《生命科学》 2026, 38(7): 1266-1283

日本基因编辑食品标识制度：现状、比较及启示

段 蔚¹ , 张文斐^2,*

¹同济大学法学院，上海 200092 ²华中农业大学文法学院/农业农村法治创新研究中心，武汉 430070

摘　要：

基因编辑等新兴生物育种技术的发展对提高人类福祉意义深远。日本作为最早规范基因编辑食品标识的 国家之一，相较于美国、英国和欧盟，更为完整地构建了豁免标识、自愿标识、追溯标识和阴性标识体系，且精简了监 管流程。在新兴生物育种技术快速发展的大背景下，我国需加快建立符合本国国情的基因编辑食品标识制度，明确 豁免标识、自愿标识和阴性标识，落实基因编辑食品追溯机制，构建差异化的基因编辑食品审查程序，加强对动物健 康和福利的伦理审查，提高公众参与法律监督的力度，以期实现粮食安全和生物资源可持续利用的战略目标。

通讯作者：张文斐 , Email:zhangwenfei@mail.hzau.edu.cn

Genome-edited food labeling system in Japan: status quo, comparison and implications

DUAN Wei¹ , ZHANG Wen-Fei^2,*

¹College of Law, Tongji University, Shanghai 200092, China ²College of Humanities & Social Sciences, Agricultural and Rural Rule of Law Innovation Research Center, Huazhong Agricultural University, Wuhan 430070, China

Abstract:

The development of emerging biological breeding technologies such as genome editing has profound significance for improving human welfare. Japan, as one of the earliest countries to regulate the labeling of genome-edited foods, has established a more comprehensive system encompassing exempt labeling, voluntary labeling, traceable labeling, and negative labeling compared with the United States, the United Kingdom, and the European Union, while also streamlining the two supervisory procedures of pre-market consultation and notification. Comparative analysis reveals that although the United States adopts a more lenient stance toward genome-edited plants and their derived foods, with pre-market consultation being voluntary and mandatory labeling only required on a case-by-case basis within the consultation, it imposes stricter tiered safety reviews on genome-edited animals and their derived foods. The United Kingdom has even more lenient labeling requirements for genome-edited plants and their derived foods, completely exempting traceability obligations, but it emphasizes welfare review for genome-edited animals and has postponed precision breeding of animals, including those involving genome editing. The European Union’s recent legislative proposals show a tendency to exempt labeling for certain genome-edited plants, but they do not address supervisory requirements for genome-edited animals and their derived foods. It is evident, however, that Japan’s genome-edited food labeling system still has deficiencies in scientific review. It overlooks health issues such as the nutritional composition and allergenicity of genome-edited plants and their derived foods, and fails to consider the physiological and even psychological impacts of the genome editing technology itself on animals, as well as the risks posed by the escape or reproduction of genome-edited animals to their offspring, to the genetic diversity of the biosphere, and to the ecological environment. Against the background of rapid development in emerging biological breeding technologies, China should, on the basis of critically drawing on foreign experiences, accelerate the establishment of a genome-edited food labeling system that suits its national conditions. This entails clearly defining exempt labeling, voluntary labeling, and negative labeling, implementing a traceability mechanism for genome-edited foods, establishing differentiated review procedures for genome-edited foods, strengthening ethical review of animal health and welfare, and enhancing public participation in legal supervision, with a view to achieving the strategic goals of food security and the sustainable use of biological resources.

Communication Author：ZHANG Wen-Fei , Email:zhangwenfei@mail.hzau.edu.cn