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
Presidential Decree No. 27178, May 17, 2016
Presidential Decree No. 27826, Jan. 31, 2017
Presidential Decree No. 27960, Mar. 27, 2018
Presidential Decree No. 28809, Apr. 17, 2018
Presidential Decree No. 29622, Mar. 14, 2019
Presidential Decree No. 29974, Jul. 9, 2019
Presidential Decree No. 30545, Mar. 24, 2020
Presidential Decree No. 30754, jun. 2, 2020
Presidential Decree No. 31380, Jan. 5, 2021
The purpose of this Decree is to provide for the matters mandated by the Health Functional Foods Act and matters necessary for the enforcement thereof. <Amended on Jan. 18, 2007>
| Article 2 (Types of Business) |
The detailed types of business and the business scope under Article 4 (2) of the Health Functional Foods Act (hereinafter referred to as the “Act”) shall meet the following requirements: <Amended on Jan. 18, 2007; Jun. 29, 2012; Jul. 10, 2012; Nov. 11, 2014; Jan. 31, 2017> | 1. | Manufacturing health functional foods: |
| (a) | Specialized business of manufacturing health functional foods: Business specialized in manufacturing heath functional foods; |
| 2. | Deleted; <Jan. 22, 2016> |
| 3. | Selling health functional foods: |
| (a) | General sales business of health functional foods: Business of selling health functional foods: Provided, That this shall not apply to distribution-specialized sales business of heath functional foods referred to in item (b); |
| (b) | Distribution-specialized sales business of health functional foods: Business of distributing and selling, under its brand, the health functional foods a specialized manufacturer referred to in subparagraph 1 (a) has manufactured under outsourcing contracts. |
| 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 3-2 (Publication of Outcomes of Risk Assessment) |
Where the Minister of Food and Drug Safety publishes the results of examination and analysis of causal relations, etc. of the safety and abnormal cases of health functional foods (referring to signs, symptoms, or diseases which are neither desirable nor deliberate and suspected to have been caused by health functional foods; hereinafter the same shall apply) under Article 10-2 (3) of the Act, the Minister shall publish it on the website within seven days from the date the relevant investigation and analysis is completed. [This Article Newly Inserted on Jun. 2, 2020]
| Article 3-3 (Entrustment of Duties of Receipt of Reports on Abnormal Cases) |
| 2. | Examination and analysis of causal relations, etc. of the safety and abnormal cases of health functional foods under Article 10-2 (2) of the Act. |
[This Article Newly Inserted on Jun. 2, 2020]
| Article 4 (Qualifications for Quality Control Managers) |
Qualifications for a quality control manager under Article 12 (1) of the Act (hereinafter referred to as “quality control manager”) shall be as follows: <Amended on Feb. 29, 2008; Mar. 15, 2010; Nov. 18, 2010; Mar. 23, 2013; Nov. 11, 2014; Jan. 31, 2017; Apr. 17, 2018; Jun. 2, 2020> | 2. | Any person who has at least one year of experience in manufacturing health functional foods and their raw materials or ingredients and other general food or food additives (hereafter referred to in this Article as “health functional foods, etc.”) (including inspecting jobs referred to in Articles 21 (1) and 21-2 (1) of the Act, and in cases of a quality control manager who works in the venture business of manufacturing health functional foods under subparagraph 1 (b) of Article 2, researching health functional foods, etc. shall be included therein; hereafter the same shall apply in this Article) after being qualified as an industrial engineer food processing under the National Technical Qualifications Act; |
| 2-2. | Deleted; <Jun. 2, 2020> |
| 3. | Any person who has at least one year of experience in manufacturing health functional foods, etc. after earning a bachelor’s degree (including anyone recognized by the statutes to have the equivalent academic background; hereafter the same shall apply in this Article) from any school under the subparagraphs of Article 2 of the Higher Education Act (excluding a junior 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, and biotechnology (hereafter referred to as “food-related area” in this Article).; |
| 4. | Deleted; <Jun. 2, 2020> |
| 5. | Any person who has at least two years of experience in manufacturing health functional foods, etc. after earning a bachelor’s degree with a major not related to food; |
| 6. | Any person who has at least three years of experience in manufacturing health functional foods, etc. (two years for anyone who has graduated from a three-year junior college under Article 48 (1) of the Higher Education Act) after graduating from a junior college under subparagraph 4 of Article 2 of the Higher Education Act with a major in a food-related area (including cases where the statutes recognize a person has the equivalent academic background; hereinafter the same shall apply in this Article). |
| 6-2. | A person who has at least four years of experience in manufacturing health functional foods, etc. after obtaining an associate degree in a field other than a food-related area from a junior college under subparagraph 4 of Article 2 of the Higher Education Act. |
| 7. | Any person who has at least five years of experience in manufacturing health functional foods, etc. after graduating from a high school or high technical school under subparagraph 3 of Article 2 of the Elementary and Secondary Education Act (including cases where the statutes recognize a person has the equivalent academic background); |
| 8. | Any other person determined and publicly notified by the Minister of Food and Drug Safety as deemed to have the qualifications, academic backgrounds or experiences equivalent to or above the criteria prescribed in subparagraphs 1 through 3, 5, 6, 6-2, and 7.. |
[This Article Wholly Amended on Jan. 18, 2007]
| Article 5 (Duties of Quality Control Managers) |
| 1. | To manage manufacturing facilities in a hygienic way so as to keep them free of any risks to health and sanitation, and thus to prevent any substance causing risks to human bodies from being mixed with foods in the process of manufacturing or from contaminating foods; |
| 2. | To guide and supervise employees to ensure their compliance with what they have been trained on the management of the status of health and sanitation and of quality and sanitation; |
| 3. | To check if raw materials and health functional foods are in compliance with the standards for manufacturing good health functional foods and managing the quality thereof under Article 22 (1) of the Act; |
| 4. | To inform, without delay, a business entity when there is any problem or room for improvement with the safety, quality, or sanitation of health functional foods. |
[This Article Newly Inserted on Apr. 17, 2018]
| Article 5-2 Deleted. <Mar. 14, 2019> |
| Article 6 (The Heads of Affiliated Organizations) |
“The heads of affiliated organizations prescribed by Presidential Decree” in Article 20 (1) of the Act means the head of a Regional Office of Food and Drug Safety. <Amended on Jan. 18, 2007; Apr. 20, 2010>
| Article 6-2 (Requirements and Procedures for Requests by Consumers for Hygiene Inspections) |
| (1) | “The heads of affiliated agencies prescribed by Presidential Decree” and “consumers exceeding a certain number prescribed by Presidential Decree” in the main sentence, with the exception of the subparagraph, of Article 20-2 (1) of the Act means the heads of Regional Offices of Food and Drug Safety and at least 20 consumers who have suffered the same injuries from the same product, respectively. |
| (2) | Any person who intends to request the entry, inspections, collections, etc. under Article 20 of the Act (hereafter “hygiene inspections, etc.” in this Article) pursuant to Article 20-2 (1) of the Act shall submit a request in the form prescribed by Ordinance of the Prime Minister, to the Minister of Food and Drug Safety (including the heads of Regional Offices of Food and Drug Safety; hereafter the same shall apply in this Article) or a Special Self-Governing City Mayor, Special Self-Governing Province Governor or the head of a Si/Gun/Gu (the head of a Gu means the head of an autonomous Gu; hereinafter “head of a Si/Gun/Gu). In such cases, a request shall be submitted by the representative of a group of consumers, the head of a consumer organization (referring to a consumer organization under Article 20-2 (1) of the Act; hereafter the same shall apply in this Article) or the head of a testing and inspection agency (referring to a testing and inspection agency under Article 20-2 (1) of the Act; hereafter the same shall apply in this Article). |
| (3) | Where the Minister of Food and Drug Safety or the head of a Si/Gun/Gu informs the results of hygiene inspections, etc. pursuant to Article 20-2 (2) of the Act, he/she shall inform them by means requested by the representative of a group of consumers, the head of a consumer organization or the head of a testing and inspection agency or in writing unless otherwise specified. |
[This Article Newly Inserted on Jan. 31, 2017]
| Article 7 Deleted. <Jul. 9, 2019> |
| Article 7-2 (Disqualification of, Challenge to, or Refrainment by, Members of Health Functional Foods Deliberation Committee) |
| (1) | Where any committee member of the health functional foods deliberation committee under Article 27 of the Act (hereinafter referred to as the committee) (hereinafter referred to as “committee member”) falls under any of the following subparagraphs, he/she shall be disqualified for investigation and deliberation by the committee: <Amended on Jul. 9, 2019> |
| 1. | Where the committee member or his/her current or former spouse becomes a party to the relevant agenda item (including executive officers or employees if the party is a corporation, organization, etc.; hereafter the same shall apply in subparagraphs 1 and 2) or is holding any right or duty jointly with a party to such agenda item; |
| 2. | Where the committee member is a current or former relative of a party to the relevant agenda item; |
| 3. | Where the committee member or any corporation, organization, etc. to which the committee member belongs has given testimony, made a statement, consulted on, researched, provided services for, or appraised, the relevant agenda item; |
| 4. | Where the committee member or any corporation, organization, etc. to which the committee member belongs is a current or former agent of a party to the relevant agenda item; |
| 5. | Where the committee member has been an executive officer or employee of a corporation, organization, etc. which is a party to the relevant agenda item during the last three years. |
| (2) | If there is any reason to believe it is difficult to expect impartial investigation and deliberation by any committee member, a party to the relevant agenda item may file a request with the committee to challenge the committee member; and the relevant committee shall determine whether it challenges such committee member by its resolution. In such cases, the committee member subject to such request for challenge shall refrain from participating in the resolution. <Amended on Jul. 9, 2019> |
| (3) | If a committee member falls under any ground for disqualification prescribed in paragraph (1), he/she shall voluntarily refrain from investigation and deliberation on the relevant agenda item. |
[This Article Newly Inserted on May 17, 2016]
[Title Amended on Jul. 9, 2019]
[Previous Article 7-2 moved to Article 7-3 <May 17, 2016>]
| Article 7-3 (Dismissal of Committee Members) |
The Minister of Food and Drug Safety may dismiss a committee member who falls under any of the following cases: <Amended on Mar. 17, 2016; Jul. 9, 2019>
| 1. | Where he/she is unable to perform his/her duties due to any mental or physical impairment; |
| 2. | Where he/she engages in misconduct in relation to his/her duties; |
| 3. | Where he/she is deemed inappropriate for a committee member of the committee due to neglect of duties, injury to dignity, or other reason; |
| 3-2. | Where he/she fails to refrain from investigation or deliberation, notwithstanding the fact that he/she falls under any of the cases provided for in Article 7-2 (1); |
| 4. | Where he/she voluntarily expresses that it is impracticable to perform his/her duties. |
[This Article Newly Inserted on Dec. 31, 2015]
[Title Amended on Jul. 9, 2019]
[Moved from Article 7-2 <May 17, 2016>]
| Article 8 (Operation of the Committee) |
| (1) | The chairperson shall represent the committee and control work of the committee. <Amended on Jul. 9, 2019> |
| (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 committee. <Amended on Jul. 9, 2019> |
| (4) | A majority of the members of the 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 on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
[Title Amended on Jul. 9, 2019]
| (1) | The committee may have a subcommittee by a special sector in order to achieve the duty efficiently. <Amended on Jul. 9, 2019> |
| (2) | Decided matters by the subcommittee shall be reported to the chairperson and deliberated by the committee: Provided, That if the chairperson deems matters minor, a resolution by the subcommittee may be in lieu of a resolution by the committee. <Amended on Jul. 9, 2019> |
| (1) | The committee may have 20 researchers or less in order to examine and research the standards, specifications, functionality, and safety of health functional foods. <Amended on Mar. 14, 2019; Jul. 9, 2019> |
| (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 on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| (3) | Researchers may attend and speak in the committee or subcommittee. <Amended on Jul. 9, 2019> |
| Article 11 (Hearing of Opinions) |
The chairperson may hear opinions by requesting a relevant person to attend when he/she recognizes the needs in relation to matters for deliberation by the committee or subcommittee. <Amended on Jul. 9, 2019>
| Article 12 (Administrative Secretary) |
| (1) | The committee shall have one administrative secretary in order to manage administrative affairs of the committee. <Amended on Jul. 9, 2019> |
| (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 on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
The chairperson shall report matters deliberated on by the committee to the Minister of Food and Drug Safety without delay. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013; Jul. 9, 2019>
| Article 14 (Allowance and Traveling Expenses) |
| (1) | Members who attend the committee shall be paid with an allowance, traveling expenses, and other necessary expenses within budgetary limits: Provided, That this shall not apply where a committee member who is a public official attends due to an affair directly related to his/her duties. <Amended on Jul. 9, 2019> |
| (2) | The Minister of Food and Drug Safety may grant investigation and research expenses and required expenses within budgetary limits to a researcher. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| Article 15 (Detailed Rules of Operation) |
Operational matters of the 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 on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013; Jul. 9, 2019>
| Article 16 (Authorization of Organizations) |
| (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 on Jan. 18, 2007; Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| Article 17 (Timing of Dispositions Such as Revocation of Permission) |
Where the Minister of Food and Drug Safety or the head of a Si/Gun/Gu holds a hearing under Article 36 of the Act in order to take a disposition such as revocation of permission for business, suspension of business operations, closure of places of business, 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 take such disposition within 14 days from the date the relevant procedure is completed in the absence of special circumstances. <Amended on Jan. 18, 2007; Sep. 22, 2008; Mar. 23, 2013; May 18, 2015; Jan. 31, 2017>
| 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 the criteria for calculation of penalty surcharge in attached Table 1, based on the period of business suspension, period of suspension of manufacturing the items or the relevant types of items, which are prescribed by Ordinance of the Prime Minister in consideration of classification and degree of violation. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013; Jan. 5, 2021>
| 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 on Feb. 29, 2008; 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 seven days from the date when the reason ceases to exist. <Amended on Sep. 22, 2008; 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 on Sep. 22, 2008; Mar. 23, 2013> |
| (4) | The procedures for the collection of penalty surcharges shall be prescribed by Ordinance of the Prime Minister. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| (5) | Deleted. <Sep. 22, 2008> |
| Article 19-2 (Postponement of Payment Deadline for Penalty Surcharges and Payment by Installment) |
| (1) | Where the Minister of Food and Drug Safety or the head of a Si/Gun/Gu deems that it is difficult for a person who is imposed a penalty surcharge pursuant to Article 37 (1) of the Act (hereinafter referred to as "person liable to pay a penalty surcharge), the amount of which is at least one million won, to pay the full amount of the penalty surcharge at once for any of the following reasons, he/she may extend the deadline for payment or allow the person to pay it in installments. In such cases, he/she may, if deemed necessary, require the person to provide security: |
| 1. | Where the person suffers a serious loss in property due to a natural disaster or other catastrophe; |
| 2. | Where the business of the person is in a serious crisis due to the worsening of business conditions; |
| 3. | Where the person is expected to face substantial financial difficulties if he/she pays the penalty surcharge at once; |
| 4. | Where the Minister of Food and Drug Safety acknowledges that there are other reasons corresponding to those prescribed in subparagraphs 1 through 3. |
| (2) | Where a person liable to pay a penalty surcharge intends to request a postponement of deadline for payment or payment in installments pursuant to paragraph (1), he/she shall file an application with the Minister of Food and Drug Safety or the head of the Si/Gun/Gu along with documents evidencing the grounds for postponing the deadline for payment or paying in installments ten days prior to the deadline for payment. |
| (3) | Where the deadline for paying a penalty surcharge is postponed or paying a penalty surcharge in installments is permitted pursuant to paragraph (1), the duration of postponement shall be within one year from the date following the date of deadline for payment, and the interval of installed payments shall be within four months, and the number of installed payments shall be limited to three times. |
| (4) | Where a person liable to pay a penalty surcharge, in whose case the deadline for the payment of the penalty surcharge has been extended or installment payments have been determined, falls under any of the following subparagraphs, the Minister of Food and Drug Safety or the head of a Si/Gun/Gu may cancel the extension of the deadline for payment or the determination of installment payments, and collect the penalty surcharge at once: |
| 1. | Where he or she fails to pay the penalty surcharge to be paid in installments by the relevant payment deadline; |
| 2. | Where the person fails to comply with the order of the Minister of Food and Drug Safety to change security or to preserve security; |
| 3. | Where the Minister deems it impossible to collect the full amount or remainder of the penalty surcharge due to such reasons as compulsory execution, commencement of a public auction, declaration of bankruptcy, dissolution of a corporation, or a disposition on delinquent national or local taxes; |
| 4. | Where it is deemed possible for the person to pay the penalty surcharge in a lump sum because any of the causes provided for in the subparagraphs of paragraph (1) has ceased. |
[This Article Newly Inserted on Jul. 9, 2019]
[Previous Article 19-2 moved to Article 19-3 <Jul. 9, 2019>]
| Article 19-3 (Persons Subject to Revocation of Penalty Surcharges) |
If any person who fails to pay a penalty surcharge by the payment deadline (or due date for penalty surcharge in a lump sum where the determination of installment payments is cancelled under Article 19-2 (4)) fails again to pay the penalty surcharge within 15 days after receiving a reminder, he/she shall be subject to revocation of imposition of the penalty surcharge under the main sentence of Article 37 (4) of the Act and be subject to an administrative disposition such as suspension of business; or the penalty surcharge shall be collected in the same manner as delinquent national taxes are collected or in accordance with the Act on the Collection of Local Administrative Penalty Charges. <Amended on Jul. 9, 2019; Mar. 24, 2020> [This Article Newly Inserted on Jan. 31, 2017]
[Moved from Article 19-2; previous Article 19-3 moved to Article 19-4 <Jul. 9, 2019>]
| Article 19-4 (Criteria for Calculating Penalty Surcharges on Sale of Harmful Health Functional Foods) |
| (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 foods sold by any person falling under the subparagraphs of Article 37-2 (1) of the Act. |
| (2) | The sales volume under paragraph (1) shall be the amount of harmful health functional foods shipped to the market from the initiation of sale to the time of discovery of violations, exclusive of the amount recalled and unsold due to refund, checkup, etc.; and the selling price shall be calculated by each period of sale, if the price has changed during the selling period. |
[This Article Newly Inserted on May 18, 2015]
[Moved from Article 19-3; Previous Article 19-4 Moved to Article 19-5 <Jul. 9, 2019>]
| Article 19-5 (Publication of Violations) |
Pursuant to Article 37-3 of the Act, the Minister of Food and Drug Safety or the head of a Si/Gun/Gu shall, without delay, publish the following matters concerning a business entity subject to the administrative disposition confirmed on the website of the relevant institution or in general daily nationwide newspapers registered under Article 9 (1) of the Act on the Promotion of Newspapers: | 3. | The name and location of the relevant place of business and the name of its representative; |
| 4. | The name of the health functional food; |
| 5. | Particulars of violations (including details of violating acts and applicable statutes); |
| 6. | Particulars, date, and period of administrative dispositions; |
| 8. | The date of crackdown or of discovery. |
[This Article Newly Inserted on May 17, 2016]
[Moved from Article 19-4; Previous Article 19-5 Moved to Article 19-6 <Jul. 9, 2019>]
| Article 19-6 (Payment of Monetary Reward) |
| (2) | The investigation agency which has been filed an accusation under Article 40 (1) of the Act shall notify 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 need 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 on 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 he/she pays a monetary 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 on Mar. 23, 2013> |
| (4) | Where a person who has reported or accused is informed of the decision of payment of a monetary reward under paragraph (3) shall apply for the payment of the monetary reward to the Minister of Food and Drug Safety or the head of a Si/Gun/Gu as determined and publicly notified by the Minister of Food and Drug Safety. <Amended on Mar. 23, 2013> |
| (5) | The Minister of Food and Drug Safety or the head of a Si/Gun/Gu shall pay a monetary reward to a person who has reported or accused violations within one month from the date of the application for the payment of the monetary reward under paragraph (4). <Amended on Mar. 23, 2013> |
| (6) | The amount of monetary rewards under paragraph (5) shall be determined and publicly notified by the Minister of Food and Drug Safety, not exceeding the following amounts: <Amended on Mar. 23, 2013; Jan. 22, 2016> |
| (7) | Where any person reports or accuses the same violations as reported or accused under Article 40 (1) of the Act, a monetary reward shall not be paid to such person; and where at least two persons jointly report or accuse a violation, a monetary reward shall be paid to the representative designated by them. |
| (8) | Other than those prescribed in paragraphs (1) through (7), matters necessary for the standards, methods, and procedures for monetary rewards under shall be determined and publicly notified by the Minister of Food and Drug Safety. <Amended on Mar. 23, 2013> |
[This Article Newly Inserted on Sep. 22, 2008]
[Moved from Article 19-3 <Jul. 9, 2019>]
| Article 20 (Delegation or Entrustment of Authority) |
| (1) | Pursuant to Article 41 (1) of the Act, the Minister of Food and Drug Safety shall entrust his/her authority for the following matters to the head of a Regional Office of Food and Drug Safety: <Amended on Nov. 18, 2010; Mar. 23, 2013; Apr. 1, 2014; Jan. 31, 2017; Jul. 9, 2019> |
| 1. | Permission for business or revision of permission, and reporting on business closure or revision related to manufacturing business of health functional foods under Article 5 (1) and (2) of the Act; |
| 2. | Deleted; <May 18, 2015> |
| 4. | Deleted; <Jan. 22, 2016> |
| 9. | Examination and evaluation as to whether the Regulations for Good Manufacturing Practice has been complied with as prescribed in Article 22 (2) of the Act; |
| 9-3. | Inspections and evaluation as to whether the standards for tracking management of records on health functional foods are complied with pursuant to Article 22-2 (5) of the Act; |
| 9-4. | Revocation of registration of, or corrective order to, a person who has obtained registration of tracking management of records on health functional foods under Article 22-2 (7) of the Act; |
| (2) | Pursuant to Article 41 (1) of the Act, the Minister of Food and Drug Safety shall entrust his/her authority (limited to business operators of manufacturing health functional foods under Article 4 (1) 1 of the Act) for the following matters to a Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, or a Special Self-Governing Province Governor: <Amended on Mar. 23, 2013; May 18, 2015> |
| 2. | Deleted; <Mar. 14, 2019> |
| 4. | Reporting, entry, inspections, collections, and perusal under Article 20 of the Act to conduct duties under subparagraphs 1 through 3. |
| (3) | When a Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, or a Special Self-Governing Province Governor finds violations under paragraph (2), he/she shall report such violations to the head of the competent Regional Office of Food and Drug Safety. <Amended on May 18, 2015> |
| (4) | The head of a Regional Office of Food and Drug Safety in receipt of a report under paragraph (3) shall take necessary measures such as administrative dispositions. |
[This Article Wholly Amended on Apr. 20, 2010]
| Article 20-2 (Management of Sensitive Information or Personally Identifiable Information) |
| 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; |
| 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; |
| 5-2. | Affairs concerning authorization for the establishment of an organization under Article 28 of the Act; |
[This Article Newly Inserted on Jan. 6, 2012]
| Article 21 (Standards for Imposition of Administrative Fines) |
The standards for imposition of administrative fines under the Article 47 (1) and (2) of the Act shall be as prescribed in attached Table 2. <Amended on Jun. 2, 2020> [This Article Wholly Amended on Mar. 30, 2011]
ADDENDA <Presidential Decree No. 18164, Dec. 18, 2003>
| (1) | (Enforcement Date) 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-specialized sales business 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. |
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 on the date of its promulgation.
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force on 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 on 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 head of a Regional Office of Food and Drug Safety or acts by the head of a Regional Office of Food and Drug Safety under the amended provisions 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.)
Article 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.
Article 2 (Transitional Measures concerning 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, notwithstanding the amended provisions of attached Table 2. |
| (2) | Disposition of imposing fines for violations committed before this Decree enters into force shall not be included in dispositions of imposing fines under amended provisions of 3) of (c) of subparagraph 1 of attached Table. |
ADDENDA <Presidential Decree No. 23488, Jan. 6, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 23907, Jun. 29, 2012>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <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 force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 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 the date of its promulgation: Provided, That the amended provisions of subparagraph 3 (a) of Article 2 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.)
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.
ADDENDUM <Presidential Decree No. 27178, May 17, 2016>
This Decree shall enter into force on May 19, 2016.
ADDENDUM <Presidential Decree No. 27826, Jan. 31, 2017>
This Decree shall enter into force on February 4, 2017: Provided, That the amended provisions of subparagraphs 1 (b) and 3 (b) of Article 2 and Article 20 (1) 9 shall enter into force on the dates specified, as follows: | 1. | A manufacturer with a turnover of at least two billion won for 2017: December 1, 2018; |
| 2. | A manufacturer with a turnover of at least one billion won and less than two billion won for 2017: December 1, 2019; |
| 3. | A manufacturer with a turnover of less than one billion won for 2017: December 1, 2020. |
ADDENDUM <Presidential Decree No. 27960, Mar. 27, 2017>
This Decree shall enter into force on March 30, 2017. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 28809, Apr. 17, 2018>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Transitional Measures concerning Criteria for Calculating Penalty Surcharges)
The application of criteria for calculating penalty surcharges for violations committed before this Decree enters into force shall be governed by former provisions notwithstanding the amended provisions of subparagraph 2 of attached Table 1.
Article 3 (Transitional Measures concerning Standards for Imposition of Administrative Fines)
The application of standards for imposing administrative fines for violations committed before this Decree enters into force shall be governed by former provisions notwithstanding the amended provisions of attached Table 2.
ADDENDA <Presidential Decree No. 29622, Mar. 14, 2019>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 14, 2019.
Article 2 Omitted.
ADDENDA <Presidential Decree No. 29974, Jul. 9, 2019>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 16, 2019: Provided, That the amended provisions of Articles 19-2 and 19-3, and attached Table 2 shall enter into force on the date of its promulgation. Article 2 (Applicability to Extension of Deadline for Payment of Penalty Surcharges and Payment in Installments)
The amended provisions of Article 19-2 shall apply to national health insurance premiums, the notices of which are given on or after the enforcement date described in the proviso to Article 1 of these Addenda.
ADDENDA <Presidential Decree No. 30545, Mar. 24, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 30754, Jun. 2, 2020>
This Decree shall enter into force on June 4, 2020.
ADDENDUM <Presidential Decree No. 31380, Jan. 5, 2021>
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)