Food safety and quality
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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:
Biól. Erica L. Hagman Aguilar
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 53227700
Fax number:
Country introduction:

México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población. Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano. En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.

Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley. Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.


Courtesy translation

Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.

The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.

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: [email protected]%20