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Évaluation des risques générée par un processus de réglementation (RA)
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last updated: 28 avr. 2026
Informations générales
Risk assessment of soybean event DAS-44406-6 x DAS-81419-2 - Technical Opinion No. 5500/2017
EN
03 août 2017
Détails de l’évaluation des risques
  • BCH-LMO-SCBD-112356-1
    DAS-81419-2 × DAS-444Ø6-6 - Conkesta Enlist E3™ Soybean
    | Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites)), Résistance aux herbicides (Glufosinate, Glyphosate), Tolerance to 2,4-Dichlorophenoxyacetic acid
    Show detection method(s)
The DAS-81419-2 soybean was developed through genetic transformation mediated by A. tumefaciens from the conventional soybean variety Maverick. The DAS-81419-2 soybean presents, integrated into its genome, the T-DNA insert originated from the pDAB9582 plasmid, which contains the cry1F, cry1Ac and pat genes. Such genes encode, respectively, the CRY1F, CRY1Ac and PAT proteins. The CRY1F and CRY1Ac proteins provide DAS-81419-2 soybean resistance to insects while the PAT protein confers 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 will be provided by the cry1Ac, cry1F and pat genes introduced in DAS-81419-2 soybean, when compared to conventional soybean. The DAS-81419-2 soybean underwent genetic transformation mediated by Agrobacterium tumefaciens strain EHA101, using the plasmid pDAB9582.
EN
Méthode et points à examiner
The company sent a study to evaluate the effect of the cultivation of soybean DAS-44406-6 × DAS-814192, soybean DAS-44406-6 and soybean DAS-81419-2 on the community of soil microorganisms in different locations representative of the cultivation of soy in Brazil. For a better estimate of the effect, the experiments were carried out in different climate and soil regions, in Operating Units located in Cascavel/PR, Restinga Seca/RS and Lucas do Rio Verde/MT. The methodology used to detect possible effects of genetically modified plants, that is, to primarily detect differences between soybean DAS-44406-6 × DAS-81419-2 and soybean conventional in the soil microbial community, were analyzes of bacterial and fungal counts in plates, evaluation of carbon biomass, evaluation of the probable number of ammonifiers and cellulolytics and analyzes of the enzyme β-glucosidase and acid phosphatase. Statistical treatment through analysis of variance (ANOVA) showed that the effect of DAS-44406-6 × DAS-81419-2 soybean is similar to the effect of conventional/commercial soybean on the soil microorganism community.
EN
From the analysis of the information presented by the proponent, it is concluded that DAS-44406-6 x DAS-81419-2 soy does not produce toxins or metabolites that cause any adverse effect on the consumer, animal or human, different from those caused by conventional soy. The substantial equivalence of DAS-44406-6 soybean x DAS-81419-2 compared to conventional soy and the rapid denaturation and degradation of AAD-12, 2mEPSPS, CRY1F, CRY1Ac and PAT proteins during processing ensure the safe consumption of GM soy and/or products derived therefrom.
EN
In Brazil, studies were carried out to verify the impact of soybean DAS-44406-6 x DAS-81419-2 on the main groups of non-target arthropods that may occur in soybean. For that, it was used
sampling with traps, with visual inspection and with evaluation of the soil mesofauna. The results showed that it is possible to affirm that the event DAS-44406-6 x DAS-81419-2 does not cause a negative impact on the communities of non-target arthropods associated with the soybean crop.
EN
The nutritional composition analyzes of DAS-44406-6 x DAS-81419-2 soybean, as well as its singular events, compared to conventional soybean, show similarities between the two products in terms of protein, fiber, carbohydrates, oils, ash, minerals, fatty acids, amino acids, vitamins, metabolites, antinutrients and isoflavones. The presence of genes cry1Ac and cry1F, which confer resistance to lepidopteran pests, and genes aad-12, 2mepsps and pat, which confer tolerance to 2,4-D herbicides, glyphosate and glufosinate ammonium, respectively, does not cause changes in the composition. nutritional status of the GMO, in addition to those that may be caused by biotic and abiotic factors in conventional soybean farming. No significant homology was observed between CRY1F, CRY1Ac, AAD-12, 2mEPSPS and PAT proteins with respect to proteins known to be allergenic or toxic.
EN
Studies carried out in the USA and in Brazil involved the analysis of phenotypic, agronomic, nutrient composition characters, the effect of DAS-44406-6 soybean on soil chemical and physical characteristics, the degradability of plant organic matter in the soil and the effect of of genetically modified plants on the nutritional status of plants. In all these studies, no significant difference was detected between DAS-44406-6 soybean and its conventional control of the same genetic background, which could indicate the occurrence of interactions between the genes inserted in DAS-44406-6 soybean and other genes in the genome with emergence of detectable pleiotropic and epistatic effects.
EN
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health.
EN
In the process of risk analysis of genetically modified raw materials, it is possible to conclude that DAS-44406-6 x DAS-81419-2 soy is as safe as its conventional equivalent. Within the scope of the powers assigned to it by art. 14 of Law 11,105/05, CTNBio considered that the request complies with the rules and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that soy DAS-44406-6 x DAS-81419-2 is substantially equivalent to conventional soy, and its consumption is safe for human and animal health.
EN
Molecular traddicional methods. 
EN
Partage d’informations avec d’autres bases de données
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Information supplémentaire
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