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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of corn event TC15Ø7 x MON81Ø x MIR162 x NK6Ø3 - Technical Opinion No. 4409/2015.
EN
09 Apr 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:Du Pont do Brasil S.A. (Du Pont - Divisão Pioneer Sementes)Private sector (business and industry)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 × SYN-IR162-4 × MON-ØØ6Ø3-6 - Herbicide tolerant, insect resistant corn| Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
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DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ6Ø3-6 - Herbicide tolerant, insect resistant corn| Dupont Poineer | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate), Selectable marker genes and reporter genes
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SYN-IR162-4 × MON-ØØ6Ø3-6 - Insect resistant, herbicide tolerant maize| Dupont Poineer | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate), Selectable marker genes and reporter genes
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MON-ØØ81Ø-6 × SYN-IR162-4 - Herbicide tolerant, insect resistant corn| Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Selectable marker genes and reporter genes
- Commercial release 4409 - 2015 (1).pdf [ Portuguese ]
The combined event maize TC1507 x MON810 x MIR162 x NK603 was obtained by the applicant through classical genetic improvement, by sexual crossing of lines containing the individual events. Event TC1507 expresses Cry1F and PAT proteins that confer resistance to certain lepidopteran corn pests and tolerance to glufosinate-ammonium-based herbicides; the MON810 event confers resistance to lepidopteran insect pests via the action of the Cry1Ab protein; the event MIR162 expresses the protein Vip3Aa that confers resistance to lepidopteran pests of corn and the event NK603 expresses the protein CP4-EPSPS that confers resistance to herbicides formulated with glyphosate.
Safety for human and animal consumption can be demonstrated by the results obtained with the proteins Cry1F, Cry1Ab, Vip3Aa, PAT, CP4 EPSPS and PMI which include studies with animal feed, protein digestibility in simulated gastric and intestinal systems, acute toxicity studies by oral and intravenous application and verification of protein homology with toxic/allergenic compounds. These studies indicate that the related proteins do not pose any risk to human/animal health, compared to the use of conventional corn and its by-products in food (protein cry1F and PAT - process no. -54, Vip3Aa protein - process 01200.007493/2007-08 and CP4 EPSPS protein - process no
01200.002293/2004-16).
01200.002293/2004-16).
The individual events have already been extensively analyzed, having been approved for commercial release by CTNBio; the information provided in this process regarding maize 1507 x MON810 x MIR162 x NK603, from molecular characterization analyses, grain and forage composition, ̃ expression of heterologous ́ proteins, control of target insects and herbicide tolerance, do not evidence the existence of interactions between the four events that make additional risk analyzes necessary to those already carried out for the individualized events, in the aspects of human and animal health.
The evidence obtained from experimental and observational studies indicates similarity between genetically modified corn and its conventional counterpart, in toxicological, allergenic and nutritional aspects. There is no evidence of any toxicological risk, indicating that the only consequence of the modification introduced by genetic manipulation was herbicide tolerance and insect resistance.
Field and laboratory tests demonstrate no interaction between proteins Cry1F, Cry1Ab, Vip3Aa, PAT, CP4-EPSPS and PMI in the combination of events TC1507 x MON810 x MIR162 x NK603. O
The study presented confirms that there is independence in the specific mode of action of heterologous proteins in the combined tetra regarding the acquired characteristics of pest control or
herbicide tolerance. Biosafety studies show equivalence in the presence and expression of heterologous proteins when compared to the four single events. The results of the comparison of the nutritional composition reveal equivalence between the event and the commercial isoline, in six trials evaluated.
The study presented confirms that there is independence in the specific mode of action of heterologous proteins in the combined tetra regarding the acquired characteristics of pest control or
herbicide tolerance. Biosafety studies show equivalence in the presence and expression of heterologous proteins when compared to the four single events. The results of the comparison of the nutritional composition reveal equivalence between the event and the commercial isoline, in six trials evaluated.
Data from efficacy studies related to two major corn pests in Brazil, the fall armyworm (Spodoptera frugiperda) and the earworm (Helicoverpa zea) were presented. The experiments were carried out in three locations in the 2011 harvest, with natural and manual infestation with the pests studied. The results were obtained in damage notes, using the scale published by Davis et. al (1992) with the numbering in reverse order. The results demonstrate the effectiveness of event TC1507 x MON810 x MIR162 x NK603 in the control of S. frugiperda and H. zea, however, as presented by the applicant, given that the effectiveness of controlling event MIR162 is high against H. zea and S frugiperda, it is difficult to observe significant differences in control efficiency between MIR162 and the combination of the MIR162 event with the TC1507 and MON810 insect resistance events. The advantage of the combination of events TC1507 x MON810 x MIR162 x NK603 would therefore be a greater durability of the resistance conferred, considering that the proteins Cry1F, Cry1Ab, and Vip3A offer independent modes of action against H. zea and MIR162 offers a mode of additional action against S. frugiperda. increase resistance durability against H. zea and S. frugiperda.
The combined event TC1507 x MON810 x MIR162 x NK603 complies with the relevant regulations and legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health.
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 corn is substantially equivalent to conventional corn. Regarding the environment, CTNBio concluded that corn is not a potential cause of significant degradation of the environment, keeping with the biota an identical relationship to conventional corn.
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 | |
