1. Introduction

1.1 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 especially labeled or advertised, and do not aim at treating or remedying human diseases”.

1.2 Major laws and regulations

• 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

1.3 Functional claims

“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

1.4 Differentiation of health food from conventional food and medicine

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 in tablet and capsule forms

2. Health food registration in Taiwan

2.1 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.

2.2 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:

(a) The application form;

(b) A list of the ingredients, their composition and specified content;

(c) An assessment report on product safety;

(d) An assessment report on the health maintenance effects of the product;

(e) A verification report on the ingredients furnishing health maintenance effects and the method of testing;

(f) A report on the stability of the health maintenance effects;

(g) A summary of the manufacturing process;

(h) Supporting documentation on GMP;

(i) Specifications on product sanitation and the inspection report;

(j) An analysis report on the general nutrient content;

(k) Relevant research reports and literature;

(l) Packaging, labeling and specifications of the product;

(m) A photocopy of the business license held by the applicant; and

(n) 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.

Flow Chart on Health Food Registration

3. Labeling requirements of health food in Taiwan

The labeling and advertisement of health food shall not contain information which 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 in commonly used symbols:

(a) Product name;

(b) Name, weight or volume of the contents; separate labeling is required if the health food is a mixture of two or more ingredients;

(c) Name of the food additives;

(d) Expiry date, methods and conditions of preservation;

(e) Name and address of the manufacturer, importer has to supply the name and address of the responsible local business operator;

(f) Approved health maintenance effects;

(g) Permit number, legend of “health food” and standard logo;

(h) Dosage, important message on the consumption of the health food and other necessary warnings;

(i) Nutrient composition and their content; and

(j) Other material facts designated by the Ministry of Health and Welfare by way of public notice.