Korea's 2025 Chemical Regulatory Overhaul: What Global Industry Needs to Know

In August 2025, South Korea finalized sweeping reforms to its chemical regulatory framework, including the Chemical Control Act (CCA), the Act on the Registration and Evaluation of Chemicals (K-REACH), and the Ministry of Employment and Labor's (MoEL) Material Safety Data Sheet (MSDS) standards. These amendments mark one of the most consequential shifts in Korea's regulatory landscape, impacting manufacturers, importers, and downstream users alike.

Companies operating in or supplying to the Korean market must now undertake immediate compliance planning, portfolio reviews, and safety documentation updates to align with the new obligations. This article provides an expert analysis of the amendments, their implications, challenges for industry, and the areas that require close monitoring going forward.

1. Amendments to the Chemical Control Act (CCA)

On August 7, 2025, the National Institute of Chemical Safety (NICS) finalized the reclassification of toxic substances into three new hazard categories:

• Acutely Hazardous to Human Health
• Chronically Hazardous to Human Health
• Hazardous to the Environment

This action replaces the long-standing single category of “Toxic Chemicals.” The change was prompted by increasing concerns that the growing number of toxic chemicals (over 1,100 by December 2022) imposed excessive administrative burdens and overly restrictive controls on substances of relatively low hazard or common use. For example, mixtures with just 0.1% benzene were classified as toxic, subjecting a widely used substance like gasoline (0.7% benzene) to stringent protective measures. The new approach aims to achieve more nuanced and effective management by grouping substances by hazard type and severity.

Notice No. 2025-19 via Gwanbo, Korea's official gazette, requires all toxic chemicals - with IDs from 97-1-1 to 2025-1-1280 - to be reclassified into the three new hazardous categories. Each toxic chemical substance is newly categorized based on concentration thresholds and other hazard criteria. For example, guazatine (CAS RN 13516-27-3, 108173-90-6), is now classified as acutely hazardous to humans if the mixture containing it exceeds 1% and hazardous to the environment if it exceeds 25%.

Companies should note that substances not previously listed as toxic chemicals have been newly added (e.g., IDs from 2025-1-1264 octabromodiphenyl oxide to ID 2025-1-1280 silicon tetrafluoride). Companies also can search for a substance in the new classifications of hazardous groups in the government-operated database portal system (English version site). The revision took effect August 7, 2025, with a grace period until July 1, 2026.

Impacts of the CCA Amendment

Companies must update multiple dossiers to include new CCA hazardous categories. They must use the revised Letter of Confirmation (LoC Form, see Figure 1) to identify chemicals meeting the hazardous definition. Under Article 9 of the CCA, chemical identification is required before manufacturing or importing products into Korea, with the LoC as a mandatory submission.

For imports, foreign manufacturers or Korean importers are responsible for submitting the LoC. According to NICS's recent notice, the revised LoC was effective starting August 7, 2025, with a grace period until December 31, 2025. While a grace period is granted, the authority is encouraging industry to use the revised LoC Form as soon as possible.

The new CCA hazardous chemicals categories also must be reflected in post-market facility management. Pursuant to CCA Article 23, companies installing or handling hazardous chemicals at their facilities must assess potential off-site accident impacts and submit a Chemical Accident Prevention and Management Plan to the MoE. The Regulations on the Quantity of Hazardous Chemicals set minimum/maximum holdings in Appendices 2 (Hazardous Chemicals).

Furthermore, new CCA hazardous chemicals in the three categories must be displayed in the Korean MSDS. Details will be provided in the MoEL Notice on MSDS section in this article.

2. Amendments to K-REACH

Starting January 1, 2025, K-REACH offers redefined registration thresholds and hazard designations. New chemicals manufactured or imported at ≥1 ton/year must be registered. Below this threshold, substances require notification rather than full registration, reducing the regulatory burden for some companies/chemicals. However, companies now provide certain hazard data during notification. Without such data, the chemicals are designated as Substances with Unidentified Hazards.

K-REACH Rule Appendix 1(2) provides the parameter of substances considered as unidentified hazards:

“Substances with Unidentified Hazards” refers to chemical substances that fall under any of the following categories, excluding polymers:

• Chemical substances for which acute oral toxicity has not been confirmed. However, in cases where the substance is gaseous at room temperature or its main exposure route is determined to be inhalation, this refers to substances for which acute inhalation toxicity has not been confirmed.
• Chemical substances for which neither mutagenicity (reverse mutation) nor chromosomal aberration (using cultured mammalian cells) has been confirmed.
• Chemical substances for which none of the following has been confirmed: acute toxicity in fish, acute toxicity in daphnia, or growth inhibition in freshwater algae.
• Chemical substances for which biodegradability has not been confirmed.

These substances are considered hazardous until data proves otherwise. They require certain safety measures and disclosure in Chemical Safety Information (CSI) for downstream users and possibly in MSDS (per KOSHA, MoEL agency, recommendations).

3. MoEL Notice on MSDS (No. 2025-50)

The Ministry of Employment and Labor (MoEL) issued the MoEL Notice No. 2025-50 on August 6, 2025, amending the legally binding Standards for Classification and Labeling of Chemical Substances and Material Safety Data Sheets under the Korean Occupational Safety and Health Act (KOSHA). The amended standards overhaul Section 15 of the MSDS format effective August 7, 2025. The revision introduced K-REACH as a new subhead within Section 15, shifting the order of other regulatory references. This alignment ensures consistency with the restructured CCA/K-REACH classification framework. Below are the core changes found in the revised MSDS Standards.

• Classification criteria and pictograms are revised on certain hazard categories such as flammable liquids (Appendix 1 in the Standards).
• Section 15 (Appendix 4 in the Standards) includes a change to its Subhead layout with the addition of K-REACH for the third subhead:
  • Section 15: Regulatory Information
    • 1: Occupational Safety and Health Act (K-OSHA)
    • 2: Chemical Control Act (CCA)
    • 3: Act on Registration and Evaluation of Chemicals, etc. (K-REACH) – newly added
    • 4: Dangerous Substances Safety Management Act (DSSMA) – change from 3 to 4
    • 5: Waste Control Act – change from 4 to 5
    • 6: Other domestic and foreign regulations – change from 5 to 6

Under the CCA in Section 15, newly classified hazardous chemicals (formerly “Toxic Chemicals”) must be disclosed. However, industry has not been given clear guidelines by the authority on whether to include specific cut-off values for hazards or simply state “listed” or “not listed” for each hazard group.

Another challenge is displaying “substances with unidentified hazards” under the newly added K-REACH sub-heading. KOSHA, MoEL agency, which provides guidance to display the following items when disclosing unidentified hazards:

• Unidentified hazard criteria (e.g., hazards confirmation for acute oral toxicity, mutagenicity, aquatic toxicity, and biodegradability is not confirmed/pending).
• Handling Instructions such as: “Safe handling in accordance with the National Institute of Chemical Safety's guidelines for substances with unidentified hazards under Article 5 of the Act is required.”

Industry feedback has highlighted practical difficulties in implementing these changes within the one-year grace period ending June 30, 2026. Companies must closely monitor further clarifications from the MoE and its sub-agency KOSHA, which have issued preliminary but non-binding recommendations.

4. Industry Impacts and Compliance Challenges

Some of the most important impacts and challenges of the new regulatory reforms include:

• Companies must reclassify large numbers of substances, update SDSs/labels, and prepare new dossiers.
• K-REACH notifications require hazard data; missing data leads to the “unidentified hazard” designation, adding to the compliance burden.
• The grace period until mid-2026 is short, relative to the scope of required updates. It will require rapid internal mobilization and supplier coordination.

5. Key Timelines

6. Outlook and Conclusion

South Korea's 2025 reforms represent a paradigm shift in chemical regulation, aiming for greater hazard differentiation and alignment with international frameworks. However, they also impose significant short-term burdens on industry, especially given the tight deadlines and ongoing ambiguities.

Companies must immediately establish compliance strategies, initiate data gathering programs, and engage proactively with Korean authorities. Monitoring forthcoming MoEL/KOSHA guidance on MSDS formatting, updates to the list of unidentified hazards, and enforcement practices for LoC submissions will be critical.

Companies that act early and invest in compliance readiness will reduce regulatory risks, maintain market access, and strengthen trust with regulators and stakeholders.