Chapter 1 Taiwan TFDA regulatory information brief

1. Eaa and Introduction

（Taiwan Food and Drug Administration，TFDA）Responsible for the approval and supervision of food market access, sales and subsequent compliance supervision.

2. Supervision and regulation

Food Safety and Hygiene Administration Law

Health Food Management Act

3. Definition and classification of health food in Taiwan

Taiwan food is divided into：

①General food refers to the products and raw materials used for human eating or chewing.

②Special nutritional food refers to formula food for infants and older infants, formula food for specific diseases and other formula food approved by the central competent authority for use by people with special nutritional needs.

③Food additive: a single or consistent ingredient added to or in contact with food for the purpose of coloring, flavoring, preservative, bleaching, emulsification, enhancing flavor, stabilizing quality, promoting fermentation, thickening, strengthening nutrition, preventing oxidation, or other necessary purposes. The additives used in compound food additives shall consist only of food additives approved by the central competent authority, and the aforesaid unilateral food additives shall have the license number approved by the central competent authority.

4. 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.
  

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5. Declaration language 

English, or traditional Chinese.

Chapter 2 Declaration process & cycle & Government fee

1. Declaration flow chart

2. Reporting cycle and official fees (Currency: NT dollar)

At present, the application for health food inspection and registration is a two-stage review and charging system: the first review. Ten thousand yuan, reexamined. Ten thousand yuan, plus a license fee of 2,000 yuan.

The number of days for the first review is 60 days, and the number of days for the review is 180 days, excluding the time for the manufacturer to make up the parts.

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.