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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
European Union
Name of product applicant: Bayer CropScience LP
Summary of application:

The genetically modified maize MON-87427-7 expresses the CP4 epsps gene, which confers tolerance to glyphosate-based herbicides.

The genetically modified maize MON-89Ø34-3 expresses the cry1A.105 and cry2Ab2 genes, which confer protection against certain lepidopteran pests.

The genetically modified maize SYN-IR162-4 expresses a modified vip3Aa20 gene, which provides protection against certain lepidopteran pests. In addition, the pmi gene coding for the PMI protein was used as a selection marker in the genetic modification process.

The genetically modified maize MON-87411-9 expresses the CP4 epsps gene, which confers tolerance to glyphosate-based herbicides, the cry3Bb1 gene and the DvSnf7 dsRNA, which confer protection against corn rootworm (Diabrotica spp.).

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Date of authorization: 22/01/2022
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.): EU Register of authorised GMOs
Summary of the safety assessment (food safety):
Please see the EU relevant links below.
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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:
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-87427-7, MON-89Ø34-3, SYN-IR162-4 and MON-87411-9 and further verified on maize stack MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9. Reference Material: AOCS 0512 (for MON-87427-7), AOCS 0906 (for MON-89Ø34-3), AOCS 1208 (for SYN-IR162-4) and AOCS 0215 (for MON-87411-9) are accessible via the American Oil Chemists Society.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Method for detection
Reference Material
Opinion of the European Food Safety Authority
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Authorization expiration date (a blank field means there is no expiration date) 21/01/2031
E-mail:
Organization/agency name (Full name):
European Union
Contact person name:
Alexandre Huchelmann
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
3222954092
Fax number:
Country introduction:

The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).

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Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
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:
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Andrés Maggi
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 5222 5986
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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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

Colombia
Name of product applicant: Compañia Agricola S.A.S
Summary of application:

Authorization of the genetically modified maize MON87427 x MON89034 x MIR 162 x MON87411 resistant to lepidoptera and coleoptera pest attack and tolerant to herbicides glyphosate and glufosinate

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Date of authorization: 04/07/2018
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):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization.
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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:
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
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:
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Consuelo López López
Website:
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

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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

Paraguay
Name of product applicant: MONSANTO
Summary of application:

The stacked maize line MON-87427-7 x MON-89Ø34-3 x SYN-IR162-4 x MON-87411-9 was obtained through the traditional cross breeding each of the parental organisms. The line inherited genes that express cry1A.105, cry2Ab2, vip3Aa19 and cp4epsps. The expression of these genes confer glyphosate herbicide tolerance and resistance to Lepidoptera and Coleoptera. The line also contains a suppression cassette that expresses an inverted repeat sequence that results in the formation of a double-stranded RNA (dsRNA) transcript containing a 240 bp fragment of the WCR Snf7 gene (DvSnf7) and is designed to match the sequence of western corn rootworm (WCR).

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Date of authorization: 08/11/2019
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.): MON-87427-7 x MON-89Ø34-3 x SYN-IR162-4 x MON-87411-9
Summary of the safety assessment (food safety):
Simplified approval procedure: Through Ministry of Agriculture and Livestock Resolutions 1030 and 1071 there was stated a differentiated treatment for the commercial release of novel GE crops and for GE crops that have been approved in third countries, whose scientific, technical and safety characteristics are well-founded. Paraguayan Ministry of Agriculture’s Resolutions authorize taking into consideration the decision documents from third countries with regard to both human and animal food safety in the cases where these evaluations have been based on Codex Alimentarius, such as the Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants and carried out in countries with time-tested regulatory systems and transparent procedures. Concerning environmental safety, assessments are accepted for GE crops that besides having been authorized for commercial planting in countries with sound regulatory systems, include in the decision documents considerations as follows: that the GE crop under review has been studied under different environmental conditions, behaving in the same way as the conventional non-GE counterpart; that it will be managed in an agronomic manner similar to any GE or conventional hybrid/variety of the species; another aspect is that Paraguay is not center of origin of that crop, and finally two relevant characteristics are that there are no related weeds in Paraguay with which the GE crop could cross-breed and that the main target pests and the main non-target arthropod species present in Paraguay have been taken into account in the GE risk assessment carried out in those countries. The Commercial Release Opinion of the National Commission for Agricultural and Forestry Biosafety (CONBIO), in its substantial part states: "...Recommends technically: (1) The commercial release of the event MON-87427-7 X MON-89Ø34-3 X SYN-IR162-4 X MON-87411-9 (2) In case of detection of an unexpected effect, the company is obliged to inform CONBIO".
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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: Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de Agricultura y Ganadería
Contact person name:
Santiago Bertoni
Website:
Physical full address:
Yegros 437 entre 25 de mayo y Cerro Cora
Phone number:
+595 981 256262
Fax number:
Country introduction:

The agricultural sector is one of the economic pillars of Paraguay in its contribution to the GDP, with the main crops being soybean, cassava, maize, wheat, sugar cane, and cotton. It should also be noted that Paraguay is the world’s fourth exporter of soybean. In 2020, the area planted with crops was 4.67 million hectares and consisted of soybean (3.56 million hectares), maize (1.08 million hectares), and cotton (18,000 hectares). Agricultural biotechnology was first regulated in Paraguay in 1997. In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops” Almost 94% of the soybean, 36% of the maize, and 56% of the cotton planted in the country are GE.

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Stacked events:

When a stacked event is approved, all possible combinations are approved. Previously evaluated single events are not reevaluated in stacks.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops”. Additional information https://conbio.mag.gov.py/

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).
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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:
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: