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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:

La Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados está integrada por los titulares de las Secretarías de Medio Ambiente y Recursos Naturales Renovables (SEMARNAT), Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA); Salud (SS); Hacienda y Crédito Público (SHCP); Economía (SE) y Educación Pública (SEP); así como por el Director General del Consejo Nacional de Ciencia y Tecnología (CONACYT).

La presidencia de la Comisión es rotatoria por periodos de dos años, entre los Secretarios de Salud, SAGARPA y SEMARNAT ya que son las Secretarías con un mayor ámbito de competencia en relación con el uso seguro de los Organismos Genéticamente Modificados (OGMs).

Ley de Bioseguridad de Organismos Genéticamente Modificados, estipula que para su implementación la Comisión debe coordinar las acciones pertinentes con las instancias del Gobierno para cumplir su objetivo.

La CIBIOGEM, cuenta con grupos de apoyo que son sus órganos técnicos y consultivos: Comité Técnico, Consejo Consultivo Científico, Consejo Consultivo Mixto y la Secretaría Ejecutiva.

¿Cuál es el propósito de la CIBIOGEM?

Coordinar las políticas de la administración pública federal referentes a diferentes actividades relacionadas con OGMs como son: la producción, importación, exportación, movilización, transporte, siembra, consumo y, en general uso y aprovechamiento de OGMs.


-Courtesy Translation-

The Intersecretarial Commission on Biosafety of Genetically Modified Organisms is made up of the heads of the Secreataries of Health (SSA); Agriculture, Livestock, Rural, Development, Fisheries and Food (SAGARPA); Environment and Natural Resources (SEMARNAT); Finance and Public Credit (SHCP); Economy (SE); Public Education, and the General Director of the National Council of Science and Technology.

The chair of the Commission rotates every two years among the Secretaries of Health, SEMARNAT and SAGARPA, the three entities most directly involved in policies concerning the use and biosafety of Genetically Modified Organisms (GMOs).

The Law on Biosafety of Genetically Modified Organisms states that the Commission aims to promote and coordinate the actions of Government agencies. CIBIOGEM receives support from the Executive Secretariat of CIBIOGEM, the Technical Committee, the Scientific Advisory Board and the Joint Advisory Council.

What is the purpose of the CIBIOGEM?

To coordinate the policies and federal regulation of activities related to Genetically Modified Organisms (GMOs) such as: production, import, export, mobilization, transportation, release into the environment, consumption, and general use of GMOs.

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: