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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 28 avr. 2026
Risk assessment of soybean event DAS44406-6 - Technical Opinion No. 4867/2015.
EN
10 déc. 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,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-444Ø6-6 - Enlist E3™ Soybean| Dow AgroSciences | Resistance to 2,4-Dichlorophenoxyacetic acid, Résistance aux herbicides (Glufosinate, Glyphosate)
- Commecial release 4867 - 2015.pdf [ Portugais ]
Soybean DAS-44406-6 was obtained by genetic transformation mediated by Agrobacterium tumefaciens strain EHA101, using plasmid pDAB8264. DAS-44406-6 soybean carries the aad-12 v1 gene, which encodes the protein aryloxyalkanoate dioxygenase (AAD-12), which gives soybean tolerance to the 2,4-D herbicide (2,4-Dichlorophenoxyacetic acid), of the gene 2mepsps encoding the 2mEPSPS protein which confers tolerance to the herbicide glyphosate and the pat v6 gene which encodes the PAT protein which confers tolerance to the glufosinate ammonium herbicide. This product was developed with the objective of providing the farmer with greater flexibility in the choice of herbicides for the control of weeds that infest the soybean crop.
The cultivation of DAS-44406-6 soy and the consumption of the plant or its derivatives will not cause adverse effects to the environment or human and/or animal health, being as safe as conventional soy.
AAD-12, PAT and 2mEPSPS proteins were studied to detect potential adverse effects in humans and animals. Studies through bioinformatics revealed the absence of similarity of the amino acid sequences of the three proteins with sequences of toxic or allergenic proteins and no evidence was found for the glycosylation of the proteins AAD-12, PAT and 2mEPSPS. The proteins studied degrade rapidly in the presence of simulated gastric fluids and high temperatures during industrial processing, prior to soybean consumption. In addition, soybean oil is virtually protein-free.
None of the proteins expressed by the DAS-44406-6 event affect the survival potential of the DAS-44406-6 soybean plant, since the survival potential in an environment depends on morphological and physiological changes that do not occur in soybean plants. DAS-44406-6.
The phenotype of the transformed plants containing the DAS-44406-6 event is equivalent to the phenotype of the original plant with regard to reproductive organs, the duration of the period of
development of the plant, to its method of propagation. Furthermore, DAS-44406-6 soy, like conventional soy, is not an invasive species in natural ecosystems and is not
tends to proliferate as a weed.
development of the plant, to its method of propagation. Furthermore, DAS-44406-6 soy, like conventional soy, is not an invasive species in natural ecosystems and is not
tends to proliferate as a weed.
Field studies conducted with the authorization of CTNBio demonstrated the effectiveness and economic feasibility of using DAS-44406-6 soybean under cultivation conditions in Brazil, confirming results similar to those obtained in the United States. The results of these studies also showed that DAS-44406-6 soybean is similar to the conventional cultivar in agronomic characteristics such as emergence, vigor, plant height, lodging, etc. DAS-44406-6 soybean, like conventional soybean, does not tend to proliferate as weeds and is not invasive in natural ecosystems.
Studies carried out in Brazil and the United States have shown that DAS44406-6 soybean does not differ from conventional soybean in agronomic, morphological and reproductive characteristics, being equivalent in chemical and nutritional composition, with the exception of characteristics of tolerance to glufosinate-ammonium herbicides. by the expression of the pat gene, tolerance to herbicides based on glyphosate by the expression of the gene 2mepsps and to herbicides based on 2,4-D by the gene aad-12. Through the results of these studies it can be concluded that the event DAS-44406-6 does not produce significant changes in the botanical characteristics, agronomic characteristics and nutritional composition of plants that can differentiate them from their conventional counterparts. These data demonstrate the equivalence of the two products and the absence of adverse genetic interactions resulting from the transformation process.
They aim to guarantee the biosecurity of the environment, agriculture, human and animal health, and concluded that DAS-44406-6 soy is substantially equivalent to conventional soy, and its consumption is safe for human and animal health. Regarding the environment, it can be concluded that DAS-44406-6 soybean is not a potential cause of significant environmental degradation, keeping with the biota an identical relationship to that of soybean conventional.
Molecular traddicional methods.
FR
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