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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of corn event NK603 & MON810, Technical Opinion 2041/2009
EN
17 Sep 2009
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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:Monsanto do Brasil Ltda ()Private sector (business and industry)Geraldo Ubirajara Berger Avenida das Nações Unidas, 12901 - Torre Norte - 7º andarSao Paulo, SP
04578-000, BrazilPhone: +55(11) 3383-8356,Fax: +55(11) 3383-8102 ; +55 (61) 3245-2523,Email: geraldo.u.berger@monsanto.com,Website:
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MON-ØØ6Ø3-6 × MON-ØØ81Ø-6 - Roundup Ready™ YieldGard™ maize| Monsanto | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glyphosate)
- Commercial release 2041-2009.pdf [ Portuguese ]
MON 810 corn is the result of the genetic modification of the "Hi-ll" corn hybrid, which had the Cry1Ab gene that determines the expression of the resistance trait to some insect pest species of the Lepidoptera Order. The expression product of the Cry1Ab gene is the Cry1Ab protein, which exerts insecticidal activity on target pests, protecting plants from damage caused by them. The cry1Ab gene was isolated from the bacterium B. thuringiensis subspecies kurstaki strain HD-1 (8, 9). NK603 corn contains the cp4 epsps gene, which comes from the bacterium Agrobacterium sp. strain CP4 and is responsible for the expression of the protein CP4-EPSPS (CP4-5-enolpyruvylshikimate-3-phosphate synthase) which determines the expression of the herbicide tolerance trait glyphosate. The CP4-EPSPS protein expressed in glyphosate-tolerant genetically modified plants is functionally identical to the endogenous plant EPSPS protein. In conventional plants, glyphosate binds to the EPSPS enzyme and blocks the biosynthesis of 5-hydroxylshikimate-3-phosphate, preventing the formation of aromatic amino acids and secondary metabolites. In glyphosate-tolerant genetically modified plants such as NK603 corn, aromatic amino acids and other metabolites necessary for plant development continue to be produced by the activity of the CP4-EPSPS protein.
The CP4-EPSPS and Cry1Ab proteins and their modes of action do not have known mechanisms of interaction that could cause adverse effects on human and animal health, nor on the environment.
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health. Restrictions on the use of the GMO under analysis and its derivatives are subject to the provisions of Law 11,460, of March 21, 2007, in Normative Resolution No. 03
The MON 810 x NK603 corn contains the combination of two genetically modified events whose biosafety was analyzed in different processes and approved by CTNBio, and these events were extensively tested in the field in various environments of the national territory.
The impacts that Cry proteins, in general, could cause on insects and non-target soil organisms have been extensively studied as part of the environmental safety assessment of crops with the isolated event MON810 that expresses the Cry1Ab protein. Studies have shown that the non-target terrestrial and soil organisms tested were not affected by the Cry1Ab protein, even though the protein level was above the maximum levels that could be verified in case of natural exposure. Additionally, a comparison between the Cry proteins produced by B. thuringiensis and the Cry1Ab protein produced by MON810 corn showed that they can persist in tropical soils for longer due to their binding to clay particles, however, the effects on the soil microbiota are not They have been observed.
After analyzing the data provided by the applicant, as well as the analysis of independent scientific literature, that the selective biological activities of the CP4-EPSPS and Cry1Ab proteins were not affected, having the same function and metabolic efficiency individually in NK603 corn and MON 810 corn, as well as corn MON 810 x NK603. Thus, it is concluded that corn containing the combined events (MON 810 x NK603) is as safe as its conventional isoline.
Concluded CTNBio that the cultivation of MON 810 x NK603 corn is not potentially causing significant degradation of the environment, keeping with the biota a relationship identical to that of conventional cotton.
The mode of action and biological activities of CP4 EPSPS and Cry1Ab proteins expressed in MON 810 x NK603 maize are distinct and do not have known mechanisms of interaction that could cause adverse effects to human and animal health, nor to the environment.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
