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OECD Unique Identifier details

Commodity: Soyabean / Soybeans
Traits: Acetolactate synthase (ALS) inhibitors tolerance,Glyphosate tolerance
Name of product applicant: PHI México, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 90

Proposed use:

To be processed and used in food and feed, feed and industrial products in the same way as the products obtained with conventional soybeans.

Description from transformation:

For the genetically modified organism with gene stacking, the two single lines DP-356Ø43-5 parental events and MON-Ø4Ø32-6, which were obtained by processing independently, were combined by traditional breeding techniques, resulting in a events stacked product with DP-356Ø43-5 x MON-Ø4Ø32-6 molecular inserts containing the two events.

The DP-356Ø43-5 soybeans was obtained by micro projectile bombardment covered with exogenous DNA. Exogenous DNA constructs consists of two insert in plasmid PHP20163, one containing the gene gat4601 obtained by a "shuffling" of DNA (DNA "shuffling") acetyl transferase gene of Bacillus licheniformis. The GAT4601 protein, encoded by the gat4601 gene confers tolerance to the herbicide active ingredient; glyphosate. The other genetic construct or "expression cassette" containing the gm-hra, the gene encoding GM-HRA protein, which confers tolerance to herbicides that inhibit acetolactate synthase.

Soybean line MON-Ø4Ø32-6 was generated by inserting a gene of Agrobacterium tumefaciens strain CP4 encoding a glyphosate tolerant EPSPS enzyme. This insertion confers tolerance to glyphosate to soy. MON-Ø4Ø32-6 line was produced by bombardment with micro particles coated with DNA of the gene construct inserted into the plasmid PV-GMGT04.

Date of authorization: 19/01/2011
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.):
Summary of the safety assessment (food safety):
UI OECD: DP-356Ø43-5xMON-Ø4Ø32-6 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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):
Contact person name:
Dra. Sol Ortiz García
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: