Imported Food Violations — Cases and Practical Import Response

Import Food Violation Cases at the Time of Import

Import food violation cases at the time of import refer to instances where non-compliance with the Food Sanitation Act is confirmed during Quarantine Station import notification review or import inspection processes for food, food additives, utensils, containers and packaging, infant toys, and similar items.

The Ministry of Health, Labour and Welfare publishes confirmed violation cases found at import, providing practical information such as product name, manufacturing and exporting country, manufacturer, details of the violation, Quarantine Station, measures taken, and inspection category.

Violation cases are not merely historical administrative records.

They serve as risk information to help importers, overseas manufacturers, customs brokers, freight forwarders, and quality control personnel identify ingredients, additives, residual pesticides, veterinary drugs, microorganisms, manufacturing processes, containers and packaging, and the presence or absence of inspection orders to be checked before import.

However, the existence of violation cases for specific countries, regions, manufacturers, or products alone should not lead to the blanket judgment that all products from those countries or businesses are hazardous.

In practice, prioritization for pre-import confirmation is determined by combining factors such as country of origin, product type, manufacturer, raw materials, manufacturing process, violation items, inspection category, and recurrence prevention status.

Scope Covered in This Article

Item	Contents Covered in This Article	Items Requiring Individual Confirmation
Violation Cases	How to read and utilize Ministry of Health, Labour and Welfare published materials	Individual cases of the latest month/year
Food Additives	Non-designated additives, usage standards, target foods, residual amounts	Individual additives and product-specific standards
Residual Pesticides	Exceeding standards, uniform standards, raw material and production-stage verification	Pesticide-specific and food-specific residue standards
Veterinary Drugs	Residue risks in seafood, livestock products, etc.	Substance-specific standards and usage history
Microorganisms	Component standards for frozen foods, heated foods, etc.	Food-specific test items and evaluation criteria
Harmful/Toxic Substances	Aflatoxins, natural toxins, putrefaction, deterioration, etc.	Hazards and testing methods by product
Instruments, Containers, Packaging, etc.	Material and standard criteria, toys for infants and toddlers	Individual materials and testing methods
Notification Form for Importation of Foods, etc.	Submission destination, submission timing, entry items, review process	Attachment documents for individual products
Inspection Categories	Inspection orders, guidance inspections, voluntary inspections, monitoring inspections	Target items, inspection items, inspection institutions
Inspection Orders	Concept of activation, inspection of all lots, cancellation mechanism	Latest target countries, items, and inspection items
Measures After Violations	Disposal, Re-export, recall, sales suspension, cause investigation	Individual Quarantine Station and local government instructions
Food Recalls	Connection with domestic voluntary recall notification system after distribution	Target notifications, exclusions, class classification
Freight Forwarders	Logistics information, coordination of storage, inspection, and Re-export	Final judgment on compliance with the Food Sanitation Act

Purpose of Reviewing Violation Cases

Purpose of Review	Information to Confirm	Pre-Import Measures	Consequences if Overlooked
Understanding Item Risk	Details and frequency of violations of similar food items	Determine priority inspection items	Delay in arranging inspections after arrival
Country/Region Trends	Country of manufacture, export country, origin of raw materials	Confirm pesticide, pharmaceutical, and hygiene controls	Overlook risks unique to the supplying country
Manufacturer-Specific Trends	Manufacturer name, past violations, improvement status	Consider factory audits and pre-shipment inspections	Reoccurrence of issues from the same causes
Verification of Ingredients and Additives	Non-permitted additives, usage amount, purpose	Obtain formulation sheets and specification documents	Import may be denied even if appearance is normal
Logistics Planning	Inspection category, corrective measures, Quarantine Station	Ensure bonded storage, temperature control, and schedule margin	Increased storage fees, demurrage, and detention charges
Contract Terms	Cause of violation, measures taken, importer’s responsibility	Establish intellectual property and regulatory compliance guarantees, indemnity clauses	Disputes due to disposal or return costs

Main Information Confirmed from Violation Cases

Information	Practical Significance	Points to Note When Verifying
Product Name	Identify the food/additives involved in the violation	Check not only the product name but also the food category and processing state
Country of Manufacture/Export	Verify trends at the production and export stages	Raw material origin and country of manufacture may differ
Manufacturer	Assess recurrence risk by factory	Be aware of variations in naming, factory relocations, and group companies
Violated Regulation / Details	Understand ingredient standards, additives, harmful substances, etc.	Confirm the relationship between detected values and regulatory limits
Inspection Type	Identify which inspection detected the violation	Inspection orders and monitoring inspections have different logistics impacts
Quarantine Station	Know the office responsible for notification and inspection	The Quarantine Station handling the next import may differ
Measures	Confirm outcomes such as disposal, Re-export, or recall	Preliminary information may be released before measures are completed

Main Types of Violations

Violation Type	Commonly Problematic Foods, etc.	Main Verification Documents	Impact on Import & Logistics
Unapproved Additives / Usage Standards Violation	Confectionery, Beverages, Seasonings, Processed Foods, Health Foods	Formulation Sheet, Additives List, Specifications	Disposal, Re-export, Reformulation
Pesticide Residue Standard Violation	Agricultural Products, Spices, Tea, Processed Raw Materials	Pesticide Usage Records, Test Certificates	Enhanced Inspections, Inspection Orders
Veterinary Drug Standards Violation	Marine Products, Livestock Products, Aquaculture Products	Medication Records, Withdrawal Periods, Analysis Results	Full Lot Inspection, Supply Suspension
Microbiological Component Standards Violation	Frozen Foods, Meat Products, Processed Marine Products, Confectionery	Process Charts, Heating Records, Microbiology Tests	Bonded Detention, Temperature Control Costs
Harmful/Toxic Substances	Nuts, Grains, Spices, Seafood, etc.	Raw Material Management, Lot Analysis, Origin Certificates	May Result in Immediate Inspection Orders
Spoilage, Deterioration, Mold	Fresh Products, Grains, Dried Goods, Temperature-Controlled Products	Temperature Records, Cargo Photos, Incident Reports	Response Required for Both Cargo Incident and Food Sanitation Violations
Equipment/Packaging Standards Violation	Tableware, Cooking Utensils, Food Containers, Packaging Materials	Material Certification, Test Reports	Import Prohibition on Containers or Packaging Even if Food is Compliant
Hygiene Certificate Deficiency	Meat, Meat Products, Pufferfish, etc.	Hygiene Certificates Issued by Government Agencies	Import Procedures Delayed Due to Document Shortages

Violations Related to Food Additives

Even additives permitted overseas cannot be used in principle if they are not designated additives in Japan.

For additives allowed in Japan, violations may occur if the target food, purpose of use, usage amount, residual amount, or method of use does not comply with the specified standards.

Importers should not rely only on overseas labels but must check ingredient lists, additive lists, blending ratios, carry-over, processing aids, flavorings, colorings, preservatives, and other such details.

Additives contained in composite ingredients and substances treated as processing aids by the manufacturer but not disclosed on the label are also subject to verification.

Violations Related to Residual Pesticides and Veterinary Drugs

For agricultural products, marine products, livestock products, and processed foods using these as raw materials, pesticides, feed additives, aquaculture drugs, antimicrobial agents, and veterinary drugs used during the production stage affect Japan’s residue standards.

Even for the same product, risks vary depending on the production area, cultivation period, farm or aquaculture site, raw material lot, and the chemicals used.

It is important to review past violation cases and inspection order targets, and as needed, conduct pre-shipment lot inspections, obtain pesticide application records, medication records, withdrawal periods, and analytical certificates.

Violations Related to Microbiological Standards

In frozen foods, cooked foods, meat products, processed seafood, confectionery, etc., component standards such as total viable count, coliform group, E. coli, and pathogenic microorganisms specific to each type of food may be the issue.

Causes include raw material contamination, insufficient heating, post-heating contamination, inadequate cleaning, defective packaging, poor refrigeration or freezing management, and temperature deviations during transportation.

Importers should verify not only the test results of the final product but also hygiene management according to HACCP, heating conditions, cooling conditions, environmental inspections, packaging processes, and temperature records.

Violations Related to Prohibited Substances and Unusable Raw Materials

For health foods, supplement-type foods, plant extracts, concentrated extracts, and new raw materials, it must be confirmed whether they can be legally used as food in Japan, whether they contain any pharmaceutical ingredients, and whether the parts used or extraction methods are appropriate.

The fact that these are sold as food overseas does not by itself prove compliance with Japanese Food Sanitation Law, Pharmaceuticals and Medical Devices Act (PMD Act), or other regulations.

All ingredients, their quantities, the origin of raw materials, parts used, extraction solvents, concentration ratios, manufacturing processes, and specifications should be obtained. If judgement is difficult, consultation with the Quarantine Station or specialists prior to shipment is recommended.

Issues Related to Hygiene Management and Manufacturing Control

Violations in imported food products arise not only from the presence of specific substances but also from contamination during the manufacturing process, insufficient heating, inadequate cleaning, foreign matter inclusion, poor packaging, and improper temperature control.

When violations are repeatedly found with the same manufacturer or the same product, importers review whether to continue transactions, conduct factory audits, verify corrective actions, perform pre-shipment inspections, and reassess contractually agreed quality guarantees.

Analyze by Combining Country of Origin, Item, and Manufacturer

Analytical Axis	Limitations When Viewed Alone	Complementary Information	Practical Decisions
Country of Origin	Risks treating the entire country uniformly	Item, production area, farm, manufacturer	Focus and narrow down the priority inspection targets
Item	Overlooks differences in processing or raw materials	Frozen, dried, heat-treated condition, etc.	Determine applicable standards and inspection items
Manufacturer	Overlooks differences in raw material suppliers	Factory, production line, raw material lot	Conduct factory audits and lot inspections
Violating Substance	Cannot definitively identify the cause	Pesticide use, formulation, process, temperature	Confirm appropriateness of recurrence prevention measures
Inspection Category	Logistics impact alone does not clarify cause	Violation history, administrative actions	Develop inspection and storage plans for subsequent imports

What is the Notification Form for Importation of Foods, etc.?

When importing food, food additives, utensils, containers and packaging, or infant toys for sale or business use, the importer is generally required to submit a Notification Form for Importation of Foods, etc. to the Quarantine Station responsible for the location where customs clearance takes place.

Food sanitation inspectors at the Quarantine Station review compliance with the Food Sanitation Act based on the notification and attached documents, then decide whether an inspection is necessary.

Main Sections of the Notification	Information to be Entered	Supporting Documents	Impact of Errors
Importer	Name, address, code, contact person	Corporate information, customs clearance instruction	The reporting party and contact details may be unclear
Country of Production	Country where the food, etc. was produced	Specification sheets, origin documents	Incorrect target for monitoring and standards verification
Manufacturer / Production Site	Name, address, code	Factory registration, specification sheets	Mistakes in cross-checking past violations
Exporter / Packer	Name, address, code	Invoice, packaging documents	Difficulty verifying commercial flow and packaging processes
Transport Information	Loading port, unloading port, vessel name/voyage number, arrival date	B/L, Arrival Notice	Errors in identifying responsible Quarantine Station and cargo
Cargo Information	Product name, quantity, weight, packaging type, usage	Invoice, Packing List	Issues confirming identity with actual cargo
Ingredients / Materials	Raw materials of processed foods, materials of utensils, etc.	Raw materials list, material certificates	Misapplication of standard criteria
Additives	Additive name, components, code	Formulation sheet, additives list	Overlooking unauthorized additives, etc.
Manufacturing / Processing Methods	Processes such as heating, freezing, drying, fermentation, etc.	Manufacturing process chart	Incorrect food classification and component standards
Sanitary Certificate	Certificate numbers when required	Certificates issued by the exporting country government	Procedures may be unable to continue
Occurrence of Accidents	Accidents during transport, damage, temperature deviations, etc.	Accident reports, temperature records	Cargo inspection and additional verification may be required

Basic Process for Submitting the Notification Form for Importation of Foods, etc.

1. The importer confirms product specifications, raw materials, additives, manufacturing processes, etc.
2. Prepare the Notification Form for Importation of Foods, etc. and required attachments.
3. Submit the notification to the Quarantine Station responsible for the customs clearance location.
4. A food sanitation inspector reviews the notification details, violation history, and compliance with standards.
5. Determine if inspection is unnecessary, if inspection orders or guidance inspections are required, or if monitoring inspection applies.
6. If necessary, sample collection and testing are conducted in a bonded area.
7. If there are no issues, a Certificate of Notification is issued.
8. In case of violations, domestic sale is prohibited; disposal, Re-export, or other measures are carried out.

Comparison of Inspection Types

Inspection Type	Responsible Party & Costs	Cargo Handling	Main Purpose & Target	Importer / Freight Forwarder Actions
Inspection Order	Inspector is the importer; costs generally borne by importer	Import prohibited until compliance is confirmed	Food products with high likelihood of legal violation	Full lot inspection, bonded storage and temperature control, delivery schedule adjustments
Guidance Inspection	Importer conducts inspection under the Quarantine Station’s guidance	Procedures may proceed after inspection results are confirmed	Initial imports, standard compliance, confirmation based on violation information	Prearrange inspection agency, test items, and sample collection
Voluntary Inspection	Importer conducts inspection as voluntary hygiene control	Performed before shipment or at import depending on purpose and situation	Standards compliance, supplier management, recurrence prevention	Confirm lot representativeness and test items
Monitoring Inspection	Conducted systematically by the government; costs covered by national budget	Generally, import permitted before results are known	Monitoring hygiene status of various imported food items	Maintain a system for distribution tracking and recall
Cargo Confirmation Inspection	Quarantine Station verifies actual cargo against declaration	Procedures withheld until confirmation is complete	Identity between declaration and cargo, accident cargo, etc.	Clarify product number, labeling, packaging, and lot

Mechanism for Issuing Inspection Orders

Inspection orders are issued under Article 26, Paragraph 2 or Paragraph 3 of the Food Sanitation Act to importers when there is a high likelihood that the imported food or related products violate the Food Sanitation Act.

If an inspection order applies, all lots covered by the respective import declaration must be inspected, and importation will not be permitted until compliance is confirmed.

Basis for Activation	Representative Situations	Scope	Practical Confirmation
Risk or occurrence of health hazards	Health hazards arise or are suspected in the exporting country or Japan	Same manufacturer/processor or same exporting country for the same food product	Confirm target notification and inspection items
Violations involving pathogens, aflatoxins, etc.	Legal violations detected through monitoring inspections	An inspection order may be issued immediately	Halt shipment of the next lot
Multiple violations of pesticide residues, etc.	Repeated violations for the same food from the same manufacturer or export country	Whole or partial scope based on regulatory framework and history	Check whether the scope is limited to specific farms or factories
Emergency response based on overseas information	Problem information obtained from exporting country government or international organizations	Set target country, manufacturer, food product, and inspection items	Investigate already shipped goods, inventory, and distribution status

Lift of Inspection Orders

Inspection orders do not continue indefinitely once imposed.

The Ministry of Health, Labour and Welfare may lift an inspection order and return to the normal monitoring system when it deems there is no risk of unlawful food products being exported to Japan.

Path to Lift	Main Conditions	Verification Method	After Lift
Recurrence Prevention Measures by Exporting Country	Root cause investigation, new regulations, pesticide management, strengthened inspection systems, etc.	Bilateral consultations, on-site investigations, inspections upon import	Lifted after confirming effectiveness
No Violations for a Period	No new violations for a certain period after notification and most recent violation	Review violation history and inspection records	Monitoring inspections strengthened as necessary
Accumulated Number of Inspections	No violations for a set period and sufficient number of inspections conducted	Confirm inspection order records	Transition to normal monitoring

According to the operational plan, a judgment to lift may be made if no new violations occur for two years from the most recent violation date for certain inspection order subjects, or if no new violations occur for one year and the number of inspections conducted under the order exceeds 300.

Even after lifting, monitoring inspections may be strengthened as needed, and if violations are found again, the inspection order could be reinstated.

If a Violation Is Found in Monitoring Inspection

Monitoring inspections generally allow importation without awaiting the test results, so by the time results are confirmed, the cargo may already be in domestic distribution.

If a violation is identified, the importer must have a system in place to track sales destinations, inventory, lots, and shipment destinations, facilitating recall, sales suspension, disposal, and other necessary responses.

For the same item or manufacturer, this may lead to increased inspection frequency in monitoring inspections, transition to inspection orders, or requests for investigation of causes in the exporting country.

Handling When Violations Are Confirmed

Action	Description	Conditions / Points to Note	Main Costs / Impact
Disposal	Dispose of the affected cargo without allowing it to enter domestic distribution	Coordinate with Quarantine Station, customs, and disposal contractors	Disposal costs, storage fees
Re-export	Re-export cargo to the exporting country or a third country	Confirm acceptance and vessel space with the receiving country	Re-export costs, Demurrage, Detention
Sorting / Processing, etc.	Consider removal of the non-compliant parts	Individually confirm whether permitted by relevant laws and regulations	Labor costs, re-inspection fees
Change of Use	Consider using cargo for non-food purposes or other alternatives	Confirmation by administrative authorities is required	Price reduction, additional procedures
Sales Suspension / Recall	Stop and recall cargo that has already entered domestic distribution	Verify distribution tracking and notification to local governments	Recall costs, reputational damage
Cause Investigation / Improvement Report	Organize the cause and recurrence prevention measures with the manufacturer	May be a prerequisite for future imports	Factory audits, analysis costs

Relation to Domestic Food Recall Notification System

If a violation or potential violation of the Food Sanitation Act is discovered after imported food has already been distributed domestically and the business operator conducts a voluntary recall, the relationship to Japan’s food voluntary recall reporting system should be confirmed.

Since June 1, 2021, notification to authorities has been made mandatory when conducting voluntary recalls of foods, etc.

Items to Confirm	Details	Importer’s Actions	Impact on Logistics and Sales
Subject	Foods, etc. with violations or suspected violations of the Food Sanitation Act	Identify the applicable lot and scope of recall	Sales suspension, inventory segregation
Notification	Report via Food Sanitation Application System, etc.	Confirm procedures with the relevant local government	Public disclosure, notify business partners
Classification	Categorize considering the risk of health damage	Assess the degree of hazard	Speed and scope of recall affected
Distribution Tracking	Destination of sales, inventory, consumer reach status	Prepare lot tracking documentation	Risk of unrecovered items
Completion Report	Recall results, handling, recurrence prevention	Explain quantity discrepancies	Prolonged administrative response

While it is sometimes necessary to check U.S. FDA recall information as a related reference, the fundamental system for recalling imported food in Japan is the voluntary recall reporting system based on Japan’s Food Sanitation Act and Food Labeling Act.

Matters Importers Should Confirm in Advance

• Check violation cases involving the same item, country of manufacture, and manufacturer
• Confirm inspection orders and targets of enhanced monitoring inspections
• Obtain raw material lists, additive lists, and formulation sheets
• Obtain production process details, heating conditions, and hygiene management records
• Review records of pesticide residues and use of veterinary drugs
• Verify microbial and hazardous substance analysis certificates
• For equipment, containers, and packaging, obtain material certificates and test results
• Ensure consistency between descriptions in the Notification Form for Importation of Foods, etc. and related cargo documents
• Plan bonded, refrigerated, and frozen storage while awaiting inspection results
• Specify in contracts the party responsible for disposal, return, or recall costs in case of violations

Points Overseas Manufacturers Should Understand

Even if a food product can be sold in the exporting country, it does not necessarily mean it can be imported and sold in Japan as is.

Overseas manufacturers may be asked by Japanese importers to submit documentation regarding raw materials, additives, formulation, pesticides and veterinary drugs, manufacturing processes, hygiene control, analysis results, packaging material composition, and other relevant details.

Rather than explaining the formulation or processes after a violation occurs, it is important to confirm compliance with Japan-specific specifications before shipment and to manage changes for each lot accordingly.

Role of Freight Forwarders and Customs Brokers

Freight forwarders and customs brokers are generally not in a position to make the final judgment on compliance with the Food Sanitation Act.

However, when inspections or violations occur, logistics coordination involving bonded area detention, temperature control, sampling, container return, disposal, Re-export, and delivery schedule changes becomes necessary.

• Confirm with the importer that the Notification Form for Importation of Foods, etc. and regulatory checks have been completed
• Organize contact information for the responsible Quarantine Station, inspection agencies, and bonded warehouses
• Have the importer check the possibility of being subject to an inspection order
• Confirm cold storage or refrigeration facilities and the waiting period for inspection
• Explain the conditions under which Demurrage, Detention, and storage fees may be incurred
• Confirm whether it is possible to separate and gate out the violating cargo from other cargo
• Avoid readily guaranteeing compliance with the Food Sanitation Act

Organization by Freight Forwarder’s Standard Five Classifications

The following Standard Five Classifications are not legally or industry-wide established categories, but rather an analytical framework used in this series to organize the scope of freight forwarders’ involvement.

Standard Five Classifications	Tasks Related to Imported Food Violations	Judgments or Guarantees Typically Not Included	Confirmation Materials	Practical Considerations
Simple Intermediary	Quarantine Station inquiries, inspection results, document transmission	Guarantee of compliance with the Food Sanitation Act	Email, work instructions	Convey accurate receipt dates and deadlines
Cargo Transportation Service Provider	Transport during inspection wait, storage, and coordination of Re-export	Judgment on ingredient or standard compliance	Carriage contract, booking	Clarify temperature control and additional charges
NVOCC / House B/L Issuer	Identification of cargo by House B/L units, separation of consolidated cargo	Guarantee of inspection results or Import Permit	House B/L, Master B/L	Check for impact on other cargo owners' shipments
Door-to-Door Single Contractor	Process management from collection through import customs clearance and inland delivery	Guarantee of product regulatory compliance itself	Door-to-Door contract, carriage clauses	Delineate transport liability and product legality
Agent / Coordinator for Specific Operations	Coordination of inspection, disposal, and Re-export logistics	Administrative or legal judgments beyond mandate scope	Power of attorney, customs clearance request	Identify the final decision maker

Contracting Carrier and Actual Carrier refer to positions in the transport contract and do not replace the Standard Five Classifications.

Transfer of food declaration forms, adjustment of sample collection, temperature control, and arrangements for disposal or Re-export do not individually constitute a sixth classification.

Cases Commonly Problematic in Practice

Case	Main Issue	Initial Confirmation	Logistics Response	Main Documents
Additives allowed overseas but not specified in Japan	Formulation and additive regulations	Check all ingredients and formulations	Consider disposal or Re-export	Specification sheets, formulation tables
Detection of pesticide residues in agricultural products	Exceeding standards and strengthened inspections	Identify farm, pesticide, and lot	Arrange inspections for next import	Pesticide records, analysis certificates
Microbial standard violation in frozen foods	Process and temperature control	Check heating, cooling, and transport records	Continue frozen storage	Process charts, temperature logs
Insufficient documentation on first import	Delays in notification review and guidance inspection	Obtain raw materials, additives, and process details	Extend bonded storage period	Notification forms, specification sheets
Inspection order identified only after arrival	Inspection of all lots and delivery schedules	Confirm target notification and inspection items	Urgently arrange inspection agency and storage	Inspection order notice
Violation detected after monitoring inspection with product already distributed domestically	Tracking sales destinations and recall	Identify lot and distribution destinations	Organize recall logistics	Sales records, inventory records
Only part of mixed cargo violates regulations	Separation of targeted cargo from other cargo owners’ goods	Check House B/L and packing numbers	Discuss partial gate-out	House B/L, packing list
Disputes over cost responsibility after violation	Liabilities of seller, importer, and freight forwarder	Check contracts, instructions, and warranty clauses	Record storage and disposal costs	Sales contract, transport contract

Example 1: Case Where a Non-Designated Additive Was Discovered After Shipment

The importer ordered a soft drink that is commonly sold overseas for the Japanese market.

The overseas label listed only the general names of additives, and the detailed formulation was not obtained before shipment.

During the import notification review, it was found that additives not designated in Japan had been used.

Although there were no abnormalities in the appearance or quality of the cargo, it could not be sold domestically, and the importer chose to Re-export the shipment.

In this case, it was necessary to confirm all ingredients and additives specifically for Japan prior to shipment, rather than relying on the overseas sales record.

Example 2: Case Transitioning to Inspection Orders Due to Residual Pesticide Violations

Residual pesticide violations were identified during monitoring inspections of agricultural products from specific countries.

Repeated violations were confirmed for similar food products, resulting in the targeted items being placed under inspection orders.

Importers of the subsequent lots were required to conduct inspections each time they imported, and were prohibited from importing until compliance was confirmed.

The freight forwarder only became aware of the subject items after arrival and had to urgently arrange for inspection agencies and bonded warehouses, incurring additional container return costs.

In this case, the latest list of items subject to inspection orders should have been checked before departure.

Example 3: A Case with Divergent Causes for Microbial Violation in Frozen Food

A microbial standard violation was identified in frozen food intended for consumption after heating.

The importer initially suspected temperature deviation during transportation; however, temperature records showed no abnormalities.

Upon reviewing the manufacturing process, a possibility of secondary contamination during the post-heating cooling and packaging stage was found.

In this case, it was necessary to separately address the transport incident from the perspective of marine cargo insurance and the Food Sanitation Act violation originating in the manufacturing process.

Example 4: Case of Sales Made Before Monitoring Inspection Results

The processed food subject to monitoring inspection was granted Import Permit without waiting for the inspection results and was shipped to multiple retail stores.

Later, a violation of the Food Sanitation Act was identified, and the importer initiated a voluntary recall by tracing the sales destinations and inventory.

Due to insufficient sales records by lot, the scope of the recall had to be set broadly.

In this case, the monitoring inspection was not a "no-issue inspection"; management including a post-distribution recall system was required.

Example 5: Case Where Only Part of an LCL Consolidated Cargo Violated Regulations

Part of the LCL consolidated cargo included food suspected of additive violations.

Other non-food cargo belonging to different importers was also loaded in the same container.

The NVOCC confirmed the House B/L, package numbers, and storage location, then coordinated with customs, Quarantine Stations, and the bonded warehouse to separate the relevant cargo.

Delays in identifying the specific cargo could affect the release of other cargo owners’ goods and increase storage costs.

In this case, the freight forwarder’s role was not a legal determination but the prompt identification of the concerned cargo and minimizing logistics impact.

Common Misconceptions

Misconception	Actual Understanding	Practical Notes
If food can be sold overseas, it can be imported into Japan.	It must meet Japan's Food Sanitation Act standards.	Confirm specifications for the Japanese market.
Only additives listed on the label need to be checked.	Composite ingredients and processing aids also require verification.	Obtain formulation sheets and process flowcharts.
Products from countries with violation cases are all risky.	Assessment depends on the item, manufacturer, raw materials, and processes.	Do not make uniform judgments based solely on the country.
Inspection orders target only importers who violated regulations.	Orders may be issued based on the country, manufacturer, or food category.	Check the latest notifications.
Once an inspection order is issued, it is never lifted.	It may be lifted based on recurrence prevention, violation-free periods, and inspection records.	Remain vigilant after lifting of inspection orders.
Voluntary inspections and monitoring inspections are the same.	The implementing party, costs, and cargo handling differ.	Clearly distinguish the type of inspection.
Monitoring inspections are safe because results are not awaited.	Recall and other actions are required after violations are confirmed.	Establish distribution tracking systems.
The customs broker can prepare the Notification Form for Importation of Foods, etc. without the importer’s involvement.	The importer must prepare product information and conformity evidence.	The importer should review the contents.
If the cargo appearance is normal, there is no violation of the Food Sanitation Act.	Ingredients, residues, and microorganisms cannot be identified by appearance.	Verify by documentation and inspection.
Non-compliant cargo can always be Re-exported.	Response differs based on cargo, country of origin, and administrative procedures.	Check individually in each case.
Recalls after domestic distribution are voluntary and do not require administrative notification.	Certain voluntary recalls require reporting obligations.	Confirm with local authorities and systems.
Violations of the Food Sanitation Act are automatically covered by cargo insurance.	Regulatory non-compliance differs from accidental physical damage during transportation.	Confirm insurance terms and causation separately.
Freight forwarders guarantee import eligibility.	Freight forwarders provide information transmission and logistics coordination.	Clarify who holds the final decision.

Decision Flow from Before Import to Post-Violation

1. Confirm the classification, raw materials, additives, and manufacturing process of the food or related products to be imported.
2. Check violation cases by item, country, and manufacturer from the Ministry of Health, Labour and Welfare.
3. Confirm the latest inspection orders and enhanced monitoring inspection targets.
4. Obtain specifications, formulation sheets, process charts, and analysis certificates from overseas manufacturers.
5. Finalize the information to be entered in the Notification Form for Importation of Foods, etc..
6. Prepare the necessary sanitary certificates and test reports.
7. Confirm the inspection category and storage method while awaiting inspection results.
8. Determine whether pre-shipment inspection or prior consultation is required.
9. Submit import notification to the Quarantine Station and respond to inquiries or requests for additional documents.
10. Coordinate sample collection, testing agencies, bonded storage, and temperature management.
11. If compliant, proceed to import customs clearance after receiving the notification certificate.
12. If non-compliant, consider measures such as disposal or Re-export.
13. If already distributed domestically, enforce sales suspension, recall, and submit notification.
14. Request the manufacturer to investigate the cause and implement recurrence prevention measures.
15. Review the next import, contract, inspection, and logistics plans.

Practical Decision-Making Checklist

Timing of Check	Counterpart / Documents	Items to Confirm	Actions if Issues Are Found
Before Product Adoption	Manufacturer, Specification Sheet	All Ingredients, Food Category, Japanese Standards	Consult on Import
At Contract Signing	Seller, Sales Contract	Regulatory Compliance Guarantee, Costs for Violations	Add Guarantee and Indemnity Clauses
Before Ordering	Violation Cases, Inspection Order Information	Item, Country, Manufacturer History	Make Pre-Shipment Inspection a Condition
Before Shipping	Formulation Table, Process Chart, Analysis Results	Additives, Residual Substances, Microorganisms	Hold Shipment
At Booking	Freight Forwarder, Shipping Line	Temperature, Pending Inspections, Free Time	Adjust to a More Flexible Transport Schedule
At Filing Preparation	Notification Form for Importation of Foods, etc.	Manufacturer, Ingredients, Additives, Process	Obtain Additional Supporting Documentation
During Quarantine Inquiry	Quarantine Station, Customs Broker	Inquiry Details, Submission Deadlines, Inspection Requirements	Assign Responsible Person and Respond Immediately
Upon Inspection Order	Notification, Registered Inspection Agency	Scope, Items, Lot	Arrange Bonded Storage and Inspection
While Waiting for Inspection	Warehouse, Shipping Line	Temperature, Storage Fee, Demurrage, Detention	Share Cost Estimates
When Violation Is Confirmed	Quarantine Station, Manufacturer	Cause, Measures, Recurrence Prevention	Decide on Disposal or Re-export
After Domestic Distribution	Local Government, Sales Destinations	Inventory, Shipping Destinations, Recall Notification	Stop Sales and Initiate Recall
Before Next Import	Improvement Reports, Factory Documents	Effectiveness of Corrective Actions	Review Business and Inspection Conditions

Situations Where Consultation with Experts Is Recommended

• When the classification between food and pharmaceuticals is unclear
• When it is difficult to determine the specifications or usage standards for additives
• When additives or carry-over in compound raw materials are unknown
• When the appropriate inspection items for pesticide residues or veterinary drugs cannot be decided
• When the applicable categories for microbiological component standards are unclear
• When the scope of inspection orders is uncertain
• When manufacturing processes or food classifications in the Notification Form for Importation of Foods, etc. are difficult to determine
• When considering sorting, repurposing, or the Re-export of non-compliant cargo
• When a voluntary recall notification is required after domestic distribution
• When recourse claims against sellers or manufacturers become an issue
• When separating marine cargo insurance coverage from manufacturing or regulatory non-compliance issues is necessary
• When accountability of freight forwarders or customs brokers is under question

Related Laws and Systems

• Food Sanitation Act
• Enforcement Order of the Food Sanitation Act
• Enforcement Regulations of the Food Sanitation Act
• Standards for Food, Additives, etc.
• Import Food Surveillance and Guidance Plan
• Import Notification System for Foods, etc.
• Food Voluntary Recall Reporting System
• Food Labeling Act
• Customs Act

Practical Points of Caution

• Violation cases are checked before import, not after.
• Analysis combines not only the country of origin but also item, manufacturer, raw materials, and processing.
• Handling and cost responsibility differ between inspection orders and monitoring inspections.
• Subjects of inspection orders should be confirmed with the latest notifications.
• Inspection orders have mechanisms for both activation and cancellation.
• The Notification Form for Importation of Foods, etc. serves as basic documentation for product information review.
• Notification forms, Invoices, Packing Lists, specification sheets, and actual cargo should be matched.
• For first-time imports, prepare raw materials, additives, and processing data early.
• Compliance with Japanese standards should not be judged solely by overseas labels.
• Establish lot traceability to prepare for violations discovered after monitoring inspections.
• Voluntary recalls after domestic distribution may require official notification to authorities.
• Do not confuse FDA recall information with Japan’s food recall system.
• Consider quality deterioration due to inspection waiting periods for refrigerated or frozen cargo.
• Costs for storage, inspection, disposal and Re-export in case of violations should be clarified in contracts.
• Freight forwarders are not in a position to guarantee compliance with the Food Sanitation Act.

Summary

• Cases of imported food violations refer to instances where non-compliance with the Food Sanitation Act was confirmed during import notification review or inspection at the time of import.
• Information published by the Ministry of Health, Labour and Welfare can be used for risk assessment before import.
• Violation cases are checked by combining factors such as item, country/region, manufacturer, raw materials, violation details, and inspection category.
• Main types of violations include additives, pesticide residues, veterinary drugs, microorganisms, harmful substances, spoilage/deterioration, and equipment/containers/packaging.
• Food products intended for sale or business purposes are, in principle, required to submit the Notification Form for Importation of Foods, etc. to the Quarantine Station.
• The Notification Form for Importation of Foods, etc. includes details such as importer, country of origin, manufacturer, product name, raw materials, additives, manufacturing process, and transport information.
• The Quarantine Station reviews the notification details and attached documents to determine whether inspection is necessary.
• An inspection order is a system that requires inspection each time for food suspected of legal violations at import.
• The criteria for issuing inspection orders include potential health hazards, violations involving pathogenic microorganisms or aflatoxins, multiple violations such as pesticide residues, and others.
• Inspection orders may be lifted based on the effectiveness of recurrence prevention measures, the period without violations, and the number of inspections conducted.
• Guidance inspections, voluntary inspections, and monitoring inspections differ with regard to the responsible party, costs, and treatment of cargo.
• For monitoring inspections, imports may proceed without waiting for the results, but a recall system must be in place in case violations are later found.
• Violating cargo may be subject to disposal, Re-export, sales suspension, or recall.
• For voluntary recalls after domestic distribution, the Japanese Food Voluntary Recall Reporting System should be confirmed.
• The Japanese recall notification system and the US FDA recall information are separate systems.
• Importers should obtain specifications, formulation tables, process sheets, pesticide and drug information, and analysis certificates before shipment.
• Overseas manufacturers distinguish between products approved for domestic sale in their country and those allowed for import into Japan.
• Freight forwarders coordinate bonded storage, temperature control, inspections, container returns, and disposal or Re-export.
• The Standard Five Classifications organize involvement as Simple Intermediary, Cargo Transportation Service Provider, NVOCC/House B/L issuer, Door-to-Door Single Contractor, and Agent / Coordinator for Specific Operations.
• Contracting Carrier and Actual Carrier refer to transport contract statuses and do not replace the Standard Five Classifications.
• Individual operations such as notification transfer, sample collection, temperature control, and disposal or Re-export do not themselves constitute a sixth classification.

Cases of imported food violations are not reference materials to be read after cargo arrives in Japan. They should be used at the stages of product adoption, procurement contract, formulation confirmation, pre-shipment inspection, and booking.

For food potentially subject to inspection orders, refrigerated/frozen items, or products with short shelf lives, incorporate the costs of bonded storage, temperature control, and container returns while awaiting inspection results into transport planning.

If violations are discovered after domestic distribution, promptly track inventory and sales destinations and respond swiftly, including through the Japanese Food Voluntary Recall Reporting System.

This article provides general information on imported food violation cases at import, the Notification Form for Importation of Foods, etc., inspection orders, guidance inspections, voluntary inspections, monitoring inspections, food recalls, cargo insurance, and freight forwarder operations. It does not determine specific compliance with the Food Sanitation Act for individual food products, inspection requirements, inspection order applicability, import eligibility, disposal or Re-export procedures, recall notifications, insurance claim payments, or legal responsibilities of parties. Actual import confirmation should be based on applicable Food Sanitation Act provisions at import, related laws and standards, the Import Food Monitoring and Guidance Plan, the latest information from the Ministry of Health, Labour and Welfare and Quarantine Stations, Notification Form for Importation of Foods, etc., product documentation, analysis results, and expert judgment.