Decree No. 5.591 implementing Law No. 11.105 on Genetically Modified Organisms (GMO).

This Decree is composed of 95 articles and one Annex divided into nine Chapters; it implements Law No. 11.105 and further regulates the security norms and control mechanisms over the use, transport, production, storage, research and release in the environment of Genetically Modified Organisms (GMO). The Decree defines general rules for GMO risk classification. Moreover, it regulates the necessary procedures for the issuing of a Biological Security Quality certificate. The Decree also institutes a National Technical Committee on Biological Security and a National Council for Biological Security defining, for both committees, functions, composition and working procedures. In addition, the Decree defines the bodies and institutions in charge for the registration and control over GMO, and regulates the national information system on biological security. Particular attention is devoted to the regulation of specific research activities and therapies using GMO. Finally, the Decree defines civil and administrative liability for non-compliance with relevant provisions. The Annex provides a classification of Risk for the GMOs.