Food safety and quality
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OECD Unique Identifier details

MON-87427-7 × MON-87419-8 × MON-ØØ6Ø3-6
Commodity: Corn / Maize
Traits: Glyphosate tolerance,Dicamba tolerance,Glufosinate tolerance
Argentina
Name of product applicant: Monsanto Argentina S.A.I.C.
Summary of application:

The accumulation of events of corn MON 87427 × MON 87419 × NK603 is the result of the conventional crossing of the individual events MON 87427, MON 87419 and NK603 developed by Monsanto through modern biotechnology techniques, which confer to the corn plant tolerance to herbicides formulated based on dicamba, glufosinate and glyphosate.
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 MON 87419 event produces the dicamba mono-oxygenase (DMO) protein that gives the plant tolerance to dicamba-based herbicides, and the protein phosphinothricin acetyltransferase (PAT), whose expression gives plants the characteristic of tolerance to herbicides formulated based on glufosinate.
The NK603 event produces the CP4 EPSPS protein, which gives the plant tolerance for the application of herbicides formulated on the basis of glyphosate.
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Date of authorization: 20/10/2018
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:
[email protected]
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Andrés Maggi
Website:
https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia
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.

Useful links
Food/Feed Safety Assessment of Genetically Modified Organisms
Decision Documents of Food/Feed Safety Assessment
Principles for the Assessment of Food and Feed derived from GMO in Argentina - Resolution Nº 412
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

Brazil
Name of product applicant: Monsanto do Brasil Ltda.
Summary of application: 
Exemption from analysis on the commercial release of herbicide-tolerant corn MON 87427 × MON 87419 × NK603, combined by crossing the respective individual events (MON 87427, MON 87419 and NK603)
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Date of authorization: 09/05/2019
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.):
Summary of the safety assessment (food safety):
The applicant, through the requirements set out in Normative Resolution 05 of CTNBio, requests the commercial release, with the exemption of analysis and the issuance by CTNBio of a Conclusive Technical Opinion, of the herbicide-tolerant corn MON 87427 × MON 87419 × NK603, combined by the crossing of the respective individual events (MON 87427, MON 87419 and NK603) through classical genetic improvement and that express, together, the proteins of agronomic interest CP4 EPSPS, DMO and PAT. The aforementioned individual events, as well as other combinations of these events developed by Monsanto or by other applicants, have already been approved by CTNBio.
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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:
Molecular traddicional methods.
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) not applicable
E-mail:
[email protected]
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Paulo Augusto Viana Barroso
Website:
http://www.ctnbio.gov.br
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556120335087
Fax number:
Country introduction:

Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques.

Useful links
Brazilian National Biosafety Commission – CTNBio
Relevant documents
Stacked events:

At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio

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

Dr. Paulo Augusto Viana Barroso (President of national Biosafety Commission)

Colombia
Name of product applicant: Compañía Agrícola S.A.S
Summary of application:

GMO authorization for MON 87427 X MON 89034 X MON 88017 maize as food for direct use or processing.
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Date of authorization: 10/06/2020
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 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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
[email protected]
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
http://[email protected]
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.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: