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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 28 avr. 2026
Risk assessment f soybean event MON87751 - Technical Opinion 5398/2017.
EN
09 mars 2017
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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 :Monsanto do Brasil Ltda ()Secteur privé (affaires et industrie)Geraldo Ubirajara Berger Avenida das Nações Unidas, 12901 - Torre Norte - 7º andarSao Paulo, SP
04578-000,Téléphone : +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-87751-7 - Insect resistant soybean| Monsanto | Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites))
- Commercial release 5398 - 2017.pdf [ Portugais ]
The genetically modified soybean MON 87751 contains the cry1A.105 and cry2Ab2 genes from Bacillus thuringiensis(Bt) subsp. Kurstakie the regulatory genetic elements responsible for expression of proteins Cry1A.105 and Cry2Ab2 which confer resistance to insects. Proteins Cry1A.105 and Cry2Ab2 expressed in soybean MON 87751 have respectively more than 99% and 98% of amino acid identity, with proteins Cry1A.105 and Cry2Ab2 expressed in corn MON 89034, already commercially approved in Brazil, as an individual and also in combination with other transformation events. The genetic transformation events inserted in the MON 87751 soybean confer protection against lepidopteran insects soy pests: Anticarsiagemmatalis, Chrysodeixisincludens, Heliothisvirescens, Crocidosemaaporema, Elasmopalpuslignosellus, Helicoverpazea, Helicoverpaarmigera, Spodopterafrugiperda, Spodopteracosmioides, and Spodopteraeridania. The combination of the expression of two insecticidal proteins (Cry1A.105 and Cry2Ab2) in a single plant will provide a greater spectrum of insect control and a more efficient management of insect resistance, resulting in greater durability of plant resistance. Proteins Cry1A.105 and Cry2Ab2 act differently, more specifically in the way they bind to receptors in the midgut of target insects.
Insect resistant soybean MON 87751 according to Normative Resolution No. 02 of CTNBio, dated 11/27/2006, is classified as a risk class 1 GMO (low individual risk and low risk to the community), it contains DNA/RNA sequences from donor and recipient organisms that do not cause harm to human health and and adverse effects on plants and the environment.
The results of the composition analyzes presented in this report demonstrated the equivalence of nutrients, anti-nutrients and other components of grains and forage of MON 87751 soybean with conventional control soybeans and with commercial soybean references. Centesimal composition data with grain and forage samples collected in Brazil in the 2013/2014 harvest and in the US in the 2012 harvest also showed nutritional equivalence between MON 87751 soybean, conventional control soybean and commercial soybean references.
The company reports that adverse effects on the human and animal food chain from the ingestion of MON 87751 soy and its derivatives are not expected based on the results of the food safety assessment of this transformation event and the proteins Cry1A.105 and Cry2Ab2 expressed therein.
Studies of the presence of proteins Cry1A.105 and Cry2Ab2 in soybean MON 87751 in several generations of selfing, using Western blot analysis, were carried out with tissues of leaf collected from generations R3, R4, R5, R6 and R7 of soybean MON 87751, and leaf tissue of conventional control soybean (A3555). The presence of Cry1A.105 and Cry2Ab2 proteins was demonstrated in five generations of self-fertilization of the MON 87751 soybean. in Bacillus thuringiensis (Bt) was used as a reference for the identification of the Cry2Ab2 protein. The presence of Cry1A.105 and Cry2Ab2 proteins in MON 87751 soybean leaf tissues was determined by visual comparison of signals produced in several generations of selfing and was present in the studied five generations of soybean MON 87751 and migrated with mobility indistinguishable from the Cry1A.105 protein produced in E. coli and the Cry2Ab2 produced in Bt, analyzed by Westernblot.
The proximate composition of grains and forage of MON soybean 87751, produced in field experiments in Brazil in the 2013/2014 harvest, in six representative locations of soybean growing regions in the country: Cachoeira Dourada, MG (CAD); Luiz Eduardo Magalhaes, BA (LEM); Don't Touch Me, RS (NMT); Rolândia, PR (ROL); Santa Cruz das Palmeiras, SP (SCP); and Sorriso, MT (SOR) was determined and compared to conventional control soybeans of similar genetic background and thirteen commercial references. Forage samples were collected at the R6 phenological stage, and grain samples were collected at the physiological maturity stage. The samples were analyzed for centesimal components (ash, fat, proteins) and carbohydrates, the latter calculated by subtraction (calculated carbohydrates). The data presented showed that the differences in the proximate composition components were smaller than the range of values measured in soybean conventional control and commercial references, as well as in the database of the ILSI-CCDB, and were not significant in terms of composition with respect to the safety of food for humans and animals. The results of evaluations on forage and grain samples collected in Brazil were presented in Tables Table VI-10 to VI-13 of the present report under analysis.
The MON87751 soybean is not a potential cause of significant degradation of the environment, keeping with the biota an identical relationship to conventional soybean.
Genetically modified soybean MON87751, containing the cry1A.105 and cry2Ab2 genes, does not have greater potential to cause significant environmental degradation or to have adverse effects on human and animal health when compared to conventional soybeans.
Molecular traddicional methods.
Oui
Oui
Oui
Oui
Oui
FR
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