Japan Food and Agricultural Import Regulations and Standards 2018 Review

Legal Framework and General Food Laws in Japan

There are seven primary statutes that govern the regulation of food and agricultural products, including imports, in the Japanese market. These include the Food Safety Basic Act, the Food Sanitation Act, the Health Promotion Law, the Japan Agricultural Standards Law (JAS Law), the Plant Protection Law, the Act on Domestic Animal Infectious Diseases Control, and the Food Labeling Law. Each law serves a distinct purpose and is administered by various government agencies to ensure safety, quality, and consumer transparency.

The Food Safety Basic Act establishes the fundamental principles for the nation’s food safety regime. It notably established the Food Safety Commission (FSC), which serves as a specialized risk assessment body for food-related hazards. Risk management, on the other hand, is handled by the Ministry of Health, Labour and Welfare (MHLW). The Food Sanitation Act, under MHLW jurisdiction, aims to protect public health by ensuring the safety and sanitation of foods, beverages, apparatus, containers, and packaging. This act sets specific standards for additives, contaminants, and agrochemical residues, while prohibiting the import of harmful substances. It also outlines monitoring guidelines and inspection measures, including penalties for non-compliance. In June 2018, this act was revised to include requirements for public health attestations for dairy and certain seafood products (like pufferfish and raw oysters) and the implementation of Hazard Analysis Critical Control Point (HACCP) based management for products such as meat. These revisions are largely set to take effect in $2020$.

The Health Promotion Law, also managed by MHLW, focuses on public health improvement through nutrition management. It establishes the system for labeling "Food for Special Dietary Uses," which requires Prime Ministerial approval for foods targeting infants, children, pregnant women, or the ill. The JAS Law, administered by the Ministry of Agriculture, Forestry and Fisheries (MAFF), provides a voluntary quality assurance system for food, non-alcoholic beverages, and forestry products. MAFF also oversees the Plant Protection Law and the Act on Domestic Animal Infectious Diseases Control, which mandate inspections for domestic and imported plants and animals to prevent the spread of pests and diseases. Finally, the Food Labeling Law, under the Consumer Affairs Agency (CAA), dictates standards for allergen labeling, expiration dates, country of origin labeling (COOL), and functional claims.

Food Additives and Approval Regulations

Food additives in Japan are strictly regulated under a positive list system defined by the Food Sanitation Act. Only additives assessed and designated as safe by the MHLW are permitted; any product containing unapproved additives is barred from sale. Additives are divided into four categories: Designated Additives, Existing Additives, Natural Flavoring Agents, and Ordinary Foods Used as Food Additives. Designated Additives are especially scrutinized, as their approval may be limited to specific products, set concentrations, and particular uses. For instance, a substance might be permitted in one food type but not another based on estimated dietary exposure and the Acceptable Daily Intake (ADI).

Japan’s definition of food additives is broader than that of the Codex Alimentarius Commission. It includes substances used as processing aids, antimicrobial treatments, vitamins, minerals, amino acids, and flavoring agents. To ensure smooth customs clearance, exporters must provide the chemical names and content in parts per million ($ppm$) for all synthetic additives with set tolerances. Natural additives must be named, and artificial colors must be identified by chemical name and international color index number. For alcoholic beverages, additives require additional approval from the National Tax Agency (NTA) under the Liquor Tax Act, following MHLW approval. Applications to the NTA must include detailed data on the material, the specific liquor item, the purpose of use, manufacturing methods, and component analysis.

The approval process for new additives involves an application to the MHLW, followed by a risk assessment by the FSC. The MHLW then determines the application level for each food based on toxicity data and exposure levels. To assist companies, the Food Additive Designation Consultation Center (FADCC) was established in $2014$ at the National Institute of Health Sciences. The FADCC provides free face-to-face consultations in Japanese to help applicants prepare complete documentation, which can significantly reduce regulatory approval time.

Pesticides, Agricultural Chemicals, and Contaminants

Japan utilizes a positive list system for agricultural chemical residues, feed additives, and veterinary drugs. Introduced on May 29, $2006$, this system established provisional Maximum Residue Levels (MRLs) for $758$ chemicals, adding to approximately $10000$ existing official MRLs. Any food found to exceed these levels is prohibited from entry. If a specific chemical-commodity combination lacks an official or provisional MRL, a uniform tolerance of $0.01\,ppm$ is applied. Some substances ($20$ in total) have a "not detected" or zero-tolerance status, while others ($71$ substances) are categorized as exempted due to their lack of adverse health effects.

Violations of MRL standards trigger specific enforcement actions. A single violation can lead to "enhanced monitoring," where $30\%$ of all imports of that product from the offending country are inspected. This is lifted after $60$ clean tests or one year with no further detections. Simultaneously, the specific violator’s future shipments are subject to a $100\%$ "hold and test" requirement until $60$ clean tests are recorded. If two different operators violate the same MRL, MHLW may issue an "Inspection Order" for the entire country, requiring $300$ clean tests before the status is lifted. Monitoring is conducted by MHLW quarantine offices and local government laboratories, with results generally showing that less than $0.1\%$ of samples exceed MRLs.

Beyond pesticides, the Japanese government monitors various other contaminants. This includes Aflatoxin in nuts and spices, Enterohemorrhagic E. coli ($O26$, $O103$, $O111$, and $O157$) in beef and raw meat, Norovirus and Hepatitis A in raw shellfish, mercury and PCB in fish/shellfish, and cyanide in certain beans. Irradiation is generally prohibited in Japan, with the sole exception of potatoes used to suppress germination. Potatoes that are irradiated must be clearly labeled as such.

Packaging, Containers, and Recycling Regulations

Article $16$ of the Food Sanitation Act prohibits the sale or use of any apparatus or container containing toxic substances that could harm human health or impart harmful influences to food. Specifications exist for synthetic resins, metal cans, glass, ceramic, and rubber. Importers are responsible for ensuring that appropriate recycling labels are present on all packaging and that they contribute to the costs associated with recycling, as mandated by Japanese law.

A significant revision to the Food Sanitation Act in June $2018$ introduced a positive list system specifically for food packaging materials. This system primarily targets synthetic resins. MHLW is currently compiling a provisional list of materials used by domestic and foreign suppliers, with full implementation expected in Japanese Fiscal Year (JFY) $2020$. After this point, only packaging materials that have been safety-assessed and designated by the MHLW will be allowed in the market.

Mandatory and Voluntary Food Labeling Standards

The Food Labeling Law requires imported processed food labels to be in Japanese and include the product name, country of origin, importer name and address, ingredients (in descending order of weight), additives, net weight (metric), best-before date, storage instructions, and GE ingredients. Allergen labeling is mandatory for seven items: shrimp, crab, wheat, buckwheat, egg, dairy, and peanut. There are $20$ additional recommended allergens: abalone, squid, salmon roe, orange, cashew nut, kiwi fruit, beef, walnut, sesame, salmon, mackerel, soybean, chicken, banana, pork, matsutake mushroom, peach, yam, apple, and gelatin.

Biotechnology labeling is mandatory for products classified as GE or non-segregated. "Non-GE" labeling is voluntary but requires the ingredient to be handled under an identity preservation system with less than $5\%$ GE content. Country of Origin Labeling (COOL) is currently required for ingredients in $22$ food groups and $5$ food items manufactured in Japan, though not for imported processed foods. However, COOL requirements are expanding; by JFY $2022$, the country where the main ingredient (by weight) was manufactured must be identified for all domestically produced products.

Nutritional labeling will become mandatory for calories ($kcal$), protein ($g$), fat ($g$), carbohydrate ($g$), and sodium (as salt equivalent in $g$) by April $2020$. Manufacturers must convert U.S. nutrition panels into the Japanese format. Claims regarding nutritional content are strictly regulated. For example, a "no sodium" claim requires content below $5\,mg$ per $100\,g$, while "low sodium" must not exceed $120\,mg$ per $100\,g$. "No fat" requires a level lower than $0.5\,g$, and "low fat" must be $3\,g$ or less per $100\,g$. Furthermore, Japan identifies special health categories: Food for Special Dietary Uses (FOSDU), Food for Specified Health Uses (FOSHU), Foods with Nutrient Function Claims (FNFC), and Food with Functional Claims (FFC), each with specific registration and wording requirements.

Specific Standards for Biotech, Organics, and Forestry

All genetically engineered (GE) products must undergo environmental and food safety assessments before export to Japan. Recombinant DNA techniques used in food or ingredients must be approved by the GOJ. As of November $26$, $2018$, Japan has approved $319$ GE events. The MHLW enforces a zero-tolerance policy for unapproved GE varieties. Non-protein additives produced by GMOs, such as amino acids, also require MHLW review for substantial equivalence to conventional products.

Organic food standards are governed by the JAS Law. Since January $1$, $2014$, the U.S. and Japan have maintained an equivalency arrangement for organic plant products and plant-based processed foods, allowing them to be sold as organic in either country. This was expanded in $2017$ to include certified organic animal feed. Fresh fruits and vegetables like apricots, peppers, and peaches are often prohibited under quarantine law, though frozen versions may be permitted if they meet specific temperature requirements ($0^{\circ}\text{F}$ or lower) and are accompanied by appropriate certification.

Forestry products used in construction must often be JAS-certified to comply with the Building Standards Law (BSL). The Clean Wood Act (implemented May $20$, $2017$) promotes the use of legally harvested wood. While its registration is voluntary, Japanese buyers frequently demand documentation proving the legality of the wood. Imported woody biomass for power facilities also requires proof of legality under the Feed-in Tariff scheme.

Import Procedures and Facility Registration

Specific facilities must be registered or listed for certain products: beef must be on the AMS Official Listing for the LT30 QSA Program, ovine/caprine meat must be on the AMS Export Verification list, and oyster exporters must be on the Interstate Certified Shellfish Shippers List (ICSSL). For most other products, notification is required per shipment rather than via general facility registration.

To import food, firms must submit a "Notification Form of Importation of Foods, etc." to MHLW Quarantine Stations. Officials examine the notification and may inspect the product at a bonded warehouse. Documentation required includes the notification form, export certificates, test results, and details on ingredients and manufacturing processes. Processed foods being imported for the first time require extensive documentation regarding raw materials. For maritime cargo, the Advance Filing Rules require shipping information to be submitted electronically $24$ hours before the vessel departs the loading port.

Intellectual Property and Geographical Indications

Japan protects intellectual property through the Madrid Protocol for international trademark registration. The Geographical Indication (GI) Act protects the names of specific agricultural, forestry, and fishery products. This prevents the unauthorized use of names associated with certain regions and qualities. Additionally, Regional Collective Trademarks allow associations to own trademarks that combine a region's name with a common name for goods. As of February $2018$, there were $621$ registered regional collective trademarks, including $361$ food products.

Appendix II: Mandatory COOL Ingredient List

Country of origin labeling for ingredients is required for the following food groups and items:

1. Dried mushrooms, vegetables, and fruits (excluding flaked/powdered).
2. Salted mushrooms, vegetables, and fruits.
3. Boiled or steamed mushrooms, vegetables, pulses, and bean jams (excluding canned/bottled/retort).
4. Mixed vegetables, fruits, and mushrooms.
5. Green tea and packaged/bottled green tea beverages.
6. Rice cake.
7. Roasted peanuts and beans.
8. Sugar cane sugar and its products.
9. Alimentary konjac products.
10. Seasoned meat (unheated/not frozen after processing).
11. Boiled or steamed poultry and eggs (excluding canned/bottled/retort).
12. Slightly roasted meat.
13. Prepared meat with deep-fry batter (unheated/not frozen after heating).
14. Ground meats and other mixed meats.
15. Unsalted/salted/boiled/dried fish, shellfish, and seaweed.
16. Salted fish, shellfish, and seaweed.
17. Seasoned fish, shellfish, and seaweed (unheated/not canned/bottled/retort).
18. Kelp roll with fish.
19. Boiled or steamed fish, shellfish, and seaweed (excluding canned/bottled/retort).
20. Slightly roasted fish and shellfish.
21. Prepared fish and shellfish with deep-fry batter.
22. Mixtures of fresh foods (other than groups 4 and 14).
23. Pickled vegetables.
24. Frozen vegetables.
25. Processed eels.
26. Fried bonito flakes.
27. Rice balls.