CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to comprehensively evaluate the risks that may arise when risk factors existing in products directly applicable to the human body are exposed to the human body and to prescribe matters for safety management, thereby protecting and improving the public health.
| (2) | The Minister of Food and Drug Safety shall formulate and implement a comprehensive safety management plan, such as the establishment of health-based guidance value and a plan to reduce risk factors, in order to protect public health from risk factors existing in products for human use; Provided, That excluded herefrom shall be matters for which the Minister of Food and Drug Safety has entrusted his or her authority to the heads of other central administrative agencies under other statutes or regulations: |
The terms used in this Act are defined as follows:
| 1. | The term "product for human use" means any of the following products that can directly affect the human body through its consumption, administration, contact, inhalation, etc. by a human: |
| (j) | Hygiene products defined in subparagraph 1 of Article 2 of the Hygiene Products Control Act; |
| (k) | Other products managed by the Minister of Food and Drug Safety pursuant to statutes prescribed by Presidential Decree; |
| 2. | The term "risk factor" means a chemical, biological, or physical factor that harms or is likely to harm human health; |
| 3. | The term "risk" means the degree to which exposure to a risk factor existing in a product for human use may cause harm to human health; |
| 4. | The term "risk assessment" means a series of processes assessing a single or two or more types of products for human use as to whether a risk factor poses a risk to the human body and the degree thereof; |
| 5. | The term "health-based guidance value" means criteria for the exposure to risk factors existing in a single or two or more types of products for human use that is deemed to have no harmful effect on the human body; |
| 6. | The term "business entity" means a person who engages in the business of producing, collecting, manufacturing, processing, importing, transporting, storing, cooking, leasing, leasing, or selling products for human use (hereinafter referred to as "production, sale, etc."): Provided, That a business entity related to matters entrusted by the Minister of Food and Drug Safety to the heads of other central administrative agencies pursuant to other statutes or regulations shall be excluded herefrom. |
| Article 3 (Relationship to Other Statutes) |
Except as otherwise provided in other statutes, this Act shall apply to the risk assessment and safety management of products for human use.
| Article 4 (Responsibilities of the State) |
| (1) | The State shall formulate and implement policies necessary to protect the lives and health of citizens from risks posed by products for human use and shall endeavor to ensure that they can communicate with citizens by transparently disclosing the results of risk assessments, etc. |
| (2) | Business entities shall take necessary measures, such as prevention, control, etc., to prevent products for human use from posing risks to the human body, and shall actively participate in and cooperate with the State's policies. |
CHAPTER II FORMULATION OF, AND SYSTEMS FOR PROMOTING, RISK ASSESSMENT POLICIES
| Article 5 (Comprehensive Risk Assessment and Control) |
| (1) | The Minister of Food and Drug Safety shall conduct a risk assessment by comprehensively considering various products and pathways in order to ascertain the overall impact of risk factors existing in products for human use on the human body. |
| (2) | The Minister of Food and Drug Safety shall formulate and implement a comprehensive safety management plan, such as the establishment of health-based guidance values and a plan to reduce risk factors, in order to protect the public health from risk factors existing in products for human use: Provided, That excluded herefrom shall be matters for which the Minister of Food and Drug Safety has entrusted his or her authority to the heads of other central administrative agencies under other statutes or regulations: |
| (3) | The Minister of Food and Drug Safety shall take the following matters into consideration when formulating safety management plans under paragraph (2): |
| 2. | The feasibility of a safety management plan and whether alternative means exist; |
| 3. | A comparative analysis of the expenses incurred in safety management and the resulting benefits. |
| (4) | The Minister of Food and Drug Safety shall endeavor to lay the foundation for promoting risk assessments. |
| (5) | The Minister of Food and Drug Safety shall cooperate with the heads of relevant central administrative agencies to comprehensively manage risks. |
| Article 6 (Master Plan for Risk Assessments) |
| (1) | The Minister of Food and Drug Safety shall formulate and implement a master plan for risk assessments of products for human use (hereinafter referred to as "master plan") every five years, subject to deliberation by the Hazard Assessment Policy Committee under Article 7 (1), in order to systematically and efficiently conduct risk assessments of products for human use. The same shall also apply where the Minister intends to amend the master plan. |
| (2) | A master plan shall include the following: |
| 1. | Objectives and basic directions for risk assessments of products for human use; |
| 2. | Research and technology development related to risk assessments of products for human use; |
| 3. | International cooperation related to risk assessments of products for human use; |
| 4. | Other matters necessary for the promotion of risk assessments of products for human use. |
| (3) | In order to implement the master plan, the Minister of Food and Drug Safety shall formulate an implementation plan (hereinafter referred to as the "implementation plan") for risk assessments of products for human use in consultation with the heads of relevant central administrative agencies every year. |
| (4) | If necessary to formulate and implement a master plan and an implementation plan, the Minister of Food and Drug Safety may request the head of a relevant central administrative agency, the head of a local government, a relevant business entity, or the head of a relevant corporation or organization to submit necessary data. |
| (5) | Other matters necessary for the formulation and implementation of a master plan and an implementation plan shall be prescribed by Presidential Decree. |
| Article 7 (Risk Assessment Policy Committee) |
| (1) | The Risk Assessment Policy Committee (hereinafter referred to as the "Committee") shall be established under the jurisdiction of the Minister of Food and Drug Safety to deliberate on matters regarding risk assessments, etc. |
| (2) | The Committee shall deliberate on the following matters: |
| 1. | Formulating and implementing a master plan under Article 6; |
| 2. | Selecting subjects for a risk assessment under Article 9; |
| 3. | Methods of risk assessments under Article 10 (2); |
| 4. | Matters regarding temporary prohibition measures under Article 13; |
| 5. | Matters regarding comprehensive health-based guidance values under Article 14 (1); |
| 6. | Matters regarding a request by a consumer, etc. for a risk assessment under Article 16; |
| 7. | Other matters submitted for deliberation by the Minister of Food and Drug Safety regarding risk assessments, etc. |
| Article 8 (Composition of Committee) |
| (1) | The Committee shall be composed of up to 20 members including one chairperson. |
| (2) | The Vice Minister of Food and Drug Safety shall serve as the chairperson of the Committee, and the following persons shall serve as members of the Committee; in such cases, members who are not public officials shall constitute a majority of all members: |
| 1. | Public officials belonging to a central administrative agency prescribed by Presidential Decree, who are designated by the head of the relevant agency; |
| 2. | Persons commissioned by the Minister of Food and Drug Safety from among those with extensive knowledge of and experience in the field of risk assessments. |
| (3) | The chairperson shall represent the Committee and shall convene and preside over meetings of the Committee: Provided, That if the chairperson is unable to perform his or her duties due to unavoidable reasons, a member designated in advance by the chairperson shall act on his or her behalf. |
| (4) | The Committee shall have one executive secretary to efficiently operate and support the Committee, and the executive secretary shall be appointed by the Chairperson. |
| (5) | The Committee may establish a specialized committee for each field in order to examine matters to be deliberated under Article 7 (2) in a specialized manner. |
| (6) | Other matters necessary for the composition, operation, etc., of the Committee and specialized committees shall be prescribed by Presidential Decree. |
CHAPTER III PERFORMANCE OF RISK ASSESSMENTS
| Article 9 (Subjects of Risk Assessments) |
Where a product for human use falls under any of the following cases, the Minister of Food and Drug Safety may select a product for human use to be subject to a risk assessment after deliberation by the Committee: Provided, That where it is likely to pose a imminent harm to the safety and health of citizens, the Minister of Food and Drug Safety need not undergo deliberation by the Committee:
| 1. | Products for human use, the sale of which is prohibited or the production of which for sale is prohibited by an international organization or a foreign government on the grounds that such products are likely to harm human health; |
| 2. | Products for human use which use new raw materials or ingredients or to which new technologies are applied, and for which safety standards and specifications are yet to be determined; |
| 3. | Products for human use for which a consumer, etc. has requested a risk assessment pursuant to Article 16 (1); |
| 4. | Other products for human use which are deemed likely to harm human health. |
| Article 10 (Performance of Risk Assessments) |
| (1) | The Minister of Food and Drug Safety shall conduct a risk assessment of products for human use selected pursuant to Article 9: Provided, That if the heads of the relevant central administrative agencies have agreed to conduct a risk assessment or to jointly conduct a risk assessment after consulting with the heads of the relevant central administrative agencies, such agreement shall apply. |
| (2) | The Minister of Food and Drug Safety shall conduct a risk assessment in the following order: Provided, That the Minister of Food and Drug Safety may conduct the risk assessment by determining different methods of risk assessment in consideration of the technological level related to risk assessment, the characteristics of risk factors, etc. after deliberation by the Committee: |
| 1. | Review of the current health-based guidance values; |
| 2. | Verification of risk factors such as toxicity in the human body; |
| 3. | Calculation of the level of contribution to the exposure to risk factors for each product for human use; |
| 4. | A comprehensive risk assessment of risk factors. |
| (3) | If necessary to conduct a risk assessment, the Minister of Food and Drug Safety may request the head of the relevant central administrative agency to provide necessary data. In such cases, the head of the relevant central administrative agency in receipt of such request shall comply therewith, unless there is a compelling reason not to do so. |
| (4) | If necessary to conduct a risk assessment, the Minister of Food and Drug Safety may request relevant business entities or the heads of relevant corporations or organizations to submit necessary data or opinions. |
| (5) | Other matters necessary for conducting risk assessments shall be prescribed by Ordinance of the Prime Minister. |
| Article 11 (Performance of Toxicity Test) |
| (1) | In order to secure data necessary for a risk assessment, the Minister of Food and Drug Safety may conduct a toxicity test that scientifically evaluates the degree of toxicity through animal testing, etc. |
| (2) | Matters necessary for the procedures, methods, etc. for a toxicity test under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
| Article 12 (Access, Investigation, and Collection) |
| (1) | If necessary for a risk assessment under Article 10, the Minister of Food and Drug Safety may require relevant public officials to enter a business place of a business entity to investigate facilities, documents, etc. and collect the minimum quantity necessary for a risk assessment without compensation. |
| (2) | The relevant public official who accesses, investigates, or collects pursuant to paragraph (1) shall present identification verifying his or her authority to relevant persons. |
| (3) | Matters necessary for access, investigation, collection, etc. under paragraphs (1) and (2) shall be prescribed by Ordinance of the Prime Minister. |
| Article 13 (Temporary Prohibition Measures) |
| (1) | If it is necessary to take preventive measures for the safety and health of citizens even before the risk assessment is completed, the Minister of Food and Drug Safety may temporarily prohibit the production, sale, etc. of the relevant product for human use, subject to deliberation by the Committee: Provided, That if there is a risk of imminent harm to the safety and health of citizens, a temporary prohibition measure may be first taken, and then deliberation by the Committee may be conducted. |
| (2) | If the Minister of Food and Drug Safety deems that the relevant product for human use poses no risk, he or she shall, without delay, revoke the temporary prohibition measure under paragraph (1). |
| Article 14 (Establishment of Comprehensive Health-Based Guidance Values) |
| (1) | The Minister of Food and Drug Safety shall establish health-based guidance values for risk factors existing in two or more types of products for human use after deliberation by the Committee according to the results of risk assessments of products for human use. |
| (2) | The Minister of Food and Drug Safety may reflect the health-based guidance values established under paragraph (1) (hereinafter referred to as "comprehensive health-based guidance value") in the establishment, etc. of standards and specifications prescribed by the statutes referred to in the items of subparagraph 1 of Article 2. |
| (3) | Where the comprehensive health-based guidance values relate to matters under the jurisdiction of other central administrative agencies, the Minister of Food and Drug Safety shall notify the heads of the relevant central administrative agencies of the details. |
| Article 15 (Disclosure of Results of Risk Assessments) |
| (1) | If the Minister of Food and Drug Safety deems it necessary for the protection of the public health, the results of risk assessments under Article 10, the temporary prohibition measures and the revocation thereof under Article 13, and all or part of the details of the health-based guidance values under Article 14 shall be disclosed. |
| (2) | Matters necessary for the scope, methods, procedures, etc. of disclosure under paragraph (1) shall be prescribed by Presidential Decree. |
| Article 16 (Consumer's Request for Risk Assessment) |
| (1) | A consumer organization under Article 29 of the Framework Act on Consumers or consumers of a number no smaller than the number prescribed by Presidential Decree (hereinafter referred to as "consumer, etc.") may request the Minister of Food and Drug Safety to conduct a risk assessment for a product for human use. |
| (2) | Upon receiving a request under paragraph (1), the Minister of Food and Drug Safety may select the relevant product to be subject to a risk assessment under Article 9: Provided, That this shall not apply in any of the following cases: |
| 1. | Where the same consumer, etc. makes repeated requests for a risk assessment for the same purpose; |
| 2. | Where it goes against the public interest, such as a request for a risk assessment for the purpose of benefiting a specific business entity; |
| 3. | Where a risk assessment requested by a consumer, etc. is incapable or impracticable of performance in consideration of the level of technology, facilities, costs, etc.; |
| 4. | Other cases prescribed by Presidential Decree, as it is deemed inappropriate to select the relevant product to be subject to a risk assessment, such as where there is a pending investigation under this Act or other statutes or regulations. |
| (3) | If the Minister of Food and Drug Safety determines whether to select a product for human use to be subject to a risk assessment under paragraph (2), he or she shall notify the consumers, etc. who has requested the risk assessment of the result thereof without delay. |
| (4) | If the Minister of Food and Drug Safety selects a product for human use to be subject to a risk assessment under paragraph (2), he or she shall complete the risk assessment on the relevant product for human use within one year from the date he or she gives notice under paragraph (3), and shall notify the consumer, etc. who has made the relevant request the result thereof, as prescribed by Presidential Decree: Provided, That if there are unavoidable reasons, the period may be extended after deliberation by the Committee, and in such cases, the grounds for extension and the extension period shall be notified to the consumer, etc. |
| Article 17 (Investigation of Adverse Events Caused by Products for Human Use) |
The Minister of Food and Drug Safety may investigate adverse events caused by a product for human use in order to utilize them for a risk assessment, such as selecting the product to be subject to a risk assessment. In such cases, matters necessary for the subject of investigation, methods, procedures, etc. shall be prescribed by Ordinance of the Prime Minister.
CHAPTER IV CREATION OF FOUNDATION FOR PROMOTING RISK ASSESSMENTS
| Article 18 (Collection, Analysis, and Utilization of Information Related to Risk Assessments) |
| (1) | The Minister of Food and Drug Safety shall formulate and implement policy measures necessary to facilitate the collection, analysis, and utilization of information related to risk assessments. |
| (2) | The Minister of Food and Drug Safety shall establish and operate a computerized information processing system for the collection, analysis, and other integrated management of information related to risk assessments. |
| (3) | The Minister of Food and Drug Safety may request the heads of the relevant central administrative agencies to provide information related to risk assessments secured pursuant to statutes within their purview in order to establish the computerized information processing system under paragraph (2). In such cases, the heads of the relevant central administrative agencies in receipt of such request shall comply therewith, unless there is a compelling reason not to do so. |
| (4) | The Minister of Food and Drug Safety may, upon request of the head of a relevant central administrative agency, share information related to risk assessments in the computerized information processing system under paragraph (2) in consultation with the head of the relevant central administrative agency. |
| (5) | Matters necessary for the establishment and operation of the computerized information processing system under paragraph (2) shall be prescribed by Presidential Decree. |
| Article 19 (Education and Public Relations) |
| (1) | The Minister of Food and Drug Safety may provide education and engage in public relations towards business entities and consumers so as to enhance their understanding of the safety of products for human use and to ensure that products for human use are safely handled in the process of manufacturing, production, processing, use, etc. |
| (2) | Matters necessary for the methods, etc. of education and public relations under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
| Article 20 (Training Experts in Risk Assessments) |
| (1) | The Minister of Food and Drug Safety shall train experts necessary for risk assessments. |
| (2) | The Minister of Food and Drug Safety shall cooperate with the industry, academia, research circles, civic and social organizations, etc. to train experts under paragraph (1). |
| (3) | The Minister of Food and Drug Safety may subsidize public research institutes, business entities, etc. to cover all or part of expenses necessary for educational facilities, the development of teaching materials, the implementation of education, etc. in order to train experts under paragraph (1). |
| Article 21 (Facilitation of International Cooperation in Risk Assessments) |
In order to improve the level of risk assessments, the Minister of Food and Drug Safety may promote policy measures to promote international cooperation, such as international joint research and development related to risk assessments.
CHAPTER V SUPPLEMENTARY PROVISIONS
| Article 22 (Delegation of Authority) |
Part of the authority of the Minister of Food and Drug Safety under this Act may be delegated to the head of the agency under his or her jurisdiction, as prescribed by Presidential Decree.
| Article 23 (Entrustment of Business Affairs) |
| (1) | All or part of the following business affairs among those of the Minister of Food and Drug Safety under this Act may be entrusted to an institution prescribed by Presidential Decree: |
| 1. | Investigation of adverse events caused by products for human use under Article 17; |
| 2. | Collection, analysis, and utilization of information related to risk assessments and the establishment and operation of the computerized information processing system under Article 18; |
| 3. | Education and public relations towards business entities and consumers under Article 19; |
| 5. | International cooperation related to risk assessments under Article 21; |
| 6. | Other business affairs prescribed by Presidential Decree in relation to the promotion of risk assessments. |
| (2) | Where the Minister of Food and Drug Safety entrusts business affairs pursuant to paragraph (1), he or she may subsidize all or part of necessary expenses within the budget. |
| (3) | Other matters necessary for entrusting business affairs under paragraph (1) shall be prescribed by Presidential Decree. |
| Article 24 (Legal Fiction as Public Officials for Purposes of Applying Penalty Provisions) |
| Article 25 (Penalty Provisions) |
A person who produces, sells, etc. products for human use for which the production, sale, etc. is temporarily prohibited, in violation of Article 13 (1), shall be punished by imprisonment for not more than three years or by a fine not exceeding 30 million won.
Addendum <Act No. 18365, Jul. 27, 2021>
This Act shall enter into force six months after the date of its promulgation.