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ENFORCEMENT DECREE OF THE SPECIAL ACT ON IMPORTED FOOD SAFETY CONTROL

Presidential Decree No. 26936, Jan. 22, 2016

Amended by Presidential Decree No. 29763, May 14, 2019

Presidential Decree No. 31110, Oct. 8, 2020

Presidential Decree No. 31672, May 4, 2021

 Article 1 (Purpose)
The purpose of this Decree is to provide for matters mandated by the Special Act on Imported Food Safety Control and those necessary for the enforcement thereof.
 Article 1-2 (Entrustment of Affairs Regarding Certification of HACCP-certified foreign facilities for imported food)
The Minister of Food and Drug Safety shall entrust the following affairs 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 pursuant to Article 6-2 (6) of the Special Act on Imported Food Safety Control (hereinafter referred to as the "Act"):
1. Analysis of harmful elements for each process or item of HACCP-certified foreign facilities for imported food under the former part of Article 6-2 (1) of the Act (hereinafter referred to as "HACCP-certified foreign facility for imported food");
2. Certification, certification for modification, and extension of the period of validity of certification or of certification for modification as a HACCP-certified foreign facility for imported food under Article 6-2 (1) through (3) of the Act;
3. Investigation and audit of, among other things, compliance with HACCP under the main clause of Article 6-2 (5) of the Act (referring to hazard analysis and critical control points (HACCP) under Article 48 (1) of the Food Sanitation Act).
[This Article Newly Inserted on May 4, 2021]
[Previous Article 1-2 moved to Article 1-3 <May 4, 2021>]
 Article 1-3 (Foods Subject to Special Sanitation Control)
(1) “Food items prescribed by Presidential Decree" in Article 10-2 (1) of the Act means the following food items: <Amended on May 4, 2021>
1. Heads of fish;
2. Intestines of fish and molluscs.
(2) The detailed scope of food items falling under the subparagraphs of paragraph (1) shall be determined and publicly notified by the Minister of Food and Drug Safety.
[This Article Newly Inserted on May 14, 2019]
[Moved from Article 1-2 <May 4, 2021>]
 Article 2 (Types and Scope of Business)
Types of business under the subparagraphs of Article 14 (1) of the Act and the scope thereof shall be as specified in the following classification: <Amended on May 14, 2019>
1. Business of importing and selling imported food, etc.: Business of importing food and selling imported food, etc.: Provided, That the foregoing shall not apply to the import of a machine used for collecting, manufacturing, or processing food, etc. referred to in subparagraph 1 of Article 2 of the Act;
2. Business of filing import declarations of imported food, etc. by proxy: Business of filing import declarations required under Article 20 (1) of the Act on behalf of and for importers and distributors of imported food, etc. under subparagraph 1 (including business entities deemed registered pursuant to Article 15 (6) of the Act);
3. Business of purchasing imported food, etc. through the Internet by proxy: Business of importing food, etc. after purchasing food, etc. from a cyber-mall (referring to a virtual store in which goods, etc. can be traded using computers, etc. and information and communications facilities), etc. of an overseas seller on behalf of and at the request of domestic consumers;
4. Business of storing imported food, etc.: Business of storing imported food, etc. subject to import declaration under Article 20 (1) of the Act in a facility or place prescribed by Ordinance of the Prime Minister.
 Article 3 (Matters Subject to Modified Registration)
"Important matter prescribed by Presidential Decree" in the latter part of Article 15 (1) of the Act means the location of a place of business.
 Article 4 (Business Entities Deemed to Have Obtained Registration of Business)
"Business entity prescribed by Presidential Decree" in Article 15 (6) of the Act means any of the following business entities:
1. A business entity engaged in the business of manufacturing and processing foods under subparagraph 1 of Article 21 of the Enforcement Decree of the Food Sanitation Act, the business of manufacturing food additives under subparagraph 3 of the aforesaid Article, distribution-specialized sales business under subparagraph 5 (b) (iii)) of the aforesaid Article, or the business of manufacturing containers or packages under subparagraph 7 of the aforesaid Article;
2. A business entity engaged in health functional food manufacturing business under subparagraph 1 of Article 2 of the Enforcement Decree of the Health Functional Foods Act, or health functional food distribution-specialized sales business under subparagraph 3 (b) of the aforesaid Article;
3. A business entity engaged in the business of processing livestock products under subparagraph 3 of Article 21 of the Enforcement Decree of the Livestock Products Sanitary Control Act, meat packaging business under subparagraph 4 of the aforesaid Article, or livestock products distribution-specialized sales business under subparagraph 7 (e) of the aforesaid Article.
 Article 5 (Head of Agency under Jurisdiction)
"Head of an agency under his or her jurisdiction as prescribed by Presidential Decree" in Article 25 (1) of the Act means the commissioner of each regional office of Food and Drug Safety.
 Article 6 (Procedures for Administrative Support)
(1) When the Minister of Food and Drug Safety (including the commissioner of each regional office of Food and Drug Safety; hereinafter the same shall apply in this Article) requests, in accordance with Article 25 (2) of the Act, the head of a relevant administrative agency, the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, a Special Self-Governing Province Governor, or the head of a Si/Gun/Gu (the head of a Gu refers to the head of an autonomous Gu) to provide administrative support, he or she shall formulate a plan regarding areas which need support, details of affairs to be conducted, the formation and operation of a sanitary inspection team, and notify him or her of such plan.
(2) Public officials who perform administrative support services pursuant to paragraph (1) shall provide such support under the direction and supervision of the Minister of Food and Drug Safety.
(3) Expenses incurred in providing administrative support pursuant to paragraph (1) shall be borne by the Minister of Food and Drug Safety.
 Article 7 (Revocation of Registration)
(1) Where the Minister of Food and Drug Safety revokes the registration of business or issues an order to suspend business pursuant to Article 29 (1) of the Act, he or she shall render such disposition in writing, specifying reasons for such disposition, details of such disposition, etc.
(2) Where the Minister of Food and Drug Safety holds a hearing under subparagraph 2 of Article 32 of the Act or receives a statement of opinion under Article 27 of the Administrative Procedures Act to render a disposition under paragraph (1), he or she shall render a disposition within 14 days from the date he or she completes the procedures for granting the disposition unless there is a compelling reason not to do so.
 Article 8 (Exceptions to Procedures for Taking Measures for Closure)
"Urgent reasons prescribed by Presidential Decree" in the proviso to Article 31 (3) of the Act means any of the following cases:
1. Where a business entity continues its business, in violation of subparagraphs 1 through 4 of Article 4 of the Food Sanitation Act, subparagraphs 1 through 4 of Article 23 of the Health Functional Foods Act, or Article 33 (1) 1 through 4 of the Livestock Products Sanitary Control Act;
2. Where a significant hazard to public health, such as zoonosis or foodborne illness, is likely to occur if a business entity continues its business at the place of business, subject to any of the measures taken under Article 31 (1) of the Act.
 Article 9 (Criteria for Calculation of Penalty Surcharges Imposed in Lieu of Disposition for Suspension of Business)
The criteria for calculation of penalty surcharges imposed pursuant to the main sentence of Article 33 (1) of the Act shall be as specified in attached Table 1.
 Article 10 (Procedures for Imposition and Payment of Penalty Surcharges)
(1) Where the Minister of Food and Drug Safety intends to impose a penalty surcharge pursuant to the main sentence of Article 33 (1) of the Act, he or she shall give written notice of the payment of the penalty surcharge, specifying the type of violation, the amount of the relevant penalty surcharge, etc.
(2) A person who receives notice pursuant to paragraph (1) shall pay a penalty surcharge to a collecting agency designated by the Minister of Food and Drug Safety within 20 days from the date he or she receives the notice: Provided, That where he or she is unable to pay the penalty surcharge within that period due to a natural disaster or any other unavoidable cause, he or she shall pay the penalty surcharge within seven days from the date such cause ceases to exist.
(3) A collecting agency that has received a penalty surcharge pursuant to paragraph (2) shall issue a receipt to the payer and notify the Minister of Food and Drug Safety of the receipt of the penalty surcharge without delay.
 Article 11 (Persons Subject to Revocation of Imposition of Penalty Surcharges and Other Relevant Matters)
A person on whom the imposition of a penalty surcharge should be revoked and who should be ordered to suspend his or her business in accordance with the main sentence of Article 33 (4) of the Act, or from whom a penalty surcharge should be collected in the same manner as delinquent national taxes are collected, shall be a person who fails to pay the penalty surcharge within the deadline for payment and fails to pay such penalty surcharge within 15 days from the date he or she has been urged to pay it once.
 Article 12 (Criteria for Calculation of Penalty Surcharges Due to Sale of Hazardous Imported Food and Other Relevant Matters)
(1) The amount of a penalty surcharge imposed pursuant to Article 34 (1) of the Act shall be the amount calculated by multiplying the sales volume of the relevant imported food, etc. sold by a person who falls under any of the subparagraphs of the aforesaid paragraph by the selling price.
(2) A sales volume under paragraph (1) shall be the quantity calculated by subtracting the quantity of recalled imported food, etc. and the quantity of imported food, etc. actually not sold for reasons of the return, inspection, etc., of imported food, etc. from the quantity of the relevant imported food, etc. shipped from the point in time of the first sale to the point in time of the disclosure of the sale of hazardous imported food, etc.
(3) Where the price fluctuates during the sales period, the selling price under paragraph (1) shall be the price by period of sales.
(4) Article 10 shall apply mutatis mutandis to procedures for imposition and payment of penalty surcharges provided for in Article 34 (1) of the Act.
 Article 13 (Official Announcement of Violations)
An official announcement required under Article 35 of the Act shall be made by means of posting the following matters on the Internet web site of the Ministry of Food and Drug Safety or in a general daily newspaper distributed nationwide, registered pursuant to Article 9 (1) of the Act on the Promotion of Newspapers, Etc.:
1. Headline indicating the official announcement of an act violating the Special Act on Imported Food Safety Control;
2. Type of business;
3. Name and location of the place of business and the name of the representative;
4. Name of imported food, etc. (in the case of meat among livestock products, referring to a kind and cut of meat);
5. Date of manufacture, date of import, or shelf life;
6. Details of a violation (including the particular details of a violation and relevant statutes or regulations);
7. Details of an administrative disposition, the date and period of the administrative disposition;
8. Regulatory agency and the date a violation is uncovered.
 Article 14 (Delegation or Entrustment of Authority)
(1) The Minister of Food and Drug Safety shall delegate the following authority to the commissioner of each regional office of Food and Drug Safety pursuant to Article 40 (1) of the Act: <Amended on May 14, 2019>
1. Registration of business and registration of modification thereof under Article 15 (1) of the Act;
2. Receipt of reports of the closure of business and reports of modification thereof under Article 15 (3) of the Act;
3. Provision of information on the cancellation of registered matters by official authority and whether a business entity has closed its business under Article 15 (4) of the Act;
4. Acceptance of reports of the succession to the status under Article 16 (3) of the Act;
4-2. Matters prescribed by Ordinance of the Prime Minister, among those regarding the control of business entities by classification under Article 19 (1) of the Act;
5. Acceptance of import declarations under Article 20 (1) of the Act and receipt of reporting on statements of reasons for setting the expiration date and reporting on modification thereof under paragraph (9) of the aforesaid Article;
6. Inspections conducted under Article 21 (1) and (2) of the Act;
7. Registration of traceability of imported food, etc., issuance of dispositions including the revocation of registration, and inspection and assessment under Article 23 of the Act;
8. Orders to undergo education under Article 26 (1) of the Act;
9. Corrective orders issued under Article 27 of the Act;
10. Orders to improve facilities under Article 28 (1) of the Act;
11. Revocation of the registration of business and issuance of an order to suspend business under Article 29 of the Act;
12. Measures for closure of a place of business, removal of a seal, and removal of a notice, etc. under Article 31 (1) and (2) of the Act;
13. Hearings under subparagraph 2 of Article 32 of the Act;
14. Imposition and collection of penalty surcharges under Articles 33 and 34 of the Act;
15. Issuance of health certificates, etc. under Article 38 (2) of the Act (excluding the issuance of certificates regarding recognition under Article 15 (2) of the Health Functional Foods Act);
16. Imposition and collection of administrative fines under Article 46 (1) and (2) of the Act.
(2) Pursuant to Article 40 (2) of the Act, the Minister of Food and Drug Safety shall entrust the following affairs to the National Food Safety Information Service under Article 67 (1) of the Food Sanitation Act: <Amended on Oct. 8, 2020>
1. The following affairs among affairs relating to traceability of imported food, etc. under Article 23 of the Act:
(a) Establishment and operation of an information system for the traceability of imported food, etc.;
(b) Education and public relations regarding traceability of imported food, etc.;
2. Operation of an integrated information system for imported food under Article 39-2 (1) of the Act.
 Article 15 (Management of Personally Identifiable Information)
Where it is unavoidable for performing the following affairs, the Minister of Food and Drug Safety (including a person to whom his or her authority is delegated pursuant to Article 14 (1)) may manage data, including resident registration numbers under subparagraph 1 of Article 19 of the Enforcement Decree of the Personal Information Protection Act or alien registration numbers under subparagraph 4 of the aforesaid Article:
1. Affairs regarding designation, etc. of an Institution for Safety Audit of Imported Food under Article 10 of the Act;
2. Affairs regarding registration, etc. of business under Article 15 of the Act;
3. Affairs regarding succession to business under Article 16 of the Act.
4. Affairs regarding import declaration, etc. under Article 20 of the Act;
5. Affairs regarding inspection of imported goods, etc. under Article 21 of the Act;
6. Affairs regarding access, inspection, collection, etc. under Article 25 of the Act.
 Article 16 (Criteria for Imposition of Administrative Fines)
The criteria for imposition of administrative fines provided for in Article 46 (1) and (2) of the Act shall be as specified in attached Table 2.
ADDENDA <Presidential Decree No. 26936, Jan. 22, 2016>
Article 1 (Enforcement Date)
This Decree shall enter into force on February. 4, 2016.
Article 2 (Transitional Measures concerning Registration of Business)
A person who conducts the business of filing import declarations of imported food, etc. by proxy under subparagraph 2 of Article 2, the business of purchasing imported food, etc. through the Internet by proxy under subparagraph 3 of the aforesaid Article, or the business of storing imported food, etc. under subparagraph 4 of the aforesaid Article, as at the time this Decree enters into force, may conduct the relevant business without the registration thereof required under Article 15 (1) of the Act for six months after this Decree enters into force.
Article 3 Omitted.
Article 4 (Relationship to Other Statutes or Regulations)
Where the previous Enforcement Decree of the Food Sanitation Act, the previous Enforcement Decree of the Health Functional Foods Act, the previous Enforcement Decree of the Livestock Products Sanitary Control Act, or any provision thereof is cited by other statutes or regulations, as at the time this Decree enters into force, and this Decree contains any provision corresponding thereto, this Decree or the corresponding provision of this Decree shall be deemed cited in lieu of the previous Enforcement Decree of the Food Sanitation Act, the previous Enforcement Decree of the Health Functional Foods Act, the previous Enforcement Decree of the Livestock Products Sanitary Control Act, or the provision thereof.
ADDENDUM <Presidential Decree No. 29763, May 14, 2019>
This Decree shall enter into force on the date of its promulgation: Provided, That the amended provisions of Articles 1-2 and 2 and attached Table 2 shall enter into force on June 12, 2019.
ADDENDUM <Presidential Decree No. 31110, Oct. 8, 2020>
This Decree shall enter into force on October 8, 2020.
ADDENDUM <Presidential Decree No. 31672, May 4, 2021>
This Decree shall enter into force on July 1, 2021.