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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of corn event Bt11, Technical Opinion 1255/2008.
EN
20 Sep 2007
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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,Phone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Organization:Syngenta Seeds Ltda. ()Lilian Aguiar Saldanha Rodovia BR-452, Km 142 + 543m.Uberlândia, MG
38405-232,Phone: +55(11) 5643-6747,Fax: +55(11) 5643-6750 ; 5643-6750,Email: lilian.saldanha@syngenta.com,Website:
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SYN-BTØ11-1 - Agrisure™ CB/LL| Syngenta | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate)
- Commercial release 1255-2008.pdf [ Portuguese ]
Bt11 corn was genetically modified by inserting the plasmid pZO1502 containing the fusion of the cry1A gene (Btk) with the pat gene. This corn expresses the cry1A(b) gene, derived from soil bacterium B. thuringiensis subsp. kurstaki, strain HD-1.B. thuringiensis (Bt) is a gram positive bacterium of the Bacillaceae family that produces, at the time of its sporulation, crystalline protein inclusions. These inclusions contain proteins called δ-endotoxins, which currently form a family of 300 members, classified into 49 groups. They are produced in the form of protoxins, which are transformed into toxic peptides in the insect's intestine, by the action of intestinal alkaline pH and proteases. The active toxin causes lysis of epithelial cells and the death of larvae. B. thuringiensis can be considered the biological agent with the greatest potential for controlling forest and agricultural pest insects and disease vectors, thanks to the specificity of δ-endotoxins to target insects and invertebrates, and their innocuity to vertebrates and the environment, including beneficial insects and natural enemies, making this agent a key component in integrated pest management strategies.
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The applicant responded to all the questions postulated in Normative Instruction No. 20 of the CTNBio and that none of the questions indicates that this corn may have adverse effects on human or animal nutrition.
No problems were detected for human and animal health or for the environment that could be attributed to transgenic maize. It is necessary to emphasize that the lack of negative effects resulting from the cultivation of transgenic corn plants does not mean that they cannot happen. zero risk and absolute safety do not exist in the biological world, although there is already an accumulation of reliable scientific information and a safe ten-year history of use that allows us to say that Bt11 corn is as safe as the conventional.conventional versions.
The cultivation and consumption of Bt 11 maize do not potentially cause significant environmental degradation or risks to human and animal health. For these reasons, there are no restrictions on the use of this corn or its derivatives.
Cry and PAT proteins do not volatilize or are absorbed by the epidermis and, for these reasons, it would not be justified to assess the toxicity of these proteins via inhalation or dermal route. No significant unintended biological changes occurred in the composition or nutritional value of Bt11 corn grain and forage as a consequence of the expression of the cry1A(b) and pat transgenes, thus suggesting that Bt11 corn is substantially equivalent in nutritional composition to respective non-genetically modified isogenic hybrid and commercial corn hybrids.
According to the analysis of factorial variance of the data presented by the proponent, no difference was observed between the hybrids derived from original elite lines and those derived from selected Bt11 converted lines for the aspects of productivity, moisture at harvest, root lodging, ear height. , plant height and thermal units for donning or dehiscence of pollen grains. However, significant differences were described between the original elite lines and the Bt11 conversions for the stalk lodging characteristics and integrity score.
After ten years of use in several countries, no problem has been detected for human and animal health or for the environment that can be attributed to transgenic corn. IT ISIt is necessary to emphasize that the lack of negative effects resulting from the cultivation of transgenic corn plants does not mean that they cannot happen. Zero risk and absolute safety do not exist in the biological world, although there is already an accumulation of reliable scientific information and a safe ten-year history of use that allows us to say that Bt11 corn is as safe as conventional versions.
CTNBio considered that the request complies with the relevant rules and legislation that aim to guarantee the biosafety of the environment, agriculture and 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 | |
