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On 30 Oct 2015, the revised Ministerial Decree (also known as the Enforcement Rules) under the Act on Registration and Evaluation of Chemical Substances (K-REACH) was published and came into force immediately.
The Ministerial Decree was officially published on 24 Dec 2014 specifying the registration requirements and any possible registration exemptions, etc. The revised draft was issued on 10 Jul 2015 for public consultation until 20 Aug (CL news). After months, the final revised version came out.
Compared to the previous version, major changes are made as below:
Previous version | Revised version | |
| Reduce documentation and data submission requirements for new chemical substances manufactured or imported in less than 1t/y (from 2020 the volume should be less than 0.1 t/y) | Required to submit "exposure information related to the use of the newchemical substances" | Delete |
Reduce documentation and data submission requirements for the “application for registration exemption confirmation” of substances used for R&D purpose | Required to submit: (1)general information (2)safety management plan, (3)post-management plan, (4)transferring plan | ⦁ Requirements integrated ⦁ Post-treatment result report can be omitted if the substance is manufactured/imported below 0.1 ton each time |
Change period for registration exemption application for a reagent used for scientific study, analysis or research | Every year | Only once |
Change the procedure for appointing a lead registrant | Majority vote | Voluntary negotiation |
Improve Annual reporting | Importer should report substance name and volume, etc. | Non-Korean manufacturers can report the items regarding substance name and volume, etc. instead of importer |
Change the appointment and dismissal procedures of ORs | Submit formal POA and dismissal letter when changing OR | Submit one amendment report is enough |
Product name should be used in the OR application form | Product name can be used instead of chemical name in the OR application form | |
Delete duplicated item | Duplicated item of “Exposure information” in application form for a simplified registration | Delete |
Duplicated item of “Import volume” in reporting and registration forms |
