China's Taiwan Health Food Regulation

1. Definition & classification

According to Health Food Control Act, in Taiwan, China, health food is defined as food with health care effects announced by the central competent authority, and labeled or advertised with such effects. Health food shall be scientifically proven to be capable of improving people’s health, and decreasing the harms and risks of diseases. However, health food cannot be used as medical treatment aimed at treating or remedying human diseases.

2. Competent authorities

3. Market access requirements

3.1 Health food permit

In Taiwan, a dual system is established for health food permit, including two tracks: individual case review and specification standard review.

• Track 1 Individual case review: The safety assessment, health care effect assessment and stability test for the certified products are reviewed by the competent authority.

• Track 2 Specification standard review: The product ingredients shall conform to the Health Food Specification Standards set by the central competent authority. Currently, there are specification standards for fish oil and red yeast rice in Taiwan, China.

For the specific registration procedures and requirements, please refer to Regulations for Application of Health Food Permit.

3.2 Import inspection

Imported health food must be inspected at the ports of entry as per the Regulations of Inspection of Imported Foods and Related Products. The inspection authority may proceed product inspection with the following measures: batch-by-batch inspection, batch inspection based on random selection, batch-by-batch verification, certification inspection, and oversee inspection. Import permission notice will be issued if the inspection is passed. Imported products that fail the inspection may be returned or destroyed.

4. Product Compliance

4.1 Product requirements

Health food is subject to ingredients review and testing of during the application of health food permit. Businesses can check TFDA Integrated Information Platform for Food Ingredients for ingredient requirements. In addition, approved food additives can be found in Standards for Specification, Scope, Application and Limitation of Food Additives.

4.2 Label

The following material facts shall be conspicuously displayed on the containers, packaging or the written instruction of health food in Chinese:

• product name

• ingredients names

• net weight, volume or quantity

• food additives names

• expiry date, method and conditions of preservation

• name and address of the responsible business operator; name and address of the importer

• the approved health care effects

• reference number of the permit, the legend of "health food" and the standard logo;

• the amount of intake and important message for consumption of the health food, possible side effect, as well as other necessary warnings;

• nutrient and its content

• other material facts designated by the central competent authority

Health food Logo

For more labeling requirements, please refer to Health Food Control Act, Enforcement Rules of Health Food Control Act and Regulations Governing the Labeling of Health Food.

In addition, products in tablet and capsule forms can be “food”, “health food” or “medicine” according to their functions. For some health food in tablet or capsule forms, please refer nutrition labeling requirements in Regulations on Nutrition Labeling for Prepackaged Vitamin and Mineral Tablets and Capsules.

Health claims shall be limited to the content registered at the central competent authority, without information beyond the approved scope. Currently, TFDA approves 13 health claims that can be used for health food subject to Track 1 Individual case review.

• anti-fatigue

• blood lipids regulation

• blood sugar regulation

• Immunoregulation

• Bone care

• Dental care

• Anti-aging

• Accelerate absorption of iron

• Gastrointestinal function improvement

• Adjuvant regulation on blood pressure

• Prevention of body fat accumulation

• Adjuvant regulation on allergic constitution

For health food subject to Track 2 Specification standard review, fish oil products can have health claims as follows: "This product may help reduce blood triglyceride levels;” “the health care effect of the product is known from academic theory but not approved by experiments". Red yeast rice products can have health claims as follows: "This product may help lower total cholesterol levels;" "the health care effect of the product is known from academic theory but not approved by experiments".

* Global Food Compliance Service

We provide various market entry services to help stakeholders better understand exporting requirements, establish business and secure a competitive place to facilitate trade development.

 Covered Countries

China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.

Our Services

• Food Ingredient Review

• Label Review

• Product Registration

• Regulatory Consultation

• Monitoring, Training and customized report

Please feel free to contact us via food@chemlinked.com if you need any help.