For the Approval Process of GMOs : The Japanese Case

This article reviews the approval process of genetically modified organisms (GMOs) in Japan. The purpose of this review is to explain the Japanese safety approval procedures for food, feed, and imported GMOs and place it in an international context through a comparison with the United States and the European Union (EU). While the regulatory regime in the United States and EU is often discussed, little is understood about the Japanese regulations. However, Japan plays an important role in terms of biotechnological development as well as international trade through agricultural and food imports. Therefore, this article tries to fill the gap in the existing literature. Within Japanese regulations, GMOs are first tested following the Cartagena Protocol on Biosafety. In a second and final step, compliance with the national laws as well as food and feed safety is assessed. We also summarize the processes used in identity preservation and labeling of approved GMOs. The last section of the article reveals the pragmatic nature of Japanese GMO regulations as compared to the EU and the United States