South Korea Regulatory News

On August 19, 2025, South Korea has announced a proposed revision to the regulation titled "Guidelines on the Preparation of Registration Application Data and Methods for Hazard Assessment" in line wi...

On July 30, 2025, South Korea notified WTO of proposed revision to the “Labelling Standards for Biocidal Products”. This amendment aims to make safety and usage information more accessible and int...

On July 29, the South Korean approved amendments to the enforcement decrees of the Act on the Registration and Evaluation of Chemical Substances (K-REACH) and the Chemical Control Act (CCA), set to ta...

On July 3rd, 2025, South Korea announced a partial amendment of Cosmetic Act, in response to international regulatory trends—such as mandatory cosmetic safety assessments recently adopted in the U....

On July 3rd, 2025, South Korea announced a partial amendment of Cosmetic Act, in response to international regulatory trends—such as mandatory cosmetic safety assessments recently adopted in the U.S. and China. The amendment aims to enhance its cosmetic safety standards to match or exceed global benchmarks.  

Key Contents  

1. Mandatory Cosmetic Safety Assessments 

• Cosmetic manufacturers (responsible sellers) must prepare and retain safety assessment documentation for each product before distribution or sale. 

• Assessments must be reviewed by qualified safety experts. 

• The Ministry of Food and Drug Safety (MFDS) may request submission of safety documents if health risks are suspected. 

• Administrative and financial support will be available to assist companies with compliance. 

2. Establishment of a Cosmetic Safety Information Center 

• MFDS will designate specialized institutions to act as Cosmetic Safety Information Centers, responsible for performing ingredient risk assessment, supporting product safety evaluations, training safety evaluators, conducting testing, R&D, and public education. 

3. Launch of an Integrated Cosmetic Information System 

• A centralized digital platform will be created to manage safety data, covering Ingredient risk assessments and manufacturing, import, and usage records. 

• Public agencies must share relevant data upon request, in compliance with privacy laws. 

4. Penalties & Compliance Measures 

• Companies that fail to prepare or store safety assessments, including those not complying with MFDS submission requests, will face legal penalties. 

• Specific products, such as those marketed for infants or children, will require stricter review. 

Implementation Timeline 

• Law will come into effect one year after promulgation, and enforcement dates may vary by product, based on production volume or market relevance, as determined by Presidential Decree. 

On July 8, 2025, South Korea announced the draft establishment of “Standard Quantity Thresholds for Hazardous Chemicals”.  In response to the overhaul of the toxic substance designation and manag...

On July 8, 2025, South Korea announced the draft establishment of “Standard Quantity Thresholds for Hazardous Chemicals”.  In response to the overhaul of the toxic substance designation and management framework, amendments to the subordinate legislation under the Chemical Substances Control Act are being proposed. The draft introduces specific quantity thresholds for hazardous chemicals, as delegated to the Chemical Safety Agency under Articles 19(2), 19(8), 23(12), 27(1), 27(7), and 29(1) of the enforcement rules. The goal is to establish a clear regulatory basis and update existing thresholds accordingly. 

Key Provisions of the Draft Regulation 

A. Classification-Based Quantity Thresholds 

A new reference table is introduced to determine standard control quantities based on the revised classification system under the Act on the Registration and Evaluation of Chemicals. The table covers: 

• Acute toxicity 

• Chronic toxicity 

• Physical and chemical hazards 

• Ecotoxicity 

Each group is assigned upper and lower threshold limits to reflect hazard severity. 

B. Updated and Expanded Quantity Criteria 

Existing quantity thresholds are revised to align with the updated hazard categories (acute, chronic, and ecological). A new minimum control threshold is introduced for lower-risk substances. 

Additional notes include: 

• For substances designated as accident-preparedness substances, specific thresholds listed in Annex 3 will apply. 

• For substances listed as items 282 and 557, if the material is in liquid form under standard conditions, the quantity marked with an asterisk (*) applies. 

• For entries marked ** or ***, the applicable threshold depends on whether the substance is handled in liquid or solid form. 

C. Consolidation of Existing Standards 

The quantity standards currently found in [Annex 3-2] of the enforcement rules will be migrated and integrated into a separate public notice by the Chemical Safety Agency for clarity and unified management. 

Public Comment Submission 

Stakeholders, including institutions, organizations, and individuals, are encouraged to submit feedback on this draft by July 21, 2025. Responses may be submitted online through the National Legislative Participation Center or by sending a written opinion including name, affiliation, contact information, and comments to the Director of the NICS. 

On July 6, 2025, South Korea proposed a full revision of the “Detailed Handling Standards for Hazardous Chemicals” to align with recent amendments to the Chemical Substances Control Act and the Ac...

On July 6, 2025, South Korea proposed a full revision of the “Detailed Handling Standards for Hazardous Chemicals” to align with recent amendments to the Chemical Substances Control Act and the Act on the Registration and Evaluation of Chemicals (K-REACH). These legislative changes shift the management system for toxic substance from a uniform to a differentiated framework based on chemical hazard levels. Consequently, the handling standards for hazardous substances need to be updated to reflect this new approach. 

Key Highlights of the Proposed Changes 

A. Updated Objective (Article 1 Draft) 

This regulation aims to establish specific handling guidelines and best practices for hazardous chemicals, as defined under Article 13 of the Chemical Substances Control Act and Rule 8, Annex 1 of its enforcement ordinance. 

B. New Definitions Introduced (Article 2 Draft) 

New terms are defined to clarify the scope of the regulation: 

• General Standards: Basic safety protocols that all handlers must follow, regardless of the substance’s hazard classification. 

• Substance-Specific Standards: Detailed handling requirements tailored to each hazardous chemical. 

• Core Handling Requirements: Mandatory safety measures based on a substance’s known risks. 

• Recommended Practices: Informational guidelines to support the safe handling of substances on-site. 

C. General Safety Requirements Established (Article 3 Draft) 

All handlers of hazardous substances must adhere to the following protocols: 

1. Fully understand the safety information before use. 

2. Wear the appropriate personal protective equipment (PPE). 

3. Avoid eating, drinking, or smoking near hazardous materials. 

4. Prevent environmental discharge through proper containment and disposal. 

5. Inform nearby personnel of potential dangers in case of spills or accidents. 

6. Dispose of any spilled or leaked chemicals in accordance with legal standards. 

Additionally, employers are responsible for ensuring immediate medical evaluation for workers suspected of exposure to hazardous substances. 

D. New Recommendations by Substance (Annex 1) 

A new annex provides guidance tailored to individual chemicals, supporting safer site-level management. 

E. Updated Hazardous Chemicals List 

The list of regulated substances has been revised and now includes new annotations for clarity and ease of use. 

F. Operational Improvements 

Minor amendments have been made to enhance the regulation’s usability and enforceability. 

Public Comments Invited 

Organizations, associations, or individuals who wish to provide feedback on the draft revision must submit their comments to the Chemical Safety Agency by July 27, 2025. Submissions should include relevant contact details and clear feedback on the proposed changes. 

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.