by June Kang
On May 30, 2018, South Korea’s Ministry of Environment (MOE) proposed amendments to the Decree and Regulation of K-REACH (known formally as the Act on the Registration and Evaluation of Chemicals). This is a result of the amendments to K-REACH announced earlier this year and establishes the details necessary to legally enforce the amended Act.
As stipulated in the amended Act, the registration of hazard data for all the existing chemical substances (listed in Korea Existing Chemicals Inventory, KECI) manufactured or imported in quantities of 1 tonne/year or more will be required by 2030. This will acquire hazard information of chemical substances and tighten control of chemicals in circulation.
The registration will be enforced in stages and the grace period for each stage is based on the volume and hazard. The deadlines are as follows:
- June 30, 2018 – 510 substances as scheduled under current K-REACH
- 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 will also be authorized to designate any chemical substances having potential adverse effect to public health as subject to registration, even when used in low volume. Hazard and risk level will be considered to designate the substances subject to registration. The detailed criteria in volumes for substances with potential to be designated as substances subject to registration are shown in the table below.
|Category||Per Business||Total production in Korea (manufactured and imported)|
|New substance||0.1 tonne/year or more||Exceed 1 tonne/year|
|Existing Substance||1 tonne/year or more||Exceed 10 tonne/year|
To minimize burden on industry, the number of required test data will be reduced to a minimum of 15 for the substances not classified as hazardous in accordance with GHS (Globally Harmonized System of classification and labeling of chemicals, UN), while a maximum of 47 test data would be required for a full registration. However, the MOE may order the submission of additional test data, if necessary.
In addition, data requirements for registration of transported isolated intermediates* will be reduced or simplified if all of the intermediate is consumed during chemical processing and consumers are not exposed. Test data will be exempted for a transported isolated intermediate in a volume less than 1000 tonnes and only 15 types of test data will be required for the volume of 1000 tonnes or more.
Under the current regulation, it is mandated to provide chemical and hazard information of designated hazardous substances only. After the amendments, any substances posing any hazard including carcinogenicity, mutagenicity or reproduction toxicity will be required to provide the name, composition and hazard labelling and classifications to the recipients or buyers. In order not to disclose chemical information, a prior approval must be obtained from MOE. The review and processing period will take 60 days.
The public comment period closed July 9, 2018.
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*A transported isolated intermediate is a substance manufactured for or used for chemical processing in order to be transformed into another substance, the synthesis of which is transported between or supplied to other sites.
References (in Korean only):
- [MOE Press Release] Implementation of Prior Approval System for Biocides and Securement of Hazard Information of Chemicals; [보도자료] 살생물제 사전승인제 도입하고 모든 화학물질 정보 확보
- The draft of amendments to the Decree of the Act on the Registration and Evaluation of Chemicals (MOE’s Public Announcement No. 2018-0426); 화학물질의 등록 및 평가 등에 관한 법률 시행령 일부개정령(안) 입법예고 (환경부 공고 2018-0426 호)
- The draft of amendments to the Regulation of the Act on the Registration and Evaluation of Chemicals (MOE’s Public Announcement No. 2018-0427); 화학물질의 등록 및 평가 등에 관한 법률 시행규칙 일부개정규칙(안) 입법예고 (환경부 공고 2018-0247)
Ministry of Environment (MOE)
Act on the Registration and Evaluation of Chemicals