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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 16 juin 2026
Risk assessment of soybean (Glycine max L.) Technical Opinion No. 5148/2016
EN
28 juil. 2016
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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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DAS-81419-2 - Conkesta™ Soybean| Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites)), Résistance aux herbicides (Glufosinate)
- Commercial release 5148 - 2016.pdf [ Portugais ]
Genetically Modified (GM) soybean, event DAS-81419-2, was generated by transforming the conventional variety Maverick, mediated by Agrobacterium, using plasmid pDAB9582 to express proteins CRY1F, CRY1Ac and PAT, as described in detail in the release application and complying with CTNBio's Normative Resolution no.
The safety of corn event EH913 for human and animal food and for the environment. As well as the studies carried out for several proteins of the Cry1 and PAT family, already used in genetically modified cultures, the results show that corn EH913 is substantially equivalent to conventional corn and presents a negligible risk when consumed by humans or animals, and when grown under conditions of use in the environment.
A detailed study on the possible impacts of EH913 on non-target organisms was conducted in 7 different representative locations of corn cultivation in Brazil during the 2020-2021 harvest. Field collection methods (pitfall traps and sticky cards e) and visual inspections of arthropods in the EH913 and conventional counterpart plots were conducted at four main stages of maize development. A large number of arthropod species were recorded (134 species), orders (14) and trophic guilds (9), and comparatively evaluated. Statistical analysis showed that EH913 did not cause adverse effects. reproducible or biologically significant in any non-target arthropod species, and no non-target indicator species of the technology was identified that would justify further studies.
The EH913 event corn, the genetically modified subcombinations are not potentially causing significant degradation of the environment, keeping with the biota an identical relationship to that of conventional corn. they do not potentially cause significant degradation of the environment, keeping with the biota a relationship identical to that of conventional corn.
Several field studies were carried out with authorization from the National Technical Biosafety Commission (CTNBio), which demonstrated the efficacy, agronomic feasibility and biosafety of the use of DAS-81419-2 soybean for cultivation in Brazil. After analyzing the data presented by the company and available in the world scientific literature, it is possible to verify that DAS-81419-2 soybean does not differ significantly from conventional soybean in its chemical and nutritional composition, except for the presence and expression of the genes cry1Ac, cry1F and pat , which confer resistance to some soybean pest insects and tolerance to the herbicide glufosinate ammonium. DAS-81419-2 soy, like conventional soy, does not tend to proliferate like weeds and is not invasive in natural ecosystems. No competitive advantage, outside the conditions of cultivation of the culture, will be provided by the genes cry1Ac, cry1F and pat introduced in soybean DAS-81419-2, when compared to conventional soybean. During the evaluations for commercial release of the DAS-81419-2 soybean, the food safety for human and animal consumption was exhaustively verified through the raw data of tests of toxicity, allergenicity, digestibility and proximate composition of the new varieties, both in vitro and in vivo. .
The results of the environmental safety assessments support the conclusion that the cultivation of EH913 corn is as safe for the environment and for microorganisms, animals and plants that co-inhabit these environments as the cultivation of its conventional isoline. The listed results established the safety of event EH913 corn for food and feed and for the environment. As well as the studies carried out for several proteins of the Cry1 and PAT family, already used in genetically modified cultures, the results show that corn EH913 is substantially equivalent to conventional corn and presents a negligible risk when consumed by humans or animals, and when grown under conditions of use in the environment.EH913 is substantially equivalent to conventional corn and presents a negligible risk when consumed by humans or animals, and when grown under conditions of use in the environment.
EH913 corn meets the standards and legislation in force that aim to guarantee the biosecurity of the environment, agriculture, human and animal health.
CTNBio considered that the proposed biosafety measures meet the norms and pertinent legislation that aim to guarantee the biosafety 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 human health.
Molecular traditional methods.
Oui
Oui
Oui
Oui
Oui
FR
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