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OECD Unique Identifier details

SYN-BTØ11-1xSYN-IR162-4xDAS-Ø15Ø7-1xMON-ØØØ21-9
Commodity: Corn / Maize
Traits: Glufosinate tolerance,Glyphosate tolerance,Lepidoptera resistance
European Union
Name of product applicant: Syngenta Crop Protection AG
Summary of application:

The genetically modified SYN-BTØ11-1 maize expresses the Cry1Ab protein, which confers protection against certain lepidopteran pests, and the PAT protein, which confers tolerance to glufosinate-ammonium-based herbicides. The genetically modified SYN-IR162-4 maize expresses the Vip3Aa20 protein, which confers protection against certain lepidopteran pests, and the PMI protein, which was used as a selectable marker. The genetically modified DAS-Ø15Ø7-1 maize expresses the Cry1F protein, which confers protection against certain lepidopteran pests, and the PAT protein, which confers tolerance to glufosinate-ammonium-based herbicides. The genetically modified MON-ØØØ21-9 maize expresses the mEPSPS protein, which confers tolerance to glyphosate-based herbicides.  
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Date of authorization: 26/07/2019
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.): 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:
Method for detection: the quantitative event-specific PCR detection methods for maize Bt11 × MIR162 × 1507 × GA21 are those validated for genetically modified maize events SYN-BTØ11-1, SYN-IR162-4, DAS-Ø15Ø7-1 and MON-ØØØ21-9. Reference material: ERM®-BF412 (for SYN-BTØ11-1) and ERM®-BF418 (for DAS-Ø15Ø7-1) are accessible via the Joint Research Centre (JRC) of the European Commission, and AOCS 1208-A and AOCS 0407-A (for SYN-IR162-4), AOCS 0407-A and AOCS 0407-B (for MON-ØØØ21-9) are accessible via the American Oil Chemists Society (https://www.aocs.org/crm). The relevant links are provided below.
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) 28/07/2029
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Colombia
Name of product applicant: SYNGENTA
Summary of application:

Authorization of the genetically modified maize Bt11 X MIR162 X TC1507 X GA21 resistant to lepidoptera  pest attack and tolerant to herbicides glyphosate and glufosinate
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Date of authorization: 27/01/2016
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:
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Iran
Name of product applicant: Syngenta Seeds GmbH
Summary of application:

The stacked maize line SYN-BTØ11-1 x SYN-IR162-4 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 was obtained through the traditional cross breading of each of the parental organisms to produce a maize that expresses each of Cry1Ab, Cry1F, PAT, Vip3Aa, EPSPS and PMI genes. The expression of these genes are expected to confer resistance to Lepidoptera and Coleoptera, and tolerant to glufosinate herbicide and glyphosate herbicide and allows the LMO to use mannose as a carbon source.
 


 
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Date of authorization: 17/07/2021
Scope of authorization: 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):
Competent National Authority: Ministry of Agriculture-Jehad, Agricultural Research, Education and Extension Organization (AREEO). Risk Assessment file is uploaded. https://bch.cbd.int/en/database/RA/BCH-RA-IR-116237/1
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Japan
Name of product applicant: Syngenta Seeds K.K.
Summary of application:

Bt11 x MIR 162 x TC1507 x GA21 has been genetically modified for resistant to Lepidoptera and Coleoptera, and tolerant to glufosinate and glyphosate herbicides (modified cry1Ab, modified vip3A, modified cry3Aa2, pat, mEPSPS, Zea mays subsp. mays (L.) Iltis).
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Date of authorization: 12/05/2010
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.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the link below (in Japanese).
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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: Food safety assessment performed by Food Safety Commission of Japan (in Japanese)
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E-mail:
[email protected]
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Ms Yuki Tomokuni
Website:
http://www.fsc.go.jp/
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Country introduction:

Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.

Useful links
Food Safety Commission of Japan(English)
Food Safety Commission of Japan, Risk Assessment Report (Genetically Modified Food)
Ministry of Health, Labour and Welfare / Foods Produced by Recombinant DNA Techniques
Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

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

Food Safety Commission of Japan (http://www.fsc.go.jp/english/index.html), Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/policy/health-medical/food/index.html)

Mexico
Name of product applicant: Syngenta Agro, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 95


Bt11 x MIR 162 x TC1507 x GA21 has been genetically modified for resistant to Lepidoptera and Coleoptera, and tolerant to glufosinate and glyphosate herbicides (modified cry1Ab, modified vip3A, modified cry3Aa2, pat, mEPSPS, Zea mays subsp. mays (L.) Iltis).
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Date of authorization: 02/05/2011
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):
UI OECD: SYN-BTØ11-1xSYN-IR162-4xDAS-Ø15Ø7-1xMON-ØØØ21-9 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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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:
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Philippines
Name of product applicant: Syngenta Philippines
Summary of application:
Corn BT11 x MIR604 x TC1507 x GA21 is a stacked hybrid developed by crossing Event Bt 11, Event MIR162, Event TC1507 x Event GA21 using conventional breeding techniques.
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Date of authorization: 22/12/2010
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):
Syngenta Philippines had filed an application with attached technical dossiers to the Bureau of Plant Industry (BPI) for a biosafety notification for direct use as food, feed and for processing under Administrative Order (AO) No. 8 Part 5 for stacked trait product corn: Bt11 x MIR 162 x TC1507 x GA21 which has been genetically modified for insect resistance and herbicide tolerance. A safety assessment of combined trait product corn: Bt11 x MIR 162 x TC1507 x GA21 was conducted as per Department of Agriculture Administrative Order No. 8 Series of 2002 and Memorandum Circulars Nos. 6 and 8, Series of 2004. The focus of risk assessment is the gene interactions between/among the transgenes.
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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:
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Republic of Korea
Name of product applicant: Syngenta Korea
Summary of application:

Glufosinate herbicide tolerance,  Glyphosate herbicide tolerance ,  Lepidopteran insect resistance        
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Date of authorization: 23/07/2012
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:
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E-mail:
[email protected]
Organization/agency name (Full name):
Ministry of Food and Drug Safety
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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
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South Africa
Name of product applicant: Syngenta
Summary of application:

The GM maize BT11 x MIR162 xTC1507 xGA21 is produced through conventional breeding.  The maize expresses Cry1Ab, Vip3Aa20, Cry1F Pmi, Pat and mepsp proteins which control certain lepidopteran pests and confer tolerance to herbicide products containing glufosinate and glyphosate.
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Date of authorization: 26/09/2011
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.): Biosafety Clearing House (BCH)
Summary of the safety assessment (food safety):
The GM maize BT11 xMIR162 xTC1507 x GA21 has been assessed in terms of the Genetically Modified Organisms Act, 1997 by the Advisory Committee a scientific panel and the Executive Council an intergovernmental decision making body. The assessment considered amongst others the following: The source of the gene, nature of host organism, protein expression, toxicology and allergenicity issues.
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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:
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