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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 28 avr. 2026
Risk assessment of soybean event FG72 - Technical Opinion 4750/2015.
EN
08 oct. 2015
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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,Téléphone : (5561) 3411-5516,Télécopieur : (5561) 3317-7475,E-mail : ctnbio@mct.gov.br,Site Web : http://www.ctnbio.gov.br,
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Personne :Bayer S.ARua Domingos Jorge, 1100, Prédio 9504, 3º Andar Bairro SocorroSão Paulo, SP
04779-900,Téléphone : +55 (11) 2165-7803,Télécopieur : +55 (11) 2165-7711,E-mail : bayer.comunicacao.bc@bayer.com.br,Site Web : http://www.bayerscheringpharma.com.br,Organisations reliéesBayer Schering Pharma ()Secteur privé (affaires et industrie)Rua Domingos Jorge, 1100, Prédio 9504, 3º Andar Bairro SocorroSão Paulo, SP
04779-900,Téléphone : +55 (11) 2165-7803,Télécopieur : +55 (11) 2165-7711,E-mail : bayer.comunicacao.bc@bayer.com.br,Site Web : http://www.bayerscheringpharma.com.br,
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MST-FGØ72-2 - Soy modified for tolerance to glyphosate and HPPD inhibitors| Bayer CropScience LP | HPPD Herbicides, Résistance aux herbicides (Glyphosate)
- Commercial release 4750 - 2015.pdf [ Portugais ]
Genetically modified soybean, event FG72, hereinafter called soybean FG72, GMO classified as Risk Class 1, presents tolerance to the herbicides glyphosate and isoxaflutole, which was conferred by the introduction of two genes: a modified version of the corn epsps gene ( Zea mays), which confers tolerance to the herbicide glyphosate, and an also modified version of the hppd gene from the bacterium Pseudomonas fluorescens isolated A32, which confers tolerance to the herbicide isoxaflutole (IFT).
The results obtained did not identify any changes related to the consumption of FG72 soy, that is, no adverse effects were observed. Due to the fact that animals are used a lot sensitive to environmental and dietary variations, this experiment also provides evidence that the 2mepsps and HPPD W336 genes do not produce toxins or other metabolites that may pose a risk to animal or human health.
FG72 soybean shows substantial equivalence with conventional soybean and no phenotypic or agronomic differences were found in field tests carried out in Brazil and in United States between FG72 and conventional soybeans. Each test was conducted under the same environmental conditions, including soil fertility, which indicates that Event FG72 has no differentiated ability to utilize or remove soil components.
There is also no evidence of adverse reactions to the use of FG72 soy. For this reason, there are no restrictions on the use of this soy or its derivatives, whether for human or animal consumption.
The data presented by the proposal in relation to phenotypic estimates from the trials, instructions in Brazil (INOUE2011) in the United States (KOITE, 2001) indicates that no characteristic was observed between FG72 GM soybeans and non-GM soybeans that indicate any interference of genes in the adaptability of the species. Therefore, a genetic modification does not attribute any advantage to FG72 soybeans over conventional soybeans.
These studies were carried out by the bidder with samples from three field trials that were carried out in the 2012-2013 harvest in Taquarivaí/SP, Poxoréu/MT and Água Santa/RS. The analyzes of the samples produced in Brazil were carried out by the TECAM Laboratory, São Paulo, SP (phase analysis of the study and determinations of proximate composition and fiber, minerals, vitamin A, vitamin B1, vitamin B2, folic acid, tryptophan, trypsin inhibitor, phytic acid, stachyose, raffinose and fatty acids), by the Center for Science and Food Quality from the Food Technology Institute – CCQA / ITAL (determinations of lectin, isoflavones and total tocopherols) and by the LABTEC Chemical Analysis Laboratory, Hortolândia, SP (total amino acid determinations, except tryptophan). The components selected for nutritional composition analysis represent important basic soybean nutrients, such as proximate composition (including fiber), micronutrients such as minerals and vitamins, isoflavones, antinutrients such as raffinose, stachyose, phytic acid, trypsin inhibitors, lecithins, total amino acids, and fatty acids.
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health.
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 FG72 soy is substantially equivalent to conventional soy, and its consumption is safe for human health and animal.
Molecular traddicional methods.
Oui
Oui
Oui
Oui
Oui
FR
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