Chemical Regulation Updates in Japan and South Korea

Japan Adds 164 General Chemical Substances

Recently, Japanese authorities added 164 substances to the General Chemical Substances List under the Chemical Substances Control Law (CSCL). The notices was issued by the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of the Environment (MOE) of Japan. This notice publishes the names of the 164 new chemical substances and their environmental and health impact assessments. These assessments particularly focus on the degradability and bioaccumulation of the chemicals, aiming to enhance protection for the environment and public health.

The newly announced chemicals are categorized based on their notification date, divided into those notified before and after April 1, 2011. Chemicals listed under the Newly Announced Chemical Substances (Notified after April 1, 2011) in the CSCL are those notified, newly manufactured, or imported into Japan after this date, and are jointly regulated by the three departments. These substances are classified as general chemical substances, which include all chemicals except priority assessment chemical substances, monitoring chemical substances, Class I specified chemical substances, and Class II specified chemical substances. Companies manufacturing or importing these chemicals in quantities of 1 ton or more per year are required to submit annual reports.

The notice highlights three substances designated as specific general chemicals, indicating that these substances could have significant adverse effects on human health or the ecological environment under continuous intake or exposure. These three substances include:

• (eta(5)-cyclopentadienido)tris(n-methylmethanaminido-kappaN)zirconium;

• 2-(4-aminophenyl)-1,3-benzoxazol-5-amine;

• reaction products of hydrogen peroxide and 1,4-bis{[(prop-2-en-1-yl)oxy]methyl}cyclohexane, which consists of 80% or more of 2,2'-[cyclohexane-1,4-diylbis(methyleneoxymethylene)]bis(oxirane).

South Korea Releases Hazard Assessment Results for 91 Chemicals and Revises Announced Results for 27 Substances

On August 27, 2024, the National Institute of Chemical Safety (NICS) of South Korea released Notice No. 2024-70, with a draft revision of the Results of the Hazard Assessment of Chemical Substances. This revision, based on the Act on the Registration and Evaluation of Chemicals (K-REACH), aims to disclose the names, hazards, and toxicity status of registered chemicals following their hazard assessment, and to solicit public comments.

This revision releases the hazard assessment results for 91 registered chemicals, including 32 new chemicals (Nos. 2024-38 to 2024-69) and 59 existing chemicals (Nos. 2024-463 to 2024-521). These results specify each chemical's name, CAS number, toxicity status, and primary hazards, such as environmental and human health risks.

Additionally, NICS revised the announced assessment results for 27 chemicals. Of these, revisions for 25 new chemicals involved updates related to toxicity, chemical names, and hazard information. Revisions for the two existing chemicals included updates to hazard information (No. 2020-033) and corrections of chemical misrecords (No. 2022-234).

NICS calls for public comments on this draft revision from individuals, institutions, and organizations by September 19, 2024. This administrative preview is important towards transparency in chemical management in South Korea, aimed at further strengthening the safety management of chemicals to protect public health and environmental safety.

Further Information

METI

NICS