By Johnny Andon, Global Regulatory Affairs Manager
New Requirements in South Korea
South Korea has updated their GHS regulation MoEL 2016-19 to the new MoEL Notice No. 2020-130 which entered into force on January 16, 2021. Primarily, these changes affect the process of claiming CBI for products and also introduce a new component of having to submit SDSs to the MoEL agency prior to importing. As an importer of products into South Korea, you will have to comply with the requirements of this new regulation effective immediately.
One of the new requirements is for first-time importers of a product to submit the corresponding product SDS to the South Korean Ministry of Employment and Labor (MoEL) prior to import into South Korea. If approved, the South Korean agency will then assign a number to the SDS which must be added to Section 1 of the SDS for that product being imported into South Korea.
Grace Period Deadlines
However, there are grace periods if the product in question has already been in the South Korean market and an SDS has been created in accordance with the old standard. Only these products in the market before the new regulation came into force are afforded the grace periods. All new products on the market must immediately comply with the new regulation. The grace periods are dependent on the tonnage of the product being imported.
- For products >= 1,000 tons, the grace period is until 01/16/2022
- For products between 100 and 1,000 tons, the grace period is until 01/16/2023
- For products between 10 and 100 tons, the grace period is until 01/16/2024
- For products between 1 and 10 tons, the grace period is until 01/16/2025
- For products <1 ton, the grace period is until 01/16/2026
Implications for Manufacturers & Importers
This SDS submission process requires an Only Representative (OR) to be designated in South Korea for a foreign manufacturer. Only a local representative can process the SDS submission to the South Korean MoEL. The drafting of the SDS, however, can still be done outside of South Korea by the Manufacturer, Importer, or 3rd party.
Included in the MoEL No. 2020-130 is also a change to the process to claim Confidential Business Information (CBI) on an SDS. Masking a hazardous ingredient name with a Generic Name and using an expanded concentration range will now require a CBI application which can only be processed by a South Korean OR. Manufacturers should be made aware that the claims for CBI will need to be substantiated by providing the business, economic, or other applicable reasons. And only if the claim is approved can the ingredients/formula use a generic name or expanded concentration. Otherwise, all hazardous substances shall be fully disclosed on the SDSs.
GSM is committed to helping Manufactures/Importers by authoring future SDSs for South Korea. Please contact GSM to find out more.