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ENFORCEMENT DECREE OF THE HEALTH FUNCTIONAL FOODS ACT

Presidential Decree No. 18164, Dec. 18, 2003

Amended by Presidential Decree No. 19513, jun. 12, 2006

Presidential Decree No. 19836, Jan. 18, 2007

Presidential Decree No. 20679, Feb. 29, 2008

Presidential Decree No. 21023, Sep. 22, 2008

Presidential Decree No. 21214, Dec. 31, 2008

Presidential Decree No. 22075, Mar. 15, 2010

Presidential Decree No. 22132, Apr. 20, 2010

Presidential Decree No. 22495, Nov. 18, 2010

Presidential Decree No. 22792, Mar. 30, 2011

Presidential Decree No. 23488, Jan. 6, 2012

Presidential Decree No. 23907, jun. 29, 2012

Presidential Decree No. 23947, Jul. 10, 2012

Presidential Decree No. 24454, Mar. 23, 2013

Presidential Decree No. 25294, Apr. 1, 2014

Presidential Decree No. 25752, Nov. 11, 2014

Presidential Decree No. 26244, May 18, 2015

Presidential Decree No. 26844, Dec. 31, 2015

Presidential Decree No. 26936, Jan. 22, 2016

 Article 1 (Purpose)
The purpose of this Decree is to provide for matters delegated by the Health Functional Foods Act (hereinafter referred to as the “Act”) and matters necessary for the enforcement thereof. <Amended by Presidential Decree No. 19836, Jan. 18, 2007>
 Article 2 (Type of Business)
The detailed types of business and the business scope under Article 4 (2) of the Act shall meet the following requirements: <Amended by Presidential Decree No. 19836, Jan. 18, 2007; Presidential Decree No. 23907, Jun. 29, 2012; Presidential Decree No. 23947, Jul. 10, 2012; Presidential Decree No. 25725. Nov. 11, 2014>
1. Manufacturing of health functional foods:
(a) Specialized manufacturing business of health functional foods: Business specializing in manufacturing heath functional food;
(b) Manufacturing venture business of health functional foods: Manufacturing business that a venture business under Article 2 of the Act on Special Measures for the Promotion of Venture Businesses outsources to a specialized manufacturer (limited to a specialized manufacturer designated as a business place in compliance with Good Manufacturing Practice under Article 22 (2) of the Act) under item (a);
2. Deleted; <by Presidential Decree No. 26936, Jan. 22, 2016>
3. Selling health functional foods:
(a) General sale of health functional foods: Business selling health functional foods. Provided, this shall not apply where distribution specialty selling heath functional foods under (b);
(b) Specialized distribution sale of health functional foods: Business distributing and selling health functional foods upon request of a specialized manufacturer of health functional foods (limited to manufacturer designated as a business place in compliance with the Good Manufacturing Practice under Article 22 (2) of the Act) prescribed in paragraph 1 (a) and manufacturing using its trademark.
 Article 3 (Permission for Change in Permitted Matters)
Modification that shall be permitted as prescribed in the latter part of Article 5 (1) of the Act means change of business places.
 Article 4 (Qualifications for Quality Control Managers)
Qualifications for a quality control manager of Article 12 (5) of the Act shall be as follows: <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 22495, Nov. 18, 2010; Presidential Decree No. 24454, Mar. 23, 2013; Presidential 25725. Nov. 11, 2014>
1. Any person qualified for professional engineer food stuff under the National Technical Qualifications Act;
2. Any person qualified for engineer food processing under the National Technical Qualifications Act and has experience of one year or more in business (When a quality control manager who works for manufacturing venture business of health functional foods under Article 2 (1) b, research of health functional foods etc. shall be included; the same shall apply in this Article) manufacturing health functional foods and its raw material or ingredient (hereafter in this Article referred to as “health functional foods etc.” ), and other general food or food additives;
3. Any person who has earned a bachelor’s degree (including anyone recognized by the provisions of statutes to hold the same academic background or higher; the same shall apply in this Article) from any school under subparagraphs of Article 2 of the Higher Education Act (excluding a college under subparagraph 4 of the same Article; hereinafter referred to as “university, etc.”) with food-related majors including food processing, food chemistry, food manufacturing, food engineering, food science, food and nutritional science, hygienics, fermentation technology, agricultural chemistry, microbiology, genetic engineering, biotechnology, etc. (hereafter “food-related area” in this Article) or any person who is qualified for an industrial engineer food processing under the National technical Qualifications Act and has experience of three years or more in manufacturing health functional foods etc.;
4. Any person who holds a bachelor’s degree of food-related area in university etc. and holds a master’s degree of food-related area or higher in graduate school (referred to as “graduate school” in this Article) under the Article 29 of the Higher Education Act and has experience of one year or more in manufacturing health functional food etc.;
5. Any person who has earned a bachelor’s degree in major not related to food and holds a master’s degree of food-related area, and has experience of three years or more in manufacturing health functional foods etc.;
6. Any junior college graduate (including those with equivalent degrees recognized by the provisions of statutes) under Article 2 (4) who majored in food-related area and has experience in manufacturing health functional foods etc. for five years (four years for those who has graduated from a three?year junior college, under Article 48 (1) of the Higher Education Act) or more;
7. Any person who is a high school or high technical school graduate (including those with equivalent degrees recognized by the provisions of statutes) under Article 2 (4) of the Elementary and Secondary Education Act and has experience of eight years or more in manufacturing health functional foods etc.;
8. Any other person recognized to meet qualifications under subparagraphs 1 or 7 or to have higher degrees or more experience, and designated and announced by the Minister of Food and Drug Safety.
[This Article Wholly Amended by Presidential Decree No. 19836, Jan. 18, 2007]
 Article 5 (The Duties of Quality Control Managers)
The duties of a quality control manager under Article 12 (5) of the Act shall be as follows:
1. Ensuring the stability of the health functional foods;
2. Quality control of products and raw material by self-inspection for quality control under Article 21 of the Act;
3. Health management of manufacturing facilities and products;
4. Guidance, supervision, education, and training of employees.
 Article 5-2 (Entrustment of Deliberation on Advertisement)
The Minister of Food and Drug Safety shall entrust deliberation on functionality labelling and advertisement of health functional foods to an organization designated and notified by the Minister of Food and Drug Safety among the organizations established under Article 16 (2) of the Act.
[This Article Newly Inserted by Presidential Decree No. 25725, Nov. 11, 2014]
 Article 6 (The Heads of Affiliated Organizations)
“The heads of affiliated organizations prescribed by Presidential Decree” of Article 20 (1) of the Act means the Commissioner of the Regional Food and Drug Safety. <Amended by Presidential Decree No. 19836, Jan. 18, 2007; Presidential Decree No. 22132, Apr. 20, 2010>
 Article 7 (Composition of Health Functional Food the Deliberation Committee)
(1) The Health Functional Food Deliberation Committee (hereinafter referred to as “the Deliberation Committee”) under Article 27 of the Act shall be composed of no less than 30 or no more than 80 members including a chairperson and two vice chairpersons.
(2) The chairperson shall be elected by the Committee from among its members, and the vice chairpersons shall be designated by the chairman.
(3) The members shall fall under any of the following: <Amended by Presidential Decree No. 19513, Jun. 12, 2006; Presidential Decree No. 19836, Jan. 18, 2007; Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24454, Mar. 23, 2013>
1. Any person appointed by the Minister of Food and Drug Safety among public officials of Class V or above in charge of related work or public officials in general service belonging to Senior Civil Service Corps;
2. Any person appointed by the Minister of Food and Drug Safety from among any of the following persons:
(a) Any person who has extensive knowledge and experience in food, drug, nutrition, and health and medical service;
(b) Any person recommended by the heads of health functional food related organizations, civic groups (referring to non-profit, non-governmental organization under the Article 2 of the Assistance for Non-profit, Non-governmental Organizations Act), academic societies related health functional foods, or colleges.
(4) The term of office of each member prescribed in paragraph (3) 1 shall be the term of his/her service, and that of each member in subparagraph 2 of the same paragraph shall be two years.
 Article 7-2 (Dismissal of Member of Deliberation Committee)
The Minister of Food and Drug Safety may dismiss a member of the Deliberation Committee referred to in Article 7 (3) 2, if he/she falls under any of the following cases:
1. Where he/she is unable to perform his/her duties due to a mental disorder;
2. Where he/she engages in misconduct in relation to his/her duties;
3. Where he/she is deemed inappropriate for a member of the Deliberation Committee due to neglect of duties, injury to dignity, or other reason;
4. Where he/she voluntarily expresses the intention that it is impracticable to perform his/her duties.
[This Article Newly Inserted by Presidential Decree No. 26844, Dec. 31, 2015]
 Article 8 (Operation of the Deliberation Committee)
(1) The chairperson shall represent the Deliberation Committee and control work of the Deliberation Committee.
(2) The vice chairpersons shall assist the chairman, and a vice chairperson designated by the chairperson shall execute duties on behalf of him/her when he/she is unable to perform duties owing to unavoidable circumstances.
(3) The chairperson shall call and preside a meeting of the Deliberation Committee.
(4) A majority of the members of the Deliberation Committee shall constitute a quorum, and any decision thereof shall require the concurring vote of at least a majority of those present.
(5) The chairperson shall call a meeting without delay when the Minister of Food and Drug Safety or one third or more of the members require calling a meeting. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24454, Mar. 23, 2013>
 Article 9 (Subcommittee)
(1) the Deliberation Committee may have a subcommittee by a special sector in order to achieve the duty efficiently.
(2) Decided matters by the subcommittee shall be reported to the chairperson and deliberated by the Deliberation Committee: Provided, That if the chairperson deems matters minor, a resolution by the subcommittee may be in lieu of a resolution by the Deliberation Committee.
 Article 10 (Researcher)
(1) the Deliberation Committee may have 20 researchers or less in order to investigate and research criteria, standard, labels, and advertisements of health functional foods.
(2) Researchers shall be appointed by the Minister of Food and Drug Safety from among those who have rich knowledge and experience in health functional foods, food, etc. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24454, Mar. 23, 2013>
(3) Researchers may attend and speak in the Deliberation Committee or subcommittee.
 Article 11 (Listening to Opinion)
The chairperson may listen to opinion by requesting a relevant person to attend when he/she recognizes the need for deliberation on matters of the Deliberation Committee or subcommittee.
 Article 12 (Administrative Secretary)
(1) The Deliberation Committee shall have one administrative secretary in order to manage business of the Deliberation Committee.
(2) An administrative secretary shall be appointed by the Minister of Food and Drug Safety from among public officials of the Ministry of Food and Drug Safety. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. Mar. 15, 2010; presidential Decree No. 24454, Mar. 23, 2013>
 Article 13 (Reporting)
The chairperson shall report deliberated matters by the Deliberation Committee to the Minister of Food and Drug Safety without delay. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. Mar. 15, 2010; presidential Decree No. 24454, Mar. 23, 2013>
 Article 14 (Allowance and Traveling Expenses)
(1) Members who attend the Deliberation Committee shall be paid with an allowance, traveling expenses, and other necessary expenses within budgetary limits: Provided, That this shall not apply where the member who is a public official attends due to an affair directly related to his/her duties.
(2) the Minister of Food and Drug Safety may grant investigation and research expenses and required expenses within budgetary limits to a researcher. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. Mar. 15, 2010; presidential Decree No. 24454, Mar. 23, 2013>
 Article 15 (Detailed Rules of Operation)
Operational matters of the Deliberation Committee except those expressly prescribed in this Decree and necessary matters for researchers' service shall be designated by the Minister of Food and Drug Safety. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. Mar. 15, 2010; presidential Decree No. 24454, Mar. 23, 2013>
 Article 16 (Authorization of Organizations)
(1) “Type of business prescribed by Presidential Decree” in the Article 28 (1) of the Act means business types under Article 2.
(2) Anyone who intends to obtain authorization from organizations under Article 28 (3) of the Act shall submit documents prescribed by Ordinance of the Prime Minister (including electronic documents) to the Minister of Food and Drug Safety. <Amended by Presidential Decree No. 19836, Jan. 18, 2007; Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. Mar. 15, 2010; presidential Decree No. 24454, Mar. 23, 2013>
 Article 17 (Time of Disposition)
Where the Minister of Food and Drug Safety or the Mayor of a Special Self-Governing Province or the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu (referring to the head of a Self-Governing Gu; hereinafter referred to as “the head of a Si/Gun/ Gu”) holds a hearing under Article 36 of the Act in order to render a disposition such as revocation of permission for business, shutdown of business place, suspension of manufacturing of the items or the relevant types of items etc., or receives submission of opinion under the Article 27 of the Administrative Procedures Act, he/she shall render a disposition within 14 days from the date when the relevant procedure is finished in the absence of special circumstances. <Amended by Presidential Decree No. 19836, Jan. 18, 2007; Presidential Decree No. 21023, Sep. 22, 2008; Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 26244, May 18, 2015>
 Article 18 (Classification of Violation and the Amount of Penalty Surcharge)
The amount of penalty surcharge under Article 37 (2) of the Act shall be calculated by applying criteria for calculation of penalty surcharge of attached Table 1 based on the period of business suspension, and period of suspension of manufacturing the items or the relevant types of items prescribed by Ordinance of the Prime Minister, having regard to classification and degree of violation. <Amended by Presidential Decree No. No. 20679, Feb. 29, 2008; Presidential Decree No. Mar. 15, 2010; presidential Decree No. 24454, Mar. 23, 2013>
 Article 19 (The Imposition of Penalty Surcharges and Payment Procedure)
(1) The Minister of Food and Drug Safety or the head of a Si/Gun/Gu shall clarify classification of violation and the amount of penalty surcharge and give written notice of payment when he/she intends to impose penalty surcharges under Article 39 of the Act. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; presidential Decree No. 24454, Mar. 23, 2013>
(2) Anyone informed under paragraph (1) shall pay penalty surcharges to a collecting agency designated by the Minister of Food and Drug Safety or the head of a Si/Gun/Gu within 20 days from the date when he/she is notified of the payment: Provided, That if he/she is unable to pay the surcharge by the deadline owing to unavoidable circumstances such as a natural disaster, he/she shall pay within 7 days from the date when the reason ceases to exist. <Amended by Presidential Decree No. 21023, Sep. 22, 2008; presidential Decree No. 24454, Mar. 23, 2013>
(3) In receipt of penalty surcharges under paragraph (2), the collecting agency shall deliver a receipt to the payer, and notify the fact of payment to the Minister of Food and Drug Safety or the head of a Si/Gun/Gu without delay. <Amended by Presidential Decree No. 21023, Sep. 22, 2008; presidential Decree No. 24454, Mar. 23, 2013>
(4) The Procedure of collection of penalty surcharges shall be prescribed by Ordinance of the Prime Minister. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential No. 24454, Mar. 23, 2013>
(5) Deleted. <by Presidential Decree No. 21023, Sep. 22, 2008>
 Article 19-2 (Criteria for Calculating Penalty Surcharges of Selling Harmful Health Functional Food etc.)
(1) The amount of a penalty surcharge imposed under Article 37-2 (1) of the Act shall be calculated by multiplying the sales volume by the selling price of harmful health functional food sold by any person under subparagraphs of Article 37-2 (1) of the Act.
(2) The sales volume under paragraph (1) shall be calculated between the time of initially selling harmful health functional food and the time of being uncovered excluding amount not sold for a reason of recall, refund, checkup, etc. from the total shipments, and the selling price under the same paragraph shall be calculated by each point of the time of the sale if the price has changed during the selling period.
[This Article Newly Inserted by Presidential Decree No. 26244, May 18, 2015]
 Article 19-3 (Payment of Monetary Reward)
(1) Pursuant to the Article 40 (1) of the Act, anyone who intends to report persons who have violated Articles 5 (1), 6 (2), and 23 through 26 of the Act shall report to the Minister of Food and Drug Safety or the head of a Si/Gun/Gu as described by the Minister of Food and Drug Safety. <Amended by Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 26936, Jan. 22, 2016>
(2) The investigation agency which has been filed an accusation under Article 40 (1) of the Act shall notify the fact to the Minister of Food and Drug Safety or the head of a Si/Gun/Gu without delay: Provided, That this shall not apply where such investigation agency recognizes that such accusation may not be notified to the Minister of Food and Drug Safety or the head of a Si/Gun/Gu for the reason that the accusation is false or already disclosed to the public through news media, or for other reasons. <Amended by Presidential Decree No. 24454, Mar. 23, 2013>
(3) In receipt of a report or notification under paragraphs (1) and (2), the Minister of Food and Drug Safety or the head of a Si/Gun/Gu shall decide whether to pay a reward after examining the details of such report or accusation, and inform the person who has filed an accusation or report of the decision. <Amended by Presidential Decree No. 24454, Mar. 23, 2013>
(4) Where a person who has reported or accused is informed of the decision on the reward payment under paragraph (3) shall apply for the payment of a reward to the Minister of Food and Drug Safety or the head of a Si/Gun/Gu as decided and notified by the Minister of Food and Drug Safety. <Amended by Presidential Decree No. 24454, Mar. 23, 2013>
(5) The Minister of Food and Drug Safety or the head of a Si/Gun/Gu shall pay a reward to a reporter and accuser within one month from the time he/she applies for the payment of a reward under paragraph (4). <Amended by Presidential Decree No. 24454, Mar. 23, 2013>
(6) The amount of rewards under paragraph (5) shall be decided and notified by the Minister of Food and Drug Safety within the following amounts: <Amended by Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 26936, Jan. 22, 2016>
1. Any case of report on or accusation of violations under Articles 5 (1) or 23 of the Act: 500,000 won;
2. Any case of report on or accusation of violations under Articles 6 (2), 24 (1), 25 or 26 of the Act: 200,000 won;
3. Any case of report on or accusation of violations under Article 24 (2) and (3): 10 million won.
(7) The same report or accusation filed on the violation of which a report or accusation has already been filed under Article 40 (1) shall not be paid with a reward; and where report or accusation filed by a joint name of at least two people, a delegator thereof shall be designated and a reward shall be paid to such delegator.
(8) Matters necessary for the standards, methods, and procedures for paying rewards under paragraphs (1) through (7) shall be decided and notified by the Minister of Food and Drug Safety. <Amended by Presidential Decree No. 24454, Mar. 23, 2013>
[This Article Newly Inserted by Presidential Decree No. 21023, Sep. 22, 2008]
 Article 20 (Delegation or Entrustment etc. of Authority)
(1) The Minister of Food and Drug Safety shall entrust his/her authority for the following matters under Article 41 (1) of the Act to the head of a Regional Ministry of Food and Drug Safety: <Amended by Presidential Decree No. 22495, Nov. 18, 2010; Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 25294, Apr. 1, 2014>
1. Permission for business or revision of permission, and reporting on business closedown or revisions related to manufacturing business of health functional foods under Article 5 (1) and (2) of the Act;
2. Deleted; <Amended by Presidential Decree No. 26244, May 18, 2015>
3. Report on manufacturing items and revisions under Article 7 (1) of the Act;
4. Deleted; <by Presidential Decree No. 26936, Jan. 22, 2016>
5. Report on production records etc. under Article 10 (2) of the Act;
6. Report on succession to the status of any former business entity under Article 11 (3) of the Act;
7. Report on appointment or dismissal of quality control managers under Article 12 (4) of the Act;
8. Orders to entrust inspection under Article 21 (2) of the Act;
9. Designation and public notification of a business place in compliance with the Good Manufacturing Practice Regulations under Article 22 (2) of the Act or an order to cancel the designation and a corrective order under paragraph (4) of the same Article:
9-2. Registration or reporting revisions of follow-up management of records on health functional foods under Article 22-2 (1) and (3) of the Act;
9-3. Inspection and evaluation of conformity to the standards for tracking management of records of health functional foods under Article 22-2 (5) of the Act;
9-4. An order to cancel registration or a corrective order by any person who has obtained registration of tracking management of records on health functional foods under Article 22-2 (7) of the Act;
10. Disposition, etc. of administrative sanctions under Articles 29 through 33, 35, 36 or 38 (2) of the Act;
11. Imposing or collecting penalty surcharges or administrative fines under Article 37 or 47 of the Act;
12. Payment of rewards under Article 40 of the Act.
(2) Under the Article 41 (1) of the Act, the Minister of Food and Drug Safety entrusts his/her authority (limited to business operator of manufacturing health functional foods under Article 4 (1) 1) for the following matters to a Special Metropolitan City Mayor, a Metropolitan City Mayor, a Metropolitan Autonomous City Mayor, a Do Governor, the Governor of a Special Self-Governing Province: <Amended by Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 26244, May 18, 2015>
1. Checkup on observance of requirements for business entities under Article 10 (1) of the Act;
2. Checkup on violations of prohibiting false or exaggerative label or advertisement of Article 18 (1) of the Act;
3. Checkup on observance of obligations for inspections under Article 21 (1) and (2);
4. Reporting, entry, inspections, collections, and perusal under Article 20 to conduct duties under subparagraphs 1 through 3.
(3) When a Special Metropolitan City Mayor, a Metropolitan City Mayor, a Metropolitan Autonomous City Mayor, a Do Governor, or the Governor of a Special Self-Governing Province checks and finds out violations under paragraph (2), he/she shall report the results to the heads of competent Regional Food and Drug Safety. <Amended by Presidential Decree No. 26244, May 18, 2015>
(4) The head of the Regional Food and Drug Safety informed of the results under paragraph (3) shall take necessary measures including disposition of administrative sanction, etc.
[This Article Wholly Amended by 22132, Apr. 20, 2010]
 Article 20-2 (Management of Sensitive Information or Personally Identifiable Information)
The Minister of Food and Drug Safety (including the person entrusted with the authority of the Minister of Food and Drug Safety under Article 20) or the head of a Si/Gun/Gu may manage data including information on health under Article 23 of the Personal Information Protection Act, information about data of criminal records under Article 18 (2) of the Enforcement Decree on the same Act, resident registration number or foreign registration number under Article 19 (1) or (4) of the same Decree when they are unevitably necessary to perform the following affairs: <Amended by Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 25294, Apr. 1, 2014; Presidential Decree No. 26244, May 18, 2015>
1. Affairs concerning permission for business and revision thereof, reporting and revisions thereof under Article 5 or 6 of the Act;
2. Affairs concerning confirmation of restriction on permission for business, etc. under Article 9 of the Act;
3. Affairs concerning reporting succession to business under Article 11 (3) of the Act;
4. Affairs concerning entry, inspections, collections, etc. under Article 20 of the Act;
5. Affairs concerning the registration, reporting revisions, inspection and evaluation, fund support, revocation of registration or corrective order for tracking management of records on health functional foods, under Article 22-2 of the Act;
6. Affairs concerning imposition of administrative sanctions under Article 29 through 37 of the Act;
7. Affairs concerning payment of reward under Article 40 of the Act.
[This Article Newly Inserted by Presidential Decree No. 23488, Jan. 6, 2012]
 Article 21 (Standards for Imposition of Administrative Fines)
The standards for imposition of administrative fines under the Article 47 (1) of the Act shall be as prescribed in attached Table 2.
[This Article Wholly Amended by 22792, Mar. 30, 2011]
ADDENDA
(1) This Decree shall enter into force on the date of its promulgation.
(2) (Transitional Measures concerning Reporting Business of Selling Health Functional Foods)
When any person who has sold health functional foods or reported Distribution specialty sale under Article 13 of Enforcement Decree on the Food Sanitation Act shall have proper facilities for each type of business for standards as prescribed by the Ministry of Health and Welfare and report within six months.
(3) Omitted.
ADDENDA <Presidential Decree No. 19513, Jun. 12, 2006>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 1, 2006.
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 19836, Jan. 18, 2007>
This Decree shall enter into force the date of its promulgation.
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force the date of its promulgation.
Articles 2 through 9 Omitted.
ADDENDA <Presidential Decree No. 21023, Sep. 22, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force the date of its promulgation.
Articles 2 (Transitional Measures concerning Reporting or Inspection on Import of Health Functional Foods)
Acts to the head of National Quarantine Station on reporting or inspection on import of health functional foods under clues of previous Article 20 (1) 2 or (3) or acts by the head of National Quarantine Station at the time this Decree enters into force, shall be deemed acts to The Commissioner of the Regional Food and Drug Safety or acts by The Commissioner of the Regional Food and Drug Safety under revised regulations of Article 20.
ADDENDA <Presidential Decree No. 21214, Dec. 31, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
Articles 2 Omitted.
ADDENDUM <Presidential Decree No. 22132, Apr. 20, 2010>
This Decree shall enter into force on May 1, 2010.
ADDENDUM <Presidential Decree No. 22495, Nov. 18, 2010>
This Decree shall enter into force on the date of its promulgation: Provided, That the amended provisions of Article 20 (1) 2 shall enter into force on January 1, 2011.
ADDENDA <Presidential Decree No. 22792, Mar. 30, 2011>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 (Transitional Measures concerning and Administrative Fines)
(1) The application of standards of imposing administrative fines for acts done before this Decree enters into force shall be governed by the previous provisions despite amended provisions of attached Table 2.
(2) Disposition of imposing fines for violations done before this Decree enters into force shall not be included disposition of imposing fines under amended provisons of 3) of (c) of subparagraph 1 of attached Table.
ADDENDUM <Presidential Decree No. 23488, Jan. 6, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into on the date of its promulgation. (Proviso Omitted.)
Articles 2 Omitted.
ADDENDUM <Presidential Decree No. 23907, Jun. 29, 2012>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 23947, Jul. 10, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on August 18, 2012.
Articles 2 through 8 Omitted.
ADDENDA <Presidential Decree No. 24454, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into on the date of its promulgation. (Proviso Omitted.)
Articles 2 and 4 Omitted.
ADDENDUM <Presidential Decree No. 25294, Apr. 1, 2014>
This Decree shall enter into force on July 1, 2014: Provided, That the amended provisions of Article 20-2 (5) shall enter into force the date of its promulgation.
ADDENDUM <Presidential Decree No. 25725, Nov. 11, 2014>
This Decree shall enter into force on November 11, 2014: Provided, That the amended provisions of Article 2 (3) 1 shall enter into force on March 1, 2015.
ADDENDA <Presidential Decree No. 26244, May 18, 2015>
Article 1 (Enforcement Date)
This Decree shall enter into force on May 22, 2015.
Articles 2 (Applicable Example of Estimated Standard on Selling Harmful Health Functional Foods etc.)
The amended provisions of Article 19 (2) shall be applied to anyone who comes under imposition of penalty surcharges under Article 37 (2) 1 of the Act in violations of Article 18 (1) 1, subparagraphs 2, 3, 5, 6 of Article 23, or Article 24 (2) of the Act first after this Decree enters into force. In this case, sales volumes shall be estimated beginning with the sales after this Decree enters into force.
ADDENDUM <Presidential Decree No. 26844, Dec. 31, 2015>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 26936, Jan. 22, 2016>
Article 1 (Enforcement Date)
This Decree shall enter into force on February 4, 2016.
Articles 2 through 4 Omitted.