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ENFORCEMENT DECREE OF THE FRAMEWORK ACT ON FOOD SAFETY

Presidential Decree No. 21158, Dec. 9, 2008

Amended by Presidential Decree No. 22003, Jan. 27, 2010

Presidential Decree No. 22497, Nov. 19, 2010

Presidential Decree No. 22715, Mar. 22, 2011

Presidential Decree No. 23807, May 23, 2012

Presidential Decree No. 23964, Jul. 20, 2012

Presidential Decree No. 24195, Nov. 23, 2012

Presidential Decree No. 24454, Mar. 23, 2013

Presidential Decree No. 25133, Jan. 28, 2014

Presidential Decree No. 25792, Nov. 28, 2014

Presidential Decree No. 26936, Jan. 22, 2016

Presidential Decree No. 27443, Aug. 9, 2016

Presidential Decree No. 28008, May 2, 2017

Presidential Decree No. 28211, Jul. 26, 2017

 Article 1 (Purpose)
The purpose of this Decree is to prescribe matters delegated by the Framework Act on Food Safety and those necessary for the enforcement thereof.
 Article 2 (Scope of Business Entities)
“Matters related to food, prescribed by Presidential Decree” in subparagraph 2 (j) of Article 2 of the Framework Act on Food Safety (hereinafter referred to as the “Act”) shall be as follows: <Amended by Presidential Decree No. 22715, Mar. 22, 2011; Presidential Decree No. 24195, Nov. 23, 2012>
1. Health functional food as defined in the Health Functional Foods Act;
2. Drinking spring water, etc. as defined in the Drinking Water Management Act;
3. Drinking deep see water as defined in the Development and Management of Deep Sea Water Act;
4. Sun-dried salt as defined in the Salt Industry Promotion Act (excluding such salts prescribed as food under Article 7 (1) of the Food Sanitation Act);
5. Ginseng varieties as defined in the Ginseng Business Act;
6. Grain as defined in the Grain Management Act.
 Article 3 (Formulation of Food Safety Control Plans)
The head of each relevant central administrative agency in charge of the matters falling under subparagraph 2 of Article 2 (hereinafter referred to as “food, etc.”) shall formulate a safety control plan on food, etc. under his/her control under Article 6 (1) of the Act and submit such plan to the Prime Minister by no later than June 30 of the year before the year in which a basic plan for food safety control defined in Article 6 (2) of the Act (hereinafter referred to as “basic plan”) is executed.
 Article 4 (Formulation of Implementation Plans)
(1) The head of each Si/Gun/Gu (referring to the head of an autonomous Gu; hereinafter the same shall apply) shall formulate an implementation plan for food safety management (hereinafter referred to as “implementation plan”) under Article 6 (4) of the Act and submit such plan to the Special Metropolitan City Mayor, a Metropolitan City Mayor, or a Do Governor, as is competent, by no later than November 30 of the year before the year in which the implementation plan is executed; the Special Metropolitan City Mayor and each Metropolitan City Mayor and Do Governor shall incorporate the implementation plans of Sis/Guns/Gus (referring to autonomous Gus; hereinafter the same shall apply) under his/her jurisdiction and the relevant Special Metropolitan City, Metropolitan City, or Do, and submit them to the heads of relevant central administrative agencies by no later than December 31 of the year before the year in which the implementation plans are executed.
(2) The Special Self-Governing Province Governor shall formulate an implementation plan and submit such plan to the head of a relevant central administrative agency by no later than December 31 of the year before the year in which the implementation plan is executed.
(3) The head of each relevant central administrative agency shall incorporate the implementation plans submitted under paragraphs (1) and (2), by the Special Metropolitan City, Metropolitan Cities, Dos, and the Special Self-Governing Province (hereinafter referred to as “Cities/Dos) as well as Sis/Guns/Gus, and submit them to the Prime Minister by no later than the end of February in the year of execution of the implementation plans.
(4) If the head of the relevant central administrative agency, the Special Metropolitan City Mayor, Metropolitan City Mayor, Do Governor and the Special Self-Governing Province Governor (hereinafter referred to as “Mayor/Do Governor), and the head of each Si/Gun/Gu, formulates an implementation plan under paragraphs (1) through (3), he/she shall reflect the results of performance evaluation notified under Article 5 (4), therein.
 Article 5 (Submission, etc. of Performance Reports)
(1) The head of each Si/Gun/Gu shall submit the report on the performance of an implementation plan formulated under Article 4 (1), to the Special Metropolitan City Mayor, a Metropolitan City Mayor, or a Do Governor, whoever is competent, by no later than January 15 of the following year; the Special Metropolitan City Mayor and each Metropolitan City Mayor and Do Governor shall incorporate the reports on the performance of implantation plans of Sis/Guns/Gus under his/her jurisdiction and the relevant Special Metropolitan City, Metropolitan City, or Do; and submit them to the heads of relevant central administrative agencies, by no later than January 31 of the following year.
(2) The Special Self-Governing Province Governor shall submit a report on the performance of an implementation plan formulated under Article 4 (2), to the head of a relevant central administrative agency, by no later than January 31 of the following year.
(3) The head of each relevant central administrative agency shall incorporate the performance reports of Cities/Dos and Sis/Guns/Gus submitted under paragraphs (1) and (2), and submit them to the Prime Minister by no later than the end of February in the following year.
(4) The Prime Minister shall incorporate the performance reports submitted under paragraph (3), present them for deliberation to the Food Safety Policy Committee established under Article 7 of the Act (hereinafter referred to as the “Committee”), and notify the head of each relevant central administrative agency, Mayor/Do Governor, and the head of each Si/Gun/Gu of the results of the deliberation.
 Article 6 (Organization, etc. of Specialized Committee)
(1) A Specialized Committee under Article 12 of the Act may be established for each relevant field, which shall be comprised of not more than 15 members, including one chairperson.
(2) Members of each Specialized Committee shall be commissioned or appointed by the Chairperson of the Committee, from among public officials belonging to the Senior Executive Service of the relevant central administrative agencies and persons who have abundant knowledge and experience in the food industry.
(3) Members of each Specialized Committee commissioned by the Chairperson of the Committee shall hold office for a term of two years.
(4) The chairperson of each Specialized Committee shall be appointed by the Chairperson of the Committee.
(5) Meetings of each Specialized Committee shall be convened if deemed necessary by its chairperson; a majority of its members shall constitute a quorum, and any decision thereof shall require the concurring vote of at least a majority of those present.
(6) The chairperson of each Specialized Committee shall report the results of the meetings convened to the Chairperson of the Committee.
 Article 7 (Secretary, etc. of Committee)
(1) The Committee shall appoint one secretary and other necessary personnel to handle administrative affairs under Article 13 (3) of the Act.
(2) The secretary shall be appointed by the Chairperson of the Committee, from among public officials in general service belonging to the Senior Executive Service of the Office for Government Policy Coordination. <Amended by Presidential Decree No. 24454, Mar. 23, 2013>
(3) The personnel mentioned in paragraph (1) may be recruited from among public officials dispatched from relevant central administrative agencies or local governments as well as contractual personnel: Provided, That priority may be given to those with substantial knowledge and experience in food safety when recruiting contractual personnel.
(4) The secretary may handle administrative affairs of the Committee by order of the Chairperson and appear before the Committee and state his/her opinions.
 Article 8 (Reimbursement of Expenses)
Members having attended any meeting of the Committee or a Specialized Committee are, within the budget, allowed to be granted allowances and be reimbursed expenses incurred in relation thereto: Provided, That this shall not apply to public officials who are members who have attended any meeting of the Committee or a Specialized Committee in direct relation to his/her official duties.
 Article 9 (Detailed Operating Rules)
Matters necessary for operating the Committee and a Specialized Committee, other than those provided for in this Decree, shall be determined by the Chairperson of the Committee, subject to the resolution of the Committee.
 Article 10 (Scope of Interested Persons)
“Interested persons prescribed by Presidential Decree” in Article 16 (3) of the Act, means any business entity that has suffered or is to suffer disadvantages in business activities due to the prohibition of production, collection, manufacture, processing, import, transportation, storage, cooking, or sale under paragraph (1) of said Article (hereinafter referred to as “production, sale, etc.”), and the counter party to the transaction directly related to the relevant prevention.
 Article 11 (Request for Revocation of Prohibition)
(1) A business entity who has an objection to the prohibition of production, sale, etc. under Article 16 (5) of the Act, shall submit a request for revocation of prohibition of the production, sale, etc. of food, etc. as presented in attached Form 1, to the head of a relevant administrative agency.
(2) Upon receipt of a request for revocation of prohibition of the production, sale, etc. under paragraph (1), the head of a relevant administrative agency shall report such request to the head of the relevant central administrative agency taking control of the food, etc. at issue.
(3) The head of the relevant central administrative agency who has received a report under paragraph (2) shall, without delay, report thereon to the Chairperson of the Committee for Committee’s deliberation.
(4) The head of a relevant central administrative agency shall notify the result of deliberation undertaken under paragraph (3) to the head of the relevant administrative agency, who shall report the revocation or retention of the relevant prohibition of production, sale, etc. to the relevant business entity, following deliberation.
 Article 12 (Food, etc. Subject to Order of Inspection)
Food, etc. subject to an order of inspection by a business entity under Article 17 (1) 3 of the Act shall be such food, etc. as determined likely to pose any hazard to public health, since hazardous substance has been found as a result of hazard evaluation performed under Article 20 of the Act.
 Article 13 (Inspection Period, etc.)
(1) A business entity in receipt of an order of inspection under Article 17 (1) of the Act shall immediately request an inspecting institution designated by the head of a relevant administrative agency to conduct the inspection.
(2) The inspecting institution that has received an inspection request under paragraph (1) shall carry out said inspection in preference to other activities and inform the relevant business entity and the head of the relevant administrative agency of the result of the inspection; it shall preserve the inspection findings for two years from the date of completing the inspection.
 Article 14 (Scope of Business Entities Mandated to Keep Records of and Maintain Sales Procedures)
The business entities who are mandated to keep the record of and maintain procedures for producing, purchasing, and selling food, etc. under Article 18 (4) of the Act, are as follows: <Amended by Presidential Decree No. 22497, Nov. 19, 2010; Presidential Decree No. 25133, Jan. 28, 2014; Presidential Decree No. 26936, Jan. 22, 2016>
1. Any person manufacturing or processing food or manufacturing food additives, as defined in the Food Sanitation Act;
2. Any person manufacturing health functional food, as defined in the Health Functional Foods Act;
3. Any person slaughtering livestock, milking, or making processed meat, dairy products or egg products, as defined in the Livestock Products Sanitary Control Act;
4. Manufactures and importers as defined in the Pesticide Control Act;
5. Manufactures and importers of drugs for animals, as defined in the Pharmaceutical Affairs Act;
6. Importers and sellers of imported food, etc. as defined in the Special Act on Imported Food Safety Control.
 Article 15 (Information Required to Be Recorded and Maintained)
(1) Each business entity listed in Article 14 shall keep records of and maintain the following information:
1. Name of the product;
2. Date of sale or purchase of food, etc.;
3. Date of manufacture or importation of the product, or its expiration or best before date;
4. Names and origins of raw materials for the product (applicable only to such business entities engaged in the business of manufacturing or processing food, etc.);
5. Quantities of food, etc. manufactured, imported, purchased, or sold;
6. Names and contact numbers of customers or purchasers of the product.
(2) Information recorded (including where electronically recorded) in the course of producing, purchasing, or selling food, etc. under paragraph (1), shall be preserved for three years from the date of its last entry.
 Article 16 (Disclosure of Recall Plans)
(1) A business entity mandated to recall food, etc. under Article 19 (1) of the Act shall, without delay, disclose a recall plan on its website (only applicable to business entities having their own websites), the official websites of the relevant central administrative agencies and the relevant administrative agencies, and in either of the following ways: <Amended by Presidential Decree No. 22003, Jan. 27, 2010>
1. Television broadcasting as defined in subparagraph 1 (a) of Article 2 of the Broadcasting Act;
2. Daily newspapers having a nationwide circulation, registered under Article 9 (1) of the Act on the Promotion of Newspapers, Etc.
(2) A recall plan to be disclosed under paragraph (1) shall include the following information:
1. A heading about the proposed recall of the relevant food, etc.;
2. Name of the relevant food, etc. and the title and location of the recalling business entity;
3. Date of manufacture or importation of the food, etc. for recall, or its expiration or best before date;
4. The volume of planned recall;
5. Reason for recall;
6. Strategies for recall;
7. Recall period;
8. Other information necessary for recall.
(3) A business entity who has disclosed a recall plan for food, etc. under paragraph (1) shall disclose the recall status of the relevant food etc. in the ways described in paragraph (1) within two days of the end of the recall period.
 Article 17 (Request for Disclosure of Information, etc.)
(1) If at least 20 consumers file a request for disclosure of information on safety of food, etc. in attached Form 2 under Article 24 (4) of the Act, the head of a relevant administrative agency shall disclose the information if such information on safety of food, etc. is related to the health of an unspecified majority of people.
(2) For a request for disclosure of information filed under paragraph (1), Articles 5, 11 and 17 of the Official Information Disclosure Act shall apply mutatis mutandis in regard to those matters involving the person entitled to request the disclosure of information, method of filing such request, determining whether to disclose the relevant information, and allotment of expenses to be incurred.
 Article 17-2 (Standardization)
The Minister of Food and Drug Safety may set standards for the following matters to build and operate the Integrated Food Safety Information Network under Article 24 (4) of the Act: <Presidential Decree No. 28008, May 2, 2017>
1. Classification system for each business office;
2. Classification system for the items and types of, and raw materials for, manufactured and processed food, etc.;
3. Classification system for agricultural, livestock, and fishery products;
4. Other matters for which standardization is deemed necessary by the Minister of Food and Drug Safety to build and operate the Integrated Food Safety Information Network.
[This Article Newly Inserted by Presidential Decree No. 27443, Aug. 9, 2016]
 Article 17-3 (Scope of Relevant Administrative Agencies, etc.)
(1) The relevant administrative agencies referred to in the latter part of Article 24-2 (2) of the Act (hereafter referred to as “relevant administrative agencies” in this Article and Article 22) shall be as follows. If their authority over safety control of food, etc. is delegated or entrusted to other agencies, such agencies shall be included in the relevant administrative agencies: <Presidential Decree No. 28008, Jun. 26, 2017>
1. The Ministry of Education, the Ministry of Justice, the Ministry of Defense, the Ministry of Interior and Safety, the Ministry of Agriculture, Food and Rural Affairs, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, the Ministry of Environment, the Ministry of Oceans and Fisheries, the Korea Customs Office, and the Defense Acquisition Program Administration;
2. Local governments.
(2) The extent of data on food safety referred to in the latter part of Article 24-2 (2) of the Act shall be as follows:
1. Data on the production, sale, etc. of food, etc.;
2. Data on the access, collection and testing, recall, destruction, administrative dispositions, safety inspections, and hazard evaluations held by the relevant administrative agencies;
3. Other data deemed necessary by the Minister of Food and Drug Safety to build and operate the Integrated Food Safety Information Network described in Article 24-2 (1) of the Act (hereinafter referred to as the “Integrated Food Safety Information Network”).
(3) In order to ensure the efficient operation of the Integrated Food Safety Information Network, the Minister of Food and Drug Safety may organize and operate a council with the relevant administrative agencies.
[This Article Newly Inserted by Presidential Decree No. 27443, Aug. 9, 2016]
 Article 17-4 (Outsourcing of Building and Operation of Integrated Food Safety Information Network)
Pursuant to Article 24-2 (4), the Minister of Food and Drug Safety shall outsource the business affairs concerning building and operating the Integrated Food Safety Information Network to the National Food Safety Information Service prescribed in Article 67 of the Food Sanitation Act.
[This Article Newly Inserted by Presidential Decree No. 28008, May 2, 2017]
 Article 18 (Sharing of Safety Information, etc.)
(1) When a public official, etc. of a relevant central administrative agency or a relevant administrative agency acquires information on the safety of food, etc. by visiting any foreign government, international organization, etc. or by signing, etc. a memorandum of understanding, agreement, etc., therewith, he/she shall inform the relevant central administrative agency or the relevant administrative agency of such information in accordance with Article 26 (2) of the Act, unless he/she has a compelling reason not to do so.
 Article 19 (Support for Facility Investment, etc.)
The heads of relevant administrative agencies may provide funds to finance facility investment, etc. as well as production technology, which are necessary to comply with any of the following standards, etc., in accordance with Article 27 (2) of the Act: <Amended by Presidential Decree No. 22497, Nov. 19, 2010; Presidential Decree No. 23964, Jul. 20, 2012; Presidential Decree No. 25133, Jan. 28, 2014; Presidential Decree No. 25792, Nov. 28, 2014>
1. The food safety management certification standards determined under Article 48 of the Food Sanitation Act;
2. The hazard analysis and critical control points (HACCP) determined under Article 9 of the Livestock Products Sanitary Control Act;
3. The rules for Hazard Analysis and Critical Control Points determined under Article 70 of the Agricultural and Fishery Products Quality Control Act;
4. The standards for intensive control of hazardous elements determined under Article 15 of the Control of Livestock and Fish Feed Act;
5. The Regulations for Good Manufacturing Practice determined under Article 22 of the Health Functional Foods Act;
6. The standards for Good Agricultural Practices determined under Article 6 of the Agricultural and Fishery Products Quality Control Act.
 Article 20 (Request for Testing, Analysis, etc.)
(1) If at least 20 consumers, consumer groups registered under Article 29 of the Framework Act on Consumers, or testing, analysis, and/or research institutions (hereafter referred to as “consumers, etc.” in this Article) request the testing, analysis and extraction of a sample of food, etc. (hereinafter referred to as “testing, analysis, etc.”) under Article 28 (2) of the Act by filing a request for the testing, analysis and extraction of sample of food, etc. as presented in attached Form 3, the head of the relevant administrative agency shall conduct such testing, analysis, etc. without delay. <Amended by Presidential Decree No. 28008, May 2, 2017>
(2) The head of a relevant administrative agency in receipt of a request for testing, analysis, etc. under paragraph (1) shall notify the representative of the consumers, etc. having requested such testing, analysis, etc. of the result thereof. In such cases, the notification shall be made in a manner requested by the relevant consumers, etc. or in writing if no specific manner has separately been determined. <Amended by Presidential Decree No. 28008, May 2, 2017>
(3) The fees charged for testing, analysis, etc. shall be borne by the consumers, etc. who have requested the relevant testing, analysis, etc. according to the following guidelines: <Amended by Presidential Decree No. 28008, May 2, 2017>
1. If any applicable food safety-related statute, etc. separately determines fees for the testing, analysis, etc.: The amount prescribed in such statute, etc.;
2. In any cases other than provided for in subparagraph 1: The amount separately set by the head of the relevant administrative agency, based on the cost of purchasing reagent material, personnel expenses, and other expenses incurred in relation to the testing, analysis, etc.
(4) The fees referred to in paragraph (3) shall be paid in the form of a revenue stamp or certificate: Provided, That payment with electronic currency or electronic settlement via an information and communications network is also allowed.
 Article 21 (Criteria for Granting Monetary Rewards)
(1) The criteria for granting monetary rewards under Article 30 of the Act shall be as follows:
1. Reporting on any business entity which has violated Article 16 (2) or 19 (1) of the Act: Not more than 500 thousand won;
2. Reporting on any business entity which has violated Article 18 (4) of the Act: Not more than 200 thousand won.
(2) Details about granting monetary rewards under paragraph (1), including persons to receive rewards, the amounts of rewards, and method and procedure for granting rewards, shall be separately determined by the heads of relevant administrative agencies.
 Article 22 (Management of Personally Identifiable Information)
The Minister of Food and Drug Safety and the heads of the relevant administrative agencies may manage data including resident registration numbers or alien registration numbers defined in subparagraph 1 or 4 of Article 19 of the Enforcement Decree of the Personal Information Protection Act, if it is inevitable to perform the business affairs relating to the operation of the Integrated Food Safety Information Network.
[This Article Newly Inserted by Presidential Decree No. 27443, Aug. 9, 2016]
ADDENDA
Article 1 (Enforcement Date)
This Decree shall enter into force on December 14, 2008.
Article 2 (Transitional Measures)
Notwithstanding the provisions of Articles 3 through 5, the Prime Minister may separately set the submission dates and dates to enter into force, for the first basic plan and implementation plans established after this Decree enters into force.
ADDENDA <Presidential Decree No. 22003, Jan. 27, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on February 1, 2010.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 22497, Nov. 19, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on November 26, 2010. (Proviso Omitted.)
Articles 2 through 8 Omitted.
ADDENDA <Presidential Decree No. 22715, Mar. 22, 2011>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 23, 2011.
Articles 2 through 4 Omitted.
ADDENDA <Presidential Decree No. 23807, May 23, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Transitional Measures concerning Revision of Forms)
The forms prescribed under the previous provisions as at the time this Decree enters into force, may be used along with the forms prescribed in this Decree until August 31, 2012.
ADDENDA <Presidential Decree No. 23964, Jul. 20, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 22, 2012.
Articles 2 through 4 Omitted.
ADDENDA <Presidential Decree No. 24195, Nov. 23, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 4 Omitted.
ADDENDA <Presidential Decree No. 24454, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 4 Omitted.
ADDENDA <Presidential Decree No. 25133, Jan. 28, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 31, 2014.
Articles 2 and 3 Omitted.
ADDENDA <Presidential Decree No. 25792, Nov. 28, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on November 29, 2014.
Article 2 Omitted.
ADDENDA <Presidential Decree No. 26936, Jan. 22, 2016>
Article 1 (Enforcement Date)
This Decree shall enter into force on February 4, 2016.
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 27443, Aug. 9, 2016>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 28008, May 2, 2017>
This Decree shall enter into force on June 3, 2017.
ADDENDA <Presidential Decree No. 28211, Jul. 26, 2017>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation: Provided, That among the Presidential Decrees amended under Article 8 of the Addenda, amendments to Presidential Decrees, which were promulgated before this Decree enters into force, but the enforcement dates of which have not yet arrived, shall enter into force on the enforcement dates of the respective Decrees.
Articles 2 through 8 Omitted.