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OECD Unique Identifier details

MON-ØØ6Ø3-6 X ACS-ZMØØ3-2X DAS4Ø278-9
Commodity: Corn / Maize
Traits: Glyphosate tolerance
Argentina
Name of product applicant: Dow AgroSciences Argentina S.R.L.
Summary of application:

The MONØØ6Ø3-6 x ACS-ZMØØ3-2 x DAS-4Ø278-9 maize was produced through the cross breeding of modified parental varieties for multiple herbicide tolerance such as Glyphosate tolerance, Glufinosate tolerance and Sphingobium herbicidovorans aryloxyalkanoate dioxygenase, which cleaves 2,4-dichlorophenoxyacetic acid into non-herbicidal dichlorophenol and glyoxylate, as well as inactivates aryloxyphenoxypropionate herbicides (acetyl‐CoA carboxylase inhibitors). 


 










The maize was produced through the cross breeding of modified parental varieties for multiple herbicide tolerance. For glyphosate tolerance, the maize expresses Agrobacterium tumefaciens 5-enolpyruvylshikimate-3-phosphate synthase, which encodes a variant of an endogenous enzyme involved in the essential biosynthesis of aromatic amino acids (shikimate pathway). The variant prevents the binding of the compound to the enzyme and the subsequent inactivation. For glufinosate tolerance, the maize expresses Streptomyces viridochromogenes phosphinothricin N-acetyltransferase, which inactivates phosphinothricin (the active ingredient in glufosinate ammonium herbicides) through acetylation. Additionally, the modified maize expresses Sphingobium herbicidovorans aryloxyalkanoate dioxygenase, which cleaves 2,4-dichlorophenoxyacetic acid into non-herbicidal dichlorophenol and glyoxylate, as well as inactivates aryloxyphenoxypropionate herbicides (acetyl‐CoA carboxylase inhibitors).
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Date of authorization: 28/07/2022
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.):
Summary of the safety assessment (food safety):
Please kindly refer to the attachment.
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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):
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: Du Pont do Brasil S.A - Divisão Pioneer Sementes.
Summary of application: 
Inclusion of subcombinations in commercial release of corn and its derivatives
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Date of authorization: 03/09/2020
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):
In view of the above and considering the criteria contained in Normative Resolution 24 of CTNBio, it is possible to conclude that this proposed exemption from the monitoring plan meets the provisions of Normative Resolution 24 of January 9, 2020. CTNBio decided to grant the request.
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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: DUPONT
Summary of application:

GMO authorization for NK603 X T25 X DAS40278 maize as food for direct use or processing.
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Date of authorization: 13/04/2021
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:
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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 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:
Paraguay
Name of product applicant: DOW AGROSCIENCES PARAGUAY S.A.
Summary of application:

The maize was produced through the cross breeding of modified parental varieties for multiple herbicide tolerance. For glyphosate tolerance, the maize expresses Agrobacterium tumefaciens 5-enolpyruvylshikimate-3-phosphate synthase, which encodes a variant of an endogenous enzyme involved in the essential biosynthesis of aromatic amino acids (shikimate pathway). The variant prevents the binding of the compound to the enzyme and the subsequent inactivation. For glufinosate tolerance, the maize expresses Streptomyces viridochromogenes phosphinothricin N-acetyltransferase, which inactivates phosphinothricin (the active ingredient in glufosinate ammonium herbicides) through acetylation. Additionally, the modified maize expresses Sphingobium herbicidovorans aryloxyalkanoate dioxygenase, which cleaves 2,4-dichlorophenoxyacetic acid into non-herbicidal dichlorophenol and glyoxylate, as well as inactivates aryloxyphenoxypropionate herbicides (acetyl‐CoA carboxylase inhibitors).
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Date of authorization: 24/02/2022
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.): MON-ØØ6Ø3-6 x ACS-ZMØØ3-2 x DAS-4Ø278-9
Summary of the safety assessment (food safety):
Differentiated 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-ØØ6Ø3-6 × ACS-ZMØØ3-2 × DAS-4Ø278-9 (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:
[email protected]
Organization/agency name (Full name):
Ministerio de Agricultura y Ganadería
Contact person name:
Santiago Bertoni
Website:
http://conbio.mag.gov.py
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.

Useful links
CONBIO
Paraguay’s approach to biotechnology governance: a comprehensive guide
Regulatory landscape for new breeding techniques (NBTs): insights from Paraguay
Relevant documents
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/