Brief description of the regulatory framework

The entities in charge of authorizing all GMO-related activities are gathered in SNB (National Biosafety System). Within the SNB, GNBio (Biosafety Cabinet) is the authority that regulates access to technologies, and it is composed of 6 ministries: Agriculture Livestock and Fisheries, Public Health, Environment, Industry, Economy, and Foreign Affairs. The process is conducted by the CGR (Commission for Risk Management), which is responsible for issuing regulations and advising GNBio in matters related to GMO risk assessment and management; it is composed of representatives of each of the six ministries. The technical and scientific assessment is performed by an entity called ERB (Biosafety Risk Assessment), which coordinates a multidisciplinary team of experts and produces reports and technical recommendations in matters of risk assessment and management for the CGR. To further coordinate such tasks, the entity is supported by the CAI (Committee for Institutional Coordination). During the regulatory process, risk assessment comprises risks for the environment, biological diversity, human and animal health, and plant health, as well as the social and economic impacts of the GMO under analysis.