Fig. 1

Relations between the main components involved in the Brazilian regulatory system. The whole system is based on the decisions of CTNBio, a technical-scientific body. The Commission assesses risks associated to GMO, authorizes field trials and, at the end of the process, may grant permission for its commercialization. Only biosafety and science-based issues are taken into account in the risk assessment that supports the technical recommendation. In turn, the CNBS, which is hierarchically superior, has the power to veto the marketing of genetically modified products based on social or economic considerations. CIBios are commissions within institutions / companies working with GMOs and are directly subordinated to CTNBio, which grants them a certificate of biosafety-CQB, which is a license given by CTNBio to the requesting institution to carry activities involving GMOs and their derivatives. Communication must be constant between them. Another important player is the set of agencies responsible for Registration and Inspection/Enforcement (ANVISA – the National Health Surveillance Agency, IBAMA - Brazilian Institute of Environment and MAPA – Ministry of Agriculture, Livestock and Supply). They inspect GMO field releases and register products once the commercial release is granted by CTNBio