Importing Health Foods～ Laws and Regulations Importers Should Be Aware of ～Issued by
Manufactured Imports and Investment Promotion Organization (MIPRO)﻿﻿

Importing Health Foods ～ Laws and Regulations Importers Should Be Aware of ～Overseas, health foods and supplements are sold based on the country’s own laws and regulations befitting
its climate, food culture and so on. Some of such products pose a concern about their safety; some containspecial ingredients claimed to be good for human health, some are in a tablet or capsule form and contain
concentrated ingredients, and some don’t have any record of consumption in Japan.
An importer is required to assume equal responsibility for ensuring the safety of imported goods as theprocessor thereof. Therefore, import of health foods needs careful prior considerations.
Importing and selling health foods involve checking based on the Pharmaceuticals and Medical Devices
Act, following procedures prescribed in the Food Sanitation Act, and complying with provisions in manyother laws. An importer needs to check where necessary information can be obtained from and what are
the legal points that must be observed.
This booklet outlines importing-related laws and regulations for importing and selling health foods in Japanand labeling-related laws and regulations for selling them in Japan as business. For details of these laws
and regulations, please check the original laws and regulations or make inquiries to the relevant
competent governmental department.

The content is subject to change due to amendments of relevant laws or other reasons. It isadvisable to always check for the latest information.
February 2020
Manufactured Imports and Investment Promotion Organization (MIPRO)

Contents
4

Ⅰ Laws and Regulations Related to Import of Health Foods

4		

Fall into Foods When Orally-ingested Goods Do Not Fall into Pharmaceuticals

6		

Be Careful of Laws and Regulations That Apply Depending on Raw Material, Item, etc.

810

Ⅱ Flow of Import Procedures of Health Foods
Ⅲ Applicability of Pharmaceuticals and Medical Devices Act and Whether the Goods Fall into
Pharmaceuticals

10		

Four Elements for Determining Whether the Goods Fall into Pharmaceuticals

12		

Self-checking Whether the Goods Fall into Pharmaceuticals

17		

Contact Points for Determining Whether the Goods Fall into Pharmaceuticals before Importing18		

Contact Points for Determining Whether the Goods Fall into Pharmaceuticals for Cargo That Has Arrived
and Was Suspended at Customs Clearance

19

Ⅳ Food Sanitation Act and Import of Foods

19		

Import Notification System for Foods

22		

Examination and Inspection at Quarantine Stations

24		

Securing Safety of Foods by Food Sanitation Act

26		

Carefully Perform Preliminary Survey to Avoid Import of Violating Foods

32

Ⅴ Laws and Regulations Related to Labeling of Health Foods

32		

Food Labeling Act

34		

Obligation of Labeling for Nutrients35		

To Label with Emphasizing Nutrition36		

To Label Function Claims38		

Be Careful with False or Exaggerated Labeling and Misrepresentation Concerning Quality

This material has been prepared by receiving subsidies for FY2019 Promotion Business
Expenses from the Foundation for International Trade and Industrial Co-operation,a general incorporated foundation.

2

Importing Health Foods﻿﻿In this booklet, health food products including supplements may be collectively referred to as“health foods.”
 What Are Health Foods?

In Japan, there is no specific legislative definition for health foods. Generally, the term“health foods”isused to refer to“any products that are sold and used as foods that broadly contribute to maintaining andpromoting health.”
Among health foods, food products for which labeling of their functions is permitted in accordance withthe standards on the safety and functions determined by the national government are called“foods withhealth claims.”(See page 36)
Meanwhile, some food products are not allowed to have function claims (hereinafter referred to as“other
health foods”). As such, health foods can be divided into two, namely, foods with health claims and other
health foods, by whether functions can be labeled on the food product or not.
The“other health foods”include supplements, nutrition supplements, health supplements, and natural
foods. However, there is no legislative definition for these names in Japan(Note).
(Note) There are some names a business operator may voluntarily label related to quality standards established by a food-related industry
organization, such as“Certified Health Food (JHFA) Mark.”■ Reference information
MHLW’s website:“Health foods”(English)
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/hokenkinou/index_00010.html

Classification of Health Foods

Foods

Pharmaceuticals
Generalfoods

Health foods

Foods forspeciﬁedhealth uses(“Tokuho”)

Permit by theConsumer Aﬀairs
AgencyFood for speciﬁed
health uses

Foods with nutrient function
claims (no special symbol)
Foods with function claims(no special symbol)

Cannot label function claims
like foods with health claims
Other
health foods

Foods withhealth claims

Can label function claims inaccordance with the rules prescribedby the national laws.

● Supplements● Nutrition supplements

Includesquasipharmaceuticalproducts● Health supplements● Natural foods,etc.

(Source) Consumer Affairs Agency’s pamphlet“Health Foods Q&A”October 2017
 What Are Supplements?

“Supplement”is a short form of“dietary supplement,”which may also be called“health supplement”or“nutrition supplement.”In EU or USA, supplements are placed as goods ingested mainly for the purposeof supplementing nutrition lacking in the daily diet, such as vitamins, minerals and amino acids. They arehandled in a category separate from foods and pharmaceuticals, and regulated by independent laws
specifically established for supplements. They are in a form of tablet, capsule, jelly, powder, etc. and are
not clearly distinguishable as foods.
Different from overseas, in Japan, there is no clear definition for supplements, and there are no
independent laws to regulate them either. Shapes like tablets and capsules used to be permitted forpharmaceuticals only, but they can now also be used for food products as a result of deregulation by thenational government in March 2001, unless conflicting with the Pharmaceutical Affairs Act (current
Pharmaceuticals and Medical Devices Act).
Since then, health foods in the form of tablet or capsule have widely spread in Japan, and the term
“supplement”is widely accepted nowadays. Supplements are recognized by the general public as one type of
health food.

Importing Health Foods

3

Ⅰ

Laws and Regulations Related to Import of Health Foods

To import health foods into Japan for marketing, first of all, it is important to check that the goods do not
fall in the category of pharmaceuticals. Importing health foods as foods is subject to the Food Sanitation
Act, but the importer needs to check applicability of other relevant laws and regulations as well.

■ Fall into Foods When Orally-ingested Goods Do Not Fall into Pharmaceuticals

By Japanese laws and regulations, orally-ingested goods are classified into either pharmaceuticals or foods.
“Pharmaceuticals”are defined by the Act on Securing Quality, Efficacy and Safety of Products Including
Pharmaceuticals and Medical Devices (Hereinafter referred to as Pharmaceuticals and Medical Devices Act)as (1) items intended for use in the diagnosis, treatment or prevention of disease or (2) items intended toaffect the structure and functions of a body.
Meanwhile,“foods”are defined by the Food Sanitation Act as all foods and drinks, excluding pharmaceuticalproducts, quasi-pharmaceutical products or regenerative medicine products specified by the Pharmaceuticals
and Medical Devices Act.
Pharmaceuticals (including quasi-pharmaceutical products and regenerative medicine products; hereinafter
the same shall apply) are subject to regulations of the Pharmaceuticals and Medical Devices Act and foods
are subject to regulations of the Food Sanitation Act to ensure their safety.
Some health foods and supplements available overseas contain ingredients classified as pharmaceuticals inJapan or claim functions similar to pharmaceuticals, and importing and selling them as foods are subject toguidance and control as unapproved or unauthorized drugs under the Pharmaceuticals and Medical Devices
Act.
Therefore, if orally-ingested goods are not clearly distinguishable as foods, the importer needs to check thatthey do not fall into the category of pharmaceuticals.
 Division between Foods and Pharmaceuticals

The legal borderline between the Pharmaceuticals and Medical Devices Act and the Food Sanitation Act iscalled the“division between foods and pharmaceuticals.”
The standards to determine the division between foods and pharmaceuticals are the“Standards on the
Scope of Pharmaceuticals” attached to the MHW/DPAB Notice, “Guidance and Regulations on
Unapproved or Unauthorized Drugs”(Yakuhatsu No. 476 dated June 1, 1971; so-called 46 (Yon-roku) Notice).
From the viewpoint of the Pharmaceuticals and Medical Devices Act, whether the goods fall into thecategory of pharmaceuticals is determined. (See page 10) Importing and Selling Pharmaceuticals Require Approval and Permit ⇒ Importing

Pharmaceuticals Is Difficult

Pharmaceuticals are used for treatment of disease by affecting human bodies in principle. Though they are
expected to provide their intended therapeutic effects, in some cases pharmaceuticals can cause
unexpected side effects. Therefore, their quality, effectiveness and safety need to be ensured. For thatreason, strict regulations are imposed on pharmaceuticals for each stage of their development, approval,
manufacturing, distribution and use, based on the Pharmaceuticals and Medical Devices Act.
If the goods to be imported fall into the category of pharmaceuticals, approval and permit based on the
Pharmaceuticals and Medical Devices Act will be needed.
 Importing and Selling Foods Require Import Notification

If the goods to be imported fall into the category of foods, the importer of the goods needs to submit animport notification based on the Food Sanitation Act, receive examination to prove that the goods arefoods that comply with regulations of the Food Sanitation Act about the safety, and obtain a certificate ofimport notification. (See page 19)
As for health foods, there is no specific definition under the Food Sanitation Act or individual standard or
criterion; safety regulations for general foods also apply to health foods.

4

Importing Health Foods

Ⅰ Laws and Regulations Related to Import of Health Foods

Orally-ingested Goods Are Classified into Pharmaceuticals or Foods
Classification

Law toensure safety

Procedures for importing
into and selling in Japan

Matters to be checked
for health foods

Pharmaceuticals
and Medical Devices
Act・Requires a business license for manufacturing/marketing pharmaceuticals
・Requires a business license for
manufacturing pharmaceuticals, etc.
for packaging, labeling and storage ofpharmaceuticals
・Requires an approval for each item
regarding its manufacturing/marketing

Check that the goods do not
fall into the category of pharmaceuticals (not an unapprovedor unauthorized drug) from theviewpoint of the Pharmaceuticals
and Medical Devices Act

See page
10 onward
for details

Requires notification of importto a quarantine station on every
importCheck the safety as foods (e.g.,whether the goods comply withstandards and criteria of theFood Sanitation Act, whether
the goods contain a toxic orhazardous substance)

See page
19 onward
for details



Pharmaceuticals(Includes quasipharmaceuticalproducts)





Foods

Food Sanitation Act

Which category do the goods to be imported fall into, pharmaceuticals or foods?
⇒ If the goods do not fall into the category of pharmaceuticals, the importer canproceed with import procedures for foods
Orally-ingested goods

Standards of the division between foods andpharmaceuticals= Standards on the Scope of Pharmaceuticals●

D etermine whether the goods
fall into the category ofpharmaceuticals

Do not fall into the category of pharmaceuticals= Fall into the category of foods

Import notification under the Food
Sanitation Act

Importing Goods Harmful to the Society (e.g., Narcotic Drugs, Hemp, Stimulants, Designated Drugs) Is Prohibited

Article 69-11 of the Customs Act bans import of narcotic drugs, psychotropic substances, hemp,
opium, poppy straw, stimulants (including raw materials thereof) and designated drugs.
Some health foods such as herbs and oils sold claiming not to be illegal may fall into narcotic drugs ordesignated drugs, and import of such goods may be prohibited.
(Note) Designated drugs refer to substances, among ingredients contained in Kiken drugs (quasi-legal drugs), designated based on the
Pharmaceuticals and Medical Devices Act as those having high probability of hallucinating and other effects and which could
cause health hazards in the event such substances are used.
■ Reference information
Japan Customs’ website:“Enforcement”
https://www.customs.go.jp/mizugiwa/index.htm

Importing Health Foods

5

Ⅰ Laws and Regulations Related to Import of Health Foods■ Be Careful of Laws and Regulations That Apply Depending on Raw Material, Item, etc.

Some Japanese laws and regulations regulate import of certain goods for the purpose of achieving the
primary objective of the law or regulation, such as protection of domestic industries, ensuring the quality
and safety of products, and preservation of nature or the social environment.
・Plant protection and animal quarantine for ensuring the safety of plants and livestock in Japan・Trade control for items covered by the CITES・For rice and wheat, salt, sugar and starch, and some dairy products, securing their stable supply to thegeneral public, stabilizing their prices, ensuring stable management of domestic producers
An importer shall obtain information about the goods to be imported, such as an ingredient list and foodproduction flow chart, and investigate what laws and regulations may apply other than the Food SanitationAct.
Depending on applicable laws and regulations, importing the relevant goods may require a certificate froma foreign government organization, or import permission, approval, etc. by the Japanese government. It isadvisable to check for necessary documents in advance.
For an overview of procedures and contact points, refer to“Guide to Food Import”issued by MIPRO.

Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and Import Restrictions

The CITES classifies endangered species of wild fauna and flora into three categories (Appendices I,
II, and III) depending on the necessity of their protection and restricts their international trade. When
importing anything regulated by the CITES, an importer needs to obtain an export permit issued by agovernment organization of the exporting country as specified in the Convention and a certificate ofimport approval issued by the Ministry of Economy, Trade and Industry. Upon making an importdeclaration, the importer must submit such documents to customs to seek confirmation therefrom.
Required procedures are specified in the Import Trade Control Order and the Points to Note on
Import, etc. Procedures vary by classification of Appendices and country of origin or place of shipment.
○ Those designated in item (ii) or item (ii)-2 of the Public Announcement on Import⇒ Application for import approval○ Those designated in item (iii) of the Public Announcement on Import⇒ Application for prior confirmation○ Those listed in Appendix II or III other than those subject to prior confirmation⇒ Confirmation upon customs clearance
It should be noted that if a person imports goods regulated by the CITES without obtaining an export
permit or a certificate of import approval, the import is rejected at customs in Japan. Import is often
rejected for crude drug raw materials such as musk deer, Saussurea costus, Gastrodia elata rhizome,
aloe, and American ginseng.
How to check for items subject to the regulations is shown on the website below.
There is no document like a“non-applicability certificate”for items not covered by the CITES. It is
recommended to prepare for giving explanations to customs that the goods to be imported are notcovered by the CITES by, for example, describing the scientific name (internationally accepted Latinname), country of origin, origin of the animal or plant, etc. on a certificate of origin issued by thechamber of commerce or on customs clearance documents such as invoices.
■ Inquiries
Wild Fauna and Flora Trade Licensing Office, Trade Control Department, Trade and Economic Cooperation Bureau, Ministry of
Economy, Trade and Industry: Tel: +81-3-3501-1723■ Reference information
Ministry of Economy, Trade and Industry’s website:“The Convention on International Trade in Endangered Species ofWild Fauna and Flora (CITES)”
https://www.meti.go.jp/policy/external_economy/trade_control/02_exandim/06_washington/index.html (Japanese)
https://www.meti.go.jp/english/policy/external_economy/CITES/index.html (English)

6

Importing Health Foods

Ⅰ Laws and Regulations Related to Import of Health Foods

Major Laws and Regulations Related to Import Depending on Raw Materials and Item of Foods
For an overview of procedures and contact points, refer to“Guide to Food Import”issued by MIPRO.
Item

Name of law or regulation

Major regulations

Plant Protection Act

・Restrictions of import, prohibition ofimport, import quarantine such as
inspection of imported plants
・Importing not permitted without aphytosanitary certificate issued by agovernment organization of theexporting country

Designated quarantine items
・Cloven-hoofed animals (e.g., cattle, pig, sheep, goat, anddeer), horse・Chicken, quail, pheasant, ostrich, guinea fowl, turkey, duck,
goose and other anserine birds (Anseriformes)
・Dog, rabbit, honey bee
・Bone, meat, fat, blood, skin, fur, feather, horns, hooves,tendons and organs of animals above
・Fresh milk, milk, etc. (e.g., milk, skim milk, cream, butter,cheese, condensed milk, powdered milk; excluding goods
brought in with people) , semen, fertilized eggs, unfertilized
eggs, dung and urine of animals above
・Bone meal, meat meal, meat-and-bone meal, blood meal, hide
powder, feather powder, hoof and horn meal and organ
powder of the above animals
・Eggs of chicken, quail, pheasant, ostrich, guinea fowl, turkey
and anserine birds
・Sausage, ham, bacon, etc. made from meat or the like of adesignated quarantine item

Act on Domestic Animal
Infectious Diseases Control

・P rohibition of import, inspection of
products, import quarantine such as
limitation of importing sites
・Importing not permitted without ahealth certificate or veterinary
certificate issued by a governmentorganization of the exporting country

Rice (e.g., rice grains, rice powder, rice cake,cooked rice), wheat variety (barley, wheat, nakedbarley, meslin, triticale and their processed or
prepared foods)

Act on Stabilization of Supply,
Demand and Prices for Staple
Food

Notification of import quantity andpayment of import levy for importexceeding the minimum access quota
Rice Retailers Notification System

Act on Price Adjustment of
Sugar and StarchContribution to adjustment funds forimporting designated sugar andstarch (transaction agreement inwriting with the Agriculture &Livestock Industries Corporation)

Act Concerning the Stabilizationof Price of Livestock Products

Contribution to adjustment funds fordesignated dairy products(procedures of purchasing andsell-back with the Agriculture &Livestock Industries Corporation)

Salt Industry Act

Registration as a specified
wholesaler of salt
Notification of specified wholesaleof special-purpose salt
Registration as a salt wholesaler

Liquor Tax Act

Obtainment of liquor sales license
Payment of liquor tax

Act on Securing of Liquor Tax andon Liquor Business Associations

Labeling of liquor item namePlantsFruits (fresh, frozen, and dried), vegetables (fresh,frozen, and dried), nuts, grain, beans, coffee beans(raw), herbs, spices, rapeseed, sesame, etc.

Sugar, starchPreparations containing added sugar

Butter, skim milk, condensed milk, etc.

Salt

Liquor (drinks with an alcoholic content of one
percent or higher)

Items covered by the CITES (e.g., aloe, musk deer,
American ginseng, Saussureae costus, Gastrodia
elata rhizome, crocodile)

Fisheries products

Foreign Exchange and Foreign
Trade Act
Import Trade Control Order・R egulation of international trades
depending on the need for protectionof plants and animals covered by
the CITES・Importing not permitted without a
CITES export permit issued by theexporting country
Import quota, import approval,
prior confirmation system

Importing Health Foods

7

Ⅱ

Flow of Import Procedures of Health Foods■ Before Importing・For goods that cannot be clearly distinguishable as foods, it is important to check that they do not fall into
the category of pharmaceuticals before importing them for smooth customs clearance procedures.
・For notification of food import, prepare necessary documents such as ingredient list and food production flow chart.
・If the goods to be imported are subject to laws and regulations that require permission, approval or  
inspection for importing (e.g., items covered by the CITES, goods subject to plant quarantine or animal
quarantine), prepare documents necessary for the relevant procedures.

■ At Importing

・Cargo that arrives in Japan is transported into bonded areas.
・Import procedures differ by types of food.
(1) Plant foods such as vegetables and fruits are subject to the Plant Protection Act, and the importer files
an application for inspection at a plant protection station under the jurisdiction of the Ministry ofAgriculture, Forestry and Fisheries (MAFF) and undergoes inspections.
(2) Livestock products such as meat and processed meat products are subject to the Act on Domestic
Animal Infectious Diseases Control, and the importer files an application for inspection at an animal
quarantine service under the jurisdiction of MAFF and undergoes inspections.
(3) All foods (including foods in (1) and (2) above) imported for the purpose of marketing (including
delivery) are subject to the Food Sanitation Act, and the importer submits import notifications toquarantine stations under the jurisdiction of the Ministry of Health, Labour and Welfare (MHLW).
If the import is judged as being legitimate as a result of an examination and inspection at a quarantine
station, a certificate of notification for importation of foods is returned to the importer.

■ Import Clearance・When making an import declaration at customs, the importer presents a certificate of notification basedon the Food Sanitation Act returned from quarantine stations for foods, a certificate for goods that
underwent plant quarantine or animal quarantine, or a proof of permission or approval for goods that
require them for importing (e.g., items covered by the CITES) and customs checks them.
・In the case of importing liquor, the importer must affix a label in Japanese under the Act on Securing of Liquor
Tax and on Liquor Business Associations and other laws to the products within a bonded area, and ispermitted to transport them out of the bonded area only after paying duties, consumption taxes and liquor tax.
・When the import is permitted after paying duties, consumption taxes, etc., the importer is allowed totransport imported foods out of a bonded area.

■ At Sales

・Foods need to carry labels compliant with regulations on food labeling while being marketed.
・Careful attention is required for representations and advertisements of health foods not to violate relevant
regulations of the Health Promotion Act, Act against Unjustifiable Premiums and Misleading
Representations (hereinafter referred to as Premiums and Representations Act) , and Pharmaceuticals
and Medical Devices Act.
・Depending on the food type or business mode, a business permit or notification may be required.
・Certain sales activities such as online sales are subject to regulations under the Act on Specified
Commercial Transactions.
・Containers and packaging are subject to regulations on identification marks for recycling.
For the laws above, their information is provided at websites of governmental agencies that have jurisdiction
over the laws, or websites of or pamphlets available at the competent division of prefectural government.

8

Importing Health Foods

Ⅱ Flow of Import Procedures of Health Foods

Flow of Import Procedures of Health Foods〈Before Importing〉

Pharmaceuticals and Medical Devices Act

Self-check that the goods do not fall into pharmaceuticals. As required, check thatthe goods do not fall into pharmaceuticals at the pharmaceutical aﬀairs
department of the competent prefectural government with jurisdiction over thebusiness oﬃce of the importer.

Food Sanitation Act

Prepare information and documents necessary for making import notiﬁcation, useprior consultation

Laws and regulations that require permission, approval, inspection, etc.
for importing
Check goods subject to relevant regulations, and prepare documents necessary
for procedures if the goods to be imported are subject to the regulations
Arrival of cargo and its transport to bonded areas[Bonded area]〈At Importing〉

PlantsLivestock products(Vegetables, fruits,nuts, grain, beans, etc.)

Foods other than plants andlivestock products,
additives

Domestic Animal Infectious
Diseases Control Act

Plant Protection Act
Plant quarantine at aplant protection station

Animal quarantine at an animal
quarantine service

Food Sanitation Act

Examination and inspection about food sanitation at quarantine stations〈Import Clearance〉

Customs
Act, etc.

Import declaration to customs
Check for other import-related laws and regulations,
examination and inspection at customs
Payment of duties,
consumption taxes, etc.

〈At Sales〉

Import permission

Transport from a bonded area

Regulations on food labeling

Food Labeling Act, Measurement Act, Health Promotion Act, Act against Unjustiﬁable
Premiums and Misleading Representations, Pharmaceuticals and Medical Devices Act, etc.

Regulations concerning permission to conduct food-related businessand relating to licensing, notiﬁcation and sales activities

Food Sanitation Act, Liquor Tax Act, local government's ordinances, Act on Speciﬁed
Commercial Transactions, etc.

Regulations on labeling for collection and recycling of containers and packaging, etc.

Domestic distribution

Importing Health Foods

9

Ⅲ

Applicability of Pharmaceuticals and Medical Devices Act
and Whether the Goods Fall into Pharmaceuticals

Some health foods and supplements available overseas contain ingredients classified as pharmaceuticals
under the Pharmaceuticals and Medical Devices Act of Japan or claim functions similar topharmaceuticals. Such products fall into the category of pharmaceuticals in Japan, and cannot be imported
as foods.
When one desires to import goods that are not clearly distinguishable as foods (e.g., supplements in a formof tablet or capsule, those that contain oriental drug(Note) or herbal raw materials, those that contain raw
materials that are not familiar in Japan), the person needs to check whether the goods fall into thecategory of pharmaceuticals.
(Note) Oriental drugs: Crude drugs used in Japan or China (a part of natural plant, mineral or animal which is simply processed and used asa drug)■ Four Elements for Determining Whether the Goods Fall into Pharmaceuticals

As described in the section about the division between foods and pharmaceuticals on page 4, the criteria of
whether goods fall into the category of pharmaceuticals are the “Standards on the Scope of
Pharmaceuticals”included in the MHLW’s Notice,“Guidance and Regulations on Unapproved or
Unauthorized Drugs.”
The judgment is made by whether the goods have a purpose as a pharmaceutical or whether people
usually recognize the goods to have a purpose as a pharmaceutical, and there are four determination
elements.
If goods are judged to fall into the category of pharmaceuticals as a result of comprehensive considerationon the four elements, the goods cannot be imported as foods into Japan.

(1) Ingredient essences (raw materials) of the goods
Whether the goods to be imported are pharmaceuticals or not is judged from their raw materials andingredients.
Specifically, two lists (list of division between foods and pharmaceuticals) are provided, and goods
containing ingredients classified into“list of ingredient essences exclusively used as pharmaceuticals”
are regarded as pharmaceuticals.
(2) Efficacy and effects labeled on the goods
If efficacy or effects for the purpose of therapy or prevention of disease or for the primary purpose ofgeneral strengthening or promotion of tissue functions in the body are represented or described on
the product container, packaging, package insert, brochures, pamphlets, and/or advertisements(including those on the Internet), the goods are regarded as pharmaceuticals, whether such claims are
explicit or implicit.
The same applies when such claims are made in a non-Japanese language.

(3) Form (e.g., dosage form, container, packaging, design)
 mpules, sublingual tablets, those sprayed into the oral cavity after filling into a spray tube areAregarded as pharmaceuticals.

(4) Dosage and administration labeled on the goodsI f detailed dosage and administration (e.g., administration time, administration intervals, dosage) arelabeled, the goods are regarded as pharmaceuticals.
■ Reference information
MHLW’s Notice“Guidance and Regulations on Unapproved or Unauthorized Drugs,”Attachment“Standards on the Scope of
Pharmaceuticals”(MHW/DPAB Notice of 1971, Yakuseihatsu No. 0418-4, amended on April 18, 2018)
MHLW’s website“Food > Health foods > Information on unapproved or unauthorized drugs > Notices”(Note) This notice has been amended multiple times since it was first issued in 1971. Always check for the latest amendment.
https://www.mhlw.go.jp/kinkyu/diet/musyounin.html

10Importing Health Foods

Ⅲ Applicability of Pharmaceuticals and Medical Devices Act
and Whether the Goods Fall into Pharmaceuticals

Goods That Are Not Judged as Pharmaceuticals in Principle
Like those that are clearly recognizable as foods from their appearances or forms, such as vegetables,
fruits and cooked products, goods that fall into one of the items below are not judged as pharmaceuticals inprinciple.

1	Those that are clearly recognizable as foods from their appearances or forms, such as vegetables, fruits andcooked products
2	Foods for special dietary uses that carry labels permitted under the provisions of Article 26 of the Health Promotion
Act (Act No. 103 of 2002)
3	Foods with function claims that carry labels permitted under the provisions of Article 2, paragraph (1), item (x) of theFood Labeling Standards (Cabinet Office Ordinance No. 10 of 2015) that was established based on the provisionsof Article 4, paragraph (1) of the Food Labeling Act (Act No. 70 of 2013)(Source) MHLW’s Notice“Standards on the Scope of Pharmaceuticals”
Items whose essences are well recognized from experience in a normal diet and that are easily recognizable as foodsfrom their appearances or forms do not cause misunderstanding about the essence of the items as foods, and there isno concern for normal persons to misinterpret such items as pharmaceuticals. Therefore, it is clear that such items
that pose no concern over giving interpretation of having pharmaceutical purposes do not fall into pharmaceuticals
and there is no need to individually examine their ingredient essences (raw materials), forms, effects and efficacy, or
dosage and administration and to make judgment in accordance with the“judgment method”described below.
(Source) MHLW’s Notice“Manual of Supervision and Guidance on Unapproved or Unauthorized Drugs,”
Chapter II-4“Interpretation of Items Clearly Recognizable as Foods”

Items to Check for Determining Whether Goods Fall into Pharmaceuticals
1 D o the goods contain an ingredient on the“list of ingredientessences exclusively used as pharmaceuticals”?

⇒ Yes⇒ Fall into pharmaceuticals⇒ Yes⇒ Fall into pharmaceuticals⇒ Yes⇒ Fall into pharmaceuticals⇒ Yes⇒ Fall into pharmaceuticals↓ No
2 A re the goods labeled with or advertised for pharmaceuticaleffects or efficacy?
↓ No
3 Are the goods in a pharmaceutical form?
↓ No
4 Does the description of the goods include pharmaceutical dosage
and/or administration?
↓ No
Do not fall into pharmaceuticals. However, checking of related laws and regulations is needed regarding the raw
materials used, labeling and advertisement.
(Source) MHLW’s Notice“Standards on the Scope of Pharmaceuticals”Chapter II“Judgment method”Edited by MIPRO.

Importing Health Foods

11

Ⅲ Applicability of Pharmaceuticals and Medical Devices Act
and Whether the Goods Fall into Pharmaceuticals■ Self-checking Whether the Goods Fall into Pharmaceuticals

To investigate whether the goods to be imported fall into pharmaceuticals, it is highly recommended torefer to the Attachment“Manual of Supervision and Guidance on Unapproved or Unauthorized Drugs”of
MHLW’s Notice“Supervision and Guidance on Unapproved or Unauthorized Drugs.”The Attachment
includes explanations on the basic approach of judgment, interpretations, points of note and other useful
information.
■ Reference information
MHLW“Supervision and Guidance on Unapproved Medicine and Unauthorized Drugs,”Attachment“Manual of Supervision andGuidance on Unapproved or Unauthorized Drugs”(last amendment, Yakushokukanmahatsu No. 0401-3, April 1, 2015).
https://www.mhlw.go.jp/kinkyu/diet/dl/kanshishidou.pdf

Obtain an ingredient list (see page 20), photos, user’s manual and the like of the product from the exporter(e.g., relevant overseas manufacturer). To judge whether the goods contain pharmaceutical ingredients or
not, also obtain information on the Japanese name and scientific name of raw materials, classification(family, genus) of raw materials of plant or animal origin, used parts, purpose of use, etc.
Checkpoint 1: Whether Raw Materials or Ingredients Fall into Pharmaceuticals

Check whether raw materials or ingredients fall into pharmaceuticals using two lists provided by the“Standards on the Scope of Pharmaceuticals.”(1) List of ingredient essences (raw materials) exclusively used as pharmaceuticals = Pharmaceuticals list(2) L ist of ingredient essences (raw materials) not judged as pharmaceuticals unless claiming
pharmaceutical effects or efficacy = Non-pharmaceuticals list

Pharmaceuticals list

Uncategorized (new) raw
materials and ingredients

Non-pharmaceuticals list

・List in which an item is judged as apharmaceutical if it contains or islabeled to contain any one of raw
materials or ingredients in the list・N o t b e i n g i n c l u d e d i n t h epharmaceuticals list or nonpharmaceuticals list does not
automatically mean the raw
material or ingredient is usable infood products.

・List in which an item is not judged
as a pharmaceutical unless
pharmaceutical effects orefficacy are included in productdescriptions on the outer box orin advertisements[If raw materials and ingredients are not categorized into the list of division between foods and pharmaceuticals(new ingredients)]
Not being included in the two lists does not automatically mean the raw material or ingredient is usable in food products.
To determine whether raw materials and ingredients not included in the two lists fall into pharmaceuticals, the importer will
have to inquire MHLW via the competent prefectural office. When inquiring MHLW, the importer needs to obtain documents
containing information on such raw materials and ingredients, including scientific names of raw materials, used parts,
pharmacological or physiological action, toxicity, narcotic or stimulative action, precedents of approval as pharmaceuticals
in Japan or overseas, and dietary habits from the processor and submit them. Please contact the pharmaceutical affairs
department of the competent prefectural government with jurisdiction over the business office of the importer for details.

Also check whether the raw materials and ingredients are the same as those found to have unapproved or
unauthorized drugs detected from health foods and others or reported to have caused health damage.

12

Importing Health Foods

Ⅲ Applicability of Pharmaceuticals and Medical Devices Act
and Whether the Goods Fall into Pharmaceuticals

 How to Read the List of Division between Foods and Pharmaceuticals

Judge as pharmaceuticals from the names and parts of raw materials.
In the example case of senna below, it falls into pharmaceuticals because products using the fruit, leaflet,petiolule, or rachis of senna are included in the pharmaceuticals list. Meanwhile, the stem of senna isshown as“non-pharmaceutical”and therefore falls under the non-pharmaceuticals list. Unless claiming
pharmaceutical effects or efficacy, it can undergo import procedures as foods. However, it must be noted
that, even if the stem of senna is used, if the used part is not labeled on the product, the product will be
judged as a pharmaceutical.
The Panax ginseng in the example case for the non-pharmaceuticals list is also called as Korean ginseng or
Asian ginseng. The fruit, root, root stalk and leaf of Panax ginseng fall under the non-pharmaceuticals list,
and can undergo import procedures as foods unless pharmaceutical effects or efficacy are claimed.
(Example case of senna which is included in the pharmaceuticals list)
Name
Senna

Other names

Part

Remarks

Alexandria senna, tinnevelly senna

Fruit, leaflet, petiolule,rachisStem is“non-pharmaceutical”(Example case of Panax ginseng which is included in the non-pharmaceuticals list)
Name

Other names

Part

Panax ginseng

Korean ginseng, Asian ginseng

Fruit, root, root stalk, leaf

Remarks(Source) MHLW’s Notice“Standards on the Scope of Pharmaceuticals”

 Points to Note about Raw Materials

Attention needs to be paid not only on whether pharmaceutical ingredients are contained but also on how
raw materials are handled.
・Crude drug names must not be used in the ingredient list of foods
If crude drug ingredients that fall into non-pharmaceuticals are to be used as foods, the names of sourced
plants, etc. are to be used in principle so that they can be easily recognized as foods.
(Examples)
Crude drug name(Not acceptable - representation
regarded as pharmaceuticals)Name of sourced plant, etc.
(Acceptable - representation permitted for foods)

Dioscorea rhizome

Japanese yam, Chinese yam

Zingiberis rhizoma

Ginger

Zizyphi fructus

Red dates

Ostreae Testa

Oyster shell

Coix seed

Job’s tears(Source) MHLW’s Notice“Manual of Supervision and Guidance on Unapproved or Unauthorized Drugs”
Edited by MIPRO.

・Other matters that should be noted include handling of raw materials that were extracted using a solvent
other than water and ethanol and handling of raw materials that are used for the purpose of coloring or
flavoring.

Importing Health Foods

13

Ⅲ Applicability of Pharmaceuticals and Medical Devices Act
and Whether the Goods Fall into Pharmaceuticals

Checkpoint 2: Whether the Goods Are Labeled with or Advertised for Pharmaceutical Effects or Efficacy(1) Efficacy or effects for the purpose of therapy or prevention of disease(2) Efficacy or effects for the primary purpose of general strengthening or promotion of tissue functions in
the body(3) Implication of pharmaceutical effects or efficacy
Claiming for the above falls under claiming pharmaceutical effects or efficacy.
Even when such claims are made in a non-Japanese language, they are treated in the same manner.
Claims (labeling and advertisements subject to regulations)(1) In this standard, claims refer to all representations and descriptions by means written below related to sale of the goods.
[1] Representations on the container, packaging, package insert, etc. of the goods[2] Brochures, pamphlets, etc. of the goods[3] Advertisements of the goods by TVs, radios, newspapers, magazines, the Internet, etc.
[4] Booklets and books titled“Miraculous XX,”“All About XX,”etc.
[5] Special member magazines such as“XX Community,”information magazine such as“XX News”and“XX News Flash”[6] Clippings of newspapers, magazines, etc., extracts from books, academic papers, etc.
[7] Product description (related) documents distributed to agents and retailing stores under the name of training
materials[8] Collections of thank-you letters and experience stories of users[9] Hung posters in stores, public transport, etc.
[10] Slides, videos, etc. used or verbal sales talks performed at stores, door-to-door sales, explanatory sessions,consultation sessions, unsolicited sales in public places, etc.
[11] Those equivalent to the previous items that are used in relation to sales of specified commodities(2) Regarding claims performed by [4] to [10] in (1), even if the name of specified commodity is not shown, when
explanations of a specified commodity is provided to those requesting them, when they are placed in the sameplace as the specified commodity as explanation of the commodity, or when explanations of a specified commodity
are given by, for example, sending them along with an offer to purchase for the specified commodity, these acts are
regarded as claiming pharmaceutical effects or efficacy for the relevant specified commodity.
(Source) MHLW’s Notice“Manual of Supervision and Guidance on Unapproved or Unauthorized Drugs”(Examples of unacceptable descriptions)(1) Efficacy or effects for the purpose of therapy or prevention of disease
For people with diabetes/hypertension/arteriosclerosis, prevention of gastric and duodenal ulcers, heals liver/kidney
disorders, improves cancers, for people with eye diseases, relieves constipation, etc.
(Source) MHLW’s Notice“Standards on the Scope of Pharmaceuticals”(2) Efficacy or effects for the primary purpose of general strengthening or promotion of tissue
functions in the body
Note that, although expressions about nutritional supplementation, health maintenance, beauty and the like
do not fall into pharmaceutical effects or efficacy, false or exaggerated expressions may conflict with thePremiums and Representations Act or Health Promotion Act.
Recovery from fatigue, invigorating (aphrodisiac) tonic, physical strength enhancing, appetite-promoting, anti-aging,
improves studying performance, rejuvenating, improves libido, improves metabolism, improves secretory functions,enhances detoxification functions, improves heart functions, purifies the blood, improves natural healing power
against diseases, improves gastrointestinal digestion and absorption, calms gastric and intestinal disorders, for during
and after disease, promotes growth, etc.
(Source) MHLW’s Notice“Standards on the Scope of Pharmaceuticals”

14Importing Health Foods

Ⅲ Applicability of Pharmaceuticals and Medical Devices Act
and Whether the Goods Fall into Pharmaceuticals(Examples of unacceptable descriptions)(3) Implication of pharmaceutical effects or efficacy[1] Those implied by the name or catch phrases

Medical XX, secret Chinese medicine therapy[2] Those implied by ingredient representations
or descriptions

Using XXXX known to have effects to improve physicalconstitution and calm gastric and intestinal disorders asa raw material, active ingredients are added to provide
synergy effects.

[3] Those implied by description of
manufacturing method

Using the plant XX that grows wild on deep mountainous
highlands of Japan as the main ingredient, this productwas prepared by a unique manufacturing method (patentpending) from various herbs such as YYY and ZZZ.

[4] Those implied by description of the origin,history, etc.

An ancient natural scientific book XXX states this opens
up the stomach, disperses low spirits, helps with digestion,
kills worms, and eliminates phlegm. Such experiences
have been passed down since ancient times and this wasalways included in meals.
MD XXXX says:[5] Those implied by citation or quotation of an “It has been said since before that eating red rice witharticle in a newspaper or magazine, talk, XXX on top prevents cancer. [...] It is possible that XXX is
doctrine or experience by a physician or r e l a t e d t o l i p i d m e t a b o l i s m d i s o r d e r , a n d f u r t h e rcarbohydrate and protein metabolism disorders of cancer
academic, etc.
cells.”[6] Those implied by expressions stating to havemedical efficacy equivalent to or better than
Korean ginseng

This ingredient is known to have better effects than
Korean ginseng.

[7] Those implied by making people to checktheir physical conditions or symptoms under
the name of“health check”andrecommending to consume the productdepending on the symptom, etc.
[8] T hose implied by expressions like “forpersons with XXX”
・ Expressions like the product is for persons witha disease, for persons who desire to prevent a
disease, or for persons in undesirable physicalconditions fall into claims of pharmaceuticaleffects or efficacy.

For persons tending to have constipation, for persons
concerned about XX disease, for persons who feel listlessand cannot recover from fatigue(Note) Expressions mainly aiming at health maintenance, beauty, or
nutritional supplementation do not immediately fall into claims ofpharmaceutical effects or efficacy.

[9] Those implied by expressions about“healingcrisis”

Those giving explanations like“Taking this product may
temporarily cause reactions like diarrhea and pimples, butthey are initial symptoms as a result of the product’s
internal cleansing and constitution improving effect, and it
is essential to keep taking the product”that discomforts
are claimed as“healing crisis,”“cleansing reaction,”etc.
and a proof of effects.

[10] Those implied by expressions like“effect,”“efficacy”or“benefit”of taking a specificproduct, without clearly stating the name of
disease, etc.

The product needs to be taken for at least 1 month for it
to take effect.
The efficacy is proven at university hospitals.
Although the product does not take effect immediately likepharmaceuticals, if you keep taking it for 2 to 3 months,
you will surely feel the benefit.

[11] T hose implied by words “medicine” and“drug”

Crude drug, miracle drug, folk medicine, medicinal herb,
Chinese medicine(Source)“Manual of Supervision and Guidance on Unapproved or Unauthorized Drugs”Edited by MIPRO.

Importing Health Foods

15

Ⅲ Applicability of Pharmaceuticals and Medical Devices Act
and Whether the Goods Fall into Pharmaceuticals

Checkpoint 3: Whether the Form Is Misleading as Pharmaceutical

The term“form”here refers to the dosage form (e.g., ampule, hard capsule, soft capsule, tablet, pill,
powder and granules and their sachets, liquid), as well as the shape of container or encapsulation(e.g., glass bottle, paper box, plastic bag), and the patterns, photos, drawings and the font, design, etc. of
letters shown on the container or encapsulation, all inclusive.
Whether the form of the goods is pharmaceutical or not is determined by comprehensively taking into
account the dosage form of the goods and design and shape of the container or encapsulation.

(1) Forms that fall into pharmaceuticals

Forms like ampule that are not used in distribution of normal foods are regarded as attempting to mislead
consumers to believe the product is a pharmaceutical, and judged as pharmaceutical.
(Examples of forms that fall into pharmaceuticals)
・Ampules・Sublingual tablets
・Liquid to be absorbed from mucosa (e.g., those to be dropped sublingually)
・Spray (those sprayed into and act on the oral cavity)(Source) MHLW’s Notice“Manual of Supervision and Guidance on Unapproved or Unauthorized
Drugs”Edited by MIPRO.

(2) Forms that are not judged as pharmaceuticals by clear statement of“food”

Even if the product is in a form used for pharmaceuticals (e.g., tablet, capsule, pill, powder and granules
and their sachets, liquid), if a statement of the product being“food”is clearly shown on its container, inprinciple, the product will not be judged as pharmaceuticals by the form alone.
Checkpoint 4: Whether Use Method Falls into Pharmaceutical Dosage and/or Administration

Pharmaceuticals are provided with administration time, administration intervals, and dosage todraw out the best performance. Therefore, if the use method of goods contains administration time,administration intervals, dosage and the like, it is regarded as pharmaceutical dosage andadministration in principle.
(Examples of unacceptable descriptions)
2-3 times a day, 2-3 tablets per day
2 pieces a day
2 spoonfuls after each meal, using theenclosed spoon
3-6 tablets a day for adults
1-2 pieces each before and after meal
1-2 tablets before sleep

16

Importing Health Foods(Source)MHLW’s Notice“Standards on the Scope of Pharmaceuticals”

Ⅲ Applicability of Pharmaceuticals and Medical Devices Act
and Whether the Goods Fall into Pharmaceuticals■ Contact Points for Determining Whether the Goods Fall into Pharmaceuticals before Importing

When one desires to import goods that are not clearly distinguishable as foods (e.g., supplements in a formof tablet or capsule, those that contain oriental drug or herbal raw materials, those that contain raw
materials that are not familiar in Japan), the person needs to check whether the goods fall into thecategory of pharmaceuticals.
Prepare documents for checking and self-check the judgment points on whether the goods fall into
pharmaceuticals before importing. As required, consult the pharmaceutical affairs department ofprefectural government that has jurisdiction over the business office of the importer with notifying thedepartment that it is an inquiry about whether the goods to be imported fall into pharmaceuticals.
 Documents for Checking Whether the Goods Fall into Pharmaceuticals

For the goods to be imported, prepare documents describing the elements (raw materials and ingredients,
representations, form) for determining whether the goods fall into pharmaceuticals.
・Ingredient list: Document that gives descriptions about all the raw materials and ingredients used.
Clearly states the name (Japanese name, scientific name, classification (family, genus)), and used parts andpurpose of use for raw materials of plant or animal origin.
・Product photos, outer packaging photos, user’s manual, package insert, advertisements, pamphlets, etc.
・A s what kind of product the goods will be marketed in Japan (marketing representations andadvertisements prepared in Japanese)・In what state the goods will be imported (individual packaging, imported in bulk and divided into smaller
portions in Japan)・In what form the goods are (tablet, capsule, powder, etc.)■ Inquiries (about whether the goods to be imported fall into pharmaceuticals)
Pharmaceutical affairs department of prefectural government with jurisdiction over the business office of the importer Make Sure to Consult Pharmaceutical Affairs Department When Importing Goods in a

Pharmaceutical Form
If an importer is thinking to import goods in a pharmaceutical form (e.g., tablet, capsule, powder), before
starting importing, the importer must consult the pharmaceutical affairs department of prefectural
government that has jurisdiction over the business office of the importer on whether the goods fall into
pharmaceuticals.
The importer records the details of checking whether the goods fall into pharmaceuticals (when and towhom the importer made inquiries, raw materials and ingredients in question and handling thereof andothers in any format) and prepares a document.
The importer must submit this document when submitting an import notification to a quarantine station.
■ Reference information
MHLW’s Notice“Handling of Import Notification Pertaining to Health Foods”(Shokukenhatsu No. 0719001, July 19, 2002).
https://www.mhlw.go.jp/kinkyu/diet/index.html

 Self-inspection for Not Containing Pharmaceutical Ingredients for Weight-loss Related

Goods in Pharmaceutical Form

In response to many incidents of health damage caused by weight-loss related health foods, MHLW
requests importers to voluntarily check (self-inspect) that pharmaceutical ingredients (e.g., fenfluramine,
N-nitroso-fenfluramine, sennoside, triiodothyronine, thyroxine) are not contained if the representations areclearly indicative of the goods being weight-loss related health foods in a form of tablet, capsule, powder,etc.
■ Reference information
MHLW’s Notice“Handling of Import Notification Pertaining to Health Foods”(Shokukenhatsu No. 0729001, July 29, 2002).
https://www.mhlw.go.jp/kinkyu/diet/index.html

Importing Health Foods

17

Ⅲ Applicability of Pharmaceuticals and Medical Devices Act
and Whether the Goods Fall into Pharmaceuticals

Contact Points for Determining Whether the Goods Fall into Pharmaceuticals■ for Cargo That Has Arrived and was Suspended at Customs Clearance

The pharmaceutical affairs department of prefectural government is unable to answer to consultations
about cargo that was imported without an inquiry or consultation to the pharmaceutical affairs department
and suspended by customs indicating the possibility of falling into pharmaceuticals, etc. or to consultations
about goods for which a prior inquiry has been made by customs or the quarantine station.
Regarding whether the cargo suspended at customs clearance falls into pharmaceuticals, the section in
charge of the Import Report of Medication (Yakkan Shoumei) of the Regional Bureau of Health andWelfare covering customs that has jurisdiction over the port the cargo has arrived at will answer.
Consultation requires the documents below.
1. N ame and contact address (telephone number) of the importer
2. C ontact address (telephone number) of the customs office at which the cargo is stopped (or customs or quarantine
station from which a prior inquiry has been made), the details of inquiry (why customs, etc. suspended the cargo) from
customs, etc., (for goods about which a prior inquiry has been made by customs or the quarantine station, include thecontact address of the customs office at which the cargo will undergo customs clearance)
3. A copy of invoice
4. A copy of AWB (or notice from B/L or customs)
5. Photos of the goods stopped at customs, outer packaging photos, user’s manual, package insert, etc. (if content
inspection and checking is performed by the transportation company, make sure to send the report of content
inspection as well)
6. A
 dvertisement materials in Japan and overseas of the goods stopped at customs (advertisement plan is acceptable) ,pamphlets, etc. (printouts of relevant websites are acceptable)(Source) Website of Kinki Regional Bureau of Health and Welfare“Consultation about Import Procedures for Cargo
Suspended at Customs Clearanc”■ Inquiries (about whether cargo stopped at customs falls into pharmaceuticals)
Section in charge of the Import Report of Medication (Yakkan Shoumei) of the Regional Bureau of Health and Welfare covering customs
that has jurisdiction over the port the cargo has arrived atta

Cargo cleared at Hakodate Customs,
Tokyo Customs, or Yokohama Customs

Kanto-Shinetsu
Regional Bureau ofHealth and Welfare

Pharmaceutical Inspector
Section of Inspection and Guidance+81-48-740-0800
e-mail: yakkan@mhlw.go.jp

Cargo cleared at Nagoya Customs (including
Chubu Airport), Osaka Customs (including
Kansai Airport), Kobe Customs, Moji Customs(including Fukuoka Airport), or Nagasaki
Customs

Kinki Regional Bureau
of Health and Welfare

Pharmaceutical Inspector
Section of Inspection and Guidance+81-6-6942-4096
e-mail: kiyakuji@mhlw.go.jp

Cargo cleared at Okinawa Regional Customs

Kyushu Regional
Bureau of Health andWelfareOkinawa Narcotics
Control Office

Pharmaceutical Inspector
Section of Inspection and Guidance+81-98-853-7100
e-mail: okinawa-yakuji@mhlw.go.jp

Health Foods That Fall into the Unapproved or Unauthorized Drugs Cannot Be Sold, Delivered, etc.

The concern health foods have in relation to the Pharmaceuticals and Medical Devices Act is that
goods that should be approved as pharmaceuticals are manufactured, imported and marketed under
the name of foods. If such health foods are distributed, problems like;・general consumers confuse the basic concept of pharmaceuticals and foods, which could lead to
distrust in pharmaceuticals;・consumers who bought health foods believing misleading claims for therapeutic effects on diseases
without actually confirming the efficacy could become victims of sanitary and health hazards by losing
opportunities of receiving proper medical treatments and the disease becoming worse will emerge.
Health foods that were judged to fall into pharmaceuticals are regarded as“unapproved or
unauthorized drugs,”and Article 55, paragraph (2) of the Pharmaceuticals and Medical Devices Act
prohibits their sales, delivery, or storage or display for the purpose of selling or delivering.
■ Reference information
MHLW’s website“Health foods”>“Information on health damage, unapproved or unauthorized drugs”
https://www.mhlw.go.jp/kinkyu/diet/musyounin.html

18

Importing Health Foods

Ⅳ

Food Sanitation Act and Import of Foods

It is important for all food importers to understand the food import notification system under the Food
Sanitation Act and the gist of food safety-related regulations.
The importers should prepare all documents necessary for making a notification, and investigate thepossibility of the goods to be imported complying with regulations of the Food Sanitation Act before
Importing.
Careful and thorough preparation helps with minimizing financial and time losses.

■ Import Notification System for Foods

When importing foods for the purpose of selling or business (including handing them over to many andunspecified persons at exhibitions or in town), the importer is obliged to make an import notification to aquarantine station each time. (Article 27 of the Food Sanitation Act)
It is prohibited to use any imported foods for sales or business without making an import notification.
 Notification Procedures (Article 32 of the Ordinance for Enforcement of the Food Sanitation Act)

Right after the arrival of a cargo,(Note) an importer must submit a“written notification for importation offoods, etc.”prepared in a prescribed format, together with the necessary documents depending on fooditems, to the quarantine station that has jurisdiction over the place for customs clearance of said cargo.

(Note) Notification must be made right after the arrival of a cargo, in principle, but there is an Advance Notification System, under which
notification is accepted from 7 days prior to the scheduled arrival of the cargo. When using this system, a certificate of notification
for importation of foods, etc. is issued promptly for cargo that does not require an inspection prior to arrival or after the transport
into a bonded area. However, where any change arises in the content of the notification after arrival of the cargo, an importer must
report to that effect to the quarantine station to which the importer made the advance notification.
 Documents Required for Making Notification□ Written notification for importation of foods, etc.: 2 copies
All required fields must be filled, including the name and address of importer, item name, product name,quantity, weight, exporting country, name and location of processor and processing facility, port ofloading, and, for processed foods, processing/production methods, raw materials, and additives.​
Where to obtain and how to fill in a notification form
⇒ MHLW’s website“Import Procedures under the Food Sanitation Act”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000144562.html (Japanese)
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/yunyu_kanshi/kanshi/index_00004.html (English)□ Documents to be attached vary depending on food type, item name, country of origin, processing method, etc.
In the case of processed foods, an ingredient list and a food production flow chart are required.
Formats are not specified but those prepared and issued by the processor or the exporter (with thecompany name and a signature of a responsible person) are preferable.
Additional documents may be requested as a result of an examination.
□ Reports of past self-inspection results as necessary(Note) Self-inspection refers to an inspection that the national government instructs an importer to conduct upon importing a cargo for
the first time and regularly thereafter as part of the importer’s own efforts for sanitary control.

Importing Health Foods

19

Ⅳ Food Sanitation Act and Import of Foods

Documents to be attached to import notification (examples)〈For all processed foods〉

Processed foods

・ An ingredient list
An ingredient list refers to a list of all raw materials (ingredients) and additives (specific substance name,E number, etc.) used in the food.
If additives subject to specified utilization criteria are used, names of the substances, purposes of their use, theiramounts, and stages where they are used must be stated.
For raw materials not familiarized in Japan, documents and photos containing information such as Japanesenames, scientific names, classification (family, genus), used parts, and history of consumption in Japan andoverseas, by which their safety as food can be confirmed.
For documents in a language other than Japanese or English, Japanese translations must be attached.
・ A food production flow chart
A food production flow chart refers to a chart showing the whole process of producing processed food from raw
materials.
For food items for which production criteria are specified (such as soft drinks and retort foods), detailed
information on the content of sanitary control during the production and processing processes (e.g., washing,sterilization conditions, pH, water activity, freezing (refrigeration) temperature, X-ray) is required.
・ A document by which the item name (commodity name and number, etc.), name and location of theprocessor, name and location of the processing facility, and materials of container and packaging canbe confirmed〈Depending on the item and raw materials〉
・For items using processed foods as ingredients, a document by which the raw materials, additives used, andproduction process (if production criteria are specified) of the processed foods can be confirmed
・For items using herbs and/or spices from countries where sterilization by irradiation is permitted, a document
issued by the processor stating that the item is not sterilized by irradiation
・For items subject to an inspection order, a document by which the country of origin and ratio (%) of raw materials
can be confirmed
・For items using soy, potato, rapeseed, corn, cotton, sugar beet, alfalfa, or papaya as raw materials, a document
by which whether they are genetically modified food or not can be confirmed
・For items containing beef or beef derived ingredients, a document by which the countries where the beef cattle
were bred and slaughtered and the beef meat was processed and the parts of the meat used as ingredients canbe confirmed
・For extracts or items using extracts, extraction method
・For items in a pharmaceutical form (tablet, capsule) or depending on the raw materials of health foods, a document
stating the results of whether they fall under the category of pharmaceutical ingredients as specified by the
Pharmaceuticals and Medical Devices Act (see page 17)

Perishable foods

・ A document by which the exporter, packager, and country/region of origin can be confirmed・ A document by which the Japanese name, scientific name, classification (family, genus) and used part can be
confirmed
・ A document and photos by which their safety as food can be confirmed (e.g., history of consumption in Japan andoverseas)・ For items containing additives, an ingredient list and a document by which the details of the additives can be
confirmed
・ A sanitary certificate issued by a government organization of the exporting country depending on the item nameand country of origin (e.g., dairy products, meat and processed meat products)

Note: Perishable foods refer to meat, vegetables, fish and seafood, and their simple processed food.
(Source) Data held at quarantine stations. Edited by MIPRO.

 Notification Method

・Ask a customs broker, etc.(Note) to submit documents by proxy (an importer must prepare documents to be
attached)
・Bring in documents directly to a quarantine station
・Send documents by post (enclose a return envelope with a stamp)
・Submit documents online using the Food Automated Import Notification and Inspection Network System(FAINS)
   (Need to register the relevant terminal equipment and others with the MHLW in advance)(Note) A customs broker refers to a person engaging in custom-house business with a license granted by the director-general of customs.
A customs broker undertakes affairs concerning import declaration (tax filing), etc. in place of the importer and often engages ininternational forwarder business, warehousing business, harbor transport business as well.

20

Importing Health Foods

Ⅳ Food Sanitation Act and Import of Foods

Flow of Import Notification for Foods

Preparation of import notiﬁcation

Written notiﬁcation for importation of foods, etc.

Documents to be attached
Processed foods: An ingredient list and a food production ﬂow chart
Perishable foods: A document by which the importer, packager, country of origin canbe conﬁrmed, etc.
Document conﬁrming the goods not falling into pharmaceuticals, sanitary certiﬁcate
issued by a government organization of the exporting country, etc. as necessary
Report of inspection results as necessary

Prior consultation at aquarantine station as necessary

Arrival of cargo and its transport tobonded areas

Import notiﬁcation to aquarantine station

Inspection
required

Examination at thequarantine station

Inspection not
required

Monitoring
inspection

Ordered inspection

Sampling andinspection by thequarantine station(Rejected) Collection orother measures
for rejected items

Self-inspection

Sampling and inspection by aregistered conformity assessment body
Submission of a report of theinspection results to the quarantine station

Examination at the quarantine station

PassedIssuance of a certiﬁcate of
notiﬁcation for importationof foods, etc.

Rejected

Disposal, reshipment,
etc.

Import declaration
to customs(Source) MHLW document. Edited by MIPRO.

Importing Health Foods

21

Ⅳ Food Sanitation Act and Import of Foods■ Examination and Inspection at Quarantine Stations

A quarantine station of the MHLW checks the details of an importer’s notification and examines whether
the relevant food items contain any toxic or hazardous substances, whether they conform to thestandards and criteria under the Food Sanitation Act and other regulations. (See page 24)
The quarantine station decides whether additional documents are required, inspection is required and soon, as a result of the documentary examination. The decision will be notified to the importer directly or
via a customs broker, and the importer complies with the decision. If an inspection order or an instruction
on self-inspection was received, the importer requests an inspection to a registered conformity
assessment body (at the expense of the importer).
If the foods were found to conform to the Food Sanitation Act based on the documentary examinationand inspection, a certificate of import notification is returned from the quarantine station and theimporter may proceed with customs clearance procedures.
On the other hand, if the cargo is rejected, it is shipped back or disposed of and the importer must bear
the expenses therefor.
■ Reference information
MHLW’s website:“Imported Foods Safety”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/yunyu_kanshi/index.html (Japanese)
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/yunyu_kanshi/index_00017.html (English)■ Inquiries
Quarantine station of the MHLW having jurisdiction over the port where the importer imports cargo
Offices that accept import notification: Food Inspection Division (32 offices in Japan)
https://www.mhlw.go.jp/topics/yunyu/soudan/index.html (Japanese)
Prior consultation: Office of Imported Food Consultation(established inside the 13 Food Inspection Divisions below; ◎ indicates a dedicated telephone number)

22

Otaru Quarantine Station; Food Inspection Division

TEL:+81-134-32-4304

Sendai Quarantine Station; Food Inspection Division

TEL:+81-22-367-8102

Narita Airport Quarantine Station; Food Inspection Division

TEL:+81-476-32-6741◎ +81-476-32-6728

Tokyo Quarantine Station; Food Inspection Division

TEL:+81-3-3599-1520◎ +81-3-3599-1519

Yokohama Quarantine Station; Food Inspection Division

TEL:+81-45-201-0505

Niigata Quarantine Station; Food Inspection Division

TEL:+81-25-244-4405

Nagoya Quarantine Station; Food Inspection Division

TEL:+81-52-661-4133◎ +81-52-661-4132

Osaka Quarantine Station; Food Inspection Division

TEL:+81-6-6571-3523◎ +81-6-6571-3554

Kansai Airport Quarantine Station; Food Inspection Division

TEL:+81-72-455-1290◎ +81-72-455-1295

Kobe Quarantine Station; Food Inspection Division

TEL:+81-78-672-9655

Hiroshima Quarantine Station; Food Inspection Division

TEL:+81-82-255-1379

Fukuoka Quarantine Station; Food Inspection Division

TEL:+81-92-271-5873

Naha Quarantine Station; Food Inspection Division

TEL:+81-98-868-4519

Importing Health Foods

Ⅳ Food Sanitation Act and Import of Foods

Testing and Inspections Directed by Quarantine Station

Orderedinspection

An inspection that a quarantine station orders an importer to
conduct, on each occasion, based on Article 26 of the Food
Sanitation Act, with regard to cargo that is considered to be highly
likely to violate a law, such as cargo found to violate a law as aresult of a self-inspection or a monitoring inspection, or a random
inspection (Note) in Japan. Items subject to ordered inspection,
matters to be inspected, sampling methods, and inspection
methods are publicized on the MHLW website.

Sampling and inspection: Registeredconformity assessment bodies
Expenses: To be borne by importers
Import is not permitted until theinspection results are obtained.

Self-inspection(instructed
inspection)

An inspection that the national government instructs an importerto conduct upon importing a cargo for the first time and regularly
thereafter as part of the importer’s own efforts for sanitary control

Sampling and inspection: Registeredconformity assessment bodies
Expenses: To be borne by importers
Import is not permitted until theinspection results are obtained.

Monitoring
inspection

An inspection that the national government conducts based on anannual plan for the purpose of monitoring food sanitation
conditions widely and taking measures, such as the strengtheningof inspections upon import, as necessary

Sampling: Quarantine stations
Expenses: To be borne by the national
government
Import is permitted without needing to
wait for inspection results.

(Note)A random inspection refers to an inspection that a food sanitation inspector of a public health center conducts basedon the Food Sanitation Act by collecting the required amount of foods as samples from processing facilities andretailing stores, etc.

FAQ

Q What should an importer do when having received an inspection order or an
instruction on self-inspection?
A The importer must request an inspection to a registered conformity assessment body (a fair andneutral third-party body that satisfies certain requirements clarified in the Food Sanitation Act and otherlaws and is registered by the national government). The registered conformity assessment body collects
samples from the relevant cargo stored in a bonded warehouse, inspects it and issues a report of theinspection results. The importer should submit this report to the quarantine station.
Please contact the relevant registered conformity assessment body for the necessary amounts of samples,
inspection fees, the number of days required for an inspection, necessary documents and so on. A list ofregistered conformity assessment bodies is available on the MHLW website. As matters covered byinspections vary by body, please check in advance when choosing a body to request an inspection.
■ Reference information
MHLW website“List of Registered Conformity Assessment Bodies”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/jigyousya/kikan/index.html

Q We have a report of the inspection results conducted in the exporting
country. Do we have to undergo an inspection in Japan again?
A When an importer has undergone an inspection by an official laboratory in the exporting country (byan official laboratory that the government of the exporting country has registered with the MHLW of
Japan as a body having a certain level of inspection capability) and attached a report of said inspection
results upon making an import notification, the importer is exempted from undergoing an instructed
inspection at a quarantine station in Japan. However, matters to be inspected for which changes may occur
during transportation (bacteria, mycotoxins, etc.) are excluded. The following should be noted when
an importer intends to receive an exemption. Please contact the relevant quarantine station for details.
・The name and location of the relevant laboratory should be the same as those stated in the list of foreign
official laboratories.
・An inspection by a branch or local office of an official laboratory is not accepted.
・The inspection method employed should be equivalent or superior to those methods specified by the
Food Sanitation Act.
・In order to check the consistency between inspected samples and products to be imported into Japan,
the report of the inspection results contains data by which the processor’s name, commodity name andnumber, and inspected samples can be identified.
■ Reference information
MHLW website“List of Foreign Official Laboratories”
https://www.mhlw.go.jp/topics/yunyu/5/index.html (Japanese)
https://www.mhlw.go.jp/english/topics/importedfoods/1-10.html (English)

MHLW website“Matters to Be Included in Report of Inspection Results Issued by Foreign Official Laboratory”
https://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/gaikokuseisekisho170428.pdf (Japanese)
https://www.mhlw.go.jp/english/topics/importedfoods/dl/1-9.pdf (English)

Importing Health Foods

23

Ⅳ Food Sanitation Act and Import of Foods■ Securing Safety of Foods by Food Sanitation Act

Each exporting country has original laws concerning food sanitation based on their climate and foodculture and so on. Import or sale of food items that do not conform to the Food Sanitation Act is not
permitted in Japan, even if they can be marketed in the exporting country.
To prevent the sanitation hazards resulting from eating and drinking, the Food Sanitation Act stipulates:・measures to prohibit distribution of foods that cause damage to health, such as rotten, deteriorated, toxic
or hazardous foods (Articles 6 to 9);・prohibition of sale, production, importing, processing of foods, additives, etc. that do not conform tostandards and criteria specified by the Minister of Health, Labour and Welfare (Articles 10 and 11);・approach and systems of supervision and guidance for imported foods in Japan to ensure food sanitation.
(See page 25)
 Matters to Be Checked At Importing

For imported foods, importers are obliged to make an import notification of the foods, and quarantine
stations established at ports check their safety. Specifically, quarantine stations check such matters as
below. (See pages 19 to 23)

Examination of documents

・ Whether the used raw materials conform to the Food Sanitation Act
・ Whether additives are used in a proper manner
・ Whether the item conforms to production criteria・ Whether the processor or the processing facility has any history of
causing sanitary problems
・ Whether the item is subject to an order for recall in the exporting
country・ Whether required documents are attachedOn-the-spot inspection at locations
such as a warehouse where foods are
stored・ Whether the item is not suited for human consumption due to being
rotten or other reasons・ Whether any foreign substances are mixed in・ Whether the storage environment (temperature, etc.) is appropriate・ Whether there is no errors in the content of the notification

Checking conformance with standards
and criteria through testing andinspection(ordered inspection, self-inspection)・ Agricultural chemicals and veterinary drugs remaining in foods・ Food additives
・ Pathogenic microorganisms such as enterohemorrhagic Escherichia
coli and Vibrio parahaemolyticus・ Bacterial counts and coliforms, etc. specified by the standards forconstituents・ Hazardous substances such as aflatoxin and other mycotoxins, andshellfish poisons・ Mixing of genetically modified foods whose safety has yet to beapproved(Source) MHLW“Quarantine Stations’ Efforts for Ensuring Safety of Imported Foods”(January 2016). Edited by MIPRO.

 Health Damage by Health Foods and Response by National Government

For supplements in a form of tablets, capsules, powder, etc., excessive intake of a certain ingredient may
cause adverse effects on the body. Since in some cases immediate action needs to be taken against foods
suspected to be causing health damage, Article 7 of the Food Sanitation Act stipulates measures to banmarketing of such foods.
Additionally, in response to health damage caused by health foods such as Sauropus androgynus andSymphytum, MHLW has provided business operators with initiatives and methods for ensuring the safetyof raw materials and ensuring the safety through manufacturing process management (GoodManufacturing Practice (GMP)), and requested business operators to introduce third-party certificate on
safety assurance through GMP. (See pages 30 to 31)■ Reference information(Third-party GMP certifying bodies for health foods)
Japan Health and Nutrition Food Association  http://www.jhnfa.org/
The Japanese Institute for Health Food Standards  http://www.jihfs.jp/

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Importing Health Foods

Ⅳ Food Sanitation Act and Import of Foods

Outline of Food Sanitation Act
PurposeTo prevent the sanitation hazards resulting from eating and drinking by enforcing the regulations and othermeasures necessary, from the viewpoint of public health, to ensure food safety and thereby to protect
citizens' good health. (Article 1)

Deﬁnitionof food

All food and drink (excluding pharmaceutical products and quasi-pharmaceutical products)(Article 4, paragraph (1))

Prohibition of sale, etc. of food, etc.

Sale, etc. is prohibited for the food, etc. below.

○Food and additives for which sale is prohibited (Article 6)
Sale is prohibited for rotten/deteriorated or toxic food, etc.
○Prohibition of sale of novel food (Article 7)○Prohibition of sale, etc. of speciﬁc food, etc. (Article 8)○Prohibition of sale, etc. of diseased meat, etc. (Article 9)

Formulation of Standards and Criteria

Stipulates criteria, standards, etc. of production, storage, etc.
for food, etc. distributed in Japan (Article 10, Article 11)

・ The Minister of Health, Labour and Welfare may establish
the criteria and standards pertaining to production, etc. offood, etc., and sale, etc. is prohibited for food, etc. that do notconform to the said standards or criteria.
・ Regarding agricultural chemicals, feed additives andveterinary drugs, only those designated by the Minister of
Health, Labour and Welfare and for which the standards andcriteria have been speciﬁed by the Minister of Health, Labourand Welfare can be used (positive list system).

Monitoringand Guidance[In Japan]○Approval of comprehensive sanitatary control
and production process, etc. (Article 13, Article
14)○Establishment of guidelines and plans related tomonitoring and guidance (Article 22, Article 24)○On-site inspections and removal (Article 28)○Establishment of the criteria for businessfacilities (Article 50, Article 51)○ Approval of business (Article 52)○ Investigation on food poisoning (Article 58,
Article 60)[Imported Food]○Establishment of the Imported Food Monitoring andGuidance Plan (Article 23)○Notiﬁcation of import (Article 27)
Measures, Penalties, etc.
●Inspection order (Article 26)●Disposal order, etc. (Article 54)●Rescission of business approval, suspension ofbusiness, etc. (Article 55, Article 56)●Provisions of criminal penalties (Articles 71 to 79)(Source) MHLW“Current Status and Problems Surrounding the Food Sanitation Act”(September 14, 2017)

Health Damage by Health Foods and Current System〈Outline of Current System〉➢ Article 6 of the Food Sanitation Act〈Prohibition of sale of insanitary food〉
・Prohibits sale, production, etc. of insanitary food, etc. containing toxic or hazardous substances. (Example applicable
case: Symphytum)➢ Article 7 of the Food Sanitation Act〈Prohibition of sale of novel food〉
・Prohibits sale of food for those not having a history of consumption or those served in a manner extraordinarily
different from ordinary manners, when they have not been proved to not involve risk to human health and deemednecessary to prevent food sanitation hazards. (Example applicable case: Processed Sauropus androgynus foods)➢ Reporting damage information (Administrative guidance: Iyakuhatsu No. 1004001 dated October 4, 2002)➢ Q uality control of production process and safety of raw materials (Administrative guidance: Shokuanhatsu
No. 0201003 dated February 1, 2005)〈Major response cases〉
Name

Advertisement phrase

Outset ・ health damage

Response

Sauropus androgynus(9.12.2003)

W e i g h t r e d u c t i o n e f f e c t , ・B ronchiolitis obliterans occurred in Provisional prohibition of distribution
constipation relief
200 people in Taiwan(Article 7, paragraph (2) of the Law)

Symphytum(6.18.2004)

Longevity, invigorating

・Many reports of liver disorders overseas

Prohibition of sale
(Article 6, item (ii) of the Law)

Garcinia cambogia(3.7.2002)

Weight reduction effect, etc.

・Effects on testes of rats
・No report of health damage

・Raised consumer awareness・A dministrative guidance to businesspersons

Coenzyme Q10(8.10.2006)

・Reports of diarrhea, vomiting, etc.
・Raised consumer awarenessAnti-aging, antioxidant effect, etc. ・Trade association discussed and reported ・A dministrative guidance to businessa tolerable upper intake guidance level
persons

Cedar pollen(4.19.2007)

Alleviation of pollen allergy
symptoms

Agaricus subrufescens(7.3.2009)

Immune strength improvement,
・Promotion of carcinogenic action
anticancer activity, cholesterol
・No report of health damage
reduction, etc.

Pueraria mirifica(9.22.2017)

・Raised consumer awareness
Breast enlarging effect, alleviation ・R e p o r t s o f m e t r o r r h a g i a , i r r e g u l a r
・A dministrative guidance to businessof menopausal symptoms, etc.
menstruation, etc.
persons

・Raised consumer awareness・G uidance on appropriate labeling to・Products aiming desensitization therapy
business personsof pollen allergy were distributed* Products for therapy or prevention were・Severe allergic symptoms
suspended from being sold aspharmaceuticals and recalled・Raised consumer awareness・A dministrative guidance to businesspersons(Source) MHLW“Material at the Explanatory Session on the State of Reviewing Governmental and Ministerial Ordinances
Based on the Act for Amending Part of the Food Sanitation Act, etc.”(November 2018)

Importing Health Foods

25

Ⅳ Food Sanitation Act and Import of Foods■ Carefully Perform Preliminary Survey to Avoid Import of Violating Foods

When importing processed food, the importer gathers information referring to“Prior consultation survey
sheet”and“Documents to prepare when consulting”posted on the website of quarantine station, in
addition to obtaining an ingredient list and a food production flow chart.
The importer should check for the standards and criteria for foods and additives related to the foods to beimported. (See pages 27 and 28)
The Imported Foods Monitoring and Guidance Plan(Note) established every year by MHLW lists up causesof hazards, matters to be checked in advance and other points to note in its Appended Schedule 2 (Basic
Guidance for Importers), which provides useful information.
If processed foods are used as ingredients, investigation must be done tracking back down to raw
materials of such ingredients. For example, if a sausage is used as an ingredient, raw materials, additives,and production method of the sausage need to be investigated to check whether the sausage meets thestandards and criteria for processed meat products and additives.
After gathering all necessary documents, the importer may seek advice from the Imported foods
inspection section of a quarantine station about information on standards and criteria, method to confirm
the safety, and points of note.
Upon executing import transactions, it is important to select reliable processors and other business
partners who comply with quality requirements on the Japanese side.
(Note) The Imported Foods Monitoring and Guidance Plan is a plan established by the national government with regard to measures to betaken by the MHLW and quarantine stations. A plan for the following fiscal year is publicized at the end of every fiscal year.

Checkpoint 1: Whether Pharmaceutical Ingredients are Contained

As described in Chapter III, when one desires to import goods that are not clearly distinguishable as foods(e.g., supplements in a form of tablet or capsule, those that contain oriental drug or herbal raw materials,
those that contain raw materials that are not familiar in Japan), the person needs to check whether the goods
fall into the category of pharmaceuticals under the Pharmaceuticals and Medical Devices Act. (See page 10)
Obtain documents for checking whether the goods fall into pharmaceuticals, and self-inspect first.
(See pages 12 to 16)
As required, consult the pharmaceutical affairs department of prefectural government that has jurisdiction
over the business office of the importer before the cargo arrives, or department in charge of certificate forimport of medicines and medical devices of the Regional Bureau of Health and Welfare covering customs that
performs import clearance for the cargo after the cargo has arrived. (See pages 17 and 18)
The importer must record the details of checking with the competent administrative department (when andto whom the importer made inquiries, raw materials and ingredients in question and handling thereof, etc.).
(See page 17)
Note that quarantine stations cannot make a judgment on whether goods fall into the category ofpharmaceuticals.
Checkpoint 2: Whether Toxic or Hazardous Substances are Contained (Article 6, item (ii) of Food Sanitation Act)

Items which contain or are covered with toxic or hazardous substances or are suspected to contain or becovered with such substances cannot be sold (including cases of being delivered but not being sold tomany and unspecified persons), or collected, produced, imported, processed, used, cooked, stored, or
displayed for the purpose of marketing.
Many things in the nature contain toxic or hazardous substances. If the food to be imported contains an
ingredient not generally consumed as food in Japan, it is advisable to check the history of its consumption
in the exporting country, health hazard information and others.
To investigate information on the safety or effectiveness on humans for an ingredient, the database“Information system on safety and effectiveness for health foods”of the National Institutes of Biomedical
Innovation, Health and Nutrition may prove useful.
■ Reference information
Website of National Institutes of Biomedical Innovation, Health and Nutrition“Information system on safety and effectiveness for health foods”
https://hfnet.nibiohn.go.jp/
Website of Food Safety Commission of Japan“Hazard Information on Health Foods”
http://www.fsc.go.jp/kigai_jyoho/

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Importing Health Foods

Ⅳ Food Sanitation Act and Import of Foods

Checkpoint 3: Whether the Additives Can Be Used in Japan and Comply with Utilization Criteria(Article 10 of Food Sanitation Act)

Additives that can be used in Japan are limited to those designated by the national government, in principle.
Exceptionally, only“existing food additives,”“natural flavoring agents,”and“items that have generally been
served for human consumption and are used as additives”may be used without obtaining designation.
For some additives, utilization criteria (maximum limits and food items in which they may be used, etc.)
are specified. The latest version of a list of designated additives and utilization criteria are available on the
MHLW website. As needed, the importer shall perform self-inspection to check whether additives are usedwithin permitted ranges. (See page 28)
Types of Additives
Designated additives(Appended Table 1 of theOrdinance for Enforcement of
the Food Sanitation Act)

Additives permitted to be used by the Minister of Health,Labour and Welfare based on Article 10 of the Food
Sanitation Act.
If a synthetic flavoring agent is used, check which one of
18 categories specified by collective names (e.g.,“Esters”) the flavoring agent falls under.

Existing food additives

Additives permitted to be used as natural additives that havebeen used for a long period of time in Japan.

Natural flavoring agents

Natural substances obtained from animals or plants,
which are used for the purpose of adding flavor to foods.
(e.g., vanilla flavor, crab flavor)

Ordinary foods used as foodadditives

Items that have generally been served for humanconsumption and are used as additives.
(e.g., strawberry juice, agar)

Outside the scopeof the designation
system■ Reference information
MHLW’s website:“Food Additives”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/syokuten/index.html (Japanese)
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/syokuten/index_00012.html (English)
Website of The Japan Food Chemical Research Foundation:“List of Food Additives”
https://www.ffcr.or.jp/tenka/index.html (Japanese)
https://www.ffcr.or.jp/en/tenka/index.html (English)

Cases of Violation by Health Foods

The item name, processor’s name, violation content of items that were found to be violating relevantlaws and regulations at import notification were listed on the MHLW website. The most common
violation by health foods is“Use of non-designated additive.”[Typical Cases of Violation at Import Notification: Health Foods]
Description of Item

Exporting
Country

Content of Violation

Spirulina tablets

United States ofAmerica

Production agent: croscarmellose sodium iscontained

Non-designatedadditive

Processed tablet-shaped
herb food

United States ofAmerica

Production agent: calcium stearate is
contained

Non-designatedadditive

Processed shark cartilage
product

Australia

Nutrition enhancer: chondroitin sulfate isused

Non-designatedadditive

Agaricus liquid preparation(Mushroom extract)

Brazil

Production agent: magnesium stearate is
contained

Non-designatedadditive

Encapsulated propolis: usedin the capsule

BrazilPreservative: methyl paraoxybenzoate is
contained

Non-designatedadditive(Source) MHLW’s website:“Typical Cases of Violations of Food Sanitation Act in Import Notifications”Edited by MIPRO.

Importing Health Foods

27

Ⅳ Food Sanitation Act and Import of Foods

Checkpoint 4: Whether Standards for Constituents, Production Criteria, etc. of Foods Are Met(Article 11 of the Food Sanitation Act)

Under Article 11 of the Food Sanitation Act, as matters that cover all food products, standards forconstituents for food in general, production criteria for food in general, processing standards, and criteria forpreserving food in general are established.
For items requiring special efforts for ensuring safety (such as soft drinks and retort pouch foods),
standards for constituents, production criteria, processing standards, and preserving criteria areestablished separately. Details of the standards and criteria are shown in the MHLW Notice No. 370.
 First, Check Using Ingredient List, Food Production Flow Chart, etc. Obtained from Processor

Whether standards and criteria are met is to be checked using information obtained from the processor, etc.
For foods subject to the established production, processing or preservation criteria, conformity to such
criteria is to be checked based on their production flow chart.
If soy, potato, rapeseed, corn, cotton, sugar beet, alfalfa, papaya, etc. is used, the importer should checkwith the processor whether they are genetically modified food or not.
If herbs and/or spices from countries at which sterilization by irradiation is permitted are used, theimporter needs to confirm with the processor in writing that the item has not been sterilized by irradiation.
As for agricultural chemicals, antibiotics and the like remaining in food, an importer should check thestatus of sanitation management with the processor, such as the use of agricultural chemicals, antibiotics,
etc. at the production stage, potential spraying or migration of agricultural chemicals from nearby farms,
and use of pesticides, etc. during storage and transportation.
 Self-inspection (Testing and Inspection) As Necessary

Regarding conformance with the criteria of residual agricultural chemicals, antibiotics, etc. and standards forconstituents, an importer shall consult a quarantine station through prior consultation or a registeredconformity assessment body, and perform self-inspection as needed.
When an importer decides to do self-inspection before starting importing, the self-inspection can be
performed:(1) using unopened samples directly sent to a registered conformity assessment body from the processor or exporter; or,(2) using samples at an official laboratory of the exporting country.
In either method, it is important to ensure that the samples are identical to the goods to be imported. Notethat all relevant requirements need to be satisfied to minor details for inspection results to be accepted. For
details, please inquire at a quarantine station or registered conformity assessment body.
“Specifications and Standards for Foods, Food Additives, etc.”(Public Notice No.370) - No.1: Outline of Food
No. 1 Food

A. Standards for constituents for food in general

Regarding constituents of food, stipulates regulations about antibiotics and the like, genetically modified food,residual agricultural chemicals, and radioactive substances.

B. Criteria for producing, processing, and cooking food in general

Regarding production, etc. of food, prohibits irradiation in principle, prohibits use of eggs not suited for humanconsumption, removal of dangerous parts of cow, prohibits use of additives that do not conform to standards andcriteria for additives and so on.

C. Criteria for preserving food in general

When food is to be stored, stipulates standards of ice, prohibits use of antibiotics, prohibits irradiation.

D. Other standards and criteria

Stipulates respective standards and criteria for soft drinks; powdered soft drinks; ice; ice confectionery; processedmeat and whale meat; processed meat to be eaten raw; edible avian eggs; blood, blood cells, and blood plasma;processed meat products; whale meat products; fish paste products; salmon roe, salted salmon roe, and salted codroe; boiled octopus; boiled crab; fresh seafood to be eaten raw; oysters to be eaten raw; agar; grain, beans, andvegetables; azuki bean paste; tofu; instant noodles; frozen food; and retort pouch food.

(Note) Standards
and criteria for milk and dairy products are separately specified in the Ministerial Ordinance Concerning the
Ingredient Standards for Milk and Dairy Products (Ordinance of the Ministry of Health, Labour and Welfare No. 52).

28

Importing Health Foods

Ⅳ Food Sanitation Act and Import of Foods■ Reference information
MHLW’s website:“Specifications and Standards for Foods”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/jigyousya/shokuhin_kikaku/index.html
MHLW’s website:“Agricultural Chemical Residues in Foods”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/zanryu/index.html (Japanese)
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/zanryu/index_00016.html (English)
Website of The Japan Food Chemical Research Foundation:“Search engine for MRLs”
http://db.ffcr.or.jp/front/ (English)
MHLW’s website:“Foods Produced by Recombinant DNA Techniques”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/bio/idenshi/index.html (Japanese)
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/idenshi/index_00002.html (English)

An importer is obliged to ensure the safety of the imported foods and prepare and retain records on
the import and sale of food items.

Article 3 of the Food Sanitation Act provides that a food business operator shall, on his/her own
responsibility, endeavor to ensure the safety of the food, and for that purpose, he/she shall endeavor to  (i) obtain the knowledge and technologies on food sanitation, (ii) ensure the safety of raw materials to
be used, (iii) conduct self- inspections, and (iv) take other necessary measures.
With regard to imported foods, the importer must confirm their safety including their conformity to
the Food Sanitation Act. Article 8 of the Food Safety Basic Act also provides for the obligations of thefood importer.
The MHLW established the guidelines concerning sanitary control of imported processed foods toemphasize basic matters for guidance on processed foods required of importers under the Imported
Foods Monitoring and Guidance Plan, and thereby requests importers to take voluntary initiatives.
Additionally, the importer is required to endeavor to make a proper record of the import and sale of thefoods they import and retain such record so that the status of distribution of imported foods can bechecked at any time. When any violation of the Food Sanitation Act is detected, the importer must submit
the relevant information promptly to the related quarantine station or prefectural government, etc.

■ Reference information
MHLW“Guidelines on Hygiene Control of Import Processed Foods”
https://www.mhlw.go.jp/english/topics/importedfoods/guideline/01.html (English)(Note) Guidelines that request importers to undertake necessary confirmation about the state of sanitary control in order to ensure
and confirm the safety of imported processed foods in the exporting country at all stages of the food supply processincluding manufacturing and processing, storage and transportation.
MHLW“Guidelines concerning Preparation and Retention of Records by Food Business Operators, based on Provisions in
Paragraph 2, Article 1-3 of the Food Sanitation Act”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/yunyu_kanshi/sankou/index.html (Japanese)

Use import consultation services and information on monitoring and guidance available at quarantine stations.

The Offices of Imported Food Consultation in quarantine stations provide prior consultations to people
intending to import foods, etc. with regard to import procedures, inspection systems, and standards andcriteria for foods, etc. under the Food Sanitation Act. Reservation is required for an over-the-counter
consultation. Check the method for making a reservation in advance by phone or on the website of therelevant quarantine station. A prior consultation does not substitute a preliminary survey or ensure
import permit.
Websites of the MHLW and quarantine stations also provide information on monitoring and guidance, suchas items subject to ordered inspection or monitoring inspection and past cases of violations of the Food
Sanitation Act.
■ Reference information
MHLW’s website:“Imported Food Safety”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/yunyu_kanshi/index_00017.html

Importing Health Foods

29

Ⅳ Food Sanitation Act and Import of Foods

Checkpoint 5: Safety of Concentrated Foods such as Tablets and Capsules

Supplements in a form of tablets, capsules, etc. often undergo processes such as concentration andprocessing. If thereby trace amount toxic substances, etc. contained in raw materials are concentrated or thecomposition of ingredients becomes nonuniform at the level of individual product, that may lead to healthhazard due to excessive intake.
To promote voluntary control by business operators in accordance with GMP (Good Manufacturing
Practice) as a manufacturing and control method of pharmaceuticals, the MHLW has established the“Basic Approach to Proper Manufacturing of Food in Tablet, Capsule and other Forms”and“Guidelines of
Self-inspection concerning the Safety of Raw Materials of Food in Tablet, Capsule and other Forms.”
In these, the MHLW requests“the importer shall confirm with the processor, import source, that the
products to be imported are manufactured under proper manufacturing process control, and endeavor toensure the quality equivalent to that of products manufactured in Japan by, for instance, preparing
documents including necessary items such as product information (e.g., raw materials, processing facility) andstorage method.”
When importing supplements in a form of tablets, capsules, etc., the importer is required to take voluntary
initiatives for ensuring their safety in accordance with the said Guidelines, including gathering informationon the safety, toxicity of source raw materials used in manufacturing through literature review,
performing toxicity tests using raw materials, etc. when the safety cannot be ensured based on the historyof consumption, and establishing a GMP system for ensuring the quality of the products.
(Note) GMP is a summary of requirements needed for manufacturing quality products in all processes from acceptance of raw materials topackaging and shipping of final products.

■ Reference information
MHLW Notice“Basic Approach to Proper Manufacturing of Food in Tablet, Capsule and other Forms”
and“Guidelines of Self-inspection concerning the Safety of Raw Materials of Food in Tablet, Capsule and other Forms”
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/hokenkinou/kankeihourei.html
Website of National Institutes of Biomedical Innovation, Health and Nutrition“Information system on safety and effectiveness for health foods”
https://hfnet.nibiohn.go.jp/(Third-party GMP certifying bodies for health foods)
Japan Health and Nutrition Food Association  http://www.jhnfa.org/
http://www.jhnfa.org/english-info.html
The Japanese Institute for Health Food Standards  http://www.jihfs.jp/
http://www.jihfs.jp/indexen.html

For foods that contain ingredients, etc. requiring special attention, the importer is obliged
to make an notification of health hazard information.

In June 2018, the Act for Amending Part of the Food Sanitation Act, etc. was promulgated for the
first time in 15 years. By this amendment, notification of health hazard information by business person
was institutionalized in order to prevent occurrence and expansion of health damage by health foods.
This is a system to obligate business persons who engage in sale, etc. of food containing ingredients,
raw materials that require special attention to report to the MHLW via the prefectural government,
etc. when information is received about health damage or potential health hazard caused by the
product (to come into effect in FY2020).
Ingredients covered by this system are to be designated by the Minister of Health, Labour andWelfare by hearing the opinions of the Pharmaceutical Affairs and Food Sanitation Council or the
Food Safety Commission of Japan. For example, alkaloids and hormone-like activity ingredients that
may cause health damage when more than a certain amount is consumed are expected to be included.
The summary of the round-table conference on amendment of the Food Sanitation Act published in
November 2017 stated that“because there are no standards and criteria set up or preliminary
regulations such as approval or certification of individual products in the current system for so-called‘health food,’ the possibility of such cases of health damage emerging in the future is undeniable.”
The report mentioned the possibility of obligating GMP and the necessity for establishing a new risk
assessment system for food with no past record of consumption in Japan or their consumption method(e.g., concentration); the health food industry is carefully watching the direction of legal regulations.

30

Importing Health Foods

Ⅳ Food Sanitation Act and Import of Foods

Proper Manufacturing Control of Food in Tablet, Capsule and other Forms
Outline of“Basic Approach to Proper Manufacturing of Food in Tablet, Capsule and other Forms”and“Guidelines of Self-inspection concerning the Safety of Raw Materials of Food in Tablet, Capsule and otherForms”(February 1, 2005. Shokuanhatsu No. 0201003)
Manufacturing process control
Establishment of control organization andimplementation of work control (intangible)
・Establishment of quality control department
・Clarification of responsibility-allocation system・D ocumentation of plan and work procedures andimplementation
・Checking and recording by multiple workers
・Arrangement and preservation of records
・Lot management
・Implementation of sanitary control such as cleaning
and washing・Hygiene and health control of workers
・Site entry restrictions
・Inspection of equipment, machinery, tools, etc.
・Quality check at each stage of process
・Preservation of samples
・Collection of complaints and improvement
・Self-inspection
・Training

Appointment of responsible persons
Preparation of standard documents
Preparation and preservation of records
Establishment of structure and facility (tangible)・Space and structure of workroom
・Contamination prevention (e.g., dust)
・Cross-contamination prevention measures
・Cleaning and sterilization
・Structure of machinery and tools to prevent
contamination of product・Allocation of machinery and equipment
・Bathrooms and changing rooms

Safety check of raw materials(1) Clarification of raw materials(2) Confirmation of division between foods andpharmaceuticals(3) Assurance of sources, used part, raw material
manufacturing method, etc.
・Quality assurance by the morphology or DNA analysis,
production history control, etc.
・GMP control of raw materials(4) Confirmation of dietary habits and intake amount(5) Implementation of literature review
・ Confirmation of safety and harmfulness(6) Literature review and composition analysis(qualitative, quantitative) for ingredients(7) Implementation of safety tests(8) Checking of final product(Source) MHLW“Reference Material from the National Meeting of Division Directors in Charge of Environmental Healthand Food Safety in FY2017”

Securing Safety by GMP
Regarding“health foods”in a form of tablet, capsule, etc. which undergo processes like concentration ofingredient, in order to stabilize the product quality across batches and to improve their safety andreliability, it is important to establish production control and quality control systems for all processes fromacceptance of raw materials to packaging and shipping of final products (GMP = Good Manufacturing
Practice).
Quality control
standard
Report inwriting

Quality control[Quality Control Manager]
Testing
Product
standard

Testing

Deliveryof rawmaterials

Intermediate
product

Instruction
Report inwriting

TestingFinal
product

Instruction

Manufacturing control[Manufacturing Control Manager]

Manufacturingcontrol standard

Shippingof product
Determination ofshipping or not
Report inwriting

Complaint
management
Product
recallGeneral management[General Manager]

Manufacturing sanitation
control standard(Source) MHLW“Current Status and Problems Surrounding the Food Sanitation Act”(September 14, 2017)

Importing Health Foods

31

Ⅴ

Laws and Regulations Related to Labeling of Health Foods

Labeling of health foods is subject to regulations under the Food Labeling Act similar to normal food.
There are other laws and regulations that stipulate rules on labeling; importers need to check outline of
their regulations. Careful planning and considerations are required on how to label and advertise healthfoods on the food markets in Japan, while complying with regulations on food labeling,■ Food Labeling Act“Food”covered by the Food Labeling Act include all kinds of food and drinks (including additives) excluding
pharmaceuticals and quasi-pharmaceutical products, etc. Liquor specified by the Liquor Tax Law is also included.
Concrete labeling rules are specified in the Food Labeling Standards and any food that is not labeled in accordancewith said standards may not be marketed. For details, refer to the website of the Consumer Affairs Agency.
When marketing“processed foods (those listed in Appended Table 1 of Food Labeling Standards)”placed in acontainer or packaging for general consumers, labeling must be in Japanese using proper and easy-to-understandterms, and item name, names of raw materials, additives, net content and other information must be displayed in aprescribed format at a location easily visible without opening the container or packaging.
Basic items on labeling of processed foods for general consumers
Item name

General name. Not the commodity name.

Names of raw materials

Present the names of raw materials used in the order of high to low weight percentage
in the raw materials.
Allergens: The 7 items (e.g., egg, wheat) must be labeled.
Genetic modification: For the 33 processed foods subject to regulations, label if
relevant plants that are genetically modified or not distinguished from geneticallymodified organisms are contained.

Additives

Present the names of additives used in the order of high to low weight percentage in
the additives. They may be presented in the section of names of raw materials clearly
separating from raw materials.
Allergens: The 7 items (e.g., egg, wheat) must be labeled.

Net content

Weight (g, kg), volume (mL, L), quantity (e.g., number of pieces)Best-before datePresent in the order of year, month and day. Presenting only year and month isacceptable if the time from manufacturing to expiration date exceeds 3 months.

Preservation method

Present detailed conditions of preservation until the expiration date. No cautions after
opening.

Name of country of origin
ImporterMust be labeled for imported goods.
Importer if the importer is the person engaged in food-related business and responsible
for the content of labeling. Present the address (business location) and name (person’sname for private person or corporate name for corporation; presenting trade nameonly is not acceptable) of the importer.

The Food Labeling Standards also stipulates labeling rules for nutrients, nutrition emphasis, foods withnutrient function claims, and foods with function claims. (See pages 34 to 37)■ Reference information
Website of the Consumer Affairs Agency:“Food Labelling”
https://www.caa.go.jp/policies/policy/food_labeling/information/ (Japanese)
https://www.caa.go.jp/en/policy/food_labeling/ (English) Be Careful with Laws and Regulations Other Than Food Labeling Act

Other laws and regulations that set forth labeling rules include the“Pharmaceuticals and Medical Devices
Act”that prohibits labeling pertaining to pharmaceutical efficacy or effects on non-pharmaceutical goods,“Measurement Act”that stipulates proper weighing and labeling,“Act on Securing of Liquor Tax and on
Liquor Business Associations”that stipulates labeling of liquor,“Rice Traceability Act”for providing
information on places of production for rice, etc., and various local government’s ordinances.
When it comes to labeling of health foods, special attention needs to be paid not to violate provisions of the
Health Promotion Act, which prohibits false or exaggerated representations regarding health maintenanceand promotion effects, or provisions of the Premiums and Representations Act, which prohibits
misrepresentations concerning quality.

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Importing Health Foods

Ⅴ Laws and Regulations Related to Labeling of Health Foods

Major Laws and Regulations That Stipulate Obligation or Prohibition of Special
Labeling Items for Sale of Food
Law or regulation

Food Labeling Act

Jurisdictional governmental
agency or contact point
Food Labeling Division, Consumer
Affairs Agency:+81-3-3507-8800 (main)
Food labeling department ofprefectural government withjurisdiction over the location of
the head office, etc. that is
responsible for the content oflabeling
Health center with jurisdiction
over the said location forsanitation matters and healthmatters

Content of regulations
For all foods marketed to consumers and businesspersons, obligates basic labeling items based on the
Food Labeling Standards
・Quality-related items
Item name, names of raw materials, name of countryof origin, net content, name/address of foodrelated business person, any item quality labelingstandards specify for the food category, etc.
・Sanitation-related items
A dditives, preservation method, expiration date,allergen, information on genetic modification, etc.
・Labeling of nutrients
Voluntary labeling by business person: Stipulates
labeling rules for nutrition emphasis, foods withnutrient function claims, foods with function claims, etc.

Pharmaceuticals andMedical Devices Act

Pharmaceutical affairs departmentof prefectural government withjurisdiction over the location of thehead office, etc. that is responsible
for the content of labeling

Prohibits labeling of pharmaceutical effects or efficacy
for goods that do not fall into the category ofpharmaceuticals.

Measurement Act

Metrology Policy Office, Industrial
Science and Technology Policy
and Environment Bureau, METI:+81-3-3501-1688
Prefectural Weights and Measures
Inspection OfficeObligates labeling based on the regulations for“specified commodities” in sealed container as
stipulated by Cabinet Orders.

Act on Securing of
Liquor Tax and on Liquor
Business Associations

Customs having jurisdiction overthe place to receive imported
liquorObligates labeling of liquor item name, etc.

Act on Japanese
Agricultural Standards,
etc. (JAS Act)

Regional Center with jurisdiction over thelocation of the business office, Food andAgricultural Materials Inspection Center

Obligates the JAS standards and relevant labeling.

Rice Traceability Act(Method to provide or label
information on places of
production) Food Labeling Division,
Consumer Affairs Agency:+81-3-3507-8800 (main)

Obligates preparation and preservation of transaction
records and provision of information on places of
production for rice, cooked rice, rice processed food,etc.

Local Governments’
Ordinances

Jurisdictional department ofrelevant local government

Obligates quality-related labeling for commodities which are
not regulated by other relevant laws and ordinances.
(In the case of Tokyo Metropolis) Subjects of quality-related labeling: cooked frozen foods, honey, cut vegetables, cut fruits, etc.

Act on the Promotion of
Effective Utilization of
Resources

Food Industrial Policy Office,Biomass Policy Division, Food
Industry Affairs Bureau, MAFF:+81-3-3502-8499

Obligates displaying identification marks for materials(paper, plastic) of containers and packaging.

Main Laws and Regulations That Prohibit False or Exaggerated Labelingand Misrepresentation Concerning Quality
Law

Health Promotion Act

Act against Unjustifiable
Premiums andMisleading
Representations(Premiums andRepresentations Act)

Jurisdictional governmental
agency or contact point

Content of regulations

Food Labeling Policy Office,Representation Division, Consumer
Affairs Agency:+81-3-3507-8800 (main)
Health center with jurisdiction overthe location of the head office, etc.
that is responsible for the content
of labeling

Prohibits false or exaggerated representations
regarding health maintenance and promotion effects.

Guidance Desk, Representation
Division, Consumer Affairs Agency:+81-3-3507-8800 (main)
Department in charge of thePremiums and Representations Act,
prefectural government

・Covers various representations used as means of
attracting customers.
・Prohibits representations that may mislead general
consumers into believing that the product issignificantly high in quality or advantageous,whether it was intentional or not of the person wholabeled (business person who involved with decision
making on the content of labeling).
・Prohibits misleading representations concerning thecountry of origin of goods.

Importing Health Foods

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Ⅴ Laws and Regulations Related to Labeling of Health Foods■ Obligation of Labeling for Nutrients

The Food Labeling Standards under the Food Labeling Act obligate, in principle, labeling the content of fiveitems, namely, energy, protein, fat, carbohydrate, and sodium (in sodium chloride equivalent), for packaged
processed foods and additives for general consumers (the transitional measure period is until March 31, 2020).
Nutrients can be voluntarily labeled on perishable food or processed food for business use, but also in thiscase the labeling must comply with the Food Labeling Standards.
(Note) In some cases, nutrient labeling can be omitted (e.g., those with little contribution as a source of nutrients (such as liquor, coffee beans,spices), those sold by small-scale entrepreneurs (such as business persons exempted from the obligation of payment of consumption
taxes)) or nutrient labeling is not required (e.g., when being delivered but not being sold to many or unspecified persons).

Nutrients Subject to Nutrient Labeling
Other than the obligated five items, recommended labeling and voluntary labeling are specified for somenutrients.
Mandatorylabeling

Five elements that must be labeled onprocessed foods for general consumers

Energy, protein, fat, carbohydrate, sodium (in sodium
chloride equivalent)

Recommendedlabeling

Nutrients recommended to be labeledconsidering the state of consumption by
the Japanese or relation with preventionof lifestyle-related diseases

Saturated fatty acid, dietary fiber

Voluntarylabeling

Nutrients other than the five mandatorylabeling items among the nutrients andenergy in Appended Table 9 of the Food
Labeling Standards
When labeling such nutrients on acontainer or packaging, they shall be shownwithin a frame in accordance with themethod specified by the Standards.

Zinc, potassium, calcium, chromium, selenium, iron,copper, magnesium, manganese, molybdenum, iodine,
phosphorus, niacin, pantothenic acid, biotin, vitamin A,
B1, B2, B6, B12, C, D, E, K, folic acid, n-3 fatty acids, n-6
fatty acids, cholesterol, saccharides and sugars(monosaccharides or disaccharides, and not sugar
alcohol)(Source) Material of Consumer Affairs Agency. Edited by MIPRO.

Method of Labeling for Nutrients[When labeling mandatory labeling matters only](Example of labeling by Form 2
attached to the Standards)
Always start with
Nutrition Facts“Nutrition Facts” .
Average Quantity per Serving (X g)
EnergyProtein
Fat
Carbohydrate
Sodium chloride
equivalent

X
X
X
X
X

kcal
g
g
g
g

Present thequantity per unit,
such as 100 g,
100 ml, serving,and sachet.
If the unit is serving,also present thequantity of serving.

For food to which sodium salts are added,
the quantity of sodium must not be presented
on the packaging (Article 9 of the Standards).
However, for food or additives to which
sodium salts are not added, the quantity of
sodium chloride equivalent maybe bepresented as “Sodium X mg (sodium chloride
equivalent Y g).”[When labeling voluntary labeling items in addition to mandatorylabeling matters](Example of labeling by Form 3 attached to the Standards)
Nutrition Facts
Average Quantity per 100 g
EnergyProteinFat- Saturated fattyacids- n-3 fatty acids- n-6 fatty acids
Cholesterol

X
X
X
X

kcal
g
g
g

X
X
X

g
g
mg

Collagenβ-Carotene
Polyphenol

400
300
50

mg
μg
mg

When labeling the content ofcompositions other than the nutrients
speciﬁed in Appended Table 9 of theStandards, they shall be separated fromthe labeling stipulated by the Standards.

Carbohydrate- Saccharides- Sugars- Dietary ﬁber
Sodium chloride
equivalentCalcium
Vitamin A

X
X
X
X
X

g
g
g
g
g

X
X

mg
μg

When labeling the quantity ofsaccharides or dietary ﬁber, boththe quantity of saccharides andthe quantity of dietary ﬁber must
be presented.
Only sugars may be presented as
breakdown of carbohydrate.

(Source) Consumer Affairs Agency“Nutrient Labeling (Food Labeling Standards)”■ Reference information
Consumer Affairs Agency“Guidelines for Nutrient Labeling under Food Labeling Act, Version 2”
https://www.caa.go.jp/policies/policy/food_labeling/food_labeling_act/pdf/food_labeling_act_180518_0001.pdf

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Importing Health Foods

Ⅴ Laws and Regulations Related to Labeling of Health Foods■ To Label with Emphasizing Nutrition

When labeling with emphasizing nutrition like containing more or less than a certain standard (e.g., lots of
dietary fiber, 40% less salt, 50% less fat) or not adding certain nutrition (e.g., sugar not used, salt not added),
the labeling needs to satisfy the conditions specified by the Food Labeling Standards.
Types and Wording Examples of Nutrition Emphasizing LabelingType of nutrition emphasis

Able to supply

Able to intake properly

Emphasis of not being added

Wording examples

High

High in XX
XX-richFull of YY

Contains

Source of XX
Supply of XX
YY-containing

Enriched

XX 30% increased
Double YY

Does not containXX-freeZero YY Non-ZZ

Low

Low in XX
Less YYZZ light

ReducedXX 30% reduced
Half YY
Salt not added
No sugar used

Applicable nutrient, etc.

Protein, dietary fiber, zinc, potassium,
calcium, iron, copper, magnesium, niacin,
pantothenic acid, biotin,
vitamin A, B1, B2, B6, B12, C, D, E, K, folic acid

Energy, fat, saturated fatty acids,cholesterol, sugars, sodium

SugarsSodium salts(Source) Material of Consumer Affairs Agency. Edited by MIPRO.
■ Inquiries
Regarding the Food Labeling Act as a whole: Food Labeling Division, Consumer Affairs Agency: TEL: +81-3-3507-8800 (main)
Regarding individual commodities: Health center with jurisdiction over the location of the head office, etc. that is responsible for thecontent of labeling
Links on the website of the Consumer Affairs Agency:“Offices Accepting Inquiries about Food Labeling Act (Each Prefecture)”https://www.caa.go.jp/policies/policy/food_labeling/information/contact/prefectures/■ Reference information
Website of the Consumer Affairs Agency:“System of Labeling about Health and Nutrition”
https://www.caa.go.jp/policies/policy/food_labeling/health_promotion/

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Ⅴ Laws and Regulations Related to Labeling of Health Foods■ To Label Function Claims

Food has the primary function (nutrition function) to maintain human life by supplying nutrients and thesecondary function to make the primary function pleasant by appealing to human senses with its taste, flavor,
and appearance. In Japan, what is focused on when developing health food is the tertiary function - the functionthat involves with control of biorhythm, anti-aging, prevention of lifestyle-related diseases and recovery from
disease. Labeling of food about its tertiary function is called“function claims.”
As a system of function claims, health foods are divided into“foods with nutrient function claims”that does not
require permit application or notification to the national government,“foods with function claims”that requires
notification to the government before marketing, and“foods for specified health uses”that requires individual
permit from the government, and these three types of food are collectively called“food with health claims.” Would like to label functions of nutrient⇒ Foods with nutrient function claims do not require permit application or notification

Food allowed to claim functions of nutrient specified by the national government for the purpose of nutrient
supply.
If the quantity of nutrient contained in the recommended daily intake of food complies with the standard set by
the national government, the food can be marketed as food with nutrient function claims on the businessperson’s own responsibility.
This claiming is self-certified and relatively easy to do, but claimable nutrients are limited. (See page 37)
W ould like to label that functional ingredients are expected to improve and maintain good health⇒ Foods with function claims need advance notification

Food allowed to claim on the company’s own responsibility that its functional ingredient is expected to improveand maintain good health for undiseased people based on scientific evidence.
As part of regulatory reform by the Japanese government, this food category started from April 2015referencing the dietary supplement labeling system in the USA.
The“scientific evidence”does not necessarily require tests on humans; it can be demonstrated by review ofstudies on the product or the functional ingredient.
The administrative burden on the business person is less compared to permit application for foods for specified
health uses, but the Consumer Affairs Agency only accepts appropriately prepared notification documents. As
such, the procedures aren’t quite easy to go through.
 Would like to label that certain health effects can be expected⇒ Foods for specified health uses need examination and permission by the national government

Foods for specified health uses are foods that contain ingredients with health functions that affect physiological
functions, etc. of the body to which labeling indicating expected achievement of specific health purposes (e.g.,assisting maintaining blood cholesterol at a proper level, improving the gastrointestinal conditions) can be
affixed. It’s generally called Tokuho.
To market as Tokuho, the food must undergo examination by the national government to verify scientificgrounds of its effectiveness and safety and receive approval by the government for the content of labeling.
Food approved as Tokuho must carry an approval symbol of the Commissioner of the Consumer Affairs
Agency. Application for examination requires carrying out tests on humans using the product to verify the
food’s safety and effectiveness.
Because of the requirement for human tests, approval procedures will likely take a substantial amount of timeand cost.

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Importing Health Foods

Ⅴ Laws and Regulations Related to Labeling of Health Foods

Nutrients Claimable in Foods with Nutrient Function Claims
Fatty acids (1 kind)n-3 fatty acids

Minerals (6 kinds)

Zinc, potassium*, calcium, iron, copper, magnesium

Vitamins (13 kinds)

Niacin, pantothenic acid, biotin, vitamin A, B1, B2, B6, B12, C, D, E, K, folic acid* While potassium is a nutrient necessary for maintaining normal blood pressure, active intake of potassium must be avoided
by persons with kidney disorders, etc. As it is undeniable that tablet, capsule, or concentrated powder or liquid
preparations could cause excessive intake of potassium, the Japanese government decided not to permit labeling
functions of potassium in processed foods in such forms.
(Source) Consumer Affairs Agency“Guidelines for Nutrient Labeling under Food Labeling Act, Version 2”

Differences between Food with Health Claims and General Food
Permitted
function claim

Foods(pharmaceutical effects or efficacy cannot be indicated)

Foods forspecifiedhealth
uses

Foods
with
healthclaims(functions
may beindicated)

Generalfoods

Claims about usefulness or
suitability on maintaining or
promoting health (including
claims on contribution to
reducing disease risks)

Claimable
components

Certification method

Components withknown action
mechanism(Note)[Permission required] Business
entities need to have each productundergo an examination concerning
their effectiveness and safety, etc.
and to obtain authorization for thelabeling from the Consumer Affairs
Agency.

Components withknown action
mechanism(excluding
nutrients)[Advance notification required]
Based on the rules specified by thenational government, business
entities need to report necessary
matters such as the scientificgrounds for the safety and functional
claims of food to the Consumer
Affairs Agency before commencing
sale of the relevant food.

Foods
with
function
claimsClaims about usefulness or
suitability on maintaining or
promoting health(excluding claims
pertaining to reduction of
disease risks)

Foods
with
nutrient
function
claimsClaims about functions of
nutrient (fixed phrases
specified by the national
government for eachcomponent)

Vitamins 13 kinds,
minerals 6 kinds,
fatty acids 1 kind

Business entities do not need to filean application for authorizationor make reports to the Consumer
Affairs Agency.
Claimable components and thestandards of content are set by thenational government

Functions may not be
indicated.

No specific rules

None

So-called
healthfoods(Note) Action mechanism refers to a mechanism how a component acts in the human body.
(Source) Consumer Affairs Agency“Outline and Current Status of the System of Foodwith Function Claims”(January 2016, table on p. 19). Edited by MIPRO.
■ Inquiries
Regarding the Food Labeling Act as a whole: Food Labeling Division, Consumer Affairs Agency: TEL: +81-3-3507-8800 (main)
Regarding individual commodities: Health center with jurisdiction over the location of the head office, etc. that is responsible for thecontent of labeling
Links on the website of the Consumer Affairs Agency:“Offices Accepting Inquiries about Food Labeling Act (Each Prefecture)”https://www.caa.go.jp/policies/policy/food_labeling/information/contact/prefectures/■ Reference information
Website of the Consumer Affairs Agency:“System of Labeling about Health and Nutrition”
https://www.caa.go.jp/policies/policy/food_labeling/health_promotion/

Importing Health Foods

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Ⅴ Laws and Regulations Related to Labeling of Health Foods■ Be Careful with False or Exaggerated Labeling and Misrepresentation Concerning Quality

While a certain level of expressions exaggerating the characteristics of commodity are expected in labeling andadvertisement of health foods, attention needs to be paid as labeling or advertisement that affect selection ofcommodities by general consumers beyond the level acceptable by society in general conflict with theprovisions of the Health Promotion Act or the Premiums and Representations Act.
 Prohibition of False or Exaggerated Representations by Health Promotion Act

Article 31, paragraph (1) of the Health Promotion Act prohibits any persons from making“representations
significantly different from the reality”or“significantly misleading representations”about health maintenanceand promotion effects, etc.* when displaying advertisement, etc. regarding those sold as food.
The provisions of this Act are not to prohibit certain wordings or expressions in a blanket manner. Violation of
the provisions is determined by the content of appeals in the overall representation, based on factors likewhether the representation appropriately matches the actual effect. Be careful not to use representations oradvertisements that may give excessive expectations or impressions to consumers.
* Health maintenance and promotion effects, etc. refer to effects for the purpose of therapy or prevention of disease, effects for the primary
purpose of general strengthening or promotion of tissue functions in the body, effects of nutrients, quantity of contained food orcomponents, and effects that contribute to beautifying human body. Those expressed implicitly or indirectly are included.
■ Inquiries
Regarding exaggerated representations under the Health Promotion Act: Food Labeling Policy Office, Representation Division,
Consumer Affairs Agency: TEL: +81-3-3507-8800 (main)
Regarding individual commodities: Health center with jurisdiction over the location of the head office, etc. that is responsible for thecontent of labeling■ Reference information
Website of the Consumer Affairs Agency:“Prohibition of Exaggerated Representations by Health Promotion Act”
https://www.caa.go.jp/policies/policy/representation/extravagant_advertisement/ Prohibition of Misrepresentation concerning Quality by Premiums and Representations Act

The“representations”under the Premiums and Representations Act cover advertisements and labeling in
general made by a business person for notifying consumers of the quality, standards, etc. of commodity orservice or transaction conditions like prices as means of attracting customers. They cover not only labeling on
the commodity, container or packaging but also advertisements by samples, brochures and pamphlets, user’s
manuals, direct mail marketing, newspapers/magazines/TVs, advertisements and displays such as posters andsign boards, advertisement via the Internet, as well as verbal sales pitches.
[Prohibition of Misrepresentation concerning Quality] (Article 5, paragraph (1), item (i))
Regarding the quality and standards of commodity marketed, representations that make consumers to believe“this is very good quality”although the quality actually is not up to the claim are regarded misrepresentations
and prohibited. Note that the point questioned by the Premiums and Representations Act is whether
representations are misleading to general consumers about the quality, not whether the representations are
made“intentionally or unintentionally”by the business person resulting in the outcome.
■ Inquiries
Guidance Desk, Representation Division, Consumer Affairs Agency: TEL: +81-3-3507-8800 (main)
Department in charge of the Premiums and Representations Act of prefectural government with jurisdiction over the location of thehead office, etc. that is responsible for the content of labeling■ Reference information
Website of the Consumer Affairs Agency:“Premiums and Representations Act”
https://www.caa.go.jp/policies/policy/representation/fair_labeling/・“Matters to Note with Regard to Health Food under the Premiums and Representations Act and the Health Promotion Act”﻿
(June 30, 2016)
https://www.caa.go.jp/policies/policy/representation/fair_labeling/pdf/160630premiums_9.pdf
・“Guidelines concerning Monitoring, Guidance, etc. for Prohibition of False or Misleading Advertising, etc. and Ensuring Proper
Advertising, etc. about Health Maintenance and Promotion Effects, etc. Conducted for Those Served for Marketing as Foods”﻿
(April 20, 2016)
https://www.caa.go.jp/policies/policy/representation/extravagant_advertisement/pdf/foods_extravagant_gl.pdf

38

Importing Health Foods

Ⅴ Laws and Regulations Related to Labeling of Health Foods

State of Monitoring on False or Exaggerated Representations of Health Foods, etc. on
the Internet
Through monitoring against false or exaggerated representations of health foods, etc. on the internet, theConsumer Affairs Agency requests making improvements for representations that may violate the Health
Promotion Act and publicize them on its website. Request for improvement was made to 381 business persons,425 commodities in FY2017.
Commodity category

Represented health maintenance and promotion effects, etc.

Perishable foods(agricultural produce)(2 commodities)

Representations claiming to have an effect for preventing myocardial infarction, cerebral
infarction, arteriosclerosis, relief of constipation, recovery from fatigue, etc.

Processed foods(6 commodities)

Representations claiming to have an effect for preventing cancers, arteriosclerosis,
myocardial infarction, cerebral infarction, improving immune strength, relief of pollen
allergy, anti-aging, etc.

Beverages, etc.
(tea, coffee andcocoa preparations,beverages, liquor)(12 commodities)

・Representations claiming to have an effect for preventing myocardial infarction, cerebral
infarction and dementia by controlling level in blood, prevention of insomnia, etc.
・Representations claiming to have an effect for preventing hypertension, menopausal
symptoms, atopic dermatitis, constipation, summer heat fatigue, etc.
・ Representations claiming to have an effect for relieving stress, beautifying the skin,anti-aging, losing weight, etc.

So-called healthfoods (capsule, tablet,
granules, etc.)(99 commodities)

・Representations claiming to have an effect for preventing depression, dementia, memory
disorders, etc.
・ R epresentations claiming to have an effect for burning fat, improving metabolism,
removing waste materials, etc.
・ Representations claiming to have an effect for enlarging the breasts, beautifying the skin,alleviating menopausal symptoms, preventing hypertension, arteriosclerosis, etc. byacting on activation of female hormones(Source) Website of the Consumer Affairs Agency:“Requests for False or Exaggerated Representations of Health Foods, etc.
on the Internet”(April to June, 2018)

Representations Without Reasonable Grounds Are Not Permitted- Regulations on Undemonstrated Advertisements (Article 7, paragraph (2) of the Premiums and Representations Act)

When a misrepresentation concerning quality is suspected, the Consumer Affairs Agency and theprefectural government may request the relevant business entity to submit materials showing reasonablegrounds for the labeling.
When the business entity fails to submit requested documents by the deadline or when the submitted
documents fail to show reasonable grounds for the labeling, said labeling is considered to bea misrepresentation.
The basic concept of the application of these regulations is shown in“Guidelines in Article 7, paragraph (2) ofthe Act against Unjustifiable Premiums and Misleading Representations - Guidelines concerning Regulations
on Undemonstrated Advertisements.”[Criteria for reasonable grounds] Both of the following requirements must be satisfied.
1. Submitted documents show objectively demonstrated facts.
(content of documents may be either the results of testing or surveys, or the opinions or academic
documents of an expert, expert body, or specialized organization)
2. Effects and efficacy in the labeling appropriately correspond to demonstrated facts.
[Deadline for the submission of documents]
By the elapse of 15 days from the day on which the Commissioner of the Consumer Affairs Agency issued
a letter to request the submission of documents(excluding cases where justifiable grounds are found (judgment is made on a case-by-case basis, but a need to conduct new oradditional testing or surveys is not accepted as justifiable grounds))■ Reference information
Website of the Consumer Affairs Agency:“Regulations on Undemonstrated Advertisement”
https://www.caa.go.jp/policies/policy/representation/fair_labeling/representation_regulation/misleading_representation/not_demonstrated_ad/

Importing Health Foods

39

Issued by: Manufactured Imports and Investment Promotion Organization (MIPRO)
6th floor, World Import Mart Bldg.
3-1-3, Higashi-Ikebukuro, Toshima-ku, Tokyo 170-8630, Japan
TEL: +81-3-3971-6571
https://www.mipro.or.jp

Unauthorized copying of the contents of this guidebook is strictly prohibited.
February 2020
〈Notes〉- The translations of the Japanese laws, regulations, announces, notices and guidelines provided in this booklet are not for official use. Only the original Japanese texts of laws andregulations have legal effect in Japan. The translations are to be used solely as reference material to aid in the understanding of Japanese laws and regulations.
- Although MIPRO has made every effort to provide as accurate information as possible in this booklet based on the latest information available at the time of preparation, MIPRO shallnot be held responsible for the accuracy, reliability or currency of the legislative materials provided in this booklet, or for any consequence resulting from use of the information inthis booklet. For all purposes of interpreting and applying law to any legal issue or dispute, readers should consult the original Japanese texts published in the Official Gazette.