News Details

The National Institute of Chemical Safety (NICS) has published a draft administrative notice proposing a partial amendment to the “Hazard Assessment Results of Chemical Substances” under the Act on the Registration and Evaluation of Chemical Substances (K-REACH). 

The proposed amendment reflects newly completed hazard assessments, revisions based on supplementary data, and the disclosure of previously confidential substance identities following the expiration of data protection periods. 

1. Background and Purpose of the Amendment 

Pursuant to Articles 18 and 21 of the Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH), chemical substances that have completed registration are subject to hazard assessment. 

Following completion of such assessment, the competent authority is required to: 

• Notify the registrant of the assessment results; and 

• Publicly disclose the substance name and relevant hazard information. 

This proposed amendment aims to formally publish updated hazard assessment outcomes and related revisions, thereby enhancing regulatory transparency and consistency in public disclosure. 

2. Key Revisions and Regulatory Updates 

A. Publication of Hazard Assessment Results for Registered Substances 

• Addition of 56 existing substances for which hazard assessment was completed between June and August 2025. 

• Reflected in Appendix 2 (Existing Substances), Serial Nos. 2026-715 through 2026-770. 

B. Revision of Five Existing Substances 

• Amendments based on newly obtained supplementary data. 

• Hazard determinations and related regulatory conclusions have been updated accordingly. 

C. Disclosure of Assessment Details 

For substances with completed hazard assessments, the notice discloses: 

• Chemical name and CAS number; 

• Whether the substance is classified as hazardous to human health or the environment under applicable standards; and 

• Principal hazard characteristics. 

This supports improved clarity in classification and labeling alignment. 

D. Public Disclosure Following Expiration of Data Protection 

A total of 69 substances are addressed in this amendment: 

• 67 new chemical substances previously published under generic names (“[generic name]”) will now have their full chemical identities disclosed, including CAS numbers, following expiration of the 2024 data protection period. 

• 2 substances previously duplicated in earlier notices (Serial Nos. 2018-384 and 2019-530) have been corrected. 

• Where identical substances exist across notices, a single consolidated entry will be maintained. Cross-references (“identical to Serial No. ___”) will be included to allow verification of hazard classification and related information. 

3. Regulatory Impact 

This proposed amendment is expected to enhance: 

• Transparency of hazard assessment outcomes; 

• Public access to verified substance identity information; 

• Consistency in hazard classification and labeling references; and 

• Accuracy of the officially published hazard assessment list. 

Companies manufacturing or importing affected substances should assess whether the updated hazard determinations require: 

• Revisions to Safety Data Sheets (SDS) 

• Updates to classification or labeling 

• Adjustments to risk communication measures 

• Downstream supply chain notifications.