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Risk Assessment generated by a regulatory process
(RA)
last updated: 28 Apr 2026
Risk assessment of corn event MON810 x TC1507 xNK603 - Technical Opinion No. 2955/2011.
EN
16 Jun 2011
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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:Du Pont do Brasil S.A. (Du Pont - Divisão Pioneer Sementes)Du Pont do Brasil S.A. - Divisão Pioneer Sementes Endereço: SGAS 902 Lt 74 Cj B Sala 221 a 224 Bloco A - Ed. Athenas - Asa SulBrasília, Distrito Federal
70390-020, BrazilPhone: 55 - 61 - 21039111,Fax: 55 - 61 -21039111,Email: goran.kuhar@pioneer.com,Website: http://www.pioneersementes.com.br/,
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DAS-Ø15Ø7-1 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6 - Maize resistant to Lepidoptera and tolerant to glufosinate and glyphosate herbicides| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate, Glyphosate)
- Commercial release 2955-2011.pdf [ Portuguese ]
The maize resistant to insects and tolerant to the herbicides glufosinate ammonium and glyphosate TC1507 x MON810 x NK603 was produced using a conventional breeding technique by crossing event maize TC1507 (Herculex I) with MON810 maize and with NK603 corn (Roundup Ready 2). The event obtained by gene pyramiding (pyramiding) TC1507 x MON810 x NK603 inherited the cry1Ab gene from the parental MON810, the cry1F and pat genes from the parental TC1507 and the cp4 epsps gene from the parental NK603. The stability of the inserts in crosses containing these three events confirmed by means of Southern blot analyses.
No unexpected effects arising from unforeseen interactions were identified when combining, by conventional crossing, the three events TC1507, MON810 and NK603.
The genetically modified parents TC1507, MON810 and NK603, which gave rise to the combined event, were previously evaluated by CTNBio and released for commercialization, after having been considered as safe to human and animal health and the environment as conventional corn.
The cultivation and consumption of corn TC1507 x MON810 x NK603 they do not potentially cause significant degradation of the environment or risks to human and animal health.
Through Southern blot analysis, the maintenance of the integrity of the genetic constructs inherited from the parents TC1507, MON810 and NK603 during the classical genetic improvement process was attested; There is no evidence of interaction between the metabolic pathways in which the proteins Cry1Ab, Cry1F, PAT and CP4 EPSPS act; The expression of Cry1Ab, Cry1F, PAT and CP4 EPSPS proteins in TC1507 x MON810 x NK603 maize is not significantly different from the expression observed in the parental events separately; There is no evidence that the expressed proteins can cause allergy or intoxication in humans and animals; Grain and forage composition data did not show significant differences between the genetically modified variety TC1507 x MON810 x NK603 and the control conventional, suggesting nutritional equivalence between them; Regarding insect control, the combined event TC1507 x MON810 x NK603 did not differ from the isolated events TC1507 and MON810, but was different from the conventional control; The TC1507 x MON810 x NK603 combination showed similar behavior to the
individual events TC1507 and NK603 in the treatments with the recommended herbicides for each one of them and, in addition, in the exposure to the mixture of active ingredients, the combination TC1507 x MON810 x NK603 showed significantly greater tolerance when compared to the conventional control; Unexpected effects from unforeseen interactions were not identified when combining, by conventional crossing, the three events TC1507, MON810 and NK603.
individual events TC1507 and NK603 in the treatments with the recommended herbicides for each one of them and, in addition, in the exposure to the mixture of active ingredients, the combination TC1507 x MON810 x NK603 showed significantly greater tolerance when compared to the conventional control; Unexpected effects from unforeseen interactions were not identified when combining, by conventional crossing, the three events TC1507, MON810 and NK603.
Field and laboratory tests show that there is no interaction between the proteins Cry1F (inherited from the parental TC1507) and Cry1Ab (inherited from the parental MON810) expressed in pyramided corn TC1507 x MON810 x NK603, and its effect is considered additive in pest control, that is , there is independence between events in their contribution to insect control. Also, no changes were detected in the composition or expression of these proteins when compared with the events individual. The same is observed in relation to PAT and CP4-EPSPS proteins.
CTNBio concluded that TC1507 x MON810 x NK603 corn is not potentially causing significant degradation of the environment, keeping with the biota a relationship identical to conventional corn.
CTNBio considered that the request complies with the norms and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that the TC1507 x MON810 x NK603 corn is substantially equivalent to conventional corn, and its consumption is safe for human and animal health.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
