Industrial Chemical

K-REACH 2025 Amendments: New Thresholds, Hazard Categories, and Compliance Obligations

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Korea Chemical Compliance | K-REACH, K-CCA and K-OSHA

To align with Korea's evolving chemical management framework, the Act on the Registration and Evaluation of Chemical Substances (K-REACH) has undergone a series of significant amendments in 2025. These updates reshape core mechanisms such as new substance notification thresholds, hazard determination standards, and interlinkages with the Chemical Control Act (K-CCA) and the Occupational Safety and Health Act (K-OSHA).

The reform affects new substance registration strategy, hazard communication, MSDS updates, substance confirmation documents, supply chain communication and transitional compliance planning for companies manufacturing, importing or distributing chemicals in Korea.

Introduction    |    New Thresholds    |    Unconfirmed Substances    |    New Hazard Categories    |    K-CCA    |    K-OSHA / MSDS    |    LOC    |    How REACH24H Can Help

Introduction

To help companies navigate this regulatory shift, REACH24H Consulting Group summarizes below the most important policy changes and compliance implications, focusing on new substance notification, “unconfirmed hazardous substances,” the new classification of human and environmental hazards, and related updates under the three key chemical regulations.

For businesses placing chemicals on the Korean market, these amendments should be reviewed together with K-REACH registration, Korea CCA compliance, Korean MSDS submission and CBI application, and downstream supply chain communication requirements.

Compliance note: The 2025 K-REACH reform is not limited to new substance tonnage thresholds. It also changes how hazard uncertainty, human health hazards, environmental hazards, MSDS updates and K-CCA transitional obligations should be managed.

New Substance Notification Thresholds

Starting January 1, 2025, Korea has raised the annual tonnage threshold for new substance registration under K-REACH. This adjustment means that substances manufactured or imported below 1 ton per year will only require notification, reducing administrative burdens for low-volume chemicals.

PeriodNotificationRegistrationBusiness Impact
Before Jan. 1, 2025< 0.1 ton/year≥ 0.1 ton/yearMore low-volume new substances were subject to registration.
From Jan. 1, 2025< 1 ton/year≥ 1 ton/yearLow-volume new substances may follow notification instead of full registration, but hazard communication duties still need attention.

Companies should not treat the higher threshold as a complete exemption. Substance identity, annual volume, use scenario, polymer status, hazard data availability and downstream communication obligations should still be reviewed before manufacturing or importing new substances into Korea.

Unconfirmed Hazardous Substances

A new category, “unconfirmed hazardous substances,” now applies to chemicals that have been notified or registered but lack sufficient data to determine their hazard properties, excluding polymers.

Key test items under OECD guidelines include:

  • Acute oral or inhalation toxicity (OECD TG 423/403);

  • Mutagenicity or in vitro chromosomal aberration tests (OECD TG 471/473);

  • Acute aquatic toxicity, including fish, daphnia and algae (OECD TG 201/202/203);

  • Biodegradability (OECD TG 301).

Effective date: August 7, 2025. The category applies to new substance notifications submitted on or after this date.

If a substance meets any of the above “unconfirmed” criteria, the registration certificate will state:

“The applicant has confirmed this substance as an unconfirmed hazardous substance.”

Such substances must be managed in accordance with safety guidelines, treated as hazardous for human health and/or the environment, and their information, including MSDS information, must be communicated to downstream users.

Triggering Data GapExample Test EndpointCompliance Impact
Human health hazard uncertaintyAcute oral / inhalation toxicity, mutagenicity, chromosomal aberration.Substance may need to be managed as potentially hazardous and communicated downstream.
Environmental hazard uncertaintyAquatic toxicity and biodegradability data.MSDS, label communication and risk management measures may need to reflect uncertainty.

New Hazard Classification: Human and Environmental Hazardous Substances

From August 7, 2025, the former category of “toxic substances” under K-CCA is officially replaced by a more detailed framework. The new system distinguishes human acute hazardous substances, human chronic hazardous substances and environmental hazardous substances.

CategoryDefinitionExample Criteria
Human Acute Hazardous SubstancesSubstances causing short-term adverse health effects after acute exposure.Acute toxicity (oral, dermal, inhalation Cat. 1–3), skin corrosion (Cat. 1A–1C), STOT SE Cat. 1.
Human Chronic Hazardous SubstancesSubstances causing adverse health effects after repeated or delayed exposure.Chronic toxicity Cat. 1, mutagenicity Cat. 1, carcinogenicity Cat. 1A/1B, reproductive toxicity Cat. 1.
Environmental Hazardous SubstancesSubstances causing adverse effects on aquatic organisms.Acute or chronic aquatic hazard Cat. 1.

Official Publication of the Updated “Human and Environmental Hazardous Substances” List

The Korean Ministry of Environment (MoE) has officially released the updated list of Human and Environmental Hazardous Substances. The key changes are summarized as follows:

  • Reclassification of existing toxic substances: The 1,246 substances previously designated as “toxic substances” under the former system retain their original substance IDs but are now reclassified according to the new hazard categories. In addition, 19 substances that no longer meet the revised hazard determination criteria have been removed from the list, such as ethyl acetate (CAS No. 141-78-6).

  • Subdivision by compound type: In cases where salts or derivatives of a given substance share the same base ID, sub-identifiers are now introduced to distinguish between variants, for example among silver salts.

  • Multiple hazard classifications with varying thresholds: For substances possessing more than one hazard type, different mixture concentration thresholds are assigned for each classification. For instance, a mixture containing 1% silver nitrate is classified as an environmental hazardous substance, whereas a mixture with ≥10% silver nitrate is classified as both environmental and human acute hazardous.

Example: Classification of Hazardous Substances (Silver Salts)

Substance Type IDSub-IDSubstance NameCAS No.Human Acute Hazardous Content in Mixture (%)Human Chronic Hazardous Content in Mixture (%)Environmental Hazardous Content in Mixture (%)Hazardous Substance Type
97-1-921Inorganic silver salts (excluding those otherwise specified in this notice)-10-25Human Acute Hazardous / Environmental Hazardous
97-1-922Silver nitrate7761-88-810-1Human Acute Hazardous / Environmental Hazardous
97-1-923Silver sulfate10294-26-5 / 19287-89-9--1Environmental Hazardous

The classification thresholds reflect Korea’s enhanced hazard differentiation approach under the 2025 K-REACH framework. Substances with overlapping hazard profiles are now subject to category-specific labeling and risk management requirements.

Companies can search the updated database through the K-REACH online system where available.

Alignment with Related Regulations: K-CCA

To synchronize with K-REACH, the K-CCA has introduced transitional measures. Domestic companies that distribute or use newly designated human/environmental hazardous substances or substances in mixtures for which the specified threshold is reduced before January 1, 2026 may benefit from a grace period. After this date, no grace period applies for newly introduced substances.

DeadlineRequired ActionsCompany Focus
July 1, 2026Submission of substance confirmation (LOC), hazard labeling, import declaration.Review product inventory, LOC formats, labels and import declaration requirements.
Jan. 1, 2027Implementation of operational standards.Prepare internal operating procedures and compliance records.
Jan. 1, 2028Chemical accident prevention plan, permit applications.Assess whether facilities, volumes and substance categories trigger accident prevention or permit obligations.
Jan. 1, 2030Facility establishment and management standards.Prepare facility-level risk management, storage and handling standards.

Special note: For mixtures containing benzene (CAS 71-43-2) at 0.1–1%, the grace period is extended by an additional two years.

Under K-OSHA: MSDS and Communication Updates

From August 7, 2025, MSDS formats must reflect the following updates:

1. For Unconfirmed Hazardous Substances

  • Information must appear under Section 15 (Regulatory Information).

  • The information includes substance identifiers, such as CAS No., confirmation of “unconfirmed” status, and missing test endpoints.

  • The information must be provided to downstream users immediately after receiving the notification certificate.

2. For Human/Environmental Hazardous Substances

  • Update Section 15 (2) “K-CCA” and Section 15 (3) “K-REACH” to reflect new substance classifications.

  • Old MSDS templates can be used until June 30, 2026 if updated accordingly.

  • From July 1, 2026, only new versions are valid.

Compliance note: MSDS updates should be coordinated with K-REACH notification certificates, K-CCA classification status, downstream communication and Korean MSDS submission or CBI application obligations.

Substance Confirmation (LOC) Version Updates

As of 2025, three official LOC formats have been released:

VersionIssued byKey ChangeValid Until / Recommended Use
Pre-2025Korea Chemical Management Association (KCMA)Legacy formatValid until Dec. 31, 2025
2024.12 VersionKECOFormat updated, content unchangedInterim updated format
2025.7 VersionKECOUpdated to reflect new “Human and Environmental Hazardous Substances”Recommended from Aug. 7, 2025

Key Takeaways for Industry

The 2025 K-REACH reform represents a major structural upgrade in Korea’s chemical management system, moving toward a more data-driven, risk-based, and harmonized approach.

REACH24H Consulting Group advises companies to:

  • Review their substance inventories against the new thresholds and classifications.

  • Assess whether any materials fall under the new “unconfirmed” or “human/environmental hazardous” categories.

  • Update internal compliance procedures, MSDS templates, and supply chain communication in advance.

  • Review whether additional obligations apply under K-CCA, K-OSHA, MSDS submission, CBI application, LOC and import declaration requirements.

Need to assess how the 2025 K-REACH amendments affect your substances?

REACH24H can help you review new substance thresholds, identify unconfirmed or human/environmental hazardous substances, update Korean MSDSs and manage K-CCA and K-OSHA compliance actions.

   Contact Our Korea Compliance Specialists  

How REACH24H Can Help

REACH24H provides Korea chemical regulatory compliance support for companies manufacturing, importing, distributing or using chemicals in Korea. Our services cover K-REACH registration and notification, K-CCA compliance, Korean MSDS submission, CBI application, supply chain communication and compliance gap assessment.

Support AreaREACH24H Services
K-REACH Threshold and Registration AssessmentAssess whether substances require notification or registration under the updated 2025 K-REACH threshold framework.
Unconfirmed Hazardous Substance ReviewReview data gaps, OECD endpoint availability and downstream communication obligations for unconfirmed hazardous substances.
K-CCA Hazard Category AssessmentCheck whether substances or mixtures fall under human acute, human chronic or environmental hazardous categories and identify transitional obligations.
Korean MSDS Submission and CBI ApplicationSupport Korean MSDS submission and CBI application, Section 15 updates and downstream information transfer.
LOC and Import ComplianceSupport substance confirmation, LOC format review, import declaration and Korean supply chain documentation.
Integrated Korea Chemical ComplianceProvide integrated support for K-REACH, Korea CCA, MSDS, CBI and GHS-related compliance obligations.

Conclusion

The 2025 K-REACH amendments bring substantial changes to Korea’s chemical compliance framework. While the increased new substance threshold may reduce the administrative burden for low-volume chemicals, the new unconfirmed hazardous substance category and human/environmental hazardous substance framework introduce new obligations for hazard communication, MSDS updates, LOC management and K-CCA compliance.

Companies should review their substance inventories, identify affected substances and mixtures, update MSDS and supply chain communication procedures, and confirm whether transitional grace periods or new compliance deadlines apply.

Recommended Reading

Official References