Food safety and quality
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OECD Unique Identifier details

SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-89Ø34-3 × SYN-Ø53Ø7-1 × MON-ØØØ21-9
Commodity: Corn / Maize
Traits: Glufosinate tolerance
Name of product applicant: Syngenta Seeds (Thailand) Limited.
Summary of application:

Commodity:Corn / Maize (Zea mays L.)

The stacked event Bt11 × MIR162 × MIR604 × MON89034 × 5307 × GA21 maize obtained from conventional breeding of the genetically modified maize events Bt11, MIR162, MIR604, MON89034, 5307 and GA21 to expresses Bt-toxin (Cry1Ab protein) which provide protection to European corn borer (ECB), and enzyme phosphinothricin N-acetyl transferase (PAT) which confers tolerance to glufosinate-ammonium herbicide, Vip3Aa20 protein which provide protection to certain lepidopteran pests, the mCry3A protein (modified version of Cry3A of Bacillus thuringiensis subsp. terebrionis) which provide protection from larval corn rootworm (CRW) damage, two Bt-toxins (Cry1A.105 and Cry2Ab2 proteins) which provide protection to certain lepidopteran pests, the chimeric eCry3.1Ab protein which confers resistance to larval corn rootworm pests, and mEPSPS protein which confers tolerance to glyphosate herbicide.
Maize Bt11 was generated by using PAT protein as a selectable marker enabling identification of transformed plant cells as well as a source of resistance to the herbicide known as glufosinate ammonium.

Application for food safety assessment.


Date of authorization: 04/12/2022
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):
The food safety assessment performed by the National Center for Genetic Engineering and Biotechnology (BIOTEC) as advisory and technical arm of Thai FDA. BIOTEC conduct food safety assessment according to codex guideline and based on the safety data and information provided by the applicant (as specified in Annex 2 attached to Notification of the Ministry of Public Health No.431). According to the existing scientific data and information available during the safety assessment, it is concluded that the stacked event Bt11 × MIR162 × MIR604 × MON89034 × 5307 × GA21 maize is expected to be as safe as the single events that has previously been assessed by the food biosafety subcommittee and technical biosafety committee of the National Center for Genetic Engineering and Biotechnology (BIOTEC).
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:
Authorization expiration date (a blank field means there is no expiration date)
Organization/agency name (Full name):
National Burequ of Agricultural Commodity and Food
Contact person name:
Director of Office of Standard Development
Physical full address:
50 Phahonyothin Rd., Lardyao, Chathuchak, Bangkok 10900
Phone number:
+6625612277 ext.1401
Fax number:
Country introduction:

National Bureau of Agricultural Commodity and Food Standards (ACFS) is a governmental agency under the Ministry of Agriculture and Cooperatives (MOAC) responsible for the development of national agricultural and food standards. The Agricultural Standards Act B.E. 2551 (2008) establishes the mechanisms for the development of Thai Agricultural Standards (TAS) as either voluntary or mandatory standards. This is based on scientific data, consumer’s health and fair trade. Within the TAS, there are four standards relating GM food assessment, namely Principle for the Risk Analysis of Foods Derived from Biotechnology (TAS 9010-2006), Assessment of Possible Allergenicity (TAS 9011-2006), Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (TAS 9012-2006) and Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (TAS 9013-2006). These standards are adapted from relevant Codex standards. Safety assessment for imported GM crops and foods is done by the cooperation of the Food and Drug Administration (FDA) and the National Center for Genetic Engineering and Biotechnology (BIOTEC)via the Committees relating National Committees to consider technical and political issues. The Committees comprise representatives from all relevant governmental and non-governmental key sectors including experts on genetic modification, toxicity and others.

The safety assessment process of GM food in Thailand is on a voluntary basis. According to the current laws and regulations, there is no approval authority. 

Useful links
Relevant documents
Stacked events:

The safety assessment for stacked events is divided into two patterns. The first pattern is for stacked events whose GM parents have never approved by FDA or other competent authority. Those stacked events shall be fully assessed in line with GM foods. Another pattern is introduced for the safety assessment of stacked event lines where from GM parents had already been approved. In the second pattern, the information of the parents could be used for consideration, as appropriate. However, the information relevant to interaction between genes and new proteins of stacked event should be mainly taken into account.

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

Food and Drug Administration (FDA) and National Center for Genetic Engineering and Biotechnology (BIOTEC)