History and Development of Korean HFF (Health Functional Food) Regulations: A Yearly Overview

1. Introduction of Health Functional Food System (2002)

• 2002
  • Background: With increasing interest in health functional foods, the need for systematic management emerged both domestically and internationally.
  • Key points:
    • Legally clarifying the definitions and concepts of health functional foods.
    • Establishing regulations for manufacturing, distribution, and sales processes.
    • Establishing procedures for verification of safety and functionality through the Ministry of Food and Drug Safety (MFDS).
• 2003
  • Specific Actions: Establishing quality control standards and monitoring systems for health functional foods.
  • Laying Legal Foundations: Initiating detailed work on relevant laws and regulations.

2. Enactment of the Health Functional Food Act (2004)

• 2004
  • Key points:
    • Defining health functional foods and setting standards and specifications.
    • Establishing approval and reporting procedures, and criteria for safety evaluation of functional ingredients.
    • Implementing regulations for product labeling and advertising.
• 2005
  • Implementation of Enforcement Rules: Establishing detailed enforcement rules and guidelines related to health functional foods.
  • Starting Public Awareness Campaigns: Launching national campaigns to raise consumer awareness.

3. System Improvement and Strengthening (2007)

• 2007
  • Key points:
    • Introducing strong legal sanctions to eliminate false and exaggerated advertisements.
    • Strengthening criteria for functionality claims, requiring scientific evidence.
    • Establishing a recall system for harmful products and enhancing penalties for violations.
• 2008
  • Ad Monitoring: Reinforcing advertising monitoring systems; investigating and sanctioning false and exaggerated ads.
  • Consumer Protection: Improving and activating the consumer complaint system.
• 2009
  • Expanding Regular Inspections: Increasing periodic quality inspections and strengthening voluntary quality control by manufacturers.

4. Recognition and Safety Evaluation of Functional Ingredients (2012)

• 2012
  • Key points:
    • Strengthening the recognition procedures for functional ingredients and enhancing scientific verification.
    • Increasing safety verification standards for functional ingredients and products to international levels.
    • Introducing Good Manufacturing Practices (GMP) for health functional foods.
• 2013
  • Harmonization with International Standards: Formulating policies to harmonize with international standards.
  • Improvement of Certification Systems: Enhancing the reliability of functional ingredient certification systems.
• 2014
  • Support for Research and Development: Expanding support for research and development (R&D) for new functional ingredients.

5. Amendment of the Health Functional Food Act (2016)

• 2016
  • Key points:
    • Strengthening management and supervision of manufacturers and distributors; mandatory GMP certification.
    • Mandatory recall and public notice of harmful products.
• 2017
  • Strengthening Quality Control: Improving quality control systems for manufacturers and expanding education on voluntary quality management.
  • Enhancing Consumer Safety: Introducing consumer-centric product safety inspection systems.
• 2018
  • Response to Harmful Foods: Establishing rapid response systems for harmful foods.
  • Compensation Systems: Strengthening compensation systems for damages caused by health functional foods.

6. Amendment of Health Functional Food Regulations (2019)

• 2019
  • Key points:
    • Easing regulations for small-scale manufacturers and introducing regulations for online sales of health functional foods.
    • Introducing policies to stimulate the export of health functional foods.
• 2020
  • Strengthening Online Regulations: Strengthening regulations for the sale of health functional foods through e-commerce.
  • Support for Small-Scale Manufacturers: Expanding technical support and funding programs for small-scale manufacturers.
• 2021
  • Strengthening Consumer Protection: Enhancing legal measures for consumer protection and improving information provision systems.
  • International Cooperation: Strengthening international cooperation for market entry into foreign countries and supporting the development of products that meet global standards.

7. Recent Trends (2020-2024)

• 2020
  • Increased Demand for Immune-Boosting Products: The COVID-19 pandemic led to a surge in demand for health functional foods aimed at boosting the immune system.
  • Expansion of Non-Face-to-Face Market: Strengthened regulations due to the expansion of e-commerce and online markets; enhanced regulations against false and exaggerated advertisements on online platforms and expanded policies for consumer protection.
• 2021
  • Addition of Specific Functional Ingredients: Initiated additional research and recognition procedures for new functional ingredients; increased recognition of various plant-based ingredients in addition to already approved ones.
  • Strengthened Regulations for Overseas Direct Purchases: Enhanced import clearance procedures and amended related laws to ensure the safety of health functional foods purchased directly from overseas.
• 2022
  • Utilization of AI and Big Data: Introduced AI and big data technology for research and evaluation of health functional foods, improving the efficiency and accuracy of functionality and safety evaluations.
  • Customized Health Functional Foods: Developed customized health functional foods based on biological information and introduced personalized consulting services.
• 2023
  • Expanded Support for Small-Scale Manufacturers: Expanded government support programs for small and medium-sized enterprises (SMEs), providing technological support, consulting services, and financial aid to enhance competitiveness.
  • Enhanced Consumer Education: Expanded education programs and promotional campaigns to help consumers choose and use health functional foods correctly.
• 2024
  • International Cooperation and Harmonization: Strengthened cooperation with international food regulatory authorities and introduced a management system for health functional foods that aligns with global standards.
  • Emphasis on Sustainability: Formulated policies for the development of environmentally friendly health functional food materials and the establishment of sustainable supply chains.