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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 28 avr. 2026
Risk assessment of soybean event DP-305423-1 x MON 04032-6 - Technical Opinion No. 5821/2018
EN
08 mars 2018
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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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Organisation :Du Pont do Brasil S.A. (Du Pont - Divisão Pioneer Sementes)Secteur privé (affaires et industrie)Du Pont do Brasil S.A. - Divisão Pioneer Sementes Endereço: SGAS 902 Lt 74 Cj B Sala 221 a 224 Bloco A - Ed. Athenas - Asa SulBrasília, Distrito Federal
70390-020,Téléphone : 55 - 61 - 21039111,Télécopieur : 55 - 61 -21039111,E-mail : goran.kuhar@pioneer.com,Site Web : http://www.pioneersementes.com.br/,
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DP-3Ø5423-1 × MON-Ø4Ø32-6 - Modified fatty acid, herbicide-tolerant soybean| Pioneer Hi-Bred | Résistance aux herbicides (Glyphosate, Sulfonyluréa)
- commercial release 5821-2018.pdf [ Portugais ]
Soybean DP-305423-1 was obtained by introducing a fragment of the gm-fad2-1a gene and the gm-hraa gene into the soybean genome. The inserted gm-fad2-1 gene fragment is part of the coding region of the soybean omega-6 desaturase gene 1 (FAD2-1) is under the control of the promoter (KTi3) of the Kunitz trypsin inhibitor gene 3 preferred by the seed of the Soy. This fragment does not encode a functional protein. The transcription of the gm-fad2-1 gene fragment (obtained from soy) acts by suppressing the transcription of the endogenous omega-6 desaturase, resulting in a high oleic acid phenotype. Soybean DP-305423-1 has an increased amount of oleic acid and decreased linoleic and linolenic acids. When processed, it produces a highly stable and healthier oil compared to conventional soybean oil. The gm-hra gene (obtained from soybean) is under the control of the S-adenosyl-L-methionine synthase (SAMS) promoter which is constitutive in soybean. This gene encodes the GM-HRA protein, an optimized version of soybean acetolactate synthase (ALS), which is used as a selection marker during the transformation process, as it can confer tolerance to ALS-inhibiting herbicides (sulfonylureas, imidazolinones, etc.)
Compositional analyzes clearly demonstrate that 305423 soybean seeds are comparable to non-GM control soybean seeds with comparable genetic background and to commercial soybean, except for the fatty acid composition of soybean seeds 305423, intentionally intended for genetic modification. And, food products from soybeans 305423x40-3-2 and 305423 are nutritionally equivalent and safe as food products derived from commercial soybeans. Furthermore, the GM-HRA and CP4 EPSPS proteins expressed in soybeans 305423x40-3-2 and 305423 do not constitute no significant allergenic risk to human and animal health.
To assess the possible adverse effects of GMO ingestion, a single dose of the test substance GMHRA diluted in water was administered via oral gavage to groups of 5 fasting male and 5 female Crl:CD(ICR) mice at a dose of 2,000 mg. /kg. This corresponds to an exposure per animal of at least 436, but less than 582, mg/kg of recombinant GM HRA protein. Bovine serum albumin was administered as a single dose of 2000 mg/kg, in water or vehicle (water), via oral gavage to two control groups, each consisting of 5 fasting male and 5 female mice. Mice were observed for mortality, body weight effects, and clinical signs of systemic toxicity for 14 days after dosing. The mice were euthanized, and then thorough pathological examinations were performed to detect observable macroscopic evidence of organ or tissue damage or dysfunction. All mice survived until the scheduled sacrifice date on the 14th day. No clinical signs of systemic toxicity or test substance related body weight loss were observed in any mice. The mice showed no macroscopic lesions at necropsy.
The GM-HRA and CP4 EPSPS proteins expressed in soybeans 305423x40-3-2 and 305423 do not pose any significant allergenic risk to human and animal health.
Studies were also carried out to evaluate the expression levels of GM-HRA and CP4 EPSPS proteins in soybeans 305423x40-3-2, 305423 and 40-3-2. A field study was carried out during the 2005 crop year at six field sites in North America to determine the expression level of GM‑HRA and CP4 EPSPS proteins in the seeds of soybeans 305423x40-3-2, 305423 and 40-3- 2 (Appendices 5 and 6). Each site where the field study was conducted contained soybeans 305423x40-3-2, as well as soybeans 305423 and 40-3-2. Expression levels of GM-HRA and CP4 EPSPS proteins were determined using a specific Enzyme-Linked Immunosorbent Assay (ELISA) designed for each protein. A detailed report was presented with the results of these studies. The expression level of the GM-HRA protein in the soybean seed 305423x40-3-2 is similar to the expression level of the GM-HRA protein in the soybean seed 305423. Likewise, the expression of the CP4 EPSPS protein in the soybean seed 305423x40 -3-2 is similar to the expression level of the CP4 EPSPS protein in soybean 40-3-2.
Nutritional equivalence between soybean 305423x40-3-2 and commercial soybean and between soybean 305423 and commercial soybean was demonstrated in a 42-day poultry feeding study. Broilers were fed diets containing soybean 305423x40-3-2, soybean 305423 or non-GM control soybean of comparable genetic background or one of three commercial non-GM soybeans. Mortality, body weight gain, feed efficiency, organ yields, carcass, breast, drumstick, wing and thigh, and abdominal fat of broilers fed with soybean 305423x40-3-2 or 305423 were compared to broilers fed with non-controlling soybean diets. GM. The results summarized and presented in the commercial release application confirmed the safety of soybeans 305423x40-3-2 and 305423, as well as demonstrating that these soybeans are nutritionally equivalent to non-GM control soybeans of comparable genetic background, and to commercial soybeans.
The events DP-305423-1 or in the combined form DP-305413-1 X MON-04032-6 were not analyzed for the risk to the environment, as provided in Normative Resolution No. 05, of March 12, 2008 and consequently the aforementioned events cannot be cultivated in any environment of the Brazilian territory. Therefore, biosecurity measures must be adopted in the transport, processing, storage, handling and processing of this GMO, to avoid its dispersion in the environment.
CTNBio is in favor of approving genetically modified soybeans that contain the events DP-305423-1 and the combination of events DP-305413-1 X MON-04032-6, which present tolerance to sulfonyurea herbicides, glyphosate and quality of fatty acids (high concentration of oleic acid) exclusively for import and use to obtain by-products to be used in human food and use in animal feed.
Molecular traddicional methods.
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| Décision de pays ou tout autre communication | Évaluation des risques | 1 | |
