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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