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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-BR-299509-1   |   PDF   |   Print   |  
last updated: 16 Jun 2026
General Information
Risk assessment of corn event MON810 - Technical opinion No. 1100/2007.
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16 Aug 2007
Risk assessment details
The maize that contains the MON 89034 event was obtained by Agrobacterium-mediated genetic transformation with the insertion of a restriction fragment of the PV-ZMIR245 vector plasmid, which has a gene construct that contains the cry2Ab2 gene, from Bacillus thuringiensis, and the cry1A105 gene. what if originated from the microorganism Streptomyces viridochromogenes. The genes cry2Ab2 and cry1A.105 encode the proteins CRY2Ab2 and CRY1A.105, which protect corn plants against the attack of certain insects of the order Lepidoptera, considered important pests of corn. Among these insects pests are the fall armyworm (Spodoptera frugiperda), the stem borer (Diatraea saccharalis) and the earworm (Helicoverpa zea).
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Methodology and points to consider
The applicant responded to all the questions postulated in Normative Instruction nº 20 of the CTNBio and that none of the questions indicate that this corn may have adverse effects in human or animal nutrition.
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Guardian corn, derived from the MON810 strain, is as safe as its conventional counterpart.
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In Brazil, analyzes of the centesimal composition of two hybrids derived from the MON810 lineage, C806-Guardian and C901-Guardian, cultivated in the municipalities of Campo Novo dos Parecis (MT), Uberaba (MG) and Pirassununga (SP) in the 1998-1999 harvest. Similar to what was observed for samples of MON810 corn grown abroad, there was no significant difference in relation to the conventional variety or the differences were within the variability normally observed in maize. The data suggest that, also in plants cultivated in Brazil, the introduction of the cry1Ab gene did not result in an apparent nutritional change. Thus, the results on chemical and proximate composition of MON810 corn are in accordance with the Principle of Substantial Equivalence, which states that, if a food is modified by any technique and has the same chemical and physical composition, texture, nutritional value and does not present different from the original food, these foods are substantially equivalent and therefore should not be differentiated or segregated. According to the Codex Alimentarius, the Principle of Substantial Equivalence is a key element in the safety assessment process. of a new food compared to its conventional counterpart.
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Studies were conducted to evaluate the toxicity of MON810 maize and Cry1Ab protein. Quails were fed with corn grains of the MON810 lineage with up to 10% of the weight of whole grain corn bran in the diet, and no adverse or toxic effects were observed. Sanden et al. (37) concluded that MON810 corn, added to 12% in fish feed, was as safe as non-transgenic varieties, evaluating parameters of the intestinal tract of Atlantic salmon. Food safety studies for mammals were carried out with the protein expressed in E. coli, which proved to be chemically and functionally equivalent to that expressed in the MON810 strain, as well as in a microbial pesticide formulation (DIPEL) containing B. thuringiensis. Acute oral toxicity studies for mice showed that the level reached, with no observed effects, was 4000 mg/kg of body weight and an LD50 higher than this value was proposed. A recently published study that evaluated the sub-chronic (90 days) toxicity of Guardian corn in rats showed that the addition of MON810 corn at levels of 11% and 33% in balanced diets did not cause any change in animals fed the genetically modified variety. when compared with the unmodified strain(24). Shimada et al.(39) demonstrated the absence of toxicity of the Cry1Ab protein on isolated bovine hepatocytes, suggesting that the protein has low acute toxicity for mammalian cells.
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Guardian corn, derived from the MON810 strain, is as safe as its conventional counterpart.
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There is no evidence of adverse reactions to the use of Guardian corn. For this reason, there are no restrictions on the use of this corn or of its derivatives, whether for human or animal consumption.
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Molecular traddicional methods. 
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Information sharing with other databases
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Additional information
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