| Commodity: |
Corn / Maize |
| Traits: |
Herbicide tolerance,Insect resistance |
| Name of product applicant: |
Du Pont do Brasil SA |
| Summary of application: |
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| Date of authorization: |
10/12/2015 |
| 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): |
Event TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 and its subcombinations are produced by conventional crosses between individual genetically modified events that have already been evaluated for risk by CTNBio. TC1507 corn contains the cry1F gene and the pat gene. The insecticidal protein present in TC1507 corn is a truncated Cry1F protein derived from the PS81I strain of Bacillus thuringiensis var. aizawai. The pat gene, from Streptomice viridrochromogenes, confers tolerance to the herbicide glufosinate ammonium. The MON810 maize line contains the B. thuringiensis cry1Ab gene. The MIR162 event, which contains the Vip3Aa protein is a Bacillus thurigiensis protein, but unlike Bacillus thuringiensis crystals (Cry) proteins, Vip (Vegetative Insecticidal Proteins) proteins are produced during bacterial vegetative growth. The NK603 event contains the cp4 epsps gene, which encodes a glyphosate tolerant form of the enzyme 5-enolpyruvlyshikimate-3-phosphate synthase (EPSPS) was isolated from the bacterium Agrobacterium tumefaciens CP4 strain. The applicant also requested authorization for the commercial release of the subcombinations: DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162) x MON-ØØ603-6 (NK603); DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162); SYN-IR162-4 (MIR162) x MON-Ø603-6 (NK603) and MON-Ø810-6 (MON810) x SYN-IR162-4 (MIR162). |
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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 traditional 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: |
Du Pont do Brasil S.A. - Divisão Pioneer Sementes |
| Summary of application: |
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| Date of authorization: |
05/11/2020 |
| 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.): |
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| Summary of the safety assessment (food safety): |
We consider, due to the issues raised in the grounds of this opinion, that the applicant's request for exemption and interruption of the post-commercial release monitoring plan of genetically modified corn resistant to insects and tolerant to the herbicides glyphosate and glufosinate ammonium, TC1507 x MON810 x MIR162 x NK603 complies with the provisions of Art. 9 of RN 24, § 2, as no non-negligible risks were identified during the risk assessment process for commercial release. CTNBio considered the event TC1507 x MON810 x MIR162 x NK603-4 not potentially causing significant degradation of the environment or harm to human and animal health. Therefore, the applicant is not required to maintain a monitoring plan for said event TC1507 x MON810 x MIR162 x NK603-4 |
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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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| Upload: |
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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: |
Dupont Poineer |
| Summary of application: |
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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.): |
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| 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-116241/1 |
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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): ABRII
Contact person name: Gholamreza Salehi Jouzani
Website:
Physical full address: Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran
Phone number: 0098(26)32701132
Fax number: 0098(26)32701132
Country introduction: Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.
The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a[email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation. 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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Agricultural Jihad Ministry
Tehran, Tehran
Iran (Islamic Republic of)
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Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
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