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Risk Assessment generated by a regulatory process
(RA)
last updated: 28 Apr 2026
Risk assessment of corn event Bt11 x MIR162 x MON 89034 x GA21, corn Bt11 x MIR162 x MON 89034 and corn MIR162 x MON 89034 - Technical Opinion 5412/2017.
EN
09 Mar 2017
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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,Phone: (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,Phone: +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 × MON-89Ø34-3 × MON-ØØØ21-9 - Maize modified for insect resistance and herbicide tolerance| Monsanto, Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate), Selectable marker genes and reporter genes
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MON-89Ø34-3 × SYN-IR162-4 - Insect-resistant maize| Syngenta Seeds GmbH, Bayer CropScience Deutschland GmbH | Mannose metabolism, Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Selectable marker genes and reporter genes
- Commercial release 5412-2017.pdf [ Portuguese ]
Bt11xMIR162xMON 89034xGA21 corn was developed through classical genetic improvement, by sexual cross between genetically modified lines containing the Bt11 event, the MIR162 event, the MON 89034 event and the GA21 event approved previously for commercial release by CTNBio. Bt11, MIR162, MON 89034 and GA21 corn are already commercialized in Brazil and in other countries and information about their transformation events is well known. During the development process of Bt11xMIR162xMON 89034xGA21 maize, there were no other genetic modifications, besides the introgression of these events in maize lines, through classical genetic improvement.
All Bt11 MIR162 x MON-89034xGA21 corn proteins have already been evaluated by CTNBio in acute toxicity assays. Oral administration of PMI, Cry1Ab, Vip3Aa20, Cry1A.105, Cry2Ab2, PAT and mEPSPS in rats did not produce adverse effects, therefore all are considered non-toxic proteins. In addition, digestibility studies on the application demonstrate that all of them are readily digested both in the gastric environment and in typical mammalian intestinal conditions. Therefore, it is unlikely that these exogenous proteins will be absorbed intact in sufficient amounts and then enter the fetal circulation.
There are no differences in chemical and nutritional composition between genetically modified and conventional corn that could lead the genetically modified hybrid to produce toxins or metabolites. Furthermore, there is no evidence that the presence of proteins PMI, Cry1Ab, Vip3Aa20, Cry1A.105, Cry2Ab2, PAT and mEPSPS in animal diets affect animal performance. All these studies corroborate the conclusion that the Bt11xMIR162xMON 89034xGA21 corn, object of this evaluation, does not have the capacity to produce toxins or metabolites that may pose a risk to human and/or animal consumption. The results of tests carried out for the events already approved, Bt11 corn, MIR162 MON 89034 and GA21, also demonstrate the absence of the ability to produce toxins or metabolites that cause adverse effects.
Bt11xMIR162xMON 89034xGA21 GM corn and non-GM corn as well as no notable difference between genetically modified corn, treated with event specific herbicides and non-genetically modified which confirms the chemical and nutritional compositional equivalence between all materials compared and the absence of impact on nutritional quality or food safety of corn Bt11xMIR162xMON 89034xGA21.
Scientific studies carried out to evaluate biosecurity, agronomic and phenotypic characteristics, as part of the risk assessment of this genetically modified corn, included several ecosystems from representative regions for corn cultivation. in Brazilian territory. An extensive body of data has already been produced and highlights that the effects of GM products must be characterized from the proteins expressed by the inserted traits or the inserted genes. In Bt11xMIR162xMON-89034xGA21 the proteins expressed are those that express properties for herbicide tolerance (PAT and mEPSPS) and those that express resistance to insect pests of the lepidopteran class (Cry1AB, Vip3A20, Cry1A.105 and Cry2AB2), all of which have already been approved. in several products evaluated by CTNBio.
Evaluations performed on Bt11xMIR162xMON 89034xGA21 corn, did not indicate any consistent pattern that suggested biologically significant changes, they follow in the same way, different, often, events, ie, insect resistance and herbicide tolerance. The analysis set in the results of the comparative molecular analysis, in the chemical and nutritional composition analysis, in the agronomic and effort comparison study, as well as in the study of the impact on non-target organisms in the cultivation of Bt11xMIR162xMON 89034xGA21 corn, indicates that the exposure levels to non-target organisms and in human and animal feed to these proteins will be the same as for Bt11, MIR162, MON 8903 and GA21 maize alone.
Bt11xMIR162xMON 89034xGA21 corn, object of this evaluation does not have the capacity to produce toxins or metabolites that may pose a risk to human and/or animal consumption. The results of the tests carried out for the events already approved corns, Bt11, MIR162 MON 89034 and GA21, also demonstrate the absence of the ability to produce toxins or metabolites that cause adverse effects.
The risk assessments already carried out for Bt11, MIR162, MON 89034 and GA21 corn, demonstrating that they are as safe as their conventional equivalents and that their cultivation does not potentially cause significant environmental degradation or health problems human and animal.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
