1. Definition & classification
In Taiwan, according to the Act Governing Food Safety and Sanitation, “infant and follow-up formula” is classified as a special dietary food
“Infant and follow-up formula” include 3 types of infant formulas as below:
Infant Formula: It refers to the specially-made food substitute for breast milk, which can be used for feeding alone before infants begin eating supplementary food, as it satisfies the nutritional needs of infants of 0-6 months.
Follow-up Infant Formula: It refers to the food for infants of 6-12 months, and serves as the weaning formula for feeding in conjunction with complementary foods. However, it is not fit for feeding alone for infants who are under six months of age.
Infant Formula for Special Medical Purposes: It refers to the food substitute for breast milk or infant formula, which satisfies the special nutritional needs of infants suffering from nutritional disorder or diseases or having health conditions. After growing older, infants may begin eating proper supplementary food.
2. Competent authorities
Competent authority | Responsibility |
Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare (MOHW) |
|
3. Market access requirements
3.1 Product registration
In Taiwan, imported infant and follow-up formula are subject to product registration. All registration applications are thoroughly reviewed to ensure that the formula product meet the compositional, quality, and safety requirements. 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 Food traceability
In Taiwan, infant and follow-up formula is a food category that require traceability systems established by food businesses. Detailed requirements can be found in Regulations Governing Traceability of Foods and Relevant Products.
3.3 Import inspection
Imported infant and follow-up formula 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
The uses of food ingredients and additives in and sanitation for infant and follow-up formula shall comply with the relevant regulations as below.
Item | Requirements |
Food ingredients | Businesses can check TFDA Integrated Information Platform for Food Ingredients for ingredient requirements. |
Food additives | Standards for Specification, Scope, Application and Limitation of Food Additives |
Microorganisms |
4.2 Label
The information on the container or external packaging of infant and follow-up formula shall be conspicuous and in Chinese. From January 1, 2025, companies of approved infant formulas are required to print a logo on the package to encourage breastfeeding, which contains an image of breastfeeding and the following two sentences:
Breastfeeding is healthier for infants
The Ministry of Health and Welfare cares about you.
The Logo for Infant and Follow-up Formula
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, Labelling Requirements for Infant and Follow-up Formula and Regulations on Nutrition Labeling for Prepackaged Food Products.
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