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Risk Assessment generated by a regulatory process
(RA)
last updated: 28 Apr 2026
Risk assessment of corn event DAS-40278-9 - Technical Opinion No. 4406/2015
EN
05 Mar 2015
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Organization:Dow AgroSciences Industrial Ltda. ()Private sector (business and industry)Rua Alexandre Dumas 1671 1º andar Ala ASao Paulo, SP
04717-903, BrazilPhone: +55 (16) 3690-1521; +55 (16) 3690-1500,Fax: +55(16) 3690-1599,Email: mjvonzuben@dow.com,Website:
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DAS-4Ø278-9 - Enlist™ Maize| Dow AgroSciences GmbH | Resistance to herbicides, Tolerance to 2,4-Dichlorophenoxyacetic acid, Tolerance to aryloxyphenoxypropionate
- Commercial release 4406-2015.pdf [ Portuguese ]
Regarding the safety of DAS-40278-9 corn for human and animal feed, a risk assessment was performed based on the average consumption and exposure to AAD-1 protein in humans and animals. It could be inferred that the magnitude of the values Estimates of apparent intake in relation to acceptable daily intake confirmed the expectations of the acute dietary risk assessment of the AAD-1 protein present in DAS-40278-9 corn indicating absence of acute toxic activity in humans and animals.
There is no verification of possible pleiotropic or epistatic effects by the genes inserted in the corn in question, since no significant alteration was observed in the analysis of characters phenotypic, agronomic, nutrient composition, effect on soil physicochemical characteristics, degradability of soil organic matter and effect on plant nutritional status.
There were no significant differences in relation to sanity and productive performance of birds in relation to three diets based on commercial corn cultivars and a diet with iso-hybrid corn, which attests to the innocuousness of said corn for animal consumption, since among the domestic production species, birds are the that consume more corn proportionally in relation to to cattle, sheep, goats and pigs. Acute toxicity studies were also performed in rats, where no significant differences were found between DAS40780-9 maize and conventional maize.
The absence of adverse effects from the consumption of said corn.
Regarding the assessment of risk to the environment, evaluations were carried out on agronomic, reproductive, plant growth parameters and evaluation of diseases and insects in field studies. All assays demonstrated equivalence between DAS40278-9 corn and conventional non-transgenic corn in different environmental and germplasm conditions. The effects of haloxyfop-R herbicide on maize plants were also analyzed. DAS40278-9 and conventional corn, the former being visibly resistant to the effects of the herbicide, due to the herbicide metabolization by the AAD-1 enzyme. It was also shown that haloxyfop-R had an effect on weed control dicotyledons reaching commercial levels in single or sequential applications, being similar to the herbicide used as standard in the test performed. It was also noted that DAS40278-9 corn, with or without herbicide application, did not cause an impact on the physicochemical characteristics of the soil or on the concentration of nutrients in the leaves in relation to conventional non-transgenic corn.
Regarding the assessment of risk to the environment, evaluations were carried out on agronomic, reproductive, plant growth parameters and evaluation of diseases and insects in field studies.
DAS40278-9 corn has been submitted for approval for commercial release in 5 different countries and the European Union. Among these, it had already been approved in the USA, Taiwan, Australia and New Zealand, which also attests to the innocuousness of the aforementioned cultivar, since it was analyzed and approved by other different technical committees such as CTNBio.
DAS-40278-9 corn is equivalent to conventional corn in all its phenotypic, genotypic and biochemical characteristics, the only differences being related to herbicide resistance conferred by the insertion and expression of the aad-1 gene in the genome.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
