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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 16 juin 2026
Risk assessment of corn event GA21 - Technical Opinion 1597/2008.
EN
18 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 :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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MON-ØØØ21-9 - Roundup Ready™ maize| Monsanto | Résistance aux herbicides (Glyphosate)
- Commercial release 1597-2008.pdf [ Portugais ]
The transgenic maize plants (Zea maize L.) derived from the GA21 event, transformed with the synthetic gene
mepsps, produce the double mutant enzyme EPSPS, which confers tolerance to the herbicide glyphosate. O.corn GA21 was obtained by transforming a maize lineage cell culture by the bombardment method with' microprojectiles. The constitutive expression of mEPSPS is controlled by the inclusion of promoter sequences from the rice actin and the gene polyadenylation signal in Agrobacterium tumefaciens. Post-translational modifications are obtained in the chloroplast by fusion with the 5'-terminal coding region of the transit peptide of sunflower chloroplast. The GA21 transformation event promotes the expression of the mutant synthase enzyme in maize 5-enolpyruvyl shikimate-3-phosphate (EPSPS), a key element in the shikimic acid process, involved in the biosynthesis of aromatic amino acids, found naturally in plants, fungi and bacteria and absent in animals.
mepsps, produce the double mutant enzyme EPSPS, which confers tolerance to the herbicide glyphosate. O.corn GA21 was obtained by transforming a maize lineage cell culture by the bombardment method with' microprojectiles. The constitutive expression of mEPSPS is controlled by the inclusion of promoter sequences from the rice actin and the gene polyadenylation signal in Agrobacterium tumefaciens. Post-translational modifications are obtained in the chloroplast by fusion with the 5'-terminal coding region of the transit peptide of sunflower chloroplast. The GA21 transformation event promotes the expression of the mutant synthase enzyme in maize 5-enolpyruvyl shikimate-3-phosphate (EPSPS), a key element in the shikimic acid process, involved in the biosynthesis of aromatic amino acids, found naturally in plants, fungi and bacteria and absent in animals.
CTNBio considered that the request complies with the relevant rules and legislation that aim to guarantee the biosafety of the environment, agriculture and human and animal health.
The GA21 corn product has already been released for human and animal consumption in the United States, Japan, Canada, Argentina, Mexico, South Africa, Australia, New Zealand, the Philippines, Thailand and China.
Being that in some countries at least 10 years showing a safe history of consumption without scientifically proven adverse effects.
Being that in some countries at least 10 years showing a safe history of consumption without scientifically proven adverse effects.
They do not pose risks to the life and health of animals or humans.
Considering that GA21 corn has already been well characterized biochemically and functionally in relation to the transformation event; Considering that the possibility of the protein again interfering with metabolic/functional pathways and/or relevant structures is null, considering the morphology of the plant, its agronomic performance, its biochemical composition, nutritional content and digestibility; Considering that the possibility of transgenics causing inadvertent genetic changes in the transgenic plant (silencing or over-expression of endogenous genes) is very low and, if these changes occur, it will not imply adverse effects either to the plant, humans or animals in view of the exposed in the previous item; ; Considering the nutritional and compositional equivalence of GA21 maize compared to its conventional isogenic version, no metabolite of GA21 maize has a potential to concentrate in the food chain, beyond that already expected by conventional maize widely cultivated. In studies of acute oral toxicity in mice performed with the EPSPS protein, it was observed that the EPSPS protein did not present an acute toxic effect to these animals at the highest dose tested. No test substance related mortality occurred during the study and no clinical signs attributable to the test substance were observed.
FR
CTNBio considered that the request complies with the relevant rules and legislation that aim to guarantee the biosafety of the environment, agriculture and human and animal health.
CTNBio concluded that the cultivation and consumption of GA21 corn do not potentially cause significant degradation of the environment or risks to human and animal health.
Molecular traddicional methods.
Oui
Oui
Oui
Oui
Oui
FR
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