Individually Approved Health Functional Foods

1. Definition of Individually Approved Health Functional Foods

Individually approved health functional foods are those for which a manufacturer has provided sufficient scientific evidence and has received individual approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for their efficacy and safety. This definition is based on the "Health Functional Food Act" and its enforcement regulations. Only products that have obtained this individual approval can claim specific health benefits, allowing consumers to understand the efficacy of these products clearly.

2. Legal Basis and History

1. Health Functional Food Act (1999)
   • Basis: Enactment of the "Health Functional Food Act".
   • Content: This act established the legal framework for defining and managing health functional foods. It was enacted to ensure the quality and safety of health functional foods and to promote public health.
2. Enforcement Rules of the Health Functional Food Act (2002 Amendment)
   • Basis: Article 5 of the "Enforcement Rules of the Health Functional Food Act".
   • Content: The concept of individually approved functional foods was introduced, and functionality claims became permissible. Manufacturers were allowed to apply for individual approval of specific products based on scientific research data.
3. Enforcement Rules of the Health Functional Food Act (2005 Re-amendment)
   • Basis: Articles 7 and 8 of the "Enforcement Rules of the Health Functional Food Act".
   • Content: Application procedures and review criteria for individually approved functional foods were further specified. Requirements for preclinical and clinical data to prove safety and efficacy were established.
4. Enforcement Rules of the Health Functional Food Act (2015 Re-amendment)
   • Basis: Article 10 of the "Enforcement Rules of the Health Functional Food Act".
   • Content: The review criteria for individually approved functional foods were tightened. Essential elements now included a robust scientific basis and mandatory safety evaluation materials from both domestic and international sources.
5. MFDS Notification (2018 Establishment)
   • Basis: "Regulations on Application and Review of Individually Approved Functional Foods".
   • Content: The procedures for the application and review of individually approved functional foods were clearly defined. Emphasis was placed on examples from abroad and reinforced safety evaluations, ensuring transparency and objectivity in the review process.
6. Improvement Plan for the Review Standards and Procedures of Individually Approved Functional Foods (2020 Release)
   • Basis: "Improvement Plan for the Review Standards and Procedures of Individually Approved Functional Foods".
   • Content: New review criteria incorporating the latest scientific data were introduced. An expert review committee was established to participate in the review process from the initial stages. The credibility evaluation standards for preclinical and clinical data were strengthened.

Major Regulatory Changes by Year

• 1999: Establishment of the Act providing the basic framework for managing health functional foods.
• 2002: Introduction of functionality claims and the concept of individually approved health functional foods (Amendment to the Act).
• 2005: Enhanced procedures and criteria, including requirements for preclinical and clinical data (Re-amendment to the Act).
• 2015: Strengthened requirement for scientific evidence and mandatory domestic and international safety evaluations (Re-amendment to the Act).
• 2018: Clearly defined application and review procedures with enhanced transparency (MFDS Notification establishment).
• 2020: Incorporation of the latest standards and involvement of expert review committees (Release of Improvement Plan).

Through these legal grounds and historical developments, individually approved health functional foods have met stringent scientific and regulatory standards, thereby gaining consumer trust in their efficacy and safety.