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CN TW(TFDA)

Asia-Pacific

CN TW(TFDA) AU(FSANZ)

North America

CA(CFIA) US(FDA)

Southeast Asia

MY(FSQD) PH(PFDA) SG(SFA) TH pet food TH(TFDA)

Food Regulatory Authority of Taiwan, China

The Food and Drug Administration, Ministry of Health and Welfare of Taiwan (Taiwan Food and Drug Administration, TFDA) is responsible for approving and supervising food market access, product distribution, and subsequent post-market compliance oversight.

Official Website of the Regulatory Authority: https://www.fda.gov.tw

Special Nutritional Food License Inquiry Portal (for licensed formula food products):https://consumer.fda.gov.tw/Food/SpecialNutrition.aspx

Health Food (Little Green Man Mark) Certification Inquiry Portal (for certified health food products):https://consumer.fda.gov.tw/Food/HealthFood.aspx

Non-compliant Food Information Inquiry Portal (for products failing border inspection or market sampling tests):https://www.fda.gov.tw/tc/siteContent.aspx?sid=11661

Applicable Regulatory Acts

Food Safety and Sanitation Management Act

Health Food Management Act

Definition and classification of health food in Taiwan

Food products in Taiwan are categorized into three types as follows:

General Food: Edible or chewable products for human consumption, as well as their raw materials.

Special Nutritional Food: Infant and follow-up formula foods, formula foods for specific diseases, and other formula foods approved by the central competent authority to meet special nutritional demands.

Food Additives: Single or compound substances added to or brought into contact with food for necessary purposes including coloring, flavoring, preservation, bleaching, emulsification, aroma enhancement, quality stabilization, fermentation promotion, thickening, nutritional fortification, antioxidation, and other legitimate uses. Compound food additives shall only consist of single food additives approved by the central competent authority, and each approved single food additive must bear an official approval number issued by the central competent authority.

Entry requirement

Letter of authorization;

GMP (evidence of good practice);

Formulations, product packaging, labels, instructions;

Safety assessment report, health efficacy assessment report, stability report;

Efficacy ingredient test report and test method;

Process, product health inspection specifications and reports;

General nutrient analysis report.

Declaration language

English, or traditional Chinese.

Required Documentation for Application Filing

1.Special Nutritional Food (e.g., infant formula, formula food for specific diseases)

Pursuant to relevant regulatory measures, applicants shall submit the following materials:

Application form: Application for Inspection and Registration

Enterprise qualification documents: Business registration certificate, factory registration certificate (or overseas manufacturing facility certification for foreign manufacturers)

（1）Product technical documentation

Formula: Raw material and ingredient content breakdown

Composition analysis: Nutritional component test reports

Specifications: Product specification sheet and corresponding test methods

Manufacturing process: Standard operating procedures for production

（2）Safety and efficacy substantiation

Clinical human consumption trial report (or overseas free sale / market launch certification)

（3）Packaging and test samples

Draft labels and product inserts intended for market launch

Product samples for official testing

2.Health Food (products applying for the official "Little Green Man" certification mark)

For products to be marketed as health food, the following core documents are mandatory under the Health Food Management Act:

Product composition analysis, including identification reports for functional health ingredients

Safety and toxicological evaluation to confirm no safety risks from long-term consumption

Health benefit assessment report conducted in accordance with evaluation protocols published by TFDA (covering benefits such as blood lipid regulation, immune modulation, etc.), typically supported by animal trial or human clinical trial data.

Declaration process & cycle & Government fee

1. Declaration flow chart

2. Reporting cycle and official fees (Currency: New Taiwan Dollar, NTD)

Health food inspection and registration adopts a two-stage review and fee structure:

Preliminary review fee: NTD 160,000

Secondary review fee: NTD 340,000

Certificate issuance administrative fee: NTD 2,000

Review durations:

Preliminary review cycle: 60 working days

Secondary review cycle: 180 working days The above timeframes exclude periods spent by applicants submitting supplementary documents upon official request.

Chapter 3 FAQ

Q：If the product has more than 2 health food health benefits, can I apply for health food inspection registration at the same time, and do different health effects have different health food license numbers?

A：1. Consider products with different health efficacy or specifications standards, need different professional review content, according to article 4 of the licensing measures, the central competent authority for each health food inspection registration case only accepts the product application for a single health efficacy or specifications of the inspection registration case is limited.

2.If the health food obtains the health benefits above item 2, the health benefits items and statements will be added to the registration content of its license, and the same health food license number is used, and no other approved number is issued.

Q：What is the number and time limit of health food license extension, inspection and registration content change, transfer, replacement and replacement?

A：In accordance with the provisions of Article 32 of the licensing measures, the health food license extension, change and transfer registration and replacement and replacement of documents and information recognized by the central competent authority are incomplete, the manufacturer shall make corrections within one month after receiving the notice from the central competent authority; If necessary, it may apply for an extension of one month, and it is limited to one time. If no rectification is made by the time limit, it shall be rejected.

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