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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 16 juin 2026
Risk assessment of soybean event DAS-68416-4 - Technical Opinion 4410-2015.
EN
15 août 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 ()Téléphone :Télécopieur :E-mail :Site Web : http://www.dowagro.com/homepage/index.htm,
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DAS-68416-4 - Enlist™ Soybeans| Dow AgroSciences GmbH | Résistance aux herbicides (Glufosinate), Tolerance to 2,4-Dichlorophenoxyacetic acid
- Commercial release 4410-2015.pdf [ Portugais ]
The human and animal food safety of event DAS-68416-4 was analyzed through studies of chemical and nutritional composition of forage and soybean DAS-68416-4, compared to conventional cultivation. The levels of protein, fiber, minerals, amino acids, vitamins, fatty acids, antinutrients, isoflavonoids, etc. were quantified. The results showed that DAS-68416-4 soybean does not differ from conventional soybean in its chemical and nutritional composition, except for the presence and expression of the aad-12 and pat genes, as explained in the opinions related to the area of Human and Animal Health.
No adverse effects caused by the cultivation of DAS-68416-4 soybean were verified for the relevant indicator organisms, when compared to conventional soybean, based on studies carried out in Brazil, the United States and Canada.
Comparative studies of soybean DAS-68416-4 with its conventional counterpart were carried out to evaluate agronomic, botanical, reproductive and compositional characteristics, involving a large number of genes, with germplasm evaluated in temperate, tropical and subtropical conditions, in America from the North and Brazil and demonstrated the similarity of these characteristics.
The low concentration of AAD-12 protein in soy containing the AAD-12 event, the low risk of human and animal exposure, the results of safety studies of the AAD-12 protein, and the history of safe use of soy, indicate that it is AAD-12 protein is unlikely to cause any toxic effects in humans and animals.
The tolerance of soybean DAS-68416-4 to herbicides based on 2,4-D and ammonium glufosinate does not increase its ability to proliferate, colonize or survive in the environment. None of the proteins expressed by the DAS-68416-4 event, since the survival potential and an environment depends on morphological and physiological changes, which occur in DAS-68416-4 soybean plants. As a consequence, no competitive advantage for plant survival or dispersal in the environment can be attributed to the introgression of aad-12 and pat genes in soybean cultivars. The phenotype of the transformed plants containing the aad-12 and pat genes is similar to the phenotypes of the original plant in terms of reproductive organs, the duration of the plant's development period and its programming method. Soybeans containing the aad-12 and pat genes, like conventional soybeans, do not tend to proliferate as a weed, and are not an invasive species in natural ecosystems.
The human and animal food safety of event DAS-68416-4 was analyzed through studies of chemical and nutritional composition of forage and soybean DAS-68416-4, compared to conventional cultivation. The levels of protein, fiber, minerals, amino acids, vitamins, fatty acids, antinutrients, isoflavonoids, etc. were quantified. The results showed that DAS-68416-4 soybean does not differ from conventional soybean in its chemical and nutritional composition, except for the presence and expression of the aad-12 and pat genes, as explained in the opinions related to the area of Human and Animal Health. The environmental safety of the event was analyzed in studies carried out in Brazil, the United States and Canada, which showed that DAS-68416-4 soybean does not differ from conventional soybean in agronomic, morphological, reproductive characteristics, as well as being equivalent in chemical composition. and nutritional, with the exception of tolerance traits to glufosinate-ammonium-based herbicides by the expression of the pat gene and to 2,4-D-based herbicides by the presence of the aad-12 gene.
Regarding the environment, DAS-68416-4 soy does not potentially cause significant degradation of the environment or harm to human and animal health, keeping with the biota an identical relationship to conventional soy.
CTNBio by art. 14 of Law 11,105/05, we consider that the request complies with the rules and legislation in force, which aim to guarantee the biosecurity of the environment, agriculture, human and animal health, and that DAS-68416-4 soybean is substantially equivalent to soybean conventional, and its consumption is safe for human and animal health.
Molecular traddicional methods.
Oui
Oui
Oui
Oui
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FR
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