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Risk Assessment generated by a regulatory process
(RA)
last updated: 16 Jun 2026
Risk assessment of cotton event MON531&MON1445 - Technical Opinion 2051-2009.
EN
15 Oct 2009
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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-ØØ531-6 × MON-Ø1445-2 - Roundup Ready™ Bollgard™ Cotton| Monsanto | Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
- Commercial release 2051-2009.pdf [ Portuguese ]
MON 531 x MON 1445 cotton was obtained from the crossing of genetically modified cotton containing the isolated event MON 531 with MON 1445 cotton through classical genetic improvement and expresses the CrylAc proteins (MON 531) and CP4 EPSPS (MON 1445 cotton).
The modes of action and biological activities of CP4 EPSPS and CrylAc proteins expressed in MON 531 x MON 1445 cotton are significantly different. And both proteins, as well as the mode of action, do not have known mechanisms of interaction that could cause adverse effects to human and animal health or the environment. These proteins accumulate in different cellular compartments of MON 531 x MON 1445 cotton.
Given the characteristic of CP4 EPSPS and CrylAc proteins to be expressed at low concentrations in MON 531 x MON 1445 cotton, the potential exposure to these proteins is extremely low in animal and human food. These proteins were shown to be rapidly digested in in vitro simulated digestion assays. Additionally, acute oral toxicity tests with purified CP4 EPSPS and CrylAc proteins, and subchronic toxicity tests, with these proteins being administered at doses substantially above the doses found in normal cotton consumption, demonstrated that these proteins do not produce adverse effects and , therefore, are not a food safety issue for animals and humans.
It does not potentially cause significant degradation of the environment or harm to human and animal health.
Phenotypic, agronomic and ecological interactions evaluations indicate that MON 531 x MON 1445 cotton is comparable to conventional cotton and does not have a greater risk of becoming an invasive plant. 6. the CP4 EPSPS protein is rapidly degraded in the gastrointestinal system of humans and animals; in addition, its mode of action, specificity and the absence of homology with toxic sequences makes this protein not pose a risk to human health or the environment. laboratory studies with indicator species have shown that CrylAc protein does not cause adverse effects on non-target organisms. in studies evaluating the potential for allergenicity, it was proved that CP4 EPSPS and NPTII proteins are not detectable in cotton products used as human and animal food, and do not pose a significant risk; the evaluations of the phenotypic and agronomic characteristics of Cotton Roundup Ready event 1445 carried out in Brazil showed results similar to those found in other regions of the world in experimental and commercial planting.
Phenotypic, agronomic and ecological interactions evaluations indicate that MON 531 x MON 1445 cotton is comparable to conventional cotton and does not have a greater risk of becoming an invasive plant. In studies evaluating the potential for allergenicity, it was proved that CP4 EPSPS and NPTII proteins are not detectable in cotton products used as human and animal food, and do not pose a significant risk; the evaluations of the phenotypic and agronomic characteristics of Cotton Roundup Ready event 1445 carried out in Brazil showed results similar to those found in other regions of the world in experimental and commercial planting.
MON 531 x MON 1445 cotton is as safe as its conventional counterpart.
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health. Restrictions on the use of the GMO under analysis and its derivatives are subject to the provisions of Law 11,460, of March 21, 2007, in Normative Resolution No. 03.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
