South Korea New Requirements for (M)SDS Submission and CBI Application Takes Effect

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Ministry of Employment and Labor has modified the Occupational Safety and Health Act in 2019. Under the Amended OSHA, the requirements regarding (Material) Safety Data Sheet/ (M)SDS is implemented from 16 Jan. 2021. 

The amended regulation applies to manufacturers and importers of hazardous chemicals based in Korea. Related enterprises should submit the (M)SDS to MoEL before manufacturing or importing.

There is a transitional period for enterprises that previously prepared an SDS in accordance with Article 41(1) or (6) of the former K-OSHA Act. Those meeting the exception may submit the SDS to MoEL within specified deadlines based on manufacture or importation volumes as noted below:

1. ≥ 1000tpa, before 16 Jan. 2022;

2.  100-1000tpa, before 16 Jan. 2023;

3.  10-100tpa, before 16 Jan. 2024;

4. 1-10tpa, before 16 Jan. 2025;

5. Less than 1tpa, before 16 Jan. 2026;

Manufacturers of hazardous chemicals based outside of South Korea may entrust an Only Representative (OR) based in Korea to submit the (M)SDS. (M)SDS shall be submitted through the official online IT system. There are 3 options:

  • Submit (M)SDS specifying 100% composition information (no matter the chemical ingredients are hazardous or non-hazardous);
  • Only submit (M)SDS specifying hazardous ingredients and a separate document providing information of other ingredients will also be submitted to MoEL together with the (M)SDS; and
  • Only submit (M)SDS specifying hazardous ingredients and a statement signed by foreign companies saying that all the non-disclosed ingredients are non-hazardous substances will also be submitted to MoEL along with the (M)SDS. This option is for imported products only.

After submitting the (M)SDS, related enterprises will receive a serial number issued by MoEL. The number shall be written on the upper side of front page on the (M)SDS. If information in the (M)SDS is altered, then related enterprises must submit the updated (M)SDS to MoEL as soon as possible.

In principle, manufacturers of non-hazardous ingredients based outside of South Korea do not need to provide (M)SDS. They can appoint an OR based in South Korea to submit full ingredients list instead of the (M)SDS.

Chemicals subject to other regulations in South Korea do not need to submit (M)SDS. For instance, health functional food as defined in the Health Functional Foods Act, source materials as defined in the Act on Protective Action Guidelines against Radiation in the Natural Environment, household chemical products and biocidal products subject to safety confirmation and that are available for regular and daily consumer use as defined in the Act on Safety Management of Household Chemical Products and Biocides, medical devices as defined in the Medical Device Act, etc.  

CBI Protection is also clearly regulated in the Amended OSHA. Manufacturers and importers based in South Korea shall submit application for CBI Protection to MoEL and manufacturers based outside of South Korea may entrust a qualified OR to submit the application. But it is worth mentioning that enterprises cannot apply for CBI Protection for substances that are prohibited in South Korea, restricted substances, hazardous substances under control, CMR substances, etc.  

Information required for CBI Protection Application includes:

  • Applicant information;
  • Reason for CBI Protection;
  • Hazardous classification of the chemical products and the ingredients;

After the application for CBI Protection is approved, MoEL will issue an authorization number to the applicant. Applicant shall fill it in Part 3 of the (M)SDS. The validity period for CBI Protection is 5 years and enterprises may apply for extension of the validity period. Substances that have registered under K-REACH and passed the CBI assessment do not need to apply for CBI Protection under OSHA.

Under the amended OSHA, if enterprises that manufacture or import hazardous chemicals fail to submit (M)SDS, or provide false information when submitting (M)SDS and applying for CBI Protection, a fine of less than KRW 5 million will be imposed on them.

CIRS warmly reminds that if enterprises intend to export hazardous chemicals to South Korea, they shall prepare a compliant (M)SDS in advance.

If you have any needs or questions, please contact us at service@cirs-reach.com.