Article

Korea Will Require Pre-Approval for Protection of CBI under K-OSHA Amendments

Posted on: July 21, 2020

by June Kang

Korean flagOn June 8, 2020, South Korea’s Ministry of Employment and Labor (MOEL) proposed amendments to the Standards for Classification and Labeling of Chemical Substances and Material Safety Data Sheets ((M)SDS and GHS Regulation). These proposed amendments were necessary as the amendments to some of the hazard communication aspects of the Occupational Safety and Health Act (K-OSHA) are scheduled to take effect on January 16, 2021.

The amendments to the (M)SDS and GHS Regulation were proposed to provide detailed criteria for the newly established pre-approval process for Confidential Business Information (CBI) protection for disclosure in (M)SDS’s and to improve the enforcement process.

The major proposed amendments scheduled to take effect on January 16, 2021 are as follows:

  • Substances excluded from the ability to disclose alternative information (Article 16)
  • More substances and criteria have been added to the substance(s) excluded from disclosing alternative information for CBI. Pre-approval from MOEL must be obtained in order to not disclose the composition or identities of chemical substances. Details are outlined in the following table:
Current Proposed Amendments
Substances excluded from CBI claim
  • Prohibited Harmful Substances under K-OSHA
  • Harmful Substances Requiring Permission under K-OSHA
  • Hazardous Substances Subject to Control under K-OSHA
  • Toxic Substances under CCA (Chemicals Control Act)
  • Prohibited Harmful Substances under K-OSHA
  • Harmful Substances Requiring Permission under K-OSHA
  • Hazardous Substances Subject to Control under K-OSHA
  • Harmful Agents Subject to Work Environment Monitoring under K-OSHA
  • Harmful Agents Subject to Workers Requiring Health Examination under K-OSHA
  • Designated hazardous substances or classified substances above the threshold limit under K-REACH
  • Criteria for approval to list alternative information (Article 17 and Annex 7)
  • Justification for alternative information: establishes the criteria for CBI and the criteria for proof that the substance should be considered a trade secret:
    • Non-public information;
    • Confidentiality;
    • Economic usefulness
  • Conformity of the alternative information: stipulates that the nomenclature of the ‘alternative name’ replacing the original name of chemicals and the scope of application of ‘alternative content’ to replace the original content:
    • Follows the MOE’s nomenclature for generic names;
    • Ranges of permitted contents: ±10% for substances contained at less than 25% and ±20% for substances contained at 25% or above
  • Adequacy of (M)SDS: Reviews items such as hazard and risk information, name and content of substance(s) and compliance of the applicable regulations:
    • When approved, alternative information is listed in Section 3, including the approval number and expiration date in the same section; the approval can be extended every 5 years
  • Definition of research and development (R&D) chemicals or chemical products (Article 19)
    • Substances or products used for scientific experiments, analysis or research, chemical (product) development, production process improvement and development, chemical application field testing, and pilot manufacturing (production)
  • Other matters to improve and complement to comply and enforce the regulation
    • Reflects the classifications and labelling criteria in accordance with UN GHS (Article 6, Article 6-2, Annex 1 and Annex 2);
    • Selects a specified use from the use classification systems in Annex 5 when submitting (M)SDS;
    • Allows one (M)SDS to be prepared when chemical substances such as perfumes and fragrances are limitedly added to multiple similar mixtures (Article 12)
    • Clarifies ambiguous provisions

Recommended Action Items:

  • Review the amendments which come into effect in January 2021 and start preparing for the changes.
  • Review CBI non-disclosure information to see how the amendments affect submission.
  • Review the amendments to GHS classifications, hazard statements, precautionary statements and additional requirements and start preparing for the changes.

 References (available in Korean only):

  • The draft of amendments to the Standards for Classification and Labeling of Chemical Substances and Material Safety Data Sheets announced on June 08, 2020: 「화학물질의 분류·표시 및 물질안전보건자료에 관한 기준」일부 개정

https://www.moel.go.kr/info/lawinfo/lawmaking/view.do?bbs_seq=20200600379

Keywords:

Korea, MOEL, Occupational Safety and Health Act (OSHA), K-OSHA, Industrial Safety and Health Act (ISHA), SDS, (M)SDS


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