Loading...
Cet enregistrement a été supprimé. Comme ce document est lié à un enregistrement publié, il est disponible ici à titre de référence uniquement.
Cliquez ici pour consulter l'enregistrement suppriméCe document a été mis à jour. Il ne s’agit pas de la dernière version publiée. Cliquez ici pour voir la dernière version du fichier.
Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 28 avr. 2026
Risk assessment of soybean event BPS-CV-127-9 - Technical Opinion No. 2236/2009
EN
10 déc. 2009
-
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,Téléphone : (5561) 3411-5516,Télécopieur : (5561) 3317-7475,E-mail : ctnbio@mct.gov.br,Site Web : http://www.ctnbio.gov.br,
-
São Paulo, SPOrganisation :BASF S.A. ()
,Téléphone : +55(11) 4343-3009 ; +55(11) 4343-2233,Télécopieur : +55(11)4343-3006,E-mail : luiz.louzano@basf.com,Site Web : -
Londrina, ParanáOrganisation :Embrapa Soja ()
,Téléphone : +55 (43) 3371-6271; +55 (43) 3371-6005,Télécopieur : +55 (43) 3371-6100,E-mail : arias@cnpso.embrapa.br,Site Web :
-
BPS-CV127-9 - Herbicide-tolerant soybean| BASF S.A. | Résistance aux herbicides (Imidazolinone, Sulfonyluréa)
- Commercial release 2236-2009.pdf [ Portugais ]
The applicants have developed a herbicide-tolerant soybean variety from the chemical group of imidazolinones, whose event was named BPS-CV127-9, hereinafter called Soy CV127. This soybean is derived from a single transformation event obtained by introduction by bioballistics of csr1-2 genes from Arabidopsis thaliana with its native promoter and its native 3' untranslated region (UTR). The csr1-2 gene encodes the larger subunit of the acetohydroxyacid synthase enzyme that confers tolerance to chemical herbicides of the imidazolinone class. A DNA fragment from the pAC321 plasmid, containing the expression cassette, was used to modify the origin tissue of the embryonic axis of the apical meristem of a soybean seed of the Brazilian variety Conquista, widely used by soybean farmers and with wide adaptability to Brazilian regions. The resulting phenotype is a soybean that allows producers to use herbicide from the imidazolinone chemical group without harming the plant.
The cultivation and consumption of CV127 soy are not potentially causing significant environmental degradation or risks to human and animal health.
No significant difference was observed between Soy CV127 and the isoline for any disease, demonstrating that the insertion of the csr1-2 gene did not affect the susceptibility to diseases.
Studies were also carried out at seven sites in the 2006/2007 harvest and six in the 2007 off-season to assess the impact of Soybean CV127 on the nematode population, with various treatments, in the presence and absence of some herbicides. The data allowed us to conclude that regardless of the herbicide used, the soybean in question does not cause an impact on free-living nematode populations, nor does it contribute to an increase in parasitic nematodes in soybean.
Studies were also carried out at seven sites in the 2006/2007 harvest and six in the 2007 off-season to assess the impact of Soybean CV127 on the nematode population, with various treatments, in the presence and absence of some herbicides. The data allowed us to conclude that regardless of the herbicide used, the soybean in question does not cause an impact on free-living nematode populations, nor does it contribute to an increase in parasitic nematodes in soybean.
There is no experimental evidence that CV127 soybean presents any toxicological or nutritional risk to humans or animals, compared to conventional varieties.
The results of the agronomic behavior of Soybean CV127, both in terms of quantitative and qualitative traits, were equivalent to conventional soybean plants in the absence or presence of herbicides derived from imidazolinones, during two harvest periods and in several locations in the country. Among the evaluated characters were included: size and germination of seeds, plant vigor, initial and final stand, green stem, height of plants, dehiscence, lodging, days to flowering and maturation, grain yield and seed quality. It was concluded that the CV127 Soybean plants and their derivatives showed agronomic characteristics compatible with those of conventional soybean plants grown commercially in Brazil.
AHAS protein is expressed in soy in small amounts. This evaluation was carried out with Brazilian samples, from seven field trials in the 2006 and 2007 harvests and six trials in the 2007 off-season. The ELISA tests revealed amounts lower than 1 part per million (in dry tissue). Values range from approximately 500 ng per gram (leaves) to approximately 15 ng per gram (grains) on a dry weight basis. In the processed fractions of the grain (oil, flour and isolated protein) it was not possible to detect the protein. The companies sent additional information regarding the materials and methods for determining the concentration of AHAS and SEC61gamma proteins in CV127 soybean tissues, in response to a request for clarification made by CTNBio. The document details the procedures employed, using 2 biological replicates per experiment, each generating 3 technical replicates for the ELISA tests. A total of 13 tables present the quantitative data of the analyzes carried out with the different samples collected. The AHAS protein was analyzed in the company's laboratory in Brazil and the tests to quantify the SEC61gamma protein were performed in Germany.
Risk analysis of genetically modified raw materials it is possible to conclude that SojaCV127 is as safe as its conventional equivalents.
CTNBio considered that the request complies with the norms and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that Soy CV127 is substantially equivalent to conventional soy, being its consumption safe for human and animal health.
Molecular traddicional methods.
Oui
Oui
Oui
Oui
Oui
FR
| Type de fichier | Champs | Fichier(s) : | |
|---|---|---|---|
| Décision de pays ou tout autre communication | Évaluation des risques | 1 | |
