No. 13330
Promulgation Date 2015-05-18
Ministry of Food and Drug Safety
ALL
CHAPTER I GENERAL PROVISIONS
Article 1 (Purpose)
Article 2 (Obligations)
Article 3 (Definitions)
CHAPTER II BUSINESS
Article 4 (Business Types and Facility Standards)
Article 5 (Permission for Business, etc.)
Article 5 (Permission for Business, etc.)
Article 6 (Reporting, etc. on Business)
Article 7 (Reporting, etc. on Manufacturing Items)
Article 8
Article 9 (Restrictions on Permission for Business, etc.)
Article 10 (Matters to be Complied with by Business Entities)
Article 11 (Succession to Business)
Article 12 (Quality Control Managers)
Article 12 (Quality Control Managers)
Article 12-2 (Order to Replace Quality Control Manager)
Article 13 (Training)
Article 13 (Training)
CHAPTER III CRITERIA, STANDARDS, LABELS AND ADVERTISEMENTS
Article 14 (Criteria and Standards)
Article 15 (Recognition of Raw Materials, etc.)
Article 15-2 (Reassessment)
Article 16 (Deliberation on Labels or Advertisements regarding Functionality)
Article 16 (Deliberation on Labels or Advertisements regarding Functionality)
Article 16-2 (Filing Objections to Deliberation on Advertisements)
Article 17 (Labeling Standards)
Article 17-2 (Labeling, etc. of Genetically Modified Functional Health Foods)
Article 18 (Prohibiting False, Exaggerative, or Negative Labels or Advertisements)
Article 19 (Codes of Functional Health Foods)
Article 19 (Codes of Functional Health Foods)
CHAPTER IV INSPECTIONS, ETC.
Article 20 (Entry, Inspections, Collections, etc.)
Article 20-2 (Requests by Consumers, etc. for Hygiene Inspection, etc.)
Article 21 (Obligations of Self-Inspection for Quality Control)
Article 21-2 (Obligations, etc. to Inspect and Confirm Materials)
Article 21-3 (Order of Inspection, etc.)
CHAPTER V REGULATIONS FOR GOOD MANUFACTURING PRACTICE, ETC.
Article 22 (Regulations for Good Manufacturing Practice, etc.)
Article 22-2 (Registration Standards, etc. for Tracking Management of Records on Functional Health Foods)
CHAPTER VI PROHIBITION AGAINST SALE, ETC.
Article 23 (Prohibition against Sale, etc. of Harmful Health Functional Foods, etc.)
Article 24 (Prohibition against Sale, etc. of Functional Health Foods which Violate Criteria and Standards)
Article 24 (Prohibition against Sale, etc. of Health Functional Foods which Violate Criteria and Standards)
Article 25 (Prohibition against Sale, etc. of Health Functional Foods which Violate Labeling Standards)
Article 26 (Prohibition against Similar Labels, etc.)
CHAPTER VII HEALTH FUNCTIONAL FOODS DELIBERATION COMMITTEE AND ESTABLISHMENT OF ORGANIZATIONS
Article 27 (Health Functional Foods Deliberation Committee)
Article 28 (Establishment of Organizations)
CHAPTER VIII ADMINISTRATIVE SANCTIONS, INCLUDING CORRECTIVE ORDERS AND REVOCATION OF PERMISSION
Article 29 (Corrective Orders)
Article 30 (Disposition of Discard, etc.)
Article 30 (Disposition of Discard, etc.)
Article 31 (Orders, etc. to Repair Facilities)
Article 32 (Revocation, etc. of Permission for Business)
Article 32 (Revocation, etc. of Permission for Business)
Article 33 (Suspension, etc. of Manufacturing Items)
Article 34 (Succession to Effects of Administrative Sanctions)
Article 35 (Measures for Closure, etc.)
Article 36 (Hearings)
Article 37 (Imposition of Penalty Surcharges in Lieu of Suspension of Business)
Article 37 (Imposition of Penalty Surcharges in Lieu of Suspension of Business)
Article 37-2 (Imposition, etc. of Penalty Surcharges for Sale, etc. of Harmful Functional Health Foods, etc.)
Article 37-2 (Imposition, etc. of Penalty Surcharges for Sale, etc. of Harmful Health Functional Foods, etc.)
Article 37-3 (Publication of Violations)
CHAPTER IX SUPPLEMENTARY PROVISIONS
Article 38 (Relationships with other Acts)
Article 39 (State Subsidies)
Article 40 (Payment of Monetary Rewards)
Article 41 (Delegation or Entrustment of Authority)
Article 42 (Fees, etc.)
Article 42-2 (Legal Fiction as Public Officials in Application of Penalty Provisions)
CHAPTER X PENALTY PROVISIONS
Article 43 (Penalty Provisions)
Article 43 (Penalty Provisions)
Article 44 (Penalty Provisions)
Article 44 (Penalty Provisions)
Article 45 (Penalty Provisions)
Article 45 (Penalty Provisions)
Article 46 (Joint Penalty Provisions)
Article 47 (Administrative Fines)
Article 47 (Administrative Fines)
Article 48 (Special Cases concerning Application of Provisions on Administrative Fines)
ADDENDA
ADDENDUM <Act No. 7211, Mar. 22, 2004>
ADDENDA <Act No. 7428, Mar. 31, 2005>
ADDENDUM <Act No. 8033, Oct. 4, 2006>
ADDENDA <Act No. 8365, Apr. 11, 2007>
ADDENDA <Act No. 8852, Feb. 29, 2008>
ADDENDUM <Act No. 8941, Mar. 21, 2008>
ADDENDA <Act No. 9932, Jan. 18, 2010>
ADDENDA <Act No. 10128, Mar. 17, 2010>
ADDENDA <Act No. 10219, Mar. 31, 2010>
ADDENDUM <Act No. 11508, Oct. 22, 2012>
ADDENDA <Act No. 11690, Mar. 23, 2013>
ADDENDA <Act No. 11985, Jul. 30, 2013>
ADDENDUM <Act No. 12106, Aug. 13, 2013>
ADDENDUM <Act No. 12389, Jan. 28, 2014>
ADDENDA <Act No. 12669, May 21, 2014>
ADDENDA <Act No. 13201, Feb. 3, 2015>
ADDENDA <Act No. 13330, May 18, 2015>
ADDENDA <Act No. 14018, Feb. 3, 2016>