List of Substances Acutely/Chronically Hazardous to Human Health and Substances Hazardous to the Environment

The List of Substances Acutely/Chronically Hazardous to Human Health and Substances Hazardous to the Environment was published on August 7, 2025, repealing and replacing the previous Toxic Chemical Substances List. Under K-REACH, registered chemical substances will undergo hazard assessments. If the hazard assessment results reveal that a substance poses risks to human health or the environment and meets the designation criteria specified in Annex 1 of the K-REACH Enforcement Decree, the substance will be included in the List through public notice. Listed substances are further classified into three categories based on their level of hazard:
- Substances Acutely Hazardous to Human Health: Chemicals that may cause adverse effects on human health within a short period following single or short-term exposure.
- Substances Chronically Hazardous to Human Health: Chemicals that may adversely affect human health through repeated exposure or after a latency period.
- Substances Hazardous to the Environment: Chemicals that may adversely affect the environment, such as aquatic organisms, through short- or long-term exposure.
According to the K-CCA amendment released in February 2024 (effective August 7, 2025), “hazardous substances” refer to substances acutely hazardous to human health, substances chronically hazardous to human health, substances hazardous to the environment, and accident precaution substances, excluding prohibited substances and restricted substances. Under K-CCA, safety measures must be implemented for the production, import, sale, storage, and use of hazardous substances to minimize risks to human health, animals, and the environment.

Substances in the List or or mixtures thereof require businesses to fulfill relevant obligations under the Chemical Control Act (K-CCA) and its Enforcement Rules:
- Manufacturers or importers must submit a “Letter of Confirmation (LoC)” pursuant to Article 9 of the K-CCA.
- The manufacture, import, sale, storage, transportation, or use of listed substances shall meet the relevant conditions specified in Article 13 of the K-CCA and Annex 1 of the K-CCA Enforcement Rules.
- For the manufacture, import, sale, storage, transportation, or use of listed substances, GHS labels shall be updated in accordance with Article 16 of the K-CCA.
- Importers shall submit an import declaration in accordance with Article 20 of the K-CCA.
- Enterprises installing or operating relevant facilities must prepare a chemical accident prevention and management plan in accordance with Article 23 of the K-CCA and comply with the standards specified in Article 24 of the K-CCA and Annex 5 of the K-CCA Enforcement Rules.
- Entities planning to engage in hazardous substance operations must obtain the corresponding license in accordance with Article 28 of the K-CCA.
Note: If the substances in the List are confirmed as new chemical substances, their manufacturers or importers shall complete the new chemical registration or new chemical notification under K-REACH before the manufacture and import.