HFF (Health Functional Foods) Code

Standards and Specifications for Health Functional Foods [MFDS Notice No. 2024-16, March 20, 2024]

1. Purpose:
   1. This notice establishes the standards and specifications for the manufacture, processing, production, import, distribution, and preservation of health functional foods intended for sale.
   2. By setting the standards and specifications for ingredients and products used in health functional foods, it aims to promote the distribution of standardized health functional foods and ensure consumer safety.
   3. It also provides guidelines for relevant officials to systematically and scientifically manage health functional foods domestically.
2. Main Contents:
   1. Definition and Classification: A. Explains the definition and classification criteria of health functional foods. B. Classified according to usage purposes, such as vitamins, minerals, probiotics, omega-3 fatty acids, etc.
   2. Usage Standards: A. Specifies the maximum allowable amounts of each health functional food ingredient and the types of foods in which they can be used. B. Regulates the daily recommended intake and maximum intake of health functional substances in detail.
   3. Quality Standards: A. Specifies the purity, residual substances, and physical properties of health functional food ingredients. B. Includes the required quality conditions and testing methods during the manufacturing process.
   4. Functionality Labeling Standards: A. Regulates the labeling and indication standards for health functional foods. B. Ensures that functionality information, content, and consumption methods are easily identifiable.
   5. Testing and Verification Methods: A. Specifies the testing methods for component analysis and safety inspection of each health functional ingredient. B. Includes methods for verifying functionality through human trials, cell tests, and animal tests.
3. Legal Basis and Managing Authority
   1. Legal Basis: The standards for health functional foods are established and managed based on the Health Functional Food Act and related laws.
   2. Managing Authority: The Ministry of Food and Drug Safety (MFDS) manages and supervises the standards for health functional foods. The MFDS undertakes the revision, supplementation, and supervisory roles related to the standards.
4. Latest Trends:
   1. Diversification of Functional Ingredients: New functional ingredients are being added based on the latest research findings.
   2. Enhancement of Safety: Increased consumer interest in health has led to stricter safety inspections and standards.
   3. International Harmonization: Efforts are being made to align the standards for health functional foods with international standards to meet the global market requirements.