Japan is emerging as a pioneer in the introduction of gene-edited foodstuffs. It allows gene-edited products to be sold to consumers without safety evaluations as long as the techniques involved meet certain criteria — a screening process similar to that adopted by the United States. It has introduced three CRISPR-edited products to date: fleshier red sea bream, high-growth tiger puffer, and a GABA-enriched tomato. Referred to in the media as a ‘super tomato’, it features five times the normal amount of GABA, an amino acid linked to lower blood pressure, thanks to tweaks to genes that normally limit GABA production.
Japan has supported gene-editing regulatory reform in hope that new breeding techniques could reduce its reliance on commodity crop imports. It imports close to 100% of its corn and 94% of its soybean supply — and domestic production remains extremely limited.
In the pre-CRISPR era, the Japanese government regulated genetically engineered foods via four ministries: The Ministry of Agriculture, Forestry and Fisheries (MAFF), the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Environment (MOE), and the Ministry of Education, Culture, Sports, Science and Technology (MEXT). The act identifies transgenic crops as Living Modified Organisms (LMOs), which require a biodiversity assessment and safety evaluation concerning cross pollination, nutrient content and more, has to be done.
In 2019, the act was updated as Japan promulgated a set of regulatory guidelines concerning gene-editing technologies, delineating a clear oversight framework for gene-edited plants. Foods derived from these techniques are exempted from the rigorous approval processes required for genetically modified organisms. Governmental agencies are empowered to monitor the safety and environmental implications of gene-edited foods.
In 2021, the Japanese company Sanatech Seed began selling tomatoes genetically modified to produce high levels of GABA — gamma-aminobutyric acid — a compound naturally found in the brain. The Japanese Ministry of Health, Labor and Welfare deemed these genetically edited tomatoes to have a safety profile congruent with products attained via traditional breeding methods.
Japan has embraced a regulatory scheme that is becoming popular in other countries considering or instituting gene editing regulations. Techniques and products are classified into three categories. As of 2023, of the three categories, only a product derived from site-directed mutagenesis SDN-1 are considered as a non-LMO (living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology). When a crop has undergone SDN-1 modification, no safety and environmental assessment is needed.
SDN-2 modification which requires the insertion of extracellularly produced nucleic acid is still considered a LMO, even though the mutation produced by SDN-2 is equivalent to those produced naturally. The European Union, among other countries, proposes to deregulated SDN-2 as non-LMO. Regulation of crops produced by an SDN-2 modification have to undergo a case-by-case assessment. Crops produced by SDN-3 are considered LMOs and are not permitted Local governments may set additional regulatory requirements for gene-edited crops.
Historically, the Japanese have been skeptical of genetically-modified foods. A 2017 survey found that the public was inclined to a zero-risk policy, which limited the growing of GM crops. To date, the introduction of the gene-edited products has not led to similar public concern, and the media has been mostly positive.
Products/Research (partial list as many products are in development)
- GABA enriched tomato, 2021: Sanatech Seed’s Sicilian Rouge Tomato’s are edited using CRISPR to contain a compound known as GABA. This compound is found in tomato fruits and is known to lower blood pressure at a rate up to 5 times higher than a regular tomato.
- Rain-resistant wheat, 2019: Researchers from the National Agriculture and Food Research Organization (NARO) and Okayama University used CRISPR to develop a rain-resistant wheat that may be used as a parent to future wheat used for food.
- Seedless tomatoes, 2019: Researchers at Tokushima University developed seedless tomatoes for research purposes only.
- New technique for high-yield crops, 2019: University of Tokyo researchers used a technique called mitoTALENs to develop high-yield strains of rice and canola.
- High-yield rice, 2017: Field trials began in 2017 by the National Agriculture and Food Research Organization for rice that produces more than traditional varieties.
- Flower color, 2017: Researchers from the University of Tsukuba, the National Agriculture and Food Research Organization (NARO) and Yokohamaa City University changed the flower color of the traditional Japanese garden plant, Japanese morning glory, from violet to white using CRISPR.
- Tomato for blood pressure, 2017: Tsukuba University researchers used CRISPR to develop a tomato with higher content of a compound that might help lower blood pressure.
- Albino apple, 2016: Researchers at NARO used CRISPR to developed albino apple strains for research purposes only.
Regulatory Timeline
2022: Japan approves the sale of two Crispr-Cas9 gene edited fish. The gene edited fish grow larger and are heavier, allowing them to go to the market sooner.
2020: Ministry of Health, Labour and Welfare (MHLW) publishes guidelines stating that gene-edited plants and food can be sold to consumers without safety evaluations as long as the techniques involved meet certain criteria, but developers must send notification to the government.
2020: Ministry of Agriculture, Forestry, and Fisheries (MAFF) Animal Products Safety Division releases final guidelines for the handling of gene-edited feed and feed additives.
2019: MHLW releases the final guidelines for the handling of genome edited food and food additives.
2019: Advisory panel publishes final report recommending that gene-edited plants and food can be sold to consumers without safety evaluations as long as the techniques involved meet certain criteria, but the recommendations must still be adopted by the MHLW.
2018: Environment ministry committee recommends regulating only gene edited organisms that have had foreign genes added.
2017: Agricultural Academy of Japan releases recommendation to cultivate genetically engineered crops in Japan, specifically mentioning potential benefits of glyphosate-resistant sugar beets.
2017: Consumer Affairs Agency (CAA) initiates review of genetic engineering labeling requirements.
2003: Japan adopts the Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (also called the Cartagena Law).
NGO Reaction
Advocacy groups like the Consumers Union of Japan and Seikatsu Club Consumers’ Co-operative Union have taken the stance that gene editing is just the newest version of transgenic modification, arguing that gene editing has not been tested enough for safety, could lead to unintended side effects and should be labeled for consumers.
Additional Resources
- Agricultural Biotechnology Annual Japan 2021
- USDA Foreign Agricultural Services Report, 2021, Japanese Health Ministry Finalizes Genome Edited Food Policy
- Regulatory Status of Genome-Edited Organisms Under the Japanese Cartagena Act
- Implications and Lessons From the Introduction of Genome-Edited Food Products in Japan
- Changing Social Order and the Quest for Justification: GMO Controversies in Japan
- Expert and public perceptions of gene-edited crops: attitude changes in relation to scientific knowledge
Updated: 10/18/2023
