Taiwan Health Food Registration
Evershine acts as your regulatory affairs consultant on Health Food, to register products licenses with supporting documents of the GMP of the country of origin. We help prepare registration documents and information and provide regulatory affairs feedback and support. Being assigned for the correspondence and related works with relevant parties, Evershine should keep the content of the product, the method of exemption, company managing affairs confidential, unless for the governmental requirement.
Send an email to tpe4ww.elr@evershinecpa.com
Director Jerry Chu, USA Graduate School Alumni and a well-English speaker
Mobile: +886-939-357-735
Tel No.: +886-2-2717-0515 ext. 103
Service Scope:
Prepare supporting documents of the GMP of the country of origin
A new application of Health Food Permit License
Renewal application of Health Food Permit License
Please click below to get more detailing information
Health Food
Definition of health food in Taiwan
Health food is defined in Health Food Control Act as “food with specific nutrient or health maintenance effects which is specially labeled or advertised, and do not aim at treating or remedying human diseases”.
Major laws and regulations on Taiwan Health Food
- Act Governing Food Safety and Sanitation
- Health Food Control Act
- Enforcement Rules of Health Food Control Act
- Sanitation Standard for Health Foods
- Regulations for Application of Health Food Permit
13 Functional claims are allowed on Taiwan Health Food
“Health maintenance effects” are the effects recognized by the Ministry of Health and Welfare.
According to the Health Food Control Act, health maintenance claims have to be approved by the Ministry of Health and Welfare.
So far, the Ministry of Health and Welfare has approved thirteen such claims, namely:
- Protection of the liver
- Relieving physical fatigue
- Regulation of blood lipid
- Regulation of blood sugar level
- Regulation of immune system
- Alleviation of osteoporosis
- Maintenance of dental health
- Anti-aging
- Promotion of iron absorption
- Promotion of gastrointestinal functions
- Aiding blood pressure regulation
- Attenuation of body fat accumulation
- Reducing allergic reactions
What kinds of differences among Health Food, Conventional Food, and Medicine in Taiwan?
In Taiwan, conventional food, health food, and medicine are all regulated by law.
Products in tablet and capsule forms are classified as “food”, “health food” or “medicine” according to their functions.
In Taiwan, products such as vitamin pills, shark extract pills, ginseng essence, and royal jelly, can only be sold as “food” but not as “health food” because their health maintenance claims have yet to be approved by the Ministry of Health and Welfare.
Such food products are regulated by the Act Governing Food Safety and Sanitation instead of the Health Food Control Act.
Conventional food, health food and medicine, all can be in tablet and capsule forms.
We summarized as below:
Item–Conventional food
Basic requirements– Compliance with food safety standards
Legislation– Act Governing Food Safety and Sanitation
Claims and functions– Therapeutic claims not permitted
Item–Health food
Basic requirements– Compliance with food safety standards
Legislation– Health Food Control Act
Claims and functions– 13 health maintenance claims as described above allowed
Item–Medicine
Basic requirements– Compliance with food safety standards
Legislation–Pharmaceutical Affairs Act
Claims and functions– Therapeutic claims allowed, Function is to diagnose, treat, relieve or prevent human illnesses
Taiwan Heath Food Competent authorities
The Ministry of Health and Welfare of the Executive Yuan is the competent authority at the central level, and the Health Department of the provincial/county/municipal government is the local regulatory authority.
Taiwan Health food registration procedure
Manufacturers and importers of health food must first submit an application to the Ministry of Health and Welfare or its commissioned body for inspection and registration.
Health food manufactured in Taiwan has to comply with Good Manufacturing Practices (GMP).
Imported health food has to conform to the GMP of the country of origin.
Manufacturers or importers of health food shall provide the following documents and information to the Ministry of Health and Welfare for examination and registration:
- The application form;
- A list of the ingredients, their composition and specified content;
- An assessment report on product safety;
- An assessment report on the health maintenance effects of the product;
- A verification report on the ingredients furnishing health maintenance effects and the method of testing;
- A report on the stability of the health maintenance effects;
- A summary of the manufacturing process;
- Supporting documentation on GMP;
- Specifications on product sanitation and the inspection report;
- An analysis report on the general nutrient content;
- Relevant research reports and literature;
- Packaging, labeling, and specifications of the product;
- A photocopy of the business license held by the applicant; and
- An intact sample of the product and the processing fee.
The Ministry of Health and Welfare will conduct an initial assessment upon receiving the application and documents.
If the basic requirements are met, the application will be forwarded to the Health Food Evaluation Committee (HFEC) under the Ministry of Health and Welfare for further examination, to ascertain, with reference to the food safety assessment report and health maintenance assessment report submitted by the applicant, that the product is safe for consumption and its health maintenance effect is valid.
Finally, the Ministry of Health and Welfare will based on the advice of HFEC, conduct an overall assessment on whether or not to approve the application. Successful applicants will be issued a permit valid for five years.
Application for renewal has to be filed within three months prior to the expiry of the permit.
Taiwan Health Food Registration Processes
*Applicant:
-Submitting Supporting Documents
*The Ministry of Health and Welfare:
-Initial Examination
*Health Food Evaluation Assessment:
-Safety Assessment +Effect Assessment
*The Ministry of Health and Welfare:
-Examination of assessment results
*Assessment result
If approved, issue a permit.
If Disapprove, notify the applicant of reasons for disapproval or request additional documents.
Labeling requirements of health food in Taiwan
The labeling and advertisement of health food shall not contain information that is false, exaggerated, and beyond the content approved by the Ministry of Health and Welfare.
Claims of therapeutic effects are not allowed.
The following information shall be conspicuously displayed on the containers, packaging or specifications of health food in Chinese and is commonly used symbols:
- Product name;
- Name, weight or volume of the contents; separate labeling is required if the health food is a mixture of two or more ingredients;
- Name of the food additives;
- Expiry date, methods and conditions of preservation;
- Name and address of the manufacturer, the importer has to supply the name and address of the responsible local business operator;
- Approved health maintenance effects;
- Permit number, legend of “health food” and standard logo;
- Dosage, important message on the consumption of the health food and other necessary warnings;
- Nutrient composition and their content; and
- Other material facts designated by the Ministry of Health and Welfare by way of public notice.
Required Documents when applying Taiwan Health Food
Regulations for Application of Health Food Permit in Taiwan, are set forth pursuant to paragraph 5 of Article 7 of the Health Food Control Act.
Article 2
All applications filed for product registration under subparagraph 1, paragraph 1 of Article 3 of the Act shall be accompanied by the preliminary review fee, intact product samples, and the following documents and information:
- Application form
- Specifications and quantity of ingredients
- Safety assessment report
- Health care effect assessment report
- Identification report on ingredients with health care effect of a product and its examination method employed
- Test report on the ingredient stability of a product and its health care effect
- Summary of the manufacturing process
- Documentary evidence of good manufacturing practices
- Sanitary specifications and its test report
- The general nutrients analysis report
- Relevant research reports and literatures
- Product package, label, and information leaflet
- Registration certificate of the applicant’s corporation or business
Article 2-1
All applications filed for product registration under subparagraph 2, paragraph 1 of Article 3 of the Act shall be accompanied by the preliminary review fee, intact product samples, and the following documents and information:
- Application form
- Specifications of the raw materials and quantity of ingredients of the product
- Ingredients specification test report of a product
- Test report on the ingredient stability of a product and its health care effect
- Summary of the manufacturing process
- Documentary evidence of good manufacturing practices
- Sanitary specifications and its test report
- The general nutrients analysis report
- Package, label and product instruction sheet
- Certificate of the applicant’s corporation or business registration
Contact Us
If you are interested in our services, please send an email to tpr2ww.elr@evershinecpa.com. We will respond to you in 1-2 working days.
You may also call in working hours (Taipei and China Time):
Director Jerry Chu, USA Graduate School Alumni and a well-English speaker
Mobile: +886-939-357-735
Tel No.: +886-2-2717-0515 ext. 103
Additional Information
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(version: 2024/07)
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