South Korea Regulatory News

On June 18, 2025, South Korea issued an official notice outlining a complete revision of the national regulation titled, “Notification on the Installation and Management of Facilities for the Manufa...

On June 18, 2025, South Korea issued an official notice outlining a complete revision of the national regulation titled, “Notification on the Installation and Management of Facilities for the Manufacture, Use, and Storage of Hazardous Chemicals”. This comprehensive amendment is part of an ongoing effort to enhance chemical safety and modernize risk management practices in line with recent legislative changes under the Chemical Substances Control Act (K-CCA). 

The purpose of the regulatory update is to subordinate newly introduced categorization of toxic substances (those with acute or chronic human toxicity, and ecotoxic substances) and specify the standards for each category. The key aspects of the amendment include:  

• Consolidation of existing notifications. 

• Establishment of differentiated facility standards based on categories. 

• Improvement of weakness and operational deficiencies in the current standards.  

Key Amendments 

This legislative revision aims to improve safety and regulatory efficiency in several critical areas: 

1. Integration of Related Notifications 

• The revised notification consolidates and restructures safety standards, shifting the focus from manufacturing and usage facilities to storage facilities.  

• This integration provides a clearer regulatory framework by aligning the rules with specific facility types and hazard classifications, ensuring consistency across different stages of chemical handling. 

2. Differentiated Facility Standards Based on Categories 

• The revised standards introduce tailored technical requirements according to the types of chemical hazards: human acute toxicity, human chronic toxicity, and ecological toxicity.  

• Facility criteria are now categorized into three detailed annexes (Annexes 1–3), each corresponding to a specific hazard class. This differentiation allows for more precise risk management and facility design based on the chemical properties involved. 

3. Improved Safety and Operational Guidelines for Chemical Handling Facilities 

• New safety protocols focus on storage-specific risks, including enhanced requirements for leakage detection, emergency response systems, spill containment, ventilation, labeling, and access control.  

• Operational guidelines have been updated to include detailed procedures for receiving, storing, and tracking chemicals.  

• A transitional grace period has been introduced for certain high-risk substances, allowing facilities time to comply with newly mandated emission control systems. 

Public Comments 

Stakeholders, including businesses, industry associations, academic institutions, and individuals, are encouraged to review the proposed amendment and provide feedback. Comments must be submitted in writing to the National Institute of Chemical Safety by July 7, 2025.  

On June 11, 2025, South Korea published a draft regulation under the Chemical Substances Control Act (K-CCA) concerning the chemical safety framework. This action follows the restructuring of the toxi...

On June 11, 2025, South Korea published a draft regulation under the Chemical Substances Control Act (K-CCA) concerning the chemical safety framework. This action follows the restructuring of the toxic substance classification system, which now differentiates regulatory levels based on hazard type—particularly between chronic human toxicity and physical hazards. 

Previously, certain chemicals were excluded from strict control if they only posed chronic health risks. However, despite not being classified as "hazardous chemicals", some of these substances still carry significant physical risks that could lead to chemical accidents or exacerbate their impact. 

Key Changes 

• Regulatory Authority Transfer: The authority for designating "Accident Preparedness Substances" will shift from the Ministry of Environment to the National Institute of Chemical Safety (NICS) via formal notice. 

• New Substance Additions:  Three substances will be added to the list of accident preparedness substances due to their physical hazard profiles: 

  • Xylene 
  • Styrene 
  • 1,3-Butadiene 

These chemicals are currently managed as toxic substances for their chronic human health effects, but the revision addresses their potential to cause or worsen chemical accidents. 

Public Comments: 

NICS is accepting public feedback on this proposal. Stakeholders can submit opinions either online or offline by June 28, 2025. 

On May 28, 2025, South Korea notified the World Trade Organization (WTO) of a proposed amendment to the designation and safety/labeling standards for daily use consumer chemical products under the Che...

On May 28, 2025, South Korea notified the World Trade Organization (WTO) of a proposed amendment to the designation and safety/labeling standards for daily use consumer chemical products under the Chemical Products Safety Act. The revision aims to strengthen mandatory safety standards and streamline regulatory measures based on updated risk assessments. 

Key Changes: 

• Product Category Removal: Tattoo ink products will be removed from the list, as they will be transferred to the Ministry of Food and Drug Safety as of June 14, 2025. 

• Labeling Improvements for Reusable Products: Moisture absorbers with refillable containers will require clearer labeling and updated precautionary wording. 

• New Safety Warnings for Combustible Items: Products such as scented candles and air fresheners that involve combustion must include specific usage warnings. 

• Child-Resistant Packaging Notices: Liquid products that may qualify for child-resistant packaging due to pH changes during use must include recommended warnings. 

• Clearer Substance Management and Labeling: The chemical names of substances subject to regulation and analysis will be standardized for improved clarity and compliance. 

Public Feedback: 

WTO opens public feedback period of 20 days since the notification date. Individuals and organizations are encouraged to submit their opinions on the proposed changes by June 17, 2025. 

On May 19, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the “Special Act on Imported Food Safety Control” aimed at strengthening consumer safety by regul...

On May 19, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the “Special Act on Imported Food Safety Control” aimed at strengthening consumer safety by regulating the use of recycled materials in imported food-contact items such as utensils and packaging. Although Korea’s Food Sanitation Act already regulates the use of recycled materials in domestically produced food-contact items, there are currently no safety standards for recycled materials used in imported items. This gap poses a potential health risk torec consumers. The proposed amendment introduces a system to ensure that recycled materials used in imported utensils, containers, and packaging comply with Korean food safety standards. 

Key Provisions 

1. Mandatory Safety Certification for Recycled Materials (Article 10-3) 

• Importers of food-contact products made with recycled materials must obtain prior approval from the Ministry of Food and Drug Safety (MFDS) to verify that the materials meet the safety criteria under the Food Sanitation Act. 

• Importers must submit the required documentation and may be asked to provide additional safety data. 

• If approved, the MFDS will issue an official certification. 

• Certifications obtained through false or misleading means will be revoked. 

2. Ban on Non-Certified Recycled Material Imports (Article 10-4) 

• It is strictly prohibited to import or sell any food-contact articles made with recycled materials that have not received official MFDS approval. 

3. Enforcement and Penalties (Article 42 Amendment) 

• Violators who import or distribute non-certified recycled products will be subject to regulatory penalties under the revised Article 42. 

On May 16, 2025, South Korea launched the construction of the nation’s first dedicated animal-free testing facility, with the aim of promoting ethical scientific practices and improving chemical saf...

On May 16, 2025, South Korea launched the construction of the nation’s first dedicated animal-free testing facility, with the aim of promoting ethical scientific practices and improving chemical safety assessments. The facility is being built at the headquarters of the Korea Environment Corporation (K-ECO) in Incheon and is scheduled for completion in October 2026. 

This project supports the global shift towards alternatives to animal testing, aligning with similar moves by the EU and the United States. It will also contribute to South Korea’s national goal of replacing over 60% of toxicity testing with alternative methods by 2030. 

Key Contents  

1. Facility Overview: 

• Size: 7,499㎡, with 4 floors above ground and 1 basement level. 

• Budget: ₩33.4 billion (approximately $24 million). 

• Focus: Testing using human cells, artificial organs, 3D models, and AI simulations. 

2. Functions and Services: 

• Perform non-animal toxicity assessments. 

• Operate a training center for researchers. 

• Host international conferences and workshops. 

• Support certification and provide technical guidance for private testing labs. 

 3. Legal and Policy Support: 

• Based on Korea’s Chemical Substances Control Act. 

• Government policy promotes animal alternatives as a first option. 

Awareness and Engagement Activities  

To coincide with the launch, the Ministry designated May 16–23 as "Animal-Free Testing Awareness Week". Activities include: 

• May 16: Government–industry roundtable on alternative testing. 

• May 20: Expert workshop in Seoul covering: 

• Current government strategies. 

• Case studies from private labs. 

• Research updates and mental health support for animal researchers. 

This facility is expected to reduce dependence on animal testing, lower costs, and improve the accuracy and speed of testing. South Korea aims to become a global leader in ethical, science-driven toxicology and chemical safety. 

On May 9, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the "Regulation on the Permission, Notification, Review, etc of Medical Devices”. The revision aims ...

On May 9, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the "Regulation on the Permission, Notification, Review, etc of Medical Devices”. The revision aims to clarify cybersecurity documentation requirements for medical devices that use wired or wireless communication. It also aligns clinical trial data requirements with international standards and addresses administrative inefficiencies identified during prior regulatory operations. 

Key Contents  

1. Procedures for Deferral of New Health Technology Assessment 

The regulations now establish clear steps for applying for approval or certification to defer new health technology evaluations. This includes adding clinical evaluation data as a new type of clinical trial documentation and providing detailed guidance on how to prepare each section. 

2. Unified Oversight for Class II Medical Device Certification 

Applicants seeking confirmation for products equivalent to already-certified Class II devices must now submit documentation to the Ministry of Food and Drug Safety (MFDS) which centralizes the process. 

3. Clarification of Manufacturing and Import Filing Procedures 

Following the amendment to the Medical Device Act Enforcement Rules, the procedure for reviewing manufacturing and import reports has been clearly defined to enhance transparency. 

4. Cybersecurity Requirements for Medical Devices 

The amendment introduces a formal definition of cybersecurity for medical devices and requires that detailed cybersecurity information be included in approval applications. Multiple related provisions and documentation templates have been updated accordingly. 

5. Support Measures for Innovative Medical Devices 

Newly developed medical devices are now eligible for expedited review. However, the exemption from submitting clinical trial data based on equivalence during post-market surveillance is restricted to ensure safety. 

6. Expanded Scope for Technical Documentation 

Examples of situations requiring the submission of clinical data are now included to help clarify when such data is necessary, thereby improving predictability and compliance. 

Public comments 

Individuals or organizations with feedback on the draft amendment may submit written comments by May 20, 2025. 

On March 27, 2025, South Korea’s Ministry of Employment and Labor (MOEL) released a list of 72 new chemical substances that were manufactured or imported into the country during the first quarter (Q...

On March 27, 2025, South Korea’s Ministry of Employment and Labor (MOEL) released a list of 72 new chemical substances that were manufactured or imported into the country during the first quarter (Q1) of 2025. The announcement is part of Korea’s continued effort to ensure chemical safety in workplaces under the Korea Occupational Safety and Health Act (KOSHA). Consequently, employers are urged to review the published list, implement the recommended safety measures, and educate all workers, especially foreign employees, on the proper chemical handling practices. 

Key Contents 

• Total Substances Announced: 72 new chemical substances registered in Q1 2025. 

• Hazardous Substances Identified: 32 substances, including 2-methylpiperazine, found to pose risks such as: 

• Acute toxicity 

• Reproductive toxicity 

• Skin corrosion/irritation 

 Compliance Requirements for Manufacturers and Importers 

• Pre-Notification Obligation: Manufacturers and importers must submit a hazard and risk assessment report to the MOEL 30 days before production/import. 

• Safety Measures for Employers: 

• Provide personal protective equipment (PPE) 

• Install local exhaust ventilation 

• Maintain and display Material Safety Data Sheets (MSDS) 

• Use proper hazard warning labels 

Foreign Worker Safety 

• To improve chemical safety for foreign employees, MOEL has published MSDS and label training materials in 17 languages, including English, Vietnamese, Chinese, and more. These materials help workers recognize hazard symbols and understand key safety instructions.