抄録
The safety assessment of foods and food additives produced by genetically modified microorganisms in Japan commenced on 1991 according to the Guidelines for Safety Analysis of Food and Food Additives from Genetically Modified Organisms by the Ministry of Health and Welfare. The safety assessment was mandated by the Food Sanitation Act Japan in 2000, and Food Safety Commission Japan was established to take on safety assessment independent of risk regulation by the Ministry of Health, Labour and Welfare in 2003, ruled by the Food Safety Basic Act. The commission legislated Standards for the Safety Assessment of Genetically Modified Foods and Food Additives, in which the definition of the recombinant-DNA organisms is identical to that in the Cartagena Protocol on Biosafety, that is “the genetic material has been changed through in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles”. Although this definition, identical to the Standards by Food Safety Commission Japan, deals with neither self-cloning nor natural occurrence, the Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms exempts both self-cloning and natural occurrence from genetically modified living organisms. The notification of the Ministry of Health, Labour and Welfare and Food Safety Commission Japan should be applied on June 27, 2014, which has been established to exempt microorganisms for production of foods and food additives having DNA with self-cloning and natural occurrence, from objects of the safety assessment. This does not mean deregulation of food safety; the fundamental stance on consideration of food safety for these microorganisms is immutable before and after the application of this notification.
