Food safety and quality
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OECD Unique Identifier details

DBN-Ø9ØØ4-6
Commodity: Soyabean / Soybeans
Traits: Herbicide tolerance
Argentina
Name of product applicant: INDEAR S.A.
Summary of application:

In soybeans with the DBN-Ø9ØØ4-6 event, two genes have been introduced: I) the pat gene encoding the enzyme phosphinothricin N-acetyltransferase (PAT), which inactivates the active ingredient L-phosphinothricin of glufosinate-based herbicides. ammonium, and II) the cp4epsps gene, which encodes the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (CP4EPSPS), a key enzyme in the shikimate pathway, essential in the biosynthesis of aromatic amino acids and many other secondary metabolites. The enzyme derived from the CP4 strain of A. tumefaciens is not sensitive to inhibition by glyphosate, which gives the plant tolerance to this herbicidal allergen known for the expressed proteins.

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Date of authorization: 20/10/2018
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):
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins are expressed in low levels. • It is compositionally equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. It is concluded that the event is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial varieties.
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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: GMO commercial approvals in Argentina
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Andrés Maggi
Website:
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)

https://www.argentina.gob.ar/senasa

 

https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia