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Risk Assessment generated by a regulatory process
(RA)
last updated: 16 Jun 2026
Risk assessment of insect resistant and herbicide tolerant cotton COT102 x MON 15985 x MON 88913 x MON 88701 and herbicide tolerant cotton MON 88913 x MON 88701 - Technical Opinion 6139/2019.
EN
08 Nov 2018
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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-887Ø1-3 × MON-88913-8 - Cotton modified for herbicide tolerance| Monsanto | Resistance to Dicamba, Resistance to herbicides (Glufosinate, Glyphosate)
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SYN-IR1Ø2-7 × MON-15985-7 × MON-88913-8 × MON 887Ø1-3 - Insect resistant, Herbicide tolerant Cotton| Monsanto | Resistance to antibiotics (Hygromycin, Kanamycin, Streptomycin), Resistance to Dicamba, Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
- commercial release 6139 - 2018.pdf [ Portuguese ]
COT102 x MON 15985 x MON 88913 x MON 88701 cotton, resistant to insects (Vip3A, Cry1Ac and Cry2Ab2) and tolerant to the herbicides glyphosate, glufosinate and dicamba (cp4epsps, PAT and DMO) and - MON 88913 x MON 88701 cotton, tolerant to the herbicides glyphosate, glyphosinate and dicamba (cp4epsps, PAT and DMO).
CTNBio is in favor of commercial release, waiving the need for analysis and issuing a new conclusive technical opinion on cotton resistant to insects and tolerant to herbicides COT102 x MON 15985 x MON 88913 x MON 88701 and cotton tolerant to herbicides MON 88913 x MON 88701, for complying with Article 4 of Normative Resolution No. 5.
The events under discussion, individually and even pyramided, have already been planted in several producing countries, having a history of safe use of more than twenty years, therefore, there is no need to
It is expected that the combinations now presented in the two combinations in question (COT102 x MON 15985 x MON 88913 x MON 88701 and MON 88913 x MON 88701) can bring any results beyond those already expected in the control of insects and weeds.
It is expected that the combinations now presented in the two combinations in question (COT102 x MON 15985 x MON 88913 x MON 88701 and MON 88913 x MON 88701) can bring any results beyond those already expected in the control of insects and weeds.
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health.
The scientific information presented by CTNBio showed that there is no interaction between the exogenous proteins expressed in the two combined products in question, COT102 x MON15985 x MON88913 x MON88701 cotton and MON88913 x MON88701 cotton; The studies presented by CTNBio for the approval of individual events and products with other combinations of these events show that they are as safe as their conventional versions for the environment and for human and animal health; The risk assessment guidelines for combined GMO products support the premise that there is no scientific evidence of interaction between exogenous proteins or of interest in products that have been combined by sexual crossing using classical genetic improvement techniques. Furthermore, they propose that even if there were some interaction, the result of this would not be expected to cause an adverse effect and that the risk of the combined product would be different from the risk of the individual events that compose it.
Based on several scientific studies, they accept that Individual and product GMO events with other combinations of these events generated by conventional genetic improvement are as safe as their original GMO versions (with the isolated events). These isolated events had their biosafety for the environment and for human and animal health tested, showing no difference in relation to conventional cotton. The absence of genetic interaction and biochemistry between the introduced gene products is also well supported in this Monsanto request.
Cry/Vip genes with a long history of safe use, there would be no reason to expect an interaction or synergistic effect that would have a significant impact on human, animal, or the environment.
environment.
environment.
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
