Food safety and quality
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OECD Unique Identifier details

SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x SYN-Ø53Ø7-1 x MON-ØØØ21-9
Commodity: Corn / Maize
Traits: Herbicide tolerance,Insect resistance
Argentina
Name of product applicant: Syngenta Agro S.A.
Summary of application:

The Bt11xMIR162xMIR605xTC1507x5307xGA21 maize was produced by combining the genetic transformation events Bt11, MIR162, MIR604, TC1507, GA21 and 5307 through conventional breeding.
The stacked event expresses a phenotype resistant to certain insects Lepidoptera and Coleoptera and tolerant to the herbicides glufosinate of ammonium and glyphosate. Below is a summary of the mechanisms involved in each case:
The resistance to Lepidoptera is given by the expression of the proteins Cry1Ab, Cry1F and Vip3Aa20, coming from the parental events Bt11, TC1507 and MIR162, respectively.
Resistance to Coleoptera is given by the expression of the mCry3A and eCry3.1Ab proteins, coming from the parental events MIR604 and 5307, respectively.
The parents Bt11 and TC1507 also contribute to the corn Bt11xMIR162xMIR604xTC1507x5307xGA21 the pat gene, which gives the crop tolerance to the herbicide glufosinate ammonium.

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Date of authorization: 14/07/2016
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
GMO approvals for food/feed
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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: SYNGENTA
Summary of application:

Authorization of the genetically modified maize Bt11 X MIR162 x MIR604 x MON89034 x 5307 x GA21 resistant to lepidoptera and coleoptera pest attacks and tolerant to herbicides gliphosate and gluphosinate

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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:
Republic of Korea
Name of product applicant: Syngenta Korea
Summary of application:

Glufosinate herbicide tolerance , Glyphosate herbicide tolerance , Coleopteran insect resistance  ,  Lepidopteran insect resistance,  Multiple insect resistance

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Date of authorization: 23/10/2013
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
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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Singapore
Name of product applicant: Syngenta
Summary of application:

Apply for food, feed and processing 

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Date of authorization: 16/04/2021
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 Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 (SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x SYN-Ø53Ø7-1 x MON-ØØØ21-9) stacked maize event was produced by conventional breeding of Bt11, MIR162, MIR604, TC1507, 5307 and GA21 single events. The stacked maize event provides herbicide tolerance and insect resistance. All the 6 single parent events have been previously approved in Singapore for food, feed and processing uses. Molecular analyses showed that the integrity of the transgenic inserts from each single event was preserved during the conventional breeding to produce the stacked maize event. The trait proteins - Bt11 (Cry1Ab, PAT), MIR162 (Vip3Aa20; PMI), MIR604 (mCry3A, PMI), TC1507 (Cry1F, PAT), 5307 (eCry3.1Ab, PMI) and GA21 (mEPSPS) have well defined modes of action and are functionally distinct. The distinct functions of all these proteins support that it is unlikely that they would interact to produce unintended effects. The levels of Cry1Ab, Vip3Aa20, mCry3A, Cry1F, eCry3.1Ab, mEPSPS, PAT and PMI proteins were similar to the levels measured in the single events. The compositional analyses showed that the nutrient composition of forage and grain of the stacked maize event is similar to conventional maize. Food derived from Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 stacked maize event is as safe as food derived from conventional maize 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:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Singapore Food Agency (SFA)
Contact person name:
Dr Tan Yong Quan
Website:
Physical full address:
52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number:
(65)68052750
Fax number:
Country introduction:

The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food.  SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption.  The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork.

Useful links
Relevant documents
Stacked events:

More information on the guidelines for the safety assessment of stacked events can be found on GMAC’s website:

http://www.gmac.sg/Index_Singapore_Guidelines_on_the_Release_of_Agriculture_Related_GMOs.html

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

Singapore Food Agency (SFA)