9. Food Sanitation Law

(1) PURPOSE OF THE LAW AND SYSTEM
The objective of the law is to protect food safety by preventing health hazards caused from foods or drinks though measures deemed necessary from a public health viewpoint, thereby protecting health of citizens.


(2) OUTLINE OF THE LAW AND SYSTEM
The law prescribes the responsibilities of national government, local government and food business, etc. (Article 2) as well as the voluntary inspection and record retention necessary for prevention of health hazards by business, including food companies (Article 3).
Except for foods or food additives (excluding natural flavoring agents) approved by the Minister of Health, Labour and Welfare, selling or producing/importing for sale the foods or the food additives that threat to damage public health is prohibited (Article 6).

When standards for methods of manufacturing, labeling, or specifications for ingredients have been established by the Minister of Health, Labour and Welfare, for food, food additives, apparatuses and container-packages for sale or business, its is forbidden to sell all products which do not conform with the relevant statutes (Articles 11, etc.).
Those who wish to import food, food additives, apparatuses or container-packages for sale or business must first notify the Minister of Health,Labour and Welfare on each occasion (Article 27).
The Minister of Health, Labour and Welfare or prefectural governor, when deemed necessary, may request a report from a business representative, conduct an on-site inspection at the place including the locationof business, and inspect substances such as foods and food addictives for sale or business use, apparatuses and container packages for sale, or business, facilities of business and account books, and request voluntary removal of those said substances within the limits necessary for examination (Article 28).
Furthermore, the law has provisions regarding risk communication with consumers (Article 64 and 65), positive list on agricultural chemicals remaining in foods, etc. (Paragraph 3 of Article 11), and surveillance system for imported foodes (Articles 23, 25, 26, 27, 30 and Paragraph 2 of Article 55).

(3) CABINET ORDER AND MINISTERIAL ORDINANCES
Enforcement Order of the Food Sanitation Law
Enforcement Regulations of the Food Sanitation Law
Ministerial Ordinance Concerning Compositional Standards, etc. for Milk and Dairy Products
Specifications and Standards for Foods and Food Additives, etc. (Ministerial Notice)

(4) OUTLINE OF SPECIFICATION, STANDARDS AND INSPECTIONS ETC.
1) Items Covered
Foods (All food and drink; drugs and quasi-drugs (iyakubugaihin) prescribed by the Pharmaceutical Affairs Law are excluded.
Food additives (those used for adding, mixing, soaking or other methods in the manufacturing process of food or used for the purpose of processing or preserving)
Apparatuses or container-packages
Toys (toys for infants)
Cleaning agents (for vegetables, fruits and tableware)

2) Outline of Specifications, Standards and Inspections
i. Specifications and standards
The Ministerial Ordinance Concerning Compositional Standards, etc. for Milk and Daily Products and the Specifications and Standards for Foods and Food Additives, etc. (Ministerial Notice) are stipulated as specifications and standards related to the Food Sanitation Law.
Ingredient specifications, standards on manufacturing, cooking and storing methods, specifications and manufacturing standards on cooking equipment, container-packages or ingredients are prescribed in the said ministerial ordinance for milk and dairy products.
Specifications and standards are prescribed by classifying other matters into foods, food additives, apparatus, container-packages, toys and cleaning agents. Ingredient specifications, manufacturing, processing and cooking standards, preserving standards, utilizing standards are prescribed for foods; whereas, general rules, the general examination method, chemical regents and trial liquids, manufacturing standards and utilizing standards are prescribed for food additives.


ii. Certification system (Import inspection)
Those who wish to import food or others must first notify the Minister of Health, Labour and Welfare on each occasion. The notification form is to be filed with a food import inspection office of the Quarantine Stations at 31 major seaports and airports. The Quarantine Stations carefully import, and when necessary take samples for testing in order to ensure food sanitation.
Furthermore, in order to simplify procedures for the importation of foods and others, in addition to major systems listed as follows, procedures for the importation are being simplified and expedited by introducing the Food Automated Import Notification and Inspection Network System (FAINS) by which notification for the importation can be made on-line or by floppy disk from terminals of an importer (1986) and by promoting interface with the Nippon Automated Cargo Clearance System (NACCS) (1997).

(a) Pre-certification System: Of foods manufactured in foreign countries, those which conform with specifications and standards in advance under the Food Sanitation Law are registered with the Ministry of Health,Labour and Welfare. In the case of notifying registered foods, etc,. a certificate of notification for importing foods, etc. is issued immediately after inspection.

(b) Planned Import System: If specially selected foods, etc. (foods subject to planned importation) are to be repeatedly imported, a one-year or three-year import plan is attached to Import Notification of Foods, etc. at the initial importation. As a result of an examination, if it is judged to have no problems, through this system notification at every importation may be omitted from the following time (limited to within the relevant period).

(c) Item Registration System: When the same foods, etc. are continuously imported, matters to be mentioned concerning foods, etc. to be imported are registered. If there are no problems in the mentioned matters, through this system matters mentioned and registered at the time of notification for import may be processed through a registration number for one year following.

(d) Minor errors on a notification for import: Minor errors such as typing mistakes related to mentioned matters on Import Notification of Foods, etc. are disregarded. (Clerical correspondence on December 20, 1971, Kanshoku No. 184 Notice to each assistant chief of quarantine on August 18, 1982)

(e) Continuous Import System: When the same foods are repeatedly imported, if inspection results for the same foods conducted within a certain period are attached, through this system inspection at the time of importation within the effective period concerning the inspection items may be omitted.

(f) System of Foreign Official Laboratories: In the case of obtaining an inspection at the time of importation by foreign official laboratories (testing organization listed on a list of foreign official laboratories), through this system inspection of inspection items may be omitted.

(g) Prior Notification System: When notification for import is accepted for all foods, etc. seven days prior to the scheduled arrival of the imported cargo, if an on-the-spot inspection for import is judged to be unnecessary, through this system a certificate of notification for import of foods, etc. is issued before the arrival of the cargo or immediately after its arrival.

(h) Electronic Transmission of an Inspection Certificate: Although it is prohibited to import meat to Japan unless an inspection certificate issued by the governmental organization in the exporting country is attached, if matters to be mentioned on an inspection certificate are transmitted to the computer of the quarantine office from the governmental organization of the exporting country and are recorded in a file provided by the said computer, this does not apply.
Electronic transmission of inspection certificates is implemented between Japan and Australia.

[Flowchart of an import notification system]
Flowchart of an import notification system

(5) HIGHLIGHTS OF THE RECENT AMENDMENT
Food Sanitation Law was drastically amended in May 2003. The amendments include: amendment of the purpose of the law (Article 1), addition of the responsibilities of national government, local government and food business, etc. (Articles 2 and 3), introduction of a dutyfor business, including food companies,. record retention (Paragraphs 2 and 3 of Article 3), implementation of risk communication with consumers (Articles 64 and 65), introduction of positive list on remaining agricultural chemicals in foods, etc., (Paragraph 3 of Article 11), repeal of the requirement for designation of foods subject to ordered inspection, etc. (Pragraph 1 to 3 of Article 26), introduction of formulation and official announcement of the surveiling and guiding plan for imported foods (Articles 23 and 30) and change from designation to registration of testing organization (Articles 31 to 47).

(6) REFERENCE INFORMATION
(Liaison Office for Further Information)
Policy Planning and Communication Division, Department of Food Safety, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
Tel: 03-5253-1111 http://www.mhlw.go.jp

(Testing Organization)

Name and Department of Testing Station Address Telephone
FAX
Jurisdiction
Otaru Quarantine Station
(Food Observation Division)
5-3 (Otaru Harbor Common Government Offices), Minato-machi, Otaru-city, Hokkaido 047-0007 0134-32-4304
0134-24-6069
Hokkaido (excluding the area administered by Branch of Chitose Airport Quarantine Station)
Branch of Chitose Airport Quarantine Station
(Quarantine, Sanitation, and Food Observation Division
Shin-Chitose Airport, Bibi, Chitose-city, Hokkaido 066-0012 0123-45-7007
0123-45-2357
Hokkaido (limited to Shin-Chitose Airport)
Sendai Quarantine Station
(Food Observation Division)
3-4-1 (Shiogama HarborCommon Government Offices), Sadayama-Dori, Shiogama-city, Miyagi 985-0011 022-367-8102
022-362-3293
Aomori, Iwate, Miyagi (excluding the area administered by Branch of Sendai Airport Quarantine Station), Akita, Yamagata and Fukushima
Branch of Sendai Airport Quarantine Station
(Quarantine, Sanitation, and Food Observation Division)
Sendai Airport New Passengers Terminal Building, Aza Nanbara, Shimo-Masuda, Natori-city, Miyagi 989-2401 022-383-1854
022-383-1856
Miyagi (limitedtoSendai Airport)
Narita Airport Quarantine Station
(Food Observation Division)
2159, Aza Tennamino, Komaino, Narita-city, Chiba 282-8691 0476-32-6741
0476-32-6742
Chiba (limited to Narita-shi ; Daiei-cho, Katori-gun ; Tako-cho, Katori-gun ; Shibayama-cho, Sanbu-gun)
Tokyo Quarantine Station
(Food Observation Division)
2-56 (Tokyo Harbor Common Government Offices), Aomi, Koutou-ku, Tokyo 135-0064 03-3599-1520
03-5530-2153
Ibaraki, Tochigi,Gumma, Saitama, Tokyo (excluding the area administered by Branch of Tokyo Airport Quarantine Station), Yamanashi and Nagano
Tokyo Quarantine Station
(Food Observation Division 2)
32-5 (Funabashi Harbor Common Government Offices), Shiomi-cho, Funabashi-city, Chiba 273-0016 0474-37-1381
0474-37-1585
Chiba (limited to Noda-city, Kashiwa-city, Nagareyama-city, Matsudo-city, Kamagaya-city, Funabashi-city, Narashino-city, Urayasu-city, Ichikawa-city and Higashi-Katsushika-gun (Numanan-cho)
Branch of Chiba Quarantine Station
(Quarantine, Sanitation, and Food Observation Division)
1-12-2 (Chiba Harbor Common Government Offices), Chuo-Minato, Chuo-ku, Chiba-city, Chiba 260-0024 043-241-6096
043-241-7281
Chiba (excluding the area administered by Narita Airport Quarantine Station and Tokyo Quarantine Station Food Observation Division 2)
Branch of Tokyo Airport Quarantine Station
(Quarantine, Sanitation and Food Observation Division)
3-4-4 (International Airlines Terminal Building of Tokyo Airport), Haneda Airport, Ota-ku, Tokyo 144-0041 03-5756-4857
03-5756-4859
Tokyo (limited to Tokyo Airport)
Branch of Kawasaki Quarantine Station
(Integrated Food Observer)
6-10 (Kawasaki-FAZ Transportation Center), Higashi-Ogijima, Kawasaki-ku, Kawasaki-city, Kanagawa 210-0865 044-277-0025
044-288-2499
Kanagawa (limited to Kawasaki-city)
Yokohama Quarantine Station
(Food Observation Division)
1-1 (Yokohama Harbor Common Government Offices No.2), Kaigan-Dori, Naka-ku, Yokohama-city, Kanagawa 231-0002 045-201-0505
045-212-0640
Kanagawa (excluding the area administered by Branch of Kawasaki Quarantine Station)
Niigata Quarantine Station
(Food Observation Division)
1-5-4 (Niigata Harbor Common Government Offices), Ryugashima, Niigata-city, Niigata 950-0072 025-244-4405
025-241-7404
Niigata
Nagoya Quarantine Station
(Food Observation Division)
11-1, Tsukiji-cho, Minato-ku, Nagoya-city, Aichi 455-0045 052-661-4133
052-655-1808
Gifu and Aichi (excluding the area administered by Branch of Nagoya Airport Quarantine Station)
Branch of Shimizu Quarantine Station
(Integrated Food Observer)
9-1 (Shimizu Harbor Common Government Offices), Hinode-cho, Shimizu-ku, Shizuoka-city, Shizuoka 424-0922 0543-52-4540
0543-53-1364
Shizuoka
Branch of Central Airport Quarantine Station
(Food Observation Division)
1-1 (Central Airport Common Government Offices), Centrair, Tokoname-city, Aichi 479-0881 0569-38-8195
0569-38-8197
Aichi (limited to Central Airport)
Branch of Yokkaichi Quarantine Station
(Quarantine, Sanitation and Food Observation Division)
5-1 (Yokkaichi Harbor Common Government Offices), Chitose-cho, Yokkaichi-city, Mie 510-0051 0593-52-3574
0593-51-7666
Mie and Wakayama (limited to Shingu-city and Higashi-Muro-gun)
Osaka Quarantine Station
(Food Observation Division)
4-10-3 (Osaka Harbor Common Government Offices), Chikkou, Minato-ku, Osaka-city, Osaka 552-0021 06-6571-3523
06-6575-1803
Toyama, Ishikawa, Fukui, Shiga, Kyoto, Osaka (excluding the area administered by Kansai Airport Quarantine Station), Nara and Wakayama (excluding the area administered by Branch of Yokkaichi Quarantine Station)
Kansai Airport Quarantine Station
(Food Observation Division)
1 (Kansai Airport Local Government Offices), Airport South, Senshu, Sennan-city, Osaka 549-0021 0724-55-1290
0724-55-1292
Osaka (limited to Kansai Airport)
Kobe Quarantine Station
(Food Observation Division)
1-1, Toyahama-cho, Hyogo-ku,Kobe-city, Hyogo 652-0866 078-672-9655
078-672-9662
Hyogo (excluding the area administered by Kobe Quarantine Station Food Observation Division2), Okayama, Tokushima and Kagawa
Kobe Quarantine Station
(Food Observation Division 2)
4-16 (Kobe Air Cargo Terminal), Higashi, Kouyou-cho, Higashi-Nada-ku, Kobe-city, Hyogo 658-0031 078-857-1671
078-857-1691
Hyogo (limited to Higashi-Nada-ku and Nada-ku, Kobe-city)
Hiroshima Quarantine Station
(Food Observation Division)
3-10-17 (Hiroshima Harbor Common Government Offices), Ushina-Kaigan, Minami-ku, Hiroshima-city, Hiroshima 734-0011 082-255-1379
082-254-4984
Hiroshima (excluding the area administered by Branch of Hiroshima Airport Quarantine Station), Ehime and Kouchi
Hiroshima Quarantine Station
(Sakai Branch Office of Food Observation Division)
9-1 (Sakai Harbor Common Government Offices), Showa-cho, Sakai-city, Tottori 684-0034 0859-42-3517
0859-42-3613
Tottori and Shimane
Branch of Hiroshima Airport Quarantine Station
(Quarantine, Sanitation and Food Observation Division)
64-31 (Hiroshima Airport Terminal Building), Aza Hiraiwa, Oaza Zen-Nyu-Ji, Hongo-cho, Toyota-gun, Hiroshima 729-0416 0848-86-8017
0848-86-8030
Hiroshima (limited to Hiroshima Airport)
Fukuoka Quarantine Station
(Food Observation Division)
8-1 (Fukuoka Harbor Common Government Offices), Okihama-cho, Hakata-ku, Fukuoka-city, Fukuoka 812-0031 092-271-5873
092-282-1004
Fukuoka (excluding the area administered by Branch of Moji Quarantine Station and Branch of Fukuoka Airport Quarantine Station), Saga, Nagasaki (excluding the area administered by Branch of Nagasaki Quarantine Station), Kumamoto and Oita
Branch of Moji Quarantine Station
(Integrated Food Observer)
1-3-10 (Moji Harbor Common Government Offices), Nishi-Kaigan, Moji-ku, Kita-Kyushu-city, Fukuoka 801-0841 093-321-2611
093-332-4129
Fukuoka (limited to Kita-Kyushu-city, Nogata-city, Iizuka-city, Tagawa-city, Yamada-city, Gyobashi-city, Buzen-city, Nakama-city, Onga-gun, Kurate-gun, Kaho-gun, Tagawa-gun, Kyoto-gun and Chikujo-gun)
Branch of Moji Quarantine Station
(Branch Office of Integrated Food Observer)
1-7-1 (Shimonoseki Harbor Common Government Offices), Higashi-Yamato-cho, Shimonoseki-city, Yamaguchi 750-0066 0832-66-1402
0832-66-8145
Yamaguchi
Branch of Fukuoka Airport Quarantine Station
(Food Observation Division)
739 (Fukuoka Airport International Passengers Terminal), Oaza Aoki, Hakata-ku, Fukuoka-city, Fukuoka 816-0051 092-477-0208
092-477-0209
Fukuoka (limited to Fukuoka Airport)
Branch of Nagasaki Quarantine Station
(Quarantine, Sanitation and Food Observation Division)
4-32-5, Tomachi, Nagasaki-city, Nagasaki 850-0952 095-878-8623
095-878-8627
Nagasaki (excluding Iki-city and Tsushima-city)
Branch of Kagoshima Quarantine Station
(Quarantine, Sanitation and Food Observation Division)
18-2-31 (Kagoshima Harbor Common Government Offices), Izumi-cho, Kagoshima-city, Kagoshima 892-0822 099-222-8670
099-223-5297
Miyazaki and Kagoshima
Naha Quarantine Station
(Food Observation Division)
2-11-1 (Naha Harbor Common Government Offices), Minato-cho, Naha-city, Okinawa 900-0001 098-868-4519
098-861-4372
Okinawa (excluding thearea administered by Branch of Naha Airport Quarantine Station)
Branch of Naha Airport Quarantine Station
(Quarantine, Sanitation and Food Observation Division)
174, Aza Kagamizu, Naha-city, Okinawa 901-0142 098-857-0057
098-859-0032
Okinawa (limited to Naha Airport)