Food safety and quality: OECD Unique Identifier details

Brazil
Name of product applicant:	Syngenta Seeds Ltda.
Summary of application:	Syngenta has developed corn (Zea mays L.), Bt11 x MIR162 x NK603 by combining three individual transformation events using classical genetic improvement. The combined product provides control of certain lepidopteran insect pests through the expression of two insecticidal proteins (Cry1Ab and Vip3Aa20) and tolerance to herbicides containing the active principle of glyphosate, through the expression of the CP4 EPSPS protein and glufosinate ammonium, through the expression of the PAT protein.
Upload:	Commercial release 8405-2023.pdf
Date of authorization:	02/03/2023
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):	Studies carried out with the individual transformation events present in the combined product Corn Bt11 x MIR162 x NK603, combined by classical genetic improvement, have demonstrated that the individual transformation events are as safe for the environment and for human and animal health as corn conventional, not genetically modified.
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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:
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:

[email protected]

Organization/agency name (Full name):

National Biosafety Technical Commission

Contact person name:

Paulo Augusto Viana Barroso

Website:

http://www.ctnbio.gov.br

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

Brazilian National Biosafety Commission – CTNBio

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)