欧、美、日转基因产品安全审批制度研究及对我国的启示

Safety License System of Genetically Modified Products in the U.S., EU and Japan and Its Implication to China

转基因安全审批制度对把控转基因产品的安全风险具有重要意义。欧盟由欧洲食品安全局统一负责转基因产品的风险评估和上市审批;美国转基因安全审批制度则主要依赖于自愿咨询程序而实施,食品药品管理局等机构并不主动发起调查,而是由申请者自行承担转基因产品安全评估责任;日本则由文部科学省、通产省、农林水产省和厚生劳动省四大部门共同负责转基因产品的安全审批工作。我国应吸取前述国家和地区的成功经验,为完善我国转基因产品安全审批制度提供参考。

The safety license system are of great significance to the control of the safety risks of genetically modified products. In the European Union, the European Food Safety Authority is responsible for the risk assessment and marketing license of GM products. In the U.S., the safety license system of GM products is carried out through the consultation procedures, where authorities like the U.S. Food and Drug Administration do not conduct independent research on its own initiative. The independent body conducts its own research for each application. While in Japan, the Ministry of Education, Culture, Sports, Science and Technology, the Ministry of International Trade and Industry, the Ministry of Agriculture, Forestry and Fisheries together with the Ministry of Health, Labour and Welfare, are in charge of the duty of safety license of GM products. China shall draw useful experience from the practice of the aforementioned countries and regions in order to provide references for improving the safety license system of GM products in China.