Article 6(Designation of Testing and Inspection Laboratories) #
(1) The Minister of Food and Drug Safety may designate agencies to conduct tests and inspections professionally and efficiently (hereinafter referred to as "testing and inspection laboratory").
(2) Types of testing and inspection laboratories that may be designated pursuant to paragraph (1) shall be as follows: <Amended on Apr. 18, 2017; Dec. 11, 2018; Jun. 10, 2022>
1. Food, etc. testing and inspection laboratory: Any agency that conducts tests and inspections according to the following:
(a) Inspections prescribed in Article 7, 9, 19-4, 22 (1), 31 (2), and 31-3 of the Food Sanitation Act; Article 14 of the Health Functional Foods Act; or Article 21 and 22 of the Special Act on Imported Food Safety Control;
(b) Tests and inspections necessary for the labeling criteria or the nutrition labeling criteria prescribed in Article 4 and 5 of the Act on Labeling and Advertising of Foods; or for the report on manufacturing or processing foods or food additives or the compliance with the food safety management certification standards prescribed in Article 37 (6) or 48 of the Food Sanitation Act;
2. Livestock product testing and inspection laboratory: An agency that conducts tests and inspections according to the following:
(a) Inspections prescribed in Article 4 (3), 12, and 19 (1) and (2) of the Livestock Products Sanitary Control Act or in Article 21 and 22 of the Special Act on Imported Food Safety Control;
(b) Tests and inspections necessary for the labeling criteria prescribed in Article 4 of the Act on Labeling and Advertising of Foods; and for the hazard analysis and critical control points (HACCP) or the compliance with the requirements for reporting items manufactured prescribed in Article 9 or 25 of the Livestock Products Sanitary Control Act;
3. Pharmaceutical drugs, etc. testing and inspection laboratory: An agency that conducts quality inspections of pharmaceutical drugs, etc. in accordance with orders to conduct inspections prescribed in Article 73 of the Pharmaceutical Affairs Act;
4. Medical device testing and inspection laboratory: An agency that conducts tests and inspections of medical devices prescribed in Article 27 of the Medical Devices Act;
5. Cosmetic testing and inspection laboratory: An agency that conducts inspections of cosmetics in accordance with orders to conduct inspections prescribed in Article 20 of the Cosmetics Act;
6. Hygiene product testing and inspection laboratory: An agency that conducts inspections of hygiene products in accordance with Articles 8, 13, 14, and 25 of Hygiene Products Control Act.
(3) Food, etc. testing and inspection laboratories specified in paragraph (2) 1 may be designated as follows within the scope of each inspection: <Amended on Dec. 11, 2018>
1. Testing and inspection laboratory specializing in food: An agency that conducts tests and inspections prescribed in Article 7, 9, 19-4, or 22 (1) of the Food Sanitation Act; Article 14 of the Health Functional Foods Act; Article 21 and 22 of the Special Act on Imported Food Safety Control; or paragraph (2) 1 (b) of this Article;
2. Agency entrusted with self quality testing and inspection: An agency that conducts tests and inspections prescribed in Article 7, 9, or 31 (2) of the Food Sanitation Act; Article 14 of the Health Functional Foods Act; or paragraph (2) 1 (b) of this Article.
(4) Any person who intends to be designated as a testing and inspection laboratory falling under any subparagraph of paragraph (2) shall meet requirements for facilities, equipment, human resources, etc. necessary for testing and inspection prescribed by Prime Ministerial Decree, and file an application for designation with the Minister of Food and Drug Safety; provided, in cases of a testing and inspection laboratory prescribed by Prime Ministerial Decree, it shall be deemed designated pursuant to paragraph (1).
(5) Where a testing and inspection laboratory designated pursuant to paragraph (1) intends to alter any important matter prescribed by Prime Ministerial Decree, including any alteration to the scope of testing and inspection, among the designated matters, it shall obtain approval from the Minister of Food and Drug Safety in advance; provided, where it alters any insignificant matter prescribed by Prime Ministerial Decree, it shall report thereon to the Minister of Food and Drug Safety within one month from the date such alterations are made.
(6) None of the following persons shall be designated as a testing and inspection laboratory prescribed in any subparagraph of paragraph (2): <Added on Dec. 11, 2018>
1. A person in whose case two years have not passed since his or her imprisonment without labor or heavier punishment declared by a court for violating this Act is completely executed (including cases where such imprisonment is deemed completely executed) or exempted;
2. A person who is under the suspension of the execution of a sentence of imprisonment without labor or heavier punishment declared by a court for violating this Act;
3. Any corporation with its representative or executive officer falling under subparagraph 1 or 2, or Article 10 (3) 1.
(7) No person designated as a testing and inspection laboratory shall allow another person to perform testing and inspection duties prescribed in this Article, using the name of his or her designated testing and inspection laboratory or lend his or her designation certificate as a testing and inspection laboratory to another person. <Added on Dec. 11, 2018>
(8) Designation, requirements, and procedures for alteration, the scope of affairs prescribed in the provisions of paragraphs (1) through (5), and other necessary matters, shall be prescribed by Prime Ministerial Decree. <Amended on Dec. 11, 2018>
(9) Paragraphs (5) and (8), Article 7, 9, 10, 17, and 27 shall not apply to testing and inspection laboratories prescribed by Prime Ministerial Decree pursuant to the proviso to paragraph (4). <Amended on Dec. 11, 2018>
[Title Amended on Dec. 11, 2018]