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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of corn event MON87427 - Technical Opinion No. 5221/2016.
EN
06 Oct 2016
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Organization:Monsanto do Brasil Ltda ()Private sector (business and industry)Geraldo Ubirajara Berger Avenida das Nações Unidas, 12901 - Torre Norte - 7º andarSao Paulo, SP
04578-000, BrazilPhone: +55(11) 3383-8356,Fax: +55(11) 3383-8102 ; +55 (61) 3245-2523,Email: geraldo.u.berger@monsanto.com,Website:
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MON-87427-7 - Maize modified for tissue selective glyphosate tolerance| Monsanto | Resistance to herbicides (Glyphosate)
- Commercial release 5221-2016.pdf [ Portuguese ]
The glyphosate-tolerant MON 87427 corn is the result of the transformation of immature corn embryos mediated by Agrobacterium and the plasmid PV-ZMAP1043 (Sidorov et al. Duncan, 2009). MON 87427 corn contains the cp4 epsps gene, derived from Agrobacterium sp. strain CP4, which encodes the CP4 EPSPS (5-enolpyruvylshikimate-3-phosphate synthase) protein, which confers tolerance to the herbicide glyphosate, the active ingredient in Roundup® herbicides. MON 87427 corn uses a specific combination of promoter and intron (e35S-hsp70) to direct the expression of the CP4 EPSPS protein in female vegetative and reproductive tissues, conferring tolerance to glyphosate in leaves, stems and roots, as well as in tissues that develop in seeds or grains and stigma-style. Use of this specific promoter and intron combination also results in limited or absent production of the CP4 EPSPS protein in two major male reproductive tissues: microspores, which develop into pollen grains, and tapetum cells, which provide nutrients for pollen ( Goldberg et al., 1993; Huang et al., 2009). Thus, male reproductive tissues critical for male gametophyte development in MON 87427 maize are not glyphosate tolerant.
Considering the information presented by the company, the data available in Scientific Literature do not point to any adverse effects in the consumption of the CP4 EPSPS protein.
The CP4 EPSPS protein shows no amino acid sequence similarities to known allergens, gliadins, glutenins, or toxic proteins that have any adverse effects on mammals. Safety studies conducted with the CP4 EPSPS protein have shown that it is rapidly degraded in simulated gastric and intestinal fluids, and that it does not cause any adverse health effects in mice when they receive high levels of the protein by gavage in an acute oral toxicity test. The safety assessment supports the conclusion that dietary exposure to maize-derived CP4 EPSPS protein MON 87427 does not confer a significant risk to human or animal health.
The safety assessment supports the conclusion that dietary exposure to maize-derived CP4 EPSPS protein MON 87427 does not confer a significant risk to human or animal health.
Considering the information presented by the company, the data available in Scientific Literature do not point to any adverse effects in the consumption of the CP4 EPSPS protein; lack of evidence on possible toxic effects of proteins expressed in maize event MON 87427; lack of similarities with known allergens deposited in databases; safe history of consumption of proteins expressed in maize event MON 87427; The consumption of MON 87427 corn does not present risks to humans or animals and the product is as safe as conventional corn.
The evaluation was based on agronomic and phenotypic characterization, on germination and vigor data, on observations of environmental interactions and voluntary plants, data collected in the Brazil in field experiments carried out in the 2014/2015 harvest in several representative regions of the country. The results of the evaluations of several parameters indicate that MON 87427 corn does not have characteristics that could confer a risk of this plant becoming a weed or cause a significant ecological impact when compared to conventional control corn. Data from environmental interactions also indicate that MON 87427 corn does not have any susceptibility or greater tolerance to diseases or insects. Taken together, these data show that MON 87427 corn does not pose a risk as a weed. or results in significant ecological impact when compared to conventional control corn and commercial references. Furthermore, the data presented show that the expression of the CP4 EPSPS protein in MON 87427 corn does not alter the phenotype, agronomic characteristics and environmental interactions of the plant beyond what was intended by the genetic modification in question. Therefore, the only difference between MON 87427 corn in relation to conventional hybrids is that intended by genetic modification, that is, tolerance to glyphosate in female vegetative and reproductive tissues.
The consumption of MON 87427 corn does not present risks to humans or animals and the product is as safe as conventional corn.
The genetically modified corn event MON 87427, complies with the relevant norms and legislation that aim to guarantee the biosecurity of the environment, agriculture, human and animal health.
Molecular traddicional methods.
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EN
| Record type | Field | Record(s) | |
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| Country's Decision or any other Communication | Risk assessment | 1 | |
