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Évaluation des risques générée par un processus de réglementation (RA)
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last updated: 28 avr. 2026
Informations générales
Brésil
Risk assessment of soybean event FG72 x A5547-127 - Technical Opinion No. 4866/2015.
EN
10 déc. 2015
Détails de l’évaluation des risques
The product resulting from the combination of Events FG72 x A5547-127 was obtained through classical genetic improvement, crosses and selection between individuals of two strains. parents: one derived from Event FG72 and the other derived from Event A5547-127. Parental events FG72 and A5547-127 were obtained by the particle acceleration method (bioballistics), using soybean apical bud tissues as target. Genetic constructs containing the nucleotide sequences of interest were inserted into pSF10 and pB2/35SAcK vectors, respectively.
EN
Méthode et points à examiner
Safety studies of PAT, 2mEPSPS and HPPDW336 proteins have already been widely presented when submitting Parental Events A5547-127 and FG72, in Processes 01200.003881/2008-92 and 01200.003609/2011-16, respectively, according to toxicity studies mentioned in table 32 on page 94 of this process. At the end of the experiments, no abnormalities were observed, or any evidence of toxicity in the treated subjects was verified during the analyzes performed, either by oral or intravenous ingestion of proteins, even in treatments containing high doses of proteins, indicating that PAT, 2mEPSPS and HPPDW336 proteins do not have any adverse or potentially adverse effect on human/animal health.
EN
Results obtained in studies carried out in Brazil and abroad, using bioinformatics tools, molecular biology tools, chemical and nutritional analyses, as well as phenotypic and agronomic evaluations, indicate that the proteins encoded by the genes in question act in different metabolic pathways, on substrates quite specific. So don't expect that the joint expression of proteins affects other attributes of the plant and does not generate adverse effects.
EN
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health.
EN
In Brazil, there were 20 representative trials under Planned Release in the Environment, (CTNBio Process. objective of undeveloped evaluation, reproduction and survival of soybean FG72 x A5547-17, compared to the conventional GM variety. The characteristics of plants of R6/ height in the models, R3-R6-were plants/heights, R3-R6-were plants of vigor (R5-R6-plants) The characteristics of seedless pods and total pods were: number of seedless pods and total pods .The characteristics of seed grains and productivity. In most of the comparisons performed, no differences were found
meaning. As significant differences between the genetically FG72 x A5547-1 variety and a conventional variety cannot be repeated as localities, demonstrating an observed effect of all environmental factors on agronomic traits all differences. For example, in Água Santa (RS), in comparison with the characteristics observed in the period after soybean, significant differences were observed only for productivity (higher average observed in GM soybeans). The same difference is not repeated in any of the other locations. Thus, the results of this study do not support the guarantee of the development of a modification that does not affect the survivability and productivity of soybean. According to those surveyed under field cultivation conditions both in Brazil and in the USA, the insertion of genes 2meps, hppdPfw336, and pat, do not interfere/alter the environmental behavior of genetically modified plants derived from Event FG72 x A5547-127. The new attributes, by allowing the selective use of herbicides, do not introduce any competitive or adaptive advantages to the individual. The differentiated phenotype of plants is only projected under the management conditions
of weeds, Gphosate, Isoxaflutole or Ammonium Glufosinate herbicides are used, where only as weeds suffered as alternative injuries by the product.
EN
The safety of Event FG72 x A5547-127 was evaluated in several studies carried out in Brazil and abroad, in order to demonstrate that the combination of Events through traditional breeding does not result in lines significantly different from those from which they originate (Parental events) nor from conventional varieties. Thus, the safety of FG72 x A5547-127 soybean is demonstrated not only by the information previously presented for the isolated Events, as well as, through analyzes that proved the absence of any interaction between the inserts present in this lineage.
EN
FG72 x A5547-127 soybeans are as safe as their conventional counterparts.
EN
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 FG72 x A5547-127 soy is substantially equivalent to conventional soy, and its consumption is safe for human and animal health.
EN
cular traddicional methods. 
EN
Partage d’informations avec d’autres bases de données
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Information supplémentaire
FR
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