The Nineteenth Seminarfor
Visiting Food Hygiene Experts－2006－

Policy Planning and Communication Division
Standards and Evaluation DivisionInspection and Safety Division
Department of Food Safety
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and WelfareContents
Part I

Administration of Food Safety

Introduction
1. Structure and responsibilities of the Department of Food Safety
2. Outline of administration of food safety
3. Relevant statutes(1)

Food Safety Basic Law<Food Safety Commission>(2)

Food Sanitation Law(3)

Confectionery Hygienists Law(4)

Abattoir Law(5)Special Measures Law Concerning Bovine Spongiform Encephalopathy(6)

Poultry Slaughtering Business Control and Poultry Inspection Law(7)

Rendering Plants Control Law(8)

Law of Temporary Measures for Enhancing the Control Method of the Food
Production Process
Health Promotion Law(9)

4. Specifications and standards
containers/packages, etc.

for

food,

food

additives,apparatus,(1)

Specifications and standards for food(2)

Specifications and standards for food additives(3)

Specifications and standards for apparatus, containers/packages, etc.

(4)Harmful chemicals in food with provisionary regulatory limits and othersubstances

5. Safety assurance of livestock and poultry meat
6. Safety Measures for BSE(1) What is Bovine Spongiform Encephalopathy?
(2) Measures taken for imported food(3) Measures taken in Japan(4) Special Measures Law Concerning Bovine Spongiform Encephalopathy

7. Action taken against food poisoning<A typical case of food poisoning associated with imported foods>

8. Comprehensive sanitation-controlled manufacturing process(Sanitary control over food based on HACCP)

<For reference: the HACCP system>

9.

Safety assurance of exported foods(1) Meat intended for the United States(2) Seafood intended for the United States(3) Seafood intended for the EU countries(4) Seafood intended for China(5) Foods intended for Malaysia

10. Safety assurance of imported foods(1)

Imported food monitoring and guidance plan(2)

Import procedure

11. Introduction of standards for business management (Good Laboratory
Practice) into food-examination laboratories
12. Foods produced by recombinant DNA technology(1)

Safety assessment(2)

Monitoring tests at import

13. Food with health claims and nutrition labeling(1)

Food with health claims(2)

Nutrition labeling

14. Global cooperation and information disclosure(1)

Global cooperation(2)

Information disclosure

Annexes1.

Map of imported food inspection offices at quarantine stations

2.

List of quarantine stations

3.

Food import system

4.

Procedure for imported food inspection

5.

Import notification form

6.

FAINS/NACCS interface

7.

Number of foreign official laboratories

8.

Excerpts from the Food Sanitation Law (Articles 4 Paragraphs 1, 2, 4 and 5;
Article 6; Article 9 paragraph 2; Articles 10; Article 11 Paragraphs 1, 2, and 3;
Articles 12, 16, and 18; and Article 26 Paragraph 3)

9.

Categories by health use of permitted/approved foods for specific health uses

10. Instances of labeling for permitted/approved foods for specific health uses
11. Outline of regulation on nutrition labeling
12. Nutrition labeling standards

Part I
Administration of Food SafetyPart I

Administration of Food Safety

Introduction
The purpose of the administrative work concerning food safety is to protect thehealth of the public through the strengthening measures for the assurance of foodsafety.
Japan carries out food safety work under the Food Safety Basic Law (enacted in
May 2003) and related laws, including the Food Sanitation Law, the Abattoir Law, and
the Poultry Slaughtering Business Control and Poultry Inspection Law.

The related

laws also include the Law of Temporary Measures for Enhancing the Control Method of
the Food Production Process and the Health Promotion Law. The work covers a wide
range of responsibilities from regulating the manufacture, import, and sale of food, foodadditives, and food apparatus and containers/packages to providing necessary
information to consumers and businesses.
This document outlines the food sanitation work. For details, please consult theattached documents and tests prepared by each division responsible for this study
program.

1.

Structure and responsibilities of the Department of Food Safety
All ministries and agencies in Japan were reorganized as of January 6, 2001.

The Ministry of Health and Welfare and the Ministry of Labour have been merged into
one ministry named the Ministry of Health, Labour and Welfare (MHLW). The
administration of food safety is now under the jurisdiction of the Department of Food
Safety under the Pharmaceutical and Food Safety Bureau. The structure and its main
responsibilities are given below. The entire organization of the Ministry is accessible on
the MHLW web site (http://www.mhlw.go.jp). For relationship between national andlocal governments, see Diagram 1.
Department of Food Safety, Pharmaceutical and Food Safety BureauPolicyPlanning

andCommunication

Division(Generalcoordinationofresponsibilities under the jurisdiction of the Department of Food Safety,
risk communication)
Office of International Food Safety (General coordination of international affairs
under the jurisdiction of the Department)
Office of Port Health Administration (Quarantine business, inspection ofimported food)Standards and Evaluation Division (Establishment of specifications/standards forfood, food additives, pesticide residues, animal drug residues, foodcontainers, and food labeling)
Office of Health Policy on Newly Developed Food
(Labeling of specified uses, nutrition labeling standards, foods with healthclaims, dietary supplements, safety assessment of genetically modified
foods)



Inspection and Safety Division (Food inspection, health risk management such asmeasures for food poisoning, safety measures for poultry and livestock
meat, dissemination and promotion of the HACCP approach, GLP,
measures for environmental contaminants, sanitary control of rendering
plants)
Office of Import Food Safety (Assurance of import food safety）

Relationship between national and local governments

Diagram 1.

Ministry of Health, Labour and Welfare

Prefectural governments, Municipal Governments
Regional Bureau of Health and Welfare

Pharmaceutical and Food Safety Bureau

Health Authorities

Food Sanitation Division
Health and Welfare Division

Food Sanitation Div.

Department of Food Safety

Food Sanitation Inspectors
7,911
Inspectors
Food Sanitation Inspectors

Policy Planning Division
Health Centers

Office of International Food Safety

Meat Inspectors
Poultry Inspectors

Office of Port Health Administration

Meat Inspection CentersStandards and Evaluation Division

Meat Inspectors
Poultry Inspectors

2,662
Meat
inspectors
2,780
Poultry
inspectors

Office of Health Policy on Newly Developed Food
Public Health Laboratories
Inspection and Safety Division
Office of Import Food Safety

Related Authorities

Note: The numbers are as of the endof fiscal 2004, and thenumber marked with asterisk(*) is as of April 2006.

Pharmaceutical Affairs and Food Sanitation Council
National Institute of Health Sciences
Quarantine Stations
National Institute of HealthNational Institute of Public Health
Related Health Bureaus

Food Inspection Div.

Food Sanitation Inspectors (314) *2.

Outline of the administration of food safety
The food safety administrative work is based on the Food Safety Basic Law(enacted in May 2003), the Food Sanitation Law, the Abattoir Law, the Poultry
Slaughtering Business Control and Poultry Inspection Law, and other related laws.
There has been a growing concern and distrust of food safety among theJapanese public, triggered by various problems involving the occurrence of BSE in 2001.
Under such circumstances Japan has enacted the Food Safety Basic Law, acomprehensive law to ensure food safety for the purpose of protecting the health of the
public, as well as has developed related laws. In the wake of the development of theselaws, Japan has introduced a risk analysis approach to food safety work.
The approach is to scientifically assess risks (expressed as the probability anddegree of adverse health effects) and develop necessary measures based on the risk
assessment. The risk analysis consists of three components: risk assessment—assess
risk scientifically; risk management—implement necessary measures based on risk
assessment; and risk communication—exchange information and opinions among
related people representing the people including public, government, and academia.
The Food Safety Basic Law is responsible for the risk assessment, and the Food
Sanitation Law and other related laws are responsible for the risk management. The
risk assessment is in practice conducted by the Food Safety Commission establishedunder the Food Safety Basic Law (See Diagram 2).
The Food Sanitation Law covers various responsibilities. They include theestablishment of standards and specifications for food, additives, apparatus, and foodcontainers/packages; inspection to see whether these established standards are met; thehygiene management of the manufacture and sale of food; and business license. (SeeDiagram 3)

The Abattoir Law and the Poultry Slaughtering Business Control andPoultry Inspection Law cover the regulation of livestock meat and fowl meat including
inspection systems for meat.

In addition, the publication of relevant information andinternational cooperation in study and research are an important part of the food safety
work.
To achieve those responsibilities, local governments play an important role, as
well. The local governments conduct inspection of and give advice to food-related
businesses. They grant a license to businesses that operate within the jurisdiction
concerned, and suspend licensed businesses and/or revoke operation if they violate thelaw. They also conduct food testing. These activities are executed through healthcenters under the jurisdiction concerned.
Imported foods are inspected by 31 quarantine stations placed across Japan
under the central government.

Diagram 2

RISK ASSESSMENTRISK MANAGEMENT

Food
FoodSafety
SafetyCommission
Commission

MHLW
MHLW

・ To conduct a risk assessment.
・ To recommend that agencies in charge of risk
management implement necessary measures for foodsafety, based on the risk assessment results.
・ To monitor the risk management by related agencies.
・ To collect and analyze domestic and international
information on food safety hazards.
・ To comprehensively manage total risk communication
including activities of the risk management agencies.
Food Safety Basic Law

MAFF
MAFF
・ Regional Agricultural

・Quarantine Stations
・Regional Bureaus of
Health and Welfare
・Health Centers, etc.
Risk management
for food safety

Food Sanitation Law, etc.

RISK COMMUNICATION
・Disclosure of information on food safety
・Ensuring opportunities for consumers to express their opinions

Administration Offices
・ Centers for Food
Quality, Labeling andConsumer Services, etc.
Risk management
for agricultural,
livestock, and fisheryproduction.
Agricultural Chemicals
Regulation Law, etc.

Diagram 3.

Overview of Administration of Food Safety
Ministry of Health, Labour and Welfare (Risk Management)

Food Safety Comission(Risk Assessment)

Foods, Additives, Apparatus, and Containers/Packages

Mutual cooperation
Execution of comprehensive
risk communication
Ministry of Agriculture,
Forestry and Fisheries(Risk Management)

Consulting

Pharmaceutical
Affairs and Food
Sanitation Council(Hadle mattersunder authority of
the Council, basedon the Law)

1. Establish specifications/standards→ Prohibit the sale of noncompliant foods.
Food additives, pesticides residues, veterinary drug residues,
GM foods, apparatus/containers.
2. Establish labeling standards→ Prohibit the sale of noncompliant foods.
Allergic food ingredients, GM foods.
3. Designate food additives→ Prohibit the use of unlisted additives.
4. Prohibit the sale of newly developed foods.
5. Prohibit the sale of foods for specified health uses
6. Prohibit the sale of harmful foods.
7. Prohibit he sale of meat of diseased animals.
8. Formulate guidelines for inspection and guidance.
9. Formulate inspectiona and guidance plan for imported foods.
10. Establish standards for preventative measures against contamination withharmful substances.

Inspection
Notification

ReportPrefectural and Municipal Governments
1. Formulate inspection and guidance plan for food hygiene.
2. Establish standard for business facilities by business type.
3. Establish standards for management/operation ofbusiness facilities.
4. License businesses.
5. Inspect food related businesses and distributed foods andgive guidance.
6. Revoke business licenses, and prohibit and suspend
business operations.
Application

Meat Inspection
Laboratories(119)

Public HealthCenters

Meat inspection
Meat inspectors(2,662)

Inspect and guidebusinesses(549)*

Food sanitation
inspectors(7,911)

Regional Bureau of Health and Welfare(7)*

BusineslicenseImported foods

Food Sanitation Division
Food sanitation inspectors (42) *Check whether
Specificatios/
standards aremet.

1. Product examination(Examination of foodcolors)
2. Examination order(Cases where hazards

Approval/renewal/change.
Application fees.

1.Approval/renewal

2.Site-inspection
3. Revocation of
approval

may occur)

Registeredlaboratories(78 labs and
100 facilities)*

Approval ofestablishment
Inspection/
guidance(221)

Food sanitation
inspectors (314) *1. Approve the type of foods or facilities.
2. Renewal of approval.
3. Establish standards f6r manufacturing/processing and sanitary control→ Revoke approval in case of noncompliance.
Guidance

Abattoirs

Hygiene inspection forimported foods

HACCP (Hazard Analysis and Critical Control Points) system

ReportingMeatinspetion

Quarantine Stations(31)*

Inspection fees
Inspection

Food related businesses
1. Facilities requiring business licenses, e.g., restaurant businesses (2,637,897).

2. Facilities not requiring business licenses (1,457,358).

“Comprehensive

sanitationcontrolled manufacturing
process” (HACCP) approved
facilities (565)*

Note: The statistics were as of the end of fiscal 2004. The statistics marked with asterks “*“ were as of April 1, 2006.

3.

Relevant statutes
Various laws are responsible for the food safety administrative work: (1) the

Food Safety Basic Law, (2) the Food Sanitation Law, (3) the Confectionery Hygienists
Law, (4) the Abattoir Law, (5) Special Measures Law Concerning Bovine Spongiform
Encephalopathy, (6) the Poultry Slaughtering Business Control and Poultry Inspection
Law, (7) the Rendering Plants Control Law, (8) the Law on Temporary Measures forEnhancing the Control Method of the Food Production Process, and (9) the Health
Promotion Law. This section outlines these laws.
(1)

Food Safety Basic Law(a)Basic principles and purpose
Basic principles―To protect human life and health―To ensure food safety at each stage in the food supply chain―To respond in line with the latest scientific knowledge and international
trends for food safety
PurposeIn consideration of the vital importance to appropriately respond to changes inthe environment surrounding the diet and life style of the public, including
advances in science and technology and the progress of globalization, this law is tocomprehensively promote policies to ensure food safety by establishing basic
principles, clarifying the responsibilities of national and local governments and food
related businesses as well as consumers’ roles, and establishing a basic direction forpolicy formulation in regards to the assurance of food safety.
(b)

Responsibilities and rolesi.

Responsibility of the national government―The national government must comprehensively formulate and implement

policies to ensure food safety.
ii.

Responsibility of local governments―Local governments must, as necessary, formulate and implement policies
with an appropriate sharing of roles with the national government.
iii. Responsibilities of food business operators

― Food business operators must recognize that they are primarily
responsible for ensuring food safety and take necessary measures on a timely basis.
― Food business operators must make efforts to provide precise andadequate information to the consumers.
iv.

Role of consumers―Consumers should deepen their knowledge and understanding about foodsafety, and use the provided opportunities for expressing their opinions.
(c)Ensuring food safety through risk analysisi.

Risk analysis
In principle, policies to ensure food safety must be formulated, revised, andrepealed, based on the following risk analysis approach.
z

Risk assessment― The risk assessment is under the responsibility of the Food Safety

Commission, an administrative agency independent of the agencies that are
responsible for risk management.
―The risk assessment must be based on the latest scientific knowledge.
z

Risk management―Relevant government agencies must establish food safety standards, basedon risk assessment results, taking into account the opinions of interested
parties, such as consumers.
― Relevant government

agencies

must

implement provisionalriskmanagement measures in a prompt and appropriate manner, when necessary
from a preventive viewpoint.
z

Risk communication―Relevant government agencies must publish information on the assuranceof food safety.
―Relevant government agencies must provide interested parties, such as
consumers, with opportunities to express their opinions.
ii. Establishment of an organization responsible for risk assessment (Food
Safety Commission)
The Commission must execute the following responsibilities as anorganization responsible for risk assessment.

―To execute the duties and tasks as the risk assessment organization.
―To formulate basic guidelines for risk analysis and crisis management.
(d)Enhancement of policies to ensure food safety
The Food Safety Basic Law stipulates―Cooperation among administrative agencies.
― Enhancement of scientific investigations and studies as well as the
security of human resources.
―Collection of domestic and international information.
―Appropriate operation of a food labeling system.
―Promotion of food education.
―Consideration of effects on the environment.

<Food Safety Commission >Duties and tasksi.

Risk assessmentz Risk assessment―The Commission must conduct a risk assessment for food safety, using arisk analysis approach.
―The Commission must recommend that related administrative agencies
implement necessary measures for food safety, based on the risk assessment
results.
―Transparency must be ensured in conducting the risk assessment.
―The risk assessment must target all foods. The risk assessment must also
cover biological, chemical, and physical agents in, and conditions of, food withpotential to pose adverse health effects (hazards). Pharmaceutical products
are excluded from the risk assessment because their safety is separately
ensured under other laws.
z

Monitoring―The Commission must monitor whether risk management agencies are

implementing

appropriate

controlmeasuresinaccordance

with

the

recommendations of the Commission. The Commission must establish aframework to directly identify consumers’ opinions.
zComprehensive collection of information―The Commission must comprehensively collect and compile domestic andinternational information on hazards.
ii.

Risk communication―The Commission must exchange necessary information and opinions on
the risk assessment conducted by the Commission with interested parties.
―The Commission must comprehensively manage total risk communication,
including the risk communication conducted by risk management agencies.
―The Commission must establish a framework for communication between
the Commission and other interested parties, including risk management
agencies, consumers, and producers.
(2)

Food Sanitation Law
PurposeThis law aims to prevent the occurrence of health hazards arising from eating

and drinking by implementing regulations and other necessary measures from thestandpoint of public health to ensure food safety, so as to protect the public health.
z

The law is roughly divided two parts: 1) establishment of standards including

specification and standards for food, standards for facilities, standards for
management/operation, and standards for labeling; 2) inspections and guidance
including inspection by national government at import and inspections and guidance by
local and municipal governments for domestic food businesses.
(a)Establishment of standards
Specifications and standards for food
The law stipulates that the Minister of Health, Labour and Welfare may, fromthe standpoint of public health, establish compositional specifications for food andfood additives and standards for the manufacturing, processing, and use of them,after hearing the opinion of the Pharmaceutical Affairs and Food Sanitation Council.
Currently, various specifications and standards are specified in the Ministry of
Health, Labour and Welfare Announcement. Products that do not comply with theestablished specifications and standards are prohibited from being manufactured,
imported, sold, used, or otherwise handled.
The law also stipulates that the Minister may, from the standpoint of publichealth, establish specifications for apparatus and containers/packages intended forsale or for use in business, specifications for their raw ingredients, or standards for
manufacturing methods of these products. Products that do not comply with theestablished specifications and standards are prohibited from being manufactured,
imported, sold, used, or otherwise handled.
Crops containing pesticides and related chemicals without residue standards
will basically be enjoined from domestic distribution after the positive list systemtakes effect (within three years from May 30, 2003 when the law was amended). The
Minister may establish provisional standards as an interim measure, based on use
conditions in Japan and international standards.
Labeling standards
The law stipulates that the Minister may establish labeling standards for food,after hearing the opinion of the Council. Products that do not comply with theestablished standards are enjoined from domestic distribution.
Standards for facilities
Prefectural governors and municipal mayors may establish standards forfacilities of businesses by the type of business that have significant influences ofpublic health such as restaurants. Currently, 34 types of businesses are specified
as targets. These standards cover structure, food handling equipment, water supply,and filth treating. Prefectural governments may license businesses, when theirfacilities meet the established standards. Also, they may revoke the license orsuspend/prohibit the operation when the facilities do not meet these standards.
Standards for management and operation
Prefectural governors establish standards for measures to be taken forbusiness facilities from the viewpoint of public health. These standards cover facility
management, management for food handling equipment, food handling, and healthmanagement of food-handling personnel. Governors may revoke the license orsuspend/prohibit the operation when the facilities do not meet these standards.
(b)

Inspection system
Domestically distributed foods
Health centers (549 centers in total) under each prefectural and municipal

government (127 governments) have food sanitation inspectors (7,911 inspectors intotal) to visit food related facilities (about 4.10 million facilities) to conduct on-site
inspection, in order to see whether the established standards for food and facilities
are met.
Import notification

The law stipulates that persons who wish to import food, food additives,apparatus, or containers/packages intended for sale or use in business must notify
the Minister each time they are imported. A notification is submitted to thequarantine station that has jurisdiction over the port/airport where costumes
clearance is performed.
Examination order and other matter
The law stipulates that the Minister may order a person who import any food,
food additive, apparatus, container, or package that is likely to violate this law, inlight of circumstances in the production area or other circumstances including aprevious violation case, to allow examinations performed by the Minister or aregistered laboratory,* when the Minister determines that such action is necessary
to prevent the occurrence of health hazards.

No person who has received any

examination order must sell or use in business any food or other target product until
it undergoes the examination and such person receives a notice of the examination
result. (Examination order)
At quarantine stations, food sanitation inspectors examine the submitted
notification, give an examination order for products that are suspected to violate thelaw, and systematically monitor other products. Products that are found to violate
the law as a result of examinations are discarded, reshipped, or otherwise treated.
* Registered laboratories: Impartial and independent organizations with testing
ability that are registered with the Minister of Health, Labour and Welfare tocarry out the tests specified in the law, such as examinations by minister’s order.

Guidelines for monitoring and guidance, and monitoring and guidance plan
The Minister has formulated the guidelines for monitoring and guidance,
which show major emphases of food safety monitoring and guidance conducted by
the national and local governments. Based on the guidelines, the Minister annually
prepares and publishes a monitoring and guidance plan for imported foods, as animplementation plan for testing imported foods. The results of tests conducted are
annually published.
Based on these guidelines and plan, the local governments annually prepare
and publish an implementation plan for monitoring and guidance, which is suited to
local circumstances. Also, test results are published.
(c)Administrative dispositions and penalty for violation cases
The Minister or prefectural governors may order persons to dispose of or recall

products, to correct noncompliant conditions of the business facilities, or to reshipthe cargo, or my revoke the license or prohibit all or part of the business when thoseperson violate the law.

Persons who violate the law are punished by penal

servitude of one year to three year, or by a fine of 50,000 to 3 million yen (up to 100
million yen for a corporation).
(3)

Confectionery Hygienists Law
PurposeThe Confectionery Hygienists Law aims to contribute to the improvement andpromotion of public health, through improving the qualifications of persons who engage
in producing confections, by establishing a license for confectionery hygienists.
zConfectionery Hygienists are persons who pass certain tests given by

Prefectural governors, obtain a license, and engage in producing confections.
Standards for the tests are established by the Minister.
z

No person other than a licensed confectionery hygienist may be called aconfectionery hygienist, or a similar name.
(4)

Abattoir Law
PurposeThe Abattoir Law aims to protect the health of the public, by implementing

regulations and other measures necessary in the view of public health, for the purposeof ensuring proper management of slaughterhouses (218 facilities) and processing offood-use livestock.
z

Any person who wishes to establish facilities to slaughter (slaughterhouses) anddress livestock (cattle, horses, swine, sheep, goats) intended for food use must obtain
permission from the prefectural governor or the mayor of the city.
z

No livestock intended for food use must be slaughtered or dressed in any place

other than a slaughterhouse.
z

Livestock inspections are required at the following three stages:— Before being slaughtered or dressed: ante-mortem inspection.
— Before slaughtered livestock is dressed: ante-dressing inspection.
— Before dressed livestock is carried out of the slaughterhouse:post-dressing inspection.
No part of the livestock including meat, viscera, blood, bones, skin may be

carried out of the slaughterhouse before they are inspected.

No person may be provided with the meat or viscera of livestock dressed in anyzplace other than a slaughterhouse, or the meat or viscera carried out without receiving
a post-dressing inspection, with intent to sell for food use.
Inspections are conducted by livestock inspectors (2,629) who are employees ofz

prefectures or cities with health centers.
When prefectural governors and mayors of cities with health centers determine,z

as a result of inspection, that animals are not fit for food use, due to the existence ofdisease, they may prohibit the slaughtering or dressing of the livestock, or may takeother appropriate measures.
(5)

Special Measures Law Concerning Bovine Spongiform Encephalopathy
PurposeThis law aims to establish a system to provide a consistent supply of safe beef by

establishing special measures for preventing the occurrence and spread of bovine
spongiform encephalopathy (BSE), in order to contribute to the protection of publichealth and the wholesome promotion of cattle production, dairy farming, the business ofbeef manufacturing, processing, distribution, and sales, and the restaurant business.
Outline of regulations under the jurisdiction of the Ministry of Health, Labour, andWelfare∗(a)

Formulation of a basic planz If BSE is confirmed or suspected, the Minister of Health, Labour, andWelfare must lay down a basic plan concerning measures to be taken by national
and prefectural governments.
(b)

Inspections, etc. concerning BSE at a slaughterhousez No one may carry the meat, offal, blood, or skin of any cattle of the age

designated by the Ministry of Health, Labour and Welfare Ordinance or older out of
the slaughterhouse before the cattle is tested by the governor of the prefecture
concerned or the mayor of the city with health centers.
z Any person who establishes or manages a slaughterhouse must incinerate∗

The Special Measures Law Concerning Bovine Spongiform Encephalopathy is under thejurisdiction of two ministries: the MHLW and the Ministry of Agriculture, Forestry and
Fisheries.

specific risk materials, such as the brain and spinal cords of cattle, except when they
are approved by the governor of the prefecture concerned or the mayor of the citywith health centers for use in academic studies.
z In a slaughterhouse all cattle must be slaughtered or dressed in a way thatcan protect the dressed carcasses and edible offal from cross-contamination by
specified risk materials.
(6)

Poultry Slaughtering Business Control and Poultry Inspection Law
PurposeThis law aims to protect the health of the public, through the prevention ofhealth hazards arising from any part of poultry, by implementing regulations and othermeasures necessary in the view of public health and by establishing a poultry inspection
system.
z

Any person who wishes to slaughter fowls (chickens, ducks, turkeys, and otherfowls) and remove the feathers and viscera from their carcasses, must obtain
permission for each processing plant from the prefectural governor or the mayor of thecity with health centers or the ward. (about 3,000 plants nationwide)z

No poultry processing business person (hereafter referred to as a “poultry

processor”) may allow another person to operate his processing plan under his own
name.
z

Any poultry processor must appoint and station licensed hygiene managers at

each processing plant to carry out hygiene management.
z

Poultry inspection are required at the following three stages:i.

Before being slaughtered: ante-mortem inspection
Any fowl must undergo inspection by the prefectural governor or otherappropriate person concerned.*ii.

Before the viscera is removed: feather-removal inspection
All carcasses must undergo inspection by the prefectural governor or otherappropriate person concerned*, to check the conditions of their surfaces.
iii. After carcasses are eviscerated: post-evisceration inspection
All removed viscera and eviscerated carcasses must undergo inspection by
the prefectural governor or other appropriate person concerned, to check theconditions of the viscera and the inside walls of the carcasses.

Note: The prefectural governors may allow persons designated by the Minister of
Health, Labour, and Welfare to conduct part or all of the poultry inspections.

z

No carcasses, eviscerated carcasses, meat, or other parts may be carried out ofthe poultry processing plant without passing poultry inspection.
z

No person may be provided with any carcass, eviscerated carcass, meat, or otherparts that were processed outside a processing plant, or with any carcass, eviscerated
carcass, meat, or other parts that were carried out of a processing plant without passing
inspection, with intent to sell for food use.
zWhen prefectural governors determine, as a result of inspection, that any parts

are not fit for food use, due to the existence of disease, or because they were derived
from a diseased fowl, they may prohibit poultry-processing, or may take otherappropriate measures. (2,780 poultry inspectors nationwide)(7)z

Rendering Plants Control Law
The manufacture of leather, glue, fats/oils, fertilizers, feeds, and other products

using parts of livestock (cattle, horses, swine, sheep, and goats) including meat, skin,bones, and organs as ingredients may only be conducted in rendering plants that havereceived a permit from the prefectural governor or other person concerned. (1,025 plants
nationwide)z

The dressing, burying, or incinerating of dead livestock may only be conductedin dead livestock treating sites that have received a permit from the prefectural
governor or other person concerned. (403 sites nationwide)z

Prefectural governors may order supervisors of dead livestock treating sites totake necessary measures, when they determine that structures and/or equipment at thedead livestock treating sites no longer comply with standards specified based on
prefectural regulations, or when supervisors do not take required sanitary measures.
z

When any person raises or impounds a number of animals (cattle, horses, swine,

sheep, goats, dogs, chickens, ducks, and other animals specified by prefectural
regulations) exceeding the number specified by prefectural regulations, in an area
designated by the prefectural governor, the person must obtain a permit from theprefectural governor.
(8)

Law on Temporary Measures for Enhancing the Control Method of the Food
Production ProcessPurposeThis law aims to contribute to the improvement and promotion of public healthand to the sound development of food manufacturing or processing industries, byimplementing measures for enhancing the management of food production process, forthe purpose of preventing health hazards arising from food and ensuring the quality offood in food production process.
z

The Ministry of Health, Labour and Welfare and the Ministry of Agriculture,

Forestry and Fisheries (MAFF) must formulate and publicize a basic policy on theenhancement of the management of food production process.
z

Accrediting organizations (i.e., organizations capable of accrediting food-related

businesses as complying with certain criteria) designated by the MHLW and MAFF may
establish and submit to the both ministries criteria for enhancing the management of
production process, according to types of food, to receive accreditation as to that thesecriteria are appropriate in light of the basic policy.
z

Food manufacturers and processors may formulate and submit to a designatedaccrediting organization a plan to enhance the management of food production for eachmanufacturing or processing facility process, according to types of food, based on the
Ministry of Health, Labour and Welfare Ordinance and the Ministry of Agriculture,
Forestry and Fisheries Ordinance, to receive accreditation as to that the plan complies
with the accredited criteria.
z

Accredited manufacturers and processors may receive a long-term, low-interest

loan necessary for enhancing the management of production process, and may obtain
preferential taxation.
(9)

Health Promotion Law
PurposeIn light of the growing importance of the promotion of the health of the public in

the wake of the rapid advance in aging and changes in the modes of diseases in Japan,
this law aims to promote public wellness, through specifying basic points concerning thecomprehensive promotion of the health of the public and to implement nutrition
improvement programs and other measures necessary for promoting the health of the
public.
Regulations under the jurisdiction of the Department of Food Safetyz

Any person who wishes to label a food intended for sale with the statement to

the effect that it is intended for certain special uses is required to obtain permission
from the Minister. Foods intended for special uses are called foods for special dietary
uses.

These special uses include those for infants, young children, pregnant women,

and ill people. This statement also includes the effect that the food enables a person who
consumes it for a certain health purpose to achieve that purpose through its
consumption. Foods required to bear such a statement are called foods for specified
health uses. For more information, see the explanation under the heading of “Foods for
special dietary uses” in Section 13.
z

When the Minister or the prefectural mayor concerned determines that action isnecessary, the Minister or mayor may require the officials concerned to visit
manufacturing facilities, storage facilities, or marketing facilities for foods for special
dietary uses, inspect foods, and collect samples of it within the quantity necessary for
conducting tests.
z

Any person who wishes to label a food intended for sale with nutrients orcalories or any person who wishes to import a food bearing nutrition labeling for
distribution in Japan is required to label the food with necessary information based on
the nutrition labeling standards established by the Minister.

4.

Specifications and Standards for food, food additives, apparatus,
containers/packages, etc.

(1)

Specifications and standards for food
The distribution of food in the domestic market is regulated by establishingspecifications and standards. There are two categories for specifications and standards.
One is those that apply generally to all foods; the other is those that apply specifically toindividual foods. Currently, specifications or standards are established for about 30
individual food groups including nonalcoholic beverages, meat, and fish and shellfish.
Individual specifications are established for heavy metals, microbial counts, andchemicals.
The Food Sanitation Law treats pesticides and veterinary drugs remaining infood as food components. Specifications for these components are established forindividual substances on individual foods. There are seven target food groups forpesticide residues, including cereal grains, legumes and pulses, fruits, vegetables, nuts,
tea leaves, and hops; four for veterinary drugs including meat and whale meat, fowl
eggs, fish and shellfish, and oysters for raw consumption.
Standards include those for manufacturing, processing, preparing, andpreserving.
(a)Pesticide residues
On May 29, 2006, Japan introduced a positive list system for agriculturalchemicals (pesticides, veterinary drugs, and feed additives) based on the May 2003
amendment of the Food Sanitation Law. Under the positive list system, any foodthat contains a pesticide without residue standards is basically enjoined fromdomestic distribution. Pesticides, however, may remain in foods as long as residue
levels are below a certain level that is determined to pose no adverse health effects.
In step with the amendment of the law, related laws have been modified. This
has enabled the Ministry of Health, Labour and Welfare to establish MRLs forpesticides at the time of registration by the Ministry of Agriculture, Forestry and
Fisheries.
An outline of the establishment of MRLs is given below. First, the acceptabledaily intake (ADI) 1 is determined by multiplying the non-effect adverse effect level(NOAEL), 2 obtained from various toxicity studies using animals, by safety factors. 3
Then, MRLs are allocated to individual foods so that the theoretical maximum daily
intake (TMDI) cannot exceed the ADI.
Japan conducts a few types of surveys from the viewpoint of food inspectionand establish of MRLs. The surveys include residue surveys and diet studies. The
former are to determine the quantity of residues in individual foods distributed inthe domestic market, and the latter are to estimate the intake of residues derived
from the diet. Survey results are published each time.
Notes:
1. ADI (Acceptable Daily Intake)An estimate of the amount of a pesticide, expressed on a body weight basis, thatcan be ingested daily over lifetime without appreciable health risk.
2. No-Observed-Adverse-Effect Level (NOAEL)The highest dose of a substance that does not cause any detectable toxic effects inexperimental animals.
3. Safety factor
A factor is obtained, considering inter-species variability in between experimental
animals, intra-species variability between humans, and other conditions.

(b)

Veterinary drugs
In Japan, veterinary drugs that remain in foods are regulated under the law inthe same manner as for pesticides. Veterinary drugs include chemically synthesized
antimicrobials, antibiotics, and anthelminthics. Target animals range from livestock(such as cows and pigs) and poultry to fish/shellfish. Once residue standards (MRLs)
are established under the law, food products that contain these drugs at levels
exceeding the MRLs are enjoined from domestic distribution. MRLs are established
for individual substances on individual parts of target animals, such as muscle andliver.
The Japanese Government had once prohibited the sale of food that includes
antibiotics as a health hazard arising from the consumption of food (1957–1995).
However, capable methods have been developed along with advances in scientifictechnology in recent years. This enabled the setting of standards of low levels thatare unlikely to pose any adverse effects on humans even if the substance isconsumed. In December 1995, Japan established first MRLs for veterinary drugs(six including oxytetracycline).
Based on the amendment of the law, the positive list system applies toveterinary drugs and feed additives as well as to pesticides.
(2)

Specifications and standards for food additives
The law defines food additives as 1) substances that are used in the course of

manufacturing food, or 2) substances that are used for the purposes of processing orpreserving food. Food additives include both substances that will remain in finishedproducts and substances that will not remain. The former include food colors andpreservatives, and the latter include infiltration aids, which are removed before thecompletion of products.
No food additive is permitted for use if it is not designated by the Minister ofHealth, Labour and Welfare.

However, the two types of food additives are exemptedfrom the designation by the Minister and may be used unless there are any problems
with safety. They are substances appearing in the List of Existing Food Additives (i.e.,
substances that were already marketed or used on the date of the 1995 amendment of
the law and appear in the List of Existing Food Additives), and natural flavoring agents.
As of the end of July 2006, there were 360 designated food additives and 450 existingfood additives.
A food additive is designated, normally based on an application made by aperson who wishes to use it. After receiving an application, the Minister will ask the
Food Safety Commission for opinions concerning health effects of the food additives.
The Commission will conduct a scientific health risk assessment and establish the ADI.
The MHLW will conduct risk management. It will have the Pharmaceutical Affairs andFood Sanitation Council discuss the adequacy of draft standards for the substance. In
the discussion by the Council, the international evaluation as well as other countries’
standards and specifications will be taken into account. Based on the Commission’s
recommendation and the Council’s report, the MHLW will designate the substance as
an approved food additive when the substance is proven safe and effective
Separately from the designation process mentioned above, the MHLW evaluatescertain food additives for the purpose of designating them without any application frombusinesses. Target food additives must meet the standards given below. Currently, 46
substances and some flavoring agents fall under these target additives. The MHLW is
examining substances for which the full documents on safety and usefulness areprepared.
Standards
Substances:¾

for which a safety assessment has been finished by the JECFA (Joint

FAO/WHO Expert Committee on Food Additives) and whose safety has been
confirmed within a certain level and¾that are widely used in the United States and EU countries and whosenecessity is considered to be high.
The MHLW reviews the safety of food additives along with advances in scientifictechnology. It is working to confirm the safety of existing food additives as well. The
2003 amendment of the law enabled the MHLW to prohibit the use of existing foodadditives by deleting them out of the list if their safety is doubtful or they are no longer
in use. In February 2004, based on the amended law, the MHLW published a list of 38
existing food additives, which are no longer in use. In July the MHLW delisted maddercolor—a coloring agent obtained from plant roots—and prohibited its use in food. Thisurgent action stemmed from the interim report of a carcinogenicity study that foundmadder color to be carcinogenic to the rat kidney. The MHLW based its decision on
discussions by the Commission and the Pharmaceutical Affairs and Commission. The
abovementioned 38 substances were delisted in December to prohibit their use.
(3)

Specifications and standards for apparatus, containers/packages, etc.
The law applies to apparatus, containers/packages for food, toys, and detergents

as well as food.
(a)Apparatus, containers/packages
There are three types of specifications for apparatus, and containers/packages:

those applying generally to all products (hereinafter referred to as general
specifications), those by material categories, and those by use categories. General
specifications are established for metals, such as lead, iron, and aluminum, and forchemically synthesized coloring agents. Material categories total seven: glass,ceramic, enamel, synthesized resin, rubber, and metal cans. Use categories total
five: containers for foods that are packed into containers and pasteurized underpressure, containers for nonalcoholic beverages, food-vending machines andcontainers that accompany a vending machine and with which the food is sold,apparatus for foods that are used for manufacturing edible ices, and apparatus orcontainers that are used for delivery of concentrates of nonalcoholic beverages for
cup-unit vending machines or full-automatic nonalcoholic-beverage preparing
machines.
The current standards are established for manufacturing.
(b)

Toys and detergentsThe law also applies to toys that are designated by the Minister as those thatcan pose health hazards to young children through direct contact with the mouth.
Young children normally refer to those of preschool age. For toys, there are
specifications for materials and standards for manufacturing.
The law also covers detergents used to wash food (vegetables and fruits only)and eating utensil. Specifications are established for arsenic, heavy metals,
methanol, and standards are established for use.
Note: For detailed descriptions about specifications and standards for food, foodadditives, apparatus, containersp/ackages, etc., consult Part II Establishment ofSpecifications and Standards Based on the Food Sanitation Law. For individual
specifications and standards, consult the publication by JETRO, Specifications andStandards for Foods, Food Additives, etc. under the Food Sanitation Law (Abstract).

(4)

Harmful chemicals in food with provisionary regulatory limits and othersubstances
Food may contain various chemicals in addition to normal food ingredients, andthese chemicals are divided into two groups. One group includes food additives,
pesticide residues, and veterinary drugs. The other includes mycotoxins, environmental
contaminants, such as dioxin and PCB, and endocrine disrupting chemicals.

The

former chemicals (food additives, pesticide residues, and veterinary drugs) remain infood as a result of the intentional application or use in producing or processing foods(including crops and livestock) and are already explained in the above section. Thissection outlines environmental contaminants, natural toxins, and endocrine disrupting
chemicals.
(a)Environmental contaminants
Environmental contaminants are derived from the living environment.

Environmental contaminants in food include dioxins, PCB (polychlorinatedbiphenyl), and heavy metals such as mercury and cadmium.
There is a need to identify the consumption of those contaminants derived
from normal foods and the degree of contamination of distributed foods.
Currently, provisional regulatory limits (maximum tolerable limits) areestablished for the following combinations of food groups and contaminants: PCB ingeneral foods, mercury in fish and shellfish, organochlorine pesticides in milk,
dieldrin in hard-shelled mussels, pesticides in meat. Also, Japan is conducting total
diet studies for environmental contaminants to identify the consumption of thesesubstances.
Reference: Reference Documents related to Food Safety and Inspection
1.

Provisional regulatory limits for environmental contaminants andnatural toxins2.
(b)Total daily intake of dioxins from foods in Japan (1999 to 2004)

Natural toxins
There are a few types of natural toxins derived from food. One type isaflatoxins, carcinogenic substances, which are produced by certain types of molds.
They are found in certain foods (such as peanuts, other nuts, and spices) cultivatedin tropical or subtropical areas.

If aflatoxins are detected in such foods at the timeof import (the detection limit is 10 ppb as aflatoxin B1), they are enjoined fromimport and domestic distribution.
Another type of natural toxins is marine toxins in seafood, which become aconcern. They include globefish poison (tetrodotoxin), shellfish poison, and ciguatera
poison. Seafood is regulated by various standards.

For globefish intended for food, the following are specified: sea areas where
fishing is permitted, types of globefish permitted for consumption, and edible parts.
Also, globefish-preparation establishments must have a licensed person, who cansurely remove toxic parts from globefish, and obtain certification from theprefectural governor.
For shellfish poison, regulative limits are established for paralytic shellfish
poison and diarrheal shellfish poison. If products contain poison at a level exceeding
the corresponding limit, their collection is banned on the sea areas where they grow.
Imported shellfish are inspected at import if necessary.
Certain types of fish containing ciguatera poison are enjoined from import andsale.

Please see the appendix for provisional regulatory limits for natural toxins.
Reference: Reference Documents related to Food Safety and Inspection
1.

Provisional regulatory limits for environmental contaminants andnatural toxins(c)Endocrine disrupting chemicals
In recent years, there has been an emerging concern that chemicals derived

from our living environment may disrupt endocrine functions and have adverse
effects on human health. These are called endocrine disrupting chemicals.
There have been various scientific discussions in the world on how to define
the endocrine disrupting chemicals, because interactions between chemicals and theendocrine system are not clear.

Currently, the IPCS (International Programme on

Chemical Safety) under the WHO defines as the following:“An endocrine disruptor is an exogenous substance or mixture that alerts
function(s) of the endocrine system and causes adverse health effects in an intact
organism, or its progeny, or (sub)populations.”
There are many problems that remain to be resolved scientifically, including
the presence or absence, type, and degree of disrupting effects. There are many
types of chemicals that are considered to possibly have such functions. They include
pesticide residues, plasticizers in plastic containers, and surfactants in detergents.
Therefore, the MHLW is comprehensively addressing this issue in cooperation
with related agencies and foreign countries. For example, the MHLW participatesin a program conducted by the OECD (Organization of Economic Cooperation andDevelopment). This program is designed to develop screening methods using
mammals, in order to develop detection methods for such chemicals and standardize
methods for risk assessments.

5.

Safety assurance of livestock and poultry meat
The Abattoir Law states that no cattle, horses, swine, sheep, or goats(hereinafter referred to as livestock) intended for food use may be slaughtered or
dressed in any place other than a slaughterhouse. Any livestock must undergo
inspection by meat inspectors from the local government concerned in a slaughterhouse
before it is slaughtered or dressed.
Meat inspection begins with an ante-mortem inspection. Livestock will bepermitted to be slaughtered if it passes this inspection. Then, it undergoes anante-dressing inspection and is permitted to be dressed if it passes this inspection.
Furthermore, it undergoes a post-dressing inspection to check the viscera and dressedcarcass. After passing the full meat inspection, the livestock is permitted for food use.
Necessary measures are taken for diseased animals (diseases include those that may
infect humans), such as prohibition of slaughtering and dressing, and the disposal of allor any portion (including meat and viscera). Also, appropriate measures are taken for
discarded animals and parts, in order not to be used as food.
Meat inspectors are local government employees who are licensed as
veterinarians. Meat inspection is based on veterinary science, including macroscopic
examination, palpation, and necropsy. If there are suspicious findings, detailed
examinationsareconducted

bacteriologicallyandhistopathogenicallytocomprehensively determine the presence or absence of any disease.
Persons who wish to slaughter chickens, ducks, turkeys, and other fowls(hereinafter referred to as poultry) and remove the feathers and viscera from theircarcasses under the Poultry Slaughtering Business Control and Poultry Inspection Law
must obtain permission from the prefectural governor or the mayor of the city or ward.
Poultry processing plants must meet structures and facilities standards and hygiene
management standards.
Poultry processors may distribute products for food use only after these products
pass disease examinations conducted by the corresponding Prefectural Governors(conducted by licensed poultry inspectors). Disease examinations are conducted before
and after slaughtering (after feather-removal and viscera-removal). If a fowl is infectedby a disease that also can infect humans or if a fowl has abnormal conditions, all of thefowl or abnormal parts are removed.
Reference: Reference Documents related to Food Safety and Inspection
3.

Statistical overview of livestock and poultry meat inspection

6.

Safety Measures for BSE(1)What is Bovine Spongiform Encephalopathy?
Bovine Spongiform Encephalopathy (hereinafter referred to as BSE) is one of agroup of diseases known as Transmissible Spongiform Encephalopathies (TSE’s),
associated with a transmissible agent—an agent that transmits disease—that is yet tobe fully identified.
(2)

Measures taken for imported foodSince 1996, an increasing number of test results have suggested that vCJD may

be associated with BSE infection. To date, however, there has been no data directly
demonstrating BSE infectivity to humans.
As a preventive measure, after March of 1996, the Japanese Government began
recommending that related businesses should refrain from importing beef, bovine offal,
and their products produced in the United Kingdom, a high-incidence country, where
preventive measures for the spread of BSE might not have been fully implemented. Also,
Japan carefully handles even meat imported from countries with a low incidence, basedon the decision—parts involving a high risk, such as the brain and spinal cord, should
not be imported, even if these parts are derived from healthy cattle—according to theOIE (Office for Epizootic Diseases) recommendation.
In December 2000, the Ministry of Agriculture, Forestry and Fisheries decided
to suspend the importation of beef and related products from European Union countries
to prevent the spread of the disease into Japan (effective January 1, 2001).

In responseto this decision, the Ministry of Health, Labour and Welfare took action to ensure thatthose concerned knew about the import suspension measure. Also, the MHLW took an
emergency measure, asking related businesses to refrain from importing bovine bone
products from EU countries because these products were not covered by MAFF’s action.
As described above, those administrative measures had been taken on an
emergency basis. However, there were persistent occurrences of BSE in Europe, andpublic concern about food safety increased. In the circumstances, the MHLW has
decided to take legal action under the Food Sanitation Law in step with MAFF’s action
under the Animal Infectious Diseases Control Law, in order to ensure that BSE would
not be brought into Japan. On February 15, 2001, the MHLW amended the ministerial
ordinance under the law, and Japan banned the import of beef, cattle offal, and theirmeat products from countries with the occurrence of BSE (EU countries,1 Israel,
Liechtenstein, Switzerland).
In addition, Japan banned the import of beef from the United state and Canada
at the occurrence of BSE in these countries, based on Article 9 Paragraph 2 of the Food
Sanitation Law. On December 12, 2005, Japan resumed importation from bothcountries, based on a report from the Food Safety Commission after bilateralconsultations between Japan and America and Canada. However, on January 20, 2006
Japan banned US beef again because veal containing the spinal cord arrived into Japan.
Japan is confirming whether the programs to which both countries agreed are being
carried out in an appropriate manner.
Note:
1. The EU countries mentioned in this section are Austria, Belgium, Czech,
Denmark, Finland, France, Germany, Greece, Italy, Ireland, Luxembourg,
Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, The Netherlands, and theUnited Kingdom.
2. For provisions of the Food Sanitation Law that appear in this text, see Annex 8
to Part I.

(3)

Measures taken in JapanThe MHLW has taken necessary action, based on the scientific evidence

obtained since March 1996 when the potential transmittal of BSE to humans was
suggested.
In April 1996, the MHLW amended the Enforcement Regulations under the
Abattoir Law to regulate native-cattle meat. TSE’s were added to the target diseases
covered by meat inspection, and surveillance was conducted by observing clinical signs.
In May 2001, a surveillance system was developed, and screening tests were started tocheck for abnormal prions in animals that showed clinical neurological signs.
In October 2001, the MHLW took several measures because the first
BSE-infected animal in Japan was identified in September 2001. Under the system,
nationwide BSE screening tests targeting all animals intended for food were started,and the removal and incineration of specified parts (skull (except cheek meat andtongue), spinal cord, the end of the intestinum tenue) obtained during meat processing
became mandatory.
The MHLW has judged that measures for BSE should be taken based on
scientific rationality, just like other food safety measures. In October 2004 the MHLW
asked the FSC to conduct risk assessment to dertermine whether the existing national
measures, including screening tests targeting all cattle, should be reviewed based on
the assessment and validation compiled by the FSC in September 2004.

Based on thereport from the Commission, in May 2005 the MHLW specified the target ages fortesting at 21 months or older. The regulation took effect in August.
The MHLW mandates the following treatments for sheep and goats intended forfood. For animals aged 12 months or over, the head (except tongue and cheek meat), thespinal cord, and the placenta must be removed and incinerated. In addition, regardlessof age, the tonsils, the spleen, and the small and large intestines (including lymph
nodes) from all animals must be removed and incinerated. The local governments
conduct BSE screening tests for sheep and goats aged 12 months or over as well as forbeef.
(4)

Special Measures Law Concerning Bovine Spongiform Encephalopathy
The Special Measures Law Concerning Bovine Spongiform Encephalopathy(Law No.70, 2002) was promulgated on June 14, 2002 and went into effect on July 4,
2002.
This law requires MAFF and the MHLW to make a basic plan concerning
measures to be taken by both national and prefectural governments when a BSE case isconfirmed or suspected.

Under the requirement of the law, in July of 2002 a basic plan

was drawn up on the specific matters given below.
z Basic guidelines concerning measures to be taken.
z The period of the plan.
z Matters concerning preventive measures for the spread of BSE.
z Matters concerning the accurate communication of information.
z Matters

concerning

cooperation

betweenrelatedadministrative

organizations and prefectural and municipal organizations.
z Other important matters concerning measures to be taken.
Reference: Reference Documents related to Food Safety and Inspection
4.

BSE Testing in Slaughterhouses—Cumulative table from October 18, 2001 to June 27, 2006

7.

Action taken against food poisoning
Once a food poisoning case occurs in Japan, various steps are taken based on the

Food Sanitation Law. These steps include the investigation of causes, measures toprevent the spread of damage and recurrence, and report to the Ministry of health andWelfare.
First, the doctor who examined a poisoned person must notify the Director of thenearest health center within 24 hours. When receiving the notification or otherwise
knowing the occurrence of a poisoning case, the Director must report in writing to thegovernor of mayor of the prefecture or municipality concerned after investigating thecause. The governor or mayor must then report in writing to the Minister of Health,Labour and Welfare.
In particular, when a serious food poisoning occurs, the corresponding
local/municipal government must promptly notify the Minister by appropriate ways
such as telephone and facsimile to prevent further spread.
The reported information is analyzed by the Pharmaceutical Affairs and Food
Sanitation Council every year, and appropriate preventive measures are taken.
In recent four years, 1,850 food poisoning incidents were reported in 2002, 1,584
in 2003, 1,666 in 2004, and 1,545 in 2005.
In response to the reports, the MHLW carried out investigations to identify thecause and took several measures to prevent further spread. Some activities are being
implemented on a regular basis.
Major measures and activitiesz

Established specifications and standards for meat, eggs, and fish andshellfish for raw consumption.

z

Established guidelines for hygiene management at mass food-preparing
facilities, which have potential to frequently cause food poisoning. Generalinspection is regularly conducted according to the established guidelines.

zPrepared leaflets for household use, showing necessary information, such as
frequently asked questions and answers, to provide consumers withinformation as to how to prevent food poisoning (associated exclusively withenterohaemorrhagic Escherichia coli (O-157), noro-virus, hepatitis E virus,

Campylobacter, Vibrio vulnificus).
z

Established a manual for food poisoning investigations.

zPeriodical investigations of the actual state of contamination of food withpoisoning-causing bacteria.

z

Developed

highly-sensitive

detectingmethodsofillness-causingmicroorganisms, including enterohaemorrhagic Escherichia coli (O-157) andnoro-virus.
z

Preparedandpublicizedamedicaltreatment

manualfor

enterohaemorrhagic Escherichia coli (O-157).

<Food poisoning cases associated with imported foods>
The MHLW has received reports on the incidents of dysentery caused by S.

sonnei from late November 2001 to January 2002. The number of infected people rose tosome 160 in 30 prefectures, mainly in western Japan until January 30, 2002.
An investigation has found that some of the infection cases were associated withoysters for raw consumption that were harvested in Korea. The MHLW determined thatit should take emergency action covering broad areas to ensure food safety for theJapanese people. The MHLW issued an order to ban the import of Korean oysters for
raw consumption on December 28, 2001. Oysters for cooking were excluded from that
action. An outline is given below.
After discussion with the Korean Government, Japan resumed the import of
Korean oysters on January 17, 2003, after Korea established a sanitary management
system. The system includes the strengthening of sanitary management, such as forwater used at the processing plants, and testing for dysentery on all lots of products
intended for Japan. Oysters must be produced by designated plants and test negativefor dysentery.
Reference: Reference Documents related to Food Safety and Inspection
5.

Guidelines for hygienic management at mass catering facilities

6.

Reported incidents of foodborne illness in Japan (1995–2005)

8.

Comprehensive sanitation-controlled manufacturing process(Sanitary control over food based on HACCP)The “Comprehensive sanitation-controlled manufacturing process” is a systemestablished in 1995 when the Ministry of Health, Labour and Welfare partiallyamended the Food Sanitation Law. This is the first legal system for sanitary control
based on the HACCP system.
Under this system, the Minister of Health, Labour and Welfare gives approval toindividual manufacturing or processing facilities, according to food categories, if the
Minister confirms, after document examinations and on-site examinations, thatsanitation/hygiene is controlled appropriately for these food categories.
Based on the 2003 amendment of the law, the MHLW established a system forrenewing approval. The approval must be renewed every three years.
The following food categories are subject to this system:z

Milk (cow’s milk, processed milk, and similar products)zDairy products (including cream, ice cream and similar products, fermented
milk, lactic acid bacterial beverages, milk drinks, and skimmed milk
powder)z

Nonalcoholic beveragesz

Meat products (including ham and sausages)zFish-paste products (including Kamaboko and fish ham/sausages)z

Foods packed into a container/package and pasteurized under pressure(canned foods and retort foods)

In the system, manufacturers or processors establish manufacturing orprocessing methods of the target foods and sanitary-control methods, based on the
HACCP system, and the Minister confirms whether these established methods comply
with the approval standards. The manufacturing or processing methods approved under
the system are considered to meet the standards for manufacturing/processing under
Article 11 Paragraph 1 of the law.
Therefore, the system enables the application of a wide variety of methods tofood production without following the uniform standards, if safety is ensured at theindividual manufacturing processes.
<For reference: The HACCP system>
The HACCP system is quite different from the previous hygiene management
practice, which places importance on inspection of final products. The HACCP system isfocused on preventing the occurrence of hazards and ensuring food safety throughout all
food production process―from its raw state through finished products. Under thesystem, possible hazards on food safety are first predicted and processes to control thesehazards are identified as critical control points.
Manufacturers must prepare an operating plan for sanitary control, based on
the seven principles and 12 tasks for the HACCP system established by the Joint
FAO/WHO Food Standards Programme of Codex Alimentarius Commission.
7 principles and 12 tasks
Task 1. Assemble HACCP teamTask 2. Describe productTask 3. Identify intended use
Task 4. Construct flow diagram
Task 5. On-site confirmation of flow diagram
Task 6. A hazard analysis (Principle 1)
Task 7. Determine critical control points (Principle 2)
Task 8. Establish critical limits for each CCP (Principle 3)
Task 9. Establish a monitoring system for each CCP (Principle 4)
Task 10. Establish corrective actions (principle 5)
Task 11. Establish verification procedures (Principle 6)
Task 12. Establish documentation and record keeping (Principle 7)
Reference: Reference Documents related to Food Safety and Inspection
7.

Approval

statusofthecomprehensive

sanitation-controlled

manufacturing process
8.

Guidance documents for the approval system of the comprehensive
sanitation-controlled manufacturing process

9.

Safety assurance of exported foods(1)

Meat intended for the United States.
When meat products are exported to the United State, the processing

establishments must meet hygiene standards specified by the United States
Department of Agriculture. The Ministry of Health, Labour and Welfare certifies
establishments, based on documents and on-site inspections. Establishments that have
met the standards are certified as “foreign meat establishments.” Target products aretested by inspectors appointed by the MHLW. When the products have passed testing,the MHLW issues a meat health certificate signed by the designated signer, who isappointed from among the appointed inspectors.
The certified establishments must manage the hygiene of their premises, basedon the hygiene management standards and HACCP system. The appointed inspectors
verify whether the hygiene management standards and HACCP standards are met. The
establishments monitor the target products monthly to check for pesticide residues andveterinary drug residues, and they conduct coliform tests regularly and salmonella tests
periodically. In addition, the establishments, on a monthly basis, undergo inspection by
employees of the Regional Bureau of Health and Welfare.
(2)

Seafood intended for the United States
When fish or fishery products are exported to the United States, these products

must be manufactured or processed based on the federal regulations about theapplication of the HACCP, which was specified by the United States Food and Drug
Administration.
The MHLW certifies processing establishments as “certified seafood processors
exporting to the United States,” when they comply with the requirements specified in
the federal regulations. The certification procedures are based on the “Directives forhandling seafood exported to the United States.”
In 1999, the FDA inspected the processing establishments and judged that thecertification system for seafood processors was adequate.
(3)

Seafood intended for the EU countries
When fish or fisheries products are exported to the EU countries, the handlingestablishments of these products must meet hygiene requirements that are legally
established by the EU. The handling establishments include all areas used forprocessing, packing, and storing. The requirements require hygiene management basedon the HACCP system.
Specifically, the MHLW must monitor veterinary medicines in cultured finfish
and shellfish. The MHLW designates sea areas for the production of bivalve molluscs,

and prohibits the production in other areas. The MHLW also must monitor shellfish
toxin at harvest.
Those who wish to export fish or fishery products to the EU must obtaincertification from the MHLW through examinations conducted by both the MHLW andthe local government, based on the directives established by Japan. The directives
include not only hygiene requirements the businesses concerned must observe, but also
the issuance procedure for health certificates.)
Establishments that have passed examinations are certified as “establishments
approved for the export of frozen or processed fish and fishery products to the European
Union.” The MHLW has food sanitation inspectors inspect the approved establishments
regularly and issues a health certificate each time when products are exported.
In August 2005, the EU inspected the Japanese management system for aquatic
products intended for the EU and determined the system to be adequate with minor
problems. In March 2006, the MHLW revised the abovementioned direction, taking
account of the problems the EU pointed out and the latest EU directive, which was
implemented in early 2006.
(4)

Seafood intended for China
The Chinese Government requests that exporting countries’ governments issue

health certificates for fish or fishery products to be imported to China. In response to
the request, Japan issues a certificate for each cargo when target products are proven tomeet the sanitary requirements specified by the Chinese Government. The priorexamination includes document examinations and if necessary on-site examination
conducted by the food sanitation inspectors enrolled in the local governments.
(5)

Foods intended for Malaysia
The Malaysian Government requests that exporting countries’ governments

issue health certificates for meat and seafood products (animal meat and offal, andprawn/shrimp) to be imported to Malaysia. This request became effective on January 1,
2005. In response to the request, Japan will issue a health certificate for each cargo iftarget products are proven to meet sanitary requirements specified by the Malaysian
government, based on examination conducted by local governments.
Reference: Reference Documents related to Food Safety and Inspection
9.

List of foreign meat establishments.

10.

Certification for Japanese seafood exported to the United States andthe EU

10.

Safety assurance of imported foods
The number of imported foods distributed in the domestic market has been

increasing year by year. Currently, it reaches some 60% on a calorie basis. Since theenforcement of the WTO Agreement in 1995, the movement for liberalized international
trade and deregulation of agricultural products has been going forward. On the other
hand, in recent years, Japanese consumers’ food preferences have diversified. Thus, agreater increase in food imports is expected. Such circumstances make the safetyassurance of imported foods a more important duty in food safety administration.
In Japan, both national and local governments are responsible for the healthinspection of imported foods. The national government carries out food inspection atquarantine stations when food products are imported. The local governments do it forimported foods distributed in the domestic market as well as domestically produced
foods. The Ministry of Health, Labour and Welfare places some 300 food sanitation
inspectors at 31 quarantine stations established at ports and airports across Japan as ofApril 2005 (Annexes 1 and 2).
The food sanitation inspectors at the quarantine stations mainly carry out thefollowing duties: Check whether the food products comply with the Food Sanitation Law
when import notifications are submitted to the quarantine stations; conduct monitoring
tests of imported products according to the annual plan in order to identify violation
cases; perform examinations by ministerial order for all products that are likely inviolation of the law.
The MHLW currently has inspection centers (Center for Inspection of Imported
Foods and Infectious Diseases) at two quarantine stations (Yokohama and Kobe) andinspection divisions at six quarantine stations (Narita Airport, Tokyo, Nagoya, Kansai
Airport, Osaka, and Fukuoka) to strengthen the inspection system. The inspection
centers concentrate on high-level analysis mainly of pesticide residues, veterinary drugs,
and genetically modified foods. The inspection divisions conduct tests mainly for foodadditives and microorganisms. The MHLW applies GLP (Good Laboratory Practice) for
examination management of testing laboratories to these inspection centers anddivisions. Application of the GLP aims to maintain international technical levels at
testing laboratories and ensuring the reliability of testing.
In April 2003, the MHLW newly established the Office of Import Food Safety
within the Inspection and Safety Division of the Ministry of Health, Labour and Welfare.
The office assumes exclusive responsibility to ensure the safety of imported foods, suchas the safety of pesticide residues in imported foods.
(1)

Imported food monitoring and guidance plan
The MHLW implements activities to assure imported food safety based on theimported food monitoring and guidance plan. The imported foods monitoring andguidance plan is formulated annually by the Minister of Health, Labour and Welfare
in light of the hygienic situations of producing sites of exporting countries, in order to
conduct inspection and guidance of imported foods efficiently, effectively, and selectively.
Before the plan is formulated, the Minister holds symposia to hear public opinion andexchange information among the national government and consumers.
The monitoring and guidance plan is based on the principle concept that theappropriate actions should be taken at three stages—“in exporting countries,” “atJapan’s ports and airports,” and “at the domestic market.” This is in response to theprovision in the Food Safety Basic Law, stating that in order to ensure food safety, thenational and local governments must take appropriate measures at each stage of thefood supply processes in and outside Japan. The above concept is stipulated in theannual plans, along with specific measures to be taken at each stage.
(a)

Import Inspection system
As already mentioned, the food inspection and guidance at the time of importis under the responsibility of quarantine stations. Specifically, the food sanitation
inspectors check whether the food products comply with the law when importnotifications are submitted to the quarantine stations. They also monitor target
products for necessary parameters and provide guidance according to the degrees oflikelihood of violation of the law, in light of violation records at the time of import orin domestic distribution, and hygiene information in exporting countries.
i.

Comprehensive import prohibition system
This system prohibits the import or sale of all of certain foods produced incertain countries or regions, without conducting prior testing on individual products,
if these foods have frequently violated the law or if they are very likely tocontinuously violate the law in light of management conditions at the producing
sites.
ii.

Examination order and monitoring tests
Examinations of imports are roughly categorized into two groups. One is

examinations conducted by order of the Minister, and the other is monitoring tests.
Examinations by order are based on Article 26 Paragraph 3 of the law, andare conducted for food and other related substances that are suspected of violating
the law, in light of hygiene conditions in the exporting countries and previous
violations. If an examination order is applied to a certain product, that product will
not be permitted to be imported unless it passes the examination each time it isimported. Examinations by order are conducted at laboratories registered with the
MHLW, and examination fees are paid by the importers who receive theexamination orders.
Monitoring tests are aimed at discovering violations for individual foods.
Tests are conducted scientifically and systematically, considering the amountimported and the violation ratio for each food group. When a food is being monitored,
it can be distributed in the Japanese market without waiting for the test results.
This is a major difference from examinations by order. Monitoring tests are based on
the statistic concept. These tests are conducted by quarantine stations in accordancewith the monitoring and guidance plan formulated in light of violation records andimport records according to food groups.
The MHLW annually sets detailed test items for individual foods. The
items include pesticide residues, veterinary drug residues, food additives,
pathogenic microorganisms, mycotoxins, and genetically modified foods. The MHLW
will conduct about 78,000 tests during fiscal 2006. If monitoring shows that
products are in violation of the law, the MHLW will, as appropriate, strengthen
inspections by increasing the frequency of tests and issuing examination orders.
iii. Publication of monitoring and guidance results
The MHLW publishes monitoring and guidance results twice a year in its
interim report (statistics of the April-September period) and its final report(year-long statistics). These reports are available on the MHLW website:
http://www.mhlw.go.jp/english/topics/importedfoods/index.html
iv. OtherszBusiness discontinuance and suspension to importers
The amended Food Sanitation Law authorizes the Minister to discontinue

or suspend the business of importers if they repeatedly import foods in violation of
the law.
z

Introduction of outsourcing
Monitoring tests for imported foods used to be conducted only by nationalorganizations, the Centers for Inspections of Imported Foods and Infectious
Diseases and other quarantine stations. The quarantine stations now outsource
clerical work involved in monitoring tests to impartial and independent registeredlaboratories, which meet certain technical requirements, in response to theincreasing number of food imports.
(b)Enhancement of safety and hygiene measures in exporting countries
The national government takes some actions to enhance safety and hygiene

measures in the exporting countries if violative products are found. If the MHLW

decides to subject certain products to examination by Minister’s order or intensive
monitoring, the MHLW notifies the importers and the exporting countries’embassies in Japan of that decision, including target product names and items to betested. Also, the MHLW asks the exporting countries’ governments to identify thecauses of violations promptly and to establish measures to prevent the recurrence.
In addition, through on-site investigation and bilateral consultations, the
MHLW encourages the exporting countries to enhance their food safety measures,
including the adequate application management of pesticides, veterinary drugs, andfeed additives; the strengthening of inspection system; and the application ofpre-shipment tests. In addition, the MHLW, as appropriate, provides technicalcooperation by dispatching experts.
Chinese frozen spinach is an example. Because Chlorpyrifos, a pesticide, wasfrequently detected in Chinese frozen spinach at levels exceeding the Japanese
residue standard, Japan strongly requested the Chinese Government to temporarily
refrain from exporting frozen spinach to Japan. Through bilateral negotiations,Japan also requested China to introduce a registration system for processors thatmeet the requirements given below and to conduct pre-shipping tests for pesticide
residues. Since Japan confirmed that the preventive measures taken by China were
working well after on-site investigations, it lifted the restriction imposed on China
and resumed the normal importation of frozen spinach from China.
Processors should:—Directly manage spinach firms.
—Use spinach that has been harvested from firms implementing
appropriate pesticide use and management practices.
—Introduce a system to enable the tracing of the spinach used from theharvest to the finished products.
—Conduct voluntary testing for pesticides at the three stages,“ harvest,”“processing,” and “shipping.”(c)Voluntary hygiene management to be conducted by importers
The amended law stipulates that food business operators—including

producers, manufacturers, importers, and distributors—should take responsibility
for necessary measures to assure food safety. The business operators should acquire
the proper knowledge and techniques, assure the safety of raw ingredients, andvoluntarily conduct testing. They also should make and retain records of necessary
information on food safety. The quarantine stations hold seminars and pre-importguidance targeting business operators, to facilitate voluntary hygiene managementby business operators.
The MHLW responds to violative imported foods with strengthenedcooperation with local governments, especially on communication and recall when aviolation is identified.
(2)

Import procedure
When foods and related substances are imported, the following procedure isusually taken based on the law (Annexes 3, 4, and 5).
i.

Import notification: An import notification form is submitted to thequarantine station concerned.
ii. Document examination: The import notification form and other documents
submitted as necessary are subject to prior examination by food sanitation
inspectors in the quarantine station. The documents include a hygiene
certificate, a manufacturing method, the names of food additives used, and theresult of testing. Examination is conducted, mainly based on the inspection
results for the same kind of products that were previously imported. Results oftesting conducted by a designated laboratory in or outside Japan are also
acceptable.
iii. On-site testing: If the document examination has found that on-site testingis needed, necessary tests are conducted at a bonded area.
iv. Laboratory testing: If necessary, additional tests (physical, chemical, or
biological tests) are conducted at the laboratory.
v. Compliance with the law: Products that comply with the law are permitted
for import.
vi. Incompliance with the law: Products are reshipped, destroyed, or otherwise
treated.
Besides these normal procedures, Japan uses several systems for importnotification, in order to speed up and simplify the formalities for import notification.
Following are outlines of these systems.
(a)Import notification through electric information processing system
In February 1996, then MHW introduced a computer-assisted system called

FAINS (Food Automated Import Notification and Inspection System).
This system is aimed at simplifying and expediting import notification, andthe system enables the effective use of various data, such as import history and test
results for imported foods and other substances. The system has enabled the
conduct of proper and efficient tests, based on the degree of possibility that thesubstance violates the law.
In February 1997, the MHLW linked the FAINS to a computer-assisted
operation system for customs clearance called NACCS (Nippon Automated Cargo
Clearance System) (Annex 6). Also, in March 1998 it established an electronictransmission system between Japan and Australia, in order to transmit healthcertificates for meat and meat products specified under the law.
Currently, FAINS is used for about 90% of all notifications.
(b)

Exemption from import notification
Certain types of foods for which there are few problems with safety are

exempted from the submission of an import notification form. Target foods specified
by the Enforcement Ordinances under the Food Sanitation Law (Cabinet Order No.
229) are:Copra, crude alcohol, crude animal and vegetable fats and oils for edible fats
and oils, hops, molasses, raw salt, raw sugar, rapeseeds.
(c)Prior notification system
Importers may submit a notification on or after the seventh day prior to the

expected date of the cargo’s arrival. Notifications should be submitted to thequarantine station that has jurisdiction over the place of customs clearance for the
cargo.
(d)Planned import
When certain types of substances are repeatedly imported, if the importer

submits an import plan for those substances at the initial import and there is no
food hygiene problem, the importers may be exempted from submitting an importnotification form for the planned period of time.
(e)Acceptance of test results from official laboratories in exporting countries
At importing foods, Japan requests importers to submit the results of tests

the importers have voluntarily conducted for compliance of the foods withrequirements (e.g., use standards of food additives) based on the Japanese Food
Sanitation Law. When tests have been performed by an official laboratory for a food,the results are accepted, and its importer is exempted from conducting the tests on
the food. Under this system, official laboratories have to meet certain qualifications,and eligible laboratories are registered with the MHLW (Annex 7).
outlines the system.

The followingQualification
Laboratories must be capable of conducting tests using AOAC methods (those
prepared by the US Association of Official Analytical Chemists) and must be
categorized into either of two groups:
i. Laboratories that are under the direct control of the national or state
government of an exporting country (official laboratories).
ii. Laboratories that are certified or designated by the national or state
government of an exporting country (designated laboratories).
Treatment of test results
Test results from qualified laboratories are treated equally to those fromlaboratories designated by the MHLW.
Exception
If sanitary conditions of the substance may change during transportation andtest results may be affected, these tests are excluded from this system (e.g.,bacteria and mycotoxins).
Pre-certification registration system
When Japan confirms that substances comply with the law prior to their importand registers the manufacturing or processing plants of them, regularinspections for these substances are exempted at import. This system enables
the prevention of the import of substances in violation of the law and theassurance of the safety of imported substances in the course of manufacturing
and processing in the exporting countries. As of April 2006, 76 substances areregistered in 2 countries and 1 region.

11.

Introduction of standards for business management (Good Laboratory
Practice) into food-examination laboratories
In view of food safety and the global expansion of food distribution, it is very

important to conduct testing for food sanitation adequately and swiftly. In 1995, Japandecided to require official laboratories that conduct tests based on the Food Sanitation
Law to observe the Good Laboratory Practice (GLP) in compliance with ISO Guide 25.
The GLP provides standards for work management of testing laboratories
should observe. The GLP aims to secure the reliability of studies and tests. It includes
various duties to achieve the aim, including the preparation of standard operation
procedures, internal and external inspections, and confirmation by the quality
assurance section as to whether required duties, including testing, are adequately
carried out.
In 1997, the ISO Guide 25-based GLP standards were introduced to public
testing facilities (laboratories under the jurisdiction of national or local governments)
and designated laboratories (institutions of public corporations designated by the
Minister of Health, Labour and Welfare).*In 2004, the GLP standards were revised to introduce the ISO/IEC 17025. Inpractice, testing laboratories manage the examination work based on the corresponding
management manuals.
Note: The system for designated laboratories was abolished in February 2004.
Laboratories wishing to conduct examination work based on the law must be
registered with the Minister of Health, Labour and Welfare.

Reference: Reference Documents related to Food Safety and Inspection
11.

Manual on how to manage examinations, etc. at testing laboratories

12.

Foods produced by recombinant DNA technology
Foods produced by recombinant DNA technology refer to those produced using

techniques in which genes that provide useful properties are taken out fromorganisms and inserted into target plants, in order to effectively utilize those properties
or functions of the plants or other organisms that are used as foods. Hereinafter, thesefoods are referred to as GM foods, or genetically modified foods.
(1)

Safety assessment
In recent years R&D of GM foods has been rapidly going forward in many

countries, and new products have appeared in the marketplace. A growing number ofGM foods are likely to distributed in the future. In the circumstances, Japan made thesafety assessment of GM foods mandatory under the Food Sanitation Law on April 1,
2001. This activity is to prohibit the domestic distribution of GM foods that are notproven safe. Currently, Japan prohibits the import and sale of GM foods that do notundergo the safety assessment and their processed products.
The safety assessment is conducted by the Food Safety Commission in the
Cabinet Office in accordance with the standards for safety assessment, which wasestablished by the Commission. The assessment targets individual substances and isconducted for detailed items specified by the above standards. The items include theinduction of allergies, the production of harmful substances, and derivative effects
involved in recombinant DNA technology. As of June 2006, 75 types of foods and 13
types of food additives underwent the safety assessment.
GM foods are also subject to an evaluation by the Ministry of Agriculture,
Forestry and Fisheries. The evaluation includes environmental effects of the cultivationof GM agricultural products and safety as animal foods.
(2)

Monitoring tests at import
Quarantine stations monitor imported GM foods to see whether they have passed

the safety assessment and whether they have followed the import notification process,based on the law. In fiscal 2005, 1,481 cases were tested and all cases were foundnegative.
Home-grown foods are monitored by local governments. As of June in fiscal 2006,
there were five violation cases involving processed foods made of GM potatoes that had
not undergone the safety assessment and one case involving papaya. These foods wererecalled, or otherwise disposed of, based on the law.
Related information on GM foods is available at

http://www.mhlw.go.jp/topics/idenshi/index.html

Reference: Reference Documents related to Food Safety and Inspection
12.

A list of products for which the safety assessment has been completed
by the MHLW (As of February 14, 2006).

13.

The procedure of the safety assessment of foods and food additives
produced by recombinant DNA techniques in Japan.

14.

Standards for the Safety Assessment of Genetically Modified Foods(Seed Plants)

15.

Results of monitoring tests in fiscal 2005.

13.

Foods with health claims and nutrition labeling(1)

Foods with health claims
Foods with health claims refer to foods that comply with the certain

requirements established by the Minister of Health, Labour and Welfare and that arelabeled with certain nutritional or health functions. These foods are categorized into
two, according to differences in purpose and function: foods with nutrient function
claims and foods for specified health uses.
“Foods with nutrient function claims” refers to foods that declare the functions of
nutritional ingredients specified by the Ministry of Health, Labour and Welfare. Such afood may be freely manufactured and distributed without any permission from or
notification to the national government, provided that it meets the establishedstandards and specification.
“Foods for specified health uses” refers to all foods containing health functions
that can have positive effects on human physiological functions. These foods areintended to be consumed for the maintenance or promotion of health or special healthuses by people who wish to control health conditions, including blood pressure or blood
cholesterol. When they are manufactured or distributed, permission by the national
government is required after evaluation for the safety and effectiveness of proposed
health functions based on sound science.
Foods for special dietary uses
Foods for special dietary uses refer to all foods are intended to be consumed bypeople with specific health conditions in dietetic therapy and for the purpose ofmaintaining and improving health.
At present, there are the following five categories for food for special dietary
uses under the Health Promotion Law. The categories are
z Foods for the ill (single foods and packed meals),z Milk powder for pregnant and lactating women,z Formulated milk powder for infants,
z Foods for the aged, andz Foods for specified health uses.
Foods for the ill are divided into the two groups: single foods and packed meals.
Single foods are further divided into the six types—low-calorie foods, low-sodium foods,
low-protein

foods,

no/low-protein

andhigh-calorie

foods,

high-protein

foods,

allergen-removed foods, and lactose-free foods. Packed meals (serving-sized meals
prepared by combining some main and side dishes) are divided into the fourtypes—salt-reduced meals, meals for diabetes, meals for liver diseases, and meals foradult obesity.
There are two types of “foods for the aged”: foods for people with difficulty inmasticating and foods for people with difficulty in both masticating and swallowing.
Foods for specified health uses are regulated in both categories: food with healthclaims categorized in the Enforcement Regulations under the Food Sanitation Law andfood for special dietary uses categorized in the Enforcement Regulations under the
Health Promotion Law.
When the foods mentioned above bear labeling to the effect that it is intended forany of the special uses given above, permission or approval is required from the
Minister (prior approval is also needed when a food is labeled for specified health uses
outside Japan with intent to market inside Japan). These foods must bear the specified
mark to display a permission or approval. Furthermore, they must be labeled withinformation, given below, as prescribed in the Ministerial Ordinance under the Health
Promotion Law.
z Product namez Name and address of manufacturer (in the case of persons other thanmanufacturers, name and business place of the person who obtained thepermission)z Permitted/approved health claim (Annexes 9 and 10)
z Amount of nutrients, calories, and food ingredientsz Use-by date or best-before
In the case of foods for specified health uses, a statement to the effect that it
is a food for specified health use, contents, recommended daily intake,notices on consumption, proportion of the target nutrient to thecorresponding nutrient reference value (NRV) (confined to nutrients with
NRVs for which approval was given as a food for a special use), and a phrase,“Aim a balanced diet with grains, fish or meat, and vegetables.”z Notice about how to consume, prepare, and preservez Specified permission/approval mark(2)

Nutrition labeling
When labeled with calories or nutrients as specified by the Minister, foods otherthan those for specified health uses must comply with the Nutrition Labeling Standards
prescribed under the Health Promotion Law (Annexes 11 and 12). When foods that havebeen labeled abroad are imported, the same standards must be met. The nutrientsconcerned are protein, fat, carbohydrate, minerals (such as sodium and calcium), andvitamins (such as vitamin A and vitamin B1).
The Nutrition Labeling Standards cover nutrients that are specified in the
Ministerial Ordinance for the reason that the deficiency or overintake of these nutrients
may have a negative effect on the maintenance of health, based on the public’s

consumption of these nutrients.

14.

Global cooperation and information disclosure(1)

Global cooperation
As the distribution of food has expanded, cooperation with foreign countries andinternational organizations is indispensable in view of food safety and healthprotection.
Japan has been engaged in activities such as collaborative studies in cooperation withinternational organizations such as the WHO, FAO, OECD, and APEC, and the UnitedStates and EU countries.
Following are outlines of international organizations with which Japan isaffiliated, and their activities in these organizations:
Joint FAO/WHO Codex Codex Alimentarius Commission (CAC)The Joint FAO/WHO Codex Alimentarius Commission was founded in 1962, inorder for the Food and Agricultural Organization and the World Health Organization to
jointly establish international standards for foods that are important for global trade,for the purpose of protecting the health of consumers and ensuring fair practices in thefood trade. Japan has actively cooperated with CAC activities by sending
representatives to general assemblies and various codex committee sessions, since its
affiliation in 1966. The Secretariat of the CAC is placed in Rome, Italy. There were 174
member countries (EC) as of July 2006. The CAC is comprised from 9 general substancecommittees, 11 commodity committees, an ad hoc intergovernmental task forces, and six
regional coordinating committees.
The Codex ad hoc Intergovernmental Task Force on Foods Derived from
Biotechnology was established at the CAC general assembly held in November 1999,
aimed at establishing international standards for the safety assessment of foods derived
from biotechnology (hereafter called “GM foods” referring to genetically modified foods).
Japan was appointed as the presidency holder of the task force.
The task force held four sessions during the period from March 2000 throughMarch 2003, and formulated the following three documents.
¾ Draft Principles of Risk Analysis for Foods Derived from Modern
Biotechnology¾ Draft guideline for Conduct of Food Safety Assessment of Foods Derived from
Recombinant-DNA Plants (including the Draft Annex on the Assessment ofPossible Allergenicity)¾ Draft Guideline for Conduct of Food Safety Assessment of Food Produced
using Recombinant-DNA Microorganisms (including the Draft Annex on theAssessment of Possible Allergenicity.

These guidelines were adopted and approved as Codex standards at the 26th
session of the Codex Alimentarius Commission held in Rome in June 2003. The Codex
ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology
accomplished its mission, and the dissolution was approved at the same session.
However, a proposal for the reestablishment of the task force was made during thesession, since there were still many issues to be discussed concerning foods produced
using biotechnology. Japan was assigned to formulate a protocol for the new project.
The CAC adopted the reestablishment of Codex ad hoc Intergovernmental Task
Force on Foods Derived from Biotechnology at the 27th session in June 2004. Japan isagain assumeing the chairmanship of the new task force. The new task force issupposed to advance its task based on the previous outcome and submit a final report in2009.
Organisation for Economic Cooperation and Development (OECD)The Organization for Economic Cooperation and Development was establishedto promote international economic cooperation. It groups 30 developed industrial
countries including the United States, EU countries, and Japan. Its purposes are 1)
economic growth, 2) aid to developing countries, and 3) free and diversified expansion of
trade.
The OECD aims to deepen common recognition and to coordinate policies made by themember countries.
The OECD has been addressing safety measures of pesticides and otherchemicals, the coordination of regulations, and biotechnology at related committees,
including the Committee for Scientific and Technological Policy, the Environment Policy
Committee, and the Committee for Agriculture..
Issues on biotechnology have been taken up by the Summit Conferences of theGroup of Eight Major Powers.

At the Koln Summit in June 1999, G8 leaders decided

that the OECD should discuss the safety of genetically modified foods and report to the
Okinawa Summit in 2000. The OECD compiled a report in June 2000 and submitted it
to the Okinawa Summit in July. At the Okinawa Summit, the OECD Edinburgh
Conference (OECD New Biotechnology Food and Crops: Science, Safety and Society)held February 2000 was highly evaluated. The G8 leaders agreed to continue to support
discussions held by the Codex ad hoc Intergovernmental Task Force (see the previous
section) on the safety of foods produced using biotechnology. (The Codex commission‘s
responsibility concerning the safety evaluation of foods produced using biotechnology
was in response to the OECD request.)
The safety of foods produced using biotechnology is being discussed at the OECDtask force on the safety of novel foods and animal foods. Japan also cooperates with thetask force as a member country.
World Trade Organization Agreement (WTO agreement)

As the global distribution of food expands, differences in food regulation
between countries have given rise to trade barriers. In the circumstances, the Sanitaryand Phytosanitary Agreement (SPS Agreement) was concluded at the Uruguay Roundof the General Agreement on Tariffs and Trade, specifying respect for international
standards and the assurance of the transparency of measures. The SPS is aimed atminimizing negative effects food hygiene regulations may have on international trade.
Japan ratified the Agreement in 1994. Member countries should coordinate with the
SPS agreement when they establish and review food standards.
Japan proposed at the General Board Meeting in July 1999 that a meeting todiscuss new issues of genetically modified foods should be established under the WTO.
Furthermore, Japan proposed at the third WTO ministerial conference (November 30 –December 3, 1999, in Seattle) that a meeting under the WTO should evaluate safety andreview labeling concerning genetically modified foods. However, the proposal has notbeen finalized, since the ministerial meeting was broken off.
Ministers met in Doha, Qatar, in November 2001(Fourth Ministerial
Conference) and decided to open a new round (the Doha Round) following the Uruguay
Round to strengthen the free global trade system. Members are conducting a new roundof negotiations.
Asia Pacific Economic Cooperation (APEC)The Asia Pacific Economic Cooperation was founded in 1989 to provide an
opportunity to discuss various issues without any binding force, in response to growing
needs for mutual cooperation in the Asian Pacific area. This organization is actively
working with the goal of expanding trade and investment within the region.
Asia-Europe Meeting (ASEM)
The Asia-Europe Meeting was founded in 1996, aimed at strengthening therelationship between Asia and Europe, which has been relatively weak in comparison
with the relationships between Europe and North America and Asia and North America.
The ASEM conducts dialogs and cooperation within the region concerning various areas
not only of economy but also of politics and culture.
(2)

Information disclosure
The promotion of food safety requires the prompt and exact provision ofnecessary information.
Various matters concerning food safety are discussed by the Pharmaceutical
Affairs and Food Sanitation Council, at the request of the Ministry of Health, Labourand Welfare. Meetings are in principle open to the public, and the proceedings (orsummaries) of council sessions and accompanying documents are also publicized on its

web site (http://www.mhlw.go.jp), unless the publication of meetings leads to therestriction of comments by council members, which may badly affect fair and neutral
discussion.
Before the MHLW establishes and revises regulations, it publishes theunderlying concepts and invites comments from the public, based on the Food
Sanitation Law and the Administrative Procedure Act. Also, before the MHLW enforces
a new system, it will notify related industries in advance, and if necessary, will prepare
leaflets to disseminate the information.
The Food Safety Basic Law stipulates that the national and local governments
should exchange information and opinions on health risks with the public and academia(risk communication). In addition, the Food Sanitation Law stipulates that the MHLW
should hear public opinion before it establishes standards, guidelines, and plans, andshould regularly exchange information with the public. In response to these directions,
the MHLW is strengthening the approach to risk communication, by working together
with the Food Safety Commission.

Annexes1.

Map of imported food inspection offices at quarantine stations

2.

List of quarantine stations

3.

Food import system

4.

Procedure for imported food inspection

5.

Import notification form

6.

FAINS/NACCS interface

7.

Number of foreign official laboratories

8.

Excerpts from the Food Sanitation Law (Articles 4 Paragraphs 1, 2, 4 and 5;
Article 6; Article 9 paragraph 2; Articles 10; Article 11 Paragraphs 1, 2, and 3;
Articles 12, 16, and 18; and Article 26 Paragraph 3)

9.

Categories by health use of permitted/approved foods for specific health uses

10. Instances of labeling for permitted/approved foods for specific health uses
11. Outline of regulation on nutrition labeling
12. Nutrition labeling standards

Annex l.

rmported Food lnspection Ofrlces at Quarantine Stantions
Ministrv of Health,Labour and Welfare
As of April l,2006● Quarantine stations that handle import notincations(31 stations)◎ Qarantine stations that have lnspection Division① Center fOr lnspections of lmported Foods and lnttctious Diseases
314 Food Sanitation lmspectors

Ot41ruChitose AirpoH

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KotDc (「ood Sanitation DIv ision)

To町 o(Food Sanittation Divhon)
Tok丁o(2nd FS Division)
Chiba

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roヽo Alrpoi
Kawasaki

IIiroshima
Sakai
Hiroshma
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Fukuoka

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Kagoshma
NagoyaAIIpo点Naha
Naha Aillxjlt

Annex 2.

List of Quarantine Stations
April 1, 2006
No.

Name of Branchand Office)Phone (FAX)

Place of Customs Clearance of Cargo

5-3, Minato-cho Otaru,
Hokkaido, 047-0007

0134-32-4304(0134-25-6069)

Hokkaido Pref. (excluding the area covered by Chitose Airport
Branch)In Chitose Airport, Bibi,
Chitose, Hokkaido, 066-0012

0123-45-7007(0123-45-2357)

Hokkaido Pref. (Chitose Airport only)

3-4-1, Josandori, shiogama,
Miyagi Pref., 985-0011

022-367-8102(022-362-3300)

Aomori Pref., Iwate Pref., Miyagi Pref., (excluding Sendai
Airport), Akita Pref., Yamagata Pref., Fukushima Pref.

Aza Minamihara,
Shimomasuda, Natori-shi,
Miyagi Pref., 989-2401

022-383-1854(022-383-1856)

Miyagi Pref .(Sendai Airport only)

Narita Airport
Quarantine Station

2159, Tennamino, OazaKomaino, Narita, Chiba Pref.,282-8691

0476-32-6741(0476-32-6742)

Chiba Pref. (Narita, Daiei-machi in Katori-gun, Tako-machi in
Katori-gun and Shibayama-machi in Sanbu-gun only)

Tokyo Quarantine
6 Station (1st Food
Sanitation Division)

2-56, Aomi, Kohto-ku, Tokyo,
135 -0064

03-3599-1520(03-5530-2153)

Ibaragi Pref., Tochigi Pref., Gunma Pref., Saitama Pref.,Tokyo Pref., (excluding the area covered by Tokyo Airport
Branch), Yamanashi Pref., Nagano Pref.

Tokyo Quarantine
7 Station (2nd Food
Sanitation Division)

2-1-1, Hamamachi, Funabashi, 047-437-1381
Chiba Pref., 273-0016(047-437-1585)

Chiba Pref. (Noda,Kashiwa, Nagareyama, Matudo, Kamagaya,
Funabashi, Narashino, Urayasu, Ichikawa and Sekiyado andShonan in Higashi Katushika-gun only)1

Name of Station
Otaru Quarantine
Station

Chitose Airport
Branch2

3

Sendai Quarantine
StationSendai Airport
Branch45Address8

Chiba Branch

1-12-2, Chuo Minato, Chuo-Ku, 043-241-6096
Chiba, Chiba Pref., 260-0024(043-241-7281)

Chiba Pref. (excluding the area covered by Narita Airport
Quarantine Station and Tokyo Quarantine Station (2nd Food
Sanitation Division)

9

Tokyo Airport
Branch3-4-4,Haneda Kuko,Ota-ku,
Tokyo, 144-0041

Tokyo Pref. (Tokyo International Airport only)

03-5756-4858(03-5756-4859)

1 / 4 ﾍﾟｰｼﾞ

Annex 2.
No.

Name of Station

10

Name of Branchand Office)Kawasaki Branch

Address

Phone (FAX)

Place of Customs Clearance of Cargo

6-10, Higashi Ogishima,
Kawasaki-ku, Kawasaki,
Kanagawa Pref., 210-0869

044-277-0025(044-288-2499)

Kanagawa Pref. (Kawasaki only)

11

Yokohama
Quarantine Station

1-1, Kaigandori, Naka-ku,
Yokohama, Kanagawa Pref.,231 -0002

045-201-0505(045-212-0640)

Kanagawa Pref. (excluding the area covered by Kawasaki
Branch)12

Niigata Quarantine
Station

1-5-4, Ryugashima, Niigata,
Niigata Pref., 950-0072

025-244-4405(025-241-7404)

Niigata Pref.

13

Nagoya Quarantine
Station

11-1, Tsukiji-cho, Minato-ku,
Nagoya, Aichi Pref., 455-0045

052-661-4133(052-655-1808)

Gifu Pref., Aichi Pref. (excluding the area covered by Nagoya
Airport Branch)

14

Shimizu Branch

9-1, Hinode-cho, Shizuoka,
Shizuoka Pref., 424-0922

0543-52-4540(0543-53-1364)

Shizuoka Pref.

15

Chubu Airport
BranchToyoba, Toyoyama-cho, NishiKasugai-gun, Aichi Pref., 4800202

0568-28-2524(0568-28-5909)

Aichi Pref. (Nagoya Airport only)

16

Yokkaichi Branch

5-1, Chitose-cho, Yokkaichi,
Mie Pref., 510-0051

0593-52-3574(0593-51-7666)

Mie Pref. Wakayama Pref. (Shingu and Higashimuro-gun
only)

4-10-3, Chikko, Minato-ku,
Osaka, 552-0021

06-6571-3523(06-6575-1803)

Toyama Pref., Ishikawa Pref., Fukui Pref., Shiga Pref., Kyouto
Pref., Osaka Pref. (excluding the area covered by Kansai
Airport Quarantine Station), Nara Pref., Wakayama Pref.
(excluding the area covered by Yokkaichi Branch)

Kansai Airport
Quarantine Station

1, Senshu Kuko Minami,
Sennan, Osaka Pref., 549-0021

0724-55-1290(0724-55-1292)

Osaka Pref. (Kansai International Airport only)

Kobe Quarantine
19 Station (1st Food
Sanitation Division)

1-1, Toyahama-cho, Hyogo-ku,
Kobe, Hyogo Pref., 652-0866

078-672-9655(078-672-9662)

Hyogo Pref. (excluding the 2nd Food Sanitation Division),
Okayama Pref., Tokushima Pref., Kagawa Pref.

Osaka Quarantine
17
Station18

2 / 4 ﾍﾟｰｼﾞ

Annex 2.
No.

Name of Station

Name of Branchand Office)Address

Phone (FAX)

Place of Customs Clearance of Cargo

Kobe Quarantine
20 Station (2nd Food
Sanitation Division)

4-16, Koyo-cho, Higashi Nada- 078-857-1671
ku, Kobe, Hyogo Pref., 658-0031 (078-857-1691)

Hyogo Pref. (Higashinada-ku and Nadaku in Kobe only)

Hiroshima
Quarantine Station

3-10-17, Ujinakaigan, Minami082-255-1379
ku, Hiroshima, Hiroshima Pref.,(082-254-4984)
734-0011

Hiroshima Pref. (excluding Hiroshima Airport), Ehime Pref.,Kouchi Pref.

21

22

Sakai Office9-1, Shouwacho, Sakaiminato,
Tottori Pref., 684-0034

0859-42-3517(0859-42-3517)

Tottori Pref., Shimane Pref.

23

Hiroshima Airport
Branch64-31, Aza Hiraiwa, Oaza
Zennyuji, Hongo-cho,
Toyotagun, Hiroshima Pref.,729-0416

0848-86-8017(0848-86-8030)

Hiroshima Pref. (Hiroshima Airport only)

Fukuoka Quarantine
24
Station

25

26

27
28

Moji Branch

1-22, Okihama-cho, Hakata-ku,
092-271-5873
Fukuoka, Fukuoka Pref., 812(092-282-1004)
0031

Fukuoka Pref. (excluding the area covered by Moji Branch andFukuoka Airport Branch), Saga Pref., Nagasaki Pref.
(excluding the area covered by Nagasaki Branch), Kumamoto
Pref., Oita Pref.

1-3-10, Nishikaigan, Moji-ku,
Kitakyushu, Fukuoka Pref.,801-0841

093-321-2611(093-332-4129)

Fukuoka Pref. (Kita-kyushu, Noogata, Iizuka, Tagawa,
Yamada, Yukuhashi, Buzen, Nakama, Onga-gun, Kurate-gun,Kaho-gun, Tagawa-gun, Miyako-gun and Chikujyou-gun only).

0832-66-1402(0832-66-8145)

Yamaguchi Pref.

092-477-0208(092-477-0209)

Fukuoka Pref. (Fukuoka Airport only)

095-878-8623(095-878-8627)

Nagasaki Pref. (excluding Iki City and Tsushima City).

1-7-1, Higashiyanamato-cho,
Shimonoseki Office Shimonoseki, Yamaguchi Pref.,750-0066
739, Oaza-Aoki, Hakataku,
Fukuoka Airport
Fukuoka, Fukuoka Pref., 816Branch
0051
Nagasaki Branch

4-32-5, Tomachi, Nagasaki,
Nagasaki Pref., 850-0952

3 / 4 ﾍﾟｰｼﾞ

Annex 2.
No.

Name of Station

29
30
31

Name of Branchand Office)Kagoshima Branch

Naha Quarantine
StationNaha Airport
BranchAddress

Phone (FAX)

Place of Customs Clearance of Cargo

18-2-31, Izumi-cho, Kagoshima, 099-222-8670
Kagoshima Pref., 892-0822(099-223-5297)

Miyazaki Pref., Kagoshima Pref.

2-11-1, Minato-cho, Naha,
Okinawa Pref., 900-0001

098-868-4519(098-861-4372)

Okinawa Pref. (excluding the area covered by Naha Airport
Branch)174, Aza Kagamizu, Naha,
Okinawa Pref., 901-0142

098-857-0057(098-859-0032)

Okinawa Pref. (Naha Airport only)

4 / 4 ﾍﾟｰｼﾞ

Annex 3.

Food Import System
Foods(All things that people eat or drink, excluding pharmaceuticals and quas-drugs regulatedby the Pharmaceutical Affairs Law).
Food additives
Food processing equipment
Containers and packages
Toys for infants

Raw meat
Meat products, etc.

Fresh fruits
Fresh vegetables, etc.

Animal Quarantine Stations

Plant Quarantine Stations[The Law for the Preventionof Infectious Disease in
Domestic Animals][Plant Quarantine Law]

MHLW Quarantine Stations
Food Sanitation Inspection Sections[Food Sanitation Law]

Customs Offices[Custom Tariff Law]

Health Centers[Food Sanitation Law]
[Health Promotion Law]

Other foods(Processed foods, etc.)

Annex 4.

Procedure of Imported Food Inspection

Quarantine Stations （31 Offices）
Arrival of cargo

Document Inspection

Notification

Examination
by OrderReshipment

Rejected

Monitoring
Tests

PassedFinished

Destruction

Customs clearanceAnnex 5

Import Notification Form
Minister of Health, Labour and Welfare, Esq.
Name and address of importer (Or name of importing corporation and its address)
Notification Receipt
NumberClassification of Notification

*1

Name
Address

Prior Notification / Planned Import(Telephone Number)

Code of Importer

Registration Number ofImporter Responsible
for Food Sanitation

Name and Code ofCountry of Production
Name, Address andCode of Manufacturer
Name, Address andCode of Manufacturing
Factory
Name and Code ofPort of Loading
Name and Code ofPort of Discharge
Name and Code of
Warehouse

Date of Loading_______(Month) _______(Day) _______(Year)

Date of Arrival_______(Month) _______(Day) _______(Year)

Date of Storage_______(Month) _______(Day) _______(Year)

Date of Notification_______(Month) _______(Day) _______(Year)

Marks and Numbers of
Cargo

Accident

Ship Name or Flight
Number of Aircraft

Name and Code ofSubmitter

1

Classification of
Cargo

Brief Explanation (if Yes)

Food / Food Additive /Apparatus /Container-Package/ Toy

Continuous
ImportY•N

Item CodeDescription of Article
Shipped Volume(Number of Units)
Shipped Volume(Weight )Usage and its Code
Kind of Package andits Code
Registration Number 1
Registration Number 2
Registration Number 3

kg

Yes

/

No

Sanitary Certificate
Number
If the cargo includes
processed food,describe its ingredientsand their codes.
If the cargo includes
apparatuses,
container/packages ortoys, describe the raw
materials and theircodes.
If the cargo includes foodwith additives, describe
the names and codes ofadditives.
If the cargo includes
manufacturing agents inthe additives, describe
the names and codes ofadditives.
(Additives used as
flavoring agents are
excluded for either case.)*2*2

If the cargo includes
processed food,describe the method of
manufacturing orprocessing, and its
code.
Remarks

Stamp for Receiving Notification

Notes:*1: Do not write here.
*2: When the article in the cargo includes food additives that are generally supplied in food or drink and regulated by the relevant statutes, describe thenames of the substances used. When the article includes manufacturing agents in the additives, excluding flavoring agents or food additives that are
generally supplied in food or drink, write the names of the agents.

再
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σ 電 露 一宮 く．
・ 中の Ｏ宮 有や卓 電 由電 車 σ 高 く 浸□雨Annex 7.

Number of Foreign Official Laboratories
As of July 1, 2006
Nations and Areas
ARGENTINE REP.
AUSTRALIA
BOLIVARIAN REP. of VENEZUELACANADA
DEM. SOC. REP. of SRI LANKA
FED. REP. of BRAZIL
FED. REP. of GERMANY
FED. REP. of YUGOSLAVIAFRENCH REP.
GRAND DUCHY of LUXEMBOURG
HELLENIC REP.
HONG KONG
INDIA
IRELANDISLAMIC REP. of PAKISTANKINGDOM of BELGIUM
KINGDOM of DENMARKKINGDOM of MOROCCOKINGDOM of NORWAY
KINGDOM of SWEDEN
KINGDOM of THAILAND
KINGDOM of the NETHERLANDSNEW ZEALANDPEOPLE'S REP. of CHINAPORTUGUESE REP.
REP. of AUSTRIA
REP. of BULGARIAREP. of CHILE
REP. of COLOMBIA
REP. OF CROATIA
REP. of CUBA
REP. of CYPRUS
REP. of FINLAND
REP. of GHANA
REP. of GUATEMALA
REP. of HONDURAS
REP. of HUNGARY
REP. of ICELAND
REP. of INDONESIA
REP. of ITALY
REP. of KOREA
REP. of PARAGUAY
REP. of POLAND
REP. of SINGAPORE
REP. of SLOVENIA
REP. of SOUTH AFRICA
REP. of the PHILIPPINES
REP. of TURKEY
ROMANIASLOVAK REP.
SPAIN
SWISS CONFEDERATIONTAIWANTHE CZECH REP.
U. S. A.
UNITED KINGDOMUNITED MEXICAN STATES
Total

57 Nations/Areas

Japanese Name
アルゼンティン共和国
オーストラリアベネズエラ・ボリバル共和国
カナダ
スリ・ランカ民主社会主義共和国
ブラジル連邦共和国
ドイツ連邦共和国
ユーゴースラヴィア連邦共和国
フランス共和国
ルクセンブルグ大公国
ギリシャ共和国
香港
インド
アイルランドパキスタン・イスラム共和国
ベルギー王国
デンマーク王国
モロッコ王国ノールウェー王国
スウェーデン王国
タイ王国
オランダ王国ニュー・ジーランド
中華人民共和国
ポルトガル共和国
オーストリア共和国
ブルガリア共和国
チリ共和国
コロンビア共和国
クロアチア共和国
キューバ共和国
キプロス共和国
フィンランド共和国
ガーナ共和国
グァテマラ共和国
ホンデュラス共和国
ハンガリー共和国
アイスランド共和国
インドネシア共和国
イタリア共和国
大韓民国
パラグアイ共和国
ポーランド共和国
シンガポール共和国
スロヴェニア共和国
南アフリカ共和国
フィリピン共和国
トルコ共和国
ルーマニア
スロヴァキア共和国
スペイン
スイス連邦
台湾
チェッコ共和国
アメリカ合衆国
英国
メキシコ合衆国

Number
3
127
1
48
3
7
831
17
455
5
77
4
18
12
1
82
21
3
107
30
13
27
95
358
51
18
12
48
3
7
2
1
8
1
1
5
22
5
4
290
39
1
92
4
4
1
5
4
1
1
192
28
8
3
78
117
51
3,452

Annex 8.

Excerpts from the Food Sanitation Law
Articles 4 Paragraphs 1, 2, 4, and 5; Article 6; Article 9 Paragraph 2; Article 10; Article 11
Paragraphs 1, 2, and 3; Articles 12, 16, and 18; and Article 26 Paragraph 3
The following provisions are excerpts from the Food Sanitation Law. The full document isaccessible at the website of JETRO.
http://www.jetro.go.jp/en/market/regulations/pdf/food2004nov-e.pdf[Definitions]
Article 4.

In this Law, the term “food” means all foods and drinks, provided, however, that

this term does not include drugs and quasi-drugs prescribed in the Pharmaceutical Affairs
Law.
2.

In this law, the term “food additive” means all substances to be used in or on food, in theprocess of the manufacturing of food or for the purpose of the processing or preserving of food,by adding, mixing, infiltrating, or other means.
4.

In this Law, the term“apparatus”means tableware, kitchen utensils, and machines, implements, and other articles that are used for handling, manufacturing, processing, preparing,storing, transporting, displaying, delivering, or consuming food or food additives and thatcome into direct contact with food or food additives; provided, however, that this term does notinclude machines, implements, and other articles used for collecting food in agriculture andfisheries.
5.

In this Law, the term“container/package”means articles in which foods or food additives

are contained or packaged and in which foods and food additives are offered when such foods
and food additives are delivered.
[Food and Additives Whose Sale is Prohibited]
Article 6. No person shall sell (hereinafter in this Law, the term“sell”includes supplying for
purposes other than sale to the public or a large number of persons), or handle, manufacture,import, process, use, prepare, store, or display with intent to sell any food or additive given
below:(1)Those which are rotten, decomposed, or immature; provided, however, that thisSubparagraph does not apply to articles that are generally deemed not to be injurious tohuman health and are deemed to be fit for human consumption.
(2)

Those which contain or bear toxic or injurious substances or which are suspected tocontain or bear these substances; provided, however, that this provision does not apply to thecases which are prescribed by the Minister of Health, Labour and Welfare as not injurious tohuman health.
(3)

Those which are either contaminated with or suspected to be contaminated withpathogenic microorganisms and which may injure human health.
(4)

Those which may injure human health due to uncleanliness, the admixture or addition of

extraneous substances, or any other causes.
[Prohibition of Sale, etc. of Meat, etc. Derived from Diseased Livestock and Poultry]
Article 9.
2.

No person shall import, with intent to sell as a food, any meat or viscera of livestock orpoultry or any product designated by the Ministerial Ordinance (hereinafter in thisParagraph, the meat, viscera, and products thereof mentioned above are referred to as“livestock meat etc.”) unless it is accompanied with a certificate or a copy thereof issued by agovernmental organization of the exporting country, stating that it is not meat or viscus nor
any of the products derived from livestock or poultry which suffers from or is suspected tosuffer from any of the diseases given in the preceding paragraph, which shows any of theabnormalities given in the preceding paragraph, or which has died of any reason before
slaughtering, and describing other items prescribed by the Ministerial Ordinance (hereinafterin this Paragraph, any statements and necessary items mentioned above are referred to as“sanitation-related information”).
[Prohibition of Sale, etc. of Food Additives, etc.]
Article 10. No person shall sell, or manufacture, import, process, use, store, or display withintent to sell any additive (excluding any natural flavoring agent and any substance that is
generally provided for eating or drinking as a food and which is used as a food additive) or any
preparation or food that contains such additive, unless the Minister of Health, Labour andWelfare designates it as not injurious to human health based upon the opinion of thePharmaceutical Affairs and Food Sanitation Council.
[Establishment of Specifications and Standards for Food or Additives]
Article 11.

The Minister of Health, Labour and Welfare, from the viewpoint of public health,

may establish standards for methods of manufacturing, processing, using, preparing, orpreserving food or additives intended for sale or may establish specifications for components
of food or additives intended for sale, based upon the opinion of the Pharmaceutical Affairs
and Food Sanitation Council.

2.

Where specifications or standards have been established pursuant to the provisions of

the preceding Paragraph, no person shall manufacture, process, use, prepare, or preserve any

food or food additive by a method not complying with the established standards; shall sell or
import any food or food additive manufactured, processed, used, prepared, or preserved by amethod not complying with the established standards; or shall manufacture, import, process,use, prepare, preserve, or sell any food or food additive not complying with the establishedspecifications.

3.

No person shall manufacture, import, process, use, prepare, store with intent to sell, or

sell food that contains pesticides [those designated under the provision of Article 1-2
Paragraph 1 of the Agricultural Chemicals Regulation Law], substances designated under theprovision of Article 2 Paragraph 3 of the Law concerning Safety Assurance and Quality
Improvement of Feed, to be used in feed by adding, mixing, infiltrating, or other means, andingredients of drugs, designated under the Article 2 Paragraph 1 of the Pharmaceutical
Affairs Law for the purpose to be used for animals, above the level established by the Ministerof Health, Labour and Welfare as not injurious to human health based upon the opinion of thePharmaceutical Affairs and Food Sanitation Council; provided, however, that this paragraphdoes not apply to foods for which residue limits have been established as compositional
specifications.

[Request for Cooperation from the Ministry of Agriculture, Forestry and Fisheries]
Article 12.

The Minister of Health, Labour and Welfare may request from the Minister ofAgriculture, Forestry and Fisheries the provision of information concerning components of apesticide and other necessary cooperation, if the Minister determines that such action isnecessary to establish quantitative limitations on ingredients of an agricultural chemical
defined in the Agricultural Chemical Control Law, a feed additive defined in the Feed
Additives Safety Control Law, or a veterinary drug defined in the Pharmaceutical Affairs Law(including a substance produced by a chemical change in the active ingredient), which may
remain in foods, as specifications for food components prescribed in Article 11 Paragraph 1.
[Prohibition of Sale, etc. of Toxic or Injurious Apparatus or Containers/Packages]
Article 16. No person shall sell, manufacture or import with intent to sell, or use in businessany apparatus or container/package which contains or bears toxic or injurious substances andmay injure human health or any apparatus or container/package which may injure humanhealth by having harmful influence on foods and additives through contact therewith.
[Establishment of Specifications and Standards for Apparatus or Containers/Packages]
Article 18.

The Minister of Health, Labour and Welfare, from the viewpoint of public health,based upon the opinion of the Pharmaceutical Affairs and Food Sanitation Council, mayestablish specifications for apparatus, containers/packages, or their raw materials intended
for sale or for use in business, or may establish standards for methods of manufacturingapparatus or containers/packages.
2.

Where specifications or standards have been established pursuant to the provisions of

the preceding Paragraph, no person shall sell, or manufacture or import with intent to sell, or
use in business any apparatus or container/package not complying with the establishedspecifications; shall use any raw material not complying with the established specifications;or shall manufacture any apparatus or container/package by a method not complying with theestablished standards.
[Examination Order]
Article 26.
3.

The Minister of Health, Labor and Welfare may order a person who imports any food,additive, apparatus, or container/package that is suspected to fall under one of the substances
given in each of the Subparagraphs of Paragraph 1, or to fall under any of the foods prescribedin Article 10, in view of circumstances in the producing district and other circumstances, toallow examinations performed by the Minister of Health, Labour and Welfare or a registeredlaboratory, when the Minister of Health, Labour and Welfare determines that such action isnecessary to prevent the occurrence of food health hazards.

Annex 9.

Categories by Health Uses of Permitted/Approved Foods for Specified Health Uses
As of May 30, 2006

Principal ingridients(ingredients exhibiting health functions)No.
of Aproval

Foods to regulate
gastrointestinal conditions

Oligosaccharides, Lactulose, Bifidobacteria, Lactic
acid bacteria, Dietary fiber (Indigestible dextrin,
Polydextrol, Guar gum, Psyllium seed coat, etc.),

255

Foods for those who areconcerned about blood sugar
levelsIndigestible dextrin, Wheat albumin, Guave tea
Polyphenol, L-arabinose, etc.

73

Foods for those with slight
hypertension

Lactotripeptide, Casein dodecapeptide, Tochu leaf
glycoside (Geniposidic acid), Sardine peptide, etc.

68

Foods for those with slight
hypercholesterol

Chitosan, Soybean protein, Degraded sodium
alginate

56

Foods less apt to cause tooth
decay

Paratinose, Maltitose, Erythrytol, etc.

36

Cholesterol plus
gastrointestinal conditions,
Neutral fat plus cholesterol

Degraded Sodium alginate, Dietary fiber frompsyllium seed coats, etc.

33

Foods for those who areconcerned about blood neutral
fat and body fat

Diacyl glycerol, etc.

29

Foods for those concerned
about bone health

Soybean isoflavone, MBP (Milk basic protein), etc.

24

Foods to help absorb minerals

Calcium citrate malate, Casein phosphopeptide,Hem iron, fracuto-oligosaccharide, etc.

9Categories

Total

583

Annex 10.

Instances of Labeling for Permitted/Approved Foods for Specified Health Uses
categories

Health uses

Remarks

Foods to regulate
gastrointestinal conditions

This product adequately increases bifidobacteria in the intestine, andmaintains proper gastrointestinal conditions.

Over consumption may lead to loose bowel movement. May cause
loose bowel movement in those with certain health conditions or
those with certain constitution.

Foods for those who areconcerned about blood sugar
levelsThis product contains indigestible dextrin, dietary fiber, which slows theabsorption of sugars. This is suitable for those who are concerned about
blood sugar levels.

The consumption of this product will not help to cure certain
illnesses. Consult a doctor before use if you have abnormal blood
sugar levels or are being treated for diabetes. Over consumption may
lead to loose bowel movement.

Foods for those with slight
hypertension

This product is suitable for slightly hypertensive people.

This product is not a preventive or curative drug. Persistentconsumption may induce coughing in those with a certain
constitution. Stop using or consult a doctor if you have such
symptoms.

Foods for those with slight
hypercholesterol

This product is made of separated soybean protein and is specially treated sothat the protein, which reduces serum cholesterol, can be easily absorbed.
This is useful for those with slight hypercholesterol in improving the qualityof their diet.

A single high dose will not help to cure certain illnesses or to promotehealth.

Foods less apt to cause toothdecayThis chocolate is less apt to cause tooth decay because it uses paratinose andtea polyphenol, which do not cause tooth decay.

The consumption of this product will not help cure toot decay.

Cholesterol plus
gastrointestinal conditions,
Neutral fat plus cholesterol

This product contains soluble-dietary fiber (degraded sodium alginate), which
restrains the absorption of cholesterol and adjusts gastrointestinal
Over consumption may lead to loose bowel movement. May cause
conditions, and is adequately treated so as to be easy to drink. This is usefulloose bowel movement in those in certain health conditions or thosein improving the quality of diet by supplementing the shortage of dietarywith a certain constitution.
fiber. This is suitable for those with slight hypercholesterol and those whowant to adjust gastrointestinal conditions. Drink it to refresh yourself.

Foods for those who areconcerned about blood neutral
fat and body fat

This oil, composed mainly of diacyl glycerol, tends to restrain not only therise in blood neutral fat after a meal, but also a gain in body fat.

High consumption will not help to cure certain illnesses or topromote health.

Foods for those concerned
about bone healthThis product is suitable for people concerned about bone health, since it
contains soybean isoflavone that helps to maintain bone calcium.

This product is not intended for the cure or prevention of certain
illnesses. High consumption will not help promote health.

This product is suitable for slightly anemic people who need an ironsupplement.

This product is suitable as a food intended for dietary cure for slightanemia, but high consumption will not help to cure illnesses. Prior
consultation with health experts, such as a doctor, pharmacist, andnutritionist, is desirable.

Foods to help absorb minerals

Annex 11.

Outline of Regulation on Nutrition Labeling
The regulation took effect on May 1, 2003, in the wake of partial amendment of the Health Promotion Law.

1. When labeling a food intended for sale with a particular nutrient and calorie level.
e.g., Calcium: 100mg, reduced salt, Vitamin C: equivalent to 100 lemons, low fat.

2. Requirements:

3.

When making a claim about the quantity of a particular nutrient using the tem, “high”

Declare the amount of the particular nutrient plusor ”low,” in the case of sections 3 and 4 below, observe the corresponding standards establishedthe principal nutrients and calorie level of the food.

by the Minister of Health, Labour and Welfare as well as the requirements given in section 2.

A food bearing the claim, “able to supply a particular

4.

A food bearing the claim, “able to restrict calorie level or anutrient,” must include the required level or more of thatparticular nutrient,” must include only the required level or less ofnutrient, according to the standards.

calorie or that nutrient, according to the standards.

e.g.,

e.g.,

Calcium-rich, source of vitamin A.

If a person does not comply with the established standards,
the Minister recommends that the person label the food with
the necessary information. If the person does not follow therecommendation, an order will be issued.

Low-calorie,

low-fat.

When the order is not observed,
Penalty up to 500,000 yen

Annex 12.

Nutrition Labeling Standards
Those who wish to make a claim about energy or a particular nutrient under the Health
Promotion Law must observe the following requirements:
In general
1.

Target items
In all cases, the nutrients given in A through E below must be indicated. If one ormore of the nutrients given in F are claimed, the corresponding nutrients must be
indicated. Indication must be in the order listed below.
A.

Calorie

B.

Protein

C.

Fat

D.

Carbohydrates (or sugars and dietary fibers)

E.

SodiumF.

OthersMinerals: Calcium, Iron, Potassium, Phosphorus, Magnesium, Zinc,
Copper, Manganese, Iodine, Selenium, Chrome.
Vitamins: Vitamin A, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin B12,
Niacin, Vitamin C, Vitamin D, Vitamin E, Vitamin K, Folic acid,
Pantothenic acid, Biotin.

2.

The information must be written in Japanese on its container or package in amanner that is easily readable without opening the container or package.
3.

The amount of each nutrient must be indicated per 100g or 100ml, or per serving,

per package, or per other appropriate unit. The amount must be expressed in thecorresponding unit below.
A.

Calorie: kilocalorie (kcal).

B.

Protein: gram (g).

C.

Fat: gram (g).

D.

Carbohydrates: gram (g).

E.

Minerals
Zinc, Calcium, Iron, Copper, Magnesium, and Sodium: milligram(mg).
If 1,000 mg or more of sodium is indicated, gram (g) can be used.

F. Vitamins
Vitamin A and Vitamin D: microgram (μg) or international unit (IU).
Niacin, Pantothenic acid, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin C,
B

B

and Vitamin E: milligram (mg).
Biotin, Vitamin B12, and Folic acid: microgram (μg).
4.

When the amount of a nutrient is indicated as being a certain level, the actual levelobtained using the specified method must be within the following range:
Calorie, Protein, Fat, Saturated fatty acid, Cholesterol, Carbohydrate, Sugars,
Dietary fiber, and Sodium: ±20%
Vitamin A, Vitamin D, Vitamin E, Calcium, and Iron: －20% to ＋50%
Vitamin B1, Vitamin B2, Vitamin B6, Vitamin B12, Vitamin C, Niacin, Pantothenic
acid, Biotin, and Folic acid: －20% to ＋80%
5.

When the amount is indicated with upper and lower limits, the actual levelobtained using specified method must be within the labeled range.
Claim using the term “high,” “source of,” or “fortified”
Target nutrients: Protein, Dietary fibers, Calcium, Iron, Zinc, Cupper, Magnesium,
Niacin, Pantothenic acid, Biotin, Vitamin A, Vitamin B1,
Vitamin B2, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D,
Vitamin E, and Folic acid.
For the above-mentioned target nutrients:
A. A food bearing the claim “high” or “rich” must contain the given level or moreof the nutrient (see Table 1).
B. A food bearing the claim “source of a nutrient” or “containing a nutrient” must
contain the given level or more of the nutrient (see Table 2).
For the above-mentioned target nutrients, a food bearing the claim that a specificnutrient is fortified to a certain level as compared with the reference food must satisfy
the following requirements:
A. The reference food must be indicated, and
B. The fortified level must be the given level or more (see Table 2).
Claim using the term “non,” “free” or “zero,” or “low” or “reduced”
Target nutrients: Calorie, Fat, Saturated fatty acid, Cholesterol, Sugars(monosaccharides and disaccharides only, except sugar alcohols), and Sodium.
For the target nutrients:

A.

A food bearing the claim “non,” “free,” or “zero” must contain the given level orless of the nutrient (see Table 3).

B.

A food bearing the claim “low” or “light” must contain the given level or less ofthe nutrient (see Table 4).

For the target nutrients, a food bearing the claim that a specific nutrient isreduced by a certain level as compared with the reference food must satisfy thefollowing requirements:
A. The reference food must be indicated, and
B. The reduced level must be the given level or more (see Table 4)
Claim using the expression “reduced-sodium soy sauce”
For soy sauce bearing the claim “reduced sodium,” sodium must be reduced by
20% or more as compared with ordinary products.

Table 1.

Nutrient

Claim using the term, “high” or “rich”

Minimum level

Protein15 g/100 g (solid), 7.5/100ml (liquid), 7.5/100 kcal

Dietary fiber

6 g/100 g (solid), 3 g/100ml (liquid), 3 g/100 kcal

Zinc

2.10 mg/100 g (solid), 1.05 mg/100 ml (liquid), 0.70 mg/100 kcal

Calcium

210 mg/100 g (solid), 105 mg/100 ml (liquid), 70 mg/100 kcal

Iron

2.25 mg/100 g (solid), 1.13 mg/100 ml (liquid), 0.75 mg/100 kcal

Cupper

0.18 mg/100 g (solid), 0.09 mg/100 ml (liquid), 0.06 mg/100 kcal

Magnesium

75 mg/100 g (solid), 38 mg/100 ml (liquid), 25 mg/100 kcal

Niacin

3.3 mg/100 g (solid), 1.7 mg/100 ml (liquid), 1.1 mg/100 kcal

Pantothenic acid1.65 g/100 g (solid), 0.83 g/100 ml (liquid), 0.55 g/100 kcal

Biotin14 μg/100 g (solid), 6.8μg/100ml (liquid), 4.5 μg/100 kcal

Vitamin A

135 μg/100 g (solid), 68 μg/100 ml (liquid), 45 μg/100 kcal

Vitamin B1

0.30 mg/100 g (solid), 0.15 mg/100 ml (liquid), 0.10 mg/100 kcal

Vitamin B2

0.33 mg/100 g (solid), 0.17 mg/100 ml (liquid), 0.11 mg/100 kcal

Vitamin B6

0.30 mg/100g (solid), 0.15 mg/100 ml (liquid), 0.10 mg/100 kcal

Vitamin B120.60 μg/100 g (solid), 0.30 μg/100 ml (liquid), 0.20 μg/100 kcal

Vitamin C

24 mg/100 g (solid), 12 mg/100 ml (liquid), 8 mg/100 kcal

Vitamin D

1.50 μg/100 g (solid), 0.75 μg/100 ml (liquid), 0.50 μg/100 kcal

Vitamin E

2.4 mg/100 g (solid), 1.2 mg/100 ml (liquid), 0.8 mg/100 kcal

Folic acid

60 μg/100 g (solid), 30 μg/100 ml (liquid), 20 μg/100 kcal

Table 2.

Nutrient

Claim using the term, “containing” or “source of,” or “fortified”

Minimum level

Protein

7.5 g/100 g (solid), 3.8 g/100ml (liquid), 3.8 g/100 kcal

Dietary fiber

3 g/100 g (solid), 1.5 g/100 ml (liquid), 1.5 g/100 kcal

Zinc

1.05 mg/100 g (solid), 0.53 mg/100ml (liquid), 035 mg/100 kcal

Calcium

105 mg/100 g (solid), 53 mg/100 ml (liquid), 35 mg/100 kcal

Iron

1.13 mg/100 g (solid), 0.56 mg/100 ml (liquid), 0.38 mg/100 kcal

Cupper

0.09 mg/100 g (solid), 0.05 mg/100 ml (liquid), 0.03 mg/100 kcal

Magnesium

38 mg/100 g (solid), 19 mg/100 ml (liquid), 13 mg/100 kcal

Niacin

1.7 mg/100 g (solid), 0.8 mg/100 ml (liquid), 0.6 mg/100 kcal

Pantothenic acid

0.83 g/100 g (solid), 0.41 g/100 ml (liquid), 0.28 g/100 kcal

Biotin6.8 μg/100 g (solid), 3.4 μg/100 ml (liquid), 2.3 μg/100 kcal

Vitamin A

68 μg/100 g (solid), 34 μg/100 ml (liquid), 23 μg/100 kcal

Vitamin B1

0.15 mg/100 g (solid), 0.08 mg/100 ml (liquid), 0.05 mg/100 kcal

Vitamin B2

0.17 mg/100 g (solid), 0.08 mg/100 ml (liquid), 0.06 mg/100 kcal

Vitamin B6

0.15 mg/100 g (solid), 0.08 mg/100 ml (liquid), 0.05 mg/100 kcal

Vitamin B120.30 μg/100 g (solid), 0.15 μg/100 ml (liquid), 0.1 μg/100 kcal

Vitamin C

12 mg/100g (solid), 6 mg/100ml (liquid), 4 mg/100kcal

Vitamin D

0.75 μg/100 g (solid), 0.38 μg/100 ml (liquid), 0.25 μg/100 kcal

Vitamin E

1.2 mg/100 g (solid), 0.6 mg/100 ml (liquid), 0.4 mg/100 kcal

Folic acid

30 μg/100 g (solid), 15 μg/100 ml (liquid), 10 μg/100 kcal

Table 3.
Item

Claim using the term, “free,” “zero,” or “non”
Maximum level

Energy5 kcal/100 g or 100 ml

Fat

0.5 g/100 g or 100 ml

Saturated fatty acid

0.1 g/100 g or 100 ml

Cholesterol

5 mg/100 g or 100 ml*,
1.5 g saturated fatty acid/100 g (solid) or 0.75 g saturated fatty
acid/100 ml (liquid), andEnergy derived from saturated fatty acid: 10% of the total energy

Sugars

0.5 g/100 g or 100 ml

Sodium5 mg/100 g or 10 0ml

Table 4.

Claim using the term, “low,” “light” or “less,” or “reduced” or “cut off”

Item
EnergyFat

Maximum level (or reduced level)
40 kcal/100 g (solid) or 20 kcal/100 ml (liquid)
3 g/100 g (solid) or 1.5 g/100 ml (liquid)

Saturated fatty acid

1.5 g/100 g (solid) or 0.75 g/100 ml (liquid) and
Energy derived from saturated fatty acid: 10% of the total energy

Cholesterol

20 mg/100 g (solid) or 10 mg/100 ml (liquid)
1.5 g saturated fatty acid/100 g (solid) or 0.75 g saturated fatty
acid/100 ml (liquid), andEnergy derived from saturated fatty acid: 10% of the total energy

Sugars

5 g/100 g (solid) or 2.5 mg/100 ml (liquid)

Sodium

120 mg/100 g or 100 ml

Note: This requirement does not apply to a food for which the single serving size is 15g orless and in which saturated fatty acid accounts for 15% or less of the total fatty acid.