by June Kang
At the end of December 2018, South Korea’s Ministry of Environment (MOE) announced amendments to the Decree and Regulation of K-REACH (known formally as the Act on the Registration and Evaluation of Chemicals). These amendments took effect on January 1, 2019. They are a result of the K-REACH amendments announced in October 2018 and establish the details necessary to legally enforce the amended Act.
The major amendments are highlighted below.
- Registration is mandatory for all new chemical substances that are manufactured or imported at 0.1 metric ton or more per year (Article 10 of the Act).
- Notification is required prior to manufacture or import of less than 0.1 metric ton of new chemical substances per year.
- All existing chemical substances manufactured or imported at 1 metric ton or more per year are subject to registration by stage. A pre-registration must be completed by July 1, 2019 for the grace periods below to apply.
- The grace period for each stage is scheduled based on the volume and hazard. It is scheduled to complete registrations by 2030.
∙ December 31, 2021 – CMR substances (carcinogenic, mutagenic or toxic for reproduction) manufactured or imported 1 tonne/year or more and existing substances manufactured or imported 1000 tonne/year or more (approximately 1100 substances)
∙ December 31, 2024 – Existing substances manufactured or imported 100 tonne/year or more (approximately 1100 substances)
∙ December 31, 2027 – Existing substances manufactured or imported 10 tonne/year or more (approximately 2000 substances)
∙ December 31, 2030 – Existing substances manufactured or imported 1 tonne/year or more (approximately 2300 substances
- MOE Notification No. 2018-232 designated 364 existing substances that cause or may cause a CMR-related disorder. As noted above, manufacturers and importers of these substances (≥ 1 metric ton/year) must complete registration by December 31, 2021.
- MOE Notification No. 2018-233 designated 672 Priority Control Substances. Under the amendment, manufacturers and importers of any product containing PCS (> 0.1% and > 1 metric tonne/year) that can be released into the environment must notify MOE prior to manufacture or import.
- Polymer compounds are subject to notification, except for polymers exempted as low-concerned under the Act.
- Provisions of Risk-Concerned Products under K-REACH have been moved to the Safety Control Act of Household Chemical Products and Biocidal Products, also known as K-BPR.
- Approval is required from the MOE when claiming substance information as CBI on the (M)SDS for substances are classified as hazardous.
- The administrative process for data protection has been improved for industry.
- Data requirements have been reduced for the substances not classified as hazardous in accordance with GHS. Non-hazardous substances may require as few as 15 test results rather than all 47.
References (in Korean only):
[MOE Press Release] Prior Approval System for Biocides and Mandatory Registration System for Chemicals Substances Circulated in Korea, announced on December 28, 2018; [보도자료] 살생물제 사전승인, 국내 유통물질 등록 제도 시행 (2018년 12 월 28일자 보도)
The Decree of the Act on the Registration and Evaluation of Chemicals announced on December 24, 2018 as Presidential Decree No. 29413; 화학물질의 등록 및 평가 등에 관한 법률 시행령 (대통령령 제29413호, 2018. 12. 24., 일부개정)
The Regulation of the Act on the Registration and Evaluation of Chemicals announced on December 28, 2018 as MOE Ordinance No. 790; 화학물질의 등록 및 평가 등에 관한 법률 시행규칙 (환경부령 제790호, 2018. 12. 28., 일부개정)
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Ministry of Environment (MOE)
Act on the Registration and Evaluation of Chemicals
Chemical Substance Registration