Du Pont do Brasil S. A - Pioneer Seeds Division, requested CTNBio's opinion on the biosafety of hybrid corn selected by conventional crossing resulting from the combination of TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 events, for the purpose of their release into the environment, Marketing, consumption and any other activities related to that GMO and its progenies. Event TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 and its subcombinations are produced by conventional crosses between individual genetically modified events that have already been evaluated for risk by CTNBio. TC1507 maize contains the cry1F gene and the pat gene. The insecticidal protein present in TC1507 maize is a truncated Cry1F protein derived from strain PS81I from Bacillus thuringiensis var. Aizawai. The pat gene, from Streptomice viridrochromogenes, confers tolerance to the herbicide glufosinate ammonium. The MON810 maize line contains the B. thuringiensis cry1Ab gene. The MIR162 event, which contains the Vip3Aa protein is a Bacillus thurigiensis protein, but unlike the crystal proteins (Cry) of Bacillus thuringiensis, Vip proteins (Vegetative Insecticidal Proteins) are produced during bacterial growth. The NK603 event contains the cp4 epsps gene encoding a glyphosate-tolerant form of the enzyme 5-enolpyruvlyshikimate-3-phosphate synthase (EPSPS) was isolated from the bacterium Agrobacterium tumefaciens CP4 strain. The applicant also requested authorization for the subcombinations: DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162) x MON-ØØ603-6 (NK603); DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162); SYN-IR162-4 (MIR162) x MON-ØØ603-6 (NK603) and MON-Ø810-6 (MON810) x SYN-IR162-4 (MIR162). The analysis of the risk assessment of the combined event TC1507 x MON810 x MIR162 x NK603 occurred on a case-by-case basis and considered, according to Art. 3 of RN 5/2008, the information previously presented for the individual events that contain the same genetic construct and The information of the present commercial release proposal, aiming to verify if the data presented by the applicant corroborate the hypothesis that there is no interaction between the inserts present in the combined event. In the proposed commercial release of the event TC1507 x MON810 x MIR162 x NK603 the information presented included the molecular characterization of the event; Evaluation of protein expression; The composition analysis of different plant tissues, insect studies and the results of experiments for agronomic and phenotypic evaluations of the combined event. CTNBio evaluated combined event data for molecular characterization (PCR and Southern Blot), grain and forage composition, expression of heterologous proteins, control of target insects and herbicide tolerance, and no evidence of interactions was found between the four events that indicated The need for additional risk analyzes to those already carried out for individualized events, both in human and animal health as well as in the environment. According to article 2 of RN no. 15/2015, which amends Art. 22 of RN no. 5/2008, the company submitted a request for commercial release of the subcombinations of this event: DAS-Ø15Ø7-1 (TC1507) x SYN-IR162 -4 (MIR162) x MON-Ø603-6 (NK603); DAS-Ø15Ø7-1 (TC1507) x SYN-IR162-4 (MIR162); SYN-IR162-4 (MIR162) x MON-Ø603-6 (NK603); MON-Ø810-6 (MON810) x SYN-IR162-4 (MIR162) and were also deferred by CTNBio. CTNBio reviewed the reports submitted by the applicant as well as independent scientific literature. Scientific studies carried out to evaluate biosafety, agronomic and phenotypic characteristics, as part of the risk assessment of this GMO, included representative regions for corn cultivation in Brazilian territory. CTNBio concluded that the event TC15Ø7 x MON81Ø x MIR162 x MON6Ø3 and said subcombinations keep with the biota the same ratio as conventional maize. The restrictions on the use of the GMO under analysis and its derivatives are conditioned to the provisions of Law 11,460 of March 21, 2007.

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