CHAPTER 3

REGULATIONS ON

FOOD IMPORTS

3-1. OUTLINE OF JAPANESE REGULATIONS ON FOOD IMPORTS

Food Sanitation Acthttp://www.japaneselawtranslation.go.jp/law/detail_main?vm=&id=12

Plant Protection Acthttp://www.cas.go.jp/jp/seisaku/hourei/data/ppa.pdf

Act on Domestic Animal Infectious Diseases Controlhttp://www.cas.go.jp/jp/seisaku/hourei/data/adaidc_2.pdf

Important laws regulating food imports

Food imports are monitored by the quarantine stations of the Ministry of Health, Labour and Welfare at the point of entry to Japan.

3-1. OUTLINE OF JAPANESE REGULATIONS ON FOOD IMPORTS

Related Laws and Procedures

Fruits and Vegetables

Meats and Meat

Products

Fish Products

Other Processed

Foods

Food Sanitation ActFood Sanitation

Inspection○ ○ ○ ○

Plant Protection ActPlant

Quarantine○

Act on Domestic Animal Infectious Diseases Control

Animal Quarantine

○

Customs Tariff Law etc.

Customs Inspection

○ ○ ○ ○

3-2. FOOD SANITATION ACT

Fundamental law to ensure food safety

Sets the specifications and standards for food(ex. food additives, microbes, remaining agricultural chemicals, packages etc.)

In line with this law all the foods imported are inspected at quarantine stations.

3-3. PLANT PROTECTION ACT (1)

To prevent the entry and spread of insects & pests harmful to plants

Fresh fruits, vegetables and nuts

Frozen or dried fruits and vegetables

Cereal grains and flour

Legumes

Flavorings and spices (coffee beans and spices)

Raw materials for plant originated herbal medicine

Grapeseed, sesame, etc. for raw materials of fat and oil

Items subject to plant quarantine

Plants

Primary agricultural

products

3-3. PLANT PROTECTION ACT (2)

1) Whether an item consists of an import- prohibited plant?

2) Which part of the plant?

3) Whether a “phytosanitary certificate” is appended?

4) Whether any soil is attached?

5) Whether any diseased organisms, insects, pests, orparasites are present?

6) Whether the fruit is from a specific place from where Japancannot import

Check Points

3-4. ACT ON DOMESTIC ANIMAL INFECTIOUS DISEASES CONTROL (1)

To prevent the spread of infectious livestock diseases.

Egg (hen, duck, turkey, etc)

Bone (unprocessed bone, crushed bone, etc)

Meat (fresh, frozen, chilled, salted, etc)

Fat (fresh, frozen, chilled, salted, etc)

Internal organs (fresh, frozen, chilled, salted, billed in casing)

Raw milk

Ham, sausage, bacon (all kinds)

Items subject to animal quarantine

1) Whether an item consists of an import-prohibited item?

2) Whether a “Health Certificate” is appended?

3) Whether there is any abnormality in the cargo?

4) Whether an inspection or sterilization is required?

Check Points

3-4. ACT ON DOMESTIC ANIMAL INFECTIOUS DISEASES CONTROL (2)

3-5. PHARMACEUTICAL AFFAIRS ACT (1)

Basic regulation for products/items classified as medicine. → The following products are to be subject to this act.

Medical ProductsQuasi-DrugsCosmeticsMedical Devices

If your products are classified as medicine, only importers with specific licenses can import them.The customs clearance procedures are very complicated and time-consuming.

3-5. PHARMACEUTICAL AFFAIRS ACT (2)

Check whether your products are classified as amedicine.

→ If your products meet one of the conditions listed below, they are classified as medicine and regulated by the act.

1) Listed on “the Japanese Pharmacopoeia”.http://jpdb.nihs.go.jp/jp15e/

2) Use ingredients enumerated on the medical ingredients list.

3) Specify medical effects of a producton the package, flyer or brochure etc.

eg. “cure gastric cancer”, “restore youth”, “purify blood” etc.

3-6. POSITIVE LIST SYSTEM (1)

Sets the maximum limits of agricultural chemicalresidues that can be found in foods.

Agricultural chemicals: pesticides, feed additives and veterinary drugs.

Chemicals not mentioned on the list can be used at a maximum of 0.01ppm.

Foods exceeding the amount of chemicalsare not allowed to be sold in the Japanese market.

<Reference>http://www.mhlw.go.jp/english/topics/foodsafety/positivelist060228/index.html

3-6. POSITIVE LIST SYSTEM (2)

Maximum Residue Limits (MRLs) : 799 substances→ For the individual limit of each substance,

please check MRLs Data Base

Uniform Limit: 0.01ppm→ Applicable for agricultural chemicals without MRLs

(same as that of European Union)

Exempted Substances: 65 substances→ Not subject to the positive list system

http://www.m5.ws001.squarestart.ne.jp/foundation/search.html

http://www.ffcr.or.jp/zaidan/FFCRHOME.nsf/pages/MRLs-p-ES

3-7. FOOD ADDITIVES (1)

Food AdditivesPreservatives, Sweeteners, Colorings, flavorings etc.

Food Sanitation Act lists food additives that can be used in foods.

Foods containing food additives that do not appear on the list are prohibited from being imported into Japan.

3-7. FOOD ADDITIVES (2)

Permitted food additives are classifiedinto 4 categories as follows:

1) Designated additives (413 substances)eg: Benzoic acid, calcium carbonate, citric acid etc.

2) Existing additives (365 substances)eg: Orange colour, palm oil caroten, pectin etc.

3) Natural flavoring (about 600 substances)eg: Aloe, durian, honey etc.

4) General food additives (about 100 substances)eg: Strawberry juice, green tea etc.

3-7. FOOD ADDITIVES (3)

Attention must be paid to the usage standards of food additives:(maximum quantity limits, purpose condition etc.)

→ Some food additives are not permitted to be used in foods, even though they may be legal in your country.

<Information>http://www.ffcr.or.jp/zaidan/FFCRHOME.nsf/pages/e-foodadditives

3-8. WASHINGTON CONVENTION (1)

CITES = Washington ConventionConvention on International Trade in Endangered Species of Wild Fauna and Flora

→Regulates an excess of commercial trade of endangered wild animals and plants in order to ensure their survival.

3-8. WASHINGTON CONVENTION (2)

All endangered species are classified into 3 categories according to the level of endangerment:

1) Appendix I (species in danger of extinction)→Trade of these species are permitted only for academic

purposes. eg. African Elephant, Certain species of Aloe, etc

. 2) Appendix II (species of which trade must be controlled)→ An export permit issued by the authority of the country of export

is required. eg. Cactus, Orchids (including wild vanilla), African manatee, etc.

3) Appendix III (species that are protected in at least one country)→ An export permit issued by the authority of the country that

included the species concerned in the Appendix III is required.eg. Anteater from Botswana, Pink Pigeon from Mauritius

3-9. QUALITY LABELING SYSTEM (1)

Imported foods as well as domestic products in Japan, must display the appropriate food labels when sold in Japan.

1) Fresh produce・Product name ・Country of origin

2) Processed food・Product name ・List of ingredients ・Net contents・Best-before date ・Preservation method ・Country of origin・Importer’s name and address

Items that have to be listed on food labels

3-9. QUALITY LABELING SYSTEM (2)

When sold in Japan, all ingredients must belisted on the labels of the product in Japanese.

Ingredients should cover all the items used in theproduct.

Ingredients (including food additives) must be listed in order from highest to lowest, according to their specific weighting in the product.

An exporter will prepare the label with an importer.

The exporter has to provide accurate information of ingredients

(including additives) so that an importer can make correct labels.

3-9. QUALITY LABELING SYSTEM (3)

Ingredients known as allergens must belisted on package labels.

* Number of people who suffer from food allergies is increasing.

Labeling Mandatory

Shrimp/Prawn, Crabs, Wheat, Buckwheat, Eggs, Milk, Peanuts

Labeling Recommended

Abalone, Squid, Salmon, Salmon roe, Bananas, Mackerel, Beef, Pork, Chicken, Oranges, Peaches, Kiwi fruit, Apples, Walnuts, Soybeans, Yams, Gelatin, Matsutake mushroom

Eg: Emulsifiers (derived from soybeans)Vegetable fats and oils (containing soybean oil)

3-9. QUALITY LABELING SYSTEM (4)

Product Name

Ingredients

Net Contents

Best-beforeDate

Importer NameCountry of Origin

PreservationMethod

Description of a food additive:Emulsifier (derived from soybeans)

Nutritional Ingredients and Calories

3-9. QUALITY LABELING SYSTEM (5)

The JAS (Japanese Agricultural Standard) Law setsthe specifications and standards for organic agricultural products.

→Registered certifying bodies check whether products comply with JAS standards.

→Only certified foods can display the “JAS mark” and the phrase “Organic”.

Labeling for organic agricultural products in Japan

Detailed Information:

http://www.maff.go.jp/e/jas/specific/organic.html

3-9. QUALITY LABELING SYSTEM (6)

How can imported foods be “organic” in the Japanese market?

CASE 1: Producers attach the JAS mark.

Ministry of Agriculture, Forestry and Fisheries

Registered Overseas Certifying Bodies

(1) application(2) accreditation

Producers, Manufacturers,

Farmers

(3) certificationAttach the JAS

mark and export

Importers

3-9. QUALITY LABELING SYSTEM (7)

CASE 2: Importers attach the JAS mark.

Ministry of Agriculture, Forestry and Fisheries

Registered Japanese Certifying Bodies

(1) application(2) accreditation

Producers, Manufacturers,

Farmers

(3) certification

Attach the JAS mark

Importers Overseas certifying body

Overseas government

(1) certification(2) Issuance

of certificate

Scheme of a country of export

▲ATTENTION▲CASE 2 is only applicable to countries(27 EU countries, Australia, U.S.A., Argentina, New Zealand and Switzerland)

whose organic rules and standards are approved as equivalent to Japanese ones.

3-10. FOOD IMPORT PROCEDURES (1)Flow Chart

Processed FoodsSeafood

FruitsVegetables

MeatsProcessed meats

PlantQuarantine

Shipper

AnimalQuarantine

Food Sanitation Inspection

Declaration with “Notification Form for Importation of Foods”

Declaration with “Form Display Only”

Customs Inspection

3-10. REQUIRED DOCUMENTS (2)FOOD IMPORT PROCEDURES

Notification Paper of Food Import- The official documents to declare at the quarantine stations

Exporter must prepare…

Importer will prepare…

List of Ingredients （for each item）

Manufacturing Process Chart （for each item）

InvoicePacking List

*Please discuss with your customs clearance agent

Phytosanitary CertificateCertificate of AnalysisCertificate of Origin

Only when required…