Chemical Regulation Updates in Japan and South Korea

Japan Adds 164 General Chemical Substances

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 jointly released an important notification under the Chemical Substances Control Law (CSCL) recently. The names of 164 new chemicals are published in this notice, together with an evaluation of their effects on the environment and human health. With the goal of improving protection for the environment and public health, these evaluations pay special attention to the chemicals’ accumulativity and degradability.

Based on when they were reported, the recently disclosed compounds are separated into groups: those notified before and after April 1, 2011. Chemicals announced, freshly made, or imported into Japan after this date are listed on the CSCL’s freshly Announced Chemical Substances (announced after April 1, 2011) list, which is jointly regulated by the three agencies. All chemicals with the exception of those included in priority assessment, monitoring, Class I and Class II defined, and other specific chemical substances are categorized as generic chemical substances. Annual reports must be submitted by businesses who import or manufacture these substances in quantities of one tonne or more annually.

The notification identifies three compounds as particular general chemicals, meaning that prolonged ingestion or exposure to these compounds may have substantial negative consequences on human health or the environment. 

Among these three substances are:

• (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 Updates Announced Results for 27 Substances and Releases Hazard Assessment Results for 91 Chemicals

Notice No. 2024-70, which provides an advance look at a draft modification of the Results of the Hazard Assessment of Chemical Substances, was issued on August 27, 2024 by the National Institute of Chemical Safety (NICS) of South Korea. The purpose of this amendment, which is based on the Act on the Registration and Evaluation of compounds (K-REACH), is to request public feedback and reveal the names, dangers, and toxicity status of compounds that have been registered after their hazard assessment.

The findings of the hazard assessments for 91 registered compounds are released in this edition. These include 59 existing chemicals (Nos. 2024-463 to 2024-521) and 32 new chemicals (Nos. 2024-38 to 2024-69). The names, CAS numbers, toxicity status, and main concerns to human and environmental health are all listed for each chemical in these findings.

NICS also updated the previously released evaluation findings for 27 substances. Of these, modifications to toxicity, chemical names, and hazard data were made for 25 new compounds. Updates to hazard information (No. 2020-033) and corrections to chemical misrecords (No. 2022-234) were among the revisions made for the two currently in use compounds.

NICS requests public feedback on this draft revision by September 19, 2024, from people, institutions, and organizations. With the goal of enhancing chemical safety management to safeguard human health and the environment, this administrative preview is crucial to the transparency of chemical management in South Korea.