| Key Amendments to the Lower Regulations of K-REACH & Chemical Substances Control Act |
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| In anticipation of forthcoming implementation of the amended Act on Registration and Evaluation of Chemical Substances (“K-REACH“) and Chemical Substances Control Act (“CSCA”), the government has been amending relevant lower regulations. These amendments will come into effect on August 7, 2025 along with the amended K-REACH/CSCA. Key changes include: (i) overhaul of the toxic substance designation and management system; (ii) a dual permit/notification system based on risk level & handling volume of workplace, (iii) relaxed qualification standards for hazardous chemical substance supervisors; (iv) the introduction of “substance with unconfirmed hazard” system, and (v) expanded scope of information disclosure. |
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| [Amendments Related to the CSCA] |
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| Differented Facility Standards Based on Restructuring of Toxic Substances Designation and Management System |
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Under the amended CSCA, the existing definition of “toxic substance” (Article 2 of the amended CSCA) will be replaced with “substances hazardous to humans, etc.”, a collective term referring to (i) substances with acute human toxicity, (ii) substances with chronic human toxicity, and (iii) substances with ecological toxicity. Reflecting this change, the Notification on Designation of Toxic Substances will be re-titled as “Notification on Designation of Substances with Acute Human Toxicity, Substances with Chronic Human Toxicity, and Substances with Ecological Toxicity.” Each toxic substance will be reclassified under this new system and assigned new concentration criteria based on its hazard level (Administrative Notice of Partial Amendment to Notification on Designation of Toxic Substances (National Institute of Chemical Safety (“NICS”) Notification No. 2025-86)). |
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When handling these newly defined ‘substances hazardous to humans, etc.,’ certain obligations such as regular and unscheduled inspections of handling facilities and safety diagnosis will vary, depending on the hazard classification of the substance and the volume handled. |
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Various grace periods will be provided (until July 1, 2026 through January 1, 2030) to allow time to prepare for compliance with the new requirements. |
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Currently, the installation and management standards for hazardous chemical substance-handling facilities are prescribed in nine separate notifications based on facility type, which will be consolidated into the following five notifications: |
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Installation and Management of Manufacturing, Use, and Storage Facilities of Hazardous Chemical Substance (Notification No. 2025-69) |
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Installation and Management of Warehouse Facilities of Hazardous Chemical Substance (Notification No. 2025-70) |
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Installation and Management of Vehicular Transportation Facilities for Hazardous Chemical Substance (Notification No. 2025-35) |
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Installation and Management of Vehicular Conveyance Facilities for Hazardous Chemical Substance (Notification No. 2025-89) |
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Installation and Management of Outside Piping Transportatio Facilities for Hazardous Chemical Substances (Notification No. 2025-90) |
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Meanwhile, the upper and lower tiers for ‘substances hazardous to humans, etc.’ have been adjusted according to the substances’ hazard/risk levels, and a ‘lower-lower tier (“LLT”)’ category has been introduced (the draft Regulation on Threshold Quantities of Hazardous Chemical Substances (NICS Announcement No. 2025-85)). Facilities handling quantities of a substance below this LLT will be exempt from facility installation inspections and periodic inspections (Article 24, Paragraph 4, Item 4 of the amended CSCA; Article 23, Paragraph 12 of the proposed amendment to the CSCA Enforcement Rules). |
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| Dual Permit/Notification System Based on Risk Level & Handling Volume of Workplace |
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If a facility handles hazardous chemical substances at a level below the lower tier, but at or above the introduced LLT as defined in the draft Regulation on Threshold Quantities of Hazardous Chemical Substances, the facility will be required to file a “notification for hazardous chemical substance business” requirement rather than to obtain a permit. In other words, such cases are designated as requiring a simple reporting of operations (registration) instead of a permit (Article 28, Paragraph 6 of the amended CSCA; Article 27 of the proposed amendment to the CSCA Enforcement Rules). This change is expected to ease the regulatory burden on small and medium-sized businesses, which will in many cases see their obligation shift from obtaining a permit to filing a notification. |
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| Relaxed Qualification Standards for Hazardous Chemical Substance Supervisors |
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Any person who has filed a notification for hazardous chemical substance business is required to appoint at least one hazardous chemical substance supervisor. Under the proposed amendment, the standards for appointing additional hazardous chemical substance supervisor for the hazardous chemical substance sales businesses are now relaxed: previously one additional supervisor was required per every 500 employees, but this threshold will be changed to one per 5,000 employees (Article 32 of the amended CSCA; Article 33 of the proposed amendment to the CSCA Enforcement Rules). |
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| [Amendments Related to K-REACH] |
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| Creation of ‘Substance with Unconfirmed Hazard’ |
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Under the amended K-REACH, a definition of ‘substance with unconfirmed hazard’ has been newly established, and accordingly, the K-REACH Enforcement Rules now prescribe detailed criteria for this new substance. Under the new criteria, if the data provided at the time of registration or declaration of a substance are insufficient to confirm the hazard for any one of the following five hazards, the substance will be classified as a ‘substance with unconfirmed hazard’ (Article 2 of the amended K-REACH; Article 2-2 & [Annex 1-2] of the proposed amendment to the K-REACH Enforcement Rules). |
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Acute oral toxicity (acute inhalation toxicity if the main exposure pathway is determined to be inhalation at room temperature or for use) |
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Mutagenicity or in vitro mammalian chromosomal aberration |
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Acute toxicity in fish, crustacea, or hindrance to the growth of freshwater algae |
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| Polymer compounds are excluded from this category. Note that the ‘substance with unconfirmed hazard’ designation only applies to the substances notified on or after August 7, 2025. |
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Any person handling a ‘substance with unconfirmed hazard’ is required to presume the substance to be hazardous until it is proven not to be, and must take appropriate measures to prevent any harm to human health or the environment in the meantime (Article 5, Paragraph 6 of the amended K-REACH). |
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Meanwhile, the scope of data that may be submitted when declaring a non phase-in substance has been expanded: previously only data already possessed by the declarant may be submitted, but now data that have been newly obtained or confirmed may also be submitted (Article 6-3 of the proposed amendment to the K-REACH Enforcement Rules). In addition, a new condition has been added to the criteria for when an amended declaration is required – specifically, when a substance no longer meets the citeria for being classified as a ‘substance with unconfirmed hazard.’ (Article 11-2 of the proposed amendment to the K-REACH Enforcement Rules). Furthemore, when transferring ‘substance with unconfirmed hazard,’ relevant information must be provided to the downstream user (Article 29, Paragraph 1 of the K-REACH; Articles 35 and 37 of the proposed amendment to the K-REACH Enforcement Rules). |
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| Expanded Scope of Information Disclosure |
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Pursuant to the amendment to Article 42 of K-REACH, more information on registered or declared chemical substances — such as the name of the chemical substance and its hazard characteristics — will be made publicly available. In particular, for declared non phase-in chemical substances, the name and identification number of the chemical substance, the purpose of use according to the chemical substance’s use classification system, the classification and labeling of the chemical substance, and the reason for preparation must be disclosed (Article 42, Paragraph 1, Item 1 of the amended K-REACH; Article 51 of the proposed amendment to the K-REACH Enforcement Rules). |
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In addition, if a person possesses data with higher reliability than the publicly disclosed hazard information, such a person may request a correction or supplementation of the disclosed information to reflect the more reliable data (Article 51-2 of the proposed amendment to the K-REACH Enforcement Rules). |
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| The proposed amendments explained in this newsletter will become finalized and effective as of August 7, 2025. The details may be subject to change in the meantime, and we will keep you informed in case of any changes. |
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This legal update is provided for general informational purposes only and should not be considered a legal opinion of KIM & CHANG nor relied upon in lieu of specific advice. Recipients of this publication, whether clients or otherwise, should not act or refrain from acting on the basis of any information included in this publication without seeking appropriate legal or other professional advice.
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