1. Reason for Enactment
With the enactment of the Act on the Management of the Harmfulness of Tobacco (Law No. 19815, promulgated on October 31, 2023, and effective from November 1, 2025), this regulation aims to establish provisions for the procedures of regular harmful substance testing, the designation of testing institutions, administrative penalty criteria, recall and disposal procedures, and reporting, access, and inspection procedures as delegated by the law.
2. Key Provisions
- Establishment of Regular Harmful Substance Testing Procedures (Article 2)-
Sets detailed regulations regarding the procedure for requesting regular harmful substance testing, the timing for requesting tests on newly released tobacco products, and the format of the test result report.
- Clarification of the Submission Timing for Test Results (Article 3)-
Manufacturers and others are required to submit the test results to the Minister of Food and Drug Safety within 15 days of receiving the test results from the testing institution.
- Designation of Testing Institutions and Administrative Penalty Criteria (Articles 4 to 8)-
Defines the necessary documents for applying for designation as a testing institution, the requirements for facilities, equipment, and personnel, as well as provisions regarding changes in designation, reissuance of designation certificates, compliance matters for testing institutions, and criteria for administrative penalties against testing institutions.
- Establishment of Corrective Orders and Recall/Disposal Procedures (Article 9)-
Provides detailed regulations regarding the corrective order period, submission of recall plans, recall improvements, and submission of recall completion reports.
- Setting Fees for Testing Institutions (Article 10)-
Establishes fees for the application and modification of testing institution designations.
- Establishment of Reporting and Access/Inspection Procedures (Article 11)-
Defines the minimum quantity of tobacco to be collected for testing, the collection procedure, and the detailed regulations for reporting and inspection procedures, including submitting collected tobacco to the testing institution or the National Institute of Food and Drug Safety Evaluation.
