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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 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.