Law No. LP152/2022 “On regulation and control of genetically modified organisms”.

The Law primarily addresses the regulatory and institutional framework governing genetically modified organisms (GMOs). Its objectives include establishing procedures for obtaining, testing, using, marketing, and cross-border movement of GMOs, with an emphasis on protecting human health and the environment through a precautionary principle. The Law delineates principles such as biosecurity, transparency, and safety of operations, and defines key concepts including genetic modification techniques, traceability, and environmental risk assessment, thereby setting a comprehensive legal context for GMO management. Key measures outlined include mandatory notification and authorization processes for deliberate release and market placement of GMOs, with specific procedures for environmental risk assessments, public participation, and labelling requirements. The Law specifies institutional responsibilities assigned to the Ministry of Environment, the Environment Agency, the Ministry of Agriculture and Food Industry, the National Food Safety Agency, and the Environmental Protection Inspectorate, detailing their roles in policy development, authorization issuance, monitoring, and enforcement. It establishes timelines, fee structures, and procedural steps for applications, evaluations, and decisions, emphasizing transparency and compliance, and mandates annual reporting and monitoring plans to oversee GMO activities. Implementation mechanisms involve the registration and management of GMO data through a public register, procedures for cross-border movement, emergency response plans, liability provisions, and enforcement measures including suspension or withdrawal of authorizations. The Law specifies institutional responsibilities, procedural timelines, and stakeholder engagement processes, such as public consultations and information dissemination, to ensure adherence to regulatory standards. It also provides for transitional provisions, timelines for entry into force, and the repeal of previous legislation, thereby framing a structured approach for the regulation and oversight of GMOs within the national legal system.