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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 - Technical Opinion No. 5226/2016 and 7891/2022.
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 - Enogen™ Maize| Utilisation dans les applications industrielles (Production de biocombustibles)
- Commercial release 5226-2016.pdf [ Portugais ]
- Commercial release 7891 - 2022.pdf [ Portugais ]
Maize 3272 was developed through genetic transformation mediated by Agrobacterium tumefaciens, by inserting the synthetic gene amy797E, whose expression produces the alpha-amylase protein thermostable AMY797E. The amy797E gene is a chimeric gene derived from sequences of three alpha-amylase genes originating from three hyperthermophilic microorganisms of the archaea order Thermococcales. This chimeric alpha-amylase gene was assembled from parental sequences using the technology GeneReassembly™ (Diversa Corporation, San Diego, CA) and was selected for the thermostability properties of the encoded amylase protein required during the starch liquefaction phase in corn grain processing, such as ethanol production. Maize 3272 also contains the pmi gene from E. coli that encodes a phosphomannose isomerase and is under regulation by the promoter of the ubiquitin gene from Zea mays and the NOS terminator from Agrobacterium tumefaciens. This gene acts as a selection marker in the transformation process.
The risk assessment of corn showed that 3272 there were no adverse effects and does not present significant risks on human and animal health.
A poultry feeding study demonstrated that there were no adverse effects in broilers that consumed diets prepared with 3272 corn grains when compared to broilers that consumed diets prepared with control corn kernels. Therefore, corn 3272 is expected to provide adequate nutrition to growing animals. The same occurred in the study of feeding mammals (rodents) with duration of 90 days, where the rats consumed diets prepared with control corn grains and diets prepared with corn grains 3272, again there were no adverse effects in the animals. The information presented by the proposing company supports that no potential harm is evident from consumption by mammals (including humans) of maize 3272 and from exposure to proteins AMY797E and PMI.
Corn 3272 does not pose significant risks to human, animal or environmental health.
To evaluate the expression levels of AMY797E and PMI proteins in Maize 3272, field studies were carried out, and the concentrations of the proteins were determined by ELISA in various plant tissues and in the whole plant in five stages of growth (cartridge, anthesis, filling of the grain, maturity seed and senescence) in Maize 3272 and in the non-genetically modified hybrid, with the same background genetic. The expression of the AMY797E protein is driven by the corn gamma-zein promoter for specific expression in the grain endosperm. As expected, relatively high levels of AMY797E protein were measured in Maize 3272 grains. On a dry basis, AMY797E levels in Maize 3272 were higher in the grain filling phase. The average levels of AMY797E in grains of the hybrid evaluated in all phases varied from 838 ± 225 mg/g (wet weight) (1004 ± 322 mg/g in dry weight) to 1627 ± 338 mg/g (wet weight) (3365 ± 780 mg/g dry weight). In addition to grains, AMY797E protein levels were measured in roots, leaves, pollen and in whole plants in five stages of development. Quantifiable levels of AMY797E protein were detected in some whole plant samples and some root samples. In whole plants, in the phases of anthesis, grain filling, grain maturity and senescence, the presence of a proportion of grain in these samples was responsible for the detection of AMY797E. The AMY797E protein was also detected in some samples of whole plants (phenological stages of cartridge and anthesis), before the development of the grain and, in some samples of roots when the plant was in the cartridge stage, in Maize 3272. This low level of AMY797E detected in some whole plants at the cartridge stage, anthesis stage and in some roots may be due to the AMY797E protein in root-bound remnants of the germinated seed. very low levels of AMY797E that were slightly above the limit of quantification were also detected in plants
control (whole plants in the grain filling phase) (0.02 and 0.1 mg/g wet weight, 0.1 and 0.4 mg/g dry weight). AMY797E protein was not detected in pollen and was detected in only one leaf sample, from senescence. The expression of the PMI protein occurs through a constitutive promoter and was detected in most of the plant and tissues analyzed, with the exception of some samples of plants in senescence. PMI levels were generally similar for corn evaluated at each time point, for each tissue type, with the highest levels being detected in pollen: 8.0 - 8.5 (mg/g fresh weight) and 17. 0 - 18.2 (mg/g dry weight).
control (whole plants in the grain filling phase) (0.02 and 0.1 mg/g wet weight, 0.1 and 0.4 mg/g dry weight). AMY797E protein was not detected in pollen and was detected in only one leaf sample, from senescence. The expression of the PMI protein occurs through a constitutive promoter and was detected in most of the plant and tissues analyzed, with the exception of some samples of plants in senescence. PMI levels were generally similar for corn evaluated at each time point, for each tissue type, with the highest levels being detected in pollen: 8.0 - 8.5 (mg/g fresh weight) and 17. 0 - 18.2 (mg/g dry weight).
A comprehensive safety assessment for human and animal consumption was conducted on Maize 3272 to determine whether: a) Maize 3272 is as safe as conventional maize and b) the expressed GM proteins are non-toxic and unlikely to be allergenic. Both the amy797E gene and the pmi gene are derived from organisms with a history of safe use, and the proteins that are produced have a well-known mode of action. Extensive bioinformatics searches were performed to confirm that the amino acid sequences of AMY797E and PMI do not share significant similarity with protein sequences identified as toxins. The potential mammalian toxicity of both proteins was evaluated by performing oral toxicity studies in rats. No toxicity was observed at very high doses (1511 mg protein/kg body weight for AMY797E and 2000 mg protein/kg body weight for PMI). Both AMY797E and PMI proteins are therefore considered non-toxic.
CIBio from Syngenta Seeds Ltd. considered that the cultivation, commercialization or use in human and animal food are not activities that potentially cause significant degradation of the environment or cause harm to human and animal health, and identified only negligible risks related to the biosafety of the GMO and, for this reason, requests an exemption from post-commercial release monitoring.
CTNBio considered that the commercial release for planting genetically modified corn 3272 complies with the relevant norms and legislation that aim to guarantee the biosecurity of the environment, agriculture, human and animal health. Thus, meeting the conditions described in the process and in this technical opinion, this activity is not potentially causing significant degradation of the environment or damage to human or animal health.
Molecular traddicional methods.
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