Japanese Food Safety Standards: HACCP, JAS & Export Requirements

Japan operates one of the most rigorous and multi-layered food safety systems in the world. Built on decades of regulatory evolution — driven by consumer expectations, domestic food incidents, and alignment with international standards — the system today encompasses legislation, certification programs, inspection regimes, and traceability requirements that collectively produce food products trusted by consumers on every continent.

For international buyers and brand owners sourcing products through Japanese OEM (Original Equipment Manufacturing) partners, understanding this system is not optional. It is the foundation of the quality promise that makes "Made in Japan" a powerful differentiator in global food markets. More practically, understanding Japan's food safety framework helps you evaluate OEM partners, anticipate compliance costs, and avoid costly delays when exporting to regulated markets like the United States, the European Union, China, and Southeast Asia.

The Regulatory Architecture

Japan's food safety system rests on four primary pillars, each governed by distinct legislation and enforced by different government bodies:

• The Food Sanitation Act (食品衛生法) — Administered by the Ministry of Health, Labour and Welfare (MHLW), this is the cornerstone of Japanese food safety law. It covers hygiene standards, food additives, contaminant limits, and — since its 2018 revision — mandatory HACCP-based sanitation management for all food businesses.
• The Food Labeling Act (食品表示法) — Enforced by the Consumer Affairs Agency (CAA), this law consolidates labeling requirements from three formerly separate statutes. It governs nutrition facts panels, allergen declarations, ingredient lists, origin labeling, and use-by/best-before date marking.
• The JAS Act (日本農林規格等に関する法律) — Overseen by the Ministry of Agriculture, Forestry and Fisheries (MAFF), this act governs voluntary quality and process standards, most notably JAS Organic certification and various Special JAS standards for production methods and handling.
• The Food Safety Basic Act (食品安全基本法) — This framework law established the Food Safety Commission of Japan (FSC) as an independent risk-assessment body. The FSC conducts scientific evaluations that inform regulatory decisions made by MHLW and MAFF.

How the System Works in Practice

In practice, every food manufacturing facility in Japan must obtain a business license from the local public health center (保健所). The license application triggers an inspection of facilities, equipment, and operational procedures. Once licensed, the business is subject to periodic inspections and must maintain HACCP-based management plans. Separate certifications — JAS Organic, FSSC 22000, ISO 22000, halal, kosher — are voluntary but increasingly important for export-oriented manufacturers.

The result is a baseline standard of food safety in Japan that often exceeds what is legally mandated in other producing countries. When you partner with a licensed Japanese OEM manufacturer, you inherit the benefits of this system. The sections that follow break down each major component so you can evaluate what your OEM partner must have, what additional certifications to look for, and what extra steps are needed to meet the requirements of your specific export destination.

If you are new to the Japanese OEM model, we recommend reading our companion article How to Start a Food Brand with Japanese OEM for a step-by-step overview of the entire product launch process.

Hazard Analysis and Critical Control Points (HACCP) is a systematic approach to food safety that identifies, evaluates, and controls biological, chemical, and physical hazards throughout the production process. While HACCP originated in the United States in the 1960s for the NASA space program, it has become the global gold standard for food safety management. In Japan, HACCP transitioned from a voluntary certification to a legal mandate through the 2018 revision of the Food Sanitation Act, with full enforcement beginning on June 1, 2021.

What the Mandate Requires

Since June 2021, all food businesses in Japan — manufacturers, processors, packagers, and food service operators — are required to implement sanitation management based on HACCP principles. The law establishes two tiers of compliance:

• HACCP-based sanitation management (HACCPに基づく衛生管理) — Required for larger food businesses, including virtually all OEM manufacturers. This is a full HACCP implementation encompassing hazard analysis, identification of critical control points (CCPs), establishment of critical limits, monitoring procedures, corrective actions, verification procedures, and documentation.
• Simplified HACCP approach (HACCPの考え方を取り入れた衛生管理) — Available to small-scale businesses with fewer than 50 employees and limited product ranges. These businesses follow industry-specific guidelines rather than developing full HACCP plans from scratch.

For anyone sourcing from a Japanese OEM manufacturer, this means your production partner is legally required to operate under HACCP principles. There is no "non-HACCP" option among licensed manufacturers in Japan. This mandatory baseline is a significant advantage compared to sourcing from countries where HACCP remains voluntary.

HACCP vs. Third-Party Certification

An important distinction that many international buyers misunderstand: Japan's mandatory HACCP is a regulatory requirement verified through government inspections — it is not the same as holding a third-party HACCP certification from bodies like SGS, Bureau Veritas, or the Japan Food Industry Association. The legal mandate ensures a minimum standard, but third-party certifications demonstrate a higher level of documentation, audit rigor, and continuous improvement.

For export purposes, many international retailers and distributors require suppliers to hold a GFSI-benchmarked certification — such as FSSC 22000, SQF, or BRC. These build on HACCP principles but add requirements for management systems, prerequisite programs, and supply chain controls. If your target market requires GFSI recognition, confirm that your OEM partner holds one of these certifications in addition to meeting the domestic HACCP mandate.

The Seven HACCP Principles in Japanese Manufacturing

Japanese food manufacturers implement HACCP through these internationally recognized principles, adapted to Japan's regulatory framework:

1. Conduct hazard analysis — Identify biological hazards (pathogens, parasites), chemical hazards (allergens, cleaning agents, heavy metals), and physical hazards (metal fragments, glass, foreign objects) at each step of production.
2. Determine Critical Control Points (CCPs) — Identify the specific points in the process where control is essential to prevent, eliminate, or reduce hazards to acceptable levels. In Japanese food manufacturing, common CCPs include metal detection, heat sterilization (retort processing), cold chain management, and pH control.
3. Establish critical limits — Set measurable thresholds for each CCP. For example, retort processing might require a core temperature of 121°C maintained for 4 minutes.
4. Establish monitoring procedures — Define how each CCP will be monitored, by whom, and at what frequency. Japanese manufacturers typically use a combination of automated sensors, manual checks, and digital recording systems.
5. Establish corrective actions — Specify what happens when a critical limit is breached. This includes isolating affected product, identifying the root cause, and documenting the incident and resolution.
6. Establish verification procedures — Confirm that the HACCP system is working effectively through periodic reviews, calibration checks, and internal audits.
7. Establish documentation and record keeping — Maintain comprehensive records of hazard analyses, CCP monitoring, corrective actions, and verification activities. Japanese manufacturers are known for meticulous record keeping, and digital traceability systems are increasingly common.

What to Ask Your OEM Partner About HACCP

When evaluating a Japanese OEM manufacturer, ask these specific questions about their HACCP implementation:

• Can you provide a copy of your HACCP plan for the product category we are discussing?
• How many CCPs does your production line for this product type have, and what are they?
• Do you hold any third-party food safety certifications (FSSC 22000, ISO 22000, SQF, BRC)?
• When was your most recent food safety audit, and what was the result?
• How do you handle product recalls or traceability requests?

A confident, transparent OEM partner will answer these questions readily. Hesitation or vagueness may indicate a less mature food safety culture.

The Food Sanitation Act (食品衛生法, Shokuhin Eisei-hō) is the legal backbone of food safety in Japan. Originally enacted in 1947 and substantially revised in 2018, this law governs virtually every aspect of food production, from the licensing of manufacturing facilities to the permissible limits of food additives and contaminants. For international buyers working with Japanese OEM partners, the Food Sanitation Act is the primary law that ensures the products you source meet world-class safety standards.

Key Provisions Relevant to OEM Sourcing

Business Licensing

Every food manufacturing business in Japan must obtain a license from the prefectural governor (in practice, administered by local public health centers). The licensing process requires demonstrating that facilities, equipment, water supply, and waste management meet prescribed standards. A licensed manufacturer has already passed an infrastructure inspection — this is your first line of assurance when selecting an OEM partner. Always confirm that your partner holds a valid and current food manufacturing business license (食品製造業許可).

Food Additives (Positive List System)

Japan operates a "positive list" system for food additives, meaning only substances explicitly approved by the MHLW may be used. As of 2026, Japan recognizes approximately 830 designated additives, 365 existing additives (substances with a long history of use in Japan), and various natural flavoring substances and general-purpose additives. This list differs significantly from the US FDA's GRAS (Generally Recognized as Safe) list and the EU's approved additives list. A food additive approved in your home market may not be permitted in Japan, and vice versa. This is critically important when formulating products with a Japanese OEM — both the Japanese domestic label and your export market's regulations must be satisfied simultaneously.

Residue Standards (Positive List for Agricultural Chemicals)

Japan implemented a "positive list" system for pesticide residues in 2006, setting Maximum Residue Limits (MRLs) for approximately 800 agricultural chemicals across hundreds of food commodities. Any pesticide-food combination not explicitly listed is subject to a "uniform limit" of 0.01 ppm — one of the strictest default standards in the world. This means raw materials used by your Japanese OEM partner are tested against extremely tight residue limits.

Contaminant Limits

The Act sets maximum levels for heavy metals (lead, cadmium, mercury, arsenic), mycotoxins (aflatoxins, deoxynivalenol), radioactive substances (following the 2011 Fukushima incident, Japan maintains some of the world's strictest limits at 100 Bq/kg for general foods), and microbiological criteria for specific food categories.

Facility and Equipment Standards

Manufacturing facilities must comply with standards covering building construction, ventilation, lighting, water supply, waste water treatment, pest control, equipment materials (food-contact surfaces), cleaning and sanitation procedures, and temperature management. These standards are verified during the initial licensing inspection and subsequent periodic inspections by public health center officials.

The 2018 Revision: Modernizing the Act

The 2018 revision brought several major changes that directly affect OEM manufacturing:

• Mandatory HACCP — As detailed in the previous section, all food businesses must now implement HACCP-based sanitation management.
• Positive list for food utensils and containers — Materials that come into contact with food (packaging films, trays, bottles) are now governed by a positive list system similar to the EU approach, replacing the previous negative list. This ensures your OEM partner's packaging materials meet safety standards.
• Enhanced recall reporting — Food businesses must report voluntary recalls to the appropriate authorities, and these reports are published on a centralized database. This transparency benefits brand owners who can monitor their OEM partner's recall history.
• Revised business license categories — The number of business license categories was consolidated from 34 to 32, with clearer definitions. This simplifies the process of confirming what types of food your OEM partner is legally authorized to manufacture.

The Japanese Agricultural Standards (JAS) system is a voluntary certification framework administered by the Ministry of Agriculture, Forestry and Fisheries (MAFF). While JAS certification is not legally required to manufacture or sell food in Japan, certain JAS marks — particularly JAS Organic — carry significant commercial value domestically and, crucially, enable streamlined organic recognition in major export markets through mutual recognition agreements.

JAS Organic (有機JAS)

JAS Organic certification is Japan's official organic standard for agricultural products, processed foods, and livestock products. To display the JAS Organic mark, products must be certified by a MAFF-registered certification body and meet standards that include:

• Agricultural products must be grown without synthetic pesticides or chemical fertilizers for at least two years (three years for perennial crops) prior to harvest.
• Processed organic foods must use at least 95% organic ingredients (by weight, excluding water and salt), and processing aids and additives are limited to a specified positive list.
• The entire supply chain — from raw material suppliers through the manufacturing facility — must be covered by organic certification. Segregation from non-organic products must be documented at every stage.
• Annual audits by the registered certification body are required to maintain the certification.

Mutual Recognition Agreements: A Major Export Advantage

One of the most valuable aspects of JAS Organic certification for export-oriented brands is Japan's network of mutual recognition agreements (also called equivalence agreements) with major markets:

• United States (USDA NOP) — Products certified as JAS Organic can be sold as "organic" in the US without separate USDA organic certification, and vice versa. This agreement has been in effect since 2014.
• European Union — Japan and the EU recognize each other's organic standards as equivalent. JAS Organic products can be imported into the EU and marketed as organic, subject to specific documentary requirements.
• Canada (COR) — Similar mutual recognition allows JAS Organic products to be sold as organic in Canada.
• Switzerland, United Kingdom, and others — Additional equivalence arrangements extend the reach of JAS Organic certification.

This means that if your Japanese OEM partner holds JAS Organic certification, the products they manufacture for you can potentially be sold as organic in multiple major markets with a single certification. This represents a substantial cost and time saving compared to obtaining separate organic certifications for each market. For detailed cost analysis of organic production, see our Japanese Food OEM Cost & Pricing Guide.

Special JAS and Specific JAS

Beyond organic certification, the JAS system includes additional voluntary standards:

• Special JAS (特色JAS) — Certifies specific production methods or qualities, such as "Ji-dori" (地鶏, free-range regional chicken breeds), aged ham, or handmade products. These standards highlight differentiated production methods that go beyond standard quality.
• Specific JAS (特定JAS) — Covers process standards for particular product categories. Examples include standards for matured meats and traditionally-produced products.
• JAS for Testing Methods — Standardized analytical methods for testing food composition, ensuring consistent and reliable quality assessment across different laboratories.
• JAS for Handling — Standards for the handling, storage, and distribution of food products, including temperature management and freshness preservation requirements.

What JAS Means for Your OEM Partnership

If you intend to market your product as organic in Japan or in any of the mutually recognized markets, your OEM partner must hold JAS Organic certification for the specific product categories you are manufacturing. Importantly, organic certification applies to the facility and the process, not just the finished product — you cannot take a non-organic-certified manufacturer and simply supply organic ingredients.

When evaluating OEM partners on our platform, you can filter by JAS Organic certification status. Manufacturers who already hold this certification can begin organic production relatively quickly (typically adding a new SKU within 1–2 months), while a manufacturer seeking new JAS Organic certification typically faces a 3–6 month process including documentation preparation, facility adjustments if needed, and the certification audit itself.

The Food Labeling Act (食品表示法, Shokuhin Hyōji-hō), enacted in 2015, consolidated food labeling requirements from three previously separate laws: the Food Sanitation Act, the JAS Act, and the Act against Unjustifiable Premiums and Misleading Representations. This unified framework governs all consumer-facing food labels in Japan and is enforced by the Consumer Affairs Agency (CAA). For brand owners working with Japanese OEM manufacturers, the Food Labeling Act defines what must appear on your product label for the Japanese domestic market and influences how your product formulation is documented for export labels.

Mandatory Label Elements for Processed Foods

Every processed food product sold in Japan must display the following information on its label, in Japanese:

• Product name (名称) — A descriptive name that accurately represents the product (e.g., "Retort Curry" not just a brand name).
• Ingredient list (原材料名) — All ingredients listed in descending order of weight percentage, including food additives listed separately after a dividing slash (/) or on a new line. Compound ingredients must be broken down into their components.
• Allergen declarations (アレルゲン表示) — Mandatory declaration of specified allergens (detailed below).
• Net content (内容量) — Weight, volume, or count as appropriate, in metric units.
• Best-before or use-by date (賞味期限/消費期限) — "Best-before" (賞味期限) for shelf-stable products; "Use-by" (消費期限) for perishable items with a shelf life of approximately 5 days or less.
• Storage instructions (保存方法) — Required storage conditions (e.g., "Store below 10°C," "Store in a cool, dark place").
• Manufacturer or seller information (製造者/販売者) — Name and address of the manufacturer, or the seller's name and address with a manufacturer code.
• Nutrition facts panel (栄養成分表示) — Mandatory since April 2020, displaying per-serving or per-100g values for energy (kcal), protein, fat, carbohydrate, and sodium (expressed as salt equivalent in grams, not milligrams of sodium — a unique Japanese requirement).

Allergen Labeling: Japan's Unique System

Japan's allergen labeling system differs significantly from those in the US, EU, and other markets. Understanding these differences is essential for formulation and cross-market labeling compliance.

Mandatory Allergens (特定原材料 — 8 items)

These allergens must be declared on every food label by law. As of 2025, when walnuts were elevated from the recommended list, the mandatory eight are:

1. Wheat (小麦)
2. Buckwheat / Soba (そば)
3. Eggs (卵)
4. Milk (乳)
5. Peanuts (落花生)
6. Shrimp (えび)
7. Crab (かに)
8. Walnuts (くるみ) — elevated to mandatory in 2025

Recommended Allergens (特定原材料に準ずるもの — 20 items)

Declaration is strongly recommended but not legally required for these 20 items, which include: abalone, squid, salmon roe, oranges, cashew nuts, kiwifruit, beef, sesame, salmon, mackerel, soybeans, chicken, banana, pork, matsutake mushroom, peach, yam, apple, gelatin, and almonds. Most responsible manufacturers declare these recommended allergens as well, and as a brand owner you should insist on comprehensive allergen declaration to protect consumers and limit liability.

Key Differences from Other Markets

Notable differences from US and EU allergen labeling include:

• Buckwheat and shrimp/crab are mandatory in Japan but not specifically listed in the US "Big 9" or the EU's 14 allergens (though crustaceans are covered in both).
• Tree nuts — The US requires declaration of all tree nuts as a group; Japan specifies walnuts (mandatory), cashew nuts, and almonds (recommended) individually.
• Sesame — Mandatory in the EU and newly mandatory in the US (as of 2023), but only "recommended" (not mandatory) in Japan.
• Precautionary labeling ("May contain") — Japan discourages vague precautionary allergen statements. Instead, manufacturers are expected to prevent cross-contact through production management, or to declare the allergen in the ingredient list if cross-contact cannot be ruled out.

When developing products with a Japanese OEM for export, work closely with your manufacturer to create an allergen matrix that satisfies both Japanese domestic requirements and your target market's allergen regulations simultaneously. This is particularly important for products destined for the US, EU, or Australian markets where allergen lists differ from Japan's.

Manufacturing a product that meets Japanese domestic standards is only half the equation if you intend to sell internationally. Each export destination imposes its own food safety regulations, labeling requirements, and import procedures. This section covers the key requirements for the four most important export regions for Japanese food products: the United States, the European Union, China, and the ASEAN bloc. For a broader overview of launching a food brand, see our guide on starting a food brand with Japanese OEM.

United States (FDA Requirements)

The US is one of the largest markets for Japanese food exports. All food imported into the United States must comply with the Federal Food, Drug, and Cosmetic Act, enforced by the Food and Drug Administration (FDA).

• Facility Registration — The manufacturing facility in Japan must be registered with the FDA under the Bioterrorism Act. Registration is free, done online, and must be renewed every two years (during even-numbered years).
• Prior Notice — Before each shipment arrives, a Prior Notice must be filed with the FDA, typically by the customs broker or importer. This provides details of the product, manufacturer, shipper, and expected arrival.
• Food Safety Modernization Act (FSMA) — The Foreign Supplier Verification Program (FSVP) requires US importers to verify that their foreign suppliers (your Japanese OEM) meet US food safety standards. Your US importer will need documentation from the manufacturer demonstrating HACCP compliance, allergen controls, and other preventive measures. Japanese manufacturers already operating under HACCP and holding FSSC 22000 certification typically satisfy FSVP requirements with existing documentation.
• Nutrition Facts Label — US nutrition labeling differs significantly from Japanese nutrition labeling. The US requires specific serving sizes based on Reference Amounts Customarily Consumed (RACC), mandatory declaration of total fat, saturated fat, trans fat, cholesterol, total carbohydrate, dietary fiber, total sugars, added sugars, vitamin D, calcium, iron, and potassium — far more nutrients than Japan's five-item requirement. The label format (the familiar "Nutrition Facts" box) is also strictly prescribed.
• Food Additive Compliance — Ensure all additives used in your product are approved under the US system (GRAS or approved food additive). Some additives permitted in Japan are not approved in the US, and vice versa. Common discrepancies include certain colorings, sweeteners, and preservatives.
• USDA Organic (if applicable) — If marketing as organic, JAS Organic certification is recognized through the US-Japan organic equivalency arrangement, but the product label must display the USDA Organic seal in addition to or instead of the JAS mark for the US market.

European Union

The EU food safety framework, anchored by the General Food Law (Regulation EC No. 178/2002) and enforced through the European Food Safety Authority (EFSA), is among the world's most stringent.

• HACCP and Food Hygiene — The EU requires all food business operators in the supply chain to implement HACCP. Japanese manufacturers' mandatory HACCP compliance satisfies this requirement in principle, but EU importers may request additional documentation or third-party audit reports (FSSC 22000, BRC, IFS).
• Contaminant Limits — EU Maximum Levels for contaminants (heavy metals, mycotoxins, processing contaminants like acrylamide) are often stricter than Japanese standards for certain substances. Verify specific limits for your product category under EU Regulation 2023/915.
• Food Additives — The EU positive list for food additives (Regulation EC No. 1333/2008) is more restrictive than Japan's in many categories. Certain colorings widely used in Japanese food (e.g., some synthetic azo dyes) require warning labels in the EU or may be prohibited entirely. Cross-check every additive in your formulation against the EU authorized list.
• Allergen Labeling — The EU mandates declaration of 14 allergens, which overlap with but differ from Japan's list. Notably, the EU includes celery, mustard, lupin, and mollusks, which are not on Japan's mandatory or recommended list.
• Novel Foods — Any food not commonly consumed in the EU before May 1997 requires novel food authorization. Some traditional Japanese ingredients (certain algae, fermented products, or functional ingredients) may be classified as novel foods in the EU and require pre-market approval — a process that can take 18–24 months.
• Organic Equivalency — JAS Organic certification is recognized as equivalent by the EU, simplifying organic imports. Specific documentation requirements (Certificate of Inspection) must accompany each shipment.

China (GACC Registration)

China is the fastest-growing destination for Japanese food exports, but its regulatory requirements have become significantly more complex in recent years under the General Administration of Customs of China (GACC).

• GACC Facility Registration — Since January 2022, all overseas food manufacturers exporting to China must be registered with GACC. For 18 categories of "high-risk" products (including meat, dairy, seafood, and certain grains), registration must be done through the Japanese government authority (MAFF or MHLW). For other categories, manufacturers can self-register through the GACC online system.
• Chinese Label Requirements — All imported food must carry a Chinese-language label (中文标签) affixed before or at the time of customs clearance. This label must include product name, ingredients, net content, production date, shelf life, storage conditions, importer name and address, and origin country. For health-functional foods, additional pre-market registration (蓝帽子, "Blue Hat" registration) is required.
• GB Standards — China's national food safety standards (GB standards) govern maximum levels for additives, contaminants, and microbiological criteria. Some GB limits differ from Japanese standards — for example, limits for certain preservatives or maximum microbial counts may be more or less restrictive depending on the product category.
• Import Restrictions — China periodically imposes or adjusts import restrictions on Japanese food products from certain prefectures, particularly related to concerns following the Fukushima nuclear incident of 2011 and the treated water release that began in 2023. These restrictions change over time, so always verify the current status of prefecture-specific restrictions before planning production with an OEM partner located in a potentially affected area.

ASEAN Markets (Southeast Asia)

The ten ASEAN member states — Singapore, Thailand, Vietnam, Indonesia, Malaysia, the Philippines, Myanmar, Cambodia, Laos, and Brunei — represent a large and growing market for Japanese food products, but each country maintains its own food safety regulations. Products targeting ASEAN markets have particular considerations:

• Halal Certification — Essential for Muslim-majority markets (Indonesia, Malaysia, Brunei) and commercially advantageous across the region. Indonesia requires halal certification through BPJPH (Badan Penyelenggara Jaminan Produk Halal) for most imported food products. Malaysia's JAKIM is the recognized halal authority. Your Japanese OEM partner must either hold halal certification from a body recognized by the target country's authority or be willing to obtain it. Halal certification covers ingredients, processing, storage, and logistics — it is a facility-wide commitment, not just a label.
• Singapore (SFA) — The Singapore Food Agency requires import permits, and specific product categories (meat, fish, dairy, eggs) require additional SFA approval. Singapore generally aligns with Codex Alimentarius standards and recognizes many international certifications.
• Thailand (Thai FDA) — Imported food must be registered with the Thai FDA, and labels must include Thai-language information. Certain categories require specific import licenses.
• Vietnam (NAFIQAD/Ministry of Health) — Pre-market registration and Vietnamese-language labeling are required. Health supplements and functional foods require additional registration with the Vietnam Food Administration.
• ASEAN Harmonization — While efforts to harmonize food safety standards across ASEAN are ongoing (e.g., the ASEAN MRA on prepared foodstuff inspection and certification systems), significant differences remain between member states. Do not assume that compliance in one ASEAN market automatically qualifies you for another.

For products like matcha and green tea, which face specific export considerations, see our detailed Matcha & Green Tea OEM guide. For supplements and health foods with unique regulatory pathways, refer to our Japanese Supplements Private Label guide.

Understanding Japan's food safety regulations is essential, but knowledge alone does not protect your brand. You must actively verify that your OEM manufacturing partner meets the standards your product and target market require. This section provides a practical framework for evaluating and continuously monitoring your OEM partner's compliance posture.

Pre-Contract Due Diligence Checklist

Before signing a manufacturing agreement, work through this verification checklist:

1. Confirm Licensing and Registration

• Request a copy of the manufacturer's food manufacturing business license (食品製造業許可) issued by the local public health center. Verify the license is current and covers the product categories you intend to manufacture.
• If exporting to the US, confirm FDA facility registration and request the registration number.
• If exporting to China, confirm GACC registration status and number.
• If exporting to ASEAN, confirm any required country-specific facility registrations.

2. Review Food Safety Certifications

• Request copies of all food safety certifications (FSSC 22000, ISO 22000, SQF, BRC, HACCP third-party certification).
• Verify certification validity dates — certifications expire and must be renewed through surveillance audits.
• Check whether the certification scope covers your specific product category. A manufacturer may hold FSSC 22000 for beverages but not for confectionery, for example.
• If organic production is needed, confirm JAS Organic certification and verify the certification body is MAFF-registered.
• If halal production is needed, confirm the certifying body is recognized by your target market's halal authority (e.g., JAKIM for Malaysia, MUI/BPJPH for Indonesia).

3. Request a Factory Audit or Visit

• For significant production contracts, conduct or commission a factory audit. Many Japanese OEMs welcome customer audits as a sign of professionalism. If travel is not possible, request a virtual factory tour or a recent third-party audit report.
• During the audit, pay attention to: hygiene practices on the production floor, segregation of allergens and organic/non-organic production, temperature monitoring systems, pest control measures, cleaning schedules and chemical management, traceability systems (can they trace a finished product back to specific raw material lots?), and the overall condition and age of equipment.

4. Review Documentation and Record-Keeping

• Request sample documentation: a Certificate of Analysis (COA) from a recent production run, a product specification sheet (製品仕様書), and allergen management procedures.
• Evaluate the manufacturer's traceability system. Can they provide full traceability from raw material receipt to finished product shipment within a reasonable time frame? Japanese law requires this capability, and well-managed facilities can typically complete a traceability exercise within hours.
• Ask about their recall history. A manufacturer who has never handled a recall may have less-tested crisis management procedures than one who has successfully managed a minor incident.

Ongoing Monitoring

Compliance verification does not end when you sign the contract. Implement these ongoing monitoring practices:

• Certificate of Analysis (COA) for every lot — Require your OEM partner to provide a COA with every production lot, including microbiological test results, weight/volume verification, and any agreed-upon chemical analyses.
• Annual certification review — Calendar reminders to request updated copies of all food safety certifications and business licenses before they expire.
• Periodic site visits — Aim for at least one site visit per year. Unannounced visits, while uncommon in Japanese business culture, are your right as a customer and can be negotiated into your manufacturing agreement.
• Regulatory change monitoring — Food safety regulations evolve. Subscribe to updates from relevant authorities (MHLW, CAA, FDA, EU Commission) or work with a regulatory consultant who monitors changes that could affect your product or labeling.
• Consumer feedback tracking — Monitor customer complaints and market feedback for any quality or safety signals. Share this information with your OEM partner as part of a continuous improvement process.

Red Flags to Watch For

During your evaluation and ongoing relationship, be alert to these warning signs:

• Reluctance to share certifications, audit reports, or HACCP documentation.
• Expired certifications or licenses with vague explanations about renewal timelines.
• Inability to demonstrate traceability within a reasonable timeframe.
• Resistance to customer audits or factory visits.
• Inconsistent product quality across production lots without clear explanation.
• Lack of documented allergen management procedures.
• No dedicated quality control staff or department.

A transparent, quality-focused OEM partner will welcome your due diligence efforts as evidence of a professional business relationship. Partners who resist scrutiny may not be the right fit for your brand, regardless of their pricing. The OEM JAPAN platform provides verified certification data for listed manufacturers, giving you a reliable starting point for your evaluation. Use our cost and pricing guide to understand the full financial picture when comparing partners.