ENFORCEMENT DECREE OF THE ACT ON RISK ASSESSMENTS OF PRODUCTS FOR HUMAN USE

Article 1(Purpose) #

The purpose of this Decree is to prescribe matters mandated by the Act on Risk Assessments of Products for Human Use and matters necessary for the enforcement thereof.

Article 2(Notification of master plan for risk assessments) #

If the Minister of Food and Drug Safety formulates or amends a master plan for risk assessment of products for human use pursuant to Article 6 (1) of the Act on the Risk Assessments of Products for Human Use (hereinafter referred to as the "Act"), he or she shall notify the heads of the relevant central administrative agencies of the details thereof.

Article 3(Procedures for formulation of implementation plans for risk assessments) #

(1) The Minister of Food and Drug Safety shall, in consultation with the heads of relevant central administrative agencies, formulate an implementation plan for risk assessments of products for human use under Article 6 (3) of the Act by December 31 of each year.

(2) Upon formulating an implementation plan under paragraph (1), the Minister of Food and Drug Safety shall notify the heads of the relevant central administrative agencies thereof.

Article 4(Composition of Risk Assessment Policy Committee) #

(1) "Public officials belonging to central administrative agencies prescribed by Presidential Decree" in Article 8 (2) 1 of the Act means Grade III public officials belonging to the following central administrative agencies or public officials in general service belonging to the Senior Executive Service: <Amended Oct. 1, 2025>

1. The Ministry of Agriculture, Food and Rural Affairs;

2. The Ministry of Trade, Industry and Resources;

3. The Ministry of Health and Welfare;

4. The Ministry of Climate, Energy and Environment;

5. The Ministry of Oceans and Fisheries;

6. The Ministry of Food and Drug Safety.

(2) The term of office of members of the Risk Assessment Policy Committee as prescribed in Article 7 (1) of the Act (hereinafter referred to as the "Policy Committee") under Article 8 (2) 2 of the Act shall be three years.

(3) The term of office of a member newly commissioned due to the dismissal, etc. of a member of the Policy Committee shall coincide with the remaining term of office of his or her predecessor.

Article 5(Dismissal of members of Policy Committee) #

The Minister of Food and Drug Safety or the head of an agency that has appointed a member of the Policy Committee pursuant to Article 8 (2) 1 of the Act may dismiss the relevant member or withdraw the appointment of the relevant member if the member falls under any of the following cases:

1. Where he or she becomes incapable of performing his or her duties due to mental or physical disability;

2. Where he or she commits any misdeed relevant to any of his or her duties;

3. Where he or she is found unfit for office due to neglect of duties, injury to dignity, or any other reason;

4. Where he or she fails to recuse himself or herself from participating in deliberation and resolution despite falling under any subparagraph of Article 6 (1);

5. Where he or she voluntarily admits that it is impracticable for him or her to perform his or her duties.

Article 6(Exclusion, challenge, and refusal of members of Policy Committee) #

(1) Where a member of the Policy Committee falls under any of the following cases, he or she shall be excluded from deliberation and resolution by the Policy Committee:

1. Where the member or the member's current or former spouse is either a party (where the party is a corporation or organization, including an executive officer thereof; hereinafter the same shall apply) to the relevant agenda item or a person holding any right or duty jointly with the party to such agenda item;

2. Where a member is or was in a relative of a party to the relevant agenda item;

3. Where the member or any corporation, organization, etc. to which the member belongs has given testimony, made a statement, consulted on, researched, provided services for, or appraised, the relevant agenda item;

4. Where the member or a corporation, organization, etc. to which he or she belongs is or was the agent of a party;

5. Where the member has served in the corporation, organization, etc. that is a party to the relevant agenda item as an executive officer or employee thereof during the last three years.

(2) Where there are circumstances indicating that it would be impracticable to expect a fair deliberation and resolution from a member of the Policy Committee, a party to the relevant agenda item may file an application for challenge of the member with the Policy Committee, and the Policy Committee shall determine by resolution whether to accept the challenge. In such cases, the member against whom the application is filed may not participate in such resolution.

(3) If a member of the Policy Committee falls under any ground for exclusion under the subparagraphs of paragraph (1), he or she shall recuse himself or herself from deliberation and resolution on the relevant agenda item.

Article 7(Meetings and operation of Policy Committee) #

(1) The chairperson of the Policy Committee shall represent the Policy Committee and have general supervision and control of the business affairs of the Committee.

(2) Meetings of the Policy Committee shall be classified into regular meetings and extraordinary meetings, and shall be held as follows:

1. Regular meetings: once a year;

2. Extraordinary meetings: When the chairperson of the Policy Committee deems it necessary or at the request of at least 1/5 of the members of the Policy Committee.

(3) If the chairperson of the Policy Committee holds a meeting pursuant to paragraph (2), he or she shall notify the members of the Policy Committee thereof not later than seven days before the date of the meeting, specifying the following matters; provided, in cases of urgency, the notice may be given no later than the day before the date of the meeting:

1. Date, time, and venue of the meeting;

2. The purpose and agenda of the meeting;

3. Other matters necessary for the meeting.

(4) A majority of the members of the Policy Committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present.

(5) If necessary for deliberation, the chairperson of the Policy Committee may invite persons or experts related to the relevant agenda to attend a meeting to ask questions or make a statement.

(6) Except as provided in paragraphs (1) through (5), matters necessary for the composition, operation, etc. of the Policy Committee shall be determined by the Minister of Food and Drug Safety.

Article 8(Composition and operation of specialized committees) #

(1) The Policy Committee shall have the following specialized committees by field (hereinafter referred to as "specialized committee") pursuant to Article 8 (5) of the Act:

1. The specialized committee on risk assessments in the field of food;

2. The specialized committee on risk assessments in the field of health functional foods and nutrition;

3. The specialized committee on risk assessments in the field of drugs and narcotics;

4. The specialized committee on risk assessments in the field of medical devices;

5. The specialized committee on risk assessments in the field of cosmetics and hygiene products;

6. The specialized committee on the establishment of health-based guidance values;

7. The specialized committee on toxicity assessment;

8. The specialized committee on communicating risks.

(2) A specialized committee shall be composed of up to 15 members including one chairperson.

(3) The chairperson of a specialized committee shall be appointed by the chairperson of the Policy Committee from among the members of the Policy Committee, and the members of a specialized committee shall be appointed or commissioned by the chairperson of the Policy Committee from among the following persons:

1. Members of the Policy Committee under Article 8 (1) of the Act;

2. Persons recommended by relevant academic societies and organizations;

3. Persons with extensive knowledge of and experience in risk assessments, etc.

(4) The term of office of members of a specialized committee shall be three years; provided, the term of office of a member newly commissioned due to the resignation, etc. of a member shall coincide with the remaining term of office of his or her predecessor.

(5) Where a member appointed or commissioned pursuant to paragraph (3) falls under any subparagraph of Article 5, the chairperson of the Policy Committee may remove or dismiss the relevant member.

(6) The chairperson of a specialized committee shall report the results of review conducted by the specialized committee to the Policy Committee.

Article 9(Disclosure of results of risk assessments) #

(1) Matters to be disclosed by the Minister of Food and Drug Safety pursuant to Article 15 (1) of the Act shall be as follows:

1. Results of a risk assessment performed under Article 10 of the Act, such as a total body exposure to risk factors;

2. Those subject to temporary prohibition measures, grounds for and period of temporary prohibition measures, and date of cancellation of temporary prohibition measures under Article 13 of the Act;

3. Comprehensive health-based guideline values established under Article 14 (1) of the Act.

(2) Disclosure pursuant to Article 15 (1) of the Act shall be made through the website of the Ministry of Food and Drug Safety or through the media such as newspapers and broadcasting.

Article 10(Requirements and procedures for requesting risk assessments) #

(1) "Consumers of a number no smaller than the number prescribed by Presidential Decree" in Article 16 (1) of the Act means at least five consumers.

(2) "Requirements prescribed by Presidential Decree" in Article 16 (1) of the Act means the following requirements:

1. The reasons for requesting a risk assessment shall be specified;

2. The name of the business entity, product name, and model name (only applicable to medical devices) of the product for human use subject to the request for a risk assessment shall be specified;

3. Certificates with which the identity of a requester for the risk assessment can be verified (in cases of a consumer organization, referring to a certificate of registration of a consumer organization under Article 23 (5) of the Enforcement Decree of the Framework Act on Consumers).

(3) A person who intends to request a risk assessment pursuant to Article 16 (1) of the Act shall submit a written request prescribed by Prime Ministerial Decree to the Minister of Food and Drug Safety. In such cases, if requesters are consumers, they shall select their representative.

(4) "Cases prescribed by Presidential Decree" in Article 16 (2) 4 of the Act means the following cases:

1. Where an investigation, appeal, or remedial procedure under statutes or regulations, such as audit, investigation, trial, administrative adjudication, conciliation, or arbitration, is pending with respect to the matters subject to the request for a risk assessment;

2. Where the requester fails to supplement the request by the deadline for supplementation even though supplementation is required due to the failure to meet the requirements for a risk assessment prescribed in paragraph (2) 1 through 3.

(5) The Minister of Food and Drug Safety shall notify a person who has requested a risk assessment pursuant to Article 16 (4) of the Act of the results thereof in writing; provided, if there is a notification method separately requested by the requester, it shall be notified by such method.

Article 11(Establishment and operation of integrated management system for human health risk assessments) #

(1) The Minister of Food and Drug Safety may perform the following business affairs through the computerized information processing system under Article 18 (2) of the Act (hereinafter referred to as "human health risk assessment system"):

1. Toxicity testing and the collection and analysis of toxicity information;

2. The collection and analysis of information on results of risk assessments;

3. Interlink of toxicity tests, toxicity information, risk assessment results, etc. and opening and utilization of information thereon;

4. Other matters necessary for the integrated management, such as the collection and analysis of risk assessment-related information.

(2) Except as provided in paragraph (1), matters necessary for establishing and operating the human health risk assessment system shall be determined by the Minister of Food and Drug Safety.

Article 12(Delegation of authority) #

(1) Pursuant to Article 22 of the Act, the Minister of Food and Drug Safety shall delegate his or her authority over access, investigation, and collection under Article 12 of the Act to the head of a regional office of food and drug safety.

(2) The Minister of Food and Drug Safety shall delegate the following authority to the Director General of the National Institute of Food and Drug Safety Evaluation pursuant to Article 22 of the Act:

1. Performing risk assessments under Article 10 of the Act;

2. Conducting toxicity tests under Article 11 of the Act;

3. Investigating adverse events caused by products for human use under Article 17 of the Act;

4. Collecting, analyzing, and utilizing information related to risk assessments and establishing and operating the human health risk assessment system under Article 18 of the Act.

5. Education and public relations towards business entities and consumers under Article 19 of the Act;

6. Training of specialized human resources under Article 20 of the Act;

7. International cooperation related to risk assessments under Article 21 of the Act.

Article 13(Entrustment of business affairs) #

(1) Pursuant to Article 23 (1) of the Act, the Minister of Food and Drug Safety may entrust all or part of the business affairs referred to in the subparagraphs of that paragraph to the following institutions:

1. The National Food Safety Information Service established under Article 67 of the Food Sanitation Act;

2. A public institution under the Act on the Management of Public Institutions;

3. A government-funded research institute under the Act on the Establishment, Operation and Fostering of Government-Funded Research Institutes or the Act on the Establishment, Operation and Fostering of Government-Funded Science and Technology Research Institutes;

4. A school defined in Article 2 of the Higher Education Act;

5. A specific research institute under Article 2 of the Specific Research Institutes Support Act;

6. Other corporations or organizations recognized by the Minister of Food and Drug Safety as having specialized human resources and organizations dedicated to business affairs related to risk assessments.

(2) "Business affairs prescribed by Presidential Decree" in Article 23 (1) 6 of the Act means research and technology development related to risk assessments of products for human use under Article 6 (2) 2 of the Act.

(3) If the Minister of Food and Drug Safety entrusts business affairs under paragraph (1), he or she shall publicly notify a person entrusted with such business affairs and the details of entrusted business affairs.

Article 14(Processing sensitive information and personally identifiable information) #

The Minister of Food and Drug Safety (including a person to whom the authority of the Minister of Food and Drug Safety is delegated pursuant to Article 12 or a person to whom the business affairs of the Minister of Food and Drug Safety are entrusted pursuant to Article 13) may process data containing information on health under Article 23 of the Personal Information Protection Act and resident registration numbers or alien registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of that Act, if unavoidable for performing the following business affairs:

1. Performing risk assessments under Article 10 of the Act;

2. Requests, etc. by consumers for risk assessments under Article 16 of the Act;

3. Investigating adverse events caused by products for human use under Article 17 of the Act;

4. Collecting, analyzing, and utilizing information related to risk assessments and establishing and operating the human health risk assessment system under Article 18 of the Act.