Food safety and quality
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OECD Unique Identifier details

ACS-GMØØ5-3xACS-GMØØ6-4
Commodity: Soyabean / Soybeans
Traits: Glufosinate tolerance
Mexico
Name of product applicant: AgrEvo Mexicana, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 21


Soybean (Glycine max L.) tolerant to glufosinate ammonium, event A2704-12 and A5547-127

OECD identifier ACS-GMØØ5-3xACS-GMØØ6-4

Submissions (documentation must be submitted in Spanish and may be contained in electronic file):


1) Description of applications or proposed uses of modified food

2) Information concerning source, identity and function of the introduced genetic material, including stability testing

3) Information on the description of the genetic modification and characterization (description of the method of genetic transformation, characterization and description of the inserted genetic material)

4) information concerning the identity and role of the expression of the modified products, including an estimate of the concentration of the modification in the modified crop or food derived

5) Information regarding any expected or known product expression and the basis for concluding that food containing it can be safely consumed allergenicity

6) Information comparing the composition or characteristics of foodstuffs modified foods derived from the original variety or other commonly consumed varieties, with particular emphasis on important nutrients and toxic which can occur naturally in food

7) Additional information (relevant for the safety and nutritional assessment of the modified food)


8) authorizations issued by other countries of the product for human consumption (copy)
 

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:

The events were developed to allow the use of glufosinate ammonium herbicide active as an option some weed control ingredient. These lines of transgenic soybeans containing the PAT (phosphinothricin acetyltransferase) enzyme that enables plants to survive applications of glufosinate that could be lethal. The pat gene inserted into events, was isolated from a common soil hogo, Streptomyces viridochromogenes and introduced into the plant genome by biolistics.
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Date of authorization: 13/08/2003
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: ACS-GMØØ5-3 X ACS-GMØØ6-4 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.
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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:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
[email protected]
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Consuelo López López
Website:
https://conacyt.mx/cibiogem/cibiogem
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.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

 

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.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

Useful links
Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados
Sistema Nacional de Información
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Teléfono: +52 55 5080 5200 / Correo electrónico: [email protected]%20