To improve the efficiency and consistency of testing harmful substances in tobacco products, South Korea has formally clarified the scope of regulated substances and detailed testing methodologies.
The Ministry of Food and Drug Safety (MFDS) has issued an official notice titled “Regulations on Harmful Substances in Tobacco Products”, establishing a comprehensive disclosure and inspection framework for cigarettes, e-cigarettes, e-liquids, and heated tobacco products.
1. Scope of Products Covered
1. Cigarettes
Products manufactured by processing tobacco leaves with added ingredients such as flavorings, then rolled into a smokable form using cigarette-making machines.
2. Electronic Cigarettes
Tobacco products or similar items that use electronic devices to deliver nicotine solutions, tobacco, or solid tobacco materials into the respiratory system, producing effects comparable to traditional smoking.
Electronic cigarettes are classified into three categories:
- Liquid-based e-cigarettes: Devices using nicotine-containing liquids
- Cigarette-type e-cigarettes: Devices that use cigarettes or solid tobacco sticks
- Other e-cigarettes: Any electronic smoking products not falling into the above categories
3. E-Cigarette Devices
Electronic terminals designed to heat nicotine liquids or solid tobacco materials, enabling users to inhale aerosol generated by the device.
2. Key Regulatory Requirements
Designation of Harmful Substances
The MFDS has formally identified harmful substances that must be monitored and disclosed:
- 44 harmful substances in cigarettes and electronic cigarettes, including nicotine, tar, and carbon monoxide
- 20 harmful substances specific to e-liquids, including nicotine, propylene glycol, and glycerin
Testing Standards
- Detection methods are established based on World Health Organization (WHO) guidelines and internationally recognized standards
- Testing procedures are standardized to ensure consistency and comparability across products
3. Mandatory Periodic Testing
Starting January 1, 2026, all manufacturers and importers must:
- Conduct harmful substance testing every two years
- Apply for testing on all cigarettes, e-cigarettes, and related products sold in South Korea
- Submit official test reports to the MFDS within the required timeframe
4. Public Disclosure of Information
The MFDS will publicly disclose:
- Ingredient information
- Toxicity data
- Carcinogenic and other health-related risk information
The first public disclosure is scheduled for mid-2026 and will be made available on the official MFDS website.
5. Penalties for Non-Compliance
Manufacturers or importers that fail to comply with the regulations may face:
- Sales suspension and mandatory recall orders issued by the MFDS
- A requirement to initiate product recalls within five days of receiving a recall order
- Submission of a detailed recall action plan to the MFDS
Failure to comply may result in further regulatory enforcement actions.
Why This Matters
This regulation represents a significant step in South Korea’s tightening oversight of tobacco and vaping products. Manufacturers, brand owners, and importers should begin preparing early by reviewing ingredient disclosures, aligning testing procedures with international standards, and ensuring internal compliance systems are in place ahead of the 2026 deadline.