health. Characterization of the event: The soybean event DBN-Ø8ØØ2-3 was obtained by transformation mediated by Agrobacterium tumefaciens in the variety of Glycine max (L.) Merr., Cultivar Jack and presents the following characteristics: - Resistance to Lepidoptera. - Tolerance to the herbicide Glufosinate ammonium. Compositional Analysis: The composition studies presented show that, although some statistically significant differences were found in the comparisons, the values ​​obtained were within the range of the scientific literature and within the range of the commercial varieties used as comparators. The results obtained show that the analyzed event is substantially equivalent to its non-transgenic counterpart. Allergenic and Toxicological Characteristics: Bioinformatic analysis of the newly expressed products demonstrated that there is no sequence similarity to any known allergens or toxins. There is no evidence to support the need for animal studies, taking into account: - History of safe food use of new expression products. - Unprecedented donor and recipient of allergenicity. - Compositional equivalence of the event. - Absence of homology with allergens and toxins of VIP3Aa and PAT According to the foregoing, based on currently available scientific knowledge and internationally accepted requirements and criteria, it is concluded that the DBN-Ø8ØØ2-3 soy event is as safe and no less nutritious than its conventional counterpart, and that, therefore, there are no objections to its approval for human and animal consumption.
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:
Authorization expiration date (a blank field means there is no expiration date)
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Andrés Maggi
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 5222 5986
Fax number:
Country introduction:

In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.

Useful links
Relevant documents
Stacked events:

Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

National Service for Agrifood Health and Quality (Senasa)