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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 16 juin 2026
Risk assessment of corn event MON 89034 x TC1507 x MIR162 x NK603 x DAS-40278-9 - Technical Opinion No. 6035/2018.
EN
05 sept. 2018
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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 :Dow AgroSciences Industrial Ltda. ()Secteur privé (affaires et industrie)Rua Alexandre Dumas 1671 1º andar Ala ASao Paulo, SP
04717-903,Téléphone : +55 (16) 3690-1521; +55 (16) 3690-1500,Télécopieur : +55(16) 3690-1599,E-mail : mjvonzuben@dow.com,Site Web :
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MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 × SYN-IR162-4 × DAS-4Ø278-9 - Power Core™ x MIR162 x Enlist™| Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites)), Résistance aux herbicides (Glufosinate, Glyphosate), Tolerance to 2,4-Dichlorophenoxyacetic acid, Tolerance to aryloxyphenoxypropionate
- Commercial release 6035-2018.pdf [ Portugais ]
MON 89034 x TC1507 x MIR162 x NK603 x DAS-40278-9 corn was developed by classical genetic improvement, resulting from the cross between MON 89034 corn, TC1507 corn, MIR162 corn, NK603 corn and DAS-40278-9 corn, all approved for commercial release by CTNBio.
Corn MON 89034 x TC1507 x MIR162 x NK603 x DAS-40278-9 demonstrate the absence of adverse effects on human and animal health.
Results of feeding studies of animals consuming a diet that contains the proteins expressed from the genes introduced in the events that compose the maize MON 89034 x TC1507 x MIR162 x NK603 x DAS-40278-9 demonstrate the absence of adverse health effects. These studies are presented in item 9 of the document presented and also in the commercial release processes, already approved by CTNBio, of genetically modified lines containing the single events that make up MON 89034 x TC1507 x MIR162 x NK603 x DAS-40278-9 corn. Thus, to date, there is no evidence of adverse effects on animal health.
They aim to guarantee the biosecurity of the environment, agriculture, human and animal health.
Whereas corn MON 89034 x TC1507 x MIR162 x NK603 x DAS-40278-9 belongs to a well-characterized species with a solid history of safety for human consumption; Whereas the proteins Cry1A.105, Cry2Ab2, Cry1F, VIP3Aa20, which confer insect resistance and the PAT, CP4 EPSPS, AAD-1 proteins that confer tolerance to herbicides, in addition to the PMI protein used as a selective marker, are expressed in several events of different agricultural crops that have already been subjected to risk assessment and approved for commercial use in several countries; Considering that the construction of this event occurred by classical genetic improvement and that the molecular characterization, analysis of protein expression, compositional analysis and agronomic and phenotypic evaluations do not show evidence of any interaction between the inserts present in the combined event; CTNBio's analysis considered the opinions issued by the members of the Commission; by Ad Hoc consultants; documents submitted to the CTNBio Executive Secretariat by the applicant; results of planned releases to the environment; lectures, related texts. Studies and scientific publications independent of the applicant and carried out by third parties were also considered and consulted.
The expression of proteins Cry1A.105, Cry2Ab2, Cry1F, PAT, VIP3Aa20, PMI, CP4-EPSPS and AAD-1 was carried out in experiments in Rio Verde (GO), Indianópolis (MG) and Pallottine (PR). The tests used a hybrid of conventional control corn (Isohybrid), two genetically modified corns under regulation, MON 89034 × TC1507 × MIR162 × NK603 × DAS-40278-9 and MON 89034 × TC1507 × NK603 × DAS-40278-9, plus a commercial MIR162 control hybrid. Leaves, roots, pollen, forage, whole plant and grains were analyzed. The mean expression between sites (pooled analysis) for Cry1A.105 protein varied between 0.70 ng/mg (PS) in R6 stage grain and 39.79 ng/mg (PS) in V9 stage leaf; for Cry2Ab2 it ranged from 1.15 ng/mg PS in R1 stage pollen to 312.82 ng/mg PS in V9 stage leaf tissue; for Cry1F it ranged from 2.94 ng/mg PS in whole plant at R6 stage to 26.63 ng/mg PS in pollen tissue at R1 stage; for Vip3Aa20 ranged from 21.29 ng/mg (PS) in whole plant at the R6 stage to 116.43 ng/mg PS in tissue of leaf at stage R1; for PAT ranged from not detectable (ND), with means considered as NA (Not applicable) in matrices such as pollen R1, grain and whole plant at stage R6 to 4.79 ng/mg PS in leaf tissue at stage R1; for PMI it ranged from 1.12 ng/mg PS in whole plant at the R6 stage to 8.69 ng/mg PS in leaf tissue at the V2-V4 stage; for CP4 EPSPS ranged from 12.01 ng/mg PS in whole plant at R6 stage to 348.92 ng/mg PS in pollen tissue at R1 stage. Control samples were negative for most of the tissues tested for the proteins analyzed.
There is no evidence of adverse effects on animal health and MON 89034 x TC1507 x MIR162 x NK603 x DAS-40278-9 corn belongs to a well characterized species with a solid history of safety for human consumption.
The National Technical Commission on Biosafety - CTNBio is in favor of the request of the company Dow AgroSciences Sementes & Biotecnologia Brasil Ltda. CQB 107/99 for the commercial release of genetically modified corn combined event MON 89034 x TC1507 x MIR162 x NK603 x DAS-40278-9 considering that it meets the norms of Normative Resolution no. 05/2008 which aim to guarantee the biosecurity of the environment, agriculture, human and animal health.
Molecular traddicional methods.
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| Décision de pays ou tout autre communication | Évaluation des risques | 1 | |
