This enforcement regulation is applicable to all kinds of health (functional) foods in Korea.This regulation includes the entrusted affairs and other affairs thereof in Health Functional Food Act and Enforcement Decree of The Health Functional Food Act. It includes detailed information of terminology and definition of health food, business types and facility standards, permission for business, reporting, criteria and standards, recognition of raw materials, label, advertisement, inspection, good manufacturing practice regulation etc.

Law Hierarchy

• Main Act: Health Functional Food Act

• Enforcement decree: Enforcement Decree of The Health Functional Food Act

• Enforcement rule: Enforcement Rule of Health Functional Food Act

• Subordinate regulations: Health Functional Food Good Manufacturing Practice (GMP); Food Traceability Management Standard; Requirements on Food, etc. Subject to an Inspection Order; Food, Food Additives, Livestock Product and Health Functional Food Shelf Life Determination; Regulation on Certification of Functional Ingredients and Specification; Labeling Standard of Health Functional Food. 

Contents:

• Article 1 (Purpose)

• Article 2 (Facility Standards by Industry)

• Article 3 (Application for Business License)

• Article 4 (Changes to Permit Matters)

• Article 5 (Notification of Business Operations, etc.)

• Article 6 (Changes to Reported Matters)

• Article 7 (Business Closure Report)

• Article 8 (Notification of Item Manufacturing, etc.)

• Article 9 (Notification of Changes to Item Manufacturing Report)

• Article 10 deleted 

• Article 10-2 deleted

• Article 11 deleted

• Article 12 Obligations of Business Operators

• Article 13 Reporting of Production Performance

• Article 14 Notification of Business Succession by the Operator

• Article 15 (Number of Quality Managers)

• Article 16 (Notification of Appointment or Dismissal of Quality Manager)

• Article 17 (Educational Participants)

• Article 18 (Educational Institutions, etc.)

• Article 19 (Education Hours)

• Article 20 (Education Plan, etc.)

• Article 21 Deleted

• Article 22 (Entry and Inspection, etc.

• Article 23 (Procedures for Free Collection Amounts and Inspection Requests, etc.)

• Article 24 (Request for Hygiene Inspection by Consumers, etc.)

• Article 25 (Self-Quality Inspection) 

• Article 26 deleted

• Article 27 deleted

• Article 28 deleted

• Article 29 deleted

• Article 30 (Application Documents for Approval of Establishing an Organization)

• Article 31 (Standards for Administrative Disposition, etc.)

• Article 32 (Register of Administrative Dispositions, etc.)

• Article 33 (Procedures for Collecting Fines, etc.)

• Article 34 Deleted

• Article 35 (Fees)

• Article 36 (Criteria for Imposing Fines)