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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 28 avr. 2026
Risk assessment of corn event 3272 x Bt11 x MIR162 x GA21 - Technical Opinion 7897/2022.
EN
03 févr. 2022
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Autorité nationale compétente :National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200,Téléphone : (5561) 3411-5516,Télécopieur : (5561) 3317-7475,E-mail : ctnbio@mct.gov.br,Site Web : http://www.ctnbio.gov.br,
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Organisation :Syngenta Seeds Ltda. ()Lilian Aguiar Saldanha Rodovia BR-452, Km 142 + 543m.Uberlândia, MG
38405-232,Téléphone : +55(11) 5643-6747,Télécopieur : +55(11) 5643-6750 ; 5643-6750,E-mail : lilian.saldanha@syngenta.com,Site Web :
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SYN-E3272-5 × SYN-BTØ11-1 × SYN-IR6Ø4-5 × MON-ØØØ21-9 - Modified thermostable alpha-amylase, insect-resistant, herbicide-tolerant maize| Résistance aux maladies et aux parasites (Insectes, Coléoptères, Chrysomèle occidentale des racines du maïs (Diabrotica virgifera), Chenille tisseuse (papillons et mites), Pyrale du maïs (Ostrinia nubilalis)), Résistance aux herbicides (Glufosinate, Glyphosate), Gènes marqueurs et gènes rapporteurs sélectables, Utilisation dans les applications industrielles (Production de biocombustibles)
- commercial release 7897 - 2022.pdf [ Portugais ]
Corn to increase product quality, insect resistance and herbicide tolerance, called Corn 3272 x Bt11 x MIR162 x GA21, was developed through classical genetic improvement, by sexual crossing between genetically modified lines containing the transformation events 3272, Bt11, MIR162, and GA21, which express the thermostable alpha-amylase (amy797E) and phosphomannose isomerase (pmi) genes (Corn 3272), cry1Ab and pat (Corn Bt11), vip3Aa20 and pmi (Corn MIR162), and mepsps (Corn GA21), all of which have been previously evaluated and approved by CTNBio for commercial use in Brazil, either with individual events or in several combined products.
The Biosafety Assessment for Human, Animal and Environmental Health, for the individual transformation events that make up the combined product Corn 3272 x Bt11 x MIR162 x GA21 were previously submitted to CTNBio for their respective risk analysis. The product Maize 3272 x Bt11 x MIR162 x GA21 did not present other genetic modifications, besides the introgression of these events in the maize lines, through classical genetic improvement.
Maize 3272, Maize Bt11, Maize MIR162 and Maize GA21 have a history of safe use, are substantially equivalent to their non-genetically modified hybrids and are approved for commercialization by CTNBio in Brazil, and based on the data presented here, from the evaluation of Biosafety for Humans and Animals and in the Biosafety Assessment for the Environment of the individual transformation events that are part of the combined product Corn 3272 x BT11 MIR162 x GA21, it is concluded that the combined product, through classical genetic improvement, does not present risks significant effects on human, animal or environmental health. Any damage, if any, would be reduced and with a negligible probability of occurrence, that is, a negligible risk.
Corn 3272, Corn Bt11, Corn MIR162 and Corn GA21 have a history of safe use, are substantially equivalent to their non-genetically modified hybrids and are approved for commercialization by CTNBio in Brazil.
The expression of the amy797E, pmi, cry1Ab, pat, vip3Aa20, and mepsps genes of the individual transformation events that make up the combined product Corn 3272 x Bt11 x MIR162 x GA21 were evaluated for their impact on agronomic performance and phenotypic traits regarding: yield per ha, growth stage, initial stand, germination and seed vigor, initial stand count, days up to 50% pollen release, ear height, plant height, final stand count, stalk-bed plants, plants root lodging, days to maturity, reaction to major corn diseases, environmental interactions (damage caused by arthropods), and no significant biological difference was detected between GM corn hybrids when compared to non-genetically modified hybrids. These data were collected in Brazil, the United States and Argentina, in field experiments in several representative regions for corn in these countries, in the respective crop years in which the studies of individual events were carried out and all this information was previously submitted , analyzed and approved by CTNBio.
Biosafety, agronomic performance and insect resistance studies and effects on non-target organisms were carried out in the field (planned release into the environment) in approximately 17 trials in Brazil, numerous trials in the US and around 10 releases in Argentina. This insertion had no effect to alter the potential behavior of the transformed corn to become more invasive than conventional non-GM hybrids, as evidenced by successive field trials in which GM corns were compared with conventional corns. Horizontal gene flow between MIR 162 maize and other species, even those closely related, has practically zero probability. to occur, as wild species related to corn do not occur naturally in Brazil. No significant differences were observed between the populations of non-target organisms when comparing the cultivation of MIR162 Maize and the non-genetically modified maize. The MIR162 corn is efficient to control the evaluated lepidopteran pests, and behaves similarly to the non-genetically modified corn regarding the evaluated agronomic parameters (plant height, ear insertion height, male and female flowering date, disease score, percentage of erect plants, type of grain, color of grain), presenting performance statistically equal to the respective non-genetically modified hybrids under conditions of cultivation of the culture in Brazil.
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 this activity does not have significant impacts on the environment.
The data presented in the majority request for maize 3272 x Bt11 x MIR162 x GA21 meet the norms and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and allow us to conclude that the subcombinations of maize 3272 x Bt11 x MIR162 x GA21 is substantially equivalent to conventional corn, and its consumption is safe for human and animal health.
Molecular traddicional methods.
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FR
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