Food safety and quality
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OECD Unique Identifier details

MON-87427-7 x MON-89Ø34-3 x SYN-IR162-4 x MON-87411-9
Commodity: Corn / Maize
Traits: Glyphosate tolerance,Lepidoptera resistance,Coleoptera resistance
Argentina
Name of product applicant: Monsanto Argentina S.A.I.C.
Summary of application:

The event MON 87427 presents tissue-selective tolerance to glyphosate, which facilitates the production of hybrid corn seed. MON 87427 corn expresses the cp4 epsps gene under a combination of promoter and specific intron that allows the expression of the protein 5-enolpiruvil-shikimate-3-phosphate synthase from Agrobacterium sp. strain CP4 (CP4 EPSPS) in all tissues of the plant, except in the male reproductive tissues key to the development of pollen, where it has a very limited or no expression. Therefore, in MON 87427 maize, the application of this herbicide in specific stages of the development of the crop, induces male sterility facilitating the production of hybrid seed.
The proteins Cry1A.105 and Cry2Ab2, expressed in the event MON 89034, as well as the protein Vip3Aa20, expressed in the event MIR162, provide protection against the attack of certain insect pests lepidoptera as Spodoptera frugiperda, Helicoverpa zea or Diatraea saccharalis.
MON 87411 corn expresses the protein 5-enolpiruvil-shiquimato-3-phosphate synthase from Agrobacterium sp. strain CP4 (CP4 EPSPS) in all plant tissues, this expression confers tolerance to glyphosate-based herbicides. MON 87411 maize also has protection against larvae of certain coleopterous insects such as rootworms (Diabrotica spp.); this protection is given by the expression of the protein Cry3Bb1 of Bacillus thuringiensis (subsp.kumamotoensis) and by the synthesis of one of a transcript of dsRNA from the Snf7 gene of Diabrotica virgifera virgifera (DvSnf7), which triggers the RNA interference mechanism (RNAi) in white insects.

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Date of authorization: 29/01/2018
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. • There is no hypothesis of risk that indicates that there are effects of metabolic interactions and between the proteins of the events when they are accumulated. It is concluded that the stacked 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:
mlema@magyp.gob.ar
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Martín Lema
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 4349 2200
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.

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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

Mexico
Name of product applicant: Monsanto Comercial, S. de R. L. de C.V.
Summary of application:

Authorization by COFEPRIS: 161


Maize (Zea mays) genetically modified (87427 × 89Ø34 × MIR-162 × 87411). Tolerant to glyphosate herbicide, resistant to Lepidoptera and Coleoptera insects; deletion of the dvsnf7 (Diabrotica sp) gene by RNAi, resistant to the rootworm; and the pmi gene as a selection marker.

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Date of authorization: 01/02/2017
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):
No toxic, allergic or substantial nutritional changes were observed. Therefore it can be ensured that the Genetically Modified Maize (Zea mays). OCDE identifier: MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9. it is, based on the existing knowledge to date, as innocuous as its conventional counterpart.
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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:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
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:

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
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: ralatorre@cofepris.gob.mx%20

Republic of Korea
Name of product applicant: Monsanto Korea Ltd.
Summary of application:

Glyphosate herbicide tolerance, Coleopteran insect resistance , Lepidopteran insect resistance

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Date of authorization: 24/07/2017
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):
Please see the link below(in Korean).
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
mytrue85@korea.kr
Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
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: