| Article 2 (Composition of Deliberative Committee on Development of Testing and Inspection) |
| (1) | Members of the Deliberative Committee on the Development of Testing and Inspection on Food and Drugs (hereinafter referred to as the "Committee") under Article 5 (1) of the Act on Testing and Inspection in the Food and Drug Industry (hereinafter referred to as the "Act") shall be appointed or commissioned by the Minister of Food and Drug Safety from among the following persons in consideration of gender: <Amended on Oct. 1, 2025> |
| 1. | One person each recommended by the head of the agency to which he or she belongs, from among public officials belonging to the Senior Executive Service of the Ministry of Agriculture, Food and Rural Affairs, the Ministry of Trade, Industry and Resources, and the Ministry of Oceans and Fisheries; |
| 2. | One public official belonging to the Senior Executive Service of the Ministry of Food and Drug Safety; |
| 3. | A person who serves or has served as an associate professor or higher in the field of food or drugs at a university or college; |
| 4. | Other persons who have extensive knowledge of and experience in testing, inspection, etc. in the field of food or drugs. |
| (2) | The term of office of a member who is not a public official shall be 2 years; provided, the term of office of a supplementary member shall be the remainder of his or her predecessor's term of office. |
| Article 3 (Operation of Committee) |
| (1) | The Chairperson of the Committee (hereinafter referred to as the "Chairperson") shall represent the Committee and preside over the business affairs of the Committee. |
| (2) | Meetings of the Committee shall be convened at the request of at least 1/3 of all incumbent members or if the Chairperson deems it necessary, and the Chairperson shall preside over such meetings. |
| (3) | If the Chairperson is unable to perform his or her duties due to any unavoidable cause, a person designated by the Chairperson from among the members shall act on behalf of the Chairperson. |
| (4) | A majority of the members of the Committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present. |
| (5) | The Committee shall have 1 executive secretary to conduct its business affairs, who shall be appointed by the Minister of Food and Drug Safety from among public officials of the Ministry of Food and Drug Safety. |
| Article 4 (Composition of working committees) |
| (1) | A working committee under Article 5 (3) of the Act (hereinafter referred to as the "working committee") shall be comprised of not less than 15 but not more than 30 working committee members, including 1 chairperson of the working committee (hereinafter referred to as the "chairperson of the working committee"). |
| (2) | Members of a working committee shall be appointed or commissioned by the Minister of Food and Drug Safety from among the following persons in consideration of gender: <Amended on Oct. 1, 2025> |
| 1. | One person each recommended by the head of the agency to which he or she belongs, from among Grade IV or higher-ranking public officials of the Ministry of Agriculture, Food and Rural Affairs, the Ministry of Trade, Industry and Resources, and the Ministry of Oceans and Fisheries; |
| 2. | Public officials of Grade IV or higher in the Ministry of Food and Drug Safety; |
| 3. | A person who serves or has served as an assistant professor or higher in the field of food or drugs at a university or college; |
| 4. | A person who has served for at least 10 years at a testing and inspection agency designated under Article 6 of the Act (hereinafter referred to as "testing and inspection agency"); |
| 5. | Other persons who have extensive knowledge of and experience in testing, inspection, etc. in the field of food or drugs. |
| (3) | The chairperson of a working committee shall be appointed or commissioned by the Minister of Food and Drug Safety from among the working committee members. |
| (4) | The term of office of a working committee member who is not a public official shall be 2 years; provided, the term of office of a supplementary member shall be the remainder of his or her predecessor's term of office. |
| Article 4-2 (Dismissal or removal of members) |
If a member of the Committee under the subparagraphs of Article 2 (1) or a member of a working committee under the subparagraphs of Article 4 (2) falls under any of the following cases, the Minister of Food and Drug Safety may dismiss or remove the relevant member from office: | 1. | Where he or she is unable to perform his or her duties due to a mental or physical disability; |
| 2. | Where he or she has committed any misconduct in connection with his or her duties; |
| 3. | Where he or she is deemed unfit as a member due to neglect of duty, injury to dignity, or other reasons; |
| 4. | Where the member voluntarily declares that it is impracticable for him or her to perform his or her duties. |
[This Article Added on Dec. 31, 2015]
| Article 5 (Operation of working committees) |
| (1) | The chairperson of a working committee shall have general supervision and control of the business affairs of the working committee. |
| (2) | If the chairperson of a working committee is unable to perform his or her duties due to any unavoidable cause, a person designated by him or her from among the working committee members shall act on his or her behalf. |
| (3) | Meetings of a working committee shall be convened when the Chairperson or the chairperson of the working committee deems it necessary, and the chairperson of the working committee shall preside over the meetings. |
| (4) | At least 7 members of the working committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present. |
| (5) | The chairperson of a working committee shall report the results of meetings of the working committee to the Chairperson. |
| (6) | A working committee shall have 1 executive secretary to conduct its business affairs, who shall be appointed by the Minister of Food and Drug Safety from among public officials of the Ministry of Food and Drug Safety. |
| Article 6 (Allowances and travel expenses) |
Allowances and travel expenses may be paid to members or working committee members who attend a meeting of the Committee or a working committee within the budget, as determined by the Minister of Food and Drug Safety; provided, this shall not apply where a member or working committee member who is a public official attends a meeting of the Committee or a working committee in direct connection with his or her duties.
| Article 7 (Detailed operational regulations) |
Except as provided in this Decree, matters necessary for the operation of the Committee and a working committee shall be determined by the Chairperson following a resolution by the Committee.
| Article 8 (Establishment and operation of laboratory information management system) |
| (1) | If the Minister of Food and Drug Safety establishes and operates a laboratory information management system pursuant to Article 14 (1) of the Act, he or she shall ensure to manage the following information: |
| 1. | Records of testing and inspection; |
| 2. | Documents related to testing and inspection under Article 12 (2) of the Act; |
| 3. | Information on tests or inspection, such as the requester of a test or inspection and the requested items. |
| (2) | If necessary to establish and operate a laboratory information management system, the Minister of Food and Drug Safety may request the head of a testing and inspection agency using the laboratory information management system to submit relevant data. |
| (3) | Except as provided in paragraphs (1) and (2), details of the establishment and operation of the laboratory information management system shall be determined by the Minister of Food and Drug Safety. |
| Article 9 (Projects for establishment of testing and inspection operating systems) |
| (1) | Upon formulating a detailed implementation plan to perform projects necessary for establishing a testing and inspection operating system under Article 15 (1) of the Act, the Minister of Food and Drug Safety publicly announce the details thereof. |
| (2) | "Agencies, organizations, or business operators prescribed by Presidential Decree, including testing and inspection agencies designated pursuant to Article 6 or national or public research institutions" in Article 15 (2) of the Act means the following: |
| 1. | Testing and inspection agencies; |
| 2. | National or public research institutes; |
| 4. | The Korea Institute of Science and Technology, the National Research Council of Science and Technology, the Korea Institute of Bioscience and Technology Support, the Korea Research Institute of Bioscience and Biotechnology, the Korea Institute of Science and Technology Information, the Korea Institute of Oriental Medicine, the Korea Research Institute of Standards and Science, the Korea Food Research Institute, the Korea Research Institute of Chemical Technology, and the Korea Atomic Energy Research Institute established under the Act on the Establishment, Operation and Fostering of Government-Funded Science and Technology Research Institutes; |
| Article 10 (Criteria for imposing penalty surcharges) |
The criteria for imposing penalty surcharges under Article 20 (1) of the Act shall be as specified in Appendix 1.
| Article 11 (Imposition and payment of penalty surcharges) |
| (1) | In imposing a penalty surcharge pursuant to Article 20 of the Act, the Minister of Food and Drug Safety shall notify a person subject to the imposition of a penalty surcharge thereof by specifying the type of violation and the amount of the penalty surcharge in writing. |
| (2) | A 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 within 30 days from the date of receipt of such notification. <Amended on Dec. 12, 2023> |
| (3) | A collecting agency that has received a penalty surcharge pursuant to paragraph (2) shall issue a receipt to the payer and notify the Minister of Food and Drug Safety of the receipt of the penalty surcharge without delay. |
| (4) | Procedures for collecting penalty surcharges under Article 20 of the Act shall be prescribed by Prime Ministerial Decree. |
| Article 12 (Disposition of business suspension against defaulters of penalty surcharges) |
| (1) | Where a person in receipt of a notice of payment of a penalty surcharge under Article 11 (1) fails to pay the penalty surcharge by the deadline for payment under paragraph (2) of that Article, the Minister of Food and Drug Safety shall issue a reminder within 15 days after the deadline for payment. The deadline for payment in such cases shall be within 10 days from the date of issuance of the reminder. |
| (2) | If it is intended to revoke the imposition of a penalty surcharge pursuant to the main clause of Article 20 (4) of the Act and to take a disposition of business suspension pursuant to Article 10 (1) or (2) of the Act against a person who fails to pay a penalty surcharge by the deadline for payment under the latter part of paragraph (1) even after a reminder pursuant to the former part of paragraph (1), he or she shall notify the person subject to such disposition of the details thereof in writing. In such cases, the written notice shall include matters necessary for the disposition of business suspension, such as the reason for the change of the disposition and the period of business suspension. |
| Article 13 (Reporting and access) |
"Head of an agency under his or her jurisdiction prescribed by Presidential Decree" in Article 22 (1) and (2) of the Act means the head of a local food and drug safety office, respectively. <Amended on May 7, 2019>
| Article 14 (Delegation of authority) |
| (1) | Pursuant to Article 26 of the Act, the Minister of Food and Drug Safety shall delegate his or her authority over the following matters concerning livestock product testing and inspection agencies under Article 6 (2) 2 of the Act (limited to livestock product testing and inspection agencies that conduct inspections under Article 12 (3) of the Livestock Products Sanitary Control Act upon entrustment pursuant to paragraph (4) of that Article) and self quality testing and inspection agencies under Article 6 (3) 2 of the Act to the head of a local food and drug safety office: <Amended on Nov. 22, 2016; May 7, 2019> |
| 1. | Designation of testing and inspection agencies, approval for changes thereof, and reporting on change under Article 6 (1), (3), and (5) of the Act; |
| 2. | Extension of the effective period of designation of testing and inspection agencies and re-designation of testing and inspection agencies under Article 7 (2) and (3) of the Act; |
| 3. | Reporting on succession to status of testing and inspection agencies under Article 9 (3) of the Act; |
| 4. | Revocation of the designation of testing and inspection agencies, business suspension, corrective orders, etc. under Article 10 (1) of the Act; |
| 5. | Reporting on results of tests and inspections under Article 12 (1) of the Act; |
| 5-2. | Evaluation and management of testing and inspection capabilities of testing and inspection agencies under the main clause of Article 16 (1) of the Act; provided, the evaluation and management of testing and inspection abilities prescribed by Prime Ministerial Decree shall be excluded herefrom; |
| 6. | Measures for closure of testing and inspection agencies and removal of sealing under Article 19 (1) and (2) of the Act; |
| 7. | Imposition and collection of a penalty surcharge under Article 20 of the Act; |
| 8. | Collection of fees under Article 24 (1) 1 of the Act; |
| 9. | Hearings under subparagraph 1 of Article 25 of the Act. |
| 10. | Imposition and collection of administrative fines under Article 30 of the Act; |
| 11. | Designation of collecting agencies and notification of collecting agencies under Article 11 (2) and (3); |
| 12. | Disposition on defaulters of penalty surcharges under Article 12. |
| (2) | Pursuant to Article 26 of the Act, the Minister of Food and Drug Safety shall delegate his or her authority concerning the evaluation and management of testing and inspection abilities (limited to the authority concerning the evaluation and management of testing and inspection abilities under the proviso of paragraph (1) 5-2) of testing and inspection agencies under the main clause of Article 16 (1) of the Act to the Director General of the National Institute of Food and Drug Safety Evaluation. <Added on May 7, 2019> |
| Article 14-2 (Processing of personally identifiable information) |
| 1. | Business affairs regarding the designation of a testing and inspection agency, approval for change, and reporting on change under Article 6 of the Act; |
| 2. | Business affairs regarding reporting on succession to the status of a testing and inspection agency under Article 9 of the Act; |
| 3. | Business affairs regarding revocation of designation of a testing and inspection agency, business suspension, issuance of corrective orders, and restrictions on designation under Article 10 (1) and (3) of the Act; |
| 4. | Business affairs regarding the designation of exemplary testing and inspection agencies, change in designation, restrictions on designation, revocation of designation, and corrective orders under Article 13 of the Act; |
| 5. | Business affairs regarding the designation of educational institutions and the revocation of such designation under Article 18 of the Act; |
| 6. | Business affairs regarding the imposition and collection of penalty surcharges under Article 20 of the Act; |
| 7. | Business affairs regarding hearings under Article 25 of the Act. |
[This Article Added on Nov. 22, 2016]
| Article 15 (Criteria for imposing administrative fines) |
Criteria for imposing administrative fines referred to in Article 30 of the Act shall be as specified in Appendix 2.
ADDENDA <Presidential Decree No. 25529, Jul. 28, 2014>
Article 1 (Enforcement date)
This Decree shall enter into force on July 31, 2014.
Article 2 (Transitional measures concerning administrative fines)
| (1) | Notwithstanding subparagraph 4 of Appendix 2 of the previous Enforcement Decree of the Food Sanitation Act, subparagraphs 1 and 2 (b) of Appendix 2 of this Decree shall apply to the imposition of administrative fines for violations committed before this Decree enters into force. |
| (2) | Notwithstanding subparagraph 1 (a) of Appendix 2 and subparagraph 2 of that Table, administrative fines imposed for the same violation under the previous provisions before this Decree enters into force shall not be included in the calculation of the number of violations committed 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. 27610, Nov. 22, 2016>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Transitional measures concerning criteria for imposition of penalty surcharges)
Notwithstanding the amended provisions of subparagraph 2 of Appendix 1, the previous provisions shall apply to the criteria for imposing penalty surcharges for violations committed before this Decree enters into force.
ADDENDUM <Presidential Decree No. 29751, May 7, 2019>
This Decree shall enter into force on June 12, 2019.
ADDENDUM <Presidential Decree No. 33913, Dec. 12, 2023>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 34259, Feb. 27, 2024>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 35811, Oct. 1, 2025>
This Decree shall enter into force on the date of its promulgation; provided, the amended provisions of Presidential Decrees, which were promulgated before the enforcement of this Decree but have not yet entered into force, shall enter into force on the respective enforcement dates of such Presidential Decrees.