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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of cotton event T304-40 x GHB 119 x COT102, Technical Opinion - 6130/2018.
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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São Paulo, SPOrganization:BASF S.A. ()
, BrazilPhone: +55(11) 4343-3009 ; +55(11) 4343-2233,Fax: +55(11)4343-3006,Email: luiz.louzano@basf.com,Website:
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BCS-GHØØ4-7 × BCS-GHØØ5-8 × SYN-IR1Ø2-7 - Insect-resistant, herbicide-tolerant cotton| BASF Plant Science GmbH | Resistance to antibiotics (Hygromycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate)
- Commercial release 6130 - 2018.pdf [ Portuguese ]
TLC cotton, Risk Class 1 GMO, was obtained by combining Events TwinLink X COT10 through classical genetic improvement, initially through crosses and selection between individuals containing Events T304-40 and GHB119 to obtain TwinLink cotton. Subsequently, the crossing of TwinLink cotton with individuals derived from Event COT102 was performed, to then result in the final combination TwinLink x COT102 (T304-40 x GHB119 x COT102) or TLC cotton.
The TLC Combined Event (TwinLink x COT102), which is a minor combination of GLTC cotton (which is already approved for commercial use as stated in CTNBio Technical Opinion No. 5400/2017), can be classified as belonging to Risk Class I ( low individual risk and low risk to the community), for containing nucleotide sequences of donor and recipient organisms that do not cause harm to human and animal health or adverse effects to plants and the environment.
The applicant sent a list of tests carried out in Brazil and data comprising molecular characterization, protein expression, agronomic behavior and phenotypic aspects, compositional analysis; aspects of survival and reproduction; evaluation on natural enemies, non-target insects and soil microorganisms and soil biomass biodegradability. The Shothem Blot results showed that the combination of the parents TwinLink (T304xGHB119) and COT102, through classical breeding, did not affect the structural stability of the inserts and the number of copies in TLC cotton. This was evidenced when fragments resulting from the digestion of genomic DNA isolated from TLC cotton with specific restriction enzymes were hybridized with probes that almost completely covered the respective T-DNAs. The results demonstrated that the combination between TwinLink and COT102 cottons did not affect the structural stability of the inserts and that there were no genetic rearrangements, since the banding pattern for the TLC combined cotton reflected exactly the same pattern for the respective parents, corroborating to have the same number of copies as the parental events. Therefore, the insert's structure, location and stability were not altered by the combination.
CTNBio concluded that the present cotton does not potentially cause significant degradation of the environment.
Typical regularity observed for phenological stages throughout the cycle; lack of distinction in morphological characters in relation to conventional varieties; absence of significant variation in chemical/nutritional composition; no observation of GM cotton plants with characters atypical to the culture; same pattern of response in relation to cultural treatments; similarity in productive capacity between GM and NM (non-GM) genotypes.
The applicant conducted field trials with samples of TLC cotton at various locations in Argentina and Brazil, regions which are representative of commercial cotton production, such as in the provinces of Chaco, Santiago del Estero and Santa Fé in Argentina, and in the states of Mato Grosso. Grosso, Bahia, Goiás, Minas Gerais and São Paulo, in Brazil. The sites present climatic and soil conditions that present variations inherent to their geographic regions, aiming at the production of plants to obtain agronomic data, survival and chemical and nutritional composition of TLC cotton. These results allow us to evaluate possible pleiotropic and epistatic effects as well as adverse effects resulting from the introduction of foreign genes to the unmodified plant, or from the association of TwinLink cottons with COT102. The results obtained from these tests showed no significant difference between the GM plants and their conventional isoline, except for the expression of the characteristic of interest in the crop tract, and it is possible to conclude that there were no epistatic or pleiotropic effects in the combination of TLC cotton
There are no additional risks to the environment with the planting of TLC cotton besides those already caused by the different varieties of conventional cotton in use in the country and there was no interaction between the inserts present in the cotton.
From the risk analysis of genetically modified raw materials it is possible to conclude that TLC cotton is as safe as its conventional equivalents. The data presented in the request meet the standards and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and allow us to conclude that TLC cotton is substantially equivalent to conventional cotton, and its consumption is safe for human health.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
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