Ministry of Health, Labour and Welfare

Original: Japanese
Provisional Translation

Guidelines on Hygiene Control of Import Processed Foods
(Annex to Notice Shoku-an No. 0605001 of June 5th, 2008)

Section 1  Objectives

Under Article 8 paragraph 1 of the Food Safety Basic Law (Law No. 48 of 2003), food-related business operators including a person who intends to import foods that have been manufactured, processed, etc., in another country (hereinafter “importers”) are required to recognize that they themselves bear primary responsibility for ensuring food safety, and to appropriately take necessary measures to ensure food safety at each stage of the food supply process. Moreover, under Article 3 paragraph 1 of the Food Sanitation Law (Law No. 233 of 1947; hereinafter “Japanese Law”), they are also required to take responsibility for obtaining necessary knowledge and techniques, ensuring the safety of raw materials, practicing self-imposed examination and taking any other measures to ensure the safety of imported foods, etc.

The Imported Foods Monitoring and Guidance Plan sets out basic matters for guidance to importers based on these responsibilities, and promotes the practice of hygiene control. However, owing to recent cases of chemical food poisoning, etc., it has now become necessary to ensure and confirm the safety of imported processed foods in the exporting country to a level equivalent to that within Japan, at all stages of the food supply process including raw materials, manufacturing and processing, storage and transportation.

The purpose of these Guidelines is not only to prevent contamination by poisonous or harmful substances, etc., but also to emphasize basic matters for guidance on processed foods required of importers under the Imported Foods Monitoring and Guidance Plan, to promote hygiene control of import processed foods, and to take steps to improve safety.

After the completion of import procedures, all stages including storage, transportation, manufacturing, processing and sale within Japan are governed by the Law, and attention is also drawn to other laws, ordinances and notices designed to prevent the contamination of distributed foods by poisonous or harmful substances.


- Food Safety Basic Law, Article 8 (Responsibility of Food-Related Business Operators)(PDF:8KB)

- Food Sanitation Law, Article 3 (Responsibility of Food-Related Business Operators)(PDF:8KB)

- Special Measures Law Concerning the Prevention of Poisonous Substances from Contaminating Food in Distribution (Law No. 103 of 1987), Article 3 (Government Measures, etc.)(PDF:12KB)

Section 2  Scope

These Guidelines are designed for importers who manufacture and import products to be exported to Japan under direct contract with overseas manufacturers, as well as importers of processed food in general. Moreover, even importers who are not in a direct contractual relationship with an overseas manufacturer should also, through the agency of an exporter or other such concern in the exporting country, strive to confirm the matters stated in these Guidelines with said manufacturer.

Section 3  Confirmation System

To confirm the matters stated in these Guidelines, importers should appoint responsible staff and contact personnel who have the necessary knowledge and skills.

Section 4  Matters to be Confirmed

Importers should confirm the matters set forth below, in writing, with the manufacturers of processed food that they intend to import. They should do so when signing contracts, upon the manufacture of products to be exported to Japan (including examination and certification), upon the renewal of contracts and whenever any problems arise, taking into account the establishment and enforcement of regulations on food hygiene in the exporting country, the level of hygiene control practiced by the manufacturer, and other factors. In addition, importers should also make necessary confirmation by conducting field surveys, posting local representatives, testing and inspecting products, etc. When confirming these matters, they should make use of manufacturers’ records concerning raw materials, records of manufacturing controls, records related to products, records related to Hazard Analysis and Critical Control Point (HACCP) system, and so on.

1     Supervision by the Government of the Exporting Country, Etc.

Importers should confirm with manufacturers the following matters concerning supervision by the government of the exporting country, the standard of establishments, facilities and equipment of the manufactory, and hygiene control in the manufactory.

(1) That the food is manufactured and processed in compliance with the laws and regulations of the exporting country. In particular, when there is a system of registration of manufactory, a system of permission for product exports, or other such system in the exporting country, that these are properly observed.


- Response Related to Imports (material used at the Emergency Inter-Sector Joint Conference on Safety Assurance of Imports, July 20th, 2007)(Under translation)

(2) That the standard of establishments, facilities and equipment of the manufactory is at least equal to the standards concerning establishments, facilities and equipment stipulated in related Japanese laws and ordinances, etc.


- Abattoir Law Enforcement Order (Cabinet Order No. 216 of 1953), Article 1 (Standards for Structure and Facilities of Ordinary Abattoirs)(Under translation)

- Enforcement Regulations of the Law Concerning Rules for Poultry Processing Business and Poultry Inspection (Ministry of Health & Welfare Ordinance No. 40 of 1990), Article 2 (Standards for Structure and Facilities)(Under translation)

- Rules for Food Business Establishment Standards Based on the Food Sanitation Law (Annex to Notice Ei-kan No. 43 of September 9th, 1957) (Under translation)

(3) That the standard of hygiene control in manufactory is at least equal to the following standards concerning hygiene control stipulated in related Japanese laws and ordinances, etc. It should be noted that using methods of hygiene control based on HACCP system is also effective, and the active introduction of these is recommended.

(a) Hygiene control in the harvesting of agricultural, forestry and fishery products

(b) Hygiene control in food handling establishments, etc.

(c) Hygiene control by food handlers and others in food handling establishments, etc.

(d) Training for food handlers and others in food handling establishments, etc.


- Guidelines on Management and Operation Standards to be Observed by Food-Related Business Operators (Annex to Notice Shoku-an No. 0227012 of February 27th, 2004; hereinafter “Guidelines on Management and Operation Standards”) (PDF:33KB)

- Procedure for Implementation of the Total Hygiene Controlled Manufacturing Process Approval System (Annex to Notice Sei-ei No. 1634 of November 6th, 2000) (Under translation)

- General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 4-2003)(PDF:115KB)

- Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application (Annex to CAC/RCP 1-1969, Rev. 4-2003)(PDF:73KB)

2     Raw Material Acceptance Stages

Importers should confirm the following matters with manufacturers at the stage of accepting raw materials.

(1)   That quality criteria including Specification and Standards based on Japanese Law have been established for each raw material, and that it has been confirmed that each delivery lot complies with these. Specifically, importers should aim to procure raw materials for which the use of agricultural chemicals, veterinary drugs and other production materials, etc., is clear from contracts or other documentation shared with specific producers or vendors. Meanwhile, basic matters for confirmation in accordance with the characteristics of raw materials are mainly those shown below.

(a)   Foods in general (universal matters)

(b)   Agricultural products and products processed from them

(c)   Livestock products and products processed from them

(d)   Fishery products and products processed from them

(2) That the matters listed in (1) above have been confirmed by regular tests, inspections, etc. Tests for residual agricultural chemicals, etc., should take into account the type of chemicals used for the agricultural products in question, records of their application, and other details on the state of use, as well as the results of soil and water quality surveys, etc.

(3) No raw materials should be accepted if it is known to contain parasites, pathogenic micro-organisms, poisonous substances, decomposed matter, deteriorated matter or foreign matter which would not be eradicated or removed to an acceptable level by normal processing, cooking, etc.

(4) When the monitoring results carried out by an administrative organ or other body in the exporting country are available, importers should confirm the results, but should also import samples and confirm said results by means of tests and inspections inside Japan whenever necessary.

(5) That each raw material has been subjected to appropriate lot management.


- Guidelines on Management and Operation Standards(PDF:33KB)

- Basic Matters for Guidance to Importers (Annex Table 2, Notice Shoku-an No. 0331001 of March 31st, 2008) (PDF:44KB)

3     Product Manufacturing and Processing Stages

Importers should confirm the following matters with manufacturers at the stages of manufacturing and processing products.

(1) That a system of control has been arranged to ensure that food can be manufactured and processed under a hygienic condition. As measures for preventing contamination by poisonous or harmful substances, in particular, that the following matters are thoroughly observed.

(a)   Hygiene control of establishments, facilities and equipment, etc.

(b)   Measures against rodents and insects

(c)   Handling of wastes and waste water

(d)   Handling of foods, etc.

(e)   Management of water used, etc.

(f)   Hygiene control of food handlers

(2) That persons responsible for food hygiene have been appointed to each food handling establishments or each division.

(3) That it has been confirmed, through regular tests and inspections, that final products comply with Specification and Standards based on the Japanese Law. Importers should also confirm this, whenever necessary, via tests and inspections by a official laboratory in the exporting country, or inside Japan. Basic matters for confirmation in accordance with the characteristics of products shall be as shown in 2 (1).

(4) That each product has been subjected to appropriate lot management.


- Guidelines on Management and Operation Standards(PDF:33KB)

- Basic Matters for Guidance to Importers(PDF:44KB)

4     Product Storage, Transportation and Distribution Stages

Importers should confirm the following matters with manufacturers at the stages of storage, transportation and distribution of products.

(1) That products are handled hygienically during storage, transportation and distribution, and that the following matters are thoroughly applied as measures to prevent contamination by poisonous or harmful substances.

(a) That measures are taken to prevent contamination of food through appropriate handling of insecticides, etc.

(b) That vehicles, haulage containers and others used for transporting foods are not those which could contaminate the foods, containers or packaging. Also, that their structure makes them easy to wash and disinfect, and that they are always kept in a clean condition.

(c) That, when foods and loads other than foods are mixed, if necessary, the food is put in appropriate containers and separated from the other loads to prevent contamination.

(d) That foods are controled during transportation in such a way as to avoide contamination by dirt, toxic gases.

(e) That, when vehicle or haulage container once used for transporting different commodities of food or loads other than foods is re-used, the vehicle or container is washed effectively and disinfected as needed.

(f) That appropriate lot management has been carried out, and that any abnormalities in volume and packaging condition, etc., are confirmed as the situation demands.

(2) Besides the matters listed in (1) above, that the following matters have been confirmed.

(a) That appropriate temperature control is carried out to prevent the occurrence of safety hazards owing to the reproduction of micro-organisms.

(b) That there is no decomposition or deterioration caused by accidents or inappropriate temperature control, etc.

(c) That, when preservation standards based on the Japanese Law have been stipulated for foods, these have been observed.

(d) That salt-cured and other foods, etc., have not been stored outdoors for long periods.

(e) That establishments are managed so that outsiders cannot access them without permission.


- Guidelines on Management and Operation Standards(PDF:33KB)

- Basic Matters for Guidance to Importers(PDF:44KB)

- Ensuring Food Safety and Proper Control of Poisonous and Deleterious Substances Pertaining to Case No. 114 (Notice Ei-shoku No. 102, Yaku No. 999 of December 20th, 1984)(PDF:11KB)

Section 5  Recall and Disposal

1     Establishment of Recall Procedures

If a food hygiene problem caused by food imported occurs, with a view to preventing health hazards to consumers in advance, importers should establish a system of responsibility for recall, specific measures of recall, and procedures of reporting to the relevant administrative organs, which allow importers to recall the products in question promptly and appropriately.

(1) Establishment of recall plans

(a) Creation of a lot code system

(b) Filing of product shipment and sale records

(c) Preparation of a sick consumer complaint records

(d) Organization of recall teams

(e) Provision on recall procedures

(f) Provision on measures of informing consumers

(g) Provision on measures of managing recalled products

(h) Provision on measures of assessing the progress of recall and the recall results

(2) Start of recall (matters to be reported to relevant administrative organs)

(a) Cause of recall

(b) Scope of recalled food

(c) Distribution area of recalled food

(d) Quantity of recalled food

(3) Measures after recall

(a) Evaluation of recall plan

(b) Implementation of necessary compensation measures

(4) Preparation and filing of recall records

(a) Names and lot numbers of recalled items

(b) Reason for recall

(c) Monitoring records at the time of manufacturing

(d) Final product inspection records

(e) Records related to storage, shipment and distribution

(f) Scope of products subject to recall

(g) Measures and route of recall and notices to consumers

(h) Communication with administrative organs

(i) Quantities recalled

(j) Test Result of recalled items

(k) Measures of disposing of recalled items

(l) Evaluation of recall effects and whether necessary to make associated changes to recall plans, etc.

(m) Records concerning details of compensation following recall


- Guidelines on Management and Operation Standards (Under translation)

2     Product Disposition Measures

Importers should accurately and promptly take measures such as disposing recalled products. Moreover, recalled products should be stored in clear distinction from normal products, and product disposition and other measures should be implemented appropriately under instructions from the relevant administrative organ.


- Guidelines on Management and Operation Standards(PDF:33KB)

3     Public Notification

Whenever necessary when recalling products, etc., importers should consider making public notification of information related to said recall, etc., with a view to creating cautionary awareness among consumers, etc.

Section 6  Other Matters

1     Education, Etc., on Japanese Food Hygiene Regulations

Importers should give education and guidance on Japanese food hygiene regulations to manufacturers that intend to export food to Japan, as well as occasionally providing information whenever there are violations, etc., in food both in Japan and abroad, and taking steps for improvement whenever necessary.

Importers should also dispatch technicians or other personnel to local establishments whenever necessary to give guidance on food hygiene, etc., and should take steps to harmonize levels of technology, knowledge and awareness.

2     Proper Labeling

Importers should ensure that the labeling of food imported by themselves complies with standards under related laws and ordinances in Japan, while also confirming these whenever necessary, for example by advance consulting the relevant administrative organ.

3     Preparing and Keepng Records

Importers should make efforts to properly prepare and file records at the time of import, sale, and other processes in the supply of food imported by themselves, to ensure that the state of distribution of said food can be confirmed at all times.


- Guidelines on the Creation and Filing of Records by Food-Related Business Operators under the Provisions of Article 1-3 Paragraph 2 of the Food Sanitation Law (Annex to Notice Shoku-an No. 0829001 of August 29th, 2003)(Under translation)

4     Tests and Inspections

When implementing tests and inspections, and handling the results thereof, importers should confirm that reliability is assured in terms of their accuracy and precision, etc.

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