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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of corn event Bt11xMIR162xMIR604xTC1507x5307xGA21 - Technical Opinion No. 4764/2015
EN
08 Oct 2015
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Organization:Syngenta Seeds Ltda. ()Lilian Aguiar Saldanha Rodovia BR-452, Km 142 + 543m.Uberlândia, MG
38405-232, BrazilPhone: +55(11) 5643-6747,Fax: +55(11) 5643-6750 ; 5643-6750,Email: lilian.saldanha@syngenta.com,Website:
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SYN-BTØ11-1 × SYN-IR162-4 - Insect Resistant Maize| Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate), Selectable marker genes and reporter genes
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SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 - Agrisure® Duracade™ 5222| Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
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SYN-Ø53Ø7-1 - Agrisure® Duracade™ Maize| Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi))
- Commercial release 4207-2014 (2).pdf [ Portuguese ]
Corn 5307 was produced by means of transformation via Agrobacterium tumefaciens of immature corn embryos, using a plasmid vector that contains the eCry3.1Ab gene that encodes the eCry3.1Ab protein. The eCry3.1Ab protein is a Bacillus thuringiensis-derived chimeric protein composed of the Cry1Ab and Cry3A proteins. The eCry3.1Ab protein was genetically modified by exchanging the variable regions (V1 to V6) between the mCry3A and the Cry1Ab proteins to enhance the effect against certain species of beetle pest of corn. The eCry3.1Ab protein consists of a fusion between the N-terminus (Domain I, the Domain II and a portion of Domain III) of mCry3A and the C-terminus (a portion of Domain III and variable region 6) of Cry1Ab. The eCry3.1Ab protein has 654 amino acids and approximately 73.7 Kd. The change in the variable region resulted in strong bioactivity of this hybrid insecticidal protein against larvae of the coleopteran Diabrotica speciosa (Coleoptera: Chrysomelidae), considered one of the main pests of corn. Maize 5307 also contains the pmi gene (manA) from E. coli that encodes a phosphomannose isomerase (PMI) and is under regulation by the promoter of the ubiquitin gene from Zea mays and the NOS terminator from A. tumefaciens. This gene was used as a selection marker in the transformation process.
Microbial formulations of B. thuringiensis have been used for decades as biopesticides in organic production systems or under conventional agricultural conditions, and so far no impacts on human, animal and environmental health have been related to their use. GM plants that express Cry proteins have been cultivated in several countries for over 19 years. The gene constructs requested in this process for commercial release have already been released in Brazil (except for Maize 5307) and in several countries, both for consumption and for cultivation, without any adverse effect on human, animal, environment and human health. non-target organisms. The overwhelming majority of scientific literature on health and environmental safety attests that there are no observable risks in the introduction of these cultures containing Cry proteins.
The agronomic evaluations, centesimal composition, substantial equivalence, among other data presented, present results that do not deviate from the standards of the corn genotypes available in the world. The agronomic results on 5307 and Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 corns did not indicate any changes that show significant changes in the impacts that a conventional corn crop can bring to human, animal or environmental health. All information presented in molecular characterization, genetic inheritance analysis and comparative analysis of protein expression levels are within the expected standards.
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health.
There is no difference between the agronomic performance of transgenic and conventional plants, as well as substantial equivalence between them. Thus, the information indicates that the transgenic corn plants do not fundamentally differ from the untransformed corn genotypes, with the exception of resistance to Coleoptera and Lepidoptera (corn 5307), resistance to Coleoptera and Lepidoptera and tolerance to the herbicides glyphosate and glyphosinate (corn Bt11xMIR162xMIR604xTC1507x5307xGA21). and resistance to lepidopterans and tolerance to the herbicide glyphosinate (corn Bt11xMIR162). There is also no evidence of adverse reactions to the use of these corns. For this reason, there are no restrictions on the use of these corn or its derivatives, whether for human or animal consumption.
All GM corns present in this commercial release proposal, classified as risk class 1, are as safe as their conventional equivalents, and do not potentially cause significant degradation of the environment or human and animal health. In the evaluations presented to CTNBio, internationally accepted criteria were used in the process of risk analysis of genetically modified raw materials and a set of evidences that demonstrated the safety for the cultivation of corns 5307, Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 and Bt11xMIR162. In the analysis, documents submitted to the CTNBio Executive Secretariat by the applicant, results of planned releases into the environment and independent scientific studies and publications by the applicant were considered.
Events BT11, MIR162, TC1507, GA21 to MIR604 and have already been approved for commercial release by CTNBio, both individually and in their combined forms Bt11xGA21, Bt11xMIR162xGA21 and Bt11xMIR162xMIR604xGA21 and have sufficient information to prove its biosafety for the environment and human and animal health.
CTNBio considered that the request complies with the norms and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that corn 5307, Bt11xMIR162xMIR604xTC1507x5307xGA21 and Bt11xMIR162 are substantially equivalent to conventional corn, and their consumption is safe for human and animal health. Regarding the environment. CTNBio concluded that the corns 5307, Bt11xMIR162xMIR604xTC1507x5307xGA21 and Bt11xMIR162 are not potentially causing significant degradation of the environment, keeping with the biota a relationship identical to that of conventional corn.
Molecular traddicional methods.
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Yes
Yes
Yes
Yes
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| Record type | Field | Record(s) | |
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| Country's Decision or any other Communication | Risk assessment | 1 | |
