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SPECIAL ACT ON IMPORTED FOOD SAFETY CONTROL — 법갈피

영문법령 / SPECIAL ACT ON IMPORTED FOOD SAFETY CONTROL

SPECIAL ACT ON IMPORTED FOOD SAFETY CONTROL

법률일부개정시행 2026-01-01식품의약품안전처 · 제20825호 · 공포 2025-03-18

CHAPTER I GENERAL PROVISIONS

Article 1(Purpose) #

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.

Article 2(Definitions) #

The terms used in this Act are defined as follows: <Amended on Aug. 17, 2021; Jun. 13, 2023>

1. "Imported food, etc." means foods, food additives, apparatus, and containers and packages as defined under Article 2 of the Food Sanitation Act (hereinafter referred to as "food, etc.") imported into the Republic of Korea from abroad, health functional foods under Article 3 of the Health Functional Foods Act (hereinafter referred to as "health functional foods"), and livestock products under Article 2 of the Livestock Products Sanitary Control Act (hereinafter referred to as "livestock products");

1-2. "Animal product" means any of the following foods prescribed by Presidential Decree, from among foods (excluding livestock products) defined in Article 2 of the Food Sanitation Act, which are imported into the Republic of Korea from abroad:

a. Meat, raw milk, or eggs of animals;

b. Foods manufactured or processed by using foods referred to in item a as raw materials;

c. Foods manufactured or processed by using livestock products as raw materials;

2. "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 can be taken by tracking such imported food, etc. where the problem occurs with the safety of the imported food, etc.;

3. "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) are produced, manufactured, processed, treated, packaged, stored, etc.;

4. "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.;

Article 5(Registration of foreign food facilities) #

(1) A person who intends to import foods, etc. into the Republic of Korea or a person who establishes and operates a foreign food facility (hereinafter referred to as "importer, etc.") shall file for the registration of matters prescribed by Prime Ministerial Decree, such as the name and location of, and items manufactured by, the relevant foreign food facility with the Minister of Food and Drug Safety before he or she files an import declaration under Article 20. <Amended on Dec. 11, 2018; Aug. 8, 2023>

(2) If any modification occurs in the matters registered pursuant to paragraph (1), an application for the registration of such modification shall be filed with the Minister of Food and Drug Safety. <Amended on Aug. 8, 2023>

(3) If the Minister of Food and Drug Safety needs to further verify any matters of which an importer, etc. filed for registration or registration of modification pursuant to paragraphs (1) and (2), the Minister may request the importer, etc. to provide necessary data. <Amended on Aug. 8, 2023>

(4) If an importer, etc. file for registration again pursuant to paragraph (1) at the same location as the foreign food facility whose registration under paragraph (1) was withdrawn after a plan for on-site inspection under Article 6(1) was notified, the registration may be determined after a review such as an on-site inspection under Article 6(1). <Amended on Aug. 8, 2023>

(5) If the importer, etc. fall under any of the following, the Minister of Food and Drug Safety may refuse to accept an import declaration filed under Article 20: <Amended on Jun. 13, 2023>

1. Where the importer, etc. have 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. have failed to provide data under paragraph (3), or has provided data by fraud or other improper means.

(6) The effective period of registration of a foreign food facility under paragraph (1) shall be two years from the date of such registration, and the Minister of Food and Drug Safety may extend the period by up to two years. <Amended on Jun. 13, 2023>

(7) An importer, etc. who intend to extend the effective period pursuant to paragraph (6) shall file an application for such extension with the Minister of Food and Drug Safety before the effective period expires. <Added on Jun. 13, 2023>

(8) Notwithstanding paragraphs (1) and (2), a person who establishes and operates a foreign food facility for animal products shall apply for the registration of a foreign food facility or the registration of modification thereof with the Minister of Food and Drug Safety via the government of an exporting country. <Added on Jun. 13, 2023>

(9) The procedures, methods, etc. for registration under paragraphs (1) and (2), procedures for extending the effective period under paragraph (7), the procedures and methods of application for registration under paragraph (8), and other relevant matters shall be prescribed by Prime Ministerial Decree. <Amended on Jun. 13, 2023>

[Enforcement Date: Jun. 14, 2024]

Article 6(On-site inspection of foreign food facilities) #

(1) The Minister of Food and Drug Safety may conduct an on-site inspection of a foreign food facility which has filed for registration or is registered under Article 5(1) in consultation with the government of an exporting country or the foreign food facility, in any of the following cases: <Amended on Aug. 8, 2023>

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) The Minister of Food and Drug Safety may take measures to suspend the importation of imported food, etc. of the relevant foreign food facility, in any of the following cases: <Amended on Apr. 23, 2019; Aug. 17, 2021; Aug. 16, 2023>

1. Where an on-site inspection provided in paragraph (1) (including a remote inspection referred to in Article 9-2; hereafter in this subparagraph the same shall apply) is refused, interfered with, or evaded (including where no answer is made without good cause);

2. Where an on-site inspection under paragraph (1) suggests that imported food, etc. are likely to cause hazards.

(3) With respect to imported food, etc., the importation of which is suspended because they fall under paragraph (2)1, the Minister of Food and Drug Safety may revoke the suspension of importation according to the result of on-site inspections, etc. of the relevant foreign food facility. <Added on Aug. 16, 2023>

(4) If the government of an exporting country, a foreign food facility, or a business entity that has imported food, etc. identifies the cause of any problem and suggests improvement measures with respect to the imported food, etc. of which importation has been suspended under paragraph (2)2, or if such imported food, etc. are deemed non-hazardous, the Minister of Food and Drug Safety may revoke the suspension of importation under paragraph (2). In such cases, if it is necessary to verify the improvements, the Minister of Food and Drug Safety may conduct an on-site inspection. <Amended on Aug. 16, 2023>

(5) Where the Minister of Food and Drug Safety takes measures to suspend the importation of imported food, etc. pursuant to paragraph (2) or revokes the suspension of importation thereof pursuant to paragraph (3) or (4), the Minister of Food and Drug Safety may disclose information on the relevant foreign food facility. <Added on Dec. 3, 2019; Aug. 16, 2023>

(6) Details regarding measures to suspend importation under paragraph (2), measures to revoke such suspension under paragraph (3) or (4), and disclosure of information under paragraph (5) shall be prescribed by Prime Ministerial Decree. <Amended on Dec. 3, 2019; Aug. 16, 2023>

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 Prime Ministerial Decree 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 effective period of certification referred to in paragraph (1) shall be three years from the date of certification, and the effective period of certification for modification referred to in paragraph (2) shall be the remainder of the original effective period of certification. In such cases, the validity period of certification or certification of modification may be extended by up to three years.

(4) Imported food, etc. prescribed by Prime Ministerial Decree, 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, 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 Prime Ministerial Decree, 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 Prime Ministerial Decree.

[This Article Added on Apr. 7, 2020]

Article 7(Registration as 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 or foreign establishment according to the standards set by the Minister of Food and Drug Safety, to ensure the safety of the relevant imported food, etc. <Amended on Jun. 10, 2022>

(2) Any person who has inspected the status of sanitation control pursuant to paragraph (1) may have such facility registered as a good importer by the Minister of Food and Drug Safety.

(3) Any person who intends to have such facility registered as a good importer pursuant to paragraph (2) shall file an application with the Minister of Food and Drug Safety as prescribed by Prime Ministerial Decree. The same shall also apply where he or she intends to modify any important matter prescribed by Prime Ministerial Decree among the matters registered.

(4) The Minister of Food and Drug Safety may conduct an on-site inspection of a foreign food facility or foreign establishment to ascertain whether an application filed for the registration as a good importer under paragraph (3) or a good importer registered complies with the standards determined by the Minister of Food and Drug Safety. <Amended on Jun. 10, 2022>

(5) The effective period of the registration as a good importer under paragraph (2) shall be three years from the date of such registration, and the Minister of Food and Drug Safety may extend the period by up to three years. <Amended on Jun. 13, 2023>

(6) A business entity who intends extend the effective period pursuant to paragraph (5) shall file an application with the Minister of Food and Drug Safety before the effective period expires. <Added on Jun. 13, 2023>

(7) If 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, where a good importer falls under subparagraph 1, he or she shall revoke its registration: <Amended on Mar. 13, 2018; Jun. 13, 2023>

1. Where the foreign establishment has its business registered by fraud or other improper means;

2. Where the good importer is subjected to an administrative disposition of business suspension for at least two months pursuant to Article 29, or Article 16(1) or (2) of the Act on Labeling and Advertising of Foods;

3. Where the good importer fails to comply with matters prescribed by Prime Ministerial Decree, which are equivalent to the cases referred to in subparagraphs 1 and 2.

(8) A facility of which registration was revoked pursuant to paragraph (7) shall not file for registration as a good importer for three years from the date its registration is revoked. <Amended on Jun. 13, 2023>

(9) Details, such as the eligibility for registration as a good importer and the procedures and methods for the registration, modification, and extension of the effective period shall be prescribed by Prime Ministerial Decree. <Amended on Jun. 13, 2023>

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 effective period of 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 effective period provided for in paragraph (2) may be extended only once by up to 1 year, as prescribed by Prime Ministerial Decree.

(4) Where an Institution for Safety Audit of Imported Food, the effective period of which expires pursuant to paragraphs (2) and (3), meets the requirements under paragraph (8), it may be re-designated 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 specified period not exceeding six months, or take necessary measures, such as the issuance of an order to make corrections, as prescribed by Prime Ministerial Decree; provided, 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 evades 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) Details, such as requirements, and procedures for designation of an Institution for Safety Audit of Imported Food, shall be prescribed by Prime Ministerial Decree.

Article 11(Import sanitation assessment of livestock products and animal foods) #

(1) In cases prescribed by Prime Ministerial Decree, such as where the government of an exporting country requests permission for the importation of livestock products or animal foods, or where it is deemed necessary to conduct a reassessment of the sanitary control of the exporting country in light of changes in the international standards of the Codex Alimentarius Commission and similar causes, the Minister of Food and Drug Safety may conduct an import sanitation assessment of the actual sanitation control status of livestock products or animal foods of the exporting country for each item of livestock products or animal foods; provided, an import sanitation assessment shall be conducted of livestock products that are designated as objects subject to quarantine under Article 31 of the Act on the Prevention of Contagious Animal Diseases, if the Minister of Agriculture, Food and Rural Affairs decides to analyze importation risks pursuant to Article 32(5) of that Act. <Amended on Dec. 11, 2018; Jun. 13, 2023>

(2) The Minister of Food and Drug Safety may determine and publicly notify the import sanitation requirements for livestock product or animal product by respective exporting country or region, according to the results of import sanitation assessment conducted under paragraph (1); provided, in the case of animal products that are manufactured and processed using livestock products from the country or region where the import sanitation requirements for livestock products have already been publicly notified as raw materials, the import sanitation requirements for the relevant animal products may be publicly notified without performing an import sanitation assessment under paragraph (1). <Amended on Jun. 13, 2023>

(3) A person who intends to import livestock products or animal products shall import them from the countries or regions for which the Minister of Food and Drug Safety has determined and publicly notified the import sanitation requirements for the relevant imported food, etc.; provided, in the case of livestock products which are designated as objects subject to quarantine under Article 31 of the Act on the Prevention of Contagious Animal Diseases, the importation of such livestock products shall be limited to the countries or regions from which importation is permitted by the Minister of Agriculture, Food and Rural Affairs. <Amended on Jun. 13, 2023>

(4) The Minister of Food and Drug Safety may conduct an on-site inspection of a foreign food facility or foreign establishment in order to examine and verify its compliance with the import sanitation requirements for livestock products or animal products publicly notified pursuant to paragraph (2). <Amended on Jun. 13, 2023>

(5) Any person who files an import declaration of livestock products or animal products shall attach a health certificate for export issued by the government of an exporting country according to the form, etc. on which the government of an exporting country has consulted with the Minister of Food and Drug Safety. <Amended on Jun. 13, 2023>

(6) The procedures, methods, etc. necessary for paragraphs (1) through (5) shall be prescribed by Prime Ministerial Decree.

[Title Amended on Jun. 13, 2023]

Article 13(Revocation of registration of foreign establishments) #

(1) Where a foreign establishment registered under Article 12 falls under any of the following subparagraphs, the Minister of Food and Drug Safety may request the government of an exporting country to make corrections, or may take other necessary measures, such as suspension of importation of livestock products or revocation of registration of relevant foreign establishment; provided, where the foreign establishment falls under subparagraph 1, the Minister shall revoke its registration: <Amended on Apr. 23, 2019; Aug. 17, 2021; Aug. 16, 2023>

1. Where the foreign establishment has its 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 fraud;

3. Where an on-site inspection provided in Article 12(2) (including a remote inspection referred to in Article 9-2; hereafter in this paragraph the same shall apply) is refused, interfered with, or evaded (including where no answer is made without good cause);

3-2. Where the foreign establishment is deemed inappropriate as a result of an on-site inspection under Article 12(2);

4. Where the foreign establishment has seriously violated the import sanitation requirements, 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 where the Minister of Food and Drug Safety deems that such livestock product is likely to be hazardous;

6. Where it is deemed necessary to take measures following deliberations by the Livestock Products Sanitation Deliberative Committee under Article 3-2 of the Livestock Products Sanitary Control Act.

(2) The Minister of Food and Drug Safety may revoke the suspension of importation of livestock products whose importation is suspended because they fall under paragraph (1)3, according to the results of on-site inspections, etc. of the relevant foreign establishment. <Added on Aug. 16, 2023>

(3) If the government of an exporting country or a person who establishes and operates a foreign establishment examines the affected foreign establishment to identify the cause of the suspension of importation or of the revocation of registration under paragraph (1) (excluding a foreign establishment of which eligibility to export its products is suspended as it falls under paragraph (1)3) and implements corrective and preventive measures, and the government of the exporting country submits the results thereof, and if such measures are deemed appropriate based on the examination of the results, the Minister of Food and Drug Safety may cancel the measures to suspend importation, or allow the foreign establishment to be registered again. In such cases, if deemed necessary, he or she may conduct an on-site inspection of the foreign establishment. <Amended on Aug. 16, 2023>

(4) Where the Minister of Food and Drug Safety takes measures to suspend the importation of livestock products pursuant to paragraph (1) or cancels the suspension of importation pursuant to paragraph (2) or (3), the Minister of Food and Drug Safety may disclose the information on the relevant foreign establishment. <Added on Dec. 3, 2019; Aug. 16, 2023>

(5) Where the registration of a foreign establishment is revoked pursuant to paragraph (1)1 or 2, the person who establishes and operates such foreign establishment shall not apply for registration pursuant to Article 12(1) until two years from the date on which the registration is revoked. <Added on Aug. 8, 2023; Aug. 16, 2023>

(6) Detailed procedures, methods, etc. regarding the suspension of importation of livestock products or the revocation of registration of a foreign establishment under paragraph (1), the cancellation of suspension of importation or the re-registration of a foreign establishment under paragraph (2) or (3), disclosure of information under paragraph (4), and other relevant matters shall be prescribed by Prime Ministerial Decree. <Amended on Dec. 3, 2019; Aug. 8, 2023; Aug. 16, 2023>

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 that 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>

(5) No business entity ordered to suspend its business under Article 29(1) of this Act or Article 16(1) of the Act on Labeling and Advertising of Foods shall file a report of the closure of its business pursuant to paragraph (3) during the period of suspension of business. <Amended on Mar. 13, 2018>

(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 or raw materials for foreign exchange earnings (referring to raw materials imported under the condition of export following manufacturing, processing, etc.; hereinafter the same shall apply), it shall be deemed to have obtained registration pursuant to paragraph (1). <Amended on Feb. 6, 2024>

(7) Where a business entity falls under any of the following subparagraphs, it shall not register its business under paragraph (1): <Amended on Mar. 13, 2018; Jun. 13, 2023>

1. Where the business facility concerned fails to meet the facility standards provided for in Article 14(1);

2. Where a business entity intends to conduct the same type of business at the same location before six months have elapsed after its business registration was revoked pursuant to Article 29(1) or (3), or Article 16(1) or (2) of the Act on Labeling and Advertising of Foods; provided, this shall not apply where the business registration is revoked because the whole business facility is demolished;

3. 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 five years have passed since such revocation, in violation of Article 4 through 6, and 8 of the Food Sanitation Act, Article 23 of the Health Functional Foods Act, or Article 33(1) of the Livestock Products Sanitary Control Act;

4. Where the same person (in the case of a corporation, including the representative thereof) intends to conduct the same type of business before two years have elapsed after its business registration was revoked pursuant to Article 29(1) or (3), or Article 16(1) or (2) of the Act on Labeling and Advertising of Foods; provided, this shall not apply to the cases specified in 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) Details regarding procedures, methods, etc. for registration of business and modification registration under paragraph (1) shall be prescribed by Prime Ministerial Decree.

Article 20(Import declaration) #

(1) A business entity who intends to import (including import declaration as agent) food, etc. for the purpose of sale or for the purpose of using them for business shall file an import declaration of the relevant imported food, etc. with the Minister of Food and Drug Safety, as prescribed by Prime Ministerial Decree; provided, this shall not apply to the cases prescribed by Prime Ministerial Decree, such as where there is little or no concern about sanitation hazards. <Amended on Jun. 13, 2023>

(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: <Amended on Feb. 6, 2024>

1. Filing an import declaration by fraud or other improper means;

2. Using or selling imported food, etc. for purposes other than those declared under paragraph (1); provided, this shall not apply where a business entity who is deemed to have filed for registration of his or her business pursuant to Article 15(6) has obtained approval for modification of the purpose of use, as prescribed by Prime Ministerial Decree, after filing an import declaration as raw materials for manufacturing his or her own products or raw materials for foreign exchange earnings;

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);

5. Filing an import declaration of imported food, etc. violating standards and specifications under Article 7 of the Food Sanitation Act, Article 14 of the Health Functional Foods Act, and Article 4 of the Livestock Products Sanitary Control Act.

(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"): <Added on Dec. 11, 2018>

1. Where there is a concern of it being used as a means of terrorism;

2. Where it has been contaminated or is likely to have been contaminated by pathogens of infectious diseases defined in subparagraph 1 of Article 2 of the Infectious Disease Control and Prevention Act;

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. have caused, or are likely 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, 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: <Added on Dec. 11, 2018>

1. Foods, etc.: The Food Sanitation Deliberation Committee established under Article 57 of the Food Sanitation Act;

2. Health functional foods: The Health Functional Foods Deliberation Committee established under Article 27 of the Health Functional Foods Act;

3. Livestock products: The Livestock Product Sanitation Deliberative Committee established under Article 3-2 of the Livestock Products Sanitary Control Act.

(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. have 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. <Added 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. <Added 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. <Added on Dec. 11, 2018>

(9) Where a business entity files an import declaration of imported food, etc. by OEM pursuant to paragraph (1), it shall report a statement of reasons for the use-by 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 Prime Ministerial Decree among the reported matters. <Amended on Dec. 11, 2018; Aug. 17, 2021>

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 Prime Ministerial Decree.

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 in this Article the same shall apply) 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 identification verifying 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 29(Revocation of registration) #

(1) If a business entity falls under any of the following subparagraphs, the Minister of Food and Drug Safety may revoke its business registration or order it to suspend its business for a specified period not exceeding six months, as prescribed by Presidential Decree: <Amended on Mar. 13, 2018; Dec. 11, 2018; Jun. 10, 2022>

1. Where the business entity violates Article 14;

2. Where the business entity violates the latter part of Article 15(1) or paragraph (3) of that Article;

3. Where the business entity falls under Article 15(7)5;

4. Where the business entity violates Article 18(1);

5. Where the business entity violates Article 20(1), (2), or (9);

6. Where the business entity fails to register traceability under the proviso of Article 23(1);

6-2. Where the business entity refuses, interferes with, or evades the access, inspection, collection, etc. under Article 25(1);

7. Where the business entity violates an order under Article 27 or 28;

8. Where the business entity violates Article 4 through 6, 7(4), 8, 9(4), 12-2(2), or 17(4) of the Food Sanitation Act;

9. Where the business entity violates Article 23 or 24(1) and (2) of the Health Functional Foods Act;

10. Where the business entity violates Article 4(5) and (6), 5(2), or 33(1) of the Livestock Products Sanitary Control Act.

11. Where the business entity fails to takes measures for recall or to report a plan for recall under Article 45(1) of the Food Sanitation Act (including cases applied mutatis mutandis pursuant to Article 38(1)7 of the Health Functional Foods Act), or fails to take measures for recall or destruction or to report a plan for recall or destruction under Article 31-2 of the Livestock Products Sanitary Control Act, or reports such plans by fraud;

12. Where the business entity refuses, interferes with, or evades seizure or destruction under Article 72(1) of the Food Sanitation Act, Article 30(1) of the Health Functional Foods Act, or Article 36(1) of the Livestock Products Sanitary Control Act;

13. Where the business entity violates an order issued under Article 72(1) and (3) of the Food Sanitation Act, Article 30(1) and (3) of the Health Functional Foods Act, or Article 36(1) and (2) of the Livestock Products Sanitary Control Act.

(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 Prime Ministerial Decree in consideration of the type and degree of violations.

Article 33(Imposition of penalty surcharges in lieu of suspension of business) #

(1) Where a business entity falls under any subparagraph of Article 29(1), the Minister of Food and Drug Safety may impose a penalty surcharge not exceeding one billion won in lieu of the disposition to suspend business, as prescribed by Presidential Decree; provided, this shall not apply to cases prescribed by Prime Ministerial Decree, which fall under Article 29(1), in violation of Article 15 and 18 of this Act, Article 4 through 7 or Article 12-2 of the Food Sanitation Act, Article 23 or 24 of the Health Functional Foods Act, or Article 4(5) and (6) or Article 33(1) of the Livestock Products Sanitary Control Act. <Amended on Mar. 13, 2018; Aug. 17, 2021>

(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;

2. The purpose of use;

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, 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 therewith unless there is good cause: <Added on Dec. 11, 2018>

1. Certified copy of registered building ledger under Article 38 of the Building Act: The Minister of Land, Infrastructure and Transport;

2. Certified copy of land cadastre under Article 71 of the Act on the Establishment and Management of Spatial Data: The Minister of Land, Infrastructure and Transport;

3. Certified copy of car registered book under Article 7 of the Motor Vehicle Management Act: A Mayor/Do Governor.

Article 34(Imposition of penalty surcharges due to sale of hazardous imported food) #

(1) The Minister of Food and Drug Safety may impose a penalty surcharge on any of the following persons of up to twice the amount of the imported food, etc. he or she sold, in cases of violations of Articles 4 through 6 or 8 of the Food Sanitation Act, Article 23 or 24 of the Health Functional Food Act, or Article 33(1) of the Livestock Products Sanitary Control Act, with regard to the prohibition on the sale, etc. of harmful imported food, etc.: <Amended on Mar. 13, 2018; Dec. 11, 2018; Jan. 2, 2024>

1. A person on whom the suspension of business for at least two months is imposed, or the registration of whose business is revoked pursuant to Article 29, for a violation of subparagraph 2,3,5 or 6 of Article 4 of the Food Sanitation Act, subparagraph 2,3 or 6 of Article 23 or Article 24(2)3 of the Health Functional Foods Act or Article 33(1)2,3,5 or 9 of the Livestock Products Sanitary Management Act;

2. A person, the registration of whose business is revoked pursuant to Article 29, for a violation of Article 5,6, or 8 of the Food Sanitation Act.

(2) The Minister of Food and Drug Safety shall take into account each of the following matters when imposing a penalty surcharge pursuant to paragraph (1): <Added on Jan. 2, 2024>

1. The details and degree of an offense;

2. The duration and frequency of an offense.

3. Size of profits derived from the violation.

(3) The calculated amount of a penalty surcharge under paragraphs (1) and (2) shall be determined as prescribed by Presidential Decree. <Amended on Jan. 2, 2024>

(4) 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. <Amended on Jan. 2, 2024>

(5) 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; Jan. 2, 2024>

SPECIAL ACT ON IMPORTED FOOD SAFETY CONTROL

Article 1(Purpose) #

Article 2(Definitions) #

Article 3(Responsibilities) #

Article 4(Relationship to other statutes) #

Article 5(Registration of foreign food facilities) #

Article 5-2(Revocation of registration of foreign food facilities) #

Article 6(On-site inspection of foreign food facilities) #

Article 6-2(Food safety management certification of foreign food facilities) #

Article 7(Registration as good importers) #

Article 8 #

Article 9(Entrustment of on-site inspection) #

Article 9-2(Remote inspection of foreign food facilities) #

Article 10(Designation of institution for safety audit of imported food) #

Article 10-2(Import sanitation assessment of food subject to special sanitation control) #

Article 11(Import sanitation assessment of livestock products and animal foods) #

Article 12(Registration of foreign establishments) #

Article 13(Revocation of registration of foreign establishments) #

Article 14(Types of business and facility standards) #

Article 15(Registration of business) #

Article 16(Succession of business) #

Article 17(Sanitation education) #

Article 18(Matters to be observed by business entities) #

Article 19(Control of business entities by classification) #

Article 20(Import declaration) #

Article 20-2(Automation of acceptance of import declarations) #

Article 21(Import inspections) #

Article 22(Inspection orders) #

Article 23(Traceability of imported food) #

Article 24(Formulation and execution of distribution management plan) #

Article 25(Access, inspections, and collection) #

Article 25-2(Posting information on hazards of directly purchased imported food) #

Article 25-3(Designation and revocation of designation of raw materials and ingredients that should be banned from importation into the Republic of Korea) #

Article 25-4(Inspection of directly purchased imported foods and provision of information to related agencies) #

Article 25-5(Fact-finding surveys on directly purchased imported foods) #

Article 25-6(Support for autonomous management of imported food) #

Article 26(Order to take training course) #

Article 27(Corrective orders) #

Article 28(Orders to improve facilities) #

Article 29(Revocation of registration) #

Article 30(Succession of effect of administrative disposition) #

Article 31(Measures for closure) #

Article 32(Hearings) #

Article 33(Imposition of penalty surcharges in lieu of suspension of business) #

Article 34(Imposition of penalty surcharges due to sale of hazardous imported food) #

Article 35(Publication of violations) #

Article 36(Government subsidies) #

Article 36-2(Payment of monetary awards) #

Article 37(International cooperation) #

Article 38(Support for safety of food for export) #

Article 39(Collection of safety information on imported food) #

Article 39-2(Establishment and operation of imported food integrated information system) #

Article 40(Delegation and entrustment of authority) #

Article 41(Fees) #

Article 42(Penalty provisions) #

Article 43(Penalty provisions) #

Article 44(Legal fiction as public officials for purposes of applying penalty provisions) #

Article 45(Joint penalty provisions) #

Article 46(Administrative fines) #

Article 47(Special cases concerning application of administrative fines) #