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Risk Assessment generated by a regulatory process
(RA)
last updated: 28 Apr 2026
Risk assessment of corn event MZIR098 - Technical Opinion 6115/2018.
EN
04 Oct 2018
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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:Syngenta Seeds Ltda. ()Lilian Aguiar Saldanha Rodovia BR-452, Km 142 + 543m.Uberlândia, MG
38405-232, BrazilPhone: +55(11) 5643-6747,Fax: +55(11) 5643-6750 ; 5643-6750,Email: lilian.saldanha@syngenta.com,Website:
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SYN-ØØØ98-3 - Insect resistant herbicide tolerant maize| Syngenta (Novartis (Ciba-Geigy)) | Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi)), Resistance to herbicides (Glufosinate)
- Commercial release 6115 - 2018.pdf [ Portuguese ]
Maize MZIR098 was developed using the following genes: ecry3.1Ab gene, which consists of a fusion between the 5' end of a modified Cry3A gene and the 3' end of a synthetic Cry1Ab gene; mcry3A gene, a synthetic sequence based on the natural Cry3A protein from B. thuringiensis sub. tenebrionis (SEKAR et al., 1987), which, once optimized for maize, was altered to incorporate a consensual recognition site of the protease G cathepsin within the expressed protein. The encoded mCry3A amino acid sequence corresponds to that of natural Cry3A. O pat-08 gene is expressed in event MZIR098 using the cauliflower mosaic virus 35S-04 promoter, which confers constitutive expression of the PAT protein, which confers tolerance to the herbicide glufosinate ammonium (phosphinothricin). This gene was used as a selection marker in the development of MZIR098 maize.
Risk analysis of genetically modified raw materials, it is It can be concluded that MZIR098 corn is as safe as its conventional counterparts.
The MZIR098 maize proteins are identical to those produced by other Syngenta maize events approved by CTNBio, such as Cry3.1Ab produced by event 5307 maize, mCry3A by event MIR604 maize, and PAT by event Bt11 maize. The insecticidal proteins produced in MZIR098 corn are commercially available in combination products offered to producers in the United States and Canada, with approvals for
use in human and animal food.
use in human and animal food.
The MZIR098 corn is not potentially a cause of significant degradation of the environment, keeping with the biota the same relationship as that of conventional corn.
Substantial equivalence between MZIR098 maize and conventional maize was demonstrated through quantitative analyzes of 73 nutritional components in the grain and nine components in the forage, including key nutrients from human and animal feed, secondary plant metabolites and anti-nutrients. The results are presented in tables comparing the values obtained from MZIR098 corn plants and the conventional reference variety with means, standard deviation of means and ANOVA, in addition to values from composition tables of the ILSI – International Life Sciences Institute. The results demonstrate the substantial equivalence of MZIR098 corn with its conventional reference hybrid, however significantly higher in β-carotene content. Composition analyzes were also conducted on forage samples in field trials with replicates planted at eight sites across the United States in 2013. Six commercial non-GMO corn varieties were included in the study design as reference inputs to establish a natural range of variation. of germplasm with a history of production in cultivation area.
Animal performance tests were performed when fed with MZIR098 corn. A 42-day study was conducted to compare the growth response and health of broilers (Gallus gallus domesticus) fed diets prepared with MZIR098 corn, with non-GMO corn as a "control", and diets prepared with three varieties of reference non-GMO corn. General health parameters, mortality, weight gain, efficiency in feed conversions and weight of market-ready carcasses, muscles (breast, drumstick, thigh and wing) and layers of abdominal fat. In summary, there were no statistical differences between MZIR098 maize and the non-GM control group, in terms of mortality, total feed intake, feed conversion ratio, mean final body weight, absolute tissue weights and relative tissue weights. Such results are very consistent to guarantee the safety and innocuousness of the present MZIR098 maize transformation event.
MZIR098 corn is substantially equivalent to conventional corn, and its consumption is safe for human and animal health.
CTNBio considered that the request complies with the rules and legislation that aims to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that MZIR098 corn is substantially equivalent to conventional corn, and its consumption is safe for human and animal health. Regarding the environment, CTNBio concluded that the MZIR098 corn is not a potential cause of significant environmental degradation, keeping with the biota a relationship identical to that of 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 | |
