This Rule aims to prescribe matters delegated by the Health Functional Food Act and its Enforcement Decree, and other matters necessary for their enforcement. It specifies detailed requirements including facility standards for different business types, procedures for business licensing and reporting, product manufacturing reports, obligations for business operators, appointment and duties of quality managers and personalized health functional food managers, education and training requirements, re-evaluation of functional ingredients, inspection and sampling, self-quality inspection, traceability management, administrative dispositions, and associated fees.

Content

• Article 1: Purpose

• Article 2: Facility Standards by Business Type

• Article 3: Application for Business License

• Article 4: Change of Licensed Matters

• Article 5: Report of Business, etc.

• Article 6: Change of Reported Matters

• Article 7: Report of Business Closure

• Article 8: Report of Product Manufacturing, etc.

• Article 9: Report of Change in Matters of Product Manufacturing Report

• Article 12: Matters to Be Observed by Business Operators

• Article 13: Report of Production Records

• Article 13-2: Report of Adverse Cases

• Article 15: Number of Quality Managers

• Article 16: Report of Appointment/Dismissal of Quality Managers

• Article 16-3: Number of Personalized Health Functional Food Managers

• Article 16-4: Report of Appointment/Dismissal of Personalized Health Functional Food Manager

• Article 17: Persons Subject to Education

• Article 18: Institutions, etc. Providing Education

• Article 19: Education Hours

• Article 20: Education Plans, etc.

• Article 20-2: Recognition of Standards, Specifications, Raw Materials or Ingredients

• Article 20-3: Scope of Disapproved Functionality

• Article 20-4: Criteria, Methods and Procedures for Re-evaluation

• Article 22: Access, Inspection, etc.

• Article 23: Quantity of Gratuitous Collection, Procedures for Request for Inspection, etc.

• Article 24: Request for Sanitary Inspection, etc. by Consumers, etc.

• Article 25: Self-Quality Inspection

• Article 25-2: Subjects, Procedures, Methods, etc. of Inspection of Raw Materials

• Article 25-3: Orders for Inspection, etc.

• Article 25-4: Standards for Manufacturing and Quality Control of Excellent Health Functional Foods, etc.

• Article 25-5: Selection Criteria for Excellent Business Places

• Article 29-2: Registration Criteria, etc. for Health Functional Food Traceability Management

• Article 29-3: Notification of Changes to Registered Information

• Article 29-4: Investigation and Evaluation of Compliance with Health Functional Food Traceability Management Standards, etc.

• Article 29-5: Eligible Recipients of Financial Support, etc.

• Article 29-6: Revocation, etc. of Registration for Health Functional Food Traceability Management

• Article 29-7: Registered Information

• Article 30: Application Documents for Authorization of the Establishment of an Organization

• Article 31: Standards for Administrative Dispositions, etc.

• Article 32: Register of Administrative Dispositions, etc.

• Article 33: Procedures for the Collection of Administrative Surcharges, etc.

• Article 35: Fees

• Article 35-2: Review of Regulations

• Article 36: Criteria for the Imposition of Administrative Fines