SPECIAL ACT ON IMPORTED FOOD SAFETY CONTROL
Act No. 13201, Feb. 3, 2015
Amended by Act No. 14478, Dec. 27, 2016
Act No. 14476, Dec. 27, 2016
Act No. 15482, Mar. 13, 2018
Act No. 15940, Dec. 11, 2018
Act No. 16101, Dec. 31, 2018
Act No. 16401, Apr. 23, 2019
Act No. 16716, Dec. 3, 2019
Act No. 17245, Apr. 7, 2020
Act No. 17653, Dec. 22, 2020
Act No. 17807, Dec. 29, 2020
CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to contribute to the establishment of sound trade order and the promotion of the health of the people by ensuring the safety of imported food, etc., promoting improvement in the quality thereof, and providing proper information.
The terms used in this Act are defined as follows:
| 2. | The term "traceability of imported food, etc." means control wherein information at every step from importation to sale of imported food, etc. has been recorded and managed so that the cause of a problem can be identified, and necessary measures shall be taken by tracking such imported food, etc. where the problem occurs with the safety of the imported food, etc.; |
| 3. | The term "foreign food facility" means a facility located abroad (including a ship where fishery products are produced or processed) where imported food, etc. (excluding livestock products) is produced, manufactured, processed, treated, packaged, stored, etc.; |
| 4. | The term "foreign establishment" means an establishment located abroad where livestock products imported into the Republic of Korea from abroad are slaughtered, milk is collected, livestock products and dairy products are manufactured, processed, stored, etc.; |
| 5. | The term "business entity" means an entity the business of which is registered pursuant to Article 15 (1); |
| 6. | The term "on-site inspection" means that a person has access to and conducts an inspection of a foreign food facility or foreign establishment. |
| Article 3 (Responsibilities) |
| (1) | The State and local governments shall prepare policies for the control of imported food, etc. and criteria therefor, and direct and supervise business entities so that all people may be provided with safe and high quality imported food, etc. |
| (2) | Business entities shall import safe and high quality imported food, etc., and always verify and inspect whether imported food, etc. with which they are dealing are hazardous. |
| Article 4 (Relationship to Other Statutes) |
| (1) | This Act shall take precedence over other statutes in regard to imported food, etc. |
CHAPTER II CONTROL OF STEPS PRIOR TO IMPORTATION
| Article 5 (Registration of Foreign Food Facilities) |
| (1) | A person who intends to import food, etc. into the Republic of Korea or person who establishes and operates a foreign food facility (hereinafter referred to as "importer, etc.") shall register matters prescribed by Ordinance of the Prime Minister, such as the name and location of, and items manufactured by the foreign food facility concerned, with the Minister of Food and Drug Safety before he or she files an import declaration under Article 20. <Amended on Dec. 11, 2018> |
| (2) | Where any modification occurs in matters registered pursuant to paragraph (1), such modification shall be registered with the Minister of Food and Drug Safety. |
| (3) | Where the Minister of Food and Drug Safety needs to further verify any matter among matters registered pursuant to paragraphs (1) and (2), he or she may request an importer, etc. to provide necessary data. |
| (4) | Where the Minister of Food and Drug Safety deems that a foreign food facility is registered under paragraph (1), or a modified matter is registered under paragraph (2), by fraud or other improper means, he or she shall revoke registration under paragraph (1). |
| (5) | Where an importer, etc. falls under any of the following, the Minister of Food and Drug Safety may reject an import declaration filed under Article 20: |
| 1. | Where the importer, etc. has failed to register such matters provided for in paragraph (1) or (2), or registers them by fraud or other improper means; |
| 2. | Where the importer, etc. has failed to provide data under paragraph (3), or has provided data by fraud or other improper means. |
| (6) | The period of validity of registration of a foreign food facility under paragraph (1) shall be two years from the date of such registration. |
| (7) | Procedures, methods, etc. for registration provided for in paragraphs (1) and (2) shall be prescribed by Ordinance of the Prime Minister. |
| Article 6 (On-Site Inspection of Foreign Food Facilities) |
| (1) | In any of the following cases, the Minister of Food and Drug Safety may conduct an on-site inspection of a foreign food facility through prior consultation with the government of an exporting country or the foreign food facility: |
| 1. | Where the Minister of Food and Drug Safety deems that an on-site inspection is necessary to prevent hazards in imported food, etc.; |
| 2. | Where the Minister of Food and Drug Safety deems that it is necessary to confirm facts about safety information on imported food, etc. collected at home and abroad. |
| (2) | Where an on-site inspection prescribed in paragraph (1) is refused, interfered with or evaded (including where no answer is made without good cause), or where imported food, etc. is likely to cause hazards according to the result of on-site inspection, the Minister of Food and Drug Safety may take measures to suspend import of imported food, etc. of the relevant foreign food facility. <Amended on Apr. 23, 2019> |
| (3) | Where the government of an exporting country, or a foreign food facility, or a business entity who has imported food, etc. identifies any cause of a problem in imported food, etc. the importation of which has been suspended pursuant to paragraph (2) and suggests improvements, or where such imported food, etc. is deemed non-hazardous, the Minister of Food and Drug Safety may revoke the suspension of importation under paragraph (2). In such cases, where it is necessary to confirm such improvements, the Minister of Food and Drug Safety may conduct an on-site inspection. |
| (4) | Where the Minister of Food and Drug Safety takes a measure to suspend the import of imported food, etc. pursuant to paragraph (2) or revokes the suspension of the import thereof pursuant to paragraph (3), the Minister may disclose information on the relevant foreign food facility. <Newly Inserted on Dec. 3, 2019> |
| (5) | Detailed matters regarding measures to suspend importation under paragraph (2), measures to revoke such suspension under paragraph (3), and disclosure of information under paragraph (4) shall be prescribed by Ordinance of the Prime Minister. <Amended on Dec. 3, 2019> |
| Article 6-2 (Food Safety Management Certification of Foreign Food Facilities) |
| (1) | The Minister of Food and Drug Safety may certify a foreign food facility which complies with HACCP prescribed in Article 48 (1) of the Food Sanitation Act (hereinafter referred to as "HACCP") as a foreign food facility that complies with HACCP for imported food, etc. (hereinafter referred to as "HACCP-certified foreign facility for imported food "). In such cases, where the Minister of Food and Drug Safety has otherwise determined and publicly notified the standards in consultation with the government of an exporting country, such standards may be deemed HACCP applicable to the foreign food facility of the relevant country. |
| (2) | Where a person who establishes and operates a HACCP-certified foreign facility for imported food intends to modify matters prescribed by Ordinance of the Prime Minister among the matters the person has obtained certification, he or she shall obtain certification for modification from the Minister of Food and Drug Safety. |
| (3) | The period of validity of certification referred to in paragraph (1) shall be three years from the date of certification, and the period of validity of certification for modification referred to in paragraph (2) shall be the remainder of the original period of validity of certification. In such cases, the validity period of certification or certification of modification may be extended within three years. |
| (4) | Imported food, etc. prescribed by Ordinance of the Prime Minister, with respect to which hazardous substances are mixed or likely to be contaminated in the process of the management, production, etc. of raw materials may be imported only when production, manufacturing, processing, treatment, packing, storing, etc. are conducted at a HACCP-certified foreign facility for imported food. |
| (5) | The Minister of Food and Drug Safety may investigate or evaluate whether a HACCP-certified foreign facility for imported food complies with HACCP and may revoke the certification or issue a corrective order if it falls under any of the following cases: Provided, That in cases falling under subparagraphs 1 and 2, the certification shall be revoked: |
| 1. | Where the person was certified by fraud or other improper means; |
| 2. | Where the facility refuses, interferes with or evades an investigation or evaluation as to whether the HACCP is complied with (including cases where it fails to respond to such investigation or evaluation without good cause); |
| 3. | Where they fail to apply HACCP; |
| 4. | Where they fail to comply with the matters prescribed by Ordinance of the Prime Minister, corresponding to those referred to in subparagraphs 1 through 3. |
| (6) | The Minister of Food and Drug Safety may entrust the work of analysis of harmful elements for each process or item of HACCP-certified foreign facilities for imported food or technological support, certification, etc. to the institutions prescribed by Presidential Decree, such as the Korea Agency of HACCP Accreditation and Services under the Act on the Establishment and Operation of the Korea Agency of HACCP Accreditation and Services. In such cases, matters necessary regarding the scope of entrusted work shall be determined by Presidential Decree. |
| (7) | The Minister of Food and Drug Safety may fully or partially subsidize expenses incurred in conducting entrusted affairs to an institution performing the entrusted affairs under paragraph (6) within budgetary limits. |
| (8) | Matters necessary for the requirements and procedures for certification and certification of modification under paragraphs (1) and (2), procedures for extending the term of validity under paragraph (3), and methods and procedures for investigation and evaluation under paragraph (5) shall be prescribed by Ordinance of the Prime Minister. |
[This Article Newly Inserted on Apr. 7, 2020]
| Article 7 (Registration of Good Importers) |
| (1) | Any person who intends to file an import declaration pursuant to Article 20 may inspect the status of sanitation control of a foreign food facility according to standards set by the Minister of Food and Drug Safety to ensure the safety of the relevant imported food, etc. |
| (2) | Any person who has inspected the status of sanitation control pursuant to paragraph (1) may register such facility as a good importer with the Minister of Food and Drug Safety. |
| (3) | Any person who intends to register such facility as a good importer pursuant to paragraph (2) shall file an application with the Minister of Food and Drug Safety as prescribed by Ordinance of the Prime Minister. The same shall also apply where he or she intends to modify any important matter prescribed by Ordinance of the Prime Minister of the matters registered. |
| (4) | The Minister of Food and Drug Safety may conduct an on-site inspection of a foreign food facility in order to verify whether an application for registration of a good importer filed, or the good importer registered, in accordance with paragraph (3), meets the standards set by the Minister of Food and Drug Safety. |
| (5) | The period of validity of the registration of a good importer under paragraph (2) shall be three years from the date on which it is registered. |
| (6) | Where a good importer falls under any of the following, the Minister of Food and Drug Safety may revoke its registration or order it to make corrections: Provided, That where a good importer falls under subparagraph 1, he or she shall revoke its registration: <Amended on Mar. 13, 2018> |
| 1. | Where he or she has his or her business registered by fraud or other improper means; |
| 3. | Where a good importer fails to comply with matters prescribed by Ordinance of the Prime Minister, which are equivalent to subparagraphs 1 and 2. |
| (7) | No facility, the registration of which is revoked pursuant to paragraph (6), shall file an application for registration of a good importer for three years from the date on which its registration is revoked. |
| (8) | Detailed matters, such as criteria for registration of a good importer and procedures and methods for registration and modification, shall be prescribed by Ordinance of the Prime Minister. |
| Article 8 Deleted. <Apr. 7, 2020> |
| Article 9 (Entrustment of On-Site Inspection) |
| (1) | The Minister of Food and Drug Safety may entrust on-site inspections to the Korea Agency of HACCP Accreditation and Services under the Act on the Establishment and Operation of the Korea Agency of HACCP Accreditation and Services where deemed necessary to efficiently conduct on-site inspections referred to in Articles 6 and 7. |
| (2) | The Minister of Food and Drug Safety may entrust such inspection, etc. to an Institution for Safety Audit of Imported Food designated pursuant to Article 10 where deemed necessary to efficiently conduct sanitation assessment, etc. under Article 18 (2). |
| (3) | Where an institution performing affairs entrusted under paragraphs (1) and (2) has conducted an on-site inspection or sanitation assessment, etc., it shall report the results thereof and submit relevant documents to the Minister of Food and Drug Safety. |
| (4) | Detailed matters, such as the timing and methods for reporting the results of on-site inspection, sanitation assessment, etc. and documents to be submitted, shall be prescribed by Ordinance of the Prime Minister. |
[This Article Wholly Amended on Dec. 29, 2020]
| Article 10 (Designation of Institution for Safety Audit of Imported Food) |
| (1) | The Minister of Food and Drug Safety may designate an institution that is professionally capable of conducting an audit to enhanced efficiency of such affairs as sanitation assessment, referred to in Article 9 (2). <Amended on Dec. 29, 2020> |
| (2) | The period of validity on the designation of an institution designated pursuant to paragraph (1) (hereinafter referred to as "Institution for Safety Audit of Imported Food") shall be three years from the date on which it is designated. |
| (3) | The period of validity provided for in paragraph (2) may be extended once only to an extent not exceeding one year, as prescribed by Ordinance of the Prime Minister. |
| (4) | Where an Institution for Safety Audit of Imported Food, the period of validity of which expires pursuant to paragraphs (2) and (3), meets the requirements under paragraph (8), it may be redesignated once pursuant to paragraph (1). |
| (5) | Where the Minister of Food and Drug Safety deems it necessary to ensure the adequacy and reliability of audits of an Institution for Safety Audit of Imported Food, he or she may require a person who conducts audits or any other interested person to make a necessary report, or a related public official to have access to the office of the Institution for Safety Audit of Imported Food or other places similar thereto to inspect employees and relevant documents, or to inspect relevant books, documents, etc. as occasion requires. |
| (6) | Where an Institution for Safety Audit of Imported Food falls under any of the following, the Minister of Food and Drug Safety may revoke its registration, order it to suspend its business for a fixed period not exceeding six months, or take necessary measures, such as the issuance of an order to make corrections, as prescribed by Ordinance of the Prime Minister: Provided, That where the Institution for Safety Audit of Imported Food falls under any of the provisions of subparagraphs 1 through 3, he or she shall revoke its registration: |
| 1. | Where the Institution for Safety Audit of Imported Food is designated by fraud or other improper means; |
| 2. | Where the Institution for Safety Audit of Imported Food has prepared false documents related to audits by intention or gross negligence; |
| 3. | Where the Institution for Safety Audit of Imported Food has violated the suspension of its business; |
| 4. | Where the Institution for Safety Audit of Imported Food has violated any of the regulations on the affairs of Institution for Safety Audit of Imported Food prescribed by the Minister of Food and Drug Safety; |
| 5. | Where the Institution for Safety Audit of Imported Food refuses, interferes with, or avoids access, inspection, inspection of relevant documents, reporting, etc. provided for in paragraph (5). |
| (7) | No Institution for Safety Audit of Imported Food, the designation of which is revoked pursuant to paragraph (6), shall obtain designation under paragraph (1) for two years from the date of such revocation. |
| (8) | Detailed matters, such as requirements, and procedures for designation of an Institution for Safety Audit of Imported Food, shall be prescribed by Ordinance of the Prime Minister. |
| Article 10-2 (Import Sanitation Assessment of Food Subject to Special Sanitation Control) |
| (1) | With respect to food items prescribed by Presidential Decree, not controlled for human consumption in an exporting country, thus requiring special sanitation control (hereinafter referred to as “food subject to special sanitation control”), the Minister of Food and Drug Safety may conduct an audit of the actual sanitation control status, etc. in the exporting country for each food item subject to special sanitation control (hereinafter referred to as "import sanitation assessment"), in cases prescribed by Ordinance of the Prime Minister, including where the government of the exporting country requests permission for import and where reassessing the sanitation control status in the exporting country is deemed necessary. |
| (2) | Foods subject to special sanitation control may be imported only where the results of import sanitation assessment are satisfactory. |
| (3) | Notwithstanding Article 5 (1) and (2), a person who establishes and operates a foreign food facility for foods subject to special sanitation control shall apply for registration thereof to the Minister of Food and Drug Safety via the government of an exporting country. The same shall also apply where he or she intends to modify registered matters. |
| (4) | Any business entity who files an import declaration of foods subject to special sanitation control pursuant to Article 20 shall attach a health certificate for export issued by the government of an exporting country according to the form, etc. on which it has consulted with the Minister of Food and Drug Safety. |
| (5) | Matters necessary for import sanitation assessment, the procedures and methods for registration or modification registration of foreign food facilities for foods subject to special sanitation control, etc. prescribed in paragraphs (1) through (4) shall be prescribed by Ordinance of the Prime Minister. |
[This Article Newly Inserted on Dec. 11, 2018]
| Article 11 (Import Sanitation Assessment of Livestock Products) |
| (1) | In cases prescribed by Ordinance of the Prime Minister, such as cases where the government of an exporting country requests the government of the Republic of Korea to permit the importation of livestock products, or reassessment on the sanitary control of the exporting country is deemed necessary according to changes, etc. in international standards of the Codex Alimentarius Commission, etc., the Minister of Food and Drug Safety may conduct import sanitation assessment on the actual sanitation control status of livestock products of the exporting country for each livestock product defined in subparagraph 2 of Article 2 of the Livestock Products Sanitary Control Act: Provided, That in the case of livestock products which are designated objects subject to quarantine under Article 31 of the Act on the Prevention of Contagious Animal Diseases, an import sanitation assessment shall be conducted on such livestock products if the Minister of Agriculture, Food and Rural Affairs determines to analyze importation risks pursuant to Article 32 (5) of the aforesaid Act. <Amended on Dec. 11, 2018> |
| (2) | The Minister of Food and Drug Safety may determine and publicly notify the requirements for import sanitation for each exporting country or each livestock product according to the results of import sanitation assessments conducted pursuant to paragraph (1). |
| (3) | Any person who intends to import livestock products shall import livestock products from countries or regions for which the Minister of Food and Drug Safety has determined and publicly notified the import sanitation requirements: Provided, That in the case of livestock products which are designated objects subject to quarantine under Article 31 of the Act on the Prevention of Contagious Animal Diseases, the importation of livestock products shall be limited to countries or regions from which the Minister of Agriculture, Food and Rural Affairs permits to import livestock products. |
| (4) | The Minister of Food and Drug Safety may conduct an on-site inspection of a foreign establishment in order to examine or verify whether the foreign establishment fulfills the requirements for import sanitation of livestock products publicly notified pursuant to paragraph (2). |
| (5) | Any person who files an import declaration of livestock products shall attach a health certificate for export issued by the government of an exporting country according to the form, etc. on which it has consulted with the Minister of Food and Drug Safety. |
| (6) | Procedures, methods, etc. necessary for paragraphs (1) through (5) shall be prescribed by Ordinance of the Prime Minister. |
| Article 12 (Registration of Foreign Establishments) |
| (1) | Any person who establishes and operates a foreign establishment shall file an application for registration with the Minister of Food and Drug Safety via the government of an exporting country before he or she submits an import declaration on livestock products under Article 20. The same shall also apply where he or she intends to modify registered matters. |
| (2) | The Minister of Food and Drug Safety may conduct an on-site inspection of the registered foreign food establishment in order to examine and verify the registration under paragraph (1). <Amended on Apr. 23, 2019> |
| (3) | Procedures, methods, etc. regarding the registration under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
| Article 13 (Revocation of Registration of Foreign Establishments) |
| (1) | Where a foreign establishment registered pursuant to Article 12 falls under any of the following, the Minister of Food and Drug Safety may request the government of an exporting country to make corrections, or take necessary measures, such as suspending the importation of livestock products or revoking the registration of the foreign establishment: Provided, That where the foreign establishment falls under subparagraph 1, he or she shall revoke such registration: <Amended on Apr. 23, 2019> |
| 1. | Where he or she has his or her business registered by fraud or other improper means; |
| 2. | Where the foreign establishment has failed to register modifications under the latter part of Article 12 (1) or has registered modifications by deceit; |
| 3. | Where an on-site inspection prescribed in Article 12 (2) is refused, interfered with or evaded (including where no answer is made without good cause), or where it is deemed inappropriate based on the result of on-site inspection; |
| 4. | Where the foreign establishment has seriously violated the requirements for import sanitation, such as the violation of maximum residue limits of prohibited drugs, etc. determined and publicly notified by the Minister of Food and Drug Safety; |
| 5. | Where a livestock product produced at the foreign establishment has been proven hazardous, or the Minister of Food and Drug Safety deems that such livestock product is likely to be hazardous; |
| (2) | Where the government of an exporting country or a person who establishes and operates a foreign establishment examines the cause of the foreign establishment from which the importation is suspended or the registration of which is revoked pursuant to paragraph (1), implements corrective and preventive measures, and the government of the exporting country submits the results thereof, the Minister of Food and Drug Safety may cease measures for the suspension of importation, or allow the foreign establishment to obtain its registration again if he or she deems it appropriate based on the examination of the result. In such cases, where he or she deems it necessary, he or she may conduct an on-site inspection on the foreign establishment. |
| (3) | Where the Minister of Food and Drug Safety takes measures to suspend the importation of livestock products pursuant to paragraph (1) or takes measures to suspend the importation pursuant to paragraph (2), the Minister may disclose information on the relevant foreign establishment. <Newly Inserted on Dec. 3, 2019> |
| (4) | Detailed procedures, methods, etc. regarding the suspension of the importation of livestock products or the revocation of the registration of a foreign establishment under paragraph (1), the revocation of the suspension of importation or the re-registration of a foreign establishment under paragraph (2), or disclosure of information under paragraph (3) shall be prescribed by Ordinance of the Prime Minister. <Amended on Dec. 3, 2019> |
CHAPTER III CONTROL OF IMPORTING BUSINESS
| Article 14 (Types of Business and Facility Standards) |
| (1) | Persons who intend to conduct any of the following business shall have facilities satisfying the facility standards prescribed by Ordinance of the Prime Minister: |
| 1. | Business of importing and selling imported food, etc. (referring to the business of importing and selling imported food, etc.); |
| 2. | Business of filing import declarations of imported food, etc. by proxy; |
| 3. | Business of online purchasing of imported food, etc. by proxy; |
| 4. | Business of storing imported food, etc. |
| (2) | The scope of business under each subparagraph of paragraph (1) shall be prescribed by Presidential Decree. |
| Article 15 (Registration of Business) |
| (1) | A person who intends to conduct business under any of the subparagraphs of Article 14 (1) shall register his or her business with the Minister of Food and Drug Safety. The same shall also apply where it is intended to modify any important matter prescribed by Presidential Decree among the registered matters. |
| (2) | Where the Minister of Food and Drug Safety grants registration of business under paragraph (1), the Minister may attach necessary conditions. |
| (3) | Where a person who has registered his or her business under paragraph (1) closes his or her business or modifies any matter, excluding important matters under the latter part of the aforesaid paragraph, among the registered matters, he or she shall file a report with the Minister of Food and Drug Safety. |
| (4) | Where a business entity has filed a report of the closure of business with the head of the competent tax office pursuant to Article 8 (8) of the Value-Added Tax Act, or the head of the competent tax office has cancelled such entity’s business registration, the Minister of Food and Drug Safety may cancel the registered matters by his or her official authority, and, if necessary, may request the head of the competent tax office to provide information on whether such business entity has closed its business. In such cases, the head of the competent tax office shall provide information on whether such business entity has discontinued its business in accordance with Article 39 of the Electronic Government Act. <Amended on Dec. 31, 2018; Dec. 22, 2020> |
| (6) | Notwithstanding paragraph (1), where a business entity prescribed by Presidential Decree, from among business entities, the permission for which has been obtained or the registration or reporting of which has been made pursuant to the Food Sanitation Act, the Health Functional Foods Act, or the Livestock Products Sanitary Control Act, imports food, etc. as raw materials for manufacturing its products, it shall be deemed to have obtained registration pursuant to paragraph (1). |
| (7) | Where a business entity falls under any of the following, it shall not register its business under paragraph (1): <Amended on Mar. 13, 2018> |
| 1. | Where the business facility concerned fails to meet the facility standards provided for in Article 14 (1); |
| 2. | Where the business entity intends to conduct the same type of business at the same location before six months have passed since the registration of its business was revoked pursuant to Article 29 (1) of this Act or Article 16 (1) or (2) of the Act on Labeling and Advertising of Foods: Provided, That the foregoing shall not apply where the registration of business has been revoked because all of the business facilities were removed; |
| 4. | Where the same person (in the case of a corporation, including the representative thereof) intends to conduct the same type of business as the business, registration of which has been revoked, before two years have passed since the registration of his or her business was revoked pursuant to Article 29 (1) of this Act or Article 16 (1) or (2) of the Act on Labeling and Advertising of Foods: Provided, That the foregoing shall not apply to cases falling under subparagraph 3; |
| 5. | Where a person who intends to register his or her business is a person under adult guardianship, or a person declared bankrupt and not yet reinstated. |
| (8) | Detailed matters regarding procedures, methods, etc. for registration of business and modification registration under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
| Article 16 (Succession of Business) |
| (1) | Where a business entity transfers its business or is dissolved, or corporations are merged, the transferee or successor of such business, or the corporation surviving the merger or the corporation incorporated according to the merger shall succeed to the status of such business entity. |
| (2) | Any person who takes over all of a business facility according to any of the following procedures shall succeed to the status of the business entity thereof. In such cases, the registration of business obtained by the previous business entity shall lose effect: <Amended on Dec. 27, 2016> |
| 4. | Other procedures equivalent to the procedures referred to in subparagraphs 1 through 3. |
| (3) | Any person who has succeeded to the status of a business entity pursuant to paragraph (1) or (2) shall report such fact to the Minister of Food and Drug Safety within one month from the date of succession, as prescribed by Ordinance of the Prime Minister. |
| (4) | Article 15 (7) shall apply mutatis mutandis to succession under paragraphs (1) and (2): Provided, That where a successor falls under Article 15 (7) 5, the foregoing shall not apply for three months from the date of succession. |
| Article 17 (Sanitation Education) |
| (1) | Any business entity shall receive education on the sanitation control, etc. of imported food, etc. every year, as prescribed by Ordinance of the Prime Minister. <Newly Inserted on Dec. 11, 2018> |
| (2) | Any person who intends to conduct business under any of the subparagraphs of Article 14 (1) shall receive education on the sanitation control, etc. of imported food, etc. in advance, as prescribed by Ordinance of the Prime Minister: Provided, That where he or she is unable to receive education in advance for unavoidable reasons, he or she may receive education after starting business as prescribed by the Minister of Food and Drug Safety. <Amended on Dec. 11, 2018> |
| (3) | Where there exists any unavoidable cause prescribed by Ordinance of the Prime Minister, a business entity or a person intending to conduct business who is required to receive education pursuant to paragraph (1) or (2) may designate a person to be in charge of management among his or her employees, and require such person to receive education on his or her behalf. <Newly Inserted on Dec. 11, 2018> |
| (4) | Necessary matters regarding education, such as educational institutions, the content of education, time of education, educational expenses under paragraphs (1) and (2), shall be prescribed by Ordinance of the Prime Minister. <Amended on Dec. 11, 2018> |
| Article 18 (Matters to Be Observed by Business Entities) |
| (1) | Any business entity shall comply with matters prescribed by Ordinance of the Prime Minister to ensure the safety of imported food, etc. and for sound trade order and the promotion of the health of the people. |
| (2) | Any business entity who imports and sells food, etc. he or she has entrusted manufacturing or processing to an exporting country by original equipment manufacturing (hereinafter referred to as "imported food, etc. by OEM") shall comply with each of the following matters: |
| 1. | It shall require an Institution for Safety Audit of Imported Food to conduct on-site sanitation audits, etc. on an enterprise manufacturing or processing imported food, etc. by OEM according to sanitation assessment standards prescribed by the Minister of Food and Drug Safety; |
| Article 19 (Control of Business Entities by Classification) |
| (1) | The Minister of Food and Drug Safety may control business entities differentially by classifying them according to the results of inspection of imported food, etc., the history of violations, and domestic and international food safety information, etc. for the safety and quality control of imported food, etc. |
| (2) | Detailed matters regarding the control of business entities by classification under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
CHAPTER IV CONTROL OF STEPS IN CUSTOMS CLEARANCE
| Article 20 (Import Declaration) |
| (1) | Where a business entity intends to import (including filing an import declaration by proxy) food, etc. for the purpose of sale or for the purpose of using them for business, he or she shall file an import declaration of the relevant imported food, etc. with the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. |
| (2) | A person who intends to file an import declaration pursuant to paragraph (1) or a person who has filed an import declaration shall be held responsible for the safety and quality of food, etc. he or she imports, and shall not engage in any of the following conducts: |
| 1. | Filing an import declaration by fraud or other improper means; |
| 2. | Using or selling imported food, etc. for purposes other than the content of the import declaration under paragraph (1): Provided, That the foregoing shall not apply where a person who has obtained the registration of business of manufacturing or processing food, or business of manufacturing food additives, or has made a report on business of manufacturing containers or packages under Article 37 of the Food Sanitation Act, or a person who has obtained permission to conduct business of processing livestock products, and business of meat packaging and handling under Article 22 of the Livestock Products Sanitary Control Act obtains approval to change purposes after he or she filed an import declaration of imported food, etc. as raw materials for manufacturing his or her own products, as prescribed by Ordinance of the Prime Minister; |
| 3. | Re-importing imported food, etc. returned to an exporting country or taken out to another country after being subject to disposition of non-compliance as a result of inspection under Article 21 (1); |
| 4. | Violating any of the conditions of import declaration under the latter part of Article 21 (1); |
| (3) | Where the Minister of Food and Drug Safety receives an import declaration pursuant to paragraph (1), he or she shall review the details thereof and accept it if it complies with this Act, and may attach conditions if necessary. <Amended on Dec. 11, 2018> |
| (4) | Where imported food, etc. declared for import pursuant to paragraph (1) falls under any of the following as a result of the review prescribed in paragraph (3), the Minister of Food and Drug Safety may defer the acceptance of the relevant import declaration (hereinafter referred to as “deferment of acceptance of declaration”): <Newly Inserted on Dec. 11, 2018> |
| 1. | Where there is a concern of it being used as a means of terrorism; |
| 3. | Where it is believed to have been contaminated by a substance harmful to the human body, but where it is difficult to specify a test item for verifying contamination or there is no predetermined testing method; |
| 4. | Where it is believed that substances such as pesticides, veterinary drugs, genetically modified foods, etc., for which report, registration, etc. have not been made or permission, approval, etc. have not been obtained in the Republic of Korea, have been used, but where there is no predetermined testing method for the relevant raw material or ingredient; |
| 5. | In other cases where the relevant imported food, etc. has caused, or is feared to cause, serious harm to the public health, requiring urgent action. |
| (5) | Where the Minister of Food and Drug Safety intends to defer the acceptance of an import declaration, he or she shall have deliberations and decisions undertaken by the relevant deliberation committee according to the following classification of imported food, etc. (hereafter in this Article referred to as “deliberation committee”): Provided, That if urgent action is required due to a concern of immediate harm to the public health, the Minister of Food and Drug Safety may defer the acceptance of an import declaration before deliberations and decisions by the relevant deliberation committee: <Newly Inserted on Dec. 11, 2018> |
| (6) | Where the Minister of Food and Drug Safety inspects imported food, etc. subject to deferment of acceptance of declaration, either ex officio or upon objection filed by the nation concerned or the business entity that has filed the import declaration, concluding that the relevant imported food, etc. has no harmful effects as a result of such inspection, he or she may wholly or partially revoke the deferment of acceptance of declaration after deliberations and decisions by the relevant deliberation committee. <Newly Inserted on Dec. 11, 2018> |
| (7) | With respect to imported food, etc. subject to deferment of acceptance of declaration, where the nation concerned or the business entity that has filed the import declaration identifies causes and presents improvement measures, the Minister of Food and Drug Safety may wholly or partially revoke the deferment of acceptance of declaration. In such cases, an on-site inspection may be performed if it is necessary to verify the presented improvement measures. <Newly Inserted on Dec. 11, 2018> |
| (8) | Where the Minister of Food and Drug Safety takes action for deferring the acceptance of declaration or revoking such deferment pursuant to paragraphs (6) and (7), he or she shall publicly notify it. <Newly Inserted on Dec. 11, 2018> |
| (9) | Where a business entity files an import declaration of imported food, etc. by OEM pursuant to paragraph (1), he or she shall report a statement of reasons for the expiration date set according to the standards determined and publicly notified by the Minister of Food and Drug Safety to the Minister of Food and Drug Safety. The same shall also apply where he or she modifies important matters prescribed by Ordinance of the Prime Minister among the reported matters. <Amended on Dec. 11, 2018> |
| Article 21 (Import Inspections) |
| (1) | The Minister of Food and Drug Safety shall require a relevant public official or inspection officer under Article 13 of the Livestock Products Sanitary Control Act (hereinafter referred to as "relevant public official, etc."), or inspection agency to conduct necessary inspections before customs clearance formalities for imported food, etc. for which an import declaration has been filed pursuant to Article 20 (1) are completed. In such cases, he or she may accept the import declaration upon attaching conditions, such as the prohibition of use or sale, before the confirmation of the results of inspection or supplementation on violated matters. <Amended on Dec. 11, 2018> |
| (2) | Where the Minister of Food and Drug Safety conducts inspections under paragraph (1), he or she may conduct inspections differentially by classifying imported food, etc. according to the history of inspections of imported food, etc., domestic and international food safety information, and other similar matters. |
| (3) | Where imported food, etc. the import declaration of which has been filed falls under any of the following, notwithstanding paragraph (1), the Minister of Food and Drug Safety may fully or partially omit the inspection of imported food, etc.: |
| 1. | Imported food, etc. imported by a person whose facility has been registered as a good importer pursuant to Article 7; |
| 2. | Deleted; <Apr. 7, 2020> |
| 3. | Where a business entity submits an inspection report or a certificate of inspection on the imported food, etc. concerned he or she has reported after undergoing inspections by an inspection agency prescribed by the Act on Testing and Inspection in Food and Drug Industry; |
| 4. | Imported food, etc. that the Minister of Food and Drug Safety deems to have no safety issues thereof, such as no history of non-compliance as a result of a thorough inspection. |
| (4) | The Minister of Food and Drug Safety may disclose the results of inspection of imported food, etc. and importers who comply with the applicable regulations appropriately in order to create an environment under which importers may import safe and high quality imported food, etc. |
| (5) | Types of inspection; imported food, etc. subject to inspection; methods and procedures for inspection; items to be inspected; conditions of inspection; and other similar matters under paragraph (1), inspection of imported food, etc. by classification under paragraph (2), and the disclosure of the result of inspection; importers who comply with the applicable regulations appropriately; and other necessary matters under paragraph (4) shall be prescribed by Ordinance of the Prime Minister. |
| Article 22 (Inspection Orders) |
| (1) | Where imported food, etc. falls under any of the following, the Minister of Food and Drug Safety may order a business entity to undergo inspections by an inspection agency prescribed by the Act on Testing and Inspection in the Food and Drug Industry: Provided, That where the Minister of Food and Drug Safety deems it impracticable to confirm hazardous ingredients through inspection, submission of related data, etc. may take the place of inspection: |
| 1. | Imported food, etc. from which harmful substances prescribed by the Minister of Food and Drug Safety have been detected both at home and abroad; |
| 2. | Imported food, etc. in which case non-compliance occurs repeatedly as a result of import inspection under Article 21, or access, inspection, and collection under Article 25; |
| 3. | Imported food, etc. in which case concerns over the occurrence of risks are raised both at home and abroad. |
| (2) | The Minister of Food and Drug Safety shall prescribe and publicly notify detailed matters, such as the scope of imported food, etc. subject to an order to undergo inspections, and data to be submitted under paragraph (1). |
CHAPTER V CONTROL OF DISTRIBUTION STEPS
| Article 23 (Traceability of Imported Food) |
| (1) | Where a problem occurs in imported food, etc. (excluding imported beef and imported pork under the Livestock and Livestock Products Traceability Act; hereafter the same shall apply in this Article), the Minister of Food and Drug safety may require business entities to register traceability by prescribing imported food, etc. subject to traceability if he or she deems it necessary to manage imported food, etc. so that he or she may track such imported product, etc., identify the cause of such problem, and take necessary measures: Provided, That business entities prescribed by Ordinance of the Prime Minister, such as business entities who import infant formula and business entities who import health functional foods which reach a certain amount of sales, shall register with the Minister of Food and Drug Safety. <Amended on Dec. 27, 2016> |
| (2) | Imported food, etc. subject to traceability under paragraph (1), procedures for registration, matters to be registered, criteria for revocation of registration, investigation, assessment, and other necessary matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 24 (Formulation and Execution of Distribution Management Plan) |
| (1) | The Minister of Food and Drug Safety shall formulate and execute a distribution management plan every year to confirm the safety and quality of imported food, etc. intended for imported food, etc. in distribution. |
| (2) | Necessary matters regarding the formulation and execution of distribution management plans under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
| Article 25 (Access, Inspections, and Collection.) |
| (1) | If necessary for the prevention of risks and sanitary control of imported food, etc., and the maintenance of business order, the Minister of Food and Drug Safety (including the head of an agency under his or her jurisdiction prescribed by Presidential Decree; hereafter the same shall apply in this Article) may take each of the following measures: |
| 1. | Requesting business entities or other relevant persons to submit necessary documents or data; |
| 2. | Requiring relevant public officials, etc. to take measures, such as access, inspection, or collection falling under the following: |
| (a) | Inspection of imported food, etc. for sale, or business facilities used for business upon having access to places of business (including offices, warehouses, storage facilities, sales points, and other places similar thereto); |
| (b) | Collection of the minimum amount of imported food, etc. necessary for inspection under item (a) without compensation; |
| (c) | Reading of books or documents related to business. |
| (2) | Where necessary to efficiently conduct affairs for the prevention of risks related to sanitation which occur due to imported food, etc. while conducting affairs, such as access, inspection, or collection under paragraph (1), the Minister of Food and Drug Safety may request the head of a relevant administrative agency, the Mayor/Do Governor, or the head of a Si/Gun/Gu to provide administrative support. In such cases, the head of a relevant administrative agency, the Mayor/Do Governor, or the head of a Si/Gun/Gu who receives a request for administrative support shall comply with such request unless there is a compelling reason not to do so. |
| (3) | A public official who intends to access, inspect, collect, or read pursuant to paragraphs (1) and (2) shall carry a certificate indicating his or her authority and present it to relevant persons. |
| (4) | Procedures for providing administrative support under paragraph (2), methods for sharing expenses, and other necessary matters shall be prescribed by Presidential Decree. |
| Article 26 (Order to Take Training Course) |
| (1) | The Minister of Food and Drug Safety may order any of the following business entities to receive education on the safety and quality control, etc. of imported food, etc.: <Amended on Mar. 13, 2018> |
| 1. | A business entity found to have imported non-compliant imported food, etc. as a result of inspection under Article 21; |
| 2. | A business entity ordered to suspend its business under Article 29 as a result of access, inspection, collection, etc. under Article 25; |
| 4. | A business entity which imports imported food, etc. designated by the Minister of Food and Dug Safety as those likely to cause risks to the human body. |
| (2) | Where a business entity which should receive education pursuant to paragraph (1) is not directly engaged in business or conducts business at least two places, it may designate a person responsible for imported food sanitation from among employees and require him or her to receive education on its behalf. |
| (3) | Detailed procedures for ordering education under paragraph (1), educational institutions, methods and content of education, and other necessary matters, shall be prescribed by Ordinance of the Prime Minister. |
CHAPTER VI ADMINISTRATIVE SANCTIONS, SUCH AS CORRECTIVE ORDERS AND REVOCATION OF REGISTRATION
| Article 27 (Corrective Orders) |
The Minister of Food and Drug Safety shall order business entities which fail to comply with this Act to make necessary corrections for the safety control of imported food, etc.
| Article 28 (Orders to Improve Facilities) |
| (1) | Where a business facility does not meet the facility standards under Article 14, the Minister of Food and Drug Safety may order the business entity to improve the facility within a fixed period. |
| (2) | Where the owner of a building and a business entity are different, the owner of the building shall cooperate as much as possible for the improvement of the facility made by the business entity in receipt of an order to improve the facility. |
| Article 29 (Cancellation of Registration) |
| (1) | Where a business entity falls under any of the following, the Minister of Food and Drug Safety may revoke its business registration or order it to suspend its business for a fixed period not exceeding six months: <Amended on Mar. 13, 2018; Dec. 11, 2018> |
| 2. | Where it violates the latter part of Article 15 (1) or paragraph (3) of the aforesaid Article; |
| 5. | If it has violated Article 20 (1), (2), or (9); |
| 6. | Where it fails to register traceability under the proviso of Article 23 (1); |
| 7. | Where it violates an order under Article 27 or 28; |
| (2) | Where a business entity suspends operations for at least six consecutive months without good cause, the Minister of Food and Drug Safety may revoke the registration of the business. |
| (3) | Where a business entity continues its business, in violation of an order to suspend its business under paragraph (1), the Minister of Food and Drug Safety may revoke the registration of the business. |
| (4) | Detailed criteria for an administrative disposition imposed under paragraph (1) shall be prescribed by Ordinance of the Prime Minister in consideration of the type and degree of violations. |
| Article 30 (Succession of Effect of Administrative Disposition) |
Where a business entity transfers its business or is dissolved, or corporations are merged, the effect of an administrative disposition imposed on the previous business entity on the ground for violation of any subparagraph of Article 29 (1) or paragraph (3) of the aforesaid Article shall be acquired by a transferee, successor, or a corporation surviving the merger for one year from the date on which the period of such disposition expires, and where procedures for the administrative disposition are in progress, the procedures for the administrative disposition may be continued against the transferee, successor, or the corporation surviving the merger: Provided, That the foregoing shall not apply where the transferee or the corporation surviving the merger proves that he or she or it did not know such disposition or violation when he or she acquires the business or it merged with the other corporation.
| Article 31 (Measures for Closure) |
| (1) | Where a business entity conducts its business without obtaining registration under Article 15 or continuously conducts its business though the registration of its business was revoked pursuant to Article 29, the Minister of Food and Drug Safety may require relevant public officials to take the following measures to close down the place of business concerned: |
| 1. | Removing or eliminating marking of the relevant place of business, such as signboards; |
| 2. | Posting notices, etc. announcing that the relevant place of business is not a legitimate place of business; |
| 3. | Putting the seal to stop the use of facilities at the place of business concerned, and machinery, appliances, etc. used for business. |
| (2) | Where it is not necessary to continuously put the seal after putting the seal pursuant to paragraph (1) 3, or a person who conducts the business concerned or his or her agent promises to close down the place of business concerned, or requests the breaking of the seal for any other good cause, the Minister of Food and Drug Safety may break the seal. The same shall also apply to a notice, etc. posted pursuant to paragraph (1) 2. |
| (3) | Where the Minister of Food and Drug Safety intends to take measures under paragraph (1), he or she shall inform the person who conducts the business concerned or the agent of such person of his or her intention in writing in advance: Provided, That the foregoing shall not apply where there exist urgent reasons prescribed by Presidential Decree. |
| (4) | The measures referred to in paragraph (1) shall be permitted to such a minimum extent to disallow the business. |
| (5) | In cases falling under paragraph (1), a relevant public official shall carry a certificate indicating his or her authority and present it to relevant persons. |
Where the Minister of Food and Drug Safety intends to take any of the following measures, he or she shall hold a hearing:
| 1. | Revocation of the designation of an Institution for Safety Audit of Imported Food under Article 10 (6); |
| 2. | Revocation of the registration of business under Article 29 (1) through (3). |
| Article 33 (Imposition of Penalty Surcharges in Lieu of Suspension of Business) |
| (2) | The amounts of penalty surcharges based on types, degrees, etc. of offenses for which penalty surcharges under paragraph (1) are imposed, and other necessary matters shall be prescribed by Presidential Decree. |
| (3) | Where necessary to collect penalty surcharges, the Minister of Food and Drug Safety may request the head of the competent tax office to provide tax information by means of a document stating the following: |
| 1. | Personal information of a taxpayer; |
| 3. | The sales as the standard amount for imposing a penalty charge. |
| (4) | Where a business entity fails to pay a penalty surcharge under paragraph (1) within a deadline, the Minister of Food and Drug Safety shall revoke the imposition of a penalty surcharge under paragraph (1) and impose a disposition for suspension of its business under Article 29 (1), or collect the penalty surcharge in the same manner as delinquent national taxes are collected: Provided, That where the Minister of Food and Drug Safety is unable to impose the suspension of business under Article 29 (1) due to the closure, etc. of business referred to in Article 15 (3), he or she shall collect the penalty surcharge in the same manner as delinquent national taxes are collected. |
| (5) | Penalty surcharges collected pursuant to paragraphs (1) and (4) shall vest in the State. |
| (6) | Where it is necessary to collect a penalty surcharge in arrears prescribed in paragraph (4), the Minister of Food and Drug Safety may request the submission of any of the following data from the relevant person. In such cases, the person in receipt of such request shall comply with it, unless there is good cause: <Newly Inserted on Dec. 11, 2018> |
| Article 34 (Imposition of Penalty Surcharges Due to Sale of Hazardous Imported Food) |
| (2) | The calculated amount of a penalty surcharge under paragraph (1) shall be determined as prescribed by Presidential Decree. |
| (3) | Where a person fails to pay a penalty surcharge imposed pursuant to paragraph (1) within a deadline, or closes his or her business pursuant to Article 15 (3), the Minister of Food and Drug Safety shall collect such penalty surcharge in the same manner as delinquent national taxes are collected. |
| (4) | Article 33 (3), (5) and (6) shall apply mutatis mutandis to the vesting of penalty surcharges imposed pursuant to paragraph (1), a percentage of the vesting thereof, procedures for the collection thereof, a request for submission of data necessary to collect penalty surcharges in arrears, etc. <Amended on Dec. 11, 2018> |
| Article 35 (Publication of Violations) |
With regard to a person on whom an administrative disposition is imposed pursuant to Article 29, 31, 33, or 34, the Minister of Food and Drug Safety shall publish information on the disposition, including the details of such disposition, the name of the place of business, and imported food, etc., as prescribed by Presidential Decree.
CHAPTER VII SUPPLEMENTARY PROVISIONS
| Article 36 (Government Subsidies) |
The Minister of Food and Drug Safety may fully or partially subsidize the following within budgetary limits: <Amended on Dec. 29, 2020>
| 1. | Expenses incurred in obtaining the registration of a foreign food facility under Article 5; |
| 2. | Expenses incurred in conducting on-site inspections under Articles 6 and 7; |
| 3. | Expenses incurred in implementing traceability of imported food, etc. under Article 23; |
| 4. | Expenses incurred in collecting and inspecting imported food, etc. in distribution by an inspection agency that participates in the process pursuant to Article 25; |
| 5. | Expenses incurred in collecting imported food, etc. safety information under Article 39; |
| 6. | Other expenses incurred in ensuring the safety of imported food, etc. |
| Article 37 (International Cooperation) |
The Minister of Food and Drug Safety shall endeavor to promote international cooperation, such as the conclusion of agreements with exporting countries for the safety, quality control, etc. of imported food, etc.
| Article 38 (Support for Safety of Food for Export) |
| (1) | The Minister of Food and Drug Safety may provide information, etc. about the foreign standards and specifications to support the safety of food, food additives, apparatus, containers and packages, health functional foods, livestock products which business entities intend to export (hereafter referred to as “food, etc. for export" in this Article). |
| (2) | Where a person who intends to export food, etc. files an application for a health certificate, etc. to certify the sanitation, etc. of the relevant food, etc. for export, the Minister of Food and Drug Safety shall verify the fact about the sanitation thereof, and issue a health certificate, etc. |
| (3) | Where it is necessary for a person who intends to export food, etc. to register a domestic food facility or a domestic establishment in a foreign country, the Minister of Food and Drug Safety may support such person by providing information on the safety management system of food, etc. for export to a foreign government, etc. <Newly Inserted on Apr. 23, 2019> |
| (4) | Necessary matters regarding procedures, etc. for filing an application for and issuing a health certificate, etc. under paragraph (2) shall be prescribed by Ordinance of the Prime Minister. <Amended on Apr. 23, 2019> |
| Article 39 (Collection of Safety Information on Imported Food) |
| (1) | The Minister of Food and Drug Safety may appoint information collection personnel of imported food, etc. to collect safety information on imported food, etc. <Amended on Apr. 23, 2019> |
| (2) | The information collection personnel under paragraph (1) shall perform the following duties: <Amended on Apr. 23, 2019> |
| 1. | Collecting and reporting food safety information generated abroad; |
| 2. | Monitoring imported food, etc. sold on the foreign Internet sites; |
| 3. | Other matters requested by the Minister of Food and Drug Safety to verify specific information. |
| (3) | Necessary matters regarding methods of the appointment, management, etc. of information collection personnel of imported food, etc. under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. <Amended on Apr. 23, 2019> |
| Article 39-2 (Establishment and Operation of Imported Food Integrated Information System) |
| (1) | The Minister of Food and Drug Safety may establish and operate an integrated information system for imported food (hereinafter referred to as "integrated information system") in order to efficiently perform duties related to safety management of imported food, etc. |
| (2) | The Minister of Food and Drug Safety may request the heads of related agencies, including local governments, etc., to provide data or information necessary for establishing and operating the integrated information system. In such cases, the head of an agency in receipt of a request shall comply therewith unless there is good cause. |
| (3) | Matters necessary for establishing and operating the integrated information system and requesting the provision of information and the connection thereof under paragraph (2) shall be prescribed by Ordinance of the Prime Minister. |
[This Article Newly Inserted on Apr. 7, 2020]
| Article 40 (Delegation and Entrustment of Authority) |
| (1) | The Minister of Food and Drug Safety may delegate part of his or her authority under this Act to the heads of Regional Offices of Food and Drug Safety, as prescribed by Presidential Decree. |
| (2) | The Minister of Food and Drug Safety may entrust a relevant specialized institution or organization with affairs regarding the registration of foreign food facilities under Article 5, affairs regarding the traceability of imported food, etc. under Article 23, and affairs related to the establishment and operation of an integrated information system under Article 39-2, as prescribed by Presidential Decree. <Amended on Apr. 7, 2020> |
| (3) | Where necessary for the supervision of affairs entrusted under paragraph (2), the Minister of Food and Drug Safety may require a relevant specialized institution or organization to report matters regarding its affairs or to submit data, or issue other necessary orders, and require public officials under his or her control to have access to its office to inspect books, documents, etc. |
| (4) | A public official who intends to access or inspect pursuant to paragraph (3) shall carry a certificate indicating his or her authority and present it to relevant persons. |
Any of the following persons shall pay fees as determined by Ordinance of the Prime Minister: <Amended on Apr. 7, 2020>
| 1. | A person who intends to obtain certification, change certification, and extension of the validity period of a HACCP-certified foreign facility for imported food under Article 6-2 (1) through (3); |
| 2. | A person who intends to register as a good importer or to register modifications pursuant to Article 7 (3); |
| 3. | A person who intends to obtain designation as an Institution for Safety Audit of Imported Food under Article 10; |
| 4. | A person who intends to register his or her business or to register modifications pursuant to Article 15 (1); |
| 5. | Any person who undergoes an inspection pursuant to Article 21 (1); |
| 6. | A person who intends to obtain the registration of traceability under Article 23 (1). |
CHAPTER VIII PENALTY PROVISIONS
| Article 42 (Penalty Provisions) |
Any of the following persons shall be punished by imprisonment with labor for not more than five years or by a fine of not more than 50 million won, or both:
| 1. | A person who fails to register his or her business, in violation of Article 15 (1); |
| 2. | A person who fails to file an import declaration, in violation of Article 20 (1); |
| 3. | A person who commits an offense falling under any of the subparagraphs of Article 20 (2). |
| Article 43 (Penalty Provisions) |
Any of the following persons shall be punished by imprisonment with labor for not more than three years or by a fine not exceeding 30 million won, or both may be imposed concurrently:
| 1. | A person who violates any of the provisions of Article 7 (6) 1 through 3; |
| 2. | A business operator who fails to meet the criteria for facilities under Article 14; |
| 3. | A business operator who fails to meet the conditions under Article 15 (2); |
| 5. | A person who fails to comply with any of the matters to be observed by a business entity pursuant Article 18: Provided, That the foregoing shall not apply to a person who violates any of the minor matters prescribed by Ordinance of the Prime Minister; |
| 6. | A person who refuses, interferes with, or avoids inspection, access, collection, etc. under Article 21 (1) or 25 (1); |
| 7. | A person who violates the proviso of Article 23 (1); |
| 8. | A person who continues to conduct his or her business, in violation of an order to suspend his or her business under Article 29 (1); |
| 9. | A person who removes or destroys a notice posted, or the seal placed, by a relevant public official pursuant to Article 31 (1) without permission. |
| Article 44 (Legal Fiction as Public Officials for Purposes of Applying Penalty Provisions) |
| 1. | Executive officers and employees of an institution performing affairs entrusted under Article 9; |
| 2. | Executive officers and employees of a related specialized institution or organization that conducts affairs entrusted pursuant to Article 40 (2). |
| Article 45 (Joint Penalty Provisions) |
If the representative of a corporation or an agent, employee, or other worker of a corporation or an individual commits an offense falling under any of Article 42 or 43 in relation to the affairs of such corporation or individual, not only shall the offender be punished, but the corporation or individual also shall be punished by a fine under the corresponding Article: Provided, That the foregoing shall not apply where the corporation or the individual has not neglected to pay due attention to, and exercise supervision over, the relevant affairs in order to prevent such offense.
| Article 46 (Administrative Fines) |
Any of the following persons shall be subject to an administrative fine not exceeding five million won: <Amended on Dec. 11, 2018>
| 1. | A person who fails to receive sanitation education, in violation of Article 17 (1) and (2); |
| 2. | A person who fails to receive education, in violation of Article 26 (1); |
| 3. | Any person who violates an order pursuant to Article 28 (1). |
| (2) | A person who fails to comply with a minor matter prescribed by Ordinance of the Prime Minister among matters to be observed by business entities pursuant to Article 18 shall be punished by an administrative fine not exceeding three million won. |
| (3) | The Minister of Food and Drug Safety shall impose and collect administrative fines under paragraphs (1) and (2), as prescribed by Presidential Decree. |
| Article 47 (Special Cases on Application of Administrative Fines) |
Where the provisions on administrative fines of Article 46 apply, no administrative fine shall be imposed for an offense for which a penalty surcharge has been imposed pursuant to Article 33: Provided, That the foregoing shall not apply where the imposition of a penalty surcharge is revoked and a disposition for suspension of business is imposed pursuant to the main clause of Article 33 (4).
ADDENDA <Act No. 13201, Feb. 3, 2015>
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation.
Article 2 (Transitional Measures concerning Business)
| (1) | A person who has obtained approval or permission to conduct business related to importation, and a person whose facility has been registered as a good importer and a prior confirmation registration facility of imported food, etc. pursuant to the Food Sanitation Act, the Health Functional Foods Act, or the Livestock Products Sanitary Control Act before this Act enters into force, shall be deemed registered as a business entity, good importer, and good foreign food facility, respectively, under this Act. |
| (2) | Matters in which case procedures for import declaration are pending as at the time this Act enters into force shall be deemed procedures under this Act. |
Article 3 (Transitional Measures concerning Import Sanitation Assessment of Livestock Products)
| (3) | Import sanitation requirements being applied, and quarantine certificates for export being issued, pursuant to Act on the Prevention of Contagious Animal Diseases before this Act enters into force, shall be deemed those applied or issued under this Act: Provided, That where the Minister of Food and Drug Safety deems it necessary, he or she may amend any of import sanitation requirements or quarantine certificates for export in consultation with the Minister of Agriculture, Food and Rural Affairs, or request the Minister of Agriculture, Food and Rural Affairs to publish special import sanitation requirements or issue a special quarantine certificate for export under this Act. |
| (4) | Matters in which case procedures for import sanitation assessment, etc. have been pending before this Act enters into force shall be deemed procedures under this Act. |
Article 4 (Transitional Measures concerning Incompetents)
A person for whom the effect of the declaration as an incompetent is maintained pursuant to Article 2 of Addenda of Civil Act (Act No. 10429) shall be deemed a person under adult guardianship under Article 15 (7) 5 (including where the aforesaid provision applies mutatis mutandis pursuant to Article 16 (4)). Article 5 (Transitional Measures concerning Payment of Monetary Rewards)
A person who informs the administrative authorities or an investigative agency of, or files a criminal charge with the authorities or agency against, a person who violates Article 6 (1) of the previous Health Functional Foods Act pursuant to Article 40 of the aforesaid Act, before this Act enters into force may be paid a reward in accordance with the previous provisions. Article 6 (Transitional Measures concerning Publications, Dispositions, Orders, Designations, and Actions Being Performed)
Any matter published, disposition granted, order issued, or designation made pursuant to the Food Sanitation Act, the Health Functional Foods Act, or the Livestock Products Sanitary Control Act; other acts performed by administrative agencies; various applications filed with, reports made to, or other acts done in administrative agencies before this Act enters into force shall be deemed acts performed by or done in administrative agencies under this Act corresponding thereto. Article 7 (Transitional Measures concerning Penalty Provisions)
Article 8 Omitted.
Article 9 (Relationship to Other Statutes or Regulations)
ADDENDA <Act No. 14476, Dec. 27, 2016>
Article 1 (Enforcement Date)
This Act shall enter into force three months from the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDA <Act No. 14478, Dec. 27, 2016>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation: Provided, That --- <Omitted> --- Article 3 of the Addenda shall enter into force two years after the date of its promulgation. Articles 2 through 3 Omitted.
ADDENDA <Act No. 15482, Mar. 13, 2018>
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation.
Article 2 (Transitional Measures concerning Administrative Dispositions and Imposition and Collection of Penalty Surcharges)
The previous provisions shall apply to administrative dispositions or penalty surcharges imposed or collected against violations committed before this Act enters into force in relation to labeling or advertising imported food, etc.
Article 3 (Transitional Measures concerning Penalty Provisions)
The previous provisions shall govern the application of penalty provisions for violations committed before this Act enters into force in relation to labeling or advertising imported food, etc.
ADDENDA <Act No. 15940, Dec. 11, 2018>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation: Provided, That the amended provisions of Articles 10-2, 17 and 46 (1) 1 shall enter into force six months after the date of its promulgation. Article 2 (Transitional Measures concerning Import Sanitation Assessment of Food Subject to Special Sanitation Control)
| (1) | In the case of food items subject to special sanitation control that have been imported before the amended provisions of Article 10-2 enter into force, they shall be deemed to satisfy the requirements of import sanitation assessment under the amended provisions of paragraph (1) of the aforesaid Article. |
| (2) | A foreign food facility for foods subject to special sanitation control registered under Article 5 before the amended provisions of Article 10-2 enter into force shall be deemed to have been registered with the Minister of Food and Drug Safety via the government of the relevant exporting country pursuant to the amended provisions of Article 10-2 (3). |
ADDENDA <Act No. 16101, Dec. 31, 2018>
Article 1 (Enforcement Date)
This Act shall enter into force on January 1, 2019. (Proviso Omitted.)
Articles 2 through 11 Omitted.
ADDENDA <Act No. 16401, Apr. 23, 2019>
This Act shall enter into force on the date of its promulgation: Provided, That the amended provision of Article 13 (1) 3 shall enter into force six months after the date of its promulgation.
ADDENDA <Act No. 16716, Dec. 3, 2019>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.
Article 2 (Applicability to Provision of Information on Foreign Food Facilities and Foreign Establishments)
The amended provisions of Articles 6 (4) and 13 (3) shall begin to apply to foreign food facilities or foreign establishments whose import became subject to suspension or revocation of suspension after this Act enters into force.
ADDENDA <Act No. 17245, Apr. 7, 2020>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.: Provided, That the amended provisions of Articles 6-2 (excluding the amended provisions of paragraph (4) of the same Article), 8, 9 (1), 21 (3) 2, and 41 shall enter into force on July 1, 2021, and the amended provisions of Article 6-2 (4) shall enter into force on October 1, 2021. Article 2 (Applicability to Importation of Imported Food prescribed by Ordinance of the Prime Minister)
The amended provisions of Article 6 (2) shall apply to imported food (referring to loading on a ship or other means of transportation that departs from the relevant exporting country) after the same amended provisions enter into force. Article 3 (Transitional Measures concerning Good Foreign Food Facilities)
Notwithstanding the amended provisions of Articles 8, 9 (1), 21 (3) 2 and 41, the previous provisions shall apply to good foreign food facilities registered under the previous provisions before July 1, 2021 until the period of validity of such registration expires.
ADDENDA <Act No. 17653, Dec. 22, 2020>
Article 1 (Enforcement Date)
This Act shall enter into force on January 1, 2021. (Proviso Omitted.)
Articles 2 through 14 Omitted.
ADDENDUM <Act No. 17807, Dec. 29, 2020>
This Act shall enter into force on July 1, 2021.