On 1 August 2022, South Korea published the revised K-REACH implementation rules. The revised rules ease the exemption requirements for new chemical substances with an annual import volume of less than 0.1t/y for R&D purposes by exempting the specific name and CAS number of the chemical substances.
Previously, enterprises are required to provide detailed information, including the specific name and CAS number of the substance when applying for R&D exemption. However, under the revised rules, enterprises may not need to provide the specific name and CAS No. of the substances and submit a material safety data sheet (MSDS) instead, for purpose of protecting the confidential business information (CBI). CBI may be concealed, where
- names or CAS numbers cannot be provided by non-Korean manufacturers for the protection of commercial secrets;
- the imported volume does not exceed 0.1 tons; and
- the imported substances are non-hazardous.
Besides, to support the R&D exemption, the following documents must be provided:
- Evidence showing that the substances are used for R&D purposes;
- Letter of Confirmation (LoC, conformation of absence of hazardous substances) prepared by importers or overseas manufacturers under the requirements of Chemical Control Act (CCA); and
- MSDS prepared in accordance with the Korean Occupational, Safety and Health Act (KOSHA).
Enterprises that manufacture/import new chemical substances for R&D use in volumes of below 0.1 t/y can be exempted from K-REACH registration but they still need to submit an application for exemption. There is no doubt that the revised rules bring benefits to the R&D and chemical reagents enterprises by protecting their commercial confidentiality.
- Exemption Application
- K-REACH Registration
- SDS Authoring
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