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Évaluation des risques générée par un processus de réglementation (RA)
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last updated: 28 avr. 2026
Informations générales
Brésil
Risk assessment of corn event Bt11 & MIR162 & GA21 - Technical Opinion 2722/2010.
EN
18 nov. 2010
Détails de l’évaluation des risques
  • BCH-LMO-SCBD-101251-11
    SYN-BTØ11-1 × SYN-IR162-4 × MON-ØØØ21-9 - Agrisure® Viptera™ 3110 Maize
    | Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites), Pyrale du maïs (Ostrinia nubilalis)), Résistance aux herbicides (Glufosinate, Glyphosate), Gènes marqueurs et gènes rapporteurs sélectables
    Show detection method(s)
Bt11xMIR162xGA21 corn is a genetically modified product that shows resistance to several lepidopterans considered pests and tolerance to the herbicide glyphosate, developed through classical breeding by sexual cross between maize lines containing the Bt11 event, the MIR162 event and the GA21 event. This corn does not contain any other genetic transformation events, besides the Bt11, MIR162 and GA21 events. Bt11 corn, MIR162 corn and GA21 corn were approved for commercial release by the National Biosafety Technical Commission (CTNBio), based on Processes 01200.002109/2000-04, 01200.007493/2007-08 and 01200.000062/2006-21, according to Technical Opinions 1255 /2008, 2042/2009 and 1597/2008, respectively. The “combined” or “pyramided” products, as in the case of Bt11xMIR162xGA21 corn, represent a future trend in the cultivation of genetically modified plants to meet the demand of producers, by combining different characteristics of importance agronomic system in the same hybrid, enabling better pest management (Aragon and Andrade, 2010). In addition to tolerance to the herbicide glyphosate through the expression of the GA21 event, the combination of the distinct modes of action of the Cry1Ab and VIP3A proteins from the Bt11 and MIR162 events will allow the preservation of the insect resistance technology for a longer term, thus guaranteeing its use. in the integrated management of corn crop pests in Brazil.
EN
Méthode et points à examiner
It was observed that Cry1Ab/Ac protein was rapidly degraded by gastric and intestinal fluids, and showed no adverse effects in mice submitted to an acute dose of 5 g (Cry1Ab/Ac protein)/kg of body weight. Again, it was observed that this protein has no sequence homology with known allergens or toxins, nor N-glycosylation sites, confirming that no harm will result from the inclusion of the Cry1Ab/Ac protein in human food or animal feed.
EN
The expression of Cry1Ab, VIP3Aa20 and mEPSPS proteins observed in Bt11xMIR162xGA21 maize did not show a trend towards changes in expression levels as a function of the combination of these events by classical genetic improvement. In the trials, Bt11xMIR162xGA21 maize had no adverse effect on the non-target insect community. Results showed the effectiveness in controlling Bt11xMIR162xGA21 corn attack by Spodoptera frugiperda, Agrotis ipsilon, Elasmopalpus lignosellus and Diatraea saccharalis, when compared with the respective non-GM isogenic hybrid.
EN
The expression of Cry1Ab, VIP3Aa20 and mEPSPS proteins observed in Bt11xMIR162xGA21 maize did not show a trend towards changes in expression levels as a function of the combination of these events by classical genetic improvement. In the trials, Bt11xMIR162xGA21 maize had no adverse effect on the non-target insect community. Results showed the effectiveness in controlling Bt11xMIR162xGA21 corn attack by Spodoptera frugiperda, Agrotis ipsilon, Elasmopalpus lignosellus and Diatraea saccharalis, when compared with the respective non-GM isogenic hybrid.
EN
The events Bt11, MIR162, GA21 were characterized at the time of individual approval, and the maintenance of the integrity of the genetic constructs inherited from the respective parents during the classical genetic improvement process was attested; There is no evidence of interaction between the metabolic pathways in which the proteins Cry1Ab, Vip3A and mEPSPS act; No pleiotropy or epistasis were reported in parental and conjoint events; Protein expression in stacked maize is not significantly different from the expression observed in parental events separately; No evidence was found that the expressed proteins cause an allergy or toxic effect in humans and animals; The agronomic and efficacy evaluations of maize indicated that the combination of events by sexual crossing did not lead to the expression of any other traits that not what was expected, ie resistance to certain insects and tolerance to glyphosate herbicide; No botanical changes were found in Bt11xMIR162xGA21 maize that could confer adaptive advantages; The internationally accepted criteria in the process of risk analysis of genetically modified raw materials regarding pyramided events; Bt11xMIR162xGA21 corn is as safe as its conventional counterpart.
EN
The agronomic and efficacy evaluations of Bt11xMIR162xGA21 corn indicated that the combination of these events by classical breeding methods did not lead to the expression of any other characteristic than those expected, ie, resistance to certain insects and tolerance to the herbicide glyphosate. The expression of Cry1Ab, VIP3Aa20 and mEPSPS proteins observed in Bt11xMIR162xGA21 maize did not show a trend towards changes in expression levels as a function of the combination of these events by classical genetic improvement. In the trials, Bt11xMIR162xGA21 maize had no adverse effect on the non-target insect community. Results showed the effectiveness in controlling Bt11xMIR162xGA21 corn attack by Spodoptera frugiperda, Agrotis ipsilon, Elasmopalpus lignosellus and Diatraea saccharalis, when compared with the respective non-GM isogenic hybrid.
EN
The report presented by the applicant showed that there was no synergistic effect between the events resulting from the conventional crossing in terms of agronomic characteristics, mode of reproduction, dissemination or ability to survive. Thus, the cultivation and consumption of Bt11xMIR162xGA21 maize are not potentially causing significant environmental degradation or risks to human and animal health.
EN
CTNBio considered that it is as safe as its conventional equivalents in terms of food and environmental safety. Agronomic and efficacy evaluations carried out in the maize Bt11xMIR162xGA21, did not indicate any consistent pattern that would suggest biologically significant changes, resulting from the combination of these events, different from those expected, that is, insect resistance and herbicide tolerance combined.
EN
Molecular traddicional methods. 
EN
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