Law No. 3339-IX “On state regulation of genetic engineering activities and state control over the placing on the market of genetically modified organisms and products”.

This Law defines the legal and organizational principles of state regulation of genetic engineering activities, ensuring the environmental, genetic, food and biological security of the state, and state control over the placing on the market of genetically modified organisms and products. Genetic engineering activities shall be intended scientific and technical activities related to the creation, research and testing of genetically modified organisms in a closed system and/or to the research and testing of genetically modified organisms in an open system. GM products as feed shall be intended feed containing, consisting of, or produced from, one or more genetically modified organisms. GM foodstuffs shall be intended food products containing, consisting of, or produced from, one or more genetically modified organisms. For the purposes of this Law, the production (cultivation) of genetically modified plants, animals, fungi, microorganisms are considered to be placing of GMOs and GM products on the market. This Law applies to relations in the field of handling GMOs: (a) genetic engineering activities in a closed system; (b) research and testing of GMOs in an open system; (c) state registration of GMOs; (d) placing GMOs and GM products on the market; (e) labelling of GM products; and (f) measures of state control over the handling of GMOs. This Law does not apply to genetic engineering activities concerning the human body, organs, tissues and individual cells within the human body. State policy in the field of GMO management is based on the principles of: (a) legality - compliance with the Constitution of Ukraine and the laws of Ukraine, international obligations of Ukraine; (b) openness - ensuring free access to information about genetic engineering activities in Ukraine, GM products and handling of GMOs; (c) the priority of preserving human health and protecting the environment over obtaining economic benefits; (d) prevention of possible negative impacts on human health and the natural environment; (e) compliance with rules for treating animals that exclude cruelty; (f) ensuring environmental safety, genetic safety, food safety and biosafety in the creation, research, testing and use of GMOs; (g) control over GMOs and GM products at all stages of handling them; and (h) coordination and consistency of long-term strategies, plans and programs for the development of genetic engineering activities in Ukraine with other national plans and programs. The State Commission for GMO Risk Assessment is a permanent expert and advisory body operating under the central executive body, which ensures the formation and implementation of state policy in the field of placing GMOs and GM products on the market, for the purpose of assessing the risk of GMOs. The subject of genetic engineering activities shall be obliged to annually assess the level of risk when carrying out genetic engineering activities in a closed system in accordance with the criteria approved by the Cabinet of Ministers of Ukraine. If the subject of genetic engineering activity has doubts about the correctness of the determination of the risk level, he is obliged to apply protective measures that correspond to the higher risk level. In order to carry out genetic engineering activities of the second, third or fourth risk level in a closed system, a subject of genetic engineering activities must obtain a permit. In the event of a risk to human health and/or the environment during research and testing of GMOs in an open system, the person conducting research and testing in an open system is obliged to: (a) notify the central executive body responsible for the formation and implementation of state policy in the field of environmental protection about such a risk; (b) review the protective measures specified in the permit application; and (c) take all possible measures to protect human health and the environment. This Law contains XII Sections divided into 43 Articles. Section I lays down general provisions. Section II establishes powers of executive bodies and other state bodies and institutions in the field of GMO management. Section III regards implementation of genetic engineering activities in a closed system. Section IV regards handling GMOs in an open system. Section V regards state registers and state registration in the field of GMO handling. Section VI regards labelling, placing on the market, monitoring, transportation, storage, disposal of GMOs and GM products. Section VII regards transboundary movement of GMOs. Section VIII establishes requirements for the scientific and methodological center for GMO testing and laboratories carrying out research (test) on GMO. Section IX establishes state control over GMO handling. Section X regards response measures and liability for violations of legislative requirements in the field of handling GMOs. Section XI regards international cooperation. Section XII lays down final and transitional provisions.