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Imported infant formula and follow-up infant formula shall be registered in Taiwan

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2019-12-31
  • Last Updated:2019-12-31

Food business operator who imports food and related products into Taiwan shall apply for import inspection with Taiwan Food and Drug Administration (TFDA) at the port of entry. Additionally, for management needs, a few categories of foods shall be registered and require pre-approval from the Ministry of Health and Welfare in Taiwan prior to import inspection, according to the Article 21 of Act Governing Food Safety and Sanitation (the Act). Because infant formula and follow-up infant formula (for babies under one year old) which is under the category of special dietary foods may be used as breast-milk substitute for nutritional needs of babies, a stricter measure of food safety management is taken and registration and pre-approval are required. On the other hand, growing up formula for children older than one year and processed cereal-based foods and baby foods for infants and young children are regulated as general foods and do not need registration.

The uses of food ingredients and additives, sanitation standards and labeling requirements for infant formula and follow-up infant formula, shall comply with the relevant provisions of the Act. All registration applications are thoroughly reviewed on a case by case basis to ensure the formula product meeting compositional, quality, and safety requirements. Related documents and information including bill of materials, nutrient analysis and specification, the evidences for product sales outside Taiwan, package labeling in Chinese, etc. are required for product registration. The Act and related regulations are available on the TFDA website (http://www.fda.gov.tw/ENG/law.aspx?cid=16). Registration regulation can be found at the following link: http://www.fda.gov.tw/ENG/lawContent.aspx?cid=16&id=3124.