Navigate the regulatory requirements for importing Japanese food and cosmetics to the United States and China.
Key regulations and requirements for importing 調味料 from Japan
Japanese seasonings such as soy sauce, miso, and mirin are popular in the US market. Key regulatory requirements include FDA facility registration, Prior Notice for imports, and compliance with US food labeling regulations. Mirin and similar products containing alcohol may fall under TTB regulation.
Products must comply with Japan's Food Sanitation Act. Export health certificates may be required depending on the product type.
Ministry of Health, Labour and Welfare (MHLW)
Mirin (hon-mirin) with alcohol content above 1% requires an alcohol export license from the NTA.
National Tax Agency (NTA)
All food facilities that manufacture, process, pack, or hold food for US consumption must register with the FDA under the Bioterrorism Act.
Food and Drug Administration (FDA)
FDA requires Prior Notice before food shipments arrive at the US port of entry. Must be submitted electronically via FDA's PNSI system.
Food and Drug Administration (FDA)
Labels must include: Nutrition Facts panel, ingredient list in English, allergen declaration (Big 9: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame), net quantity, and manufacturer/importer address.
Food and Drug Administration (FDA)
Mirin with alcohol content above 0.5% ABV may be classified as an alcoholic beverage by TTB, requiring a Federal Basic Permit and Certificate of Label Approval (COLA).
Alcohol and Tobacco Tax and Trade Bureau (TTB)
Monosodium glutamate (MSG) must be declared by its common name in the ingredient list. Products cannot claim 'No MSG' if they contain ingredients that naturally contain free glutamate.
Since January 2023, sesame is the 9th major allergen in the US under the FASTER Act. Many Japanese seasonings contain sesame and must declare it prominently.
3-6 months for initial setup (FDA registration, labeling compliance, importer arrangement)
Importing Japanese seasonings into China requires GACC overseas food facility registration (Decree 248/249), CIQ inspection, and compliance with Chinese GB national standards for food additives, labeling, and safety. The registration process has become more stringent since 2022.
China requires an official health certificate issued by Japan's competent authority for food exports. MHLW or local health centers issue these certificates.
Ministry of Health, Labour and Welfare (MHLW)
MAFF provides export promotion support and can assist with meeting China's phytosanitary and food safety requirements.
Ministry of Agriculture, Forestry and Fisheries (MAFF)
Since January 2022, all overseas food producers exporting to China must be registered with GACC. For 18 categories of high-risk foods, registration requires a recommendation from the exporting country's competent authority. Other foods can self-register via GACC's online system.
General Administration of Customs of China (GACC)
Pre-packaged foods must have a Chinese label meeting GB 7718 (General Standard for Labeling of Pre-packaged Foods). Must include: product name, ingredients, net content, production date, shelf life, storage conditions, manufacturer info, and importer info in Chinese.
State Administration for Market Regulation (SAMR)
All food additives must be listed in China's GB 2760 (Standard for Uses of Food Additives). Some additives permitted in Japan may not be approved in China. Verify every ingredient against the GB 2760 positive list.
State Administration for Market Regulation (SAMR)
All imported foods undergo inspection and quarantine by China Customs (CIQ) at the port of entry. Products may be sampled for laboratory testing.
General Administration of Customs of China (GACC)
China's approved additive list (GB 2760) differs significantly from Japan's. For example, some preservatives and colorants commonly used in Japanese seasonings may not be on China's positive list. This is the most common reason for import rejection.
Mirin with significant alcohol content may be classified as an alcoholic beverage in China, subject to different import procedures and higher tariffs. 'Mirin-style' seasonings with low alcohol are easier to import.
6-12 months (GACC registration can take 3-6 months, plus label approval and CIQ preparation)
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.
Key regulations and requirements for importing 惣菜類・調理済み食品 from Japan
Prepared and ready-to-eat Japanese foods (bento items, frozen meals, retort pouch foods) must meet FDA requirements including HACCP-based food safety plans, proper thermal processing registration for low-acid canned foods, and comprehensive allergen labeling.
Prepared foods must meet Japan's food safety regulations. For meat-containing products, MAFF export certificates may be required.
Ministry of Health, Labour and Welfare (MHLW)
Facilities must have a written Food Safety Plan under FSMA (Food Safety Modernization Act) with hazard analysis, preventive controls, and monitoring procedures.
Food and Drug Administration (FDA)
Retort pouch and canned products with pH above 4.6 must register as LACF facilities with FDA and file scheduled process information (21 CFR Parts 108 & 113).
Food and Drug Administration (FDA)
Products containing meat or poultry are regulated by USDA-FSIS (not FDA) and face stricter import requirements including plant equivalency assessments. Japan currently has USDA equivalency for some products.
4-8 months (LACF registration if applicable, food safety plan development, labeling)
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.
Key regulations and requirements for importing 菓子・デザート from Japan
Japanese confectionery (wagashi, snacks, chocolates) is increasingly popular in the US. Products must meet FDA food safety requirements, proper allergen labeling (especially sesame since 2023), and Nutrition Facts panel requirements. Color additives must comply with FDA-approved lists.
Products must comply with Japanese food safety standards. Ensure all additives used are also permitted in the destination country.
Ministry of Health, Labour and Welfare (MHLW)
Manufacturing facility must be registered with FDA. Prior Notice must be submitted before each shipment arrives.
Food and Drug Administration (FDA)
Full Nutrition Facts panel required. The Big 9 allergens must be declared. Sesame (added 2023) is particularly relevant for Japanese confectionery such as senbei and mochi.
Food and Drug Administration (FDA)
Japan and the US have different approved color additive lists. Japanese-approved colors like Red No. 2 (Amaranth) are banned in the US. Verify all colorants against FDA's FD&C approved list.
Food and Drug Administration (FDA)
Japan permits 12 synthetic tar colors while the US only permits 9 FD&C colors. Key differences: Japan's Red No. 2 (Amaranth) and Red No. 102 are not permitted in the US. Always cross-reference additive lists before export.
Many traditional Japanese sweets use sesame (goma) as an ingredient or topping. Since 2023, sesame must be declared as a major allergen in the US. Check all formulations carefully.
3-4 months (FDA registration, labeling review, color additive verification)
Japanese confectionery is highly popular in China. Since the GACC Decree 248/249 (2022), all overseas food manufacturers must register before exporting to China. Key challenges include additive compliance with GB 2760 and proper Chinese labeling per GB 7718.
China requires an official health certificate for imported confectionery products, issued by Japan's health authorities.
Ministry of Health, Labour and Welfare (MHLW)
Confectionery manufacturers can self-register through GACC's online system (not in the 18 high-risk categories requiring government recommendation).
General Administration of Customs of China (GACC)
Products must comply with relevant GB standards including GB 2760 (food additives), GB 7718 (labeling), GB 28050 (nutrition labeling), and product-specific standards for confectionery.
State Administration for Market Regulation (SAMR)
Japanese confectionery commonly uses food colorants, preservatives, and emulsifiers that may not be on China's GB 2760 positive list. Each ingredient must be verified individually. Some natural colorants may need to be registered as 'New Food Ingredients'.
4-8 months (GACC registration, additive verification, labeling preparation)
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.
Key regulations and requirements for importing 飲料 from Japan
Japanese beverages (green tea, ramune, fruit juices, functional drinks) have strong demand in the US. In addition to standard FDA food requirements, beverages may face specific regulations regarding caffeine content, functional ingredient claims, and container requirements.
All beverages must comply with Japan's food safety standards including microbiological criteria and additive limits.
Ministry of Health, Labour and Welfare (MHLW)
Standard FDA facility registration and Prior Notice requirements apply to all food imports including beverages.
Food and Drug Administration (FDA)
Beverages must display Nutrition Facts with added sugars declaration. Juice content percentage must be stated for drinks claiming to contain juice.
Food and Drug Administration (FDA)
Any beverage with more than 0.5% ABV is classified as an alcoholic beverage and requires TTB approval, a Federal Basic Permit, and COLA. This may affect fermented drinks like kombucha or amazake.
3-5 months for standard beverages; 6-12 months if TTB involvement needed
Japanese beverages including green tea, fruit juices, and functional drinks face standard GACC registration and GB standard requirements. Beverages with health claims may need health food (Blue Hat) registration.
Official health certificate required for beverage exports to China.
Ministry of Health, Labour and Welfare (MHLW)
Standard GACC facility registration and CIQ inspection at port of entry.
General Administration of Customs of China (GACC)
Must comply with GB 7101 (Beverages), GB 2760 (Additives), and GB 7718 (Labeling). Specific standards exist for categories like fruit juices (GB/T 31121) and tea drinks (GB/T 21733).
State Administration for Market Regulation (SAMR)
Beverages with alcohol content above 0.5% may be classified as alcoholic beverages, requiring different import licenses and facing higher tariffs.
4-8 months
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.
Key regulations and requirements for importing サプリメント・健康食品 from Japan
Dietary supplements in the US are regulated under DSHEA (Dietary Supplement Health and Education Act of 1994). Products must comply with FDA's Current Good Manufacturing Practices (cGMP) and may require a New Dietary Ingredient (NDI) notification. Health claims are strictly regulated.
Ensure the product does not contain ingredients classified as pharmaceuticals in Japan. Export requires confirmation that the product meets the destination country's supplement definition.
Ministry of Health, Labour and Welfare (MHLW)
Manufacturing facilities must be registered with FDA and comply with 21 CFR Part 111 (cGMP for dietary supplements). FDA may conduct inspections.
Food and Drug Administration (FDA)
If a dietary ingredient was not marketed in the US before October 15, 1994, an NDI notification must be submitted to FDA at least 75 days before marketing.
Food and Drug Administration (FDA)
Must include a 'Supplement Facts' panel (not Nutrition Facts), listing serving size, active ingredients with daily values, and other ingredients. Structure/function claims require FDA notification and disclaimer.
Food and Drug Administration (FDA)
Dietary supplements cannot claim to diagnose, treat, cure, or prevent any disease. Only structure/function claims are permitted (e.g., 'supports immune health'), and these require the disclaimer: 'This statement has not been evaluated by the FDA.'
Some ingredients common in Japanese supplements may not be permitted in the US. For example, certain botanical extracts may require NDI notification, and some ingredients may be classified as drugs rather than supplements.
6-12 months (NDI notification review takes 75+ days, cGMP audit, labeling compliance)
Importing dietary supplements (health foods) into China is one of the most challenging regulatory processes. Products claiming health benefits require SAMR 'Blue Hat' (保健食品) registration, which can take 2-5 years. Alternatively, some vitamin/mineral supplements can use the simplified filing (备案) process.
Determine whether the product is classified as a regular food, health food (保健食品), or new food ingredient in China. This classification dictates the entire regulatory pathway.
Ministry of Health, Labour and Welfare (MHLW)
Products making health function claims must undergo SAMR registration, including product testing at designated Chinese labs, clinical trials (for certain claims), and expert review. The 'Blue Hat' logo must appear on the label.
State Administration for Market Regulation (SAMR)
Imported vitamin and mineral supplements using ingredients from the approved filing list can use the simplified filing process (typically 3-6 months), avoiding the lengthy registration process.
State Administration for Market Regulation (SAMR)
Manufacturing facility must be registered with GACC in addition to the product-level registration/filing.
General Administration of Customs of China (GACC)
Blue Hat registration for imported health foods typically takes 2-5 years and costs $50,000-$200,000+. Many Japanese supplement companies choose to reformulate as 'regular foods' without health claims to avoid this process.
If the supplement contains ingredients not previously approved for use in China, a separate 'New Food Ingredient' approval must be obtained from the National Health Commission (NHC), adding another 1-2 years.
Filing route: 6-12 months | Registration (Blue Hat): 2-5 years
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.
Key regulations and requirements for importing スキンケア from Japan
The US cosmetics market was significantly reformed by the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. Effective since 2023-2024, MoCRA requires FDA facility registration, product listing, adverse event reporting, and GMP compliance for all cosmetics sold in the US.
Products must comply with Japan's cosmetics regulations. Ensure the product classification (cosmetic vs quasi-drug) and the appropriate export procedures.
Ministry of Health, Labour and Welfare (MHLW)
All facilities that manufacture or process cosmetics for the US market must register with FDA. Registration must be renewed annually. Deadline was December 29, 2023 for existing facilities.
Food and Drug Administration (FDA)
Each cosmetic product marketed in the US must be listed with FDA, including product category, ingredient list, and labeling information.
Food and Drug Administration (FDA)
Cosmetics must be manufactured in compliance with GMP requirements. FDA will recognize ISO 22716 (Cosmetics GMP) as a harmonized standard.
Food and Drug Administration (FDA)
Labels must include: product identity, net contents, ingredient list (INCI names, descending order), warning statements where required, and the name and address of the distributor or manufacturer.
Food and Drug Administration (FDA)
Serious adverse events must be reported to FDA within 15 business days. Companies must maintain adverse event records for 6 years.
Food and Drug Administration (FDA)
In the US, products that claim to treat or prevent disease, or affect the structure/function of the body, are classified as drugs (requiring NDA/OTC monograph compliance). Japanese skincare products with claims like 'anti-aging' or 'whitening' may need careful claim review to avoid drug classification.
Some ingredients permitted in Japanese cosmetics may be restricted or prohibited in the US. For example, certain UV filters, mercury compounds, and some preservatives have different regulatory status. MoCRA also bans intentional use of PFAS in cosmetics (effective 2025).
4-6 months (FDA facility registration, product listing, labeling compliance, GMP audit)
China's cosmetics market is regulated by NMPA under the Cosmetics Supervision and Administration Regulation (CSAR, effective 2021). Imported cosmetics require either registration (special cosmetics) or filing (general cosmetics). All imported products must have a designated Chinese Responsible Person (CRP).
China requires a Certificate of Free Sale (CFS) issued by Japan's competent authority, confirming the product is legally manufactured and sold in Japan.
Ministry of Health, Labour and Welfare (MHLW)
Regular skincare products (moisturizers, cleansers, toners) classified as 'general cosmetics' undergo a filing process. Filing requires: product formula, safety assessment report, product testing at NMPA-designated labs, Chinese label sample, and CRP authorization.
National Medical Products Administration (NMPA)
Every imported cosmetic must designate a CRP — a Chinese-registered company that is legally responsible for the product in China. The CRP handles filing/registration, post-market surveillance, and adverse event reporting.
National Medical Products Administration (NMPA)
Products must be tested at NMPA-designated testing institutions for: microbial limits, heavy metals, preservative efficacy, and safety assessment. Testing typically takes 2-4 months.
National Medical Products Administration (NMPA)
Labels must include: product name in Chinese, full ingredient list (INCI + Chinese names), net content, shelf life, CRP name and address, country of origin, and usage instructions in Chinese.
National Medical Products Administration (NMPA)
Since May 2021, general imported cosmetics can be exempt from animal testing if: (1) the product has been sold in another country/region for 3+ years with a good safety record, OR (2) the manufacturer holds certain international GMP certifications (ISO 22716). However, products flagged during post-market inspection may still require animal testing.
China maintains the IECIC (Inventory of Existing Cosmetic Ingredients in China). Ingredients not on this list are considered 'new cosmetic ingredients' and require a separate approval (registration or filing) that can take 1-3 years.
General cosmetics filing: 6-12 months | Special cosmetics registration: 12-24 months
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.
Key regulations and requirements for importing メイクアップ from Japan
Japanese makeup products are well-regarded globally. The US market requires compliance with MoCRA regulations and strict FDA color additive rules. Japan and the US have significantly different approved color additive lists, making reformulation a common requirement.
Products must comply with Japan's cosmetics standards. Color additives used must be verified against both Japanese and US approved lists.
Ministry of Health, Labour and Welfare (MHLW)
Same MoCRA requirements as skincare: facility registration, product listing, GMP compliance, and adverse event reporting.
Food and Drug Administration (FDA)
Color additives in cosmetics must be either FDA-certified (batch certification for synthetic colors like FD&C Red No. 40) or exempt from certification (e.g., iron oxides, titanium dioxide). Using non-approved colors renders the product adulterated under US law.
Food and Drug Administration (FDA)
Japan and the US have very different approved color additive lists. Many Japanese coal-tar colors (e.g., Red 202, Red 226, Blue 404) are NOT approved by FDA. Products may need reformulation with FDA-approved alternatives (e.g., FD&C colors, D&C colors). This is often the biggest hurdle for Japanese makeup exports.
While talc is permitted in both countries, MoCRA requires talc-containing products to undergo testing for asbestos contamination. Consider this when formulating pressed powders, eyeshadows, and foundations.
6-9 months (color additive reformulation may be needed, FDA registration, testing)
Japanese makeup products for the Chinese market follow the general cosmetics filing process under NMPA. Key considerations include ingredient compliance with IECIC, color additive approvals, and proper Chinese labeling. The CRP requirement applies to all imported makeup.
CFS required confirming the product is legally manufactured and sold in Japan.
Ministry of Health, Labour and Welfare (MHLW)
Standard makeup products (lipstick, foundation, eyeshadow, mascara) are classified as general cosmetics and require NMPA filing through a CRP.
National Medical Products Administration (NMPA)
Products must undergo testing at designated labs including microbiological testing, heavy metals analysis, and stability testing.
National Medical Products Administration (NMPA)
China has its own approved colorant list (《化妆品安全技术规范》). While there is more overlap with Japan's list than with the US, some Japanese-specific colorants may not be approved. All colorants must be cross-referenced with China's Technical Safety Standard for Cosmetics.
Under the 2021 CSAR, cosmetics making efficacy claims must provide substantiation through human efficacy tests, consumer perception tests, or literature reviews. Claims like 'anti-wrinkle' or 'brightening' require supporting data.
6-10 months (lab testing 2-4 months, filing review 2-3 months, label preparation)
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.
Key regulations and requirements for importing 医薬部外品 from Japan
Japan's 'quasi-drug' (医薬部外品) category does not exist in US law. Products may be classified as either OTC drugs or cosmetics depending on their claims and active ingredients. Medicated shampoos, sunscreens, and anti-acne products typically fall under OTC drug regulation.
Determine whether the product will be marketed as an OTC drug or cosmetic in the US. Prepare appropriate documentation including product formulation, efficacy data, and safety data.
Ministry of Health, Labour and Welfare (MHLW)
If classified as an OTC drug, the product must comply with applicable FDA OTC monograph (e.g., sunscreen monograph, acne monograph). Active ingredients must be listed in the monograph at specified concentrations.
Food and Drug Administration (FDA)
OTC drug manufacturers must register with FDA as a drug establishment and list all products. This is separate from the cosmetics registration under MoCRA.
Food and Drug Administration (FDA)
OTC drugs require a 'Drug Facts' panel listing active ingredients, uses, warnings, directions, and inactive ingredients in a specific format.
Food and Drug Administration (FDA)
Japanese quasi-drugs that make medicinal claims (whitening, hair growth, anti-dandruff) will likely be classified as OTC drugs in the US, requiring monograph compliance or an NDA. Reformulation may be necessary if the active ingredients are not in FDA OTC monographs.
6-18 months (classification determination, monograph compliance, possible reformulation, FDA registration)
Japan's quasi-drugs with cosmetic functions (whitening, sunscreen, anti-hair loss) are classified as 'special cosmetics' (特殊化妆品) in China, requiring full NMPA registration — a significantly longer and more expensive process than general cosmetics filing.
CFS plus detailed product documentation including full formula, manufacturing process, and efficacy/safety data required for NMPA registration.
Ministry of Health, Labour and Welfare (MHLW)
Special cosmetics (whitening, sunscreen, hair dye, hair perm, anti-hair loss, breast care, body odor) require NMPA registration. This includes technical review, human safety and efficacy testing, and expert panel review.
National Medical Products Administration (NMPA)
Special cosmetics require more extensive testing than general cosmetics, including SPF/PA testing for sunscreens, human patch tests, and efficacy evaluation.
National Medical Products Administration (NMPA)
NMPA special cosmetics registration typically takes 12-24 months. The process includes: sample preparation and submission, lab testing (3-6 months), technical review (3-6 months), and administrative review. Budget $30,000-$80,000+ per product.
Some Japanese quasi-drugs can be reformulated or repositioned as 'general cosmetics' in China by removing medicinal claims or active ingredients. This avoids the lengthy special cosmetics registration. Consult with a Chinese regulatory specialist.
12-24 months for special cosmetics registration
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.
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