Food safety and quality
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OECD Unique Identifier details

GHB811 x T3Ø4-4Ø x GHB119 x COT1Ø2
Commodity: Cotton
Traits: Herbicide tolerance
Brazil
Name of product applicant: BASF S.A.
Summary of application:

Commercial release of genetically modified cotton containing the combined event LLCotton25 x GBH811 (GLI)

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Date of authorization: 14/06/2023
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
GLI cotton is the result of conventional breeding, using transgenic varieties LLCotton25 and GHB811. LLCotton25 contains a single copy of the cassette with the bar gene, originating from Streptomyces hygroscopicus, which expresses the enzyme PAT (phosphinothricin-N-acetyl transferase), capable of conferring tolerance to the herbicide glufosinate ammonium. This gene is expressed from the p35S promoter and contains the NOS3 terminator. GHB811 contains a cassette with the 2mepsps gene (originating from maize), which expresses the 2mEPSPS protein or 5-enolpyruvylshikimate3-phosphate synthase and confers tolerance to the glyphosate herbicide, and the hppdPfW336-1Pa gene (originating from Pseudomonas fluorescens), which expresses HPPD W336 or 4-hydroxy-phenyl-pyruvate-dioxygenase, conferring tolerance to HPPD (4-hydroxyphenyl-pyruvate-dioxygenase)-inhibiting herbicides. Events were obtained via the Agrobacterium tumefaciens route. Furthermore, these same events were combined into the GLITP event, which also contains genes that confer insect resistance. All three events mentioned, LLCotton25, GHB811 and GLITP, were analyzed by CTNBio, which decided that they do not pose a non-negligible risk to human, animal, plant or environmental health. Likewise, the two GLI parenting events have already been approved in several countries, such as Argentina, Australia, the United States and the European Union. The GLI event, in turn, has already been approved in Japan, Singapore and the Philippines.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Molecular traddicional methods.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date) not applicable.
E-mail:
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Paulo Augusto Viana Barroso
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556120335087
Fax number:
Country introduction:

Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques.

Useful links
Relevant documents
Stacked events:

At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Dr. Paulo Augusto Viana Barroso (President of national Biosafety Commission)