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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 16 juin 2026
Risk assessment of corn event NK603 x T25 - Technical Opinion 4407-2015.
EN
05 mars 2015
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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, BrésilTéléphone : (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 :Monsanto do Brasil Ltda ()Geraldo Ubirajara Berger Avenida das Nações Unidas, 12901 - Torre Norte - 7º andarSao Paulo, SP
04578-000, BrésilTéléphone : +55(11) 3383-8356,Télécopieur : +55(11) 3383-8102 ; +55 (61) 3245-2523,E-mail : geraldo.u.berger@monsanto.com,Site Web :
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MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 - Roundup Ready™ Liberty Link™ maize| Résistance aux antibiotiques (Ampicilline), Résistance aux herbicides (Glufosinate, Glyphosate)
- Commercial release 4407-2015.pdf [ Portugais ]
The NK603 x T25 maize is the result of the cross between NK603 maize and T25 maize by classical genetic improvement techniques. NK603 corn was developed using the cp4 epsps sequence, from Agrobacterium sp. strain CP4, which encodes the CP4 EPSPS protein (5-enolpyruvylshikimate-3-phosphate synthase) and which confers tolerance to glyphosate. The genetic transformation methodology was bioballistics using corn embryogenic callus as target. The EPSPS protein is the target of glyphosate-based herbicides. In untransformed plants, glyphosate binds to the endogenous corn protein EPSPS and blocks the biosynthesis of 5-enolpyruvylshikimate-3-phosphate, which deprives the plant of amino acids and secondary metabolites essential for its development. In plants that express the CP4 EPSPS protein, aromatic amino acids and other metabolites necessary for their development are produced by the continuous action of this protein.
The CP4 EPSPS protein does not exhibit acute toxics in mammals. Results of acute toxicity studies in mice demonstrated that the protein does not cause acute toxicity or adverse effects, even at the high doses tested, much greater than those related to human exposure.
The agronomic and phenotypic observations carried out allow us to conclude that NK603 x T25 maize does not consistently differ from the control maize. Taken together, the data show that NK603 x T25 maize does not pose a greater risk as weeds and does not result in a risk to the environment when compared to conventional control maize.
NK603 x T25 maize does not differ from conventional control maize, it does not have the capacity to cause greater impact on the ecosystem.
The proposal presented meets the requirements of art. 10 of Normative Resolution No. 5; NK603 x T25 corn provides Brazilian farmers with the possibility of using two herbicides with different modes of action to control weeds and as a weed resistance management tool; NK603 x T25 corn is currently approved in the United States, Canada, Japan, Mexico, South Korea, Philippines, Colombia and Taiwan; The results presented for the individual events ( NK603 corn and T25 corn, already approved by CTNBio, the data and information presented in this Biosafety Report, as well as the information currently available in the scientific literature; Human and Animal Health Areas manifested for granting the commercial release request. A specific study was carried out to evaluate the vigor and germination of NK603 x T25 corn, when compared to the control corn and to the range of values of commercial references. The grains were collected in the plots that made up the above mentioned experiment. No significant differences were detected between NK603 x T25 maize and the control for germination percentage, either in the individual analysis by site or in the joint analysis of the five sites. Regarding vigor, in the individual analysis by location, significant differences were detected between NK603 corn and the control in the Não-Me-Toque (92.75 vs. 96.25%) and Sorriso (78.75 VC. 85, 00%). However, these values are within the range of vigor of commercial references and, within the expected due to the intrinsic genetic variability of the corn crop. No significant differences were observed in the joint analysis of the five sites. Another study was carried out to evaluate the potential for grain germination and growth of corn as a volunteer plant from grains produced in the five Monsanto Experimental Stations, in the 2011/2012 harvest. The grain samples of NK603 x T25 corn, together with those of conventional temperature and humidity control corn, in a greenhouse. The evaluations took place every 15 days, when the volunteer plants were counted and uprooted. In the individual analysis by location, a significant difference was detected between NK603 x T25 corn and the control (9.38 vs. 7.63%), for the number of plants emerged from the grain samples from Santa Cruz das Palmeiras. However, the value is within the range of commercial references. In the joint analysis, no significant difference was observed. The agronomic and phenotypic observations carried out allow us to conclude that NK603 x T25 maize does not consistently differ from the control maize. Taken together, the data show that NK603 x T25 maize does not pose a greater risk as weeds and does not result in a risk to the environment when compared to conventional control maize.
The experiments were carried out during the 2011/2012 harvest in five locations distributed in representative areas of corn in Brazil: Não-Me-Toque (RS), Rolândia (PR), Santa Cruz das Palmeiras (SP), Sorriso (MT) and Cachoeira Dourada (MG). NK603 x T25 corn was compared to conventional control corn and to commercial references regarding emergence (initial shelf), vigor, physiological maturity, stay green, final shelf, grain yield, 100-grain weight, hectoliter weight, stem damage, leaves and ears, stalk and ear rot, and abundance of non-target organisms in soil and shoots. Fourteen commercial corn hybrids were considered as references, with four references being planted in each location, that is, some references were repeated in more than one location.
NK603 x T25 maize does not differ from conventional control maize and, therefore, does not have the capacity to cause a greater impact on the ecosystem than that caused by conventional maize planting.
NK603 x T25 corn is as safe, substantially equivalent and does not have greater potential to become a weed or cause adverse human and animal health effects or any adverse environmental impacts, when compared to conventional corn or individual events already assessed with insurance.
Molecular traddicional methods.
Oui
Oui
Oui
Oui
Oui
FR
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| Décision de pays ou tout autre communication | Évaluation des risques | 2 | |