Food Sanitation Act (Full text as revised on Jun 7, 2011)
[시행 2011.12.8] [법률 제10787호, 2011.6.7]
Wholly Amended by Act No. 9432, Feb. 6, 2009
Amended by Act No. 9692, May 21, 2009
Act No. 9847, Dec. 29, 2009
Act No. 9932, Jan. 18, 2010
Act No. 10022, Feb. 4, 2010
Act No. 10191, Mar. 26, 2010
Act No. 10219, Mar. 31, 2010
Act No. 10310, May 25, 2010
Act No. 10787, Jun. 7, 2011
CHAPTER I GENERAL PROVISIONS
Article 1 (Purpose)
The purpose of this Act is to contribute to the improvement of public health by preventing sanitary risk caused by foods, promoting the qualitative improvement of food nutrition and giving accurate information on foods.
Article 2 (Definitions)
The terms used in this Act shall be defined as follows:
1. The term “foods” means all kinds of foods and beverages (excluding foods and beverages taken as medicine);
2. The term “food additives” means materials added to or mixed with foods or materials used for wetting foods in the process of manufacturing, processing or preserving foods. In such cases, food additives shall include materials used in sterilizing or disinfecting apparatus, containers or packages, which may be transmitted to foods in an indirect manner;
3. The term “chemical synthetics” means materials obtained by chemical reactions, other than a degradation reaction to elements or compounds through chemical means;
4. The term “apparatus” means machines or utensils which come into direct contact with foods or food additives, or other goods (excluding machines, utensils or other goods used for collecting foods in agriculture or fisheries), and fall under any of the following items:
(a) Goods used for eating foods or packing foods;
(b) Goods used for collecting, manufacturing, processing, cooking, storing, subdividing (referring to dividing complete products and then repackaging such products for distribution; hereinafter the same shall apply), transporting or displaying foods or food additives;
5. The term “containers and packages” means goods used for packing or wrapping foods or food additives, which are delivered with foods and food additives;
6. The term “risk” means harmful factors existing in foods, food additives, apparatus, containers or packages, which have cause or may caused risk on human bodies;
7. The term “labels” means characters, figures or diagrams labelled on foods, food additives, apparatus, containers or packages;
8. The term “nutrition labelling” means labelling of nutrition information, such as the quantity of nutrients contained in foods;
9. The term “business” means collecting, manufacturing, importing, processing, cooking, storing, subdividing, transporting or selling foods or food additives, or manufacturing, importing, transporting or selling (excluding the business of collecting foods belonging to the agriculture or fishery industry) apparatus, containers or packages;
10. The term “business operator” means a person who has obtained a business license under Article 37 (1), who has filed business notification under Article 37 (4), or who has made business registration under paragraph 5 of the same Article;
11. The term “food sanitation” means sanitation related to foods, food additives, apparatus, containers or packages;
12. The term “meal service facilities” means facilities which provide meals to many and specified persons without seeking profits, which are cafeterias of the following facilities, and which are prescribed by Presidential Decree:
(a) Dormitories;
(b) Schools;
(c) Hospitals;
(d) Other welfare institutions;
13. The term “food traceability” means following up foods showing safety problems and managing such foods to investigate the causes of safety problems and take necessary measures by recording and managing information on foods at each stage of production, processing and distribution;
14. The term “food poisoning” means an infectious or toxic disease which breaks out or is deemed to have broken out by any microbe or toxic substance harmful to the human body as a consequence of taking in food.
15. The term “menu of a meal service facility” means a meal serving plan prepared in consideration of the names, ingredients, nutritional contents, preparation methods, preparation personnel of foods according to the nutrition standards for groups that will have the meals.
Article 3 (Handling Foods, etc.)
(1) Any person shall collect, manufacture, process, use, cook, store, subdivide, transport or display foods or food additives for the purpose of sale (including offering such foods or food additives to many, unspecified persons for purposes, other than sale; hereinafter the same shall apply) in a clean and sanitary manner.
(2) Apparatus, containers and packages used for business purpose shall be handled cleanly and sanitarily.
(3) Criteria for sanitary handling of foods, food additives, apparatus, containers or packages (hereinafter referred to as “food, etc.”) as referred to in paragraphs (1) and (2) shall be determined by Ordinance of the Ministry of Health and Welfare.
CHAPTER II FOODS AND FOOD ADDITIVES
Article 4 (Prohibition against Sale, etc. of Harmful Foods, etc.)
No one shall sell, collect, manufacture, import, process, use, cook, store, subdivide, transport or display any of the following foods, etc. for the purpose of sale:
1. Rotten, stale or unripe foods, which are likely to harm a human body;
2. Foods which contain or are likely to contain poisonous or harmful substances, or are smeared or likely to be smeared with such substances: Provided, That foods deemed not to cause any harm to a human body by the Commissioner of the Korea Food and Drug Administration are excluded herefrom;
3. Foods that are or may be contaminated with microbes causing diseases, which are likely to cause harm to a human body;
4. Foods likely to harm a human body due to their uncleanness, other substances mixed with or added to such foods or other grounds;
5. Foods which have failed to undergo safety evaluation, among agricultural, livestock or fishery products subject to safety evaluation under Article 18 or foods deemed to be inedible as a result of safety evaluation;
6. Foods, the import of which is prohibited, or foods imported without making an import declaration under Article 19 (1);
7. Foods manufactured, processed or subdivided by persons, other than business operators.
Article 5 (Prohibition against Sale, etc. of Meat, etc. Affected by Diseases)
No one shall sell, as food, meat, bones, milk, organs or blood of animals which have contracted or are likely to contract diseases prescribed by Ordinance of the Ministry of Health and Welfare or animals which died of such diseases, or collect, import, process, use, cook, store, subdivide, transport or display them for the purpose of sale.
Article 6 (Prohibition against Sale, etc. of Chemical Synthetics, etc., Standards and Specifications for which are not Publicly Announced)
No one shall engage in any of the following acts: Provided, That the same shall not apply to cases deemed not to cause any harm to a human body by the Commissioner of the Korea Food and Drug Administration through a deliberation by the Food Sanitation Deliberation Committee under Article 57 (hereinafter referred to as the “Deliberation Committee”):
1. Using additives which are chemical synthetics, the standards and specifications for which are not publicly announced under Article 7 (1) and substances containing such chemical synthetics as food additives;
2. Selling foods containing food additives under subparagraph 1 or manufacturing, importing, processing, using, cooking, storing, subdividing, transporting or displaying such foods for sale.
Article 7 (Standards and Specifications concerning Foods or Food Additives)
(1) The Commissioner of the Korea Food and Drug Administration shall determine and publicly announce the following matters concerning foods or food additives for sale, when necessary for public health: Provided, That in cases of materials which may be indirectly transmitted to foods when used for sterilizing or disinfecting apparatus, containers or packages, among food additives, only the ingredients thereof may be publicly announced:
1. Standards for manufacturing, processing, using, cooking or storing foods or food additives;
2. Specifications for the ingredients of foods or food additives.
(2) The Commissioner of the Korea Food and Drug Administration may require a person who manufactures or processes foods or food additives (excluding additives which are chemical synthetics directly used for foods), the standards and specifications for which are not publicly announced under paragraph (1), to submit matters falling under each subparagraph of paragraph (1), and recognize such matters as the standards and specifications of such foods or food additives, until the standards and specifications under paragraph (1) are publicly announced through a deliberation by the food sanitary inspection institution designated under Article 24 (1) 1 and (2) 1.
(3) Notwithstanding paragraphs (1) and (2), the standards and specifications for foods or food additives to be exported may follow the standards and specifications stipulated by importers.
(4) Foods or food additives, the standards and specifications for which are determined under paragraphs (1) and (2), shall be manufactured, imported, processed, used, cooked or preserved in accordance with such standards, and no one shall sell foods or food additives, which fail to meet such standards and specifications, or manufacture, import, process, use, cook, store, subdivide, transport, preserve or display such foods or food additives for sale.
Article 7-2 (Illustrations of Recommended Specifications, etc.)
(1) If the Commissioner of the Korea Food and Drug Administration deems that foods, etc. for sale, for which standards and specifications mentioned in Articles 7 and 9 have not been determined, might cause harm to the national health and thus require preventative measures, he/she may present specifications for recommending safe management of the allegedly harmful ingredients, etc. (hereinafter referred to as “recommended specifications) until the relevant standards and specifications are determined.
(2) The Commissioner of the Korea Food and Drug Administration shall present recommended specifications pursuant to paragraph (1) in consideration of the specifications set by the Codex Alimentarius Commission and other countries as well as similar ingredients, the specifications for which have already established in other foods, etc., subject to deliberation by the Deliberation Committee.
(3) The Commissioner of the Korea Food and Drug Administration may require business operators to comply with the recommended specifications under paragraph (1) and, if any business operator fails to comply therewith, disclose such fact.
[This Article Newly Inserted by Act No. 10787, Jun. 7, 2011]
CHAPTER III APPARATUS, CONTAINERS AND PACKAGES
Article 8 (Prohibition against Sale and Use of Poisonous Apparatus, etc.)
No one shall sell apparatus, containers or packages containing or tainted with poisonous or harmful materials, which are likely to cause harm to human bodies, or apparatus, containers or packages, which cause harm to human bodies when they are in contact with foods or food additives, or manufacture, import, store, transport, display such apparatus, containers or packages for sale or use them for business.
Article 9 (Standards and Specifications concerning Apparatus, Containers and Packages)
(1) The Commissioner of the Korea Food and Drug Administration shall determine and publicly announce the following matters concerning apparatus, containers and packages sold or used for business, when necessary for public health:
1. Standards for the manufacturing methods;
2. Specifications for apparatus, containers, packages and the raw materials thereof.
(2) The Commissioner of the Korea Food and Drug Administration may require a manufacturer or processor of apparatus, containers or packages, the standards and specifications for which are not publicly announced under paragraph (1), to submit matters falling under each subparagraph of paragraph (1), and recognize such matters as the standards and specifications for the relevant apparatus, containers and packages, until the standards and specifications under paragraph (1) are publicly announced through a deliberation by a food sanitary inspection institution designated under Article 24 (1) 1 and (2) 1.
(3) Notwithstanding paragraphs (1) and (2), the standards and specifications for apparatus, containers and packages to be exported may follow the standards and specifications stipulated by importers.
(4) Apparatus, containers and packages, the standards and specifications for which are determined under paragraphs (1) and (2), shall be manufactured, in accordance with such standards, and no one shall sell apparatus, containers and packages, which fail to meet such standards and specifications, or manufacture, import, store, transport, display such apparatus, containers and packages for sale or use them for business.
CHAPTER IV LABELING
Article 10 (Standards for Labeling)
(1) The Commissioner of the Korea Food and Drug Administration may determine and publicly announce standards for the following labels, when necessary for public health:
1. Labels of foods or food additives for sale;
2. Labels of apparatus, containers and packages, the standards and specifications for which are determined under Article 9 (1);
3. Deleted.
(2) No one shall sell foods, etc., the labelling standards for which are determined under paragraph (1), or import, display or transport such foods, etc. for sale, or use them for business, when they fail to be labelled in accordance with such standards.
Article 11 (Food Nutrition Labelling)
(1) The Commissioner of the Korea Food and Drug Administration may determine and publicly announce standards for the nutrition labelling of foods prescribed by Ordinance of the Ministry of Health and Welfare.
(2) When a person who engages in manufacturing, processing, subdividing or importing foods sell, import, display, transport or use for business foods, he/she shall comply with standards for nutrition labelling determined under paragraph (1).
(3) The Commissioner of the Korea Food and Drug Administration shall provide education and publicity to enable nationals to utilize nutrition labelling under paragraph (1) in their dietary life.
Article 12 Deleted.
Article 12-2 (Labelling of Genetically Modified Foods, etc.)
(1) Foods or food additives manufactured or processed with agricultural, livestock or marine products cultivated or bred by utilizing genetic engineering technologies, such as taking useful genes from the genes of an organism and combining such genes with those of another organism, as their main raw materials (hereinafter referred to as “genetically modified foods, etc.), shall be labelled as genetically modified foods.
(2) Genetically modified foods, etc. required to be labelled pursuant to paragraph (1) shall not be sold or imported, displayed, transported, or used for business for sale, without labels.
(3) Matters necessary for persons obliged to label, objects and methods for labelling, etc. pursuant to paragraph (1) shall be determined by the Commissioner of the Korea Food and Drug Administration.
[This Article Newly Inserted by Act No. 10787, Jun. 7, 2011]
Article 12-3 (Deliberation on Labels and Advertisements)
(1) Any person who intends to place a label or advertisement on foods prescribed by Presidential Decree, such as infant foods and specially designed foods for weight control, shall undergo deliberation according to the criteria, methods and procedures for deliberation on food labels and advertisements as determined by the Commissioner of the Korea Food and Drug Administration.
(2) The Commissioner of the Korea Food and Drug Administration may entrust an institution or organization prescribed by Presidential Decree with its duties concerning prior deliberation on food labels and advertisements pursuant to paragraph (1).
[This Article Newly Inserted by Act No. 10787, Jun. 7, 2011]
Article 12-4 (Filing Objections with Regard to Deliberations on Advertisements)
(1) Any person dissatisfied with the results of deliberation under Article 12-3 (1) may file an objection to the Commissioner of the Korea Food and Drug Administration within one month of the date he/she is notified of the results of deliberation.
(2) The Commissioner of the Korea Food and Drug Administration shall, upon receipt of an objection filed under paragraph (1), review the case at issue through consultations with the Deliberation Committee and notify the claimant of the results thereof.
(3) Matters necessary for methods and procedures for, and operation of filing an objection pursuant to paragraphs (1) and (2) shall be determined by the Commissioner of the Korea Food and Drug Administration.
[This Article Newly Inserted by Act No. 10787, Jun. 7, 2011]
Article 13 (Prohibition against False Labelling, etc.)
(1) No one shall place any of the following false labels or exaggerated advertisements with regard to the names, manufacturing methods, quality, nutrition facts, or the indication of food traceability, of foods, etc. or offer exaggerated packaging. The same shall also apply to the nutritional value, raw materials, ingredients or use of foods or food additives:
1. Labels or advertisements that may lead to misconception or confusion that such foods, etc. are valuable or effective in preventing or treating diseases or that such foods, etc. are medicine or functional foods for health;
2. Labels or advertisements that are not true or exaggerated;
3. Labels or advertisements likely to deceive or mislead consumers;
4. Labels or advertisements that have not undergone deliberation under Article 12-3 (1) or whose content is different from that passed a deliberation.
(2) The scope of false labels, exaggerated advertisements and exaggerated packaging under paragraph (1) and other necessary matters shall be determined by Ordinance of the Ministry of Health and Welfare.
CHAPTER V CODE OF FOODS, ETC.
Article 14 (Code of Foods, etc.)
The Commissioner of the Korea Food and Drug Administration shall formulate and distribute the code of foods, etc., including the following standards, etc.:
1. Standards and specifications of foods or food additives, which are determined under Article 7 (1);
2. Standards and specifications of apparatus, containers or packages, which are determined under Article 9 (1);
3. Labelling standards of foods, etc. which are determined under Article 10 (1).
CHAPTER VI INSPECTIONS, ETC.
Article 15 (Risk Assessment)
(1) When foods, etc. which are likely to cause a risk and has been known to contain harmful materials in Korea and abroad, are suspected to fall under the category of foods, etc. under Article 4 or 8, the Commissioner of the Korea Food and Drug Administration shall swiftly assess the risk of such foods, etc. and determine whether such foods, etc. are harmful.
(2) The Commissioner of the Korea Food and Drug Administration may temporarily prohibit business operators from selling foods, etc., for which preventive measures are required for public health, or collecting, manufacturing, importing, processing, using, cooking, storing, subdividing, transporting or displaying such foods, etc. for sale until risk assessment under paragraph (1) is completed: Provided, That he/she shall take such prohibitive measures, when he/she deems that foods, etc. have caused or may cause imminent harm to public health.
(3) Where the Commissioner of the Korea Food and Drug Administration intends to take temporary prohibitive measures under paragraph (2), he/she shall undergo a prior deliberation and resolution by the Deliberation Committee: Provided, That in an urgent need of prohibitive measures due to the probability of imminent harm to public health, he/she may take such prohibitive measures, and then undergo a deliberation and resolution by the Deliberation Committee.
(4) When the Deliberation Committee makes a deliberation under the main sentence of or proviso to paragraph (3), it shall consider the opinions of interested persons prescribed by Presidential Decree.
(5) The Commissioner of the Korea Food and Drug Administration shall promptly cancel temporary prohibitive measures under paragraph (2) taken against foods, etc. deemed not to cause a risk to public health as a result of a risk assessment under paragraph (1) or ex post facto deliberation and resolution of the Deliberation Committee under the proviso to paragraph (3).
(6) The scope, methods or procedures for a risk assessment under paragraph (1) and other necessary matters shall be prescribed by Presidential Decree.
Article 15-2 (Publication of Outcomes, etc. of Risk Assessment)
(1) The Commissioner of the Korea Food and Drug Administration may publish matters concerning the results of a risk assessment under Article 15.
(2) Where certain foods are suspected of causing a risk or publication of a risk-related fact is scheduled and thus a risk assessment under Article 15 is required, the head of a central administrative agency, a Special Metropolitan City Mayor, a Metropolitan City Mayor, Do Governor or the Governor of a Special Self-Governing Province (hereinafter referred to as the “Mayor/Do Governor”), the head of a Si/Gun/Gu (referring to the head of an autonomous Gu; hereinafter the same shall apply), or the head of a public institution prescribed by Presidential Decree shall inform in advance the Commissioner of the Korea Food and Drug Administration of the fact and consult with him/her thereon.
(3) Matters necessary for publication under paragraph (1), such as methods for publication, shall be prescribed by Presidential Decree.
[This Article Newly Inserted by Act No. 10787, Jun. 7, 2011]
Article 16 (Request for Sanitary Inspection, etc. by Consumers)
(1) When a specified number or more of consumers or consumer organizations prescribed by Presidential Decree request the visit, inspection, collection, etc. (hereafter referred to as “sanitary inspection, etc.” in this Article) of foods, etc. or business facilities pursuant to Article 22, the Commissioner of the Korea Food and Drug Administration shall comply with such request: Provided, That the same shall not apply to any of the following cases:
1. When the same consumer or consumer organization repeatedly requests the same sanitary inspection, etc. for the purpose of obstructing the business operation of a specific business operator;
2. When the Commissioner of the Korea Food and Drug Administration deems it unable to conduct a sanitary inspection, etc., due to technology, facilities, financial resources or other grounds.
(2) When the Commissioner of the Korea Food and Drug Administration complies with a request for sanitary inspection, etc. under paragraph (1), he/she shall conduct a sanitary inspection, etc. within 14 days and notify the consumer or consumer organization that has filed such request of the outcomes of the sanitary inspection, etc. as prescribed by Presidential Decree, and post the said outcomes on the Internet.
(3) Requirements or procedures for requests for sanitary inspections, etc. and other necessary matters shall be prescribed by Presidential Decree.
Article 17 (Urgent Measures against Harmful Foods, etc.)
(1) When foods, etc. sold or foods, etc. collected, manufactured, imported, processed, cooked, stored, subdivided or transported (hereafter referred to as “manufacturing, sale, etc.” in this Article) for sale fall under any of the following subparagraphs, the Commissioner of the Korea Food and Drug Administration shall take urgent measures against such foods, etc. and necessary measures:
1. When the probability of risks to foods, etc. is raised in Korea or abroad, on the basis of scientific grounds prescribed by Ordinance of the Ministry of Health and Welfare;
2. When foods, etc. have caused or may cause serious risks to public health, as prescribed by Presidential Decree.
(2) The details of urgent measures under paragraph (1) shall include the following matters:
1. Kinds of the relevant foods, etc.;
2. Kinds and level of a risk to human health by the relevant foods, etc.;
3. Matters concerning prohibitions against manufacturing, sale, etc. under paragraph (3), when such prohibitions are needed;
4. Matters concerning education or publicity for consumers, including to take urgent measures;
5. Other matters necessary for preventing a risk to foods, etc. or stopping the spread thereof.
(3) The Commissioner of the Korea Food and Drug Administration may prohibit manufacturing, sale, etc. of foods, etc., which are deemed to require urgent measures under paragraph (1), until he/she confirms whether such foods, etc. are harmful.
(4) No business operator shall manufacture or sell foods, etc. under paragraph (3).
(5) When intending to prohibit manufacturing, sale, etc. under paragraph (3), the Commissioner of the Korea Food and Drug Administration shall consider the opinions of interested persons prescribed by Presidential Decree in advance.
(6) Any business operator may request the Commissioner of the Korea Food and Drug Administration to cancel, fully or partially, the relevant prohibitive measures, as prescribed by Presidential Decree, when he/she raises an objection against prohibitive measures under paragraph (3).
(7) The Commissioner of the Korea Food and Drug Administration shall cancel, fully or partially, prohibitive measures under paragraph (3), when he/she deems that foods, etc. have not caused or are not likely to cause a risk to public health.
(8) Where information concerning foods deemed to cause or be likely to cause imminent harm to public health shall be promptly notified to the public, and when it falls under any of the requirements prescribed by Presidential Decree, the Commissioner of the Korea Food and Drug Administration may request a broadcasting business operator prescribed by Presidential Decree, who falls under subparagraph 3 of Article 2 of the Broadcasting Act, to quickly broadcast such information or request a key telecommunications business operator prescribed by Presidential Decree, who falls under Article 5 of the Telecommunications Business Act, to promptly send a text or voice message stating such information to nationals.
(9) Upon receiving a request under paragraph (8), a broadcasting business operator or key telecommunications business operator shall comply with such request unless extenuating circumstances exist to the contrary.
Article 18 (Safety Evaluation, etc. of Genetically Modified Foods, etc.)
(1) The Commissioner of the Korea Food and Drug Administration may order business operators who import, develop or manufacture genetically modified foods, etc. as edible foods, etc. to undergo safety evaluation of the relevant foods, etc., in cases prescribed by Presidential Decree or in cases where a genetically modified food, etc. is imported for the first time.
(2) The Commissioner of the Korea Food and Drug Administration shall establish the Safety Evaluation Data Examination Committee (hereinafter referred to as the “Safety Evaluation Data Examination Committee”) at the Korea Food and Drug Administration, so as to examine the safety evaluation of genetically modified foods, etc. under paragraph (1).
(3) Necessary matters concerning the organization, functions or operation of the Safety Evaluation Data Examination Committee shall be prescribed by Presidential Decree.
(4) The subject matters of safety evaluation under paragraph (1), the scope of data submitted for safety evaluation and procedures for examination, etc. shall be determined and publicly announced by the Commissioner of the Korea Food and Drug Administration.
Article 19 (Reporting, etc. on Imported Foods, etc.)
(1) Each person who intends to import foods, etc. for sale or business shall report to the Commissioner of the Korea Food and Drug Administration, as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) The Commissioner of the Korea Food and Drug Administration shall order the relevant public officials or inspection institutions to conduct necessary examination of foods, etc. reported under paragraph (1), before customs clearance procedures are completed: Provided, That he/she may allow apparatus, containers or packages to be inspected after the customs clearance procedures are completed.
(3) When foods, etc. reported under paragraph (1) fall under any of the following subparagraphs, the Commissioner of the Korea Food and Drug Administration may omit all or some of inspections, notwithstanding paragraph (2):
1. Foods, etc. which do not fall under harmful foods, etc. under Articles 4 through 6 and 8 and meet standards, etc. under Articles 7, 9, 36 and 48, and which are confirmed in advance and registered by the Commissioner of the Korea Food and Drug Administration (hereinafter referred to as “prior confirmation and registration of imported foods, etc.”) that they do not violate Article 13 (including cases where marine animals and plants are recognized by the government of an exporting nation, but limited to cases where an exporting nation recognizes the same system for marine animals and plants imported by the Republic of Korea);
2. Foods, etc. inspected by domestic or overseas inspection institutions, recognized and publicly announced by the Commissioner of the Korea Food and Drug Administration, and the inspection outcomes or certificate of which are submitted;
3. Foods, etc. imported by an excellent import business registered under Article 20 (2);
4. Foods, etc. equivalent to those under subparagraphs 1 through 3, which fall under grounds prescribed by Ordinance of the Ministry of Health and Welfare.
(4) Necessary matters concerning the kinds, scope and methods of inspections under paragraphs (2) and (3), and standards and procedures for prior confirmation and registration of imported foods, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(5) When a person reports on original-equipment manufactured foods, etc. as described in Article 44 (5) pursuant to paragraph (1), he/she shall file a report to the Commissioner of the Korea Food and Drug Administration on the ground for setting the expiration dates determined according to criteria set and publicly announced by the Commissioner of the Korea Food and Drug Administration. The same shall also apply to revisions to important matters prescribed in Ordinance of the Ministry of Health and Welfare.
Article 19-2 (Agents, etc. for Reporting Imported Foods, etc.)
(1) Any person who intends to import foods, etc. may have a person prescribed by Presidential Decree as qualified for the safe management of foods, who has registered with the Commissioner of the Korea Food and Drug Administration (hereinafter referred to as “agent for reporting imported foods”), make an import declaration of foods, etc. under Article 19 (1).
(2) Procedures for the registration of agents for reporting imported foods, education thereof, and agency fees shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(3) The Commissioner of the Korea Food and Drug Administration may, if an agent for reporting imported foods registered pursuant to paragraph (2) corresponds to any of the following, cancel his/her registration or order him/her to suspend business for a prescribed period of not more than six months: Provided, That if an agent falls under subparagraph 1, the Commissioner of the Korea Food and Drug Administration shall cancel his/her registration:
1. Where his/her registration is made by fraudulent or other illegal means;
2. Where he/she continues to conduct business in violation of an order to suspend business;
3. Where he/she fails to fulfill the qualification requirements set forth in paragraph (1);
4. Where it is verified that he/she has offered money, valuables or other forms of entertainment to a public official in charge of business concerning importation reports;
5. Where it is verified that he/she has requested money, valuables or other forms of entertainment in addition to agency fees from an importer;
6. Where it is verified that, when requesting an inspection pertaining to business of reporting imported foods to a food sanitary examination institution pursuant to Article 24, he/she has offered money, valuables or other forms of entertainment in addition to inspection fees to the institution;
7. Where it is verified that he/she has reported imported foods on behalf of another person in an unlawful manner, such as filing a false report and attaching fabricated documents.
(4) Detailed criteria for an administrative disposition under paragraph (3) shall be prescribed by Ordinance of the Ministry of Health and Welfare, in view of the type, severity, etc. of the relevant violation.
(5) No person for whom three years have not elapsed from the date his/her registration was cancelled pursuant to paragraph (3) shall register as an agent anew.
[This Article Newly Inserted by Act No. 10787, Jun. 7, 2011]
Article 19-3 (Order for Education on Food Safety, etc.)
(1) The Commissioner of the Korea Food and Drug Administration may order any of the following business operators to receive education on food safety to ensure the safety of imported foods, etc.:
1. A business operator who imports foods, etc. judged unfit to eat as a result of inspection of foods, etc. for which import declaration has been made pursuant to Article 19 (1);
2. A business operator subject to a disposition of suspension of business as a result of a visit, inspection, collection, etc. under Article 22 (1) with regard to imported foods, etc. being circulated nationwide.
(2) Necessary matters concerning detailed procedures, education institutions, methods and content, etc. with regard to an order for education on food safety pursuant to paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
[This Article Newly Inserted by Act No. 10787, Jun. 7, 2011]
Article 19-4 (Inspection Orders, etc.)
(1) The Commissioner of the Korea Food and Drug Administration may order a business operator gathering, manufacturing, importing, processing, using, cooking, storing, subdividing, transporting or displaying any of the following foods, etc. to undergo inspections conducted at a food sanitary inspection institution defined in Article 24 (2) or a certified foreign inspection institution designated by the Commissioner of the Korea Food and Drug Administration (hereinafter referred to as “inspection order”): Provided, that related data, etc. may be substituted for such inspection in cases where the Commissioner of the Korea Food and Drug Administration acknowledges that hazardous ingredients cannot be detected through an inspection:
1. Foods, etc. from which hazardous substances are detected at home and abroad;
2. Foods, etc. with high unfitness rates as a result of inspection of foods, etc. for which import declaration has been made pursuant to Article 19 (2);
3. Other foods, etc. over which concern that such foods, etc. might cause harm is or was raised at home and abroad.
(2) A business operator in receipt of an inspection order shall undergo an inspection within the inspection period set by Ordinance of the Ministry of Health and Welfare, or submit related data, etc.
(3) Detailed matters pursuant to paragraphs (1) and (2), such as the extent of foods, etc. subject to an inspection order and related data shall be determined and publicly announced by the Commissioner of the Korea Food and Drug Administration.
[This Article Newly Inserted by Act No. 10787, Jun. 7, 2011]
Article 20 (Registration, etc. of Excellent Import Businesses)
(1) Any person who has made an import declaration under Article 19 may check the sanitary condition of manufacturing places of an exporting nation, in accordance with the criteria prescribed by the Commissioner of the Korea Food and Drug Administration, so as to ensure the safety of the relevant imported foods, etc.
(2) Any business which checks sanitary conditions under paragraph (1) may file for registration of an excellent import food business (hereinafter referred to as “excellent import business”) with the Commissioner of the Korea Food and Drug Administration.
(3) Any business which intends to be registered as an excellent import business, shall file for registration with the Commissioner of the Korea Food and Drug Administration, as prescribed by Ordinance of the Ministry of Health and Welfare. The same shall apply to revisions to important matters prescribed by Ordinance of the Ministry of Health and Welfare in a registration statement.
(4) When an excellent import business falls under any of the following subparagraphs, the Commissioner of the Korea Food and Drug Administration may cancel registration or issue an order to take corrective measures: Provided, That when an excellent import business falls under subparagraph 1, he/she shall cancel such registration:
1. When it makes a registration by fraud or other wrongful means;
2. When it is subject to an administrative disposition of business suspension for not less than two months under Article 75;
3. When it fails to observe matters prescribed by Ordinance of the Ministry of Health and Welfare, which correspond to subparagraphs 1 and 2.
(5) Detailed matters, including procedures and methods for registration of excellent import businesses or safety standards for manufacturing or processing facilities owned by manufacturers of exporting nations, shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 21 (Prohibition against Import, Sale, etc. of Specific Foods, etc.)
(1) When foods, etc., collected, manufactured, processed, used, cooked or stored in a specific nation or region are found to or are likely to be harmful in such nation or region, the Commissioner of the Korea Food and Drug Administration may prohibit importing or selling such foods, etc. or manufacturing, processing, using, cooking, storing, subdividing, transporting or displaying such foods, etc. for sale.
(2) When poisonous or harmful materials under subparagraph 2 of Article 4 are detected in foods, etc. after the risk assessment under Article 15 (1) or inspections under Article 19 (2), the Commissioner of the Korea Food and Drug Administration shall prohibit importing such foods, etc.: Provided, That the same shall not apply in cases where the Commissioner of the Korea Food and Drug Administration deems that foods, etc. do not cause any harm to a human body.
(3) When the Commissioner of the Korea Food and Drug Administration intends to take prohibitive measures under paragraphs (1) and (2), he/she shall consider the opinions of heads of the relevant central administrative agencies in advance, and undergo a deliberation and resolution by the Deliberation Committee: Provided, That in an urgent need of prohibitive measures due to the probability of imminent harm to public health, he/she may take such prohibitive measures, and then undergo a deliberation and resolution by the Deliberation Committee.
(4) When the Deliberation Committee makes a deliberation under the main sentence of and proviso to paragraph (3), interested persons prescribed by Presidential Decree may attend a meeting of the Deliberation Committee to state their opinions or present their written opinions.
(5) When foods, etc., the import or sale of which is prohibited under paragraphs (1) and (2) are recognized to cause no harm to a human body, the Commissioner of the Korea Food and Drug Administration may cancel all or some of prohibitive measures under paragraphs (1) and (2), either ex officio or upon requests of an interested nation or a business operator who has imported such foods, etc., after undergoing a deliberation and resolution by the Deliberation Committee.
(6) When the Commissioner of the Korea Food and Drug Administration takes prohibitive measures under paragraphs (1) and (2) or cancels such measures under paragraph (5), he/she shall publicly announce such fact.
(7) When a business that manufactures foods, etc., the import or sale of which is prohibited under paragraphs (1) and (2), an interested nation or a business operator who has imported such foods, etc. ascertain the causes of harm or suggest improvement measures, the Commissioner of the Korea Food and Drug Administration may cancel all or some of prohibitive measures under paragraphs (1) and (2). In such cases, he/she may conduct a field investigation, when necessary for checking whether such improvement measures are taken.
Article 22 (Visits, Inspection, Collection, etc.)
(1) A Mayor/Do Governor or the head of a Si/Gun/Gu may take the following measures, when necessary for preventing harm caused by foods, etc., managing sanitation or maintaining business order:
1. Requesting a business operator or other related persons to submit necessary documents or data;
2. Ordering the relevant public officials to take any of the following measures, such as visit, inspections or collection:
(a) Inspecting foods, etc. for sale or business, or business facilities, etc. by visiting places of business (including offices, warehouses, factories, storage places, selling places or other places similar thereto);
(b) Collecting the minimum amounts of foods, etc. necessary for inspections under item (a) without any consideration;
(c) Inspecting books or documents related to business.
(2) When it is necessary for a Mayor/Do Governor or the head of a Si/Gun/Gu to effectively prevent sanitation-related harm caused by foods, etc., while conducting the visit, inspection, collection, etc. under paragraph (1), the Commissioner of the Korea Food and Drug Administration may request the heads of the relevant administrative agencies, other Mayors/Do Governors or heads of Sis/Guns/Gus to assist the performance of administrative duties. In such cases, upon receiving a request for assistance, the heads of the relevant administrative agencies, Mayors/Do Governors or heads of Sis/Guns/Gus shall comply with such request, unless extenuating circumstances exist to the contrary.
(3) Any public official who intends to conduct the visit, inspection, collection or perusal under paragraphs (1) and (2), shall carry a certificate indicating his/her authority and present it to related persons.
(4) Procedures for assistance to perform administrative duties under paragraph (2), methods of sharing expenses and other necessary matters shall be prescribed by Presidential Decree.
Article 23 (Reinspection of Foods, etc.)
(1) When the inspection of foods, etc. under Article 19 or 22 shows that the relevant foods, etc. fail to meet the standards or specifications of foods, etc. under Article 7 or 9, the Commissioner of the Korea Food and Drug Administration (including the heads of affiliated organizations prescribed by Presidential Decree; hereafter the same shall apply in this Article), a Mayor/Do Governor or the head of a Si/Gun/Gu shall notify the relevant business operator of the outcomes of such inspection, as prescribed by Presidential Decree.
(2) When a business operator who has received a notification under paragraph (1) raises an objection against the outcome of an inspection, he/she may request the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu to reinspect foods, etc., along with a written inspection outcome or inspection certificate issued by a domestic or overseas inspection institution recognized by the Commissioner of the Korea Food and Drug Administration.
(3) Upon receiving a request for reinspection under paragraph (2), the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu shall determine as to whether he/she will conduct a reinspection, as prescribed by Presidential Decree, and notify the relevant business operator of the outcome thereof.
(4) When the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu decides to reinspect the relevant foods, etc. under paragraph (3), he/she shall conduct the reinspection without delay, and notify the relevant business operator of the outcome thereof. In such cases, expenses incurred in conducting the reinspection, such as charges for reinspection and bonded warehouse fees, shall be borne by the relevant business operator.
Article 24 (Designation, etc. of Food Sanitary Inspection Institution, etc.)
(1) The following institutions (hereinafter referred to as “food sanitary examination institutions”) may inspect the standards, specification, etc. of foods, etc. (hereinafter referred to as “food sanitary inspection”) under Articles 7 and 9 to secure the safety of foods, etc. and confirm whether foods, etc. are harmful:
1. Food sanitary inspection institutions prescribed by Ordinance of the Ministry of Health and Welfare;
2. Food sanitary inspection institutions designated by the Commissioner of the Korea Food and Drug Administration to effectively conduct food sanitary inspections.
(2) Food sanitary inspection institutions under paragraph (1) 2 may be categorized as follows, depending on the types of food sanitary inspections:
1. Institutions specializing in food sanitary inspections: Food sanitary inspections under Article 19 (2) and 22 (1);
2. Institutions entrusted with self-quality inspections: Food sanitary inspections under Article 31 (2).
(3) Necessary matters concerning food sanitary inspection facilities which shall be installed at food sanitary inspection institutions under paragraph (2), human resources specializing in food sanitary inspections (hereinafter referred to as “inspectors”) and the designation and evaluation of food sanitary inspection institutions shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 25 (Term of Validity of Designation of Food Sanitary Inspection Institutions)
(1) The term of validity of the designation of food sanitary inspection institutions designated under Article 24 (2) shall be three years from the date of designation.
(2) The term of validity under paragraph (1) may be extended only once, by a further period of up to one year, as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) Food sanitary inspection institutions, the term of validity of which has expired under paragraphs (1) and (2), and which meet the requirements for food sanitary inspection facilities and inspectors under Article 24 (3), may be re-designated pursuant to Article 24.
Article 26 (Visit, etc. to Food Sanitary Inspection Institutions)
The Commissioner of the Korea Food and Drug Administration (including the heads of affiliated organizations prescribed by Presidential Decree) may require persons engaged in food sanitary inspections or other relevant persons to submit a necessary report, or order the relevant public officials to visit the offices of food sanitary inspection institutions, places of inspection or other places similar thereto to inspect food sanitary inspection facilities, inspectors, inspection logbooks, records, etc. or review books or documents related to food sanitary inspections, when deemed necessary for securing the appropriateness and credibility of food sanitary inspections conducted by food sanitary inspection institutions designated under Article 24 (2).
Article 27 (Revocation of Designation as Food Sanitary Inspection Institutions)
When a food sanitary inspection institution designated under Article 24 (2) falls under any of the following subparagraphs, the Commissioner of the Korea Food and Drug Administration may revoke such designation, as prescribed by Ordinance of the Ministry of Health and Welfare, or issue an order to suspend food sanitary inspections within a fixed period of up to six months or corrective orders, etc.: Provided, That when it falls under subparagraphs 1 through 3, he/she shall revoke such designation:
1. When it is designated by fraud or other wrongful means;
2. When it issues false records concerning food sanitary inspections intentionally or by gross negligence;
3. When it performs food sanitary inspection work during a period of business suspension;
4. When it violates the provisions concerning food sanitary inspection work prescribed by Ordinance of the Ministry of Health and Welfare.
Article 28 (Restrictions on Designation)
No Commissioner of the Korea Food and Drug Administration shall designate any of the following institutions as a food sanitary inspection institution under Article 24 (2):
1. Food sanitary inspection institution to be established and operated by a person (in cases of a corporation, including the representative thereof) who has established and operated the food sanitary inspection institution, the designation of which is revoked under Article 27, and for whom three years have not elapsed since such revocation:
2. Food sanitary inspection institution to be established and operated in the same place as the food sanitary inspection institution, the designation of which is revoked under Article 27 within three years from the date of such revocation.
Article 29 (Succession to Inspection Institutions)
(1) When any person designated as a food sanitary inspection institution under Article 24 (2) (hereinafter referred to as “operator of inspection institution”) dies or transfers the operation thereof, or a merger of corporations occurs, the successor, transferee or a corporation surviving such merger or established after such merger shall succeed to the status of the operator of relevant inspection institution under this Act.
(2) Any person who has acquired full operating facilities of a food sanitary inspection institution, in accordance with any of the following procedures, and meets requirements for designation under Article 24, shall succeed to the status of the operator of relevant inspection institution under this Act:
1. Auction under the Civil Execution Act;
2. Conversion under the Debtor Rehabilitation and Bankruptcy Act;
3. Disposal of seized property under the National Tax Collection Act, the Customs Act or the Framework Act on Local Taxes;
4. Other procedures corresponding to those under subparagraphs 1 through 3.
(3) Any person who has succeeded to the status of the operator of an inspection institution under paragraphs (1) and (2) shall file a notification with the Commissioner of the Korea Food and Drug Administration within one month, as prescribed by Ordinance of the Ministry of Health and Welfare.
Article 30 (Education of Inspectors)
(1) The representatives or inspectors of food sanitary inspection institutions designated under Article 24 (2) shall receive education concerning the methods, etc. of conducting food sanitary inspections, each year.
(2) Institutions providing education concerning inspection methods, etc. under paragraph (1) and the details of education, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 31 (Obligation of Self-Quality Inspection)
(1) Any business operator who manufactures or processes foods, etc. shall inspect whether foods, etc. manufactured or processed meet the standards and specifications under Article 7 or 9, as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) When it is inappropriate that the relevant business operator directly conducts an inspection under paragraph (1), the Commissioner of the Korea Food and Drug Administration or a Mayor/Do Governor may request institutions entrusted with self-quality inspection under Article 24 (2) 2 to conduct an inspection.
(3) When it is found through an inspection under paragraph (1) that the relevant foods, etc. violate the provisions of Articles 4 through 6, Article 7 (4), 8 or 9 (4) and thus cause or are likely to cause harm to the national health, a business operator directly conducting an inspection under paragraph (1) and an institution entrusted with self-quality inspection under paragraph (2) shall report to the Commissioner of the Korea Food and Drug Administration without delay.
(4) The items and procedures for inspections under paragraphs (1) and (2) and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 32 (Food Sanitation Supervisors)
(1) Food sanitation supervisors shall be assigned to the Korea Food and Drug Administration (including affiliated organizations prescribed by Presidential Decree), the Special Metropolitan City, a Metropolitan City, a Do, a Special Self-Governing Province (hereinafter referred to as “City/Do”) or a Si/Gun/Gu (referring to an autonomous Gu; hereinafter the same shall apply) to provide instruction concerning the duties of the relevant public officials under Article 22 (1) and food sanitation.
(2) Qualification, appointment, and the scope of duties of food sanitation supervisors under paragraph (1) and other necessary matters shall be prescribed by Presidential Decree.
Article 33 (Customer Food Sanitation Supervisors)
(1) The Commissioner of the Korea Food and Drug Administration (including the heads of affiliated organizations prescribed by Presidential Decree; hereafter the same shall apply in this Article), a Mayor/Do Governor or the head of a Si/Gun/Gu may appoint, as customer food sanitation supervisors, persons recommended by the heads of the relevant organizations or persons with expertise about food sanitation, from among executives or employees of customer organizations registered under Article 29 of the Framework Act on Consumers.
(2) The duties of customer food sanitation supervisors appointed under paragraph (1) (hereinafter referred to as “customer food sanitation supervisor”) shall be as follows:
1. Checking the sanitation management of persons engaged in food service business (hereinafter referred to as “food service business operators”) under Article 36 (1) 3;
2. Submitting a report or providing related data to the competent administrative agency, where foods, etc. in circulation fail to meet labelling standards or violate the provisions concerning prohibition against false labelling or exaggerated advertisements;
3. Supporting the collection and inspection of foods, etc. by food sanitation supervisors under Article 32;
4. Other matters concerning food sanitation, prescribed by Presidential Decree.
(3) No customer food sanitation supervisor shall abuse his/her authority, when performing his/her duties under each subparagraph of paragraph (2).
(4) The Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu who has appointed customer food sanitation supervisors under paragraph (1), shall provide education necessary for the performance of duties to customer food sanitation supervisors.
(5) When customer food sanitation supervisors fall under any of the following subparagraphs, the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu shall dismiss the relevant customer food sanitation supervisors:
1. When they retire from or are dismissed by customer organizations which have recommended them;
2. When they commit unlawful acts or abuse their authority, with regard to duties under each subparagraph of paragraph (2);
3. When they are unable to perform their duties due to diseases or injuries.
(6) When a customer food sanitation supervisor intends to solely visit a food service business operator’s place of business to perform duties under paragraph (2) 1, he/she shall obtain prior approval from the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu.
(7) When a customer food sanitation supervisor solely visits a food service business operator’s place of business after obtaining approval under paragraph (6), he/she shall carry with him/her a written statement of approval and a certificate indicating his/her status and present them to the relevant persons.
(8) Qualification, the scope of duties or education of customer food sanitation supervisors and other necessary matters shall be prescribed by Presidential Decree.
Article 34 (Private Food Inspectors)
(1) Any business operator prescribed by Presidential Decree may appoint, as a private food inspector, a person designated by the Commissioner of the Korea Food and Drug Administration or a Mayor/Do Governor, from among persons with expertise about food sanitation who fall under any of the following subparagraphs, to check the actual status of sanitation management of foods, etc. in the relevant business:
1. A person recommended by the head of a consumer organization registered under Article 29 of the Framework Act on Consumers;
2. A person recommended by the head of an organization related to food sanitation, from among non-profit, non-governmental organizations under Article 2 of the Assistance for Non-Profit, Non-Governmental Organizations Act;
3. A person who serves as an assistant professor or in a higher position in a department related to foods at any school under Article 2 of the Higher Education Act.
(2) Any private food inspector appointed under paragraph (1) (hereinafter referred to as “private food inspector”) may check the actual status of sanitation management in the place of business of a business operator prescribed by paragraph (1) at least once a quarter and recommend the business operator to take necessary measures, such as improving sanitation management, when the findings of inspection show that the relevant place of business is unsanitary or food safety needs to be improved.
(3) When a business operator fails to implement recommendation under paragraph (2), the relevant private food inspector shall report such fact to the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu.
(4) No private food inspector shall divulge any confidential information he/she has obtained in the course of performing his/her duties or use such information for any purpose, other than for his/her duties.
(5) Any business operator who appoints or dismisses a private food inspector under paragraph (1) shall report the following matters to the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu, as prescribed by Ordinance of the Ministry of Health and Welfare:
1. The date on which a private food inspector is appointed and his/her personal information;
2. Details of improvement recommended by a private food inspector under paragraph (2) and the results of improvement;
3. The date on which a private food inspector is dismissed and grounds for such dismissal.
(6) The Commissioner of the Korea Food and Drug Administration (including the heads of affiliated organizations prescribed by Presidential Decree), a Mayor/Do Governor or the head of a Si/Gun/Gu may order the relevant public officials to suspend visit, inspection or collection under Article 22 at the place of business of a business operator who has appointed a private food inspector under paragraph (1) for a specific period prescribed by Ordinance of the Ministry of Health and Welfare: Provided, That the same shall not apply to any of the following cases:
1. When a business operator who has appointed a private food inspector fails to comply with the recommendation of the private food inspector;
2. When a private food inspector fails to conscientiously perform duties under paragraph (2) or commits wrongful acts related to his/her duties;
3. When it is confirmed that a product has a harmful factor, as a result of collecting and inspecting products manufactured, processed and distributed by a business operator who has appointed a private food inspector.
(7) Qualification and procedures for the appointment or the scope of duties of a private food inspector and other necessary matters shall be prescribed by Presidential Decree.
Article 35 (Participation, etc. in Sanitary Inspection by Customers)
(1) Any business operators prescribed by Presidential Decree may undergo a sanitary inspection conducted by persons with expertise on food sanitation or persons recommended by the head of a consumer organization registered under Article 29 of the Framework Act on Consumers and determined by the Commissioner of the Korea Food and Drug Administration.
(2) When the findings of an inspection under paragraph (1) show that business operators meet the criteria prescribed by the Commissioner of the Korea Food and Drug Administration and pass the inspection, they may label or advertise such fact on foods, etc. manufactured and processed at the relevant place of business, as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) The Commissioner of the Korea Food and Drug Administration (including the heads of affiliated organizations prescribed by Presidential Decree), a Mayor/Do Governor or the head of a Si/Gun/Gu may order the relevant public officials to suspend visit, inspection and collection under Article 22 at a place of business which has been inspected pursuant to paragraph (1) and is rated excellent by the Commissioner of the Korea Food and Drug Administration, for a specific period prescribed by Ordinance of the Ministry of Health and Welfare.
(4) The timing, etc. of sanitary inspections under paragraph (1) shall be prescribed by Presidential Decree.
CHAPTER VII BUSINESS
Article 36 (Criteria for Facilities)
(1) Any person who intends to engage in business falling under any of the following subparagraphs shall be equipped with facilities which meet the criteria for facilities prescribed by Ordinance of the Ministry of Health and Welfare:
1. Manufacturing, processing, transporting, selling and preserving foods or food additives;
2. Manufacturing apparatus, containers or packages;
3. Providing food services.
(2) The detailed types and scope of business under each subparagraph of paragraph (1) shall be determined by Presidential Decree.
Article 37 (Business Licenses, etc.)
(1) Any person who intends to engage in business prescribed by Presidential Decree, which falls under any subparagraph of Article 36 (1), shall obtain a license from the Commissioner of the Korea Food and Drug Administration, the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu, by type of business or each place of business, as prescribed by Presidential Decree. The same shall apply to revisions to important matters prescribed by Presidential Decree in the license.
(2) The Commissioner of the Korea Food and Drug Administration, the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu may attach necessary conditions to permission, when he/she grants a business license under paragraph (1).
(3) When any person who has obtained a business license under paragraph (1), discontinues business or revises insignificant matters, other than important matters under the latter part of paragraph (1) in a license, he/she shall submit a report to the Commissioner of the Korea Food and Drug Administration, or the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu.
(4) Any person who intends to engage in business prescribed by Presidential Decree, which falls under any subparagraph of Article 36 (1), shall file a notification thereof with the Commissioner of the Korea Food and Drug Administration, or the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu, by type of business or place of business. The same shall apply to revisions to important matters notified as prescribed by Presidential Decree, or to business closure.
(5) Any person who intends to engage in business prescribed by Presidential Decree, which falls under any subparagraph of Article 36 (1), shall file business registration, by type of business or a place of business, with the Commissioner of the Korea Food and Drug Administration, or the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu, as prescribed by Presidential Decree, which shall also apply to revisions to important matters registered as prescribed by Presidential Decree: Provided, that business closure or revisions to insignificant matters excepting important matters as prescribed by Presidential Decree shall be notified to the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu.
(6) When any person who has obtained a business license or filed notification or registration to manufacture or process foods or food additives under paragraph (1), (4) or (5) manufactures or processes foods or food additives, he/she shall report such fact to the Commissioner of the Korea Food and Drug Administration, or the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu, as prescribed by Ordinance of the Ministry of Health and Welfare. The same shall apply to revisions to important matters notified as prescribed by Ordinance of the Ministry of Health and Welfare.
(7) When a business operator (limited to a person who has notified business under paragraph (4) or registered business under paragraph (5)) notifies business closure to the head of the competent tax office under Article 5 of the Value-Added Tax Act, or the head of the competent tax office cancels the registration of a business operator, the Commissioner of the Korea Food and Drug Administration, or the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu may cancel notified matters ex officio.
(8) No person who closes his/her business pursuant to paragraphs (3) through (5) may file notification of business closure during the period of an administrative disciplinary measure under Articles 71 through 76, such as business suspension.
Article 38 (Restrictions on Business Licenses, etc.)
(1) In any of the following cases, no business license under Article 37 (1) shall be granted:
1. When the relevant business facilities fail to meet the criteria for facilities under Article 36;
2. When a business operator intends to engage in the same type of business in the same place before six months have elapsed since the business license was canceled under Article 75 (1) or (2) (excluding cases where a business license was canceled due to a violation of Article 44 (2) 1 or a business license was canceled under Article 75 (1) 18): Provided, That the same shall not apply in cases where a business license is canceled after all of business facilities are removed;
3. When a business operator intends to engage in a food service business under Article 36 (1) 3 in the same place before two years have elapsed since a business license was canceled due to a violation of Article 44 (2) 1 or a business license was canceled under Article 75 (1) 18;
4. When the same business operator (in cases of a corporation, including the representative thereof) intends to engage in the same type of business before two years have elapsed since the business license was canceled under Article 75 (1) or (2) (excluding cases where a business license was canceled due to a violation of Articles 4 through 6, 8 or 44 (2) 1 and a business license was canceled under Article 75 (1) 18);
5. When the same business operator (in the case of a corporation, including the representative thereof) intends to engage in a food service business under Article 36 (1) 3 before three years have elapsed since a business license was canceled due to a violation of Article 44 (2) 1 or a business license was canceled under Article 75 (1) 18;
6. When the same business operator (in the case of a corporation, including the representative thereof) intends to engage in the same type of business before five years have elapsed since a business license was canceled due to a violation of Article 4 through 6 or 8;
7. When it is deemed necessary to restrict a license of food service business under Article 36 (1) 3 that the Mayor/Do Governor designates and publicly announces for the purpose of public health;
8. When any person who intends to obtain a business license is incompetent, or was declared bankrupt and has not yet been reinstated;
(2) In any of the following cases, no business notification under Article 37 (4) or business registration under Article 37 (5) shall be filed:
1. When a business operator intends to engage in the same type of business in the same place before six months have elapsed since his/her registration was cancelled or an order to close down his/her place of business was issued under Article 75 (1) or (2) (excluding cases where an order to close down his/her place of business was issued due to a violation of Article 44 (2) 1, and such order was issued under Article 75 (1) 18): Provided, That the same shall not apply to cases where his/her business is cancelled or an order to close down his/her place of business is issued after all of business facilities are removed;
2. When a business operator intends to engage in food service business under Article 36 (1) 3 in the same place before one year has elapsed since an order to close down his/her place of business was issued due to a violation of Article 44 (2) 1, or such order was issued under Article 75 (1) 18;
3. When the same business operator (in the case of a corporation, including the representative thereof) intends to engage in the same type of business with the business subject to cancellation of registration or an order to close down his/her place of business, before two years have elapsed since his/her registration was cancelled or an order to close down his/her place of business was issued under Article 75 (1) or (2) (excluding cases where his/her registration was cancelled or an order to close down his/her place of business was issued due to a violation of Articles 4 through 6, Article 8 or 44 (2) 1 and such order was issued under Article 75 (1) 18);
4. When the same business operator (in the case of a corporation, including the representative thereof) intends to engage in food service business under Article 36 (1) 3 before two years have elapsed since an order to close down his/her place of business was issued due to a violation of Article 44 (2) 1 or such order was issued under Article 75 (1) 18;
5. When a business operator (in the case of a corporation, including the representative thereof), for whom five years have not elapsed since his/her registration was cancelled or an order to close down his/her place of business was issued due to a violation of Articles 4 through 6 or 8, intends to engage in the same type of business with the business subject to the cancellation of registration or the order to close down his/her place of business.
Article 39 (Succession to Business)
(1) When a business operator transfers his/her business or dies, or the merger of corporations is carried out, the transferee, successor, a corporation surviving such merger or a corporation established after such merger shall succeed to the status of the relevant business operator.
(2) A person who has acquired all of business facilities, in accordance with procedures falling under any subparagraph of Article 29 (2), shall succeed to the status of the relevant business operator. In such cases, the business license, registration, or notification granted or filed by the former business operator shall lose their effect.
(3) A person who has succeeded to the status of the relevant business operator under paragraph (1) or (2) shall notify such fact to the Commissioner of the Korea Food and Drug Administration, the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu within one month, as prescribed by Ordinance of the Ministry of Health and Welfare.
(4) With respect to succession under paragraphs (1) and (2), Article 38 shall apply mutatis mutandis: Provided, That the same shall not apply for three months since the date of succession, when any successor falls under Article 38 (1) 8.
Article 40 (Medical Examination)
(1) A business operator and his/her employees prescribed by Ordinance of the Ministry of Health and Welfare shall undergo medical examination: Provided, That when they undergo the same medical examination as that prescribed by other Acts and subordinate statutes, they shall be deemed to have undergone medical examination under this Act.
(2) No person, who is recognized to have a disease likely to cause harm to third persons as a result of medical examination under paragraph (1), shall be engaged in the relevant business.
(3) No business operator may order persons, who have failed to undergo medical examination, in violation of paragraph (1), or who have a disease likely to cause harm to third persons as a result of medical examination under paragraph (2), to work in the relevant business.
(4) Methods of conducting medical examination under paragraph (1) and the types of diseases likely to cause harm to third persons under paragraphs (2) and (3) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 41 (Education on Food Sanitation)
(1) Each person employed by a business operator prescribed by Presidential Decree or by a food service business operator who may employ entertainment workers shall receive education concerning food sanitation (hereinafter referred to as “education on food sanitation”) each year.
(2) Each person who intends to engage in business under each subparagraph of Article 36 (1) shall receive education on food sanitation in advance: Provided, That when he/she is unable to receive such education in advance due to inevitable grounds, he/she may receive such education, as prescribed by Ordinance of the Ministry of Health and Welfare, after starting business.
(3) When any person who shall receive education under paragraphs (1) and (2), is not directly engaged in business or engages in business at not less than two places, a person in charge of food sanitation may be designated, from among employees, and receive education on behalf of a business operator: Provided, That when any cook or dietician (referring to a licensed dietician pursuant to Article 15 of the National Nutrition Control Act; hereinafter the same shall apply) working for meal service facilities is designated as a person in charge of food sanitation and receives education under the proviso to Article 56 (1), he/she shall be deemed to have received education on food sanitation of the relevant year under paragraphs (1) and (2).
(4) When any person who has obtained a license of a cook or dietician intends to engage in food service business under Article 36 (1) 3, he/she need not receive education on food sanitation, notwithstanding paragraph (2).
(5) No business operator shall allow persons, who fail to receive education on food sanitation, to be engaged in the relevant business, unless extenuating circumstances exist to the contrary.
(6) Necessary matters concerning the details or expenses of education and an institution providing education under paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 42 (Quality Control and Reporting)
(1) Each business operator who manufactures or processes foods or food additives or his/her employees shall comply with the matters prescribed by Ordinance of the Ministry of Health and Welfare, for the control of raw materials, manufacturing processes or sanitary management of foods, etc.
(2) Each business operator under paragraph (1) shall report the records, etc. of producing foods or food additives to the Commissioner of the Korea Food and Drug Administration or a Mayor/Do Governor, as prescribed by Ordinance of the Ministry of Health and Welfare.
Article 43 (Restrictions on Business Operations)
(1) Any Mayor/Do Governor may restrict business hours or activities of food service business operators and their employees, when necessary for maintaining business order and good custom.
(2) Details of restrictions under paragraph (1) shall be prescribed by Municipal Ordinance of the relevant City/Do, within the scope prescribed by Presidential Decree.
Article 44 (Matters to be Observed by Business Operators, etc.)
(1) Each business operator prescribed by Presidential Decree, including a food service business operator, and his/her employees shall comply with the matters prescribed by Ordinance of the Ministry of Health and Welfare, so as to control the sanitation of business, maintain order and improve the health and sanitation of nationals.
(2) No food service business operator shall commit any of the following acts against juveniles under Article 2 of the Juvenile Protection Act (hereafter referred to as “juveniles” in this paragraph):
1. Having juveniles provide entertainment services by employing them as entertainment workers;
2. Employing juveniles in or giving them access to business establishments banned from employing juveniles or giving them access under subparagraph 5 (a) (i) of Article 2 of the Juvenile Protection Act;
3. Employing juveniles in business establishments banned from employing juveniles under subparagraph 5 (b) (i) of Article 2 of the Juvenile Protection Act;
4. Providing alcoholic beverages to juveniles.
(3) No person shall drink alcoholic beverages with customers, provide entertainment services (excluding performance by singers, musicians, dancers, chorus girls, etc.) which add to pleasure with songs or dance, or request a third person to provide such services at a place providing food services under Article 36 (1) 3 (excluding a place of business which may employ entertainment workers pursuant to Presidential Decree) for business purpose.
(4) No food service business operator under paragraph (3) shall employ entertainment workers, help them find a job or solicit business.
(5) Each business operator who imports or sells foods, etc. under Article 19 after entrusting the manufacturing or processing of foods, etc. to an exporting nation by the means of original equipment manufacturing (hereinafter referred to as “original-equipment manufactured foods, etc.”) shall observe the following matters:
1. Business operators shall have institutions or organizations prescribed by Presidential Decree conduct on-site sanitary inspections of companies which manufacture or process original-equipment manufactured foods, etc. in accordance with standards for sanitary inspection prescribed by the Commissioner of the Korea Food and Drug Administration:
2. Business operators shall conduct an inspection under Article 31 of original-equipment manufactured foods, etc. and retain records thereof for two years.
Article 45 (Recall of Harmful Foods, etc.)
(1) Each business operator who has manufactured, processed, subdivided, imported or sold food, etc. for sale shall recall the relevant foods, etc. in circulation without delay or take measures necessary for recalling such foods, etc., when he/she become aware that the relevant foods, etc. violate Articles 4 through 6, Article 7 (4), 8 or 9 (4) (excluding violations not related to harmful foods, etc.). In such cases, a business operator shall report a plan for such recall to the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu in advance, and the Mayor/Do Governor or the head of a Si/Gun/Gu shall, upon receiving reports on the outcomes of such recall, report such outcomes to the Commissioner of the Korea Food and Drug Administration, without delay.
(2) The Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu may exempt a business operator, who faithfully implement measures necessary for recall under paragraph (1), from administrative disposition under Article 75 or 76 due to the relevant foods, etc., as prescribed by Presidential Decree.
(3) Necessary matters concerning foods, etc. subject to recall under paragraph (1), plans or procedures for recall and reports on the outcomes of recall, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 46 (Reporting on Detection of Foreign Substances in Foods, etc.)
(1) When a business operator who has manufactured, processed, subdivided, imported or sold foods, etc. for sale receives a notification from consumers on the detection of substances (hereinafter referred to as “foreign substances”), other than raw materials or ingredients normally used in the process of manufacturing, processing, cooking or distributing foods, which are likely to cause harm to sanitation in the process of ingestion, or which are not suitable for ingestion, report such fact to the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu, without delay.
(2) The Korea Consumer Agency and consumer organizations under the Framework Act on Consumers shall, upon receiving a notification on the detection of foreign substances from consumers, report such fact to the Commissioner of the Korea Food and Drug Administration, without delay.
(3) Each Mayor/Do Governor or the head of each Si/Gun/Gu shall, upon receiving a notification on the detection of foreign substances from consumers, report such fact to the Commissioner of the Korea Food and Drug Administration.
(4) The Commissioner of the Korea Food and Drug Administration shall, upon receiving reports on the detection of foreign substances under paragraphs (1) through (3), take measures necessary to investigate the causes of including such foreign substances in foods, etc.
(5) Necessary matters concerning the standards, subject matters, procedures, etc. for reporting foreign substances under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 47 (Sanitation Grade)
(1) The Commissioner of the Korea Food and Drug Administration, the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu may designate places of manufacturing or processing foods, etc., food service businesses or meal service facilities, which show excellent sanitation management, as excellent or exemplary businesses, in accordance with standards for sanitation grade prescribed by Ordinance of the Ministry of Health and Welfare.
(2) The Commissioner of the Korea Food and Drug Administration (including the heads of affiliated organizations prescribed by Presidential Decree), a Mayor/Do Governor or the head of a Si/Gun/Gu may order the relevant public officials to suspend visit, inspection or collection under Article 22 at excellent or exemplary businesses designated under paragraph (1) for a specific period prescribed by Ordinance of the Ministry of Health and Welfare, and the Mayor/Do Governor or the head of a Si/Gun/Gu may preferentially support loan projects for improving sanitation management facilities and the sanitation equipment and facilities of business operators under Article 89 (3) 1 and projects for improving food culture and providing good menus under Article 89 (3) 6.
(3) When businesses designated as excellent or exemplary businesses under paragraph (1) fail to meet standards for designation or are subject to business suspension or heavier administrative disposition, the Commissioner of the Korea Food and Drug Administration, the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu shall revoke such designation without delay.
(4) Matters concerning the designation of excellent or exemplary businesses or the revocation of such designation under paragraphs (1) and (3) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 48 (Hazard Analysis Critical Control Points)
(1) The Commissioner of the Korea Food and Drug Administration may determine and publicly announce standards (hereinafter referred to as “HACCP”) of each food for managing harmful elements in priority by checking and evaluating harmful elements at all stages of food production process, including management of raw materials, manufacturing, processing, cooking, subdividing or distribution, to ensure that harmful materials are not mixed with foods or foods are not contaminated in the whole process.
(2) Business operators who manufacture, process, cook, subdivide, or distribute foods prescribed by Ordinance of the Ministry of Health and Welfare shall observe HACCP of each food publicly announced by the Commissioner of the Korea Food and Drug Administration under paragraph (1).
(3) The Commissioner of the Korea Food and Drug Administration may designate business operators obliged to observe HACCP under paragraph (2) and the places of business of business operators who intend to observe HACCP as businesses which adopt HACCP (hereinafter referred to as “businesses adopting HACCP”) of each food.
(4) The Commissioner of the Korea Food and Drug Administration shall issue documents proving a designation to business operators designated as businesses adopting HACCP, as prescribed by Ordinance of the Ministry of Health and Welfare.
(5) Business operators and employees of businesses adopting HACCP shall receive education and training prescribed by Ordinance of the Ministry of Health and Welfare.
(6) The Commissioner of the Korea Food and Drug Administration may provide technological or economic support necessary for HACCP to business operators who are designated as or who intend to obtain designation as businesses adopting HACCP under paragraph (3).
(7) Necessary matters concerning requirements or procedures for the designation of businesses adopting HACCP, institutions providing education to business operators and employees, methods or procedures for providing education and training or expenses of education and training under paragraph (5) and technological or economic support under paragraph (6) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(8) The Commissioner of the Korea Food and Drug Administration may examine and evaluate whether HACCP as prescribed by Ordinance of the Ministry of Health and Welfare is observed, for the efficient operation of businesses adopting HACCP and, when such businesses fall under any of the following subparagraphs, as a result of examination or evaluation, he/she may revoke such designation or order them to take corrective measures: Provided, That when such businesses fall under subparagraph 2, he/she shall revoke such designation:
1. When they cease to meet HACCP;
2. When they are subject to administrative disposition of business suspension under Article 75 for not less than two months;
3. When business operators and their employees fail to receive education and training under paragraph (5);
4. When they fail to comply with matters prescribed by Ordinance of the Ministry of Health and Welfare, corresponding to subparagraphs 1 through 3.
(9) No operator of a business, other than businesses adopting HACCP, shall use the expression “business adopting HACCP” in his/her trade name.
(10) No operator of a business adopting HACCP shall request other businesses to manufacture or process foods designated: Provided, That the same shall not apply to cases prescribed by Presidential Decree, where business operators entrust the manufacturing or processing of foods to businesses designated as businesses adopting HACCP for the same foods as foods which they intend to entrust.
(11) The Commissioner of the Korea Food and Drug Administration (including the heads of affiliated organizations prescribed by Presidential Decree), a Mayor/Do Governor or the head of a Si/Gun/Gu may order the relevant public officials to suspend visit, inspection or collection under Article 22 at businesses adopting HACCP for a specific period prescribed by Ordinance of the Ministry of Health and Welfare, and the Mayor/Do Governor or the head of a Si/Gun/Gu may preferentially support loan projects for improving sanitation management facilities and the sanitation equipment and facilities of business operators under Article 89 (3) 1.
(12) The Commissioner of the Korea Food and Drug Administration may entrust the work of analysis of harmful elements by process or product in businesses adopting HACCP or technological support to institutions prescribed by Presidential Decree, such as the Korea Health Industry Development Institute under the Korea Health Industry Development Institute Act.
(13) The Commissioner of the Korea Food and Drug Administration may subsidize all or some of expenses for institutions entrusted with work under paragraph (12) within budgetary limits.
(14) Necessary matters concerning the duties of institutions entrusted with work under paragraph (12) shall be prescribed by Presidential Decree.
Article 49 (Standards for Registration of Food Traceability)
(1) When a person, who manufactures, processes or sells foods, intends to implement food traceability, he/she may register the relevant foods with the Commissioner of the Korea Food and Drug Administration, after meeting standards for registration prescribed by Ordinance of the Ministry of Health and Welfare.
(2) Any person who manufactures, processes or sells foods registered under paragraph (1) shall comply with standards determined and publicly announced by the Commissioner of the Korea Food and Drug Administration, with regard to preparing, retaining and managing records necessary for the food traceability (hereinafter referred to as “standards for food traceability”).
(3) When the matters which a person has registered under paragraph (1) are changed, the person shall notify the Commissioner of the Korea Food and Drug Administration of such change, within one month after the grounds for such change occur.
(4) Food traceability may be labelled on foods registered under paragraph (1), as prescribed and publicly announced by the Commissioner of the Korea Food and Drug Administration.
(5) The term of validity of registration under paragraph (1) shall be three years from the date on which registration is completed: Provided, That the term may be extended, as prescribed by Ordinance of the Ministry of Health and Welfare, where such term needs to differ due to the characteristics of the relevant products.
(6) The Minister of Health and Welfare or the Commissioner of the Korea Food and Drug Administration may subsidize funds necessary for food traceability to persons who have obtained registration under paragraph (1), within budgetary limits.
(7) When any person who has obtained registration under paragraph (1) fails to meet standards for food traceability, the Commissioner of the Korea Food and Drug Administration may revoke such registration or issue an order to take corrective measures.
(8) Procedures for the registration of food traceability, matters to be registered or other necessary matters concerning registration shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 50 (Safety and Sanitation Evaluation)
(1) The Commissioner of the Korea Food and Drug Administration shall evaluate (hereinafter referred to as “safety and sanitation evaluation”) the sanitation management level in manufacturing, processing, cooking and distributing foods, etc. and supply of safe foods for business operators prescribed by Presidential Decree, including business operators obliged to adopt HACCP under Article 48, among persons who have obtained a business licenses or have filed notification or registration under Article 37, so as to provide safe foods to consumers and raise the level of food sanitation.
(2) The Commissioner of the Korea Food and Drug Administration shall determine and publicly announce standards for safety and sanitation evaluation.
(3) The Commissioner of the Korea Food and Drug Administration may entrust work concerning safety and sanitation evaluation to the relevant specialized institutions or organizations, as prescribed by Presidential Decree. In such cases, he/she may subsidize funds necessary therefor.
(4) The Commissioner of the Korea Food and Drug Administration may designate businesses which show the excellent level of food sanitation and supply safe foods, etc. to consumers, as excellent businesses prescribed by Ordinance of the Ministry of Health and Welfare, after implementing safety and sanitation evaluation, and announce such fact.
(5) Excellent businesses under paragraph (4) may label logos, etc. determined by Ordinance of the Ministry of Health and Welfare on the relevant places of business and foods, etc. manufactured, processed, cooked or distributed in such places and advertise such fact. In such cases, the period for labeling or advertisement shall be two years from the date on which businesses have received a notification of designation as excellent businesses.
(6) Each business operator subject to the safety and sanitation evaluation under paragraph (1) shall comply with such evaluation, unless extenuating circumstances exist to the contrary.
(7) Necessary matters concerning the period, scope and procedures for the safety and sanitation evaluation and announcement under paragraph (4) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(8) The Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu may exempt businesses which have undergone the safety and sanitation evaluation under paragraph (1) from visit, inspection or collection under Article 22, unless such businesses violate this Act for one year from the date of such evaluation or other extenuating circumstances exist to the contrary.
(9) The Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu may exempt excellent businesses under paragraph (4) from administrative disposition under Article 75 or 76, within the scope prescribed by Ordinance of the Ministry of Health and Welfare.
CHAPTER VIII COOKS, ETC.
Article 51 (Cooks)
(1) Food service business operators and meal service facility operators, who are prescribed by Presidential Decree, shall employ cooks: Provided, That this shall not apply in cases where they prepare food and drink in person as cooks.
(2) Cooks working for meal service facilities shall perform the following duties:
1. Culinary affairs according to menus of meal service facilities (referring to all stages of cooking, including pre-treatment of ingredients, cooking and distribution);
2. Assisting examination of purchased foods;
3. Practical matters for maintaining hygiene and safety of meal service equipment and utensils;
4. Other practical matters related to cooking.
Article 52 (Dieticians)
(1) Each meal service facility operator prescribed by Presidential Decree shall employ dieticians: Provided, That this shall not apply in cases where he/she provides guidance on nutrition in person as a dietician.
(2) Dieticians working for meal service facilities shall perform the following duties:
1. Preparation of menus, examination of meals, and management of food distribution at meal service facilities;
2. Examination and management of purchased foods;
3. Sanitary management of meal service facilities;
4. Drawing up logs for operating meal service facilities;
5. Nutritional guidance and food sanitation education for employees.
Article 53 (Cooking Licenses)
(1) Each person who intends to become a cook shall obtain a license from the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu, after obtaining qualification in the relevant technical field under the National Technical Qualifications Act.
(2) Necessary matters concerning cooking licenses under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(3) and (4) Deleted.
Article 54 (Grounds for Disqualification)
None of the following persons shall obtain a cooking license:
1. Any mental patient under subparagraph 1 of Article 3 of the Mental Health Act: Provided, That the same shall not apply to any person recognized to be suitable as a cook by a specialist;
2. Any patient with a communicable disease under subparagraph 13 of Article 2 the Communicable Disease Control and Prevention Act: Provided, That patients with hepatitis B under subparagraph 3 (h) of the same Article shall be excluded herefrom;
3. Any narcotic or drug addict under subparagraph 2 of Article 2 of the Act on the Control of Narcotics, etc.;
4. Any person for whom one year has not elapsed since his/her license was canceled.
Article 55 (Prohibition against Use of Titles)
No one, other than a cook shall use the title “cook.”
Article 56 (Education)
(1) The Minister of Health and Welfare may order cooks and dieticians to receive education (in the case of cooks, including continuing education: hereinafter the same shall apply in this Article), when necessary for improving the level of food sanitation and their job skills: Provided, That cooks and dieticians working for meal service facilities shall receive education every two years.
(2) Necessary matters concerning the subject matters, institutions, details and methods of education under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(3) The Minister of Health and Welfare may entrust some of work, including education under paragraph (1), to the relevant specialized institutions or organizations, as prescribed by Presidential Decree.
CHAPTER IX FOOD SANITATION DELIBERATION COMMITTEE
Article 57 (Establishment of Food Sanitation Deliberation Committee)
The Food Sanitation Deliberation Committee shall be established under the control of the Ministry of Health and Welfare, in an effort to investigate and deliberate on the following matters, responding to the consultation of the Minister of Health and Welfare or the Commissioner of the Korea Food and Drug Administration:
1. Matters concerning the prevention of food poisoning;
2. Matters concerning the maximum residue limits of toxic or harmful substances, such as agricultural pesticides or heavy metals;
3. Matters concerning the standards and specifications of foods, etc.;
4. Other important matters concerning food sanitation.
Article 58 (Organization and Operation of Deliberation Committee)
(1) The Deliberation Committee may have research members who investigate and study the international standards and specifications of foods, etc.
(2) Duties of the research members mentioned in paragraph (1) shall be as follows: Provided, that relevant duties performed pursuant to other Acts and subordinate statutes shall be excluded herefrom:
1. Examination and research of the standards and specifications set by the Codex Alimentarius Commission;
2. Bilateral collaboration with foreign governments, related consumer organizations and international organizations as necessary for the investigation and research of international food standards;
3. Examination and research of information and data concerning the foreign standards and specifications of foods;
4. Other matters prescribed by Presidential Decree as equivalent to those falling under subparagraphs 1 through 3.
(3) Except as otherwise provided for in this Act, necessary matters concerning the organization and operation of the Deliberation Committee shall be prescribed by Presidential Decree.
CHAPTER X FOOD SANITATION
SECTION 1 Trade Association
Article 59 (Incorporation)
(1) Business operators may incorporate a trade association (hereinafter referred to as “trade association”) by type of business or food determined by Presidential Decree, so as to contribute to the development of business and the improvement of public health.
(2) A trade association shall be a juristic person.
(3) In order to incorporate a trade association, at least ten percent (20 persons, in cases of more than 20 persons) of the persons who are qualified for membership in the trade association, as promoters, shall prepare its articles of association and obtain authorization of the Minister of Health and Welfare for the incorporation.
(4) A trade association shall be duly formed on the date when it obtains authorization for incorporation under paragraph (3).
(5) A trade association may have organizations under its control, under its articles of association.
Article 60 (Projects of Trade Association)
Each trade association shall conduct the following projects:
1. Projects for the sound development of business and the common interests of members;
2. Guidance on improving members’ business facilities;
3. Guidance on management for members;
4. Education and training for members and their employees;
5. Projects for improving the welfare of members and their employees;
6. Research and study projects entrusted by the Minister of Health and Welfare;
7. Projects incidental to those under subparagraphs 1 through 5.
Article 61 (Board of Representatives)
(1) If a trade association has more than 500 members, it may have a board of representatives which may replace the general meeting, as prescribed by the articles of association.
(2) Representatives shall be members of the relevant trade association.
Article 62 (Application Mutatis Mutandis of the Civil Act)
Except as otherwise provided for in this Act concerning trade associations, the provisions governing incorporated associations in the Civil Act shall apply mutatis mutandis to trade associations.
Article 63 (Voluntary Advisors)
(1) Any trade association may have voluntary advisors to efficiently conduct projects for improving members’ business facilities and guidance on management.
(2) Standards necessary for the management and operation of trade associations shall be prescribed by Presidential Decree.
SECTION 2 Korea Food Industry Association
Article 64 (Incorporation)
(1) The Korea Food Industry Association (hereinafter referred to as the “Association”) shall be incorporated to develop the food industry and improve food sanitation.
(2) The Association incorporated under paragraph (1) shall be a juristic person.
(3) Persons eligible as the members of the Association shall be those who manufacture or process foods or food additives, from among business operators.
(4) Except as otherwise provided for in this Act concerning the Association, the provisions governing incorporated associations in the Civil Act shall apply mutatis mutandis to the Association.
Article 65 (Projects of Association)
The Association shall conduct the following projects:
1. Research and study on the food industry;
2. Test and inspection of food, food additives and raw materials thereof;
3. Education concerning food sanitation;
4. Guidance concerning the improvement of business facilities of those who manufacture or process foods or food additives, among business operators;
5. Guidance on management for members;
6. Projects incidental to those under subparagraphs 1 through 5.
Article 66 (Application Mutatis Mutandis)
Article 63 (1) shall apply mutatis mutandis to the Association. In such cases, “trade association” shall be construed as “Association”, and “members of a trade association” shall be construed as “members of the Association.”
SECTION 3 Korea Food Safety Information Center
Article 67 (Establishment of Korea Food Safety Information Center)
(1) The Korea Food Safety Information Center (hereinafter referred to as the “Center”) shall be established to efficiently perform work under each subparagraph of Article 68 (1), among work concerning food traceability and food safety under Article 49, at the request of the Commissioner of the Korea Food and Drug Administration.
(2) The Center shall be a juristic person.
(3) Except as otherwise prescribed in this Act concerning the Center, the provisons governing incorporated foundations in the Civil Act shall apply mutatis mutandis to the Center.
Article 68 (Projects of Center)
(1) The Center shall conduct the following projects:
1. Collection, analysis or provision of information concerning food safety in Korea and abroad;
2. Establishment and operation of an information system for food traceability;
3. Registration and management of food traceability;
4. Education and promotion concerning food traceability;
5. Rapid investigation of the causes of accidents where food accidents occur and the provision of information for recall and discard of the relevant foods;
6. Establishment and operation of a cooperative network with institutions, organizations and consumer groups for common utilization of information on harmful foods and response thereto;
7. Other projects prescribed by the Commissioner of the Korea Food and Drug Administration, which are related to information on food safety and food traceability.
(2) The Commissioner of the Korea Food and Drug Administration may subsidize expenses incurred in establishing and operating the Center.
Article 69 (Submission of Business Plans, etc.)
(1) The Center shall submit business plans and budget bills to the Commission of the Korea Food and Drug Administration before the commencement of each business year, as prescribed by Ordinance of the Ministry of Health and Welfare, and obtain approval therefor from the Commissioner.
(2) The Center shall submit to the Commissioner of the Korea Food and Drug Administration written settlements of accounts concerning revenues and expenditures of each business year, which have been inspected by certified public accountants designated by the Commissioner, finalize such written settlements after obtaining approval and report the results thereof to the National Assembly by not later than the end of May of the following business year.
Article 70 (Guidance and Supervision)
(1) The Commissioner of the Korea Food and Drug Administration may require the Center to report matters concerning its work or submit data, or issue other necessary orders, and order public officials under his/her control to inspect books and documents by visiting offices, when necessary for supervision.
(2) Public officials who visit offices to inspect books, etc. under paragraph (1) shall carry with them certificates indicating their authority and show them to the relevant persons.
(3) Necessary matters concerning guidance and supervision of the Center shall be prescribed by Ordinance of the Ministry of Health and Welfare.
CHAPTER XI ADMINISTRATIVE SANCTIONS INCLUDING CORRECTIVE ORDERS AND CANCELLATION OF LICENSES
Article 71 (Corrective Orders)
(1) The Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu shall issue a corrective order to persons who fail to conduct business in accordance with standards concerning the sanitary handling of foods, etc. under Article 3 and persons who fail to comply with this Act.
(2) When the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu issues a corrective order under paragraph (1), he/she may notify the head of the administrative agency in charge of the relevant business thereof and request him/her to provide cooperation for such corrective order to be implemented.
(3) Upon receiving a request under paragraph (2), the head of the relevant administrative agency shall comply with such request unless extenuating circumstances exist to the contrary, and notify the head of the administrative agency that has made such request of the results of the measures taken without delay.
Article 72 (Dispositions of Discard)
(1) If a business operator violates Articles 4 through 6, Article 7 (4), 8, 9 (4), 10 (2), 12-2 (2) or 13, the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor, or the head of a Si/Gun/Gu shall have the relevant public officials seize or discard such foods, etc., or order business operators to take measures to eliminate any harm by determining the use or methods of processing such foods, etc.
(2) The Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor, or the head of a Si/Gun/Gu may order the relevant public officials to seize or discard foods or food additives manufactured, processed or cooked without obtaining a license or filing a report or registration, in violation of Article 37 (1), (4) or (5), or apparatus, containers or packages used therefor.
(3) When foods, etc. in circulation have caused or are likely to cause any harm to food sanitation, the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor, or the head of a Si/Gun/Gu may order the relevant business operator to recall and discard such foods, etc. or change the raw materials, manufacturing methods, ingredients or the mixing ratio of such foods, etc.
(4) Each public official who seizes or discards foods, etc. under paragraphs (1) and (2) shall carry with him/her a certificate indicating his/her authority and show it to relevant persons.
(5) Necessary matters for seizure or discard under paragraphs (1) and (2), and standards for foods, etc. subject to recall and discard under paragraph (3) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(6) When any person, who receives an order to discard foods, etc. under paragraph (1), fails to comply with such order, the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor, or the head of a Si/Gun/Gu may execute vicarious administration under the Administrative Vicarious Execution Act and collect expenses incurred in such execution from the violator.
Article 73 (Public Announcement of Harmful Foods, etc.)
(1) In any of the following cases, the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu may order the relevant business operator to publicly announce such fact: Provided, That when any harm has been caused to food sanitation, he/she shall order the relevant business operator to publicly announce such fact:
1. When it is deemed that any harm has been caused to food sanitation, in violation of Article 4 through 6, 7 (4), 8 or 9 (4);
2. When a report on recall plans is submitted under Article 45 (1).
(2) Necessary matters concerning public announcement under paragraph (1), such as methods, shall be prescribed by Presidential Decree.
Article 74 (Order, etc. to Repair Facilities)
(1) When business facilities fail to meet standards for facilities under Article 36, the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu may order the relevant business operator to repair such facilities within a fixed period.
(2) When the owner of a building is not a business operator, etc., he/she shall fully cooperate with the business operator, etc. who receives an order to repair facilities under paragraph (1), in repairing such facilities.
Article 75 (Cancellation, etc. of License)
(1) When a business operator falls under any of the following subparagraphs, the Commissioner of the Korea Food and Drug Administration, the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu may cancel his/her business license or registration, as prescribed by Presidential Decree, suspend all or some of the relevant business within a fixed period of up to six months or issue an order to close down his/her place of business (limited to business notified under Article 37 (4); hereafter the same shall apply in this Article):
1. When he/she violates Articles 4 through 6, Article 7 (4), 8, 9 (4), 10 (2), 11 (2) or 12-2 (2);
2. When he/she violates Article 13 (1);
3. When he/she violates Article 17 (4);
4. When he/she violates Article 19 (1);
4-2. When he/she files a false report or fails to report on revisions, in violation of Article 19 (5);
5. When he/she violates Article 31 (1);
6. When he/she violates Article 36;
7. When he/she violates Article 37 (1) (latter part), (3), (4) (latter part) or (6), or any condition under Article 37 (2);
7-2. When he/she fails to report on revisions under Article 37 (5) or violates the proviso to the same paragraph;
8. When he/she falls under Article 38 (1) 8;
9. When he/she violates Article 40 (3);
10. When he/she violates Article 41 (5);
11. When he/she violates Article 42 (1);
12. When he/she violates restrictions on businesses under Article 43;
13. When he/she violates Article 44 (1), (2) or (4);
14. When he/she fails to take measures to recall foods, etc. under the former part of Article 45 (1);
14-2. When he/she fails to report a plan for recall under the latter part of Article 45 (1), or files a false report;
15. When he/she fails to observe HACCP under Article 48 (2);
16. When he/she violates Article 51 (1);
17. When he/she violates an order under Article 71 (1), 72 (1) or (3), 73 (1) or 74 (1) (including Article 71 (1), 72 (1) or (3) or 74 (1) applicable mutatis mutandis to Article 88);
18. When he/she commits an offence under Article 4 of the Act on the Punishment of Acts of Arranging Sexual Traffic.
(2) When a business operator continues to conduct business, violating an order to suspend business operations under paragraph (1), the Commissioner of the Korea Food and Drug Administration, the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu may cancel his/her business license or registration, or issue an order to close down his/her place of business.
(3) In any of the following cases, the Commissioner of the Korea Food and Drug Administration, the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu may cancel a business license or registration, or issue an order to close down a place of business:
1. When a business operator suspends business operations for not less than six months without any justifiable ground;
2. When a business operator (limited to those who have obtained a business license under Article 37 (1)) notifies the head of the competent tax office of the business closure under Article 5 of the Value-Added Tax Act after closing down business or the head of the competent tax office cancels his/her business registration.
(4) Detailed standards for administrative dispositions under paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare, in consideration of the types or degrees of violation.
Article 76 (Suspension, etc. of Manufacturing Products)
(1) When a business operator falls under any of the following subparagraphs, the Commissioner of the Korea Food and Drug Administration, the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu may issue an order to suspend the manufacturing of the relevant products or kinds of products (referring to all products manufactured or processed in accordance with the same standards and specifications as those of foods, etc. determined under Article 7 or 9; hereinafter the same shall apply) within a fixed period of up to six months, as prescribed by Presidential Decree:
1. When he/she violates Article 7 (4);
2. When he/she violates Article 9 (4);
3. When he/she violates Article 10 (2);
3-2. When he/she violates Article 12-2 (2);
4. When he/she violates Article 13 (1);
5. When he/she violates Article 31 (1).
(2) Detailed standards for administrative dispositions under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare, in consideration of the types or degrees of violation.
Article 77 (Request for Cancellation of Business Licenses, etc.)
(1) When any person who has obtained a permit or a license under the Livestock Products Sanitary Control Act, the Fisheries Act or the Liquor Tax Act violates Articles 4 through 6 or Article 7 (4), the Minister of Health and Welfare or the Commissioner of the Korea Food and Drug Administration may request the head of the central administrative agency in charge of the relevant permit or license to take any of the following measures: Provided, That alcoholic beverages shall be limited to cases falling under standards concerning harm, etc. under Article 8 of the Act on Special Measures for the Control of Public Health Crimes:
1. Cancellation of full or some of a permit or a license;
2. Suspension of business operations during a specific period;
3. Other measures necessary for sanitation.
(2) Upon receiving a request for cancellation of business license, etc. under paragraph (1), the head of the relevant central administrative agency shall comply with such request unless extenuating circumstances exist to the contrary, and notify the Minister of Health and Welfare or the Commissioner of the Korea Food and Drug Administration of the outcomes of the measures taken without delay.
Article 78 (Succession to Effects of Administrative Sanctions)
Where a business operator transfers his/her business to any other person or where corporations are merged, the effects of administrative sanctions on the previous business operator due to a violation of each subparagraph of Article 75 (1), (2) or each subparagraph of Article 76 (1), shall be succeeded to the relevant transferee or corporation surviving a merger for one year after the date on which the period for sanctions expires, and, when procedures for administrative sanctions remain in place, such procedures may remain in place for the relevant transferee or corporation surviving a merger: Provided, That the same shall not apply in cases where a transferee or corporation surviving a merger proves that he/she/it has been unaware of such sanction or violation at the time of the transfer or merger.
Article 79 (Measures for Closure, etc.)
(1) Where any person conducts business without obtaining a license or filing a notification or registration, in violation of Article 37 (1), (4) or (5), or continues to conduct business after his/her license or registration is cancelled or he/she is issued an order to close down his/her place of business under Article 75 (1) or (2), the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu may order the relevant public officials to take any of the following measures to close down the relevant place of business:
1. Removing or eliminating marking of the relevant place of business, such as signboards;
2. Posting a notice showing that the relevant place of business is an illegal place of business;
3. Sealing to make the relevant business facilities and apparatuses unavailable.
(2) The Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu may eliminate a seal, when it is no longer necessary to maintain the seal after affixing it under paragraph (1) 3, when a person conducting the relevant business or his/her agent promises to close down the relevant place of business or when he/she requests the elimination of the seal with justifiable grounds. The same shall apply to a notice under paragraph (1) 2.
(3) When the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu intends to take measures under paragraph (1), he/she may give prior written notice to a person conducting the relevant business or his/her agent: Provided, That the same shall not apply in cases where urgent grounds exist.
(4) Measures under paragraph (1) shall be limited to the minimum degree necessary to have a business operator discontinue the relevant business.
(5) In cases falling under paragraph (1), the relevant public official shall carry with him/her a certificate indicating his/her authority and show it to the relevant persons.
Article 80 (Cancellation of Licenses, etc.)
(1) When a cook falls under any of the following subparagraphs, the Minister of Health and Welfare, the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu may cancel his/her license or issue an order to suspend business operations within a fixed period of up to six months: Provided, That he/she shall cancel the relevant license, when a cook falls under subparagraph 1 or 5:
1. When he/she falls under any subparagraph of Article 54;
2. When he/she fails to receive education under Article 56;
3. When he/she is responsible for food poisoning or a serious accident related to sanitation;
4. When he/she lends his/her license to a third party;
5. When he/she performs the duties of a cook during the period of business suspension.
(2) Detailed standards for administrative dispositions under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare, in consideration of the types and degrees of violation.
Article 81 (Hearings)
When the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu intends to take any of the following measures, he/she shall hold hearings:
1. Cancellation of registration of an agent for reporting imported foods;
1-2. Revocation of the designation of a food sanitary inspection institution under Article 27;
2. Revocation of the designation of a business adopting HACCP under Article 48 (8);
3. Cancellation of a business license or registration, or an order to close down a business under Article 75 (1) through (3);
4. Cancellation of a license under Article 80 (1).
Article 82 (Imposition of Penalty Surcharges in lieu of Business Suspension, etc.)
(1) When a business operator falls under any subparagraph of Article 75 (1) or 76 (1), the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu may impose penalty surcharges not exceeding 200 million won on the relevant business operator, in lieu of suspension of business, suspension of manufacturing products or suspension of manufacturing the kinds of products, as prescribed by Presidential Decree: Provided, That the same shall not apply in cases where a business operator violates Article 6, falling under Article 75 (1), or violates Article 4, 5, 7, 10, 12-2, 13, 37, 42 through 44, falling under Article 75 (1) or 76 (1), which are prescribed by Ordinance of the Ministry of Health and Welfare.
(2) The amounts of penalty surcharges, depending on the types or degrees of violation subject to penalty surcharges under paragraph (1), and other necessary matters shall be prescribed by Presidential Decree.
(3) The Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu may submit a written request stating the following information to the head of the competent tax office to receive taxation information, when necessary for imposing penalty surcharges:
1. Personal information on taxpayers;
2. Purpose of use;
3. Amounts of sales which become standards for the imposition of penalty surcharges.
(4) When a business operator fails to pay a penalty surcharge under paragraph (1) by a deadline, the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu shall revoke the imposition of the penalty surcharge under paragraph (1), as prescribed by Presidential Decree and shall take other measures, such as the suspension of food sanitary inspection business under Article 27 or the suspension of business operations or manufacturing under Article 75 (1) or 76 (1), or collect such penalty surcharge in the same manner as delinquent national or local taxes are collected: Provided, That in any of the following cases, penalty surcharges shall be collected in the same manner as dispositions on default of national or local taxes:
1. When the period of validity of a food sanitary inspection institution under Article 25 (1) and (2) expires, or it is impracticable to take measures to suspend a food sanitary inspection due to the revocation of designation under Article 27;
2. When it is impracticable to suspend business operations or manufacturing under Article 75 (1) or 76 (1) due to business closure under Article 37 (3),(4) and (5).
(5) Penalty surcharges collected and imposed by the Commissioner of the Korea Food and Drug Administration pursuant to paragraph (1) and the proviso to paragraph (4), shall devolve on the State, penalty surcharges collected and imposed by a Mayor/Do Governor shall devolve on the Food Promotion Fund (referring to the Food Promotion Fund under Article 89; hereafter the same shall apply in this paragraph) of the relevant City/Do and penalty surcharges collected and imposed by the head of a Si/Gun/Gu shall devolve on the Food Promotion Fund of the relevant City/Do or Si/Gun/Gu. In such cases, methods, etc. of devolvement on Cities/Dos or Sis/Guns/Gus shall be prescribed by Presidential Decree.
(6) When a Mayor/Do Governor entrusts the authority to collect and impose penalty surcharges under paragraph (1) to the head of a Si/Gun/Gu in accordance with Article 91, he/she may grant expenses incurred in the collection or imposition to the head of a Si/Gun/Gu, as prescribed by Presidential Decree.
Article 83 (Imposition of Penalty Surcharges due to Sale, etc. of Harmful Foods, etc.)
(1) When Articles 4 through 6 or Article 8 concerning prohibition against sale of harmful foods, etc. is violated, the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu shall impose penalty surcharges equivalent to the retail prices of the relevant foods, etc. sold on any of the following persons:
1. A person who receives an order to suspend business operations for not less than two months, cancel a business license or registration or close down a business under Article 75, in violation of subparagraph 2 or 3 or subparagraphs 5 through 7 of Article 4;
2. A person whose business license or registration is canceled, or who receives an order to close down a business under Article 75, in violation of Article 5, 6 or 8.
(2) Amounts of penalty surcharges under paragraph (1) shall be determined and imposed, as prescribed by Presidential Decree.
(3) When a business operator fails to pay a penalty surcharge imposed under paragraph (2) by a deadline or close down a business under Article 37 (3), (4) and (5), such penalty surcharge shall be collected in the same manner as dispositions on default of national or local taxes.
(4) Article 82 (3), (5) and (6) shall apply mutatis mutandis to the devolvement of penalty surcharges imposed under paragraph (2), the ratio of devolvement and procedures for collection of penalty surcharges.
Article 84 (Publication of Violations)
The Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu shall publicize business information related to dispositions, such as details of dispositions imposed on business operators, for whom administrative dispositions are determined under Article 72, 75, 76, 79, 82 or 83, or the trade names of the relevant businesses and foods, etc., as prescribed by Presidential Decree.
CHAPTER XII SUPPLEMENTARY PROVISIONS
Article 85 (State Subsidies)
The Minister of Health and Welfare or the Commissioner of the Korea Food and Drug Administration may subsidize all or some of the following expenses within budgetary limits:
1. Expenses incurred in collection under Article 22 (1) (including cases applicable mutatis mutandis under Article 88);
2. Expenses incurred in conducting the examination and testing of food sanitary inspection institutions designated under Article 24;
3. Expenses incurred in education and training by a trade association;
4. Expenses incurred in employing food sanitation supervisors under Article 32 (1) and private food sanitation supervisors under Article 33;
5. Expenses incurred in establishing and operating the Center;
6. Expenses incurred in conducting investigations and research under subparagraph 6 of Article 60;
7. Expenses incurred in employing voluntary advisors of a trade association or the Association under Article 63 (1) (including cases applicable mutatis mutandis under Article 66);
8. Expenses incurred in discarding foods, etc. under Article 72 (including cases applicable mutatis mutandis under Article 88).
Article 86 (Investigations of and Reporting on Food Poisoning)
(1) Any person falling under any of the following subparagraphs shall report to the head of the competent health center or its branch, without delay. In such cases, doctors or herb doctors shall take necessary measures to retain the blood or excreta of patients suffering from food poisoning or persons suspected of suffering from food poisoning, as prescribed by Presidential Decree:
1. A doctor or herb doctor who has diagnosed patients suffering from food poisoning or persons suspected of suffering from food poisoning or conducted the examination of the dead bodies thereof;
2. A founder or operator of meal service facilities, who discovers patients suffering from food poisoning or persons showing symptoms suspected of food poisoning due to foods, etc. provided by such facilities.
(2) The head of a health center or its branch shall, upon receiving a report under paragraph (1), report such fact to the Minister of Health and Welfare, the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu, without delay, and investigate the causes of food poisoning and report the results thereof, as prescribed by Presidential Decree.
(3) The Commissioner of the Korea Food and Drug Administration may determine the procedures for investigating facilities, where patients suspected of suffering from food poisoning are discovered, and necessary matters concerning the examination and inspection thereof, so as to find out the causes of food poisoning.
Article 87 (Establishment of Council on Food Poisoning Countermeasures)
(1) The Commissioner of the Korea Food and Drug Administration shall establish and operate the Council on Food Poisoning Countermeasures which consist of the Ministry of Education, Science and Technology, the Ministry for Food, Agriculture, Forestry and Fisheries, the Ministry of Health and Welfare, the Ministry of Environment, the Korea Food and Drug Administration, and Cities/Dos, so as to efficiently prevent food poisoning and stop the spread thereof.
(2) Organization of the Council on Food Poisoning Countermeasures under paragraph (1) and detailed matters on the operation thereof shall be prescribed by Presidential Decree.
Article 88 (Meal Service Facilities)
(1) Any person who intends to establish and operate meal service facilities shall notify the Governor of a Special Self-Governing Province or the head of a Si/Gun/Gu, as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) Any person who establishes and operates meal service facilities shall observe the following matters, so as to manage meals in a sanitary manner, including the maintenance or management of meal service facilities:
1. To throughly manage sanitation to ensure that no patients are suffering from food poisoning;
2. To preserve a serving of foods cooked and offered each time for not less than 144 hours, as prescribed by Ordinance of the Ministry of Health and Welfare;
3. Not to obstruct the duties of dieticians, if any;
4. To comply with a request made by dieticians, if any, for sanitation management of meal service facilities, unless an extenuating circumstance exists to the contrary;
5. To follow other matters prescribed by Ordinance of the Ministry of Health and Welfare for the sanitary management of foods, etc.
(3) Articles 3 through 6, 7 (4), 8, 9 (4), 10 (2), 22, 40, 41, 48, 71, 72 and 74 shall apply mutatis mutandis to meal service facilities.
(4) Standards for meal service facilities and other matters concerning the operation thereof shall be prescribed by Ordinance of the Ministry of Health and Welfare.
Article 89 (Food Promotion Fund)
(1) A Food Promotion Fund (hereinafter referred to as “Fund”) shall be established in each City/Do or Si/Gun/Gu, so as to make up for financial resources necessary for conducting projects for improving food sanitation and the national nutritional level.
(2) The financial resources of a Fund shall be as follows:
1. Contributions from food sanitation organizations;
2. Penalty surcharges collected under Articles 82 and 83 of this Act or Article 37 of the Functional Health Foods Act;
3. Proceeds from the operation of the Fund;
4. Other revenues prescribed by Presidential Decree.
(3) The funds of a Fund shall be used for the following projects:
1. Loan projects for improving sanitation management facilities and sanitation equipment and facilities of business operators (including business operators under the Functional Health Foods Act;
2. Projects for education and public relations (including the support of education and public relations of consumer organizations) concerning food sanitation and support of education and activities of customer food sanitation supervisors;
3. Projects for investigations and research of food sanitation and nutrition control under the National Nutrition Control Act (hereinafter referred to as “nutrition control”);
4. Support for the payment of rewards under Article 90;
5. Promotion and support of educational or research institutes concerning food sanitation;
6. Support of projects for improving food culture and practicing good dieting;
7. Loan projects for repairing or maintaining meal service facilities (limited to catering service facilities);
8. Other projects concerning food sanitation, nutrition control, the promotion of the food industry or health functional foods, which are prescribed by Presidential Decree.
(4) Each Fund shall be managed and operated by the relevant Mayor/Do Governor or the head of the relevant Si/Gun/Gu, and necessary matters shall be prescribed by Presidential Decree.
Article 90 (Payment of Rewards)
(1) The Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu may pay rewards of up to 10 million won to a person who has notified any violation of this Act, for each case notified.
(2) Necessary matters concerning standards, methods and procedures for the payment of rewards under paragraph (1) shall be prescribed by Presidential Decree.
Article 91 (Entrustment of Authority)
Part of the authority of the Minister of Health and Welfare or the Commissioner of the Korea Food and Drug Administration under this Act may be entrusted to a Mayor/Do Governor or the head of a regional Korea Food and Drug Administration, as prescribed by Presidential Decree, and part of the authority of a Mayor/Do Governor may be entrusted to the head of a Si/Gun/Gu or the head of a health center, respectively.
Article 92 (Fees)
Any of the following persons shall pay fees prescribed by Ordinance of the Ministry of Health and Welfare:
1. A person who applies for deliberation on labels and advertisements under Article 12-3;
2. A person who undergoes a safety evaluation under Article 18;
3. A person who undergoes an examination under Article 19 (2) or who applies for prior confirmation and registration of imported foods, etc. under Article 19 (3) 1;
3-2. A person who registers as an agent for reporting imported foods under Article 19-2;
4. A person who applies for designation as a food sanitary inspection institution under Article 24;
5. A person who obtains a license or files a notification or registration under Article 37;
6. A person who applies for designation as a business adopting HACCP under Article 48 (3) (including cases applicable mutatis mutandis under Article 88);
7. A person who applies for registration of food traceability under Article 49 (1);
8. A person who obtains a cooking license under Article 53;
9. A person who notifies the establishment and operation of meal service facilities under Article 88.
CHAPTER XIII PENAL PROVISIONS
Article 93 (Penal Provisions)
(1) Any person who manufactures, processes, imports, or cooks foods or food additives for sale by using animals which suffered from any of the following diseases shall be punished by imprisonment for not less than three years:
1. Bovine Spongiform Encephalopathy;
2. Anthrax;
3. Avian Influenza.
(2) Any person who manufactures, processes or cooks foods or food additives for sale by using any of the following raw materials or ingredients shall be punished by imprisonment for not less than one year:
1. Ephedra herb;
2. Oriental Aconite;
3. Aconite;
4. Aconitum seoulense;
5. Aconiti koreani Rhizoma;
6. Toad Venom;
7. Dictamni Radias Cortex;
8. Henbane leaf.
(3) When a business operator sells foods or food additives manufactured, processed, imported, or cooked under paragraphs (1) and (2), a fine of not less than two times the relevant retail price and not more than five times the relevant retail price shall be imposed in parallel.
Article 94 (Penal Provisions)
Any of the following persons may be punished by imprisonment for not more than seven years or by a fine not exceeding 100 million won, and imprisonment and a fine may be imposed in parallel:
1. A person who violates the provisions of Articles 4 through 6 (including cases applicable mutatis mutandis under Article 88 and excluding cases falling under Article 93 (1) and (3));
2. A person who violates Article 8 (including cases applicable mutatis mutandis under Article 88);
3. A person who violates Article 37 (1).
Article 95 (Penal Provisions)
Any of the following persons may be punished by imprisonment for not more than five years or by a fine not exceeding 50 million won, and imprisonment and a fine may be imposed in parallel:
1. A person who violates Article 7 (4) (including cases applicable mutatis mutandis under Article 88), 9 (4) (including cases applicable mutatis mutandis under Article 88) or 19 (1);
2. A person who commits a violation falling under subparagraphs 1 through 3 of Article 27;
3. A person who violates restrictions on business under Article 43;
4. A person who violates an order under Article 72 (1) or (3) (including cases applicable mutatis mutandis under Article 88) or 73 (1);
5. A person who continues to conduct business, violating an order to suspend business operations under Article 75 (1) (limited to a person who has obtained a business license under Article 37 (1)).
Article 96 (Penal Provisions)
Any person who violates Article 51 or 52 may be punished by imprisonment for not more than three years or by a fine not exceeding 30 million won, and imprisonment and a fine may be imposed in parallel.
Article 97 (Penal Provisions)
Any of the following persons shall be punished by imprisonment for not more than three years or by a fine not exceeding 30 million won:
1. A person who violates Article 10 (2) (including cases applicable mutatis mutandis under Article 88), 12-2 (2), 13 (1), 17 (4), 31 (1), 34 (4), 37 (3) or (4), 39 (3), 48 (2) or (10) or 55;
2. A person who refuses, obstructs or evades inspection, visit, collection, seizure or discard under Article 19 (2), 22 (1) (including cases applicable mutatis mutandis under Article 88) or 72 (1) and (2) (including cases applicable mutatis mutandis under Article 88);
3. A person who commits a violation falling under Article 20 (4) 1 through 3;
4. A business operator who fails to meet standards for facilities under Article 36;
5. A business operator who fails to meet a condition under Article 37 (2);
6. A person who fails to comply with a matter which business operators should observe under Article 42 (1) or 44 (1): Provided, That a person who violates insignificant matters prescribed by Ordinance of the Ministry of Health and Welfare shall be excluded herefrom;
7. A person who continues to conduct business (limited to persons who have filed a notification or registration under Article 37 (4) or (5)) in violation of an order to suspend business operations under Article 75 (1), or who continues to conduct business in violation of an order to close down the business under Article 75 (1) and (2);
8. A person who violates an order to suspend manufacturing under Article 76 (1);
9. A person who removes or damages a seal or notice, etc. posted by the relevant public official without permission under Article 79 (1).
Article 98 (Penal Provisions)
Any of the following persons shall be punished by imprisonment for not more than one year or by a fine not exceeding three million won:
1. A person who provides entertainment services or requests other persons to provide such services, in violation of Article 44 (3);
2. A person who submits a false report after receiving a notification on the detection of a foreign substance from a customer, in violation of Article 46 (1);
3. A person who falsely notifies the detection of a foreign substance;
4. A person who fails to report or submits a false report, in violation of the latter part of Article 45 (1).
Article 99 (Legal Fiction as Public Officials in Application of Penal Provisions)
Executives and employees of food sanitary inspection institutions designated under Article 24 (2) shall be deemed public officials in the application of penal provisions under Articles 129 through 132 of the Criminal Act.
Article 100 (Joint Penal Provisons)
If the representative of a juristic person, or an agent, an employee or any other person employed by a juristic person or individual commits any act prescribed in Article 93 (3) or Articles 94 through 97, in connection with the duties of the said juristic person or individual, not only shall the offender be punished accordingly, but the juristic person or individual shall also be punished by a fine under the respective provisions, and any juristic person or individual, who commits a violation under Article 93 (1), shall be punished by a fine not exceeding 150 million won and any juristic person or individual, who commits a violation under Article 93 (2), shall be punished by a fine not exceeding 50 million won: Provided, That the same shall not apply in cases where the juristic person or individual has not neglected to exercise due diligence and supervision over the relevant duties in order to prevent such violation.
Article 101 (Fines for Negligence)
(1) Any of the following persons shall be punished by a fine for negligence not exceeding 10 million won:
1. A person who fails to comply with the standards for nutrition labelling, in violation of Article 11 (2);
2. Deleted.
(2) Any of the following persons shall be punished by a fine for negligence not exceeding five million won:
1. A person who violates Article 3, 40 (1) or (3) (including cases applicable mutatis mutandis under Article 88), 41 (1) or (5) (including cases applicable mutatis mutandis under Article 88) or 86 (1);
1-2. A business operator who fails to receive education, in violation of Article 19-3 (1);
1-3. A business operator who fails to undergo an inspection within the inspection period or to submit data, etc., in violation of Article 19-4 (2);
1-4. A person who fails to file a report or submits a false report, in violation of Article 31 (3);
2. A person who fails to report or submits a false report, in violation of Article 34 (5);
3. A person who fails to report or submits a false report, in violation of Article 37 (6);
4. A person who fails to report or submits a false report, in violation of Article 42 (2);
5. Deleted;
6. A person who violates Article 48 (9) (including cases applicable mutatis mutandis under Article 88);
7. A person who fails to receive education, in violation of Article 56 (1);
8. A person who violates an order under Article 74 (1) (including cases applicable mutatis mutandis under Article 88);
9. A person who fails to report or submits a false report, in violation of Article 88 (1);
10. A person who violates Article 88 (2).
(3) Any of the following persons shall be punished by a fine for negligence not exceeding three million won:
1. A person who fails to file a notification within one month after he/she succeeds to the status of the operator of an inspection institution, in violation of Article 29 (3);
2. A person who fails to observe an insignificant matter prescribed by Ordinance of the Ministry of Health and Welfare, among matters to be observed by business operators under Article 42 (1) or 44 (1);
3. A person who fails to report after receiving a notification on the detection of a foreign substance from a customer, in violation of Article 46 (1);
4. A person who fails to file a notification within one month after grounds for change occur, where registered matters of food traceability are changed, in violation of Article 49 (3).
(4) Fines for negligence under paragraphs (1) through (3) shall be collected and imposed by the Commissioner of the Korea Food and Drug Administration, a Mayor/Do Governor or the head of a Si/Gun/Gu, as prescribed by Presidential Decree.
Article 102 (Special Cases in Application of Provisions concerning Fines for Negligence)
For the purpose of the provisions concerning fines for negligence under Article 101, no fines for negligence shall be imposed on acts, for which penalty surcharges have been imposed under Article 82: Provided, That the same shall not apply in cases where the imposition of penalty surcharges is cancelled and the suspension of business or manufacture is ordered under the main sentence of Article 82 (4).
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation: Provided, That Article 6 (12) (limited to the amendments of Article 11 (1)) of the Addenda shall enter into force on January 1, 2010.
Article 2 (Applicability to Restrictions on Business Licenses)
The amended provisions of Article 38 (1) 6 and (2) 5 shall begin to apply to the first business operator who commits any violation after July 28, 2005, which is the date on which the amended Food Sanitation Act (No. 7374) enters into force.
Article 3 (Applicability to Meal Service Facilities)
The amended provisions of Article 88 (2) 2 shall begin to apply to meal service facilities, which cooks and offers foods for the first time after this Act enters into force.
Article 4 (Transitional Measures concerning Dispositions, etc.)
Permission granted by administrative agencies, other acts of administrative agencies, or reports to or other acts committed in relation to administrative agencies under the previous provisions, at the time this Act enters into force, shall be deemed acts by or in relation to administrative agencies under this Act.
Article 5 (Transitional Measures concerning Penal Provisions or Fines for Negligence)
The previous provisions shall govern acts committed before this Act enters into force, in the application of provisions concerning punishment or fines for negligence.
Article 6 Omitted.
Article 7 (Relations with other Acts and Subordinate Statutes)
ADDENDUM
This Act shall enter into force on August 7, 2009.
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation.
Articles 2 through 22 Omitted.
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force two months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDA
Article 1 (Enforcement Date)
Articles 2 through 5 Omitted.
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 6 Omitted.
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force on January 1, 2011.
Articles 2 through 12 Omitted.
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 14 Omitted.
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation: Provided, that the amended provisions of Article 13 (1) 1 shall enter into force one year after the date of its promulgation, and the amended provisions of Article 37 (5) shall enter into force one year and six months after the date of its promulgation.
Article 2 (Transitional Measures concerning Penal Provisions or Fines for Negligence)
The previous provisions shall govern acts committed before this Act enters into force, in the application of provisions concerning punishment or fines for negligence.
Article 3 Omitted.