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Risk Assessment generated by a regulatory process
(RA)
last updated: 16 Jun 2026
Risk assessment of corn event DAS-40278-9xNK603 - Technical Opinion No. 4763/2015.
EN
08 Oct 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 ()Phone:Fax:Email:
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DAS-4Ø278-9 × MON-ØØ6Ø3-6 - Herbicide tolerant maize| Resistance to herbicides (Glyphosate), Tolerance to 2,4-Dichlorophenoxyacetic acid, Tolerance to aryloxyphenoxypropionate
- Commercial release 4763-2015.pdf [ Portuguese ]
DAS-40278-9 x NK603 corn was obtained through crosses between DAS40278-9 and NK603 corns, both already approved by CTNBio for commercial planting in Brazil. DAS-40278-9 corn was approved by CTNBio in March 2015 and has already been approved by 10 other countries (South Africa, Australia, Canada, Colombia, South Korea, United States of America, Japan, Mexico, New Zealand and Taiwan), whether for planting, animal feed or human food.
The cultivation of DAS-40278-9 x NK603 corn and the consumption of the plant or its derivatives do not cause adverse effects to the environment or human and animal health, being as safe as conventional corn, with which it has substantial equivalence.
There is no difference between the agronomic performance of transgenic and conventional plants, as well as substantial equivalence between them. Thus, the information indicates that transgenic maize plants do not fundamentally differ from untransformed maize genotypes, with the exception of tolerance to 2,4-D herbicides, to herbicides from the aryloxyphenoxypropionate group (haloxyfop-R, quizalofop, etc.) and to glyphosate. There is also no evidence of adverse reactions to the use of DAS-40278-9 x NK603 corn. For this reason, there are no restrictions on the use of this corn or its derivatives, whether for human or animal consumption.
DAS-40278-9 x NK603 corn is as safe as its conventional counterparts.
The inserts had their integrity maintained during the classical genetic improvement process; The pattern of genetic inheritance showed that the two events are independent and segregate stably over successive generations; The agronomic evaluations indicated that there was no expression of any new trait beyond those expected; The expression profile of the recombinant proteins is not different from the expression obtained in corns containing the events separately; All tests involving the animal and food safety of DAS-40278-9 x NK603 corn demonstrate that there is no toxicological or allergenic evidence; Corn is the species that has reached the highest degree of domestication among cultivated plants, being unable to survive in nature without human intervention; In Brazil there are no native wild species with which corn can intercross; Studies carried out in Brazil and the United States have shown that DAS40278-9 X NK603 corn does not differ from conventional corn in agronomic, morphological, reproductive characteristics, in survival characteristics and in the form of plant dissemination, in response to the main pathogens and pests, as well as in the chemical and nutritional composition, with the exception of the characteristics of tolerance to 2,4-D-based herbicides, to herbicides from the aryloxyphenoxypropionate group (haloxyfop-R, quizalofope, etc.) and to glyphosate, conferred by the presence and aad-1 and cp4 epsps gene expression; The GMO does not present a risk of invasiveness or weed; 10) The biosafety of this event has already been evaluated by the regulatory systems of 05 countries, being approved in all for the intended use: animal feed and/or human nutrition and/or planting; 11) The availability of DAS-40278-9 x NK603 corn will provide corn producers in Brazil with an alternative to increase the management of weeds in the crop, considering that integrated management, with rotation of herbicides, is the best way to reduce weed resistance to herbicides; It is perfectly possible to coexist in the field between crops of GM corn DAS402789 x NK603 and crops of conventional or creole corn;
Studies carried out in Brazil and the United States have shown that DAS40278-9 X NK603 corn does not differ from conventional corn in agronomic, morphological, reproductive characteristics, in survival characteristics and in the form of plant dissemination, in response to the main pathogens and pests, as well as in the chemical and nutritional composition, with the exception of the characteristics of tolerance to 2,4-D-based herbicides, to herbicides from the aryloxyphenoxypropionate group (haloxyfop-R, quizalofope, etc.) and to glyphosate, conferred by the presence and aad-1 and cp4 epsps gene expression.
CTNBio considers that the cultivation of DAS-40278-9 x NK603 corn does not potentially cause significant degradation of the environment or harm to human and animal health and maintains an identical relationship with the biota to that of conventional corn.
CTNBio considered that the request complies with the norms and legislation in force that aim to guarantee the biosafety of the environment. environment, agriculture, human and animal health, and concluded that DAS-40278-9 x NK603 corn is substantially equivalent to conventional soy, and its consumption is safe for human and animal health.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
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| Country's Decision or any other Communication | Risk assessment | 1 | |
