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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 28 avr. 2026
Risk assessment of soybean event GMB151 - Technical Opinion 7306/2021.
EN
04 févr. 2021
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Autorité nationale compétente :National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrésilTéléphone : (5561) 3411-5516,Télécopieur : (5561) 3317-7475,E-mail : ctnbio@mct.gov.br,Site Web : http://www.ctnbio.gov.br,
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São Paulo, SPOrganisation :BASF S.A. ()
, BrésilTéléphone : +55(11) 4343-3009 ; +55(11) 4343-2233,Télécopieur : +55(11)4343-3006,E-mail : luiz.louzano@basf.com,Site Web :
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BCS-GM151-6 - Plant-Parasitic Nematode-Protected and Herbicide Tolerant Soybean| BASF Plant Science GmbH | Résistance aux maladies et aux parasites (Nématodes), Résistance aux herbicides, Tolerance to isoxaflutole, Tolerance to mesotrione
- commercial release 7306-2021.pdf [ Portugais ]
Event GMB151 soybean (OECD identifier is BCS-GM151-6), object of this request to CTNBio for commercial release, was developed through genetic transformation mediated by Agrobacterium tumefaciens, from the conventional soybean variety Thorne (it is a variety of the group of maturation III), using the pSZ8832 vector containing the cry14Ab-1.b and hppdPf-4Pa gene expression cassettes.
The evaluation of the chemical and nutritional composition of the GMB151 soybean, in relation to the conventional soybean, showed that the differences found are biologically irrelevant, and that the GMB151 soybean is substantially equivalent to the conventional unmodified soybean, being as nutritionally safe as the existing commercial varieties. on the market and therefore will not have any impact on human and/or animal nutrition.
The data presented in studies carried out in the United States and Brazil demonstrate that GMB151 soybean does not differ from conventional control soybeans and commercial reference standards in different aspects. In various parts of this document it has been shown that Event GMB151 has agronomic and phenotypic characteristics similar to conventional varieties under different environmental conditions. The same was observed for other characteristics such as: compositional and nutritional equivalence, proving that the introduction of new characteristics in Event GMB151 provided by the expression of genes cry14Ab-1.b and hppdPf-4Pa did not change the survivability of soybean GMB151, even if it is unexpectedly cultivated in environments different from what is recommended for this large crop. Thus, the results support the conclusion that there was no increase in soybean invasion potential genetically modified soybean compared to conventional control soybeans.
It is not expected that any significant change will occur in the organisms present in the agricultural ecosystems where the GMB151 soybean is intended to be cultivated, since this GMO only presents the joint expression of heterologous proteins. It was observed that Event GMB151 had no pleiotropic or epistatic effect. In addition, it proved to be compositionally and nutritionally similar to the varieties commercially available on the market, demonstrating the same biosafety characteristics as other soybeans and other products already evaluated and approved by CTNBio.
The proteins present in GM151 soy have no homology to any allergenic protein, toxin or antinutrients; the proteins present in GM151 soybeans do not present any glycosylation site (present in several allergenic components); the proteins present in GM151 soy are structurally unstable in acidic environments; the proteins present in GM151 soybeans degrade and denature rapidly in the gastric and intestinal fluid of mammals; the proteins present in GM151 soy have specific activity; the proteins present in GM151 soybeans did not show any adverse effects in mammals even when the pure protein was administered in high doses intravenously; the potential for soybean GMB151 to be invasive of natural habitats or persist in the environment without human intervention is significantly negligible and that genes cry14Ab-1.b and hppdPf-4Pa are specific in attributing resistance mainly to the cyst nematode Heterodera glycines and tolerance to HPPD-inhibiting herbicides such as Isoxaflutole and bear no relation to the formation of reproductive structures; post-harvest monitoring assessments carried out in field trials in Brazil showed that GMB151 soybean does not persist in the environment and has not become a more aggressive or invasive species. So much so that it was eliminated by applying the same eradication methodology used for the conventional varieties and control of the experiment; cultivated soybeans do not present characteristics with weed aspects, such as dormancy (which results in the gradual loss of their reproductive capacity), which would allow spontaneous soybean plants to be maintained in the environment for consecutive years of cultivation. Even in the event of the emergence of voluntary plants, these plants would not compete with the successor culture, or even with the local colonizing plants.
The biosafety assessment of genetically modified soybeans for nematode resistance and selectivity to HPPD-inhibiting herbicides, Event GMB151, complied with the precepts of CTNBio's Normative Resolution N24, which deals with the Commercial Liberation of Genetically Modified Organisms and their derivatives. The results of studies carried out in Brazil and in other countries and information referenced by the scientific literature covering: the characterization of the insert; agronomic evaluation, expression of exogenous proteins, chemical and nutritional composition; of ecological and symbiotic interactions; of vigor and seed germination; of effectiveness in controlling insects; of protein degradation in Brazilian soils showed that soybean - Event GMB151, does not have greater potential to cause significant degradation of the environment, or to have adverse effects on human and animal health when compared to conventional soybeans.
Event GMB151 does not potentially cause significant degradation of the environment or harm to human and animal health, keeping a similar relationship with the biota to conventional soy.
Event GMB151 concludes on its similarity to conventional soybeans in terms of biosafety to the environment and human and animal health, CTNBio decided by GRANTING the request for commercial release, as provided for in Normative Resolution 24.
Molecular traddicional methods.
Oui
Oui
Oui
Oui
Oui
FR
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