Article 1(Purpose) #
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; Jul. 2, 2024; Dec. 31, 2024>
1. Manufacturing health functional foods:
(a) Specialized business of manufacturing health functional foods: Business specialized in manufacturing heath functional foods;
(b) Venture business of manufacturing health functional foods: Manufacturing business that a venture business under Article 2 of the Special Act on the Promotion of Venture Businesses outsources to a specialized manufacturer under item (a);
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, 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.
4. Customized health functional food sales business: business of selling customized health functional foods (including customized health functional foods subdivided and combined by entrustment).
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 Examination and Analysis of Safety of Health Functional Foods) #
Where the Minister of Food and Drug Safety publishes the results of examination and analysis of causal relations, etc. of the safety of health functional foods and their casual relationship with such adverse events (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 Added on Jun. 2, 2020]
Article 3-3(Entrustment of Duties of Receipt of Reports on Adverse Events) #
Pursuant to Article 10-2 (4), the Minister of Food and Drug Safety shall entrust the National Food Safety Information Service prescribed in Article 67 of the Food Sanitation Act with duties in each of the following subparagraphs:
1. Receipt of reports on adverse events under Article 10-2 (1) of the Act;
2. Examination and analysis of the safety of health functional foods, and causal relations, etc. of their casual relationship with such adverse events under Article 10-2 (2) of the Act.
[This Article Added on Jun. 2, 2020]
Article 3-4(Types of Liability Insurance) #
(1) Types of liability insurance referred to in Article 10-3 (1) of the Act (hereinafter referred to as "liability insurance") shall be the accident liability insurance to compensate for damage inflicted on consumers by health harm caused by subdivision or association of health functional foods by the business operator of customized health functional foods or any other insurances containing similar details.
(2) The limit on compensations covered by a liability insurance shall be at least the following standard amounts; provided, the amount of insurance to be paid shall not exceed the amount of actual damage, except in cases falling under the proviso of subparagraph 1:
1. In cases of death, 150 million won per person; provided, where the amount of actual damage caused by death is less than 20 million won, the compensations shall be 20 million won per person;
2. In cases of injury, 30 million won per person;
3. Where an injury leads to a physical disability after its treatment is completed (hereinafter referred to as "residual disability"), 150 million won per person;
4. Where one case leads to at least two damages specified in subparagraphs 1 through 3, the amounts classified as follows:
(a) If an injury leads to the death of a person during treatment, the aggregate of the amounts specified in subparagraphs 1 and 2;
(b) Where an injured person suffers from an aftereffect of his or her injury as a result of his or her injury, the aggregate of the amounts prescribed in subparagraphs 2 and 3;
(c) If an injury leads to the death of a person after the amount prescribed in item (b) is paid, the amount calculated by subtracting the amount of damage incurred after the date of death out of the amount paid under subparagraph 3, from the amount paid pursuant to subparagraph 1.
[This Article Added on Dec. 31, 2024]
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>
1. Any person qualified as a professional engineer food stuff or an engineer food processing under the National Technical Qualifications Act;
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 in this Article referred to 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 in this Article the same shall apply) 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 or regulations to have the equivalent academic background; hereafter in this Article the same shall apply) from any school under the subparagraphs of Article 2 of the Higher Education Act (excluding a junior college under subparagraph 4 of that Article; hereafter in this Article 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 in this Article referred to as "food-related area");
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 or regulations recognize a person has the equivalent academic background; hereafter in this Article the same shall apply).
Article 5(Matters Observed by Quality Control Managers) #
The matters to be observed by a quality control manager under Article 12 (8) of the Act shall be as follows: <Amended on Dec. 31, 2024>
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 Added on Apr. 17, 2018]
Article 5-2(Qualification Standards for Customized Health Functional Foods Managers) #
“Persons prescribed by Presidential Decree” in Article 12-3 (8) of the Act means the following persons:
1. A medical doctor, dentist, Korean medical doctor, or nurse, among medical personnel under Article 2 of the Medical Service Act;
2. A pharmacist or Korean medicine pharmacist defined in subparagraph 2 of Article 2 of the Pharmaceutical Affairs Act;
3. Dieticians prescribed in Article 15 of the National Nutrition Management Act.
[This Article Added on Dec. 31, 2024]
Article 6(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 clause, 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 in this Article referred to as "hygiene inspections, etc.") 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 in this Article the same shall apply) 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 referred to as "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 in this Article the same shall apply) 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 in this Article the same shall apply).
(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 or 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 Added 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 or she shall be disqualified for investigation and deliberation by the committee: <Amended on Jul. 9, 2019>
1. Where the committee member or his or 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 in this subparagraph and subparagraph 2 the same shall apply) 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 or she shall voluntarily refrain from investigation and deliberation on the relevant agenda item.
[This Article Added 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 May 17, 2016; Jul. 9, 2019>
1. Where he or she is unable to perform his or her duties due to any mental or physical disabilities;
2. Where he or she engages in misconduct in relation to his or her duties;
3. Where he or 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 or she fails to refrain from investigation or deliberation, notwithstanding the fact that he or she falls under any of the cases provided for in Article 7-2 (1);
4. Where he or she voluntarily expresses that it is impracticable to perform his or her duties.
[This Article Added 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 or her when he or 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]
Article 9(Subcommittee) #
(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, 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>
Article 10(Researcher) #
(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 or 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>
Article 13(Reporting) #
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, this shall not apply where a committee member who is a public official attends due to an affair directly related to his or 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) #
(1) "Type of business prescribed by Presidential Decree" in 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 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 or 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 Appendix 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 or she intends to impose penalty surcharges under Article 37 of the Act. <Amended on Feb. 29, 2008; Mar. 23, 2013>
(2) Any person in receipt of notification under paragraph (1) shall pay a penalty surcharge 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 of receipt of such notification. <Amended on Sep. 22, 2008; Mar. 23, 2013; Dec. 12, 2023>
(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 amount of a penalty surcharge to be paid by a person on whom a penalty surcharge is imposed pursuant to the main clause of Article 37 (1) of the Act is at least 1 million won, the Minister of Food and Drug Safety or the head of a Si/Gun/Gu may extend the deadline for payment of the penalty surcharge or allow him or her to pay it in installments pursuant to the proviso of Article 29 of the Framework Act on the Administration. <Amended on Dec. 12, 2023>
(2) Deleted. <Dec. 12, 2023>
(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) Deleted. <Dec. 12, 2023>
[This Article Added on Jul. 9, 2019]
[Title Amended on Dec. 12, 2023]
[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 or she shall be subject to revocation of imposition of the penalty surcharge under the main clause 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 Added 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 to be imposed pursuant to Article 37-2 (1) of the Act shall be twice the amount calculated by multiplying the sales volume of harmful health functional foods, etc. sold by a person falling under any subparagraph of Article 37-2 (1) of the Act by the selling price. <Amended on Jul. 23, 2024>
(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.
(3) The Minister of Food and Drug Safety, the Special Self-Governing City Mayor, the Special Self-Governing Province Governor, or the head of a Si/Gun/Gu may reduce the amount of a penalty surcharge by up to 1/2 of the amount calculated pursuant to paragraph (1), taking into account the matters specified in the subparagraphs of Article 37-2 (2) of the Act. <Added on Jul. 23, 2024>
[This Article Added 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:
1. The headline with the contents of publication of violations of the Health Functional Foods Act;
2. The type of business;
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 or regulations);
6. Particulars, date, and period of administrative dispositions;
7. Controlling agencies;
8. The date of crackdown or of discovery.
[This Article Added 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) #
(1) Anyone who intends to report persons who have violated Articles 5 (1), 6 (2) and (3), 23 or 26 of the Act pursuant to the Article 40 (1) of the Act shall report 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; Jan. 22, 2016; Dec. 31, 2024>
(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, 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 or 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; Dec. 31, 2024>
1. In cases of reports on or accusation of violations of Articles 5 (1) or 23 of the Act: 500,000 won;
2. Where a person reports or accuses a violation of Article 6 (2) or (3) of the Act or a violation of Article 24 (1) of the Act: 200,000 won;
3. In cases of report on or accusation of violations of Article 24 (2) and (3) of the Act: 10 million won.
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 or 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; May 18, 2015; Apr. 1, 2014; Jan. 31, 2017; Jul. 9, 2019; Dec. 31, 2024>
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. Reporting on customized health functional food sales business and reporting on business closure or modification thereof under Article 6 (3) and (4) of the Act;
3. Report on manufacturing items and revisions under Article 7 (1) of the Act;
4. Deleted; <Jan. 22, 2016>
5. Report on production records etc. under Article 10 (2) of the Act;
6. Report on succession to the status of a 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;
7-2. Report on the appointment or dismissal of a manager of customized health functional food under Article 12-3 (4) of the Act;
8. Orders to entrust inspections under Article 21 (2) of the Act;
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;
9-2. Registration of tracking management of records on health functional foods and reporting on the revision thereof under Article 22-2 (1) and (3) 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;
10. Imposition of administrative dispositions, etc. under Articles 29 through 33, 35, 36 or 38 (2) of the Act;
11. Imposition and collection of penalty surcharges or administrative fines under Articles 37 and 47 of the Act;
Article 20-2(Management of Sensitive Information or Personally Identifiable Information) #
The Minister of Food and Drug Safety (including a person entrusted with duties of receiving reports on abnormal cases under Article 3-3 or delegated 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 (limited to the affairs referred to in subparagraphs 1, 2-2, 3, 4, 6, and 7), criminal records under Article 18 (2) of the Enforcement Decree of that Act (limited to the affairs referred to in subparagraph 7), and resident registration numbers or foreign registration numbers under Article 19 of that Decree when they are inevitably necessary to perform the following affairs: <Amended on Mar. 23, 2013; Apr. 1, 2014; May 18, 2015; Mar. 27, 2018; Jun. 2, 2020; Dec. 20, 2022>
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;
2-2. Duties of receipt, investigation, and analysis of reports on abnormal cases under Article 10-2 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;
5-2. Affairs concerning authorization for the establishment of an organization under Article 28 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 Added on Jan. 6, 2012]
Article 21(Criteria for Imposition of Administrative Fines) #
The Criteria for imposition of administrative fines under the Article 47 (1) and (2) of the Act shall be as prescribed in Appendix 2. <Amended on Jun. 2, 2020>
[This Article Wholly Amended on Mar. 30, 2011]