China's Taiwan Formula for Certain Disease Regulation

1. Definition & classification

In Taiwan, according to the Act Governing Food Safety and Sanitation, formula for certain disease is classified as special dietary food.

Formula for certain disease is intended for the dietary management of patients who have impaired capacity to ingest, digest, absorb or metabolize ordinary foods or certain nutrients, or who, for any medically-proven reason, have special dietary requirements that cannot be easily met with re-balancing daily diet. The food products in this category are processed or formulated according to the needs of the target users.

Formula for certain disease includes the following types:

Nutritionally complete food that may be used as the single source of nutrients:

1. Nutritionally complete food with balanced formula: Products in this category are designed to maintain caloric and nutritional sustenance of patients.

2. Nutritionally complete food with customized formula: Products in this category are designed to maintain caloric and nutritional sustenance of patients by delivering complete nutrition with added or reduced nutrients to meet the patients' specific needs.

Nutrition supplement formula food that cannot be used as the single source of nutrients:

1. Nutrition adjusted supplementary formula food: Products in this category are designed to be used as part of nutritional supplement for patients with specific nutritional needs.

2. Special modular formula food: Products in this category are designed to deliver a specific nutrient or ingredient to meet the metabolic needs or nutritional needs derived from specific illness.

2. Competent authorities

3. Market access requirements

3.1 Product registration

In Taiwan, imported formula for certain disease is subject to product registration. The competent authority has different application requirements for different formula types. For instance, except for nutritionally complete foods, other formulas should be accompanied by additional documentation such as product design principles, scientific evidence, and clinical studies on human consumption. In addition, the authority may convene an expert review meeting for reviewing the applications and, where necessary, may designate the applicant for presentation or reply at the meeting.

Detailed application procedure and requirements can be found in Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products. Enterprise can look up approved formulas in the online database created by TFDA.

3.2 Import inspection

Imported formula for certain disease 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 (without sampling and inspection), 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

Businesses can check TFDA Integrated Information Platform for Food Ingredients for ingredient requirements and Standards for Specification, Scope, Application and Limitation of Food Additives for food additive requirements. The detailed nutritional specification requirements for formula for certain disease are shown in the table below.

4.2 Label

Formula for certain disease shall have container or external packaging labeled with the following information, as required in addition to the general information for prepackaged food requirements:

1. The outer packaging of the product shall be marked with the words "特定疾病配方食品 (Formula for certain diseases)". The font length and width should not be less than 0.4 cm, the font size should be the same, and its color should be significantly different from the background color.

2. The applicable subjects.

3. Storage instructions before and after the package is opened.

4. Usage and dosage instructions.

5. Warning statement: "This product is a formula food for certain disease, and it is not suitable for the general population and must be taken under the instruction of a doctor or registered dietitian", or the synonyms. Text shall appear bold and be distinct from the background color.

6. Warning statement: "Increased dosage will not help improve this type of disease", or the synonyms.

7. Warning statement: "This product is not for intravenous use", or the synonyms.

8. Tube-feeding formulas must be specified with the osmotic pressure.

9. Other precautions related to nature thereof and characteristics of the product.

For more labeling requirements, please refer to Act Governing Food Safety and Sanitation, Enforcement Rules of the Act Governing Food Safety and Sanitation, Regulation of Food Allergen Labeling, Regulations on Labeling of Formula for Certain Disease and Regulations on Nutrition Labeling for Prepackaged Food Products.

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 Covered Countries

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

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