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Food safety and quality
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| Commodity: |
Corn / Maize |
| Traits: |
Herbicide tolerance,Lepidoptera resistance |
| Name of product applicant: |
Syngenta Proteção de Cultivos Ltda. |
| Summary of application: |
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| Date of authorization: |
14/03/2019 |
| 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.): |
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| Summary of the safety assessment (food safety): |
The applicant requested the inclusion of genetically modified corn event subcombinations containing the events Bt11xMIR162xMON 89034xGA21, approved by CTNBio through technical opinion 5412/2017 (drafted on 03/24/2017), in a commercial release request. Such request is based on Arts. 3, 4 and 4A of CTNBio's Normative Resolution 05. These isolated events have insect resistance and herbicide tolerance genes and had their biosafety for the environment and human and animal health exhaustively analyzed, showing no difference in relation to conventional corn. The complete combination of all events and some of the partial combinations containing more than one of the proteins, showed a lack of genetic and biochemical interaction between the gene products introduced in the previous reports and opinions of the applicant company being previously approved for commercial release. The data presented in the majority request for Bt11xMIR162xMON 89034xGA21 corn meet current regulations and legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and allow us to conclude that the subcombinations of Bt11xMIR162xMON 89034xGA21 corn are substantially equivalent to conventional corn, and its consumption is safe for human and animal health. Regarding the environment, it can be concluded that the genetically modified subcombinations are not potentially causing significant environmental degradation, keeping with the biota a relationship identical to that of conventional corn. |
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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:
Organization/agency name (Full name): National Biosafety Technical Commission
Contact person name: Paulo Augusto Viana Barroso
Website:
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
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)
| Name of product applicant: |
SYNGENTA |
| Summary of application: |
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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.): |
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| 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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| 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) |
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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. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
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