The purpose of this Act is to prescribe matters concerning the management of harmfulness of tobacco, thereby guaranteeing the people's right to know about the harmfulness of tobacco and protecting the health of the people from harmfulness to tobacco.
The terms used in this Act are defined as follows:
| 2. | The term "manufacturer, etc." means a manufacturer or importer-seller of tobacco under the Tobacco Business Act; |
| 3. | The term "tobacco additive" means all substances added in the process of manufacturing tobacco at a manufacturing place in addition to tobacco and nicotine solutions in the process of manufacturing tobacco at a manufacturing place; |
| 4. | The term "tobacco emissions" means all substances, including smoke or steam generated or released from tobacco; |
| 5. | The term "tobacco ingredients" means tobacco (including tobacco additives; hereinafter the same shall apply) and ingredients contained in tobacco emissions; |
| 6. | The term "harmfulness" means the unique nature of a substance that has a detrimental effect on human health, such as toxicity, etc.; |
| 7. | The term "harmful ingredients" means harmful substances among tobacco ingredients, which are publicly notified by the Minister of Food and Drug Safety pursuant to Article 11 (2); |
| 8. | The term "harmfulness management of tobacco" means all kinds of activities, such as analyzing the types and contents of harmful ingredients, disclosing information on harmful ingredients by analyzing the types and contents of harmful ingredients, and utilizing information on harmful ingredients for anti-smoking policies. |
| Article 3 (Relationship to Other Statutes) |
This Act shall take precedence over other Acts with respect to the harmfulness management of tobacco.
| Article 4 (Responsibilities of the State) |
The State shall establish and implement policies to protect the health of the people from harmfulness to tobacco.
| Article 5 (Master Plans for Harmfulness Management of Tobacco) |
| (1) | The Minister of Health and Welfare and the Minister of Food and Drug Safety shall jointly formulate and implement a master plan for the harmfulness management of tobacco (hereinafter referred to as "master plan") every 5 years. |
| (2) | Where the Minister of Health and Welfare and the Minister of Food and Drug Safety formulate a master plan, he or she shall consult in advance with the heads of relevant central administrative agencies, such as the Minister of Economy and Finance, and submit it for deliberation by the Tobacco Harmfulness Management Policy Committee established under Article 9. The same shall also apply where he or she intends to amend the master plan. |
| (3) | The Master Plan shall include the following matters: |
| 1. | Basic objectives of, and direction-setting for, policies on harmfulness management of tobacco; |
| 2. | Matters concerning surveys and research on harmfulness of tobacco; |
| 3. | Matters concerning public relations activities to publicize the harmfulness of tobacco to the people; |
| 4. | Matters concerning the direction-setting for implementing non-smoking policies, formulation of plans, etc. by utilizing data concerning the matters referred to in the subparagraphs of Article 12 (1) and information on harmful ingredients; |
| 5. | Other matters prescribed by Presidential Decree as necessary for the harmfulness management of tobacco. |
| (4) | Matters necessary for the formulation, implementation, etc. of a master plan shall be prescribed by Presidential Decree. |
| Article 6 (Annual Implementation Plans) |
| (1) | The Minister of Health and Welfare and the Minister of Food and Drug Safety shall jointly formulate and implement an annual implementation plan (hereinafter referred to as "implementation plan") in accordance with the master plan. |
| (2) | Where the Minister of Health and Welfare and the Minister of Food and Drug Safety formulate an implementation plan, he or she shall consult in advance with the heads of relevant central administrative agencies, etc. such as the Minister of Economy and Finance. |
| (3) | Matters necessary for the formulation, implementation, etc. of implementation plans shall be prescribed by Presidential Decree. |
| Article 7 (Survey and Research) |
| (1) | In order to efficiently formulate and implement a master plan and an implementation plan, the Minister of Health and Welfare and the Minister of Food and Drug Safety may jointly conduct surveys and research on tobacco and tobacco emissions, etc. and reflect the results thereof in the master plan and implementation plan. |
| (2) | Matters necessary for the scope, methods, etc. of surveys and research under paragraph (1) shall be prescribed by Presidential Decree. |
| Article 8 (Cooperation in Formulation of Plans) |
| (1) | The Minister of Health and Welfare or the Minister of Food and Drug Safety may request the head of a relevant central administrative agency, the head of a local government, the head of a public institution under the Act on the Management of Public Institutions, or the head of any other relevant corporation or organization to provide cooperation, such as provision of data, if necessary for formulating and implementing a master plan and an implementation plan, or for conducting investigations and research under Article 7. |
| (2) | Any person in receipt of a request under paragraph (1) shall comply with such request unless there is just cause. |
| Article 9 (Composition and Operation of Tobacco Harmfulness Management Policy Committee) |
| (1) | In order to deliberate on the following matters concerning the hazard control of tobacco, the Tobacco Harmfulness Management Policy Committee (hereinafter referred to as the "Policy Committee") shall be established as a special committee of the Hazard Assessment Policy Committee under Article 8 (6) of the Act On Risk Assessments of Products For Human Use: |
| 1. | Master plan and implementation plan; |
| 2. | Matters concerning methods of testing harmful ingredients; |
| 3. | Matters concerning the scope of and standards for harmful ingredients subject to inspection under Article 11 (2); |
| 4. | Matters concerning the scope and methods of disclosure of information on harmful ingredients under Article 14; |
| 5. | Other matters deemed necessary by the chairperson for the harmfulness management of tobacco. |
| (2) | The Policy Committee shall be comprised of not more than 15 members, including 2 chairpersons. |
| (3) | The chairperson shall be appointed by the Vice Minister of Food and Drug Safety and persons designated by the Minister of Health and Welfare from among the Vice Minister of Food and Drug Safety and public officials belonging to the Senior Executive Service of the Ministry of Health and Welfare. |
| (4) | Members shall be appointed or commissioned from among the following persons through consultation between the Minister of Health and Welfare and the Minister of Food and Drug Safety and the Minister of Food and Drug Safety. In such cases, persons falling under subparagraph 3 shall constitute a majority of the members: |
| 1. | A member of the Senior Executive Service of a central administrative agency, such as the Ministry of Economy and Finance, who is a public official in charge of affairs concerning the harmfulness management of tobacco; |
| 3. | Persons with extensive knowledge of and experience in the harmfulness management of tobacco. |
| (5) | The term of office of a member who is a public official shall be the period during which he or she holds the relevant position, and the term of office of a commissioned member shall be 2 years: Provided, That in the event of a vacancy of a member, the term of office of a supplementary member shall be the remainder of his or her predecessor's term of office. |
| (6) | Other matters necessary for the composition and operation of the Policy Committee shall be prescribed by Presidential Decree. |
| Article 10 (Hearing of Opinions) |
The Policy Committee may, if necessary to deliberate on matters referred to in the subparagraphs of Article 9 (1), hear opinions of persons with expertise in tobacco, specialized research institutes, manufacturers, etc., including the relevant business operators, etc., if necessary.
| Article 11 (Regular Inspection of Harmful Elements) |
| (1) | A manufacturer, etc. shall request an inspection agency under Article 16 to inspect the content of harmful ingredients of each item of tobacco sold within 6 months after the commencement of the relevant year every 2 years, within 6 months after the commencement of the relevant year. |
| (2) | Harmful components subject to inspection under paragraph (1) shall be determined and publicly notified by the Minister of Food and Drug Safety. |
| (3) | An inspection agency in receipt of a request for an inspection under paragraph (1) or (4) shall issue an inspection report on the results of the inspection to a manufacturer, etc. after conducting the inspection, and keep it for 3 years. |
| (4) | Where there is any change in harmful ingredients after an inspection report is issued under paragraph (3), the manufacturer, etc. shall re-entrust the inspection under paragraph (1) without delay. |
| (5) | Matters necessary for procedures for requesting inspections under paragraphs (1) and (4), keeping of inspection reports under paragraph (3), etc. shall be prescribed by Ordinance of the Prime Minister. |
| Article 12 (Submission of Data, such as Inspection Results) |
| (1) | When a manufacturer, etc. is issued an inspection report pursuant to Article 11 (3), he or she shall submit data on the following matters (hereinafter referred to as "inspection result, etc.") to the Minister of Food and Drug Safety: |
| 1. | The name of raw materials used for the manufacture of the relevant tobacco and the ingredients included in tobacco additives, etc.; |
| 3. | Other matters prescribed by Presidential Decree as information necessary to protect the health of the people from hazards to tobacco, which are necessary to protect people's health. |
| (2) | Matters necessary for the timing, methods, etc. for submitting inspection reports, etc. under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
| Article 13 (Delivery of Inspection Results) |
The Minister of Food and Drug Safety shall, without delay, forward test reports, etc. submitted pursuant to Article 12 to the heads of relevant central administrative agencies, such as the Minister of Economy and Finance and the Minister of Health and Welfare, without delay.
| Article 14 (Disclosure of Information on Harmful Components) |
| (1) | The Minister of Food and Drug Safety shall review inspection reports, etc. and disclose information on harmful ingredients by item of tobacco to ensure that anyone can easily see them after reviewing such inspection reports, etc. |
| (2) | The scope of disclosure of information on harmful ingredients under paragraph (1), the timing and methods of disclosure, and other matters necessary for disclosure shall be prescribed by Presidential Decree. |
| Article 15 (Utilization of Information on Harmful Components) |
The Minister of Health and Welfare and the Minister of Food and Drug Safety may utilize inspection reports, etc. and information on harmful ingredients by item of tobacco under Article 14 for policies for health promotion.
| Article 16 (Designation of Tobacco Inspection Institutions) |
| (1) | The Minister of Food and Drug Safety shall designate an institution to conduct inspections under Article 11. |
| (2) | Any person who intends to be designated as an institution to perform inspection affairs pursuant to paragraph (1) shall file an application for designation with the Minister of Food and Drug Safety after meeting the requirements for facilities, equipment, human resources, etc. prescribed by Ordinance of the Prime Minister. |
| (3) | When an institution designated pursuant to paragraph (1) (hereinafter referred to as "inspection institution") intends to change important matters prescribed by Ordinance of the Prime Minister among the designated matters, it shall obtain prior approval from the Minister of Food and Drug Safety when it intends to change the important matters prescribed by Ordinance of the Prime Minister: Provided, That when it intends to change minor matters prescribed by Ordinance of the Prime Minister, it shall report to the Minister of Food and Drug Safety within 1 month from the date of occurrence of such change. |
| (4) | An inspection agency shall comply with matters prescribed by Ordinance of the Prime Minister, such as keeping inspection reports, etc. |
| (5) | Necessary matters concerning requirements and procedures for designation of inspection agencies and modification thereof shall be prescribed by Ordinance of the Prime Minister. |
| Article 17 (Revocation of Designation) |
| (1) | Where an inspection institution designated under Article 16 falls under any of the following cases, the Minister of Food and Drug Safety may revoke its designation or order it to suspend its business for a specified period not exceeding 6 months: Provided, That where it falls under subparagraphs 1 through 3, the Minister of Food and Drug Safety shall revoke its designation: |
| 1. | Where it is designated by fraud or other improper means; |
| 2. | Where it prepares and issues a false inspection report under Article 11 intentionally or by gross negligence; |
| 3. | Where it conducts inspection services during the period of business suspension; |
| 4. | Where he or she fails to obtain approval for modification or to file a report on modification within 1 month under Article 16 (3); |
| 5. | Where he or she violates any of the matters to be observed under Article 16 (4). |
| (2) | An institution subject to a disposition of revocation of designation pursuant to paragraph (1) shall not be re-designated as an inspection institution unless 2 years have passed since the date on which the designation was revoked. |
| (3) | Detailed standards for revocation of designation or suspension of business under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
| (4) | Where the Minister of Food and Drug Safety intends to revoke the designation of an inspection institution pursuant to paragraph (1), he or she shall hold a hearing. |
| Article 18 (Corrective Orders) |
| (1) | Where a manufacturer, etc. falls under any of the following cases, the Minister of Food and Drug Safety shall issue a corrective order within a specified period: |
| 1. | Where he or she fails to request an inspection of harmful ingredients, in violation of Article 11 (1) or (4); |
| 2. | Where he or she fails to submit an inspection report, etc., in violation of Article 12 (1). |
| (2) | Where a manufacturer, etc. fails to comply with a corrective order issued under paragraph (1) within the period and where it is deemed that harm to public health has occurred or is likely to occur, the Minister of Food and Drug Safety may order the manufacturer, etc. to recall or discard the relevant tobacco or to take other necessary measures. |
| (3) | Where a person in receipt of an order issued under paragraph (2) fails to comply with such order, the Minister of Food and Drug Safety may execute vicarious execution pursuant to the Administrative Vicarious Execution Act and collect expenses incurred therein from the violator of such order. |
| (4) | Procedures for corrective orders, recall and destruction under paragraphs (1) through (3), and other necessary matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 19 (Duty of Confidentiality) |
A member of the Policy Committee or a public official who is or was engaged in any duty under this Act, or a person who is or was in charge of any duty of the Policy Committee, or a person who is or was in charge of any duty of the Policy Committee, shall not divulge any confidential information he or she has become aware of in the course of performing such duty or use it for any purpose other than its original purpose.
| (1) | A person who intends to apply for designation of an inspection agency pursuant to Article 16 (2) shall pay fees to the Minister of Food and Drug Safety. |
| (2) | Necessary matters concerning the amounts of fees under paragraph (1), methods of payment, etc. shall be prescribed by Ordinance of the Prime Minister. |
| Article 21 (Reporting, Access, and Inspection) |
| (1) | Where deemed necessary, the Minister of Food and Drug Safety may require a manufacturer, etc. to file a necessary report, and may require a relevant public official to enter his or her place of business or place of business to inspect documents or articles related to the manufacture or sale of tobacco or to collect the minimum quantity of articles necessary for inspection without compensation. |
| (2) | Where a relevant public official enters, inspects, or collects pursuant to paragraph (1), he or she shall carry a certificate indicating his or her authority and present it to interested persons. |
| (4) | Matters necessary for the detailed standards, procedures, etc. for reporting, entry, inspection, and collection under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
| Article 22 (Delegation of Authority) |
The Minister of Food and Drug Safety may delegate part of his or her authority under this Act to the Director General of the National Institute of Food and Drug Safety Evaluation Service or the head of a regional office of Food and Drug Safety, as prescribed by Presidential Decree.
| Article 23 (Legal Fiction as Public Officials in Application of Penalty Provisions) |
| Article 24 (Penalty Provisions) |
Any of the following persons shall be punished by imprisonment with labor for not more than 1 year or by a fine not exceeding 10 million won:
| 1. | A person who falsely entrusts a false inspection of hazardous ingredients under Article 11 (1) or (4); |
| 2. | A person who submits a false inspection report, etc., in violation of Article 12; |
| 3. | A person who fails to comply with a corrective order issued under Article 18 (1); |
| 4. | A person who fails to comply with an order for recall, destruction, etc. issued under Article 18 (2). |
| Article 25 (Joint Penalty Provisions) |
If the representative of a corporation, or an agent, employee, or other servant of a corporation or an individual commits an offense under Article 24 in connection with the business of the corporation or individual, not only shall such offender be punished accordingly, but the corporation or individual shall also be punished by a fine under the relevant provisions: Provided, That this shall not apply where the corporation or individual has not been negligent in giving due attention and supervision concerning the relevant business in order to prevent such offense.
| Article 26 (Administrative Fine) |
| (1) | A person who fails to file a report or files a false report, in violation of Article 21 (1), or refuses, obstructs, or evades access, inspection, or collection under the same paragraph shall be subject to an administrative fine not exceeding 3 million won. |
| (2) | Administrative Fines under paragraph (1) shall be imposed and collected by the Minister of Food and Drug Safety or the head of a regional office of Food and Drug Safety, as prescribed by Presidential Decree. |
ADDENDA <Act No. 19815, Oct. 31, 2023>
Article 1 (Enforcement Date)
This Act shall enter into force two years after the date of its promulgation. (Proviso Omitted.)
Article 2 (Special Cases concerning Regular Inspections of Harmful Ingredients)
A manufacturer, etc. shall request the inspection of tobacco sold as at the time this Act enters into force under Article 11 (1) within three months from the date this Act enters into force.