Japan Health Food Regulation QA
Email: tyo4ww@evershinecpa.com
Contact : Andrea Kyu, speak both Japanese and Mandarin
Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan
HLF-JP-10
What are the categories of health food in Japan? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of health food? Website?
Evershine RD：
In Japan, healthy food is regulated by the Food Sanitation Law, the Food Labeling Law, and the Health Promotion Law, and is regulated by the competent authority, the Ministry of Health, Labour and Welfare (MHLW).
There is no legal definition of health food, and it refers to food, other than medicines, that have special effects of maintaining and improving health or that are sold in such a way as to have such effects, and refers to all foods that are expected to have health-care effects.
The Health Promotion Act categorizes healthy foods into three categories:
1. Nutritious functional food: refers to the nutrients that can provide the health of the body, including 13 vitamins (vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, folic acid , niacin, pantothenic acid, biotin), six minerals (zinc, calcium, iron, copper, magnesium, potassium) and n-3 fatty acids, and must meet the relevant benchmarks set by the government.
The functional food logo can be used on product packaging as long as a systematic literature review or clinical trial is submitted 60 days prior to the launch. However, if the claim is found to be false, exaggerated or misleading in the future, it will still be punished in accordance with the law.
2. Functional food: refers to the food that has the basis of scientific literature to show the function, the industry must report to the Japan Consumer Agency before selling, use the terms that can be declared in the Japan Consumer Agency announcement, and meet the nutritional functional food standards. , the license application and notification are not required, but the scientific literature related to safety and function needs to be submitted, and the relevant responsibilities shall be borne by yourself.
3. Specific health food: refers to food containing health-care functional ingredients that can affect physiological functions, including those with specific health-care purposes such as maintaining blood pressure, regulating blood cholesterol, and regulating gastrointestinal function, which must pass strict tests and be reviewed by the Japan Consumer Affairs Agency. Only after obtaining a license can it be sold.
【參考連結】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/hokenkinou/index.html
HLF-JP-20
If a foreign company wants to sell health food in Japan, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
Health food is classified as food, and a business license is required to sell it in accordance with the law.
Foreign companies can apply.
Required documents:
1. Application for business license
．Applicant, zip code, phone number, fax number, email address, company number, date of birth
．Responsible person (if legal person)
．Business Facility Information: Postal Code, Phone Number, Fax Number, Email Address
．Facility name, location, store name or business name
．Name of the food hygiene manager, participation in the prefectural governor’s courses, etc.
．Handles primarily food, additives, utensils/containers and packaging
2. Structure, equipment and facility drawings
3. Qualification certificate of food sanitation manager (when selling food, a food sanitation manager needs to be designated)
．Regularly attend seminars approved by the prefectural governor or prefectural governor, and strive to learn new knowledge about food hygiene.
．Manage hygiene according to the operator’s instructions.
．Take the necessary precautions and try to provide the necessary advice to the operator.
．Up-to-date food hygiene information is essential in order to manage hygiene properly.
．To become a Food Hygiene Manager, one must attend a total of approximately 6 hours of training sessions.
．Persons with the following qualifications can become food hygiene managers without taking courses: cooks, nutritionists, fruit hygienists, ship cooks, hygiene managers under the Slaughterhouse Act, work hygiene managers under the Slaughterhouse Act , Poultry Processing Hygiene Managers, Persons who meet the qualification requirements for Food Hygiene Managers or Food Hygiene Observers.
4. Water quality inspection report (when using water other than tap water, special water, or simple special water)
5. Pay the permit application fee
6. If it is a legal person registration, the legal person number needs to be filled in.
Application process:
Apply to the health center in the jurisdiction of the business office license:
When conducting food business license audits, conduct on-the-spot investigation of the business facility, and test the firmness of the facility and the durability of the equipment.
The validity period is 5 years at the shortest and 8 years at the longest according to the specified audit criteria.
【參考連結】
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/kyokatodokede/youshiki.html#kanri
HLF-JP-25
假如需要辦理，請問日本有專業服務公司可以協助辦理保健食品公司營業許可證？
Evershine RD：
東京のまどか法務行政書士事務所
日佳
HLF-JP-30
If a foreign company wants to sell health food in Japan, can it assign a Japan company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
Health food is classified as food, and a business license is required to sell it in accordance with the law..
Required documents:
1. Application for business license
．Applicant, zip code, phone number, fax number, email address, company number, date of birth
．Responsible person (if legal person)
．Business Facility Information: Postal Code, Phone Number, Fax Number, Email Address
．Facility name, location, store name or business name
．Name of the food hygiene manager, participation in the prefectural governor’s courses, etc.
．Handles primarily food, additives, utensils/containers and packaging
2. Structure, equipment and facility drawings
3. Qualification certificate of food sanitation manager (when selling food, a food sanitation manager needs to be designated)
．Regularly attend seminars approved by the prefectural governor or prefectural governor, and strive to learn new knowledge about food hygiene.
．Manage hygiene according to the operator’s instructions.
．Take the necessary precautions and try to provide the necessary advice to the operator.
．Up-to-date food hygiene information is essential in order to manage hygiene properly.
．To become a Food Hygiene Manager, one must attend a total of approximately 6 hours of training sessions.
．Persons with the following qualifications can become food hygiene managers without taking courses: cooks, nutritionists, fruit hygienists, ship cooks, hygiene managers under the Slaughterhouse Act, work hygiene managers under the Slaughterhouse Act , Poultry Processing Hygiene Managers, Persons who meet the qualification requirements for Food Hygiene Managers or Food Hygiene Observers.
4. Water quality inspection report (when using water other than tap water, special water, or simple special water)
5. Pay the permit application fee
6. If it is a legal person registration, the legal person number needs to be filled in.
Application process:
Apply to the health center in the jurisdiction of the business office
license:
When conducting food business license audits, conduct on-the-spot investigation of the business facility, and test the firmness of the facility and the durability of the equipment.
The validity period is 5 years at the shortest and 8 years at the longest according to the specified audit criteria.
【參考連結】
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/kyokatodokede/youshiki.html#kanri
HLF-JP-35
假如需要辦理指派日本公司擔任營業代理人，請問日本有專業服務公司可以協助？
Evershine RD：
Healthy-food
https://www.healthy-food-gr.jp/index.html
森下
HLF-JP-40
Do foreign companies need to apply for an approval before importing health food sold to Japan?
If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval? In addition to Japanese, which other languages are allowed? Website?
Evershine RD：
Nutritious functional foods are self-certified, and functional foods and specific health foods need to be submitted for application.
Nutritious functional food: It has a self-certification system and does not need to apply for a license separately.
Application procedure for functional indication food (registration and application from portal)
Required information:
1. Basic Information of Registered Food
．Company name, number, person in charge, postal code, address, phone number
．Department in charge, contact window, contact number (extension), email
．Product name, food classification
．Functional component name
．Confirmation of functional ingredients as extracts, safety evaluation method
．Adequate safety confirmed by evaluation of edible performance
．Eating experience was assessed based on available information, confirming adequate safety
．Adequate safety and functional evaluation methods confirmed through safety testing
．Functionality assessed by human testing using the final product
．Functionality is assessed in research review of final product
．Checklists, related materials, business association endorsements
2. Attachment data
．Main target audience of the product
．Basic safety information (safety assessment method)
．Ingestion precautions
．Information about production/manufacturing and quality control
Describe the management system, and if it is a processed food, describe the classification of GMP, HACCP, ISO 22000, FSSC 22000 and whether each manufacturing facility has certification． )
．Functional evaluation method
．Submitter comments on product features
．Eating experience evaluation
．Use existing information for assessment
．Security Test Evaluation
．Evaluate through safety testing (with in vitro and in vivo test reports)
．Evaluation of Interactions with Drugs
．Information about health hazards (e．g． contact person, telephone number, fax, email)
．Scientific evidence
．Human testing of the final product, review of the research on the final product
．Summary of Research on Functional Components
．Expected daily intake
．Storage, ingestion method, and precautions for ingestion
．Precautions for cooking or storage methods
．Accessories for showing samples
．Basic information on food-related businesses
．Manufacturer’s name (factory or processing facility name) and location
．Contact details for Consumer Services (phone number, webpage, etc．)
．Scheduled sales start date etc．
Application procedure for specified health food
1. Submit license application and review application
．Submit a permit application to the health center in the business area． (1 original, 2 copies)
．The prefectural governors, etc．, who have received the permission application, will examine the deficiencies of the permission application and submit the content deemed appropriate to the Minister of Health, Labour and Welfare．
．After submitting the permit application, attach a copy of the permit application, and submit the review application (including attachments) to the Ministry of Health, Labour and Welfare Food Safety Bureau – Food Safety Division Standards Review Division, which can be sent by mail or in person (1 original, 1 copy)
2. Information
．Whole package samples for labels and health claims
．Documents demonstrating clinical and nutritional certification of the product and/or its functional ingredients to maintain health
．Documentation of clinical and nutritional proof of intake of the product and/or its functional ingredients
．Documentation on the safety of the product and its functional ingredients, including additional human studies on eating experience
．Documents about the stability of the product and its functional composition
．Documentation of physical and biological properties of products and functional components
．Qualitative/quantitative analysis and determination methods of its functional ingredients and analysis and determination results of ingredients in products
．Product Specified Nutrients and Calorie Content Analysis Report
．Description of production method, list of plant equipment and description of quality control system
3. Free sample test inspection request
． The applicant should attach a copy of the inspection application form to the product sample, and request the National Institute of Health and Nutrition or a registered testing agency to conduct testing and testing．
． The applicant submits the original test report issued by the agency or a registered testing agency to the Office of New Food Sanitation Measures．
4. The implementing agency of the license test
Special purpose food (including food for specific health use) is licensed by the National Institute of Health and Nutrition in the United States and the following registered testing institutions.
．National Institute of Health and Nutrition
．List of registered testing institutions:
Japan Food Analysis Center
Food Environmental Inspection Association
Food Analysis Development Center SUNTEC
Japanese food inspection
Osaka Institute of Public Health
The labels of health food must comply with the Food Labeling Law, and all food for sale must be marked in Japanese on the container and packaging.
1. The display items of the nutrition and functional food label display:
．Nutrients that show function
Fatty acids (1 type): n-3 fatty acids
Minerals (6): Zinc, Potassium*, Calcium, Iron, Copper, Magnesium
Vitamins (13 types): niacin, pantothenic acid, biotin, vitamin A, vitamin
B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D,
vitamin E, vitamin K, folic acid
(Tablets, capsules do not include potassium for processed foods in the form of preparations)
．Labeling of nutritional functional foods and nutritional ingredients: It is displayed as nutritional functional food (name of nutritional ingredients)
．When multiple nutritional ingredients with set standards are displayed, the order is not fixed．
．Role of nutrition facts: Describe the function specified for each nutritional ingredient, even if the label content is the same, it is not allowed to change or omit the function of the designated nutritional ingredient．
．Estimated daily intake: “Please take ○ grains to ○ grains．” can also be displayed at both ends of the width (within the specified upper and lower limits)．
．Nutrient amounts and calories (Nutrition Facts Label): Displays the nutrient amounts and calories for the Daily Intake Guidelines．
(It needs to be represented by a numerical value obtained by a prescribed method)
．Intake method
．Ingestion precautions
．Phrasing to promote and inspire a balanced diet: It must be marked that eating habits should be based on staple food, main dishes, and side dishes, and a balanced diet
．It must be marked that the product is different from a specific health food and has not been individually reviewed by the Director of the Consumer Affairs Agency
．The percentage of the amount of nutrients and the standard value showing nutrients, etc．
．Words about target age and standard calorific value, such as standard values of nutrients
．Precautions for cooking or storage
．Matters needing attention for specific objects
．Preservation method (Fresh food only)
．For foods whose nutrient content changes significantly due to heating, etc．, it is necessary to show the method within the guaranteed upper and lower limits of cooking． (Fresh food only)
．Even fresh food, if it is to be sold as a nutritious functional food, needs to be packed in a container with the necessary label items attached, and cannot be sold naked
．When the displayable area is about 150 ㎠ or less, characters can be displayed in 5．5 dots or more．
2. Foods that express functionality
Foods with functional claims state on the container, packaging that specific health goals (excluding goals related to reducing disease risk) that help maintain and promote health can be achieved through functionally related ingredients, and must be at least 60 years before the date of sale.
Report the following matters to the Commissioner of the Consumer Affairs Agency.
Notification Items for Food Products with Functional Claims:
．Display content
．Basic information on food-related business
．Security-Based Information
．Feature-Based Information
．Information about production/manufacturing and quality control
．Health Hazard Information Collection System
．Other necessary matters
Items that should be marked on foods with functional claims:
．Food with functional claims
．Functionally relevant ingredients with scientific evidence and the function of the ingredient/food containing the ingredient
．Nutrition facts and calorie amounts
．Content of functional ingredients in daily intake guidelines
．Estimated daily intake
． Notification number
．Contact information for food-related businesses. Food related business name or name, address and contact information (fresh food only)
．Not subject to national assessment of functionality and safety
．Intake method
．Ingestion precautions
．Words to promote and inspire a balanced diet
．Precautions for items that require special attention in cooking or storage methods
．Not suitable for diagnosis, treatment or prevention of disease
Not suitable for ill persons, minors, pregnant women (including those planning pregnancy) and lactating women (processed foods only)
．Those who are ill should consult their doctor, and those taking medication should consult their doctor or pharmacist before taking the medicine.
．If you feel any change in your physical condition, you should stop taking it immediately and consult your doctor.
．Preservation method (only fresh)
．All required display items will be displayed in a size of 8 dots or more, and characters of a size of 5.5 dots or more can be displayed if the displayable area is about 150 ㎠ or less.
．If you want to sell fresh food as a food with a functional claim, you need to put it in a container and packaging that describes the necessary labeling items and notify the Consumer Affairs Department, and cannot be sold naked.
3. Foods for Specified Health Uses
For sale as a food for specified health use, each product must be checked for food effectiveness and safety, and the label must be approved by the Department of Consumer Affairs. Licenses are attached to specific health foods and conditional specific health foods, and specific health foods are divided into four categories.
． Specified health food: Those who take it in their diet for a specific health purpose. Foods that show that they can be consumed for healthful purposes
． Specified Health Foods (Disease Risk Reduction Labels): Disease Risk Reduction Labels are permitted if the ingredients involved have scientific evidence for their disease risk reduction effect and are widely accepted in medicine and nutrition.
． Specified Health Foods (Standard Type): Confirmation on a scientific basis whether the ingredients and criteria in question are adequately documented as a food for specified health uses without the need for a separate review by the Consumer Council.
． Conditional specific health food: Foods that do not meet the level of scientific evidence required for the inspection of specific health food, but whose effectiveness has been confirmed to a certain extent, need to be marked on the label that the scientific evidence is limited.
The label display items required for specific health foods show:
1. It is a food for designated health purpose
2. Content displayed with permission, etc.
3. Amounts and calories of nutrients (including related ingredients)
4. Estimated Daily Intake
5. Intake method
6. Ingestion Precautions
7. Words that promote and inspire a balanced diet
8. If reference values such as nutrients are shown for the components involved, the ratio of the components involved in the daily intake to the reference values such as nutrients.
9. Precautions for items that require special attention in cooking or storage methods
10. All required display items are displayed in 8-dot or larger characters (at least 5.5 dots or more in characters when the displayable area is about 150 cm 2 or less).
Labels:
Foods other than health claim foods shall not use names that are confused with health claim foods, functions of nutritional ingredients, and terms that can expect specific health purposes. (Example) Names of specific health food, specific functional food, health XX food, XX functional food, etc., especially the names containing the words function and health.
URL: https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/hyouji/shokuhyouhou_eiyou.html
https://www.caa.go.jp/policies/policy/food_labeling/#m02
【參考連結】
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/hyouji/shokuhyouhou_eiyou.html
https://www.caa.go.jp/policies/policy/food_labeling/#m02
https://www.caa.go.jp/policies/policy/food_labeling/foods_with_nutrient_function_claims/
HLF-JP-45
請問在日本有哪些專業服務機構，可以協助辦理保健食品產品許可證？
Evershine RD：
Jhnfa
https://www.jhnfa.org/index.html
Credevo
HLF-JP-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge?
What documents are required? What is the application process?
Do health food packaging and labeling require prior approval?
In addition to Japanese, which other languages are allowed? Website?
Evershine RD：
Importers (companies) can apply directlyNutritious functional foods are self-certified, and functional foods and specific health foods need to be submitted for application.
Nutritious functional food: It has a self-certification system and does not need to apply for a license separately.
Application procedure for functional indication food (registration and application from portal)
Required information:
1. Basic Information of Registered Food
．Company name, number, person in charge, postal code, address, phone number
．Department in charge, contact window, contact number (extension), email
．Product name, food classification
．Functional component name
．Confirmation of functional ingredients as extracts, safety evaluation method
．Adequate safety confirmed by evaluation of edible performance
．Eating experience was assessed based on available information, confirming adequate safety
．Adequate safety and functional evaluation methods confirmed through safety testing
．Functionality assessed by human testing using the final product
．Functionality is assessed in research review of final product
．Checklists, related materials, business association endorsements
2. Attachment data
．Main target audience of the product
．Basic safety information (safety assessment method)
．Ingestion precautions
．Information about production/manufacturing and quality control
Describe the management system, and if it is a processed food, describe the classification of GMP, HACCP, ISO 22000, FSSC 22000 and whether each manufacturing facility has certification． )
．Functional evaluation method
．Submitter comments on product features
．Eating experience evaluation
．Use existing information for assessment
．Security Test Evaluation
．Evaluate through safety testing (with in vitro and in vivo test reports)
．Evaluation of Interactions with Drugs
．Information about health hazards (e．g． contact person, telephone number, fax, email)
．Scientific evidence
．Human testing of the final product, review of the research on the final product
．Summary of Research on Functional Components
．Expected daily intake
．Storage, ingestion method, and precautions for ingestion
．Precautions for cooking or storage methods
．Accessories for showing samples
．Basic information on food-related businesses
．Manufacturer’s name (factory or processing facility name) and location
．Contact details for Consumer Services (phone number, webpage, etc．)
．Scheduled sales start date etc．
Application procedure for specified health food
1. Submit license application and review application
．Submit a permit application to the health center in the business area． (1 original, 2 copies)
．The prefectural governors, etc．, who have received the permission application, will examine the deficiencies of the permission application and submit the content deemed appropriate to the Minister of Health, Labour and Welfare．
．After submitting the permit application, attach a copy of the permit application, and submit the review application (including attachments) to the Ministry of Health, Labour and Welfare Food Safety Bureau – Food Safety Division Standards Review Division, which can be sent by mail or in person (1 original, 1 copy)
2. Information
．Whole package samples for labels and health claims
．Documents demonstrating clinical and nutritional certification of the product and/or its functional ingredients to maintain health
．Documentation of clinical and nutritional proof of intake of the product and/or its functional ingredients
．Documentation on the safety of the product and its functional ingredients, including additional human studies on eating experience
．Documents about the stability of the product and its functional composition
．Documentation of physical and biological properties of products and functional components
．Qualitative/quantitative analysis and determination methods of its functional ingredients and analysis and determination results of ingredients in products
．Product Specified Nutrients and Calorie Content Analysis Report
．Description of production method, list of plant equipment and description of quality control system
3. Free sample test inspection request
． The applicant should attach a copy of the inspection application form to the product sample, and request the National Institute of Health and Nutrition or a registered testing agency to conduct testing and testing．
． The applicant submits the original test report issued by the agency or a registered testing agency to the Office of New Food Sanitation Measures．
4. The implementing agency of the license test
Special purpose food (including food for specific health use) is licensed by the National Institute of Health and Nutrition in the United States and the following registered testing institutions.
．National Institute of Health and Nutrition
．List of registered testing institutions:
Japan Food Analysis Center
Food Environmental Inspection Association
Food Analysis Development Center SUNTEC
Japanese food inspection
Osaka Institute of Public Health
The labels of health food must comply with the Food Labeling Law, and all food for sale must be marked in Japanese on the container and packaging.
1. The display items of the nutrition and functional food label display:
．Nutrients that show function
Fatty acids (1 type): n-3 fatty acids
Minerals (6): Zinc, Potassium*, Calcium, Iron, Copper, Magnesium
Vitamins (13 types): niacin, pantothenic acid, biotin, vitamin A, vitamin
B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D,
vitamin E, vitamin K, folic acid
(Tablets, capsules do not include potassium for processed foods in the form of preparations)
．Labeling of nutritional functional foods and nutritional ingredients: It is displayed as nutritional functional food (name of nutritional ingredients)
．When multiple nutritional ingredients with set standards are displayed, the order is not fixed．
．Role of nutrition facts: Describe the function specified for each nutritional ingredient, even if the label content is the same, it is not allowed to change or omit the function of the designated nutritional ingredient．
．Estimated daily intake: “Please take ○ grains to ○ grains．” can also be displayed at both ends of the width (within the specified upper and lower limits)．
．Nutrient amounts and calories (Nutrition Facts Label): Displays the nutrient amounts and calories for the Daily Intake Guidelines． (It needs to be represented by a numerical value obtained by a prescribed method)
．Intake method
．Ingestion precautions
．Phrasing to promote and inspire a balanced diet: It must be marked that eating habits should be based on staple food, main dishes, and side dishes, and a balanced diet
．It must be marked that the product is different from a specific health food and has not been individually reviewed by the Director of the Consumer Affairs Agency
．The percentage of the amount of nutrients and the standard value showing nutrients, etc．
．Words about target age and standard calorific value, such as standard values of nutrients
．Precautions for cooking or storage
．Matters needing attention for specific objects
．Preservation method (Fresh food only)
．For foods whose nutrient content changes significantly due to heating, etc．, it is necessary to show the method within the guaranteed upper and lower limits of cooking． (Fresh food only)
．Even fresh food, if it is to be sold as a nutritious functional food, needs to be packed in a container with the necessary label items attached, and cannot be sold naked
．When the displayable area is about 150 ㎠ or less, characters can be displayed in 5．5 dots or more．
2. Foods that express functionality
Foods with functional claims state on the container, packaging that specific health goals (excluding goals related to reducing disease risk) that help maintain and promote health can be achieved through functionally related ingredients, and must be at least 60 years before the date of sale.
Report the following matters to the Commissioner of the Consumer Affairs Agency.
Notification Items for Food Products with Functional Claims:
．Display content
．Basic information on food-related business
．Security-Based Information
．Feature-Based Information
．Information about production/manufacturing and quality control
．Health Hazard Information Collection System
．Other necessary matters
Items that should be marked on foods with functional claims:
．Food with functional claims
．Functionally relevant ingredients with scientific evidence and the function of the ingredient/food containing the ingredient
．Nutrition facts and calorie amounts
．Content of functional ingredients in daily intake guidelines
．Estimated daily intake
． Notification number
．Contact information for food-related businesses. Food related business name or name, address and contact information (fresh food only)
．Not subject to national assessment of functionality and safety
．Intake method
．Ingestion precautions
．Words to promote and inspire a balanced diet
．Precautions for items that require special attention in cooking or storage methods
．Not suitable for diagnosis, treatment or prevention of disease
Not suitable for ill persons, minors, pregnant women (including those planning pregnancy) and lactating women (processed foods only)
．Those who are ill should consult their doctor, and those taking medication should consult their doctor or pharmacist before taking the medicine.
．If you feel any change in your physical condition, you should stop taking it immediately and consult your doctor.
．Preservation method (only fresh)
．All required display items will be displayed in a size of 8 dots or more, and characters of a size of 5.5 dots or more can be displayed if the displayable area is about 150 ㎠ or less.
．If you want to sell fresh food as a food with a functional claim, you need to put it in a container and packaging that describes the necessary labeling items and notify the Consumer Affairs Department, and cannot be sold naked.
3. Foods for Specified Health Uses
For sale as a food for specified health use, each product must be checked for food effectiveness and safety, and the label must be approved by the Department of Consumer Affairs. Licenses are attached to specific health foods and conditional specific health foods, and specific health foods are divided into four categories.
． Specified health food: Those who take it in their diet for a specific health purpose. Foods that show that they can be consumed for healthful purposes
． Specified Health Foods (Disease Risk Reduction Labels): Disease Risk Reduction Labels are permitted if the ingredients involved have scientific evidence for their disease risk reduction effect and are widely accepted in medicine and nutrition.
． Specified Health Foods (Standard Type): Confirmation on a scientific basis whether the ingredients and criteria in question are adequately documented as a food for specified health uses without the need for a separate review by the Consumer Council.
． Conditional specific health food: Foods that do not meet the level of scientific evidence required for the inspection of specific health food, but whose effectiveness has been confirmed to a certain extent, need to be marked on the label that the scientific evidence is limited. .
The label display items required for specific health foods show:
1. It is a food for designated health purpose
2. Content displayed with permission, etc.
3. Amounts and calories of nutrients (including related ingredients)
4. Estimated Daily Intake
5. Intake method
6. Ingestion Precautions
7. Words that promote and inspire a balanced diet
8. If reference values such as nutrients are shown for the components involved, the ratio of the components involved in the daily intake to the reference values such as nutrients.
9. Precautions for items that require special attention in cooking or storage methods
10. All required display items are displayed in 8-dot or larger characters (at least 5.5 dots or more in characters when the displayable area is about 150 cm 2 or less).
Labels:
Foods other than health claim foods shall not use names that are confused with health claim foods, functions of nutritional ingredients, and terms that can expect specific health purposes.
(Example) Names of specific health food, specific functional food, health XX food, XX functional food, etc., especially the names containing the words function and health.
【參考連結】
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/hyouji/shokuhyouhou_eiyou.html
https://www.caa.go.jp/policies/policy/food_labeling/#m02
https://www.caa.go.jp/policies/policy/food_labeling/foods_with_nutrient_function_claims/
HLF-JP-55
請問在日本有哪些專業服務機構，可以協助以外國公司名義辦理保健食品產品許可證？
Evershine RD：
Jhnfa
https://www.jhnfa.org/index.html
Yakujihou
https://www.yakujihou.com/globalconsulting/
HLF-JP-60
What documents are required when importing approved health food into Japan? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
According to the provisions of the Food Sanitation Law, import declarations must be submitted for food imported for sale or business. When goods arrive in Japan by ship or plane from overseas, they will be detained in the bonded area.
A bonded area is a place where goods imported from a foreign country can be held until customs clearance is completed.
Customs will review and inspect according to regulations, and those who have obtained an import license can ship it to Japan from the bonded area.
Import procedure
Prepare documents:
1. Food import declaration form
． Importer’s name and address, code
． Country of origin, code
． Imported food manager registration number
． Manufacturer’s name, code
． Factory name and code
． Exporter name, code
． Packer name, code
． Port of Loading/code
． Date of shipment, date, date
． Loading port /code
． Arrival date
． Repository/code
． Delivery date, notification date
． cargo symbol
． whether there is an accident
． The name or flight number of the ship or aircraft
． Submitter/Code
2. Other relevant documents
． Description of raw materials, manufacturing process, etc.:
Manufacturer, name and location of manufacturing plant, product number, product name, etc. can be identified as goods arriving in Japan
． Description of materials, parts list, etc.:
Raw material table (required), manufacturing process table (required), test reports of registered inspection agencies, etc., product color photos, catalogs, etc.
． Hygiene certificate (depending on item and country of origin)
． Test report (as needed)
3. It is necessary to submit two copies of the food import declaration form and the necessary annexes
． Notifications can be submitted up to 7 days before the arrival of the goods
． The place to submit the notice depends on the place of customs clearance of the goods
． Notification forms can also be submitted by post
． When mailing notices, be sure to include a stamped return envelope.
4. The arrival of the goods
． Fill in the required items on the food import declaration form
． Submit the food import declaration form to the food monitoring window of the quarantine station
Every time you import health food, you must notify the Minister of Health, Labour and Welfare (Quarantine Office) to conduct a preliminary investigation, and you need to pay:
1. Manufacturer, location
2. Factory, location
3. Raw materials (substance name and dosage including food additives)
4. Manufacturing and processing methods
5. Containers and Packaging Materials
6. Storage method
7. Application
8. Consultant name, address, contact information
9. Importer’s name, address, contact information
10. Container packaging materials, internal capacity
11. Save
12. Purpose
13. Use
14. Schedule self-check items
15. Scheduled import port/time
【參考連結】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000144562.html
https://www.mhlw.go.jp/topics/yunyu/soudan/index.html
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/jigyousya/index.html
HLF-JP-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
1. Nutritious foods and functional foods can be inspected by overseas institutions and comply with production/manufacturing and quality control (GMP, HACCP, ISO 22000, FSSC 22000, etc.), and do not need to be audited.
The safety and effectiveness are verified and managed by the operators themselves.
2. The specified health food must be certified by the performing agency that is licensed to test. Licensed testing subjects are the National Institutes of Health and Nutrition and the following registered testing institutions.
． National Institute of Health and Nutrition
． Japan Food Analysis Center
． Food Environmental Inspection Association
． Food Analysis Development Center SUNTEC
． Japanese food inspection
． Osaka Institute of Public Health
Specific health food testing content
The safety assessment of specific health food is carried out for each food according to the specific situation. In principle, the safety of the ingredients involved in the food, especially tablets and capsules, is evaluated.
1. Manufacturing/processing methods, quality control
2. Mechanism of action (quantitative methods involving components, absorption/metabolism/excretion, accumulation, etc.)
3. Information on analytical values of heavy metals, residual pesticides, etc., allergenic substances (if necessary)
4. Use of recorded data and information
5. Daily intake data for ingredients or foods contained in the product.
6. Data on Ingredient Content in Commercial Foods
7. Data on usage records, food intake, etc. in other countries
8. Data on how the food is cooked (requires heat/no heat)
9. Data should be as specific as possible using numerical values
10. Data and Information on In Vitro and In Vivo Tests Using Animals
11. The test data is as follows
． Genotoxicity test data
． Single Oral Dose Test Data (Acute Toxicity)
． 28-day or 90-day repeat oral dosing study data
． Participate in 1-year long-term oral administration test, antigenic test, allergy test, reproductive test, teratogenicity test, carcinogenicity test and other data as needed
12. It is necessary to set the allowable amount (value) and other data
13. When the components involved are microorganisms, it is necessary to check the plasmid transfer of antibiotic resistance genes, etc., and information on the possibility
13. Human trials on appropriate subjects
14. The test data, literature, etc. of the test must be processed by appropriate statistical methods.
． Using a double-blind approach, a control (placebo) between non-ingestors and ingestors
． Differences in the state of the ingestor before, during, and after ingestion by methods executed without control
． Data on subjects based on health use (e.g., healthy adult males and females and disease reserve groups) (people with high clinical trial values related to the components involved), etc.)
． Continuous intake (repeated intake test, long-term intake test), effects of excessive intake
15. Data that can assess the effect of intake (excess test)
16. Data and adequate considerations for safety when used in combination with drugs
17. The submitted data should guarantee the reliability of the test.
【參考連結】
http://www.fsc.go.jp/senmon/sinkaihatu/index.html
HLF-JP-75
日本保健食品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
HLF-JP-77
請問在日本有哪些保健食品檢驗機構可以提供保健食品檢驗服務？網頁？
Evershine RD：
Jhnfa
https://www.jhnfa.org/index.html
SGS
HLF-JP-80
Health food is classified as food, and a business license is required to sell it in accordance with the law..
Required documents:
1. Application for business license
．Applicant, zip code, phone number, fax number, email address, company number, date of birth
．Responsible person (if legal person)
．Business Facility Information: Postal Code, Phone Number, Fax Number, Email Address
．Facility name, location, store name or business name
．Name of the food hygiene manager, participation in the prefectural governor’s courses, etc.
．Handles primarily food, additives, utensils/containers and packaging
2. Structure, equipment and facility drawings
3. Qualification certificate of food sanitation manager (when selling food, a food sanitation manager needs to be designated)
．Regularly attend seminars approved by the prefectural governor or prefectural governor, and strive to learn new knowledge about food hygiene.
．Manage hygiene according to the operator’s instructions.
．Take the necessary precautions and try to provide the necessary advice to the operator.
．Up-to-date food hygiene information is essential in order to manage hygiene properly.
．To become a Food Hygiene Manager, one must attend a total of approximately 6 hours of training sessions.
．Persons with the following qualifications can become food hygiene managers without taking courses: cooks, nutritionists, fruit hygienists, ship cooks, hygiene managers under the Slaughterhouse Act, work hygiene managers under the Slaughterhouse Act , Poultry Processing Hygiene Managers, Persons who meet the qualification requirements for Food Hygiene Managers or Food Hygiene Observers.
4. Water quality inspection report (when using water other than tap water, special water, or simple special water)
5. Pay the permit application fee
6. If it is a legal person registration, the legal person number needs to be filled in.
Application process:
Apply to the health center in the jurisdiction of the business office license:
When conducting food business license audits, conduct on-the-spot investigation of the business facility, and test the firmness of the facility and the durability of the equipment.
The validity period is 5 years at the shortest and 8 years at the longest according to the specified audit criteria.
According to the Food Safety Basic Law, food importers must
1. Has primary responsibility for ensuring food safety and is responsible for taking appropriate measures to ensure food safety at every stage of the food supply process.
2. Provide accurate and appropriate information on food, or provide for it.
According to the Food Sanitation Law, food operators must
1. Responsibility to ensure food safety.
2. Need to acquire knowledge and technology related to food hygiene
3. Confirm the safety of the raw materials used.
4. Self-check
5. Take other necessary measures if necessary.
URL: https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/hokenkinou/index.html
【參考連結】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/hokenkinou/index.html
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/kyokatodokede/youshiki.html#kanri
HLF-JP-85
請問在日本有哪些專精於保健食品銷售與消費權益相關法律服務的業者？
Evershine RD：
Atsumi & Sakai
Support Gyoseishoshi Law Firm
https://gztoworld.com/
Foley & Lardner LLP
https://www.foley.com/en
Contact Us
Tokyo Evershine BPO Service Limited Corp.
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or
For investment structure relevant with multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4tyo@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable to your case.
Email address:dalechen@evershinecpa.com
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