Brief description of the regulatory framework

CTNBio (Brazilian National Biosafety Technical Commission) is in charge of the biosafety assessment of the risks for the agro-ecosystem and for human and animal health associated with GM crops. CTNBio is also the authority that grants authorization for confined activities with GMOs. To request market approval, applicants must first conduct a biosafety assessment and file a biosafety report with CTNBio containing the findings thereof. The biosafety report is assessed by the subcommittees of Human Health, Animal Health and Environment and Plants, which in turn share their opinions in the CTNBio plenary meeting, which grants market approval of the GM crop event. In case of disagreement with the CTNBio’s technical approval, the relevant registration and enforcement agency (Health, Agriculture, Fisheries and Environment) may file an appeal with the National Biosafety Council (CNBS), which is composed of 11 ministries. In case of appeal, the CNBS evaluates the social and economic convenience of the market approval of the crop in question, and renders a final decision regarding its approval.